July 31, 2003


Harvey Fierstein on the increase in HIV infected young gays

Please read this. Harvey has guts. He says what many of us believe. He has hit the nail on the head. The Culture of Disease

There are too many positive gay role models. In fighting the AIDS crisis over the last 20 years, we have done everything possible to dispel the negative connotations that come with having H.I.V. After all, it's been our brothers and sisters, our boyfriends and girlfriends, and ourselves who have been discriminated against because of a virus.

So we produced advertising, created enlightenment programs, spent endless hours making certain that having AIDS or being H.I.V. positive was nothing to be ashamed of. 1We did a great job. Maybe too great a job. After all the effort exerted to convince the world that AIDS is not a gay disease, we now have a generation embracing AIDS as its gay birthright.

According to figures just released by the Centers for Disease Control, the number of new AIDS cases rose last year for the first time in a decade. Four Americans now become infected with the disease every hour. Many of our young men see infection as a right of passage, an inevitable coming of age. I hear of them seeking the disease as entree into the cool, queer inner circle that being negative denies them.

...

I am calling for us to take back our lives and culture and to stop spreading the virus. I am calling for us to resist the normalization of disease and once again embrace health. I'm calling for an end to the false advertising for drugs and for us to stop minimizing the infection with cute little names like "the gift" or "the bug." I want to see an ad campaign showing a sexy man saying: I don't have H.I.V. I don't want to waste my life and resources on drugs. I am taking charge of my body, my health and my destiny. I am a negative gay role model.

Bravo Harvey!!!!!

Posted by at 04:10 PM | Comments (4) | TrackBack (0)





More on drug reimportation

I find Robert Prather one of the most compelling bloggers. Probably that stems from our very similar philosophy. I wrote to him, asking him to comment on yesterday's post concerning reimportation. Here is his post - Drug Reimportation And The Current Split Among Free-Marketeers. As I read his post, I believe that his main point stems from favoring a free market philosophy but not trusting other countries. His points are well made. I still believe that reimportation will move the market efficiently.

Maybe this is really the answer - Three Universities Join Researcher to Develop Drugs

But university officials say that system is breaking down as pharmaceutical companies and venture capitalists have become more averse to gambling on raw technology and more interested in drugs that have demonstrated at least some promise in a small clinical trial. That has left more promising ideas unable to pass through what some experts have called the "valley of death" between basic discovery and commercial development.

"We in the university are being deprived of a common way to develop technologies because we cannot form companies like we used to," said Joel B. Kirschbaum, director of the office of technology management at the University of California at San Francisco.

The universities say they do not plan to become drug companies. But by doing more of the basic work on drugs themselves ? like testing them for toxicity in animals ? they say they can then entice pharmaceutical companies. Moreover, they say, they will get a better deal because some of the risk has been taken out.

Whether the consortium will work is open to question. Under the deal, SRI International, which does contract research, will offer the universities up to 30 hours of free consulting for each project to develop a plan for how to test for toxicity, make the drug for clinical trials and other necessary steps. But the universities would still have to come up with the money for the tests, manufacturing or other tasks.

If this works, the straw man argument about investing in research may move towards moot.

Posted by at 11:58 AM | Comments (1) | TrackBack (0)





States's rights and marijuana

Politicians tend towards being despicable. One trick they use is to turn the other sides strategy on its head and throw it back. This strategy makes clear the inconsistency in politics. All politicians will use any argument that they think will work.

I like this trick, but that stems from agreeing with the proponents (o.k. I am a hypocrit sometimes). States' rights a solution to pot debate

Federal law should be changed: It makes no sense for marijuana to be a Schedule I substance under the federal Controlled Substance Act, which keeps doctors from recommending what they believe to be the right drugs. (I realize many doctors never would prescribe marijuana, but even they must agree that professionals of good will can have a different perspective on many drugs.)

To counter the federal act, medical-marijuana proponents have concentrated on the states. The courts have been clear about the federal law's power to trump state law. Hinchey-Rohrabacher was a way to fiddle with federal law in those states which have passed their own medical marijuana laws, rather than attempt to legalize it nationwide.

States' rights provide a good compromise. Let states decide what they want to do, then states on both sides of the issue can learn from the experience of others.

The Hinchey-Rohrabacher vote was instructive. Republicans -- like author Rep. Dana Rohrabacher, R-Huntington Beach -- are supposed to believe in states' rights. This time, however, most suddenly decided a centralized D.C.- based government knows best.

Democrats usually want Washington to tell locals how to live -- as in, Alaskans shouldn't get to choose to drill for more oil where they live. But, suddenly, many Democrats were enamored of states' rights.

OK, so neither party gets points for principled consistency. At least the House is moving in the right direction.

But if Walters and the feds choose to prosecute sick, needy people, and to go after the licenses of doctors who care for them, there could be a backlash.

In fact, there should be.

Stated beautifully. The Republicans are clearly wrong here. Too bad more Republicans are not libertarians also.

Posted by at 11:49 AM | Comments (2) | TrackBack (0)





Beware tetanus

Last year we had 2 cases of tetanus treated in our training program. This article gives an important reminder about keeping tetanus immunization up to date. Gardeners should get a tetanus booster

Gardeners are at a high risk of developing tetanus, according to public health authorities, and should make sure their booster shots are up to date.

Thirty-nine percent of the cases reported to the Centers for Disease Control and Prevention in 2001 were of people who contracted the serious disease from gardening and yard work. Two recent cases in Puerto Rico involved people who caught tetanus from splinters.

"We often think you only get tetanus if you step on a rusty nail," said Dot Richardson, an orthopedic surgeon in Clermont, Fla., who is trying to raise awareness of the issue on behalf of the National Foundation for Infectious Diseases.

A deep wound is more likely to lead to tetanus, but any injury that breaks the skin can allow the pathogen to enter the body.

The disease is caused by a bacterium that is commonly found in dirt or on plants. Once the skin is compromised, even by an insect bite, the pathogen can be rubbed into it later by an unsuspecting gardener, Richardson said.

Once inside the body, she said, the bacterium's spores release a toxin that causes the muscles to seize violently. A victim typically spends four to six weeks in intensive care; 10 to 20 percent of them die.

Posted by at 11:40 AM | Comments (0) | TrackBack (0)





July 30, 2003


The National Review reports and you decide - in favor of drug reimportation!

Conservative Drug Split

The prescription-drug-reimportation bill the House passed in the wee hours last Friday morning, by a vote of 243 to 186, was widely opposed by the thoughtful Right ? folks at AEI, CEI, the Heritage Foundation, the Manhattan Institute, Americans for Tax Reform, the Club for Growth, the Wall Street Journal, the Washington Times, even Cato's own Doug Bandow in last Thursday's NRO. When we saw, however, that principled members of the House like Jeff Flake (R., Ariz.) and Pat Toomey (R., Penn.) were on the other side, we thought we'd take a closer look. It turns out that this really is one of those issues that's as simple as it seems ? free trade is the answer ? although it's easy to be distracted by the complications that surround it. And that, unfortunately, appears to be what's happened to many of our friends and colleagues.

Nuances in the bill aside, its effect would be to allow prescription drugs ? most of them developed and manufactured in America, but available far more cheaply abroad ? to be reimported into this country at those much lower prices. To be sure, many in Congress who supported the bill did so on crass political or anti-corporate grounds: drugs cost too much; drug companies are gouging the public, as is evidenced by prices abroad; let's drive domestic prices down, and cut government outlays in the process, by letting Americans buy from abroad. "The issue is price," said Rep. Rosa DeLauro (D., Conn.). "It is time that this Congress stop acting as a wholly owned subsidiary of the pharmaceutical companies and step up to its responsibility to the consumers of this nation." Motives aside, that's an easy target for those who understand FDA regulations on drug research and development; the extraordinary upfront costs of R&D; the need for drug patents to encourage R&D; and socialized national medical systems abroad.

Because our drug market, burdened as it is with regulations and cost controls, is still free relative to such systems, America's drug companies, which do most of the world's drug research and development, recoup most of their costs, including R&D costs, in the domestic market, then sell abroad at prices far below true costs. Foreigners are thus classic free riders. As with defense, Americans are underwriting a good part of the health-care costs of the rest of the world. But if we allow those below-true-cost drugs to be reimported, critics say, there goes the R&D and all the wonder drugs of recent years. As AEI's John Calfee put it in a July 14 piece aptly titled "The High Price of Cheap Drugs," "reimportation would mean importing foreign price controls, which would destroy the pricing structure of the U.S. drug market and have disastrous consequences for future drug research and development."

Those are powerful arguments ? until you stop to think about them, as Rep. Pat Toomey did in a July 17 "Dear Colleague" letter, one paragraph of which goes to the heart of the matter:

Specifically, dropping trade barriers and freeing U.S. consumers to purchase drugs at far lower prices overseas would significantly threaten the profit margins of the pharmaceutical companies. These companies would be forced to present the price-setting countries with an ultimatum: Either liberalize your market or we will leave. It's hard to imagine that countries in this situation will deny their citizens access to life-saving drugs. Instead, they will most likely ease their controls and increase the price they are willing to pay for their drugs.

Toomey goes on say that if free trade were not reason enough to support the bill before the House, then the destruction of price controls should be. In short, reimportation is both right and good.

These paragraphs just introduce a very careful and thorough analysis of this complex issue. As a libertarian, I agree with this essay. The authors (from the Cato institute) have worked through the pros and cons nicely. I believe that careful reading (which will take around 15 minutes) is worth your time. They conclude with this thoughtful paragraph.

In a nutshell, if foreign governments want to pay less ? and will not pay more even if it means their own citizens will go without better drugs ? then let those governments police the no-resell terms that enable them to get the lower prices. Right now, not only do Americans pay higher prices because foreigners refuse to pay the actual costs of drugs, but they pay the enforcement costs of that arrangement as well, including restrictions on their freedom. And if foreign governments cannot police those discriminatory contracts ? because the incentive to resell, on one side, and to buy more cheaply, on the other side, makes enforcement difficult or impossible ? then let a truly free market, encumbered only by enforceable contracts in restraint of trade, set prices at whatever the market will bear. It is neither right nor good that Americans bear so great a portion of the health-care costs of the world.

This article has tipped the balance. I am no longer confused over this issue. I clearly favor drug reimportation!

Posted by at 08:09 AM | Comments (3) | TrackBack (1)





Race, ethnicity and medical research

I tread lightly today. Yet I must address this question. How should we include data on race in medical decision making? First, we must read what others have written. Race Plays Role in New Drug Trials

As more new drugs are made to attack disease based on their genetic origins, doctors are divided over whether race or ethnicity should play a role in treatment decisions. And, if so, there is this practical question: In a world of mixed heritages, how does a doctor even determine a person's race?

"The more we learn about how drugs work the more we see a genetic component and the race question is among the biggest mysteries," said Hilliard, who has been practicing cardiology for nearly three decades.

The notion of race was advanced centuries ago as a method of social and political grouping when new transportation methods allowed people from far-flung parts of the world to regularly interact with each other. The divisions often were drawn by the superficial: skin and hair color, shape of the eye.

However, recent advances in genetic mapping have all but dismissed race as a biological construct. Race accounts for only a tiny amount of the 0.1 percent genetic variation between one human and other. That means that someone who is considered black, for instance, might have more genes in common with someone who is white rather than someone who is also black.

Yet, on the other hand, science also has shown that certain groups share inherited traits, and often similar ailments.

Well that certainly makes things perfectly opaque. We have many studies which examine how we provide differing quality of care based on the sociologic construct of race (that is actually easy - if the patient declares themselves a race we assume that true). We also have looked at how patients of different sociologic race respond to different medications (many physicians believe that calcium channel blockers work better in those of African-American descent). But the genetic construct alluded to above should make us more confused.

Don't Base Drug Policy on Race, Geneticists Say

Health officials may be wrong in attempts to match health care and especially drugs with race, because genetically there is no such thing, gene experts said on Thursday.

It would be better to go straight to a more personalized approach to medicine, gene pioneer Craig Venter and colleague Susanne Haga said.

"It is what I call race-based medicine," Venter said in a telephone interview.

They praised the U.S. Food And Drug Administration (news - web sites) for trying to formulate guidance that would take genetics into account when testing drugs, but said using simple notions of race was not the way to go.

"They should be applauded for trying to go beyond white males," Venter, who led one team that sequenced the human genome (news - web sites), said in a telephone interview.

"But our argument is they are not going far enough in that direction."

Venter, who now heads the nonprofit Center for the Advancement of Genomics in Rockville, Maryland, has long argued that genetics do not support social and cultural ideas of race.

Several teams of scientists have found that there are more genetic differences among Africans from different regions, for example, than there are between Africans and Europeans.

I hope you are just as confused as me at this point. Genetics clearly might matter. Our perception of race may or may not predict genetics. I find it unlikely that perceived race will have enough prediction of other genetics to make it a worthwhile construct for picking drugs. We need to move (as the article suggests) to explicit genetic evaluation for drug selection. That would represent a true advance.

Posted by at 07:56 AM | Comments (0) | TrackBack (0)





The NY Times reports - you decide - on big pharmacy and drug reimportation

Drug Lobby Pushed Letter by Senators on Medicare

When the House voted last week to let Americans import less expensive medicines from Canada and Europe, 53 senators signed a letter opposing the legislation, a letter that the industry trade group, which vigorously opposed the measure, hailed as proof of its argument that the bill would jeopardize patient safety.

What the trade group, the Pharmaceutical Research and Manufacturers Association, did not say, at the time, was that it helped coordinate the signature campaign.

The Senate "Dear Colleague" letter, timed to coincide with passage of the House bill, will have an important role in whether the import measure survives a conference with the Senate on a larger drug benefits package. Several conferees, including Senators Orrin G. Hatch of Utah and Don Nickles of Oklahoma, both Republicans, are among the signers.

The trade group's involvement in gathering signatures, detailed in a document obtained by The Times, is not a surprise. It offers a glimpse into the aggressive efforts by the pharmaceutical manufacturers to defeat the import provision. That section would require the Food and Drug Administration to create a system for consumers, pharmacists and wholesalers to import less expensive drugs from Canada and Europe.

I need not comment - but maybe you will!

Posted by at 07:40 AM | Comments (2) | TrackBack (0)





July 29, 2003


GAO on the cost of malpractice insurance

I will quote this entire AP piece (which was sent to me)

Report: Legal losses spurred hike in medical malpractice insurance rates

Associated Press

July 29, 2003

By Lara Jakes Jordan

Increases in medical malpractice insurance rates in some states, including Pennsylvania, were due largely to high payoffs on legal claims, according to a congressional survey released Monday.

In Pennsylvania, insurers faced a 70.9 percent increase in successful malpractice claims against doctors and other medical providers between 1998 and 2001, according to the U.S. General Accounting Office, the investigative arm of Congress.

"Losses on medical malpractice claims appear to be the primary driver of increased premium rates in the long term," the report stated. "Such losses are by far the largest component of insurer costs."

But the report, which surveyed rates in seven states, noted that the increases varied greatly from state to state and across medical specialties. General surgeons in Florida, for example, faced a 75 percent rate increase between 1999 and 2002, but rates increased only 2 percent in Minnesota during the same period.

Pennsylvania is one of a dozen states in the country that does not cap the payout in jury awards for victims of medical malpractice seeking non-economic, or pain and suffering, damages. The U.S. House this year passed legislation, endorsed by the White House, to cap non-economic jury awards at $250,000. But Senate Democrats killed the bill, maintaining that men, women and children who were grievously injured through medical errors should be entitled to seek the damages.

Close to 1,000 Pennsylvania doctors have left the state in recent years, in large part to avoid paying the skyrocketing costs of malpractice insurance policies, according to the Pennsylvania Medical Society.

The GAO report found that insurance rates for obstetricians and gynecologists in Pennsylvania increased by 165 percent between 1999 and 2002, compared to 9 percent for their California counterparts. California law caps non-economic jury awards.

Insurance rates for Pennsylvania surgeons and internal medicine doctors both increased by 130 percent between 1999 and 2002, the report showed.

The report examined medical malpractice insurance rates in California, Florida, Minnesota, Mississippi, Nevada, Pennsylvania and Texas.

For those who care - the GAO report in full - GAO on Medical Malpractice Insurance

Posted by at 11:26 AM | Comments (3) | TrackBack (0)





Berwick on safety

I have known Don Berwick for over 20 years. He is bright and charismatic. His deep seated interest in improving quality of care combined with a captivating ability to communicate has made him a major leader in health care policy. He has an op-ed in today's Washington Post - Invisible Injuries

The Institute of Medicine, our nation's most respected adviser on medical science, says that at least 100 patients will die in hospitals in the United States today because of injuries from their care, not from their diseases.

How many will die tomorrow?

Tom Nolan, one of the leading quality-improvement scholars of our time, identifies three essential preconditions for improvement of anything: will, ideas and execution. When it comes to reducing medical errors, America's will and ideas are increasing steadily now, following the Institute of Medicine's lead.

And yet, so far I see no evidence that health care in the United States is becoming safer. The ingredient we seem to be missing most is the third one on Nolan's list: execution. Who will change the care? And when? At least four major roadblocks appear to lie between will and ideas, on the one hand, and execution, on the other.

Whoa!! Slow down Don. This op-ed starts with an assumption - that the IOM has correctly estimated the number of deaths caused by errors. Almost all experts who have reviewed this report argue that the number is markedly too high. The number is important, as it informs public perception of hospital care. It obviously informs Don Berwick's perception.

Rather than fanning the flames, I would prefer a careful analysis of what errors happen most commonly, and how do we avoid them. This seemingly simple goal actually has such complexity that we will probably continue arguing about errors rather than preventing errors.

As a physician who spends almost half the year as a ward attending in a VA hospital, I see errors every day. We see errors of omission and errors of commision. The laboratory makes errors; the nursing staff makes errors; the pharmacy makes errors; we physicians make errors. Unlike many hospitals, we can tell when we make errors more easily because we do have an outstanding computerized medical record.

Over the past few weeks we have seen laboratory tests not collected, or collected and not performed. We have seen radiologic reports not filed for weeks at a time. We see medications not given, or not delivered. We are generally understaffed for the actuity of our patients.

At the risk of being chauvinistic, we need clinical physician leadership here. We are the coordinators of care. We must make the diagnoses and develop the management plans. However, we have little ability to insure that the other services (pharmacy, nursing, radiology, laboratory, dietary) have sufficient staff and sufficient accountability.

I would agree with Don Berwick that we must reorganize medical care. Clinicians should once again have an influence on who hospitals run. Administrators have (in my opinion) too much concern for the bottom line, and not enough for quality of care. Until they who run hospitals have care as a true priority we will see errors.

All that being said, few errors are major. I do not believe the IOM numbers. I do believe that we should strive to improve care. Physicians must lead the way. If they would only let us. (Damn that sounds whiny - I better think through this better, we should not let the current systems keep us from succeding). Berwick does hit the nail on the head:

Third, improving safety costs money in the short term -- money for technical changes, such as new equipment, computerization and the redesigning of jobs, and money for cultural improvements, such as new training and support for better teamwork among doctors and nurses. Today's stressed hospital executives often feel that they cannot afford to make these investments. A distant hope for long-term returns or vague calculations about how much patient injuries are costing today don't often seem to carry the day in hospitals and clinics facing large and immediate financial losses.

Posted by at 08:46 AM | Comments (1) | TrackBack (0)





July 28, 2003


More on work hours

Go read what a surgeon has to say here - WORK HOUR LIMITS: HOW RESDIENTS FEEL and here - THE NEW 80-HOUR WORK WEEK.

Posted by at 08:26 PM | Comments (0) | TrackBack (0)





More on resident work hours

First, let me contrast two letters. The first is published in today's AMA news.

Resident work hour limits are compromising patient safety

Regarding "Resident hour limits may hit attendings" (AMNews, July 7): Of course attendings will be working longer hours to perform the work that residents no longer do. PA or nurse physician extenders cannot fill the role of upper-level supervision and experienced medical judgment that is now missing with diminished senior and chief resident clinical participation.

After a full year's experience with the 80-hour limit to surgical residents' week, I can confirm that if I don't perform the work residents can't complete, no one else does -- with the consequence that patient safety is directly compromised. Concrete examples include my need to perform even the most primary data collection regarding vital signs, intake and output records, verifying medications administered and primarily reviewing x-ray findings at morning rounds, since residents no longer have the time to perform pre-rounds.

While I have always reviewed this information, now I frequently have to collect it too, spending the time to track down the wandering nursing records, med lists, etc. And if I don't directly enforce a meticulous review of the medication changes and interventions performed by the evening-covering housestaff, they may be otherwise transparent to the "day" crew.

Communication of all these little details is rarely completed during "signout" when "call" residents are under pressure to leave promptly.

Lacking the time to examine patients, resident failures to recognize serious postoperative wound infections or to perform adequate wound care have also worsened substantially. How can a housestaff team be expected to determine whether cellulitis is improving or worsening if the same individual does not examine the patient on consecutive days?


My morning rounds now routinely last 30% to 50% longer than in previous years, forcing me to schedule fewer patients in clinic or the operating room.

Even minor calls from the evening "cross cover" resident (who often has no idea about the patient's disease process or hospital course) require my fullest attention (even if I have been deeply asleep) to avoid serious errors, since there is little chance that the physician at the other end of the phone is knowledgeable about the specific patient details.

But most disturbing of all is that when I recognize an error made by a resident, the opportunity for me to constructively educate the trainee is absent since he or she has gone home and is strictly instructed to turn off the beeper.

It remains unclear how this lack of follow-through can be consistent with the high level of care to which patients are entitled. Worst of all, if residents perceive the message that it is appropriate to walk away from patient responsibilities as the alarm sounds, this is the way they also will behave as attendings!

--Amy L. Friedman, MD, New Haven, Conn.

Read this letter carefully, for the author makes several strong points, but also exposes her hospital and residency program as not attacking these issues creatively. As our program has thought through these rules, we started with principles. We want to maximize continuity of care by a team. We understood that physicians deserved days off (this has been standard in internal medicine programs for several years). Thus, we (the attending, resident and interns) had to work as a team. As a team we make rounds daily, first discussing all the patients, then visiting every patient. These visits and discussions make clear to the entire team what the important issues are that the patient is facing. We work through decision making as a team (obviously I have the final say). We view abnormal physical findings together.

I would argue that this system maximizes both education and patient care. Only when I can challenge the housestaff's decision making can they work through a process to improve. Only when we go to the bedside and examine a patient or interview a patient can we be certain that we are all on the same page. We need a common understanding of the patient and his/her problems.

Using these principles, we are able to function very well under the new guidelines. When one intern is off, the other intern knows the patients. When the resident is off, I know the patients and can round with the interns satisfactorily. (Come to think, I am the only one who rounds every day - but then I do sleep in my own bed every night).

Contrast this letter (from my comments section).

I'm pleased that you like the new changes. I wish that every hospital would be able to follow suit. Where my girlfriend serves her residency there has been very little change. Despite the new rules she has yet to serve a call shift that is less than 36 hours. The hospital has made no changes except to hand out a memo to the attendings about getting the residents home sooner.

Personally, I think call should be abolished. I understand the whole continuity of health care "issue", but I think the real issue is money.

At my girlfriends hospital some patients are admitted by hospitalists, who work 8-10 hour shifts and pass the patient to the next shift. And some are admitted by residents who are working 36 hours. I'm sorry, but I don't see the difference. Are the patients being admitted by the hospitalists somehow receiving worse care? I find that very hard to believe. For example, my girlfriend had to administer an LP after not having slept for 28 hours. Hmmm - that seemed sort of needlessly risky. I wonder if the patient knew? You want tort reform? Maybe the medical profession should put its house in order first.

Why are the residents pulling 36 hour shifts? why 30? why 24? why 18? why not 8!!!?

The residents work massively long work weeks, and yet are paid on the basis of a 40 hour work week. As if. There is a specific exemption in the labor wage and hour overtime regulation for them. Lucky them.

The whole system has evolved simply because residents are over a barrel - they don't have full licensure (which they need), they don't have a union to protect them, and thus they are the only exploitable labor force that the hospital has.

I'm glad that you like the new ACGME rules, but, personally, I don't think they went far enough. And don't be surprised if congress doesn't agree with me on this issue. The new "limits" are pathetic. A 30 hour shift and an 80 hour work week don't sound like "limits" to most folk, that sounds like injustice.

Chris

Well, Chris, I disagree with your premise. The workweek is in fact related to education. As one goes through training, one needs to see enough patients to understand the broad spectrum of ones specialty. Evaluating new patients does require enough time to think and observe. I have always assumed that there is an optimal time for being on call.

In the old days, many attendings complained about every other night call. With every other night call, you miss half the cases!

Now our challenge is to make certain that the housestaff see enough patients so that they are adequately prepared for practice (or further training). No amount of reading and studying substitutes for interviewing patients and caring for them.

I believe the 80 hour work week actually is reasonable doing this stage of training. I would not want to go to a physician who had insufficient clinical experience.

On the other hand, your girlfriend's residency program and hospital may well get into trouble. We have gone to great lengths to adhere to the guidelines. Many of our residents would like to abolish the guidelines. They remain concerned about continuity of care. Passing off care is hazardous. Housestaff will tell you that you never know a patient as well when you do not do the initial evaulation.

The hospitalist example sounds good, but probably fails on two counts. At most teaching programs, the sicker patients go to the housestaff - because they provide better night coverage. Second, the hospitalists are already trained. They can pass patients off a bit better because of their previous housestaff training.

As I have written previously, this year represents a year of adjustment for housestaff and training programs. We must find new methods of teaching while providing high quality care. Our program is reviewing our systems regularly, and we are prepared to continue to tweak the system until both education and patient care remain excellent. I only hope that all other programs are taking the same attitude.

Posted by at 06:40 AM | Comments (10) | TrackBack (0)





Retainer medicine spreads

While I have not had any rants on retainer medicine recently, the movement continues to grow. As I had assumed, this movement stems from dissatisfication in our current system. This dissatisfaction occurs in both physicians and patients. Appeal of retainer practices: Boutique care goes mainstream

After 11 years in hurried motion as an emergency physician, Daniel Frank, MD, decided he wanted to treat all of his patients as if they were his own family members. The Seattle internist liked the idea of starting a boutique practice -- one in which patients are charged a set fee for certain extra services -- so he could spend more time with a smaller set of patients. But he wasn't interested in following the boutique tradition of catering only to the wealthiest members of society.

So, for what he considers a reasonable price of $99 a month -- which equals about $3.30 a day -- Dr. Frank offers extended-time and same-day appointments, e-mail and easy phone access, routine check-ups that might not be covered by insurance, a wellness program and a monthly newsletter. He also offers home visits for an additional charge. The way he figures it, the cost of membership to his practice is comparable to what his patients would spend each day on a grande Iced Caffe Mocha at Starbucks.
 "My goal is to make it widely available to the middle class," Dr. Frank said. "For the patients who pay that extra $99, it makes their experience unbelievably better."

Dr. Frank isn't the only physician bringing boutique practices to the masses. Boutique practices arrived on the health care scene in the last decade as a fringe benefit for the wealthy, but they have become much more mainstream in recent years. The $20,000 annual fees that were characteristic of the first practices are far outnumbered now by those that charge between $1,000 and $1,500 a year.

I have written about the potential advantages of such practices. These paragraphs summarize those thoughts.

The additional income and lighter schedules allow physicians to spend more time with each patient, but most are hesitant to say their patients are treated better than if they visited a traditional practice. But some doctors point out that the extra time spent with a patient could equal better health down the line.

"In seven and a half minutes, I'm not saying I can offer the same exact care that I can in 30 minutes," said Brent Agin, MD, who opened a retainer practice last year in Palm Harbor, Fla., with Michael O'Neal, DO. "We're not better doctors, but we've created a system that allows us to spend more time with each patient."

Retainer medicine is about money, but it is also about time. I have written about time repeatedly. Time is the curse of internal medicine and family medicine. We cannot provide the highest quality care without sufficient time. Since time is money, current reimbursement rates combined with increasing overhead makes it nigh impossible to spend enough time with each patient. In rushing through patients several things happen.

Shorter times tend to diminish the doctor-patient relationship. Short visits make physicians develop undesirable skills, like not giving patients the opportunity to raise new issues. The shortened times also decrease our ability to think through all the details of the patient. We should provide cognitive services, working through complaints logically, rather than ordering a few expensive tests, or referring quickly to a subspecialist.

Patients have several complaints. As I talk with non-physicians, they often complain of the difficulty the have in finding a physician. When they find a physician, they then complain of not being able to get a timely appointment.

The greatest compliment that I hear from patients is that a doctor spent so much time with them. Patients want to talk with their physicians. They understand the quickies are not satisfying. They (patients) need to tell the physician all their concerns, not just answer the questions that the physician wants to pose.

I think this movement will continue to grow. The cited article does a nice job of presenting both the pros and cons of this movement. The opponents are fighting a losing battle (in my opinion). This practice solution makes too much sense. It will continue to grow.

Posted by at 06:12 AM | Comments (9) | TrackBack (0)





The extent of expert witnesses - end speculation!!

California court throws out "speculative" expert testimony

In a medical malpractice trial in California, physicians admitted that leaving a retractor in a man's peritoneal cavity after a September 2000 surgery was a deviation from the standard of care. It was the question of how much damage the mistake caused that was left to a jury, particularly whether the oversight contributed to an infection.

The jury's decision would rest on what medical expert witnesses had to say. But after the plaintiff's expert witness testified, the trial court judge told the jury to disregard the expert's testimony and threw it out, saying the opinion was based on speculation, not science.

...

n the California case, Jennings v. Palomar Pomerado Health Systems Inc. et al., the plaintiff's expert testified that the retractor left below the patient's peritoneal cavity during abdominal surgery contributed to an infection in the upper subcutaneous tissue and fascia, according to court records.

Doctors discovered the infection when they went in to remove the retractor. There was no infection in the area around the retractor.

The plaintiff's expert testified that there was "guilt by association" even though there wasn't evidence of an infection where the retractor was lodged, court records show. He told the jury that the omentum encased the retractor to isolate and kill germs in the peritoneal area where it was lodged.

The expert testified that the sutures used to close the surgical opening could have brought the infection back up to the peritoneal area, before the omentum was able to take care of any infection below.

As soon as he was finished testifying, defense attorneys for the hospital and two physicians who were named in the lawsuit moved to strike the testimony because there was no basis for the expert's opinion that the retractor left in the man's body contributed to the infection.

The judge agreed.

He said the infection, under either explanation the expert outlined, "would have happened anyway even if the retractor had been removed during the original surgery," according to court records.

Plaintiffs argue that the judge engaged in fact-finding. But the hospital, physicians and the CMA argue that the judge was just doing his job -- keeping out speculative and unreliable testimony.

"Trial judges should not abdicate responsibility for determining the reliability and admissibility of evidence before it may be submitted to the jury," the CMA said in its brief. "In fact, trial courts should be encouraged to do exactly what the court in this case did: carefully analyze expert testimony to ensure that only well-founded, nonspeculative expert opinions reach the jury."

Indeed, that's happening more often today than it did a decade ago.

First, a round of applause for the judge. This case illustrates some points that Mr. Howard made in his NY Times piece last week - my rant on that op-ed - Rethinking malpractice . Judges can and should influence malpractice cases in just the way that this judge did. They should not allow speculative testimony. Rather they should remember that the jury is a fact finding group. They should not have to make theoretical judgements.

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July 27, 2003


A letter to the editor about the pharmaceutical industry

Lashing Back at Drug Companies

In addition, while the drug companies trot out the shibboleth that they need high prices to continue to fund high levels of research, the public is realizing that these companies spend a great deal on promotional and marketing activities -- including, presumably, the massive campaign contributions to Congress.

It's not difficult to understand why the public resents the drug companies when prices in the United States for critical medicines are often two, three or four times higher than the prices for the same medicines, made by the same companies, sold in Canada, Mexico and other countries.

We need them, but darn it could they just act a little more responsibly. (I know, they are acting responsible to their share holders).

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About Well-behaved little butterballs

How do we deal with the obesity epidemic (and yes it is an epidemic)? Girth control The author paints a fair picture of our obesity problem. He concludes his essay with these perceptive points.

Among other remedies, Mr. Brownell favors taxing unhealthy foods (a definition, he grants, that won't always be easy to assign), with the funds earmarked for projects such as advertising healthy foods and lifestyles.

Despite my own use of "junk," I don't like the idea of labeling specific foods "bad" because almost anything in moderation is fine. And the hint of any tax raise makes my free-market knee jerk. Yet while I once considered Mr. Brownell a radical, the fatter we grow the less radical he seems.

Still, there will never be a substitute for personal responsibility regarding obesity or anything else. For a child, there will never be a substitute for a caring, attentive parent who is willing to endure occasional whining and weeping, a tantrum ? or even the ultimate guilt-trip trick, "But all the other kids' parents let them do it." Yes, and their children may die because of it.

As my mother has always said, if all the other kids are jumping off the building should you jump? We actually can control our behavior. And we should.

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No pain no gain

I love the feeling of a good workout. A knowledge and feeling that I have exerted makes me feel energized. This physician shares that feeling. Pain Gains

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July 26, 2003


Disagreeing with a reader's comment on the pharmaceutical industry

A stellar commenter, RG, writes:

There is also a deeply held impression that these new drugs have revolutionized medical care in this country, as Doug Bandow seems to believe in his article. That may only be true to a certain extent.

In a compelling book, THE RISE AND FALL OF MODERN MEDICINE, Dr. James Le Fanu, a renowed medical writer from London, made the point that the fall of the pharmaceutical industry started around the late 1970s, when nothing new was added to our pharmocopeia in comparison to the drugs that were discovered and synthesized from after World War II to the end of the 1970s. And he is probably right.

There may have been a profusion of drugs over the last 25 years, but Dr. Le Fanu again pointed out that most of these were copy-cats from previously released drugs, costing much more and with at most marginal benefits. We can think of anti-inflammatories, antibiotics, hypertensive drugs, H2 acid antagonists, and a host of other me-too drugs that really have not made a dent in revolutionizing treatment. In short, he is suggesting Big Pharma had met a dead-end, a reason why it had to concentrate on life-style drugs (Viagra for impotence, Rogaine for baldness, the ill-fated phen-phen for weight loss) and forced many of the companies to merge into mega-giants to consolidate their dwindling new-product potential.

I beg to disagree. Having graduated from medical school in 1975, I would bring this perspective to argue the point. Let us start with heart failure. Back in 1975 we had no ACE inhibitors, or ARBs. The first study showing the CHF survival benefit of an ACE inhibitor was published in 1988.

The profusion of anticoagulants, helpful in treating acute coronary syndromes, which range from thrombolytics to platelet inhibitor drugs, have made signficant strides. We see more such drugs under development, enhancing our options to care for such patients.

In cardiac prevention, we have the statins - first represented by lovastatin. These drugs represent the only major class which clearly helps in secondary prevention and probably helps some patients in primary prevention.

Adult onset diabetes mellitus has several classes of hypoglycemics to draw on. We had first generation sulfonylureas.

AIDS is a new disease, and all the antivirals developed to treat AIDS have arrived over the past 15-20 years.

The proton pump inhibitors have revolutionized the treatment of acid disorders, and are not a me too drug when compared with H2 blockers. They represent the application of further physiologic understanding.

Since the 70s we have made remarkable progress in treating heart disease - and prolonging quality life! We have more specific cancer cures, especially with regards to lymphomas and leukemias. We have a greater assortment of antimicrobial agents, from newer antibiotics, to antifungals, to a variety of antivirals. We have a plethora of options for ameliorating mental illnesses (from depression to psychosis).

I do not accept Dr. Le Fanu's argument. While I have quibbles with the pharmaceutical industry, I cannot argue that they have done nothing worthwhile. Au contraire, they have provided me the tools to often modify the natural history of disease. Our profession (and here I speak principally of internal medicine as I am most familiar with internal medicine) is intellectually richer and more satisfying because of these and other pharmaceutical advances.

db descends from his soapbox. Back to pimping.

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Will and Power

The Fat Environment written by Ellen Goodman is worth reading. Just click and read. It is very simple.

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On medical pimping

Recently, two excellent bloggers have commented on pimping. For those readers who have never experienced medical school and residency, we must discuss the definition of pimping first. I must disclose at this time that I pride myself on pimping, and consider this a positive term. Hopefully my exposition will clarify my position here.

According to one MEDICAL STUDENT DICTIONARY

Pimping: (verb) The act whereby students are quizzed on minutiae and medical trivia during rounds or class (i.e. "Which 19th Century Prussian scientist discovered?"). This activity is usually reserved for the Attending or residents and fellows with attitude.

This source clearly defines pimping negatively.

A medical student provides a more balanced discussion - Clinical Pimping

Presenting can be nerve-wracking, because some attendings (generally not at the volunteer clinics), do something called "pimping".

"Pimping" is the term used when attendings ask students questions. Stickler questions. Random questions. Difficult questions. Obscure questions. Not just one. Many.

"Pimping", if done with good intentions, is meant to teach and reinforce information. It is usually gentle, constructive, and purposeful.

"Pimping", if done maliciously, is meant to humiliate and publicly embarrass the student. "Ha ha... I know more than you and I want you to remember that."

No, I'm not making it up. Fraternities have hazing, and so do medical schools. Some attendings actually do it for sport.

I like this discussion very much. Pimping comes in varieties. Let me digress and contrast pimping styles.

A patient is admitted to our service with abnormal liver tests. As the attending I start asking questions. I ask the students and then the interns to develop an exhaustive list of the causes of abnormal liver tets. We use that list to sort through the likely possibilities for the patient's presentation. The process of asking the questions is called pimping. If done right, pimping accomplishes much. When we discuss pimping in polite company, we state that we use the Socratic method in our teaching.

One of my heroes is Kelley Skeff. He helped teach me how to teach - Demystifying Teaching. One thing that he taught me that has always stuck is that we must create mild anxiety in the learner so that learning can occur. I believe that I should ask questions which the learner understands that he/she should know. The process of exposing them to their incomplete knowledge should cause them to focus and seek to complete their information.

This process is tricky. While we try to create mild anxiety, we also want to maintain a positive learning environment. Hopefully, we can accomplish this with positive feedback and a lack of dwelling on incorrect answers.

I often start a ward teaching month with a brief speech. "I have been an attending for over 20 years. I know a lot of questions. My job is to find out what you know, and what you do not know. I should focus on teaching you what you do not know. Teaching you what you already know is a waste of your time. I will make you slightly uncomfortable at times. When you start to get nervous, remember that learning is about to occur."

When done right, pimping as an art. The key to righteous pimping is in the pimper's attitude. When pimping, one must always remember one's days as a student and resident. As one remembers that, one can pimp with respect.

This obviously does not always translate into a positive experience. The Art of Pimping

For the uninitiated, "pimping occurs whenever an attending poses a series of very difficult questions to an intern or student." It is the principal tool by which the shame-based motivational system of medical education is applied. This article is unquestionably a masterpiece.

Force of Mouth (the blog) introduces what is clearly a sarcastic humorous description of pimping as if it were a serious exposition. One must read the article with tongue firmly in cheek.

Finally, we get the surgical view (and for those who have never gone through a medical school surgery rotation, surgeon's are not known for gentle pimping). Pimping, Surgeon Style

Well, time to quit typing. I have to read some medical trivia so that later today I can transform into my alter ego - Pimp Master!!!

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Why some people do not get depressed?

Do you have the resiliency gene? Have you heard about it?

How do you respond to adversity? Do you seem to "spin" everything in a positive way? Perhaps your genetics allow you this resilience. Tapping the Mood Gene

A report in the current issue of Science looks at the effects of stressful events in early adulthood ? and the way that responses to them are mediated by a single gene, called 5-HTT. This same gene was in the news in the 1990's, when its variant forms, long and short, were discovered. The gene makes a protein that modifies nerve cells' use of serotonin, a chemical messenger important in the regulation of mood. The short version of the gene was linked (if weakly) to neuroticism, as a personality trait ? the news media called 5-HTT the "Woody Allen gene."

The long variant of the gene seems to confer emotional resilience. The new study, headed by behavioral geneticists from King's College, London, looked at developmental data on 847 New Zealanders who had been followed from ages 3 to 26. In young men and women with two long genes, stress did not produce depression. It made no difference whether the subjects had been mistreated severely in early childhood, nor whether they had later encountered deaths in the family, ill health or financial losses. But among subjects with one or two short genes, adversity, whether early or recent, led to an increase in depression at age 26.

The study is important because it bears on the nature of depression, a subject about which our culture is ambivalent. Public health campaigns call depression a disabling illness. But in memoirs and novels, it retains a romantic cast ? as if mood disorder were not an illness but a character trait conferring a special emotional sensitivity. A survey last month in The Journal of the American Medical Association shows that general practitioners still undertreat depression in a way that would be scandalous if lung or liver disease were at stake. Whether depression should have full status as a physical disease in health insurance coverage or as a workplace disability remains a matter of public debate.

At first glance, the new genetic finding makes depression look like an aspect of normal temperament. After all, 70 percent of us have at least one short 5-HTT gene, and vulnerability to depression is normal. But the study also meshes with the prevailing model of mood disorder, in which depression is every inch an illness. According to theory, most depression arises from an interaction of genes and experience. In the predisposed, early trauma and subsequent adversity lead to depressive symptoms and subtle changes in the brain. Chronic depression produces marked changes. Particular brain regions begin to shrink or show structural disorganization. Resilience factors ? perhaps including the protein produced by the 5-HTT gene ? mitigate that damage or allow for repair.

So would you rather be resilient or become "normally" depressed. Which confers a greater advantage in life? Will this research provide us the tools to all become resilient? And will that be good?

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July 25, 2003


The House passes the re-importation bill

House Approves Bill Easing Imports of Less Expensive Drugs

In a major defeat for the pharmaceutical industry, the House voted by a wide margin early this morning to approve a measure that would make it easier for Americans to import inexpensive prescription medicines from Canada and Europe.

The vote, 243-186, came shortly before 3 a.m., after a fiery hour-long debate that capped a long and stressful day for lawmakers, who are rushing to finish their business by tonight so they can leave the Capitol to start their month-long summer recess.

The outcome was a surprise. Until the last minute, lawmakers on both sides were saying the vote would be too close to call. Even as the votes were being cast, some lawmakers held back, to see which way their colleagues were voting.

"I think this is the Congress saying, ?We hear you, drug prices are too high," said Representative Jo Ann H. Emerson, Republican of Missouri, who forced the vote by extracting a promise from the House leadership in exchange for favoring a broader Medicare prescription drug benefit that is a high priority of the White House. She added, "It's time we stopped subsidizing the world and bring fairness and fair prices to Americans."

The measure now becomes the official position of the House in its negotiations with the Senate to reconcile differences in their two versions of the prescription drug legislation. But its fate is uncertain; on Thursday, 53 senators released a letter saying they oppose the provision. And it is unclear how hard the House representatives in the Medicare negotiations will fight for it.

The Republican leadership of the House worked vigorously against the bill, as did the drug manufacturers--who stand to lose millions if it becomes law--and the Food and Drug Administration, whose officials argued the measure would jeopardize safety. The vote did not fall along party lines; rather, the debate turned on whether lawmakers were willing to accept the drug makers' argument that the measure would harm patients and defy free trade by allow the importation of not only drugs, but price controls.

"This is an interesting debate, because its not between the Democrats and the Republicans" said Representative Ted Strickland, Democrat of Ohio, who supported the measure. He added, "It's between the people and the pharmaceutical companies."

About this bill, I just do not know. Read my earlier post (scroll down, it is the 3rd post down from this one) on the pharmaceutical industry. I am confused.

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The public's opinions on the obesity lawsuits

Overlawyered has collected the information. Go over to his blog and read all about it - "Public balks at obesity lawsuits"

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More malpractice angst

Hospitals Helping Doctors With Insurance

When a group of specialists were dropped from their malpractice insurance last year and began job-hunting in other states, their cash-strapped community hospital started weighing its options.

``Our board took a look at the situation and the first question was, 'What will happen when these doctors leave?''' said Perry Pepper, chief executive officer at Chester County Hospital.

``And the answer was, 'Well, we won't be able to recruit any more obstetrician-gynecologists,''' Pepper said.

So the hospital offered to make a subsidiary of the obstetrician-gynecologists' group, and now pays to insure the eight doctors in it.

Hospitals across the nation are making the same tough choice, particularly those in states hard-hit by rising malpractice insurance costs: Help doctors pay their rising malpractice liability premiums, or risk losing them to states where conditions might be better.

This is not a cure. This is not a solution. This is a band-aid. And the cut is widening.

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The pharmaceutical industry dilemma

Today's Lancet has an editorial which explicates the problem of how we should treat the pharmaceutical industry. What price competitiveness in the drugs industry? This article refers to a consideration of the issues which have made the United States the leader in new drug development. The article takes a European perspective, but it gives an excellent balance to our philosophical conundrum.

Since 1990, the US pharmaceutical industry has surged ahead of that in Europe. While spending on research and development in Europe increased 2·5-fold from 1990 to 2002, in the USA such spending jumped 5-fold. US firms are adopting and exploiting new technologies more rapidly and claiming more patents in important areas like biotechnology. Indeed, to take advantage of this American productivity, European-based drug companies are spending more and more of their research and development budgets in the USA.

In 2000, a panel of experts commissioned by the European Commission produced a report, Global Competitiveness in Pharmaceuticals, that concluded: "Europe is lagging behind [the USA] in its ability to generate, organise, and sustain innovative processes that are increasingly expensive and organisationally complex." The report identified several reasons why the US industry has pulled ahead. It found, for example, that American research is "an integrated system, highly differentiated and pluralistic within a common framework", while European science "is composed of fragmented and relatively small national systems". In fact, European scientists are more likely to collaborate with US researchers than with scientists in other European nations. The USA has also created a vertical system in which small innovative exploratory companies develop new products which can then be exploited by larger firms that have the staff, expertise, and capital to refine and market those products.

But a major factor behind the US success is money: drug prices are not fixed in the huge American market, whereas in Europe many countries control drug prices or place regulatory caps on profits. As a result, while drug prices in the USA have been rising steadily over the past several years, price increases have been kept down and several European governments have actually been initiating price cuts. As one drug industry official told the Wall Street Journal, "Companies go where they get the best return on their investment and right now that is the US".

And that defines the dilemma. We want to keep drug prices reasonable and affordable for the masses. Yet we also desire the advances that the pharmaceutical industry provides. Our challenge comes in striking the right balance of price and innovation.

Many of the Commission's recommendations are interesting, in particular the establishment of an NIH-like organisation to help bring European scientists together. The degree to which the market should be allowed to determine drug prices is more problematic. Any reform would need to take into the account the risk such changes will pose to the health systems of Europe, which have sought to provide affordable health care for all. The success of the American system has encouraged scientific advances but it has failed to give access to those advances to everyone who needs them.

So we are left to consider the greater good. Which do we prefer? Should we have rapid advances in pharmacotherapeutics? Or should we slow down advances so that everyone can afford their medications? We have no good answers to this dilemma.

In the US we are still considering the possibility of allowing importation of drugs from Canada and elsewhere. This certainly would help some patients financially, but will it effect innovation. I am stumped. The questions seem simple, but the answers evade me.

For another opinion on this issue - Demonizing Those Who Cure Us

The research group Europe Economics found that patients often wait years for access to even life-saving new medicines. Incredibly, the more useful the product and the more people to be helped, the smaller likelihood that European governments will quickly approve it. Explained Europe Economics: countries "facing tight budget constraints will be more resistant to a given price demanded by a company the higher they expect the demand for the product to be."

The rest of the article deals mostly with the importation issue. I continue to have mixed thoughts on these issues. I present these links so that you can share my confusion.

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Banning ephedra?

Long time readers know my feelings about the dietary supplement industry. I find it dangerous and cannot understand the law that allows its existence (without any proof of efficacy and minimal proof of safety). The FDA agrees with my stance.

How many athletes have to die from ephedra before we agree to its danger? FDA Considers Banning Supplement Ephedra

The government is considering banning ephedra, an herbal stimulant used in dietary supplements that has been linked to scores of deaths and myriad health problems, the head of the Food and Drug Administration said Thursday.

Commissioner Mark McClellan's testimony before two House Energy and Commerce subcommittees marked a departure for his agency, which had said it had been prevented from banning such products by a 1994 law that left dietary supplements largely unregulated.

"A ban on ephedra use is in the range of options we are considering," he told the lawmakers.

McClellan said the agency needs to make sure the evidence it is reviewing, such as studies on the herb and health complaints submitted to companies that use it in their products, could support a ban under the law. The 1994 statute requires the FDA to prove that a dietary supplement is harmful rather than having the manufacturer prove that it is safe, as with drugs.

Ephedra, which can be used to lose weight and boost athletic performance, has been linked to as many as 100 deaths. Health problems can include strokes, heart attacks and seizures.

This story fits my definition of a tragedy. We have a bad law, which has enabled these companies to market a dangerous drug - yes, I know it is called a supplement, but it fits every definition that I know of a drug. Still, many in the health industry support its use - SUPPLEMENTS UNDER SIEGE . These apologists believe that supplements are the answer (I still do not know exactly what the question is). They ignore data, just like the supplement sellers.

We need rigorous data, not testimonials. Some supplements may have benefit. The data on creatine are impressive. The studies show efficacy and safety. We need such data on any supplement that consumers might buy. Until such time caveat emptor .

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July 24, 2003


The Yips!

If you do not play golf, this rant might seem boring. If you have the yips, this is fascinating. If you have ever seen the yips ....

Yips, the Curse of Golfers, Are Put to the Test

Sixteen golfers, and good golfers at that, wandered through lush grass here today, putting and missing, putting and missing. They tapped the simplest putts well beyond the holes, left others far short and sent some golf balls whizzing off in puzzling directions.

All for the sake of science.

As cameras rolled and researchers from the Mayo Clinic monitored their heart rates, grip tension, hormone levels and, in some cases, brain waves, the 16 men, who traveled here from as far away as Scotland, revealed the humiliating woes that have, unhappily, come to dominate their golf games ? the yips.

Yips are the sudden jerks, clenches, twitches or spasms that can send an easy two-foot putt right off the green. Golf greats like Sam Snead and Ben Hogan were afflicted. Professional careers have been ruined and fortunes spent in the search for proven cures. Not that there are any.

I hope this research teaches us something about fine muscle control and why it sometimes goes bad. This research has relevance to more than golfers.

Ugly golf, to be sure, but is there any reason for anyone beyond the country club to care? The Mayo researchers think so, since the yips ? a baffling collection of symptoms that are fiendishly difficult to understand and treat ? are similar to the problems suffered by surgeons, dentists, musicians and others who make repeated motions in small, precise areas. Chuck Knoblauch, the ex-Yankee second baseman who suddenly lost his ability to throw reliably to first base, may have had some permutation of a yip.

I eagerly await the results of this research. And for those interested, no I do not personally have the yips. But I have seen them and they are UGLY!!!!

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Part 4

More excellent comments and questions from Lisa.

Ah, see, now we are beginning to tease out the tangled meanings. I appreciate your explanation of the difference between the informed consent a patient may be giving before a medical procedure and what you mean by "a juror judging standards of care." Since it seems that universal standards of care don't (perhaps can't?) exist, this is where the issue lies. Would you support a national standard of care, or is that a nonsensical suggestion?

Medical care really does have great complexity. The problem with developing a national standard of care comes from patient factors and new knowledge. Let me try to explain.

We all know that we should anticoagulate patients with atrial fibrillation. All guidelines support this idea; all the studies support the practice. However, anticoagulation puts the patient at risk of bleeding. We often decide that the risks (in an individual patient) of anticoagulation exceed the risk of not anticoagulating. I do not know how to make that a standard of care. Perhaps our problem here is in developing a documentation record.

The more difficult problem is the one that I described in part 3. When we have new information, how fast should we incorporate that information into practice. How do we revise the standard of care? The standard of care is now an informal understanding amongst physicians. Perhaps we should set explicit parameters with the goal of improving quality of care. Such a proposal would require careful pilot studies to understand the "unintended consequences" of a standard setting body.

I think the "finding of fact" system could be entered into by private parties today as a form of binding arbitration. I wonder, if I were presented by my HMO with a contract saying, "As a condition of your insurance, you may not sue your doctor but must instead submit to our binding arbitration/mediation process" would I sign it? Would I be better off if I did? I might (maybe) be better off as a patient, but maybe not better off as a citizen.

Lisa has a start at a solution here. Our goal should be several fold. We want fair compensation for injured patients. We want a system that identifies substandard physicians - and either directs them to improve or revokes their license. We want a system that allows physicians to continue to practice.

We need a new system. Perhaps arbitration would work. Perhaps a medical court system would work. What we currently have fails both patients and physicians!
 

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July 23, 2003


Go veggie

Vegetarian diet may cut cholesterol as well as drugs - reports on a 4 week study.

The fiber-rich vegetarian diet included eggplant, okra, soy protein, almonds, margarine containing plant sterols, barley and psyllium -- foods that alone have been shown to have potentially beneficial effects on cholesterol.

The diet was prepackaged and provided to patients; whether people in a non-study setting would be as successful in following the strict diet is unclear, Dr. James Anderson of the University of Kentucky said in an accompanying editorial.

Still, Anderson said that if the results are confirmed in other rigorous studies, they could have "far-reaching implications for a large number of patients" by enabling them to lower their cholesterol without drugs.

This diet may well work. Perhaps some patients with hypercholesterolemia will try to duplicate the diet. It may well work for long time periods.

I would certainly encourage patients interested in avoiding statins to try such a diet. Some very motivated patients will succeed in totally changing their eating habits. However, I doubt that I can convince many patients to accept this diet.

Nonetheless, these finds are extremely interesting. We need more research on how and why this particular diet had such success. Those answers may help us design more modest and easily accepted dietary changes.

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Part 3

So Bernie writes:

Third, the attitude that patients can't understand complex medical cases strikes me as a bit arrogant. The older I get, the more I understand that the most important quality to cultivate is not knowledge, but judgement. Doctors may be very knowledgable about the practice of medicine, but they sometimes show poor judgement. I think the case you present undercuts your own argument. You ably presented the facts and I think a resonable person could reach a conclusion on the facts you present. And I don't think a further knowledge of the facts of the effectiveness of NAC would significantly aid in reaching this conclusion.

Bernie, Bernie, Bernie. Please reread my rant. You seemingly misunderstand my point.

We are not arguing against jury trials per se. Rather we are arguing over the responsibility that a jury should have. In the simple hypothetical case that I outlined, the facts are not disputed. We are disputing a concept called standard of care. How does one establish standards of care? Who can judge when new knowledge reaches the threshold that makes us change our practice standards?

As I wrote on July 4th

Thus, the authors make the case that we need to study methods for translating knowledge into practice. Identifying suboptimal practice no longer should interest us. We know that many new findings are not quickly translated into practice.

As one studies adoption of new practice, one finds an interesting curve of adoption.

Scurve.gif

At what point on this curve would you find someone guilty of malpractice. How do we decide when everyone should have adopted an innovation (and I would argue from my example that many still consider NAC an innovation in protecting against dye induced renal failure)?

We should look at the flip side of this curve. What if I am an early innovator of a drug which causes a serious side effect? Am I guilty of malpractice then? Where should I lie on the technology adoption curve?

My argument is simple. The judge(s) should set the parameters for the jury. They should define the problem. The jury should decide the facts of the trial, not the standards of care. I am not even asking for physicians to make the decisions, but rather legal experts on the problem of care standards.

My simple case is actualy quite complex and full of nuance. We regularly use NAC to decrease the risk of dye induced renal failure on my service. But are we early adopters or the early majority? How does one decide?

Posted by at 06:36 AM | Comments (3) | TrackBack (0)





July 22, 2003


Malpractice and Common Good continued

Go to the next rant (written earlier today) and read the comments. Lisa comments

Howard merely states that jurors are unable to judge, but gives no reasons why.

I would take issue with that comment. Read again his exact wording.

The role of juries in civil cases is to decide disputed facts, like whether someone is telling the truth. It is not to declare standards of care that affect society as a whole. That's why the Seventh Amendment qualifies the jury right as applying to "suits at common law" and ends by saying that "no fact tried by jury shall be otherwise re-examined . . . than according to the rules of the common law." Judges declare the standards of law that affect all of society; juries decide disputed facts in a particular case.

Howard makes the point that when one asks a jury to judge a standard of care, that oversteps the legal responsibility that one should accord to a jury. Juries, he states, have the responsibility of deciding disputed facts not disputed standards . As he states, the problem in many malpractice cases comes from the difficulty of anyone including physicians discerning the standard of care.

As I read his op-ed, he does not make the point that juries are too ignorant, but rather that the question being asked is not one for which we have a jury system.

She goes on to pose the following hypothetical:

If an individual without medical training can give informed consent to a complex procedure that involves risk, why can't twelve of his or her peers, also with no medical training, understand the same material?

I agree that informed consent represents a difficult problem. But it does not equate to the problem that a juror faces. An example might help.

You get admitted to the hospital with chest pain. I take your history, do a physical exam, check your laboratory data and interpret your EKG. Your history suggests that you have coronary artery disease. I recommend that you undergo cardiac catheterization. I represent the risks and potential benefits of that procedure. You then decide whether or not to undergo the cardiac catheterization. This is a personal decision based on how I explain the risks and benefits and your understanding and experience with physicians and heart disease.

This process of informed consent involves a discussion of risks and benefits. Most often patients ask me for my opinion. Thus, often we revert (at the patient's request) to a paternalistic process.

Contrast the following example. You are admitted with chest pain. I recommend a cardiac catheterization, for which you give your informed consent. You develop acute renal failure related to the dye used for the cardiac catheterization. You hire a lawyer to sue me (even though you have a complete recovery).

The lawyer argues that I could have prevented the acute renal failure by using n-acetylcysteine prior to the dye injection.

The data supporting this claim are new, and do not yet reach the standard of care in my hospital. You obtain an expert who quotes recent articles that show the benefit of n-acetylcysteine. I obtain an expert who states that the articles remain controversial.

Should a jury judge this case? Who should establish the criteria involved in this case?

I have used real situations. We make these decisions every day. The level of decision making in informed consent is more clear and definable than the level of decision making in the acute renal failure situation.

I do not believe that we have a paradox here. We need a clearer method of defining the standard of care. Remember that malpractice implies that the physician has not complied with the standard of care. If we hold physicians to that standard, we should expect a clear and consistent way of determining that standard.

For further explication of this thinking please see the reference cited towards the end of the rant. Admittedly, these are difficult issues to sort through. I believe that patients would benefit, and medical care would benefit from a fair system rather than the random lottery system that we currently have.

Posted by at 07:34 PM | Comments (4) | TrackBack (0)





Rethinking malpractice

Previously, I have lauded Common Good. Yesterday, the chair of Common Good, Philip K. Howard (a lawyer), published an op-ed piece in the NY Times. I will give 2 sites for the op-ed entitled The Best Course of Treatment , The Common Good site, and the online NY Times version. This op-ed does a better job than I have done in presenting an alternative to our current malpractice nonsystem.

Lose-lose is perhaps the best way of describing the sorry state of justice in American health care. Doctors are going on strike and even quitting because of ruinous increases in liability premiums. Patients aren't doing so well, either: thousands die annually because of simple slip-ups, and no one seems to be able to revoke the licenses of inept physicians.

He starts by defining the problem. This definition is fair. We would like a system that would protect patients, and not put good physicians at unnecessary financial hardship.

Doctors and patients aren't natural enemies. They've been driven apart by an unreliable system of justice that tolerates both abusive claims and bad care, breeding distrust on both sides. Studies about jury awards in health care confirm what every doctor fears ? and every victim should fear: justice is random. Most doctors who make mistakes don't get sued. But most lawsuits are against doctors who did nothing wrong; the cases involve human tragedy but not medical negligence.

Remember this is a lawyer writing. He understands (as did Mike Kingsley in his column within the last month). The problem is the random nature of justice. We need a more reliable system. One which protects patients and physicians.

The Constitution's right to a jury trial does not require judges to abjure their traditional role of defining the boundaries of reasonable dispute. The role of juries in civil cases is to decide disputed facts, like whether someone is telling the truth. It is not to declare standards of care that affect society as a whole. That's why the Seventh Amendment qualifies the jury right as applying to "suits at common law" and ends by saying that "no fact tried by jury shall be otherwise re-examined . . . than according to the rules of the common law." Judges declare the standards of law that affect all of society; juries decide disputed facts in a particular case.

Today, however, juries are being asked to decide not only disputed facts but standards of medical care. How does a jury know how to do that? More important, how does a doctor know what standards to abide by? Every time a sick person gets sicker, it's easy to come up with a theory of what a doctor might have done differently. Chemotherapy didn't work, but maybe radiation would have.

He reinforces my point, that juries cannot reliably and should not decide standards of care. Those judgements remain very difficult, even for experienced physicians. He challenges us to have judges decide on the merits of considering malpractice.

Unreliable justice harms patients more than it does doctors. Pervasive distrust is causing a meltdown in American health care. Quality suffers as fear of lawsuits chills the professional interaction necessary for informed and humane care. Costs spiral out of control in part because doctors squander resources with unnecessary tests in order to build a record just in case they get sued.

A reliable system of medical justice could take many forms, but because the critical issue in virtually all cases is whether the doctor complied with appropriate standards of care, the key element must be expert judges ruling on standards of care. Specialized tribunals are common, in areas ranging from taxes to vaccine liability. A bill to finance pilot projects for special medical courts is scheduled to be introduced in the Senate later this week.

The common ground here is the need for reliable justice. For doctors, reliability would offer protection against baseless claims. For patients, it would provide victims with quicker compensation without the legal costs that consume almost half the awards. A system of reliable justice could also remove from practice incompetent doctors who often escape accountability now by threatening to sue their hospital or state licensing board.

This proposal makes so much sense that it can not possibly succeed. Trial lawyers will oppose this ferociously, because (I fear) many trial lawyers are more interested in jackpots than justice. This proposal focuses on justice. I believe we would all benefit from fair justice. Fair trumps random every time!

Here is an editorial supporting the idea of medical courts - Medical Courts Would Heal Infirmities Of Legal System. If your are interested in these issues, please read both pieces carefully. I am impressed with the though process behind this proposal. Now to figure out how I can make a difference!

Posted by at 08:35 AM | Comments (7) | TrackBack (0)





July 21, 2003


On communication - the value of apology

Clinical care can result in undesirable outcomes. Sometimes we make mistakes. Sometimes the system fails. Sometimes undesirable outcomes just happen. Research suggests that patients and their families get frustrated (and then more often sue) when we do not acknowledge the problem - The power of an apology: Patients appreciate open communication

While doctors and lawyers duked it out over tort reform and liability caps in state legislatures last spring, two states quietly passed bills that could significantly impact malpractice lawsuits by extending physicians' freedom of speech to include two words: "I'm sorry."

The Colorado and Oregon legislatures passed laws allowing physicians to make statements of sympathy and condolence with the assurance that these statements would not be used against them later in court.

"The world is a crazy place," said Oregon Medical Assn. President Colin Cave, MD, a Lake Oswego-based otolaryngologist. "Who would have thought that a doctor would have to be protected by a law in order to express his or her compassion?"


California, Massachusetts and Texas already have similar laws, but many doctors and hospitals are discovering that, even without legal protection, acknowledging and apologizing for errors and adverse outcomes has its own rewards, both ethical and financial. There also is optimism that disclosure will lead to better communication that might help prevent errors in the first place.

When errors do occur, studies indicate that it's not necessarily the medical error itself that causes patients or their families to sue, but the response to it. A study in the Feb. 26 Journal of the American Medical Association reported that after an error occurs, patients want information about why it happened, how consequences will be mitigated and what's being done to prevent reoccurrence. They also want emotional support from doctors -- including an apology.

"Patients will keep looking until their questions are answered," said Ilene Corina, president of Persons United Limiting Substandards and Errors in Health Care, an advocacy group for people affected by medical errors. "If all the doors are closed to them, they will go to lawyers."

The typical posterror scenario, Corina said, is that the patient or family can't reach doctors and instead are circled by risk managers who won't give straight answers. "The classic line you hear is, 'We're looking into it,' " said Corina, whose 3-year-old son died 13 years ago after surgery to remove his tonsils and adenoids. "In my case, the doctor said he was sorry but never acknowledged that something went wrong."

I hate the entire concept of risk management in medicine. I try to discuss all issues openly with patients. Probably I only succeed sometimes, but I will continue to work on improving my communication.

Good communication skills do lead to better patient care, better enjoyment of the doctor patient relationship, and according to this article less need for risk management. I try to teach communication to students, interns and residents when we make bedside rounds. I only hope that I am sometimes successful.

Posted by at 08:44 PM | Comments (0) | TrackBack (0)





Not giving up on tort reform

One of the most important lessons my mother taught me was the necessity for persistence. We often lose the first battle (or battles) in a war. But if the cause is just and logical, eventually we just might win. So is (in my opinion) the war for tort reform Our system is broken and needs to be fixed. The AMA agrees. Measure stalls in Senate: "We'll be back," say tort reformers

"Medical liability is going to pass at the federal level," AMA President Donald J. Palmisano, MD, said. "It's a question of when, not if."

"This is a stop along the road," added Richard Anderson, MD, chair of The Doctors Company, a physician-owned, national medical liability insurer. "I am not discouraged."

In fact, advocates say there are several reasons to be encouraged. President George W. Bush supports legislation. The House of Representatives in March passed a bill that includes a $250,000 noneconomic damages cap. And a Gallup poll shows that 72% of Americans favor caps on noneconomic damages.

"The only people we haven't convinced are the Democrats in the Senate," Dr. Anderson said. "When they go home, I think they will find that their constituents want this."

With physicians continuing to leave medicine because of high insurance rates, both sides acknowledge that the issue won't be going away anytime soon. During Senate floor debate, Republicans said they would make tort reform a campaign issue.

"The American public will know where the responsibility lies" for legislation not being passed, Dr. Palmisano said.

The vow from tort reform champions to continue their push comes after a 49-48 Senate vote July 9 -- almost entirely along party lines -- not to let debate continue on the Patients First Act of 2003, introduced by Sen. John Ensign (R, Nev.) and endorsed by the Senate majority leadership as well as the AMA. The measure needed 60 votes in order to clear this procedural hurdle.

In addition to capping noneconomic damages, the measure proposed limiting punitive damages, setting a statute of limitations on filing lawsuits and establishing tougher standards for expert witnesses.

So I will continuing blogging this subject. As will my physician blogging colleagues. Perhaps we will need a more obvious crisis to get something done. I hope not.

Posted by at 11:32 AM | Comments (2) | TrackBack (1)





July 20, 2003


What is causing the bumps?

Lisa Sanders writes medical stories for the NY Times Magazine. I recommend that all physicians read the clues carefully. Try to think through your differential diagnosis. Be honest and see if you would make the diagnosis. Here is the link - Severely Painful Ankles, Bruiselike Lumps

The patient walked carefully into the examining room. Holding the wall for support, she winced with each step, lifting her feet and setting them back on the floor with great care, as if they were fragile objects. She sat down on the exam table and softly massaged her right ankle, which was reddened and visibly swollen.

So we have our first clues. The patient has difficulty walking because of pain. She has a swollen reddened right ankle.

But it didn't get better; it got worse. The following week she began to get flulike aches in her joints and muscles. After two more unproductive visits to the E.R., she came to our clinic, where she was seen by a nurse practitioner, who took blood samples and sent them off for tests. The patient was supposed to come back in several weeks to get the results, but one day she woke up with her ankle red and swollen and immediately returned. ''I kept telling you doctors there was something wrong with my ankles,'' she said. ''But nobody believed me because they looked normal. Well this doesn't look normal.''

So she has systemic complaints, and finally has an abnormal exam.

Our exam, however, turned up another abnormal finding. The patient had three distinctive marks on her right shin. They were each about the size of a quarter and were black and blue. They looked like bruises, but they had a rubbery lump at their center, as though a grape were buried deep beneath the skin. When asked about them, the patient expressed no concern. They had first appeared about a month before, she said, and she thought they might be insect bites, though they didn't itch.

This description made sense to me. Try to imagine the lesions, and assign a name to this finding.

erynodo1.jpg

Does that help?

The description and the pictures describe erythema nodosum . The author and her resident were stumped, but thought someone would make a connection. I actually did make the diagnosis while reading this case. Did you?

This was the case with the rheumatologist. When he saw our patient, he immediately saw a pattern. To his eyes, the combination of arthritis and erythema nodosum suggested an unusual form of sarcoidosis. He ordered the relevant tests, and by the end of the day, he was confident in his diagnosis. Sarcoidosis, a disease of the immune system, most commonly affects the lungs, the skin and the eyes, but it can be found anywhere in the body, including the ankles.

The resident and I were surprised and intrigued when we learned the diagnosis. Why hadn't we considered it? After all, as a generalist and internist, I know sarcoidosis. I know it best, however, in its most common manifestation: as a lung disease. If our patient had had erythema nodosum and shortness of breath, we would have diagnosed the symptoms with relative ease. The rheumatologist, by contrast, most commonly sees this disease when it affects the muscles and joints, as with our patient. For him, arthritis and erythema nodosum was sarcoidosis's most familiar face. It was instantly recognizable to him, and now to us as well.

For the rheumatologist this diagnosis seemed simple. He sees sarcoid in a different context than most generalists (who much more commonly see the pulmonary variety). Context always helps make diagnoses.

I love this case presentation. It reminds us of how internists think, and also how subspecialists think. This presentation may help me make a diagnosis one day. Maybe it will help you. And by the way, the patient recovered nicely making it indeed a great case .

Posted by at 07:14 PM | Comments (2) | TrackBack (0)





July 19, 2003


On developing advanced directives

You owe it to yourself and your family to consider advanced directives. Choosing a Final Care Plan

In order that patients get the health care they want if illness prevents them from making decisions, doctors and organizations like AARP, the American Medical Association and the American Geriatrics Society recommend that people develop care plans. This means drafting legal documents specifying their preferences and telling their doctors and relatives their wishes.

Several documents address these matters. A living will spells out what procedures you want or don not want if you are in a terminal state. A more flexible document is the medical power of attorney, also known as a health care proxy, that permits you to appoint someone to make health care decisions for you if you cannot and allows you to include wide-ranging instructions on any care that you want done or withheld.

Most states, including New York, combine these documents in one set of advance directives.

Experts say people should be as specific and comprehensive as possible, or doctors will be unable to interpret them. You can, for instance, make clear that you do not want to be resuscitated if you go into cardiac arrest. You could state that you no longer want to be transferred to a hospital once you have deteriorated to a certain state.

Neither a lawyer nor a doctor is necessary to execute a directive. State law varies on signing procedures, though usually two witnesses are needed. Partnership for Caring allows you to download the advance directive forms for any state from its Web site Partnership for Caring

Please consider these issues especially when you develop any chronic disease. We need your input. We (physicians) want to tailor your care to your needs. You can help us greatly!!!!

If you want to understand this issue in more depth - Patients Whose Final Wishes Go Unsaid Put Doctors in a Bind. If you are undecided about this issue - please read the article . Thanks!

Posted by at 05:42 PM | Comments (1) | TrackBack (0)





July 18, 2003


Dangers of aldosterone blocking

The RALES study opened an era of using aldosterone blockers to treat (and now prevent) congestive heart failure. Unfortunately, many physicians have started using these drugs (spironalactone and the new eplerenone) without a complete understanding of dosage. Here is the problem. We use spironalactone for cirrhotic ascites and use much higher doses than the RALES study used. Moreover, most CHF patients are already taking either an ACE inhibitor or an angiotensin receptor blocker, which increases the likelihood of full aldosterone suppression. While we want aldosterone inhibition, we do put patients at risk for the renal implications of hypoaldosteronism. These patients do risk hyperkalemia.

Interaction of spironolactone with ACE inhibitors or angiotensin receptor blockers: analysis of 44 cases appears in today's BMJ.

From January 1999 until December 2002 we observed 44 patients (17 men) with congestive heart failure who were taking spironolactone and ACE inhibitors or AT1 receptor blockers and were admitted to our nephrology unit (serving a population of about 250 000) for treatment of life threatening hyperkalaemia. Their mean age was 76 (standard deviation 11) years. The mean dosage of spironolactone was 88 (SD 45, range 25-200) mg daily. All patients also received ACE inhibitors or AT1 receptor blockers (table). Fourteen patients were treated with receptor blockers and 40 with loop diuretics.

Going back to the RALES study, they determined in their pilot study, that the doses of 25 mg and 50 mg led to few cases of hyperkalemia. As soon as one raises the dose to 75 mg in such patients (this does not apply to spironalctone given for cirrhotic ascites), the risk of clinical important hyperkemia rises to around 1 in 4 (25%). As one looks at the data provided in this study, many patients took 100 mg daily. A careful reading of RALES could have prevented the severe hyperkalemia that these patients developed.

In our series, the dose of spironolactone was larger than the 25-50 mg a day used in RALES (the randomised aldactone evaluation study) in most cases. The dosage of spironolactone in RALES was chosen on the basis of this increasing incidence of hyperkalaemia with increasing dosage of spironolactone. This dose limitation had been ignored in our patients and supposedly was an important factor contributing to their hyperkalaemia. Many pharmaceutical companies, however, do not supply the 25 mg dose of generic spironolactone, which might also contribute to overdose in daily practice.

One can only surmise that we might find the same effect when using the newer aldosterone blocker - eplerenone (trade name Inspra).

The authors point out that in addition to the higher dose of spironalactone used in these patients, the patients often had decreased renal function and diabetes mellitus type II.

There seem to be conditions that may lead to the development of severe hyperkalaemia in patients with heart failure who are taking spironolactone and ACE inhibitors or AT1 receptor blockers: advanced age, dose of spironolactone > 25 mg daily, reduced renal function, and diabetes mellitus type 2. Plasma potassium concentration should be monitored frequently in these patients, in whom we recommend that the dose of spironolactone should be limited to 25 mg a day or even every other day. A test of renal function (at least by applying the Cockroft and Gault formula) before treatment is started is useful as a plasma creatinine concentration < 221 µmol/l does not reliably exclude patients with renal failure. Undetected hyperkalaemia may be suspected as a possible cause of sudden death in some patients treated for heart failure with spironolactone and ACE inhibitors or AT1 receptor blockers.

I had to search for the appropriate conversion factor for creatinine - this represents a value of 2.5. Thus, I interpret these data as a caution in patients with elevated creatinine or diabetes mellitus type II. Creatinine clearance does decrease with age, thus as patients get older, we must lower our creatinine threshold for worrying about hyperkalemia. The authors suggest using the Cockroft-Gault formula prior to starting aldosterone blockers. They do not mention their creatinine clearance threshold for using spironalactone, however I will state that I would have caution at clearances below 20 cc/min.

I would also note that many patients in their report had diabetes mellitus type II. As these patients develop renal insufficiency, they often have type IV RTA (the hyporenin, hypoaldo syndrom). I wonder if some patients in their report had some decrease in renin and aldosterone prior to starting spironalactone. Thus, they would have more susceptibility to hyperkalemia.

This article reminds us to think carefully about adding aldosterone blockade. It provides another example of the complexity of modern medical care - and how we must keep current so that we can weigh the risks and benefits of our therapeutic and diagnostic options.

Posted by at 08:15 AM | Comments (0) | TrackBack (0)





July 17, 2003


More on Neurontin

On July 12, I ranted about how Warner Lambert use deceitful practices to market Neurontin (gabapentin). I have done my research and want to provide more context.

A major use for Neurontin is in painful neuropathies. The drug does work in some patients - Neurontin Significantly Reduces Chronic Neuropathic Pain.

One study examined the effects of Neurontin on patients with diabetic peripheral neuropathy (DPN), a chronic, often painful condition that affects approximately half of the estimated 1.5 million diabetes patients in Canada. A companion study examined the use of Neurontin in patients suffering from post-herpetic neuralgia (PHN), the chronic neuropathic pain condition that can follow shingles (herpes zoster).

Results of the national, multi-centre DPN study demonstrated that patients suffering from diabetic peripheral neuropathy experienced a significant reduction in pain after treatment with the drug and that 26 percent of those patients treated with Neurontin were pain-free at the end of the trial compared to 15 percent of patients treated with placebo. This difference was statistically significant.

Findings of the national, multi-centre PHN study showed that patients suffering from the condition experienced a statistically significant reduction in average daily pain after treatment with Neurontin. Importantly, almost twice as many patients treated with Neurontin (16 percent) were pain-free versus those treated with placebo (8.8 percent) at the end of the trial. Both studies also showed that patients receiving Neurontin experienced improvement in sleep and overall quality of life.

Neurontin does work, although the results are clearly not dramatic. One must remember the side effect profile of this drug.

The most common adverse events during clinical trials were somnolence (19.3 percent versus 8.7 percent with placebo); dizziness (17.1 percent versus 6.9 percent with placebo); ataxia (12.5 percent versus 5.6 percent with placebo); fatigue (11 percent versus five percent with placebo); nystagmus (8.3 percent versus four percent with placebo); and tremor (6.8 percent versus 3.2 percent with placebo).

So let us figure out the "bottom line". Neurontin seems to work for some patients with neuropathic pain (number needed to treat of approximately 9 - i.e., about 1 in 9 patients treated will benefit - n.b. I originally made a math error which an astute reader corrected!!!!). If one starts neurontin, one should beware of adverse reactions. If the patient is receiving no benefit, please stop the drug. If the patient gets significant adverse effect, please stop the drug.

Posted by at 08:34 AM | Comments (24) | TrackBack (0)





Washington Post on Medicare

Medicare Robbery

But the conference now is faced with the need to square the square, keeping on board both Senate Democrats who want to spend even more money and House Republicans who want an even bigger role for the private sector. A few weeks ago, all players involved were talking optimistically of finishing the conference by the end of this month. Now some are talking about September -- or later. Myriad squabbles will doubtless break out over precise numbers, levels of benefit and how much cash should be spent to encourage private insurers, who, so far, have shown little interest in participating in any of the new roles the bill designs for them. Lobbyists have persuaded Congress to add on a wealth of provisions, benefiting groups ranging from rural ambulance services and Alaskan doctors to the weight-management industry. They will no doubt try to add more.

Yet behind the squabbles lurk deeper issues. Of these, perhaps the one that has received the most attention is Medicare's universality. Many Democrats and some Republicans consider this to be Medicare's central attraction. It is a program, they say, that gives the same benefits to everybody, rich or poor, and therefore receives universal political support. To preserve this universality, many are fighting against a provision in the House bill, for example, that calls for people with incomes above $60,000 to pay a larger share of their drug bills. They object on the grounds that nobody should be treated differently.

This kind of thinking helps to illustrate what has gone so deeply wrong with the bill, a piece of legislation that seems to be oblivious to its long-term consequences. In practice, the refusal to countenance any means-testing will set in motion a vast transfer of wealth, from the pockets of America's poorer children -- who will eventually be working adults -- to America's wealthier elderly. The desire to maintain political support for Medicare is understandable, but the zealous opposition to any reform that would provide fewer benefits for the rich is profoundly misplaced. It guarantees the swindling of a generation that cannot vote in order to benefit a wealthy constituency that can.

I agree with the Washington Post. I should not receive the same benefit as someone with little retirement income (I assume that my retirement savings will provide a better than average lifestyle). We should help the needy, but getting older does not necessarily imply neediness.

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Do dust covers work?

Doubt Is Cast on a Remedy for Asthma

The findings of the two European studies, being reported on Thursday in the journal, were so surprising that some doctors vowed to keep recommending bed coverings.

Small studies, conducted earlier, reached mixed conclusions on the value of bed coverings, but strong evidence suggests that blocking allergens relieves symptoms.

Yet the yearlong European studies found no difference in symptoms between people with and without bed coverings. A study in Britain was the largest yet to address the questions, with 1,122 asthma patients. A Dutch study looked at 232 patients with allergies like hay fever.

The researchers and specialists familiar with the findings said so many dust mites might be present that the bedding's benefits were largely eclipsed. Pets, mold and other allergens may also confuse the question.

Strongly held beliefs die slowly. We should heed the data.

Posted by at 06:51 AM | Comments (3) | TrackBack (0)





July 16, 2003


More on the metabolic syndrome

New Definition of Metabolic Syndrome Improves CHD and Diabetes Risk Prediction

Under the NCEP definition, metabolic syndrome is diagnosed if at least three of five criteria are present: increase waist circumference, elevated triglyceride levels, low HDL cholesterol levels, increased blood glucose levels, and hypertension. In the new study, Dr. Sattar's team used BMI instead of waist circumference.

The previous definition, which was created by the World Health Organization, was more complex and relied heavily on evidence of glucose dysregulation. The problem was that by the time such dysregulation was present, the opportunity for preventing diabetes was limited, the researchers note.

Dr. Sattar's group followed more than 5000 men for nearly 5 years to assess the incidence of CHD and diabetes. At baseline, all of the subjects were evaluated for metabolic syndrome based on the modified definition.

Twenty-six percent of the men met criteria for metabolic syndrome, the authors note. Overall, such men were 76% more likely to develop CHD and 3.5-times more likely to develop diabetes than were men without the disorder. When the analysis was limited to men with four or five criteria, the increased risks were even more dramatic--a 3.7-fold increase for CHD and a 24.4-fold increase for diabetes (p < 0.0001 for both).

While we do not yet understand completely the physiology of this syndrome (one could call this problem the genotype), we certainly recognize the phenotype. Physicians implicitly recognize these patients. They populate our offices and our wards. I believe that patients can often prevent this syndrome.

These findings strengthen the call for exercise and prudent diet. Now we need to develop methods for inducing ourselves and our patients to exercise and eat more healthy. As Hamlet says in his famous speech: Aye, there's the rub!

Posted by at 08:27 AM | Comments (1) | TrackBack (0)





July 15, 2003


On hypothyroidism

This story helps us remember the nonspecific presentation of hypothyroidism. We hate to miss this diagnosis, because the treatment is cheap, simple and effective. A Malady That Mimics Depression

Hypothyroidism can mimic many symptoms of major depression, including forgetfulness, low energy and the inability to concentrate. In 1888, the Clinical Society of London published the first major report on the disorder, calling it myxedema and comparing it to childhood cretinism. Its most severe form brings on a reduced level of consciousness and even paranoia and hallucinations.

The next day his mother brought in a brown bag. In it was an empty bottle of thyroid hormone. He had been taking the drug but had stopped six months earlier after it ran out, slowly sinking into an amnesiac delirium that made him forget he needed it, a lapse that almost cost him his life.

Hypothyroid coma has a 20 percent mortality rate even if recognized and treated appropriately.

Every day in emergency rooms, patients get inappropriate treatments because they don't carry lists of their medications. When someone rolls in unconscious, the medication list can be the most valuable piece of diagnostic information.

"Remember to write this down," I told his mother.

After what they had been through, she agreed it was a sensible plan.

So this story gives us a useful reminder about hypothyroidism. It also reminds me that we should always examine the medication list as a possible clue to new symptoms.

Posted by at 01:48 PM | Comments (2) | TrackBack (0)





On HDL cholesterol

Jane E Brody has written a nice discussion of the "good" cholesterol - Cholesterol: When It's Good, It's Very, Very Good

Strategies for raising levels of good cholesterol include medications and changes in diet and habits. Let's start with weight. Overweight or obese people are more likely to have abnormal levels of blood lipids, including low levels of good cholesterol and elevated triglyceride levels. Weight loss raises the high-density lipoprotein levels but not necessarily during dieting. But once the weight is lost, Dr. Miller wrote, "there is a surge in the H.D.L.-C. level of about one milligram per deciliter for every seven pounds lost."

While there is no magic for selectively raising the good cholesterol, certain diets favor a higher level. Interestingly, one of them is not low-fat. If you merely reduce dietary fat and replace it with carbohydrates without also reducing the number of calories consumed, levels of good cholesterol may fall as much as 20 percent, Dr. Miller noted.

But the kind of fats consumed can make a difference. Evidence indicates that foods rich in monounsaturated fats like canola and olive oil, most nuts and avocados can improve levels of good cholesterol without raising the total. Polyunsaturates like corn, safflower and soybean oils tend to lower the levels of both the good and the bad.

The idea, then, is to replace harmful saturated fats and refined carbohydrates (sugars and white starches) with monounsaturates without increasing total calories. Dr. Miller cautioned that by increasing carbohydrate consumption above 60 percent of calories, triglyceride levels rise, even if all the carbohydrates are whole grains.

Dr. Miller favors a Mediterranean-style diet with 30 to 35 percent of calories coming from fat. It consists of lots of vegetables and fruits, nuts and fish but little meat or high-fat dairy products. The best fish are the fatty ones, rich in omega-3 fatty acids, like Atlantic salmon and mackerel.

The article goes on to tout exercise, modest alcohol, and note the modest benefit from cholesterol drugs (like statins).

Posted by at 01:43 PM | Comments (2) | TrackBack (0)





July 14, 2003


The new ACGME rules

Over the past year, I have ranted periodically on the new ACGME rules for residency training. These regulations started on July 1st. Now that I have worked with my housestaff team for almost 1/2 a month I want to share some thoughts.

Any new rules will have pros and cons. The major benefit to the housestaff comes from sleeping in their own bed more often. Our system (described in a June 30th rant - The end of an era) gives housestaff more opportunities to sleep in their own beds. For example, tonight my resident and one of the two interns will leave the VA around 9 and return at 7 tomorrow morning (at which time I will also arrive for post call rounds). The remaining intern will evaluate admissions overnight (up to our 10 patient max) along with a float resident.

When I make rounds tomorrow morning I will notice several things (at least I have noticed these things thus far). The housestaff will be in good spirits. Sleeping in ones own bed does great things for attitude. I will have a receptive audience for teaching. Over the past few years, I almost eschewed post call teaching - but now it has returned! The intern and resident who slept at home will address clinical issues all day on Tuesday.

I actually have little bad to say about our new system. My resident worries that he does not know some patients (those that he did not admit ) as well as others. I believe he actually does, but I understand those feelings. We all want the continuity which stems from the initial evaluation.

I have not seen any patient care problems with the new system. We very carefully work through the "handoff" - including the resident, the float resident and me (the attending physician). The first hour of rounds tomorrow morning concern the "handoff".

I hope some readers have also had experience with the new rules. I understand that our program has had long discussions to develop a workable system. Thus far I believe we are succeeding. I hope some readers can provide more information about their experiences.

Posted by at 09:29 PM | Comments (3) | TrackBack (0)





Step to it

An effort to get America walking seeks to stop obesity in its tracks

Results from the Colorado walking effort are being submitted to scientific journals.

Over 16 weeks, 85 percent of all participants raised their activity level by a total of 2,000-2,500 steps a day, the researchers say. But it will take a year to see if they stabilize, or even lose pounds, and it will take several years to see if the weight loss is sustained.

Like the Colorado experiment, only a fraction of America on the Move participants nationwide will be enrolled in a supervised study. Others can follow the same recommendations independently by registering on the program's Web site.

James Hill, the program's co-founder, says it's the first effort at systematically studying "how you stop obesity from getting worse."

"Our idea is dirt simple," says Hill, director of the Center for Human Nutrition at the University of Colorado Health Sciences Center. "If it doesn't work, we're in big trouble as a nation."

Statistics suggest we already are.

Obesity-related ailments cost $117 billion to treat, and contribute to 300,000 deaths annually, according to federal estimates.

Two out of three adult Americans are overweight, the government says, and they're gaining nearly 2 pounds every year. A quarter of them get virtually no exercise.

This article talks mostly about walking. They believe (as do I) that the key to weight control is movement, not diet. Diet will follow nicely. Quit suing fast food outlets; quit taxing fat content; reward walking, or any other movement.

Posted by at 04:09 PM | Comments (2) | TrackBack (0)





Teaching gets shorted

We all want well trained physicians. We expect superb education. However, our current reimbursement and overhead problems are decreasing medical education volunteerism. Fewer clinical faculty volunteer to teach

"This is a real serious problem that if not resolved will have consequences for all medical students, not just those at Harvard," said Dr. Fingold, who has recruited physicians for teaching positions for 10 years. "The biggest barrier primary care physicians face is increased patient loads, sicker patients, huge documentation requirements and an avalanche of paperwork. The goodwill that used to be there for teaching has been squeezed right out of them. They've nothing left to give."

What's happening at Harvard is happening across the country. It costs 30% more to operate a clinical practice where physicians teach. Departments have productivity goals and budgets to meet. Managed care companies pressure doctors to see more patients for less reimbursement, and time spent teaching is often viewed as similar to fitting in a hobby during one's work schedule. As a result, it is becoming harder to find volunteer clinical faculty to train the next generation of physicians.

David Cardozo, PhD, course director for Harvard's department of neurobiology, got his wake-up call to the extent of the problem eight months ago.

"A few weeks before a core course on patient doctoring skills, the course director said she didn't have sufficient faculty to teach it," Dr. Cardozo said. "We have 10,000 doctors at Harvard, and I thought, 'This is crazy.'

"We can't have our whole faculty wandering around saying that it's too hard to do this. 'Gosh, I have to see patients, go to meetings and write papers. There's no way I can fit in medical students.' Teaching at medical schools ought to be one of the highest priorities," he said.

The great schools will figure out how to prioritize education. We must figure out how to pay educators. Great education takes time and committment.

Posted by at 08:47 AM | Comments (3) | TrackBack (0)





For those seniors who cannot afford their drugs

As stated recently, I doubt that we will have a satisfactory compromise on the prescription drug benefit. In the meantime, there are options. Discount cards can help seniors until Congress passes a drug benefit

This article has great information on the various drug discount programs. Many patients can benefit from these programs.

Seventeen million American seniors don't have prescription drug coverage, but only a small fraction of them are taking advantage of prescription drug discount cards offered by various pharmaceutical companies.

The latest figures show less than 10 percent of that number actually have signed up for the so-called share cards as senior citizen groups such as AARP push Congress to pass universal prescription drug benefits.

That's a shame because the cards offer excellent savings on many of America's most popular drugs and can help needy seniors stretch their budgets until Congress passes the long-anticipated prescription drug benefit.

With the average price of a brand-name prescription running at $70, the cards can help needy seniors afford the top-rated medicines for their specific illnesses and avoid have to take low-cost generics.

Without the proper prescription drugs to treat their illnesses, ailing, low-income seniors are likely to get sicker and require more emergency room visits, more hospitalization and more major surgery.

As the country waits for the federal government to act, seven of America's top pharmaceutical firms are now offering some sort of assistance program to help seniors obtain prescription drugs.

The article goes on to provide links to various programs. I have several comments.

First, why do we need so many programs. Everytime I think about the number of different forms I fill out for free drug programs, I get aggravated. Why not have a single form for all companies? The industry works well as a single voice when lobbying. Why not develop a single program for all companies? Their organization - PhRMA - could sponsor such a program. Our seniors can get discount cards, but it rankles me that patients need so many cards!

Second, we (physicians) must strive to minimize the drug numbers for each patient. I see too many patients who take too many drugs. My rule is that once a patient exceeds 6 prescriptions, we need a careful review. Often we can simplify the regimen, decrease side effects and save money. When patients develop symptoms, we should first think drug side effect - not add another drug.

Third, generic drugs work great! The author uses the term generic pejoratively. I gladly take generics when available - including OTC drugs. The key is the chemical formulation. The FDA checks and regulates generics. They work, they work well, and they work for much less money.

So I present you this article as a public service. It may help you, friends, family or patients. But please note my ranting!

Posted by at 08:39 AM | Comments (2) | TrackBack (0)





July 13, 2003


Is Legionnaire's increasing?

We academic internists love inclusive differential diagnoses. Often we will include Legionnaire's in our differential diagnosis. This report suggests that the incidence of this infection may be increasing. Health Officials Baffled by Rising Number of Legionnaires' Cases

Among the questions officials are trying to answer is whether the increase in the prevalence of the disease is real, whether there might be problems with the urine antigen test used to diagnose most cases, or whether reporting simply has improved.

"We've always assumed that Legionnaires' is pretty underreported," said Richard McGarvey, a spokesman for the Pennsylvania Department of Health.

People contract Legionnaires' disease after inhaling mists from a water source contaminated with the legionella bacteria, which thrives in warm, stagnant water. Sources can include hot water tanks, cooling towers and evaporative condensers of large air-conditioning systems, whirlpool spas and showers.

Symptoms of the disease include fever, chills, cough, body aches, headache, fatigue, loss of appetite and, occasionally, diarrhea. The disease can be treated with antibiotics, but 5 to 30 percent of cases are fatal.

While the disease can affect anyone, middle-aged and older persons are at highest risk, particularly smokers and those with chronic lung disease. Also at increased risk are those whose immune systems are suppressed by medications or by diseases like cancer, diabetes and AIDS.

I will continue to look for Legionnaire's - including it my differential diagnosis. Often we use antibiotics which treat Legionnaire's as past of a more general protocol.

Posted by at 05:24 PM | Comments (0) | TrackBack (0)





An obesity tax?

Tax Policy That Uses Economies of Scales

First of all, obesity often persists as a result of individual choice. It may result from a disease or an inherited condition. But most individuals have the power to affect their own weight through diet, exercise and other habits.

Second, obesity is easily observable. A few measurements are all it takes to place a person somewhere along the continuum from dangerously skinny to Brobdingnagian.

Third, an individual's obesity can affect many people. As a result, it becomes a societal issue as well as a medical problem.

Precisely identifying these effects can be difficult. At least one seems much more important than squeezed seats on airplanes, however. Obesity increases the risk of many medical problems. When someone has a heart attack, chances are either taxpayers or members of a private insurance plan will foot most of the bill. And, thanks to modern medicine, the obese elderly survive almost as long as their thinner counterparts.

Last month, a state assemblyman from Brooklyn suggested a tax on fatty foods to discourage their consumption. An economist might take exception to this plan, because the tax would punish even people who ate such foods in moderation. Of course, that has not stopped similar justifications for taxes on alcohol and cigarettes. Even if you have just one drink or cigarette a year, you still pay heavy "sin" taxes.

Two weeks ago, Kraft Foods decided to lower the fat content of some recipes and reduce the sizes of single-serving snacks. Again, this approach is slightly clumsy. Even if you're eating rice cakes, you'll gain weight if you eat enough of them. And though some Americans may be happy with a smaller packet of cookies, others may just buy two and finish them both. (Kraft said nothing about cutting the snacks' prices in line with the portions.)

Another kind of remedy might have more success. The problem is obesity, not fatty food or anything else that contributes to being overweight. So why not take aim at obesity directly?

Basic economics recommends taxing individual behaviors that hurt society. But taxing overweight people, perhaps by identifying them and then assessing them some social cost of obesity every year, sounds draconian and impractical.

A more palatable solution might be to collect a lump-sum tax from every American and put the proceeds into a reward pool. Each year, anyone who wanted to could go to an existing government office for a simple series of measurements. People who registered normal weights throughout the year would receive cash rewards from the pool ? much like a tax refund.

This system would still tax obesity, though it would not tax the heaviest people more than the merely rotund. Nor would it tax the middle-aged and disease-prone more than the roly-poly young. Nevertheless, the incentive to lose a few pounds might be quite powerful.

He almost has the right idea. I would rather see body fat used as a factor in insurance rates. Rather than a tax, I would like to see health insurance scaled for behaviors - including obesity. Nonetheless, this type of thinking is worthwhile. It encourages us to more explicitly define the problem.

Posted by at 04:20 PM | Comments (9) | TrackBack (0)





Will we have a Medicare bill?

I would guess not. The current bills are huge, technical and significantly different. It appears that House Republicans and Senate Democrats are digging in their heels. Compromise Seen as Harder to Find on Medicare Drugs

Differences between the Senate and the House bills have become more apparent in the two weeks since the competing versions of the legislation were adopted. Now conservative House Republicans and Senate Democrats are issuing ultimatums, threatening to oppose the final legislation if it does not address their concerns.

...

Many Republicans say such competition is essential if Medicare's costs are to be brought under control. But Democrats say the competition and the higher premiums could be devastating to the oldest and sickest beneficiaries, who are most likely to stay with the traditional program.

...

The Senate and House bills have significant similarities, often overlooked in the debate over the most contentious provisions. Both bills are officially estimated to cost $400 billion over 10 years. Both rely on private insurance companies to deliver drug benefits under Medicare, starting in 2006. Both call for drug discount cards, to help the elderly in 2004 and 2005. And both increase Medicare payments to doctors and hospitals in rural areas.

Much of the recent maneuvering is simply an effort to lay down markers for the approaching negotiations. But nobody is sure how much is positioning and how much is nonnegotiable principle.

"The question is: what is the deal killer in the Senate, and what's the deal killer in the House?" said a House Republican strategist. "It's not clear what the walk-away point is for either side. It's just not clear."

I would like to see a good bill. But my limited observation does not suggest that either side has a good bill. I believe that an error of commission would harm us more than an error of omission. We do not need a bad bill. We have enough of those already.

Posted by at 07:20 AM | Comments (1) | TrackBack (0)





July 12, 2003


Walter Olson on medical tort reform

He is the best. His blog, Overlawyered, should go on your daily routine. Here is his update - Kinsley: GOP is right on malpractice

Posted by at 07:07 AM | Comments (1) | TrackBack (1)





The Neurontin story

On May 30th I ranted The whistle blower and Warner-Lambert . Today I found an interview with the whistle blower - Drug giant accused of false claims

DAVID FRANKLIN: "I was trained to deceive, to lie to doctors."

John Hockenberry: "So these doctors were completely misled?"

Franklin: "Absolutely."

Who would train and then pay someone to mislead doctors? Scientist David Franklin says pharmaceutical company Warner-Lambert paid him to do that back in 1996.

Franklin: "It was my responsibility to leverage the trust that physicians had with pharmaceutical companies to corrupt the relationship between the physician and the patient."

John Hockenberry: "Your job was to find trust, and exploit it, to produce more sales for Warner-Lambert."

Franklin: "Absolutely."

Read this account (I assume some readers watched the show) on an empty stomach. The story may cause nausea and disgust.

The pharmaceutical industry has done wonderful things over that past 3 decades. Our quality of life has greatly improved. Our ability to treat many diseases has become enhanced. Just when I start to soften on the industry, I read a story like this. Once again I have anger at the industry.

Posted by at 07:02 AM | Comments (22) | TrackBack (0)





What are they thinking?

I hope readers understand that I am happy to criticize both parties. The Democrats behavior concerning tort reform and the Bush administration's persistent war on medical marijuana both deserve scorn. Today the Justice Department should feel db's Wrath! White House escalates pot war: It asks high court to let doctors be punished

The Bush administration, pressing its campaign against state medical marijuana laws, has asked the U.S. Supreme Court to let federal authorities punish California doctors who recommend pot to their patients.

The administration would revoke the federal prescription licenses of doctors who tell their patients marijuana would help them, a prerequisite for obtaining the drug under the state's voter-approved medical marijuana law.

Justice Department lawyers this week asked the high court to take up the issue in its next term, which begins in October. The department is appealing a ruling by an appellate court in San Francisco that said the proposed penalties would violate the freedom of speech of both doctors and patients.

If the justices agree to review the case, it would be their first look at medical marijuana since May 2001, when they upheld the federal government's authority to close down a pot dispensary in Oakland and others in the state.

The October decision by the U.S. Court of Appeals in San Francisco "effectively licensed physicians to treat patients with prohibited substances" and interfered with the government's authority "to enforce the law in an area vital to the public health and safety," Justice Department lawyers Mark Stern and Colette Matzzie wrote in court papers. The appeal "is a sign that this administration will do everything they can to defeat the will of the voters of California and many other states," said Graham Boyd, an American Civil Liberties Union lawyer for doctors, patients and AIDS support groups. Those groups sued the federal government in 1997 over the policy, which the Clinton administration originally introduced but later decided not to pursue.

In many ways this appeal aggravates me for the same reasons that tort lawyers aggravate me. In my opinion, the Justice Department lawyers want to make medical decisions. They have decided (without any clear data) that medical marijuana (1) does not help patients and (2) endangers the public health. Who are they to decide? Why is this a court issue?

Medicine, while based on scientific principles, does require some artistry. Patients have circumstances which require creative solutions. If some patients and some physicians believe that marijuana can help symptoms (especially lack of appetite and nausea), then any law against that is a law against compassionate care.

But then, why would I expect lawyers to understand? Their training and jobs involve decoding the law in ways that help the side that engages them. While truth is important, truth is not the only goal. Oft times lawyers must (and this is not meant as criticism) ignore truth so that they can advocate for their client. Here the Justice Department has (in my opinion) misunderstood their client. I wonder if the majority of our citizens would favor their interpretation here. Hopefully the Supreme Court will not accept the case. If they do, I hope they show common sense.

Posted by at 06:52 AM | Comments (1) | TrackBack (0)





July 11, 2003


Senator Enzi on medical liability reform

Many readers know that I have become a fan of Our Common Good. This organization is working to provide common sense in tort matters. They have an important piece from Senator Enzi that everyone should read: Statement of U.S. Senator Mike Enzi on Medical Liability Reform. He ends this statement:

When I spoke on this bill yesterday, I said that the current medical liability crisis and the shortcomings of our medical litigation system make it clear that it is time for a major change. I also said that regardless of how we vote on this legislation before us, we all ought to start working toward replacing the current medical tort liability scheme with a more reliable and predictable system of medical justice. I've heard Members on the other side of the aisle say that they want to work with Republicans to find a better way to solve this problem ? to find reasonable, good-faith alternatives to this legislation. If we vote not to proceed to this bill, I hope that process will begin sooner rather than later. The people of Wyoming and other states in crisis cannot afford to lose any more doctors than we've already lost. If we do not proceed to this bill today, I also pledge to continue working to find solutions to this medical liability crisis. I hope that Members on both sides of the aisle will also take this pledge to keep working on this. I yield the floor.

Please read his statement, and then explore the entire site.

Posted by at 02:12 PM | Comments (0) | TrackBack (0)





Medpundit on tort reform

Get out of here - go read what she says - The Threat to Medical Innovation

Posted by at 12:32 PM | Comments (1) | TrackBack (0)





Who should judge malpractice?

Educated Guesswork rags on my idea of having physicians judge malpractice - Doctors punishing doctors? Given the following criticism I would like to clarify my points:

It's not like there would be any conflict of interest in having doctors judge other doctors. They wouldn't circle the wagons or anything like that. That would never happen.

Well this represents an excellent use of sarcasm, however one cannot really classify these statement as criticism. Physicians do want to see high quality care. State medical boards do censure other physicians regularly. While we may do a great job of self-policing, we are improving. I believe (as a physician) that we could develop a system which would protect patients.

Physicians have the knowledge to review the chart, interview the patient and the physician. They will less likely succumb to legalese. They will less likely provide a "verdict" based on sympathy for the "victim". I truly believe that non-physicians would have great difficulty judging patient care decisions. It takes medical school, residency and continuing practice to understand many intricacies of patient care. Lawyers would not like a rational solution, because they would prefer sophistry and other legal tricks.

I am advocating a system which tries to judge truth. I thought that was the goal of our legal system. Our point (and here I do believe I speak for most physicians) is that our current tort system make truth only one of many variables in the legal equation. All too often other variables trump truth. We would support any rational system of judging our performance. The current tort system does not meet that standard.

Posted by at 06:47 AM | Comments (12) | TrackBack (1)





On improving quality

I often focus on quality studies, since our research group specializes in such studies. Medicare has started an interesting experiment at the hospital level - Medicare test will tie dollars to quality of care

Medicare began an experiment Thursday to see whether the promise of more money will translate into better patient care in hospitals, the first time the government has tied payments directly to quality of medicine.

Under the three-year demonstration, hospitals that do the best job caring for patients with five specific conditions will be paid extra; any that fail to meet minimum standards will lose money.

"Think of it as a bonus system for hospitals," said Health and Human Services Secretary Tommy Thompson. "Just as individuals earn bonuses for high-quality work on the job, we are going to reward hospitals that excel."

The conditions being measured are heart attack, heart failure, pneumonia, coronary artery bypass graft and hip and knee replacements. Each of these ailments is associated with standard care measures that will be used to judge hospitals.

For instance, a hospital will get credit for prescribing aspirin to patients after bypass surgery, but lose credit for every person with a knee replacement who had to be readmitted within 30 days.

Officials hope that the financial incentives, combined with publicity about which hospitals are best, will motivate hospitals to meet certain key quality indicators.

This test makes the credible assumption that a good way to improve quality comes from stimulating an organization (here the hospital) to develop systems to stimulate quality. Successful hospitals will not rely on individual physicians. Rather they will use a various methods to strongly suggest, question, and ultimately stimulate correct quality care.

I hope this test has rigorous methods attached (and assume that it does). We may learn much from such a demonstration.

Posted by at 06:33 AM | Comments (1) | TrackBack (0)





Phamaceutical companies try to deny the truth

I just might be unbiased. I doubt it, but I have received criticism that I am pro pharmaceutical companies, and criticism that I am blindly anti pharmaceutical companies. That diversity of criticism makes one suspect that perhaps there is a quest for truth herein. Today you decide. Study Finds Drug Costs Are Soaring for Elderly

The study, which was issued yesterday by Families USA, a consumer group, shows "how important it is to offer significant subsidies to the lowest-income seniors," Ron Pollack, the group's executive director, said in a telephone interview.

As many as half of the elderly do not have insurance for drugs for some part of the year, he said, because they either lack coverage or have exceeded the limits on their policies, which frequently cap the amount the insurer must pay.

Prices for the 50 drugs increased an average of 6 percent, compared with a rise of 1.8 percent in the Consumer Price Index, excluding energy prices, the study said. More than half of the drugs increased by three or more times the inflation rate, while a quarter stayed the same.

Over the years, drug prices have consistently outpaced inflation, said Mr. Pollack, who noted that these increases are particularly hard on the elderly, who are often on fixed incomes.

An elderly person without coverage buying Lipitor, Vioxx, Synthroid and Fosamax would pay nearly $3,000 a year for all four drugs, Families USA said.

The study met with sharp criticism from the pharmaceutical industry, which argued that many elderly people were able to buy drugs at discounted prices. "Regrettably, Families USA has decided to continue complaining about prescription medicines, rather than to pitch in and help seniors get the medicines they need," the Pharmaceutical Research and Manufacturers of America, a trade association, said in a statement. "Instead of misleading seniors by referencing only undiscounted prices, it should be helping them gain access to the life-saving, cost-effective medicines they need."

Some economists read this site. They appropriately jump all over me when I beat up the pharmaceutical companies too much. Perhaps they can explain the hyperinflation of drug prices. Perhaps they cannot.

Posted by at 06:24 AM | Comments (5) | TrackBack (0)





July 10, 2003


The main point of today

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Posted by at 08:35 PM | Comments (1) | TrackBack (0)





On the metabolic syndrome

Periodically I rant about the metabolic syndrome. It is endemic in Alabama - we are number 1 in adult onset diabetes mellitus (per capita). This commentary in the BMJ brings us up to date on the syndrome. The metabolic syndrome

The worldwide epidemic of type 2 diabetes is fuelled in large part by a parallel epidemic of obesity and physical inactivity, clearly pointing to prevention of obesity as the most direct route to prevention of the metabolic syndrome and its sequelae. From this perspective, perhaps the best reason to consider a diagnosis of the metabolic syndrome is to identify obese people who are most likely to benefit from aggressive efforts to achieve a healthy weight, physical activity habits, and normal risk factor levels. In the end, even modest changes towards a healthy lifestyle may be the most direct route to treating the metabolic syndrome and preventing its type 2 diabetes and cardiovascular disease outcomes.

While defining the metabolic syndrome remains controversial, the goals of treatment and prevention are not. We need to increase our activity. We need to eat healthy foods and portions.

Posted by at 07:54 PM | Comments (0) | TrackBack (0)





Medical marijuana legal - in Canada

Canada to Offer Marijuana to Medical Patients

The cabinet is divided on whether the government should be growing and distributing marijuana, an activity that is otherwise illegal. Ms. McClellan noted today that there is a lack of clinical evidence that marijuana has medicinal benefits. She added that the government will conduct its own clinical trials, scheduled to begin this fall, to gauge possible benefits.

The government says it intends to distribute the marijuana through doctors. Some officials of doctors associations have raised cautions about doing so before there is more study about the impact of marijuana use on people's health.

While the courts decide on the government's appeal, Ottawa will provide as many as 500 people, who have received letters from doctors saying the drug offered them medical benefits, with dried marijuana and marijuana seeds for their own planting.

We will follow the Canadian experience closely. Why are they socially more progressive?

Posted by at 07:48 PM | Comments (6) | TrackBack (1)





Big food is responding

"Big Food" is changing what they sell. 'Big Food' Gets the Obesity Message

Trying to stay one step ahead of the regulators, Kraft, McDonald's and Frito-Lay have all said they will work to reduce or eliminate artery-clogging trans fats from their foods. The Food and Drug Adminstration has not yet determined how much trans fat is acceptable, but yesterday the agency said it would require food makers to start listing the amount in their products on the labels. That is the least that can be done to help consumers avoid some particularly unhealthy fats that are ubiquitous in snack foods, baked goods and many offerings at fast-food outlets and family-style restaurants.

Skeptics worry, with good reason, about the depth and sincerity of the food industry's late-inning conversion to healthy eating. An industry that has prospered by selling high-fat, high-calorie or sugary foods in ever larger quantities will probably be loath to deviate too much from a proven path to profits. But any smart chief executive will feel the increasing pressure from public health officials to combat obesity and will heed recent warnings from Wall Street that big food companies with a high percentage of unhealthy products face major legal and financial risks. If the companies are really serious about refashioning and downsizing their products, they can give a major boost to the global fight against obesity.

I remain skeptical. I do not think that food composition is the problem as much as lack of exercise. When one examines the data carefully, our biggest problem is activity (or the lack thereof). But maybe this will help.

Posted by at 07:45 PM | Comments (6) | TrackBack (0)





July 09, 2003


A plea for malpractice

Please read the comments contained herein - New Jersey game of chicken. The writer tells a story which moves any reader. It is certainly possible that a physician erred. Without reviewing the records, one cannot tell.

While this story is poignant, it does not change my position. The accused physician should have his records and other evidence judged by a panel of peer physicians (perhaps from another state to decrease conflicts of interest). That panel could best judge whether the physician made errors. They could then authorize appropriate payments. We all agree with the payment of legitimate damages. Physicians want a cap on punitive damages only. The writer, if the victim of medical error, deserves financial support for medical care and disability and the equivalent of his expected income. Our position would not deny that.

Posted by at 12:22 PM | Comments (6) | TrackBack (1)





More on the medical marijuana front

I am beating this horse to death - but I find it necessary to continue to rant. Judge seeks help from pot advocates: Hunting for a legal 'hook' for injunction

A San Jose federal judge, expressing sympathy for the suffering of terminally ill patients, asked medical marijuana advocates Monday for a legal "hook" to grant an injunction halting federal raids against a free Santa Cruz pot cooperative.

During arguments before U.S. District Judge Jeremy Fogel, patient advocates said their case was unique among federal-state pot skirmishes. It is the first time local government officials have joined in a legal battle to stop federal drug agents from raiding a medical marijuana operation.

In this case, officials of the city and county of Santa Cruz have joined in seeking to stop a repeat of the controversial September crackdown on Wo/Men's Alliance for Medical Marijuana, during which the cooperative's entire 2002 pot crop was seized.

Fogel said he was moved by accounts of how 15 patients had swiftly and painfully died since the raid deprived them of their pain-relieving pot, but he warned that federal law and court precedents don't allow exceptions for marijuana use even for medical necessity.

In December, Fogel rejected a request by WAMM founders Mike and Valerie Corral to force the federal government to return the 160 pot plants that were seized.

"Frankly, I'm looking for a hook that's very different from the one I've looked at and been forced to reject," said Fogel, who vowed to issue a quick ruling on the injunction request. "I would need something new and different other than someone saying: 'Judge you got it wrong last time.' "

So on this issue we have a judge who is strictly interpreting the law. Judges often interpret laws as they wish. This judge wants a rationale.

What we really need is a new law! What national politicians will have the courage to address this issue rationally? Send me your suggestions. I have not seen anyone with the intestinal fortitude to walk down that street.

Posted by at 12:15 PM | Comments (5) | TrackBack (1)





Trial lawyers and the Democrats

Political Malpractice: Trial lawyers ask Democrats to walk the plank--again.

Democrats are expected to muster the 41 votes needed to kill medical liability reform in the Senate today, so why are Republicans smiling? Perhaps because they know they're teeing up what promises to be one of their better issues going into 2004.

Democrats have long made the Senate the graveyard of any and all legal reform. The news is that they're having a harder time getting away with it. The scandal of asbestos litigation has forced them at least to bargain on that issue, while momentum is also building to limit class-action suits. It says something about Tom Daschle's devotion to the trial bar that he's willing to ask his Members to walk the plank even on medical liability, just as voters are discovering the damage it is doing to health care across the country.

Read the entire article. I do believe that malpractice is becoming an important issue - and not just for doctors and doctor blogging. We must continue to educate the public about the problems with our current tort system. The Wall Street Journal makes a nice contribution to education here. Shame on the Democrats!

Posted by at 07:50 AM | Comments (2) | TrackBack (0)





The problem with precise rules

Desperate dieters gain weight to qualify for surgery

While celebrities like singer Carnie Wilson and weatherman Al Roker are boasting of dramatic results from their own weight-loss surgeries, a darker side to the sometimes risky procedure is beginning to emerge. Desperate patients who are turned down for the surgery because they don't weigh enough are returning to doctors' offices weeks or months later after intentionally gaining 10, 15 or even 25 pounds to qualify.

The phenomenon isn't widespread. But it is one reason that the American Society for Bariatric Surgery last month decided to hold a major conference next spring to re-evaluate the guidelines for who qualifies for the surgical procedure, which essentially shrinks the stomach, prompting drastic weight loss.

"This is not at all isolated -- it's happening," says Walter J. Pories, past president of the ASBS. "We should not be forcing patients to overeat" in order to get surgery.

To qualify for surgery, a patient must be at least 100 pounds overweight or have a body mass index of at least 40, putting them in the high-risk category of the morbidly obese. (BMI is a formula based on weight and height.)

At that point, doctors consider the risk of being overweight to be bigger than the risk of the surgery. In some cases, patients with a BMI above 35 are considered for the surgery if they have other life-threatening health problems such as heart disease that could be helped by weight loss.

If a patient doesn't meet the guidelines, insurers won't pay for surgery and most doctors won't operate even if the patient offers to pay for it themselves.

We must always remember that guidelines are just that - guidelines. Somehow we must insert a common sense factor into medical care. We make many decisions each day on whether or not to use a particular drug for a medical condition. These decisions weigh the pros and cons of the drug or surgery. Many such decisions take the patient's quality of life into account. The surgeons who tried unsuccessfully to separate the Iranian conjoined twins understood the risk of the surgery. The twins understood. They felt it worth the risk.

How do we define morbidly obese? The definition should include some leeway for common sense. If a 5 foot woman is 90 pounds overweight, is she not morbidly obese. We need better definitions, but we always need room for careful clinical judgement.

Posted by at 07:45 AM | Comments (2) | TrackBack (0)





My point exactly

This week I have blogged several times on 'illegal drugs'. This policeman makes one of my points beautifully - Victims of the War on Drugs

Most citizens in and out of our ghettoes, including drug users, despise drug dealers. But nobody supports heavy-handed drug enforcement.

Those at the receiving end of our drug policy know it simply doesn't work. People will riot as long as police keep locking them up without anything getting better.

Liberals are correct to note that rioting does not happen in the absence of poverty, poor education and poor policing. Conservatives are right to blame the individual rioters. But both sides miss the central point: The problems that lead to riots stem from the drug trade. Eighty years of failed drug prohibition have destroyed swaths of urban America.

While the damage from heroin and cocaine use is real and severe, prohibition creates an illegal market based on cash, guns and violence. While drug use can destroy an individual, the illegal and violent drug trade destroys whole neighborhoods.

If the war on drugs were winnable, we would already have won it. Drug prohibition criminalizes large segments of the population, even the majority in some areas. Police can't hire from some areas they police because not enough men reach hiring age without a drug conviction.

We need to accept the fact that drug addiction is a personal and medical problem. We need to push violent dealers off the street even if it means tolerating inconspicuous and peaceful indoor drug dealing.

Users don't belong in jail. Drug dealers see themselves as businessmen. Arrest one and another will quickly move to take the market. As long as addicts need to buy, somebody will sell.

How can tolerance lower drug use? We can learn from our already legal recreational drugs.

In 40 years cigarette smoking has decreased by half. This is a great victory against drugs. Public education hammered home the harm and changed our culture's attitudes towards tobacco.

Alcohol prohibition was tried and failed. Few argue that alcohol is an absolute "good." But for the most part people are happy with their localities regulating sales, balancing the rights of individuals with the harm to society. For both tobacco and alcohol, high taxation discourages new users and raises money for education.

We should implement similar policies for drug use. Treat drug abuse as a medical problem. Separate the problems of drug use from the violence of the drug trade. Acknowledge that drugs are bad, but don't frame drug policy as a moral war against evil.

Until we do these things, people in communities such as Benton Harbor will be under siege and sparks will set off riots.

Our current drug laws harm the fabric of society. They lead to less trust of government and the police. They create too many criminals. And I believe the laws are based mostly on moral objections.

We should discourage drug use. We should penalize the combination of drug use and criminal activity or driving or working with heavy equipment. But much drug use represents an issue of personal responsibility. Just like responsible drinking represents an issue of personal responsibility. Laws are not the answer here.

Posted by at 07:35 AM | Comments (0) | TrackBack (1)





July 08, 2003


Medical marijuana

Some readers, some physicians, and many politicians think medical marijuana an oxymoron. If smoking marijuana gives relief to a patient, why should we deny that relief. We provide high grade narcotics gladly to our palliative care patients.

Medical marijuana should be a medical concern, not a legal concern. On this I strongly disagree with our government. Medical Marijuana Backers: Raid Illegal

A Drug Enforcement Administration raid on a farm that cultivated pot for ailing patients was both illegal and immoral, medical marijuana supporters argued at the start of a federal trial Monday.

The trial comes three months after the city and county of Santa Cruz sued the federal government over the raid, demanding that agents stay away from a farm that grows marijuana on a quiet coastal road about 15 miles north of the city. In September, agents uprooted about 165 plants and arrested the owners of the Wo/Men's Alliance for Medical Marijuana.

The lawsuit claims that seven patients have had their marijuana intake substantially decreased since the raid, and that the farm has been unable to provide members with necessary medicine to relieve nausea, pain and other chronic conditions.

This has caused an "insurmountable" level of pain and suffering and hastened the deaths of the most vulnerable patients, lawyers said.

"We are not asserting the right to market marijuana, but to cultivate and use it to prolong life and give comfort to the dying," said Santa Clara University law professor Gerald Uelmen, who represents about 200 chronically and terminally ill people. "We are asserting the fundamental rights of patients ... so they can meet their death without agony and suffering."

The case pits state rules on medical marijuana against federal laws declaring it an illegal drug, and it marks the first time a public entity has sued the federal government on behalf of patients who need medical marijuana.

Marijuana is illegal under federal law. State law in California and seven other states allows marijuana to be grown and distributed to people with a doctor's recommendation.

The article continues with a clear discussion of the legal arguments. While I will sit here rooting for Santa Cruz, I regret that we need such lawsuits. The arguments against medical marijuana seems so puritanical as to be laughable. But then palliation is not a laughing matter. If marijuana provides another tool to maintain quality of life, why should we as a society deny patients. AAAAAARRRRRRGGGGGGGGGGHHHHHHHHHHH!

Posted by at 08:46 AM | Comments (5) | TrackBack (1)





Withholding information

Sometimes we (physicians) do not do the right thing. Many Doctors Withhold Info From Patients

Nearly one in three doctors reports withholding information from patients about useful medical services that aren't covered by their health insurance companies, and the number may be on the rise, a study reports.

Study authors say their work offers the first empirical evidence for what many have long suspected: that coverage limitations imposed by managed care are infiltrating doctor-patient communications.

``Patients aren't getting the whole story,'' said Matthew K. Wynia, director of the Institute for Ethics at the American Medical Association and lead author of the article being published in the journal Health Affairs.

Wynia and his colleagues surveyed 700 physicians and asked how often they had decided not to offer a ``useful service to a patient because of health plan rules.'' Forty-two percent said never, and 27 percent said rarely.

But 23 percent said ``sometimes,'' and 8 percent said ``often'' or ``very often.''

The results harken back to several years ago, when some managed care companies barred doctors from discussing medical options not covered by the health plan. Public outcry persuaded most companies to drop those rules, known as ``gag clauses,'' and many states banned them from contracts.

The study found that doctors whose own salaries are closely tied to controlling costs were more likely than other doctors to report withholding information.

In addition, those who serve a large number of Medicaid patients were more likely to stay silent, as were those who believed patients might want them to deceive their insurance companies to get services covered.

Authors note an important caveat: The term ``useful service'' was not defined in the survey. To one doctor that could mean steering a patient to a generic drug rather than the more expensive brand-name version, while to another it could mean not mentioning a major surgical procedure.

Interpreting these data are very difficult. We could quickly chastise physicians, insurers, or society. However, I remain skeptical about survey design. They did not ask physicians about specific situations. This report may induce unwise interpretations. Someone should have thought through the survey design prior to collecting the data.

Posted by at 08:37 AM | Comments (1) | TrackBack (0)





On expert witnesses

Expert medical witnesses face review: Lawyers say move intimidates doctors

Feeling under siege by malpractice lawsuits, medical societies are setting up tribunals to review the testimony of doctors who act as expert witnesses in malpractice cases.

Doctors whose testimony does not pass muster can be suspended or expelled from the societies.

Lawyers who represent those suing doctors in malpractice cases say such reviews and the threat of sanctions are meant to intimidate witnesses. They say the mere existence of the reviews has made it harder to find experts, whose testimony is crucial in most malpractice trials.

The idea for the grievance review seems to have started with the American Association of Neurological Surgeons, which has prevailed in three court battles over their legality. Societies of obstetricians, gynecologists and spine doctors followed, and societies of anesthesiologists and ear, nose and throat specialists are expected to vote on establishing similar procedures this summer and fall.

"There are probably another 10 that are studying it closely," said Russell M. Pelton, a lawyer in Chicago who represents the neurosurgeons' association.

The American Medical Association supports the moves, said Dr. Donald J. Palmisano, the association's president-elect.

"The giving of expert testimony should be considered the practice of medicine, and it should be the subject of peer review," Palmisano said. "If someone comes into court and gives junk science, we don't want fraudulent testimony in court."

We (physicians) all know that there are "witnesses for hire". Testifying in malpractice cases results in significant billing and collection. Lawyers gladly pay (as do insurers for defense work).

The challenge for juries is to evaluate the experts. Each side will have experts who will argue for their position.

If the plantiff's expert is really an "expert for hire", then his/her credentials become very important. If the expert gives scientifically unsound testimony, then he/she should receive censure.

This tactic makes great sense. If we expect physicians to police ourselves, then we should include expert testimony among the activities that we evaluate.

The plantiff's lawyers want to get the most convincing expert testimony that money can buy. The tort system cannot provide a fair assessment of malpractice. We need a new system; one based on true expert review. We need peer evaluation. But then the trial lawyers could not charge a percentage of the damages.

Surprise, surprise, if you want to understand the true problem in malpractice, just follow the money. And when you do, it goes mostly to the trial lawyers.

Posted by at 08:28 AM | Comments (2) | TrackBack (0)





July 07, 2003


More on drug legalization

My post yesterday on drug legalization has received a healthy response. I love the give and take. Today I will take some comments and expand my thoughts.

The toll in the number of destroyed lives, and of occasional deaths, testifies to the other side of this story. The rationale is being peddled that legalizing these drugs will reverse statistics. That is not likely to happen. Legalization will destroy the drug lords and all the pimps involved in their distribution, but they will not make Americans more virtuous and less dependent on them. If we go back to the Prohibition Act as a parallel, its demise did not curb the American instinct to drink; to the contrary, it has created a class of addicts who have populated the margins of our society.

I do understand this argument. I personally am not advocating such drug use. However, I do not see our current laws preventing drug use. Perhaps, in a perverse way, our laws encourage drug use. Given the profit motive, drug lords work hard to get more people to use drugs.

We always have to ask about the relative costs. I stake my position on a belief that the cost of our current laws (in violence, criminalization and even disease from 'dirty needles') greatly exceeds the costs of legalization. Some people will use drugs regardless of the laws. Some might try drugs if they were legal. I believe that we will have less problems as a society if we legalize than we currently have.

I agree with your comments regarding drug policy. The impact of violence arising from illegal drug markets is even worse than you describe here, however. In countries where drugs are produced, entire regions or even whole countries have collapsed into warlordism and kleptocracy as armed gangs and juntas struggle for control of what may be the country's largest cash crop. Afghanistan, Burma, and Columbia suffer from our drug policies, too -- any hope of having a safe, democratically controlled country is dramatically undermined by large illegal drug operations run by warlords in cooperation with corrupt governments.

These are points well made. Our drug laws have a negative impact around the globe.

I haven't had a chance to read the Slocum article, but I'll say this -- I'm in favor of legalizing drugs, but I would be a lot more enthusiastic about it if there existed some reasonably effective (say, success rates of at least 75%) to treat drug addiction.

The methods we have today are, to put it bluntly, ridiculous: people go off to a resort (of sorts), where they sit in a circle, complain about their lousy childhood, and promise to turn their will and their lives over to the care of God (AA's third step). After a month of this, they're returned back to society.

Again, we have well made points which seem (to me) tangential to my main argument. I do not believe that we decrease drug addiction through laws. In fact our laws may make it more difficult to address the underlying problems.

We must decide how to allocate our resources. Should we spend governmental moneys on jails, courts, lawyers, etc. or should we invest in a better understanding of addiction and its treatments? The answer seems so obvious that I cannot fathom why we have gone down this destructive path.

Maybe we need to limit our efforts at one drug: marijuana. No deaths, so far as I know, have been reported with its use and is probably not any more toxic than alcohol. A few states in fact have decriminalized the drug although its use at present is mainly for medicinal purposes.Legalizing marijuana would represent a positive step (and one that I strongly support). Perhaps that is all our puritanical society can accept. However, the gains from legalizing marijuana actually pale when compared to the gains from more widespread legalization.

Posted by at 12:31 PM | Comments (8) | TrackBack (1)





July 06, 2003


Q&A 14

I have not had time for an extensive Q&A, but this question deserves some ranting.

I would still be interested in your input regarding my earlier comment on your post on Quality Medical Care. Recent experiences of my own make me doubt that healthcare is even as rational as "rationed by ability to pay." I have excellent health insurance and the ability to pay out of pocket for what I need, but here in Boston it is virtually impossible to get a doctor's appointment with a GP or an obstetrician (forget about a specialist), even when I tell them I'm recovering from a pulmonary embolism that landed me in the hospital. Is there a doctor shortage? If so, money doesn't appear to move you to the front of the line. What is going on? No one seems to know, or at least want to discuss it.

Amazingly, I do think we have a doctor shortage. The shortage is subtle, but known to most practicing physicians. It differs among specialties.

I am often asked to help someone find a physician. Despite working in a major academic medical center, I find this a difficult task. Access seems no better in the private sector.

We need more first contact physicians - internists, family physicians, and obstetricians. Obstetricians are leaving practice secondary to malpractice costs. Internists and family physicians are leaving for the reasons that I state almost weekly. Overhead continues to increase while reimbursement is either flat or decreasing.

From the physician viewpoint, medical care does not work as a free market. Our patients get first preference of our time. Eventually you fill your practice and no longer take new patients.

I know that this does not make sense. It seems counterintuitive to me. We have often little incentive to accept an additional patient. Patient care is suffering - and ability to pay (while a factor) does not necessarily help one find a physician.

I expect some excellent comments from my physician readers.

Posted by at 08:49 PM | Comments (4) | TrackBack (0)





On our drug laws

I argue here periodically that we should legalize all drugs. When I first announce this, I generally receive strange looks. We are so conditioned to view "drugs" as evil that we have a difficult time working through the pros and cons of our current prohibitions.

The editor of Reason magazine (Jacob Sollum) has recently published a book which seems to explain my points better than I generally do. Saying Yes:
In Defense of Drug Use

After decades of a futile war on drugs, Saying Yes makes public what many Americans discuss only in private: Drug use as it is described by politicians and propagandists is dramatically different from drug use as it is experienced by the silent majority of users--the decent people who, despite their politically incorrect choice of intoxicants, lead productive and fulfilling lives.

In Saying Yes, Jacob Sullum argues that illegal drug use should be viewed the same way as drinking, with an emphasis on temperance rather than abstinence. Sullum rejects the idea that there is something inherently wrong with using chemicals to alter one's mood or mind. He uses compelling stories about real people to illustrate the point that there is such a thing as responsible drug use.

The drug war is based on the demonization of drugs and the people who use them. The assumption that certain drugs cannot be used responsibly is one of the biggest obstacles to drug policy reform. By refuting this myth, Saying Yes takes a bold and important step toward ending the nation's costly and devastating war on drugs.

Now most readers (including me) will probably not spend over 20 dollars for the book. For you (and me) I provide this link to an interesting opinion piece from the SF Chronicle - Reefer gladness:
Drug users in the next office and atop the corporate ladder

The fact that responsible drug use is not only possible but typical has important implications for the drug policy debate. Honest supporters of the drug laws have to acknowledge that the case for prohibition rests on a morally questionable premise: that it's acceptable to punish one group of people for the sins of another -- in this case, that the majority of drug users, who do not harm others or even themselves, should suffer because of a minority's failure to exercise self-control. The drug laws can be defended only in the way that alcohol prohibition might have been defended by someone who acknowledged that the typical drinker was not an alcoholic: by claiming that the burden imposed on the innocent majority is justified by the harm that a minority would otherwise cause to themselves and others.

Such a policy will strike many people as fundamentally unjust. Certainly it seemed that way to Clarence Darrow. "Prohibition," the renowned attorney remarked, "is an outrageous and senseless invasion of the personal liberty of millions of intelligent and temperate persons who see nothing dangerous or immoral in the moderate consumption of alcoholic beverages."

Temperate users of other drugs have at least as much cause to be outraged.

I would take the argument several steps further. Our current drug laws cause most college students become criminals and thereby distrust the law. Ask college students about marijuana and they cannot understand why we criminalize this drug. They all see less damage to and from marijuana smokers than alcohol causes.

When any of our laws makes no sense, then one necessarily begins to question all the laws. This position will make sense to all readers with a libertarian bent, but will seem strange to those who want to use laws for moral enforcement.

If that argument does not persuade, then I offer the cost argument. Our current drug laws artificially raise prices (supply and demand curves work extremely efficiently with illegal purchases). For those who become addicted (and yes I understand that some users will get addicted), then price becomes no object. If they need their drug, they will obtain the money. Hence, some drug use leads to crime.

Moreover, illegal markets can lead to huge profits, thus competition thrives. Because the markets are illegal, and the profits are huge, we get violent competition. This violence undermines society, especially in financially disadvantaged neighborhoods.

Thus, we have a war on drugs, which in many ways decreases respect for the police, the government and our legal system. We stimulate violent criminal activity through our laws. We send all the wrong messages. Why do we persist in such destructive behavior?

Posted by at 08:13 AM | Comments (5) | TrackBack (1)





The food police

This is a long article, but many will find it interesting. The Anti-Pleasure Principle: The "food police" and the pseudoscience of self-denial. This article discusses the pronouncements of the Center for Science in the Public Interest (CSPI). This group apparently tries to tell us what not to eat. The article goes into great depth on the evils of many foods. For example:

CSPI?s resistance to diet soda -- an innovation you might think the organization would embrace, given its frequently expressed concern about the "epidemic of obesity" -- is a matter of prejudice, not science. It reflects the group?s preference for the natural over the synthetic, its dislike of big business and mass trends, and, perhaps most fundamentally, its suspicion of pleasure without pain, of enjoyment unencumbered by fear. That suspicion is the thread that runs through CSPI?s uneasiness about artificial sweeteners and caffeine, its dire warnings about fat and salt, its campaign against the fat substitute olestra, its hysteria about acrylamide in French fries, its discomfort with food irradiation, its condemnation of the imitation-meat product Quorn, and its opposition to alcohol consumption as a way of preventing heart disease. For those who share its asceticism, CSPI offers pseudoscientific rationales to justify their phobias.

The author runs through many examples of CSPI pronouncements. He finishes with this humorous paragraph.

If CSPI?s hypervigilant lifestyle seems overwhelming, you can start small. Avoiding olestra and Quorn is easy enough. Then you can move on to alcohol, caffeine, diet soda, nonorganic produce, salt, sugar, fat, and the rest of CSPI?s food taboos. Soon, perhaps, you will feel safer and healthier, or at least more virtuous. For my part, I think I?ll try some cheese fries with ranch dressing. They?ve never tempted me before, but if CSPI says they?re "worse than anything we?ve analyzed," they must be pretty damned good.

Posted by at 07:51 AM | Comments (0) | TrackBack (0)





Do anti-pharmaceutical groups inhibit new HIV drugs?

This commentary implies that anti-pharmaceutical industry organizations are having a negative impact on future development of HIV drugs. AIDS drug incentive dilemma

Dr. Des Martin, president of the South African HIV Clinicians Society, suspects that "among several reasons, the threat of generic competition and attacks on multinational companies could be behind the recent decline in HIV anti-retroviral compounds." Some drug company boardrooms are certainly switching investment from AIDS research into areas where they can still make profits, such as erectile dysfunction and baldness.

As drug prices have fallen more than 90 percent in poor countries, treatment of the afflicted has risen, but not by much. Why? Prices are a small factor in creating access to AIDS drugs. However, the price fixation of left-leaning health nongovernmental organizations (NGOs) has led them to concentrate on this issue at the expense of more important matters such as building health infrastructure and training medical personnel. While the Bush team commendably plans to spend money on these essential components, it seems to be unaware of the long-term harm of the anti-pharma campaigns. It may even compound the problem as it announced that the Bush program will purchase generics from Indian producers.

I need more data here. We do need a balance between greed and enough profit to incentivize research. How do we balance the drug company's interests and the interests of poor countries with overwhelming numbers of AIDS patients.

We need incentives for HIV drug research. Pharmaceutical companies, like all companies, exist first to make a profit for the owners. They will apportion their resources in those areas where they expect the highest probability of return on investment.

Thus, we have a dilemma. We can easily ponder the questions and conjecture hypothetical answers. In the meantime the international AIDS epidemic is not decreasing.

Posted by at 07:43 AM | Comments (2) | TrackBack (0)





Tort reform unlikely

I think the Democrats just get too much money from the trial lawyers. Short of Votes, Senate G.O.P. Still Pushes Malpractice Issue

A bill that would impose strict limits on jury awards in medical malpractice cases ? a central element of President Bush's plan to revamp tort law ? appears headed for defeat in the Senate. But the majority leader, Bill Frist, intends to introduce the measure on Monday anyway, forcing a vote that could be used against Democrats in the next election.

The bill, similar to one the House passed in March, would limit awards for pain and suffering to $250,000.

The bill has no Democratic sponsors, and Republican leaders, including Dr. Frist and Senator Mitch McConnell, the Republican whip who will manage the bill on the floor, concede they do not have the 60 votes needed to overcome a filibuster.

"It's going to be difficult," Mr. McConnell said.

A vote could occur as early as Wednesday. But proponents say that even if they lose, as expected, the issue is not dead for this Congress.

Instead, Dr. Frist, who has made malpractice changes a signature issue, hopes the vote will force lawmakers to take a stand. That would expose them to more pressure from lobbyists, and might yield a compromise later in the year.

So we have a national problem (admittedly worse in some states than others). We may have no acceptable solution. The politics are bothersome.

With medical liability premiums rising and some doctors leaving their practices as a result, proponents of malpractice changes say caps on jury awards are necessary.

Doctors, insurers and business groups, all of whom contribute substantially to Republicans, are lobbying heavily for the bill.

But opponents, mainly trial lawyers and consumer groups and the Democrats they support, say the bill, modeled after a California law, would deprive malpractice victims of their day in court without solving the insurance problem.

They say the $250,000 cap is too restrictive.

"We have tried during the first six months of the year to see if we can't build a bipartisan consensus on this, and thus far have been unsuccessful," said a spokesman for Senator Frist, Bob Stevenson. He added, "We view this as a long march, and this is the beginning of it."

That march may well extend until the next election, in 2004. Some Democrats ? who complained that Dr. Frist is circumventing Senate procedure by bringing the measure up for a vote before it has been considered in committee ? said he is using the vote to generate a political issue for Republicans.

Republicans made it clear that they intended to use the vote against Democrats.

"Women are having trouble finding obstetricians to be able to deliver their babies," said Senator John Ensign, Republican of Nevada, the chief sponsor of the measure.

"In states like Nevada, doctors are leaving in droves, and that kind of scenario is repeating itself over and over around the country," Mr. Ensign said. "As voters become aware of it, I think you're going to see the change of minds of senators who may now be against it. We bring it up for a vote now, and it may cost them in the next election."

Posted by at 07:32 AM | Comments (1) | TrackBack (0)





July 05, 2003


On carvedilol for CHF

For years I have skeptically believed that all beta blockers should provide the same benefit for CHF patients. However, I cannot deny the data (although some do). Yesterday's Lancet has the COMET trial published. Medscape has a good summary - COMET: Late-Breaking Clinical Trial Results of the Carvedilol or Metoprolol European Trial

COMET was a multicenter, double-blind, randomized, parallel group trial in patients with mild, moderate, or severe chronic HF. The trial was set up to compare the effects on morbidity and mortality of carvedilol, an adrenoceptor antagonist with beta1-, beta2-, and alpha1-adrenergic receptor blocking activity, with that of metoprolol, a selective antagonist of beta1-adrenergic receptors, in chronic HF patients. COMET was jointly sponsored by Hoffmann-La Roche and GlaxoSmithKline. Hoffmann-La Roche markets carvedilol in Europe and elsewhere worldwide, except the United States and Japan, where it is marketed by GlaxoSmithKline and Daiichi, respectively.

Between December 1996 and January 1999, COMET enrolled a total of 3029 patients at 317 centers in 15 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Norway, Portugal, Spain, Sweden, Switzerland, The Netherlands, and the United Kingdom).

All patients had:

  • Mild, moderate, or severe chronic HF (NYHA class II-III with a few class IV)
  • Left ventricular ejection fraction (LVEF) less than or equal to 35%
  • no more than 1 hospitalization for a cardiovascular reason within the previous 2 years

All patients were on:

  • Stable treatment with diuretics for at least2 weeks
  • ACE inhibitors for at least 4 weeks (unless contraindicated)

Patients were excluded if they had:

  • A recent change of HF therapy, ie, introduction to a new class of drug within 2 weeks prior to randomization
  • Treatment with beta- or alpha-adrenergic blockers within 2 weeks prior to randomization
  • Requirement for intravenous inotropic therapy, calcium channel blockers of the verapamil or diltiazem class, or amiodarone > 200 mg/day within 2 months prior to the study
  • Contraindication to the use of a beta-blocker

Patients were randomized to treatment with either metoprolol (metoprolol tartrate formulation; n = 1518) or carvedilol (n = 1511). The drugs were started at 5 mg twice daily and 3.125 mg twice daily, respectively, and titrated to the maximum tolerated dose or target dose of 50 mg twice daily of metoprolol and 25 mg twice daily of carvedilol.

It always helps to carefully understand the patient population. This population looks like many patients that I see in the hospital. The entry criteria seem inclusive.

For one of the primary endpoints of the study, all-cause mortality, there was a significant 17% risk reduction with carvedilol vs metoprolol (hazard ratio = 0.83, 95% CI = 0.736-0.932, P = .0017) (Table 1). This difference first appeared at about 6 months. Sensitivity analysis showed this result was not affected by baseline characteristics, loss to follow-up, or open-label beta-blockade. The effect on mortality did not influence the mode of death and was consistent across all predefined subgroups: sex, age, NYHA class, cause, LVEF, heart rate, systolic blood pressure (SBP), diabetes, and overall effect. The absolute difference in mortality was 5.8%. The annual mortality was 8.3% for carvedilol vs 10.0% for metoprolol, consistent with or slightly higher than the results of previous trials, Professor Poole-Wilson pointed out.

I believe this difference clinically significant and important. I cannot ignore the difference.

Several other meeting delegates suggested that the effect of metoprolol might have been more favorable had the extended-release formulation of metoprolol, metoprolol succinate (metoprolol CR/XL), been used instead of metoprolol tartrate. In response, session co-chair Professor Michel Komajda, MD (Hôpital Pitié Salpétrière, Paris, France), wondered whether the bioavailability of metoprolol tartrate and succinate are not, in fact, the same. Admitting that he had been anticipating this question for 6 years, Professor Poole-Wilson replied that in his view, the COMET result is "so definitive that it is very unlikely that the result can be explained by differences in dose and formulation." The steering committee looked at the pharmacokinetics and pharmacodynamics of these drugs and believes it made a fair choice, he recalled.

The question of the COMET target dose of metoprolol, 100 mg/day, had been raised even before the trial was completed, since the target dose in MERIT-HF (the Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure) was 200 mg/day. Professor Poole-Wilson noted that the final dose of metoprolol achieved in COMET, 85 mg/day, was midway between the tartrate formulation equivalents of the high and low doses of metoprolol CR/XL (76 mg and 192 mg once daily, respectively), which showed no difference in outcome in a posthoc analysis of MERIT-HF data.

Physicians often ask for such studies comparing two drugs. Here we have the study for which we have clamored. This study has already changed my practice. I believe that carvedilol is likely worth the extra money. I will only use metoprolol in CHF now when the patient cannot afford carvedelilol and does not qualify for a pharmaceutical free drug program.

Posted by at 07:11 AM | Comments (3) | TrackBack (0)





Wall Street Journal on the fast food suits

McLawsuits

As silly as it is, the coming legal assault on junk food was predictable. The tobacco victories, which followed big scores in asbestos and breast implants, have made the trial lawyers richer and more cocksure than ever. The profession seems incapable of policing its own, and the result has been an explosion of self-interested legal entrepreneurs masquerading as public servants. The politicians, particularly Democrats, have done little to advance the cause of tort reform, lest they clog a major artery of campaign contributions. What distinguishes this latest class-action money grab, however, is that, at bottom, it's a bald assault on the public's intelligence.

The case against the food industry--broadly defined by opponents to include everyone from farmers and retailers to advertisers and restaurant owners--ultimately rests on the assumption that overweight Americans are too weak-willed or too stupid to resist food marketing. Hence Prof. Banzhaf's pep rally was preceded and followed by presentations from a dozen or so other activists with tenure, all attempting to separate obesity from individual responsibility.

Prof. James Hyde of Tufts University told the audience the idea that a healthy lifestyle is a matter of personal choice is a common myth. "The reality," he continued, "is that healthy behavior is often dictated by factors completely outside the individual's control." Prof. Marion Nestle of New York University--she's quick to note that her name is pronounced NES-uhl--said that obesity is the result of America's food supply being too plentiful and too cheap, and that "deliberate federal policies make this so." Ben Kelley, who heads the Public Health Advocacy Institute, which sponsored the conference, said he simply wants "to help the many who can't resist the blandishments of the marketplace."

Others couldn't resist dragging their sundry liberal political causes into the mix. After calculating that obesity-related illnesses cost the U.S. up to $50 billion annually, Prof. Aviva Must of Tufts University remarked, "That's a lot, even for very wealthy countries that have a lot of money to spend on things like war." Michael Jacobson of the Center for Science in the Public Interest said the federal government isn't spending enough on the problem because "the Republicans' $400 billion federal deficit will not allow for such things." Stephen Joseph, the San Francisco trial lawyer who filed (and later dropped) a suit to ban Oreo cookies, warned that "male conservative Republican right-wing elements" are the biggest opponents of this litigation. "They're more worried about freedom," he said. "They don't care about kids."

So they paint a bleak picture. The problem with laws and lawyers comes when they twist meanings and intent solely to seek out deep pockets.

The Personal Responsibility in Food Consumption Act, recently introduced by Rep. Ric Keller, a Florida Republican, would quash much of this nonsense pronto. But like all tort-reform legislation approved by the House--a similar bill banning frivolous suits against gun manufacturers passed earlier this year--the measure is likely to stall in the Senate unless Republicans can muster a filibuster-proof majority. In the meantime, says Walter Olson of Overlawyered.com, we can only hope that "a fit of sense will descend on the judiciary and the press, and that this will all be laughed off the national stage eventually."

Posted by at 06:47 AM | Comments (1) | TrackBack (0)





July 04, 2003


On knowledge translation

I hope the title did not lose you. Knowledge translation represents the missing link between publication and practice change. The case for knowledge translation: shortening the journey from evidence to effect and From publication to change

Since knowledge translation focuses on health outcomes and changing behaviour, it is set in the site of practice and its social, organisational, and policy environment rather than in learning situations. Furthermore, it identifies best evidence and pathways that make it easier for the target individual or group to follow this evidence. The production of these aids to knowledge translation, called tools or toolkits, is commonplace.

Thus, the authors make the case that we need to study methods for translating knowledge into practice. Identifying suboptimal practice no longer should interest us. We know that many new findings are not quickly translated into practice.

Knowledge translation uses a wide range of methods to achieve change. It's set in practice rather than lecture theatres and uses prompts and various information tools. Rather than being aimed at individual doctors it's aimed at teams, health systems, populations, and policy makers. One of the most interesting differences from traditional continuing medical education is that knowledge translation is aimed at patients as well as doctors. Patients may be more enthusiastic about change than their doctors, and the patient may cause the doctor to change.

As I have implied previously, our research group focuses on methods for knowledge translation. Contrary to the above quote, we have had success aiming at individual physicians also. For outpatient practice, one must develop methods for working with individual physicians.

This field represents the action. We need to continue to understand the barriers to change, and then learn how to overcome those barriers. We should not berate physicians nor should we criticize their practices. Rather we (the medical education community and specifically the continuing professional development community) must strive to achieve improvement. The issues are too complex for most individual physicians to have complete success on their own.

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July 03, 2003


Robert Goldberg on Canadian drug importation

A terrible mistake

It is a bill that will bar the Food and Drug Administration, which was expressly created to guarantee the safety of drugs, from stopping drugs from coming in from Canada and 25 other countries, including South Africa, where more than 20 percent of its drugs are counterfeit or adulterated, even if it thinks it might undermine the safety or security of the supply of medicines in America. Imagine that: Congress telling the FDA to take a powder when it comes to the basic mission of ensuring that the medicines we take are safe.

This bill is at odds with a letter Mark McClellan, the FDA's commissioner, recently wrote saying that he couldn't guarantee safety, and neither could his Canadian counterparts. But Mrs. Emerson and her GOP colleague, Gil Gutknecht of Minnesota, are so determined to import Canadian-style price controls that they ignore Mr. McClellan's warnings. In the FDA's place, Mr. Gutknecht would require that packaging of every prescription drug incorporate "overt optically variable counterfeit-resistant technologies," whatever that means.

I always find Robert Goldberg's opinions interesting and thought provoking. This commentary addresses the problem of importing pharmaceuticals.

While I agree with some of his points, as usual I cannot agree with all his points. I do agree that the FDA should have jurisdiction regarding this situation. Patients are at risk from imported drugs. Quality control should concern everyone.

I disagree with him on the problem of financially impacting the pharmaceutical industry. If we could insure quality concerns, I would favor the competition. The pharmaceutical industry could (and should) live within a true market economy. He opines:

Drug companies and biotech firms alike would be forced to sell their products at generic drug margins and at the lower value of the Canadian dollar, devastating investment in a generation of smarter drugs and personalized medicine. Mrs. Emerson and Mr. Gutknecht blather on about how their bills promote "free trade," but if they really did, they wouldn't stop at drugs. They would allow for the reimportation of automobiles, which, if just limited to the top selling 50 models, would save Americans $11 billion a year. Why not just turn Canada into one big Costco, for that matter?

I find this paragraph hyperbolic. Why should the US (and only the US) fund pharmaceutical research? How much profit margin does the pharmaceutical industry need? I doubt that competition would prevent ongoing research.

Are the pharmaceutical firms selling drugs at less than cost to other countries? Again I find this unlikely. I suspect that the pharmaceutical industry would still make money and still make research.

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July 02, 2003


Cervical cancer screening in the UK - new recommendations

These recommendations make sense. I wonder about their practicality. Guidance on smear frequency

All women aged between 25 and 49 should be offered cervical screening every three years, leading experts have concluded.

However, they say that every five years is regular enough for women aged 50 to 64.

Until now there has been no precise direction on how often screening should be offered - it has been left to individual health authorities to decide.

According to the most recent figures, 60% of health authorities offer screening every three years, while the remaining 40% opt for either five-yearly screening or a mixture of the two.

This represents a very different recommendation than we use in the US. The UK model is data driven and makes sense.

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On feeding tubes

When I am ward attending I have many rules. One rule is that feeding tube decisions require significant thought. Prior to placing a feeding tube we must understand what advantages the feeding tube will provide. Feeding tubes (here I am speaking most about PEG tubes) can help nutrition, in those cases when there is no reasonable alternative. Feeding tubes do not prevent aspiration. Feeding tubes are generally not indicated towards the end of life.

Two reports on a JAMA article put feeding tubes into perspective. The first discusses ethnic differences in the use of feeding tubes - Study Finds Racial Differences in Use of Feeding Tubes

Senile residents of nursing homes are more likely to be put on feeding tubes instead of being hand fed if they are black or Asian and live in a big urban nursing home run for profit, a new study finds.

The study, which surveyed 186,000 residents in all 15,135 licensed nursing homes in the country, sheds light on a debate among the operators of nursing homes and advocates for the aged over whether it is more humane or more sensible to put dying patients on feeding tubes.

The study appears today in The Journal of the American Medical Association. Its lead author, Dr. Susan L. Mitchell of the Research and Training Institute of Hebrew Rehabilitation for Aged in Boston, said the use of tubes was worrying "amid growing empirical data and expert opinion indicating that feeding tube use has no demonstrable health benefits in this population and may be associated with increased risks and discomfort."

Religiously conservative families and religion-based nursing homes may see feeding tubes as a way to prolong life as much as possible. So refusing one may be viewed as consigning a patient to death.

The author does discuss the ethnic differerences. Her speculations:

Dr. Mitchell cited possibilities for the discrepancies noted in the study. Medicaid pays more for patients on tubes, she said, and hand feeding means adding employees, "so there's a fiscal incentive" for profit-seeking homes.

People who have not been carefully counseled and have not signed living wills to direct their care tend to be given tubes, often at their family's request. Also, Dr. Mitchell said, "it's a well-known fact that nonwhite families tend to get more aggressive care at the end of life."

Although the sample surveyed had relatively few Asians, Dr. Mitchell said, that tendency is in Asian and black families and may stem from language problems, mistrust of the medical establishment or feelings that family members should "get everything coming to them."

White patients more often make decisions without consulting their families and sign statements saying they do not want tubes or other interventions, Dr. Mitchell said.

Another report on this study - Study Says Feeding Tubes May Be Overused. This report makes several important points -

The Alzheimer's Association's guidelines on patients in the final stages of the disease say that it is ethically permissible to withhold feeding tubes and that spoon-feeding should be continued if needed for comfort.

Sandra Fitzler of the American Health Care Association, which represents over 12,000 nursing homes and other institutions, disputed the suggestion that some places may be inappropriately using feeding tubes for patients with advanced dementia.

Fitzler said the study underscores the importance of living wills and advanced directives, so that health care providers and families are not left guessing about patients' preferences.

I would add that this issue represents another argument for a strong palliative care service. We are very successful at avoiding unnecessary feeding tubes because we proactively discourage them! Our palliative care service uses them only in situations where everyone would agree on a strong indication.

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July 01, 2003


More questions

Yesterday I asked Donald Johnson to provide more questions concerning my worries about the hospitalist movement. He has provided more questions - some directly relevant, and some which move the discussion in unexpected ways. I hope these rants are interesting to some readers. They are interesting for me to consider and write.

1. How do you train medical students and residents to communicate their concerns and uncertainties to patients without alarming them? Can you?This question does challenge us. I would suggest that the higher level attending becomes a role model for students and residents. As an attending, I try to role model difficult discussion for these learners. After these discussions, we debrief. We discuss both style and content. I invite them to critique my performance, and I often critique myself. Hopefully, we make progress when we openly discuss the difficult situations in doctor patient communications.

2. You say there are no good studies of hospitalists and officists and their effectiveness. Business people---hospital administrators---like doctors have to make decisions with incomplete information. They have to speculate and use their common sense based on experience.

If you were a hospital administrator having to decide whether to outsource to a hospitalist (inpatient physician) company, assuming all other factors such as medical staff politics were positive, what would you recommend to a hospital considering hiring hospitalists?

I love these loaded questions! I would try not to outsource these important hires. Currently I am reading the book Good to Great (check out this interview concerning the book - Good to Great. The book makes a very important point:

In fact, leaders of companies that go from good to great start not with "where" but with "who." They start by getting the right people on the bus, the wrong people off the bus, and the right people in the right seats. And they stick with that discipline -- first the people, then the direction -- no matter how dire the circumstances. Take David Maxwell's bus ride. When he became CEO of Fannie Mae in 1981, the company was losing $1 million every business day, with $56 billion worth of mortgage loans under water. The board desperately wanted to know what Maxwell was going to do to rescue the company.

Maxwell responded to the "what" question the same way that all good-to-great leaders do: He told them, That's the wrong first question. To decide where to drive the bus before you have the right people on the bus, and the wrong people off the bus, is absolutely the wrong approach.

Thus, I would argue that the hospital administrator should work to recruit great physicians who want to practice inpatient medicine. Using a firm will solve the short term problem, but could cause more long term problems. Recruit people!

3. Wachter and others have told me that medical groups are hiring hospitalists so that their physicians can be officists. If you were managing director of a group practice and your colleagues wanted to be officists and refer their patients
to hospitalists, what questions would you ask before making such a decision?
I would encourage them to recruit hospitalists in a similar fashion to my answer above. They should understand clearly the advantages and disadvantages (to their practice) of engaging hospitalists.

4. What would you ask the hospitalist company , what would you ask your colleagues and what would you ask the hospital involved? See my answer above. I would be reluctant to work with a company - I would much rather recruit people.


3. You mention that some patients complain about losing contact with their physicians when they are cared for by hospitalists. And hospitalist advocates say patients don't care or are understanding after a hospitalist explains what's going on and why, because the hospitalist is available round the clock, and officists aren't. Are you aware of any patient satisfaction studies that deal with this question? Are people hearing what they want to? Another nebulous question?

The question is not nebulous, but it is unanswerable. Satisfaction can occur with either system. It depends on the physician and his/her ability to interact with patients. I do worry about 2 issues. First, we must all be very careful about "hand offs". I work on VA wards. When we discharge patients, I have the interns and resident personally call the outpatient physician to discuss our plans and changes to care.

The hospitalist system also has hand offs within the system. Hospitalists rarely work every day. In some hospitalist systems the patient may have as many as 3 physicians in a 4 day admission. Everytime the physician changes, the risk of errors increases.

To summarize, patients generally like physicians. We can make almost any system work. However, the hospitalist system requires more and better communication between physicians.

4. Medpundit brought up the expected arguments with Rand's methodology and priorities. On the one hand, it appears Rand went out of its way to create a credible study. And on the other, critics have some credible questions. What will physicians take from the Rand study as credible, and what will they brush off as impractical? The Rand study is "old news". It merely replicates many previous studies, albeit with an interesting new methodology. We all need to strive to provide indicated care (e.g. immunizations, checking cholesterol, using beta blockers after MI, using aspirin after MI). The study does not tell us (the medical community) how to improve. The study does not tell us why!

I believe that the Rand study does a disservice if it stops at this point. We must conduct more research into causes and solutions.

5. Similarly, if you were the medical director of a teaching hospital or community hospital, what useable lessons come from the Rand study? And what lessons will important to group practices? See my above answer. We do not really have any useable lessons. I would look to other research to find out what methods work for improving adherence to guidelines. Medical directors should adopt the findings from such research to improve adherence to selected guidelines. The challenge is choosing (from the huge number of guidelines) those actions which need addressing.

6. Going a step further, the NEJM article and related editorial talk about strategies for improving use of recommended guidelines, some of which I feel are pie in the sky. What practical strategies can individual physicians, hospitals and group practices implement while we wait 20 or 30 years for reliable information systems, fair payment schemes and easier-to -follow guidelines? Yes, you can write your book right here on your blog. The answer to this question would require a several day conference. The first step is "buy in". We need to do a better job in our Continuing Medical Education of discussing the important guidelines, and developing system for adhering to those guidelines. The CME should not use lectures, but rather discussion amongst groups of physicians. Only when physicians agree on the importance of the guidelines will they have the motivation to change their practice systems.

We need a culture of improvement, not a culture of finger pointing. When physicians feel motivated to improve practice, then we can provide tools to help them.

7. Say you have a Ph.D. candidate who wants to write a dissertation on the Rand study. What's the title?

I cannot imagine such a dissertation. I hope my previous answers have clarified my beliefs on these issues.

Posted by at 10:58 AM | Comments (5) | TrackBack (0)





More on the new rules

Hospitals Face Limit on Residents' Hours

Dr. Debra Weinstein, who oversees 1,400 residents at Massachusetts General and other area hospitals, is reserving judgment until she sees the results of an extensive study the hospital is doing on how the hours affect patient care and medical education. But she said she is confident that, in a pinch, patients will still come first.

``Doctors 100 percent of the time will take care of the patient before they follow a rule that says their shift is over,'' she said.

Hospitals insist the limit on residents' hours do not mean lesser care, since doctors hand off patients to colleagues all the time. Besides, the guidelines have some flexibility; for example, in some instances, residents can stay at work to see a case through if necessary.

``We're not talking about a factory floor here where people put down their tools and go home,'' Dr. Jordan Cohen, president of the American Association of Medical Colleges. ``There are patient needs that need to be attended to, and that's going to trump anything.''

I love reading this optimism, but I suspect that we will have some problems. As I stated yesterday, I will provide some updates on my experiences with our new system for handling the regulations.

Posted by at 05:11 AM | Comments (1) | TrackBack (0)





It would be nice if everybody could find a doctor with half the common sense of this one. - Junkyardblog

An academic general internist comments on medical issues and the current state of medicine.

I reserve the right to be blatantly opinionated; you should take the right to criticize me!!



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The Sunday Issue of the Week continues. This feature will challenge me to carefully ponder an issue that I've referenced and commented on recently.

Current hot issues:

• Malpractice crisis
• Resident work hours
• Pharmaceutical industry
• Obesity and fitness