So what do increased cigarette taxes really do? Supply-Side Smokers: New York City is about to learn the cost of high cigarette taxes. This is a very well considered opinion piece about the recent New York City cigarette tax increase. (Registration required - but free)

FTC Seeks Generic Drug Delay Limits

The Federal Trade Commission wants to limit the ability of drug companies to delay the marketing of generic competitors and to require the firms to disclose agreements covering the sales of generic drugs.

``The commission's recommendations today are designed to accomplish two goals: to facilitate generic entry and to maintain appropriate incentives for the development of new drug products,'' said FTC chairman Timothy J. Muris.

Hopefully, this recommendation will allow faster entry of generics into the market.

I did not watch this report last night, but the text makes sense. John Stossel has defined the problem in a way that I like. Just Say No: Government’s War on Drugs Fails

We know the terrible things drugs can do. We've seen the despair, the sunken face of the junkie. No wonder those in government say that we have to fight drugs. And polls show most Americans agree. Drug use should be illegal. Or as former "drug czar" Bill Bennett put it: "It's a matter of right and wrong."

But when "right and wrong" conflict with supply and demand, nasty things happen. The government declaring drugs illegal doesn't mean people can't get them, it just means they get them on the black market, where they pay much more for them.

"The only reason that coke is worth that much money is that it's illegal," argues Father Joseph Kane, a priest in a drug-ravaged Bronx neighborhood in New York City. "Pure cocaine is three times the cost of gold. Now if that's the case, how are you gonna stop people from selling cocaine?"

Kane has come to believe that while drug abuse is bad, drug prohibition is worse — because the black market does horrible things to his community. "There's so much money in it, it's staggering," he says.

Orange County, Calif., Superior Court Judge James Gray agrees with Kane. He spent years locking drug dealers up, but concluded it's pointless, because drug prohibition makes the drugs so absurdly valuable. "We are recruiting children in the Bronx, in the barrios, and all over the nation, because of drug money," he says.

Besides luring kids into the underworld, drug money is also corrupting law enforcement officers, he argues.

Cops are seduced by drug money. They have been for years. "With all the money, with all the cash, it's easy for [dealers] to purchase police officers, to purchase prosecutors, to purchase judges," says Oliver, the Detroit police chief.

This should remind us of prohibition. That worked just as well. The article goes on to consider the Dutch experience in legalizing marijuana. They have seen a drop in adolescent pot smoking.

This story should make us think. While drugs can devastate lives, how many more lives are devastated by their illegality? This question should boil down to logical trade offs - risks and benefits of legalization. It seems like a 'no brainer' to me.

This will take resources. I hope we understand that investing in prevention of diabetes will save future medical expenditures. Pre-Diabetes: Are You at Risk?: Interventions Can Keep Those with Pre-Diabetes From Developing Full Disease

"Progression to type 2 diabetes can be prevented by lifestyle modification," says Dr. Joann E. Manson, chief of the division of preventive medicine at Brigham and Women's Hospital in Boston, Mass. "Most importantly, lose weight and become physically active."

Medications, such as metformin, may be used in some instances to lower blood sugar. But some experts emphasize the importance of diet and exercise over medical intervention.

"We know that losing weight is effective," says Daly. "In order to create a calorie deficit, which is how you lose weight, you've got to decrease what's coming in the door and increase what's going out the door. You need to work on both sides of that energy equation. You can try to be a couch potato and eat like a bird, but it isn't going to work."

One should not wait until given a pre-diabetes diagnosis. Diet and exercise can help us all.

As a physician, Senator Frist champions medical care. He also champions prevention. Senators Take Up Arms Against Obesity.

"Obesity is, for the most part, preventable," said Frist, R-Tenn. "There is no single solution, but better information, improved nutrition and greater opportunities for physical activity will guarantee progress."

To provide those resources, the three senators are proposing spending as much as $217 million next year and additional money in future years on a variety of programs to encourage proper nutrition and increased physical activity.

The money would go to the Institutes of Medicine, the Centers for Disease Control and Prevention and the Department of Health and Human Services to identify risk factors, analyze government food assistance programs and work with state governments on nutrition and exercise programs.

While I generally oppose government solutions, government funding can stimulate great research. On the surface this sounds like a well placed effort.

This leaves me in a quandry. The managed care organizations are (in my opinion) responsible for much malaise in physicians, and responsible for lower quality care (although admittedly I cannot prove that). The trial lawyers ... well you know how I feel about the trial lawyers. Health Insurers Lose Bid on Case Records.

Aetna Inc., the Cigna Corporation, Humana Inc. and other health insurers lost a bid to bar plaintiffs' lawyers from obtaining internal records in cases that accuse the companies of skimping on patient care.

Judge Federico Moreno of United States District Court in Miami issued a one-page ruling today instructing the insurers that, beginning Sept. 30, they must provide documents requested by lawyers for the plaintiffs, according to a court order.

Or as Yogi once said, 'It ain't over until it's over'. The Senate will apparently try again today. I won't bore you with the details unless the bill passes - Big Senate Vote on Medicare Drug Benefits Is Set for Today. Passage is doubtful.

What a feel good story! By now everyone knows of the amazing rescue of 9 Pennsylvania miners over the weekend. After so many heart wrenching stories, this one made the whole country smile. Fortunately, the decision to rescue the miners was not controlled by considerations of cost effectiveness.

Medical care costs money. We can improve the quality and quantity of life for many patients. Primary prevention works for many problems (colon cancer,hypertension, hypercholesterolemia, adult onset diabetes, skin cancer). Secondary prevention works for coronary artery disease, congestive heart failure and diabetes mellitus (these come quickly to mind). Yet many medical decision come under the scrutiny of cost effectiveness.

I have published papers on cost effectiveness. I find the subject intellectually fascinating. As a researcher, I understand the limitations of the technique.

The key to understanding cost effectiveness comes from both words. We want to understand what benefit (effectiveness) we get for what cost. Cost effectiveness studies require estimates of costs and effectiveness, and often those data are not readily available. Recently, the US Preventive Services Task Force published their analysis of colo-rectal screening Screening for Colorectal Cancer: Recommendation and Rationale

There are insufficient data to determine which screening strategy is best in terms of the balance of benefits and potential harms or cost-effectiveness. Studies reviewed by the USPSTF indicate that colorectal cancer screening is likely to be cost-effective (<$30 000 per additional year of life gained) regardless of the strategy chosen.

It is unclear whether the increased accuracy of colonoscopy compared with alternative screening methods (for example, the identification of lesions that FOBT and flexible sigmoidoscopy would not detect) offsets the procedure's additional complications, inconvenience, and costs.

Note two things. The USPSTF considers cost-effective as less than $30,000 per additional year of life gained. They are worried about the cost of colonscopy. Ask any gastroenterologist which one he/she would have. I believe that the cost issues prevented a strong endorsement of colonoscopy.

Was the miners rescue cost effective? Did anyone ask? What makes medical care different? In times of crisis, our society ignores cost to save lives. Our understanding that we should expend such effort to save lives defines our country (in a very positive way I think). What is it about medical care that escapes this understanding? Why can politicians complain about costs of health care? I do not understand. I'm happy for the miners and their families, but frustrated over how Medicare and insurers fund health care. What about the value of life do I not understand?

Recently, Medical Rants has focussed much attention on diet. This article summarizes a study about the value of whole grains in ones diet. Whole Grains Can Help Cut Insulin, Cholesterol

In their study of close to 3,000 middle-aged adults, these foods were associated with lower levels of total cholesterol and LDL (the so-called "bad" cholesterol) and improved insulin sensitivity. Insulin, the body's key blood-sugar-regulating hormone, tends to be elevated in those at risk of type 2 diabetes.

People who consumed the most whole-grain foods also had a lower body mass index (BMI), a measure of weight in relation to height that is considered a more reliable gauge of overweight than weight alone. Indeed, adults who were overweight or obese had the highest insulin levels and consumed the least amount of whole-grain foods, researchers report in the August issue of the American Journal of Clinical Nutrition.

This study adds to a growing perception that refined carbohydrates are the bad actors. My wife has only provided whole grain foods for year. She has a point.

I really like this series from the Washington Post - A Year of Lean Living -- Together: Lean Plate Club Members Encourage One Another in Their Adventures in Good Nutrition

The Lean Plate Club, once a mere nugget of an idea, marks its first anniversary today as a solid corps of enthusiastic members who help each other to eat and live more healthfully by sharing their triumphs, their tips, their recipes and, yes, their stumbles.

The club -- formed around the Health section's weekly nutrition column and accompanying Web chat -- is not about dieting, but rather about eating smart and setting realistic goals. It's about rediscovering the joy in eating good-tasting, healthful foods and finding the fun in being physically active -- whether you do it by walking, stretching, tap dancing, riding a bike or simply taking the stairs instead of the elevator.

I continue to have a goal of getting my BMI to less than 25. I started at around 28. I'm stuck at around 25.2. Over the past 6 months my body fat decreased from 23% to 18% (measured by fat calipers). Weight lifting and a great personal trainer have made this possible. I am not overweight by body fat criteria; most people think I'm in very good shape, but technically I'm still 2 pounds overweight. This self revelation highlights the point of this article - Who you calling fat?

These questions ring with new resonance following the release last week of a report from the state Department of Public Health showing that 52 percent of adults in the state are officially fat. In fact, researchers discovered that the number of people who are overweight or obese ballooned by 29 percent during the 1990s.

Those findings relied on the body-mass index, the same standard employed by the US Centers for Disease Control and Prevention when it declared an epidemic of obesity last year.

''It definitely has some drawbacks - it's not perfect,'' said Megan McCrory, a Tufts University nutrition research scientist. ''If somebody is relatively muscular, because muscle is more dense than fat, they'll have a BMI that's relatively high. It might look like they're overweight, but, actually, if you measured their percentage of body fat, they would be really lean.

''But,'' and McCrory paused, ''let's be honest. Most people in the United States who have a high BMI are not going to have a high BMI because they have too much muscle.''

I consider BMIs between 25 and 29 and opportunity to discuss diet and exercise with patients. I should probably add fat calipers to my obesity screening. Knowing one's percentage of body fat is often chilling. Few with a BMI over 29 are just too muscular, and I do not need calipers to recognize them. Nonetheless, we may hear more abou this controversy.

Budgets cuts have decreased the former emphasis on physical education in schools. Some have argued that physical education was not important for students. I would argue that we have a chance to create life long habits of exercise. I stole this idea from those who are trying to do that. Regimens: When P.E. Class Includes Exercise

When they looked at physical education classes for 1,140 older children, ages 11 to 14, the researchers found that some classes required students to take part in as little as 6 to 10 minutes of aerobic exercise.

They then set out to modify the classes by tripling the amount of time some of the students were active.

After eight weeks, the students in the group that exercised more were found to have slightly lower blood pressure readings, and when "skin-fold" tests were used, those students also had lower levels of body fat.

Physicians see these patients every day. Drug companies advertise to them constantly. Osteoarthritis plagues millions in this country. Jane Brody has written a beautiful summary of osteoarthritis today - Arthritis: Your `Reward' for Wear and Tear.

But the leading risk factor for arthritis is obesity, particularly excessive weight gain in midlife and beyond. The heavier you are, the more stress is placed on your spine, hips, knees and ankles.

Also, heavier people tend to resist exercise, resulting in another risk factor — weak muscles, particularly in the thigh. Weakness in the thigh, in turn, places extra stress on the knees.

Read the entire article, and you may want to print it for patients. I never knew exactly what to say to the 250 pound, 5 foot 3 inch woman who complained that her knees hurt. She thought I had a magic pill that I was hiding from her. Could this article have helped? ... Nah

I hope my economist friends read this one. Maybe they can explain it with the 'dismal science'. Doctors knock Medicare vaccination payments as too low: CMS' refusal to increase immunization pay rates may hurt chances of reaching Healthy People 2010 goals.

In its recent proposed rule on the Medicare physician fee schedule for 2003, CMS increased payment rates for most immunizations but not for influenza, pneumococcal and hepatitis B vaccine administration. Physician practices may not be able to continue to absorb those losses along with increases in costs.

"When you consider the fact that physicians are facing financial pressure from so many sources, such as the reduction in Medicare payment for physician services and increasing medical liability insurance premiums, it's very difficult to handle inadequate reimbursement for individual services such as this one," said Ronald M. Davis, MD, a preventive medicine physician from East Lansing, Mich., and an AMA trustee.

Medicare pays just over $3 for flu, pneumonia and hepatitis B vaccination. The vaccines cost much more than that. Medicare gives one payment, they do not take into consideration the cost of the vaccine, nor the supplies needed. And they have the audacity to consider vaccination rates a quality indicator. I wish I were confused about this, but it is very clear, and very unfair.

Medical Rants started about 2 months ago. I spent some time this weekend thinking about the blog, why I blog, and what I hope to accomplish. As you can see I have nice new digs, and I also want to comment on those.

Generally, I view myself as better at oral communication than written communication. My comfort zone comes on rounds, giving talks, and morning report. Speaking spontaneously feels comfortable. I never feel as comfortable when writing. Writing is more permanent, requires more thought, and is more easily dissected. Writing takes time. I have wanted to improve my writing, and have searched for the right place to practice.

Earlier this year, I discovered blogging. I do not remember the first blog that I read. I do remember that the concept intrigued me immediately. I found Blogger, figured 'what the heck', and started blogging. But I did not really know what to blog about. My rookie blogging was very boring, even to me. I was not sure that blogging was my thing. Then I read Medpundit. Eureka! I had a role model. Time to blog about my passion - medicine. I seem to remember reading advice on writing. Write what you know. The best way to improve your writing is write everyday. I had a forum. I had a place to practice. And, if nothing else, I would enjoy the daily research involved in staying up to date on medical issues.

This blog does not have a grand plan. I browse the web and look for stories that grab my attention. I rarely write about bioterrorism. The pharmaceutical industry grabs my attention. Fitness and weight loss have become a passion, so I concentrate on those issues. Medical advances intrigue me. I like reading the latest articles, and trying to put them into perspective.

As my blogging became a daily passion, I wanted a better web page than Blogger could provide. Blogger is a very good site, and allows one to start blogging almost instantly. But I wanted to improve my site, mostly for myself. I wanted searching capability. Often I have written a piece and want to find it quickly. Adding searching helps me find the piece that I want to look over. I did not realize that I was going to be able to use categories, but have found that a nice touch. Already some readers are using the comments section. Comments keep me honest, make me think and force me to write more clearly.

Thanks and kudos go to Sekimori. Stacy and especially Robyn (what a great design job she did [db claps enthusiastically] and how easy and smooth she made my transition) have my thanks and gratitude. I am personally very happy with the new site, and feel that it adds to my personal project.

Thanks for visiting and commenting. I probably would continue to blog now even if I had no readers. But it certainly is more fun when you know a few readers enjoy what you say, and you induce thinking!

As I have come to expect, medpundit has written an excellent piece on drug pricing. Her numbers are chilling; her reasoning sound. The Sky’s the Limit:

A British study will try to prove what we believe. Obese patients to diet for science Actually, they have an interesting hypothesis to test.

Researchers are hoping to recruit 400 overweight and obese people for a study to see whether excess weight and a lack of exercise causes the joints of the knee to fail.

...

They will be split into two groups, one undergoing a tough weight loss programme, the others will simply get advice leaflets.

Half of both groups will also be put through an exercise programme to strengthen the quadricep muscles in their knees.

This will allow scientists to study whether it is the lack of exercise or the excess weight which has caused the problems.

This is an interesting study design. I will be interested in the results, and especially at their success rate. Can we do a better job motivating patients and helping them lose weight and become more active? We probably should do many such studies.

We have our new diet philosophy emerging. Decrease grains, maybe even whole grains. Rethinking Our Daily Bread: As obesity and diabetes soar, some U.S. nutritionists and researchers back off from pushing pasta and rice. The emphasis is on vegetables and fruits. This article present a well balanced discussion of this current nutritional controversy. Few would argue with the mantra of increasing fruits and vegatables.

The dust settles. Decision making replaces reflex actions. We reflect and put the latest data into perspective. Doctors Working To Clear the Fog Of Hormone Study is a good read, and makes the right points.

I often give an impromptu talk on rounds about how medicine has changed since I graduated from medical school (class of 1975). We laugh about many things that I was taught. We marvel at the advances. As I share my personal view of medicine over the past 25+ years, I am often amazed at the advances, but also at our naivete.

Ann Patchett, writing in the New York Times Magazine, has written an essay - Estrogen, After a Fashion - which mostly looks at how estrogen use has changed over the years. Embedded in that discussion, she makes some very important observations.

What we want is for medicine to be a science. We want competent, well-informed doctors to give us consistent answers based on exhaustive research. We want them to be right. But medicine is a peculiar combination of science and fashion, half penicillin, half shoulder pads. It takes what is known at the moment, combines the knowledge with what the consuming public wants and comes up with a product. One doctor endorses the product, and while you can always go for a second opinion, it's hard to stop at just two, especially when the opinions turn out to be in direct conflict with one another. Read the papers. One doctor says to discontinue Prempro immediately. Another says more studies are needed and what we're facing is a massive overreaction. In the end it will be up to you, who never went to medical school, to make the decision your life may depend on, and while there might not be one definitive right answer, you can bet on the fact there are plenty of wrong ones.

She has much more to say, and even comments (from a consumer perspective) on pharmaceutical direct to patient advertising.

This week Jane Galt and I have had a stimulating discussion - Discourse with Jane Galt. Many interesting issues have arisen, and today I would like to focus on knowledge.

The chief of Cardiology discussed Congestive Heart Failure (CHF) at this week's Medical Grand Rounds. During his presentation, he discussed a variety of medical devices available for managing severe CHF. He made an important observation when he pointed out the the device manufacturers had no interest in funding studies which carefully delineate which patients should benefit from a particular expensive device. They would rather show efficacy, and do not apparently mind if physicians implant excess devices (two examples include automatic implantable cardioverter defibrillators (AICD) and atrial synchronous biventricular pacing (ASBP)). Each of these treatments cost approximately $30,000 per patient. We know that in carefully designed studies and carefully selected patients these devices work, improve quantity and often quality of life. We do not know the proper indications for the devices. For ASBP in particular, data suggest that not all patients benefit. Cardiologist would benefit from studies which examine predictors of efficacy. The device manufacturer will not fund these studies, and given our current regulations they have no such obligation. Economic advisors would tell them not to limit the potential market, and the right efficacy study would limit their market. Thus, the economic incentives for society (use these expensive devices only in those patients likely to benefit) clash with the economic incentives for the device manufacturer (sell as many devices as feasible).

A naive response comes to mind. Let the NIH fund the study. But the NIH (actually in this case the NHLBI) will probably not fund that study, stating that they have higher priorities for their research dollars. Medicare rarely funds such studies - their bureaucracy does not seem to understand the importance of efficacy studies.

Let me switch to a pharmaceutical example. Adult onset diabetes mellitus causes more kidney failure than any other disease in the United States (and probably the world). We have learned much about the onset and progression of kidney disease in diabetic patients. We know that very small amounts of protein in the urine predict eventual kidney failure. We have learned that we can both decrease the amount of protein in the urine (without treatment these small amounts become grams of protein) and delay or even prevent the onset of kidney failure.

Recently published studies (for those interested, I have a slide series available from a talk I gave on this subject last year - Update in Nephrology) have documented both a decrease in urine protein and delayed progression of kidney disease. The studies that I cite in that talk all used a class of antihypertensives called angiotensin receptor blockers (ARBs). Of interest, earlier research in patients with childhood type diabetes used angiotensin converting enzyme inhibitors (ACE-Is). The firms that produce ARBs funded the recent studies. They have not, and likely will not fund studies to compare ARBs and ACE-Is. The ACE-I manufacturers will not fund any studies, because those drugs are nearing their patent expiration (at least 2 of that class have available generics, and that number will increase soon). One would expect that the ACE-Is should work as well as the ARBs, but how can we find out? One could easily design that study, but such studies are very expensive. No manufacturer has a financial incentive to fund the desired study, and the NIH apparently will not fund such a study.

We need a new mechanism to insure that we fund important clinical studies. The current system works only when it benefits the manufacture or the issue is so large that the NIH funds the work.

Therefore, I make this modest proposal. We should charge a research fee to device manufacturers and pharmaceutical manufacturers. I have not worked out whether a fee or a research tax makes more sense. We would then have moneys to fund efficacy studies. An expert clinical panel would prioritize proposed studies, and fund them in order until that year's moneys expire. This would allow us to do the right studies.

I suppose that this idea has many flaws. It seems too simple to work. What do you think? How important are efficacy studies? Can we fund the right ones?

Pejmanpundit clued me into this article - Just What the Doctor Ordered. This article discusses genetic engineering of corn, tomatoes, etc. as factories for a variety of proteins even vaccines.

While I encourage exercise to everyone I know (and many I do not know), exercise and hot weather do scare me. Living in Alabama, we know heat. Anecdotes suggested that heat strokes (especially in summer football) had increased recently.

“We were interested in the perception that there were more deaths related to heat stroke in football in recent years,” Dr. Julian Bailes, a neurosurgeon and team doctor at West Virginia University who led the study, said in a telephone interview.

“So we studied the last three decades and we found out in fact there has been substantial increase — there were 11 (health-related) deaths last year, four of them from heat stroke.”

Writing in the journal Neurosurgery, Bailes and colleagues said deaths from heat stroke were nearly eliminated from U.S. football by 1985 because coaches and managers came to realize that players had to be kept supplied with water.

But a new trend may be counteracting the healthy habit of drinking plenty of water — taking supplements. Bailes cited studies that show up to 70 percent of college athletes and between 30 and 50 percent of high school athletes take performance-enhancing or body-building supplements.

The trouble is, he said, creatine, ephedra — also known as ma huang — and amphetamines can affect the brain’s ability to regulate body temperature. “It causes constriction of the peripheral blood vessels that diminish the ability to sweat,” he said.

He may be right. I rant often about the supplement industry. How do they stay unregulated? How many patients suffer from these snake oil salesmen?

Ulcer disease fascinates me. As a medical student and resident, the most common surgery at our VA Hospital was the Bilroth II. Stress and hyperacidity caused ulcers. Over the next decade we had the emergence of H2 blockers, which greatly decreased ulcer surgeries. Soon thereafter, we had the first proton pump inhibitor. And then this iconoclast - Barry Marshall (Smug as a bug ) figured out and proved that a bacteria caused most ulcer disease.

This discovery has revolutionized our care of patients with peptic ulcer disease. Many questions remain, as h. pylori remains a risk factor for gastric cancer, and probably has other important implications. This fascinating article describes new work on how h. pylori lives in the stomach. Apparently this gives us hope for a vaccine. This many represent a very important medical science advance. Study may show how to knock ulcer bugs for a loop

Being a doctor makes so much sense. Being a politician ...

The posturing has occurred; the political points made; now the compromising begins. Apparently, we do have a reasonable chance for Medicare drug benefit - Senators Scale Back Drug Proposal. Did we not really know this all along?

The compromise is a retreat from Democrats' longtime push for a comprehensive benefit that covers all senior citizens. But it also omits Republicans' push to have a plan that relies on private insurers. The compromise calls for a benefit administered through Medicare, according to one Senate Democratic aide, who spoke on the condition of anonymity.

The proposal would cost between $400 billion and $450 billion over 10 years and would cover about half of the 40 million senior citizens on Medicare, Kennedy said. That's substantially smaller than the $594 billion plan Democrats unsuccessfully brought to the House floor earlier this week. That plan, as well as a $370 billion proposal offered by a coalition of Republicans, a Democrat and the Senate's lone independent, failed to get the 60 votes necessary for passage.

We are probably getting to the right place. Those senior citizens who can afford the medications do not need our subsidies. The poor need our help. I wonder if the plan could actually save some money. How many preventable hospital admissions come from financially induced drug non-adherence? Whether that speculation makes the true amount smaller, a compromise plan seems the right thing. More this week.

Rising from the ashes of the twin Medicare plan defeats, some Senators are trying to resurrect the issue - Medicare Drugs for Those in Need Sway Democrats in Senate.

The bipartisan compromise emerging in the Senate would provide comprehensive Medicare coverage of prescription drugs for people with incomes under 150 percent or 200 percent of the federal poverty level. (The poverty level is $8,860 for an individual and $11,940 for a couple.) Medicare would also cover 90 percent of prescription costs exceeding $4,000 a year for any beneficiary, regardless of income. All beneficiaries could obtain drug discounts of the type already available to many people who receive private health insurance through their employers.

Democratic senators had insisted on an expansive program of prescription benefits that would have cost the federal government $594 billion from 2005 to 2012. But today many said they could accept a $400 billion program. "If we have to compromise to get something done, then so be it," a Democratic aide said.

...

The majority leader, Tom Daschle, Democrat of South Dakota, said the Senate must pass a prescription drug bill by Aug. 2, when it plans to begin a monthlong recess.

"Our highest priority is to get this bill done," Mr. Daschle said today. "We won't do other things, which are very important, until we get it done."

The Congressional Budget Office estimates that nearly one-fourth of Medicare beneficiaries will have prescription drug costs of more than $4,000 a year in 2005.

Sometimes you witness a competition and you root against both sides. This suit epitomizes the problem with dietary supplements - Andro firms to face lawsuits in at least 6 states: Attorneys seeking class-action status

The suits, which also allege these companies are committing fraud because andro does not work, are being filed on behalf of all people who have bought andro products from the companies.

...

According to the suits, the companies claim their andro products "are effective at promoting muscle growth, are legal and are proven to be effective."

"We believe the makers and sellers of andro are caught in a Catch-22," Lynch said. "If andro works, they are criminally liable, and if andro doesn't work, they are liable for civil damages."

Blah, blah, blah - why do we not have some regulation of these snake oil salemen? But why do we need another lawsuit?

Survey finds most smokers want to quit. That simple title conveys our frustration. Working mostly as a teaching hospitalist, I see the ravages of cigarettes. I see end-stage chronic lung patients sneaking outside to smoke. I see patients sneak outside to smoke 3 days after their myocardial infarction. I talk to them, and they do not want to smoke, but say they just can not stop. What an insidious addiction!

Alcohol 'only benefits old' - according to a British study, one can (and perhaps should) drink more as one gets older.

Previous studies have suggested that moderate consumption of alcohol can protect against heart disease.

But this latest study suggests that any benefits only apply if people drink later in life.

The President focussed attention on the malpractice problem (and the evil trial lawyers - oops I should not use redundant phrasing) during a campaign stop for North Carolina gubernatorial candidate Elizabeth Dole. Bush Urges a Cap on Medical Liability. Now for your daily dose of ipecac

The trip put Mr. Bush squarely on the home turf of a potential political rival in 2004, Senator John Edwards, a Democrat who became wealthy as a medical malpractice lawyer.

In a telephone conference call with reporters, Mr. Edwards said today: "I spent most of my life before I came to the Senate fighting for kids and families against insurance companies, and I think that's the right side to be on. If the president wants to be on the side of the insurance companies, we'll let him do that."

Slick politics, avoid the issue and blame the insurance companies!

Since I responded to Jane Galt's discussion of pharmaceutical company budgets, and particularly marketing, I felt it polite to let her know of my discourse. She kindly emailed this reply

I think we're arguing two different things. Doctors who (forgive me) are a little irrational on the subject of pharma advertising, are arguing that in some sort of ideal world, there would be no marketing. There are a couple of ways in which I think this is ill-informed; in fact, it costs pharmas a lot less to do junkets than it would to do advertising or direct mailings, which have a much lower hit rate; similarly, it costs them less to have sales reps than it would to staff a hotline 24-7. Physicians, left to their own devices, apparently have a very poor record of tracking developments in pharmaceuticals; those marketing efforts do serve a purpose, and in fact do so at a lower cost than many alternatives.

But I certainly wouldn't dispute that there are excesses in the marketing budget, or that pharmaceuticals attempt to get people to take drugs when there are perfectly viable alternatives that are cheaper and just as good. However, the question I was asking is not whether in some ideal world there would be less marketing, but whether lowering drug prices would have the effect of lowering R&D or marketing spending; I think that the evidence indicates that it would be the former rather than the latter. And as you are probably well aware of all the ways in which nationalizing health care would call quality of care to suffer, you should not have difficulty understanding why I believe that there would be similar effects on pharmaceutical research.

So I'm not making an ethical judgement on what I think should happen, but an analytical judgement on what I think will. And I think that reimportation would damage R&D beyond repair. I view the excessive advertising etc. as a small transaction cost to pay for a largely efficient research process.

I do take umbrage in the generalization that physicians have a poor record of tracking developments in pharmaceuticals. The longer one practices medicine, the more cautious one becomes over the latest and greatest advancement. I have seen too many new drugs found to have major side effects after FDA approval. Unfortunately, sometimes the pharmaceutical company had strong clues, but acknowledgement of difficulties would hurt their marketing efforts.

I believe that there remain major rewards to new drug development. I'm in favor of a reasonable return on investment for advances. I am against the aggressive marketing of "me too" drugs. I am against legal games which delay the introduction of generics. I am against direct to patient advertising for a variety of reasons. When patients ask for a certain medication, I either have to spend time (and time is money) explaining why I do not want to use that drug, or I could just relent and prescribe the drug (even when it is not the best choice). That form of advertising places the physician in an uncomfortable position, can negatively impact the doctor-patient relationship, and rarely benefits anyone (other than the drug company).

There are many new pharmaceutical companies. They are all trying for the big new advance. NIH basic science research allows new ideas and approaches. Not all drugs come from pharmaceutical sponsored research. I really do not believe that research will go out of business if prices decrease (by whatever means).

Finally, I would argue that ethics should trump economics here. The implications of selling your drug by buying influence with physicians are worth considering. This is a societal concern. We should strive for the best care, not care which benefits AstraZeneca (to pick on my favorite target). Who is looking out for the patient? I believe that is the crucial question here. (db steps back off his soapbox - only to return in the near future).

The prestigious IOM will report to the FDA on six supplements later this year.

The supplements chosen for the first safety evaluations cover a variety of types and uses, the institute noted. The selected supplements and the reason they were chosen, are:

• Chaparral, because of concerns about liver toxicity. Used in an herbal tea.
• Chromium picolinate, because of reports of kidney toxicity and effects on insulin regulation in diabetics. Promoted to reduce body fat.
• Glucosamine, because of concerns about its use by diabetics. Sold as an arthritis treatment.
• Melatonin, because of reports of complications. Used to treat sleep disorders and jet lag.
• Saw palmetto, because of reports of heart problems. Sold as a prostate treatment.
• Shark cartilage, because of a report of hepatitis following ingestion. Promoted as a treatment for cancer and other health conditions.

These evaluations are overdue. We make it more difficult to release a medication with known benefits than these pseudomedicines. I look forward to the reports - Institute of Medicine to evaluate supplements

Being a man 'is bad for health'

The administration may try to help the malpractice crisis. Bush Addressing Malpractice Insurance

-- The Bush administration renewed its push Wednesday to rein in medical malpractice litigation and address soaring insurance costs that are causing many doctors to flee certain communities and high-risk practices.

The fresh effort to restrict awards in malpractice cases was seen in a report Wednesday by Health and Human Services Department. President Bush also was making the issue a centerpiece of his visit Thursday to a hospital and university in High Point, N.C.

...

The result has been closed practices, rising health care costs overall as doctors defensively prescribe unnecessary tests and treatments, and fewer physicians entering high-risk areas.

The solution is to limit damages for pain and suffering in malpractice cases, the report suggests.

"We must put an end to the malpractice litigation lottery that favors a handful of powerful personal injury lawyers and instead create a commonsense system," HHS Secretary Tommy Thompson said.

Legislation in Congress would limit the pain and suffering and punitive portions of malpractice awards. The bill, intended to override state laws, would curtail lawyers' fees and allow juries to hear about the plaintiffs' other sources of income.

I hope that this initiative focusses the debate, but I fear politics will intervene again. The trial lawyers are whining. I really do not like the trial lawyers.

I only post these things because they are so ridiculous. Ailing Man Sues Fast-Food Firms.

A New York City lawyer has filed suit against the four big fast-food corporations, saying their fatty foods are responsible for his client’s obesity and related health problems.

Samuel Hirsch filed his lawsuit Wednesday at a New York state court in the Bronx, alleging that McDonald’s, Burger King, Wendy’s and KFC Corporation are irresponsible and deceptive in the posting of their nutritional information, that they need to offer healthier options on their menus, and that they create a de facto addiction in their consumers, particularly the poor and children.

"You don't need nicotine or an illegal drug to create an addiction, you're creating a craving," Hirsch said. "I think we'll find that the fast-food industry has not been totally up front with the consumers."

One can only imagine the variety of suits over obesity. We should sue Hersheys for making good chocolate, or better yet Godiva! Why not sue Mrs. Fields - her cookies are irresistible to me? We could even sue the Wonder bread company. Maybe Shakespeare was right!

Blovi8r just emailed me this link (which he has on his web site also) - This Promotional Pen Works so Great, Imagine how Well the Drug Must Work. This comes from the Onion and as one would expect is hilarious. Thanks Bloviator!

Medpundit showed me the link to this long diatribe by - Jane Galt. Now I do not know Jane Galt, but I suspect she has not been on the receiving end of drug company marketing. I do understand the economics of new drug development. I understand market share. I do not understand the ethics of pharmaceutical company marketing.

We have this problem in medicine. We want to find truth, not opinion, not guesswork, but truth. When confronted with a patient who has just entered menopause, I want as much information as possible to help her decide on potential prevention measures. I would like to either have read the literature, or have a competent expert summarize that literature as an aid to our decision making.

The pharmaceutical companies have a different incentive. They want us to use their drug, at the highest feasible price. Given two potential drugs for the same indication, they will always "spin" the drug that they sell. Understanding their profit motive (which is not a bad thing per se), I understand that they do not necessarily care about the best therapy. They care that we use their therapy. Thus, they work hard to influence us. Influence comes in many forms (for a good start on understanding influence - Influence At Work: The Psychology of Persuasion). That is their job, but I do not have to like it. I prefer to obtain information from unbiased sources. I object to the flagrant boondoggles that they fund (dinner at expensive restaurants, vacations, tickets to football games, etc.).

Each company seems to function under a different ethic. I find some companies more acceptable in their tactics. The general feeling we physicians have is that the drug reps are just salespeople, they rarely provide useful information, they are JUST SELLING. That is my objection.

Frequent readers expect me to link articles like this one - Give me Strength!

Researchers are learning that a moderate strength-training (weight-lifting) program can do wonders for our bodies. After we turn 30, we lose about 10 percent of our muscle per decade, or a half-pound of muscle every year. That may not sound like much - but by age 70 it means we've been sapped of at least 40 percent of our strength. Lugging a 20-pound bag of groceries at age 30 may be a chore; by age 70 it could be a pipe dream unless we do something to maintain muscle.

Whether you are 20 or 90, strength training stops muscle loss and builds new muscle tissue. That muscle will burn calories, give your body shape, influence your flexibility and sense of balance, and protect you against several diseases.

To a certain extent, strength training even reverses some of the changes normally associated with old age, such as decreased stamina, energy and balance.

Are you taking care of your body?

We care for the broad spectrum of our society. At least many of us do. One knows anecdotally that the more intelligent, informed, and literate patients generally do better in their own medical care. We now know that observation is more than an anecdote - Poor literacy puts diabetics at risk. I assume that the less literate the patient, the more time we should spend educating them. We should be teaching these patients how to care properly for themselves. But there is the rub, teaching takes time. We do not have time. Our payment system only rewards quick visits. Get them in and out. The heck with complete patient care. The heck with quality. I so quickly jump back onto my soapbox. But I cannot let this issue go. We need more time to see patients each year. We can do so much more if we could only focus on all the issues with each patient.

I was working with an intern in clinic yesterday afternoon. The Wyeth representative had bought him dinner the previous night (actually dinner for the entire team on call). That rep was downplaying the HRT study results. He got directions from the company. Wyeth Criticizes Media Coverage of Hormone Replacement Drugs

The chief executive of Wyeth, Robert A. Essner, criticized the media yesterday for what he termed its "sensationalizing" of a study that found that the company's hormone replacement therapy, Prempro, did more harm than good.

"Once the media sensation over the study subsides, the data will speak for themselves and hormone replacement therapy will remain an important part of women's health care," Mr. Essner said in a conference call with analysts.

To Wyeth's credit they paid for the study. However, I am very tired of drug rep and drug company spin. Reps are salepeople. They always have the BEST drug compared to their competitors. Nothing is every wrong. one gets tired of the spin. Thus, I cannot believe anything they say. I must go elsewhere for drug information. So should you!

Everyone wants a Medicare prescription provision. Each party wants their own - Two Parties' Plans on Prescriptions Falter in Senate

Today's votes, the most significant in a two-week Senate debate on prescription drugs, were the latest illustration of the deep philosophical differences over the proper role of government in meeting one of the nation's greatest social needs.

Democrats wanted the government to establish uniform drug benefits, while Republicans wanted the government to pay subsidies to private insurers to provide coverage for drug costs, with insurers allowed to vary premiums and other details.

"We are not going to give up," said the Senate majority leader, Tom Daschle, Democrat of South Dakota. "Everything is on the table. If we can find a role for the private sector, for the insurance industry, I would not be averse to doing that."

Likewise, when asked if he would consider a proposal to provide drug coverage just to Medicare beneficiaries with low incomes or high drug expenses, Mr. Daschle said, "I'm not averse to that."

But Senator Edward M. Kennedy, Democrat of Massachusetts, said he would prefer not to make such concessions in a program that provides health insurance to virtually all the elderly, regardless of income.

So instead of compromise we have posturing. Instead of compassion we have politics. But then, this is what we expected.

Apparently, some patient data are not confidential. I do not like this story at all. I do not like the implications. Selling Privacy: Lines of Health Care Confidentiality May Get Blurrier

Some interesting thought here, although I believe more in changing dietary patterns and exercising. Nonetheless, this might help someone. The best ways to banish your hunger cravings...

Senators Ready to Vote on Proposals While the are ready, there is no apparent compromise in sight. Many remain skeptical

Senate Minority Whip Don Nickles, R-Okla., said over the weekend he was afraid the Senate might not be able to pass a bill. ``I'm afraid that might happen,'' Nickles said on CBS' ``Face the Nation.'' ``I hope not. I hope that we can pass something.''

A spokesman for Finance Committee Chairm