Stomach test 'could cut cancer deaths'. To summarize, h.pylori - the bacteria which causes most ulcer disease - also causes most stomach cancer. Therefore, we have a large prospective study of screening for and treating asymptomatic h.pylori infection.

Professor Nicholas Wald, who is leading the research, told BBC News Online: "We know H pylori is a major cause of stomach cancer.

"What we don't know is whether treating it in middle life will reduce the risk of stomach cancer."

He said if the trial did show screening was beneficial, it should be widely introduced.

"If it is shown to be beneficial, and had been effective in reducing stomach cancer deaths, there's a strong case for introducing it.

"The impact of doing this through the world would be massive. Stomach cancer is the second most commonest fatal cancer in the world, behind lung cancer.

Is this ready for prime time? I believe it to be an interesting and debatable point. My gut feeling is that we should not ignore h.pylori when we find it, but I am not ready to screen asymptomatic patients yet.

Alan Milstein is at it again. I previously have written about this lawsuit. Today's Washington Post lays out the case in more detail. Artificial Heart Implant Leads to Suit Over Consent Process: Recipient's Widow Says She and Her Husband Were Misinformed and Misled on Risks, Benefits This article is worth reading in its entirety. The challenge here is an interesting one. Despite a detailed informed consent document AND a patient advocate to explain the details, the surviving wife claims she and her husband did not understand.

"I figured it was like a regular heart," Irene Quinn said last week. "You get it, and we come home and do the things we normally do."

Instead, she said, after a remarkably promising recovery in the weeks after the surgery, her husband suffered complications and setbacks over the next nine months before suffering a massive stroke Aug. 23. Three days later, after Quinn had been declared brain dead, Louis E. Samuels, the surgeon who implanted the heart in Quinn, was at his side when the heart was turned off.

"He would have been better off dead," Irene Quinn said of her husband and her experience with the artificial heart. "There was no quality of life. It was too painful. He said he wished he'd never done it."

So who gets sued, the manufacturer, or the surgeon, or the patient advocate?

Now, Irene Quinn is suing Abiomed Inc., the maker of the AbioCor artificial heart; Hahnemann University Hospital, its parent company and affiliated medical school; and the patient advocate assigned to help the Quinns understand the consent process. She claims they were misinformed and misled about the risks and benefits of the procedure and the potential for pain and suffering.

"The informed-consent process failed," said Alan Milstein, Quinn's attorney, who has represented plaintiffs in other cases involving clinical trials. "They didn't understand what it meant to volunteer for a human subject experiment. They thought this was his only chance, that it was a therapeutic option, and not that he was a human guinea pig."

Note the use of language here - 'a human guinea pig'. These words are carefully chosen to invoke an image of mean scientists doing things to patients. These words are like cursing to medical researchers. Note that they are not suing the surgeon!

In setting up the trial, Abiomed, the Danvers, Mass., firm that makes the AbioCor heart, took steps beyond those required to help families make informed choices about participating. The company set up a trust establishing an independent patient advocacy council to provide advocates not affiliated with any of the trial sponsors to help patients understand the informed-consent process. The advocates typically have medical training and are experienced in end-of-life issues and medical ethics.

"What's new here is that a commercial organization has hired a person experienced in patient care and ethics to serve as an advocate for each patient," said Robert A. Levine, Yale University professor of medicine and bioethics.

"We believe it's the most progressive practical model yet devised to protect patients in high-stakes clinical trials," said Abiomed Vice President Edward E. Berger. "We're very proud of the effort that was made by the clinical staff at Hahnemann Hospital and by the original patient advocate to assure well-informed decision making. We do intend to defend against this lawsuit very vigorously."

The Quinns' advocate, David Casarett, a bioethicist and geriatrics specialist at the University of Pennsylvania, is being sued by Irene Quinn. But notably absent from the lawsuit is Samuels, with whom the Quinns had grown close and who, ultimately, was the person responsible for ensuring they were fully informed and getting them to sign the consent document. Neither Casarett nor Samuels would comment on the case.

We all know that informed consent is a dangerous phrase. Can patients really understand the consent process? Patients hear what they want to here and ignore what they want to ignore. One could argue that no informed consent process is ever satisfactory. We can always find flaws when we use the retrospectoscope.

I feel badly for Mrs. Quinn, but I do not believe she should have sued. I do not believe that Mr. Milstein should have taken this case. The company clearly went to great lengths to insure informed consent. If this case succeeds how much damage will occur to good science. What are the risks and benefits of persuing this case?

These overarching questions never seem to matter in such cases. Sometimes we should consider the good of future patients and investigation. This study is important, well conceived and well done. I hope the lawsuit is 'thrown out'.

I do not really understand the war on drugs (the illegal ones). Our government spends billions of dollars and what do we get? We support semi-organized crime, gang wars, and make millions of Americans criminals. We allow drug prices to increase (law of supply and demand), and at least for the more addicting drugs, either bankrupt users, or see them commit various crimes (theft, armed robbery, embezzlement). For very interesting reasons, the 'war on drugs' is now focusing on marijuana. I recommend this well conceived op-ed piece from the NY Times - Reefer Madness

The drug liberalizers — an alliance of legal reformers, liberals, libertarians and potheads — dwell on marijuana in part because a lot of the energy and money in their campaign comes from people who like to smoke pot and want the government off their backs. Also, marijuana has provided them with their most marketable wedge issue, the use of pot to relieve the suffering of AIDS and cancer patients. Never mind that the medical benefits of smoking marijuana are still mostly unproven (in part because the F.D.A. almost never approves the research and the pharmaceuticals industry sees no money in it). The issue may be peripheral, but it appeals to our compassion, especially when the administration plays the heartless heavy by sending SWAT teams to arrest people in wheelchairs. Thus a movement that started, at least in the minds of reform sponsors like the billionaire George Soros, as an effort to reduce the ravages of both drugs and the war on drugs, has become mostly about pot smoking.

The more interesting question is why the White House is so obsessed with marijuana. The memorable achievements of Mr. Walters's brief tenure have been things like cutting off student loans for kids with pot convictions, threatening doctors who recommend pot to cancer patients and introducing TV commercials that have the tone and credibility of wartime propaganda. One commercial tells pot smokers that they are subsidizing terrorists. Another shows a stoned teenager discovering a handgun in Dad's desk drawer and dreamily shooting a friend. (You'll find it at www.mediacampaign.org. Watch it with the sound off and you'd swear it was an ad for gun control.)

Drug czars used to draw a distinction between casual-use drugs like marijuana and the hard drugs whose craving breeds crime and community desolation. But this is not your father's drug czar. Mr. Walters insists marijuana is inseparable from heroin or cocaine. He offers two arguments, both of which sound as if they came from the same people who manufacture the Bush administration's flimsy economic logic.

One is that marijuana is a "gateway" to hard-drug use. Actually Mr. Walters, who is a political scientist but likes to sound like an epidemiologist, prefers to say that pot use is an "increased risk factor" for other drugs. The point in our conversation when my nonsense-alarm went off was when he likened the relationship between pot and hard drugs to that between cholesterol and heart disease. In fact, the claim that marijuana leads to the use of other drugs appears to be unfounded. On the contrary, an interesting new study by Andrew Morral of RAND, out in the December issue of the British journal Addiction, shows that the correlation between pot and hard drugs can be fully explained by the fact that some people, by virtue of genetics or circumstances, have a predisposition to use drugs.

We need some common sense here - but I do not expect to see any.

My Life's Not FDA-Approved: Why do I have to die for the sake of government rules?

I have something called metastatic soft tissue sarcoma. It's rare, but every oncologist in the civilized world knows I'm a goner if I don't get lucky. A few thousand cases are diagnosed each year; an equal number die. There's no cure. For about a third of us chemotherapy can "buy some time," but at a terrible price. Generally, regular surgery is the way to stay alive. The cancer grows slowly, and the tumors can be "resected" as they appear. Eventually, you have so many that surgery is no longer possible.

That's where I am. My only hope is a drug that might shrink them.

The good news is that there is one out there called ET 743 that might help me. The bad news is that I'm told I can't get it without spending the next six months making weekly trips from Boston to San Antonio, where an FDA-approved clinical trial is being held.

When I think of the number of trips to and from San Antonio I feel like an out-of-shape climber standing in front of Mount Everest. I'm tired: 50% of my lung capacity has been removed. It's hard to breathe. I have a husband and five kids to love and take care of. Two days of travel every week is going to take every ounce of strength I've got left. The financial cost of the travel would be breathtaking even if I had three lungs. Excellent doctors here in Boston have experience administering this drug. Why can't they give it to me? Why must I lay down what's left of my health, my treasure, and my family life to get it?

Johnson & Johnson has the U.S. marketing rights to ET 743. It's been approved by the FDA for trials in cancer patients who have failed other therapies. It's been given to hundreds of patients in U.S. clinical trials over the past few years. It's been shown to be safe. It's the only drug in the world that has had significant success with sarcoma patients.

Legally, the company could obtain a "compassionate use" waiver for me from the FDA so I would not have to commute or move to San Antonio. It costs some money and takes some time, and I've offered to pay the cost. Pharma Mar, the tiny Cambridge, Mass., company that had the original U.S. rights to ET 743, used to allow compassionate use of the drug. Compassionate use is also available in Europe. Johnson & Johnson just says "no."

Why? FDA rules. ET 743 is now being tested in San Antonio. Any outside use of the drug that cannot be monitored directly by the doctors in charge of the test could "taint" the whole test, if the patient were to experience an unpredicted symptom. Even if the symptom were minor and seemingly unrelated, like feeling dizzy in an overheated car, questions could be raised about the drug, jeopardizing its approval. The FDA could require more tests, costing Johnson & Johnson millions more in testing costs and delays and hurting its reputation with the FDA.

It's not hard to understand the company's problem: They're running numerous drug trials and they don't need trouble with the FDA. But if you're me, you wonder what the FDA is thinking. I'm dying here; I'm a citizen and a taxpayer. Why must Johnson & Johnson be paralyzed by the prospect of getting in trouble with the government if it gives its drug to dying people? The drug has already made it through several phase one trials and shown itself to be safe.

This passionate plea makes sense, but so do the FDA rules. If the FDA approves a drug which causes undo side effects, then future patients may suffer greatly. The FDA sits in a no win seat. What would you do? Are you really certain?

America's Epidemic of Youth Obesity

That Americans are getting heavier is especially hard to deny the day after Thanksgiving. But America's weight problem has less to do with holiday binges than with everyday choices and circumstances. That's especially true for children, who are gaining weight in epidemic numbers, particularly in minority communities. Mexican-American and African-American children are twice as likely as non-Hispanic white children to have a body mass index of more than 25, the definition of overweight. In the last three decades, the number of overweight young Americans has tripled, with no sign the trend is abating.

Far from being just the stuff of cruel schoolyard taunts, the issue has serious long-term implications. For the first time, children are being diagnosed with weight-related chronic ailments that usually strike much later in life, including hypertension and Type 2 diabetes, popularly known as adult-onset diabetes — a name that now needs rethinking. These diseased children are at risk, as similarly stricken adults are, for heart and kidney troubles, blindness and limb amputation, but at an earlier age. Further, as odd as it seems, a number of these children suffer from malnutrition from the unhealthy diets that made them fat. As they age, they can be expected to strain the health care system.

Genetics, while important, is just one piece of a larger physiological and psychological puzzle. At the National Institutes of Health, no fewer than 16 studies are being financed to study how to change environments to encourage a healthier lifestyle for young people — from day care and after-school activities to educating children about food. "There is a panoply of forces that are all conspiring to get us to eat more and exercise less," says Dr. Susan Yanovski, director of an institute obesity and eating disorders program.

...

In many low-income minority neighborhoods, fried carryout is a cinch to find, but affordable fresh produce and nutritious food are not. Those same neighborhoods often lack many safe public places to play and exercise — an essential part of any weight-management equation. Dr. Michael Myers, who works daily with obese patients in Los Alamitos, Calif., says that even when an ideal weight cannot be achieved, regular exercise and activity can delay or prevent the onset of health complications for an overweight child. While more study of the problem is needed, helping to make the victims of this epidemic more active cannot hurt either.

While it seems politically correct to focus on obesity in underprivileged areas, we see obesity in the rich suburbs also. Hopefully, the NIH funded studies will reveal the multifactorial nature of obesity. When in doubt, start moving that body, walk, lift some weights and turn off the TV. Get rid of the video games, using them as a reward after an hour of exerise.

Should we subsidize healthy food options? A reader suggested a special program to help startup companies interested in offering 'healthy fast food chains'. Interesting concept.

Most of us will eat too much today (I certainly plan to overeat). That is not necessarily bad and I will exercise first (helps decrease any chances of a guilty conscious) and then again exercise all weekend (have to get rid of those excess calories). How do we decide how much to eat today, or any other day? This article may help our understanding - Scientists study hunger signals: How the body knows when to say when at Thanksgiving feast

Studies Conflict on Danger in Mercury-Laden Fish - describes two studies in today's NEJM which have conflicting results.

Two studies have yielded contradictory findings about the possible heart dangers of eating mercury-laden fish.

The studies, reported in today's New England Journal of Medicine, looked at the long-term effects of mercury exposure on the hearts of middle-aged and elderly men.

One found no clear link between mercury levels in the body and the risk of developing heart disease; the other found that men who had suffered a heart attack had higher mercury levels than similar men who had not.

As I have discussed previously, body fat is a much better measure than BMI. Ideally we should strive towards a goal body fat rather than a weight. As you and your patients make plans for the inevitable New Year's resolution (more exercise, better diet), you might want to consider this as a measuring stick - No Calipers or Cringing: A Discreet Gauge of Body Fat

As an alternative, Mrs. Lawton, 38, purchased a body fat analysis scale that she could use at home.

"I wanted to keep on top of my measurements since I had a certain goal of losing a specific amount of body fat, but I didn't want the hassle of having to go to the gym," she said.

Mrs. Lawton had plenty of options. Fat-analysis scales were introduced six years ago, and as early as 2000 most manufacturers offered at least one model. Today fat-analysis scales are so mainstream they can be found in most home, hardware and department stores alongside traditional mechanical and digital scales. Companies like Measurement Specialties, Tanita and Taylor Precision Products make the scales, which cost from $50 to $200.

Fat-analysis scales look like traditional bathroom scales, and, in one respect, act like them too: they weigh the body when they are stepped on. But placing your feet on a fat-analysis scale also puts them in contact with electrodes that send a small (and undetectable) electrical current through the body. The scale compares the current entering the body with the current leaving it and calculates body fat composition using bioelectric impedance analysis, or B.I.A., which is based on the difference in the ways that an electrical current is affected by muscle and fat.

I just might buy myself one to compare with my caliper measurements.

Acute renal failure (or acute tubuler necrosis - ATN) is a vexing problem. Critically ill patients often have 'renal shutdown' (generally secondary to a hypotensive episode). True oliguric acute renal failure (also caused by rhabdomyolysis, certain drugs and contrast dyes) has several characteristics including a drop in GFR to less than 5 cc/min and profound oliguria (less than 20 cc/hour).

For years physicians have give diuretics in hopes of 'priming the pump'. Physiologically this never made sense to me. ATN patients already can neither conserve sodium and water. Since diuretic works to inhibit sodium chloride reabsoprtion, and ATN patients are not absorbing avidly, I never understood the rationale for using a loop diuretic. I always attributed this to simplistic thinking - if the patient is not peeing, give them a peeing drug.

An article in today's JAMA shows that diuretics may indeed worsen outcomes of ATN - Diuretics, Mortality, and Nonrecovery of Renal Function in Acute Renal Failure

The use of diuretics in critically ill patients with acute renal failure was associated with an increased risk of death and nonrecovery of renal function. Although observational data prohibit causal inference, it is unlikely that diuretics afford any material benefit in this clinical setting. In the absence of compelling contradictory data from a randomized, blinded clinical trial, the widespread use of diuretics in critically ill patients with acute renal failure should be discouraged.

An accompanying editorial has this to say.

Despite these limitations, the study by Mehta et al is timely and clinically important because administration of diuretics to oliguric patients in the ICU is still a relatively common practice. Until data from a sufficiently powered clinical trial can properly answer the question of whether critically ill patients are harmed by loop diuretics, the practice of routine administration of these agents to such patients should be discouraged. Accordingly, physicians should think twice before prescribing loop diuretics for critically ill patients with ARF. A trial of high-dose loop diuretics in an oliguric patient should only be attempted after careful correction of the volume status, should be limited in time, and, more important, should not postpone obtaining consultation with a nephrologist experienced in ARF. Nephrologists and intensivists should also realize that even successful conversion of oliguria to diuresis only reflects the existence of a milder form of ARF, has no prognostic effect, and does not justify postponing dialysis when needed.

Hopefully this study will change this practice pattern.

A reader sends this rant:

I enjoy your blog site...I recently read of your disgust with Astra Zeneca and the Nexium patent extention nonsense. I agree.

On the bright side, as an example of a firm doing "the right thing," I wanted to call your attention to what Wyeth has done with their PPI, Protonix and Protonix IV. When this drug was launched two years ago, the average price to a hospital for any of the current PPI's (Prevacid, Prilosec, Aciphex) was about 3.00. Wyeth chose to offer BOTH Protonix PO and Protonix IV to hospitals at nominal pricing. As a result, this product is availiable to hospitals who choose to adopt a minimum 60% market share of Protonix at current pricing of:

.16 tablet 40 mg. PO
4.00 dose, 40 mg. IV

Each of these prices are BELOW Wyeth's cost. As an interesting sidenote, this is probably the first time a pharma company has launched a first to market, unique to class drug such as Protonix IV BELOW COST! The end result consists of hospitals saving many thousands per year in this drug class.

Well stated and accurate. I will repeat - JUST SAY NO TO NEXIUM. AVOID THE NEW PURPLE PILL!

FDA Approves 1st Drug to Build New Bone

The first drug designed to stimulate the growth of new bone won Food and Drug Administration approval Tuesday for treatment of osteoporosis, the brittle-bone disease that affects 10 million Americans.

The new drug, known as teriparatide, works by increasing the action of osteoblasts, the body's bone-building cells. This causes bones to become denser and more resistant to fractures, officials said.

FDA officials said the drug, given by injection daily, will carry a special warning because in laboratory tests teriparatide caused cancerous bone tumors in rats. The tumors, however, have not been seen in 2,000 people who tested the drug in clinical trials, officials said.

Teriparatide will be marketed by Eli Lilly and Company of Indianapolis under the brand name Forteo.

"We feel this is an important drug," said Dr. Eric Colman, a team leader in the FDA division of metabolic and endocrine drug products. "It is the first approved that stimulates bone formation instead of slowing the breakdown of bone."

I have not previously read about this drug. Being the cautious sort, I will wait until I learn more. Hopefully I can learn from either the Medical Letter or the Prescriber's Newsletter. If I find more information I will try to write about it here.

Nuts May Help Prevent Diabetes, Study of 83,000 Women Shows.

Women in the study who reported eating the equivalent of a handful of nuts or one tablespoon of peanut butter at least five times a week were more than 20 percent less likely to develop diabetes than those who rarely or never ate those products.

The original article is in today's JAMA.

Just click on Medpundit in the left hand column. She has hit several home runs today. Read her and save me the time I would use to say the same things less well.

For those who are interested in resident work hours, I found this article informative and thought provoking. ARE MEDICAL RESIDENTS WORKING TOO HARD? - Resident Aliens

Even before Congress had a chance to consider the bill, the Accreditation Council for Graduate Medical Education (ACGME)--a national organization that oversees all residents--mounted a massive, preemptive response. Scrambling to placate the public, the ACGME ginned up a set of totally new stipulations for resident work hours. Starting in July 2003, residents will no longer be allowed to work more than 80 hours per week; in addition, shifts longer than 24 hours will be banned. In mid-June, the ACGME sent notice to all programs around the country, asking them to bring their training programs to heel. And that's when Ferguson suddenly found himself with an onerous task: revamping MGH's surgical training program to meet the ACGME's regulations.
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"Imagine the actual details," Ferguson said dejectedly, walking me through the task. "We start off by cutting out several hours of the workweek. That means that the residents won't be able to scrub in to as many cases. And that means someone--some committee or other--will have to decide what's necessary and unnecessary in training. Do you need to remove five gallbladders or ten before you can do the surgery safely?" Ferguson seemed melancholy at the prospect of all the changes. "The council has really asked us to rethink the residency system itself," he added. "But that means breaking down the entire culture of residency, the very basis of our teaching and training. Why would anyone want to do that?"

While I do have some philosophical disagreements with some of the ACGME provisions, I do understand their intent. Our challenge (and one which our residency program is taking very seriously) is to figure out how to provide the best possible education under these new rules. I recommend this article as one which may challenge ones assumptions.

'Standard' Heart Treatment Is Hit and Miss. This article refers to our groups current research interest! We are interested in helping physicians accept and use clearly supported guidelines to improve medical care.

Findings from a small number of studies reported at a meeting of the American Heart Association here last week highlighted a gap between what guidelines call for in preventing and treating particular heart conditions and what doctors actually prescribe for them. Differences in how often doctors apply guidelines for heart disease, which is the nation's leading cause of death, have exposed serious flaws in health care.

The reasons cited for the gap are many and complex. One reason is that some hospitals and doctors are less aggressive than others in carrying them out. A second reason is that even when guideline-recommended drugs are prescribed, many patients do not comply with the instructions. Still another reason is that guidelines are based on clinical trials in which most participants are middle-aged. The relatively narrow focus can make it hard to extrapolate findings to the elderly and children, limiting the usefulness of guidelines, which are published periodically in specialty journals.

Using guidelines as a tool to measure patient outcomes in everyday practice is a new phase of research for the relatively young specialty of cardiology. The heart group held its first scientific meeting in 1925, 13 years after James B. Herrick of Chicago became the first doctor to diagnose a heart attack in a living patient.

The field of outcomes research has this specific application as a common thread. We have studied a variety of methods for educating physicians and helping them change their practice. We have also studied methods for changing hospital cultures.

To non-physicians this may seem simple. If post-MI patients should receive a beta blocker, then why does not every patient. The reality of medical practice revolves around complexity. Patients do not just have myocardial infarctions. They have myocardial infarctions in the context of their other medical conditions. Patients are complex, and guidelines try to simplify their care. We (physicians) learn contraindications to medications, and are slow to unlearn those contraindications. For example, I was taught 2 major contraindications to beta blockers - congestive heart failure and chronic obstructive pulmonary disease. We have since learned the beta blockers paradoxically help CHF. We also now know that most COPD patients can safely take cardioselective beta blockers.

Note that I have only mentioned one medication and one indication. Many patients have several problems, each may have a relevant guideline. The challenge of incorporating these everchanging data increases the complexity of providing care.

The article does a nice job of summarizing some thoughts about this field. We will continue to study this question in hopes of helping physicians meet their goals - providing the best possible care for all patients.

Why We Eat (and Eat and Eat). Denise Grady has written a very nice summary of our inborn tendency to overeat. She discusses possible hormonal influences. I found these quotes very interesting.

Lawsuits? Drastic operations? Why don't these people just stop eating so much?

"People can't stop eating any more than they're able to stop having sex or grabbing money or anything else," said Dr. Stephen R. Bloom, an obesity researcher at Hammersmith Hospital at the Imperial College school of medicine in London. "When you crash a plane in the Andes and there's no food, you eat your neighbor. Here we have the action of a very important, basic human drive."

Though most researchers advocate exercise programs and education about nutrition to try to prevent obesity, especially in children, they say people who already have a weight problem need more help. Rather than just telling heavy people to resist eating too much, Dr. Bloom and other researchers hope to find ways to ease the hunger pangs.

"I think we should do what we do for high blood pressure and high cholesterol," Dr. Bloom said. "We give them a tablet. It's not their fault. They're designed to get fat."

That concept, that many of us are 'designed' to get fat, underlies a philosophical attitude. Is the obese person lazy, bad or dumb? Or rather was fat storage a survival advantage for our ancestors? Perhaps we should modify our paradigm of obesity.

Patients may pay more for better care

Some insurance companies are trying yet another tactic to drive down health care costs, using tiered medical coverage to steer patients from high-priced hospitals and doctors to less expensive ones.

The new plans establish price categories for hospitals and doctors in the same way that many plans now are "tiering" prescription drugs, requiring patients to pay more themselves for the costlier alternatives.

The rationale is the same: If some of the money comes from their own pockets, patients will opt for cheaper services.

Consumer advocates and hospital executives fear the plans will force people to make medical decisions based on cost rather than quality. The insurers say the wide differences in prices for similar services aren't always justified. Hospital prices, in particular, can vary by thousands of dollars in the same city.

CompCareBlue, a unit of BlueCross & BlueShield United of Wisconsin, began offering a tiered product last month. Michael Bernstein, CompCareBlue's president, called it "probably the most elegant way for consumers to understand the price differences."

He said all the hospitals included in the plan provide quality care, and that some major academic medical centers are included in the policy's low cost option.

"We think every hospital in the network measures up on quality," said Bernstein. "We based the program solely on cost to us, because we didn't feel equipped to make quality distinctions."

Plans typically have two tiers -- one less expensive and one more -- with a third category for out-of-network services.

One plan option offered by CompCareBlue would require patients to pay nearly $3,000 for an out-of-network hospital stay. Treatment at the hospital in the least expensive tier would cost the patient $300. Other plans have less dramatic differences, mandating patients to pay a $250 per-stay premium for more expensive hospitals.

Very interesting concept. I would add another feature. Those who live a healthy lifestyle should pay lower rates - just like life insurance. Why should me rates increase because others smoke or gain weight yearly?

Problem of Lost Health Benefits Is Reaching Into the Middle Class

According to recently released Census Bureau figures, 1.4 million Americans lost their health insurance last year, an increase largely attributed to the economic slowdown and resulting rise in unemployment. The largest group of the newly uninsured — some 800,000 people — had incomes in excess of $75,000. They either lost their jobs, or were priced out of the health care market by rapidly rising insurance premiums, or, like Ms. MacPherson, both.

While it is true that the number of uninsured people rises when unemployment goes up, it is also true that the rolls of the uninsured can expand even when joblessness is going down, as it did through most of the 1990's.

So how do we improve the system. As one would expect we have differing opinions from the Democrats and the Republicans.

On the other hand, proposals to aid the uninsured could easily touch off a partisan brawl, in which lawmakers fight over the merits of government programs versus the private market.

President Bush has already proposed tax credits and is expected to offer more proposals to help the uninsured as part of his budget early next year.

In his first two budgets, Mr. Bush earmarked a large amount of money for health insurance tax credits: $89 billion over 10 years, for people who are not covered by an employer's plan and not eligible for public programs. The proposal languished in Congress, but Mr. Bush will have a greater incentive to push for action this year.

"The president wants to develop a record on health care to neutralize this issue going into the 2004 elections," Mr. Pollack said.

The issue is of particular concern to small-business owners, who say they would like to offer their employees health insurance but cannot keep up with the fast-rising premiums. They are a large and influential lobby and an important base for the Republican Party.

Regardless of political action, we have a huge problem. The care we expect costs too much money. The tests are expensive; the hospital care is expensive; and medication costs ... well no sense in flogging a dead horse.

Read this passionate story about a physician and her sister's death - Binge Drinking, Persistent Abdominal Pain, Sudden Heart Stops

Don't Blame the Eater

If ever there were a newspaper headline custom-made for Jay Leno's monologue, this was it. Kids taking on McDonald's this week, suing the company for making them fat. Isn't that like middle-aged men suing Porsche for making them get speeding tickets? Whatever happened to personal responsibility?

I tend to sympathize with these portly fast-food patrons, though. Maybe that's because I used to be one of them.

I grew up as a typical mid-1980's latchkey kid. My parents were split up, my dad off trying to rebuild his life, my mom working long hours to make the monthly bills. Lunch and dinner, for me, was a daily choice between McDonald's, Taco Bell, Kentucky Fried Chicken or Pizza Hut. Then as now, these were the only available options for an American kid to get an affordable meal. By age 15, I had packed 212 pounds of torpid teenage tallow on my once lanky 5-foot-10 frame.

Then I got lucky. I went to college, joined the Navy Reserves and got involved with a health magazine. I learned how to manage my diet. But most of the teenagers who live, as I once did, on a fast-food diet won't turn their lives around: They've crossed under the golden arches to a likely fate of lifetime obesity. And the problem isn't just theirs — it's all of ours.

His op-ed piece continues, but he misses the point. One cannot single out McDonald's or even the fast food industry. We can distribute the responsibility for obesity across society, and it remains an individual responsibility. We (society) should accept the blame for not emphasizing a healthy lifestyle in schools. We need to demand stronger physical education programs, which would include solid dietary advice. Our schools could teach students exercise principles - but they do not.

Obesity is a complex problem with many contributors. Suing one factor in a multifactorial process makes no sense.

A New York Times editorial - Drastic Surgery for Drastic Obesity

I have written previously about medical marijuana and discussed the benefits. This article refers to the apparent mental health consequences of marijuana use - Marijuana Linked to Schizophrenia, Depression

Boutique Docs Set Up Shops

In Knoxville, Tennessee, Dr. Bryan Smith and registered nurse Pam Williams are trying to practice modern medicine -- the old fashioned way.

Together they are "Doctor at Your Door" -- one of a growing number of boutique medical practices. For an annual fee of $1,100 Smith and Williams will treat you in your home, reports CBS News Correspondent Elizabeth Kaledin.

They make office calls; they're available 24-7. And there's no voice mail. They forward their landlines to their cell phones when they're out on a call. And they carry a back-up phone in case the first one dies.

They have no staff, minimal overhead, and most important, they don't accept Medicare -- or insurance.

"I felt like the insurance companies were practicing medicine," Smith explained.

Before starting "Doctor at your Door," Smith was ready to quit medicine altogether. He said he was going broke.

"I would end up hiring two or three people in the back just to work the insurance. And then we would only get back 40 percent of what we billed."

Insurance sounds like a great deal to non-physicians. At first it sounds good to physicians. Insurance works well for procedures, and perhaps even for hospitilizations, but for routine outpatient visits (the cornerstone of medical practice) the costs seem to exceed the benefits.

Determined not to hang up his stethoscope, Dr. Todd Coulter is trying an experiment of his own. At his small family practice in Ocean Springs, he has also sworn off insurance and charges $40 dollars cash per visit.

"When we stopped taking insurance our overhead dropped immediately by $2,800 a month. Just dropped," he told Kaledin.

Rejecting that third party has allowed Coulter to limit expenses while increasing the quantity and quality of time he gets to spend with his patients.

"I'm not under a time table. It's not like I'm working for Kaiser Permanent and I've got to see 50 people by lunch time," he said.

There are no forms to fill out, no waiting for basic care. The patient is happy. And the doctor is staying in business carving out a nice living.

My students, interns and residents often accuse me of wanting to put ACE inhibitors in the water (along with statins). When tolerated, ACE-I seem to help many patients by decreasing coronary artery disease, heart failure, and progression of renal disease. Over the past 15 years, many physicians taught and believed that while ACE-I may serve as initial desirable therapy in Caucasians, they were not as effective in African-Americans. A study in this week's JAMA suggests that ACE-I are clearly preferred in African-Americans as they do a better job of preventing the kidney damage associated with hypertension. Effect of Blood Pressure Lowering and Antihypertensive Drug Class on Progression of Hypertensive Kidney Disease

We conclude that although BP reduction to levels below current guidelines for cardiovascular risk reduction are achievable, our results do not support additional reduction as a strategy to prevent progression of hypertensive nephrosclerosis. Our results do support recommendations that angiotensin-converting enzyme inhibitors should be considered as first line therapy over beta-blockers and dihydropyridine calcium channel blockers in these patients. Moreover, beta-blockers may be more effective than dihydropyridine calcium channel blockers in slowing progression among patients with proteinuria.

This study points out a very interesting phenomenon. When patients start on calcium channel blockers they get an initial decrease in creatinine (increase in GFR) due to hemodynamic factors. Nonetheless, over time, ACE-I have a clear benefit. Their data also suggest that beta-blockers have an advantage as second line therapy.

These data confirm my beliefs that ACE-I and beta blockers have complex and positive benefits in many patients. On the other hand, I only use calcium channel blockers when they remain the only choice. As a class, I believe they are overused and not as helpful in preventing the real outcomes of interest.

Folic acid 'could save lives'. This article refers to an article in today's British Medical Journal. The original article describes a meta-analysis of the data on homocysteine and 3 diseases - stroke, ischemic heart disease and DVT/pulmonary embolism. The authors conclude that indeed homocysteine qualifies as an important modifiable risk factor. They present more data defining the risk than on proving the benefit from folate alone.

Dr David Wald and colleagues at Barts and the London School of Medicine reviewed 72 studies looking at the link between homocysteine levels and heart disease.

They found a strong link between high levels of the chemical and an increased risk of heart disease.

Folic acid is known to reduce levels of homocysteine.

The doctors suggested that people at high risk of heart disease or stroke should take folic acid supplements.

These include people with existing heart disease and everyone over the age of 55.

"Our results indicate that an estimated 16% of heart attacks and about 24% of strokes can be prevented just by taking a folic acid supplement everyday," Dr Wald said in a statement.

"Everyone over 55 years of age, and in particular anyone with diabetes and existing cardiovascular disease should consider this. It would be ineffective, inexpensive and safe."

The article, while quite complex, does make a strong case for homocysteine levels correlating with risk. I am somewhat skeptical of the conclusion that we should fortify our food with folate though. Quoting from the BMJ article,

Evidence of risk reduction
A placebo controlled randomised trial of treatment with B vitamins (folic acid, B-6, and B-12) to lower serum homocysteine concentration in patients with ischaemic heart disease has shown a rapid reduction of risk. There were 13 major cardiac events (coronary death, non-fatal myocardial infarction, or revascularisation procedure) over six months in 102 vitamin treated patients and 23 events in 94 placebo treated patients (P=0.04). Studies of patients with homocystinuria treated with B vitamins have also shown reduction in risk. In one study treatment with B vitamin led to two vascular events when 30 would have been expected (from previous observation in untreated patients), and in another study there were two events when 21 would have been expected.

Note that in that one study a market basket of B vitamins (folic acid, B-6 & B-12) decreased risk and homocysteine levels. Some would argue that indiscriminant folate use may mask the diagnosis of pernicious anemia (B 12 deficiency). Somehow we must consider that possibility when making policy. I believe that someone must test the hypothesis that folate supplementation will decrease the disease burden. We should not go down the road of extrapolating epidemiologic data to policy. We must understand that epidemiological studies generate hypotheses; randomized controlled trials test the validity of those hypotheses.

Back in September I wrote this piece - More on the 2nd McDonalds suit. Over the past 2 days it has received several comments. I did not understand what was happening. Then I saw that the lawsuit had become a class action suit - Lawsuit claims McDonald's burgers and fries are making kids fat

Lawyers have filed a class-action lawsuit against McDonald's on behalf of New York children who have suffered health problems, including diabetes, high blood pressure, and obesity.

In federal court in Manhattan on Wednesday, a lawyer alleged that the fast-food chain has created a national epidemic of obese children. Samuel Hirsch argued that the high fat, sugar and cholesterol content of McDonald's food is "a very insipid, toxic kind of thing" when ingested regularly by young kids.

The plaintiffs include a Bronx teen who ate every meal at McDonald's for three years while living in a homeless shelter. Another is a 13-year-old boy from Staten Island who says he ate at McDonald's food three to four times a week and is now 5-foot-4 and 278 pounds.

McDonald's lawyer Brad Lerman insisted the lawsuit was a frivolous attempt to cash in on the Golden Arches, "the kind of lawsuit that shouldn't be in court."

"People don't go to sleep thin and wake up obese," Lerman said. "The understanding and comprehension of what hamburgers and french fries do has been with us for a long, long time."

Suits like this one will cost taxpayers money. Having such suits in our courts makes no sense. I hope the defending lawyers explain that obesity does not just come from food. These teenagers probably have no exercise regimen. Should he sue the schools for having ineffective physical education programs? Or should he sue the gangs for making the streets unsafe? Or should he sue the TV networks for providing entertainment which makes teenagers couch potatoes?

It does not seem that this subject will go away quickly. But I wish it would.

HPV (human papilloma virus) causes cervical cancer. Cervical cancer causes 3/4 million deaths each year worldwide (the second most important cancer in women). We heard a wonderful Grand Rounds yesterday by Sue Goldie from Harvard. She discussed the use of mathematical modeling to understand screening options for women.

Only certain strains of HPV cause cancer. There are over 50 strains known at this time. Her models show that HPV screening is more efficient than PAP smears. We will probably go to an HPV screening policy (at least starting after age 30) in the relatively near future. She did point out that vaccination would trump screening in the near future. Therefore, I was not surprised to hear yesterday afternoon that the first HPV vaccine trial was in today's NEJM. Vaccine Appears to Prevent Cervical Cancer.

In a study of 2,392 young women, half of them vaccinated and half given placebo shots, the vaccine was 100 percent effective. Followed for 17 to 27 months, no vaccinated women developed infections or precancerous growths from the virus, whereas 41 nonvaccinated women did become infected, including 9 with precancerous cervical growths. A report on the study is being published today in The New England Journal of Medicine.

The investigators called this study a 'proof of concept' study. It only used the most important strain - HPV-16. Merck is now working on a vaccine against several strains.

One type of human papillomavirus, HPV-16, is most commonly linked with cancer; it is found in 50 percent of cervical cancers. Another type, HPV-18, causes 20 percent. Others cause the rest. Still other types of human papillomavirus cause noncancerous genital and anal warts in both men and women.

In trying to develop a vaccine, the researchers chose as their target HPV-16, the leading cause of cervical cancer. They made the vaccine by splicing a viral gene into yeast so that the yeast would produce a protein normally found in the outer shell of the virus. The protein, also called a virus-like particle, is the vaccine. It cannot cause infection, but it sparks the patient's immune system to make antibodies that fight off HPV-16.

The vaccine that Merck is now testing, and hopes to market, will immunize patients against both HPV-16 and HPV-18, which together cause 70 percent of all cases of cervical cancer. The vaccine will also protect against two other HPV types, 6 and 11, which cause about 90 percent of genital warts.

The wart protection was included to "give incentive to young men to also take the vaccine," Dr. Jansen said.

She explained: "Men don't get cervical cancer. I always strongly felt that if we only go for cervical cancer types, there would be no reason for men to accept the vaccine. Even though they are vectors for transmitting the virus, they don't usually have effects."

These data portend a new route for prevention. Prevention almost always trumps screening.

Over the last decade the hospice movement has done much to improve the quality of the dying process. I am fortunate to work with an outstanding hospice team at our VA. Once we identify that a patient has a bleak prognosis, we involve hospice. A recent report suggests that we might want to consider involving them even earlier. Report: Time in hospice care declining for the dying

In 2001, the report said, hospice stays for patients of any age were longest — a median of 30 to 45 days — in Alabama, Louisiana, Mississippi, New Mexico, North Carolina and South Carolina.

It's not known why hospice time is dropping, although recent studies have found it is harder to predict remaining life expectancy with certain diseases. Some cancers, for instance, progress steadily while other diseases, such as heart failure, may wax and wane.

Members of Congress two years ago called the decline in hospice lengths of stay troubling. They urged Medicare to remind doctors that if a patient lives longer than the six months initially expected, recertifying that he or she remains close to death ensures that payment continues.

First, it is certainly nice to find an article tout Alabama as doing well in a health care category. But the major question that researchers should address is why the time is short. We need to know who goes into hospice and whether the decision was delayed.

Yesterday afternoon I was supervising residents in clinic. The possibility of involving hospice came up twice in the afternoon. We delayed in one because chemotherapy was continuing; we delayed in the other because we do not yet have a firm diagnosis. We are planning for both patients to start discussions of advanced directives and move to hospice at an appropriate time. But what is an appropriate time?

Hopefully, we will all continue to improve in providing this dignity enhancing option to our patients.

Readers of this blog know that I have repeatedly referred to our health care crisis. The Institute of Medicine agrees with me. Panel, Citing Health Care Crisis, Presses Bush to Act Note the negative headline from the New York Times. Interestingly, read the title from the Wall Street Journals article on the same subject - Bush Administration Unveils
Health-Care Project Proposals. Just consider those headlines on the same subject!!

The National Academy of Sciences said today that the United States health care system was in crisis and that the Bush administration should immediately test possible solutions, including universal insurance coverage and no-fault payment for medical malpractice, in a handful of states.

Administration officials said the report would probably become a blueprint for pilot projects to be proposed by President Bush and Tommy G. Thompson, the secretary of health and human services, who requested the study.

"The American health care system is confronting a crisis," said the report, from a panel of experts appointed by the academy's Institute of Medicine. "The health care delivery system is incapable of meeting the present, let alone the future, needs of the American public."

The report cataloged the problems this way: "The cost of private health insurance is increasing at an annual rate in excess of 12 percent. Individuals are paying more out of pocket and receiving fewer benefits. One in seven Americans is uninsured, and the number of uninsured is on the rise."

States, suffering severe fiscal problems, are cutting eligibility and benefits in Medicaid and other health programs, the panel said, and tens of thousands of people die from medical errors each year.

The tone recalled the alarm and urgency of President Bill Clinton, who in 1993 and 1994 asked Congress to guarantee health insurance for all Americans. In its report today, the panel proposed a more modest agenda, using states as laboratories to reverse "disturbing trends" that it said had worsened in the last two years.

The panel suggested that three to five states pursue the goal of affordable "coverage for all citizens and legal residents," by providing tax credits or expanding Medicaid or the Children's Health Insurance Program.

"We learned in 1993 and 1994 that you cannot be prescriptive," said Gail Warden, president of the Henry Ford Health System in Detroit, who was chairman of the panel that wrote the report.

The 16-member panel proposed pilot projects in four other areas: medical malpractice, community health centers, treatment of chronic illnesses and information technology, to computerize medical records and reduce paperwork. The panel, which included doctors, lawyers, a nurse and several professors, did not estimate the costs of its proposals.

Those who wish can read the report Fostering Rapid Advances in Health Care: Learning from System Demonstrations (2002). I commend the committee for their understanding that we need 'experiements' and results to influence change in our health care system. Demonstration projects make much sense. I also note that this report was requested by the Secretary of HHS. I look forward to this measured approach to investigating our health care system.

I reported (in a positive way) on CRP last week. Medpundit took a much more skeptical view - Inflammatory Screening:. I like relative risk analyses. But then I like statistics. Those in the highest risk group of CRP have a relative risk of 2. Thus, if one has a 10 year 10% risk (based on other factors) and you have the highest quintile of CRP, your risk becomes 20%. Relative risk of 2 are huge. And remember that risk continues for longer than the 10 years.

Nonetheless, the CRP data require more study. Even Ridker understands that we must more carefully study the final piece to the puzzle - can we treat the risk and decrease events. Docs look at new sign of heart disease risk: Clinical trial to study how drugs affect CRP levels

Scientists are launching a trial to determine if drugs used to lower cholesterol, called statins, could also lower the levels of c-reactive proteins (CRP), an indicator of risk for heart disease.

CRP levels are measured by a simple blood test and provide doctors with a measurement of how much inflammation is in the body, thus providing a clearer picture of who is at risk of suffering a heart attack or stroke as far as 15 to 20 years in the future.

Dr. Paul Ridker of Brigham and Women's Hospital in Boston announced the clinical trial at the American Heart Association conference in Chicago and is the primary investigator for the study, which plans to enroll patients in the mid- to late spring of 2003.

The study hopes to follow 15,000 patients for three to four years. Ridker said the study will comprise men over 55 and women over 65 who have no evidence of heart disease.

All study participants must have an LDL, or "bad cholesterol" level, of less than 130 and a CRP level of less than two. Patients in the multi-site, randomized study will not know whether they are taking a placebo or the drug rosuvastatin.

Rosuvastatin is made by AstraZeneca and received approval this month for use in the Netherlands. It has not been approved for use in the United States. The U.S. Food and Drug Administration is overseeing the clinical trial, which is being sponsored by the drugmaker.

Ridker said the sample of patients will be representative of the approximately 25 to 30 million Americans who have low LDL and high CRP.

In the meantime, CRP research is leading a paradigm shift in our understanding of coronary heart disease. We used to only work about plaque formation. We now know that while plaques start the process, acute coronary syndromes generally occur from plaque rupture. Inflammation occurs concurrently with plaque rupture.

Moreover, when one plaque has ruptured (causing unstable angina or myocardial infarction) multiple placques have often ruptured. This phenemenon and inflammation seem linked. Understanding what causes the inflammatory activation, how to diagnosis the inflammatory propensity and whether we can treat the inflammation prior to heart damage now becomes an important focus of heart disease research.

If a patient comes to me with a strong family history of premature heart disease and normal cholesterol levels, I would check CRP. Those with an elevated CRP might benefit from a statin. Until the Jupiter trial (by the way that is the name of the trial) shows results, I will err on the side of treating high CRP in normal LDL patients with other risks - especially premature family history.

For more on CRP you can go to theheart.org. They have an excellent (although unlinkable) story about CRP yesterday. theheart.org has free registration.

Lean Plate Club: Gone Fishin' for Nutrition

The American Heart Association (AHA) yesterday urged all Americans to eat more healthy fat from fish and plants to help protect their hearts -- a recommendation that fits with the U.S. Dietary Guidelines and the latest recommendations of the National Academy of Sciences (NAS). It's also part of the Lean Plate Club philosophy.

Where the AHA breaks new ground, however, is in recommending at least one gram a day of fish oil for those who already have heart disease and in suggesting two to four grams a day of fish oil for people with elevated levels of blood fats known as trigylcerides.

For the official statement - Fish Consumption, Fish Oil, Omega-3 Fatty Acids, and Cardiovascular Disease

A dietary (ie, food-based) approach to increasing omega-3 fatty acid intake is preferable. Still, for patients with coronary artery disease, the dose of omega-3 ({approx}1 g/d) may be greater than what can readily be achieved through diet alone (Table 5). These individuals, in consultation with their physician, could consider supplements for CHD risk reduction. Supplements also could be a component of the medical management of hypertriglyceridemia, a setting in which even larger doses (2 to 4 g/d) are required (Table 5). The availability of high-quality omega-3 fatty acid supplements, free of contaminants, is an important prerequisite to their extensive use.

Now we need guidance for non-fish eaters as to which fish oil supplements are of high quality. I would rather eat the fish.

Reborn to Run: How a Non-Jock Learned to Love Running, or at Least Act as if She Does. Before any quotes, click on the article and read it. This is fun writing. She is honest, explains her motivations and gives some great tips.

For me, running has always been a source of dread, recalling memories of despotic gym teachers and certain humiliation. The sensory memories themselves are painful: feeling winded and slightly nauseated, saliva coursing down my chin as I pant around a hard asphalt track.

So how can I explain that, at age 47, I now happily run 20 to 25 miles a week?

Quite simply, I lie, cheat and steal. I throw out the rules and make my own. Instead of a macho, suck-it-up approach, I use goofy tricks, mind games and some nifty headphones to diminish the pain of my exertions, or at least distract myself from them. I know these strategies are infantile. Just try to take them away from me.

In the past 18 months I've dropped nearly 30 pounds and, more or less, kept them off. My heart rate has fallen to that of a hibernating animal and I have more energy than I've had for years. My approach will never appeal to serious athletes, but they have never needed much help. You, I figure, might be another story.

Please read the article. It is great!

I agree with much that she says. I do have a suggestion though. Buy a flash memory mp3 player. I recently bought RCA's Lyra (128 mB) which will hold up to 4 hours of songs. I use funk tunes to either run or use the elliptical machine. The author has discovered a truth that many know. Music does enhance the workout. Another trick is to have a TV in your workout room and find a TV show to run/walk/jog. I will often pick a show and use the show to set the time of my workout.

I hope this article will help some of you and your patients. You (they) may never love it, but you (they) will like how it makes one feel and look. I love the complements I get from friends. Vanity is a reasonable motivation.

Atkins diet beats low-fat fare

At least three formal studies of the Atkins diet have been presented at medical conferences over the past year, and all have reached similar results. The latest, conducted by Dr. Eric Westman of Duke University, was presented Monday at the annual scientific meeting of the American Heart Association, long a stronghold of support for the traditional low-fat approach.

Westman, an internist at Duke’s diet and fitness center, said he decided to study the Atkins approach because of concern over so many patients and friends taking it up on their own. He approached the Robert C. Atkins foundation in New York City to finance the research.

Westman studied 120 overweight volunteers, who were randomly assigned to the Atkins diet or the heart association’s Step 1 diet, a widely used low-fat approach. On the Atkins diet, people limited their carbs to less than 20 grams a day, and 60 percent of their calories came from fat.

“It was high fat, off the scale,” he said.

After six months, the people on the Atkins diet had lost 31 pounds, compared with 20 pounds on the AHA diet, and more people stuck with the Atkins regimen.

Total cholesterol fell slightly in both groups. However, those on the Atkins diet had an 11 percent increase in HDL, the good cholesterol, and a 49 percent drop in triglycerides. On the AHA diet, HDL was unchanged, and triglycerides dropped 22 percent. High triglycerides may raise the risk of heart disease.

While the volunteers’ total amounts of LDL, the bad cholesterol, did not change much on either diet, there was evidence that it had shifted to a form that may be less likely to clog the arteries.

Wow!! These studies are causing a paradigm shift. While the medical research establishment sometimes embraces the wrong theories, it consistently respects data. These studies will probably 'open the flood gates' of research into the Atkins diet. In the meantime, I have changed my position on advising patients and friends. If they want to use the Atkins diet I support them psychologically. I do not yet understand why this happens, but this is certainly a fascinating development.

Fish oil's multiplying benefits

The fish oil story keeps getting better.

British researchers last month reported that eating fish cut the risk of dementia among a group of elderly people living in France. Those who ate fish or seafood at least once a week significantly lowered their risk of being diagnosed with the memory disorder. The British study was one of a series of reports this year that have helped bolster the case for increasing our consumption of certain types of fish. Consider:

Researchers in Scotland and England reported that fish oil supplements helped alleviate depression in patients who had not responded well to prescription antidepressants.

A major Italian study published found that fish oil supplements reduced the chance that heart-attack survivors would suffer sudden death from a cardiac arrest.

Several infant formula companies have begun adding a particular type of fat found in fish to their products based on research that links the fat to enhanced brain development in children.

This research centers on the health benefits of fats found in the flesh of deep-sea fish such as cod, salmon, shrimp, tuna, mackerel and herring.

While this seems straightforward, there does remain some controversy. Nonetheless, I do believe that the prudent eater should have fish once or twice each week. Fish oil supplements though are a much more difficult decision.

Doctors and nutritionists recommend making fish a regular part of your diet by eating at least two 3- to 6-ounce servings of fish weekly. For a meaty fish, such as a salmon steak, the appropriate serving size is about the size of a deck of cards. For thinner fish, such as trout, the serving size is about the size of a checkbook, said Joan Carter, a registered dietitian at Baylor College of Medicine in Houston. However, because cold-water fish such as tuna often are contaminated with mercury and other toxins such as PCBs, pregnant or nursing women and young children are advised to limit their fish eating, and questions have begun being raised about risks to healthy people.

...

Although the heart association has not formally recommended fish oil supplements for healthy people, its revised guidelines suggest that those with high triglycerides or cardiovascular disease may need more than they can get through diet alone, so they should talk to their doctors about fish oil supplements.

But they should be cautious. Anyone taking blood thinners, such as Coumadin, should avoid fish oils because of bleeding risks. Diabetics should monitor sugar levels because fish oil might interfere with glucose levels.

By choosing fish rather than fish oil supplements, said Carter, you avoid some uncertainties, such as the content of certain products, which the U.S. government does not regulate for safety or effectiveness. Also, the quality of the supplements may vary. ConsumerLab.com, an independent product-testing firm, found that six of 20 fish oil products it sampled had levels of DHA ranging from 50% to 83% of the amount stated on the label; two of those six contained less than stated amounts of EPA. Also, some people who take fish capsules complain of a lingering fishy taste and indigestion, or diarrhea.

Hopefully more studies will allow us to paint a clearer picture of the pros and cons of fish and fish oil supplements. In the meantime, I love tuna and try to eat it regularly.

Decline in New Drugs Raises Concerns: FDA Approvals Are Lowest in a Decade

New drugs to treat and cure sick patients are coming into the market in the United States at the slowest rate in a decade, despite billions invested by pharmaceutical companies on research and a costly expansion by the federal agency that reviews new medicines.

The decline in the number of new drugs is most pronounced in the category considered by the Food and Drug Administration to have the greatest promise for patients -- those listed as breakthrough "priority" drugs and "new molecular entities" that are different from any others on the market.

The slowdown is troubling to many because it is largely unexpected. The drug industry now invests three times as much money in research as it did a decade ago, and the FDA has already undergone a major revamping to become more efficient and prompt -- an expansion funded largely by user fees from the drug makers. Yet the number of industry applications for innovative new drugs is down significantly, and the average time needed by the FDA to review applications is moving up.

The net result of both trends is a steep drop in the number of new drugs coming to the market to help cure and treat illnesses, and growing disappointment among many patients and their families and advocates.

"We hear talk all the time from the drug makers of the great drugs waiting in line, but the reality doesn't seem to match the facts," said Ellen Stovall, director of the Cancer Leadership Council, a patients advocacy group. "There's been a lot of hope about new drug cures and treatments and we've seen some progress, but lots more disappointment."

The possible reasons for the decline -- whether it is a function of FDA caution after some high-profile drug withdrawals, industry shortcomings and strategies, or a troublesome combination of both -- is the subject of an increasingly urgent debate. Some believe the drop is a relatively short-term development that will resolve on its own, while others believe there is a deeper and more fundamental problem.

"Industry was trying to hit home runs, and it struck out a lot," Henry McKinnell, chief executive of the largest pharmaceutical company, Pfizer Inc., said in an interview. "Added to that, the [FDA] is giving greater scrutiny to each drug application. The result is that we are spending more time on each drug, spending much more on research, but seeing a definite drop in the number of new drugs."

Perhaps much of the pharmaceutical industries intensity in legal tricks to keep drugs on patent stems from the lack of replacments in the pipeline. We should continue to watch this issue as it does portend the state of medical care in the next 25 years.

The Washington Post speculates on the probability of a Medicare drug plan from the new Congress - Medicare drug plan likely to move

Bextra can cause Stevens-Johnson syndrome! FDA Issues Warning About Painkiller

People who develop a rash upon taking a new painkiller called Bextra should immediately stop the drug because it has been linked to some rare but life-threatening skin diseases, federal health officials warned Friday.

The Food and Drug Administration has about 20 reports of serious reactions -- including the skin diseases Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis, as well as allergic reactions -- among Bextra users since sales began in March.

The FDA estimates about 800,000 to 1 million people had recently begun taking Bextra when the reactions were reported. The immune system-linked skin disorders are thought to be more likely during the first few weeks of a drug's use than after the body becomes accustomed to the medicine.

Still, because those skin conditions are so rare, the FDA was surprised to see even that small cluster reported during Bextra's first year of sales. The conditions can be lifethreatening, and a few of the patients required hospitalization.

Stopping Bextra at the first sign of a rash lowers the chance of suffering a severe reaction, said Dr. Lawrence Goldkind, FDA's deputy director for painkillers.

In addition, the FDA warned that Bextra should not be used by anyone allergic to sulfa-containing drugs.

Bottomline for me - I see no reason to use Bextra. We have other Cox-2 drugs (Vioxx and Celebrex). I know of no advantage to Bextra and this is clearly a disadvantage!!!

Browsing here at my hotel in Peru, I came across this interesting piece - Cancer-Linked Virus Common in U.S. Men, Women-CDC

There are about 100 different types of HPV, which has been linked to genital warts and the development of cervical cancer. While some HPV types cause genital warts and others produce no symptoms, only a handful increase the risk of cervical cancer. HPV-16 is thought to account for as many as half of all cases of cervical cancer nationwide.

In many cases, the body can successfully combat the virus, which eventually disappears from the cervix. HPV is very common in sexually active men and women.

In the current study, lead author Dr. Katherine M. Stone of the Centers for Disease Control and Prevention in Atlanta, Georgia and colleagues evaluated blood samples from 9,629 men and women between the ages of 12 and 59 for HPV-16. The samples were collected as part of a national survey conducted in the early 1990s. Their findings are published in the November issue of The Journal of Infectious Diseases.

In all, 13% of the tested samples carried antibodies to HPV-16, suggesting that people had been exposed to the virus and were infected with it. While about 18% of women carried the antibodies, 8% of men did. The researchers also found that about 13% of whites, 19% of African Americans and 9% of Mexican Americans tested positive for HPV-16 exposure.

"These findings document the high levels of HPV-16 infection in the United States, especially in women," the authors write. The authors note that the prevalence of infection in their study may actually underestimate how common HPV-16 infection actually is, since some people infected with the virus do not develop antibodies to it.

Women need fewer Pap tests: Cancer group says most women over 30 can skip yearly exam

Most women over 30 can skip the annual Pap test for cervical cancer, and instead safely have the check only every two to three years, the American Cancer Society said on Thursday.

...

Cervical cancer is usually caused by the sexually transmitted human wart virus. Pre-cancerous changes can be detected with the Pap smear test, and suspect areas removed before cancer develops.

The new guidelines say testing every two to three years is usually sufficient for women older than 30 who have had several “clear” tests.

“A doctor may suggest getting the test more often if a woman has certain risk factors such as human immunodeficiency virus (HIV) infection or a weakened immune system. Women 70 years of age and older who have had three or more normal Pap test results and no abnormal results in the last 10 years may choose to stop cervical cancer screening,” the society said in a statement.

The group also said a new test for the wart virus, if it is approved by the U.S. Food and Drug Administration, may be added to the guidelines.

The wart virus - human papilloma virus - does hold great value as a predictor of cervical cancer. Many physicians already screen abnormal Pap results with an HPV test. This strategy allows us to be more aggressive in HPV positive patients. The data do support this strategy which saves on culposcopies.

Study Says a Protein May Be Better Than Cholesterol in Predicting Heart Disease Risk. This reports a study in today's NEJM.

An inexpensive blood test for a protein linked to artery disease may be better than a cholesterol test at predicting a person's risk for a heart attack or stroke, researchers are reporting today.

The test, for the substance, C-reactive protein, may help identify people who have an increased risk even though they do not have high cholesterol. About half of the people with heart disease have normal cholesterol levels, a finding that has led many researchers to suspect that other factors must play a role in cardiovascular disease.

Recognizing risk can help determine whether patients need to do things like change their diets, lose weight, exercise more or take medication.

Previous reports have also found the protein test to be a good measure of risk. The new report, being published today in The New England Journal of Medicine, is considered the strongest evidence yet because the study was large, with 27,939 women, and tracked their health for eight years. The results are thought to apply equally to men.

The researchers, led by Dr. Paul M. Ridker, director of the center for cardiovascular disease prevention at Brigham and Women's Hospital in Boston, concluded that women with high C-reactive protein were twice as likely to have a heart attack or stroke as women with high cholesterol.

"This is a very powerful and I would even argue overwhelming demonstration of the fact that it's time to move beyond cholesterol if we're trying to prevent this disease," Dr. Ridker said.

Accumulating data over the past few years anticipates this finding. We have known that cholesterol (even LDL cholesterol) does not have great predictive properties. I suspect that in the very near future we will use CRP (note that the studies all use a highly sensitive version of CRP) to decide on the use of statins. Interestingly statins decrease CRP levels as well as cholesterol levels. The data are strong enough for me to extrapolate and start patients on statins if they have a positive family history and I screen for CRP finding an elevation. I do not think the statins are dangerous (although costly) and they should help these patients.

Greetings from Lima. I will probably be able to post one or two rants each day. This article caught my eye (my hotel has free internet access!!) - Bracelets 'fail to give pain relief' . This article will not really surprise anyone. Placebo bracelets do work and just as well as magnetic bracelets.

I suspect that I will be blogging very little for the next 5 days. I leave for Lima, Peru this afternoon to teach a course in evidence based medicine. If I can find good internet access, then I will post a few times. If not, I will return on Sunday. Have a great week!

db

Fat chance: How physicians can help patients lighten their load: The directions are clear: Eat your fruits and vegetables. Drink water. Exercise regularly. Still the numbers on the scale go up. How can doctors get patients to comply? Read this long article. It clearly defines the problem Doctor, heal thy self!

But with time and scheduling tight, some doctors shy away from this investment, instead feeling relief when a patient actually doesn't gain weight. Others, however, maintain that there is something to be said for taking on the issue and being a role model.

"Some doctors don't address [weight and exercise] with patients because they don't address it for themselves," said Melina Jampolis, MD, a San Francisco internist who specializes in bariatric medicine. "You can't expect to have a meaningful conversation with a patient when you are winded from walking down the hall and into an exam room."

When physicians talk about their own diet and exercise behavior, they generally agree that they are not all that different from their patients.

"It is a huge challenge to get out and exercise," said Michael Schneider, MD, an anesthesiologist in Orange County, Calif., mostly because of the hours. But when it is a priority, it happens. A colleague doesn't schedule surgery before 8:30 a.m. so she can go running first.

Some studies, Dr. Cheskin said, show that doctors are somewhat more adherent, but there is a lot of variability.

What Dr. Schneider sees when he looks around a hospital "runs the gamut." There are plenty of physicians who are overweight, and there are anesthesiologists who smoke. It's hard to say whether doctors overall are healthier than the general population. "As a physician, you are exposed [to the message] more frequently. If you don't internalize it, that's a different problem."

The fact that doctors and patients are in this together plays a prominent role in the physician-patient dynamic. And physicians who admit to not always doing the right thing say it makes them more empathetic.

This is important. We are role models. We must figure out how to balance our lives and succeed in healthy behaviors. Then we can help our patients. This is important.

Over the past 2 years, I have seen several reports showing that elevated BNP (brain natriuretic peptide) predicted a worse prognosis in patients with coronary disease. Some studies have suggested a that 3 independent tests help stratify patients - CRP, BNP and troponin. BNP may give the most information. Test to predict heart attack survival - describes a 'prerelease' article in Circulation.

Identification of those people at high risk is vital, as they may need surgery to try to minimise the likelihood of further problems.

High levels of the hormone B-type natriuretic peptide (BNP) are secreted by heart tissue when the heart is overloaded.

BNP is a diuretic, which helps to relieve pressure on the heart by stimulating the body to get rid of excess fluid through urination.

The new test focuses on a fragment of the hormone, called N-BNP.

The researchers, from Sahlgrenska University Hospital in Göthenburg, Sweden, followed the progress of 609 patients with heart problems over a six year period.

They found N-BNP levels were on average three times higher in patients who died during the period of the study than in those who survived.

People with the highest N-BNP levels were twice as likely to have died than those with the lowest levels.

The authors argue (prematurely in my opinion) that we could use BNP levels to target our more aggressive medication interventions. Showing an important association does not necessarily tell us that the same patients will benefit more from treatment. I agree that the theory makes sense, but I have seen many theories make sense and not work.

Nonetheless, we are entering a new era in risk stratification. How we can use that information to help patients becomes a very important question?

Why do we not all eat a healthy diet? Some would argue that accessibility is a major factor. Good Health Is Linked to Grocer

The more supermarkets a neighborhood has, the more fruits and vegetables its residents eat, according to a study from the University of North Carolina.

The effect was found to be especially strong in predominantly black neighborhoods, where produce consumption rose by 32 percent for each additional supermarket. In mainly white neighborhoods, the comparable increase was 11 percent.

The presence of at least one supermarket in a black neighborhood was also associated with a 25 percent increase in the number of residents who limited the amount of fat in their diets, as compared with people in neighborhoods with no supermarket. In white neighborhoods with one supermarket, 10 percent more of the residents watched their fat intake.

Only 8 percent of the black participants in the study lived in neighborhoods with at least one supermarket, while 31 percent of the white participants did. The largely white neighborhoods had, on average, five times as many supermarkets as the black neighborhoods, the researchers found.

"There is an assumption that we all have access to healthy foods, and that when people aren't eating healthy, it's because they choose not to," said Dr. Kimberly Morland, an epidemiologist and lead researcher on the study, who is now at Mount Sinai School of Medicine. "But this demonstrates that the availability of food varies between neighborhoods, and it's related to the affluence and the race of the neighborhood."

Definitely food for thought (db groans as he types this bad pun). Should we use a concept like the enterprise zones specifically for groceries to encourage them to locate in 'underserved' areas? I suspect the lack a groceries stems from economic considerations. We could incent grocery store location and see what happens.

We must always be careful to evaluate technology and "good ideas". I have written previously about the lure of the body CT scan clinics. If you are tempted, please read this - How Perils Can Await the 'Worried Wealthy'. Sometimes spending money does not help!

Bush and G.O.P. to Push for Medicare Drug Benefit

Republicans say they are planning to use their new control of Congress to provide prescription drug benefits to the elderly, while offering tax credits to the uninsured and imposing new limits on damages in medical malpractice cases.

President Bush, Speaker J. Dennis Hastert and Trent Lott, the Senate Republican leader, all said health care legislation would have a high priority in the 108th Congress, which convenes in January. Republican candidates for Congress promised to add drug benefits to Medicare, Mr. Bush made a similar promise two years ago and Democrats have vowed to hold Republicans accountable in the 2004 elections.

...

The biggest source of disagreement is how to balance the roles of government and private industry — a question that goes to the heart of the two parties' philosophical differences. Democrats favor a larger role for the government, while President Bush and Congressional Republicans would rely heavily on competing private health plans and pharmaceutical benefit managers, like Express Scripts and Medco Health Solutions, a unit of Merck & Company.

Republicans said the starting point for any measure would be a "tripartisan bill" drafted over the last two years by Senators Charles E. Grassley of Iowa, Olympia J. Snowe of Maine and Orrin G. Hatch of Utah, all Republicans; James E. Jeffords, independent of Vermont; and John B. Breaux, Democrat of Louisiana.

Under the proposal, the government would pay subsidies to private insurers to get them to offer drug coverage with a monthly premium of about $24 and an annual deductible of $250. The standard Medicare insurance policy would cover 50 percent of drug costs up to $3,450 a year; after beneficiaries spent $3,700 of their own money, the government would cover 90 percent of drug costs.

So that is their plan for a drug benefit. They argue that we just cannot afford a 'no holds barred' benefit, this is expensive enough. This plan would certainly help many and may be practical.

The other items on the Republicans' health agenda are intended to address the rising cost of care and coverage. For two years, Mr. Bush has asked Congress to authorize tax credits for the cost of health insurance bought by people who are not covered by an employer's plan and not eligible for public programs. The president's commitment is reflected in the large amount of money he would devote to this proposal: $89 billion over 10 years.

Many Democrats have balked at tax credits for health insurance. They say the government could cover more people at lower cost by expanding programs like Medicaid, for low-income families. But recently, some have said they are willing to consider tax credits, if the government sets standards for the insurance bought with such assistance.

This plan seems quite fair. It would greatly reduce the number of uninsured if I understand the plan correctly.

Republicans in both houses said they would also push for legislation to cap damage awards in medical malpractice lawsuits. The House passed such a bill in September, 217 to 203, but Senate Democrats have shown no desire to act on it.

President Bush strongly supports the House bill, saying it would slow the rise of malpractice insurance costs for doctors and hospitals.

The House bill would cap damages for "pain and suffering" at $250,000 and limit punitive damages to $250,000 or twice the amount of economic damages, whichever is greater. Plaintiffs' lawyers oppose the bill, saying it would unfairly limit compensation for the loss of a child or a spouse, or a limb or sight.

These provisions work well in California. We have discussed it often in the past. I hope that we get this relief in the very near future.

Having trouble developing your own exercise program - read this - In Your Corner: Motivation

Here's the truth about exercise: If you dread it, you won't do it. How is it that we say we've got no time to exercise, yet we've seen every episode of West Wing since it began? The truth is, we choose not to spend some of our free time exercising. The psychology is simple: We make time for what we enjoy, and we put off - or avoid entirely - what we don't.

The key is finding ways to make exercise less of a chore and more of a choice, says James Annesi, Ph.D., exercise psychologist and director of wellness for the Metro Atlanta YMCA. Try these simple strategies, he says, and you may find yourself skipping - OK, taping - West Wing episodes to avoid missing workouts.

A Mediterranean-style diet rich in alphalinolenic acid seems to be more effective in primary and secondary prevention of coronary artery disease than a conventional "low-fat" diet, according to a new study in the Lancet this week.

Dr Ram B Singh (Medical Hospital and Research Centre, Moradabad, India) and colleagues found that the group of patients randomized to an "Indo-Mediterranean" dietrich in whole grains, fruits, vegetables, and nutshad approximately half the risk of sudden cardiac death and nonfatal heart attacks as the second group, given a local diet similar to the National Cholesterol Education Program (NCEP) step-1 diet.

This quote comes from theheart.org which uses windows, thus I cannot give you a link. The value of this diet is supported now in multiple studies.

The Indo-Mediterranean diet used in this study provided results "comparable to drug medicationbut at a cost of about $1US per day. That makes tremendous health and economic sense," Berry commented. The whole grains, fruits, vegetables, and oils used in the study were seasonal, traditional, and produced by farmers at this low cost. "The Mediterranean diet is applicablewith variationsto everybody," he added.

"Our trial in a non-Western population has shown that . . . a [Mediterranean-style] diet is associated with a pronounced decline in CAD morbidity and mortality, without an increase in noncardiac deaths and in the presence of improved metabolic profiles. The long-term benefits may be even more substantial," the authors conclude.

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I can find no reference to this article on the free web. Yesterday's Wall Street Journal has a very interesting article about the problems of developing a mathematical model for a smallpox outbreak. I will quote and paraphrase a few key points.

But as the White House weighs that and other options, some experts are trying to break through the hysteria with a starkly different message: Smallpox spreads slowly and is not very contagious. "It is imperative that we step back from the sensationalistic press and marketing hype emerging from the burgeoning biodefense industry and ask if such a vaccination scheme is a good idea," writes biodefense expert Peter Merkle in the journal Science.

The key question for developing models becomes the rate of spread. How can we estimate that? Some experts (sensationalists?) have suggested that we should use a rate of spread equal to 10. That it, each smallpox patient would infect 10 uninfected healthy persons. However, a true expert says otherwise:

Consider the disputed "R(0)." Pronounced R-nought, it is the number of secondary cases per primary case in a susceptible population. Dark Winter used 10: Everyone infected in the terrorist attack spread smallpox to 10 others. But epidemiologist James Koopman of the University of Michigan, Ann Arbor, suspects R(0) today would be hardly greater than 1. When he helped eradicate smallpox in India 30 years ago, even people packed onto buses for long trips didn't catch smallpox from infected passengers. An R(0) just over 1 means an outbreak would spread so slowly as to be easily contained.

We should be able to use our historical information to predict an outbreak. More from Dr. Koopman:

Historically, smallpox spread most among people living together, and in hospitals that didn't quickly isolate cases and vaccinate staff. For everyone else, experts tell me you have to spend hours with, and probably within six feet of, an infected person. Sitting in adjacent cubicles might not do it. And people today don't live in eight-member households. In one model, based on travel and contact, some runs have no secondary cases: Carriers didn't meet anyone in a way that spreads disease.

"Modeling person-to-person interactions this way is much more realistic," says Dr. Koopman. It also suggests that smallpox would quickly peter out, contrary to models that assume everyone is in contact with everyone else and that the disease propagates indefinitely. In fact, an unpublished analysis says Dark Winter overestimated the toll by a factor of 100.

Other models using realistic parameters find ring vaccination (inoculating around an outbreak) as effective as mass vaccination. That holds even if officials don't recognize the outbreak until two dozen or so people are sick, say sources familiar with a soon-to-be-published model, as long as vaccination reached 80% of those exposed. "If we're prepared, we shouldn't have any trouble containing smallpox from individuals in the first wave," says Dr. Koopman.

Still, what's "realistic" today might seem naive tomorrow. This week, officials leaked a Central Intelligence Agency finding that Iraq, North Korea, France and Russia have covert stocks of variola. Some modelers believe it only prudent to lay out "the worst case," as Edward Kaplan of Yale University argues. Modeling an attack that initially infects 1,000 people, he finds that mass vaccination results in fewer deaths than isolating the sick and vaccinating their contacts. That partly reflects the difficulty of tracing contacts in a mobile, panicked populace.

If smallpox vaccine were risk-free, we would not be having this debate. But it kills two or three people per million, and injures more. "Smallpox scenarios are now being promulgated as 'ground truth' to lawmakers and the public and are being used to justify the potential vaccination of possibly hundreds of thousands of people," argued Dr. Merkle. If the best science is telling us that we can spare most people that risk and still contain a smallpox attack, we should listen.

This article points out the important questions. If we are to make public policy, we must understand several factors. How would they spread the infection - most important how many infected people would they 'send' to infect us? How many people would acquire the infection? How fast could we respond? If spread is truly slow (as Dr. Koopman suggests - and he was there!) then I believe that widespread vaccination would do much more harm than good.

This article hardens my feelings against widespread vaccination. I really do not believe that smallpox is a major bioterror threat to the US.

Leaner times in fast food

In a Harris Interactive survey of 1,900 adults last November, one-third of the respondents reported eating less often at fast-food restaurants than they had a year earlier. Asked why, almost two-thirds said they were shunning burger joints in order to eat more nutritiously.

Quick, turn up the grill. Jazz up the flavors. Toss a salad, bring on the poultry, and modify the fries. That's one path - along with lower prices - that the fast-food industry is taking to attract new customers and hang onto old ones.

Chicken - grilled, roasted or broiled, in sandwiches and salads - is a key element in strategies to coax diners back to McDonald's, Wendy's and other quick spots.

I saw yesterday that McDonald's had a poor financial quarter. Maybe, just maybe, capitalism works. When we (the consumer) start expecting a different diet, by gosh the restaurants will provide it.

A Chill on Patients' Trust

The investigation into the coronary-care unit and Medicare payments it generates for the Redding hospital is just part of the story. Red flags appeared late in October after a Wall Street health-care analyst questioned the overall heavy reliance on Medicare payments at Tenet, one of the nation's largest hospital companies.

The federal Department of Health and Human Services then said it would audit Tenet's receipt nationwide of special Medicare payments that are designed to help hospitals defray financial losses from difficult and invasive procedures. Worried investors quickly fled, Tenet's share price took an abrupt nose dive and the company's chief operating and chief financial officers unexpectedly resigned.

Patients can't help worrying about collisions between medicine and profit, because their very lives are at stake.

It's bad enough to think of doctors performing unnecessary procedures for their own gain. It's even worse if the push for profits could combine with a poorly designed and badly monitored Medicare payment program to create an environment that encourages fraud or gaming the system.

The tension between income and medical recommendations affects physicians and patients alike. Whether the physician makes recommendations that would benefit him/her financially, or the insurance company refuses to pay for investigations or therapy, the problems of money plague our system. I wish I knew a better system. A one payor system still has financial problems.

Get the skinny on fatty foods : What’s healthy and what’s not

Drug Agency Approves a Quick Test for H.I.V.

The Food and Drug Administration approved a test today that can detect whether someone is infected with H.I.V., the virus that causes AIDS, in as little as 20 minutes. Experts said that advance might prompt thousands more Americans to get tested, which in turn might slow the spread of the disease.

The "while you wait" test, by OraSure Technologies Inc. of Bethlehem, Pa., will not be the first rapid H.I.V. test on the market. But, with a 99.6 percent accuracy rate, it is the first one that is highly reliable.

Standard tests for H.I.V. now take two days to two weeks to provide results, a time lag that experts say discourages thousands of people each year from returning to their testing center to find out whether they are infected.

I actually worry a bit about the 0.4 inaccurary. Is the problem sensitivity or specificity?

There is, however, one hitch: people infected with H.I.V. do not develop antibodies to the virus until three months after exposure. So the Food and Drug Administration recommends that people who test negative repeat the test if they believe they have been exposed to the virus. The agency also recommends that, in the case of a positive test, a more traditional test be conducted to confirm the results.

The agency has approved the test, called the OraQuick, for use in hospitals, clinics and doctors' offices that meet certain federal laboratory standards.

Interesting, and I expect that many hospitals will provide this test in the near future.

We have all seen it - unnecessary ER visits. Now someone has actually studied it - Next-day health care touted as cost-cutter

Many people with inadequate or no health insurance are going to emergency rooms with ordinary aches and pains, and many of them could safely be sent home and told to return for treatment the next day at a hospital clinic, researchers said. The study, published in Tuesday's issue of Annals of Internal Medicine, concluded that patients with non-acute ailments suffered no ill effects after being told to come back the next day.

The researchers suggested that giving some patients the option of next-day care might help ease crowding and cut costs in overburdened emergency rooms. The study was done at the 500-bed Harbor-UCLA Medical Center in Los Angeles.

Ah! Now we just need to pay the clinic and the clinic doctors to provide the care. Probably would save a lot of money and improve ER efficiency.

Study: Exercise Hits Cholesterol Risk

Cholesterol is an essential fat, or lipid. It circulates through the body by attaching to protein particles. Cholesterol appears more likely to clog the arteries when it is carried by small, dense protein particles than when it is moved by relatively large, fluffy ones.

The latest study finds that people who exercise develop these bigger particles, even if their total amount of cholesterol stays the same.

``Using this analysis shows clearly that exercise has beneficial effects that are not revealed by standard tests,'' said Dr. Ronald M. Krauss of the Lawrence Berkeley National Laboratory, who studies the protein particles.

The study, conducted at Duke and East Carolina University, involved 111 sedentary, overweight men and women. They were randomly assigned to three exercise groups: the equivalent of walking 12 miles a week, jogging 12 miles a week or jogging 20 miles a week. All were instructed to eat enough to keep their weight constant.

They found that the cholesterol effects of walking and jogging 12 miles were the same, while jogging 20 miles resulted in more pronounced changes.

Measuring protein particle size is sometimes done in large medical centers, but it is not part of standard physicals. Kraus said he expects the tests, which cost two or three times more than standard cholesterol tests, to become more widely used.

Dr. Joann Manson, head of preventive medicine at Harvard's Brigham and Women's Hospital, noted that exercise has already been found to have many other benefits for the heart, including improvements in blood pressure, blood sugar, clotting and inflammation.

Studies show that briskly walking 30 minutes a day can lower the risk of heart disease by 30 percent to 40 percent.

This study provides another explanation of the benefits of exercise. Do you get it 20 miles each week?

In an apparently overwhelming vote, Oregon has defeated measure 23 by almost 4-1. Sanity reigns in Oregon. The voters understood the trade-off between a great ideal and the fiscal insanity that it would bring.

Cannabis link to schizophrenia

Two recent studies have shown that heavy use of cannabis is associated with a fourfold increased risk of developing the mental illness.

"There are some dangers to using high doses of cannabis that people need to know about," said Dr Deepak Cyril D'Souza, Associate Professor of Psychiatry at Yale University School of Medicine.

He said there was concern in the medical profession that people who smoke large amounts of cannabis for a long period of time are at higher risk of developing schizophrenia.

This needs to be kept in mind in the testing of new cannabis-based medicines, he added.

This raises a legitimate concern about heavy marijuana use. Perhaps cannabis, like many other drugs, has dose related side effects. If we are to use it for patients, we must understand those dose relationships.

Drug Doesn't Cut Heart Patient Risk

Among patients with acute myocardial infarction, combination reperfusion therapy with a platelet glycoprotein IIb/IIIa receptor inhibitor (abciximab) and a half dose of a plasminogen activator (reteplase) did not significantly reduce mortality at 30 days compared with a full dose of reteplase. Rates of nonfatal ischemic complications were significantly diminished.

Let me put that conclusion into context. The question asked here is whether abciximab (Rheopro) helps patients having an acute MI. We do know that it helps patients having stents placed. The results suggest no benefit in MI patients. These results were reported previously at cardiology meetings. Most cardiologists have already incorporated these data into their practice.

Another Tale of Government-Run Medicine. Sydney Smith quotes a reader who tells a story about antiquated equipment at a VA.

First, a fair disclosure - the VA pays a small part of my salary. Second, I do not have data, only opinion.

I like taking care of veterans. They deserve our care, and are generally a very grateful patient population. Unfortunately, most of their diseases come from tobacco, alcohol and general neglect.

The VA has some major plusses. They have the best computerized medical record, bar none, in the US. It works in a physician friendly way. When I make rounds this weekend, I can review the labs, the pharmacy orders, the notes and even the X-rays from a single computer. I write my notes there, obviating the search for charts.

Our VA has state-of-the-art radiology equipment, but they have difficulty keeping enough technicians to do studies promptly. I believe they tend to understaff the wards, but the ICUs have good staffing ratios. They have improved greatly since my days of training in the 70s. I too trained with open 20 bed wards, today my patients either have private or semiprivate rooms.

The VA unfortunately segregates their budget, thus pharmacy has a set budget. This does lead to problems. For example, the fight for low molecular weight heparin revolved around cost rather than efficacy. Because of the silo budgetting, the pharmacy was penalized for saving the rest of the hospital money (due to earlier discharges).

Since I do not work in a community hospital, I cannot compare. I do believe the VA has major inefficiencies due to its bureaucracy, nonetheless, we provide excellent care.

We must always look to England. They experiment for us. Read this diatribe Bedside stories: When Alan Milburn starts being rude about doctors on the telly, it's hard to see how the NHS is going to survive

"The NHS is over; we're all going to be rich. They have really pissed on their chips this time." My registrar is in a particularly bad mood: he has just seen the health minister on TV, accusing doctors of being greedy for not accepting the new consultants' contract. I look around the drab on-call room. It is not easy doing a day's work, working the whole night and then working the whole of the next day. Working 33 hours in a row makes you feel shit: it makes you split up with your girlfriend, it loses you your mates, it stops you going out and it makes you crap at your job. It's illegal, except that the government got some special dispensation to exempt us from European employment law. And it's cruel. You just need more doctors. So train more doctors.

So why have we always done it? Not for the money: my basic salary is £23,000 and I'll send you a photocopy of my payslip to prove it. We do it because we have a collective Mother Teresa complex and, to be honest, because it feels good to work insanely hard, but to know that you are doing a good job for society, and that you are appreciated for it.

But when people start to be rude about us on telly, when we are all made to look like the minority who practise badly, when patients are over-demanding and rude to us in casualty and in GP surgeries, then that's it. I'm telling you, with the mood every doctor in the country is in, this is the end of the NHS, the greatest state healthcare system in the world, which we were all truly proud to work in.

And get this: with the attacks on doctors in the media, and patients' temper tantrums in casualty at three in the morning, the NHS will be killed forever, not by some restructuring or government policy, but by sheer, simple, old-fashioned rudeness. It's not ironic, it's stupid and sad.

So this is what happened with the new contract. We are not greedy. We did not go to the government demanding more money. They came to us and told us we had to stop doing private practice, and be available to work until 10pm and over the whole weekend for the entirety of our working lives, until we retire. And we told them to forget it. You would too.

Physicians in England are about to revolt! This could happen to us. It just might happen in Oregon.

For us to prevent heart failure, we need to fully understand the risk factors. Study gauges risks to heart.

One of every five people 40 and older will someday develop congestive heart failure, says the first study to calculate the lifetime risk of getting the potentially fatal disease. Untreated high blood pressure doubles a person's risk.

The study, released Monday in the journal Circulation, offers baby boomers an opportunity to gauge their risk and take steps to reduce it now that they've reached their heart disease years.

Congestive heart failure occurs when the heart muscle enlarges and loses its power to pump blood. It is the leading cause of hospitalization for those older than 65. Nearly 60% of men and 49% of women die within five years of diagnosis.

"Since heart failure is so prevalent and so lethal we're hoping that the findings will motivate people to avoid hypertension, avoid heart attacks and avoid congestive heart failure," says lead author Donald Lloyd-Jones, a researcher with the Framingham (Mass.) Heart Study, a population-based study of risk factors for heart disease.

How does one prevent hypertension? Diet and exercise makes it much less likely. I do not mean to be boring but one of the best ways to improve ones odds of a longer healthy life is an exercise lifestyle (with appropriate diet). From my vantage point, this makes great sense. I believe that once you commit to that lifestyle, it becomes fun and rewarding. I feel better when I exercise. It helps me in multiple ways.

If one can remove the barriers to exercise, then what? With Enough Help, Even High Barriers to Exercise Fall .

In the best circumstances, sticking with an exercise routine is difficult. Under the worst circumstances -- living in extreme poverty with gang members on the doorstep, say, or coping with obesity and diabetes, or maybe an utter lack of social support and a long-entrenched habit of sedentary living -- it can seem nearly impossible.

But it's not. A study funded by the federal Centers for Disease Control and Prevention (CDC) and the National Institute on Aging recently found that members of high-risk, low-activity groups who cited some or all of the above conditions can be helped to start and maintain an exercise program. A group of 31 people living in Chicago's urban core, most of them African American women with an average age of 54, showed up for 87 percent of their three-times-a-week workouts over three months. For their efforts, participants reaped measurable improvements in strength, endurance and fitness with no major adverse medical events.

The tactics that made it work? The program was free and provided both transportation to the gym and telephone check-ins by program coordinators after missed sessions. "Removing obstacles to working out results in a high turnout rate," says the study's lead author, James H. Rimmer, an exercise physiologist and professor at the University of Illinois at Chicago. "Providing transportation and love and care will help people get results for good health." The study was published in the American Journal of Preventive Medicine.

The one-hour fitness sessions, which took place under a trainer's supervision, included 20 minutes of strength training; 30 minutes of cardiovascular activity on treadmills, exercise bikes or elliptical trainers; and 10 minutes of stretching for flexibility. Lower body strength improved by 40 percent, cardiovascular fitness by 14 percent and flexibility by 10 percent. "Movement is critical to feeling good," says Rimmer. "So many of our participants were sitting or lying down almost 24 hours a day. They'd come into the sessions moping around and end up laughing and joking around."

I wonder if our society would benefit from programs like this one. If exercise programs can decrease health care costs, they just might pay for themselves. We evolved as an active people first, only in the last century have we become such couch potatoes. This could be (and probably should be) a major concern of public health.

Doctors must be adept at "20 Questions"

Playing "20 Questions" reminds us there is no such thing as a brief office call or a simple visit.

Yet, now, from all sides we are being assailed and criticized that we are not asking enough. Like Oliver Twist, society wants more.

Doctors in the trenches are under new pressures. We are reminded that all we've learned of the human body in the last 300 years has been from our patients' waking state.

True, we've always asked our cardiac patients if they've had to use more pillows. But sleep has, otherwise, been the big black hole and we've not been asking the necessary questions: How well do you sleep? Do you snore? Are your legs restless? Do you waken refreshed?

But we're still not pushing the envelope with our questions. We're told by the consumer movement that we have been insensitive and judgmental so now we need to ask: What is your sexual preference?

Sociologists say our interest in lifestyle issues has been inadequate, so today, it isn't enough to know if our patients smoke and drink, we need to ask: Are you taking any recreational or street drugs?

The media declares we've been elitist and superior and have not asked what components of the $40 billion-a-year alternative medicine market our patients have been buying. They've got a point. How can we know if our patients are swallowing blue-green algae if we don't ask them: Are you buying any of that frog pond scum?

This article does a wonderful job of summarizing the challenges of good primary care that I addressed yesterday. 20 questions take time. You really cannot stop at 10 questions!

CME is difficult to deliver. We have many lecturers, but few teachers. The family medicine community has endorsed an evidence based framework for a portion of CME. I hope they study this experiment. CME deserves careful analysis. We must improve our ability to deliver 'the message'.

Medical practice backed by solid science sounds like common sense, but the introduction of evidenced-based continuing medical education has found skeptics among CME providers, who will have to revise their courses and alter faculty guidelines if they want to meet the American Academy of Family Physicians' new standards.

The AAFP has approved 142.4 credit hours as evidence-based CME since it rolled out this new designation in January, and it offered 30 evidence-based CME classes at its annual meeting in October. Relative to the 100,000 credit hours of AAFP-approved CME, this is a tiny amount, but AAFP leaders think this will change as more doctors hear of evidence-based CME.

At the AAFP annual meeting, many physicians weren't aware of the difference between evidence-based and conventional CME content as they selected courses. But this isn't surprising, given the newness of the designation. Physicians chose their lecture by topic, not by whether it contained evidence-based material. The AAFP expects that once physicians have seen several evidence-based presentations, they'll start to keep an eye out for them.

For now, evidence-based CME is optional, but if it proves to have a positive impact on getting physicians to carry their new knowledge back to the office, and if patient outcomes improve, there could well be a move to make it mandatory.

We (the UAB Division of General Internal Medicine) started evidence based conferences 4 years ago. They are very well received. We believe the best way to teach evidence based medicine is demonstration. As we discuss articles, we show the learners how we use the theories of evidence based medicine in understanding an issue. I hope this experiment works, but once again I implore them to collect data.

Hospitalist practice: Could it work for you? I have such mixed feelings about this issue. Many would argue that I am an academic hospitalist - I attend 5 months each year on the wards. I still feel like an internist. What are the implications for patient care when one has different physicians in the hospital from the outpatient clinic? Nonetheless, I begrudingly accept the phenomenon.

Initially, the idea of turning over the management of their hospitalized patients' care to another physician was not embraced by many in the profession.

Many office-based doctors worried about losing patients to hospitalists. They feared that continuity of care would suffer. They didn't want to be forced to make referrals. Some thought they would miss the collegiality of seeing other doctors at the hospital, or their hospital skills would start to slip.

"When we first started, some of the [primary care physicians] were very threatened, particularly the pulmonologists who thought we would take their market away," said Don Krause, MD, who left an internal medicine practice to become a staff hospitalist at St. Joseph's Hospital in Bangor, Maine.

Now, much of the controversy has subsided. Shorter hospital stays and medical advances mean office-based physicians have fewer patients in the hospital, and the patients they do have in the hospital don't stay very long.

Doctors save time and money by concentrating their efforts on office visits. One study, Dr. Wachter said, showed that primary care physicians can save $40,000 a year by referring to hospitalists and swapping commute time for office time.

This Friday I will speak to the Southern region NAIP (National Association of Inpatient Physicians) meeting - Update on Acute Coronary Syndromes. During that meeting I plan to interact with many hospital physicians and learn from them about their concerns and working conditions.

Internists who are hospitalists typically make $10,000 to $30,000 more than internists with office practices, the NAIP said.

A NAIP survey this July found that 60% of hospitalists are compensated on a salary basis and earn an average of $164,000 a year. Independent or self-employed hospitalists averaged $194,000 a year, more than those employed in other practice models, the survey found.

Another NAIP survey, released in May 2001, showed that 36% of hospitalists were employed by a hospital and 31% worked for a medical group. Another 12% were self-employed, and 11% worked for managed care companies.

About nine of 10 hospitalists are internists, said Dr. Wellikson of the NAIP. Most of the rest are pediatricians and family physicians.

Rangel works as a hospitalist in Dallas. I hope he comments on this article and post.

I have ranted on this issue often. An assurance of safety: Treat supplements like drugs: Physicians call for better federal regulation of dietary supplements.

Snack Attack: After Taking On Big Tobacco, Social Reformer Jabs at a New Target: Big Fat.

Oh, it's important to be on the right side and all, but what really gets John Banzhaf going is being on the short side of a long-odds fight. He likes to position himself as a little fellow with a pickax, digging away at social ills and wrongheaded industries. He did it with tobacco for 35 years, arguing for nonsmoker's rights, helping eliminate cigarette advertising on television, helping establish nonsmoking sections in public places and smoking bans on planes, trains and buses.

Now, he wants to sue for obesity.

The public, he allows, may not quite be ready for this; they may find the notion downright "bizarre." But they'll come around. After all, this is about "using legal action for what seems to me very important," says Banzhaf, an unflappable, roly-poly law professor at George Washington University. "Saving human lives."

It's too bad it has to be this way, Banzhaf says, but when legislators don't step up to the plate, the lawyers have to push for social reform. So, in the past, for causes ranging from discrimination to preventing a tobacco-sponsored tournament, he has sued Hertz, Spiro Agnew and the Interstate Commerce Commission, filed legal complaints against dry cleaners, male-only clubs, the National Park Service, Rep. Barney Frank and Mrs. Simpson's Dance Classes, threatened Dulles Airport, and delivered a Freedom of Information Act to the Office of the President. Sue 'em all!

This guy is a pest. You would hate to have him coming after you.

The way John Banzhaf sees the obesity lawsuits, they're just the latest in his lifelong effort toward "pushing the boundaries." He says he has nothing personal against the food industry; in fact, he used to eat in fast-food joints several times a week. He says he will make no money from the New York litigation.

No, it's nothing personal. It's about personality. On Banzhaf's Web site, he boasts of having been called a "legal terrorist." He has built a public persona on this principle, for decades teaching a legal activism course that encourages law students to bring to court social reform lawsuits. His favorite saying -- "Sue the bastards" -- has been linked to him so many times, it's downright trite to bring it up. The saying is on his office wall, and also on his office wall in Latin. His license plate says SUE BAST.

Needless to say, certain people rather dislike him.

"He is the loudest and most relentless voice," says John Doyle of the Center for Consumer Freedom, a Washington-based restaurant trade association, who finds Banzhaf a little, um, shrill and likes to tell about the time he says a radio station had to turn off Banzhaf's mike to shut him up. (Banzhaf doesn't remember it that way.)

If you ask Doyle -- and indeed, some of the very same lawyers who pushed for Big Tobacco litigation along with Banzhaf -- the problem with suing Big Fat is that it ignores the consumer's free will.

So we can expect a long semi-coordinated effort to harass restaurants, food manufacturers, soft drink companies, etc. The challenge for this legal attack is to separate the free will argument from the seduction of the fast food industry.

Is public opinion changing?

For the time being, the weight of it does not appear to fall on Banzhaf's side. Samuel Hirsch's first obesity suit involved the 270-pound maintenance supervisor Caesar Barber, whose capacity to elicit sympathy was questionable. Barber kept eating fast food even after a heart attack and the warning of a doctor. Hirsch has since decided to put Barber's suit on hold because he thinks it may be tough to bring for a variety of reasons.

Anyway, when Hirsch, Barber and Roberta Pelman (mother of an overweight girl in the second suit) appeared on the Dr. Phil show in September, they got . . . perhaps the best word is creamed.

Dr. Phil McGraw: Did you choose the food?

Pelman: Yes, I did.

McGraw: And did you serve it to your child?

Pelman: Yes, I did.

McGraw: So she could sue you for putting it in front of her?

Pelman: Well, you know . . .

Hirsch: Yes, she could.

McGraw: Okay. Anyway. Next, a grown man who makes his own decisions and also blames fast-food chains for his super size.

Reactions like this are why Banzhaf's efforts have as much a public relations goal as a legal one. One hopeful scenario is that, as more information about the food industry comes to light, companies will be shamed into changing their ways, or into settling cases instead of taking them to trial.

I doubt that this campaign will have the success of the tobacco campaign. Food is not addictive, one has choices. One can go to fast food restaurants and not get fat. I doubt that the public will buy into the arguments.

I will put a positive spin on the legal action though. The publicity of the lawsuits will get consumers to think about what they are eating (I hope). We do need a culture change concerning food and exercise. If the suits stimulate that in any way then we will have a minor victory.

Since I started this blog, no issue has captured commentary as passionate and thoughtful as Oregon's Measure 23 - On Oregon's measure 23. I urge you to go back and read the original post and the subsequent comments.

Thanks to the many comments, I have focused on this issue. In the car returning from my golf trip, I discussed these issues with 2 good friends (not physicians). Several issues have crystallized as I have pondered this measure.

Our health care system is broken. While we provide the best specialty care in the world, we have too many holes in the safety net. Most Americans can get bypass surgery almost on demand, while others cannot afford their blood pressure medications. Thus, one must ask, whether the trade-off for excellence is a system of winners and losers.

Many would argue that this trade off defines capitalism, and why should medical care be any different. We rarely decry inequality in housing, transportation, clothing or food, why is medical care different? One could imagine that once one socializes medical care, one starts down a slippery slope.

We should, however, be able to afford a reasonable (defining reasonable may be impossible) base of care for all. Our current system makes that very difficult. However, would we accept the cure? Read Brian Gray's comments written earlier today

My brother in law just died in England. He was 65. He has been waiting months for a quadruple by-pass operation. He rose to be number 10 on the waiting list then he died. My friend Tom Kennedy age 71 in England needed a hip replacement. Waiting time, 4 years. He flew to the USA and paid to have it done here. Waiting time One day. I lived for 36 years in Britain before moving to the USA and saw the abuse in the system there. Everyone feels they should go to the doctor for the slightest thing. Got a cold? Go to the doctor. Want time off work? Go to the doctor and tell him your back hurts. Britain has now introduced private medical insurance. There's a clue. The Scandinavian countries are having an even worse time with their Government run health plans. Having lived with both systems I can say that the existing American model is light years ahead of the European welfare state. The proposed Oregan plan is far more extreme than the money losing European ones. Taxes will go through the roof. Treatment will be limited to save money. Doctors will leave the State, just as doctors and dentists leave Britain. Deductibles and co-payments control abuse of the system. How many people leave the USA and go to Britain or Cuba or Russia or Germany for medical treatment? NONE, but thousands of their citizens come to America in order to receive the best treatment in the world. There is no free lunch.

Please read that again. Our system works in its own way. We are the envy of the world. That does not mean that we could not improve our system.

I would like to see several improvements, but I do understand the political realities. We would need the Democrats to show courage against the trial lawyers and the Republicans to show courage against the large pharmaceutical firms and the HMOs. I doubt this will happen.

We need an intelligent system of 'first contact' care. I hesitate to use the term primary care because most readers will not read that phrase as I mean it. I consider primary care's most important attributes as comprehensiveness and continuity. A good primary care physician works to aid the patient through the health care maze. This includes advising the patient on how to improve their health (diet, exercise, seat belts, immunizations, screening), evaluating for risk factors, and treating those risk factors. The good primary care physician can diagnose and treat most complaints, and when the patient needs referral, then pick the appropriate subspecialist. Many patients will then consult that primary care physician about the proposed plan of action (should the patient have an operation, or take chemotherapy).

Alas, my concept of primary care differs from the picture painted by too many subspecialists and by the insurance companies. My concept of primary care is not hurried, the patient and physician have time to spend together to plan an approach to health or an approach to treating either a risk factor or an illness. One cannot do that in 15 minutes. One cannot do that for $39 when the overhead costs $50.

Unfortunately, my concept of primary care is not accepted in most of the US or Canada or Europe. If we could support this concept, we would not have as many holes in the safety net. Supporting such a solution does not have enough flare for politicians. I fear that few understand the implications of such a solution. Most primary care physicians understand, but despair at even dreaming of that solution.

So where does that leave us with Measure 23? This measure has good intentions. We would like to provide health care to all. I wonder if our society will ever be willing to pay for that luxury. Measure 23 has major flaws, from the financing structure, to the naive assumptions. It should fail for those flaws. Hopefully, it will fail on a close vote, and the debate will continue. I only hope that those in favor approach the debate in a rational way. They must develop a better solution than Canada or England, because those systems are not worth emulating.

As I get back off my soapbox, I would like to thank all the commenters on this issue. You make important points which we should all consider seriously. As in many political issues, there are no right or wrong answers. Our challenge is to anticipate the unintended consequences. In this case, I believe those consequences would negatively impact health care in Oregon.

I leave soon for a 3 day golf vacation. My computer will not accompany me ( nor probably my brain). I will return Sunday evening. Please frequent those good blogs you see on the left hand column.

I have previously written about the battle against generic Prilosec (omeprazole). AstraZeneca has 'pulled out all stops' to prevent this release. Today's Wall Street Journal (available on the web only for money) has an article on this issue, from which I will quote.

The three drug makers -- Andrx Corp., Genpharm Inc. and Kudco -- have been in negotiations since a ruling on Oct. 11 by a federal judge that knockoff Prilosec pills made by Andrx and Genpharm both infringe on ancillary patents owned by AstraZeneca PLC, the maker of Prilosec.

However, Judge Barbara Jones, of U.S. District Court for the Southern District of New York, ruled that Kudco's pill didn't infringe on the patents. Kudco successfully argued that it coats omeprazole -- the generic version of Prilosec -- with a nonalkaline substance, and that it has its own patent on this method, valid until 2016.

That court win alone, though, wasn't enough to clear the way for Kudco to begin selling the prescription drug. Kudco, a subsidiary of Schwarz Pharma AG of Germany, couldn't launch first, because under a federal rule to encourage generic competition, Andrx and Genpharm had previously won exclusive rights to be first on the market with a generic Prilosec, which lost its main patent protection in October 2001.

Andrx and Genpharm are appealing Judge Jones's ruling. But in the meantime, they are pressing ahead in the consortium with Kudco. Had they not decided to team up with Kudco, the two other generics makers could have delayed a generic launch by months or years.

...

Prilosec was once the biggest-selling drug in the world, with $6 billion in annual sales. Sales slumped somewhat in the past year to $5.7 billion, making it the world's third-biggest seller behind cholesterol pills Lipitor and Zocor, made respectively by Pfizer Inc. and Merck & Co.

Prilosec costs nearly $4 a pill. A generic version of the drug will probably cost $3.50 in the first six months, but the price is expected to drop to below $2 within a year of launch.

Prilosec has been at the center of the debate over legal and regulatory moves by some major drug makers to delay generic competition against big sellers. AstraZeneca's original patent protection on the purple pill ended a year ago, but the company sought additional protection from generic competition.

This story (and the entire story is worthwhile of you have access to the newspaper) highlights my disgust with the pharmaceutical industry. I understand that they deserve a profit and patent protection. However, their legal manipulations to extend that protection are disingenuous and harmful to patients. Hopefully, we will have generic omeprazole soon.

US Teen Dies After Following High-Protein Diet

Missouri doctors describe the case of an apparently healthy 16-year-old girl who collapsed suddenly and died after spending one to two weeks on a high-protein, low-carbohydrate diet.

Electrolyte imbalances due to the diet, and the resulting damage to her heart function, were likely responsible, the physicians who cared for her report in a recent issue of the Southern Medical Journal. The girl had no known illnesses or medical conditions.

The teen had low potassium and calcium levels when she arrived at the University of Missouri Health Sciences Center, most likely as a consequence of the diet, the doctors state in their report. This disrupted the normal electrical function of her heart, leading it to stop and causing her to collapse, they write.

Dietitians and proponents of the Atkins diet, one example of a low-carbohydrate/high-protein diet, say that other weight-loss measures including eating disorders like bulimia or the use of diuretics were far more likely to have contributed to the low electrolyte levels found in the teen's blood.

Low potassium and calcium suggest low magnesium to me. I cannot understand how a high protein diet would lead to low magnesium, potassium or calcium. Therefore, I am skeptical of the association in this anecdotal report. Nonetheless, I share this report for your consideration.

The Dangers Of Health Supplements

... warnings aren't required for any dietary supplements. They don't have to be proven safe or effective. And there are no purity standards.

It's all due to a 1994 law pushed through by the industry. It officially defines supplements as "foods" not "drugs", exempting them from nearly any and all federal scrutiny.

Since the government doesn't treat supplements like drugs, many consumers don't either. But there are countless risks. Some may inhibit blood clotting. St. John's Wort may negate birth control pills while Melatonin has been linked to seizures in children.

But it's nearly impossible to yank bad supplements off the market, says pharmacologist and FDA consultant Dr. Raymond Woosle.

While drugs must be proven "unsafe", supplements have to be proven dangerous.

Woosley explains, "It's much easier to prove a product is unsafe, than it is to prove that a rare reaction, beyond a shadow of a doubt, is harmful."

One reason getting proof is so hard, is that supplement makers don't have to report adverse events. For years, the FDA tried to get Metabolife to turn over health complaints it got about its popular Ephedra products. When it finally did, there were 13,000 of them.

Read this blog long enough and I will find an article like this one. I will overdo this subject, as will my colleagues. Supplements are dangerous, unregulated and expensive. Why would anyone ingest something recommended by a 'health food store' employee or Larry King? The medical establishment consistently rails against supplements. We are correct!

Syphilis Reported Increasing for First Time in a Decade. This is a scary headline. Syphilis rising must mean 'unsafe sex' is rising.

The increase was slight. Last year, 6,103 cases were reported, up from 5,979 in 2000, the agency said. For every 100,000 Americans, 2.2 were infected with syphilis in 2001, compared with 2.1 in 2000.

Health authorities said the increase was troubling for two reasons. First, it is a setback for the two-year-old effort to eliminate syphilis. Second, it sends yet another signal that many gay and bisexual men are no longer practicing safe sex, a trend that experts say has worrisome implications not only for syphilis, which can be cured with antibiotics, but also for the AIDS epidemic.

"We're concerned about it, even though it is a relatively small number of cases and a relatively slight increase," said Dr. Ronald O. Valdiserri, a C.D.C. expert in sexually transmitted diseases. "We are concerned about it in the context of other reports of unsafe behavior."

This disease still has many complications and leads to bad outcomes. What is our lesson? Do not remove syphilis from your differential in those who engage in promiscuity. Also, education may not convince some in our society of the dangers of this behavior. The lure of sexual activity is great.