Yesterday I linked to Sydney Smith's piece on Edwards. One of my most frequent commentors - Bernie - had this to say:

I read the article you linked to and it had lots to say about defensive medicine as a consequence of malpractice litigation and little to say about Senator Edwards' supposed misconduct as a malpractice lawyer. Unless you assume taking malpractice cases is prima facie evidence of moral depravity, I have yet to see how any of these opinion pieces impeaches Senator Edwards' character.

Bernie and I often disagree - and we both give and take arguments well. I really have not problem with his character, rather his apparent philosophy scares me. Rangel has a great post on this - How Edwards and his ilk are destroying America Quoting from Rangel-

Despite such manipulation of the court system, as repulsive as it is to rational, thinking Americans who have a sense of fairness and justice, a surprising number of people feel that this kind of behavior is perfectly acceptable as long as there is a sense that some type of "justice" has prevailed. This mentality goes along with the commonly held idea that things are not supposed to go wrong without someone else being responsible for causing it. This is a mentality that trial lawyers like Edwards have successfully cultivated over the last 40 years. Americans are more suspicious about big government, big business, industry, and professionals like their own physicians. If something goes wrong then someone is to blame. Call the lawyer!

Obviously, physicians and lawyers view the world through different prisms. (Well maybe not all lawyers, but likely most trial lawyers). These prisms differ due to a fundamentally different motivation for our professions.

Physicians have the patient's well being in mind as a first priority. We "adjudicate" information to try the best known therapy for our patient. We espouse evidence based medicine as our goal. New studies change our practice (the recent data on HRT represents a study which has caused a sea change).

We often will consult a colleague if we believe that the colleague can add valuable insights into our patient's care.

The job of the trial lawyer is to win the case for his/her client. Some lawyers take cases to change policy. But most cases are chosen for monetary benefit. The underlying principle is to win.

There are exceptions to this generalization, however, it is not the lawyer's job to worry about the health care system. He/her will often put the client's interest above the greater good. That is the nature of the lawyer/client relationship and of trial law in this country.

I believe that lawyers like John Edwards undermine our medical system. They can ignore data, science and greater good, and they do regularly. They are doing their job - and Edwards does that job well.

I admire his skill, but I disdain what his cases do to our health care system. I do not blame him, but I do not want someone with his attitude about the law as my president.

We need tort reform, and not just in medicine. With Edwards in power any hopes of reform would vanish. The court system, as used in this country, does not protect the public good. It does not evaluate the scientific evidence as scientists do.

We need a change, and since Edwards represents the current sorry state of affairs, he scares me.

Edwards scares me. He scares Sydney also - Our Edwardian Healthcare System

Tell the consumers about side effects! US FDA Wants Ads for Medicine to Highlight Risks

Prescription drug advertisements should highlight key risks rather than just list a string of possible side effects in tiny print, U.S. regulators said in new guidelines unveiled on Wednesday.

"Consumers want and deserve information presented in a way that's clear, accurate and understandable," Food and Drug Administration Commissioner Mark McClellan said.

To which I must clap wildly! Now let us have the same guidelines for supplements and then I will do a jig!

Perhaps this is a stretch, but one can argue that we should provide safety advice. If that argument does not convince you, then just read the article anyway. I admire Malcolm Gladwell and wait eagerly for his New Yorker pieces, which I consider the best medical/science reporting that I read. Big and Bad: How the S.U.V. ran over automotive safety. That SUV is more dangerous than your smaller cars!

I recently blogged about academic medicine - stimulated by our favorite surgeon blogger, Bard Parker. He has pointed out this important article concerning academic teaching hospitals - Multiple Missions Put Teaching Hospitals at Risk

For more than a century, Americans have expressed confidence that an ever-increasing, well-trained cadre of physicians and medical scientists will protect and enhance their health. So for much of this period, the steady expansion of medical schools, research laboratories and teaching hospitals has been justified as an agent of public good.

More recently, however, with the fiscal crisis in health care, experts are beginning to question whether the nation's academic medical centers are financially sustainable in these times when Americans tend to worship the free market.

It has become increasingly difficult in recent years simultaneously to educate and train young doctors, treat patients, advance medical research, and hew to the bottom line. All these endeavors require more and more costly technology. Salaries and health care delivery expenses continue to rise. And the competition among all medical centers, whether affiliated with universities or independent, is ferocious.

The academic medical center is big business. Because it is big business, we often have mission confusion. At times the medical school and the hospital administrations are at war.

So what should the priorities be? Are academic medical centers chiefly about education, or research, or patient care? Given current finances how many academic medical centers will remain "triple threats"?

What has changed most over the past century is that today's academic medical centers are almost or completely financially independent from their parent universities. To make matters more precarious, when economic times are good, many university presidents look to their hospitals' profits to support other growth plans in the less lucrative schools or colleges. But when these revenues are threatened or reduced, they often seek ways to minimize the university's financial responsibility to its academic medical center.

"This places an enormous premium on the entrepreneurial skills of administrators and faculty and seriously threatens the older notions of humanitarianism and scholarship that guided these institutions," Dr. Risse said.

Dr. Ruth Macklin, a bioethicist at the Albert Einstein College of Medicine in the Bronx, observed, "Academic medical centers are caught in a squeeze to bring in more and more dollars, leading to the common doctors' complaint: `I just don't have time to talk to patients because I am not reimbursed for it.' "

Dr. Arthur L. Caplan, a professor of medical ethics at Penn, believes this tension may be largely generational in nature. "Older physicians and medical scientists who came of age before the end of the 1980's tend to be more concerned about the public service mission of academic medical centers than their students, who are very much the product of the concept of medicine as a business," Dr. Caplan said.

So we have these large businesses that care for complex patients, perform major research projects and, oh by the way, train our future physicians (both students and residents). With these multiple missions, few centers do all well. And too often the education piece suffers.

Oh, but this reminds me of the famous tale - The Emperor’s New Suit. There is nothing there (speaking of the industry) and yet many Americans spend large amounts of money on supplements.

At the risk of offending a reader, I will quote from his diatribe concerning Sunday's rant:

As a chiropractor, I'm a part of the alternative trend. I realize some reigns need to be put on herbs and other so-called alternative therapies, but I don't think we need to dismiss the right of the patient to make their own educated decision. After all, a patient is not going to keep up with something that is harmful to them, unless their doctor tells them to. If millions, thousands, heck hundreds within a year were suffering problems from these herbal supplements, the word of mouth of their failure would kill the sales.

So he uses sophistry (see yesterday's rant) to argue for alternative therapies. I am a simple minded physician. I need data. I want to see what happens to patients who receive a therapy - do they improve or do they get worse or does nothing happen. Clearly, I try not to prescribe medications that have no effect.

The commentor urges us to allow patients to make their own educated decision. Unfortunately, many patients cannot make an educated decision about their medical care.

This argument stems from the general argument between science and belief. As a scientist, I want evidence that a therapy both will increase the probability of helping me and have a limited probability of hurting me. I certainly do not want to spend large amounts of money on placebos.

The commentor argues that patients know. Of course, in the land of believers the anecdote is king.

I'm sure we all know how statistics can be used to get results we need, or at least point our direction. Everybody knows that if you flip a "roll-over" prone SUV that it was probably your fault. If the plane craches, well that was out of your hands. Personally I like to have control of the reigns, like most Americans.

This is a simply classic diatribe against medical statistics. We should not trust statistics - because they define outcomes precisely .

With no apologies, this reasoning leads to many patients down the wrong roads.

Many patients are not smart about their health. If they were they would not smoke, drink to excess, have multiple sexual partners, use IV drugs, or become obese. But they do!!! People often do not know what is best for them.

Ephedra "helped" many patients - but at the risk of death! Patients died because of a bad law. Perhaps they should sue Congress (oops - you cannot really do that).

We need a better law. We need to advance evidence as the determinant of medical decision making. When we have no evidence and someone wants to try either an off-label drug or a dietary approach - I have no objection, if, and only if, the patient fully understands the lack of data and the potential risks.

The dietary and supplement industry presents themselves as authoritative. They are not, and they hurt many patients. Fortunately, they mostly just bilk naive believers out of their money. That is bad enough.

Malpractice cases often are about the money, not justice. Read this article for some outrageous examples (I know the Bloviator will argue that the exceptions are just that - but these cases are real and do hurt physicians). - Lawyers try new tacks in malpractice suits

• Last year, an Ohio jury awarded $3.5 million to the family of a man who died of a heart attack.

  His family claimed that the physician didn't do enough to help the man lose weight and stop smoking, given that physicians now know how smoking and excess weight contribute to heart disease and given the significant advances in treatment.

• Florida resident Miriam Kamin, along with her husband and son, filed a medical malpractice claim against Baptist Hospital of Miami and several of its physicians in 2002. Instead of claiming the standard of care wasn't met, the woman argues that she should have been referred to a hospital down the street to have a low-grade pancreatic tumor removed.
• In Ohio, the basis of a case against a Dayton physician practice is that a medical test was not performed according to the standard of care. But the facts leading up to the claim offer a different twist on the law.

  The patient, John Dobran, is suing because he says he is being denied the best information possible on whether his melanoma could return. The Ohio Supreme Court is poised to decide whether he has a claim.

  When doctors discovered that a mole on Dobran's arm was malignant melanoma, Dobran decided that he wanted a sentinel lymph node biopsy. By harvesting the lymph nodes first encountered when melanoma metastasizes, doctors can determine the chances of the cancer coming back.

  The tissue had to be sent to a lab in California. But it thawed before it arrived, making it untestable, and Dobran now wants to be compensated for the emotional pain and suffering of not having those results.

These examples are (in my not so humble opinion) outrageous! We need a filter prior to jury trials - or no jury trials at all. Our system encourages lawyers to gamble on the big hit. They know that they can convince jurors, regardless of the facts. From Webster's

sophistry

n : a deliberately invalid argument displaying ingenuity in reasoning in the hope of deceiving someone [syn: sophism]

The fundamental underpinnings of our legal system have nothing to do with sophistry. Yet sophistry wins cases. We need a system that protects us against these tactics.

I will probably go buy this issue to have a better, more readable copy of this article. The author has done outstanding research and puts the entire industry into both historical and current perspective. I hope this link lasts (not sure about the New Yorker's links) - MIRACLE IN A BOTTLE

I will quote a few key paragraphs to make some points and highlight the issue:

The diet-pill business may be the most visible segment of the vitamin-, mineral-, and herbal-supplement industry, but it is by no means the largest. Thousands of different tablets, elixirs, potions, and pills are sold in the United States, and remarkably little is known about most of them. That doesn't deter consumers. Since 1994, when Congress passed a law that deregulated the supplement industry and opened it to a flood of new products, the use of largely unproved herbal remedies - from blueberry extract for impaired vision to saw palmetto for the treatment of enlarged prostates and echinacea to prevent colds - has increased as rapidly as the use of any commonly prescribed drug.

Since that legislation, the Dietary Supplement Health and Education Act, became law, companies have been able to say nearly anything they want about the potential health benefits of what they sell. As long as they don't blatantly lie or claim to have a cure for a specific disease, such as cancer, diabetes, or aids, they can assert, without providing evidence, that a product is designed to support a healthy heart (CardiAll, for example), protect cells from damage (Liverite), or improve the function of a compromised immune system (Resist). There are almost no standards that regulate how the pills are made, and they receive almost no scrutiny once they are, so consumers never truly know what they are getting. Companies are not required to prove that products are effective, or even safe, before they are put on the market.

Those two paragraphs nicely summarize the effects of the DSHEA.

Since then, the English language has been stretched to its limits in the attempt to link products to health benefits. Even claims that are true may be irrelevant. Vitamin A, for example, is important for good vision - as supplements for sale in any health-food store will tell you. Insufficient consumption of Vitamin A causes hundreds of thousands of cases of blindness around the world each year, but not in the United States; here people don't have vision problems arising from a lack of Vitamin A. Although statements advertising Vitamin A for good vision may, like many others, be legally permissible, they are meaningless. "The laws allow manufacturers to make fine legalistic claims," Paul M. Coates, the director of the Office of Dietary Supplements at the National Institutes of Health, told me. "What we now have is an entire cottage industry of creative linguistics dedicated solely to selling these products." Instead of mentioning a disease (which in most cases would be illegal without F.D.A. approval), companies make claims that a food can affect the structure or function of the body. Such claims can appear on any food, no matter how unhealthy it is. You cannot assert that a product "reduces" cholesterol, but you can certainly say that it "maintains healthy cholesterol levels." You cannot state that the herb echinacea cures anything, since it has never been shown to do that. But there is no prohibition on stating that it "has natural antibiotic actions" and is considered "an excellent herb for infections of all kinds." Gingko biloba has been recommended to Alzheimer's patients because it "supports memory function." Does it? Since research is not required before a supplement is released, there are not nearly enough data to know.

Obviously the key here is the advertising. You can obviously sell almost anything to some people with good enough advertising. Data are irrelevant.

One recent Harris poll found that most people believe that if a supplement is on the market it must have been approved by some government agency (not true); that manufacturers are prohibited from making claims for their products unless they have provided data to back those claims up (no such laws exist); and that companies are required to include warnings about potential risks and side effects (they aren?t). "When something goes wrong, though, most people expect government health officials to find a solution," David A. Kessler told me. Kessler, who is the dean of the School of Medicine at the University of California at San Francisco, was the F.D.A. commissioner when Congress passed the Dietary Supplement Act, which he adamantly opposed. "This is really the classic American ambivalence, and it has always been part of our nature," he said. "The view of most people is simple: I want access to everything and I want it now." The Federal Trade Commission - not the F.D.A. - regulates supplement advertising. But the F.T.C. is principally concerned with commerce, not science: it focusses on the content of the labels, not the content of the pills. Although since 1994 the agency has sued more than a hundred diet-pill companies, in 2002 it found that at least half of all weight-loss ads contained false or misleading statements. Despite its vigilance, the agency has an impossible job; for each success, ten new companies seem to appear.

When people get sick, Dr. Kessler pointed out, the refrain is always "'Where the hell is the F.D.A. to protect me'? The supplement industry doesn't have to report adverse events, so the F.D.A. doesn't have the data it needs to protect people. You cannot prove something is unsafe if you don't have the data. It's the ultimate Catch-22. It is also a colossal failure to protect the public health of this country."

I hope that these excerpts have whet your appetite to read the best single overview of the dietary and supplement industry that I have yet read. DSHEA respresents the worst of our political process. The government has put the citizenry at both health and financial disadvantage. I hope that common sense and good science can prevail. Unfortunately, I am skeptical.

A vote for Edwards would be a vote against malpractice reform. A reader emailed me to comment on Medpundit's post from yesterday. I can only say - brilliant - Fortune's Son