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Archive for Politics and Regulation

South Dakota’s Abortion Script: The Hijacking of Informed Consent

In a previous post, I suggested that informed consent could sometimes be misused. South Dakota has provided a clear example of such misuse and has set a frightening precedent reminiscent of Big Brother in George Orwell’s 1984.

A law went into effect in July, 2008, requiring that any woman seeking an abortion in South Dakota must be told that she is terminating the life of “a whole, separate, unique, living human being” with whom she has an “existing relationship” and that abortion terminates “her existing constitutional rights with regards to that relationship.”

It requires that doctors give patients information about medical risks, but it doesn’t leave anything to chance: it specifies what the risks are, including depression, suicide, danger to subsequent pregnancies, and death. The current state of development of the fetus must be described, and the woman must be asked if she wants to see a sonogram of the fetus. All of this must be done in writing, and the woman must sign each page of documentation. Physicians who fail to comply can lose their license or be charged with a misdemeanor. (more…)

Posted in: Politics and Regulation, Surgical Procedures

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“Battlefield acupuncture”?

THE SCENE: Iraq, Afghanistan, or anywhere where U.S. troops are risking life and limb.

THE TIME: The not-too-distant-future. Maybe even 2009.

Joe is on patrol.

It’s the middle of summer in the desert town. The air hangs heavy, hot, dry and dusty, like a blast furnace firing steel. The heat penetrates Joe’s 80 lb pack in much the same way the heat from boiling water penetrates the shell of an unfortunate lobster. Joe’s heart races. His squad is on edge; their eyes dart furiously to and fro, looking for the deadly threat that might lurk in the shadows. Every shadow is a potential source of death, every alley a refuge from which the enemy can attack and kill him or his buddies, every rooftop a fortress from which the enemy can rain death upon the squad. The area is known to be thick with terrorists and insurgents. Joe pictured them waiting unseen from every nook and cranny for the opportunity to attack. The skin on Joe’s back is all prickly. He distinctly feels as though he has a huge bullseye pointed on his back. He feels a bead of sweat dripping down his forehead and onto his eyelid, all slimy and salty. Joe desperately wants to wipe it away, but that would necessitate removing one of his hands from his weapon. The split second it would take for him to put it back might mean the difference between life and death for him or one of his buddies.

A loud roar fills Joe’s ears, and suddenly he feels as though he has no weight. The scene unfolds in slow motion, just like in the movies. Dazed, Joe hears a tumult as though from a great distance, but can see nothing. Yelling and gunfire all around, he becomes conscious enough to realize that he’s lying flat on his back. He feels searing pain in his legs and a hot liquid oozing around them. It occurs to Joe that it must be his own blood or even perhaps his own urine, but he’s just too dazed to care.

“Medic!” Joe hears someone scream. He feels someone pull his helmet from his head and realizes that the sound of gunfire and yelling is receding. His unit must be driving away the ambushers. Good! He thinks. Give those assholes hell, guys! He opens his eyes, and realizes that his buddy’s got his back, and turns to see another man, a medic, drop to his knees at his side. His uniform is stained a disturbing red. Joe feels the medic wrapping something around his thigh. It’s a tourniquet, and Joe cries out in pain as he feels it constricting around his upper thigh.

“Bleeding’s better!” Joe hears the medic say to his buddy. “I’ll take it from here.” Joe’s buddy runs off to join the rest of his unit, and the medic moves his face close to Joe’s. He feels himself being moved from side to side and then his legs being moved. More pain. Joe cries out.

The medic leans in to talk to Joe, “I think we’ve got the bleeding under control for now. I put a tourniquet on your leg. Let’s get you out of here. The docs’ll patch you up in no time.” Joe is vaguely aware of another corpsmen with a stretcher nearby. The medic leans in again, “Are you in pain, soldier?”

“What do you think? My leg hurts like a sonofabitch! I could really use something for the pain,” Joe hears himself yelling, again as if from a distance. Pain is shooting through his leg, setting every nerve on fire, and the tourniquet is biting into raw muscle through the edge of a wound that comes all the way up to his groin. The flayed edges of his skin shoot fire to his brain, and he can feel his broken bones grinding against each other every time he moves in spite of the splint.

“I’ve got something better that’ll help,” the medic screams over the din.

Better? Joe thinks. I’m in agony here. I need something! Anything!

The medic pulls a small box out of his pack. Joe sees that it’s a small case. He opens it. Its contents look something like this:

acupuncturekit

Joe is puzzled. Where’s the morphine? He wonders. “What are those needles?” Joe asks. “What are you doing? I’ve never seen syringes that look like that before!”

“Acupuncture,” replies the medic. “I’ll take care of you.”

“What are you going to do with them?” Joe replies.

“Stick them into your earlobe. It’ll take the pain away really fast.”

“Are you shittin’ me?” Joe screeches, trying to get up to grab the medic by the front of his uniform. “My leg’s a bloody mess, I’m in agony, and you’re tellin’ me you’re gonna stick little needles in my ear and make it all better? Like that‘s going to do anything! I need real pain medicine! Give me morphine! NOW!
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Posted in: Acupuncture, Medical Ethics, Politics and Regulation

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The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

A Review

Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation

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Gulf War Illness

One-fourth of the veterans of the 1990-91 Gulf War complain of persistent memory and concentration problems, chronic headaches, widespread pain, gastrointestinal problems, and other chronic abnormalities not explained by well-established diagnoses. Treatments are ineffective and symptoms do not improve over time. Gulf War Syndrome or Gulf War Illness is a controversial diagnosis, and some have questioned whether it really exists. Now a new report from the Research Advisory Committee on Gulf War Veterans’ Illnesses has concluded that Gulf War Illness is real and that it is probably attributable to pyridostigmine bromide (PB) and pesticide exposures.

Its major conclusions:

  • Gulf War illness is a serious condition that affects at least one fourth of the 697,000 U.S. veterans who served in the 1990-1991 Gulf War.
  • Gulf War illness fundamentally differs from trauma and stress-related syndromes described after other wars.
  • Evidence strongly and consistently indicates that two Gulf War neurotoxic exposures are causally associated with Gulf War illness: 1) use of pyridostigmine bromide (PB) pills, given to protect troops from effects of nerve agents, and 2) pesticide use during deployment.

The Research Advisory Committee on Gulf War Veterans’ Illnesses was mandated by Congress and appointed in 2002. The report, published November 17, 2008, is an exhaustive review of all available data, including some that is unpublished. It runs to 454 pages, has multiple authors and consultants, lists 1840 references and has multiple appendices. I can’t pretend to have mastered all the information, but I have read enough to understand the basis of their conclusions. They are based on good evidence and logic, but they leave me with some doubts.
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Posted in: Politics and Regulation

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NCCAM: the not-even-wrong agency

The National Center for Complementary and Alternative Medicine (NCCAM) is a government agency tasked with (among other things), “[exploring] complementary and alternative healing practices in the context of rigorous science.” In this space we have talked about NCCAM quite a bit, but I have to admit that I don’t think about them very much. The other day, though, I was reading though JAMA and I came across a study funded by the agency. The study, which showed that Ginkgo does not prevent Alzheimer’s-type dementia, was pretty good, so I cruised on over to NCCAM’s website to see what else they’ve been up to.

A quick glance at NCCAM’s front page:

    “Ginkgo Evaluation of Memory (GEM) Study Fails To Show Benefit in Preventing Dementia in the Elderly”
    “CAM and Hepatitis C: A Focus on Herbal Supplements ‘No CAM treatment has yet been proven effective for treating hepatitis C or its complications.’”
    “Selenium and Vitamin E in Prostate Cancer Prevention Study, ‘selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer.’”

It seems that NCCAM is finding out something we already strongly suspected:  improbable medical claims are usually wrong.  Since that’s not how they see things,  and since I don’t believe that there is such a thing as alternative medicine, I was curious how they defined CAM.

CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Some health care providers practice both CAM and conventional medicine. While some scientific evidence exists regarding some CAM therapies, for most there are key questions that are yet to be answered through well-designed scientific studies–questions such as whether these therapies are safe and whether they work for the diseases or medical conditions for which they are used.

The list of what is considered to be CAM changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge. emphasis mine, ed.

The list of NCCAM studies appears to fall into three broad categories.

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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine

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Health Care Freedom

Freedom is a cherished commodity in our culture, as it should be. Our laws are largely based upon the premise that individuals should have the liberty to do what they want, unless there is a compelling public or governmental concern that overrides such liberties.

It is therefore no surprise that freedom is a common marketing theme – selling the idea of individuality or personal freedom of choice.

The marketers of dubious, unscientific, or fraudulent health care products and services are savvy to the marketing theme of freedom and have used it to great effect. It is all ultimately, however, a deception. There is an ulterior motive that has nothing to do with the freedoms of the public but rather is an end run around regulations meant to protect the public.

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Posted in: Politics and Regulation, Science and Medicine

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“Integrative Medicine Experts”: Another Barrier to Effective Discipline

This is the final entry in the current series having to do with state regulation of physicians.† It is the final one merely because I’m tired of the topic, for now. There is plenty more to write about, including an event that occurred only yesterday right here at my own hospital. I’ll give a preview of that at the end of this post, but first we’ll look at another recent event.

Dazing Arizona  

Arizona’s citizens, more than most, can expect to be bamboozled by pseudomedicine. We’ve seen that the Arizona Board of Homeopathic Medical Examiners has, for years, provided a regulatory safe haven for quacks with MD and DO degrees. Although I haven’t previously mentioned it in this series, which is about quack medical doctors, Arizona is also a haven for another group of quacks: “naturopathic doctors.” Like its homeopathy board, Arizona’s Naturopathic Physicians Board of Medical Examiners has been less than committed to protecting the public from its licensees. In each board’s case, the state Office of the Auditor General has suggested numerous fixes, but there has been little indication of improvements.

Nor would improvements be expected: in the words of Edzard Ernst,

Those who believe that regulation is a substitute for evidence will find that even the most meticulous regulation of nonsense must still result in nonsense.

Arizona is also the home of one of the first academic “integrative medicine” programs, begun by Andrew Weil at the University of Arizona. We have previously seen examples of misleading language emanating from that program. We’ve also seen the program’s inordinate effect on the Federation of State Medical Boards (FSMB). We’ve seen examples of the writings of Kenneth Pelletier, one of the U of Arizona program’s consultants to the FSMB. A recent disciplinary case in Arizona illustrates the potential danger of a state medical board seeking consultation from another “integrative medicine expert” from that program.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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Vitamin Cocktail with a Meme Twist (Supplement my gimlet with a dash of dissonance)

A trail of recent reports is trying to tell us something. But are we listening, and are “they” listening? If so, does it mean the same to “them” as it does to us?

The report trail is telling us that multiple vitamins fail as preventatives against cardiovascular disease, cancer, or even for anything other than for dietary vitamin deficiency. And that is what we were saying in the first place – forty and more years ago.

Here is a partial list of these recent reports –  followed by an odd turn

Vitamins E and C were ineffective in preventing `cardiovascular disease in men. Sesso HD, Buring JE, Christen WG et al. JAMA, 2008;300 (Physicians’ Health Study II, mong 14,641 male physicians. [...] The study participants were randomized to receive 400 IU of vitamin E every other day or a placebo and 500 mg of vitamin C daily or a placebo.

B Vitamins (B12, B6, folate) May Not Reduce Cardiovascular Events For Coronary Artery Disease Patients Ebbing M, et al, JAMA 2008, Aug 20 — In a large clinical trial involving patients with coronary artery disease, use of B vitamins B6, B12, folate was not effective for preventing death or cardiovascular events. Patients were randomly assigned to one of four groups receiving a daily oral dose of one of the following treatments: folic acid, 0.8mg, plus vitamin B12 , 0.4mg, plus vitamin B6 , 40mg (n= 772); folic acid plus vitamin B12 (n = 772); vitamin B6 alone (n = 772); or placebo (n = 780).The study was stopped early because of concerns among the participants about preliminary results from another similar Norwegian study suggesting no benefits from the treatment and an increased risk of cancer from the B vitamins. Daily supplementation combination that included folic acid and vitamin B6 and B12 had no significant effect on the overall risk of cancer, including breast cancer, among women at high risk of cardiovascular disease. Zhang M et al, JAMA 2008 Nov. 5.

Certain Vitamin Supplements May Increase Lung Cancer Risk, Especially In Smokers. November 11, 2008, from American Thoracic Society. March of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

Selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer; these results came from initial, independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute. (publication  Feb. 1 in the Journal of Clinical Oncology.)

These reports, along with those showing inefficacy of vitamin E in CV prevention and others, all in recent months, dovetail on more reported over the past decade. Now for the dissonance. A popular Web portal posted a brief questionnaire following one of last week’s reports. It asked readers to answer if they took vitamins regularly, infrequently, or not at all.
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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Nutrition, Politics and Regulation

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Robert F. Kennedy, Jr., vaccines, the EPA, and the interface with science-based medicine and public policy

This blog is entitled Science-Based Medicine for a reason, and that’s because we here at SBM believe that the best method to result in the most efficacious treatments for the most people is through the application of science to the evaluation of the biology, pathophysiology, and treatment of disease and disorders.

I may (or may not) be departing a bit from the views of my co-bloggers with this belief, but for purposes of this blog I consider “medicine” to go far beyond what we as physicians do when we undertake to treat patients. In fact, in my view, the purview of science-based medicine should not be so limited but should include any area where decisions, actions, or policy have a direct impact on health. Thus, my definition of science-based medicine encompasses environmental policy, because of the profound effect on human health environmental pollution and toxins can have. Unfortunately for those of us who don’t like its messiness, such a view drives me even more directly into politics than previous issues I’ve taken on. Like Dr. Novella, I rarely write about politics, but when it directly impacts science-based medicine. Mostly, such discussions here on SBM have involved the regulation of the medical profession by government, as Dr. Atwood discussed recently (1, 2, 3) in the context of the difficulties medical boards have in preventing quackery to my discussion of how a quack like Dr. Rashid Buttar could continue to practice in North Carolina, despite his despicable preying upon desperate cancer patients and the parents of children with autism, not to mention the frequent criticisms of the National Center for Complementary and Alternative Medicine. Dr. Sampson, on the other hand, was more than willing to examine a much more explicitly political issue, namely the number of Iraq War dead (1, 2), and that provoked a bit of disagreement with our commenters, not to mention me.

Recently, hot on the heels of the election of Barack Obama in the Presidential election last week, an issue relevant to several aspects of where science-based medicine intersects public policy popped up. Steve Novella has already commented on it on his own blog, as have numerous other medical bloggers, science bloggers, and political bloggers but I feel justified in commenting on it here, for the reasons that I’ve just mentioned. The controversy is that antivaccine activist and true believer in the scientifically discredited notion that mercury in the thimerosal preservative in vaccines causes autism, Robert F. Kennedy, Jr., is being seriously considered by Barack Obama either to head the Environmental Protection Agency or even to be Secretary of the Interior. Like our fearless leader Steve, I believe that such a selection would be an unmitigated disaster for science policy in government.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Wyeth vs. Levine: Should Drug Label Standards Be Determined By Juries?

It is with some degree of trepidation that I enter the fray on the Wyeth vs. Levine case. I’ve been watching the media frenzy about the lawsuit with interest – mostly because (for the first time in a while) I think that the pharmaceutical company is in the right on this one – and that most journalists (and even medical journal editors) have missed the salient points.

I think that a close review of the case is instructive in two ways. It shows: 1) the dangers of making legal decisions based on the perspective of the victim (a risk of harm equal to 1 in 20 million is unacceptable to that one person who suffered the consequence, but tolerable to the other 19,999,999 others) and 2) that a simple case of medical malpractice has made it all the way to the US Supreme Court because (as I discussed in my last post) a democratization of knowledge (juries reading a drug label) was believed to democratize expertise (how a physician would understand the label).
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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