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SBM Problems

As many of you have probably noticed, the science-based medicine site has been having connection problems for the last week, and was in fact down for most of Friday. We are actively working on the problem and hopefully will have it fixed soon. The site is functioning now, but remains very slow.

Thanks for your patience, and sorry for any inconvenience.

Posted in: Science and Medicine

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Crank “scientific” conferences: A parody of science-based medicine that can deceive even reputable scientists and institutions

If there’s one thing that purveyors of pseudoscientific medical modalities crave, probably above all else, it’s legitimacy. They want to be taken seriously as Real Scientists. Of course, my usual reaction to this desire is to point out that anyone can be take seriously as a real scientist if he is able to do science and that science actually shows that there is something to his claims. In other words, do his hypotheses make testable predictions, and does testing these predictions fail to falsify his hypotheses? That’s what it takes, but advocates of so-called “complementary and alternative medicine” (CAM) or “integrative medicine” (IM, or, as I like to refer to it: “integrating” quackery with scientific medicine) want their woo to be considered science without actually doing the hard work of science.

There are several strategies that pseudoscientists use to give their beliefs the appearance of science, a patina of “science-y” camouflage, if you will. One, of course, is the cooptation and corruption of the language of science, which has been a frequent topic on this blog, particularly in posts written by Drs. Atwood and Sampson. Another is to produce journals that appear to be science, but are anything but. I’ve discussed one example, the Journal of American Physicians and Surgeons and Medical Acupuncture, but others include Homeopathy, the Journal of Alternative and Complementary Medicine, and Medical Hypotheses, which recently was forced to retract a horrible paper by arch-HIV/AIDS denialist Peter Duesberg. What’s worse is that some of these journals are even published by what are considered major publishers, such as Mary Ann Liebert, Inc., and Elsevier.

There is, however, a third strategy. How do scientists communicate their findings to other scientists, as well as meeting and mingling with other scientists? Why, they hold scientific meetings, of course! These meetings can be small or even as large as the American Association for Cancer Research meeting, which is attended by around 15,000 cancer researchers each year. So, too, do cranks hold meetings. These meetings often have all the trappings of scientific meetings, with plenary sessions, smaller parallel sessions, poster sesssions, and an exhibition hall, complete with exhibits by sponsoring companies. Sometimes these meetings can even appear so much like the real thing that they take in legitimate researchers and legitimate universities. Here, I present two examples of such conferences.
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Posted in: Medical Academia, Public Health, Science and the Media, Vaccines

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.

The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.

After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.

Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:

Snapshot 2009-09-11 16-16-15

The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.

Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)

Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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Report a doctor’s dubious practices, go to jail?

Althought I and other SBM bloggers have criticized state medical boards for not doing enough to protect patients from physicians who practice pseudoscientific medicine and quackery, they do nonetheless serve a purpose. Moreover, critical to medical boards doing even the limited amount of enforcement that they do is the ability of health care providers or other citizens to submit anonymous complaints against physicians who are not practicing up to the standard of care or who may be in other ways taking advantage of patients. Unfortunately, the other day I found out via one of the that I frequent of a very disturbing case in Kermit, Texas. Two nurses who were dismayed and disturbed by a physician peddling all manner of herbal supplements reported him to the authorities. Now, they are facing jail:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

The nurses, in their 50s and both members of the American Nurses Association/Texas Nurses Association, reported concerns about a doctor practicing at Winkler County Memorial Hospital in Kermit. They were unamused by his improperly encouraging patients in the hospital emergency department and in the rural health clinic to buy his own herbal “medicines,” and they thought it improper for him to take hospital supplies to perform a procedure at a patient’s home rather than in the hospital. (The doctor did not succeed, as reportedly he was stopped by the hospital chief of staff.)

How can this be? This is how:
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Posted in: Herbs & Supplements, Politics and Regulation, Public Health

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The HPV Vaccine (Gardasil) Safety Revisited

Gardasil (qHPV) was licensed in 2006 as a vaccine against four types of Human Papillomavirus (HPV) and marketed as, “The first vaccine targeted to prevent cancer.”  From its inception it has been one of the more controversial vaccines.  Some religious groups feared that the reduced threat of a sexually transmitted disease would lead to increased sexual promiscuity.  Other groups were concerned about its safety.  Some have questioned whether its high financial cost would make it a cost-effective intervention, while others have questioned the marketing tactics of its manufacturer Merck.

Most of these concerns bear consideration (though I have no time for those who advocate using the threat of disease and death to force conformation to their religious beliefs), and were in large part addressed by David Gorski in a SBM article last year.  If you’ve not read his post, I strongly suggest you do so.  Now that a large post-licensure study on qHPV has been published, it seems a good time to revisit the issue of greatest concern to me as a pediatrician and to most parents, namely qHPV’s safety and efficacy profile.

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Posted in: Public Health, Vaccines

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Even with the H1N1 pandemic flu strain going around, you should still be vaccinated against the seasonal flu

Even with the H1N1 pandemic flu going around you should still be vaccinated against the seasonal flu. revere has the details. Read. Enjoy. Be educated.

I guess that means Dr. Doug Bremner must think that revere is an idiot. After all, Bremner tells us that the flu vaccine is all a plot for big pharma to make money, don’t you know? Subtlety and weighing of risk-benefit ratios in a manner that doesn’t turn into an anti-big pharma rant is beyond him, as both Peter Lipson and I discussed (and Peter discussed again) not too long ago.

Fortunately it is not beyond revere to rationally weigh the risks and benefits of being vaccinated:

The truth is this. No one knows what’s going to happen. We’re all guessing. But in my estimation, the risk-benefit calculation for vaccine side-effects and flu is so markedly in favor of the vaccine that I made the decision to get vaccinated and that’s what I’d advise others, too. How confident am I? I’m confident it is the most rational thing to do given what we know.

Exactly. It is quite possible to look at the evidence and science and decide that the risk-benefit ratio is so much in favor of vaccination that it makes sense to be vaccinated. It’s also possible to look at the same literature and be less enthusiastic. You don’t need to appeal to big pharma conspiracy theories, and, in fact, such appeals only muddy the issue unnecessarily.

I’d love to see Bremner try to counter the arguments of a highly respected senior epidemiologist who can calmly discuss the pros and cons of flu vaccines from a scientific and practical standpoint based on evidence. Bremner points to “experts” who say that vaccination against the seasonal flu is a waste of money and time, but here’s one expert I bet that Bremner can’t refute. I won’t hold my breath waiting for him to try, though. It’s so much easier just to say that you’re an idiot if you get vaccinated against the seasonal flu. Obviously, in Bremner’s world, revere must be in the thrall of big pharma and pro-vaccination ideology.

Just like me, I guess.

Posted in: Public Health, Vaccines

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Platelet-Rich Plasma

As I mentioned in a not-so-recent blog post, I’ve often marveled at the marketing successes of “integrative” medicine – a practice which generally refers to the act of blending effective treatments with ineffective or untested/equivocal ones. Only the marketing elite know how integrative medicine became associated with enlightenment. Perhaps they’re the very same people who came up with the idea that women should be excessively concerned about cellulite? Thanks a lot, guys.

But I do find a lot of integrative medicine vexing because it often starts with a grain of truth, and then usually proceeds to make wildly exaggerated claims about its efficacy.

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Posted in: Surgical Procedures

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Kevin Trudeau’s Legal Trouble

Kevin Trudeau has made millions of dollars selling dubious medical products. He started his snake-oil salesman career selling coral calcium through infomercials. Trudeau claimed that this magical form of calcium could cure cancer and whatever ails you. The Federal Trade Commission (FTC) investigated Trudeau, who was making millions off his claims, and found that he was being, let us say, less than honest. As a result the FTC banned Trudeau from selling health products through infomercials.

But Trudeau is tenacious and creative – an innovator. Prior to getting into infomercials he was small time – he was convicted for writing bad checks and credit card fraud and spent some time in prison. I always find it interesting that convicted con-artists seem to hit upon such well-guarded secrets. Dennis Lee claims to have found the secret of limitless energy, if only he were not attacked by Big Oil and a corrupt government. Kevin Trudeau claims to have found the cures for just about everything, but The Man is trying to shut him down.

Undeterred by the FTC ban, Trudeau decided that even though he could not sell health products he could sell information – that was protected under free speech – so he started selling books through infomercial, including Natural Cures They Don’t Want You To Know About. Trudeau claimed he went from writing bad checks to discovering not only hundreds of natural cures but uncovering a government and Big Medicine conspiracy to keep this vital information from the public.

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Posted in: Politics and Regulation, Public Health, Science and Medicine

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AFP Promotes Acupuncture

I subscribe to American Family Physician, the peer-reviewed journal of the American Academy of Family Physicians. It emphasizes evidence-based medicine and most articles include a table showing strength of evidence ratings for key recommendations for practice. Lately, its scientific rigor has been slipping. I have complained to the editor about several articles whose recommendations were not based on the best science, and I have been consistently ignored. 

Acupuncture for Chronic Low Back Pain 

A recent article on chronic low back pain recommended acupuncture and gave it an “A” rating corresponding to “consistent, good-quality patient-oriented evidence.” I wrote the following letter to the editor and to the author of the article:  (more…)

Posted in: Acupuncture

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Tom Harkin, NCCAM, health care reform, and a cancer treatment that is worse than useless

ResearchBlogging.orgPRELUDE: SOME BAD NEWS FOR ADVOCATES OF SCIENCE-BASED MEDICINE

It was a bad week for science-based medicine. It was a good week (sort of) for science-based medcine.

First the bad.

There has been a development that anyone who supports science in medicine and opposes quackery will likely find disturbing. Do you remember Senator Tom Harkin (D-IA)? We’ve written about him extensively over the last several months on this blog. First of all, he is the man most responsible for the creation of that government-sanctioned, government-funded bastion of pseudoscience, the National Center for Complementary and Alternative Medicine. He’s also one of the men most responsible for the Dietary Supplement Health and Education Act (DSHEA) of 1994, which has done more to protect the supplement industry from making dubious health claims than any other piece of federal legislation. More recently, Harkin has made a name for himself in the health care reform debate currently ongoing by inviting advocates of “integrative” medicine (IM), which in essence integrates quackery and the pseudoscientific with scientific medicine, to Capitol Hill as a means of trying to persuade his fellow legislators to include a CAM/IM version of “wellness” care as part of any bill that might pass this fall. In essence, he is trying to hijack any health care reform bill to include government sanction of unscientific medicine. Meanwhile, he has been chastising NCCAM because it hasn’t “validated” enough “alternative medicine” for his taste. (Actually, it’s validated none, because virtually none of it is likely to be valid.)

This is the man who, according to reports, will almost certainly be taking over the chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP) after the death of its former chair, Senator Edward Kennedy. This committee is among the most important for government health policy and will be in the thick of the final negotiations and battles over any health care reform that may arise from Congress this fall.

The existence of powerful supporters of pseudoscience in the highest eschelons of government has real consequences. As I’ve described before, NCCAM, being based entirely on studying highly–even ridiculously implausible–notions about disease and how to treat it, has resulted in the infiltration of quackery into academia, where ideas once rightly dismissed as quackery are respectfully given deference and studied as though they were anything other than Tooth Fairy science, a process that Dr. R. W. Donnell has amusingly termed “quackademic medicine.” One result was the expenditure of $30 million on an unethical, poorly designed, and corrupt trial of chelation therapy for cardiovascular disease. Another result was an even more unethical trial of an even more scientifically implausible remedy for a deadly cancer. Although the fact that the trial was even done is a horror, at least last week we finally found out the results, which had been suppressed for nearly four years, namely that this protocol is not just useless, but worse than useless. It’s a Pyrrhic victory for science-based medicine and cold comfort to patients with pancreatic cancer who may have continued to use this protocol during those four years, but at least we finally know.

Let’s take a look at the study. But first, a little background.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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