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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

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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Applying Rigorous Science to Messy Medicine

The PowerPoint presentation that I gave at the Skeptic’s Toolbox workshop at the University of Oregon on August 7, 2009 is up on their website with the complete text of what I said. The theme of the workshop was scientific method. The title of my talk is “Tooth Fairy Science and Other Pitfalls: Applying Rigorous Science to Messy Medicine.” Click here for the link. It covers a lot of things that are pertinent to the subjects we discuss on this blog, and I thought some of our readers might enjoy it. I put in a lot of information and some good cartoons. Note: this was a talk to the general public, not an academic presentation, and it does not include citations or references.

Posted in: Science and Medicine

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An open letter to Dr. J. Douglas Bremner

Peter Lipson wrote a post last week entitled Before You Trust That Blog…, which was a criticism of Dr. J. Douglas Bremner’s blog Before You Take That Pill. Dr. Bremner was not pleased, and posted a rebuttal entitled Response to Peter Lipson MD of “Science” Based Blogs, My Blog Does Not Suck, Yours Does. Given the kerfuffle and my role as managing editor of SBM, I felt the need to put my two cents in, which is why I’m posting this open letter to Dr. Bremner. This letter started as a much briefer response that I was going to e-mail to Dr. Bremner, but as I wrote it grew and grew to the point where I decided that, given the public nature of the disagreement between Dr. Lipson and Dr. Bremner, I might as well make my commentary public too. Consider it a bonus post from me. I still plan a post for my usual slot on Monday. In the meantime, here’s my open letter:
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Posted in: Medical Academia, Pharmaceuticals, Public Health, Science and the Media, Vaccines

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

ResearchBlogging.org

Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

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.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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More Flu Woo For You, Boo Boo

In which we try to be smarter than the average bear.

Flu season is upon us (it kind of never left us this year), and there is a new strain of flu, the H1N1, aka Swine flu that adds a wrinkle or two to the usual potential for influenza related morbidity and mortality. And with the new flu is the new woo. I know that others have addressed flu in this forum and some of this may be redundant. Still, we each have our different styles and interests, so I hope the various posts are additive rather than redundant. I am going to wander through some odds and ends about flu in general and H1N1 specifically and compare some of the woo with the reality. At least my reality.
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Posted in: Public Health, Vaccines

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