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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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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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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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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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The Golden State of Pseudo-Science

The state of California (CA) which is home to the most advanced education and research in biomedical sciences, computational biology, genomics and proteomics, etc, is also home to 19 institutions that have state-approved training programs in Traditional Chinese Medicine (TCM), a pseudo-medicine that is based on ideas and practices sourced by ancient cosmology, mythology, astrology, and a range of other pre-scientific beliefs that have been partially “sanitized” during the Maoist era.

Emerging out of the recent hype about complementary and alternative medicine (CAM), the educational curricula of these institutions include the study of acupuncture’s point-and-meridian system, the health and safety beliefs of ancient and medieval China, humoral pathology, herbalism, Asian massage, and a limited amount of modern biomedical sciences at a level below what is required from vocational nurses. These curricula are supposed to provide the necessary knowledge and skills for the graduates to pass a comprehensive state licensing exam and provide “primary” healthcare in CA. However, pursuant to CA Code of Regulations, Title 16, Section 1399.451(b) it is improper for these “primary” healthcare providers, “to disseminate any advertising which represents in any manner that they can cure any type of disease, condition or symptom!” Nonetheless, both the internet and the local press abound with ads by CA licensed practitioners who claim that acupuncture can cure or mitigate many diseases, ranging from allergies and infertility to stroke and paralysis.

Under the banner of CAM, a handful of these practitioners also advertise that they can communicate with spirits and heal with crystals, colors or sounds; they practice healing touch (reiki) and distance healing (via PayPal!); provide spiritual counseling and ministerial services, and make implausible medical claims such as healing a chronic condition with just one needle!

All 19 programs are approved by the CA Department Affairs’ (DCA) Board of Acupuncture, since CA law requires that the content of an acupuncture training program be assessed and approved by the State.

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Posted in: Acupuncture, Politics and Regulation, Public Health

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“Oh, come on, Superman!”: Bill Maher versus “Western medicine”

I realize that I’ve spent a fair amount of verbiage (to put it mildly) expressing my frustration with celebrities whose support for pseudoscience and even outright quackery endanger public health. The two most frequent targets of the wrath, sarcasm, frustration, and puzzlement of me and my partners in crime at SBM have been Jenny McCarthy and her boyfriend Jim Carrey for their having emerged over the last two years as the most vocal celebrity faces of the anti-vaccine movement in general and the anti-vaccine organization Generation Rescue in particular and Oprah Winfrey for her promotion of pseudoscience, quackery, and mysticism on her show. That doesn’t even count Oprah’s inking of a development deal with Jenny McCarthy to do her own weekday talk show, which has poised McCarthy to walk in the footsteps of previous Oprah proteges, such as Dr. Phil McGraw and Dr. Mehmet Oz. I’ve also lamented how celebrity physicians like Dr. Jay Gordon, Robert “Bob” Sears, and the hosts of the daytime TV show The Doctors have promoted, through the mantra of “balance,” anti-vaccine views in particular and pseudoscience about health in general.

As bad as celebrities such as Oprah, Jim Carrey, and Jenny McCarthy are, though, no one views them as skeptics, at least no one I know and no one in the skeptical movement. Even the reporters and newscasters who credulously interview them, I suspect, realize that Oprah, Jim, and Jenny are not exactly the most scientific of people. Unfortunately, if there’s one thing I’ve learned over the years since I became more involved with the skeptical movement, it’s that being an agnostic, atheist, or skeptic is no guarantee against falling for pseudoscience. The problem is that when someone becomes associated with the skeptic movement for another reason, even if that person is a total woo-meister when it comes to medicine, they tend to be given a pass. I don’t give such people a pass because of their anti-religion views because I consider myself a skeptic and don’t really care much about religion, except when it intersects issues of science and health, such as Jehovah’s Witnesses refusing blood transfusions, faith healers offering prayer instead of medicine, and fundamentalists undermining the teaching of evolution. If someone who promotes pseudoscience is a prominent critic of religion, to me that makes it even worse when they spout nonsense.

I’m referring to Bill Maher, comedian and host of the HBO show Real Time With Bill Maher. Thanks to an anti-religion movie (Religulous) and his frequent stance as a “skeptic,” many of my fellow skeptics consider him one of our own, even to the point of giving him an award named after Richard Dawkins. Yet, when it comes to medicine, nothing could be further from the truth. Maher’s own words show that he has anti-vaccine views, flirts with germ theory denialism and HIV/AIDS denialism, buys into extreme conspiracy theories about big pharma, and promotes animal rights pseudoscience. That’s not a skeptic or a supporter of science-based medicine.
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Posted in: Pharmaceuticals, Public Health, Science and the Media, Vaccines

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An Influenza Primer

The President’s Council of Advisors on Science and Technology recently submitted its report to the president in which they stated that this influenza season might kill 30-90,000 people in the US.  This forecast of the upcoming season caught the media’s attention and appears to have stoked the public interest in influenza.  We have had many requests for more information about influenza here at SBM, and so in this post I am going to discuss the basics of influenza and try to put the current pandemic and upcoming season in perspective.

I find it is best to start at the beginning.

What Is Influenza?

Within the public sphere, “The flu” has become shorthand for “I feel like crap.”  I suspect that this is part of the reason why some people think the influenza vaccine doesn’t work.  Medically speaking, however, influenza is a very specific family of viruses that cause a reasonably narrow set of problems for humans.

The influenza season in the Northern hemisphere usually runs from October through May, with a peak mid-February.  Every season in the US between 5-20% of the US population is infected by influenza, and while the majority of people recover well from an influenza infection, not everyone will.  Annually 200,000 people are hospitalized, and on average 36,000 will die either from influenza or its complications.

The classic influenza infection incubates for 1-4 days after exposure.  Its onset is rapid, with most people experiencing high fever, headache, muscle aches, dry cough, sore throat, and nasal congestion.  Gastro-intestinal symptoms like nausea, vomiting, and diarrhea are less common.  Symptoms last from several days to almost two weeks, and a person is contagious from one day before symptoms begin to more than a week after symptom onset.

There are many strains of influenza. The current seasonal influenza is made up of three different influenza subtypes: A(H3N2), A(H1N1), and B.  Don’t confuse the seasonal A(H1N1) strain with the current pandemic 2009 A(H1N1); they are distinct.  I will refer to them as A(H1N1) for the seasonal strain, and 2009 (H1N1) for the pandemic “swine flu” strain.  Influenza B is less common, less virulent, has a slower mutation rate, and is thus a lesser risk; the rest of this discussion is focused on Influenza A. (more…)

Posted in: Public Health, Science and Medicine, Vaccines

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The perils and pitfalls of doing a “vaccinated versus unvaccinated” study

The anti-vaccine movement is nothing if not plastic. It “evolves” very rapidly in response to selective pressures applied to it in the form of science refuting its key beliefs. For instance, when multiple studies looking at the MMR vaccine and autism failed to confirm the myth that the MMR causes autism or “autistic enterocolitis,” most recently late last year, it was not a problem to the anti-vaccine movement. Neither was it a major problem to the movement when multiple studies similarly failed to find a link between mercury in the preservative thimerosal that used to be in most childhood vaccines and is no more (except the flu vaccine) and autism. No problem! Andrew Wakefield is alleged, based on strong evidence, to have falsified his data alleging a link between the MMR vaccine and “autistic enterocolitis”? Fuggedabouddit! The anti-vaccine movement simply pivoted neatly, de-emphasized points that the evidence was so clearly against that even they couldn’t spin it to a positive anymore, and found new bogeymen. These days, it’s the “toxins” (such as formaldehyde and the latest antivax bogeyman, squalene), and “too many too soon” (a gambit given seeming respectability by Dr. Bob Sears and Dr. Jay Gordon, apologists for and supplicants to the anti-vaccine movement both.

However, there is one trait of the anti-vaccine movement that, however its camouflaging plumage may evolve, never, ever changes. It is as immutable as believers say that God is. That trait is that, whatever other claims, the anti-vaccine movement makes, at its core it is always about the vaccines. Always. No matter how often science fails to find a link between vaccines and autism or vaccines and whatever other horreur du jour the anti-vaccine movement tries to pin on vaccines, no matter how many studies do not support the viewpoint that vaccines cause autism, no matter how much the anti-vaccine movement tries to deny and obfuscate by saying that it is not “anti-vaccine” but rather “pro-safe vaccine,” at its core the anti-vaccine movement is about fear and loathing of vaccines. Always. When inconvenient science doesn’t support their views, anti-vaccine activists either ignore the science, distort the science, or launch ad hominems against the people doing the science or citing the science. And, as I said before, the claims of the anti-vaccine movement evolve. Never again will the anti-vaccine movement make the horrific mistake of yoking itself to a hypothesis that is as easily testable as the hypothesis that mercury in vaccines causes autism. The claim that mercury in vaccines causes autism predicted that, if thimerosal were removed from vaccines or reduced to pre-“epidemic levels” of the early 1990s, then autism rates should plummet. Thimerosal was removed from nearly all childhood vaccines (the sole exception being some flu vaccines), reducing infant mercury exposure from vaccines to levels not seen since the 1980s; yet autism rates continue to rise. This is about as resounding a refutation of the hypothesis that mercury in vaccines is a major cause or contributor to autism that even the anti-vaccine movement has backed away from the pure claim, which has now evolved to unnamed “environmental toxins,” either in concert with mercury or with other nasty things, as being the Real One True Cause of Autism.

It’s evolution in action. These new claims are much “fitter” because they are much harder to falsify through scientific research, epidemiology, and clinical trials.
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Posted in: Clinical Trials, Medical Ethics, Public Health, Science and Medicine, Vaccines

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