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More Data on Vaccine Safety Amid New Outbreaks

The more recent issue of the Journal Pediatrics contains two article providing further evidence for the safety of vaccines and is published amid news reports of recent outbreaks of vaccine-preventable diseases in those who chose not to vaccinate over unwarranted fears. This highlights the need to continue our PR battle against the antivaccinationist movement that seeks to spread pseudoscientific fears about vaccine safety.

The Outbreaks

Haemophilus influenza type B (Hib) is a bacteria that can cause meningitis, pneumonia, and epiglotitis in young children – all serious illnesses. A Hib vaccine was introduced in 1992 followed by a significant decrease in the number of Hib infections. Last year in Minnesota, however, there were five cases of Hib meningitis, including a 7-month old infant who died. This is a significant spike above the rate we have seen since the Hib vaccine, and occuring in a cluster. Three of the five children who were affected did not have the Hib vaccine by their parent’s choice.

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Posted in: Public Health, Vaccines

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Dismantling NCCAM: A How-To Primer

Two of the earliest posts I wrote for Science-Based Medicine were entitled The infiltration of complementary and alternative medicine (CAM) and “integrative medicine” into academia and The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Both were intended as a lament over how not only is pseudoscientific quackery, much of it based on a prescientific understanding of how the human body works and disease occurs, finding its way into some of the most prestigious academic medical centers in the U.S. (for example, Georgetown and Beth Israel) but it’s even finding its way into the heart of the U.S. military.

Worse, aiding and abetting this infiltration is the federal government itself in the form of NCCAM. As I discussed in my usual excruciating detail in my original post and as Steve Novella, Kimball Atwood, and I have subsequently discussed many times on this very blog, particularly recently (so much so that I’m thinking of giving NCCAM its very own category here on SBM), NCCAM not only funds studies of dubious “alternative” therapies, such as reiki and homeopathy, that estimates of prior probability alone would argue to be so close to impossible as to be not worth spending millions, much less thousands, of dollars upon, but it also promotes quackery by funding “fellowships” at various institutions to teach “complementary and alterantive medicine” (CAM) sometimes also called “integrative medicine” (IM). Given that it spends over $120 million a year on mostly dubious studies and CAM promotion, we all have called for NCCAM to be defunded and disbanded.

Nearly a year has passed since I wrote those two posts. Ironically enough, at the time I wrote my first post about NCCAM for this blog, I pointed out that at first I had disagreed with my co-blogger Wally Sampson and his call to “defund” the NCCAM in an article published on Quackwatch nearly five years ago. My original reason was that I thought that there was value in studying these therapies to find out once and for all whether these therapies do anything greater than placebo or not. I now admit that I was very naive, and this was how I admitted it:

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine.

Nothing has changed since I wrote those words–except for one thing. We now have a new President who stated in his inaugural address:

We will restore science to its rightful place, and wield technology’s wonders to raise health care’s quality and lower its cost. We will harness the sun and the winds and the soil to fuel our cars and run our factories. And we will transform our schools and colleges and universities to meet the demands of a new age. All this we can do. And all this we will do.

As Kimball Atwood put it, Yes We Can! We Can Abolish the NCCAM! The big and as yet unasked (and unanswered) question is: How? Neither defunding nor dismantling NCCAM will be easy, and we have to think about how to preserve the functions of NCCAM that might be worth saving.
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Posted in: Medical Academia, Politics and Regulation, Public Health, Science and Medicine

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Let President-Elect Obama know that NCCAM should be defunded!

As you may or may not know, Change.gov is being used by Obama’s team to solicit policy ideas. Americans submit ideas, along with supporting rationale, and people “vote up” or vote down” the proposals. “Up” votes increase the score of the proposals, and “down” votes decrease the score. It is described thusly on the Change.gov website:

Share your ideas on any issue facing the new administration, then rate or comment on other ideas. The best rated ideas will rise to the top — and be gathered into a Citizen’s Briefing Book to be delivered to President Obama after he is sworn in.

A couple of days ago, P.Z. Myers let me know about an excellent proposal over at the Citizen’s Briefing Book: Defund the National Center for Complementary and Alternative Medicine:

Here’s a way to increase the available funding to NIH without increasing the NIH budget: halt funding to NCCAM, the National Center for Complementary and Alternative Medicine. This Center was created not by scientists, who never thought it was a good idea, but by Congress, and specifically by just two Congressmen in the 1990′s who believed in particular “alternative” (but scientifically dubious) treatments. Defunding NCCAM would save at least $225 million, possibly more.

Defunding NCCAM would also provide a direct societal benefit. Practitioners of so-called “alternative” medicines constantly refer to NIH’s support as a way of validating their practices and beliefs, most of which are not supported by evidence. The fact is that after >10 years, NCCAM has not yet found a single piece of positive evidence for any of these methods, which include acupuncture, “qi”, homoepathy, magnet therapy, and other treatments.

Any legitimate, promising medical treatment can be funded by one of the existing NIH Institutes. There’s no need for a separate center for “alternative” therapies – but what has happened is that NCCAM has become a last refuge for poorly designed, unscientific studies that couldn’t get funded through the normal peer-reviewed process.

He even cited our co-blogger’s (in)famous article Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded. Maybe he should take a gander at my post The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work, as well.
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Posted in: Politics and Regulation, Public Health, Science and Medicine

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Who Should Ascend To The Office Of Surgeon General?

President-elect Obama’s nomination of CNN medical correspondent, Sanjay Gupta, for the Office of Surgeon General of the United States has ignited a firestorm of debate across the Internet. Some argue that he is not qualified for the position, others say that his charisma would be a boon to public health communications, though the lay majority appear to have mixed feelings.

It is highly irregular for a Surgeon General nominee to be announced before the Secretary of Health and Human Services is confirmed. This faux pas in itself may speak to an irresistible opportunity for self-promotion, or that the Senate confirmation hearing is not the independent review event that we assume it is.

At age 39, Gupta has long aspired to become the Surgeon General, as sources close to him report that he has been saying (since age 33) that “it’s the next logical step in his career development.”

But before we draw conclusions about who’s right for the job, we need to understand what the job entails.

I asked Dr. Richard Carmona, 17th Surgeon General of the United States, to explain the roles and responsibilities of the office. A summary of our conversation follows:
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Posted in: Politics and Regulation, Public Health, Science and the Media

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Christine Maggiore and Eliza Jane Scovill: Living and dying with HIV/AIDS denialism

Christine Maggiore

On Science-Based Medicine, we strive to apply the light of science and reason on all manner of unscientific belief systems about medicine. For the most part, but by no means exclusively, we have concentrated on so-called “complementary and alternative medicine” (CAM) because there is an active movement to infiltrate faith-based, rather than science-based, modalities into “conventional” medicine. Indeed, such efforts are well-financed, both by public and private organizations, and are alarmingly successful at insinuating postmodernist and pseudoscientific beliefs into academia to form an unholy new monster that has been termed by some as “quackademic medicine.”

However, one pseudoscientific belief system about medicine that we at SBM have perhaps not dealt with as much as we should is the belief that, contrary to the overwhelming scientific consensus built up over 25 years, the Human Immunodeficiency Virus (HIV) does not cause Acquired Immune Deficiency Syndrome (AIDS). True, working with Tara Smith, our fearless leader Steve Novella has published an excellent primer on the phenomenon, but not on this blog. This belief system, which is commonly called HIV/AIDS denial or HIV/AIDS denialism, is championed by virologist Peter Duesberg, along with a panoply of groups, such as Alive & Well AIDS Alternatives and Rethinking AIDS; blogs, such as Science Guardian, HIV/AIDS Skepticism, and AIDS Is Over; podcasts, such as How Positive Are You?; books, such as What If Everything You Thought You Knew About AIDS Was Wrong? by Christine Maggiore; and movies, such as The Other Side of AIDS (which resembles in many ways the anti-evolution movie Expelled! and the pro-quackery movie The Beautiful Truth). The influence of HIV/AIDS denialism is horrific, too, particularly in Africa, where advocates of such nonsense, such as Matthias Rath, have advocated quackery over antiretroviral therapy and had the ear of South African President Thabo Mbeki, who lost power in late 2007.
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Posted in: Health Fraud, Public Health, Science and Medicine, Science and the Media

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The $150,000 Vaccine Challenge

At the request of a correspondent from the Quackwatch Healthfraud discussion list, I recently got embroiled in a debate with a couple of anti-vaccinationists in the pages of an Amish community newspaper, Plain Interests, published in Millersburg PA. They followed the usual pattern: they told the same old lies, they told partial truths distorted out of all recognition, and they omitted all those other truths that contradict their beliefs. Then they both challenged me to take all the recommended baby vaccines adjusted for weight to “demonstrate that vaccines are safe and effective.” If I refuse to do this, they say it will show that vaccinators are dishonest and that I’m afraid of my own medicine. They said I could win $150,000 by taking the challenge.

I did a little investigating. There is indeed a published challenge by Jock Doubleday, although the exact amount of money currently offered is unclear. His challenge reads:

The offer will continued to increase $5,000 per month, in perpetuity, until an M.D. or pharmaceutical company CEO, or any of the 14 relevant members of the ACIP (see below), agrees to drink a body-weight calibrated dose of the poisonous vaccine additives that M.D.s routinely inject into children in the name of health. The mixture will include, but will not be limited to, the following ingredients: thimerosal (a mercury derivative), ethylene glycol (antifreeze), phenol (a disinfectant dye), benzethonium chloride (a disinfectant), formaldehyde (a preservative and disinfectant), and aluminum.

According to Ratbags, this offer is bogus. (more…)

Posted in: Public Health, Vaccines

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Influenza Deaths

“There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don’t know. But there are also unknown unknowns. There are things we don’t know we don’t know.”- Donald Rumsfeld

How do we know what we know? It is said by some anti-vaccine proponents that vaccines are not needed because the diseases they prevent are either gone or no longer as severe as they were in pre vaccine times. People may have suffered and died in the distant past, but no longer. The risk now is from the vaccines not the diseases they no longer prevent.

36,000 people, more or less, die every year from influenza. That is the number of deaths according to the CDC web site; the NEJM review uses the higher number of 56,000 (7). Which number is correct? Isn’t that why the flu vaccine is recommended: to prevent all those people from dying.

36,000 is a lot of people. That’s about 120 deaths per million people in the US. In Oregon, population about 3 million, that would be about 360 people a year, which is two deaths a day for the six month flu season.

“Death is caused by swallowing small amounts of saliva over a long period of time.”–George Carlin.

2,400,000 people die every year in the US, about 6600 a day. In Oregon, that is about 65 deaths a day. No one outside a epidemiologist is going to notice 2 extra deaths a day during flu season. I have seen a lot of people die of influenza, but I have a biased experience: I am an infectious disease doc, so I am likely to see people with influenza, especially patients with disease severe enough to kill them.

About the same number of people die from car accidents and die from handguns in the US each year as die from influenza. I have never known a person in my real, as opposed to my professional, life to die from influenza or handguns or a car accident. My personal experience suggests no one dies from these causes, but since I take care of patients at one of the Portland trauma hospitals, I know what cars and guns do to people. My professional life confirms that people do indeed die from being shot or car accidents. I would wager that most people reading this blog have not known anyone who has died from influenza, guns or car accidents. The fact that people do die of influenza seems contradicted by experience. Why get the vaccine? I don’t get the flu and and no one I know has ever died from it.

As an illustrative example, a relative of mine, a retired physician, mentioned that he thought the shingles vaccine was a waste of time and money as he had never known anyone to get shingles. Using personal experience to judge disease prevalence is unreliable. If I applied the same rationale to driving, I would not wear a seat belt as I have never been in a high speed crash.

36,000 people die of influenza each year. What is the source of that statistic? From “Mortality associated with influenza and respiratory syncytial virus in the United States”. JAMA 2003. Is that really how many deaths are there from influenza? It depends on what you mean by ‘death’ and what you mean by ‘influenza’ and what you mean by ‘from’.

“It depends on what the meaning of the words ‘is’ is.” – Bill Clinton

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Posted in: Basic Science, General, Public Health, Vaccines

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The Infection Schedule versus the Vaccination Schedule

A baby’s body is bombarded with immunologic challenges—from bacteria in food to the dust they breathe. Compared to what they typically encounter and manage during the day, vaccines are literally a drop in the ocean”, and Dr. Offits studies theoretically show an infant could handle up to 100,000 vaccines at one time … safely (6).

It is not the mercury in vaccines, its the vaccine schedule that is the problem. Too many shots, too many antigens, too close together. Our children need to be exposed to fewer antigens, less often, so they don’t get complications from the vaccine like autism and autoimmune diseases. It is all part of greening our vaccines.

That is part of propaganda on vaccines from the More Infectious Diseases for Children, a.k.a. antivaccine groups.

What is the vaccine schedule? How much exposure do children receive from organisms and antigens as part of the vaccination schedule? The entire schedule is at CDC.

In summary there are 5 live attenuated or altered organisms and 21 different antigens by age 6. A couple of vaccines are added from age 7 to 18, but by then it is too late, your child already has autism and autoimmune diseases from the immunologic and toxic scourging of vaccines. BTW. Sarcasm.

Is the vaccine schedule a lot of virus and a lot of antigens? Is this an enormous load on the immune system, sending it spiraling out of control to damage the child? Lets find out.
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Posted in: Public Health, Science and the Media, Vaccines

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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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