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All You Need To Know About Dr. Oz And The Dietary Supplement Scandal

Comedian John Oliver did an excellent job explaining everything that’s wrong with the Dr. Oz show and the dietary supplement industry. Please watch this video for a good laugh:

I’ve been warning folks about Dr. Oz for many years – and I hope that John reaches more people with his message.

To be fair, there are reputable companies who manufacture safe and effective vitamins and supplements too, as I have noted here.

Congressmen For Snake Oil: How The Supplement Industry Is Preventing The FDA From Protecting Consumers

The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.

Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:

It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, Read more »

*This blog post was originally published at Science-Based Medicine*

Will Quackery Be Legislated By The Senate? Better Call Your Senator

For those of you following the surprising healthcare reform bill mandate of Christian Science prayer as a medical treatment to be payed for by your taxes… I have good news. That was stricken from the merged legislation.

The bad news is that there is currently even more worrisome language in the S.3950 bill. Senator Tom Harkin has introduced language that would essentially require ineffective medical treatment systems like homeopathy to be paid for by government programs, and give people without legitimate medical training the right to become primary care physicians who would establish a “medical home” for patients. Read more »

The 5 Best And Worst Recent Health Policy Quotes

I’ve been attending a series of health policy conferences recently – and twittering them live. I’ve heard a lot of smart ideas and a lot of not-so-smart ideas. For your consideration, I offer you my best and worst recent health policy quotes:

The best quotes:

1. Evan Falchuk, Best Doctors: “Since the leading cause of misdiagnosis is a failure of synthesis – a failure by the doctor to put together available information in a way that leads them to the right conclusion – our system ought to be built around helping make sure this happens each and every time.”

2. Aneesh Chopra, Federal CTO“HIT should not be in a box unto itself – put in a corner, making a capital-sucking sound.”

3. Clay Shirky, New Media Guru: “The problem is that, since we all die eventually, everyone will be unhappy with their healthcare at some point. This creates a social dilemma that’s neither transitory nor small. First, there will always be snake oil salesmen peddling ‘eternal life,’ and second, there will always be an unhappy faction who rail against the medical establishment.”

4. Joshua Ofman, Amgen, on comparative clinical effectiveness research: “We don’t want 2 different evidence standards. One to gain market access and a second to lose market access… There is a role for observational data to gain insights. There is a great allure of large, readily accessible databases that are fast – but the power and speed cannot overcome bias and confounding.

5. Vivek Kundra, Federal CIO: “We need to bake security into the architecture that we purchase from the private sector. The sprinkler system is part of any house you purchase – you don’t have to add it later.”

The Worst Quotes:

1. Senator Tom Harkin: “The NCCAM has failed to do their job of validating complementary and alternative medicine therapies.”

2. Senator Max Baucus: “Going to the doctor is like buying a car, except buying a car is a lot more fun.” Bonus quote: “If men liked shopping, they’d call it research.” [???]

3. Theresa Cullen, CIO, Indian Health Service : “At some point we’ll have to tell providers ‘you have to use EHR, we’ve drawn a line. If you don’t use it you’ll have to leave.’”

4. Sean Tunis, Center for Medical Technology Policy: “Randomized Clinical Trials can be designed with generous inclusion and exclusion criteria. Their limited inclusion criteria are not a permanent defect… We can’t wait 5 years for RCTs to be done. We have to find new methods that we can use (a “silver level of evidence” rather than the RCT “gold level”) to help inform our care decisions.”

5. Congressman Pete Stark: “I’m sick of rich doctors driving up in their Porsches saying ‘I’m pulling out of Medicare.’”

Why Non-Scientists Should Not Direct Scientific Efforts: Senator Harkin’s Misguided Beliefs Exposed

I’ve been blogging a lot recently about the problems caused by health policy makers who don’t appear to understand medicine or science. I’ve also been lamenting the relative lack of physician input at the highest level of health reform. But today I’d like to present a prime example of the perfect storm in health policy: when willfulness, ignorance, and magical thinking combine to push an agenda despite billions of tax payer research dollars proving the futility of such efforts.

In this video, Senator Tom Harkin describes the impetus behind the creation of the National Center for Complementary and Alternative Medicine (NCCAM). Harkin suggests that he single-handedly introduced legislation in 1992 that created the Office of Alternative Medicine at the National Institutes of Health (NIH). This office paved the way for an entire new branch of research at NIH devoted to exploring the potential validity of non-science based medical practices such as homeopathy, acupuncture, traditional Chinese medicine, energy healing, meditation and more. He introduced the legislation because a friend of his experienced a substantial health improvement after trying one of these non-science based therapies. Essentially, an entire branch of the NIH was founded on an anecdote.

What’s worse is that after a decade of careful analysis of these alternative therapies, science has shown that not a single one of them appears to be efficacious beyond placebo. One would think that Senator Harkin would be embarrassed by the colossal waste of tax payer resources spent on this pet project of his. But no, instead he chastises the scientists who did the research, saying that they had failed to do their job of “validating” the therapeutic modalities. Wow. I guess he was never interested in finding out the truth about what works and what doesn’t – because when objective analysis reveals that these modalities don’t work, then the science must be flawed.

Now don’t get me wrong – healthy eating, regular exercise, emotional and psychological support are critical factors in good healthcare, and I fully believe that America needs to become a “wellness culture” in order to prevent chronic diseases and improve quality of life. I also believe that Americans are often over-treated and over-medicated when lifestyle interventions might be their best treatment option. However, in encouraging behavior modifications, we don’t need to foist placebo therapies on them under the banner of science. The problem with “integrative medicine” is that it takes some good medical principles and infuses them with scientifically debunked and outdated systems of thought (debunked repeatedly by NCCAM, the very scientific body that Harkin hoped would validate them.)

What we really need to do is stop splitting the practice of medicine into “integrative” vs “non-integrative” and simply follow scientifically vetted best practices. Patients need a comprehensive approach to their health, a medical home with a good primary care physician coordinating their care, reliable health information to support their decision-making, a strategy to eat well and exercise regularly, and mental health services as needed.

Senator Harkins’ plan to continue flogging the alternative medicine “dead horse” is not helpful – it’s not good science, and it’s not a good way to spend our tax dollars. I can only hope that one of the positive effects of Comparative Clinical Effectiveness Research will be to put an end to the promotion of the ineffective therapies that Harkin fervently hoped would be validated. I also hope that the new Federal Coordinating Council will not support funding to pet projects that are founded upon anecdotes, pseudoscience, and wishful thinking. Now more than ever we need good science underpinning our healthcare spending, and we need informed scientists advising our government on priorities for America’s health.



More outrage from the medical blogosphere over Harkin’s views:

1. Dr. David Gorski:  Senator Tom Harkin: “Disappointed” that NCCAM hasn’t “validated” more CAM

2. Dr. Peter Lipson: Harkin’s War On Science

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