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Archive for February 8th, 2010

The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?

BACKGROUND: A BAD, BAD LAW

One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:
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Posted in: Herbs & Supplements, Nutrition, Politics and Regulation

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The legal establishment of Winkler County, Texas conspires to punish whistle blowing nurses

On Science-Based Medicine, several of us have at various times criticized state medical boards for their tolerance of unscientific medical practices and even outright quackery. After all, Dr. Rashid Buttar still practices in North Carolina and the medical board there seems powerless to do anything about it. However, state medical boards have other functions, one of which is to respond to complaints of unethical and dubious behavior about doctors. Key to this function is protection; i.e., if someone reports a doctor, that person needs to be sure that the state will protect her from retaliation from that doctor of the hospital. About five months ago, I reported a true miscarriage of justice, the sort of thing that should never, ever happen. In brief, it was the story of two nurses who, disturbed at how a local doctor was peddling his dubious “herbal” concoctions in the emergency room of the local hospital when he came in to see patients, reported him to the authorities. Moreover, they had gone up the chain of command, first complaining to hospital authorities. After nothing happened for months, they decided to report the physician, Dr. Rolando Arafiles, to the Texas Medical Board because they honestly believed that this physician was abusing his trust with patients and behaving unethically by improperly hawking herbal supplements that he was selling in the rural health clinic and the emergency room of Winkler County Memorial Hospital.

Even though under whistleblower laws the identities of these nurses should have been kept secret, after he learned that a complaint had been filed against him Dr. Arafiles went to his buddy the Winkler County Sheriff Robert L. Roberts, who left no stone unturned in trying to find out who had ratted out Dr. Arafiles:

To find out who made the anonymous complaint, the sheriff left no stone unturned. He interviewed all of the patients whose medical record case numbers were listed in the report and asked the hospital to identify who would have had access to the patient records in question.

At some point, the sheriff obtained a copy of the anonymous complaint and used the description of a “female over 50″ to narrow the potential complainants to the two nurses. He then got a search warrant to seize their work computers and found a copy of the letter to the medical board on one of them.

The result was this:

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.

On Saturday, the New York Times reported on the story, as there have been significant developments since August. Specifically, although the charges against one of the nurses has been dismissed, Anne Mitchell, RN, is going to stand trial beginning today:
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Posted in: Medical Ethics, Politics and Regulation

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