Consumer Health Digest #16-01
Your Weekly Update of News and Reviews
January 3, 2016
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
FDA creates dietary supplement office. The U.S. Food and Drug Administration is setting up an Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements, which will be renamed the Office of Nutrition and Food Labeling. The FDA believes that during the past 20 years, the industry has grown from about $6 billion to more than $35 billion in annual sales and that elevating the program's position will enable the regulators to better compete for government resources and regulatory capability. The ODSP's functions will include:
- Acting to remove dangerous products, including falsely labeled "dietary supplements" that contain potentially harmful drug ingredients.
- Enforcing good manufacturing practices (GMP) regulation, giving priority to cases in which violations pose safety risks or result in consumer deception (including cases where the raw ingredients are not identified).
- Targeting claims that pose serious risk of harm to consumers (such as egregious claims of benefit in treating serious diseases) or widespread economic fraud.
Lab settles "whistleblower" suit about food sensitivity tests. Gottfried and Mieke Kellermann and their companies, Pharmasan Labs, Inc., and Neuroscience, Inc. (which does Pharmasan's billing), have agreed to pay $8.5 million to the United States. The settlement resolves False Claims Act allegations that Pharmasan miscoded Medicare claims and improperly billed for services referred by non-physicians. As part of the agreement, Pharmasan agreed that the United States could prove that (a) Pharmasan falsely billed Medicare for ineligible food sensitivity testing for nearly five years, (b) Pharmasan employees knew that Medicare prohibited payment for food sensitivity testing; and (c) Pharmasan employees submitted false codes to Medicare for the type of test that Pharmasan was performing so that Medicare would pay for the services. Many of Pharmasan's referrals for laboratory services came from non-physician practitioners who were not eligible to refer for Medicare-paid services. Pharmasan employees nevertheless billed Medicare for these services for nearly five years. [Osceola Laboratory agrees to pay $8.5 million to resolve false billing case. U.S. Attorney's Office news release, Dec 1, 2015]
The original complaint was filed by Richard T. Forrest, who was hired by Pharmasan in 2007 as an insurance specialist, was later promoted to insurance billing manager, and resigned in 2012 because of concerns about improper billing procedures. As the "whistleblower," he was awarded $1,129,145 as part of the settlement. However, in 2014, Pharmasan and Neuroscience obtained a default judgment against him for $548,477.32 in a suit that alleged that he had diverted money from them and was responsible for miscoding of claims. Those allegations were not adjudicated because Forrest wrote to the judge that he was unable to defend himself.
Gottfried Kellermann has been in serious trouble in the past. In 1992, he was convicted of making false statements to an agency of the United States and conspiracy for failure to provide accurate financial records in connection with a government grant. He was subsequently ordered to be deported but has managed to remain here while appealing it.
Graedons blasted in Science-Based Medicine blog. Harriet Hall, M.D., has severely criticized a preposterous article about chelation therapy published on the People's Pharmacy Web site. The article, titled Doctors despise EDTA chelation but science supports its use, claimed that the Trial to Assess Chelation Therapy (TACT) demonstrated that EDTA chelation outperformed statins. But Dr. Hall concludes:
That's just wrong. It compares oranges to apples (truckloads of statin oranges to one wormy, rotten chelation apple). The benefits of statins have been established in multiple studies; the alleged benefits of chelation are based on a single fatally-flawed study. You can't say chelation outperforms statins unless you have done a controlled study comparing the two. In fact, in the TACT study the subjects were all on standard therapy after a heart attack; most of them were taking statins. The Graedons don't seem to understand the actual results of the study. The Graedons downplay the known risks of chelation and the serious flaws that make the study unreliable, and they provide anecdotes, saying that in combination with the TACT results, those anecdotes mean that some people do get benefit from EDTA chelation therapy. No, they don't mean that at all, and the Graedons should know better. [Hall H. Misinterpreting TACT: No, chelation does not outperform statins for heart disease. Science-Based Medicine Blog, Dec 8, 2015]
The People's Pharmacy Web site is maintained by Joe Graedon, who has a masters degree in pharmacology, and his wife Terry, who has a Ph.D. in anthropology. They co-host a radio talk show; have produced many books that advise consumers about drugs, herbs, dietary supplements, and other home remedies; and have, for more than 35 years, produced newspaper columns distributed by King Features Syndicate. Much of their advice is standard, but they habitually publish anecdotes and encourage self-experimentation based on flimsy evidence.
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