Consumer Health Digest #11-01
Your Weekly Update of News and Reviews
January 6, 2011
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.
Wakefield paper declared fraudulent. The British Medical Journal (BMJ) has accused Dr. Andrew Wakefield of fraud. In 1998, The Lancet published a paper—spearheaded by Wakefield—which suggested that the measles-mumps-rubella (MMR) vaccine might be linked to autism. The paper didn't declare that cause-and-effect had been demonstrated, but at the press conference announcing its publication, Wakefield attacked the triple vaccine; and he has continued to do so ever since. Last year, The Lancet retracted Wakefield's paper and the British Medical Council concluded that Wakefield acted dishonestly and irresponsibly and struck him from its register (the equivalent of license revocation in the United States).
The BMJ plans to publish three articles by Brian Deer, the investigative reporter who uncovered Wakefield's misconduct. In an accompanying blog, Deer summarized his findings this way:
The British Medical Journal has begun a series that will bare the MMR scandal in detail never published before. Drawing on interviews, documents, and properly obtained data collected during seven years of inquiries, we show how one man, former gastroenterology researcher Andrew Wakefield, was able to manufacture the appearance of a purported medical syndrome, whilst not only in receipt of large sums of money, but also scheming businesses that promised him more. His was a fraud, moreover, of more than academic vanity. It unleashed fear, parental guilt, costly government intervention, and outbreaks of infectious disease. [Deer B. Piltdown medicine: The missing link between MMR and autism. BMJ Group Blogs, Jan 6, 2011]
The first of Deer's three articles details how he examined the medical records and interviewed the parents of the 12 children used in Wakefield's study and found that all of the cases reported in the 1998 Lancet paper were misrepresented. [Deer B. How the case against the MMR vaccine was fixed. BMJ 342:c5347, 2011] In an accompanying editorial, three of the BMJ's top editors wrote:
The Lancet paper has of course been retracted, but for far narrower misconduct than is now apparent. The retraction statement cites the GMC's findings that the patients were not consecutively referred and the study did not have ethical approval, leaving the door open for those who want to continue to believe that the science, flawed though it always was, still stands. We hope that declaring the paper a fraud will close that door for good. [Godlee F and others. Wakefield's article linking MMR vaccine and autism was fraudulent: Clear evidence of falsification should now close the door on this damaging vaccine scare. BMJ 342:c7452, 2011]
DAN! doc threatened with debarment. The FDA has asked Amy K. Holmes, M.D. to show cause why she should not be disqualified as a clinical investigator. Referring to a clinical trial in which she was repeatedly inspected, the agency stated:
Based on our evaluation of information obtained by the Agency, we believe that you have repeatedly or deliberately submitted false information to the sponsor or FDA in required reports, and repeatedly or deliberately violated regulations governing the proper conduct of clinical studies involving investigational products.
The name of the trial is redacted, but it appears to have been a study of an antibiotic for severe skin infections. The company overseeing the research appears to have been Gulf Coast Associates of Baton Rouge, Louisiana. In 2008, laboratories directed by Holmes and by Gulf Coast Research's president David Deshotels had their CLIA certifications revoked for "condition level noncompliance." Holmes's lab (Stat Lab I, Inc.) lost its Medicare approval for at least two years, and Gulf Coast's lab lost both Medicare and Medicaid approval.
Holmes, who appears to have retired from active practice, is one of a small network of doctors who claim that autism is is caused by heavy metal toxicity and should be treated by chelation therapy and other "biomedical" approaches. This approach, referred to as the "DAN! protocol," has no legitimate scientific support.
Dannon Company settles FTC charges. The Dannon Company, Inc. has agreed to stop making unsubstantiated claims about its Activia yogurt and DanActive dairy drink, which contain potentially beneficial bacteria known as probiotics. [Dannon agrees to drop exaggerated health claims for Activia yogurt and DanActive dairy drink. FTC news release, Dec 15, 2010] Under the settlement:
- Dannon is prohibited from claiming that any yogurt, dairy drink, or probiotic food or drink reduces the likelihood of getting a cold or the flu, unless the claim is approved by the FDA.
- Dannon may not claim that any other yogurt, dairy drink, or probiotic food or drink will relieve temporary irregularity or help with slow intestinal transit time unless the claim is substantiated by at least two well-designed human clinical studies.
- Dannon may not make any other claims about health benefits, performance, or efficacy of any yogurt, dairy drink, or probiotic food or drink, unless the claims are true and backed by competent and reliable scientific evidence.
The FTC worked in close coordination with 39 state attorneys general, who are simultaneously announcing the resolution of their own inquiries into Dannon's advertising of DanActive and Activia. Dannon has agreed to pay the states $21 million to resolve these investigations. Dannon has also settled a class-action suit by agreeing to create a $35 million fund to reimburse consumers for up to $100 for products purchased.
This page was revised on January 7, 2011.