New York Times Examines Opposition To Proposed Off-Label Promotion Guidelines Amid Allegations Of 'Ghostwriting'

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Apr 2008 - 6:00 PDT

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The New York Times on Saturday examined how a recent report indicating that Merck used "ghostwriters" to produce medical journal articles in support of the COX-2 inhibitor Vioxx "has galvanized opponents to a federal proposal that would relax some restrictions on drug promotion" in the U.S. According to the Times, new guidelines proposed by FDA would allow drug companies to use reprints of journal articles to promote drugs for so-called "off-label" uses that the agency has not approved. Under the guidelines, the articles must have been published in peer-reviewed medical journals. However, the Vioxx report, published in Wednesday's Journal of the American Medical Association, has "raised new questions about the validity of many published research studies, even in peer-reviewed publications," the Times reports.

The pharmaceutical industry supports FDA's proposed guidelines, according to the Times. A working group of 10 major pharmaceutical companies at a news briefing on Wednesday said that off-label uses of drugs and medical devices are necessary because researchers find possible new uses for the products before FDA can review them.

Opposition to the guidelines has "come from a diverse group that includes Public Citizen, New York state's health commissioner and the Blue Cross Blue Shield Association," the Times reports. BCBSA vice president Allan Korn sent a letter to FDA on March 21 warning that ghostwritten articles could be used to bolster off-label uses of drugs. New York Health Commissioner Richard Daines sent a letter to FDA on April 8 expressing concerns about possible industry manipulation of peer-reviewed journals. Daines said the disclosure about Merck "points out the potential weakness" in the FDA proposal.

Merck has denied that the physicians named as authors of the Vioxx studies did not play an integral role in writing the articles (Saul, New York Times, 4/19).

Editorial, Op-ed Address 'Ghostwriter' Issue

• Baltimore Sun: While physicians "are expected to have nothing but their patients' best interests at heart as they dispense treatment and advice," the "symbiotic relationships that have developed between doctors and drug makers present conflicts that can no longer be ignored," a Sun editorial states. According to the Sun, "For too long, a cozy relationship has existed between the medical profession and various industries whose interest in promoting health is, by definition, secondary to their interest in selling products." Medical researchers "so often accept industry funding to perform research, do consulting, attend meetings and sit on corporate boards that few eyebrows are raised at the inherent conflict of interest in such a state of affairs," the editorial states. The Sun writes that "a small number of prominent doctors now say they will no longer accept corporate funding of any kind," adding, "We hope this ripple turns into a tidal wave." According to the Sun, the "Merck controversy may end up being just what the doctor ordered to end this insidious practice" (Baltimore Sun, 4/20).
  
  
• Melody Petersen, Chicago Tribune: The issue concerning Merck "is hardly an isolated case," because "ghostwriting of scientific articles is not a fraud perpetrated by a rogue company," but "one of the pharmaceutical industry's standard marketing tactics for more than two decades," Petersen, an author and former New York Times reporter, writes in a Tribune opinion piece. According to Petersen, "The public rarely discovers how these articles have been created because secrecy is required for the highest impact." She adds, "The ghostwriters work hard to stay in the shadows and not raise suspicions that the articles are anything other than the words and thoughts of academic physicians." Petersen writes, "Despite protests that ghostwriting is deceitful and dangerous, it has continued because it benefits all those involved," adding that the "academics enjoy a source of easy money to supplement their university salaries," the "writers make a great living" and the "marketing firms rake in millions," while the "drug companies can sell billions worth of ... a potentially deadly drug." Petersen concludes, "Everyone wins but those who matter most: patients" (Petersen, Chicago Tribune, 4/21).

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