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Merck Vioxx Study Scandal Fans Opposition to Proposed FDA Rule Changes

Apr 21, 2008 | Parker Waichman LLP Last week's revelation that Merck Inc. manipulated two Vioxx studies in order to downplay death rates has prompted more criticism of a Food & Drug Administration (FDA) plan to loosen off-label marketing rules that drug makers must adhere to. If approved, the proposed FDA rule change would allow drug and medical device makers to provide doctors with copies of medical journal articles that discuss off-label uses of their products.  

Off-label use is the use of a drug or medical device for a purpose not approved by the FDA.  For example, gadolinium contrast dyes are often used off-label in MRA (Magnetic Resonance Angiography) procedures, even though such agents are only approved for use in MRI procedures.  Once a drug or medical device has been approved by the FDA, doctors are free to prescribe it as they see fit.  In fact, a 2006 study estimated that more than 20 percent of all prescriptions written by doctors were for unapproved uses. However, drug and medical device companies are prohibited from advertising off-label uses.  In 1997, Congress created a temporary exception to the off-label marketing rule by allowing drug makers and medical device companies to distribute reprints of peer-reviewed research from reputable medical journals that discussed off-label uses to physicians.  Drug makers and medical device manufacturers were able to do so long as they submitted the articles to the FDA for advance review and had formally asked the FDA to approve the new use described in the journal article.  That exception expired in 2006.

The FDA wants to renew the exception, with some very big changes.  Under the proposed rule, the agency would let drug and device companies pass out articles to doctors if the articles were peer-reviewed and came from a journal with an expert editorial board. The article must be accompanied by a prominent warning that the use described is not approved or cleared by the FDA.  However, the FDA wants to drop the requirement that drug and device makers must provide the studies to the FDA beforehand or promise to seek approval of the discussed use.   According to The New York Times, the FDA has justified this proposed loosening of the rules by claiming it never really enforced those requirements anyway.

The proposed change has raised the ire of many law makers and consumer advocates.  They point out that drug and medical device makers have long flouted the rules governing off-label marketing, often to the detriment of consumers.   Last week, Merck only added fuel to the fire, when two reports published in the Journal of the American Medical Association (JAMA) found that two Merck-funded studies investigating the benefits of Vioxx for Alzheimer's disease patients had actually down played death rates for people taking the now-recalled drug.  The reports also revealed that Merck also hired outside firms to write Vioxx studies, and then paid prominent researches to list their names as authors of the research.  The JAMA reports also indicated such practices were widespread within the pharmaceutical industry.

The Vioxx report has raised new questions about the validity of many published research studies, even in peer-reviewed publications.  The lead author of the JAMA article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in Manhattan, told The New York Times that his findings helped highlight flaws in the FDA. proposal’s reliance on peer-reviewed journals to provide the evidence supporting off-label drug use. “What does it mean to be peer-reviewed,” Dr. Ross said, “if the company has essentially conceived the article, composed the draft and written the paper?”

Groups including  Public Citizen, New York State’s health commissioner and the Blue Cross Blue Shield Association, a trade association of 39 major health insurance plans, also oppose the FDA's plans.  According to The New York Times, both the Blue Cross association’s vice president, Dr. Allan M. Korn, and New York State health commissioner, Dr. Richard F. Daines, have written the FDA, citing concerns of possible pharmaceutical industry manipulation of peer-reviewed journals and how those articles could be used to promote off-label uses.

In the past, drug makers have shown a willingness to flout off-label use rules.  For instance, Pfizer Inc. settled a case about the epilepsy drug Neurontin in 2004 for $430 million. In another high-profile case, Eli Lilly is said to be in negotiations with the Justice Department over illegal marketing of Zyprexa.  According to media reports, Eli Lilly could end up paying in excess of $1 billion to settle allegations it marketed Zyprexa for unapproved uses, including dementia, depression and autism.

The FDA has justified its off-label use proposal by claiming that the peer-review process used by major medical journals prevents drug companies from manipulating study data.  But last weeks Merck revelations blew a huge hole in that theory.  Whether or not the FDA will rethink its position remains to be seen.

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