An editorial in a leading medical journal is calling for all scientific publications to enact reform measures, citing troubling behavior by GlaxoSmithKline and scientists on its payroll in studies the drug maker sponsored attempting to downplay the risk of health problems from Avandia, which was a top-selling diabetes drug at the time.
In a blistering editorial, writers for the Journal of the American Medical Association (JAMA), lambasted GlaxoSmithKline’s activities in research over potential side effects of Avandia, which some say are responsible for tens of thousands of heart attacks and deaths. The authors are calling for new, stringent, medical and scientific journal reforms that would ensure integrity and minimize the ability of corporations to obfuscate scientific data.
As an example, the authors, Drs. Catherine DeAngelis and Phil Fontanarosa, cite GlaxoSmithKline’s RECORD trial, which was purported to study the heart attack problems with the Avandia. The editorial calls Glaxo’s RECORD trial “a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial of [Avandia] and reveals a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.”
DeAngelis and Fontanarosa went on to say that “[a]nalyzing this situation and others involving misleading reporting and possible misrepresentation of industry-sponsored research has become only too common, and it appears that physicians functioning at several levels failed to put the well-being of patients first.”
The harshly worded editorial follows revelations resulting from an investigation by the Mayo Clinic that found an alarming number scientists and medical experts, who supported Avandia after it was linked to an increased risk of heart attacks, had undeclared financial ties to GlaxoSmithKline. The Mayo Clinic study found that 87% of scientists who downplayed Avandia side effects had links to the drug maker, and about a quarter of them failed to declare the potential conflict of interest.
Avandia (rosiglitazone) was approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of potentially life-threatening side effects. GlaxoSmithKline currently faces several thousand lawsuits over Avandia filed by users who allege that serious injuries were caused by the drug makers failure to adequately research their medication or warn about the risk of problems.
Among a host of industry-wide reforms proposed by the JAMA editorial, the authors are calling for medical journals to require an independent statistical analysis of all corporate-sponsored studies before the articles are published. They also say that academic researchers should have full access to all clinical data.
Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack.
Avandia was placed back under the spotlight last month by a U.S. Senate report that blasted GlaxoSmithKline for allegedly trying to cover up Avandia heart attack risks by deceiving the FDA and pressuring scientists to support the drug. The report revealed that some drug reviewers in FDA have been calling for an Avandia recall since 2007.