Drug Researchers Admit Failure to Disclose Ties to Industry

A controversial May study of the dangers of certain rheumatoid-arthritis treatments has returned to the news in full force this week, thanks to two letters published in the November 8 issue of the Journal of the American Medical Association (JAMA). Most notably, one of the study’s authors, Dr. Eric Matteson of the Mayo Clinic, wrote a letter of apology to the JAMA, admitting that he neglected to inform the journal of the study’s connections to the pharmaceutical industry. In the second letter, however, Matteson and colleagues claimed that the original study overstated the risks associated with these drugs, known as TNF blockers.

In the apology letter, Matteson and colleague Tim Bongartz wrote: “We acknowledge that the disclosure statement initially prepared at the time of the original submission of our article to JAMA in May 2005 was incomplete and required correction.”

“We further acknowledge that there were 4 opportunities for the disclosure to be made correctly during the several iterations of the manuscript as it went through the review process. We apologize to the readers and the editors of JAMA for the error.

“The manuscript was reviewed, per written agreement, by representatives of Abbott [Laboratories]…”

Abbott’s Humira was one of the drugs included in the study. Also noted in the letter was the fact that Dr. Bongartz received a $25,000 education fellowship from Amgen, who markets Enbrel, or etanercept, a third type of TNF blocker not explicitly covered in the study–although no connection was made between the grant and the study in question.

In the same issue of the JAMA, the authors published a second letter, this one stating that the risks associated with anti-TNF antibodies, while still high, were not as elevated as the May study first assessed. After re-analyzing the original data and adding new data to the equation, the authors said the risk of cancer for those taking infliximab (generic for Remicade) and adalimumab (generic for Humira) was 2.4 times greater and the risk of serious infection 1.8 times greater. The original May 17 study put those figures at 3.3 and 2.0, respectively.

Roughly 2 million people in the United States are afflicted with rheumatoid arthritis, and estimates say the market for treatment of the ailment may reach $11 billion over the next decade.

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