Posted by: Salvatore J. Zambri, founding member and partner
Have drug companies become too close to the organization that is supposed to regulate them?
According to a recent article in the Washington Post, this question may have legitimacy as the recent discovery that drug companies paid as much as $25,000 to attend the panel-meetings to become part of "an essential collaborative effort" between the Food and Drug Administration and major pharmaceutical companies. The stated goal of the panel meetings was to publish "consensus" statements on scientific matters related to testing drugs. Members of the panels included FDA and NIH officials, academics, and pharmaceutical company representatives (the only ones who paid fees to attend).
Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington organized the group IMMPACT, and they were paid as much as $50,000 per meeting. A goal of the group was to "design clinical trials that would eliminate the benefits of new drugs that might be missed in standard test, avoiding ‘false negatives.’ " According to Mr. Dworkin, “Everybody has been very happy with [the meetings] and they are getting a huge amount for very little money (impact on FDA thinking, exposure to FDA thinking, exposure to academic opinion leaders and their expertise, journal article authorship, etc.) and they know it.”
A critic of the meetings from the NIH suggested more openness for the IMMPACT meetings to "avoid the stigma that this initiative is a ‘pay to play’ process."
Whether there was undue influence by the drug companies on the FDA decisions may not ever become known. However, the secrecy of the meetings indicates a definite need for transparency among government agencies and the businesses they are intended to regulate.
About the author:
Mr. Zambri is a board-certified civil trial attorney by the National Board of Trial Advocates and a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association recently named him "Trial Lawyer of the Year" (2011). He has been rated by Washingtonian magazine as a "Big Gun" and among the "top 100" lawyers (out of more than 80,000 attorneys) in the entire metropolitan area. The magazine also describes him as "one of Washington’s best–most honest and effective lawyers" who specializes in personal injury matters, including automobile accident claims, premises liability, product liability, medical malpractice, and work-accident claims. He has successfully litigated multiple cases against truck and bus companies, the Washington Metropolitan Area transit Authority, and other automobile owners. His law firm, in fact, has obtained the largest settlement ever in a personal injury case involving WMATA. Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2014 edition) and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2013)– national publications that honor the top lawyers in America.