Last week, just one week before the opening of Michael Moores new movie, Capitalism: A Love Story, the U.S. Food and Drug Administration (FDA) admitted what has been known for a while that its approval of the Menaflex device in December 2008, came after intense political pressure from politicians made just months after they received significant campaign contributions from the manufacturer of Menaflex.
In issuing its approval, the FDA overrode the agency’s scientific reviewers who repeatedly and unanimously over many years decided that the device was unsafe because the device often failed, forcing patients to get another operation. This was the first time that the agency publicly questioned the process behind one of its approvals, admitted that a regulatory decision was influenced by politics, and accused a former commissioner of questionable conduct. You have to know its really bad.
The FDA report described as extreme, unusual and persistent pressure from its own former commissioner, Dr. Andrew C. von Eschenbach, and from four Democrats New Jersey Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman – all four of whom made their inquiries within a few months of receiving significant campaign contributions from Menaflexs manufacturer, ReGen, which is based in New Jersey. In a display of chutzpah, we’ve come to expect from politicians, they all said they had acted appropriately and were not influenced by the money. Menaflex is a C-shaped pad used to repair a torn or damaged meniscus, the cushion between knee bones. A clinical trial of the device failed to show that it worked any better than routine surgery. Political lobbying has run so amok that the public health is being sacrificed. This problem cuts across party lines.
A November, 2007 review of internal U.S. Consumer Product Safety Commission (CPSC) documents by The Washington Post reveals that since 2002 Chairman Nancy Nord, as well as her predecessor, Hal Stratton, have enjoyed nearly 30 trips totaling nearly $60,000.00 that was paid for in full or in part by trade associations or manufacturers of products ranging from space heaters to disinfectants. The destinations included China, Hong Kong, Barcelona, Spain, San Francisco, New Orleans and a golf resort on Hilton Head Island, South Carolina. It came as no surprise that Chairman Nord opposed a Senate bill that would increase the budget and authority of the CPSC to regulate consumer products such as children’s toys.
The FDA cleared the Menaflex device formerly known as the Collagen Scaffold (CS) under the 510(k) premarket notification process, which permits manufacturers to market devices that are established to be substantially equivalent to previously-cleared devices (known as predicate devices) without first undergoing rigorous testing. The FDA’s report called for an independent review of that process because of predicate creep in which devices are approved based on information from older devices that often bear little resemblance to each other.
The FDA’s announcement contained some startling and blunt language. The FDA said that there was a clear deviation from principles of integrity in that important decision-makers failed to sufficiently explain and document the basis for their decisions in an administrative record. The integrity of the process was also damaged, stated the FDA, by the agency’s failure to respond appropriately to external pressure on decision-makers, the exclusion of individuals, if not viewpoints, from parts of the scientific debate, and excessive reliance on advisory panel deliberations in reaching the final decision to clear the CS device for marketing.