For the first time, the U.S. Food and Drug Administration has publicly admitted that politics has trumped science. The agency acknowledged yesterday that it approved a device to help with knee-replacement surgeries—a device the agency’s own scientists said often failed—only after it received pressure from a cohort of Democratic congressmen from New Jersey, where the device’s manufacturer is located.
The $3000 device was known as the Menaflex, a “collagen scaffold” that supported a damaged meniscus in the knee. It failed its initial reviews but received approval in December of last year anyway, during the waning days of the Bush Administration. In a new report, FDA cited pressure from senators Robert Menendez and Frank R. Lautenberg and representatives Frank Pallone Jr. and Steven R. Rothman as a decisive factor in gaining approval: “The Director of FDA’s Office of Legislation described the pressure from the [Capitol] Hill as the most extreme he had seen and the agency’s acquiescence to the Company’s demands for access to the Commissioner and other officials in the Commissioner’s office as unprecedented in his experience.”
News reports point out that all four congresscritters received campaign contributions from the manufacturer.
FDA’s internal review found that, while the pressure from Congress was “not inappropriate,” it “contributed to a sense that the matter had become politicized.” Adding to that sense, then-FDA Commissioner von Eschenbach granted what investigators describe “unusual access” to the manufacturer (ReGen):
In addition to the almost daily conversations between the Integrity Officer and ReGen or ReGen’s consultants, ReGen had unusual access to the Commissioner and Principal Deputy Commissioner. The Commissioner granted the Company a 90-minute meeting while the Principal Deputy also met with ReGen to hear its claim of unfair treatment and to listen to ReGen’s case for substantial equivalence. Following their meeting, at the urging of a Company official, the Principal Deputy also spoke to an orthopedic surgeon characterized by the ReGen as independent. The unusual level of access fueled the view that Congressional pressure had been effective, which in turn contributed to the perception that the ReGen matter had become politicized.
Investigators further note that:
The Office of the Commissioner did not appear to have in place or to follow standard operating procedures (SOPs) for handling company inquiries and efforts to influence the review process. No rules or practices limiting the access of ReGen officials or its consultants to agency officials appear to have been observed. As a result, the Company and its political consultant had unusual and repeated access to agency officials at a time when the integrity of the decision-making process was at risk.
Commissioner von Eschenbach pushed through a hasty and politicized review process after the device was rejected. The panel’s recommendation to allow the device’s use was then given greater weight than other recommendations and analyses.
Let it be said that I think Rothman, Pallone, Lautenberg, and Menendez acted inappropriately. FDA should be allowed to operate independently of political pressure. However, ReGen’s owners and employees are constituents, and it is the job of elected officials to represent their constitutents. FDA’s job is to fend them off and protect the process. In that sense, the real failure was at FDA. I think the elected officials overstepped, but von Eschenbach erred in allowing political pressure to influence his decisions.
Whether this speaks to a culture in the Bush administration that allowed such abuses is a topic worth discussing. It is a problem that legal bribery exists, and that Congressmen are willing to sell out medical safety on behalf of campaign contributors. But that system is nothing new, while this bogus approval is far from normal. If the problem is the intersection of broken campaign finance laws and a broken system of scientific decision-making in the Bush administration, we need to be sure that both components are fixed.