Politics often supersedes medical science as the determining factor behind the Food and Drug Administration’s granting or denying of approval of prescription drugs. This is the result of a long-term trend that has come sharply into focus with the FDA’s handling of the diabetes drug Avandia.
Three years ago, a political and public relations campaign began to drive Avandia from the market. It was not prompted by the findings of any particular clinical trial but on the “meta-analysis” of many small, short-term trials. The method of such analysis was to selectively isolate data from these trials and combine apples and oranges developed under varying criteria and controls to form a “meta-conclusion” not reached by the scientists who conducted any of the actual trials. Anyone can now replace lengthy and expensive clinical trials with a Web browser, a pocket calculator and a press conference to announce their conclusions.
This “research” was not rushed to the FDA to alert physicians. Instead it was given to the majority staff of the House Committee on Oversight and Government Reform for the purpose of “discussing pending legislation.” The chairman of that committee immediately issued a press release evaluating the meta-analysis and calling it “a case study of the need for reform of the nation’s drug safety laws.”
Was this press release based on then-Chairman Henry Waxman’s vast clinical experience? Or was his press release itself a case study of how to distort, manipulate and manufacture research data to support a political agenda?
The study was later given to a prestigious medical journal for publication.
That was delayed so the publication could first write an editorial using the study in pursuit of its political agenda — hostility toward firms developing new pharmaceuticals.
About the time the study was finally sent to the FDA, a national publicity campaign included the author of the analysis proclaiming, on ABC news and other media, that “the deaths caused by Avandia could dwarf the carnage of September 11, 2001.” So much for professional, dispassionate clinical analysis — which is not very effective in frightening the general public or encouraging litigation.
In spite of this aggressive public relations campaign, in 2007 the Endocrinology and Metabolic Drug Safety and Risk Management Advisory Committees of the FDA found (by a large majority) no reason to remove the drug from the market. One of the testifying FDA department heads urged that Avandia be removed immediately because it had not been proven to reduce heart attacks. He expressed no concern for the millions of patients benefiting from the drug’s ability to prevent kidney failure, amputation of extremities and loss of vision.
This year the ritual was repeated with more dubious analysis of clinical trials by people who did not conduct them. This time the campaign was first taken to the staff of the Senate Finance Committee, who faithfully reported to their chairman and ranking member what they wanted to hear. The public, on this occasion, was treated to the mature medical and clinical judgment of Senator Grassley on national network television.
The FDA Advisory Committee once again refused to recommend withdrawal of the drug, in favor of more cautionary labeling.
However, a major influence had come into play since 2007: political appointments by President Obama to the highest levels of the FDA, which overruled the recommendations of the physicians on the Advisory Committee.
After use of Avandia for years by millions of patients, objective evaluation of its long-term effectiveness and safety has been taken out of the hands of physicians. Instead we must rely on the verdict of politicians.
Medical decisions by agents of government, like the FDA, inevitably and necessarily become political decisions. We cannot remove the politicians from these decisions without first removing the FDA.