News Nature 438, 401 (24 November 2005) | doi:10.1038/438401a US watchdog finds bias against morning-after pill
Meredith Wadman, Washington DC Drug agency accused of mixing politics with science. A US government watchdog has announced that there was a high-level effort within the US Food and Drug Administration (FDA) to overrule agency scientists and block over-the-counter access to an emergency contraceptive. Many critics suspected as much when over-the-counter access to Plan B (levonorgestrel) was denied in 2004 despite the recommendations of agency scientists and outside experts. But a government report issued on 14 November has now reached the same conclusion. The Government Accountability Office (GAO), the investigative arm of Congress, says the effort was led by the then commissioner of the FDA, Mark McClellan, and note that McClellan's involvement along with his high-level colleagues in what is normally a staff decision was "unusual". Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, told Nature that in 20 years of watching and advising the FDA, "I've never seen this level of high-up administrative intervention into the scientific review process. The science indisputably supports approval, but the politics didn't. I think the higher-ups including the then commissioner put the politics first." Plan B works by preventing fertilization or implantation if it is taken within 72 hours of intercourse. Conservatives adamantly opposed making the contraceptive accessible without a prescription, fearing it would increase teenage promiscuity. In 2003 an FDA advisory committee of external experts voted 23–4 to make Plan B available over-the-counter, a change backed by staff reviewers at the agency. But the GAO reports that McClellan repeatedly resisted approval of the move, because of concerns about its use by younger teenagers, despite data showing that the safety issues were no different for younger women. In May 2004, two months after McClellan had been replaced by acting commissioner Lester Crawford, the change was rejected. The manufacturer of Plan B, Barr Laboratories, was encouraged to resubmit an application to make Plan B available to women over 16. But this August the agency indefinitely postponed the decision on that application (see Nature 437, 179; 2005). The FDA responded to the GAO report saying it "mischaracterizes facts... We question the integrity of the investigative process." Gary Karr, spokesman for McClellan also insists that the former FDA chief "neither made a decision nor did he recommend a decision" on Plan B. Susan Wood, a former assistant FDA commissioner who quit in September in protest over the FDA's handling of Plan B, said in a statement: "This report is a sad reminder of why I felt compelled to resign — that the FDA leadership is ignoring its process and not relying on science and medical evidence." The Bush administration has been under increasing fire for politicizing scientific decisions on matters from global warming to the reliability of condoms. Last week, attention also focused on upcoming recommendations for vaccination against cervical cancer. A vaccine has been shown to be effective in preventing the cancer, which is caused by the sexually transmitted human papilloma virus. Conservative groups argue that widespread vaccination will encourage sexual promiscuity among young people. In an effort to pre-empt these groups' influence on the upcoming vaccination policy, Senator Hillary Clinton (Democrat, New York), who also spoke out against the FDA's treatment of Plan B, wrote last week to Mike Leavitt, the Health and Human Services secretary. The Bush administration, Clinton said in the letter, "has repeatedly allowed ideology, not science, to form the basis of policy... We do not want to see another instance of ideology trumping the health and well-being of the American people." -- www.e-laser.org Laser@inventati.org
