www.wesjones.com/specter2.htm
Michael Specter** The Bush Administration's war on the laboratory. On December 1st, Merck & Company applied to the Food and Drug Administration for a license to sell a vaccine that it has developed to protect women against the human papilloma virus. HPV is the most common sexually transmitted disease in the United States; more than half of all Americans become infected at some point in their lives. The virus is also the primary cause of cervical cancer, which kills nearly five thousand American women every year and hundreds of thousands more in the developing world. There are at least a hundred strains of HPV, but just two are responsible for most of the cancer. Two others cause genital warts, which afflict millions of people. Merck's vaccine, designed to protect against those four strains, has been tested in thirteen countries, including the United States. More than twelve thousand women between the ages of sixteen and twenty-six were monitored for an average of two years. The results were conclusive: twenty-one of the women who received a placebo during the trial developed the cellular abnormalities that are associated with cancer and other illnesses. Another vaccine, which is being developed by GlaxoSmithKline, promises to be just as effective. Even in the age of molecular medicine, such unqualified successes are rare. "This is a cancer vaccine, and an immensely effective one," the Nobel laureate David Baltimore, who has served for the past eight years as president of the California Institute of Technology, told me. It has the potential to save hundreds of thousands of lives every year." The vaccine is now under review by the FDA and could be approved for use in the United States by June; what happens after that will depend largely on the Bush Administration's Advisory Committee on Immunization Practices. The committee's recommendations are not binding, but most states rely on them in determining which vaccines a child must receive in order to attend public school. To prevent infection with HPV, and to minimize the risk of cervical cancer, girls would need inoculations before becoming sexually active. The average age of first intercourse in America is under seventeen; to insure the broadest possible coverage, the vaccines would have to be administered much earlier. Vaccinations for contagious diseases like measles and mumps are required before a child can enter public school. The Bush Administration, its allies on Capitol Hill, and the religious base of the Republican Party are opposed to mandatory HPV vaccinations. They prefer to rely on education programs that promote abstinence from sexual activity, and see the HPV vaccine as a threat to that policy. For years, conservatives have regarded the human papilloma virus as a kind of index of promiscuity. Many abstinence supporters argue that eliminating the threat of infection would only encourage teenagers to have sex. "I personally object to vaccinating children when they don't need vaccinations, particularly against a disease that is one hundred per cent preventable with proper sexual behavior," Leslee J Unruh, the founder and president of the Abstinence Clearinghouse, said. Let's not encourage it by vaccinating ten-year-olds so they think they're safe." Senator Tom Coburn, Republican of Oklahoma, a family physician and a prominent leader among those who believe that abortion should be illegal, has argued repeatedly in Congress that since condoms can fail, the nation should stop relying on them so heavily. In 2004, he made his position clear when he testified about his experience treating patients who have been infected with HPV: "Studies have indicated for years that promiscuity was associated with cervical cancer." Bush Administration health officials decline to discuss the vaccine while it is under consideration by the FDA "I can't talk about that," Andrew Von Eschenbach said when I visited him at the National Cancer Institute, which he runs. I had asked to speak to Von Eschenbach in his capacity as the acting commissioner of the Food and Drug Administration, a post that he has held since last fall, when his predecessor resigned suddenly. Von Eschenbach, a urological oncologist, is a friend of President Bush's from Texas, and spent twenty-five years at the University of Texas's M D Anderson Cancer Center. He is the first person in American history to oversee both an enormous federal bureaucracy that is responsible for discovering drugs and another, even larger agency that must approve those drugs. Despite the official silence, the Bush Administration has been relentless in its opposition to any drug, vaccine, or initiative that could be interpreted as lessening the risks associated with premarital sex. It has made every effort to diminish the use of condoms as a method of birth control in the United States and throughout the world. Government policy requires that one-third of HIV-prevention spending go to "abstinence until marriage" programs. Since George W Bush became President, the United States has spent hundreds of millions of dollars on abstinence programs, and it has cut almost that much in aid to groups that support abortion and the use of condoms as a primary method of birth control. Several years ago, the Centers for Disease Control removed a fact sheet about condoms from its Web site; the sheet disappeared for more than a year, and, when it was replaced, instructions on how to use condoms had been supplanted by a message denigrating them. The CDC also removed a summary of studies that showed there was no increase in sexual activity among teenagers who had been taught about condoms. "They were the most horrific examples of manipulating science I have ever seen," a former senior official at the CDC told me. "Abstinence is the only thing that matters to this crowd. They have even brought people to Washington from Atlanta"--where the CDC is based--"just to lecture about the value of teaching abstinence. He asked not to be identified because he is dependent upon receiving government funds in his current job. Nearly every group across the political spectrum supports abstinence as a first line of defense against sexually transmitted diseases as well as against unwanted pregnancies. In one recent study, researchers at Columbia and Yale found that though virginity "pledge" programs helped many participants to delay sex, eighty-eight per cent of those who took such pledges and had sex before the end of the study did so before marriage. When it came to preventing sexually transmitted diseases, students in the programs fared no better than those in the control group. The study also found that students who promised to remain virgins were less likely to use contraception when they did have sex, and they were less likely to seek STD testing. Two years ago, in one of the most contentious decisions in the history of the FDA, the agency rejected an application by Barr Pharmaceuticals to make the emergency contraceptive Plan B--commonly referred to as the morning-after pill--available over the counter, after the members of its scientific advisory committee voted, twenty-three to four, in favor of permitting the switch. Agency officials said that they did not have enough information about how easier availability of the drug would affect adolescent girls. Last year, the FDA again refused to approve the application, even after the company altered its proposal to address those concerns. The agency had never rejected a similar request against the advice of its scientific advisers and its own staff. "This just came from nowhere, and it was clearly not a decision that was made on behalf of women or families," Susan F Wood told me. Wood, who was the director of the agency's Office of Women's Health at the time, quit in protest. "I felt there was no role--not just for me but for the people who have expertise. But this time I just couldn't look in the mirror and live with myself." She was not the only scientist who felt that way: Frank Davidoff, the editor emeritus of the Annals of Internal Medicine, resigned as a consultant to one of the committees that voted to approve over-the-counter use of P...
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