By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, February 12, 2008
Stung by a crackdown on unproven claims about the safety and effectiveness of medications made by pharmacies to treat menopause, supporters of the drugs have launched a lobbying campaign aimed at the Food and Drug Administration.
Last week the HOME (Hands Off My Estrogens!) Coalition, a group based in tiny Edinburg, Va., placed a full-page ad in five newspapers, including USA Today and the Wall Street Journal, accusing regulators of being hostile to "natural" hormonal medicines made according to a doctor's prescription by a compounding pharmacy.
The ads urge women and their physicians to e-mail the White House and members of Congress asking them to protect patients' access to medications they claim are "bio-identical" to those found in the body. A key ingredient in these made-to-order drugs is estriol, a form of estrogen that the coalition claims is safe and protects against breast cancer -- but that the FDA says is unapproved.
Compounded drugs for menopause have become increasingly popular since 2002, when a landmark federal study linked conventional replacement hormones in women over 50 to an increased risk of cancer, stroke, heart attack and dementia -- diseases they were thought to prevent. Some manufacturers of compounded hormones, often prescribed by doctors who specialize in alternative or anti-aging medicine, have made similar unsubstantiated claims, according to the FDA.
On Jan. 7 the FDA sent letters to seven pharmacies across the country warning them that marketing claims about the safety and effectiveness of their products were "false and misleading" because they have never been proven. The agency also ordered the pharmacies to stop making products containing estriol. Mainstream physicians groups, including the Endocrine Society, applauded the enforcement action, as did the National Women's Health Network, a Washington-based advocacy group.
Steven Silverman, assistant director of the FDA's Center for Drug Evaluation and Research, criticized the coalition's assertions and said the FDA has heard from some women unhappy with the agency's action.
"There is no credible science to back the claim that compounded hormones are biologically identical to the hormones produced by the body," Silverman said in a statement. "This kind of unreliable information may mislead women and their health-care providers." The term "bio-identical," the FDA has said, is a marketing term, not a scientific one.
Jonathan V. Wright, a Seattle physician whose name appears on the ad, said drugs made by compounding pharmacies are "a heck of a lot safer than approved drugs."
Wright has had a long, adversarial relationship with the FDA, which in 1991 seized bottles of a banned supplement from a clinic and pharmacy with which he is affiliated.
"A woman should be able to take care of her own health in any way she and her doctor see fit," he said. Since 1983, Wright added, he has prescribed estriol-containing products to more than 2,000 women with no ill effects. "This is a safe hormone produced by the human body."
But women's health advocates and even some alternative medicine proponents caution that "natural" is not synonymous with "safe." After all, they note, arsenic and cyanide are "natural."
"Women need to ask the same questions about these drugs as they do about conventional hormones: What is the evidence of safety and efficacy?" said Amy Allina, program director of the women's health network. The ad, Allina said, is "so full of inaccuracies it's hard to know where to begin." The FDA, she notes, did not take action against all compounded hormone products, as the ad implies.
Compounding pharmacies, Allina added, are not required to meet the same manufacturing and purity standards as are drugmakers.
Adriane Fugh-Berman, an associate professor of physiology and biophysics at Georgetown Univeristy and an expert in alternative medicine, echoes Allina.
Estriol by itself, she said, has been shown to increase the risk of endometrial cancer. And excessive doses of hormones can cause harm, including cancers. Fugh-Berman said the ad misrepresents the conclusion of a Department of Defense study: The coalition says that the study demonstrates a reduction in breast cancer cases and high estriol levels. "Just because our bodies make the hormones doesn't mean that higher levels are beneficial," she said.
Wright said he had no role in paying for the ad. He said he agreed to lend his name in response to a request by the coalition, which he said is composed of concerned alternative medicine practitioners and their patients.
Stephanie Bosserman said the coalition is an offshoot of the Reproduction Research Institute, of which she is the director. She described the Virginia-based institute as a nonprofit carrying out research into contraceptive technology.
Bosserman said she did not know the cost of the ads, which also appeared in Roll Call, the New York Times and the Seattle Times. ¿