Many Web sites have ignored federal warnings against making unfounded health claims in promoting hormone products to treat menopause, the government said Thursday.
In letters to 34 Web sites, the Federal Trade Commission said in November 2005 it may be illegal for them to assert that their hormone products prevent or treat cancer, heart disease, osteoporosis or other health problems. The sites billed the products as natural alternatives to hormone replacement therapy.
Yet 19 of those sites still are selling the “natural” hormone creams and sprays by citing unsupported claims for the products’ benefits, an FTC official told the Senate Special Committee on Aging.
Many of the other Web sites reviewed have modified or removed the objectionable claims, said Eileen Harrington, deputy director of the FTC’s bureau of consumer protection.
She said the agency is following up with the companies that did not make such changes.
“We could have moved faster here and we should have,” Harrington told Sen. Gordon Smith of Oregon. The committee’s top Republican, Smith was the lone lawmaker present for most of the hearing.
Smith held the hearing to spur action by the FTC and Food and Drug Administration, and increase federal oversight. At issue are hormones that are custom mixed or compounded by specialized pharmacies according to a doctor’s prescription.
“The FDA needs to step it up and so does the FTC,” Smith told reporters.
The FDA has warned some Web sites that are selling hormone products, according to Dr. Steven Galson, the agency’s drug chief.
No studies backup claims
Smith said his staff members recently bought a tub of progesterone cream from one of the 34 Web sites warned by the FTC in 2005. Advertising material from the site claims the cream increases bone mass density, prevents osteoporosis and decreases the risk of breast cancer.
“There are no studies that would support such a claim,” said Dr. Jacques Rossouw, chief of the Women’s Health Initiative branch in the National Institutes of Health’s national heart, lung and blood institute.
Five years ago, an initiative study found that replacement hormones made by drug companies raised the risk of heart attacks, breast cancer and strokes. Research published this week offered the strongest evidence yet that the hormones can raise the risk of breast cancer and are tied to a slightly higher risk of ovarian cancer.
The 2002 findings led millions of women to the estrogen, progesterone and testosterone products sold by compounding pharmacies, which often promote their custom-made alternatives as safer and more natural.
“Hormones are hormones are hormones. The same risks apply to compounded ones as apply to FDA-approved ones,” the FDA’s Galson told The Associated Press before testifying. “Our position is these pharmacies are taking advantage of women, preying on their fears of menopause.”
Loyd Allen, executive director of the International Academy of Compounding Pharmacists, said compounding meets the needs of patients when off-the-shelf prescription drugs do not.