Experts are worried over the unfettered sale of hormone replacement products claiming to be safe and natural alternatives to the ones prescribed by doctors and tagged with the warnings of breast cancer, ovarian cancer and the like.
In 2005, officials of the Federal Trade Commission (FTC), had found around 34 websites guilty of violating FTC rules against the sale of such products without evidence of claims and as well as federal permission. According to them, it is illegal for such producers to assert that their hormone products prevent or treat cancer, heart disease, osteoporosis or other health problems.
AdvertisementOf late, FTC investigations have revealed that 19 of those sites are still selling the ''natural'' hormone creams and sprays by citing unsupported claims for the products' benefits.
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.
According to Eileen Harrington, deputy director of the FTC's bureau of consumer protection, many of the other websites reviewed have modified or removed the objectionable claims. She says 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 was quoted.
The committee's top Republican, Sen. Gordon Smith held a 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 also warned some websites that are selling hormone products, according to Dr. Steven Galson, the agency's drug chief.
Commenting on an advertising material from a site claiming that its progesterone cream increases bone mass density, prevents osteoporosis and decreases the risk of breast cancer, Dr. Jacques Rossouw, chief of the Women's Health Initiative branch in the National Institutes of Health's national heart, lung and blood institute was quoted: 'There are no studies that would support such a claim.'
The 2002 findings against HRT products 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,' says FDA's Galson.
'Our position is these pharmacies are taking advantage of women, preying on their fears of menopause.'
In response, Lloyd Allen, executive director of the International Academy of Compounding Pharmacists, has come out with the statement that compounding meets the needs of patients when off-the-shelf prescription drugs do not.
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