This comes from the Hearing of the Reproductive Health Drugs Advisory Committee held on Monday, October 18, 1999 - Afternoon session, in Gaithersburg, Maryland.

The goal of this hearing was to review for public comment 
(1) the non-contraceptive labeling for estrogen drugs since last reviewed in 1992, 
(2) review study protocol for recommended uses 
(3) review study protocol for uterine protection when using estrogen drug products.

The discussion of this panel of "experts" is chilling and should be a must-read for anyone who still "trusts" their doctor to know about these drugs. If this is what "experts" know about these drugs, and menopause, it is time to flush them all (including the "experts") down the toilet, but only if you know the excrement will not harm the oceans or ground water. Incineration may be better.

The problem which got the most "public" response was the inadvertent omission of "osteoporosis" as a recommended use in the patient information. This brought out all the big guns, for some pretty surprising reasons, none of which were related to proof that estrogen has any efficacy for this condition. They all agreed that there was no proof, but
they claimed that including "osteoporosis" as a recommended use, would offer the doctors the opportunity to discuss estrogen drugs with their patients. They did not want to lose this marketing tool.

"For years clinicians have utilized the information on the importance of estrogens on bone to counsel their patients on the prevention and treatment of osteoporosis. This opportunity may be compromised if the suggested changes (the inadvertent deletion of this reference in the patient information) to the labeling guidelines are approved."

"The use of estrogen replacement therapy has become an important part of the practice of many of our members." (From the National Osteoporosis Society - an industry fronted group)

"Given the millions of baby-boomers entering the mid-life, the prevention of post-menopausal osteoporosis, and its associated fractures, is extremely important in reducing health care costs and elder disability."

..."physicians must be able to adequately counsel their patients on the benefits of estrogen, particularly for the prevention and management of post-menopausal osteoporosis."

"The 1999 draft guidelines has deleted this important information about the risks and management of osteoporosis, but this section is critical to the prescribing of non-contraceptive estrogens, and that's because it gives health-care providers accurate and relevant information about post-menopausal osteoporosis. This is information that they can use when counseling their patients."

He states all of the problems with what is known about estrogen and osteoporosis, but fails to rebut those problems. He merely goes on to make it sound as though estrogen "works" while at the same time admitting there is no proof that estrogen prevents fractures.

Lindsay admits studies show there is no difference in fracture rates between estrogen drug use and placebo studies. This he explains by saying it is too hard to study fractures, so that is why they can't prove the estrogen drugs do better than placebos.

Then he makes the sweeping statement that "the effects of estrogen are well known" and bases this on a 1940's study by Fuller, Albright that estrogens reduce bone turn-over and are active as long as they are given. He fails to mention those early studies used 2.0 mgs of estrogen a day and that all they measured was the bone density in the finger, using crude xrays. But let's not let petty facts get in the way of what is "well-known" about estrogen and bone.

He claims he was "naughty" in doctoring up one of his slides showing how various agents affect bone density and claims somewhat confusingly, --"that bone density changes that occur account for only some 25% of the reduction of vertebral fractures that one sees."

He concludes with today's winning argument....

"the idea that one would not have, in estrogen labeling, effects on osteoporosis, which affects, as you know, this huge number of post-menopausal women in particular, and would not be able ----that they would not be able to learn the benefits of the prevention of bone loss, and the reduction in bone turnover, and presumed fracture outcome from that, I believe would be detrimental for the health of the post-menopausal women."

Also this argument makes the claim that unless this information is on the estrogen drug label, doctors would be prevented from discussing osteoporosis with their patients.

In fact the only thing they would be prevented from doing is making any claim that osteoporosis was an acceptable use of estrogen drugs. Remember, all parties admit there is no proof estrogen drugs work for osteoporosis to justify its use. The FDA Medical Officers Reports admitted this in 1997. All studies presented by W/A to prove Premarin worked were rejected and the FDA Officer presenting at this hearing admits that osteoporosis, alone of all the recommended uses for estrogen drugs is without studies to prove it works.

And that is just the story on estrogen drugs and osteoporosis. It gets worse as the public hearing delves into other acceptable uses for estrogen drugs.

Joan