Creative Commons for Hormone Therapy? Much of the current chat about HRT has focused on new, “customizable” forms of estrogen  known also as “bioidenticals,”  many
still subject both to new review by the FDA and to
intellectual-property disputes. (No, we didn’t know you could patent a
hormone either.) This week,two U.S. senators  weighed  in on the issue of one such derivative, estriol.

Newsmix had mostly heard of one such derivative,estriol because of new studies last year  conducted by the University of California’s Dr. Rhonda Voskuhl (pictured) that showed promise for women with multiple sclerosis, a chronic illness that
tends to abate during pregnancy. Since women comprise most of the
300,000 Americans living with MS,  we can only marvel at the elegance
of Voskuhl’s possible remedy for an illness that has a brew of implications for the body’s endocrine,
autoimmune and neurological systems. Its use for menopause has been more controversial, perhaps because it could involve millions more women:

S. Con. Res. 88 [is] a resolution stating that “the
Food and Drug Administration’s (FDA) new policy restricting women’s
access to medications containing estriol does not serve the public
interest” and calling on the FDA to “reverse its policy.”  The
resolution, introduced in the U.S. Senate by Senators John Cornyn
(R-Texas) and Jim Bunning (R-Ky.) follows the introduction of a similar
measure in the U.S. House of Representatives in early May, which has
gained 24 new cosponsors in the past two weeks.

Thirty-two members of the House total now co-sponsor H. Con. Res. 342.
“We applaud Sen. John Cornyn and Sen. Jim Bunning for their commitment to protecting
hundreds of thousands of women,” said IACP’s Executive Director L.D. King. “Women with
menopause suffer enough. Fortunately, this resolution aims to provide them with some relief.”

For decades, doctors have prescribed hormones containing estriol to women suffering from the
painful symptoms of menopause. IACP estimates that hundreds of thousands of women are
prescribed these drugs today. Unfortunately, in Oct. 2005, Wyeth Pharmaceuticals – maker of
proprietary hormones – petitioned the FDA to eliminate women’s access to hormones
containing an ingredient called estriol, one of three estrogens produced by the woman’s body and
a common component of individualized, bio-identical hormone treatments. In Jan. 2008, FDA
announced a policy that would do exactly that.

The response from patients, doctors and pharmacists has been overwhelming. Since Oct. 2005,
more than 70,000 patients, doctors and pharmacists have written to FDA opposing Wyeth’s
petition. Since Jan. 2008, more than 10,000 have written to FDA opposing the agency’s new
estriol policy. And since the first resolution was introduced in the House last month, more than
4,000 have written to Congress in strong support of the measure.

But the FDA is not taking the new resolution sitting down, instead going on a PR campaign against bioidenticals. From Channell 11 Houston:

“The FDA has not approved any drug containing estriol. The
safety and effectiveness of estriol are unknown. “No data have been
submitted to the FDA that demonstrate that estriol is safe and
effective,” according to Daniel Shames, M.D., a senior official in the
FDA office that oversees reproductive products.”

[And] “Unlike commercial drug manufacturers, pharmacies aren’t required to
report adverse events associated with compounded drugs,” says Steve
Silverman, Assistant Director of the Office of Compliance in FDA’s
Center for Drug Evaluation and Research. “Also, while some health risks
associated with “BHRT” drug products may arise after a relatively short
period of use, others may not occur for many years. One of the big
problems is that we just don’t know what risks are associated with
these so-called bio-identicals.”

Juuuuust right: In case you thought sleep issues were all about insomnia, see yesterday’s news from the University of North Carolina: oversleeping can be life-threatening.

…Sleeping
longer — nine hours to be exact — increased the risk of stroke in
post-menopausal women by 60 to 70 per cent over those who slept seven
hours.

“After accounting for all common clinical conditions predictive of
stroke, we found this increase was statistically significant: sleeping
nine hours or more is strongly associated with increased risk of
ischemic stroke,” said lead author Jiu-Chiuan Chen, assistant professor
of epidemiology at the University of North Carolina’s School of Public
Health in Chapel Hill, in a release.

Sleeping less than six hours meant the women were 14 per cent more at risk of stroke than those sleeping seven hours.

The
UNC study cautioned that since far more women were in the insomniac
<7 hour crowd than in the Sleeping Beauty crowd, we should still all
focus on getting more sleep, not less. But we’re still waiting for them
to invent the alarm clock that cuts off REM sleep at exactly 8 hours,
before the dream-cycle takes sleepers from Goldilocks territory into
the danger zone.

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