Jun 02, 2008 Filed in:
MedicalFireworks tomorrow, 31 days early!
In case you haven't heard, Wyeth, the maker of Premarin and Prempro (Premarin + Provera), has been plotting to maintain their marketshare by restricting women's freedom to choose safer medications for themselves. Ever since the Women's Health Initiative revealed in 2002 that Prempro increased the risk of stroke, breast cancer, heart attacks, and blood clots (a finding that I, in residency at the time, thought was obvious since Provera was well known to increase the risk of clots), Wyeth has been struggling to maintain its sales of these patent medicines.
Wyeth has managed to keep a monopoly on PREgnant MARe urINe (PREMARIN, get it?) products in the US since it was introduced in 1942 by dubious legal and political maneuvers including using at least seven women's advocacy groups it funded to influence congressional hearings in 1995. By maintaining this stranglehold on relief of menopausal symptoms, Wyeth has extended its dominion well past the 20 year patent protection and in 2001 had over 11 million women using its hormone medications and over $2 billion in sales of those medications. Following the revelations of the Women's Health Initiative, sales of Premarin and Prempro drop and by 2006 sales are half of 2001 levels (though they had dipped even lower before Wyeth made lower strength versions and pushed for more prescribing).
As women flock to safer treatments like bioidentical hormone replacement (using hormones identical to the ones originally in the women's body), Wyeth decides to protect its profits at the expense of women seeking relief of menopausal symptoms and preventing other changes related to loss of estrogen like osteoporosis and memory loss. In 2005, Wyeth files a "citizen's petition" with the FDA that pushes the FDA to ban estriol, an estrogen naturally produced by women, as an unapproved new drug. Within 70 days, 11 organizations, mostly funded by Wyeth (in a stunning repeat of their tactics 63 years earlier), submit letters of support for this petition. Again, May 19, 2008, members of congress received a letter (coordinated by Wyeth) from 14 organizations (all with major funding from Wyeth) supporting the FDA's actions.
Besides estriol having a 50 year history of use and listing in the US Pharmacopeia, it was in the precursor to Premarin (that was made from pregnant women's urine- but it proved too difficult to collect), and is used by Wyeth itself in products sold overseas. Recent research has shown estriol may reduce the risk of breast cancer and be beneficial in treating multiple sclerosis.
This year, in response to Wyeth's petition, the FDA bans the use of estriol (though the FDA does not have jurisdiction over compounding pharmacies, so this is also a power grab by the FDA) despite admitting that there have been no reports of adverse events associated with its use ever. Somehow, the FDA has managed to put an import restriction on estriol as well, so even though compounding pharmacies shouldn't be subject to the FDA's decrees they are having trouble getting supplies of estriol. Under the FDA's plan, it would require a physician to file an Investigational New Drug form (with the associated $50,000 fee to the FDA) to order estriol for patients.
In the end, women are losing their options so Wyeth can make more profits.
So, what's with the fireworks? Well, Tuesday, June 3, is the day that hundreds of compounding pharmacists will descend on capitol hill to support H. Con. Res. 342 at the same time the AAHF is delivering independent letters of support, and a full page ad will appear in Roll Call.
Learn more about this issue here, and learn more about estriol specifically here.
Corporations will only be able to get away with this as long as we remain quiet, so speak up for this and get active in politics: corporations pay big money to bend the laws in the direction of increased profits whatever the human cost, so the humans have to speak up. It's time.
Tags: Hormones, Medical Orthodoxy
Sep 17, 2007 Filed in:
MedicalA recent American Family Physician journal, citing a JAMA article, puts the lie to the idea that people (particularly women) with osteopenia (low bone density) should be on medications. With all the evidence that these medications (like Fosamax or its friends) shouldn't be first-line treatments, why are doctors still prescribing them so quickly? If your doctor pulls out the pad for this, ask them when the last time they saw that drug rep and whether they are pushing the doc to use it as a preventative. This kind of behavior is occurring more and more, so let your doctor know that it's getting so obvious and blatant that even the patients are picking up on it. There are some movement among conventional docs to limit their exposure to drug reps, No Free Lunch for practicing physicians and Pharmfree for medical students. Sadly, the No Free Lunch doesn't turn up any drug-rep free primary care physicians in Ann Arbor (though it does find a pediatrician in Ypsilanti).
Interestingly, the article points out that the only treatment that has been shown to reduce nonvertebral fracture risk in women with osteopenia is estrogen. Bioidenticals, anyone?Tags: Drug reps, Hormones, Medical Orthodoxy, Osteoporosis
Sep 09, 2007 Filed in:
MedicalI just got a note from SaveMyMedicine.org about the latest way that insurance companies are working to help the drug companies: by refusing to pay for compounded hormones. You'd think they'd be smart enough to see that by covering compounded bioidentical hormones they could be saving themselves drastic amounts of money: Premarin or Prometrium are about $45 a month each and testosterone gel or patches are upwards of $200 a month, while compounded estrogen (usually a combination of estrone, estradiol, and estriol), progesterone, or testosterone each start at around $25 or so a month (they can go a little higher at higher doses). Add the additional costs of higher incidences of breast cancer in women taking Provera and they could really be making out by supporting bioidenticals.
Aetna's going to stop on October 1, while BCBS changed their policy back in May (note that BCBS cites an unscientific 2001 FDA study that even the FDA doesn't support).
As the note I got says: If you are an Aetna or BlueCross BlueShield customer, please contact your employer’s HR department and ask them to petition your health insurance company to reinstate coverage of bioidentical hormones and other compounded medicines. Remind them that healthy employees are productive employees and your health depends on these drugs. Your doctor has decided that compounded medicines such as bioidenticals are the best treatment option for you. Both your employer and your insurer have a responsibility to provide you with the medicines you need at a reasonable cost.Tags: Hormones, Insurance
Mar 17, 2007 Filed in:
MedicalSometimes I'm disappointed by the journals. Circulation recently had an article on reducing women's risk of cardiovascular risk, in which hormone replacement was listed as class III (not useful/effective, may cause harm). A summary of the article in Medscape breaks down the variation in risk:
Researchers found that "route, type, and dose" of hormone therapy matters, in the Estrogen and Thromboembolism and Risk Study (ESTHER), a multicenter study conducted in 8 hospitals in France that included 271 cases and 610 controls. Compared with nonusers, oral estrogen users had an odds ratio of 4.2 (95% confidence interval [CI], 1.5 - 11.6) and 0.09 [this is probably a typo and the risk should be 0.9] (95% CI, 0.4 - 2.3) for transdermal estrogen. Norpregnane derivatives were linked to a 4-fold increase in venous thromboembolism; but there was no risk for venous thromboembolism with micronized progesterone and pregnane derivatives in the study.
So, there is risk in the standard hormone treatment of oral estrogen and progestins (synthetic progesterone-like molecules): each raises the risk of a clot 4-fold. However, it also shows that transdermal estrogen doesn't increase the risk and may lower it and that progesterone similarly doesn't raise the risk. Using bioidentical hormones in a smart manner, then doesn't raise the risk and likely lowers it going from this article.
Sadly, they also list folic acid and antioxidants in the same class that says "may cause harm". Clearly, no one has died from antioxidants or folic acid. There has been a limited number of studies showing some increase in risk with fractionated antioxidants (beta-carotene or alpha-tocopherol alone) in certain circumstances, so it is important to get use full-spectrum antioxidants when using higher doses (mixed carotenoids with selenium or mixed tocopherols).
Sadly, newspapers often pick up these articles without any background and trumpet it as fact. It pays to read in more depth, and be cautious about people who paint all hormone replacement with the same brush: there are clear differences in risk between approaches, and this is why I do not use oral estrogen at all.Tags: Hormones, Medical Orthodoxy