Why, oh why, Wyeth?
02, 06 08, 23:28 Filed in: Medical
Fireworks 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.
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.
