Back in February, we ran a guest blog post here on the Prescription Access Litigation blog titled “Nat’l Women’s Health Network debunks ‘Hands Off My Estrogens!’ Ad on FDA enforcement re: “bioidential hormones”” The post addressed ads that a group called Hands Off My Estrogens ran in several major newspapers. The ads criticized the FDA for cracking down on the sales of estriol, an unapproved drug that has not been proven safe and effective. The National Women’s Health Network’s blog post analyzed the ad and its claims.

Well, we’re back for some more on the hot-button issue — last month, a group of Congressional Reps sponsored a resolution criticizing the FDA for taking action on unapproved hormones distributed by compounding pharmacies. Below is another guest blog entry by the National Women’s Health Network on this issue. We note that the National Women’s Health Network does not accept money or donations from pharmaceutical companies.

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The public’s confidence in the safety of the U.S. drug supply and in the Food and Drug Administration’s (FDA) commitment to protecting public health have been shaken by repeated drug safety scandals in recent years. So when your health care providers say one thing and the FDA says another, whom do you trust?

It’s not always an easy question to answer, but one thing is clear: drug safety decisions shouldn’t be made by politicians. We need legislators who will make sure the FDA has the authority and resources to protect our health. Unfortunately, last month members of Congress jumped into the fray in a less than helpful way, challenging an FDA decision that had stirred up controversy about the safety and effectiveness of “bioidentical” – or natural – hormones that compounding pharmacies had been selling to women as an alternative to conventional hormone replacement therapy.

Earlier this year, the Food and Drug Administration took a firm and public stand against the false and misleading promotion of natural hormones and outlined several marketing claims that it had found to be unsupported by medical evidence. The agency specifically warned that selling estriol, a chemical that has never been approved by the FDA, is a violation of federal law. (See PAL’s blog entry from dateTK, to read more about the FDA decision.)

It is this last action – the effort to stop sales of estriol – that prompted Congressional action. House Concurrent Resolution 342 calls on the FDA to reverse its policy on compounded medications containing estriol. Representative Gabrielle Giffords of Arizona, one of the original cosponsors of the resolution, says that allowing the FDA’s action on estriol to stand “would unnecessarily disrupt the lives of countless women.” She says doctors should decide which medications are safe for their patients, and the FDA shouldn’t “inject itself into the doctor-patient relationship.”

In a world turned upside down, consumer advocates who have been responsible for helping to bring to light many of the drug safety scandals that have shaken public confidence in the FDA have come to the agency’s defense. The National Women’s Health Network (NWHN), the Center for Medical Consumers, the Government Accountability Project, the National Consumers League, and the National Research Center for Women & Families wrote to Congress, to express our strong opposition to the resolution. We pointed out that estriol has not been clinically proven safe and effective and has not been approved by the FDA for any use. We also noted that compounding pharmacies selling estriol are telling women that estriol is safer and more effective than other hormone therapy products and that it will prevent serious diseases, despite a lack of scientific evidence to support these claims.

With doctors and pharmacists telling them one thing and the FDA telling them another, where can women go to get the facts? On the NWHN website, we have fact sheets for women with reliable, science-based information about conventional hormone therapy and alternatives, including natural hormones. Research on conventional hormone therapy has shown that it can increase a woman’s risk for heart disease, breast cancer and stroke. Research on natural hormones is spotty, and most of these drugs haven’t been adequately tested to support the claims being made and safety or effectiveness. When it comes to estriol, studies have found mixed results about whether it hurts or helps with breast cancer, but it’s clear that it increases the risk for endometrial cancer. Yet few of the women taking estriol have been provided with that warning.

But it’s not enough to give women information on a case by case basis. We need an FDA that we can count on to make sure that the drugs being marketed to women are safe and effective. And we need a Congress that understands and supports the important role of the FDA in regulating the drug industry. Preventing the sale of an unapproved drug is one of the most basic functions of the FDA; and yet with the estriol resolution in the House of Representatives, we have legislators claiming that it’s inappropriate for the agency to come between patients and doctors to do just that.

It’s unfortunate that the FDA’s failure to act on drug safety problems in so many cases has left women uncertain about whom to trust on questions about the safety and effectiveness of natural hormones. The case of estriol is a powerful example of why we need to build up the FDA’s capacity to evaluate and monitor drug safety, and reinvigorate the scientific leadership and integrity of the agency.

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Thanks to National Women’s Health Network for contributing this guest blog post… Readers, we welcome your comments!

Consumers and third party payors in California who paid for Premarin, used to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women, may be eligible to receive payments from a $5.2 million settlement fund. For more details, go to premarinclassaction.com

Claims must be filed by October 1, 2007. Objections to the settlement must be filed by August 15, 2007.

Trivia tidbit: Premarin is made from the urine of pregnant horses — Premarin = PREgnant MARes uRINe.

Excerpted from www.premarinclassaction.com/premarin/california.htm

A Proposed Settlement has been reached in a class action, Elizabeth Blevins, et al. v. Wyeth-Ayerst Laboratories, Inc., et al., Case No. 324380, filed in the Superior Court of California, County of San Francisco.

The Superior Court of the State of California for the County of San Francisco entered an Order Granting Preliminary Approval of Settlement, Directing Notice to the Class, and Scheduling Fairness Hearing. The Court has scheduled a Fairness Hearing on final settlement approval on September 10, 2007.

Description of the Lawsuit
Premarin® is a conjugated estrogens product prescribed by doctors to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women. Plaintiff alleges that the manufactures Wyeth Pharmaceuticals (formerly Wyeth-Ayerst Laboratories, Inc.) and Wyeth (formerly American Home Products Corporation) violated California’s antitrust and unfair competition laws by engaging in anti-competitive and exclusionary conduct that blocked consumer access to Cenestin®, which was an alternative to Premarin®. Plaintiff does not challenge the safety or effectiveness of Premarin®.

The lawsuit claims that the Defendants violated California antitrust, unfair competition, unfair trade practices, and unjust enrichment laws by entering into exclusive rebate contracts with managed care organizations such as HMOs, insurance companies, and pharmacy benefit managers (“Third-Party Payors”). Defendants deny that they committed any violation of law or any wrongdoing or that they have any liability with respect to Plaintiff or the Class. However, the parties have agreed to this Proposed Settlement to avoid the risks and expense of continuing the case.

The Class includes all persons or entities who purchased or reimbursed others for the purchase of Premarin® from March 24, 1999 through April 3, 2007 in California for consumption by themselves, family members or covered individuals, and not for resale.

The Defendants have agreed to pay $5.2 million to settle this case. After deductions of Court-approved costs and expenses, the remaining amount will be divided between consumers and Third-Party Payors in the Class, subject to available funds based on the actual claims received.

“Class Member” Description
The proposed “Class” includes:

All persons or entities who, during the period from March 24, 1999 to April 3, 2007, purchased, paid for, or reimbursed for Premarin® purchased in the State of California for consumption by themselves, family members or covered individuals (including members, beneficiaries, employees and insureds) and who suffered economic loss thereby as a result of allegedly anticompetitive conduct by Defendants.

Excluded from the Class are Defendants and their respective subsidiaries and affiliates, all governmental entities, and all persons or entities that purchased Premarin®: (i) for purposes of resale, or (ii) directly from any of the Defendants. The Class also excludes those Class Members who have properly opted out of the Class.