Prescription Access Litigation coalition member National Women’s Health Network recently sent a news item about the FDA’s September 29 letter to LabCorp, advising it that its ovarian cancer screening test is a medical device that must be pre-approved by the FDA before it can be marketed. In response to the letter, LabCorp (NYSE:LH) announced at the end of October that it is halting sales of OvaSure.

Back in August, the New York Times ran an article on the test: Cancer Test for Women Raises Hope, and Concern

As the FDA’s letter said:

Our review indicates that this product is a device under section 201(h) of the Food, Drug, and Cosmetic Act (FDCA or Act), 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention, or mitigation of disease. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale….

According to our records, no such determination has been made for OvaSure™. Because you do not have marketing clearance or approval from the FDA, marketing OvaSure™ is in violation of the law. The device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B)…. The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o)….

Here’s what National Women’s Health Network had to say about the test:

Don’t Be Fooled by OvaSure

The Food and Drug Administration (FDA) recently warned that the marketing of a new ovarian cancer test violates the laws guarding against promotion of unproven technologies, vindicating skeptics like the National Women’s Health Network, who were concerned that the test was not ready to be used for routine cancer screening. OvaSure is a test that measures six different proteins in blood samples and calculates the odds that a woman will develop ovarian cancer. The $220 test was developed by LabCorp and has been available since late June.

When ovarian cancer is detected in its earliest stages, more than 90 percent of women survive at least five years. When the cancer is discovered in its late stages, after it has spread beyond the ovaries, only about 30 percent of women survive five years. There is currently no effective screening tool for ovarian cancer, so only about 20 percent of cases are detected early. OvaSure was developed to fill this void, but the test has not yet been shown to be very effective at detecting early disease. False positives are also a serious concern. A screening test that says a woman has a cancer when she doesn’t is dangerous because it subjects women to unnecessary worry and sometimes even surgery, including the possibility of unnecessary removal of a healthy ovary. (It shouldn’t happen, but it does.)

The NWHN worked hard with other consumer safety organizations and with our allies in Congress to enact FDA reform in 2007 sending the FDA a clear message that the agency should be tougher in enforcing its rules to protect women from ineffective drugs, devices and tests that could put their health at risk.

LabCorp has been told by the FDA that it must meet premarketing approval requirements before getting the okay to market Ovasure. Thanks to everyone who helped us send a message that women want safe and effective health products, as well as speedy approvals. We urge Labcorps, and others trying to find a good screening test for ovarian cancer, to do the research necessary to prove the tests will meet the FDA’s standards and actually improve women’s health. Women are waiting.

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!

Prescription Access Litigation (PAL) coalition member National Women’s Health Network and MergerWatch, which is also part of PAL’s parent organization, Community Catalyst, announce an important national conference coming up on April 17 and 18 in Boston, MA:

RAISING WOMEN’S VOICES FOR THE HEALTH CARE WE NEED!
National Conference – Simmons College, Boston
April 17 & 18

To get the health care debate to reflect women’s issues and concerns, we must join the conversation!

Dynamic conference workshops will prepare you to talk about:

• Why reproductive health must be included in health reform
• Why dependent health insurance is a women’s Issue
• How health care must become culturally competent
• What kinds of childbirth choices women want to see included
• What are the health concerns of older women
• How can we better support women who are providing care at home for elderly relatives

Learn valuable lessons from advocates in states like Massachusetts that have been experimenting with health care reform:

• How you can use personal stories to advocate for health reform
• How you can do effective grassroots organizing
• How to build a health reform law based on existing models
• How to decide on things like whether to require individuals to purchase health insurance
• How you can work with the progressive faith community in your state to advocate for health care for all

For more info, go raisingwomensvoices.net

Raising Women’s Voices for the Health Care We Need is a joint project of
The Avery Institute for Social Change
National Women’s Health Network
MergerWatch Project

Questions? Give us a call! 866-210-3114 or email us at
info@raisingwomensvoices.net

From time to time, we here at Prescription Access Litigation invite members of our coalition of advocacy organizations and labor unions to write guest posts for the PAL blog. We present to you a great post by Marian Sadler, from PAL member National Women’s Health Network. The National Women’s Health Network improves the health of all women by developing and promoting a critical analysis of health issues in order to affect policy and support consumer decision-making. The Network aspires to a health care system that is guided by social justice and reflects the needs of diverse women.

The post below is about a recent ad taken out by a group called “Hands Off My Estrogens.” The ad criticizes the Food and Drug Administration for recently taking action against misleading marketing claims about natural hormones that are sold by compounding pharmacies.

Here’s a partial screen shot of the ad:

Without further ado, here is the terrific analysis of this ad and this issue by Marian Sadler of NWHN:

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Many of you may have opened up your newspapers last week to find a full page ad warning you about the Food and Drug Administration’s (FDA) new position on bio-identical hormones, also known as natural hormones. The ad presents the issue as an attack on “natural health” and women’s rights, claiming that the FDA is defending the “sales and profits of its clients, the big drug companies.” If you’re a regular reader of this blog, that probably sounds pretty believable to you. And it’s true that big drug companies wanted the FDA to crack down on the widespread marketing of natural hormones. Unfortunately, that’s about all that’s true in the ad. The rest of the text seriously misrepresents what the FDA did, and even worse, repeats the same unsubstantiated promotional claims about natural hormones that the FDA rightly took a stand against.

The ad was run by the HOME (Hands Off My Estrogens!) Coalition, a group based in Edinburg, Virginia. The Coalition is referring to an all-too-rare enforcement action that the FDA took in January 2008 against misleading marketing claims about natural hormones that are sold by compounding pharmacies. The FDA told the pharmacies that the safety and effectiveness claims they were making about bio-identical hormone products “are unsupported by medical evidence and are considered false and misleading by the agency.”

The FDA identified several specific claims as misleading including statements that natural hormones are better or safer than conventional hormone therapy; that natural hormones can treat or prevent Alzheimer’s disease, stroke and cancer; and the use of the term bio-identical which implies “a benefit for the drug, for which there is no medical or scientific basis.” The agency also warned that selling products containing estriol is a violation of federal law because it has never been approved by the FDA.

The HOME Coalition ad reaches out to readers on an emotional level, with its photo of a concerned young woman and a wise female doctor. It prompts you to feel indignant about the FDA’s action and supportive of women who rely on alternative medicine options, like natural hormones. It’s designed to make you feel that the HOME Coalition is looking out for women’s health and women’s rights, defending natural care from hostile attacks by drug companies and the FDA, and “speaking the truth”. But the reality is not so simple.

In fact, the ad is a poorly disguised sales pitch for natural hormones. To justify its inaccurate claim that estriol (a form of estrogen that’s chemically identical to the estrogen that women’s own bodies produce) has been proven safe, it cites a study that found that women who produced the most estriol during their first pregnancy had 58 percent less breast cancer over the next forty years. But that doesn’t prove taking estriol that’s not produced by your body is safe or beneficial. And the HOME Coalition fails to cite studies showing that estriol increases the risk of endometrial cancer. These defenders of natural hormones don’t think it’s necessary to tell women there’s no reasonable scientific evidence that estriol has anticancer effects or that it’s safer than other estrogens. Like hormones that are synthesized in a lab and sold by drug companies, natural hormones are powerful chemicals that affect many parts of the body. It is very important to understand that products are not necessarily safe just because they’re natural. The same questions we ask about drugs need to be answered for alternative therapies too.

Just as pharmaceutical companies promote drugs, there is a large industry that produces and sells alternative health care products. Whether they are recommended by a doctor, a nurse practitioner, a naturopath or the cashier at the health food store, women should be skeptical of products that claim they will extend life, reverse aging, restore youth or prevent disease without causing any adverse effects.

The National Women’s Health Network has been urging the FDA for years to exercise better oversight over natural hormones. When the agency finally took action last month, we applauded its actions although we remain concerned that the steps taken are not enough to protect women’s health. These were good first steps, but we’ve also called on the agency to publish regulations to govern appropriate labeling and advertising of pharmacy-compounded hormone products. All labeling and advertisements for natural hormones provided to patients and health care professionals should include the facts that the product is not approved by the FDA, the product was compounded in a pharmacy and is not subject to FDA standards for good manufacturing practices, and that the product has not been demonstrated as safe or effective in clinical trials.

For more information on natural hormones and about the FDA decision, read the National Women’s Health Network’s newly updated fact sheet on Natural Hormones at Menopause. And if you see ads or other promotions for natural hormone therapy that make unproven claims – please send them to us at nwhn@nwhn.org.