Outrage: We Have Met the Enemy and He is Us

When Pogo, the late-lamented comic-strip denizen of the Okefenokee Swamp, remarked that “we have met the enemy and he is us,” he might well have been talking about one of the country’s key guardians of health, the Food and Drug Administration (FDA).

Over the past several months, medical journals and the popular press have been awash in a tide of bad news on hormone replacement therapy (HRT). HRT causes blood clots. HRT causes breast cancer. HRT increases the risk of cardiovascular disease instead of preventing it. HRT does not prevent Alzheimer’s disease or memory loss, but may instead cause dementia. Women, after decades of being persuaded by physicians on the receiving end of drug company propaganda to take this now largely discredited therapy, have every right to be confused.

So the FDA’s announcement on September 9 of a “Collaborative Campaign to Inform Women About Menopausal Hormone Therapy” sounded as though it might
hold some promise; that is, until you actually went to the Collaborative Campaign web site (www.4woman.gov/menopause). Instead of the dry, fact-filled explanation of the risks and benefits of HRT one might expect from the FDA, the opening page on the site contained no substantive information whatsoever. Instead, the page, which is entitled “Menopause and Hormone Therapy” and is completely unnecessary from a web design perspective, offers only a collage of photographs of attractive seniors frolicking in sun-drenched fields and riding bicycles. One must then click on this image to reach the information on HRT, which is actually housed on the FDA’s own web site.

From there it is downhill all the way. In 1997, the FDA agreed that all information for consumers should be based on material that is provided to doctors, which itself sometimes includes FDA-approved information for patients. So we took the agency at its word and compared the new web site to the FDA-approved patient information on PREMARIN (conjugated estrogens), a Wyeth-Ayerst Laboratories product that is the leading brand of HRT. This comparison shows several gaping holes in the web site information.

For starters, although FDA regulations regarding prescription drug information for consumers mandate that the information in the “black-box warning” (the strongest type of warning the FDA can require) must appear at the beginning of written information intended for patients, the Collaborative Campaign relegates this material to its sixth topic, after the benefit information and other data about hormones and menopause.

The Collaborative Campaign web site lists conditions under which women should never use HRT (contraindications), but these are displayed in a sidebar under yet another listing of the benefits of the hormones. In contrast, the FDA-approved Premarin information for patients prominently advises women not to take Premarin if they have certain conditions such as cancer, vaginal bleeding, heart attack or stroke.

Moreover, the web site makes no mention of the symptoms of hormone-induced illness or of steps to take if such symptoms occur. References to alternative therapies for osteoporosis are similarly missing in action. Both are present in the FDA-approved patient information.

Why would the FDA go to such effort to create this grossly misleading information, when it simply could have linked users to its own generally well-crafted information for patients? A possible explanation can be found in a Washington Post report, which noted that, “... there was direct and indirect pressure on the FDA ... from the largest maker of hormone products, Wyeth Pharmaceuticals” during the development of the Collaborative Campaign.

Recently, FDA Commissioner Mark McClellan said: “I consider it a public health hazard when people are misled by false claims.” But a man cannot (or, at least, should not) survive on rhetoric alone, and the facts speak otherwise. Since 1998, when the FDA’s drug advertising division took 157 enforcement actions for false or misleading ads, the number of such actions has plummeted an astonishing 86% to a projected 22 actions so far in 2003. How come? This is not because the drug industry has cleaned up its act, but in part because the FDA has quietly changed the rules. The agency now requires an additional layer of internal legal review before actions can be issued. And its chief lawyer, at one time a hatchet man for various industries, including tobacco, has long been hostile to many attempts to regulate commercial speech.

So, Dr. McClellan, we have a modest proposal for you: In order to pump up your agency’s flagging enforcement statistics, why don’t you launch an investigation into why the FDA permitted this misleading web site? Maybe you’ll consider bringing an action against yourselves, the way you would against any company that produced information as contrary to FDA regulations as the Collaborative Campaign has turned out to be. The enemy, indeed, seems to be “us” — or at least those charged with protecting us.