The Politics of Women's Health

Direct to Consumer Advertising

Feminists Challenge Unethical Marketing by Prescription Drug Companies

It's your future. Be there.
--Three-page ad for cholesterol lowering drug

The fracture-fighters. Women against osteoporosis.
--Three-page ad for anti-calcium loss medication

Think it's PMS? Think again. It could be PMDD. Premenstrual Dysphoric Disorder.
--page-and-a-half ad for drug to fix this new disorder

I’m proud of him because be asked about Viagra ... I love him because he did it for us.
--Ad of almost two Pages

Ads for prescription drugs covered 15 of the first 66 pages of a recent mainstream women's magazine. The others in that issue pushed an adolescent acne medication, a diabetes drug, and an asthma treatment.

Before 1997, prescription drugs generally were not advertised directly to consumer audiences. Instead, such advertisements appeared only in journals published for doctors and other health professionals. Since the August 1997 issuance of a special "guidance" from the Food and Drug Administration (FDA), pharmaceutical companies have been formally allowed to market these drugs directly to consumers, and this phenomenon of "direct-to-consumer (DTC) advertising" has burgeoned into a multi-million dollar effort.

In 1999 alone, the pharmaceutical industry spent $1.8 billion on consumer ads, and estimates for the year 2000 put the figure over $2.5 billion. How has this affected women in particular, and what can we do about it?

Predictably, DTC advertising has led to an increase of consumers and patients who request a wide range of prescription drugs from their doctors. In many cases, people are responding to advertising hype that greatly overstates a drug's benefits while downplaying its risks and problems. Most lay people -- and even many physicians -- are unaware of the hundreds of letters sent out each year by the FDA requiring drug companies to retract their ads (and rarely do we see rectifying statements).

The case of tamoxifen (marketed by AstraZeneca Pharmaceuticals under the brand name of Nolvadex) underscores some of the dilemmas confronting all of us who read these ads and who may be making decisions based upon misleading information. Although tamoxifen has a well-studied and often beneficial track record in the treatment of certain types of hormone-dependent breast cancer, it is a drug now marketed widely for breast cancer "risk reduction," incorrectly interpreted by many as meaning "prevention."

"Prevention" vs. Risk

Prevention means keeping something from happening. Risk reduction, by contrast, lowers but does not eliminate the chances of something happening. For example, in the trial of tamoxifen for healthy women, 85 women in the group taking tamoxifen developed breast cancer. While women in the tamoxifen arm were less likely to get breast cancer than those in the placebo arm of the trial, the drug did not render women immune to breast cancer.

A closer look at AstraZeneca's advertising campaign for tamoxifen exposes how drug company hype can seriously mislead women and suggest several responses from women's health advocates that might effectively counter this hype.

Last year, 200,000 women in the United States heard from their doctors the dreaded words, "You have breast cancer." Despite billions of dollars spent on breast cancer treatment, we have made relatively little progress in improving the research on mortality rates from this disease. Thus, heightened emphasis on and support of breast cancer prevention makes eminent sense. Unfortunately, much of the recent focus on "prevention" has been directed toward the appealing but limited and risky approach of "pills for prevention," rather than toward research into a primary prevention approach that would address the causes of breast cancer, especially environmental links to cancer.

Tamoxifen is the first (though almost certainly not the last) drug to gain FDA approval for reducing the risk of breast cancer. AstraZeneca's multi-million dollar advertising campaign to sell these potentially dangerous pills as breast cancer "prevention" to healthy women sets a disturbing precedent that requires renewed activism on the part of women's groups.

Hyped First Reports

First, some recent history. The original data on tamoxifen for breast cancer risk reduction were released in April 1998 with widespread publicity and glowing news reports. "Tamoxifen Lowers Risk of Breast Cancer" (Washington Post April 7,1998), and "Researchers Find the First Drug Known to Prevent Breast Cancer' (New York Times, April 7, 1998), are just two sample headlines that greeted readers that day. Dr. Allen Lichtman, then president of the American Society of Clinical Oncology, was quoted as saying, "People will look back at 1998 as the year that was the beginning of the end of breast cancer." At the time, every woman over 60 was considered by the National Cancer Institute (NCI) to be of sufficiently high risk that she should consider taking tamoxifen. AstraZeneca saw this as a market of 29 million women.

With ongoing analysis of the data, a clearer picture emerged of how few women really stood to benefit from taking tamoxifen for risk reduction. In 1999, the NCI quietly published an article entitled "Weighing the Risks and Benefits for Tamoxifen Treatment for Preventing Breast Cancer" that presented a far less positive profile. The article reported that the group of healthy people for whom tamoxifen's potential benefits appear to outweigh the risks is much smaller than originally claimed, and therefore, the drug has a limited customer base. Unfortunately, this newer information never garnered the media attention and hype of the 1998 findings.

Thanks to the efforts of women's health activists, AstraZeneca was not permitted by the FDA to use the term "prevention" in its advertising. The company did, however, continue to run numerous ads in women's magazines presenting data in such a misleading fashion that many women now have a distorted picture of tamoxifen's true risks and benefits. Some ads, for example, compared relative benefits of the drug with absolute risk, pointing out a 46 percent reduction in breast cancer risk along with "only" a I to 2 percent risk of serious problems like endometrial cancer or blood clots. These ads did not mention the 253 percent increased relative risk of endometrial cancer (that is, the risk of endometrial cancer for women taking tamoxifen compared with the risk of endometrial cancer for women not taking the drug), nor the fact that women had only a 1.8 percent absolute chance of benefiting from the drug. National Women's Health Network (NWHM) director Cindy Pearson sent a complaint to the FDA pointing out how one of these ads violated the DTC advertising regulations. She wrote:

If the ad used relative risk consistently, it would say that women who took tamoxifen had 44 percent fewer breast cancers and 253 percent more endometrial cancers. Or alternatively, if Zeneca wants to use the absolute numbers to assert that women have a less than I percent chance of being harmed by tamoxifen, they should also explain that in absolute terms women have only a I to 2 percent chance of benefiting from the drug depending on their underlying risk of getting breast cancer in the first place.... It is no coincidence that Zeneca chose to use the relative and absolute risk numbers in this way. They have deliberately attempted to deceive consumers.

These ads also failed to note that tamoxifen is listed by the National Toxicology Program as a known human carcinogen. Representing the data in a more complete and accurate manner would, of course, have painted a less rosy picture (and been less likely to "sell" the product). After receiving Pearson’s complaint, the FDA sent AstraZeneca a strongly worded letter requiring retraction of the ad.

Other AstraZeneca-sponsored television ads about breast cancer did not mention tamoxifen and were thus not constrained by the DTC advertising regulations. These ads said, "There is something you can do" and invited calls to an 800 number. Callers (apparently thousands of them) received a free and misleading "Assessing Your Risk" video that heavily promotes tamoxifen.

On to  Raloxifene

Another ad campaign for raloxifene, a SERM (selective estrogen receptor modulator), is likely in the near future. Officially approved only to reduce the risk of osteoporosis, raloxifene (brand name Evista) also has a brisk "off-label" use for breast cancer risk reduction. Raloxifene manufacturer Eli Lilly has already promoted this use of the drug at cancer meetings and sales calls to doctors' offices, and many physicians already recommend it as an alternative to hormone replacement therapy at menopause, especially when a woman has an elevated risk of breast cancer. This is especially critical in light of a case that recently established the right of drug companies to promote off-label use if they have data to support such use -- without any constraints from the FDA. As a result, there may be more and more problems with off-label promotion. There are often benefits from off-label drug use, but there can be problems as well, especially with unexpected complications. SERMs such as tamoxifen and raloxifene will be increasingly promoted by pharmaceutical companies for heart disease "prevention," Alzheimer's "prevention," and colon cancer "prevention," despite the very minimal data available on the benefits (and risks) of these drugs in association with these diseases.

Women’s Groups Respond

In response to these problems with DTC advertising, a coalition of women's health advocacy groups recently formed Prevention First. The group hopes to launch a campaign to alert the general public and encourage greater caution towards such highly advertised drugs. In addition, the coalition seeks to create more widespread understanding and appreciation of the precautionary principle of public health, sometimes referred to as the "First, do no harm" approach. Briefly summarized, this principle states:

When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause-and-effect relationships are not fully established. Implementing the principle requires exploring alternatives to possibly harmful actions; placing the burden of proof on proponents of an activity rather than on victims or potential victims of the activity; and using democratic processes to carry out and enforce the principle.
--Science and Environmental Health Network

Members of the collaborative define true prevention of breast cancer as the ability to identify and eliminate its actual causes. The collaborative calls for focused attention on the following points:

• The difference between "prevention in a pill" and true, or primary, prevention that involves discovering the causes of breast cancer and developing policies that will eradicate them.
  
     
• The negative consequences of drug marketing directed at consumers.
  
  
• How relationships between pharmaceutical companies and medical researchers and/or research centers can compromise research findings and reporting.

A longer-term goal of Prevention First is to lay the groundwork for a new understanding of health and disease prevention that will support the ultimate implementation of the precautionary principle as the basis of regulatory and health policy. The coalition also hopes to challenge an emerging double standard in the cancer establishment, where, for example, tamoxifen is regarded as "not perfect but a step on the way to the kind of pill we want," while the imperfections and uncertainties inherent in environmental prevention become the basis for dismissing the environmental approach altogether.

One of the reasons that alternative viewpoints remain marginal is that the groups espousing them typically do not have the money that corporations do to conduct sustained media work. The Collaborative is looking for funding for a media campaign countering the drug companies’ sales campaigns and bringing these alternate viewpoints more into the mainstream, thereby galvanizing the public pressure necessary to shift policy on prevention strategies.

This article was originally printed in the March 2001 issue of Sojourner: The Women's Forum and is posted here with their permission.

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