Healthy Skepticism Library item: 20124

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Magazine

Tudiver S
Advertising Prescription Drugs to Consumers: Why women should be wary of direct advertising of drugs
A Friend Indeed 2001 Mar1-3
http://www.straightgoods.ca/ViewConsForum.cfm?REF=259&Cookies=yes

Abstract:

Advertising inevitably downplays risks, exaggerates benefits and will not admit that a competing product or alternative, non-drug therapies are superior

Full text:

What is Direct-to-Consumer-Advertising?
Commercials for prescription drugs are now common on U.S. TV and radio, in popular magazines, and on the Internet. Promoted not only to physicians – the professionals with prescribing authority – drugs to treat depression, cholesterol levels, menopausal symptoms and ulcers are marketed alongside cosmetics, clothing, detergents, food products and cars. Through this marketing strategy, companies aim to increase sales by directing consumers to their doctors to discuss specific, advertised drugs. While direct-to-consumer-advertising of prescription drugs (referred to as “DTCA”) is currently legal only in the U.S. and New Zealand among industrialized countries, U.S. ads enter Canada through cable TV networks and magazines and cross other virtual borders via the Web.

Many of the ads are directed to women in their menopausal and postmenopausal years, a demographic group with huge market potential. Among the most frequently aired ads are those promoting hormone therapy and drugs to treat, or reduce the risk of, osteoporosis and breast cancer. Drug ads for treatment of Alzheimer’s, arthritis and asthma often portray women as caregivers to aging parents or spouses, recognizing that women may read the ads with greater interest than men. Other drug ads for an overactive bladder, insomnia, migraine, antidepressants and obesity, are also geared to midlife and menopausal women.

This article looks at concerns and trends associated with DTCA and at some of the implications for midlife women. It suggests that DTCA is not the best way to achieve safer and more appropriate use of prescription medicines. Rather, consumers and physicians require access to sources of drug information independent of the drug industry.

DTCA in the U.S: A Healthy Business
The appearance of these ads in the U.S. is the result of pressure on the Food and Drug Administration (FDA) by the pharmaceutical industry to liberalize advertising regulations. Since 1997, U.S. commercials may name a product and a disease, as long as major risks of the product are noted and the consumer is directed to other information sources. Changes to the law made it easier for companies to launch more explicit TV, print and radio ads of prescription drugs.

Huge expenditures on marketing by the pharmaceutical industry suggest the strategy is working to stimulate prescriptions, particularly for newer, more expensive drugs. In 2000, the industry spent $2.3 billion on consumer advertising (the majority on TV ads), up from $1.8 billion in 1999 and $1.3 billion in 1998, and 40 times the $55 million spent on mass media ads in 1991. This marketing surge is matched by a sharp rise in the number of prescriptions written and in overall spending on prescription drugs – the latter rose over 18 percent between 1997 and 1998 and a further 19 percent by 1999, with projected increases between 12-18 percent annually through 2004. While we don’t have studies to establish a cause and effect relationship between DTCA and the rise in drug spending, the massive expenditures on DTCA by manufacturers suggest they believe the returns are worth the investment.

DTCA in Canada
Canadian legislation prohibits advertising drugs to the public as a “treatment, preventative or cure of any diseases, disorders or abnormal physical states” and specifically lists these diseases, such as cancer, diabetes, heart disease, in the Food and Drugs Act. Only the name, price and quantity of a prescription drug are permitted in a consumer-directed ad.

The Canadian government is currently renewing its health protection legislation, and there is industry pressure to loosen DTCA regulations to be more in line with the U.S. (A number of ads that violate Canadian regulations recently appeared in bus shelters and magazines.) The Canadian government has held consultations on the issue with industry, consumer groups and health organizations and is sponsoring research on possible benefits, risks and cost impacts of DTCA, including impacts on physician and patient attitudes.

DTCA is a contentious issue in North America and internationally. The pharmaceutical industry is aggressively pursuing DTCA, while many consumer groups, professional organizations and agencies, including the World Health Organization, are critical of the practice.

DTCA: What are the issues?

Doctor Visits:
Supporters of DTCA argue that ads encourage doctor visits, contributing to more frequent health monitoring and better care. While this may apply to some, women already tend to be frequent users of health care services. If a drug ad spurred the visit, the drug, rather than a thorough assessment of the patient’s health, may become the focus of the limited time between patient and doctor. Surveys show that U.S. doctors tend to have a negative opinion of DTCA. The effects of DTCA on the doctor/patient relationship are not well studied.

Market research suggests dramatic increases in doctor visits for conditions targeted by DTCA, such as male impotence. Patient visits for osteoporosis doubled between 1995 and 1996, the year osteoporosis drug ads were a leading DTCA focus. Several surveys in 1999 show that between 10 and 30 percent of consumers asked their doctor about a drug they saw advertised and between 50-90 percent of those who did, left with a prescription for that or another drug. There is a need to research whether such visits lead to improved health for women and men. More physician visits and increased pharmaceutical use place a heavy burden on publicly and privately funded health care services.

New drugs are less well known
: New patented drugs tend to be the ones promoted directly to consumers since companies seek to recoup the costs of research and development. Yet, only a limited amount is known about a drug’s safety when it first comes on the market. Approval is usually based on studies of no more than several thousand people, under defined research conditions and for relatively short periods of time. Many drugs are approved for an indication based on limited results, while large clinical trials are still going on.

Heavy promotion soon after a drug is launched puts more people at risk of adverse reactions than if it were monitored and introduced more slowly

Increased risk of Adverse Reactions:
New drugs require careful post-marketing surveillance in case unexpected reactions appear. Heavy promotion soon after a drug is launched puts more people at risk of adverse reactions than if it were monitored and introduced more slowly. Many drugs for use by both sexes are not as extensively tested, or not tested at all, in women, making them more vulnerable to possible harmful reactions. Elderly men and women are also at increased risk of adverse reactions to new drugs because they metabolize drugs more slowly, take a number of drugs, the interactions among which are uncertain, and because problems with memory, reduced eyesight or hearing, may make instructions confusing.

Advertising vs. balanced information:
Advertising inevitably downplays risks, exaggerates benefits and will not admit that a competing product or alternative, non-drug therapies are superior. A large proportion of DTC ads are factually inaccurate or don’t provide necessary risk information; many radio and TV ads have been found to violate FDA regulations. In some magazine ads, the side effects and warnings are provided in such fine print that readers require a magnifying glass – and high literacy as well. Many people assume ads are “government approved”, when in fact, the FDA relies on voluntary submission of ads after they have been released to the public.

DTCA plays on women’s fears:
Many of the ads directed to midlife women include short questionnaires, some of which can be mailed to the manufacturer for more information. Questions are worded to raise worries – about an overactive bladder, loss of memory (is it Alzheimer’s?), and anxiety in social situations. In providing “answers” to personal questions, women are offered a single option: a drug can alleviate their fears.

For example, ads for Nolvadex (tamoxifen), a “designer estrogen”, play on women’s fears of breast cancer. Approved in the U.S. for “risk reduction” in women at high risk of breast cancer, the ads suggest that ALL women are at risk. Women are told, “You can predict your chances of getting breast cancer” and are encouraged to take a self-administered test, to be followed by a more formal risk assessment by their doctor. While ads stress: “There IS something you can do,” non-drug options are not highlighted. Tamoxifen is a drug with serious side effects, still being studied in clinical trials, but that information is not prominent in advertising.

DTC Advertising distorts consumer “choice” and women’s empowerment:
The pharmaceutical industry uses the rationale that women are no longer content to be passive patients, but want to be active participants in their health care. As the argument goes, women want drug information presented to them directly, not mediated by doctors.

“Consumer empowerment” and “choice” have been hallmarks of the consumer and women’s health movement. However, those promoting DTCA fail to distinguish between balanced, independent information that would allow for true choices among products and non-drug therapies, and advertising claims

“Consumer empowerment” and “choice” have been hallmarks of the consumer and women’s health movement. However, those promoting DTCA fail to distinguish between balanced, independent information that would allow for true choices among products and non-drug therapies, and advertising claims that are directed to securing product loyalty and market shares.

Some lessons from direct-to-physician advertising
Aggressive marketing by companies to physicians takes many forms such as gifts, trips and lucrative consulting contracts. Drug ads in medical journals are also designed to create product recognition, emphasize benefits and downplay risks. Studies show that physicians who rely on company promotion for much of their information about drugs are less likely to be appropriate prescribers, i.e. to prescribe a drug for the condition it is indicated to treat, less likely to prescribe the right dose, more likely to prescribe unnecessary drugs, and less likely to prescribe a less costly, equivalent drug, when available. It is, therefore, unlikely that direct-to-consumer advertising would encourage appropriate use of prescription drugs by consumers.

What lies ahead?
Given the demographics of an aging population and the high profits associated with DTCA, we are likely to see more direct marketing of drugs related to menopause and aging. In addition, DTCA opens the door to other trends relevant to midlife and older women:

Old Drugs, New Image:
As patents expire on many well-known drugs, some manufacturers are marketing essentially the same molecular product under new names and to new subgroups. For example, patent protection on Prozac, the antidepressant, ended in 2001, with an estimated loss in revenue of $1 billion to generic competition in the first year. Eli Lilly, the manufacturer, has launched a massive DTC marketing campaign for Serafem, basically identical to Prozac, but approved for treatment of Premenstrual Dysphoric Disorder (PMDD), a form of very severe PMS that affects a small subset of women. Mass advertising of Serafem, however, targets a much broader population of potential users. As the ad reads: “Irritability, sadness, sudden mood changes, tension, bloating….Think it’s PMS? Think Again. It could be PMDD.” Many women, including those in the menopausal years, can identify with an ad showing a woman arguing with her husband or frustrated because her pants don’t fit.

In another marketing variation, GlaxoWellcome markets Wellbutrin SR as an antidepressant, and Zyban for smoking cessation – both have the same active ingredient. Serious side effects and even deaths have been associated with Zyban use. Wellbutrin SR ads target midlife women and include important warnings about the risk of seizures and against taking it “with other medicines with the same active ingredient, such as Zyban.” Most consumers would not readily identify the two drugs as the same.

DTCA of Genetic Tests:
Since the mid-1990s, over 50 biotechnology firms in the U.S. have been developing or providing tests to diagnose genetic disorders or predict the risk of such disorders occurring in the future. These include tests for Alzheimer’s disease, breast cancer, a hereditary form of colon cancer, cystic fibrosis and others, but the list of genetic screenings for late onset diseases, including osteoporosis, premature menopause and others is growing longer with the mapping of the genome. Currently, most of these tests are marketed to geneticists, genetic counsellors, general physicians and managed care organizations. However, there is a trend – predicted to increase – to market genetic testing directly to consumers.

The marketing of genetic tests has huge profit potential for the companies and patent holders of the tests. But testing raises ethical and social issues – concerns about privacy, access to genetic information and about the impacts genetic information may have on the mental health of the person tested and other family members. How will the need be met for counselling people to understand what tests can and cannot tell about a condition? Direct to consumer advertising of such tests exploits people’s fears about future diseases and creates expectations of therapy, when in fact gene therapies remain experimental and potentially harmful. Promoting genetic testing as another “consumer choice” reinforces the view that most diseases are caused by our genes, when in fact, illness and health reflect the complex interplay of genetic predispositions, social, economic and environmental conditions. Consumer marketing of “genetic futures” may be good business, but is not necessarily the route to good health.

Increased Internet Marketing of Drugs and Diagnostic Services:
While restrictions about DTC advertising apply to Canadian Internet sites and in other countries where it is illegal, it is difficult to regulate and influence the information that consumers are getting from U.S. and other sources. Consumers will likely have increased access to mail order drugs and a variety of health-related tests internationally.

Responding to DTCA
Consumers need information about drugs that is independent of company promotion and commercial gain. Independent drug assessments address questions such as: How long has this drug been studied? On which populations of women and men? What are the outcomes of the research – what do we know about it and what do we not know? Are there alternative treatments with fewer risks that may be tried first? There are many excellent models to guide the development of balanced, critical information, accessible to diverse consumers. (See suggested sources of information).

As gatekeepers of prescription drugs, physicians must be scrupulous about the accuracy of the drug information they provide. Yet, their training about drugs is limited. Greater collaboration is needed among physicians, pharmacists, other health providers, consumer and women’s groups — to avoid inappropriate use of drugs. Many doctors refuse to accept perks from the pharmaceutical industry and resist the pressures to prescribe heavily marketed drugs, unless there is a demonstrated need.

As major targets of pharmaceutical advertising, midlife women have significant economic and political clout to speak out on this issue, by registering formal complaints about specific drugs, or supporting initiatives for improved access to consumer health information. Many midlife women remember past tragedies, such as DES, when drugs were aggressively promoted to physicians. Direct to consumer advertising would have compounded that tragedy and may in the future incur other costs. Governments should apply a “precautionary principle” in relation to drug advertising and take action to avoid future harm. As women well know, the bottom line of pharmaceutical policies should be good health, not healthy business.

For Further Information….

Working Group on Women and Health Protection www.web.net/~desact 74 Plateau Cres.
Toronto, Ontario M3C 1M8
416-447-1649
A coalition of women’s health, consumer, public interest organizations and academics doing research and advocacy on women’s health, including DTCA. The DES Action Canada website hosts a special section for the Working Group’s information on DTCA and other related issues.

Drug and Therapeutics Bulletin www.which.net Consumers’ Association
Castlemead, Gascoyne Way
Hertfordshire, England SG14 1LH

An 8 page, monthly bulletin of independent evaluations of drugs and other treatments aimed at doctors and pharmacists. The web site has numerous links to other relevant sources of drug information.

Public Citizen’s Health Research Group www.citizen.org 1600 20th Street NW Washington, DC 20009 202-588-1000

The health arm of Public Citizen, the non-profit, consumer research and advocacy organization founded by Ralph Nader and Dr. Sidney Wolfe in 1971. Major publications address the safety and efficacy of prescription drugs and medical devices.

This article first appeared in ‘A Friend Indeed’, the health newsletter for women in menopause and midlife. For subscription information, a free issue and other health news and articles, visit: www.afriendindeed.ca