BARBARA MINTZES*

A WOMAN boards a bus in Vancouver, Canada. A large billboard at the bus shelter shows a woman laughing and playing with her daughter: "Lose a little weight and you'll feel better," says the advertisement, "Ask your doctor about weight-loss options that are available now." Inside the bus, another advertisement shows an attractive young woman with the caption: "A lesson in first impressions… Always leave something to the imagination. Be mysterious." At the bottom of the advertisement is the name of a birth control pill, with the pill's blister pack.

Each message has strong social content. The obesity drug publicity advises women to conform to a cultural standard of slim beauty. The birth control advertisement tells young women that in new relationships by taking the pill they can "be mysterious," and avoid talking to their partner about birth control.

From a public health perspective, these messages leave much to be desired. Obesity can cause serious health problems, but so do eating disorders and anti-obesity drugs. Young women should protect themselves against pregnancy, but protection against sexually transmitted diseases and HIV/AIDS is equally if not more important. Ironically, city buses carried the advertisement across a district with the highest rate of new HIV infections in Canada.

In Canada, as in most other countries, advertising of prescription drugs to the public is illegal. However, legislation is often inadequately enforced, and many governments are under pressure from the pharmaceutical and advertising industries to change the law.

Does direct-to-consumer prescription drug advertising affect women differently from men? What about the effects of other forms of drug promotion, such as that targeting physicians and other health professionals?

Why do national laws prohibit prescription drug advertising to the public?

The aim of drug promotion is to sell a product. Used judiciously, medicines can cure diseases, prevent complications, and provide much needed relief of pain, discomfort and other symptoms. However, even when used appropriately, medicines can cause harm as well as benefit. Any decision to prescribe or use a medicine is a balancing act, weighing the probability of benefit, given a person's circumstances and health condition, against the possibility of harm.

A rational weighing of probabilities, however, is far from the experience of someone who is seriously ill or a mother caring for a child in distress. Illness, pain and fear of death or disability create a vulnerability that is very different from a decision to buy a loaf of bread or a new pair of shoes.

The toxicity of medicines and people's vulnerability when they are ill distinguish pharmaceutical promotion from the advertising of other consumer products.

Many types of drug promotion

Drug promotion is defined as: "all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs²."

Direct-to-consumer advertising (DTCA) of prescription drugs has grown rapidly in the 1990's in the USA and New Zealand, where it is allowed. US spending reached nearly $2.5 billion last year, up from less than $100 million per year in the early 1990's. Spending is highly concentrated among new, expensive drugs for long-term use by broad target audiences, generally healthier people.

Many of the drugs most heavily advertised to the US public are used mainly by women, such as drugs for menopause, obesity, migraine, arthritis, depression and bladder control. A systematic review of 10 years of magazine advertising found that when there was sex specific targeting, women were 2.6 times as likely to be targeted as men³.

Most promotional spending everywhere, including in the USA, is on sales representatives ('drug detailers'), who make one-to-one visits to doctors. Companies also sponsor educational and scientific meetings, journal supplements, post-marketing research studies and media events, and advertise their products in medical journals and through direct mail. There are other more subtle forms of drug promotion: a recent study in the Journal of the American Medical Association found that 90% of authors of clinical guidelines receive funding from or acted as consultants to drug companies⁴ (see p. 4).

Over-the-counter drugs are advertised directly to the public in a variety of media, including print, billboards, radio and television. In addition to DTCA, described above, companies use a variety of methods to advertise medicines to the public, including press campaigns and patient group sponsorship.

Ashley Wazana carried out a systematic review of 29 empirical studies on the influence of interactions with the pharmaceutical industry on physicians⁵. Effects on physicians' knowledge and practice were mostly negative, including: inability to identify inaccurate claims; formulary requests for medications without treatment advantages; irrational prescribing; increased prescribing rates; less generic prescribing; and prescribing of more expensive new medicines without treatment advantages (see p. 22).

A tension exists between judicious use of medicines only if and when they are needed, and manufacturers' need to continually garner and expand market share. There are only so many ill people at any given time.

The medicalisation of menopause

If a healthy life stage experienced by half the population can be redefined as a medical event, the result is an enormous market opportunity.

Menopause marks the end of menstruation and in many ways mirrors the menarche, or beginning of menstruation. However, whereas menarche is seen as a young woman's passage into adulthood, with mood swings accepted as normal, menopause has become a medical event requiring treatment. Hormonal drugs are frequently prescribed both for symptoms of menopause and disease prevention. Drug promotion has played a large role globally in redefining menopause as a medical event in need of drug treatment⁶.

Medical texts describe a set of symptoms associated with the hormonal changes of menopause: hot flushes, night sweats and vaginal dryness⁷. However, not all women experience any or all of these symptoms and frequency varies greatly between cultures. In population based surveys in Thailand, 23% of menopausal women experienced hot flushes⁸. In the UK, the proportion was 57%9. Mayan women in rural Mexico experienced no hot flushes despite hormone levels similar to US menopausal women¹⁰. Menopause may be seen as a positive event marking freedom from childbearing or purdah, as in Northern India, or as a sign of loss of social status, as in the west.

Hormone therapies provide symptomatic relief from hot flushes, night sweats and vaginal dryness. They are not effective against ageing. However, a best-selling estrogen was promoted to physicians as "a gift of time³." Advertisements often portray menopause negatively. In Bolivia one called menopause "a visible problem¹¹"; another in Peru called it a "daily impediment to the quality of life¹¹". and a US advertisement suggested that women, "…Forget menopause." It is hard to miss the suggestion that being female and of a certain age is a visible problem that needs forgetting.

Post-menopausal women and disease prevention

Short-term symptomatic treatment of large populations is lucrative. However, the profitability pales in comparison to lifelong drug treatment. The discovery that hormone use could delay bone density loss created a new avenue for widespread promotion in both lay and medical media during the 1980's and 1990's. Kazanjian and colleagues point out that this type of marketing works because it perpetuates two trends in popular western culture: the medical model of the ageing female body; and fear of ageing, with associated disability, dependency and immobility¹².

M. van Vilet

Prevention of osteoporosis

Gradual bone loss occurs normally with age in both women and men, but osteoporosis provides an excellent example of a process Lyn Payer described as the 'diseasing' of risk factors¹³. In 2000, the manufacturer of a leading osteoporosis drug ran an advertisement in women's magazines in the USA saying, "See how beautiful 60 can look? See how invisible osteoporosis can be?" The advertisement cites a nearly 1 in 2 chance of having osteoporosis, ominously "no matter how healthy you look on the outside." The company urged women to get their bone density tested, saying that osteoporosis can lead to broken bones and disfiguring dowager's hump, which can be prevented if detected early enough.

Bone density does not accurately identify women who will go on to fracture as they age; many more women are misclassified than are accurately classified¹⁴. Age alone is a better predictor of the risk of hip fracture. Women over 80 with bone mineral densities more than one standard deviation above the mean experience more fractures than any group of women aged 70 - 79, irrespective of their bone mineral density¹⁵. Bone density testing does predict use of drug therapy, however¹⁶. For many women, benefits of treatment may not outweigh risks, age-related bone loss is common at age 60, but hip fractures are rare.

Cardio protection: an unfulfilled promise?

Hormone treatments have been widely promoted to prevent heart disease in post-menopausal women, based on changes in lipid levels¹⁷, and less observed heart disease in hormone users than non-users¹⁸. However, lipid changes do not necessarily reflect lower disease risk, and observational studies may reflect a systematic bias, since hormone users tend to be healthier and wealthier than non-users¹⁹.

The only way to know if hormones prevent heart disease is through well designed randomized controlled trials. The first randomised controlled trial of hormones and heart disease prevention in post-menopausal women, the HERS trial, was published in 199820. This is the best available evidence, and hormone treatment did not prevent heart disease, shattering previous assumptions.

"The good news is that a woman's risk of heart disease increases dramatically after menopause, but can be significantly reduced by 35 to 50 per cent with hormone replacement therapy (HRT)," said a newspaper article in September 2000, over two years after the HERS trial was published²¹. "Post-menopausal and not taking hormone replacement therapy (HRT)" is the first 'risk factors' for heart disease listed in the article.

Isabelle Savoie and colleagues examined reports on women and heart disease in major US and Canadian women's magazines in 1997 and 1998²². They found over 100 articles and advertisements. Three themes predominated: heart disease is the number one killer of women; women must demand equal access to prevention and treatment; and lifestyle changes are likely to be inadequate, drug treatment is needed. A constant theme was that, "one of the most compelling reasons to take replacement hormones is for your heart's sake."

Heart disease risks were frequently exaggerated with messages that after menopause women's risk 'skyrockets' or equals that of men, which is untrue at comparable ages.

Without evidence of fracture or heart disease prevention, and with ongoing concerns about increased breast cancer risks, long-term hormone use may cause more harm than benefit. Drug promotion is not solely responsible, but it clearly contributes.

Overprescribing of psychotropic drugs: a pervasive problem

Women have long been targeted in psychotropic drug advertising, mainly those for benzodiazepine tranquillizers and sleeping pills in the 1970's and 1980's, and antidepressants in the 1990's. These advertisements often convey messages about the position of women in society. A May 2000 advertisement for an anti-anxiety drug features a cartoon drawing of an overwhelmed woman, kneeling under the weight of her anxiety, unable to cope. Unlike earlier images of housewives in benzodiazepine advertisements she is wearing office clothes, but the stereotyped message that women need their 'little helper' remains unchanged.

A 1987 Dutch study of benzodiazepine prescribing found that women were more likely than men to receive benzodiazepines when the diagnosis did not warrant it²³. Ten years later, a US study of 8,536 physician consultations compared a random sample of visits in which patients received psychotropic drugs to visits in which they did not²⁴. With similar diagnoses, health conditions, age, use and payment of clinical services and physician specialty, women were 55% more likely to receive a psychotropic drug than men.

Safety concerns?

Many drugs have been tested primarily or only on men in pre-marketing trials but are used by women - in some cases mainly by women - once they are approved. This includes many psychotropic drugs, such as anti-anxiety drugs, sleeping pills and antidepressants. Although regulatory requirements have improved, a May 2000 review by the US General Accounting Office, the investigative arm of the US Congress, found that numbers are insufficient to allow for separate analysis of drugs' effects in women.

In January 2001, the US General Accounting Office reported that eight of ten drugs withdrawn from the US market for safety reasons from 1997 through to 2000 had caused greater harm to women than men²⁵. In half, this was because more women took the drug. The remaining four were due to biological differences. For example, women are more likely than men to suffer a potentially fatal heart arrhythmia from drugs that prolong the interval between the heart muscle's contractions.

Drugs withdrawn for safety reasons represent the tip of the iceberg of drug safety. A UK study combined the experience of over half a million patients: 13 men per thousand experienced suspected adverse drug reactions as compared to 21 women per thousand²⁶. Many reactions were dose-related, and the difference may reflect women's smaller average body size.

Promotion of more medicine use in women of child-bearing age increases the risk of accidental exposure in early pregnancy, when women are often unaware they are pregnant. Often little is known about risks of newer drugs in pregnancy and breastfeeding.

Conclusion: what is to be done?

The medicalisation of menopause and the promotion of psychotropic drugs for women are case studies showing that drug promotion can have social as well as health effects, and can affect women differently from men. There is little systematic research on the influence of drug promotion on women.

The risks may be to society as well as to the individual if research and development focuses on 'lifestyle products' for the healthy rather than needed medicines for untreated serious diseases. A largely unexamined risk is to women's equality if individual drug treatment is the only solution offered to distressing life situations or to ill health caused by social inequality.

WHO's Ethical Criteria for Medicinal Drug Promotion stress the principle that drug promotion should be in keeping with national health policies. National governments have been slow to integrate the regulation of drug promotion into broader health and drug policies, or to consider special measures to control promotion of certain classes of drugs or targeting of certain groups. Politically such a move may be difficult, as governments often balance health against economic priorities and face international pressures. Many countries lack adequate resources for effective regulation of drug promotion, and regional or international collaboration may be the answer.

In 2001, the US Government told manufacturers of AIDS drugs to stop showing unrealistic images of treatment success. This was after a San Francisco Public Health Department study had shown that young gay men who saw many drug advertisements were at higher risk for HIV infection because they practiced more unsafe sex and tended to believe that HIV/AIDS was no longer a problem.

This is only one small step, but it shows that regulation of drug promotion can go beyond consistency with approved labelling and also reflect broader health policies.

* Barbara Mintzes is a researcher at the Centre for Health Services and Policy Research, University of British Columbia, Canada.

References

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