Bulletin Index/

Safety and the Precautionary Principle

1. Safety First: Women and Health Protection

2. Hormone Therapy: Health Protection Lessons from the Women’s Health Initiative

3. Registering the Impact of Breast Implants

4. Women and Adverse Drug Reactions: Reporting in the Canadian Context

Public Health vs. Profit

5. Direct-to-Consumer Advertising of Prescription Drugs – Whatever the Problem, You Can Always Pop a Pill

6. International Harmonisation of New Drugs Regulation: Not in Women’s Best Interest

7. Communicating about Environmental Risks and Infant Feeding

8. Canadian Women’s Health Network

Lessons from the Past - Ongoing Risks

9. Beyond DES – Hormones in the Environment

10. DES Action Canada

11. The Over-Prescription of Benzodiazepines

Direct-to-Consumer Advertising of Prescription Drugs – Whatever the Problem, You Can Always Pop a Pill

Barbara Mintzes, Centre for Health Services and Policy Research, University of British Columbia, and Women and Health Protection

A billboard at a bus shelter shows an attractive brown-skinned young woman, with the caption, "A lesson in first impressions… Always leave something to the imagination. Be mysterious." Alesse is the name of the drug printed below with an image of the 21-day birth control pill pack. A television ad for a hormonal acne drug shows young girls with beautiful skin dancing to pop music and preening in front of a mirror. The ad ends with the drug name, Diane-35.

These are recent Canadian prescription drug ads. The messages vary but both are aimed at women and include advice about gender roles: take medicines to be blemish-free, or to be "mysterious", which means quietly assuming sole responsibility for birth control.

Prescription Drugs Advertising to the Public
The United States and New Zealand are the only countries to allow direct-to-consumer advertising of prescription drugs (DTCA). Spending on DTCA in the U.S. has grown rapidly, reaching U.S. $2.5 billion in 2000.[1] Since late 1997, when the U.S. Food and Drug Administration (FDA) eased regulatory restrictions, television advertising has grown dramatically.

DTCA is not currently allowed under Canada’s Food and Drugs Act, except for "name, price and quantity", a 1978 amendment allowing comparative price advertising. However, the federal government is considering legislative change to introduce DTCA, and Canadians are increasingly exposed to cross-border advertising from the U.S. as well as to Canadian ads of questionable legality, such as those described above.

Canada is not alone in reviewing its legislation: Australia, the European Union, and South Africa have also considered introduction. DTCA is controversial, with many claims made about benefits and harm. Proponents say that it educates and empowers patients, improves compliance and leads to earlier medicine use, better health, and fewer hospitalizations. Critics raise concerns that it stimulates unnecessary and inappropriate drug use, interferes with doctor/patient relations, and leads to increased drug costs.

What Do We Know About Effects of DTCA?
A U.S. congressional research agency summarized the results of surveys of random samples of the U.S. public, estimating that 8 million Americans request and receive a prescription for an advertised drug each year.[2] Consistently, American consumer surveys show that someone who asks for an advertised medicine usually gets it.[3]

An FDA survey asked doctors about their last patient who had requested an advertised drug.[4] Over a quarter felt somewhat or very pressured to prescribe and fewer than half reported no pressure. In another study of 1,400 consultations in family doctors’ offices in Vancouver and Sacramento, three-quarters of patients who asked for an advertised drug received a prescription, although doctors only judged this to be a "very likely" choice for other similar patients half the time.[5]

In both the U.S. and New Zealand, regulatory violations are common, mainly due to inadequate provision of risk information.[6] Over 90 U.S. DTCA campaigns were found to violate U.S. law between 1997 and 2001 and repeat violations were common.[7]

A 10-year review of ads in 18 major U.S. magazines found that most ads omitted key information needed for informed health care choices. Nine out of 10 failed to say how likely a treatment was to work and seven out of ten mentioned no other possible treatments.[8] A 1998-1999 study found that nearly nine out of 10 ads described benefits only in vague, emotional terms,[9] and that nearly one-quarter offered financial incentives such as free trial offers. In sex-specific ads, women are targeted more than twice as often as men[10] and the volume of DTCA is highest in women’s magazines.[11]

Around 40% of spending on DTCA is on just 10 products each year.[12] These are generally new, expensive drugs for long-term use by large target audiences. The choice is a marketing decision. Drugs for baldness, runny nose, and toenail fungus are all heavily advertised, whether or not these are pressing public health concerns.

Little is known about longer-term or less common risks of the newest drugs, raising questions about the public health impact of stimulating widespread use. Several drugs later withdrawn for safety reasons have been advertised to the U.S. public, including the diabetes drug Rezulin, which was named as the suspected cause in nearly 400 deaths before its March 2000 withdrawal.[13]

Advertised drugs are linked to rapidly escalating U.S. drug costs. The 25 drugs with the highest advertising spending in 1999 were responsible for over 40% of the U.S. $17.7 billion increase in spending on drugs in 1999 as compared to 1998.[14]

In summary, there is evidence that DTCA affects patient behaviours, prescribing decisions, and drug costs. The educational value of DTCA is inadequate for informed choice, but doctors usually prescribe a drug if a patient requests it. No research has been done on effects on health, hospitalization rates, serious illness, or mortality.

No New Legislation, But a Dramatic Shift in Policy
In March 2002 the federal Health Minister announced that the government would not introduce DTCA. However, recent policy changes had already opened the door to many "made-in-Canada" ads.

Women and Health Protection made a complaint about ads for Alesse, a birth control pill, in May 2000. In November 2000, Health Canada published a policy paper in response, saying that it was illegal to run two similar ads, one saying the drug’s name, the other talking about its use, in the same media.[15] This paper implies that it is legal to advertise just the drug name ("reminder" ads) or the approved use ("helpseeking" ads), but not both. The justification given is the 1978 price-advertising clause. This is consistent neither with the public health aims of prohibiting prescription drug advertising to the public, nor the 1978 clause, which prohibits all representations other than name, price, and quantity.

Some of the most blatant DTCA campaigns in Canada target young women. In March 2001, Women and Health Protection made another complaint about ads for Diane-35, a drug approved in 1998 in Canada to treat severe acne. This drug had been used for birth control in Europe, but its use was restricted to acne in 1995 because of liver toxicity.[16] New Zealand, the U.K., and Canada have posted warnings of risks of potentially fatal blood clots.[17] Health Canada has not informed us of any action taken in response to this complaint beyond referring it to another department. The ads, which target teenaged girls, were still running months later and the drug is increasingly being prescribed for birth control.

Debates on DTCA in Canada tend to focus on whether full U.S.-style DTCA should be allowed, not on current enforcement of the law. If the Act has loopholes that make no sense from a public health perspective, we need clarifying language introduced. We also need publicly accountable enforcement procedures, including active monitoring and escalating fines and sanctions to prevent future violations.

DTCA sends a powerful message: whatever the problem, no matter how minor, you can always pop a pill. The Canadian public needs access to up-to-date, accurate, comparative information about all treatment options, drug and nondrug, independent of vested financial interests. Advertising aims to sell a product and has quite a different message.

Women and Health Protection
Web site: www.whp-apsf.ca
E-mail: info@whp-apsf.ca

NOTES

[1] Rosenthal MB, et al. Promotion of prescription drugs to consumers. New England Journal of Medicine 2002; 46:498-505.

[2] Heinrich J. US Prescription Drugs. FDA Oversight to direct-to-consumer advertising has limitations. Report to Congressional Requesters. US General Accounting Office. GAO-03-177. October 2002.

[3] Consumer and Physician Attitudes Towards Direct-to-Consumer Advertising. Time Inc., 1998 Aug.; Slaughter E, Schumacher M. Prevention’s International Survey on Wellness and Consumer Reactions to DTC Advertising of Rx Drugs. Prevention Magazine, Rodale Press, 2000/2001.

[4] Aikin K. USA FDA. Division of Drug Marketing, Advertising and Communication. Direct-to-consumer advertising of prescription drugs: Physician survey preliminary results. January 13, 2002. Web reference: http://www.fda.gov/cder/ddmac/globalsummit2003/index.htm.

[5] Mintzes B, et al. Influence of direct to consumer pharmaceutical advertising and patients’ requests on prescribing decisions: two site cross sectional survey. British Medical Journal 2002;324:278-279.

[6] Koerner C. US FDA. Division of Drug Marketing, Advertising and Communications. The Regulation of Direct-to-Consumer Promotion of Prescription Drugs. Presentation at Health Canada Multi-Stakeholders’ Consultation on Direct-to-Consumer Advertising. Aylmer, Québec, April 14, 1999; Pratt P. Assessment of Regulatory Compliance for Medicines Advertised Direct to Consumer. Medsafe. New Zealand Ministry of Health. Wellington, 2000.

[7] Heinrich, 2002.

[8] Bell RA, et al. The educational value of consumer-targeted prescription drug print advertising. Journal of Family Practice 2000;49:1092- 1098.

[9] Woloshin S, et al. Direct-to-consumer advertisements for prescription drugs: what are Americans being sold? Lancet 2001;358:1141-46.

[10] Bell RA, et al. Direct-to-consumer prescription drug advertising 1989-1998. A content analysis of conditions, targets, inducements and appeals. Journal of Family Practice 2000;49:329-335.

[11] Woloshin S, et al., 2001.

[12] Findlay S. Prescription drugs and mass media advertising. Washington DC: National Institute of Health Care Management. September 2000. Web reference: http://www.nihcm.org.

[13] Willman D. FDA: How a new policy led to seven deadly drugs. Los Angeles Times. 2000 Dec 20. Web reference: http://www.latimes/news/nation/reports/ fda/lat_fda001220.htm.

[14] Findlay, 2000.

[15] Rowsell LB. Policy Statement. Advertising campaigns of branded and unbranded messages. Therapeutic Products Directorate, Health Canada. November 2000. Web reference: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/policy/issued/adv_campaign_e.html.

[16] Cyproterone acetate: further restrictive action. Current problems in pharmacovigilance. WHO Pharmaceuticals Newsletter. Issue No. 4, 1995. Report of Committee for Proprietary Medicinal Products, European Commission. Pharmacovigilance opinion No. 19: cyproterone acetate. Meeting of 13-14 December 1994.

[17] New Zealand Ministry of Health. Letter to Doctors/Midwives/Pharmacists about VTE with cyproterone-containing OCs. March 2002. Web reference: www.medsafe.govt.nz/Profs/PUarticles/CPAletter.htm; Therapeutic Products Directorate. Health Canada. Important safety concerns on the use of Diane-35. December 23, 2002. Web reference: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/adviss_tpd_bgtd_e.html.

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