Healthy Skepticism Library item: 2165

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: news

Silversides A.
Health Canada "reinterprets" laws about prescription drug ads for consumers
http://www.straightgoods.com/item456.asp 2001 Jun 11

Full text: Stand in the subway, go to a movie, or watch TV these days and you’d think that it’s perfectly legal to pitch prescription drugs directly to consumers in this country. You may have seen the ads: “Don’t wait for the phone to ring. Get an answering machine” (one of a series that featuring young women discussing relationship issues and a photo of a birth control pill package) or “The acne solution for women only” (a photo of a woman whose name, Diane, just happens to be the key word in the trade name of the prescription drug being alluded to). These types of ads have proliferated in the last couple of years – there’ve also been TV ads for a smoking cessation drug (“I tried to quit other times”), and for another drug that helps correct “erectile dysfunction.” It’s still illegal in Canada to advertise prescription drugs to consumers. But Health Canada has lowered the bar and drug companies are skipping over. There’s been no change in the 1978 Canadian law that forbids advertisements of prescription drugs to the general public – advertising being “activities with the primary aim of stimulating product sales,” according to a 1996 Health Canada policy paper on the issue. Pharmaceutical companies are seeing what they can get away with and Health Canada, which enforces Canada’s Food and Drugs Act, has not objected to campaigns that critics say clearly fit the definition of advertising. “I think what’s happened, for reasons that aren’t entirely clear, is that Health Canada has reinterpreted the law (about direct-to-consumer advertising or DTCA). But in a strict reading of the law these advertisements are illegal,” says Dr. Joel Lexchin, a Toronto physician and expert on the pharmaceutical industry. Vancouver researcher and activist Barbara Mintzes is angry that “with no discussion, no democratic process… the law has (effectively) changed because Health Canada is not enforcing the law.” When Health Canada does raise objections, bureaucrats act so slowly that advertising campaigns have run their course by the time an official objection is raised. This happened recently with television advertisements for Wyeth Ayerst’s Alesse birth control pills and Glaxo Wellcome’s Zyban, an antidepressant prescribed to help people quit smoking. Information about risk isn’t included in the advertising aimed at consumers In the United States, laws about advertising of prescription drugs to consumers are more permissive, and we’re inundated with such cross-border ads in US magazines and on US television. The change in what is appearing in Canadian ads concerns groups like the Canadian Medical Association (CMA). There’s definitely been an attempt by drug companies to push the boundaries, says CMA president Dr. Peter Bearett. When prescription drugs are advertised to doctors, detailed information about associated risks must be printed. Such information is absent from the advertising now being aimed at consumers “and that’s definitely one reason we oppose it,” he said. The CMA, along with the Canadian Pharmacists Association and the Consumers Association of Canada are on record as opposing legalization of DTCA of prescription drugs, in anticipation of proposed changes to legislation. But the Working Group on Women and Health Protection argues the situation is already “careening out of control” and has repeatedly urged Health Canada to enforce Canada’s existing Food and Drugs Act. The working group represents over 20 women’s and consumers’ groups across Canada, including DES Action Canada and the Canadian Women’s Health Network. The Food and Drugs Act prohibits prescription drug advertising to the public because it recognizes that such drugs are not like other consumer items, explains Ross Duncan, Health Canada policy advisor on DTCA. There are public safety concerns associated with prescription drugs. But Duncan says most of what we are seeing on transit ads, at movie theatres and on television is permissible under the law. He notes that a 1978 amendment (designed to let pharmacists post comparative prices) allowed DTCA of prescription drugs as long as “the person shall not make any representation other than with respect to the brand name, proper name, price and quantity of the drug.” Duncan adds: “Also allowed is information. If it is considered information, the law is silent.” Thus, he says, the clear violation of the law is mentioning brand name and use in the same advertisement. As a result, Health Canada now says that “help seeking” and “reminder” advertisements are legal. (Those terms aren’t in the legislation or regulations but rather “reflect the evolution of what is occurring in the marketplace,” Duncan says.) Help seeking ads are those that describe a disease or condition and point the public to help (a 1-800 number, a web site or a doctor) but don’t mention a particular drug. So-called “reminder” ads mention the brand name of the drug, but don’t say what condition it treats. Those who are alarmed by the new trend say reminder ads clearly violate the law against advertising prescription drugs to consumers, while help seeking ads occupy greyer terrain. But Duncan maintains reminder ads only cross the line when both they contain both “branded” (the drug name) and “unbranded” (the use to which the drug is put) information. Hence transit advertisements for Alesse birth control pills which feature young women, mention the drug name, and show a picture of a birth control pill pack, are legal, he says. “Lots of pills come in blister packs,” he replied, when asked if the picture of the pills and the context doesn’t reveal the purpose of the drug. Health Canada did, however, decide that Wyeth-Ayerst crossed the line with its two-advertisement television campaign for Alesse birth control pills – branded and unbranded ads featuring the same women but aired with a gap of two weeks between them. Fully six months after the ads began airing, Health Canada wrote to the company to say the campaign “is considered to contravene the Food and Drugs Regulations.” Even then, officials suggested no further action or penalties and instead advised: “The basis for Health Canada’s decision must be considered when developing future advertisements.” Wyeth Ayerst is now airing only the unbranded television ads, says spokesperson Theodora Samiotis. Branded transit ads meanwhile are visible at most Toronto subway stops. Because “technically you can’t” advertise prescription drugs directly to consumers in Canada, there is no agency mandated to oversee such advertising, says Ray Chepesiuk, commissioner for the Pharmaceutical Advertising Advisory Board, a third party agency which acts as a watchdog for drug advertising aimed at doctors. Advertising Standards Canada is endorsed to pre-clear advertisements of over-the-counter drugs, but not prescription drugs, he notes. Pharmaceutical companies sometimes turn to Chepesiuk’s board for help with advertisements and “we tell them how to make it not advertising” under the Food and Drugs Act, he said. But even Chepesiuk admits to being puzzled why some ads aren’t considered by Health Canada to be advertisements. “Health Canada says it’s okay to show (the birth control pill package picture in the Alesse ad). I think that is distinctive packaging.” The public, meanwhile, seems to know an advertisement when it sees one. “I’ve seen surveys that show one half of the population believes that there is direct to consumer advertising in Canada. It is so prevalent, they believe the law allows it,” Chepsiuk said. The Working Group on Women and Health Protection was founded by the group DES Action Canada. For more information, visit: the DES web site.

This article originally appeared in Eye magazine, April 12, 2001.

Study shows drug ads work – critics push for limits

Newest drugs are often the most heavily advertised

Mass media advertising of prescription drugs appears to lead to a dramatic increase in the number of prescriptions written, according to a major U.S report. The number of such advertisements and the volume of sales exploded south of the border after a 1997 “clarification” of the law led to a sharp increase in television, radio and print campaigns, states the report by the National Institute of Health Care Management. The growth in both advertising and sales has been so dramatic that many U.S. critics, including doctors and private health insurers, are pushing for limits on advertising aimed at the general public, citing cost and safety concerns. The most-advertised drugs include oral antihistamines, diet pills, and drugs for male baldness, smoking reduction and cholesterol lowering. “Why is a second-line drug with potentially serious side effects being advertised in bus shelters?” The increases in sales have also “raised concerns whether mass media ads are inappropriately inducing demand for some new prescription drugs . . . (and transforming) medicines into just another consumer product,” states the NIHCM report. Surveys also show that U.S. consumers believe the drug information in ads is “approved by the government”. The 25 top-selling medicines promoted directly to U.S. consumers accounted for 40.7 percent of the overall $17.7 billion increase in drug spending in 1999 compared to 1998, according to the September 2000 NIHCM study. Those same 25 drugs enjoyed an overall one-year 43 percent growth in sales in 1999, compared to a 13.3 percent sales growth in all other drugs. In the United States, as in Canada, prescription drug spending is the fastest growing component of health care costs. The United States and New Zealand are the only countries where it is legal to advertise prescription drugs to consumers, according to the Working Group on Women and Health Protection. However, Canadian health protection legislation is under review, and drug companies are pushing for changes. For example, Berlex Canada, which manufactures the anti-acne treatment Diane-35 issued a release stating they hope Health Canada will “eventually allow greater use of these [advertising] campaigns in Canada since numerous studies clearly show that the better informed consumers are about the health care issues, the better the health outcomes.” Doctors and other critics, however, are concerned that direct to consumer advertising (DTCA) may contribute to inappropriate and over-prescribing of drugs. Studies show that doctors strive to please their patients and that they are open to patients’ requests to try treatments, according to the NIHCM report. One main safety concern is that “the drugs that tend to be most heavily advertised are the newest ones – the ones for which we have the least safety data,” says Joel Lexchin, a Toronto doctor and expert on the pharmaceutical industry. “As a result of DTCA lots of people who aren’t suitable for a new drug will end up getting it and they are ones who potentially might get these serious adverse reactions.” The hormonal drug Diane-35, originally a birth control pill, has been widely advertised in “reminder ads” in Canada as “the acne solution for women only.” But researcher Barbara Mintzes says is has been approved here only for the treatment of severe acne when other options have been tried and failed. As well the drug, which is manufactured by Berlex and has not been approved for use in the United States, has been associated with serious risks of liver toxicity, she says. “Why is a second-line drug with potentially serious side effects being advertised in bus shelters?” asks Mintzes, who is completing a PhD in epidemiology at the University of British Columbia. GlaxoSmithKline’s Zyban is antidepressant which, in low doses, has recently been marketed as smoking cessation drug. The NIMH study ranked the smoking cessation drug Zyban as 7th in terms of the 1999 spending on DTCA, with $53.9 million spent. In Canada [see main article] Health Canada recently slapped GlaxoSmithKline’s wrists for an advertisement which appeared on CTV. In Britain as of last week, 37 patients had died after taking Zyban, which was introduced to the country last June, according to a coroner’s inquest into the death of Kerry Weston, a 21-year-old British Airways hostess. The company issued a release stating there is “no evidence of an increased risk of death associated with the use of this medicine.” But the inquest coroner criticized GlaxoSmithKline for not providing doctors with enough information about the use of the drug, and ordered it to clarify its advice to people using the drug in combination with other drugs. Weston was also taking anti-malarial medication when she died.