Healthy Skepticism Library item: 20168

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

Silversides A
Under the counter: Pharmaceutical companies are pushing the boudnaries of the law against direct-to-consumer drug advertising
Eye Weekly 2001 Mar 5
http://contests.eyeweekly.com/eye/issue/issue_05.03.01/news/drugs.php

Full text:

Stand in the subway, go to a movie or watch TV these days, and you’d think it was 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 feature 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 one that helps correct “erectile dysfunction.”

There’s been no change since 1978 in the Food and Drugs Act, which forbids direct-to-consumer advertising (DTCA) of prescription drugs — advertising being “activities with the primary aim of stimulating product sales,” according to a 1996 Health Canada policy paper on the issue.

But increasingly, pharmaceutical companies are seeing what they can get away with, and Health Canada, which is responsible for enforcing Canada’s Food and Drugs Act, has not objected to campaigns that many 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 DTCA]. But in a strict reading of the law, these advertisements are illegal,” says Joel Lexchin, a Toronto doctor 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.”

On the rare occasions that Health Canada has raised objections, bureaucrats act so slowly that advertising campaigns have run their course by the time anything can be done. This happened recently with television ads for Wyeth-Ayerst’s Alesse birth-control pills and GlaxoSmithKline’s Zyban, an antidepressant prescribed to help people quit smoking.

In the United States, DTCA laws for prescription drugs are more permissive, and Canada is inundated with ads in American magazines and on American television. But at issue is the change in what is appearing in Canadian advertisements — and it’s a concern to 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 Barrette. 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 says.

The CMA, along with the Canadian Pharmacists Association and the Consumers Association of Canada, is on record as opposing the legalization of DTCA of prescription drugs, positions taken in anticipation of proposed changes to the legislation.

But the Working Group on Women’s Health and Protection — which represents more than 20 women’s and consumers’ groups across Canada, including DES Action Canada and the Canadian Women’s Health Network — argues that the situation is already “careening out of control,” and has repeatedly urged Health Canada to enforce Canada’s Food and Drugs Act. The 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 obvious public-safety concerns associated with prescription drugs.

But Duncan says most of what we are increasingly seeing in transit, movie and television ads is permissable 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.”

“Also allowed is information,” Duncan adds. “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 doctor, Web site or 1-800 number) without mentioning 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 that reminder ads only cross the line when 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 that 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 replies 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 a number of weeks apart.

Fully six months after the ads began airing, Health Canada wrote to the company to say that the compaign “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 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 that acts as a watchdog for drug advertising aimed at doctors. Advertising Standards Canada can 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. “We tell them how to make it not advertising” under the Food and Drugs Act, he explains. But even Chepesiuk admits to being puzzled about why some ads aren’t considered by Health Canada to be advertisements. “Health Canada says it’s OK to show [the birth-control pill package in the Alesse ad]. I think that is distinctive packaging.”

The public, meanwhile, seems to know an ad when it sees one. “I’ve seen surveys that show half of the population believes there is direct-to-consumer advertising in Canada,” says Chepesiuk. “It is so prevalent, they believe the law allows it.”
More ads, more prescriptions?

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 ads and the volume of sales exploded south of the border after a 1997 “clarification” of the law led to a sharp increase in TV, radio and print campaigns, states the report by the National Institute of Health Care Management (NIHCM).

The growth in both advertising and sales has been so dramatic that many critics, including doctors and private health insurers, are pushing for limits on advertising aimed at the public, citing cost and safety concerns. The most frequently advertised drugs include antihistamines, diet pills and those for slowing male baldness, reducing smoking and lowering cholesterol — drugs that treat relatively minor conditions, but have a huge potential market.

The increases in sales have also “raised concerns whether mass-media ads are inappropriately inducing demand for new prescription drugs… [and transforming] medicines into just another consumer product,” states the NIHCM report. Surveys show that U.S. consumers believe the drug information in ads is approved by the government, which makes them less skeptical than they are of other advertising.

The 25 top-selling medicines promoted directly to U.S. consumers accounted for 40.7 per cent 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 a one-year 43 per cent growth in sales in 1999, compared to 13.3 per cent for all other drugs.

In the U.S., as in Canada, prescription-drug spending is the fastest-growing component of health-care costs. The U.S. 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. Canadian legislation is under review, however, and drug companies are pushing for changes. For example, Berlex Canada, which manufactures the anti-acne treatment Diane-35, issued a release stating it hopes Health Canada will “allow greater use of these [ad] campaigns since numerous studies show that the better informed consumers are about 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 prescribing. Studies show that doctors strive to please patients, and are open to patients’ requests to try treatments.

One concern is that “the drugs that tend to be most heavily advertised are the newest ones, for which we have the least safety data,” says Dr. Joel Lexchin, a pharmaceutical industry expert. “As a result of DTCA, lots of people who aren’t suitable for a new drug will get it, and they are the ones who might get adverse reactions.”

Diane-35, originally a birth-control pill, has been advertised in Canada as “the acne solution for women only.” But researcher Barbara Mintzes says it has been approved here for use only when other options have failed. The drug, which has not been approved for use in the U.S., has been associated with liver toxicity, she says.

“Why is a second-line drug with potentially serious side effects advertised in bus shelters?” asks Mintzes, who is completing a PhD in epidemiology at U.B.C.

GlaxoSmithKline’s Zyban is an antidepressant that’s marketed as a smoking-cessation drug. The NIHCM ranked it seventh in terms of 1999 spending on DTCA, at U.S.$53.9 million. In Canada, Health Canada recently slapped GlaxoSmithKline’s wrists for an ad that appeared on CTV.

In Britain as of last week, 37 patients had died after taking Zyban, which was introduced in June, according to a coroner’s inquest into the death of 21-year-old Kerry Weston. The company stated 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, 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.)