Healthy Skepticism Library item: 1660

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Publication type: news

Page S.
Drug ads: Saving lives, or selling snake oil?
The Ottawa Citizen 2002 Jan 28

Full text:

Just as smokers were making New Year’s resolutions to give up the evil weed, billboards appeared across Canada carrying messages of hope. One featured a steaming cup of coffee. Another showed a man and a woman in bed snuggling in the post-coital glow. The billboards carried the message, “Zyban? Ask Your Doctor.”

The images were meant to conjure that jittery desire to have a long draw on a cigarette while drinking coffee or lingering in bed. The point couldn’t be missed: Zyban will help you quit.

In Canada, pharmaceutical companies are forbidden from advertising prescription drugs to patients, yet these billboards appeared to be doing just that: promoting the smoking-cessation drug Zyban to smokers.

Print and television campaigns for drugs such as Alesse birth control pills, the anti-acne medication Diane-35, Zyban and, most recently, Viagra, have become more common during the past few years, leading to criticism that Health Canada is not enforcing the federal Food and Drug Act.

“I find these ads disguised as health,care information really offensive,” says public health researcher Barbara Mintzes, an expert on consumer-targeted advertising who two years ago wrote a letter of complaint about the Zyban billboards, which she says are “pure pitch” without even a hint the medication might cause side-effects.

And in fact, there are serious side-effects. Hundreds of thousands of Canadians have been prescribed the drug since it was approved in 1998. Twelve people have died while taking Zyban and 573 serious adverse reactions have occurred, including 172 seizures. Last July, Health Canada ordered the drug’s manufacturers, GlaxoSmithKline, to notify all Canadian doctors about the adverse reactions. Yet, the company continues to promote the drug without mentioning any adverse reactions, instead calling their billboards “informational.” The patient is supposed to learn about side-effects from their doctor.

A Glaxo spokesman says the ads aren’t illegal because they don’t mention any disease. The fact that Zyban is a smoking cessation treatment is only inferred.

More drug ads may be coming soon to a TV or newspaper near you.

Brand-name pharmaceutical companies and television, publishing and advertising industries are lobbying the federal government to allow direct-to-consumer advertising of prescription drugs, similar to the American ads that have already been filtering across the border on television and in magazines. This coalition — the Alliance for Access to Medical Information — has visited 65 members of Parliament in recent months to press for the legalization of drug ads.

Former Ontario health minister Murray Elston, who is now president of Rx&D, a pharmaceutical industry lobby group, says prohibiting drug ads is akin to “censorship.”

“I don’t understand why government officials are prepared to be paternalistic about people understanding that there are products out there that just might improve their health.”

Mr. Elston argues that direct-to-consumer advertising will provide information about important, treatable health conditions and encourage doctor-patient communication. Drug ads are particularly important, he says, for people who suffer from under-diagnosed illnesses such as depression and hypertension. Ads for drugs that treat those diseases might prompt sufferers to get help, he says.

There is also an economic interest for the drug companies and the other industries pushing for the ads. The pharmaceutical industry, one of the most profitable in the world, requires revenue from consumer advertising to continue its current rate of growth. Direct-to-consumer advertising could also bring tens of millions of dollars to television networks, newspapers and magazines.

Groups opposed to drug advertising, such as the Canadian Medical Association, the Canadian Pharmacists Association and the Consumers Association of Canada, are lobbying politicians not to legalize drug ads.

These critics say the ads contribute to rising drug costs and lead people to demand unnecessary, or even harmful, medications. One U.S. study says 80 per cent of those who asked for a drug they’d seen on television got it from their doctor. They also contend that drug companies, whose main purpose is to sell their products, are not objective sources of drug information.

Probably more than the citizens of any industrialized country, Canadians don’t have access to information about the drugs they’re prescribed. In some cases, patients have had to apply under the Access to Information Act to obtain the product monograph for a prescription drug they are taking. Unlike European countries, Canadian pharmacists aren’t required by law to include detailed drug information along with prescriptions. And drug companies are not allowed to communicate directly with patients with the intent to sell the drugs. Doctors are the gatekeepers and providers of information on drugs. And evidence shows that in a 15-minute visit, there is little time for a doctor to explain how a drug works or what its side-effects might be.

The key to the drug ad debate is where Canadians will get unbiased information about their medications.

Health Canada has prepared a number of options that will allow some form of mass media drug advertising. These proposals will be debated in the coming months.

Canadians are looking to the U.S. to see whether direct-to-consumer advertising has resulted in better health care, or whether it has needlessly driven up health care costs. There are hopes that a made-in-Canada solution will be better.

American essayist and doctor Lewis Thomas wrote in 1980 about the risks long before the advent of direct-to-consumer advertising: “If people are educated to believe they are fundamentally fragile, always on the verge of mortal diseases, perpetually in need of health care professionals at every side … the new danger to our well-being, if we continue to listen to all the talk, is in becoming a nation of healthy hypochondriacs, living gingerly, worrying ourselves half to death.”

Will ads for drugs promising to treat every possible illness “medicalize” patients, so that they come to expect a pill for every purpose? Will doctors be pressured even more to become drug pushers instead of healers?

Dr. Henry Haddad, president of the Canadian Medical Association, is worried about the effects of drug advertising. “It makes people see prescription drugs as a consumer good just like any other, instead of a health care benefit. We’ll have an enormous amount of pressure on us by the patient. If we don’t give them a drug they see advertised, they’ll say, ‘You’re depriving me of a drug that will give me some benefits.’ It’s not a good situation.”

Or will we become “expert patients” who demand — and get — the best for ourselves?

Ads for dozens of new drug products flooded the airwaves in 1997, when the U.S. Food and Drug Administration (FDA) relaxed its rules for advertising prescription drugs on radio, TV and the Internet. Expenditures on advertising to consumers have risen from almost nothing to around $2.5 billion U.S. a year. And the advertisements have been effective.

According to a study by the National Institute of Health Care Management, a non-profit foundation founded by the Blue Cross Blue Shield health insurance plans, the most heavily advertised drugs were the most heavily prescribed.

The anti-arthritis drug Vioxx was the most heavily advertised drug to consumers in 2000. Its maker, Merck, spent $160.8 million promoting the drug in the mass media — more than PepsiCo spent to promote Pepsi or Budweiser shelled out to sell its beer.

Retail sales of Vioxx (approved in 1999) quadrupled from $329.5 million in 1999 to $1.5 billion last year.

The study found that Pfizer spent $58 million U.S. to promote the cholesterol-lowering drug Lipitor in 2000, prompting a 39-per-cent increase in sales over the previous year.

But the report says there are still many uncertainties about the impact of such consumer advertising. Do these ads induce consumers to press their doctors for specific drugs? Do doctors comply? Do the ads drive consumers to seek expensive, brand-name drugs when less expensive drugs might be better? Are the ads leading to the inappropriate clinical use of some drugs? Do the ads contain sufficient information on potential side-effects? How much of the recent rise in drug spending can be traced to current direct-to-consumer advertising?

The drug company ads in American newspapers, on television, radio, and the Internet are for such life-threatening illnesses as cancer and HIV infection, as well as conditions that traditionally are treated with drugs.

For example, in a TV ad for Sarafem, a frustrated woman is shown trying to free a stubborn shopping cart from others in front of a store. An announcer asks: “Think it’s pre-menstrual syndrome? It could be premenstrual dysphoric disorder.”

Sarafem has been described as “Prozac in pink” because it’s the popular anti-depressant, repackaged by maker Eli Lilly and targeted at women, three to 10 per cent of whom suffer from premenstrual dysphoric disorder (PMDD). Symptoms of the disorder include profound depression, anxiety or tension, persistent anger or irritability that interfere with work, school, and relationships. The FDA made Eli Lilly pull the ad because it didn’t distinguish between pre-menstrual syndrome and the far more serious, and significantly less common, PMDD. “It broadens the message and trivializes PMDD,” the FDA said.

“The company was advertising the drug as though it was useful for everyone with PMS,” says Ms. Mintzes, who has analysed many of the ads for a report she is preparing for Health Canada. She works for the Centre for Health Services and Policy Research at the University of British Columbia and is finishing her doctorate on direct-to-consumer advertising.

Among the ads she’s studied are those advertising the antidepressant Paxil for the controversial condition called “social anxiety disorder.”

In one ad, accompanying the text, “What it feels like, what it is,” a businessman in a boardroom is tied to a chair with a light beaming down on him as though he is being interrogated, and in another shot, he’s in a real board meeting, looking content and calm.

The suggestion is that Paxil will treat “social anxiety disorder,” and help people function normally. But Ms. Mintzes says the ad is targeting people who don’t even have the disorder. “There is severe agoraphobia, but this guy clearly doesn’t have that. In a lot of cases, social-anxiety disorder sounds a lot like shyness.”

Another ad — “Know your breast cancer risk. And do something about it.” — encourages healthy women over 35 to use Nolvadex to prevent breast cancer. Nolvadex (tamoxifen) can cause cancer of the uterus and potentially fatal blood clots, but it’s still not clear whether it prevents breast cancer deaths because it hasn’t been studied long enough to know, Ms. Mintzes says.

Another ad — “Is it forgetfulness … or is it Alzheimer’s?” — could lead healthy people to believe they need medication, she says.

In some cases, advertised drugs have been pulled off the market because of serious side-effects. Rezulin (troglitazone), the drug for type 2 diabetes, was advertised in the U.S. for more than two years after Britain withdrew it for safety reasons. By the time it was withdrawn from the U.S. market in 2000, it was suspected in nearly 400 deaths, 63 from liver failure.

The content of drug ads has been challenged as misleading. Recently, the San Francisco health department threatened to ban advertising of AIDS drugs on city billboards that showed vibrant young men climbing mountains: They had found that young, gay men were less likely to practise safe sex because they believed AIDS is curable.

A 1999 FDA telephone survey of 1,081 consumers found that 25 per cent who had seen an ad said they had asked a doctor about the condition or illness featured in the ad. Thirteen per cent asked for a specific drug and about half of those got it.

A survey of 1,222 people in June 2000 commissioned by Prevention magazine found that 91 per cent had seen or heard a prescription drug ad. Thirty-two per cent of those had talked with their doctor about an advertised medicine, and 26 per cent of that group asked for the advertised medicine. Eighty per cent of those left their doctor’s office with a prescription.

In a random sample of 329 people in Sacramento, 21 per cent said that if their doctor refused a requested medicine, they would try to persuade the doctor to prescribe it. Those who thought only completely safe, extremely effective drugs were advertised were more than three times as likely to pressure their doctors — and seven times as likely to switch doctors — if a requested drug was refused.

Ms. Mintzes says these results show Americans are doing a lot of self-diagnosing and doctors, instead of being gatekeepers, seem easily persuaded to prescribe medications.

“If over 80 per cent are getting the drug when they ask for it, you have to ask, ‘Did the person accurately self-diagnose?’ You can pretty well say you’re ending up with people who have contraindications. Were they aware of all the treatments available for their problem? Did they know how the treatment they received compared to other available treatments?” she asks.

Studies show that Americans usually don’t understand or are unaware of the information on side-effects offered in the ads. In many cases, the information itself is misleading.

In one national survey, 33 per cent were unaware of the fine-print risk information accompanying published direct-to-consumer ads. Among those aged 60 and older, 52 per cent failed to notice labelling information.

A Consumer Reports survey of 28 ads in consumer magazines found that 33 per cent contained factual errors, half did not convey needed risk information, and only 40 per cent honestly portrayed efficacy, risks and benefits.

A study in the Journal of Family Practice looked at 320 ads over 10 years in 18 leading magazines and found that women were 2.6 times more likely to be targeted exclusively than men. The researchers also found that in most cases, the ads did not provide information necessary for informed decision-making: 64 per cent of ads did not explain how the drug works; 71 per cent didn’t mention other possible treatments; 76 per cent didn’t describe other helpful activities, such as exercise or diet; 80 per cent didn’t say how long it takes the drug to work; 89 per cent didn’t say how long a person needs to take the drug; 91 per cent did not describe the likelihood the treatment would succeed.

In surveys, doctors claim not to like the impact such advertising has had on their practices.

About 65 per cent of American doctors and 75 per cent of New Zealand doctors would like to see direct-to-consumer advertising limited or stopped altogether.

Doctors are wrestling with how to curb the influence of these ads on patients. The American Medical Association this summer approved a resolution asking drug companies to voluntarily place disclaimers on each ad that say, “Your physician may recommend other appropriate treatments.”

In Canada, there is no question patients need better information about prescription drugs. During a 15-minute appointment with a doctor, which involves an examination, a diagnosis and often the prescribing of a medication, something falls by the wayside. Often, doctors don’t have or take the time to explain how a drug works or its side-effects. When the patient gets the prescription filled, there is no law guaranteeing they’ll receive an insert describing the drug. Often, they don’t.

The campaign to legalize direct-to-consumer advertising in Canada has been framed as a way to provide patients with information about drugs or inform them of available treatments.

Murray Elston, of Rx&D, says he’s heard of cases where men saw ads for Viagra and went to their doctors to get a prescription. “They discovered that the problem was not what they suspected, but there was some urinary condition and it was correctable. What they ended up doing was catching other problems earlier.”

Paul Jones, publisher of Maclean’s magazine, says if drug companies decide to flood Canadian markets with direct-to-consumer advertising, it might be a “boon to the media, given the downturns we’ve all suffered.” More important, “we just don’t like to see commercial speech arbitrarily restrained.

“Is there any other area of my life where I allow the government to tell me what I can and can’t know?”

The large pharmaceutical companies have also been lobbying the European Union to allow direct-to-consumer advertising.

The international drug industry has been lobbying hard to make such advertising legal throughout Europe, Canada and Australia because the industry is in “crisis and has become unsustainable,” according to a briefing to the European Union, written by Charles Medawar, a consumer advocate and member of the World Health Organization’s Expert Advisory Panel on Drug Policies and Management.

Mr. Medawar says the pharmaceutical companies require blockbuster drugs — those with product sales of at least $500 million a year — to continue to be prosperous and create new drugs. To create blockbuster drugs, pharmaceutical companies need to market them.

In Britain, according to Pharmaceutical Marketing, this means the pharmaceutical industry employs “ground troops in the form of patient support groups, sympathetic medical opinion and health care professionals which will lead the debate on the informed patient use.”

The lobbying effort in Europe appears to have been effective. The EU is seriously considering allowing ads for drugs that treat HIV, diabetes and asthma.

These diseases were chosen because they are easily definable, chronic conditions and won’t lead people to demand medications for illnesses they don’t have.

In large part, drug companies are considered vital to the economy, primarily because of their investment. Drug companies repeatedly say that if anything is done to moderate prices or profits, vital research and development will suffer. “It’s going to harm millions of Americans with life-threatening conditions,” the president of the Pharmaceutical Research and Manufacturers of America said recently.

But Mr. Medawar asks how the continual increase in government and consumer spending on drugs is sustainable. “Health expenditures of this order would very rapidly cripple the kind of national health care provision enjoyed in EU countries and elsewhere,” he writes.

In Canada, Mr. Elston says he finds it unconscionable that people would think of the bottom line before a patient’s health. “It’s scandalous,” he says.

While Health Canada debates the issue of direct-to-consumer advertising, pharmaceutical companies are increasingly running ads that appear to push the envelope.

Under Canada’s Food and Drugs Act, prescription drug ads aimed at consumers are forbidden, but Health Canada’s Ross Duncan says most of the recent ads are permissible under a 1978 amendment originally intended to allow pharmacists to advertise the price of medications.

The amendment allows drug ads, provided they mention only “the brand name, proper name, price and quantity of drug.” Health care information, through which drug companies educate patients about high cholesterol or Alzheimer’s, is also allowed.

Current drug ads don’t show prices or quantities — but they do mention a brand name drug and allude to a condition, or vice versa.

For example, in one ad running in Canada, the caption reads, “The acne solution for women only,” and there is an accompanying 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, Diane-35.

In another information campaign, a body lies on a slab, with a rigid toe tagged. The dead man is 42 years old, and described as not overweight. The ad copy asks: “Which would you rather have, a cholesterol test or a final exam?”

The ad is sponsored by Pfizer, the maker of the cholesterol-lowering drug Lipitor, the No. 1 selling drug in Canada.

Ray Chepesiuk, of the Pharmaceutical Advertising Advisory Board, a group that reviews drug ads targeted at doctors, was highly critical of this campaign.

“You end up with dead bodies on a gurney and you wonder, ‘What the hell does this mean? What does this mean and why are they telling me this’?”

Ms. Mintzes finds this ad “scandalous.”

“It’s very true that for people with heart disease, statins (such as Lipitor) are helpful, whether somebody has high cholesterol or not. But without heart disease, there is no evidence that statins reduce mortality for anyone, especially women. This ad was running in Chatelaine. The whole thing is so offensive it’s unbelievable. You use scare tactics using an image of a corpse to get the public to buy a product.”

The pro-advertising Alliance for Access to Medical Information has drawn up a “Made in Canada Solution,” which mirrors the proposals Health Canada will put forward for Canadians to debate in coming months.

Some form of direct advertising could be included in law when the Health Protection Act is revamped later this year, says Mr. Duncan.

Among the proposals:

* “Mandatory pre-clearance” of all ads to ensure they’re of high quality, accurate and balanced. They would be required to state who the product is for, and who should not consider the product, as well as the side-effects. There is no pre-clearance of U.S. ads. * A ban on advertising new drugs until doctors have had a reasonable time to learn about medications before being faced with patient demand. The alliance suggests a waiting period of six months, while others have proposed five years, by which time any long-term problems with the new drugs may have emerged. * Ads must suggest that physicians be consulted about the advertised drugs. * Governments must have the ability to pull ads found to be misleading. * Advertisements would be required to direct people to other sources of information on that drug. * It must be clear that the drugs are available in Canada.

Mr. Duncan acknowledges that some critics of direct advertising would prefer that Health Canada focus on helping doctors become better prescribers, and getting patients better information, without it being tied to an advertisement meant to sell a drug.

To satisfy these concerns, Health Canada is asking — although not legally requiring — drug manufacturers to include a new section on all product monographs that provides “patient-friendly information.”

Right now, section one provides information for doctors. Section two is for pharmacists. A third section would summarize the doctor and pharmacist information in “plain language.”

Health Canada plans to make these “patient-friendly monographs” available on the Internet.

“We’re hearing loud and clear from consumers, ‘We want more information.’ This is about getting the right information in the right format into the right hands at the right time.”

It would seem that Canadians are destined to get some form of direct drug advertising, putting more pressure on doctors to act as gatekeepers, who must weigh the demands of their patients against their actual health needs.

Mr. Duncan says it’s clear that, under direct advertising, more prescriptions are written and drug spending increases. It’s still not clear whether this leads to better or worse care for patients.

Health Canada is sponsoring a study to compare the prescribing practices of doctors in California, where there is drug advertising, to prescribing practices in British Columbia, where there isn’t, to see how care differs.

Ms. Mintzes doesn’t have faith that doctors can be effective gatekeepers.

“If 80 per cent or more of requests for advertised drugs result in prescriptions in the U.S., doctors aren’t saying no very often,” she says.

As Canadians and interest groups prepare to debate this issue, it’s clear the drug industry, along with advertisers, broadcasters and publishers, have a lot to gain.

It’s not clear a made-in-Canada solution will create the “expert patient” those in favour of drug advertising have been promoting.

Photo: Barbara Mintzes, a Vancouver epidemiologist and an expert on consumer-targeted advertising;

Photo: Glaxo-Wellcome Inc. (now GlaxoSmithKline) launched Zyban in 1998 using ads aimed at smokers trying to quit. Ogilvy & Mather Canada Ltd., the advertising company that created the campaign, said ‘the creative challenge was to work within the laws and regulations that Health Canada upholds for prescription drug advertising.’ The ad’s caption read: ‘Having a little trouble quitting smoking? You have options. Including the gum, the patch, and oral medications. Ask your doctor about all your options. Because quitting smoking doesn’t have to feel like quitting smoking.’