• Introduction
• Ask your doctor
• Newer is not necessarily better
• Empowered and informed by advertising?
• A Commitment to Non-Enforcement
• An unnecessarily risky drug
• Twenty million Americans exposed to unsafe drugs
• The right to know or the right to advertise?

Introduction

‘Has social anxiety put your life on hold? Ask your doctor about PAXIL today… your life is waiting!’ proclaims a full-page advertisement in the New York Times, featuring an anguished young woman with her eyes closed, head in hands, leaning against a wall. According to the advertising text, 10 million Americans suffer from social anxiety disorder. Many might be forgiven for confusing ‘social anxiety disorder’ with what we used to call shyness.

‘Is it just forgetfulness…or Alzheimer’s disease?’ asks another ad, echoing my thoughts as I search for my keys yet again. ‘Know your breast cancer risk. And do something about it’ urges an ad pushing healthy women over 35 to use a drug for many years to prevent breast cancer. This drug, Nolvadex (tamoxifen), can cause cancer of the uterus and potentially fatal blood clots. Whether it prevents breast cancer deaths is unknown. It just hasn’t been studied for long enough to know.

These are recent direct-to-consumer prescription drug ads aimed at the American public. Direct-to-consumer advertising is only legal in the U.S. and New Zealand. It’s illegal in all other industrialized countries. However, the drug and advertising industries have been lobbying hard to make it legal elsewhere – throughout Europe, Canada and Australia.

Why not allow direct-to-consumer prescription drug advertising? There are two main reasons, reflected in the laws prohibiting it. The first is related to the disease. For example, Canada’s Food & Drugs Act contains a list of serious diseases for which treatments or prevention should not be advertised to the public. The idea is not to take advantage of people’s vulnerability. Being seriously ill or caring for a sick child isn’t the same as going out to buy a new perfume. No one chooses to be sick and to need a medicine.

The other reason is related to prescription-only status. Some medicines are considered safe enough to be sold without a doctor’s prescription. Others are prescription-only drugs because they are more toxic, they need to be used with greater care, or simply because they are so new that we know very little about rare or longer-term risks. The ban on advertising to the public is part of the protection offered by prescription-only status.

Ask your doctor

One of the differences between this type of advertising and any other ads is the constant refrain to “ask your doctor”. You can’t see the ad and go buy the product. You need to go to the doctor and get a prescription. The industry argues that because a prescription is needed, the public is protected from misleading advertising. It’s the doctor’s responsibility to make the final decision.

U.S. consumer surveys paint a different picture. Four out of five times, when a person asks for a prescription, they get it. About a quarter also report that they’ll go to another doctor if their doctor won’t prescribe a medicine they want. Doctors often feel pressured and prescribe medicines to please their patients, whether or not a prescription is really needed. This has been shown in studies of antibiotic prescribing for coughs and colds; it’s not likely to be any different for advertised medicines.

Newer is not necessarily better

Most of the most heavily advertised drugs are new, expensive products. For the most part, they’re not breakthroughs.

Take the new arthritis drugs Celebrex and Vioxx. They’re no more effective than a dozen other arthritis drugs. They also don’t seem to be any safer. Vioxx causes a few less stomach bleeds but a few more heart attacks than other arthritis drugs. Similarly, Celebrex causes around the same number of serious harmful reactions as other arthritis drugs.

The ads tell another story. The headline is “What will you do on the day you discover Celebrex?” They imply instant relief like you never had before. Instead of the woman running on the beach with her dog, she should be frowning at her empty wallet.

In the U.S. 40% of the $2.5 billion dollars spent on ads last year was for just 10 products. These were mainly new, expensive drugs for long-term use for wide target audience. This makes a lot of sense if you’re thinking of returns on investment. It makes a lot less sense if you’re thinking about public health, especially if you’re getting more and more people to take potent drugs for milder conditions like a runny nose or for problems like shyness or baldness that have little to do with health.

Empowered and informed by advertising?

One of the arguments for allowing prescription drug advertising is that it empowers consumers, gives them more of a choice, and helps them to take part in informed treatment choice. But, advertising isn’t neutral information. It won’t provide full, unbiased information on the pros and cons of all available treatment options, both drug and non-drug. No diet drug advertiser, for example, is going to tell you to go to the gym instead of taking the drug because exercise is a more likely to lead to sustained weight loss.

In addition, violations of U.S. advertising regulations are common. In the U.S., the FDA sent out over 90 warning letters to companies about misleading ads in the last year alone. The most common reason for violations were inadequate risk information and exaggerated benefits.

In New Zealand, the situation is even worse. There, the government relies on the industry to regulate itself. TV ads don’t even mention risks in the voice-over. They flash a box of information on screen, often too fast to read it.

A Commitment to Non-Enforcement

In Canada, also, there are serious problems. U.S. ads are streaming across the border and the government is doing little to enforce the law. More and more companies are running ads that skirt the limits of the law – and beyond. They’ve had no fines, no sanctions. During one massive ad campaign, the only response from the government was to say "This is illegal. Don’t do it again". They didn’t say: “Pull those ads immediately."

In Canada, the federal government is responsible for regulating advertising, but provincial governments pay for drugs and administer health services. The federal government has less than one dedicated staff position to regulate advertising. This is doubtless saving money in salaries, but it’s likely to be costing the provincial governments a lot more money in unnecessary prescriptions. And no one is following up to know how many people end up in hospital or die from unnecessary drug use.

An unnecessarily risky drug

Berlex has been running ads on bus shelters and in movies for an acne drug, Diane-35. This hormonal drug was sold for birth control in Europe in the ’80s and early ’90s, until a long-term user died of liver cancer. First Germany and then the rest of Europe reviewed its safety and restricted it to a second-line acne treatment. It may or may not cause liver cancer, but one of the ingredients can cause liver injuries and liver failure at higher doses. In Canada, it’s only approved as a second-line treatment for severe acne when other options have failed. The product is not sold in the U.S.

This bus shelter ad makes it look like a harmless cosmetic. Diane-35 was one of the top 200 drugs with the most prescriptions in Canada in 2000. It’s been heavily promoted to doctors as well as to the public. Do teenage girls really deserve to risk liver failure for the sake of a few pimples?

Twenty million Americans exposed to unsafe drugs

Unlike a new computer, a new medicine isn’t necessarily any better. Often it’s worse. When a new drug first comes to market it usually has only been tested against a placebo or sugar pill, not other treatments. Only about 3,000 people are involved in pre-market tests on average, not enough to know anything about rare or longer-term risks.

Ten drugs were withdrawn from the U.S. market for safety reasons between 1997 and the present. Twenty million Americans – around 10% of the adult population – took one or more of these ten drugs. They’re the suspected cause of over 1,000 reported deaths.

One of these was the diabetes drug Rezulin, which was advertised to the U.S. public. How many people took it after seeing ads and asking their doctor for it? Were they among the 390 people who died with Rezulin named as a suspected cause? Rezulin has never been shown to save any lives. It can lower blood sugar, but it was not been tested for long enough to know if it prevents serious complications or deaths from diabetes.

The right to know or the right to advertise?

The debate on direct-to-consumer advertising isn’t really about the public’s right to know. None of the countries with laws against advertising forbid information on medicines. In Europe and Australia, consumers have a legal right to approved product information when they receive a prescription drug. Canadians and Americans don’t have that legal right.

The debate is about the company’s right to advertise. The real question is whether marketing or public health is the priority. Whether the ads are for baldness, allergy, Alzheimer’s or AIDS, the message is the same: you can just pop a pill. Reality is a little different.

Barbara Mintzes is with the Centre for Health Services and Policy Research at the University of British Columbia, Vancouver, British Columbia, Canada. She can be reached at bmintzes@chspr.ubc.ca

For further information visit these sites:

• DES Action - Canada
• Breast Cancer Action