HOW TO READ A DRUG AD

By Maryann Napoli

 

Fear mongering is the subtext of many of the prescription drugs ads you see on TV and in print. These ads might just as well come out and say: OK, you're healthy now, but any time in the near future you can die from a heart attack, cancer, or hip fracture. The surest route to high profits is the expensive drug that must be taken daily for years, preferably for life, out of fear of a disease that might create symptoms 10, 20, 30 years down the road.

Many of the ads play on fears of aging. Middle-aged people (with the necessary drug-coverage) are the natural targets. It helps to read these ads skeptically because many are riddled with half-truths. Here are some representative examples of the different approaches to advertising prescription drugs to the public. All are bound by the rules of the Food and Drug Administration (FDA).

 

Sell Fear of the Disease

“Osteoporosis—Could you be at Risk” This is the headline of the current ad campaign sponsored by Eli Lilly, which does not mention its osteoporosis drug, Evista (generic name: raloxifene). Anytime the drug and its purpose appears in an ad, then the side effects and adverse reactions must also be included. But Eli Lilly's ad illustrates another option in drug advertising. Instead of identifying its drug, a company can choose to sell the dangers of a given disease, in this case, osteoporosis. Ads like this one must list an 800 number that will generate a free packet of information and your name on the company's mailing list for life.

“Up to half of women over age 50 will break a bone due to osteoporosis in their lifetime. And the risk increases when menopause ends,” warns the Eli Lilly ad, which features a fiftyish woman. The statement is true, but choosing the age of 50 as the cut-off is guaranteed to instill fear. The following statements are not found in the ad, but they are also true: A woman's odds of having an osteoporosis-related hip fracture between the ages of 50 and 70 are low. Half of all hip fractures in women occur after the age of 80.

Years ago, the diagnosis of osteoporosis was made only after the person experienced a fracture due to thinning bones. Now, the definition of osteoporosis has changed to simply mean low bone mass. In other words, what was once a risk factor for fracture is now a disease. Susan M. Love, MD, author of Dr. Susan Love's Hormone Book , writes that the panel of experts that changed the definition of osteoporosis was funded in part by pharmaceutical companies.

 

Sell a Test

“See how beautiful 60 can look? See how invisible osteoporosis can be?” This is the headline for Merck's ad, featuring an older woman. It's a good example of the indirect approach to selling drugs: Encourage people to go for testing and invariably you will create many new customers for your drug. Several years ago, Merck announced that it had entered a financial agreement with a major bone density measurement equipment company, in order to get these expensive machines into as many doctor offices as possible.

Merck does not mention its osteoporosis drug, Fosamax, in this ad which simply advises, “Ask your doctor if a bone density test is right for you.” It almost comes across as a public service announcement. To prompt the hesitant women into action, Merck adds, ominously, “The fact is, if you're 60 or older, there's a nearly 1 in 2 chance you have osteoporosis.” Yes, this statement is probably true given the above, expanded redefinition of the “disease.” However, there is a debate among osteoporosis researchers about the value of measuring bone density because the test can't predict who will eventually have a fracture. Some evidence indicates that bone turnover may be more relevant, but there is no available test for it.

 

Name the Drug…and its Side Effects

HIGH CHOLESTEROL ISN'T JUST A NUMBER IT'S A WARNING . The message screams out from Bristol-Myers Squibb's ad for its cholesterol-lowering drug, Pravachol (generic name: pravastatin sodium). This represents the type of ad that identifies the drug and its purpose (“protect your heart”), so it must also list side effects and adverse reactions. In the case of a print ad, the side effects appear in tiny type on the next page. Surveys show that few people read the fine print, and this includes doctors.

The ad emphasizes the Pravachol's safety because a competing cholesterol-lowering drug, Baycol, was withdrawn last summer after it caused 31 deaths. The ad attempts to get the people who just went off Baycol to: “Ask your doctor to tell you more about high cholesterol, the risk of heart attack, and if Pravachol is right for you.”

The safety claims in this ad are: “Pravachol is no more likely to cause side effects than a placebo (sugar pill) in landmark clinical studies.” Well, yes, that's true, but only the people who turn the page and read the fine print will learn that this refers solely to the FDA-required trials that lasted only four months. Most people who take cholesterol drugs do so indefinitely, and the fine print has 16 lines of side effects experienced by drug-treated people in the longer trials that lasted five to six years.

The long list of side effects was attributed to the entire class of “statin” drugs, which includes Pravachol (pravastatin) and Baycol ( cervistatin ), Mevacor (lovastatin), and Zocor (simvastatin). The 31 deaths attributed to Baycol were due to a rare condition called rhabdomyolysis, which causes a breakdown of muscle tissue. All statin drugs have this rare risk, according to The Medical Letter (9/10/01), a physician publication with no drug advertising.

 

Name the Drug, But Not the Condition

This is the strangest approach to drug advertising because it mentions the name of a drug but not what it's for. This type of ad circumvents the FDA-requirement of listing side effects once the drug's purpose is identified. It is best exemplified by Schering-Plough Corporation's ads for Claritin, a drug for seasonal allergies. They usually feature a close-up of a young woman's face against a bright blue sky and often some flowers in the background. The message is simply: “Ask your doctor about Claritin.”

Claritin stands as a testament to the power of advertising and as a classic example why a drug doesn't have to be any good to become a big seller. Schering-Plough spent a record $136.8 million advertising Claritin directly to consumers in 1999 alone. It paid off. Claritin is the most profitable antihistamine of all time, with annual sales of more than $2 billion, according to The New York Times. A month's supply costs about $85.

Claritin is no more effective than older, cheaper antihistamines. Its much-touted advantage is the lack of drowsiness that comes with other antihistamines. Two FDA-required trials showed that Claritin is better than a placebo, but not much better. At 10-milligram doses, Claritin was only 11% more effective than a placebo. Taken at higher, more effective doses, the drug causes drowsiness.

 

End-Run Around the FDA

TV ads are generally bound by rules similar to those of print ads. In 1997, however, the FDA relaxed the rules for broadcast advertising where it concerns side effects. From that year on, only the major side effects had to be mentioned in radio and TV ads that name the drug and its purpose. This accounts for the massive increase in TV ads for prescription drugs.

But some major side effects can be a major turn-off, and that has led to some creative bending of the FDA rules. And this is best illustrated by Roche's ads for Xenical, a weight-loss drug. How many people would run out and ask their doctors for Xenical after hearing that anal leakage is a common side effect?

Roche has found a way to avoid this information with its two-part TV commercials for Xenical. The first ad does not mention Xenical; it simply shows quick images a baby growing up to be a heavy-set woman while describing excess weight as unhealthy. The second ad names the drug but not the condition, using the same background music and images. By separating the two ads with brief unrelated commercials, Roche has circumvented FDA rules about describing side effects. The ads appeared early this year, and thus far, no warning letter to Roche from the FDA has appeared on the agency's Web site.

 

What to consider when reading a drug ad:

-Many ads leave the impression that everyone who takes the drug will benefit from it. You will want to know how effective the drug has been proven to be in terms of, say, reducing heart attacks, fractures, or cancer recurrences, etc. Rarely, will a drug ad ever provide this crucial information. Consult the Physicians' Desk Reference , which is available at most community libraries. It can also be purchased at most chain bookstores. The book is difficult to read, but it is the only readily available source of data concerning what has been proven in drug trials and how long the trials lasted.

 

-Avoid taking any newly approved drug when there is an alternative. The pre-approval studies required by the FDA usually last only a few months and do not include enough participants to uncover rare side effects. In the last decade, a number of prescription drugs have been withdrawn within five years of becoming available due to life-threatening side effects. This has led many consumer advocates to advise people to wait at least five years from the date of release before taking any new drug. This also allows time for follow-up studies to determine whether the new drug is truly an improvement over the older versions of the same medication.

 

-These ads are increasing the cost of health care for everyone. The 50 most-advertised prescription medicines contributed significantly last year to the increase in the country's spending on drugs, according a new report. It also found that these 50 drugs accounted for almost half of the $20.8 billion increase in drug spending last year. The report was prepared by the National Institute for Health Care Management, a nonprofit research foundation. Only the drugs still under patent, and therefore expensive, are advertised directly to the public.

 

-Drug ads are not checked by the FDA for accuracy beforehand, though drug companies are free to do so voluntarily. This occurs infrequently. Instead, the ads are pulled only after complaints are made and verified. This usually takes about six months, and the drug company is given several additional months grace period. Companies whose ads are judged to be misleading will receive a warning letter that is published on the FDA Web site. Offending drug companies incur no penalty for misleading the public. They are merely told to withdraw the ad. Many drug companies change their ads every six to 12 months anyway. On rare occasions, a company may be required to run a corrective ad.

 

-Go to the FDA's Web site (www.fda.gov). You will find a wealth of information about drugs, as well as dietary supplements (herbs and vitamins). On the home page alone, you can go to “Safety Alerts” and see the latest recalls; “Product Approvals” for information about the new drug approvals; “How to Report a Problem to the FDA;” and “Drug Information” for standard labeling facts, such as side effects, purpose, warnings for specific drugs.

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Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.
December 2001