Nearly 110 years later, drug advertisements are the leading source of revenue for most medical journals, and the pharmaceutical industry spends hundreds of millions of dollars per year promoting its products.
But when do drug ads stop becoming "reputable" and start misleading people into potentially harmful situations? A recent study in Consumer Reports highlights the beguiling effect such advertisements have not only on America's citizens, but the health care providers whose priority is to serve the public.
In its analysis, Consumer Reports examined every regulatory letter posted by the FDA on its Web site from January 1997 to November 2002 regarding false or misleading drug promotions - a total of 564 letters. The list underscores a wide range of discrepancies that have occurred in drug advertisements in the past few years:
- There were 363 instances in which an advertisement omitted, minimized or obscured a drug's risks. For example, in one commercial for a skin care ointment, the narrator stated that the drug "soothes eczema anywhere on your body." What the ad failed to mention was that studies found even a less potent version of the ointment caused itching in one-fourth of users and a burning sensation in almost half. The ad was eventually pulled from the airwaves, even though a spokesperson for its manufacturer said, "We don't think the ad was misleading."
- Incorrect, inadequate or inconsistent labeling was found in 230 instances. Several publications ran an ad for Lipitor, a drug that lowers cholesterol, claiming that other drugs in the same class reportedly caused serious muscle damage. A letter sent by the Food and Drug Administration corrected this claim by stating that while some risks of muscle damage applied to all drugs in the same class as Lipitor, several other risks applied only to Lipitor.
- False, unsupported or misleading claims of comparison or superiority were noted 214 times. In one television commercial for the migraine drug Imitrex, a nurse beamed that, unlike her old medication, "Imitrex targets your total migraine." However, in a regulatory letter sent to GlaxoSmithKline, the FDA said it was "not aware of any studies comparing Imitrex to other prescription pain relievers."
- There were even 44 instances in which false or misleading information was given to physicians by drug representatives or paid speakers. One of the most egregious occurrences happened at a drug therapy conference in Chicago, where representatives of a new anti-HIV medication claimed it was a "miracle drug" that was "extremely safe" and had "no toxicities." The drug's label, however, told a different story: A warning box noted that anti-HIV medications have reportedly caused fatal liver enlargement and acid buildup in the blood. A warning letter from the FDA added the clinical benefit of the "miracle drug" had yet to be determined. A spokesperson for the drug's manufacturer said that the company took steps to rectify the problem by instituting "proper training" of its sales force.
Other violations included claims that were false, misleading, or of unsubstantiated efficacy (203 citations); promotion of approved drugs for unapproved purposes or patient groups (121 citations); and promotion of unapproved, still-experimental medications (62 citations).
Consumer Reports also referenced several recent studies showing that most drug ads do not adequately transmit information about their products, particularly their risks:
- In a 2000 survey of 1,310 members of the American Association of Retired Persons (AARP), one-third of the respondents who saw a print drug ad failed to notice the small print that summarizes a drug's risks and side-effects. Of those who did notice the small print, only one-third said they usually read it.
- In a 2001 survey of 1,872 adults by the Kaiser Family Foundation, more than two-thirds of the participants shown drug ads said they learned "little or nothing" about the condition being treated; 59 percent said they learned "little or nothing" about the drug being advertised.
- A study conducted by researchers at the University of California at Los Angeles and Davis (UCLA/UCD) found that 43 percent of the respondents believed only drugs that are "completely safe" can be advertised.
Perhaps most alarmingly, pharmaceutical ads appeared to have a direct effect on the way doctors prescribe drugs for their patients.
- In two studies funded by the drug manufacturer Pfizer, involving nearly 420 physicians, between 19 percent and 30 percent of the doctors surveyed said they felt pressured to prescribe either cholesterol-lowering or mood-altering medications by patients who mentioned ads for those medications.
- In another finding from the UCLA/UCD study, 46 percent of the respondents said they would be "disappointed" if their doctor turned down the patient's request for an advertised drug; 15 percent said they'd actually consider switching physicians.
What's more, the proliferation of drug ads appears to contribute significantly to the rapid rise in spending on prescription drugs. Such spending increased 19 percent in 2000, according to the National Institute for Health Care Management Foundation, and almost half of that increase was caused by sales of the 50 most-heavily advertised drugs.
What Can You Do?
As the results of the Consumer Reports analysis show, objective drug ads appear to be the exception, rather than the rule. To combat misleading drug information, the authors of the article offer several suggestions for patients:
- Treat drug ads as you would any other type of sales gimmick. If an ad makes you think a drug will help you, seek unbiased information, such as in the Physicians' Desk Reference, and take that information to your health care provider.
- Bring a list of questions to discuss with your health care provider, such as: Do I have the condition this drug is supposed to treat? What are its risks and benefits? Do the benefits outweigh the side-effects (or costs)? How does this drug compare with other medications or drugless therapies?
- If you suspect a drug advertisement is incorrect or misleading, report it to the FDA (Tel: 888-463-6332; address: Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-0001) or contact the National Advertising Division (www.nadreview.org).
Doctors of chiropractic are known for championing natural health and wellness. As a DC, there are several steps you can also take to ensure your patients do not fall prey to misleading advertising. Ask your patients if they are taking any medications, and if so, what conditions they are taking those medications for. Visit the FDA's web site (www.fda.gov) for updates and warning letters about pharmaceuticals, or join its MedWatch discussion list to receive safety alerts. Above all else, educate yourself about what medications really do, not what advertisements claim. By being informed, you'll be doing a great service to yourself and to your patients.
References
- Anonymous. Can the advertisements in a reputable medical journal promote quackery? Journal of the American Medical Association 1894;22:958.
- Free rein for drug ads? A slowdown in FDA review has left consumers more vulnerable to misleading messages. Consumer Reports February 2003;33-37.
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