Executive Health and Health CareTen Misleading Drug Ads
Rebecca Ruiz, 02.02.10, 06:00 PM EST
The FDA is finally cracking down on drug companies for ads that underplay serious risks.
When drug maker Allergan came out with the new eyelash thickening drug Latisse last year, it put on a marketing blitz featuring actress Brooke Shields. The Latisse Web site showed her longer, thicker lashes from the drug.
But the site barely mentioned Latisse's nasty side effects, which can include hair growth outside of the treatment area, a permanent darkening of eye color and bacterial infections that can lead to blindness.
The Food and Drug Administration lashed out in September 2009. In an official warning letter the FDA scolded Allergan ( AGN - news - people ) for its "misleading" claims about Latisse, which it said "omit and minimize" the drug's side effects. It demanded the company fix the Web site immediately.
The FDA's decision to confront Allergan is part of a renewed effort by the agency to crack down on questionable marketing claims under President Obama. The agency’s unit that regulates advertising sent 41 enforcement letters in 2009, twice the number sent in 2008.
In addition to Latisse, the FDA went after Eli Lilly ( LLY - news - people ) for a print ad misrepresenting its depression and pain drug Cymbalta; Abbott Laboratories ( ABT - news - people ) for an upbeat DVD interview in which Earvin "Magic" Johnson suggests the HIV drug Kaletra is more effective than studies show; and GlaxoSmithKline ( GSK - news - people ) for online ads marketing its migraine cheap viagra
Treximet without sufficiently mentioning rare but potentially life-threatening side effects.
Of course, stretched-thin or downright misleading drug marketing claims are nothing new. For most of the 1990s drugs were rarely advertised on television because regulators required that all ads list detailed information about every possible side effect. But in 1997, the FDA issued new rules for direct-to-consumer advertising, opening the floodgates for drug companies to advertise on television. Spending on drug ads aimed at consumers soared. By 2000 it had risen to $2.2. billion a year from just $844 million in 1997.
"Since at least 2000, the manufacturers have consistently tried to push the envelope with excessively rosy messages about benefits and less-than-robust descriptions of risks," says Harvard Medical School internist Jerome Avorn, author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs. During the Bush administration, he adds, "FDA leadership made it clear they were not going to be zealous in keeping the industry's feet to the fire on such ads."
By 2006 the number of FDA warning letters about dubious marketing claims had plummeted to 21 from 142 in 1997. Some very dubious ads were produced along the way. Lipitor ads featured artificial heart inventor Dr. Robert Jarvik endorsing the popular cholesterol drug. Some appeared to show him rowing across a lake. Pfizer ( PFE - news - people ) stopped running the ads in 2008 only after congressional investigators revealed that Dr. Jarvik was not licensed to practice medicine. It also turned out that Pfizer used a body double to do the rowing scenes.
These days the FDA is being much more aggressive in going after companies that try to bury side effect information in miniscule print. Last year GlaxoSmithKline put out online banner ads for its migraine cialis
Treximet featuring a migraine sufferer holding her head in her hands. The picture caption read, "I just want to take my head off." She was smiling happily in the next photo--after taking Treximet.
The FDA complained that GSK didn't do enough to highlight the serious risks of taking Treximet, which appeared in quickly scrolling text at the bottom of the banner. These include heart attack, stroke and gastrointestinal bleeding.
Sometimes companies egregiously exaggerate how well their drugs work. In a brochure given to doctors and nurses last year, the Japanese drug company Eisai claimed that its Dacogen drug helped 38% of patients with a rare blood cell disorder in a clinical study. This figure was false, the FDA said in a November 2009 warning letter. In fact, the figure was taken from a tiny subgroup of patients who responded well to the drug. When all patients in the study were included, the real response rate was a much less impressive 20%, the FDA noted.
"It’s almost impossible for the public to actually parse the ads and come to their own independent conclusions," says Cleveland Clinic cardiologist Steven Nissen, a fierce critic of drug ads.
But Nissen is suspicious of most drugs that are advertised because he thinks that the marketing campaigns distract and mislead consumers. His advice: avoid the most heavily advertised drugs and stick to generics.
How can you avoid getting misled by drug ads? One way is to skip over the glowing patient testimonials and seek hard data about the medication's risks and how it performed in clinical trials. Every drug Web site also includes a link to the drug’s official FDA label (the link usually says something like "Full Prescribing Information.") It’s heavy reading, and many doctors don’t even bother to do it. But it will have definitive, unvarnished information on how effective the drug was in its clinical trials and exactly what all the side effects were.Latisse
Actress Brooke Shields is the spokeswoman for this prescription eyelash thickening agent. In September 2009 the FDA went after Latisse's maker, Allergan, for a Web site that downplayed the drug's risks, which include cornea infections, hair growth outside of the treatment area and permanent darkening of eye color. The FDA accused Allergan of minimizing the link between using Latisse and allergic reactions like itching and redness. Cymbalta
The FDA warned Eli Lilly in January 2010 for failing to prominently include risk information in a print ad touting its Cymbalta for fibromyalgia (the drug is also approved for treating depression.) That ad featured a woman suffering from chronic knee pain and suggested that Cymbalta could relieve her symptoms. But information about the drug's risks--including nausea, insomnia, diarrhea and increased likelihood of suicidal thoughts--appeared on an adjacent page sandwiched between unrelated advertisements.Kaletra
To sell its AIDS drug Kaletra, Abbott Laboratories produced a DVD testimonial featuring Kaletra user and former basketball star Earvin "Magic" Johnson. He suggested that Kaletra can help most or all HIV patients manage their disease. Not true, said the FDA in a July 2009 warning letter. In fact, the drug was ineffective for 37% of patients in one study. The agency noted Johnson also didn't discuss life-threatening risks like pancreatitis, new-onset diabetes and spontaneous skin hemorrhages.
Bayer HealthCare, maker of the hormone-releasing IUD Mirena, marketed its device in part by sending a nurse practitioner to make at-home presentations to "busy moms." The nurses suggested the device could bring romance and intimacy back into their lives and make them "look and feel great." But the FDA cracked down in December 2009. It said Bayer failed to include discussion of side effects, including decreased sex drive, abdominal pain, nausea, headache and depressed mood.Treximet
Banner Internet ads for GlaxoSmithKline's migraine medication Treximet featured a woman who had removed her head because of migraine pain. The caption read "I just want to take my head off." After taking Treximet, she was smiling happily. The FDA complained that GSK didn't do enough to highlight the drug's risks, which only appeared in quickly scrolling text at the bottom of the banner. These include heart attack, stroke and gastrointestinal bleeding.Depakote ER
In January 2009 the FDA admonished Abbott Laboratories for distributing pharmacy flashcards that promoted Depakote ER for bipolar disorder without prominently discussing its numerous side effects. The drug's risks include potentially fatal liver damage, pancreatitis and brain and spinal cord birth defects. The flashcard also implied that Depakote ER can be used to treat mania not associated with bipolar disorder; it hasn't been approved for such use.Ertaczo
Johnson & Johnson claimed in a medical journal this cream would "Crush. Kill. Destroy" the fungus that causes athlete's foot. Yet studies found it only completely cured the disease in a quarter of patients at best, the FDA said in a warning letter. It was also advertised as an anti-itch and anti-inflammatory drug, but the FDA said those claims were not supported by the studies cited in the ad. Fosrenol
The FDA went after Shire in November 2009 after the company exaggerated the effectiveness of its kidney failure drug Fosrenol. A promotional brochure portrayed Fosrenol chewable tablets as a "sponge" that could soak up excess phosphate in the blood, which the body can't do after kidney failure. The presentation, argued the FDA, implied that the drug is more effective and works more quickly than similar drugs. There is no evidence of this. Visipaque
The FDA scolded General Electric in January 2010 after reviewing its Web site for Visipaque, an agent used in heart imaging procedures. The Web site implied that Visipaque was superior to and safer than similar products, the FDA said. But there is no clinical data backing this claim. It also failed to mention some of the serious adverse events that occur when the drug is improperly administered. These include cardiac arrest, paralysis and seizures.Dacogen
Eisai's Dacogen is used to treat certain rare blood cell disorders and blood cancers. In a patient brochure distributed by salespeople to doctors and nurses, Eisai claimed 38% of study patients had a positive response to the drug. This is false, the FDA said in a November 2009 warning letter. In fact, that figure was taken from a small subgroup of patients who responded well to the drug. Including all the patients in the study, the response rate was a mere 20%.