August 20, 2007
Drug Ads Booming
By Tom Ryan
A study released last week found that the pharmaceutical industry’s
direct-to-consumer advertising increased more than 300 percent in the past
10 years, while regulatory scrutiny of the ads’ claims has declined.
According
to its findings in the August 16 issue of the New England Journal of Medicine,
the FDA sent fewer letters warning drug companies that commercials were overly
minimizing risks or exaggerating the effectiveness of the drugs despite the
rise in ads.
"In 2004, four [FDA] staffers were reviewing such advertisements,
even though spending on this form of advertising (and probably the volume of
ads to review) had increased by 45 percent, from $2.9 billion to $4.2 billion," said
study author Julie M. Donohue, an assistant professor of health policy and
management at the University of Pittsburgh Graduate School of Public Health.
In 2006, 21 warning letters were sent out versus 142 such letters in 1997,
the study found. In addition, 64 percent of the ads broadcast on television
in 1999 were reviewed by the FDA, but in 2004, that percentage had already
declined to 32 percent.
The study comes amid growing calls for Congress to pass
legislation tightening control over the ads. Critics say direct-to-consumer
advertising drives up drug spending, encourages overuse of medications, and
heightens risks, such as those that led to the withdrawal of Merck’s Vioxx
arthritis drug.
The most heavily marketed drug in 2005 was Nexium ($224 million spent),
followed by Lunesta ($214 million), Vytorin ($155 million), Crestor ($144 million),
and Advair ($137 million).
The study’s authors said a moratorium, rather than
just restrictions, on such advertising might be required, especially since
advertising blitzes generally start before a drug’s safety track record has
been established in the marketplace.
"My view is that the advertising regulations
that are on the books now are adequate. Prescription drug ads are among the
most heavily regulated advertisements if you look at all other consumer products," Ms.
Donohue told HealthDay News. "But the enforcement of the regulations
needs to be there as well, and resources necessary for reviewing advertisements
need to be adequate."
"And drug manufacturers do not have to have
FDA approval of advertisements before airing them, so an ad campaign can run
its course before the FDA is able to review the ads," she added.
In response
to the study, Ken Johnson, senior vice president of the Pharmaceutical Research
and Manufacturers of America (PhRMA), said in a statement that direct-to-consumer
advertising has been shown to play a key role in educating and empowering patients,
improving patient understanding of disease and available treatments, and fostering
strong relationships between patients and their health-care providers, and
the study overlooked these "important contributions" to health.
"A
national survey by Prevention Magazine found that 29 million patients talked
to their doctor for the first time about a health condition after seeing a
DTC ad," said Mr. Johnson. "The survey also found that of these
patients, most discuss behavioural and lifestyle changes and more than half
receive a recommendation for non-prescription or generic alternatives."
Discussion Question: Do you think more regulatory oversight is needed over
the advertising content of drug ads? How do you weigh the benefits of "educating
and empowering" patients through such ads versus the potential risks?
Should drug companies pay for the brunt of costs around any increased monitoring?
Discussion Questions
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Just because a drug company advertises a drug as part of a treatment program, doesn’t mean that the physician should automatically write a prescription just because the patient wants the drug. Yes, the amount spent on prescription drugs have grown tremendously, but hasn’t the median age of the population grown as well? Don’t those things go hand-in-hand? Aren’t people living longer? Aren’t we aging better? As Sy Sims used to say, “An educated consumer is the best customer.” Because of advertising, isn’t the consumer more aware and more involved in what works and doesn’t work for them? Is this a bad thing? I don’t think so.
When the pressure is on public pharmaceutical companies to grow sales profitably, their advertising practices inevitably expand implied promises. While the ads project cautions in using their “special” products (often noted only in the small print) hope springs eternal in the breasts of hopeful or afflicted potential users. This raises the possibility of some abuse unless there is some practical regulatory oversight. While I endorse unencumbered free enterprise–the drug fox shouldn’t be the only guardian of the henhouse.
The current regulations, restrictions, and requirements for pharmaceutical advertising appear to be adequate. When it comes down to the actual prescription, it’s still up to the medical professional to determine if any given drug is appropriate and safe for the patient. Let the drug companies run the ads the way they currently air. Besides, can anyone really put up with even more voice-over devoted to the disclaimers and side effects?
It would be unfair to stop drug manufacturers from advertising. Furthermore, if the media ads were stopped, they’d just use other marketing methods more often (taking doctors on trips, increasing MD consulting fees, etc.) How about these suggestions? Require that every ad and package insert have legible-size print. Require that every drug product have the ad and marketing budget per unit, as well as the research cost and profit margin, disclosed in all advertising and in the package insert. And why not require that the prices charged in 10 other countries also be disclosed in the advertising and in the package inserts? Maybe if people saw the facts, the adoption patterns, pricing, and advertising budgets would change appropriately.