May 16,2008 00:00
the St. Louis Post-Dispatch
Surely you've seen the television ads, the ones with attractive and carefree people gamboling through fields of flowers thanks to Miracle Drug X, or kayaking up a river thanks to Miracle Cure Y. Life would be better if only your doctor would prescribe X and Y, wouldn't it?
Maybe not. Weighing the risks and benefits of a particular drug is a serious challenge, even for the best-trained and best-informed physicians. For the rest of us, it can be all but impossible.
That's why it takes a prescription to buy certain medications; someone who knows what he is doing is supposed to make that decision. It's also why, until 1997, pharmaceutical companies couldn't pitch their advertising directly to the public.
But these days, drug companies bombard the public with billions of dollars in advertising each year, pumping up demand. Sure, you still have to get a doctor to write a prescription, but the drug companies are bombarding them even more heavily.
It's time for Congress to revisit this issue, place common sense limits on direct-to-consumer drug advertising and hike the fines for companies that violate the law.
Spending on those ads - though still just a fraction of what is spent on marketing to doctors - jumped more than 300 percent between 1997 and 2005. Over the past two years combined, it topped $10 billion.
The ads work. During a U.S. House hearing this month, Rep. Bart Stupak, D-Mich., cited one study that found for every $1 spent on consumer drug ads, sales increased by $6. Ten of the 12 most advertised brand-name drugs had sales of more than $1 billion last year.
One recent medical study found that advertising is creating markets for drugs that would otherwise not exist. It's one reason that more than half of all insured Americans are taking at least one prescription medication for chronic health problems.
The number of direct-to-consumer ads more than doubled between 2003 and 2007. Among them was a campaign for the cholesterol drug Vytorin, a subject of Stupak's congressional hearing this week. That's the one with those "food and family" ads talking about two sources of cholesterol.
Ads for the drug, made jointly by Merck and Schering-Plough, were pulled in January after release of a study that showed Vytorin is no more effective at reducing cholesterol build-up than a cheaper drug called Zocor, which is available as a generic.
Merck and Schering-Plough sat on that study for two years, advertising heavily the whole time. Last year, after data had been collected but before it was released, Vytorin rang up sales of $5.1 billion.
Incredibly, medical devices - not just drugs - now are being advertised directly to consumers. An article published this week in the highly respected New England Journal of Medicine calls for a federal investigation into television ads for a drug-coated stent, a device used to prop open clogged arteries. The ad details several potential benefits of the stent, but only limited information about the risks, or the fact you have to have surgery.
Rep. Rosa DeLauro, D-Conn., has sponsored a bill that would ban consumer advertising for the first three years a new drug is on the market. That would give regulators time to better assess its potential risks. The idea is endorsed by Consumers Union, publisher of Consumer Reports.
A Senate committee is scheduled to hear testimony on a proposal to require that all drug ads list a telephone number where consumers can file reports about drug side-effects.
In theory, the U.S. Food and Drug Administration polices drug company advertising. In reality, it's overwhelmed and understaffed. The FDA reviews just a fraction of consumer drug ads. It takes action very rarely - usually after an offending ad has been pulled off the air.
In 2002 the Bush administration issued new rules that cut the number of so-called regulatory letters issued to companies that violate advertising laws. Between 1998 and 2001, the FDA issued 15 to 25 letters each year. It issued just eight to 11 annually between 2002 and 2005. Four were issued in 2006 and only two last year, even as the number of drug ads continued to soar.
The FDA must do a better job of policing drug ads. But it won't until Congress gives it the tools it needs. Lawmakers should do so without delay.
Reprinted from the St. Louis Post-Dispatch – CNS.