Turn on the television, and the flood of drug advertisements might lead one to suspect there's a pill for almost anything. There's a purple one that purportedly reduces heartburn, and a chewable cherry tablet for child asthma. To say nothing of a white pill that promises a crystal blue sky to people diagnosed with seasonal allergies.
Since the advertising was first allowed in 1997, the amount that pharmaceutical companies have spent on it has more than tripled to $2.5 billion. With every dollar, the controversy over the benefits and risks of bypassing doctors and going directly to consumers has grown, prompting calls for new restrictions and even greater demands for more research.
Two recent studies, one of which was released yesterday in Washington by the Kaiser Family Foundation, have added fuel to the debate. The Kaiser study found that 30 percent of Americans have asked their doctor about a drug they saw advertised. Of those, 44 percent received a prescription. That translates into 1 in 8 Americans who saw a drug on TV and ended up with it in a medicine cabinet.
"More research needs to be done on whether those prescriptions would have been written anyway. Are they actually making people healthier? Were they medically necessary or not?" says Mollyann Brodie of the Kaiser Family Foundation. "I don't think enough is known about that piece of the puzzle."
Even with almost 3 billion prescriptions being written a year in the US - a record number - no one really knows yet just how much impact the TV ads are having. "There is a critical public-health issue here, and that's whether it's leading to an increase in inappropriate prescriptions," says Steven Findlay, director of research at the National Institute for Health Care Management in Washington. "We can't answer that question."
Critics of the direct-to-consumer ads, known as DTC, contend that anecdotal evidence indicates people are indeed asking for and getting drugs they don't necessarily need, or ones that may be less effective than another treatment.
For instance, according to Blue Cross and Blue Shield, clinical studies show that 95 percent of people diagnosed with arthritis would be fine taking ibuprofen for a few pennies a day. But drug manufacturers are heavily advertising Vioxx for all arthritis patients - a drug that costs a few dollars a day. Its sales have increased steadily since the advertising began.
Critics also say that such ads are fueling skyrocketing prescription-drug costs, which are threatening the nation's already precarious healthcare financing system.
A study released last week by the National Institute for Health Care Management found that the 50 drugs most heavily advertised last year accounted for almost half of the increase in spending on pharmaceutical drugs. Their combined sales went up 32 percent, compared with an only 13 percent increase for the almost 10,000 other prescription drugs on the market.
But the drug companies insist there is no evidence that directly ties the advertising to increased sales. They say the newer drugs are selling because they're better and more effective.
The industry also argues the DTC ads empower consumers by getting them more involved in their own healthcare decisions. And it contends that the commercials are the best prescription to deal with what they call an "epidemic of untreated serious illnesses" in the United States, from depression to high blood pressure.
"Surveys of both patients and physicians show that direct-to-consumer advertising leads patients who would otherwise go without medical care ... to seek treatment for the first time," says Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's trade association.
The Kaiser study did find that 30 percent of Americans talked to their doctors about what they see on TV. But Ms. Brodie says the study was designed more to see how well the ads impart information. It found that almost 60 percent of the people who viewed a specific ad said afterward that they knew little or nothing more about the drug being advertised.
Seventy percent said they had learned little or nothing more about the health condition it was supposed to treat.
"Advertising is not intended to be a benefit to the people it reaches," says Larry Sasich, a pharmacist at Public Citizen's Health Research Group, a nonprofit consumer advocacy group in Washington. "Its purpose is to increase demand, and it appears to be doing that well."
While PhRMA spokesman Jeff Trewhitt declined to comment directly on the finding that 60 percent of people learned little or nothing more from specific ads, he says the Kaiser study confirmed what the industry had been saying all along: that DTC ads prompt people to talk with their doctor about potential problems.
"The study also confirms that not every patient that asks for a particular drug gets it. For us, that really underscores the fact that the vast majority of doctors do prescribe medicines that they think are best," he says.
The Food and Drug Administration, which is in the process of designing two studies to try to answer some of the unknown questions, is expected to produce new proposed guidelines for DTC within the year.