Lawmakers want research on DTC ads, discounts on drugs

Washington -- With the federal government preparing to take on a greater role in purchasing prescription medications for seniors, drug companies are coming under increasing political pressure to restrict their use of direct-to-consumer advertising.

Lawmakers are starting to take notice of drug spending and what drives it, leading some in Congress to call for studies to analyze how much DTC advertising costs the government when it purchases drugs.

It also prompted Senate Majority Leader Bill Frist, MD (R, Tenn.), earlier this month to propose that the pharmaceutical industry voluntarily adopt a two-year waiting period before advertising new brand-name drugs directly to consumers.

"In recent years, spending on direct-to-consumer advertising of prescription drugs has skyrocketed," Dr. Frist said. "This advertising can lead to inappropriate prescribing and fuel prescription drug spending. It can also oversell benefits and undersell risks."

In a statement, Dr. Frist said appropriate DTC advertising can empower patients "without inflating need or distorting medical realities." But he said that "research evidence indicates that this blitz in direct marketing has unwittingly led to inappropriate prescribing, which most importantly can compromise patient safety and care."

In addition, Dr. Frist asked the Government Accountability Office to analyze how much money drug companies are spending on such advertising and whether the Food and Drug Administration has enough power to regulate the ads.

In response to Dr. Frist's statement, the Pharmaceutical Research and Manufacturers of America announced that the industry is working on voluntary advertising principles. Drugmakers say that education is the goal of DTC advertising.

"Educational advertising empowers patients to seek guidance from their doctors, which can lead to earlier detection and treatment of diseases," said Ken Johnson, PhRMA senior vice president. "A recent national survey by Prevention magazine and Men's Health found that 28 million patients talked to their doctor for the first time about a health condition after seeing ads."

Senate bill offered

Dr. Frist plans to wait to see the response from the industry and GAO before considering any legislation to address the issue, said spokesman Nick Smith. But other senators are moving forward with legislation that would target costs the government incurs from drugs that are marketed directly to consumers.

A bill that Sens. Ron Wyden (D, Ore.) and John Sununu (R, N.H.) introduced in May would require drugmakers to offer a discount to Medicare, Medicaid and the Dept. of Veterans Affairs for any covered drugs that are advertised directly to consumers.

The measure also would require a study of what the real cost of such advertising is to the government.

Companies spent $4.5 billion on DTC drug advertising in 2004, up from $1.1 billion in 1997. That cost is passed on to the consumer, which many times is for a public program, Sununu said in a floor statement.

"This legislation presents an opportunity to get our hands around the cost issue, to fund some important studies, to take a closer look at questions of overutilization," he said.

Further study needed

Experts suggest, though, that the available evidence might not yet be clear on what the benefit of direct-to-consumer advertising is for patients.

In an editorial in the April 27 Journal of the American Medical Association, Matthew F. Hollon, MD, MPH, describes direct-to-consumer advertising as a "haphazard approach to health promotion."

Dr. Hollon also concluded that physicians and patients could be well served if a waiting period was placed on advertising for new drugs.

"I'm gratified that politicians are willing to rethink the way DTCA affects public health," he said.

At best, DTC advertising may be encouraging unnecessary use of new drugs and at worst, it can put patients at risk, said Dr. Hollon, an acting assistant professor of medicine at the University of Washington in Seattle.

Most recent research seems to suggest that DTC drug ads do increase patient access to new medicines, but not in a very targeted manner, he said.

Additionally, the safety of new medicines is often unclear in the first few years after FDA approval, he said.

Because most clinical trials include a few thousand subjects at best, it is only after the drug has been on the market for some time that rare but serious adverse reactions become apparent, Dr. Hollon said.

But long before those types of findings come out, DTC advertising has artificially accelerated distribution of new drugs into the market. This phenomenon was made clear with the introduction, promotion and eventual pulling from the market of several COX-2 inhibitors, he said.

More understanding sought

Direct-to-consumer advertising is likely to continue to have a place in public education about prescription drugs, but the industry might need to take a step back while researchers gain a better understanding of how advertising impacts patients, Dr. Hollon said in an interview.

"From a physician, patient and consumer perspective, the net benefit of direct-to-consumer advertising remains controversial," he said.

The AMA House of Delegates also recently called for further research into DTC drug advertising over concerns that patients are not being appropriately educated about the benefits and risks of drug through the ads.

"Research clearly indicates that direct-to-consumer advertising increases the demand for specific medication," said AMA Trustee Cyril M. Hetsko, MD. "We will study the overall effect of this advertising on patient care and consider strategies that could minimize its potential negative impact."