Drug Problems
Truth gets half-time from Sen. John Edwards?


Jim Geraghty

Senator John Edwards is worried about all those prescription-drug advertisements on television these days.

Whether it’s commercials for medications that let allergy sufferers frolic in pollen-laden fields of wildflowers, antidepressants that make glum little anthropomorphic ovals suddenly turn into happy faces, or Bob Dole doing cartwheels about his “little blue friend,” Edwards thinks that the commercials gloss over the risks and side effects.

“Does anyone think drug advertising today is genuinely about educating consumers, as PhRMA [Pharmaceutical Research and Manufacturers of America] says, rather than marketing?” the North Carolina Democrat asked on the Senate floor Wednesday. “Does anyone believe that? Are drug companies educating consumers about allergy medicines by showing this picture of a woman running through a field? I think all of us know, when this kind of advertisement, as in this picture, is shown on television, it is clearly about selling and about marketing.”

Edwards, along with Sen. Tom Harkin, decided to offer an amendment that would require prescription-drug advertisers to provide equal time for information about potential side effects and effectiveness in their commercials.

“These are matters of life and death for families, for seniors, and for kids,” Edwards said. “Advertisements for these products should be held to a much higher standard. They should educate, not just market. “

While touting his amendment on the Senate floor, Edwards cited reports by two federal agencies to support his case that tough new regulations are needed for the drug commercials.

But it turns out that those reports don’t paint nearly as dire a picture as Edwards does. One says that most doctors feel they can handle patients’ inquiries about drugs they see advertised, and the other calls the current government oversight of prescription-drug advertisements “generally effective.”

During the debate on his amendment Wednesday afternoon, Edwards pointed to a survey conducted in January by the U.S. Food and Drug Administration on what doctors think of direct-to-consumer advertising of prescription drugs.

“In a recent FDA survey of 500 general practitioners, family doctors, seven out of ten said advertisements about drugs confused patients about the risks and benefits of medicines,” Edwards said.

Edwards’s statement, in and of itself, was correct. In fact, the FDA’s release on the survey stated that 75 percent of physicians believed that direct-to-consumer ads caused patients to think the drug works better than it did, and “many” physicians said they felt some pressure to prescribe something when patients mentioned DTC ads.

But the same survey found that most doctors feel they can handle these situations. Only 8 percent said they felt “very pressured” to prescribe the specific brand name drug when patients asked about one. About 80 percent of the doctors surveyed said they believed patients understood what condition the drug treats, and 82 percent of physicians believe patients understand very well or somewhat well that only a doctor can decide if the drug is right for the patient.

Similarly, Edwards cited a study by the General Accounting Office, the investigative arm of Congress, about how effectively the FDA was keeping an eye on the claims in drug commercials.

“Last year the Bush administration’s FDA instituted a new policy that slows down the FDA’s efforts,” Edwards said. “As a result, the FDA issued two-thirds fewer warning letters last year than the year before. The GAO looked into this and found that warning letters are often ‘not issued until after the advertising campaign has run its course.’”

But the GAO study also called the FDA’s oversight “generally effective” and said an argument could be made that the recent reduction in warnings “occurred because pharmaceutical companies are doing a better job of meeting FDA’s requirements.”

The report also quoted FDA officials as saying that pharmaceutical companies that have received regulatory letters “have invariably ceased dissemination of the misleading advertisement.”

As for the “slow down” of the agency’s ad review process, the GAO report said that officials with that FDA officials said the change in procedure was “to ensure that warning letters are based on a solid legal foundation and promote voluntary compliance.” The officials told the GAO “that it is important to issue DTC regulatory letters quickly and said that it intends to reduce the number of days that the letters are under review.”

Michael Briggs, a spokesman for Edwards, denied that the senator’s press release was too selective in its facts from those studies.

“I don’t see anything in those statements that is contradictory to what was said in the release,” Briggs said. “It’s just a matter of where you put the focus.”

Edwards’s amendment was rejected Thursday morning, 39 to 59. Briggs said the senator would “definitely” attempt to get more restrictions on drug advertising in the future.

“We just need to persuade a few more senators,” he said.

Edwards’s cosponsor Harkin hinted that he supports an even more ambitious goal: Banning prescription-drug commercials entirely.

“Every time I go back to Iowa, I hear from consumers and others: Why do I get inundated with all these ads, and I cannot buy them unless I go to the doctor?” Harkin said. “This all changed a few years ago. If my colleagues will remember, before 1997 [when the FDA set new rules for drug advertising], we did not see all these ads. Now it is time to cut out this massive advertising of drugs that we cannot even buy in the marketplace.”

Drugmakers were relieved.

“Fortunately, an overwhelming bipartisan majority of senators saw through Senator Edward’s claims and soundly defeated his proposal,” said Bruce Lott, spokesman for PhRMA

Some of Edwards’ presidential rivals are eagerly pointing out the irony of a lawmaker who promoted legislation aimed at helping consumers get the whole story by selectively quoting from government reports.

“Edwards is trying to score political points with cheap lawyer’s tricks,” said an adviser to a rival campaign. “He pitches the issue like a lawyer who runs commercials specializing in slip and fall cases. He better be careful playing fast and loose with the facts before the label sticks.”

Harkin also made a factual error while debating their amendment on the Senate floor.

“Right now, the drug companies are spending more on advertising every year than they are on research, and we wonder why the price of drugs keeps going up,” Harkin said.

But the GAO study that Edwards cited found that according to industry estimates, pharmaceutical companies spent $30.3 billion on research and development and $19.1 billion on all promotional activities, which includes $2.7 billion on direct-to-consumer advertising in 2001.

Pharmaceutical companies have increased spending on direct-to-consumer advertising more rapidly than they have increased spending on research and development. Between 1997 and 2001, direct-to-consumer advertising spending increased 145 percent, while research and development spending increased 59 percent, according to the GAO study.

The GAO report on drug advertising was requested by several members of Congress, including Sens. Barbara Mikulski (D., Md.), Susan Collins (R., Me.), and James Jeffords (I., Vt.). Collins and Jeffords voted against Edwards’s amendment; Mikulski voted in favor of it.

Jim Geraghty, a reporter at States News Service, is a regular contributor to NRO.