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FDA Vows To Police To Get Tough On Drug Ads

Posted on: Friday, 25 February 2005, 00:00 CST

Feb. 25--WASHINGTON -- Citing the boom-bust history of Celebrex and Vioxx, blockbuster drugs that jeopardized the health of thousands, the Food and Drug Administration says it will be more vigilant in monitoring drug advertising to consumers.

The agency isn't expected to take the extreme measures some critics are calling for -- such as banning consumer ads altogether. And unless a strong push comes from Congress, the FDA is not expected to reinstitute rules that once required manufacturers to provide much more detail on a drug's risks.

But Lester Crawford, the FDA's acting commissioner, pledged to aggressively police ads that make unrealistic promises of benefits with scant mention of a drug's risks. In the coming months, the FDA will push for improvements "in the type and character" of drug ads, he said.

Fifty-one percent of Americans polled this month favored increased regulation of drug advertising, compared with 37 percent in 2000, according to a Kaiser Family Foundation survey unveiled yesterday. The telephone poll of 1,201 adults, conducted from Feb. 3 to 6, has a margin of error of 3 percentage points.

The drug ad controversy flared anew last week when an FDA advisory panel gave split votes of confidence to the safety of Bextra, Celebrex, and Vioxx but nearly uniform condemnation of advertising that transformed the new painkillers into blockbusters.

Critics say the ads target consumers who are more easily convinced of a drug's benefits than doctors, who have access to journal articles pointing to risks. The combination of aging TV viewers with chronic health woes and ads that promote brands helps to explain a sudden rise in blockbuster drugs that swell in popularity before their true risks are known, many say.

"We ought to do away with direct-to-consumer advertising, because the harm outweighs the good," said James Fries, a Stanford University medical professor who had grudgingly accepted the ads.

Proponents say the advertising serves the public by encouraging more savvy conversations between patients and doctors -- at a time when managed care has shortened these chats. Consistently, patients say they have discussed a health problem for the first time with a doctor after seeing it in an ad.

Designer painkillers hit the market shortly after the FDA relaxed TV advertising rules in 1997. Last year Pfizer Inc. spent $118 million advertising Celebrex, while Merck & Co. spent $71.8 million for Vioxx ads, according to Nielsen Monitor-Plus. Ipsos Health, which tracks consumer drug purchases, projects drug companies will spend as much on advertising this year as last year, $3.8 billion.

Crawford said ads can quickly alert consumers to new products and can result in more informed conversations with doctors.

However, the nation's trading partners, including the European Union, do not permit such ads. And some drug companies have committed "malfeasances," Crawford said. "We have to send out letters instructing firms in no uncertain terms to stop this line of advertising and get back to informing the public about the virtues of the drug and the limitations of the drug," Crawford said.

This year, the agency has halted an Amgen Inc. TV ad that overstates the effectiveness of the plaque psoriasis drug Enbrel. Pfizer faced the same regulatory action for misleading safety claims and omitted risk information about Bextra and Celebrex. Pfizer had voluntarily suspended consumer advertising for Celebrex.

"Our patience is sometimes worn thin by what happens," Crawford said. "Because the industry knows that we're in charge of making sure that these things proceed along ethical and scientifically defensible lines and the public is not misled or not beguiled into thinking that a certain drug will give them the ability to levitate, or whatever."

The majority of the FDA advisory panel on cox-2 inhibitors, drugs that include Bextra, Celebrex, and Vioxx, called for a ban on all cox-2 advertising. The agency is unlikely to follow that recommendation. "Such a ban would be almost certainly illegal. The FDA has no statutory authority to ban advertising. Even if it were to have such authority, such a ban would almost certainly be unconstitutional," said Daniel Troy, the FDA's former chief counsel.

Troy now works for the Washington law firm Sidley Austin Brown and Wood and, three months after leaving the FDA, represents a drug firm that makes cox-2-inhibiting painkillers.

Fariba Zamaniyan, an Ipsos Health vice president, expects a shift away from brand-specific advertising in favor of ads that promote awareness of diseases and educational initiatives that indirectly create brand awareness.

The drug industry says silencing advertising would harm consumers more than help them.

"The most compelling statistic I have seen drawn from seven years of Prevention magazine surveys and two major FDA surveys is that between 25 [million] and 32 million Americans, after seeing an ad for a prescription drug, ask their doctor for the first time about a condition they had never discussed before," said Jim Davidson, founder of the Washington public policy firm Davidson & Co.

Others say even if the FDA does not -- or cannot -- end cox-2 drug advertising, adding black-box warnings would accomplish the same aim: reducing the number of prescriptions sharply.

Dr. Norman Fost, a member of the panel that recommended the FDA add strident warnings to antidepressants, said such black-box warnings place legal pressure on doctors because the frightening warnings make clear who should -- and should not -- receive the prescription. "Being a physician and knowing how physicians think, they're more concerned about staying out of jail than out of hell," Fost said.

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PFE, MRK, AMGN,

Source: The Boston Globe

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