The NewStandard ceased publishing on April 27, 2007.

FDA Complicit in Pushing Prescription Drugs, Ad Critics Say

by Shreema Mehta

In light of news that government regulators have neglected their duties to review pharmaceutical commercials, their proposed fix involves crawling even deeper into bed with drugmakers.

*A correction was appended to this news article after initial publication.

Apr. 20, 2007 – A blueprint animation of an older man enjoying his day tells viewers that the arthritis drug Celebrex carries the same cardiovascular warnings as several common pain medications. The actress Sally Field says she "feels great" after taking Boniva, a drug to treat osteoporosis. A beaver and Abraham Lincoln escape a man’s dreams to chastise him for failing to take action for his sleep troubles, telling him, "We miss you."

Consumer and health groups say prescription-drug advertisements like these are often deceitful, interfere with the doctor-patient relationship, and lead to unnecessary drug use.

The Food and Drug Administration (FDA) does impose some requirements on pharmaceutical advertisements, such as mandatory risk information and supposedly prohibiting "false and misleading" messages. Though drug companies are required to submit their advertisements to the FDA, the agency does not review them before they are released to the public.

In fact, it’s not clear whether the FDA reviews most advertisements at all. The agency can direct drug companies to change their advertisements if it finds they violate regulations, but a Government Accountability Office report released last November found that the FDA reviews only a "small portion" of the advertisements it receives, and does not review them using the same, consistent criteria. The report said the GAO could not calculate the percentage of submissions reviewed because the FDA does not keep track of that information.

"People see these ads in magazines or television or hear them on the radio and they write it down and they call their doctor… and that puts the doctor on the spot."

Now, in an effort to impose greater regulations on drug marketing, the FDA plans to ask Congress to charge drug companies fees in order to fund FDA review of advertisements before they go public. The initiative is part of the renewal of the Prescription Drug User Fee Act (PDUFA), which currently charges drug companies to review the safety of new medicines.

The FDA hopes that if Congress approves the plan, it will raise more than $6 million annually through "user fees" to review advertisements.

As previously reported by The NewStandard, PDUFA has come under fire from consumer advocates who say it gives the pharmaceutical industry too much leverage over the FDA and has resulted in rushing drugs to market.

Groups like Public Citizen and Consumers Union say the FDA review of drug advertisements will likewise be tainted if funded by the very companies the FDA would be charged with scrutinizing. Critics are calling for stricter regulations over drug companies, and they say eliminating the financial ties between the FDA and the pharmaceutical industry should be the first step.

A range of public-interest groups, from ad critics Commercial Alert to senior advocates Gray Panthers, want an outright ban on all prescription-drug advertisements.

Industry representatives, on the other hand, say banning ads would violate the First Amendment. "In our system of jurisprudence we have a very high threshold that protects the right to free speech, whether it's political or commercial," Jim Davidson, attorney for the drug-company-funded Advertising Coalition, told the Associated Press on Tuesday.

Public spending on prescription drugs has also steadily increased, to about $140 billion in 2001, more than tripling since 1990.

In 2005, pharmaceutical companies spent about $4.2 billion in advertisements aimed at the public, known as "direct-to-consumer" ads – up from about $2.5 billion in 2000 and $1.1 billion in 1997. Advertising to the public is dwarfed by promoting drugs to physicians, with almost $7.2 billion spent in 2005.

At the same time, public spending on prescription drugs has also steadily increased, to about $140 billion in 2001, more than tripling since 1990.

Richard Frank, a professor at Harvard Medical School and co-author of a report published by the Kaiser Family Foundation on direct-to-consumer prescription-drug advertisements, said advertising was a contributing factor, but not the only driver of increased prescription-drug spending.

"It’s just a general trend in this country, there are more drugs available [and] they have greater capacities so people are using them more," he said. Frank added that many people are increasingly taking drugs for conditions they previously thought they just had to accept, ranging from depression to toenail fungus.

Frank said drug advertisements can be beneficial if they help people with untreated illnesses, such as depression, get treatment. But he also called for stricter advertisement regulations, such as banning celebrity endorsements of drugs. "There are things that could be done to make the advertising less persuasion-oriented, and more factual-oriented," he said.

John Pippin, a physician and adviser to the Physicians Committee for Responsible Medicine, who favors a ban on direct advertisements, said they put unfair pressure on doctors. "People see these ads in magazines or television or hear them on the radio and they write it down and they call their doctor… and that puts the doctor on the spot, because there’s always more to it than the media coverage and advertising lets on," he said. "A lot of times doctors acquiesce to what their patients want."

Survey results released by IMS Health, a market-research firm, stated that physicians were "responsive" to requests for brand-name drugs. The survey of about 2,300 physicians found that about half of them granted more than 50 percent of patient requests for specific brands. Patients requested Claritin, Celebrex and Viagra the most often, drugs which were also among the most heavily advertised, according to the survey.

"[FDA officials] behave as if their job is to get as many ‘good products’ to the American public as quickly as they can," Pippin said. "The focus should be on public safety rather than on facilitation of the drug availability process."


Clarifying Note:

John Pippin was inaccurately identified as a “former physician� in the original version of this article. Pippin is still a physician and is on sabbatical from patient care while he serves as an adviser to the Physicians Committee for Responsible Medicine.

 | Change Posted April 24, 2007 at 14:18 PM EST

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The NewStandard ceased publishing on April 27, 2007.

Shreema Mehta is a staff journalist.

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