Fwd: NYT: Repeated Deception in Drug Ads

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Investigators Find Repeated Deception in Ads for Drugs

 

NY Times

December 4, 2002

By ROBERT PEAR

 

WASHINGTON, Dec. 3 - Some companies have repeatedly

disseminated misleading advertisements for prescription

drugs, even after being cited for violations, and millions

of people see the deceptive commercials before the

government tries to halt them, Congressional investigators

said today.

 

The investigators, from the General Accounting Office, said

Pfizer, for example, had continued to make misleading

claims in advertisements for its cholesterol-lowering drug

Lipitor, despite several letters from the Food and Drug

Administration in the last four years.

 

In a new report, the accounting office said that drug

company advertising appeared to produce a significant

increase in the use of prescription drugs, as well as

higher drug spending. The report criticized delays in the

enforcement of federal standards for the accuracy of drug

advertising and attributed much of the delay to a recent

change in procedure by the Bush administration that

lengthens the review process

 

The study estimates that at least 8.5 million Americans

each year request and receive prescriptions for specific

drugs after seeing or hearing advertisements for those

products. The drugs cited in the report include Flonase, an

allergy drug; Prilosec, for ulcers and heartburn; and

Actonel, for osteoporosis.

 

Senator Susan Collins, a Maine Republican who was one of

five members of Congress who requested the study, said:

" The evidence suggests that consumers are paying a lot of

attention to these ads, so it's imperative that they be

accurate. If the increase in utilization is based on false

claims, that's very troubling. "

 

The report rejected a contention by critics of the

pharmaceutical industry, including many Democrats in

Congress, who say drug companies spend more on advertising

than on research and development. Using data obtained

mainly from the drug industry, the report said that drug

makers spent much more on research. Last year, it said,

companies spent $30.3 billion on research and development

and $19.1 billion on all promotional activities, including

$2.7 billion for advertising aimed at consumers. But the

report said that ad spending rose at a far greater rate

than spending on research.

 

Consumer advertising has shot up almost 150 percent since

1997, when the Food and Drug Administration revised its

guidelines to permit more ads, and drug makers have shifted

much of their spending from print media to television, the

report said.

 

The accounting office said that the recent change by the

Bush administration had " adversely affected " the

government's ability to curb deceptive ads, by

significantly increasing the amount of time required to

issue a notice of violation. The new procedure has delayed

enforcement actions anywhere from 2 weeks to 11 weeks, the

accounting office said. Government lawyers have used that

time to review the notices.

 

But Senator Collins said, " It takes so long to get letters

issued by the F.D.A. that the advertising campaign for a

drug may have run its course before the company receives a

letter demanding corrective action. "

 

Typically, when the F.D.A. finds that a drug advertisement

is so inaccurate, misleading or incomplete that it violates

federal law and regulations, the agency writes a letter

instructing the manufacturer to halt the ads. In November

2001, the Department of Health and Human Services told the

agency that it could not issue such letters until they had

been reviewed for " legal sufficiency and consistency with

agency policy. "

 

But, the report said, many advertisements " are on the air

for only a short time - about one-fifth of them for one

month, and about one-third for two months or less. " Under

the new policy, it observed, misleading television ads for

prescription drugs can complete their " broadcast life

cycle " before the agency admonishes the manufacturer.

 

Since 1997, the report said, the F.D.A. " has issued

repeated regulatory letters to several pharmaceutical

companies, including 14 to GlaxoSmithKline, 6 to Schering

Corporation and 5 to Merck & Company. " Some companies, it

said, " have received multiple regulatory letters over time

for new advertisements promoting the same drug. "

 

In its most recent letter to Pfizer, on Aug. 12, the agency

said that an advertisement in Time, Reader's Digest, Good

Housekeeping and other magazines was misleading because it

falsely suggested that Lipitor was safer than other statin

drugs used to lower cholesterol.

 

Vanessa McGowan, a spokeswoman for Pfizer, said: " We

complied with F.D.A.'s request. We pulled the ads and

corrected them. "

 

Commenting on the report, the Department of Health and

Human Services acknowledged that it needed to issue

enforcement letters more quickly. But it said the letters

had to go through a rigorous legal review because " the

F.D.A. cannot afford to be considered a paper tiger. "

 

Federal rules say drug ads must present a fair, accurate

account of both benefits and risks. From August 1997 to

last August, the food and drug agency issued 88 letters

accusing drug companies of advertising violations - 44 for

broadcast advertisements, 35 for print ads and 9 that cited

both types of ads.

 

In many cases, the agency said, companies overstated the

effectiveness or minimized the risks of medicines. Last

year, for example, the agency told Procter & Gamble to halt

certain commercials for its osteoporosis drug Actonel after

finding that information about the drug's risks was

obscured by " fast-paced, rapidly changing, distracting

images " on the screen.

 

http://www.nytimes.com/2002/12/04/health/04DRUG.html?

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