January 23

Showdown Looms in Congress Over Drug Advertising on TV

Direct to consumer drug advertising is a U.S. phenomenon (with the exception
of New Zealand drug ads are verboten). In the U.S. the prescription drug
industry spent $4.5 billion last year to advertise its mostly clinically
unremarkable drugs–many advertised drugs pose risks of harm far more
serious than the conditions for which they were prescribed. 

The New York Times reports that industry itself acknowledges having an image
problem. “It would be naïve to not acknowledge the fact that D.T.C. advertising is
also a lightening-rod in the health care debate in this country,” said Billy
Tauzin, the former congressman who is now president and chief executive of
the Pharmaceutical Research and Manufacturers of America, in a speech to
venture capitalists last spring. There is “one great problem” that the
manufacturers face, he said: “in a word, it is trust.”

That loss of public trust has been fully earned by an industry that markets
drugs through deceptive practices. As their internal documents reveal, Big
Pharma companies market their drugs by inflating minimal benefits and
concealing very substantial, lethal risks of harm.

See video: Money Talks
Contact: Vera Hassner Sharav

 January 22, 2007
Showdown Looms in Congress Over Drug Advertising on TV


Drug advertising aimed at consumers, a fast-growing category that reached
$4.5 billion last year, will face hard scrutiny in the new Congress,
according to industry critics in both the House and Senate.

The consumer ads will be on the griddle early in this session at hearings on
the user fees that manufacturers pay to speed the reviewing of new drugs by
the Food and Drug Administration.  The user fee law will die in the fall
unless Congress acts to renew it.

The pharmaceutical industry, which often gets what it asks for from Congress
and the executive branch, seeks to renew the law and add a new set of user
fees that would be pay salaries for additional F.D.A. employees to evaluate
all consumer drug ads, before they are shown on television.
Both the industry and its critics agree that there should be a pause before
the advertising starts — to allow time for doctors to learn about a new
The companies want the delay to be left up to them, but critics say the
F.D.A. should require a wait of up to two years. Criticism of
direct-to-consumer advertising has intensified since 2004, after Merck
withdrew Vioxx, a heavily advertised painkiller, after a clinical trial
showed that it sharply increased the risk of heart attacks and strokes.

“From the beginning , everyone, including the company, agreed that not
everybody ought to be getting Vioxx,” said Helen Darling, president of the
National Business Group on Health, an organization of large employers. “But
the ads implied there was a widespread need for it.”

Spending on consumer drug advertising, meanwhile, has been growing robustly,
from $1.1 billion in 1997 to $4.2 billion in 2005, according to a recent
report to Congress by the Government Accountability Office . In the first
nine months of 2006, spending rose 8.4 percent to $3.29 billion, on track
toward $4.5 billion for the year, according to TNS Media Intelligence, an
advertising research firm.

Spending on the ads faltered in 2005 after soaring 27 percent in 2004,
before Vioxx was withdrawn, said David Kweskin, a senior executive at the
firm. “Now they are in a catch-up phase.”

Two independent government watchdog groups sharply criticized consumer drug
advertising recently, and a separate survey Jan. 9 commissioned by the
PricewaterhouseCoopers accounting and consulting firm indicated that
skepticism is widespread among the public, too. Only 1 in 10 consumers said
the direct-to-consumer, or D.T.C., ads could provide useful information to a
large audience, the survey said. (Consumer drug advertising is not permitted
in most of the world, except New Zealand and the United States.)

The pharmaceutical industry itself acknowledges having an image problem.
“It would be naïve to not acknowledge the fact that D.T.C. advertising is
also a lightening-rod in the health care debate in this country,” said Billy
Tauzin, the former congressman who is now president and chief executive of
the Pharmaceutical Research and Manufacturers of America, in a speech to
venture capitalists last spring. There is “one great problem” that the
manufacturers face, he said: “in a word, it is trust.”

“While individual patients find the information useful in discussions with
their physicians,” he added in his speech, “patients, physicians and
consumers generally express unhappiness with D.T.C. advertising.”

Mr. Tauzin’s organization issued voluntary guidelines for consumer ads,
which took effect last year. Under the guidelines, the companies have
promised to hold off on consumer advertising of a new medicine for an
unspecified “appropriate” period. That would allow time to tell doctors
about risks and benefits, before television and Web site viewers see an ad
and demand a prescription.

Twenty-seven members of the pharmaceutical manufacturers organization have
endorsed the guidelines, but it is hard to figure exactly how long the
delays in advertising will run. Bristol-Myers Squibb has said that it would
delay for 12 months. Johnson & Johnson and Pfizer said they would wait six
months. The manufacturers group cannot say how other companies have
interpreted the guidelines, a spokesman said.

But according to TNS Media Intelligence, the companies have actually been
waiting 15 months, on average, since the Vioxx debacle.
Critics say that even after F.D.A. approval, the full safety profile of a
new drug cannot be known until it has been widely used for a number of
But the manufacturers’ guidelines have to be voluntary, said Daniel E. Troy,
a former chief counsel of the F.D.A., because the Supreme Court has “struck
down restrictions on advertising of tobacco, alcohol, gambling and
unapproved compounded drugs.”

The agency sent 15 warning letters to drug companies regarding ads in 2005
and a total of 22 complaints last year.
The F.D.A. told AstraZeneca, for example, to “immediately cease” a
“misleading superiority claim” in a 2005 TV commercial. The ad said
AstraZeneca’s Crestor was “clearly the best” in a “head to head” test with
the three largest-selling cholesterol drugs.
Emily Y. Denney, an AstraZeneca spokeswoman, said that by the time the
letter was received, in March 2005, the ads were no longer running. The
company defended its message in the advertising as “appropriate.”

Another F.D.A. letter told Amgen, a biotechnology company, to stop running
commercials for Enbrel, a treatment for the skin disease psoriasis, that the
F.D.A. said minimized “serious risks” associated with the drug. Amgen
immediately withdrew the commercial.

Last year, the company obtained F.D.A. approval of the contents of a new
Enbrel television ad before showing it, David Polk, an Amgen spokesman said.
Corporate lawyers say such advertising is protected by the First Amendment
under a doctrine of commercial free speech. But some experts say the limits
of the protection are murky.

The closest approach to clarity was in 2002 when the Supreme Court rejected,
by a 5-to-4 vote, a federal restriction on advertising by pharmacists who
make their own compounds.

“It is a giant game of chicken between the government and the industry,”
said R. Alta Charo, a law professor and bioethics specialist at the
University of Wisconsin in Madison. “I don’t believe either side really
wants to see a definitive case go to the Supreme Court because neither side
is willing to take the risk that they will lose.”

Professor Charo was a member of a committee of experts of the Institute of
Medicine, which examined drug safety issues at the request of the F.D.A.
Last fall, the committee called on Congress to give the F.D.A. new authority
over advertising, including the power to require a two-year moratorium on
advertising before approving a new drug.

“I think the Congress has clearly indicated its strong interest and concerns
about the F.D.A. and drug safety for consumers,” said Sheila P. Burke, a
longtime Republican health policy expert who headed the Institute of
Medicine committee. “Broad-scale advertising can sometimes lead to a rapid
increase in the use of a drug” that raises the risk of harm for patients,
she said.

F.D.A. regulators would be granted the power to require moratoriums under a
bill sponsored by Senators Edward M. Kennedy and Michael B. Enzi, the
chairman and ranking Republican member of the Senate Health, Labor,
Education and Pensions Committee.

“Patients deserve the best and most accurate information about the medicines
they take,” Senator Kennedy said in a statement. “An essential part of any
drug safety proposal must be to give the F.D.A. the authority and resources
it needs to oversee direct-to-consumer advertising, and to allow the F.D.A.
to impose conditions or limits on that advertising, where needed to protect
the public health."

Testifying for the pharmaceutical industry last year, Dr. Adrian Thomas, a
vice president of Johnson & Johnson, insisted that “the important First
Amendment issues that arise from banning truthful speech, even for a period
of time, must be carefully considered before legislating in this area.”

The Government Accountability Office said last November that the F.D.A.
should be doing a better job of overseeing consumer drug ads. Now, the
F.D.A. reviews only a small fraction of the advertising, picking and
choosing without proper priorities, the G.A.O. said.

The G.A.O. report had been requested by three influential senators: Bill
Frist, a doctor, before he stepped down as Republican leader of the Senate;
Charles E. Grassley , now the ranking Republican on the finance committee,
and Herb Kohl, a Democrat who heads an appropriations subcommittee that
oversees the F.D.A.

Representative Henry A. Waxman, a California Democrat who is chairman of the
House Oversight and Reform Committee, added a further criticism: that the
F.D.A. had been slow to crack down on drug ads that included “false and
misleading” claims, he said in a telephone interview.

F.D.A. officials said they had to deal with 54,000 drug promotions each
year, aimed at both doctors and consumers.
* “We are seriously considering all of the recommendations” of the Institute
of Medicine report, said Thomas Abrams, director of the F.D.A.’s division of
drug marketing, advertising and communications.

Copyright 2007  The New York Times Company

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