A Gift for Drug Makers
January 14, 2005
By BOB HERBERT
Vioxx, Celebrex, Prozac. ...
With all the problems and the bad publicity that drug
companies have been facing recently, you might think that
this would not be a good time for the Bush administration
to toss yet another bonanza their way.
But the administration is like an ardent lover in its zeal
to shower the rich and powerful with every imaginable
benefit. So tucked like a gleaming diamond in proposed
legislation to curb malpractice lawsuits is a provision
that would give an unconscionable degree of protection to
firms responsible for drugs or medical devices that turn
out to be harmful.
The provision would go beyond caps on certain damages. It
would actually prohibit punitive damages in cases in which
the drug or medical device had received Food and Drug
Administration approval. We know the F.D.A. has failed time
and again to ensure that unsafe drugs are kept off the
market. To provide blanket legal protection against
punitive damages in such cases is both unwarranted and
We learned just last month that Celebrex, the phenomenally
popular painkiller from Pfizer, more than tripled the risk
of heart attacks, strokes and death among those taking high
doses in a national trial. Those findings, as noted in an
article in The Times, "raised new questions about how well
federal drug regulators protect the public and worsened
drug makers' already dismal image."
Senator Chuck Grassley, an Iowa Republican who held
hearings on recent F.D.A. actions, said, "At this point, no
one can say with confidence whether the worst drug safety
problems are behind us or ahead of us."
The Celebrex disclosure came on the heels of a decision by
Merck to withdraw its arthritis drug Vioxx from the market
after a study showed a link between long-term use of the
drug and an increased risk of heart attacks and strokes.
Two weeks ago, an article in The British Medical Journal
suggested that Eli Lilly & Company had long concealed
evidence that the antidepressant Prozac could cause violent
and suicidal behavior. The company denies the accusation,
which the journal forwarded to the F.D.A.
If the malpractice legislation so relentlessly touted by
President Bush became law, Pfizer, Merck and Eli Lilly
would be immunized against even the possibility of punitive
damages arising from any harm to patients that resulted
from use of these drugs - as long as the companies followed
F.D.A. rules. All three drugs were approved by the F.D.A.
The whole idea behind punitive damages is to severely
punish the most egregious offenders. Huge punitive damage
awards are supposed to serve as a deterrent to extremely
"It's an important system to have in place," said Joanne
Doroshow, executive director of the Center for Justice and
Democracy, a nonprofit consumer advocacy group. "The F.D.A.
is certainly not doing its job. The legal system is a very
important backup. It's really the last line of defense to
ensure that the marketplace only has safe products."
If Mr. Bush has his way, that line of defense will be
substantially weakened. With the possibility of punitive
damages eliminated, drug companies will be even less
vigilant than they are now about problems with products
that pose a serious - even fatal - threat to patients.
The Democratic leader in the Senate, Harry Reid of Nevada,
was blunt on the matter. He said, "Congress should not be
giving a free pass to big drug companies at a time when
millions of Americans may have had their health put at risk
by pharmaceutical giants."
The drug companies have an incredible racket going, as
Marcia Angell, the former editor in chief of The New
England Journal of Medicine, documents in her book "The
Truth About the Drug Companies."
"Now primarily a marketing machine to sell drugs of dubious
benefit," she wrote, "this industry uses its wealth and
power to co-opt every institution that might stand in its
way, including the U.S. Congress, the Food and Drug
Administration, academic medical centers, and the medical
profession itself. (Most of its marketing efforts are
focused on influencing doctors, since they must write the
Among those co-opted is the president himself. Nothing's
too good for the drug companies. If ordinary Americans got
the same sweet treatment from this administration as the
great pharmaceutical houses, we'd all be in a much better