|
 n
a remarkable scientific achievement that would seem a reversal of
its opposition to human cloning, the Bush administration is prepared
to create a carbon copy of David Kessler to run the Food and Drug
Administration. He may not look like Kessler, but Vanderbilt University
Vice Chancellor Alastair Wood has exactly the same political genes.
Like Kessler, he is a doctor sponsored by a Republican senator —
and a buddy of Senator Ted Kennedy, the guy who really nominates
FDA commissioners. (Kessler's godfather with Kennedy ties was Orrin
Hatch. Wood's is Senator Frist.)
And —
thanks to advances in genetic technology — Wood will have something
Kessler never had: the enthusiastic endorsement of Sidney Wolfe,
who heads up Health Research, Public Citizen, an organization which,
among other things, is devoted to undoing FDA reforms that require
the agency to get lifesaving drugs to Americans faster. Wolfe has
said: "This guy is clearly qualified… Wood has shown in
his writings that he is willing to criticize the FDA and the pharmaceutical
industry. That's exactly what we need."
Here's a little
of what Wood wrote (in case the White House hasn't read it yet)
and that has Wolfe so happy. In an article for The Journal of
the American Medical Association (volume 281, May 12, 1999),
entitled "The Safety of New Medicines: Asking the Right Questions,"
Wood wonders why so "many" people were "exposed"
(his words — not mine) to drugs associated with serious and
even fatal events before the drugs were withdrawn from the market.
He further wonders why these drugs were even approved at all, since
he believes that "none of the drugs was indicated for a life-threatening
condition nor, in many cases, were they the only drugs available
for that indication."
In doing so,
Wood reveals a misunderstanding of medical practice and, more disturbingly,
a willingness to assume that drug companies ignore deadly side effects
in the development process, deliberately marketing those drugs because
they place profits above the health of patients.
He writes:
"For example, in the 11 months that bromfenac was available,
it is remarkable that physicians prescribed this new nonsteroidal,
known to elevate liver enzymes, to 2.5 million patients with acute
pain, even though many well-tested similar drugs were available.
How could a nonsteroidal for the treatment of pain, with a restriction
that patients take it for no more than 10 days, be cost-effective
for a pharmaceutical manufacturer to market?"
The implication
here, of course, is that such a drug couldn't have been cost-effective
unless it was marketed to be used beyond ten days, where elevated
liver enzymes would be a serious problem. In other words, Wood was
suggesting that the drug company can only make money by deliberately
poisoning people.
Here are the
rest of the facts, however. After a standard-time-track review —
not the fast-track review Sid Wolfe fears — bromfenac was approved
for acute pain only, and carried a warning about liver-enzyme elevation
with prolonged use. Such elevations are "consistent with experience
with other agents of its class," according to an article in
the September 1999 issue of The Annals of Pharmacotherapy.
Despite a strengthened warning of liver failure after extended use,
physicians kept prescribing the drug for more than ten days at a
time. The total number of liver failures, out of 2.5 million patients?
Twelve — or .00048 percent of all patients. And as for a conspiracy
to promote the drug for use beyond the ten-day period — thereby
making it more "cost-effective" to market — it turns
out that almost all of these cases occurred among an estimated 200,000
to 400,000 patients who took the drug for longer periods of time.
That included patients who took the drug after a stronger
warning about its side effects went out from both the FDA and the
company.
Wood calls
it "surprising" that Seldane, an allergy drug, was —
as he put it — "removed from the market, not when the
adverse events were identified, but after the manufacturer had developed
a new product to substitute for it." Yet the first adverse
event, ventricular tachycardia, was identified in 1990. At the time,
it was assumed that tachycardia was a result of an interaction between
Seldane and certain antibiotics and antifungals.
Thereafter,
nearly a hundred articles researched and discussed the possible
hazards of this combination. Seldane's developers issued warning
letters and sponsored research into possible other interactions.
As a result, use of Seldane with drugs that might cause the deadly
reaction declined by nearly 60 percent. The rate of Seldane prescribing
dropped as well. The drug was withdrawn from market because despite
these efforts, the combined use and prescribing of Seldane and certain
antibiotics and antifungals continued.
What is remarkable
is that while prescription-drug use has increased in the past decade,
the number of adverse events as a percentage of total prescriptions
has hardly budged. Drug withdrawals as a percentage of new drugs
remains at about 3 percent, essentially the same ratio from decades
ago.
Wood ignores
this safety record. Instead, he calls for companies to adhere to
an impossible safety standard: "Manufacturers should behave
responsibly in the promotion of new drugs for which toxicity is,
by definition, currently unknown." Further, "to encourage
such responsibility direct to consumer advertising should be permitted
only for drugs that have undergone a monitored post marketing testing
process that would include a sufficient number of patients to provide
adequate confidence in their safety for widespread clinical use.
This step could help prevent the excessively rapid uptake of new
drugs at a rate that exceeds the capacity available to review their
safety in practice."
Translation:
FDA to patients: Drop dead. It's troubling enough that a proposal
to link marketing to an unclear and shifting post-marketing safety
standard would likely be unconstitutional and smacks of regulatory
overreach. Worse, it would compromise the public health.
In Wood's world,
doctors shouldn't get access to new drugs and shouldn't learn about
them because drug companies have no idea what side effects lie ahead
as a drug moves from the pristine environment of a clinical trial
into the real world. So for example, if a new drug for diabetes,
depression, cancer, AIDS, or heart failure had some terrific benefits,
but months or years after it was on the market some questions about
side effects came up that no one could anticipate, patients would
be denied direct access to information about these drugs until companies
went through yet another round of clinical trials or studies —
a process that could take months. It would also mean that new dosing
levels and new uses for existing drugs could not be promoted or
widely disseminated unless companies provided his FDA "adequate
confidence in their safety for widespread clinical use."
Finally Wood
questions the value of bringing another drug for the same illness
to market. But if one or more drug has side effects that are dangerous
to a group of patients or if some people don't respond to a particular
drug, isn't that reason enough to for people to be free to have
it available. Or does Dr. Wood, like Kessler before him, believe
that the FDA is the best arbiter of whose life is worth living or
cutting short? Like his cheering section in the Public Citizen,
does he have contempt for private pharmaceutical profits that blinds
and biases him against the right of companies to develop and market
products based on their ability to make a clinical difference in
people's lives? These are questions the Bush administration should
have asked before they decided to clone another Kessler.
|
