August 21, 2002
U.S. Opposes Order to Pull Paxil TV Ads
(by Ronald D. White, The Los Angeles Times)
Siegfried writes:
In response to the order by Federal judge Mariana Pfaelzer of Los Angeles
that ads for Paxil be withdrawn, the Justice Department has intervened
on
behalf of the Food and Drug Administration. Judge Pfaelzer had ruled in
favor
of 35 plaintiffs who complained of withdrawal symptoms. The ads claimed
that
the drug was not habit-forming, so the judge ruled that they were misleading
in the sense that they discounted the severity of withdrawal symptoms.
Since the FDA had already approved the ads, the Justice Department argued
that the ruling set up a conflict between the FDA and the courts. This
is
most curious. If this argument holds, then any ruling of a Federal court
with
respect to any action of a Federal agency can be said to "set up
a conflict
between the court and the agency." Should the citizen not have any
recourse
to court protection against the improprieties of Federal agencies?
Let's go back to facts underneath this case. Is Paxil habit-forming?
Of
course it is. People do exist who find it very difficult to scale back
the
dosage and discontinue the medication when it is time to do so. The
plaintiffs in this case complained of nausea, fever, and "electric
zaps" to
their system. Others have sleep irregularities. How universal is this
problem? That's not as easy to determine. In the therapeutic world, we
tend
to see the people with the problem, and don't get to count the ones without
it. But the problem clearly exists, and both the drug company and the
FDA
must surely be aware of it.
There is also history to consider. In the early days of opium and morphine,
dependency was not recognized there either. And cocaine was touted as
a
miracle drug by Sigmund Freud himself, and he could be persuaded only
at
great length to drop his advocacy when negative consequences of cocaine
use
eventually surfaced. Even in the fifties, I remember being taught in High
School that cocaine was not addictive! (It used to be an ingredient in
Coca
Cola, which is even named after the miracle drug.) Essentially all of
the
drugs prescribed for anxiety disorder are known to induce dependency.
The
same goes for sleep medications and for the stronger prescription pain
medications.
At some level, this observation only recognizes that over the long term
the
brain adapts to the presence of mood-altering medications, and from then
on
the brain depends to some extent on the presence of the medication. This
issue can be quite minor and inconsequential, as in the case of Ritalin,
or
it can be quite significant, as in the case of morphine. And then there
is
Paxil. It is not in a world apart. Dependency is an issue, and people
should
be given notice of this along with the other litany of possible side effects.
I cannot imagine an objection being raised to our enjoying the protection
of
the courts in this matter. The real conflict of interest here is of course
between the FDA and manufacturer of Paxil, GlaxoSmithKline. With a $2B
market
at stake, the FDA is not inclined to rock the boat. As Kenneth Galbraith
laid
out in his book "The Industrial State," industrial enterprises
need to
arrange their affairs so that they become predictable to the largest degree
possible. In the case of drug companies, this means that the regulatory
process cannot hold any surprises. We also have confirmation of this from
the
right, as Milton Friedman points out that the regulators in our government
eventually become the regulated. As is so glaringly apparent here, the
FDA in
this case is a mere pawn of GlaxoSmithKline.
However, the real need is for a more organic remedy in which the brain
is
gently trained out of anxiety and depression. Again, this involves brain
adaptations, but in this case the adaptation is entirely wholesome, being
produced by the brain itself in the interest of improved self-regulation.
Such an organic remedy is neurofeedback.
P.S.
Has anyone else worked with Paxil withdrawal? I'd like to know how
commonplace this is among our affiliates.
Siegfried