7/25/2000 – Ewing’s Letter to the New York Times

Mr. Rick Ewing, a trial attorney for the firm of Vickery and Waldner,
responds to the purported balance of opinions expressed in the
New York Times article on Prozac and violence (Article #108 on
our eGroups list).

It is a wonderful analysis, and I hope you’ll read it. Mark
——-

Ms. Goode’s article is a balanced account of an ongoing debate
about suicide and violence temporally associated with the SSRI
drugs. If “opinion leaders” differ sharply then we are in
intellectual equilibrium.

Right? Wrong. The leaders are as data-starved as the public.
The FDA is charged with accumulating and interpreting
post-marketing data on drug adverse events, and there is data
on well over a million events in the records of that agency. There
is no funding for meaningful analysis, and no initiatives for
funding. The data simply sit there. Neither is there any
requirement that drug companies investigate and report in detail
to the agency on adverse events. They are simply reported. If
the death and injury toll from a particular formulation, such as
“Oraflex” or “Fen-Phen” is overwhelming, the drug may be
withdrawn, not because of a systematic analysis, but because
the death toll speaks for itself.

What about less blatant data? By the fall of 1997, the FDA had
collected more than 44,000 adverse event in connection with
Prozac, more than the sum total of all reports on all psychoactive
drugs in history. The FDA receives reports on less than 10% of
the actual events by its own estimates. www.fda.gov. Those
reports now include more than 2500 deaths reasonably related
to suicide and violence. In fact, the pre 1998 reports are
scattered among some fifteen different “CO-START” terms
depending on the subjectivity’s or thoroughness of the reporting
physician. (There were 15 single-spaced pages of such terms,
a monument to ambiguity when applied to psychoactive drugs.)
Interestingly there was no term for either “suicide” or “murder.”
The majority of deaths (OUTCOME: DIE) are coded to the terms
“suicide attempt”, somewhat euphemistic applied to completed
suicides. By October of 1997, there were more than 1500 Prozac
deaths clearly coded to suicide or murder and another 300 for
which suicide or murder was the most plausible conclusion.

The United States Army developed an accepted technique for
investigating an alarming suicide rate among recruits – the
psychological autopsy, based on in-depth study of the subject’s
psychological history, and immediate life circumstances. It is
accepted as a generally useful technique. What kinds of
questions could have been answered if drug companies were
required to utilize psychological autopsies through independent
investigators?

Were there suicidal thoughts before the administration of the
drug? Did the suicide appear impulsive? Was the suicide
inconsistent with life-affirming elements? Did survivors consider
the suicide shocking and inconsistent? Did the deceased use
violent or grotesque modalities for suicide?
……………………..

Would it be useful and germane to the ongoing debate which
Ms. Goode so ably describes to have answers to those
questions for some 2500 deaths under SSRI drugs?

Would it be of interest that while men in the general population
are more than 8 times as lethal in their suicidal gestures as
women, that under these drugs men and women commit
suicide at almost equal rates? The suicide rates in the United
States hover around 30,000 per year, varying a few hundred.
Men commit suicide at a rate 4.3 to 1 over women. But
depression is thought to be twice as prevalent in women. It
would follow that men are more than 8 times as lethal in
depression suicides as women. Yet the demographic figures
connected with the adverse reports on Prozac (and other SSRI
drugs) show that women commit suicide at almost equal rates
with men, over 40%. Are these drugs obliterating what is
otherwise an immutable behavioral difference between men and
women?

If anyone has struggled through this letter, I have to admit that I
am a plaintiff’s lawyer who has been involved in SSRI litigation
for the past 10 years. You can now turn me into a cartoon
symbol of unalloyed greed, but before you do, isn’t it a frightening
thought that the only people on the trail of SSRI tragedy are
people like me? Shouldn’t there be others?

Congratulations on a very professional article. How I would love
to see you take on an in-depth study of the sources of
information and misinformation relating to licensed drugs!

Sincerely,
Richard W. Ewing
rick@…

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