Posts tagged ‘Derek Lowe’

Jury Kills Vioxx. Penicillin Next?

The other day, I wrote about the left of late lamenting that the machinery of state control that they created, agencies like the FDA and public schools, are being taken over by their political enemies, the "Neanderthal southern religious conservatives".  I observed that they were not apologizing for creating a statist structure to control individual decision-making, but just were upset they lost control of it.

In using the FDA as one example:

Today, via Instapundit, comes this story about the GAO audit of the decision by the FDA to not allow the plan B morning after pill to be sold over the counter.
And, knock me over with a feather, it appears that the decision was
political, based on a conservative administration's opposition to
abortion.  And again the technocrats on the left are freaked.  Well,
what did you expect?  You applauded the Clinton FDA's politically
motivated ban on breast implants as a sop to NOW and the trial
lawyers.  In
establishing the FDA, it was you on the left that established the
principal, contradictory to the left's own stand on abortion, that the
government does indeed trump the individual on decision making for
their own body
  (other thoughts here).
Again we hear the lament that the game was great until these
conservative yahoos took over.  No, it wasn't.  It was unjust to scheme
to control other people's lives, and just plain stupid to expect that
the machinery of control you created would never fall into your
political enemy's hands.

That has spurred a lot of email pointing me to other FDA-related articles.  I posted this one in the updates of that same post, pointing out how the FDA process (and the tort process, by the way) puts a much higher value on a life lost to drug side-effects than to a life saved from drug benefits.

Today I was pointed to this article by Derek Lowe who has been a drug development researcher for a number of years:

As a drug discovery researcher, I can tell you something that might sound
crazy: many of these older drugs would have a hard time getting approved today.
Some of them would never even have made it to the FDA at all.

The best example is aspirin itself. It's one of the foundation stones of the
drug industry, and it's hard to even guess how many billions of doses of it have
been taken over the last hundred years. But if you were somehow able to change
history so that aspirin had never been discovered until this year, I can
guarantee you that it would have died in the lab. No modern drug development
organization would touch it.

Thanks in part to advertisements for competing drugs, people know that there
are some stomach problems associated with aspirin. Actually, its use more or
less doubles the risk of a severe gastrointestinal event, which in most cases
means bleeding seriously enough to require hospitalization. Lower doses such as
those prescribed for cardiovascular patients and various formulation
improvements (coatings and the like) only seem to improve these numbers by a
small amount. Such incidents, along with others brought on by other oral
anti-inflammatory drugs, are the most common severe drug side effects seen in
medical practice....

That brings us up to penicillin, a drug with a clean reputation if ever there
was one. But at the same time, everyone has heard of the occasional bad allergic
reaction to it and related antibiotics. Even with the availability of skin tests
for sensitivity, these antibiotics cause about one fatality per 50 to 100,000
patient courses of treatment. Other severe reactions are twenty times as common.
Those are interesting figures to put into today's legal context: over 9 million
prescriptions were written for Vioxx, for example. Any modern drug that directly
caused that number of patient deaths and injuries would bury its company in a
hailstorm of lawsuits, because (unlike the Vioxx cases) there would be little
room to argue about