From: leonard@qiclab.scn.rain.com (Leonard Erickson)
Subject: Re: The FDA can't be criminal, can they?
Reply-To: 70465.203@compuserve.com
Organization: SCN Research/Qic Laboratories of Tigard, Oregon.
Date: Fri, 9 Oct 1992 22:01:11 GMT

yazz@locus.com (Bob Yazz) writes:

>Slight correction after the fact:

>| Incidentally, thalidomide was kept out of the US by co-incidence.  An
>| FDA staffer thought that there was some rat brain damage in a study
>| and her efforts kept the drug from being approved in this country.

>...kept it from being approved in this country for some time.

And the company trying to get the drug approved (in good faith, as far as
can be determined) was getting ready to *sue* the FDA when the news of the
birth defects broke. The FDA staffer in question was *not* following the
rules. It was pure luck that her (very much *incorrect*) hunch delayed the
drug approval. 

BTW, there are *far* more dangerous drugs than thalidomide routinely
prescribed. Thalidomide only causes birth defects if adminstered during
a certain stage of pregnancy (true of *many* drugs that are approved),
and as I vaguely recall, also required a specific (bordeline) vitamin
defiecincy to cause the defects. 

These other drugs are routinely prescribed with appropriate warnings
and precautions. Yet thalidomide is still totally banned. This does not
indicate anything even *approaching* rationallity in the standards or
approval process.

We are going to continue to have unexpected drug side effects until we
have *complete* understanding of the biochemical systems that comprise
the human body. 

All we can do is take reasonable precautions. 

BTW. Most drug testing in the US is *severely* flawed because of a
well-intentioned, but wrong-headed law Congress passed back in the 70s.
Under this law, any mdeical program receiving federal funds *may not*
withold potentially helpful treatments from pastients as part of a study.

Sounds real good. But what it has done is *destroy* the possibility of
"double blind" studies. That is, studies that remove the possibility of
researcher bias by have the researcher not know which of the two groups
is the control group.

In a double blind test series, you'd have two groups of *volunteeers*.
One both get the pills or injection or whatever. But one set of pills
is the drug being tested, the other set is a placebo. The researcher that 
marked the two sets of pills doesn't know which set of patients will get
which set of pills. And the ones administering them don't know if set A
or set B is the real drug. At the end of the study, they check to see
which set of pills produced the best results. Then and only then do
the observers get told which set of pills was the drug. It's not at all
uncommon for there to be no significant difference, or even to have the
placebos produce better results.

Without the "double-blind" setup, researchers tend to let "wishful
thinking" get the best of them. There are cases now where after being
in use for 10 years, they finally accumalated enough statiscs to show
a given drug treatment was a waste of time. Think of all the wasted
time and money (and possibly lives lost because something else wasn't
tried). All because of the pennywise and poundfoolish idea that it wasn't
"fair" to let some of the volunteers in a study not really get the drug.



-- 
Leonard Erickson		      leonard@qiclab.scn.rain.com
CIS: [70465,203]			 70465.203@compuserve.com
FIDO:   1:105/51	 Leonard.Erickson@f51.n105.z1.fidonet.org
(The CIS & Fido addresses are preferred)
Newsgroups: alt.society.civil-liberty,alt.politics.elections,alt.drugs