From: learn@gargoyle.uchicago.edu (William Vajk (igloo))
Subject: Re: Suppressing innovations 
Reply-To: learn@gargoyle.uchicago.edu (William Vajk (igloo))
Organization: Dares No Organization Like Dis Organization
Date: Mon, 13 Apr 1992 13:17:14 GMT

In article <1992Apr12.231605.16913@yang.earlham.edu> Allen Smith writes:

>In article <1992Apr7.211401.21952@leland.Stanford.EDU> William Shepherd writes:

>> In article <1992Apr04.013822.23814@norton.com> Brian Yoder writes:

>>>In <1992Apr2.054515.20041@leland.Stanford.EDU> William Shepherd wrote:

>>>> Dead bodies?  I've got two words for you:  DDT and thalidomide.  

>>>OK, thalidomide did cause a number of birth defects, but as far as I am 
>>>aware, there was no indication that one could expect this. Compare those 
>>>birth defects to the enormous numbers of people who die and suffer 
>>>because of strict FDA rules. It's no contest, we'd be FAR better without 
>>>the FDA restrictions.

>>>As for DDT, I don't know of a single case of DDT killing ANYONE.  On the
>>>other hand, since it has been banned, the number of deaths from malaria
>>>have exploded from a few thousand when DDT was widely used to (if memory
>>>serves) about a million per year (almost as high asblem that comes 
>>>along.  That it is more often than not "something bad" doesn't seem to 
>>>concern either the politicians or the pundits much.

It is very easy to feel sympathy for those misfortunate individuals who were 
born deformed as a result of thalidomide and paraded in front of news cameras.
Death seems easier to accept. In fact, death is forgotten relatively quickly.
Yesterday's news....

What is interesting about thalidomide is the response. Homes were set up
in Germany, the source of the medication and the largest national victim, 
for those unfortunates. I haven't heard about them in years, but at last
reports (some long time back) they were doing well leading happy lives.

This may sound heartless, but something like thalidomide was bound to
happen. The FDA's rules were revised as a result, but the main lesson
was the wide spread recognition that chemistry does affect genetics in
many ways.

We cannot and will not have the FDA riding herd on each and every aspect 
of life and manufacturing. The latest discovery regarding genetics and
chemistry has to do with a sunglasses factory in Massachusetts. 

>>Finally, in many situations (and this is why I brought up DDT), the 
>>parties to the transaction do not bear the full costs of the transaction 
>>(i.e. there are externalities). The bald eagle is not an endangered 
>>species just by chance.  The same goes for many other species.  

This may come as a shock to you, but it is not so certain that DDT was
the culprit after all. Not only that, but this information has been
floating around for close to 20 years. It seems that the early tests
for DDT were pretty sloppy and did not differentiate between DDT and 
PCB's. The witch hunt was on, and although later testing did distinguish 
the two, no one delved into determining whether the original diagnosis
was correct. Further, DDT was supposed to be indestructable. In the past
15 years, numerous searches have been made to find traces in the
environment, from marshes (where it was liberally applied in the 1950's)
to the deep ocean. Not traces have been found. This is surprising given
the millions of tons of the stuff which was manufactured and set loose
in the environment.

There was a general carelessness with PCB's historically. It was thought
relatively an inert compound. It is difficult to destroy, though it can
be incinerated at very high tempratures (molten sodium bed techniques.)

Neither of these two, DDT or PCB's, would normally come under FDA scrutiny
before marketing is permitted. Nor did, or will, compounds such as freon,
used for refrigeration and cleaning. The fact that freon causes the sort
of damage it does required understandings and techniques unknown till the
space age was, relatively speaking, mature. We've been dumping freon into
the atmosphere for a long time. 

>	I can see the point on DDT- environmental protection does need 
>some degree of enforcement.

DDT is not covered by FDA. It is neither a food nor a drug. It had no place
in a discussion of the FDA, although it is an interesting subject.

Some years ago, most states adapted regulations requiring those involved
in spraying trees, lawns, and such, to have insurance providing coverage
to the third generation. FDA had not one word to say about agent orange
either. Seems you folks are assigning missions to FDA it never had.

>> given the fact that most (and it should be more...) Americans have health
>> insurance, they rarely bear the full costs of treatment.  

Wrong! Most Americans do NOT have health insurance. Insurance must have
no play or consideration in anything involving the FDA.

>> My whole point is that there aren't really any patients who know "full well"
>> the risks involved in a given drug.

My pharmacy places a PDR in the waiting lounge. It is almost unused. Most 
people simply wouldn't understand what it has to say about their medication(s) 
anyway. Most public libraries have all the information as well. It is not the 
lack of availability of information so much as the general trust individuals 
have in the health care system which leads to the current apathy.

>	That's the fault of the patient. If someone decides to take a drug 
>without full knowledge of side effects, etc. when they could have that 
>knowledge (and I support forcing companies to disclose all such 
>information), then any side effects are their problem.

Generally speaking, drug companies report all side effects. Generally
speaking, there is a PDR available. For those drugs too new to be
in the current edition, there is always the sheet enclosed by the
manufacturer which every pharmacist I have ever talked with has gladly
given out on request, even for drugs for which I had no prescription.

Bill Vajk

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