From: baron@cattell.psych.upenn.edu (Jonathan Baron)
Newsgroups: bit.listserv.biosph-l
Subject: Re: phantom risk
Date: 26 Jul 92 10:36:22 GMT
Organization: University of Pennsylvania

The relation between scientific evidence and the courts is dealt
with in Peter Huber's two earlier books, "Liability" and
"Galileo's revenge."  I agree with Marianne Dugan (as does Huber)
that standards of proof are ultimately probabilistic (although
this idea is considered suspect by some legal scholars).  But
Huber's point, especially in "Galileo's revenge" is that these
standards have not been adequately met in many cases.  Showing a
correlation between (say) VDTs and birth defects WITH OTHER
FACTORS CONSTANT should indeed be evidence for the
"preponderance" standard at least, but other factors are not
adequately examined, and "showing a correlation" means that
"chance" has been ruled out as well.  The latter typically
requires replication of initial results, since most of these
correlations are recognized after the fact.  Such post hoc
correlations NECESSARILY arise by chance.  There MUST be some
environmental factors that are more associated with birth defects
than others (even among a group in which no factors are causal)
and there must be some region in which defects are unusually
high.  Huber agrues that these kinds of scientific issues (and
there are others of this sort) used to be dealt with by the Frye
rule, which put limits on allowable expert testimony.  For
variousreasons, that rule has been given up in the U.S.
Moreover, Huber cites cases in which legal expenses alone have
caused withdrawal of beneficial products, even when the
plaintiffs never won a single case.  (The U.S. is unusual in
making defendants pay their legal costs in such cases.)  Huber
suggests a number of reforms, such as having expert witnesses
appointed by judges (which is sometimes done).

As to whether liability has had bad effects on the pharmaceutical
industry, I believe that the answer is yes.  Inglehart, in New
England Journal of Medicine 1987, describes how the price of DPT
vaccine increased from less than a dollar a dose to over $10
because of self-insurance against litigation.  The evidence that
this vaccine causes ANY serious damage is still unclear, but
infants do get serious diseases, and some of them coincide in
time with vaccination.  In England and Japan, rumors about DPT
vaccine led parents to stop vaccinating, and, as a result,
epidemics of whooping cough led to hundreds of infant deaths.
(In the U.S., it is required in most states.)

The situation with birth control products is if anything worse
(see Djerassi in Science magazine 1989; and the report
"Developing new contraceptives" of the U.S. National Academy of
Sciences).  Despite the importance of birth control for
population control (which I consider to be of major importance
throughout the world), expenditures on birth-control research by
pharmaceutical companies have plummeted to a fraction of their
earlier amounts since the litigation against such products began.
This has been recognized in a bill submitted to congress by Pat
Schroeder and Olympia Snowe, which called for protection from
lawsuits as part of a plan to increase contraceptive research.
(I'm sure that the bill got nowhere.)

I am not saying that we should pity the poor stockholders of
pharmaceutical companies.  Indeed, this is a profitable business.
New medicines for high cholesterol and high blood pressure are
turned out every year.  (Nobody ever sues about them, because
they are not given to healthy people.)  But these ARE for-profit
enterprises, and we either have to accept that or change it.
Given what I take to be the immediate need for new contraceptives
and vaccines (e.g., against malaria - and even the development of
AIDS vaccines is being held back by fear of lawsuits), I would
rather try to change the U.S. liability system than try to
nationalize the pharmaceutical industry (if that is indeed the
solution at all).  According to an article by Schwartz in the
Huber ant Litan book ("The liability maze"), the problem IS
largely in the U.S., and it is just unfortunate that most of the
big pharmaceutical companies are here.

As for the point about drug testing, it is true that the FDA
relies heavily on research done by companies (and much of the
legal wrangling has to do with reporting requirements), but the
U.S. government does spend some money on clinical trials too, and
the FDA has been relying more heavily on research done outside
the U.S.  Perhaps part of the solution is for governments to do
more on their own, without waiting for the companies.  Indeed,
another part of the Schroeder/Snowe bill was for increased
funding of contraceptive research (in part through collaborative
efforts between university researchers and pharmaceutical
companies).  Even now, despite the anti-birth-control political
climate in the U.S. government, the government is sponsoring
studies of Norplant use.  (I should know.  I applied for a grant
and had it turned down!  But someone else got it.)

In sum, making the companies pay for harms they may not even have
caused (or that, in other cases, may be neccesary and known
outcomes to prevent much greater harm, as in the cases of the
Sabin polio vaccine, which DOES cause a few cases of polio every
year in order to prevent many more), may make us feel good, but
it has negative consequences for some of the world's major
problems.  I am not saying that liability is the only problem.
Indeed, the greatest need for vaccines and birth-control products
is in the third world, where people are often unable to pay for
them, and this too inhibits research.  (Merck recently made a
substantial donation of a river-blindness vaccine for use in the
third world, but we can't expect for-profit companies to do this
very often.)

I could go on about this.  It is a topic of great interest to me,
but I'd better stop here for now. - Jon Baron
(baron@cattell.psych.upenn.edu)

Comments: Gated by NETNEWS@AUVM.AMERICAN.EDU