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8  What About the Pill?
   The Washington Post, Sunday, September 18, 1966

     Do the Possible Dangers of the Drug
     Exceed Natural Risks of Childbirth

     The safety of the pill has been studied by a distinguished
advisory group commissioned by the Food and Drug Administration.
Its report over the signature of chairman Dr. Lou Hellman was
headlined throughout the country on Aug. 15.

     Having once enjoyed serving with Dr. Hellman on another 
committee, I looked forward to seeing his temper and wisdom in
the full text of the report.  I also hoped that it might clear
up the confusion and contradictions which permeated the news
accounts interpreting the report.

     The published interpretations have ranged from direct approval
to a Scotch verdict: "Guilt not proven."  Allegations that the 
report offered an "amber light" go ahead must not be very helpful
to women or their physicians who have reserved judgment about use of 
the pill.

     Well over five million women in the United States are using
chemical contraceptives.  This means that more women at any one
time are under the influence of a chemically induced 
pseudo-pregnancy than are actually undergoing natural pregnancy.

     The report itself is much less glib than the newspaper accounts
in its assessment of a complex problem.  "The committee finds no
adequate scientific data, at this time, proving these compounds 
unsafe for human use.  It has nevertheless taken full cognizance
of certain very infrequent but serious side effects and of possible
theoretic risks suggested by animal experimental data and by some
of the metabolic changes in human beings.

     "In the final analysis, each physician must evaluate the
advantages and the risks of this method of contraception in 
comparison with other available methods or with no contraception
at all.  He can do this wisely only when there is presented to
him dispassionate scientific knowledge of the available data."

     Each physician does indeed carry the moral and legal 
responsibility to evaluate the benefits and risks of the pill for his
individual patients.  Above all, he must examine his patient for
concurrent disease that might contraindicate the use of the pill
and she must also be tested for the possibility of various side
effects, most of which are more subjectively unpleasant than
medically dangerous.

     On the other hand, it is quite doubtful that most physicians
have the necessary scientific background to reach a wiser decision
than the experts have been able to do.  In so controversial a field,
it is especially difficult to assure the neutralization of social
or religious prejudgments which should have nothing to do with the
evaluation of the safety of these techniques.

     These judgments about the pill are confounded precisely
because it is not a life-saving drug directed against traditionally
mortal disease for which there is no alternative remedy.  To this
extent, the physician's and the patient's attitudes about 
pregnancy, and the value attached to convenient methods of security
against it, are bound to influence the level of risk regarded
as acceptable.

     Nowhere in the main text of the report is there an explicit 
mention of the risks connected with the pregnancies potentially
averted or postponed by the use of the pill.  However, one of
the most striking statistical remarks is the guess that one
million pregnancies are terminated each year by illegal abortion
(compared to about four million live births).

     The medical hazards connected with such illegal operations
are quite unknown statistically, for obvious reasons, but it is
difficult to believe that these operations are even nearly as safe 
as full maternity.  The care of the pregnant woman is one of the
outstanding accomplishments of medical progress during the past
50 years, but even today pregnancy carries a risk of 300 maternal
deaths per million gestations.  This number is at least 20 times
higher than for any specific side effects that might conceivably
be attributed to the pill by interpretation of the existing
statistics.

     Since chances of deaths per million are perhaps beyond the
comprehension that ordinary experience gives us, it might help
to point out that one per million is approximately the risk of
being killed in the course of a 40-mile automobile trip or a
500-mile air trip. (This remark is not intended as a mitigation
of possible hazards.  Any avoidable risk that came even close to
what we unaccountably tolerate in traffic hazards would be a  
disgrace of judgment.)

     Before turning to the findings of the committee, we must
first consider what they could possibly hope to discover from
examination of existing data.  The medical use of contraceptive
drugs was first approved by the FDA on the basis of experience
with some few hundred or thousand women, which showed no important
evidence of major acute toxicity.  This work had in turn been
preceded by extensive animal studies in order to justify the first
clinical trials.

     Over a period of observation of a few years, chemical 
contraception was then certainly safer than pregnancy.  This does not
dignify the pill with "absolute safety," a concept which is a
delusion of the same genus as "absolute security" in world politics,
or "zero residues" of pesticides in agricultural practice.

     There can be no operational criterion for these absolute
ideas.  The committee could however scrutinize the available data
for any significant increase in deaths or serious illnesses in
specific categories that might be associated with taking the pill.
They would then have to analyze the data to determine whether the
differences, if any, in the observed numbers were statistically
significant, on the one hand, or could be attributed to mere
chance variation on the other.

     The absolute numbers of women in question are rather small, and
this certainly does intensify the difficulties of statistical 
evaluation.

     A much more important problem is that of knowing just what
population is exposed to the pill and how it compares with the
over-all population from which the mortality and disease statistics
are taken.  Most diseases show considerable variation in their
incidence with respect to age and sex, and often with respect to
socioeconomic conditions and geography.

     Furthermore, the physician must decide on the general health
of his patient before prescribing the pill.  This inevitably 
introduces another bias in the characteristics of pill-users 
compared to the rest of the population.  Mortality statistics
on specific diseases are as a whole not very reliable, but at
least we can look at the entire population of the United States
as a reasonable statistical base.

     On the other hand, the way in which medical records are kept
and processed makes it difficult to be sure which women have been
exposed to contraceptive drugs.  Over the past few years, there have 
been any number of alarming claims about a superincidence of certain
medical conditions among pill-taking women.  None of these isolated
observations is statistically conclusive, but they do indicate where
the focus of attention should be placed.

     There is a proper and obvious human motive in calling to
attention any unexpected clustering or other hint of apparent drug-
induced disease, but it is a virtual certainty that even an
absolutely safe drug, if there were such a thing, would provoke
many isolated observations of this kind.

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