Evening star. [volume] (Washington, D.C.) 1854-1972, 1962-08-24
Gray Market
ThaIidomide
SaIesFeared
By WILLIAM GRIGG
star staff Writer

star 6LAII writer
Thalidomide's use by some
physicians was such that the
Food and Drug Administration
fears some samples Of the drug
may have entered the Nations
gray market" for sale by drug
gists.
Because Of this and because
410 doctors apparently have
not contacted patients to whom
thalidomide was given. FDA
warned yesterday that all drugs
left over from previous illnesses
and all unidentifiable drugs
still in medicine cabinets
should be destroyed.
FDA representatives said
that many Of the 40 agreed to
check on their patients.
The tablets were generally
given out in envelopes and con-
tanners which did not bear the
name Of the drug. The tablets
were in a variety of sizes and
colors. Some liquids and pow
derS also were distributed.
Potentially dangerous drug
samples have reached the gray
market before.
This is the way It works:
physicians samples are collect
ed by persons who say they will
be used for charity work or even
by janitors who pick them out
Of the physicians trash cans.
These are sold, to a repacker
who sells repacked drugs to
pharmacists.
Mistakes Occur
Sometimes these small out
fits make mistakes.
Two months ago, for example,
a potent drug for treating
mental depression was found
by FDA to be mixed with drugs
for mild gastro-intestinal con-
ditionS and with a vitamin
product that is sold without
prescription.
What would make such mix
ups possible in the case of tha-
lidomide. which has been linked
to infant malformations, is the
widespread distribution Of the
drug for 'investigational use"
to more than a thousand ply
sicians.
Figures released by the Food
and Drug Administration yes
terday indicated some Of these
physicians have handled the
investigational drug as intro
ductory samples. These samples
should not be provided before
a drug is released for sale.
which thalidomide never was.
Cite Competitive Squeeze"
But some believe the dis
tinction between distributing
drugs for investigation and dis
tributing them for prornotional
purposes has become confused
in today's highly competitive
drug industry.
For example. in the thalido-
mide investigation. FDA found
that six doctors donated sup
plies of the drug to religious
groups for charitable distribu-
ton overseas and are unable to
trace the present location Of
these drugs"
Further. only $40 OF the !, 1863
doctors with whom FDA has
talked said they had signed
statements that they were
qualified to investigate a drug.
Federal regulations require that
the manufacturer, in this case
the William S. Merrell Co. OBJ
tain such signed statements.
But in FDA's investigation,
BAT doctors said they had not
signed such statements and
more than geo said they could
not remember or did not an
swer the question.
Few Reported on Use
And further, Of the 1.f68
doctors. only 276 said they
made written reports of their
investigations to the Merrell
Co. Another 102 physicians said
they told their experience with
the drug to company detail
men-the drug statesmen. many
with pharmacy degrees. who
are the primary distributors
of promotional samples.
Seventy-nine Of the physi-
clans still had the drug on hand
when FDA representatives
reached them in recent weeks.
Most of the doctor investiga-
tors said they had received the
manufacturers advice in March
to stop using the drug, but IS
said they had not been warned
of adverse reactions and AZ said
they did not get any message
from the manufacturer.
ANA Backs Move
The American Medical Asso-
citation has pledged aid to We'll
fare Secretary Celebrezze in
getting the cooperation of some
of the 40 doctors whom FDA
representatives have not yet
been able to convince Of the
necessity of contracting the
patients to whom they gave
thalidomide supplies.
The ANA also pointedly has
called the attention of ply
sicianS to the ANA Code of
Ethics which says that investi-