FDA Tests Buyers' Club ddC

On January 24 the U. S. Food and Drug Administration asked buyers'
clubs in New York and San Francisco for samples of the experimental AIDS
treatment ddC, in order to check the potency -- to make sure that each
capsule contained the stated amount of ddC. Samples were provided and
are now being analyzed, both by the FDA and by the distributor, and
results are expected within days.
At this time there is little more information, but there has been
much confusion and rumor. According to early press reports, previous
tests had found too little or too much ddC in some capsules. AIDS
TREATMENT NEWS has asked the FDA for lot numbers of any samples found to
be defective. So far, however, no such information is available.
The following excerpt from a January 29 press statement from
Project Inform, which has worked with the buyers' clubs in this
situation, provides background information and perspective:
"It is clear that no firm information has been presented by any
source in this matter. Since apparently anonymous accusations have been
made, however, it is appropriate that the FDA examine samples of the
product. Buyers' club personnel and community activists welcome this
inspection.
"ddC supplied to the buyers' club is quality-controlled by its
manufacturer, as are all products sold by pharmacies. Neither buyers'
clubs nor retail pharmacies routinely perform independent quality
assurance testing. The manufacturer of the buyers' club ddC does
routinely supply analyses of random samples of the product shipped to
the clubs. This analysis is performed by a reputable, independent
laboratory and the results are supplied both to the clubs and sometimes
to community organizations like Project Inform. These analyses, which
include measuring the dosage of individual pills, have not identified
any problem in the past, although some degree of variance from the
labeled dosing is likely -- as it is even with Hoffmann-La Roche
supplied ddC. This does not mean that problems are impossible, however,
since even major pharmaceutical companies sometimes experience problems
of this nature.
"To date, Project Inform has received no significant reports of
toxicity from buyers' club ddC, other than the toxicities which are
likewise associated with Hoffmann-La Roche ddC. At this time, we believe
that serious concern over the product seems unwarranted. Out of concern
for patient safety some buyers' clubs, but not all, have temporarily
suspended sale of the ddC pending analysis by FDA and independent
sampling.
"Those patients seeking the advice of Project Inform will be told
that they may choose to continue use of the product in hand unless they
are experiencing evidence of the side effects known to be common to ddC,
such as peripheral neuropathy. In the event of such problems, patients
should stop using the drug, whether it comes from a buyers' club or from
Hoffmann-La Roche. Project Inform further hopes that this incident,
whatever its cause, does not cause undue panic or anxiety among
patients. Although a dose ranging from 50 percent below to 300 percent
above that recommended might be problematic, it is instructive to
remember that early clinical trials of ddC by the government used a dose
several hundred times higher than that now employed. Although this
produced significant side effects, in no case was it known to endanger a
patient's life." [Note: the figure of doses 50 percent too low to 300
percent too high has appeared in some newspaper reports on this matter,
but has never been verified.]