Answers
02/06/1992


<TITLE>FDA URGES BUYERS CLUBS TO END SALES OF UNDERGROUND DDC</TITLE>
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T92-7                                                 Brad Stone
Feb. 6, 1992                                         (301) 443-3285


           FDA URGES BUYERS CLUBS TO END SALES OF UNDERGROUND DDC

    On Feb. 5, 1992, FDA informed AIDS buyers clubs throughout the United     
States that FDA-sponsored laboratory analysis of samples of unauthorized, or  
underground, versions of dideoxycytidine (DDC) -- an experimental AIDS        
treatment -- showed potentially serious variations in product potency and     
quality.  The agency has determined that these results indicate that          
underground DDC is produced under poor manufacturing conditions and that the  
overall safety and purity of underground DDC is suspect.  As a result, FDA    
has strongly urged buyers clubs to cease the sale or distribution of          
underground DDC and to notify their clientele of FDA's findings. 
    The term "buyers club" is loosely used to describe groups which           
facilitate patient access to drugs and other products purportedly useful in   
treating AIDS and related diseases.  
    In January 1992, the agency received reports that the amounts of DDC      
contained in some capsules of the underground product were far higher or      
lower than labelled.  In response to these reports, FDA undertook to do its   
own analysis of the product, collected samples from various buyers clubs and  
had its laboratory analyze these samples.

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                                                      Page 2, T92-7, DDC
    FDA's analysis confirmed wide variations among the individual samples of  
tested underground DDC.  Some individual capsules were shown to contain no    
DDC at all, while others contained more than twice the labelled amount.       
Variations from labelled dosage levels were also found when the individual    
units from each buyers club were combined into a composite sample for each    
site; one composite contained only half the expected content.
    FDA is concerned about these results because a significant variation      
from recommended dosage levels of DDC could put patients at risk of injury,   
particularly if the levels were too high.  Excessive levels of DDC are known  
to cause nerve damage in the hands and feet.  Although the excess potency     
found in FDA's analysis of the sampled underground DDC was short of the       
levels certain to produce these conditions, it nevertheless could increase    
patient risk of experiencing some serious adverse reactions. 
    Moreover, FDA believes that the significant inconsistency found in these  
samples reflects lapses in manufacturing practices that could be associated   
with increased risk of product contamination or other problems.  At a         
minimum, these findings demonstrate that it is not possible to assure the     
quality or safety of these products. 
    In view of these concerns, FDA has notified buyers clubs that             
underground DDC poses an unacceptable risk to public health, that sales and   
distribution of the product should cease immediately and that they should     
inform their clientele about the potential problems associated with these     
products.  FDA will work in cooperation with buyers clubs in this effort and  
will take other appropriate steps to protect the public health.
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                                                    Page 3, T92-7, DDC
    Unlike underground DDC, the authorized version of DDC is manufactured     
under strictly regulated conditions that ensure consistent product quality.   
Nevertheless, it is an experimental drug whose safety and efficacy are still  
under evaluation by FDA.  The agency is currently reviewing, on an expedited  
basis, a new drug application for DDC submitted in October 1991 by the        
drug's authorized manufacturer, Hoffmann-La Roche of Nutley, N.J.
    In the meantime, more than 3,500 patients are enrolled in FDA-sanctioned  
clinical trials of the drug being conducted by the National Cancer            
Institute, the National Institutes of Health and Hoffmann-La Roche.  In       
addition, DDC is being made available to more than 6,000 patients with AIDS   
and advanced AIDS-related complex who fail to benefit from or are unable to   
tolerate treatment with the approved AIDS treatment, zidovudine, commonly     
called AZT.
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