From: Billi Goldberg <bigoldberg@igc.apc.org>
Subject: Repost of AZT and Science Response
Note: non-commercial reproduction.
Archive-Number: 5780
Organization: UCLA, Computer Science Department
Date: Fri, 24 Jul 92 20:45:56 PDT

I am reposting this response because I totally messed up the table 
because I didn't leave a line between each of the table entries.  

I apologize for my mistake.

In post <07-22-92 11:48:00 rpetsche@mrg.tmc.edu (Rolfe G. Petschek)> 
Rolfe writes:

>Wrong.  AZT, DDI and DDC established by good, clear, well-designed peer 
>reviewed studies to decrease the rate at which people with 
>significantly progressed disease die.  I believe that they are the only 
>such drugs with immediate impact on HIV, as opposed to opportunistic 
>infections.

Since physics requires an in-depth knowledge of math, statistics, etc., 
I couldn't think of an individual more suited to evaluate the results of 
ACTG016 and ACTG019: the clinical trials or studies that resulted in the 
widespread use of AZT for treatment of HIV infection.

It would be greatly appreciated if you would pull those studies and 
evaluate them from your physical science background, scientific 
objectivity and expertise.

ACTG016: "The Efficacy of Azidothymidine (AZT) in the Treatment of 
Patients with AIDS and AIDS-Related Complex, July 23, 1987, Number 4, 
The New England Journal of Medicine, pages 185-191 by Fischl et al.

ACTG019: "Zidovudine in Asymptomatic Human Immunodeficiency Virus 
Infection, April 5, 1990, Number 14, The New England Journal of 
Medicine, pages 941-949 by Volberding et al.

The following table is from Fischl's study: the first using AZT.

Counts in table refer to CD4 T cell counts.

                 AZT GROUP                     PLACEBO GROUP 

            PATIENTS   MEDIAN    MEAN     PATIENTS   MEDIAN   MEAN 

             TESTED    COUNT     COUNT     TESTED    COUNT    COUNT 

PATIENTS WITH AIDS 

Base line     85        54.0     65.6        75       49.0    77.0     

Week 4        69       133.0    151.6        68       38.5    68.8     

Week 8        72        96.0    123.4        60       43.1    64.4     

Week 12       67        68.0    105.7        56       32.7    55.8     

Week 16       44        49.0     81.0        36       29.0    60.2     

Week 20       25        49.0     64.7        14       32.0    47.3     

Week 24        8        18.5     36.6         5       20.0    34.0     

PATIENTS WITH AIDS-RELATED COMPLEX 

Base line     60       190.0    199.3        61      128.0   175.0     

Week 4        54       251.0    257.9        51      154.0   182.7     

Week 8        54       204.5    222.4        48      114.5   161.5     

Week 12       46       277.6    254.0        47       93.0   164.3     

Week 16       38       209.0    269.7        38      157.6   178.0    

Week 20       20       340.0    297.0        22      103.0   156.9   
  
Week 24       11       217.0    262.6         9      154.0   232.9     

The following info is contained on page 186 of this double-blind, 
placebo-controlled trial of the efficacy of AZT:

"The placebo was indistinguishable in appearance from AZT and was 
similar in taste.  Drug therapy was temporarily discontinued or the 
frequency of doses decreased to one capsule every eight hours or longer 
is severe adverse reactions were noted.  The study medication was 
withdrawn if unacceptable toxic effects or a neoplasm requiring therapy 
developed.  Subjects in whom an opportunistic infection developed were 
withdrawn from the study only if therapy with another experimental 
medication was required or if antimicrobial therapy might have resulted 
in serious additive toxic effects."

My training was as a civil engineer, and I spent many years working with 
statistical data concerning accidents on California's state highway.
I am not impressed with the statistical information derived from the 
above study.  Remember, it must be considered that the dosages were 
decreased in individuals that had side effects or adverse reactions. 
That action results in skewing of the data, and is certainly not kosher 
in a double-blinded placebo controlled study.  Also, when preparing 
results of studies and experiments for publication, you attempt to show 
the data in the best light possible.  

>I have never ceased to be amazed at the rate at which science is 
>supposed to progress.  Ever since I learned of AIDS I was convinced 
>that many, many people would die thereof before an effective vaccine, 
>to say nothing of a cure (or effective long term treatment) was found. 
>Had I known it was a retrovirus at the time I would have been yet more 
>convinced of this.  

I have never ceased to be amazed at what science says it can do as 
compared to what it has actually accomplished.  

>The scientific community is doing the very best it can to find drugs, 
>cures and vaccines for HIV.  Significant progress has been made.  The 
>fact that people continue to die of the disease in the meantime does 
>not imply that anyone is particularly hard-hearted -rather it reflects 
>the difficulty of finding a cure for this (or, indeed any) disease.  

Is it really doing the very best it can do or is it doing the very best 
it can depending on who pays for the research that leads to drugs and 
treatments that can make the most profit.  The majority of AIDS victims 
are Third World.  How many of the scientific community are developing 
cheap, efficient treatments for these individuals?  No, it does not 
imply that the scientists are *particularly* hard-heated, just that they 
need money for research and to live.  The drug companies have the money 
so that is where the scientists go.  I can guarantee that drug companies 
are interested more in drugs that will realize profit than they are in 
being *humanitarians* and providing non-profit making drugs to indigent 
people.  

Do you really think that doctors and researchers are donating their time 
and efforts in running the multitude of AZT + everything studies?  I 
would surmise that Burroughs Wellcome is footing the bill and giving the 
doctors and researchers something extra for their time and effort along 
with *contributions* to proactive AIDS organizations that recommend BW 
drugs.

Now the focus of the research is shifting to the immune system and the 
cell mediated immune response.  Salk has stated that an antibody vaccine 
will not work as have many others.  There are now more and more 
discussions about T8 cells, dendritic cells, NK cells and focusing on 
treatments that will activate the immune system to fight off infections 
rather than just focusing on destruction of the HIV virus.

I figured out the immune system focus a few months after I became 
involved in AIDS.  Elswood, Epstein, Mills and others had a treatment 
years ago that focused on activating the immune system to fight 
microbial agents with DNCB.  

Why has it taken scientists 11 years to come to the same conclusion?  
Why do you think a contact sensitizing agent like DNCB works?  Why don't 
you check the literature about DNCB and activating the immune system?  
There were articles over 20 years ago that used the cell mediated immune 
system response and DNCB to control microbial agents and neoplasms.

Billi Goldberg