From: Billi Goldberg <bigoldberg@igc.apc.org>
Subject: CDC Summary 10/6/92
Note: Copyright 1992, Dan R. Greening. Non-commercial reproduction allowed.
Archive-Number: 6285
Organization: unspecified
Date: Tue, 6 Oct 92 07:48:22 PDT

                         AIDS Daily Summary
                          October 6, 1992 
 The Centers for Disease Control (CDC) National AIDS Clearinghouse makes 
available the following information as a public service only.  Providing 
this information does not constitute endorsement by the CDC, the CDC 
Clearinghouse, or any other organization.  Reproduction  of this text is 
encouraged; however, copies may not be sold.  Copyright 1992, 
Information, Inc., Bethesda, MD 
************************************************************************
 "FDA Approves Expanded Use of AIDS Drug" Washington Post (10/06/92), P. 
A10
     The Food and Drug Administration yesterday approved a new drug  for 
expanded use for AIDS patients who cannot tolerate AZT or  DDI, two 
drugs already approved to treat the disease.  The drug,  stavudine, also 
known as d4T, prevents further spread of HIV, the FDA said in a 
statement.  Bristol-Myers Squibb Co. manufactures  the drug, which is 
being tested to see if it can prolong life or  slow the progression of 
AIDS.  Early results from the clinical  trials on 259 patients suggest 
at least a temporary beneficial  effect, said the federal agency.  The 
FDA decided to permit  expanded use of d4T after determining that the 
potential benefits outweigh the risks and the drug satisfies a health 
need.  AIDS  patients who were previously ineligible to receive the drug  
should have their physicians contact the manufacturer to ask  about 
getting it now, said the FDA.  Related Stories: Wall Street Journal 
(10/06) P. B4; Philadelphia Inquirer (10/06) P. A4 

"Documents Threaten US Bid to Share Patent, Cut AZT Price" Journal of 
Commerce (10/06/92), P. 7A
     Several federal documents that have been accidentally disclosed  
are threatening the Bush administration's attempts to reduce the  cost 
of AZT.  The National Institutes of Health unintentionally  made the 
documents public in a response to a request under the  Freedom of 
Information Act.  They contain a series of legal  opinions concluding 
that the government has no concrete claim to  sharing credit for the 
development of AZT.  The conclusion goes  against the administration's 
public stance that the NIH  researchers who first tested AZT against HIV 
deserve to be  included as inventors on the U.S. patent for the drug.  
Burroughs Wellcome, the international pharmaceutical giant that holds 
the  patent and a monopoly on the sale of the drug in the U.S.,  
received the legal opinions in June among several hundred pages  of 
documents.  For several years, AIDS activists have chastised  Burroughs 
for taking advantage of its monopoly to overcharge for  the drug, and 
the Reagan and Bush administrations have been  blamed for allowing 
Burroughs to obtain an exclusive patent in  the first place.  If NIH 
were to be added to the patent as a  co-inventor, the government could 
license companies other than  Burroughs to make and sell AZT, which 
would dramatically lower  its cost to consumers.  NIH Director Bernadine 
Healy accused  Burroughs in May 1991 of unfairly taking credit for the  
development of AZT, which was actually discovered in 1964 during  an NIH 
search for anti-cancer drugs.  Instead of suing Burroughs, the 
government decided to fight the company by giving a license  to a 
generic firm to make and sell the drug.  That company, as  well as 
another one intending to sell AZT for half of its current price, are 
being sued by Burroughs. 

"AIDS Deaths a Record in Area and the U.S." Washington Post (Health) 
(10/06/92), P. 5  (Colburn, Don)
     Last year, AIDS became one of the nation's 10 leading causes of  
death, for the first time ever surpassing homicide and liver  disease.  
Also, AIDS has become the top killer of young adult men in U.S. cities, 
including Washington, D.C., and Baltimore.  AIDS  is second only to 
cancer as a cause of death in young women in  Washington, D.C., reports 
the Department of Human Services.  The  new statistics are particularly 
alarming because the increase in  AIDS deaths is becoming more rapid.  
Deaths from HIV increased 24 percent between 1990 and 1991, compared 
with a 13 percent  increase the previous year.  Death rates from four 
top  causes--heart disease, stroke, accidents, pneumonia, and  
influenza--declined last year.  But death rates from HIV and  homicide 
increased.  In the most recent national rankings, heart  disease is the 
largest killer, followed by cancer, stroke,  accidents, lung disease, 
pneumonia and influenza, diabetes,  suicide, AIDS, and homicide.  The 15 
top causes account for 86  percent of all deaths in the United States.  
Aside from AIDS,  which now ranks ninth, the list has not varied much in 
the last  ten years, though the order has shifted.  According to the  
report, approximately 30,000 Americans died of AIDS last year.   Among 
those, 61 percent were white males, 25 percent black males, 6 percent 
white females and 7 percent black females.  The  majority of AIDS 
patients were between the ages of 25 and 45. 

"Supreme Court Allows Religious Role in AIDS Curriculum" United Press 
International (10/05/92)  (Henderson, Greg)
     Washington--The Supreme Court Monday upheld New York state's  
policy of mandating that religious figures act as advisors when  forming 
the public school district's AIDS curriculum.  The court, without 
comment, refused to examine the policy, which has been  enacted 
statewide since 1988 and has been upheld by three lower  courts.  But 
adversaries argue that it infringes upon the  Constitution's mandate of 
a separation between church and state.  The state education commissioner 
demanded that public schools  adopt some form of AIDS education in 1988.  
The policy calls for  all New York state school districts to implement 
their own AIDS  advisory councils to make recommendations to local 
school boards  on what should be included in AIDS-awareness curricula 
for  students.  The rule requires that each advisory council consist  of 
"parents, school board members, appropriate school personnel,  and 
community representatives, including representatives from  religious 
organizations."  The New York State School Boards  Association contested 
the policy, saying it breaches the First  Amendment by requiring 
religious participation in public  education, and by mandating that 
local officials in some  instances choose one religion over another for 
a seat on an  advisory panel.  However, the state courts decided the 
role of  the religious figures--working as advisors with no direct role 
in actually establishing the curriculum--does not go so far as to  
illegally impose religious beliefs on public schools. 

"HIV-Infected Drug-Users Less Likely to Keep Kids" United Press 
International (10/05/92)
     Chicago--Children born to HIV-positive mothers are less inclined  
to live with their biological parents if the woman is an IV-drug  user, 
reported a study published Monday in the October issue of  Pediatrics, 
the American Academy of Pediatrics' journal.  The  study involved 1,683 
children born to HIV-positive mothers.  The  families were from New York 
City, Dallas, San Antonio, Houston,  Massachusetts, Los Angeles, San 
Francisco, and the District of  Columbia.  In all areas, children whose 
mothers used IV drugs  were more likely to be living with someone who 
was unrelated to  them, the study said.  About 56 percent of the 
children surveyed  were living with a biological parent, 27 percent were 
in foster  care, 10 percent lived with another relative, 4 percent were  
living in group settings or with other care givers, and 3 percent had 
been adopted.  However, the study found significant regional  
differences in care placement.  The study revealed that a child  in Los 
Angeles was seven times more likely to live with an  alternative care-
giver if the mother had used intravenous drugs.  The figure fell to 1.4 
times more likely for the Texas area.   Texas also had the highest count 
of children living with a  biological parent.  New York City accounted 
for 42 percent, but  ranked first in children housed in foster care with 
41 percent.   Washington, D.C., had the lowest percentage of children 
born to  HIV-positive mothers living in foster care, at 8 percent.   
Experts predict the proportion of perinatally HIV-positive  children in 
foster care across the country is about 34 percent. 

"The HIV Dating Game" Newsweek (10/05/92) Vol.120, No.14, P.56 
(Seligman, Jean et al.)
     HIV-positive people have a very difficult time dating  HIV-negative 
people because of the accompanying fears by both  parties.  When the 
epidemic started ten years ago, people became  sick so quickly that 
romance was not a top priority for those  HIV-positive individuals.  But 
with earlier diagnosis and better  drugs to prevent and treat symptoms, 
HIV-positive men and women  now may live for several years with the 
virus, often looking and  feeling healthy.  HIV-positive people usually 
go through a period of celibacy while coping with their diagnosis, but 
eventually  acknowledge the need for companionship and intimacy.  In Los  
Angeles there is a support group for HIV-positive people who seek 
romance and companionship called Friends for Life.  In New York,  every 
Thursday night it is Blood Brothers night at the Comeback  Club, which 
draws nearly 200 HIV-positive men every week.  The  founder, Will 
Leonard, who discovered he was HIV-positive last  year said, "For a 
person with AIDS, it feels like returning to  the mainstream.  Kevin 
Dimmick, a 35-year-old California computer programmer, who contracted 
HIV 12 years ago, believes that most  of the major AIDS organizations 
have ignored the needs of  heterosexuals who are affected by the 
disease.  Dimmick organized the Infected and Affected Straight Folks 
Party last March, five  more of which followed. 

"User Fees Advance in Congress" Nature (09/24/92) Vol. 359, No. 6393, P. 
261  (Gershon, Diane)
     User fees paid by drug companies to supplement the budget of the  
U.S. Food and Drug Administration (FDA) won the approval of a key 
congressional panel in the House of Representatives last month.   The 
proposal, which is the only one since the mid-1980s to have  received 
the support of industry, Congress, and the president,  would enable the 
FDA to hire 600 additional staff members to  clear the backlog of new 
drug applications awaiting review by the agency and hasten the drug 
review and approval process.  The  proposal co-sponsored by 
Representatives John Dingell (D-Mich.)  and Henry Waxman (D-Calif.) 
would yield about $330 million during the next five years through three 
types of user fees--a one-time  payment for new drug applications and 
annual fees on all approved prescription drugs on the market and on 
manufacturing  establishments.  FDA Commissioner David Kessler said that 
the  fees would allow the agency to rid itself of the backlog of new  
drug applications within two years. 

"Alpha-APA: New Anti-HIV Compound" AIDS Treatment News (09/18/92) No. 
159, P. 4  (James, John S.)
     A new drug in a class of chemicals known as alpha-anilino phenyl  
acetamides (alpha-APA) has been found to be a highly effective  anti-
HIV-1 agent by the Riga Institute for Medical Research in  Leuven, 
Belgium, in collaboration with the Janssen Research  Foundation in 
Beerse, Belgium.  The drug code-named R89439 has  been presented at 
three scientific conferences so far including  the Eighth International 
Conference on AIDS in Amsterdam.  The  treatment has been found to be 
effective against HIV-1 at very  small concentrations, a few nanograms 
per ml.  The drug also has  an uncommonly large ratio (about 1 to 
50,000) between the  concentration effective against HIV and the 
concentration toxic  to cells.  R89439 has been used in standard animal 
toxicity tests and has been tested in few HIV-negative human volunteers.  
The  drug is available orally and will likely need to be taken only  
once or twice a day.  Blood levels in humans are 30 times the  amount 
needed to inhibit HIV eight hours after taking a single  100 mg dose.  
Laboratory tests indicate that the drug is  synergistic when combined 
with AZT or with ddI.  Some alpha-APA  drugs are relatively easy to 
produce, and could be available in  any country worldwide.  Alpha-APA 
derivatives function by  inhibiting reverse transcriptase and are very 
specific to HIV-1,  which suggests that resistance may develop to this 
class of  compounds, as it has with other drugs that are targeted at the  
HIV-1 reverse transcriptase.

"ICAAC Conference October 11-14, Anaheim, California" AIDS Treatment 
News (09/18/92) No. 159, P. 6
     The annual Interscience Conference on Antimicrobial Agents and  
Chemotherapy (ICAAC) will be held October 11-14, 1992 at the  Anaheim 
Convention Center in Anaheim, Calif.  The conference will concentrate on 
the technical aspects of the development of new  antibiotics.  AIDS has 
been increasingly covered at recent  meetings.  Another meeting, of the 
Infectious Diseases Society of America, is held along with ICAAC, taking 
place right before  ICAAC, in Anaheim.  This year's ICAAC will involve 
symposia on  tuberculosis, cytokines, antiviral therapies, antiviral  
resistance, protease inhibitors, prophylaxis in persons with HIV, new 
antibiotics and antifungals, and a joint symposium on AIDS  with the 
Infectious Diseases Society of America.  

"d4T (Stavudine) Background" AIDS Treatment News (09/18/92) No. 159, P. 
1  (James, John S.)
     The drug d4T, also called stavudine, will be used in a "parallel  
track" trial by its developer Bristol-Myers Squibb, which will  soon 
provide the drug to AIDS patients who have failed both AZT  and ddI, and 
therefore have no approved HIV treatment options.   Results of the early 
trials indicate that d4T might be somewhat  better than either AZT or 
ddI as a single agent.  Therefore, the  drug could be a modest but 
significant improvement in AIDS/HIV  treatment.  However, d4T can only 
prevent infection of new  cells--as do AZT, ddI, and ddC--but cannot 
reduce viral activity  in chronically infected cells.  Though some 
studies found d4T to  work less well than AZT, d4T may compensate for 
this disadvantage by being processed more efficiently in human cells.  
d4T has been found to have very good oral bioavailability; and unlike 
ddI, it  doesn't need a buffer to protect it from stomach acidity.  It 
has been discovered that T-cell increases last longer with d4T than  
with AZT, often lasting for more than a year before returning to  
baseline.  The drug also shows antiviral activity in humans by  reducing 
p24 antigen.  The primary side effect is peripheral  neuropathy, similar 
to that caused by ddI or ddC.  d4T has not  been tested in combination 
with other antiretrovirals in clinical trials, but experts believe that 
a combination with AZT will  probably not work. 

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