
AIDS TREATMENT NEWS Issue #240, February 9, 1996
   phone 800/TREAT-1-2, or 415/255-0588



CONTENTS:

Protease Inhibitors at Retroviruses Conference

Protease Inhibitors in Human Testing: Annotated List

Ritonavir (Abbott Protease Inhibitor) Proves Survival Benefit 
in Late-Stage AIDS

Agouron Starts Phase III Protease Inhibitor Studies

Vancouver International Conference: Community Booths Deadline 
Extended

FDA Antiviral Advisory Committee Meetings This Month

Prisoners: Send Address Updates; Contacting Organizations

NMAC Skills Building Conference in South Africa: Facilitators 
Wanted

Computer Censorship Law, ACLU Test Case, Begin February 8


***** Protease Inhibitors at Retroviruses Conference

The big media story from the 3rd Conference on Retroviruses 
and Opportunistic Infections concerned two protease 
inhibitors, one developed by Abbott Laboratories, the other 
by Merck & Co. Triple combination trials, which combined each 
of these experimental drugs with two approved AIDS drugs, 
showed exceptionally promising results.

The overall outcome was not a surprise, as the general 
picture has been discussed quietly among inside-track 
researchers, physicians, and activists for several weeks. But 
the data had not been available before.

The ritonavir article below will look at the details of the 
new Abbott trial results, and at other research on this drug 
presented at the conference. Next week we will look at the 
Merck protease inhibitor, and at other news from the 
conference, which was an important meeting even aside from 
the high-profile protease inhibitor reports.

For More Information

Jules Levin of the National AIDS Treatment Advocacy Project 
(NATAP) has written in-depth articles on the protease 
inhibitor news from the 3rd Conference on Retroviruses and 
Opportunistic Infections. They are on the NATAP Web site, 
http://health.nyam.org:8000/public_html/natap (note that "l" 
is always the letter in this address, not the number one).

Also, audio tapes of many of the sessions of the 3rd 
Conference on Retroviruses and Opportunistic Infections are 
available from Sound Images, Inc. 7388 South Revere Parkway, 
Suite 806, Englewood, Colorado, 303/649-1811, fax 303/790-
4230. Probably the most important single set of tapes is for 
Late Breaker Session #1, which includes the major Abbott and 
Merck reports.


***** Protease Inhibitors in Human Testing: Annotated List

This brief directory of some protease inhibitors includes 
company, generic name, brand name if known (in parentheses), 
and comments. It is included to help readers follow our 
coverage of these drugs.

* Merck & Co.: indinavir (Crixivan(R)). This drug appears to 
be generally the best regarded among treatment activists at 
this time. It has very good viral suppression, and apparently 
limited side effects. The main disadvantage is that viral 
resistance and cross resistance can develop rapidly, 
especially if the drug is used improperly. It is possible 
that indinavir might still provide some benefit against 
resistant viruses.

* Abbott Laboratories: ritonavir. The main advantage of 
ritonavir is that now it has proven survival benefit in 
advanced AIDS; the other protease inhibitors have not yet 
been tested in any trial that could have determined whether 
or not they also can keep people alive longer. Ritonavir's 
main disadvantage is serious interactions with a number of 
other drugs. Also there are often gastrointestinal side 
effects, at least with the current formulation.

* Hoffmann La-Roche: saquinavir (Invirase(TM)). This is the 
only protease inhibitor which is FDA-approved at this time. 
It seems to have less viral resistance problem than the Merck 
and Abbott drugs. Its main disadvantage is that it was 
approved at a dose which is clearly too low; drawbacks to 
just taking more include the drug's great expense, and the 
lack of much safety data at higher doses. The dosage problem 
is being corrected, with a new formulation which will deliver 
a higher dose economically; however, it will take some time 
to get enough clinical-trial experience with the new dose and 
formulation for the FDA to be confident of safety, and 
approve this formulation for marketing.

* Agouron Pharmaceuticals, Inc.: nelfinavir mesylate 
(VIRACEPT(TM)). See the clinical trials announcement, below.

* Glaxo Wellcome/Vertex: 141W94, or VX478. No information 
about this protease inhibitor was presented at the 
Retroviruses conference, except for a passing reference in 
one abstract.

* CIBA-Geigy Ltd.: CGP 61755. This drug is in early 
development, and is not yet available in trials in the U.S. 
There was one abstract at the conference.

* Pharmacia & Upjohn: This company's protease inhibitor has 
not yet been tested in people; the first small, single-dose 
human studies might start later this year. There was no 
information about this drug at the conference.


***** Ritonavir (Abbott Protease Inhibitor) Proves Survival 
Benefit in Late-Stage AIDS

by John S. James

The most important single presentation at the Retroviruses 
conference was the report from Abbott Laboratories that its 
protease inhibitor, ritonavir, reduced the risk of death by 
43% in a clinical trial with 1090 volunteers. This is the 
first time that a protease inhibitor has been proven to 
extend life. Abbott ran this study remarkably quickly; the 
volunteers were recruited between April and July 1995, and 
yet the researchers were able to report survival results in 
late January.

All the volunteers had a CD4 (T-helper) count of 100 or less; 
the median CD4 count was about 30, and about a quarter of the 
volunteers had counts under 10. All had used approved 
antiretrovirals (mostly AZT and d4T) for more than nine 
months. These volunteers were randomly assigned to receive 
either ritonavir (600 mg twice daily) or placebo for one 
year. But after four months, anyone who developed an AIDS-
defining event was allowed to end the placebo phase of the 
study and use the drug.

In addition to the study drug, the volunteers were permitted 
but not required to continue using up to two other anti-HIV 
drugs; if they chose to do so, they needed to be on these 
drugs for at least six weeks before entering the study. 3TC 
was not permitted, since it was not officially approved when 
this trial started, although it was widely available in an 
expanded-access program. Also, volunteers were not allowed to 
use any other protease inhibitor.

The double-blind portion of this one-year study was stopped 
early because it reached a predetermined stopping number of 
191 clinical outcomes. The 43% reduction in risk of death was 
found after the volunteers had been in the study for a median 
of 6.1 months. (The improvement was even more impressive 
after the first month of the study, with a reduction in the 
risk of either an AIDS-defining event or death of 58%. The 
risk reduction was somewhat less for CMV retinitis than for 
other AIDS-defining conditions.) Both the six-month survival 
result, and the one-month progression-or-survival result, 
were statistically significant. On the other hand, 17% of the 
volunteers on ritonavir had to discontinue treatment due to 
adverse events, as compared to a 6% discontinuation rate on 
the placebo.

Viral load, CD4, and CD8 measures were studied in a subset of 
the volunteers in this trial, and were reported in a separate 
paper, reviewed below.

Ritonavir is the only protease inhibitor so far to have 
proven survival benefit. It is widely suspected that other 
protease inhibitors would have comparable results if they 
were tested the same way. But in view of Abbott's result, as 
well as new information about viral load, there would be 
ethical problems in running the same placebo trial with other 
drugs.

Comment

In all past trials it has been very difficult to prove a 
survival benefit from a drug. (The earliest controlled study 
of AZT did show a survival benefit of AZT vs. placebo, but 
that result is not entirely credible because of problems with 
the trial.) How could Abbott prove survival benefit today in 
such a short time?

There are basically two reasons. First, the new protease 
inhibitors, especially in combination with other 
antiretrovirals, are much more effective against HIV than 
previous treatments were, making it easier to show a 
difference between treated and untreated patients.

Also, Abbott overcame the widespread industry prejudice 
against allowing volunteers with very low CD4 counts in 
trials. Many researchers had come to believe that these 
patients were too advanced to benefit from antiviral drugs; 
companies excluded them so that their drugs would look good. 
But the belief that these people could not benefit came from 
experience with much less effective drugs. In addition, for 
several years it has been known that when persons with AIDS 
are receiving excellent medical care, almost all the deaths 
occur in those with a CD4 count below 50. Abbott realized 
that the very people who were being excluded by other 
companies were the ones it needed to prove that its drug 
could prolong life.

Recruiting patients is often the critical weakness of 
clinical trials. The ritonavir trial recruited quickly 
because persons with a low CD4 count had no other trials 
available, because Abbott opened 67 trial sites in the U.S., 
Europe, and Australia, and because persons in the trial could 
continue the anti-HIV medications they were already using. 
This trial has been well accepted by patients and activists.

Ritonavir does have a major disadvantage, however. It 
interacts with many other drugs by preventing them from being 
metabolized by the body, causing the normal dose of some 
drugs to become a dangerous overdose. Some medications can be 
used with appropriate dose adjustments; others cannot be 
combined with ritonavir at all.

The Merck protease inhibitor indinavir (Crixivan(R)) has much 
less of a drug-interaction problem, and probably at least as 
much ability to suppress HIV as ritonavir does. But it does 
not have data proving that it prolongs survival.

Where do we go from here in proving clinical benefit? Must 
every new protease inhibitor prove that it can extend life? 
We think not, for several reasons:

* Any proof of survival benefit requires that people die in 
the trial. These trials become increasingly problematic 
ethically, as evidence accumulates that viral load changes 
predict clinical response to therapy.

* It is clearly unworkable to prove survival benefit EARLY in 
HIV infection, because the trial would have to run for many 
years before deaths occurred. It would be nearly impossible 
to run such a trial, and unconscionable to deny early 
treatment until its results were in. We will have to find 
other ways of investigating the effects of early treatment, 
based on better understanding of the disease process.

* All indications to date are that the key contribution of 
ritonavir was in lowering viral load. If the viral load could 
be lowered as much by another protease inhibitor, by other 
drugs, or even by herbal treatment, without introducing major 
toxicities, all indications are that the survival benefit 
would be about equal.

* Viral load trials can be run much more rapidly than 
clinical-endpoint trials, with far less resources, allowing 
screening of many drugs and combinations at all stages of HIV 
disease, and without ethical problems as no one has to die or 
suffer significant harm.

We believe that clinical-endpoint trials should be used very 
selectively, and no longer be required by the FDA for every 
new drug. Resources should be shifted to rapid trials which 
look at viral load, CD4 counts, and other measures of HIV 
disease status, to determine how well treatments are working 
-- trials which include long-term followup. Resources now 
spent on confirming final certainty in regulatory decisions 
should be focused instead on answering physicians' practical 
questions on how best to use the drugs.

What about the risk of long-term drug toxicity? This is 
always a danger; but is the best way to look for it a 
randomized trial designed to determine whether or not the 
drug works against the disease? If the benefit and harm of 
the drug are nearly balanced, then a clinical-endpoint trial 
might be necessary to tell which was greater. But today there 
are many protease inhibitors and combinations with major 
impact on HIV; a drug which caused equivalent damage in side 
effects would be abandoned long before such a trial could be 
completed.

This issue remains controversial, however, because in theory 
at least, clinical benefit trials still offer the most 
certain proof that a drug does more good than harm. Many 
people are philosophically attached to this promise of 
certainty.

[Note: The ritonavir survival results were presented in the 
"late breaker" session of the conference, abstract #LB6a. The 
late breaker session is for results which are too recent to 
have been submitted by the regular deadline, but important 
enough to be accepted anyway.]

Other Ritonavir Results

The following additional results on ritonavir were presented 
at the Retroviruses conference:

* Ritonavir plus AZT plus ddC produced very good viral load 
suppression. A study in France treated 29 patients with 
advanced, untreated HIV infection with this combination; 21 
of them were able to tolerate the treatment for at least six 
months. Median viral load decreased to less than 1% of its 
starting value by month two, but was slightly over 1% at 
month six. Median CD4 count went from 156 at baseline to 303 
at month six. Twelve of the 21 patients had the number of 
infectious cells reduced by over 99.99%. [Abstract #285]

* A substudy of the ritonavir survival trial reported viral 
load, CD4, CD8 changes in the first 159 patients enrolled who 
started with a viral load over 15,000 copies (which included 
most patients, since the typical viral load was about 200,000 
copies). They were studied for the first four months of the 
trial (that is, before the point at which some patients were 
allowed to leave the placebo-controlled treatment and begin 
open-label ritonavir). The greatest difference in viral load 
between the ritonavir and placebo groups was 1.3 logs (20 
fold), measured at two weeks; at the end of the four-month 
substudy, the viral load of the treatment group was about 0.6 
logs (4 fold) lower than that of the placebo group, which had 
changed little during the trial, as expected. The greatest 
average difference in CD4 count was 45, measured at 16 weeks. 
The greatest difference in CD8 count was 363, measured at 
eight weeks (over an average baseline value of about 500). 
All these differences were highly statistically significant. 
[abstract #LB6b, with additional information from the oral 
presentation.]

* An Australian paper looked at immunological changes in 21 
patients treated with ritonavir, using two-color flow 
cytometry, and found improved immunologic function, as well 
as increased cell number. [abstract #232]

* A study in animals found that when ritonavir was combined 
with other protease inhibitors, the blood level of the other 
drug was greatly increased. This effect could vary greatly; 
the increase in blood level of saquinavir (the Roche protease 
inhibitor) was 29,000 percent (290 times), while the increase 
in indinavir (the Merck protease inhibitor) blood level was 
800%. [abstract #143]

* A resistance study compared viral load and particular 
mutations of HIV in seven patients treated with a low dose of 
ritonavir without other drugs. After two weeks, average viral 
load had decreased by 1.62 logs (42 fold); but later the 
viral load increased, and it returned to baseline values in 
six of the seven patients. The rise in viral load was 
strongly associated with mutations, especially at positions 
82 and 63 of the protease gene. The mutant virus appears to 
have been present before the patients ever saw the drug, but 
at very low levels, less than one one hundredth of one 
percent of the total virus. [abstract #201]

* A retrospective study compared the CD8 count changes in 
eight previous trials, of nucleoside analog reverse 
transcriptase inhibitors (such as AZT, or 3TC), non-
nucleoside analog reverse transcriptase inhibitors (such as 
nevirapine), and the protease inhibitor ritonavir. Patients 
using ritonavir had large CD8 increases, up to 892 in higher-
dose groups -- compared to small increases, or even 
decreases, with the other therapies. [abstract #451]


***** Agouron Starts Phase III Protease Inhibitor Studies

Agouron Pharmaceuticals, Inc. is starting two large studies 
of its protease inhibitor VIRACEPT(TM) (nelfinavir mesylate) 
in combination with approved HIV drugs. A smaller study of 
nelfinavir alone is also beginning.

One trial, protocol 506, will study two doses of nelfinavir 
(500 and 750 mg) combined with stavudine (d4T), vs. stavudine 
alone. Volunteers will have a two-thirds chance of getting 
one of the combination regimens. This trial will enroll 240 
patients; three quarters of the slots are for persons who 
have been treated with AZT for at least six months, and the 
other 25% are for those who have either had no AZT use, or 
less than six months of it. Volunteers must be at least 13 
years old, and must have a CD4 count of at least 50 and a 
viral load of at least 15,000 copies. They cannot have used 
any protease inhibitor, nor d4T, at any time. In case of 
treatment failure (defined as return to baseline viral load, 
CD4, or both on two consecutive visits following four weeks 
of drug administration), certain treatment changes will be 
allowed. This study will last 24 weeks, and may provide drug 
for an additional six months.

Another trial, protocol 511, will study the same two doses of 
nelfinavir in combination with AZT plus 3TC, vs. AZT plus 3TC 
alone. Volunteers will have a two-thirds chance of getting a 
triple combination treatment. They must be at least 13 years 
old, and have a viral load of at least 15,000 copies. They 
can have any CD4 count, but cannot have received any anti-HIV 
drugs except for a lifetime total of less than one month of 
AZT. This study will last for 24 weeks, after which drug may 
be provided for another six months. Provisions similar to 
protocol 506 are available for treatment failure. This study 
is seeking to enroll 210 patients.

Protocol 505 will study the same two doses of nelfinavir 
alone, compared to placebo. After four weeks, the placebo 
volunteers will be randomized into one of the treatment 
groups. Volunteers must have a CD4 count of at least 50, and 
a viral load of at least 15,000.

For more information about these trials, which are now 
recruiting in about 30 cities in the U.S., call Agouron's 
information line, 800/501-2474, and follow the voicemail 
instructions to find a contact number in your city.

Comment

It is difficult for patients and physicians to make decisions 
about protease inhibitor therapies at this time. The main 
disadvantage of the Agouron drug is that much less is known 
about it than is known about the Merck, Abbott, or Roche 
protease inhibitors. On the other hand, it may not have some 
of the drawbacks of those other drugs. For today and for the 
near future, there is no way to know which treatment options 
are best.


***** Vancouver International Conference: Community Booths 
Deadline Extended

The February 1 deadline to apply for an NGO (non-government 
organization, i.e. not-for-profit organization) booth at the 
XI International Conference on AIDS (Vancouver, July 7-12, 
1996) has been extended. There is no charge for these booths, 
but a deposit is required, to discourage organizations from 
reserving space and not using it.

For more information, call the XI International Conference on 
AIDS, Exhibit Management Office, attn: Ms. Val Levy, 1030 
Mainland St., Vancouver, V6B 2T4, 604/688-0855, fax 604/688-
0270.


***** FDA Antiviral Advisory Committee Meetings

The Antiviral Drugs Advisory Committee has four AIDS-related 
meetings in the next month; all are open to the public, and 
public testimony will be taken. Note that some information 
about the locations which was published in the FEDERAL 
REGISTER on January 31 is erroneous.

February 28, 8:30-5:00: Recent studies with nucleoside 
analogs (ACTG 175, the Delta study, and others), and how the 
results should affect standard of care.

February 29, 8:30-5:00: Ritonavir (Abbott Laboratories 
protease inhibitor).

March 1, 8:30-5:00: Crixivan(R) (Merck & Co. protease 
inhibitor).

March 1 also, 8:00-5:00: A joint meeting of the Antiviral 
Drugs Advisory Committee and the Endocrine and Metabolic 
Drugs Advisory Committee, on Serostim(TM) (human growth 
hormone) to treat AIDS-related wasting. (This meeting will be 
at the Holiday Inn, Silver Spring, Maryland; the other three 
meetings will be at the Holiday Inn, Gaithersburg, Maryland. 
The Antiviral Drugs Advisory Committee will be divided for 
the two simultaneous March 1 meetings.)

For the most current information, call the FDA Advisory 
Committee Hotline, 800/741-8138. When it asks for a 5-digit 
code, enter the code for the Antiviral Drugs Advisory 
Committee, 12531.


***** Prisoners: Send Address Updates; Contacting 
Organizations

If you are transferred or released, send us your new address 
if you want to continue receiving AIDS TREATMENT NEWS. We 
will automatically continue a free subscription for six 
months after you are released; after that time you can use 
our regular sliding scale if you have financial difficulties. 
But if you do not send us a forwarding address, our mailings 
are returned and there is no way we can contact you.

Also, in our January 5 issue (#238) listing of AIDS 
organizations, we only had space to publish telephone 
numbers, not addresses. If you need to contact one of those 
organizations but cannot call them, you can send a letter to 
us, and we will forward it to them for you.


***** NMAC Skills Building Conference in South Africa: 
Facilitators Wanted

The National Minority AIDS Council, working with several 
other organizations, will hold the NMAC Skills Building 
Conference for South African Community-Based AIDS Service 
Providers, in Johannesburg, April 15-19. NMAC is now seeking 
ten facilitators to help with this training conference; two 
will receive full travel expenses, the others partial 
expenses.

Applications are due February 20. For more information, call 
Jackyie Coleman or Harold Phillips at 202/483-6622.


***** Computer Censorship Law, ACLU Test Case, Begin 
February 8

by John S. James

On February 1 both houses of Congress passed The 
Communications Act of 1995, the major telecommunications bill 
which includes the computer censorship provisions described 
in previous issues of AIDS TREATMENT NEWS (issues #227, #229, 
#236, #237, and #238). The censorship legislation will take 
effect when Clinton signs the bill, probably on February 8.

Unless the Supreme Court rules the provision 
unconstitutional, it is now a felony punishable by five years 
in prison for anyone in the U.S. to just RECEIVE an "obscene" 
communication by computer, even in your own home by private 
email or otherwise, even if you never show it to anyone -- up 
to ten years for the second and each subsequent reception, 
with a fine for each offense up to $250,000. You do not need 
to know that the communication is legally obscene -- just 
knowing it is sexually oriented is enough. By the time you 
see it to judge whether it is obscene, the crime has already 
been committed. And if you used the Internet, open-and-shut 
evidence against you passed through any number of different 
sites controlled by different organizations, and can remain 
there for years, legally dangerous until the statute of 
limitations expires.

Abortion became an issue on the day of the final vote in 
Congress, because the same legislation likewise makes it a 
felony to knowingly receive by computer (as well as to send) 
any information about how an abortion pill or other device 
can be obtained or made. Members of Congress disagree as to 
whether all of the prohibition of abortion information has 
already been ruled unconstitutional. As a compromise, some 
sponsors of the censorship legislation read language into the 
CONGRESSIONAL RECORD saying that Congress did not intend the 
telecommunications bill to criminalize abortion information; 
this might help if someone is prosecuted for discussing 
abortion by computer. Congress was unwilling to make any 
change in the language of the bill, however, because it was 
determined to pass the entire telecommunications bill that 
day or the next, before it went home for recess. (For more 
information on this abortion controversy in the 
telecommunications bill, see the SAN JOSE MERCURY NEWS, 
February 2, page 1.)

These obscenity and abortion provisions of the law have 
nothing to do with the protection of minors, since they apply 
to anyone, even if no minor is involved in any way. About the 
only fact in your favor is that prosecution would presumably 
have to occur in your local area, or wherever you were when 
you received the message (not anywhere in the country, as 
with other sections of the law); in many areas, such as San 
Francisco, malicious or political prosecution of an 
inadvertent or incidental offense would seem unlikely. And 
the law applies to "interstate commerce," so it might not 
apply to local use of a local bulletin board not connected to 
the Internet.

Few members of Congress even knew that this provision was in 
the legislation until the day of the vote on the entire 
telecommunications bill, when the abortion issue was raised 
by Congresswoman Pat Schroeder. There have never been 
Congressional hearings on any of the computer censorship 
legislation; most members of Congress did not follow this 
issue at all. And the new crime of receiving information by 
computer was created by a few words in a six-page list of 
"technical" changes, words which apply an unrelated law 
(against importing pornography and abortion devices) to 
people who just explore on their own computer. This provision 
did not appear in the official text of the telecommunications 
bill until the morning of February 1, the day of the final 
vote in both houses of Congress. It never appeared anywhere 
in Thomas, the Library of Congress Web site intended to 
provide the public with the text of legislation Congress is 
currently considering, until after final passage. (The 
language has existed unofficially since December or early 
January, and it has been posted on public Web sites by civil 
liberties organizations; but it was not made official, and 
therefore not released to the public through usual channels, 
until shortly before the final vote in Congress. Those who 
looked where one would normally look for pending legislation 
did not find it. There appears to have been a deliberate 
effort to prevent the public from knowing, by keeping the 
censorship language in unofficial, unpublished status, until 
the day Congress cast its final votes.)

The better-known provisions of the bill are equally 
threatening. Putting any "indecent" message on the Internet 
is now a felony punishable by two years in prison and a 
$250,000 fine -- even if the same text or picture would be 
legal if published in a newspaper. "Indecent" is not clearly 
defined -- but redeeming social importance is not a legal 
defense (Congress rejected a proposal to exempt such 
material). And the indecency legal standard is so broad that 
it may even include the Bible; the King James version uses 
one of the Federal Communication Commission's "seven dirty 
words," a word specifically defined as indecent by the U.S. 
Supreme Court (II Kings 18:27).

Also, the crime is committed wherever someone under 18 
RECEIVES the material, meaning that a person can be 
prosecuted anywhere in the country that prosecutors or 
influential organizations may be so inclined.

This new law affects AIDS TREATMENT NEWS, despite our 
completely non-sexual material:

* If we set up a Web site or any other computer facility 
which allows many-to-many discussion, we may be criminally 
liable for messages others post on our site; both the text of 
the legislation and the statements of its supporters in 
Congress suggest that this is the Congressional intent, as 
service providers are specifically exempted for "providing 
such access or connection that does not include the creation 
of the content of the communication," language apparently 
intended to protect companies in the business of leasing 
phone lines, computer hardware, etc. In a Web site, we would 
of course be creating content. No one knows if removing any 
problematic message as soon as we become aware of it would be 
enough to avoid trouble.

* If we set up an annotated directory of where to find AIDS 
information on the Internet and elsewhere online (which we 
have been planning to do), we may similarly be criminally 
liable for material that appears in any system we point to or 
describe, in the U.S. or abroad -- either material which 
exists when we set up the link, or which is added in the 
future -- even if we do not let the public add any 
information to our own site. What if a site we link to is 
inoffensive, but sites it links to are not?  (It can take 
surprisingly few successive links to reach from a large 
directory to almost any site on Earth.) Obviously we cannot 
keep monitoring all AIDS-related systems on the Internet, 
which are the systems our directory would point to. We may 
have to publish our online directory in print only, and not 
allow copies online.

* The law against receiving anything obscene makes it 
dangerous to explore what information is available. Sexually 
explicit sites sometimes include an AIDS section; if we must 
never look at those sites, we will not have a comprehensive 
picture. In order to obey the law, we may have to travel 
abroad, or ask persons abroad to research certain areas for 
us.

This concern may seem exaggerated, when no one is likely to 
prosecute AIDS TREATMENT NEWS for researching and running an 
AIDS directory on the Internet. But the issue is not only the 
actual risk of prosecution; also it is how we define 
ourselves and set the policies that build our relationships 
in society. We are not comfortable if enforcement of the laws 
literally as written could send us to prison for decades -- 
no matter how unlikely this is to actually happen.

* Many academic archives, directories, and other information 
services now available on the Internet are likely to 
disappear, and many others will silently never begin -- even 
concerning completely non-sexual topics. Manual screening of 
massive back archives to assure legality would be 
prohibitively expensive for most institutions, as would 
sophisticated legal advice. And no software could screen the 
material and tell what might upset a prosecutor or jury 
somewhere, sometime, under who knows what political 
atmosphere or regime. Administrators at academic, government, 
and other large institutions are cautious by nature, and are 
likely to avoid possible trouble by not allowing their 
experts to make information available to the public. (The 
remarkable tradition of open access on the Internet could be 
lost permanently, even if the law is later changed -- because 
universities may find that they need to withhold their data 
in order to trade it to assure permission for their scholars 
to access the databases of others. This dynamic could 
permanently restrict to large institutions information which 
is now available to all.)

* And of course it will be more difficult to publish our 
material on the Internet, because we will need to find 
service providers willing to check everything we write in 
advance, or who know us well enough to trust us not to get 
them in trouble. We will always be able to find servers to 
carry us, but we may be blocked from public areas of the big 
service providers where most people have their accounts. We 
can still distribute our material by email, but it will be 
more difficult to reach new people and let them know what 
resources exist.

Why not avoid some of the problems by restricting our Web 
page to adult-only areas, as supporters of the law have 
suggested? One major reason is that there are no adult-only 
areas on the Internet of any consequence -- and there never 
will be, no matter what technology and institutions are 
developed. The reason is that the Internet is what could be 
called an information commons -- and inherently there is only 
one of those, not one for adults only and another for 
everyone. Once you limit or restrict a commons, it is not a 
commons any more, but a proprietary system controlled by 
somebody, because someone must police the restriction. This 
owner, manager, or authority can then police content, too, 
imposing whatever political or other restrictions it wishes. 
You no longer have a First Amendment right to be heard, just 
as you have no First Amendment right to be published in a 
particular newspaper. When a commons has been enclosed, its 
essence has been destroyed.

Strategy

AIDS organizations had no input at all into the new 
censorship legislation. In the past, our strategy at AIDS 
TREATMENT NEWS was to inform the AIDS community about the 
threat, so that it could have input into what Congress did. 
But there was no time, because the censorship provisions 
appeared dead until just weeks before they were locked in 
concrete, with Congress unwilling to change even a single 
word before final passage.

Now that it is too late to prevent the legislation, other 
strategies are needed. At this time we see three:

* Support the court challenges which are now being prepared 
by the American Civil Liberties Union and others (see below). 
Three AIDS service organizations are among the plaintiffs in 
this ACLU lawsuit.

Much of the new law is likely to be declared 
unconstitutional, as violating the First Amendment of the 
Bill of Rights. But court decisions could be many years away. 
And no matter what the courts do, we will need to fight this 
issue forever; we will need both institutional coalitions and 
personal working relationships with civil libertarians.

* Find and publish ways of staying out of trouble. For 
example, it still appears safe to distribute completely non-
sexual information (such as AIDS TREATMENT NEWS) by email. We 
can now focus our computer distribution efforts on much more 
skillful use of email lists, which clearly needs to be done 
anyway (NOT using lists to broadcast massively as junk mail, 
but targeting massively yet with precision those who are 
likely to be interested, approaching dozens or hundreds of 
existing online communities, each in its own terms, its own 
contexts).

So far we do not know anyone who has learned how to do this 
well on the Internet. The AIDS community and others can apply 
their full energies to building expertise in appropriately 
targeted mass distribution, with confidence that this avenue 
will always be open, while the bill's legal consequences for 
participatory Internet sites are worked out.

Certainly we will seek legal advice, but no one can know how 
the law will be enforced. Our guess is that for some time it 
will be enforced selectively -- usually against those 
actually involved with pornography, sometimes against 
individuals and organizations targeted for their political 
work (especially gays), and occasionally against ordinary 
people whose incidental transgression happens to come to 
someone's attention and fit their agenda. But if a 
bureaucracy of inquisition develops, it will need cases to 
justify its existence, and the proportion of political and 
incidental prosecutions will increase. The fines of up to 
$250,000 per message could also motivate prosecutions. 
Enforcement philosophy is likely to depend heavily on the 
political atmosphere of the time, and on who is President.

* It is becoming clear that without a mass movement to defend 
civil liberties in the digital age -- comparable to what the 
National Rifle Association has done over the years on behalf 
of gun owners, or the pro-choice movement in supporting 
abortion rights -- we face increasingly serious threats to 
our future. Telephone and video are now merging with 
computers; soon all of the important means of public 
communication may come under the same censorship which 
computer users now face. And computers have unprecedented 
ability to preserve all traces of communication forever, 
making messages instantly available by person, topic, or any 
other search criteria desired; the cost of storage is now so 
low that it is becoming feasible to archive everybody's 
online communication. (Also, "spy viruses," computer viruses 
that instead of being pranks or causing immediate damage, 
secretly collect information and ship it to other parties 
through telephone or data lines, may either steal business 
information or turn one's own computer into an informer.) The 
new law imposes prohibitions so broad and undefined that 
anyone can be targeted for discriminatory enforcement, for 
political, personal, or other reasons, because no one can go 
though their whole life using computers regularly without 
ever making a mistake. The new law sets the stage for massive 
abuses; and the U.S. can use its superpower muscle to require 
such abuses elsewhere.

The only long-term protection is well-organized mass 
movements to make sure that the First Amendment rights U.S. 
citizens have defended throughout this nation's history are 
still meaningful, for today and for tomorrow. Congress could 
pass the current law only because it heard from very few 
people who knew or cared. That must never be allowed to 
happen again.

But in civil liberties -- as also in AIDS -- we have never 
yet found an organization that offers meaningful 
participation to any willing, committed volunteer, regardless 
of what skills they have, and wherever they may live. Some 
right-wing organizations do seem able to do this. Religious 
groups may have an advantage, because they can offer prayer 
at first, allowing people to become comfortable with each 
other before the egos and divisiveness of politics are 
introduced. Building equally massive grassroots organizations 
to defend a free society, instead of taking freedom away in 
the pursuit of power, is today's critical bridge to moving 
forward.

Test Case Filed This Week

As this issue went to press on February 7, the ACLU announced 
that it is filing a test case (ACLU v Reno) against the 
computer censorship provisions of the telecommunication law, 
immediately after Clinton signs the legislation (probably 
February 8). The group of 20 plaintiffs in this case includes 
three AIDS organizations: 

* Critical Path AIDS Project in Philadelphia, which receives 
up to 10,000 access requests per day for AIDS information, 
reaches some of the most underserved communities in the 
nation, and will soon offer AIDS information in eight 
different Asian languages; 

* AEGIS (AIDS Education Global Information System) in 
Southern California, which operates a free computer bulletin 
board with one of the largest online archives of AIDS 
information in the world; and

* The Safer Sex Page, a large archive of sex education 
materials on the World Wide Web which receives 35,000 access 
requests per week from around the world.

Other plaintiffs include Human Rights Watch (at risk because 
its reports include accounts of rape and torture in 
documentation of human-rights violations), Planned Parenthood 
Federation of America (which provides information on topics 
which include abortion), and the Institute for Global 
Communication (which operates a computer facility that serves 
about 400 nonprofit groups and 500 schools).

Also note: A number of World Wide Web sites are reversing the 
contrast on their lettering to turn their pages black, for a 
two-day protest after Clinton signs the bill, which he is 
expected to do on February 8. For more information about this 
protest, contact the Voters Telecommunications Watch 
(vtw@vtw.org), or check their free-speech Web page at 
http://www.vtw.org/speech/.

For More Information:

American Civil Liberties Union, 212/944-9800x414 (or its new 
Web page, http://www.aclu.org -- or America Online, keyword 
'ACLU')

Center for Democracy and Technology, http://www.cdt.org

Electronic Frontier Foundation, http://www.eff.org

Voters Telecommunications Watch, http://www. vtw.org/, or 
vtw@vtw.org


***** AIDS TREATMENT NEWS
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AIDS TREATMENT NEWS reports on experimental and 
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and found combinations which work for them. AIDS 
Treatment News does not recommend particular 
therapies, but seeks to increase the options available.

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ISSN # 1052-4207 

Copyright 1996 by John S. James.  Permission granted for 
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