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AIDS Treatment News
February 9, 1996

CONTENTS:

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

Advertisement
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




  
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This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
 

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