Advertisement
The Body: The Complete HIV/AIDS Resource
Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App
Professionals >> Visit The Body PROThe Body en Espanol
  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

AIDS Treatment News
April 5, 1996

CONTENTS:

San Francisco: 
3TC Available Now to Residents 
through ADAP Program

In San Francisco the Mayor's HIV Planning Council found money unspent on other AIDS programs and used it to cover lamivudine (Epivir(TM), 3TC) under the ADAP program (AIDS Drug Assistance Program, for persons with limited income). The money, $900,000, should last for the several months which it is likely to take for California to add the drug to the statewide ADAP formulary. 3TC was added to the ADAP formulary for San Francisco residents on April 1. (The unspent money totaled $1.5 million; besides the $900,000, $285,000 was allocated to vouchers for food, clothing, taxis, and household necessities, and the remainder went to food programs.)

Despite early reports to the contrary, San Francisco residents DO NOT need to already be in the ADAP program to be eligible for Epivir. They can join the AIDS Drug Assistance Program now. They must be San Francisco residents, be HIV positive, and qualify under fairly generous income limits. Also, initial reports that only the tablets are covered were erroneous; the oral solution, which is mainly for pediatric use and also for adults who need to use doses lower than usual, is covered by this program as well.


Protease Inhibitors: 
Patient Education Critical

by John S. James
It is widely agreed that successful use of the new protease inhibitors -- especially indinavir (Crixivan(R)) from Merck & Co., and ritonavir (Norvir(TM)) from Abbott Laboratories -- will depend on effective patient education. This education is not yet in place; for example, some important materials are not ready yet, and some are ready but not being distributed successfully.

Advertisement
One major concern is drug safety, especially drug interactions with Abbott's ritonavir. Many drugs must not be taken together with ritonavir, because ritonavir prevents those drugs from being metabolized by the body, resulting in a large overdose (not of ritonavir, but of the other drug). Abbott has prepared a card for patients to carry, listing some of the most important drugs to avoid; unfortunately this card has not yet been distributed with many of the prescriptions dispensed so far. Therefore, we are reproducing it below, with permission [not reproduced online]. But be sure to check with your doctor, because this list is not complete, and it will probably change as new interaction problems are discovered. (Merck's indinavir seems to cause much less problem with drug interactions and with side effects, although there are some of each.) And the different protease inhibitors MUST NOT be combined until clinical trials have shown whether, and how, this might be done safely.

The other major concern, with both Merck's indinavir and Abbott's ritonavir, is that the drugs must be used properly, or viral resistance will develop rapidly -- and once resistance develops to either of these drugs, then both are likely to be much less useful (if useful at all) for that patient, at any time in the future. (With the only other protease inhibitor which is now approved -- saquinavir (Invirase(TM)) from Hoffmann-La Roche -- resistance seems to develop more slowly, so the problem is not so critical.) Because of the resistance problem, past practices such as casual dose reductions, "drug holidays," or general laxity in following instructions, must now be changed with the Merck and Abbott drugs. Compliance with instructions on prescription drugs is always a problem, and there is much concern that patients may not comply closely enough to use these new drugs effectively.

Also, resistance can be minimized and patients can get maximum benefit from these drugs if they are used in combination with other approved antiretrovirals; this keeps the overall level of viral replication at a minimum, and reduces the chance that a mutant virus will be resistant to all the drugs. One combination of interest is indinavir plus AZT plus 3TC. But combinations are likely to work best when all of the drugs are new to the patient, so that the virus has never seen any of them before. Since many patients have already taken AZT for a long time, and may have virus resistant to it, other combinations might be better for them. Research is urgently needed to learn more about which combinations are best for which patients.

For these reasons we believe that if people are doing fairly well and can afford to wait, they should consider waiting before starting protease inhibitors. In the next few months, more will be learned about longer-term safety, and how to use these drugs most effectively. Since most or all HIV drugs are likely to work best the first time they are started (due to the absence of resistant virus), it may be worth waiting in order to get the maximum benefit out of one's first exposure to these drugs.

But many people cannot afford to wait. If you do plan to start using Merck's indinavir within the next few months, while supplies are limited, you may want to start as soon as possible, in order to have the best chance of obtaining this drug -- see article below. (There seems to be no supply problem with Abbott's ritonavir, however, and therefore no occasion to hurry to get in line for it.)


Indinavir (Crixivan(R)) 
Access and Distribution

by John S. James
Because Merck will have limited supplies of indinavir (Crixivan), its recently approved protease inhibitor, until new factories are running this fall -- and because this drug, once started, should not be interrupted, in order to avoid giving the virus opportunities to become resistant -- Merck has set up a complex temporary distribution system. The purpose of this system is to make sure that there is enough drug to provide refills to everyone who starts using it. There may be enough supply for everyone; but if there is not, Merck will have to put new people on a waiting list, to save enough drug to continue those who have already begun. (If supplies do run short, Merck plans to reserve enough drug for about 2,500 people with CD4 (T-cell) counts under 50.) Merck now has enough drug to supply about 30,000 persons in the U.S. for the next several months, until the new factories are ready. (This number is likely to change depending on international approvals and demand.)

Because of the need to track prescriptions, and because Merck does not have the inventory available to spare enough drug to fill the standard pharmaceutical distribution pipeline, Merck will temporarily sell indinavir only through one mail-order pharmacy, Stadtlanders (hotline for Crixivan, 800/238-1548) -- and by certain special arrangements otherwise. The rest of this article will outline how the distribution system is supposed to work, including how Merck plans to handle a number of special cases -- certain states, various HMOs, Medicaid, ADAP, Federal institutions, patients in hospitals, and persons now taking indinavir in SOME of Merck's clinical trials (who will be offered free drug for three to five years for a followup study, and therefore will not need to buy it).

  • Patients who are already using Stadtlanders, or whose insurance allows them to use it, should have no problem. A simple form will be required to start a new prescription, but the paperwork is not difficult -- and Stadtlanders has a good reputation for customer service and followup.

Merck is encouraging physicians and patients to submit their initial forms by fax -- although prescriptions by mail and by phone will also be accepted. (In New York City, Stadtlanders has opened a pharmacy in order to qualify to do mail-order business in New York State under certain laws. But patients still must enroll through the main phone number. Our understanding is that the New York store will be used mainly for mailing prescriptions to New York State Medicaid recipients -- and for local people who may prefer to have their prescription mailed for them for pick up there, instead of to their home.)

The disadvantage for Stadtlanders' customers -- and for everyone else -- is the price; Stadtlanders has a monopoly for the next several months, and patients who pay out of pocket for their indinavir will have to pay $5820 per year -- a markup of more than 32% over the $4400 per year which Merck charges Stadtlanders. This is more than $1400 per year just for the filling of the prescription (plus associated user services, such as direct insurance billing, and calling customers to remind them when their prescription is about to expire). Stadtlanders told us that most of their customers will pay prices set by their health plan, not by Stadtlanders.

Stadtlanders also told us that their retail price has been set at average wholesale price plus 10%. But since there are no wholesalers in this case, with Stadtlanders buying the drug from Merck and selling it directly to the patient, it appears that the division between average wholesale price and retail markup is at whatever point Stadtlanders wishes to pick. (The "average wholesale price" is $15, which is a 25% markup over Merck's price to Stadtlanders -- an average wholesale price markup which we have been told is unusually high for the industry.)

Merck says that antitrust laws prevent it from negotiating a price with Stadtlanders, or from bringing any pressure on that company to lower its price. (We talked to one lawyer familiar with antitrust, who said that while Merck is correct that attempts at vertical price fixing are unlawful, an exclusive distributorship agreement may be unlawful if it decreases competition without some other procompetitive justification.)

  • At least two other mail-order pharmacies -- Community Prescription Service (800/842-0502), and MedExpress (800/808- 8060) have announced that they will accept orders for indinavir, and do the paperwork to get the drug through Stadtlanders. Others may follow, since otherwise they risk losing much of their business to Stadtlanders, as their clients who have to go there for indinavir may take their other prescriptions there too, to avoid having to deal with separate mail-order pharmacies.
  • For persons in HMOs, Merck is negotiating with the HMOs and is finding that almost all of them are willing to work with Stadtlanders. Merck does not expect much access problem for persons in managed care. No HMOs so far have declined to provide indinavir -- although many have not yet made a decision.
  • For a few staff-run HMOs like Kaiser, Merck has agreed to supply the drug directly under certain conditions, not going through Stadtlanders. Kaiser has already received indinavir at this time.
  • For Medicaid patients, Stadtlanders is a licensed provider in 22 states and the District of Columbia -- accounting for over two thirds of all patients who would be placed on therapy. In the other states, Stadtlanders is working with The Medicine Shoppe to distribute the drug. Stadtlanders will still get the forms, monitor patients, and report to Merck, but will ship each patient's drug to The Medicine Shoppe, which will then re-ship it to the patient. As of April 1, 21 states currently plan to cover indinavir, and others are making their decisions.
  • For ADAP, like Medicaid, Stadtlanders will work with the ADAP in states where Stadtlanders cannot provide the drug directly to determine an acceptable method of counting and tracking patients.
  • For long-term care institutions, Stadtlanders will again act like a wholesaler. The long term care provider will need to count and track patients and provide these numbers to Merck.
  • Federal institutions -- the Veterans Administration, the military, the National Institutes of Health, the Public Health Service, and Federal prisons -- will get indinavir directly from Merck. The drug was added to the Federal supply schedule on April 1. These institutions will have the responsibility of tacking and counting their patients and reporting these numbers to Merck.
  • Hospital inpatients will need to take their own indinavir into the hospital, where it will be dispensed by the hospital pharmacy. Large AIDS hospitals will also be allowed to buy one bottle for emergency use, for example when a patient forgets to bring the drug when being admitted.

Note: For all users of indinavir, Merck is now preparing a patient package insert to explain how to use the drug correctly. But this document needs approvals from within Merck, and then from the FDA, before it will be released.

Payment Assistance Program

Persons who have no other way to pay can apply to Merck's patient assistance program, called SUPPORT(TM), which will help to find payment sources the patient may have overlooked, help advocate with payers if necessary -- or as a last resort provide free drug to those who meet certain financial criteria, which Merck will not reveal.

But Merck has set a policy that if a state's ADAP program decides not to cover indinavir, then Merck will not let new patients in that state into its patient assistance program, no matter what their financial need. Merck is applying this policy to all insurance programs; if an HMO or insurance company declines to pay for indinavir, then Merck will not let any of that plan's patients start receiving the drug through its patient assistance program. The company is concerned that otherwise payers will refuse to pay for its drug, with the argument that Merck will pick up the people who could not possibly pay out of pocket.

But if someone is already on indinavir when their state or their plan announces that it will not pay, it would then be clearly unethical to cut them off, so Merck will continue them in the program in that case. (This means that if someone has already decided that they need indinavir -- and they might qualify for free drug under the patient assistance program because they have a low income -- they may be able to get into that program now, before their state or plan makes the decision, but not be able to get in later, if their plan should decide not to pay).

Persons in Indinavir Clinical Trials

In order to collect long-term data on indinavir use, Merck will offer free indinavir to persons who have been in most of its phase II and one of its phase III studies, by extending those studies for three to five years. The phase II trials are: protocols 004, 006, 010, 018, 019, 020, 021, 025, and 035; and the phase III trial is protocol 039. Volunteers in these studies can get free indinavir, so they will not need to buy it.

Those in other Merck trials (such as 033 and 037) will be "transitioned to commercial distribution" when these trials end as planned. This transition usually includes at least eight weeks of free open-label drug, giving people time to decide if they want to continue the treatment, and to make arrangements to do so. Those in Merck's "Advanced AIDS Program" (i.e., those who won the expanded-access lottery), are being transitioned starting April 1.

To ensure that there will be drug supply for patients who will be prescribed indinavir once they have completed their study, patients will receive a card (sent by Merck to their physician) with an 800 number on it. They must call the 800 number and give their name and social security number. The call from the patient is important to help Merck plan for their future drug refill needs. If a patient does not receive this card soon, they should contact their physician.

About 12,000 persons with advanced HIV disease who failed to win the lottery for Merck's expanded-access program are now being sent letters explaining the distribution and patient- assistance programs.

Comment

No one knows how well this complex distribution system will work. Clearly it has lots of potential to work badly. Fortunately it should be ended within a few months, allowing indinavir to be distributed through normal channels, with normal competition to reduce the distribution cost.

We received much of the above information on April 1, two days before going to press, so we have had no time to deal with many concerns, including ethical issues, which need larger public discussion. Is it OK for Stadtlanders to be given an absolute monopoly of a life-critical drug, be allowed to set whatever price it wants, and then to use this situation to set an unusually high markup? Is it OK for Merck to wash its hands in the antitrust laws?

And what about Merck's cutting off entry to its indigent- patient program, no matter what one's financial need, because one's insurance plan or state ADAP program refused to pay for indinavir? Everyone knows that the Federally funded state programs are going to run out of money. Persons with critical illnesses are being used as pawns in this payment dispute among large institutions, and are being forced to take the loss when the institutions choose not to reach agreement.

And Merck appears to be mistaken in its apparent belief that this cutoff policy will be necessary to get the drug paid for. Any refusal to pay for indinavir, either by private insurance or ADAP, will not only hurt the poor, but also be a serious hardship for many middle-class persons who would not qualify for free drug under the patient-assistance program in any case. Since the poor have the least political influence, their loss as advocates for indinavir coverage would be a disproportionately small loss of the total constituency for reimbursement.

Also, this distribution program is full of inefficient special arrangements which exist only to avoid crossing the letter of some law or rule -- rules instituted with or without good intentions, but in either case with no comprehension of how they would actually apply in this case. Is this bizarre and wasteful outcome just part of the price we pay for living under an organized society and rule of law? Or is some fix possible? Would it be different if there were the kind of widespread political support that would certainly exist if AIDS struck randomly at anybody?

The ultimate issue is the political failure of this country to create a workable healthcare system. No one knows how to transform more than half a trillion dollars of greed into something people can live with.


AIDS Research at NIH: 
Study Panel Issues Major Report

by John S. James
On March 14 the Office of AIDS Research of the U.S. National Institutes of Health (NIH) released an overview evaluation of AIDS research at NIH, conducted by 114 outside experts and representatives under Princeton virologist Dr. Arnold Levine. A number of subpanel reports are still confidential, but are expected to be released in April. (This writer was a community representative on one of the subpanels, on complementary and alternative treatments.)

The overall report (REPORT OF THE NIH AIDS RESEARCH PROGRAM EVALUATION WORKING GROUP OF THE OFFICE OF AIDS RESEARCH ADVISORY COUNCIL) is by far the most important ever on AIDS research. (It is limited to U.S. National Institutes of Health, but the U.S. funds 85% of all publicly funded AIDS research in the world.) The evaluation's conclusions and recommendations are unusually strong for the scientific world, which usually covers for each other's inadequacies and mistakes. The report is being greeted with near-universal enthusiasm among AIDS organizations and advocates -- and panic from some researchers who fear their funding will be cut.

One crucial document -- the report from the clinical trials subpanel -- is still confidential. We have heard that it will be less threatening to pediatric researchers than the overall report which has been published. A major controversy around pediatric AIDS research is that it has been disproportionately funded due to a Congressional mandate. But there is also recognition that the area does need special government attention, since pharmaceutical companies have been remarkably negligent in conducting pediatric studies.

When the rest of the documentation is available, we will report in depth on this review of AIDS research. An important article on the initial document appeared in THE NEW YORK TIMES on March 14.

An immediate issue is the moves in Congress to take away the central budget authority of OAR over NIH AIDS research (authority which Congress gave OAR in 1993 when it last reauthorized NIH) -- returning this authority to the separate Institutes. There is widespread concern that this change would prevent the panel's recommendations from being implemented, and lead to a continuation of poor overall management and uncoordinated research efforts.

You can get a copy of the report from the World Wide Web; go to the NIH home page, http://www.nih.gov/, and look under News and Events. Or call 301/402-3357; or mail a request (including your address and phone number) to Office of AIDS Research, Building 31, room 4B54, National Institutes of Health, Bethesda, MD 20892-2340. You can also stop by that office for a copy.


Viral Load: 
Inconclusive FDA Hearing

by John S. James
On March 21, the FDA's Blood Products Advisory Committee (plus members of the Antiviral Drugs Advisory Committee, the group which usually reviews AIDS issues) met to discuss the first application for formal FDA approval of a viral load testing kit, for the Amplicor HIV Monitor(TM) assay of Hoffmann-La Roche. There was little community input at this hearing -- not because of lack of interest, but because it was widely believed that viral load is almost certain to be approved anyway, so community support would not be necessary. (Viral load has long been available without formal approval, but approval would be advantageous for a number of reasons.)

But now there is concern that while the FDA is indeed likely to approve viral load tests, it may approve them for prognosis only -- which managed care and insurance companies could use as an excuse to pay for no more than one or two tests in a patient's lifetime. That, of course, would not be the way practicing physicians want to employ these tests. Many physicians see them as essential for effective use of the protease inhibitors, and for making intelligent choices among the far greater number of combination regimens now becoming available. But this view was not well represented at the FDA's hearing. Some activists are now concerned that the FDA may be about to make a serious mistake, by discouraging the use of viral load testing to help in choosing the best antiviral regimen for each patient.

Sometimes scientific confusion is really the projection of a political landscape beneath. We are preparing a longer report on the current status of viral load.


AZT, ddI, and ddC Combinations 
at FDA Advisory Hearing

by John S. James
The February 28 meeting of the FDA Antiviral Drugs Advisory Committee asked whether the recently-available results of four major clinical trials should change the standard use of AZT (Retrovir(R), zidovudine), ddI (VIDEX(R), didanosine), and ddC (HIVID(R), zalcitabine) -- especially combination use of these antiretrovirals. Specifically, the FDA asked:
  • "(1) Do the results of ACTG Study 175 and the other studies [the Delta trials, CPCRA 007, and ACTG Study 152 -- which tested various treatment approaches with AZT, ddI, and sometimes ddC] support the safety and efficacy of didanosine as initial therapy in persons with no prior history of antiretroviral use? [Note: The current FDA-approved prescribing information for didanosine (ddI) recommends that AZT be tried first.]
  • "(2) Do the results of these studies provide evidence that didanosine in combination with zidovudine is clinically more effective than didanosine monotherapy? In your discussion, please include comments on treatment of persons with and without a prior history of antiretroviral use.
  • "(3) Do the results of ACTG Study 175 and other studies support a traditional approval of HIVID (ddC) in combination with Retrovir [AZT]." [Note: ddC is currently approved for combination use with AZT, under the FDA's accelerated approval regulations. This means that the combination has demonstrated benefit through markers of HIV disease progression such as viral load or CD4 count, but the developer, Hoffmann-La Roche, was expected to do further clinical trials to demonstrate direct clinical benefit to patients, such as increased survival or reduced incidence of opportunistic infections. The FDA asked the advisory committee to discuss and vote on whether newly available clinical-trial results have sufficiently demonstrated clinical benefit.]

These questions led to long and complicated discussions. Two analyses, one of the survival data from ACTG 175, the Delta trials, and CPCRA 007, and another based on an overview of seven studies of ddI and AZT, compiled by Jim Neaton, Ph.D., of the University of Minnesota, and others, suggested that:

  • Overall both AZT+ddI and AZT+ddC were better than AZT alone in reducing the risk of death. In each of the four combination nucleoside studies considered, the reduction in risk of death (compared to AZT monotherapy) was greater with AZT+ddI than with AZT+ddC.
  • The effects of ddI and AZT on survival were similar both overall and in patients who were antiretroviral naive. This analysis included ACTG 175 but did not include ACTG 152, which was presented for the first time the same day. (ACTG 152 is a pediatric trial in which children on AZT alone did worse than those on at least one of the other treatments, resulting in early closure of the AZT monotherapy arm of the trial.)
  • There are not enough data to know whether or not AZT+ddI is more effective than ddI alone in reducing risk of disease progression and death.

On the FDA's questions:

  • The Committee voted unanimously Yes on #1, indicating that ddI should be approved for initial treatment of HIV disease.
  • The Committee voted No on #2 (meaning that there is no proof that ddI+AZT is better than ddI alone). But the Committee was uncomfortable with this vote, fearing that many patients would be denied combination treatment when it is generally believed that combination treatment is best and has become the standard of care. It also seemed "bizarre" to fail to recommend approval of AZT+ddI, when the Committee was clearly prepared to recommend approval of AZT+ddC, and when many believe that AZT+ddI is at least as good as AZT+ddC.
  • On question #3, the Committee unanimously voted to recommend approval of AZT+ddC for antiretroviral-naive persons, and unanimously voted against approval for antiretroviral-experienced persons.

[Note: In support of ddI, Bristol-Myers Squibb pointed out in a February press release that it is less expensive than AZT or other antiretrovirals, and will soon be available in a new tablet which is easier for patients to use than the formulation available until now in the U.S.]

Comment

The discussion above needs to be kept in perspective. Today it is widely believed that 3TC is better than either ddI or ddC for use in combination with AZT. But there is no clinical-endpoint data on this combination yet -- only viral load and CD4 counts -- which is why 3TC was not considered at the February 28 hearing.

Also, all of the discussion outlined above dealt with averages, when really there is no such thing as the average patient. Averages may suggest which treatment to try first, when there is no better way to guess. But if viral load tests or other indications suggest that a treatment is not working well for an individual, other treatments can quickly be tried instead.

[Note: AIDS Treatment News did not attend the February 28 hearing, and acknowledges the assistance with this article from Mark Mascolini and from Dr. Jim Neaton.]


Cidofovir Recommended for Approval 
for CMV Retinitis

by John S. James
On March 15 an FDA advisory panel unanimously recommended approval of cidofovir for injection (Vistide(R), also known as GS 504 intravenous, and by its chemical initials HPMPC), a new drug for treating CMV retinitis. Panel members were concerned about safety and lack of long-term data; but they voted for approval because the drug has proved effective against a condition which urgently needs more treatment options -- effective both in newly diagnosed patients, and in those who had failed other therapies.

Cidofovir, being developed by Gilead Sciences of Foster City, California, is given intravenously (in the trials considered at this meeting); however, it is used only once a week for two weeks, and then every other week after that, so it does not require an implanted catheter (unlike ganciclovir or foscarnet intravenous treatment). Note: Ganciclovir has now been approved by the FDA as an eye implant, and as orally administered capsules, for treating CMV retinitis in certain patients, avoiding the need for a catheter.

The main safety concern with the new drug cidofovir is kidney toxicity; another drug, probenecid, is used to reduce this problem, and hydration is also necessary. In one trial, two thirds of the volunteers had adverse reactions to at least one of the drugs.

The other major concern is that in a laboratory study, cidofovir caused cancers in the mammary glands of female rats. It is not known if this problem occurs in people; however, Gilead reported that no carcinogenicity was found in a 52-week study in primates, and that there were no cases of non-AIDS cancers in over 500 people who have taken the drug, and their AIDS-related cancers were consistent with controls. Very few women have taken cidofovir in trials, so the safety for women is unknown.

Different formulations of cidofovir is also being tested for direct injection into the eye, and as an eyedrop for other infections, and as a topical gel for herpes and for genital warts.

Cidofovir is now available free of charge in the U.S. and Canada through an expanded access program for patients with relapsing disease who have failed or are intolerant to either ganciclovir or foscarnet. For more information about this program, call 800/GILEAD-5.

Note: AIDS Treatment News did not attend the March 15 hearing. This article is largely based on coverage in the March 18 issue of BIOCENTURY (a weekly biotechnology newsletter delivered by fax or email, published by BioCentury Publications Inc., in San Carlos, California), and on March 11 and March 15 press releases from Gilead. Also note the coverage March 19 in THE NEW YORK TIMES, of a large initial drop in Gilead's stock price which occurred when a reporter stepped out of the meeting early and headlined old data about the tumors in rats.


California: Clinical Trials 
Computer Service Now Available Statewide

Trials Search, which matches a patient's confidential medical information to over 100 HIV-related clinical trials in its database and finds the ones for which the patient is qualified, has been available without charge in the San Francisco area since 1991 but is now being expanded throughout the state. Patients complete a two-page questionnaire giving their medical status and contact information, and receive a list of open trials which they are likely to be eligible to join.

Trials Search, originally developed in 1991 at Ralph K. Davies Medical Center in San Francisco, is now operated by the Community Consortium, an association of more than 200 physicians and other health-care professionals who provide care for a majority of patients with HIV disease in the nine San Francisco Bay Area counties. The expansion of the service to Southern California was financed by the Kaiser Family Foundation; however, the Community Consortium is still seeking financial support for other Trials Search expenses.

Persons interested in receiving the questionnaire can call either 800/492-5777, or 415/476-5777.

Also, the Community Consortium will make the Trials Search software and database available to medical centers, AIDS service organizations, and patient advocacy groups so that searches can be done on site. In addition, the service will be available to anyone through the Internet. (Currently it is less useful outside of California, however, because the database consists of trials which have sites within California. But other medical centers could use the Trials Search software, and enter their own database of the trials available in their area.)

The Community Consortium also publishes the GUIDE TO HIV CLINICAL TRIALS IN CALIFORNIA (both a Northern California and Southern California edition), which provide in printed form the same data in the Trials Search database. Both editions are available now, and will be updated three times a year. For a free copy of either guide, call either 800/492-5777, or 415/476-5777.


San Francisco Protest 
Against Meeting Disruptions

by John S. James
On April 4, over 25 leading AIDS activists and organizers in San Francisco -- all of them persons with HIV -- published a letter asking a group calling itself ACT UP San Francisco to stop disrupting public forums on treatment options for AIDS and HIV. About a half-dozen persons identifying themselves as ACT UP San Francisco have targeted public forums of the Community Consortium (a local medical association which includes the physicians who treat most of the people with HIV in the nine San Francisco Bay Area counties), and of Project Inform and others.

This long-simmering controversy escalated with the disruption of a Community Consortium meeting at Davies Hospital on March 16. A scuffle occurred before the police arrived to restore order, and speakers Donald Abrams, M.D., and Paul Volberding, M.D., were drowned out or unable to complete their talks on viral load and other topics.

From an ACT UP San Francisco press release after the incident: "'This game of promoting expensive, harmful drugs by touting their temporary effects on dubious surrogate markers like CD4 counts and blood viral load must stop now,' demands ACT UP member Todd Swindell. 'We're dying while AIDS research is held hostage by drug companies and the virologists, clinicians and so-called AIDS advocates on their payrolls. This isn't science; it's exploitation of the sick in its most vile form.'" ("ACT UP SF Questions Turn Drug Company Forum into Brawl in the Hall," ACT UP San Francisco, March 17.)

From the April 4 activists' statement opposing the meeting disruptions: "People with AIDS have the right to choose our own sources of information and the wisdom to know whom to believe. We are committing ourselves now to stop any such disruptions in the future. We need your support... Please contact the mayor, your supervisors, the Department of Public Health, AIDS organizations, the media, forum presenters and especially 'ACT UP SF'. Let them know you need safety and treatment information."

A January 15 release from ACT UP San Francisco described an earlier incident (against a Project Inform Town Hall meeting on January 11, 1996) as part of a series: "The disruption was the first in a planned series of attacks on mainstream AIDS organizations in San Francisco that ACT UP SF has identified as embroiled in conflict of interest through their acceptance of pharmaceutical industry contributions."

Comment

The main concern has been that disruptions have been serious enough to prevent information from being presented; people leave and do not come back. Also, physicians and researchers are becoming reluctant to speak in the San Francisco area. The result is that people are prevented from getting information they need for making treatment decisions.

ACT UP San Francisco can legitimately raise its issues, including the excessive influence of pharmaceutical companies, in the question and answer periods of community forums, or by distributing flyers, or by holding its own meetings. What is not legitimate is to prevent others from getting the treatment information they have come to hear.

For more information on this controversy, you can obtain a copy of the April 4 statement and list of signers from Ben Collins, 415/558-8669, ext. 211. To reach ACT UP San Francisco, call 415/522-2907, or call Michael Bellefountaine, 415/487-9954. Or see the debates on the Internet newsgroup sci.med.aids -- including "Demean, Dupe, Dose, Die" (March 25, from "DaveACTUP," strongly supportive of ACT Up San Francisco although not signed by that organization), and replies from Martin Delaney and others. Delaney's March 28 reply addresses the substance of the scientific disputes, as well as the allegations of pharmaceutical-company influence. If you cannot easily get it by computer, a copy is available from Ben Collins, or from the Project Inform hotline, 800/822-7422 or 415/558-9051, 10 a.m. - 4 p.m. Pacific time, Monday through Saturday. (Project Inform also has a World Wide Web site, http://www.projinf.org.)

Note: AIDS Treatment News often reports on the treatment activist work of ACT UP/Golden Gate (415/252-9200). ACT UP/Golden Gate wants the public to know that it is not affiliated with ACT UP San Francisco. ACT UP/Golden Gate signed the April 4 statement, and also issued its own March 28 press release condemning the meeting disruptions.


California: AB 2812 
Would Outlaw Anonymous Testing

by John S. James
A bill in the California legislature (AB 2812, Bondonaro, Republican, Santa Barbara) would end anonymous testing in the state by adding HIV infection to the list of diseases that must be reported to the State Department of Health Services. The practical result would be that many people will avoid being tested, and miss early treatment if they are infected, as well as missing the prevention education they would get no matter how the test turns out. According to the Grass Roots Networks of AIDS Project Los Angeles, "AB 2812 is sponsored by the Capitol Resources Institute, an extremely conservative lobbying group affiliated with Focus on the Family and State Senator Rob Hurtt. These are the same folks that support quarantine camps for all people living with HIV and AIDS!"

A hearing is scheduled for April 16 in the Assembly Health Committee. You can help by writing to your California Assembly representative opposing AB 2812, and by getting others to do so.

For more information on this and other California issues, and what you can do, call the Grass Roots Hotline at 213/993- 1680. It is a 24 hour voicemail information number, but it lets you reach a person during business hours.


AIDS Medications Needed Abroad

Unused medications which otherwise would be discarded can be a lifesaver in clinics which otherwise would not have access to them. Recently we heard about three efforts to collect medicines for clinics abroad.

For Guatemala, the Guatemalan Association to Prevent and Control AIDS is seeking HIV-related medications for their two clinics in Guatemala City. Bactrim, AZT, and other drugs are needed. For more information, contact Matt Anderson, M.D., Montefiore Family Health Center, 718/933-2400 (voice mail 644), or by beeper at 917/556-5046.

For South Africa, if you have medicines to donate, leave a message with ACT UP/Golden Gate, 415/252-9200. The South African clinics do not need Bactrim, but do need many other medications.

And to find out about donating medicines for Cuba, contact Alfredo Martinez-Garcia, 407/932-4482, on weekdays. His group also needs vitamins and antibiotics. They can accept outdated medications because many companies will exchange dated medications for new ones.




  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

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

Tools
 

Advertisement