
AIDS TREATMENT NEWS Issue #244, April 5, 1996
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

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

Protease Inhibitors: Patient Education Critical

Indinavir (Crixivan(R)) Access and Distribution

AIDS Research at NIH: Study Panel Issues Major Report

Viral Load: Inconclusive FDA Hearing

AZT, ddI, and ddC Combinations at FDA Advisory Hearing

Cidofovir Recommended for Approval for CMV Retinitis

California: Clinical Trials Computer Service Now Available 
Statewide

San Francisco Protest Against Meeting Disruptions

California: AB 2812 Would Outlaw Anonymous Testing

AIDS Medications Needed Abroad


***** 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.

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.


***** AIDS TREATMENT NEWS
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Editor and Publisher:
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AIDS TREATMENT NEWS reports on experimental and 
standard treatments, especially those available now. We 
interview physicians, scientists, other health 
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collect information from meetings and conferences, 
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survivors have usually tried many different treatments, 
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 
noncommercial reproduction, provided that our address 
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