AIDS TREATMENT NEWS Issue #241
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

Merck Protease Inhibitor: More News from Retroviruses 
Conference

d4T Plus ddI Antiviral Results

Growing Crisis in Paying for Care

AB 9: California Bill Would End County Mandate for Last-
Resort Care, Including Communicable Diseases

Press Gag Rules at AIDS Conference


***** Merck Protease Inhibitor: More News from Retroviruses 
Conference

by John S. James

Our last article on the 3rd Conference on Retroviruses and 
Opportunistic Infections (January 28 to February 1, 
Washington D.C.) focused on results of the Abbott protease 
inhibitor, ritonavir (Norvir(TM)), especially the proof that 
the drug substantially reduced the death rate in late-stage 
AIDS. The other highest-profile result from the same meeting 
concerned the Merck protease inhibitor, indinavir 
(Crixivan(R)), and its effect on viral load, especially in 
combination therapy.

The indinavir results must be viewed in context of their 
limitations, however. The two combination trials which 
attracted much attention at the Retroviruses conference have 
a total of 78 volunteers each; one is a six-month trial, the 
other will last one year but has not been completed yet. 
Also, there are no results today on clinical outcome, since 
trials to get that proof are ongoing, and no data are yet 
available.

The following outlines the major indinavir reports at the 
Retroviruses conference (and also includes information from 
elsewhere):

* The most impressive result was from the ongoing trial of 
the triple combination of indinavir plus AZT plus 3TC [late 
breaker abstract #LB7]. All the volunteers included in this 
study were AZT experienced, with at least six months prior 
treatment with that drug. All had T-helper counts of 50-400, 
and a viral load of at least 20,000 copies per ml. of blood 
serum, when they entered the study.

This study mainly looked at the percentage of the volunteers 
whose viral load dropped to an undetectable level (below 500 
copies per ml., in the test which was used). Emphasizing this 
outcome -- instead of the more usual number of logs (factors 
of 10) that the viral load dropped -- is justifiable, because 
there is a problem with reporting the average log drop: since 
the lower limit of detection was 500 copies, it would be 
mathematically impossible for anyone who started with under 
50,000 copies to record as much as a two-log drop, meaning 
that this study could not show a drop bigger than about two 
logs, even if it occurred. (Merck also reported the median 
viral load drop, despite this problem, which tends to make 
the drug look less active than it really is.)

At 16 weeks, 24 of 26 volunteers taking indinavir plus AZT 
plus 3TC had undetectable viral load -- compared to 13 of 26 
on indinavir alone, and none of 26 on AZT plus 3TC. (Merck 
gave us this 16-week data after the Retroviruses conference; 
at that meeting, Merck presented 12-week results, which were 
comparable.)

Only a few of the volunteers have yet reached the 24-week 
point, since the trial is still ongoing. But the percentages 
at that time do suggest that the results may be sustained; at 
24 weeks, six of seven volunteers in the triple combination 
arm, four of nine using indinavir alone, and none of eight in 
the AZT plus 3TC treatment arm, had undetectable viral loads.

Median CD4 increases for the triple combination were 79 at 12 
weeks and 146 at 24 weeks; the latter figure is less reliable 
because it is based on a small number of patients.

* Another study tested a similar combination, only indinavir 
plus AZT plus ddI was used instead of indinavir plus AZT plus 
3TC [Abstract #200]. This study also differed in that only 
antiretroviral-naive volunteers were included. CD4 counts 
allowed were anything under 500, and as in the study above, 
viral load had to be greater than 20,000 copies. (The actual 
median CD4 count at entry to this study was 150 cells per ml, 
and the actual median viral load was about 5 logs, or 100,000 
copies.)

At 20 weeks, 59% of those on the triple combination had an 
undetectable viral load.

The maximum median decline in viral load with the triple 
combination was 3.1 logs. (This may seem impossible if the 
starting median was 5 logs and no value under 2.3 logs (200 
copies) could be recorded, but computations with medians can 
give unexpected results. Those with over 200,000 copies at 
the start of the trial could record drops of over three 
logs.)

The median CD4 increase for the triple combination therapy 
was 90 at 24 weeks.

* Early studies of indinavir alone, in doses that are now 
known to have been too low, found that the resistance 
developed fairly rapidly; the virus usually returned to about 
its starting value within 24 weeks. Persons who developed 
resistance to indinavir were also resistant to other protease 
inhibitors. This problem of resistance and cross resistance 
is the reason for the advice to start protease inhibitors 
with an adequate dose, and in combination with other anti-HIV 
drugs; the hope is to reduce HIV replication enough to 
greatly delay the development of resistant mutants. This is 
also the reason patients are advised to take these drugs on 
schedule and not interrupt treatment. (The resistance and 
cross resistance problems appear to be less with saquinavir, 
the Hoffmann-La Roche protease inhibitor, although resistance 
to that drug does develop.) This information was well known 
before the Retroviruses conference.

Indinavir might continue to have some benefit even after 
resistance develops. In the early low-dose studies, while the 
virus had come back by 24 weeks, CD4 count increases of a 
median of 80 to 100 were maintained for at least 52 weeks. It 
is possible that the resistant viruses are defective in some 
way and may cause less damage than the patients' original 
viruses, but this is not known for sure.

At the conference, results were presented from mathematical 
modeling of the changes in CD4 count before and after 
patients received indinavir [abstract #148]. This research 
suggested that "CD4 return is determined in large part by 
starting CD4 count."

* Side effects of indinavir include kidney stones or 
associated symptoms in about 2% to 3% of cases, and elevation 
of bilirubin. Usually patients are able to continue using the 
drug even if these effects occur. It is important to drink 
enough water when using indinavir, to minimize the risk of 
kidney stones.


***** d4T Plus ddI Antiviral Results

A combination of two approved drugs showed encouraging viral 
suppression results in a one-year clinical trial [3rd 
Conference on Retroviruses and Opportunistic Infections, 
abstract #197]. The results are preliminary, however, as the 
trial is still continuing; it will not end until October 
1996. Also, this trial was primarily designed to test the 
safety of the combination regimen, not to see how well it 
worked.

A total of 92 volunteers have entered the trial and were 
randomly assigned to one of five different dose combinations; 
the lowest-dose group received half the standard dose of ddI 
and a quarter the standard dose of d4T, while the highest-
dose group combined the full dose of both drugs. Note that 
everyone received some of each drug. Also, since the trial is 
ongoing the dose assignments are still blinded, so dose-
response information on antiviral activity is not yet 
available.

The volunteers had CD4 counts between 200 and 500, and no 
previous HIV therapy; note that these are persons who are 
more likely to show a strong response to treatment than those 
who were more advanced, or had extensive prior antiretroviral 
treatment.

Most of the volunteers had a viral load of at least 1000 at 
baseline; they were selected for a study of viral load 
changes. (Those with a very low viral load at the beginning 
were not included, since they could not show much of an 
antiviral effect even if it were there, as the viral load 
tests could not have recorded much decrease). Preliminary 
data from the ongoing study showed a median viral load 
decrease of about 1.2 logs (16 fold), and a median CD4 
increase of about 60 to 80; these increases appear to be 
sustained for at least a year, but it is not possible to be 
sure yet, as only 14 patients in the viral-load substudy have 
completed the full year.

Six of the volunteers discontinued the trial due to adverse 
events which might have been caused by the drug; however, 
these events did not seem to be dose related. [The eight 
events which led to drug discontinuation in six people were 
grade 2-4 lipase elevation (3 cases), abdominal pain (2 
cases), and one case each of grade 4 liver transaminase 
elevation, grade 3 neutropenia, and grade 3 depression.] Only 
one volunteer had to interrupt therapy due to peripheral 
neuropathy, and he was able to go back on treatment at a 
lower dose.

The next report from this study is likely to be at the 
Vancouver conference in July -- although the trial will still 
not be finished by then.

Note: A separate, laboratory study reported at the 
Retroviruses conference compared the antiviral activity of 
the d4T plus ddI combination with that of the two drugs 
individually (abstract 294). The combination showed additive 
antiviral effects in one test (meaning that the combination 
worked as well as would be expected by adding the activities 
of the separate drugs), and synergistic (better than 
additive) activity in another test, depending on the cells 
and viruses used.

Comment

One of the most critical research tasks now is to learn which 
combinations of drug tend to work well together. Small trials 
like this, with about ten to 20 volunteers per arm and 
measuring viral load for at least six months, may be the most 
feasible way to test combinations which have some clinical, 
laboratory, or theoretical rationale. The main challenge will 
be getting different pharmaceutical companies to work 
together; that was not a problem with d4T plus ddI, since 
both are marketed by the same company, Bristol-Myers Squibb, 
which funded this clinical trial.

This trial focused on the safety of the drug combination; its 
design is less than ideal for looking at drug activity. For 
example, only one viral load baseline measurement was used; 
and there were provisions for replacing volunteers in the 
study arms, instead of analyzing everyone assigned to 
treatment and/or everyone treated. There is a need to develop 
realistic consensus guidelines for small drug-activity trials 
-- based on the realization that physicians will use the 
results in making treatment decisions, and that with the 
great number of potential combination treatments available 
today, "definitive" phase III trials for most of them will 
never be run.


***** Growing Crisis in Paying for Care

by John S. James

How will the rapidly emerging new standard of care -- 
antiretroviral combinations usually including a protease 
inhibitor, and viral load tests to tell which combinations 
are working for a patient -- be paid for? This question is 
rapidly becoming perhaps the most critical AIDS issue in 1996 
and beyond.

* The cost of standard anti-HIV therapy, including 
monitoring, is now rising from an estimated $3,000 to $5,000 
per year, to an estimated $12,000 to $18,000. This increase 
is due to using more drugs simultaneously, and to the 
protease inhibitors, which are expected to cost more than 
drugs in the AZT class. A relatively small part of the cost 
will be due to viral load testing -- probably well under 
$1,000 per year, but there is no way to know for sure until 
testing kits are approved for commercial use. (Prices can 
drop substantially when the kits are used.)

Total antiretroviral costs will also rise as physicians use 
combination treatments earlier in HIV disease -- and as many 
patients who rejected AZT come to accept the new drugs. But 
other major costs, including hospitalization, should decline 
as improved treatment prevents HIV-related illnesses.

* Fewer than 29 percent of people with HIV were covered by 
private insurance in 1994, according to a February 1, 1996 
press release of the AIDS Action Council and the AIDS 
Healthcare Foundation, and that proportion is rapidly 
decreasing (as private insurance finds more effective ways to 
dump expensive patients). And many of those who are covered 
have no prescription coverage, or have annual or lifetime 
caps.

* Half of people with AIDS are covered by Medicaid (Medi-Cal 
in California), according to the same press release. But 
"income cut-offs for Medicaid average $434 per month, and 
many states limit the number of prescriptions per month to 
three." Fifteen state Medicaid programs include no drug 
coverage for the "medically needy" -- people who qualified 
for Medicaid only after medical expenses were deducted from 
their incomes. "For the tens of thousands of uninsured or 
underinsured people with AIDS who exceed these limits, the 
only options are state AIDS Drug Assistance Programs (ADAP) 
funded under Title II of the Ryan White Care Act, or indigent 
programs operated by the pharmaceutical manufacturers."

Access to Medicaid is also threatened by proposals to turn 
the program into a block grant to states, with few Federal 
standards on how the money is spent. Under these plans, state 
legislatures could define eligibility, formulary, and other 
rules to largely exclude HIV treatment from Medicaid.

* Managed care systems (which will increasingly include 
public programs like Medicaid in many areas, as well as 
nonprofit organizations like Kaiser, and the for-profit 
megacorporations which are extracting billions of dollars 
from the healthcare system) are based on "capitated" payment, 
meaning that the managed care organization is paid so much 
for every patient covered; the organization provides 
treatment, then keeps whatever money is left over. This 
payment system creates a tremendous incentive to restrict 
care, and to make oneself unattractive to expensive patients. 
The capitated payment amount must be adjusted for people with 
chronic, costly diseases like AIDS and cancer; otherwise, 
inadequate treatment is all but guaranteed.

The move to force Medicaid and Medicare into managed care 
creates another problem. Some public-health systems have been 
able to survive on Medicaid money, and provide indigent care 
to those not in Medicaid. As money is squeezed out of the 
system, one of the last means of funding indigent care will 
be lost. (See article below on AB 9, another threat to 
indigent care in California.)

* ADAP (AIDS Drug Assistance Programs), relied on today by 
over 50,000 people, have a severe funding crisis even under 
the old standard of care. Part of the problem is political -- 
the Ryan White CARE Act has not passed because of divisive 
issues like mandatory testing and funding formulas. 
Continuing resolutions have filled the gap so far, but they 
have frozen funding at last year's level.

According to a January 26 statement of the National 
Association of State and Territorial AIDS Directors, 21 
states now have severe budget shortfalls in their ADAP 
programs. Eleven other states are reporting difficulties in 
meeting demands for combination therapies. Few have been able 
to add the new FDA-approved drugs 3TC and saquinavir to their 
programs. At least two states suspended providing drugs 
entirely in 1995, almost certainly leading to death or 
permanent harm to persons with no other way to pay for 
treatment; in February 1996, Washington D.C. shut down its 
program for a week. Other states have removed many important 
drugs, or restricted their programs in other ways.

What Can Be Done?

* Build coalitions including both AIDS service 
providers/activists, and pharmaceutical companies. A January 
24 letter to Congress on Ryan White CARE Act funding was 
signed by activist organizations across the ideological 
spectrum from TAG to Log Cabin Republicans, by service 
organizations, and by Glaxo-Wellcome, Abbott Laboratories, 
Serono Laboratories, Merck & Co., Hoffmann-La Roche, and 
Bristol-Myers Squibb.

On the issue of paying for care, a shared interest and 
natural coalition exists between pharmaceutical companies on 
one hand, and AIDS patients, physicians, service 
organizations, and activists on the other. This coalition is 
potentially powerful, since the two major partners bring 
different and complementary strengths; for example, different 
members of Congress, different reporters, etc. will listen to 
one but not to the other. This strategy of focusing first on 
getting resources into the pipeline may require postponing or 
de-emphasizing issues like drug prices, which would divide 
the coalition.

* Build grassroots support to let Congress and the President 
hear from their constituents that services which save lives 
are a priority, and cannot be held hostage to unrelated 
political disputes.

* Even aside from the issue of payment, there is an urgent 
need for more research to tell doctors when and how to use 
the new drugs (and other treatment options) more effectively. 
The same research data will also help prioritize and support 
reimbursement for the most effective treatment strategies.

* Hopefully it will be possible to negotiate some compromise 
which could include better research for prioritization and 
justification of treatments, additional money from Congress 
and other payers, and price reductions by pharmaceutical 
companies.

Comment

The following also need attention:

* How are other major chronic illnesses paid for in the U.S.? 
There seem to be disease-specific arrangements for each 
different disease. Research is needed; if AIDS care is not 
exceptional in having disease-specific programs, the public 
and politicians must hear that.

* One possible strategy is to focus on better pharmaceutical 
company patient-assistance programs, more than on lower drug 
prices. The reason is that most people either can pay or they 
cannot; since there is little middle ground, a small price 
reduction is unlikely to make much difference in access.

There may be more leverage in asking companies to do their 
share by improving patient assistance-programs. Unless 
manufacturing cost is an issue (as with some protease 
inhibitors), these programs cost the companies little -- 
either in cash or in lost sales, since their clients are 
screened and have no way to buy the drug. Also, these 
programs would be easy for private organizations to monitor, 
since persons who fall through the cracks are likely to 
complain, and such cases can easily be brought to public 
attention.

* In discussion and analysis of why health care is so 
expensive, one major cause is almost never mentioned -- that 
only the most expensive treatments are researched. It is 
understandable that industry will only study high-priced 
proprietary products. But taxpayer-funded government research 
also serves the same corporate agenda, due to corporate 
influence over the funding and therefore careers of research 
professionals. Even community-based AIDS research 
organizations have only occasionally studied non-proprietary 
treatments. They seldom have independent funding to do so, 
because the big contributions usually follow the big 
researcher names, which usually follow the big companies.

What is needed are more activist groups to make sure that the 
public interests is represented. One organization we work 
with, ACT UP/Golden Gate, is doing this very well. But few 
cities have any comparable organization or vehicle for people 
to be involved in this effort.

* The vast majority of people with AIDS in the world will 
probably never have access to protease inhibitors (or even 
AZT-type drugs), due to economics. One thing that can be done 
about this -- especially now, when viral load is almost 
universally accepted for testing antiviral drugs -- is to 
screen low-cost options, such as herbal treatments or generic 
pharmaceuticals, which could be made widely available if they 
could be proven to lower viral load safely. Such research 
would help everywhere, even when expensive treatments are 
available, by providing new combination options which may 
lower viral load better than the standard drugs alone.

It would cost relatively little to screen available drugs for 
antiviral activity in small trials. The problem so far has 
been lack of political will and social organization.

* Much of the work needed will involve pressuring third-party 
payers and pharmaceutical companies. The latter are 
notoriously reluctant to combine drugs from different 
companies, to compare drugs from different companies head to 
head, or to provide drugs or even data to support AIDS 
research on non-AIDS drugs (out of concern that if a non-AIDS 
drug gets AIDS publicity, physicians will be reluctant to 
prescribe it, for fear that patients may think they are being 
secretly treated for AIDS, or that their family or friends 
might think so). And many companies strongly resist allowing 
compassionate use of their experimental drugs, even when 
doctors say it is someone's only hope.

Traditional grassroots pressure tactics may now need legal 
advice, however, since the new telecommunications law not 
only censors computer speech, but may restrict activism by 
phone and fax as well. It is now a felony, in interstate or 
foreign communications, if anyone "makes repeated telephone 
calls or repeatedly initiates communication with a 
telecommunications device, during which conversation or 
communication ensues, solely to harass any person at the 
called number who receives the communication." Does this make 
it illegal to repeatedly fax an ACT UP leaflet to an 
insurance or pharmaceutical company? That may depend on 
authorities' attitudes toward AIDS activists.

Alternative strategies could include organizing a phone bank 
to go through the telephone book, looking for allies -- who 
will each call only once to the company and to other 
appropriate parties. Or we can learn from the new labor union 
strategies, which bring unsafe or substandard products, 
facilities, and employers to wide public attention.

Ironically the target corporations would probably prefer the 
traditional zaps, because the protesting communications 
stayed in house. Single calls from one or a few individuals 
are ignored by companies and government agencies alike; zaps 
have provided a harmless way to get an organization's 
attention, putting an issue onto the table so that it can be 
addressed on its merits. But now Congress has spoken, 
requiring legal research to update activist tactics. It may 
now be necessary to involve a wider public from the start -- 
or to walk away from the issues and let people die.


***** AB 9: California Bill Would End County Mandate for 
Last-Resort Care, Including Communicable Diseases

The California Assembly has passed a bill, AB 9 (Goldsmith, 
R-Poway), that would end the current requirement that 
counties provide General Assistance, and medical care of last 
resort for persons who do not have access to Medi-Cal, 
private insurance, or any other way of getting medical care. 
If this bill becomes law, counties could decide to have no 
such care at all; and if they did provide indigent medical 
care, it could only be for life-threatening or limb-
threatening conditions. There is concern that all counties 
will close facilities and reduce or eliminate last-resort 
care, leaving people with no access to treatment when they 
become ill.

The effect on communicable disease control does not seem to 
have been thought through. Unless a loophole can be found, 
the bill prohibits counties from providing last-resort care 
for communicable diseases which are not life threatening. The 
law would allow counties to treat life-threatening diseases 
like tuberculosis if they wanted to; but how would these 
illnesses be diagnosed if indigent persons could not see a 
healthcare professional when they get sick?

AB 9 could pass without thought to the consequences, because 
of the extreme partisanship of the California legislature. 
Under the Democrats, the bill had no serious chance; under 
the Republicans -- who achieved control of the Assembly in 
January 1996, when Assemblyman Willie Brown was forced out by 
term limits and left to become Mayor of San Francisco -- 
passage was all but automatic. Since minds were already made 
up, the bill never needed to build support through the normal 
political processes of accommodation and improvement.

The bill is now in the California State Senate. AIDS 
organizations are urging Californians to call their state 
senator immediately and tell him or her to oppose AB 9, then 
to follow up the call with a letter.

For more information, contact:

AIDS Project Los Angeles Sacramento office, Sophia Kwong, 
916/443-9055;

LIFE AIDS Lobby, 916/444-0424;

ACT UP/Golden Gate, 415/252-9200.


***** Press Gag Rules at AIDS Conference

by John S. James

[Although this conference is over, the issues it raised will 
affect future AIDS research meetings. Especially important is 
how press restrictions can change the depth of media coverage 
which AIDS research receives.]

Those who did not attend the 3rd Conference on Retroviruses 
and Opportunistic Infections, but saw only the media hype, 
may have visualized reporters crawling over the meeting like 
ants, packing the press room while they filed the hundreds of 
stories that were published. Nothing could be further from 
the truth. The press room was sterile and empty; we have 
seldom seen fewer reporters at a major AIDS conference (or 
fewer people with AIDS, either). Look again at the newspaper 
articles you read, and note the authors, if any. Most of the 
articles were reprinted from elsewhere, or attributed to 
unnamed "wire services," meaning that a rookie reporter who 
never got near the meeting and knew nothing about the subject 
was assigned to rewrite articles and wire dispatches by 
others, to avoid the need to pay royalties. The lack of 
reporters paradoxically contributed to the media feeding 
frenzy, allowing half-truth and hearsay to soar without 
reality checks.

The reporters were absent because they were turned away at 
the door; this conference rigidly imposed advance 
registration requirements, with press reportedly traveling 
from as far as Mexico and Europe having to return empty 
handed. We have no idea how mainstream reporters, especially 
foreign ones, were expected to learn about these 
extraordinary requirements, or how to meet them; we were 
warned by friends and colleagues to apply early. Also, this 
meeting was not hot until shortly before it started; 
mainstream reporters had no reason to apply, until after it 
was too late. Even well-known AIDS publications like AIDS 
TREATMENT NEWS, CRITICAL PATH AIDS PROJECT, and the JOURNAL 
OF THE INTERNATIONAL ASSOCIATION OF PHYSICIANS IN AIDS CARE, 
had great difficulties being allowed to register; we do not 
know who was turned away. AIDS TREATMENT NEWS was not 
accepted until less than a week before the meeting, even 
though we started the application process almost two months 
earlier, on December 1, and pursued it meticulously. Our 
airfare would have cost us almost a thousand dollars extra, 
if we had not bought tickets in advance of acceptance, 
planning to cover the meeting by interviewing people in the 
aisles if necessary. (A list of 21 "community press" 
organizations got in without trouble.)

In many past conferences, people with AIDS have been quietly 
allowed to register as press, with an editor's letter or 
other showing of a press connection; these activists in fact 
do report on the conference to many others, although they are 
not full-time journalists. This meeting went to some trouble 
to discourage such arrangements. Instead, there were supposed 
to be scholarships open to people with HIV; ten thousand 
dollars would be raised from the pharmaceutical industry to 
finance admission for about 50 people. But, for reasons we do 
not know, it never happened.

In the conference, an extraordinarily sterile press 
environment meant that to learn what was going on, reporters 
had to recognize people in the hallways, or be recognized by 
them -- a serious disadvantage for reporters new to AIDS. 
Press rooms usually distribute dozens of press releases, from 
the conference staff, from pharmaceutical companies, and from 
others; in this entire conference we saw only a single 
release ever in the press room -- a government release on Dr. 
Anthony Fauci's keynote address, a talk which practicing 
physicians found useless. There was also a list of program 
highlights distributed by the conference staff; sometimes 
photocopies of NEW YORK TIMES, WASHINGTON POST, and USA TODAY 
articles; a few faxes and other private messages for 
reporters laid out on a table; and some computers, which were 
useful because Merck & Co had computerized the conference 
abstracts and made them available on disk. Beyond that, there 
was nothing. The press room had a bulletin board, but it was 
empty throughout; we never saw a single notice posted on it 
in the entire five days. Reporters seldom visited the room, 
and they did not stay. The reason for this lack of 
communication was rigid press rules forbidding those 
registering as press from distributing anything to other 
press or anyone else at the conference, under threat of being 
kicked out of this and future meetings. (There was a table 
labeled "newsletters," and thanks to chance meetings in the 
hotel hallways, we were able to get permission to leave 
copies of AIDS TREATMENT NEWS there.)

We had no such luck on photographing posters. Our request for 
permission was denied, although we promised in writing that 
the pictures would never be published or distributed, only 
used for our own review to assure the accuracy of our 
reporting. This rule made it unfeasible for us to visit most 
of the posters, which were available for only one day while 
competing meetings were going on; our time could be better 
used elsewhere. Incidentally, we had never once seen such a 
rule during our first ten years of covering AIDS meetings -- 
the first no-picture rule was at the ICAAC conference last 
fall. Until then the rule had been no *flash* photography 
during the oral presentations, which makes sense.

(The reason for the no-picture rule is the fear that 
scientific and medical journals will consider results 
presented at the conference to be "published," and therefore 
reject later articles by the researchers which are based on 
the same data. The organizers of the Retroviruses conference 
seem to believe that by making it more difficult for press to 
cover their meeting, they make it less likely that journals 
will reject work presented there as being previously 
published. In our ten years of reporting the epidemic, what 
we have found consistently among almost all high-level 
researchers is that no matter how much they may want to save 
lives, publication rules and journal exclusives come first. 
That is how their successful careers have been built.)

A press conference took place on the first full day of the 
meeting, and the reporters' main request was for more press 
conferences so they could question major speakers. The 
organizers promised more conferences, but they never 
happened.

There was a Community Liaison Subcommittee of the Scientific 
Program Committee, the governing body which was ultimately 
responsible for the rules of the Retroviruses conference. 
According to former member Mark Harrington, that entire 
subcommittee "resigned in protest at the conference's 
mishandling of press and community registration and 
participation."

Why?

The difficulties at this meeting were not accidental; next 
year's conference could be as bad or worse. The problems stem 
from a particular vision and goal of the conference, one 
which seems to be widely shared on the Scientific Program 
Committee.

This goal -- which we certainly do support -- is for the 
conference to bring together basic and clinical researchers, 
who usually do not talk much to each other. The clinical 
researchers who largely run the meeting seem to believe that 
if there is much else going on -- such as activism, or press 
coverage, or pharmaceutical industry activity -- the basic 
researchers will leave or not come next year. The organizers 
want to avoid the big-tent model of the international AIDS 
conferences since 1990, which some see as circus-like, and 
focus the Retroviruses conference as a scientific meeting 
only. That may explain the hostility to activists, and the 
rules which make it difficult for the press to function, such 
as forbidding pharmaceutical companies and others from 
distributing press releases.

Other problems stem from limiting the total size of the 
meeting, which also required limiting press, and therefore 
turning away reporters and scientists alike because the 
meeting was full. The organizers say that no hotel in 
Washington could hold a larger conference -- they would have 
to move to the convention center, meaning a less convenient 
and intimate conference, or use more than one hotel. We 
counted hundreds of empty seats during the keynote address, 
however, and floor space for hundreds of seats more, while 
other large meeting rooms available to the conference were 
empty.

Bringing together basic and clinical researchers would be 
extraordinarily important, perhaps the best thing that could 
happen in AIDS research. But we do not believe that 
discouraging press, activists, and industry is the key to 
doing so. Both kinds of researchers were at this conference; 
but they seemed to be living in different worlds, with little 
reason to talk to each other. Most of the basic research had 
no visible relevance to treating patients, perhaps because 
most basic researchers listen to other scientists, not to 
physicians who see patients, when they decide what scientific 
problems they will work on.

The fundamental error, we believe, lies in a currently 
prevailing definition of science. For background, see an 
extraordinarily insightful commentary, "The Slowing of 
Treatment Discovery, 1965-1995," by Richard J. Wurtman and 
Robert L. Bettiker, published in NATURE MEDICINE, November 
1995, pages 1122-1125. This article analyzes why modern 
science has done so well in advancing fundamental biological 
knowledge, including knowledge about the human body -- while 
at the same time it has done so poorly in translating this 
knowledge into new treatments and cures.

If the Scientific Program Committee of the Retroviruses 
conference is right about what it takes to get basic 
researchers to come and talk to clinicians -- a comfortable 
hotel, and suppression of activism, industry, and the press 
-- then all the rules are worth it. But if they are wrong, 
they are doing significant damage for nothing. For this 
meeting has effectively become the U.S. national AIDS 
meeting, the most important AIDS research meeting in the 
country every year, the most important in the world during 
some years. It serves many purposes and publics, not only the 
single-minded agenda of bringing basic and clinical 
researchers together. One purpose it is supposed to serve is 
the effective dissemination of information to the public.

This year's meeting showed that organizers can exclude much 
of the press without reducing the quantity of press coverage. 
What was lost instead was quality. Reporters at the meeting 
did their jobs, but there were not enough of them to cover 
the news in depth. For example, the important good news about 
the Abbott protease inhibitor, which has saved many lives 
already in a clinical trial, went out to the world without 
notice of its dangerous drug interactions, an omission which 
could be life-threatening. And what the news means to Mexico 
and other countries was not reported, and the information is 
now lost, because their journalists were turned away while 
CNN blared out sound bites to the world. The same narrow 
perspectives were endlessly regurgitated in the media -- so 
if measured by total column inches, the conference media 
coverage was a success.

The reason this meeting got press is that leading government-
certified experts agreed among themselves that the protease-
inhibitor news was important -- and a few major companies, 
mainly Merck & Co., and Abbott Laboratories, built on that 
consensus in pursuit of their interests. Indeed the news was 
good. But the exclusion of much of the press replaced depth 
of coverage with media hype and manipulation, a disservice to 
the public.

What Should Be Done?

We have two suggestions:

(1) Bringing basic and clinical researchers together via 
conferences could be better pursued by small, specialized 
meetings which focus on specific problems selected with this 
purpose in mind. An excellent model is the Project Immune 
Restoration Think Tanks, organized by Project Inform. These 
meetings are invitation only, and press -- including AIDS 
TREATMENT NEWS -- is excluded except sometimes for a press 
conference at the end. We have no problem with that. Our 
concern is with seriously restricting press coverage of the 
major national AIDS research meeting of the year.

(2) It would speed medical research substantially to break 
the tyranny of the professional journals which now demand 
that new research findings be kept semi-secret for months or 
even years, just so that leading journals can further 
aggrandize themselves. The consequences are deadly, because 
scientific and medical findings are withheld not only from 
the public, but also from other scientists in different but 
related fields who are outside of the professional circles of 
the researchers -- scientists who could otherwise be using 
the findings to improve their own research. The resulting 
delays are cumulative, seriously delaying new treatments for 
AIDS, cancer, and all other diseases, as well as reducing 
national competitiveness and inflicting long-term economic 
loss on the country.

We believe that the best way to correct this problem would be 
to establish top-quality peer review panels which are not 
connected to journals or other publications. These panels, 
which could be organized by professional societies, would 
review papers or other reports of scientific work 
independently of publication; they would have no incentive to 
demand exclusivity or secrecy. The approved papers (and 
pending or rejected papers, as well) could be distributed 
through the Internet, through journals which do not demand 
pre-publication secrecy, in compilations, or otherwise; 
whatever the format or distribution system, readers would 
know that the approved articles had been through professional 
peer review, so the work could get the attention it deserved.

This system would allow scientists and scholars to earn 
professional recognition for their work without having to 
keep it secret first, greatly improving scientific 
communication and thereby accelerating discovery. And the 
final quality of the published articles would be higher than 
today, because busy reviewers (usually only two of them) 
cannot check everything; without secrecy, the entire 
scientific community would be able to comment on the work as 
it was being reviewed. Studies of today's "peer reviewed" 
articles have found many errors which the reviewers should 
have caught. Such problems could be greatly reduced by open 
public exposure instead of secrecy during the review.

What motive would professional societies have to review 
scientific papers if they are not going to publish them? The 
same motive those societies now have to grant professional 
awards of various sorts, awards which develop their own 
credibility over the years and reflect well on the 
organizations which sponsor them. And most researchers are 
unhappy with the current system -- although they seldom 
discuss the issue publicly, as their careers depend on the 
journals.


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Treatment News does not recommend particular 
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ISSN # 1052-4207 

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