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AIDS TREATMENT NEWS #216, February 12, 1995
 phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

Patent Office Expedites AIDS, Cancer Inventions

AIDS, Cancer Patent Priority: Interview with Commissioner 
Bruce Lehman

Human Retroviruses and Related Infections -- Major U.S. 
Scientific AIDS Conference of 1995, Part I

San Francisco Area: Computerized Search for Local Clinical 
Trials

San Francisco: Self-Empowerment in HIV Disease Symposium, 
March 4

Action Alert: Balanced Budget Amendment


***** Patent Office Expedites AIDS, Cancer Inventions

by John S. James

The U.S. Patent and Trademark Office (PTO) will now allow 
AIDS and cancer patent applications to receive top priority 
review, PTO Commissioner Bruce Lehman told AIDS TREATMENT 
NEWS on February 3. The new priority applies only if the 
patent applicant requests it, and the request is approved by 
the PTO. The new change is not yet well known, even by 
pharmaceutical companies applying for patents; we believe 
this article is the first public report. [See interview with 
Commissioner Lehman, page 4.]

The new system allows the applicant for a patent on a 
treatment for AIDS or cancer to ask that the application be 
"made special," under rules outlined in the MANUAL OF PATENT 
EXAMINING PROCEDURE (section 708.02). This special status has 
previously been available only for patents related to 
environmental quality, energy, safety of recombinant DNA 
research, and superconductivity, and in certain unusual 
situations. Patent examiners are instructed to give these 
"special" applications top priority, not only initially, but 
also in all subsequent actions while the application is 
pending.

Biotechnology patents now take an average of about 21 months 
from the time of filing until they are granted or rejected. 
The new rule will be important in cases where a drug 
developer or other inventor has a high-priority invention and 
wants to move it quickly. This will not only speed the 
development of the drug in question, but can also facilitate 
discovery of other treatments as well, since companies often 
keep their research secret until the patent is granted.

But the public should realize that many medical patents are 
deliberately delayed by the companies that apply for them -- 
and the new rule will not help in this case. Why would anyone 
purposely slow their own patent application? The reason is 
that if the patent is granted years before the FDA approves 
the drug for marketing, the 17-year patent term will start 
running, and by the time the FDA approves the drug or medical 
device, part of the 17 years will have already expired. The 
company must APPLY for the patent early, to avoid a 
competitor applying first; but it may not want to RECEIVE the 
patent until later. As a result, information important for 
medical research and for patient care can be withheld for 
long periods.

This problem should be reduced in the future, because of the 
new implementing legislation for the GATT treaty (the General 
Agreement on Tariffs and Trade), recently approved by 
Congress. Under the new law, the U.S. patent term will follow 
the international standard of 20 years from the date of 
filing, not 17 years from the date of issuance; this 
provision will take effect on June 8, 1995. There will be 
less incentive to deliberately delay pharmaceutical patents 
filed after that date.


***** AIDS, Cancer Patent Priority: Interview with 
      Commissioner Bruce Lehman

by John S. James

On February 3 AIDS TREATMENT NEWS interviewed Bruce Lehman, 
Assistant Secretary of Commerce and Commissioner of Patents 
and Trademarks, in his office near Washington D.C. We had 
requested the interview to discuss proposals for giving 
priority to inventions for serious or life-threatening 
illnesses -- a recommendation most recently made by the 
National Task Force on AIDS Prevention, at its January 19 
meeting. We did not know until the interview that the PTO had 
already gone ahead and implemented the rule, though only for 
AIDS and cancer.

The patent system, while exceedingly important for medical 
research, has long been neglected by the AIDS community. But 
the PTO on its own has made important changes. It made AIDS 
patents available free through the Internet (see AIDS 
TREATMENT NEWS #210). On December 21, 1994, it issued new 
guidelines to prevent some patent examiners from requiring 
clinical trials before a new drug could be patented, after 
complaints from biotechnology companies (which usually need 
the patent in order to raise money to run the trials). And 
now it has made AIDS and cancer patent applications eligible 
for priority review.

The following interview with Commissioner Lehman is important 
for companies, for AIDS and cancer researchers, and for 
treatment and policy activists alike.

ATN: The National Task Force on AIDS Drug Development 
recently recommended that "drugs involved in the diagnosis 
and treatment of serious or life-threatening disease should 
undergo an expedited review process by the Patent and 
Trademark Office." Do you have any plans for priority review 
of these applications?

Lehman: We have already established a policy inside the 
Patent and Trademark Office to allow applicants to apply for 
expedited handling of inventions related to therapies for 
AIDS-related illnesses, and for cancer.

We have also made all of the AIDS-related patents available 
on the Internet. Eventually all of the patents will be 
available in the same manner, probably in about six or seven 
years.

ATN: On the rapid review, the FDA has special procedures for 
"serious or life-threatening illnesses" -- including heart 
disease, diabetes, Alzheimer's disease, and others. Could the 
patent office allow special priority for all these illnesses, 
instead of limiting it to AIDS and cancer?

Lehman: Keep in mind that there are many priorities in the 
patent system, which is an engine of economic growth for the 
country. So it is not easy to establish these priorities; it 
is a serious matter. Frankly it is not something we hear a 
huge clamor for, from the biotechnology and pharmaceutical 
industries. There is a reason for that; speeding patent 
applications is vastly different from speeding up regulatory 
review. By and large biotech companies are quite happy with a 
LONG pendency of the patent -- precisely because of its 
linkage to regulatory review. We can get the patent out as 
soon as six months after the application comes in, but then 
the companies may have to undergo years of clinical testing 
before they can sell the drug. Often companies do NOT want us 
to issue the patent -- because under the old law, you had 17 
years from the issuance of patent for a patent term. So your 
term is running while you are going through regulatory 
review, and companies would rather delay the patent [and 
avoid losing time to sell their drug under patent 
protection].

We have just gone to a new system -- 20 years from filing, as 
opposed to 17 years from issuance. To some degree, that 
advantage of delay has been eliminated. And we still have 
patent term extension legislation, which permits you to 
extend the patent to compensate for regulatory delay at the 
FDA. The average patent is issued 19 months after it is 
filed; and the average biotech patent is less than 21 months. 
So without any expediting at all, the average patent is 
issued less than two years after it has come into the office, 
and it is the rare biotech or pharmaceutical invention which 
would be anywhere near through the regulatory process in that 
period of time. In that sense, the potential market, for 
purchasers of the therapy, is not really prejudiced at all 
[by delays in the patent office].

But often the patent applicant needs to have the patent in 
hand in order to obtain financing for the extended clinical 
testing that is necessary. Then they want to get the patent 
out quickly. It is this category of patent applicants who I 
think will use the expedited procedures that we now have, and 
be most benefited by them.

Recently we made another change which also relates to 
treatment development. Last September we had a hearing in San 
Diego, a major center of the biotech industry, where we 
invited comment on problems of the industry. Overwhelmingly 
the number one criticism we heard was that patent examiners 
were demanding results from clinical testing, as a 
precondition to demonstrating that the patent had "utility," 
which is one of the requirements of the patent law. That 
clearly was a problem that was causing a great deal of 
dissatisfaction in industry; people thought we were being 
unreasonable, that it was getting out of hand. So in December 
I issued new rules where we vastly streamlined that 
procedure, and made it clear that one did not have to have 
the actual results of human testing in order to demonstrate 
utility; instead, evidence such as affidavits of scientists 
knowledgeable in the area, indicating that the treatment was 
likely to be useful in human beings, would be enough. That 
change has been favorably received in the biotech industry, 
and hopefully it will have a positive impact on research and 
development in this area, because it will enable people to 
obtain capital to support the development process.

ATN: There is another problem in getting better AIDS 
treatments developed. Often the patent applicant keeps 
research findings secret while the application is pending. 
Apparently they fear that if the application has to be re-
filed, somebody else could get in and have an earlier filing 
date.

Lehman: We have addressed that problem. I'm very glad you 
raised it, because right now our solution is under attack, 
and people who see the value of our addressing the problem 
need to let their views be known.

One of the differences between the U.S. patent system and all 
others in the world is that we keep all patents secret until 
they are issued, while others publish patent applications 18 
months after they are filed. This, combined with the old 17-
year term from issuance, enabled some applicants to game the 
system. They could file continuances, etc., to keep the 
patent bottled up in the patent office for quite a period of 
time before it issued -- and keep the whole thing secret. In 
fact, in some cases, they did not market anything; they 
waited until somebody else got into the marketplace with a 
product, then they sued them; they let their patent be 
granted, and then could show that they were in the patent 
office first -- and we have a first-to-invent system. That is 
totally counterproductive, because then the patent system has 
provided no incentive to get to the marketplace with the 
product, and it has provided a disincentive to the person who 
did, because they have to pay royalties to the "submarine 
patent" owner. [Note: The term "submarine patent" refers to a 
patent application deliberately delayed and kept secret, 
sometimes for many years, waiting to surface strategically at 
some later time, with the weapon of its early filing date. 
This abuse of the U.S. patent system has become a serious 
problem.]

This is the fundamental reason for our shift to the 
international standard of a 20-year term from filing and an 
18-month publication. Also, conforming to the standard will 
give us advantages in dealing with other countries. The 20-
year term is already passed, as part of the GATT legislation. 
The 18-month publication was introduced but not passed in the 
last Congress; we hope it will be passed in this one.

These changes can have a number of salutary effects. One of 
them is to speed things up, not slow things down. You want 
people to get into and out of the patent office with a good, 
solid patent as quickly as possible, then use that to get to 
the marketplace to finance the research and development, and 
get out there with a product. That is the whole function of 
the patent system. The function is not served when somebody 
deliberately delays; it is not served when they keep their 
patent secret indefinitely. The whole reason for the patent 
system is that in return for getting exclusivity, the right 
solely to make, use, and sell your invention, you have to 
fully disclose everything about it, including how to make it, 
to other people, so that they can go to work on something 
else and get their own patent that will compete with it. By 
that you get a leapfrogging effect, presumably accelerating 
the pace of innovation. It not only stimulates economic 
activity, in this case it stimulates the creation of new 
therapies. I think that the patent system, in combination 
with the best and biggest basic research enterprise in the 
world, NIH and related government-funded enterprises, are the 
reasons we have the world's most dynamic and far-reaching 
medical research industry. But clearly the patent system has 
had some flaws in it, and this in one that would be 
addressed.

Now Congressman Dana Rohrabacher (Republican, Orange County) 
is out there doing everything humanly possible to turn this 
back. He is opposed to 18-month publication, he is opposed to 
the 20-year term. He has legislation pending in Congress 
which has 90 cosponsors to reverse our progress, and is 
trying to work against us in many ways. Members of Congress 
might be interested to know that there are people who would 
like their patent to be published in 18 months, who would 
like people to be incented (given incentive) to get in and 
out of this patent office, and there are people perhaps whose 
life may depend on it.

ATN: We have found that the procedure to "make special" 
certain applications is not well known, even among people who 
are knowledgeable about patents. No one I talked to has known 
that AIDS and cancer were included.

Lehman: We just did it recently, a couple of months ago. One 
of the things we are trying to do is to beef up our whole 
public-affairs operation, because I think the whole patent 
office has been a bit of a secret for quite a few years, and 
I think we need to change that around. Probably that is not 
widely known in the industry.

There is a whole suite of things we are working on, to make 
the system work better. There are two sides to this. There 
are people, like Congressman Rohrabacher, who want to permit 
people to game the system to make money, as opposed to 
incenting innovation. And other people are interested in 
having the most dynamic patent system, where the sole 
objective is to enable people to get in and out of this 
office as quickly as possible with a dynamite patent that 
they can take to the bank, and not to the courthouse, and 
turn into a product or process that is going to help the 
consuming public. And then, by disclosure of the invention, 
encourage somebody else, a competitor, to get out there and 
have full access to the technology so they can develop their 
own patent, or at least, the moment that patent term expires, 
be in there with a competing generic product.

ATN: What is Congressman Rohrabacher's argument for keeping 
the current system?

Lehman: His argument is that a long patent term is good, and 
we should not do anything to shorten patent term, and that 
there is a possibility that someone will not get the patent 
out of the patent office in three years, and therefore people 
will lose patent term.

The question of how much patent term is appropriate to incent 
research and development is a serious question. I think that 
by and large the 17-year term from issuance in the United 
States has generally been considered to equate to the 
international norm of 20 years from filing, as it gives you 
three years to get into and out of the patent office. Over 
the years patent pendency in this office has depended on its 
efficiency and resources available to it. We have just about 
always been able to get most of the patents out within three 
years. That is also true of many patent offices in the world.

I do not think any case has been made that we need to 
lengthen patent term beyond what we have right now. 
Rohrabacher favors the ability to get the longest patent term 
possible. There are serious consumer and public-interest 
considerations in that. I am a total, 100 percent believer in 
the patent system and in intellectual property; I am one of 
the strongest advocates for the owners of intellectual 
property rights in the world. But the genius of the 
constitutional system that we have is that those rights are 
limited. There comes a point at which the knowledge goes into 
the public domain to be used by all, and that is the essence 
of the generic industry, for example, and other industries.

Once you have provided the incentive -- and our system 
provides that -- for getting a fair reward on your 
investment, then we ought to open it up. Then you have two 
things going at once: you encourage the development of the 
generic industry with cheap, older therapies, but you are 
constantly incenting the production of new innovative 
therapies, which may cost more for the period that they are 
under exclusivity, because you have to amortize the 
investment -- that's the tradeoff. In many cases these new 
therapies may cost more than a generic older therapy on a 
per-pill basis, but many times they are much more cost 
effective, because they are cheaper than hospitalization, the 
use of medical devices, whatever -- not to mention cases 
where there are no other therapies, and the alternative is 
catastrophic for the patient.

I think we have a good basic fundamental approach, and I 
think Congressman Rohrabacher is playing with it, and people 
do not understand that. Rohrabacher is no more generous to 
the AIDS community on other matters. He is now going around 
on Capitol Hill collaring many members of Congress who do not 
know anything about this issue. In the new environment, there 
is some mob mentality that if it's a Clinton Administration 
idea it must be bad. He is taking advantage of that.

ATN: On another issue, we are concerned about intellectual 
property denying access to AIDS care in many parts of the 
world. When a really effective treatment is found, what about 
Africa, India, Thailand, Brazil, and other countries, where 
few can pay U.S. drug prices? What can be done about this -- 
or is there nothing that can be done?

Lehman: Until the signing of the GATT treaty, there has been 
no patent law in Brazil for example, and in much of the 
developing world. Any drug invented here can be replicated 
there for the cost of manufacture. The GATT treaty brought 
that situation to an end. I think there is a very good 
rationale for doing so -- lack of patent protection 
ultimately helps nobody. First of all, it creates higher 
pharmaceutical costs in the few markets where you do have 
protection; it means that the cost of development of drugs is 
borne entirely by the citizens of the advanced industrial 
countries, particularly the United States. Their drugs cost 
more so others pay less.

Also, lack of patent protection virtually rules out the 
creation of indigenous, research-oriented pharmaceutical 
industries in those countries. Some countries are not ready 
for a research-intensive industry, but certainly Brazil is -- 
yet they have no research-intensive pharmaceutical industry. 
They have many diseases that are unique to those kinds of 
climates, which there is no particular incentive for 
companies to research. I think it is short-sighted to assume 
that no patent protection in these countries is even to their 
benefit. And it disproportionately penalizes consumers in 
countries like the United States, and reduces the resources 
available to pharmaceutical innovators to spend money on 
developing new treatments. The GATT treaty has changed all of 
that; over a ten-year phase-in, all signatory countries to 
the GATT treaty will have to start providing full protection 
to pharmaceuticals the same way we do here in the United 
States. Incidentally, the U.S. biotech industry thinks the 
10-year phase-in is overgenerous; I think it will allow the 
countries to adjust.

Ultimately there are always going to be poor countries in the 
world that cannot afford anything. Many countries in Africa 
cannot even afford generic drugs, much less research-
intensive ones. That is why we have the World Health 
Organization, and various aid programs, because ultimately 
the answer to universal access to any product or service is 
not necessarily to make it free, so that you have no market, 
and therefore no incentive. Instead, address the specific 
problem; identify the group of people who need and should 
have access, as a matter of public policy. Then provide the 
funding, usually from a public funding source, to subsidize 
them and see that they have access.

ATN: Often people do not think of the patent system when they 
think of medical research.

Lehman: Some people's eyes glaze over when you start talking 
about patents and intellectual property; they want to just 
forget about it. Yet patent protection is fundamentally 
important to the growth of technology and innovation. It is 
absolutely at the core of commercialized medical research. 
Pharmaceutical companies do not make pharmaceuticals, they 
make patents. That is what they own (except for generic-drug 
companies). Obviously there is a value to generic drugs, 
because they are cheap. But if we just had a generic drug 
system, we would not have a single new therapy; there would 
not be anything other than what we have out there right now, 
unless we had some socialized system.

We obviously have much government input in basic research, 
but government does not get the pill into the customer's 
medicine cabinet without the patent system, which is the 
critical link. So if the patent system is not working right, 
we have a problem every bit as fundamental as problems at the 
FDA or anywhere else.


***** Human Retroviruses and Related Infections -- 
      Major U.S. Scientific AIDS Conference of 1995. Part I.

by John S. James

With no International Conference on AIDS this year (in the 
future, that meeting will occur only in even-numbered years), 
the Second National Conference on Human Retroviruses and 
Related Infections, January 29 - February 2 in Washington, 
D.C., with about 2300 people attending, was probably the 
largest conference on AIDS basic science and clinical trials 
to occur in 1995. Many felt that this was a better conference 
than most, with a higher quality of work presented and a more 
consistent focus on important research issues, reflecting 
improvements in the research today. There was more sense of 
optimism, based on a growing understanding of HIV, and 
growing agreement on some of the important research 
directions.

Lack of access by persons with HIV was a serious problem, 
however. The conference was expensive -- $425 on-site 
registration. The absence of corporate advertising booths may 
have been a welcome contribution to the focused scientific 
atmosphere, but also meant that the considerable expenses of 
the meeting had to be paid largely by those who attended. And 
there were no HIV scholarships, which meant that few people 
with AIDS could go unless they could register as press. 
Because many people were not there, AIDS TREATMENT NEWS is 
expanding its coverage of the information presented.

We urge organizers of future AIDS conferences to re-think the 
entire project in view of the development of computer 
communication. As much as possible of the information to be 
presented -- in writing, slides, and eventually video -- 
should be released on the Internet BEFORE the conference, and 
made freely copyable so that it will be immediately available 
to AIDS physicians and other service providers throughout the 
world. Future conferences will focus less on formal, mass 
lectures, and more on working groups of people who need to 
meet face to face to discuss and extend the information 
already released.

Highlights

These are some of the areas we found most memorable and 
important:

* Protease inhibitors. This new class of HIV treatments -- 
not yet widely available to patients -- is getting the most 
research and public attention today. It is fairly clear that 
protease inhibitors will be an important advance in AIDS 
treatment, but will not be the answer. They will need to be 
used in combination -- with each other, and with other drugs. 
Their development is one of a number of incremental steps 
toward better treatment. The new information presented at the 
conference was about as expected -- neither more nor less 
optimistic. More information should become available next 
week at the protease meeting of the National Task Force on 
AIDS Drug Development.

* 3TC plus AZT. This treatment is more widely available, at 
least to U.S. patients who are failing other treatments. Data 
from U.S. trials presented at the Human Retroviruses meeting 
basically confirmed the data from European trials presented 
in Glasgow last November (see AIDS TREATMENT NEWS #212, 
December 2, 1994). But as at the Glasgow meeting, most of the 
data now available is only for the first 24 weeks of the 
trial, and is only from blood tests; also, there was a fairly 
high dropout rate from both the European and U.S. trials. 
And, as expected, the results are less dramatic for people 
who have already used AZT extensively. The apparent benefit 
of this combination is not enough to keep skeptics from 
arguing that it may be no better than other combinations 
already available; for example, both  3TC plus AZT and ddC 
plus AZT caused comparable reductions in viral load (almost 
10 fold) sustained at least for 24 weeks and perhaps beyond 
48 weeks, when they were compared head to head in the same 
trial. But the general sense is that the AZT plus 3TC 
combination appears to give better and especially more 
sustained blood-work improvement than more standard 
combinations, and probably to be safer as well.

* Long-term non-progressors. It is now generally believed 
that not everyone with HIV disease will eventually become 
ill. About five percent are "long-term non-progressors" -- 
defined in one study as persons who have had HIV for at least 
seven years, have stable CD4 counts over 600, and no HIV-
related illnesses. (Although the definition specified seven 
years, most of the people studied have been HIV-positive and 
stable for over ten years.)

While this information is not new, an important report 
appeared in the NEW ENGLAND JOURNAL OF MEDICINE on January 
26, just before the Human Retroviruses conference -- and the 
conference seems to have marked a change in the "conventional 
wisdom" about HIV, the general assumptions that pass 
unthinkingly into newspaper stories, etc. In the past, the 
conventional wisdom had been that everyone would probably 
progress to AIDS eventually. Now the conventional wisdom is 
that, as far as we know today, about five percent of people 
with HIV will never become ill as a result.

Another study presented at the Human Retroviruses conference 
used statistical methods to project AIDS-free survival, based 
on data from the MACS project, which includes a large cohort 
of men with HIV who have been followed for many years. This 
study predicted that about 13 percent of people with HIV 
would be AIDS-free 20 years after they became HIV positive.

There is no contradiction between the five percent estimated 
by one study, and the 13 percent estimated by the other. This 
is because there are many kinds of long-term survivors, not 
all of whom fit the above definition of "long-term non-
progressor." The 13 percent probably includes the five 
percent who may never get sick as a result of HIV infection, 
and others who will develop AIDS but very slowly, after 20 
years or more -- unless better treatments are found by then.

Neither figure includes another group, who are HIV negative 
but whose immune systems show that they have been exposed to 
HIV in the past. This group may have recovered from HIV 
infection, or may have had a small exposure which did not 
result in infection.

It is clearly important to study all kinds of long-term 
survivors, to find out what is different about them and/or 
about their virus. This information might lead to new ways to 
treat HIV disease, whether or not it has already progressed 
to AIDS.

* Clinical trial design. There were signs of movement toward 
consensus on this controversial issue -- perhaps more in the 
hallway conversations and overall atmosphere of the meetings 
than in the formal sessions on this topic. And it was 
encouraging to see that seemingly obscure meetings on 
clinical trials could pack large lecture halls.

The general professional opinion is clearly accepting viral 
load as a useful measure, and wants to see it used in small, 
rapid trials (the position we have long advocated in AIDS 
TREATMENT NEWS), while also acknowledging that there is much 
to be learned about how well viral load reduction translates 
into clinical benefit to patients. A minority does not argue 
that viral load is useless, but rather that it is unproven. 
These people are concerned that we could be making a mistake 
-- that "treating the marker" (blood test value) may not mean 
that we are "treating the patient" -- in other words, that 
the strategy of lowering viral load might not prove helpful. 
They point to the Concorde trial, which showed that early use 
of AZT raised the T-helper count but did not lead to longer 
survival, as an example of the need for caution in judging 
drugs by blood-test results. They want to see a large trial 
to test the strategy of changing drugs to lower viral load, 
compared with changing drugs by other criteria without using 
viral load, to prove that viral load is superior for this 
purpose.

The practical controversy is between those who emphasize 
small, rapid, data-intensive trials generally using blood 
tests, and those who emphasize large, long-lasting trials 
with "clinical endpoints" -- statistics on how many people 
progress to more serious illness or death. But a working 
compromise seems to be developing. Those who want the large 
trials know that there can be very few of them (because of 
the limited number of qualified patients, as well as limited 
money, trained personnel, and other resources); therefore, 
rapid small trials will be needed to find the best treatments 
to put into the large trials. And those who emphasize small 
trials know that large trials will also be necessary, and 
that these large trials will help to define the appropriate 
use of viral load and other blood tests for studying new 
drugs in the future, and for managing patient care.

* New immune-function tests. Even with viral load tests in 
addition to T-cell counts, doctors are missing something 
important -- measures of how well the T-cells are working. 
Specialized research tests can measure immune function, but 
they have been labor intensive, expensive, and inherently 
imprecise. They are not suitable for widespread use, and even 
research use can be problematic.

Now there is a new kind of immune-function test, based on an 
"early activation" marker called CD69; this test is becoming 
commercially available for research use (but not for routine 
patient care) this month. The new test has many advantages. 
It uses whole blood at body temperature, greatly simplifying 
the procedure and leaving the cells in their natural 
environment, so that the test result will better reflect how 
the cells behave in the body. The entire procedure takes a 
few hours, compared to two weeks for earlier methods; only a 
few minutes of labor is required, and no radioactivity is 
used. Also, the cells are typed and measured individually, 
while previous methods gave bulk answers; variations of the 
technique can even show the production of certain substances, 
such as IL-2, within each cell. And the new test is 
inexpensive -- probably well under $100 for reagents and 
labor. An expensive flow cytometer is required, but many 
laboratories have one already; they can begin running these 
tests at little start-up cost, only a few thousand dollars 
for reagents. The major barrier to widespread use is 
conceptual; this new technology makes possible many different 
immune tests, and doctors do not know what tests to order or 
how to interpret the results.

Different patients can have the same disease status by all 
conventional measures, but have different results on immune 
function tests, predicting different disease outcomes. As 
more becomes known, these tests will be used not only to 
study the pathogenesis of HIV disease, but also to see if 
treatment or lifestyle changes are correcting the immune 
defects they find. Much research will be necessary before 
this technology can become part of routine care; but existing 
AIDS research organizations, including specialized medical 
practices, can begin this research now.

The Human Retroviruses conference had only one poster 
involving this technology, which has been developed by 
Beckton-Dickinson Immunocytometry Systems and is being 
marketed under the name FastImmune (TM) (see poster #174, 
"Diminished V-Beta T Cell Subset Responses to Superantigen in 
HIV+ Individuals as Determined by Multiparameter Flow 
Cytometry," VC Maino, JJ Ruitenberg, MA Suni, L Mole, and M 
Holodniy; also see abstract #504A from the Yokohama 
conference, "Rapid Flow Cytometry Detection of T Cell Subset 
Activation in AIDS," by the same research group). We will 
continue to report on these and other immune-function tests 
as we learn more about them.

[Part II of this article will continue our report from the 
Human Retroviruses conference.]


***** San Francisco Area: Computerized Search for Local 
      Clinical Trials

by Denny Smith

The Community Consortium, an organization of HIV care 
providers in the San Francisco Bay Area, is now offering the 
use of a computerized data base by which people with HIV can 
quickly and easily find out about local clinical trials. The 
project is called "Trials Search," and is a free service to 
any Bay Area resident.

The information offered by Trials Search is the same as that 
contained in a published directory of trials that the 
Consortium also produces. But the computer search has the 
most current information, since new trials are available as 
soon as they are entered, while the printed directory is only 
published several times a year and will not have the latest 
listings.

In addition, the results of the search are completely 
specific to the needs of the inquirer. Information about 
health history and current lab work, especially the CD4 
count, is entered into the computer. That data is then 
compared to the sometimes complicated entry criteria of all 
local clinical trials, and the resulting printout matches the 
patient with those trials for which he or she eligible. Our 
own experience has shown that the search can winnow out 
interesting trials that a visual scan of the hard-copy 
directory might miss. 

To obtain copies of the questionnaire for Trials Search, or 
the DIRECTORY OF HIV CLINICAL TRIALS IN THE BAY AREA, 
interested persons should call the Consortium office at 
415/476-9554.


***** San Francisco: Self-Empowerment in HIV Disease 
      Symposium, Mar. 4

This Saturday afternoon symposium includes talks on viral 
load tests, and on fatigue.

Tarek Elbeik, Ph.D., Supervisor, Virology Research 
Laboratory, San Francisco General Hospital, will speak on New 
Concepts in Lab Testing: The New Viral Load Assays, PCR vs. 
bDNA. And Jon D. Kaiser, M.D., will talk on New Directions in 
the Evaluation & Management of Fatigue: A Practical Approach.

This free public program, Saturday, March 4, from 2:00 to 
5:00, is sponsored by Ortho Biotech. It will take place in 
the Pacific Conference Center, California Pacific Medical 
Center, 2333 Buchannan St. (at Clay), San Francisco; persons 
are advised to call 415/922-8971 to reserve a space. Take the 
1, 22, or 24 bus lines, or parking is available in the 
Clay/Webster garage.


***** Action Alert: Balanced Budget Amendment

by John S. James

The future of AIDS research, prevention, human rights, and 
care will depend on how well we explain the need to the 
larger public, and also on how well we establish a grassroots 
culture in which tens of thousands of people regularly speak 
out to their elected representatives, the media, and others, 
as a part of everyday life. Today, if you live in California 
or one of other 15 states listed below, your calls to one or 
both of your Senators are especially important; also get 
friends living in those states to call.

The U.S. Senate may vote next week on a "balanced budget" 
amendment to the U.S. Constitution; the House has already 
passed it. The bottom line is that a balanced-budget 
amendment will hurt people who need help, including people 
with AIDS. Also, the Constitution should not be changed 
without good reason; the deficit has already been reduced by 
almost half since 1992, without changing the Constitution; 
and many economists believe that the Federal government needs 
the flexibility of deficit spending to help people during 
recessions, stabilizing the economy in the process. This 
attempt to change the Constitution is being rammed through 
before people have a chance to understand the consequences. 
Call or write your Senators and ask them to OPPOSE the 
balanced budget amendment.

On February 11 the AIDS Action Council listed the following 
Senators as especially important, because they are undecided 
or not firm about how they will vote. The vote will be close; 
if you live in any of these states, call the Capitol at 
202/224-3121, ask for your Senator's office, and ask them to 
vote NO on the balanced budget amendment. [Note: The busy 
office staff will seldom ask why you are opposed; they just 
need to get the count of those who call for and against. If 
the receptionist does ask, you could say that you are 
concerned about AIDS funding -- or about changing the 
Constitution unnecessarily.]

Alaska: Ted Stevens (R-AK)
California: Diane Feinstein (D-CA)
Delaware: Joe Biden (D-DE)
Georgia: Sam Nunn (D-GA)
Iowa: Tom Harkin (D-IA)
Kentucky: Wendell Ford (D-KY)
Louisiana: John Breaux (D-LA)
Maryland: Barbara Mikulski (D-MD)
Massachusetts: John Kerry (D-MA)
Montana: Max Baucus (D-MT)
Nevada: Harry Reid (D-NV)
New Mexico: Jeff Bingaman (D-NM)
North Dakota: Kent Conrad and Byron Dorgan
Rhode Island: Clairborne Pell (D-RI)
South Dakota: Tom Daschle (D-SD)
Vermont: Jim Jeffords (R-VT)


***** AIDS TREATMENT NEWS
      Published twice monthly

Subscription and Editorial Office:
   P.O. Box 411256
   San Francisco, CA 94141
   800/TREAT-1-2  toll-free U.S. and Canada
   415/255-0588 regular office number
   fax: 415/255-4659
   Internet: aidsnews@igc.apc.org
Editor and Publisher:
   John S. James
Reader Services and Business:
   Richard Copeland
   Thom Fontaine
   Tadd Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and 
standard treatments, especially those available now. We 
interview physicians, scientists, other health 
professionals, and persons with AIDS or HIV; we also 
collect information from meetings and conferences, 
medical journals, and computer databases. Long-term 
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.

Subscription Information: Call 800/TREAT-1-2
   Businesses, Institutions, Professionals: $230/year.
   Nonprofit organizations: $115/year.
   Individuals: $100/year, or $60 for six months.
   Special discount for persons with financial difficulties:
   $45/year, or $24 for six months. If you cannot afford 
   a subscription, please write or call.
   Outside North, Central, or South America, add air mail 
   postage: $20/year, $10 for six months.
   Back issues available.
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   VISA, Mastercard, and purchase orders also accepted.

ISSN # 1052-4207 

Copyright 1995 by John S. James.  Permission granted for 
noncommercial reproduction, provided that our address 
and phone number are included if more than short 
quotations are used.

