Community Research Group, San Diego: Interview with Gary R. Lewis, Ph.D.

Last month we visited the San Diego Community Research
Group, which has rapidly established a successful clinical-trials
program, and is now developing a nonprofit clinic to provide
primary care for persons without insurance. Since these programs
may offer useful examples for other efforts, we interviewed Gary
R. Lewis, Ph.D., president and CEO of the organization. [Our
comments within Dr. Lewis' replies are in brackets.]

JJ: How did the Community Research Group (CRG) begin?

GL: In August of 1989 a group of eight or nine people,
headed by Terry Dearstone, Ed.D., met and decided that San Diego
needed a community-based research organization. So they called
AmFAR [the American Foundation for AIDS Research, in New York and
Los Angeles] and asked how to become one of the groups in AmFAR's
Community-Based Clinical Trials Network. AmFAR told them and sent
them an application for a seed grant. They submitted the grant
that fall, and in February 1990 were notified that they were
awarded a grant of $25,000. They received the money in March.

They did a nationwide search for an administrative person to
head the new organization, and hired me in April to start the
organization.

Clinical Trials

JJ: What trials have been conducted by the CRG -- either
completed trials, or ones currently underway?

GL: We had a rifabutin prophylaxis trial which was ended
last week [after data showed that rifabutin is effective for
prophylaxis of MAC]; this study should continue on open label
[with all the volunteers offered the drug]. A separate trial of
rifabutin in treatment of MAC is still going.

We completed an early study with Viagene, a local
biotechnology company which is developing a therapeutic vaccine
for HIV. We recruited the 20 volunteers they needed for skin
biopsies, to develop methods for laboratory testing of whether or
not the vaccine is likely to work, when they do the genetic
manipulation and splicing. Now they've asked for those people to
come back for an additional one to three visits for more blood
work, to develop what are called "target cells." In animals they
have had very encouraging responses to what they are doing, and
they are hoping to start phase I tests in the fall of this year.
[Note: Viagene, located in San Diego, was in the news last
April, when Green Cross, a pharmaceutical company in Osaka,
Japan, invested up to $40 million in Viagene's AIDS research.
According to an article in the April 26, 1991 Los Angeles Times,
the company hopes that the treatment "could help the immune
system destroy HIV-infected cells." San Diego is a major center
of the biotechnology industry in the United States.]

We are also doing a toxoplasmosis prophylaxis study using
two different doses of pyrimethamine. There is no placebo in
this study.

And we are also testing itraconazole vs. fluconazole for
treating cryptococcal meningitis. [For ethical reasons, this
test is being done with patients who are less seriously ill, so
they are not at immediate risk if the experimental therapy
fails.]

We have just started a study of Intron-A [alpha interferon],
to see if the combination of AZT and interferon reduces disease
progression when compared to AZT alone.

We are also running a clarithromycin study, which is now
closed to enrollment. We were the only community-based site to
be doing this study; the other sites were in the ACTG [AIDS
Clinical Trials Group of the U. S. National Institute of Allergy
and Infectious Diseases]. According to Abbott, they are pleased
with the community-based method of doing research. They were
able to accrue very rapidly and obtain good data.

One nutritional study which is now finished tested the
Vivonex brand elemental nutritional supplement, for Norwich
Eaton. We saw very good results with that. We had over 25
people in that study. Some had their diarrhea lessen, they
gained weight, they went from not being able to keep anything
down to being able to drink this liquid and gain weight on it,
and later they went back to eating regular food.

HIV Educational Classes

JJ: Your brochure mentions classes organized by the CRG for
persons with AIDS or HIV.

GL: We've put about 2,000 people through our "Fightback"
class ["a nine-hour AIDS survival course ...designed to teach
people who have tested HIV+ the information they need to know, to
enhance their chances for survival"]. We are beginning a formal
evaluation of the program; but just from peoples' responses we
can tell that it made a big difference for them.

We have almost finished development of a self-contained
program that we can mail to anybody, including audio tape, a
video tape, a workbook, everything in one package. We expect it
will cost about $25 or $30 for the whole package; then people can
use it alone or with others wherever they are. Anyone can call us
for more information [phone number below].

We also give the OPTIONS program, a choice-making stress
reduction program.

And we are also negotiating to be the fiscal sponsor of
RISE, a stress-reduction program presented at the international
AIDS conferences in San Francisco (June 1990) and Florence (June
1991).

Future Plans

GL: The Community Research Group is in the process of
establishing a nonprofit clinic. We want to be able to support
primary care using research dollars, for persons who have no
insurance or other payer. We're looking at bringing in people
with only Medicaid, or county medical, or nothing, and be able to
subsidize 80 cents on the dollar with research and fund raising.
We hope to take some of the load off the physicians who otherwise
could be inundated by patients who do not have any way to pay for
healthcare.

At this time we are looking for space for the clinic; we do
have the funding to begin. We hope to have something in
operation by summer or fall at the latest.

We are not designating ourselves exclusively as an AIDS
agency; we are dealing with life-threatening diseases. We have
found that the community-based approach is a very valuable way to
do research. It would be unfortunate to lose this approach when
there is a cure for AIDS. So we will attempt to establish
ourselves for the long run. Right now we are working almost
exclusively with AIDS, but in the future we may branch out to
research in cancer, Alzheimer's, extreme hypertension, and other
life-threatening diseases, and provide the services to these
populations as well.

Nuts and Bolts

JJ: You mentioned the importance of getting legal advice
for a community-based group.

GL: We have retained a major San Diego law firm to
represent us. What's most important is that any time I have a
question- -about a contract, or a document from a pharmaceutical
company, or whatever -- I can fax it to our attorney, and he
immediately faxes back an answer about it. This way I know that
I'm not putting us in any kind of jeopardy.

We also hired a business consultant to do a complete
evaluation of the program, and do a strategic planning meeting
for our board and myself, to present the findings and suggest
ways to improve and strengthen the organization.

In addition, we are audited every year. It costs between
two and three thousand dollars. But it alleviates any questions
in somebody's mind.

For More Information

For more information about the San Diego Community Research
Group, or any of its programs, call them at 619/291-AIDS, or
write to: San Diego Community Research Group, 3800 Ray St., San
Diego, CA 92104.