The Latest on Gallo

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Mon Jul 31 16:30:16 EST 1995



jscutero at panix.com (James Scutero) posted in misc.health.aids on
28 Jul 1995 14:06:20 -0400:

Subject: Gallo May Make A Fresh Start in Baltimore

                          THE SCIENTIST


VOLUME 9, No:15                                   JULY 24, 1995
(Copyright, The Scientist, Inc.)

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Articles published in THE SCIENTIST reflect the views of their
authors and not the official views of the publication,
its editorial staff, or its ownership.
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TI : With New Virology Institute, Gallo May Make A Fresh Start In
     Baltimore

AU : Franklin Hoke

TY : NEWS

PG : 3

With a powerful group of local backers to ease the transition,
controversial virologist Robert Gallo hopes for a fresh start,
both personally and scientifically, when his Institute of Human
Virology opens its doors this fall. The new institute, intended
to advance the fight against AIDS and other diseases, will be
affiliated with the University of Maryland at Baltimore.

And it appears that his fellow scientists -- with a few sharp
exceptions -- are ready to let accusations of scientific misconduct
that have marked the last decade of his 30-year career at the
National Institutes of Health fade. Indeed, many support him and
wish him success in his endeavor.

"Gallo is a rare resource," asserts William Haseltine, chairman
and chief executive officer of Human Genome Sciences Inc., a
biotechnology company in Rockville, Md., and a former Harvard
Medical School AIDS investigator. "He's one of our finest
scientists, enormously imaginative and very productive, and we're
fortunate to keep him in the Maryland area."

"The university is very fortunate to be able to attract Gallo, an
investigator and scientist of such stature," says Judah Folkman,
a professor of pediatric surgery and cell biology at Harvard
Medical School.

Gallo's new institute, involving about 50 people, will receive
start-up funds of about $9 million from the state of Maryland and
$3 million from the city of Baltimore, which has a fast-growing
population of HIV-infected individuals and AIDS patients. The
university will contribute laboratory facilities in the Medical
Biotechnology Center (which is a part of the University of
Maryland Biotechnology Institute), faculty salaries, and other
expenses, bringing the total costs to about $50 million, state
officials report.

According to Donald E. Wilson, dean of the university's school of
medicine, where institute researchers will have joint
appointments, a local citizen also called him with an offer of
money to support the new institute; Wilson declines to provide
further details, including whether the money will be accepted. In
addition to pursuing grants, academic collaborations, and
pharmaceutical industry partnerships, Gallo plans to supplement
institute income with revenue from a new biotechnology company to
be called Virex, which will develop products based on the
institute's research. The state will be a part-owner in Virex.

Some scientists say they are dismayed that, with this move, Gallo
may elude further inquiry into whether he misappropriated the HIV
virus in 1984 from Luc Montagnier and his colleagues at the
Institut Pasteur in Paris. And at NIH, where rumors have
circulated over the past year that administrators had asked Gallo
to find a new base of activities, a few are angry at the use of
taxpayer money to finance what they view as Gallo's escape.

"It's obvious that the deal is designed to be a money-making
operation for Gallo personally, with an associated business
that's supposed to sell products from the AIDS research
laboratories and market them throughout the world," charges
William A. Hagins, a neurophysiologist at the National Institute
of Diabetes and Digestive and Kidney Diseases. Hagins  has
organized a letter-writing campaign to Maryland legislators to
protest Gallo's role in the new institute. "What is happening is
that we're essentially using taxpayers' money to create a new
industry for the benefit of Robert Gallo, who's already
discredited himself on the basis of his prior conduct."

Hagins wrote Maryland Gov. Parris N. Glendening to inform him
that "Gallo's reputation is under a very dark moral cloud." To
support that view, he included a computer copy of a staff report
prepared by the House Energy and Commerce Committee's
subcommittee on oversight and investigations under then-chairman
Rep. John Dingell (D-Mich.).

The report, which alleges mishandling of the French HIV samples
in Gallo's lab in the early 1980s, became widely available
earlier this year, although it was never officially released by
the subcommittee (P. Kefalides, The Scientist, April 3, 1995,
page 1). However, Dingell wrote NIH director Harold Varmus in
February that he could not "vouch for the authenticity" of the
document.

The ongoing criticism notwithstanding, there are suggestions that
some of Gallo's detractors within the scientific community are
moderating their views.

"Even though there is still something of a cloud around his name,
the work he has done is sufficiently distinguished so that he can
probably make more important contributions regarding AIDS,"
comments John Edsall, a professor, emeritus, of biochemistry at
Harvard University who has been critical in the past of Gallo's
conduct. "And he has certainly suffered a good deal from the
charges made against him, which are painful things. I think,
after all, I want to see him going on with his work and making
contributions."

Edsall adds: "It's probably a good thing for all concerned that
he will be out of NIH."

Gallo denies that the primary purpose of the new institute is to
enrich him: "Its purpose is to help develop better therapy for
AIDS. That's number one. Number two, it will bring jobs to
Baltimore, and it will bring jobs to Maryland. We will succeed,
so, economically, it is for the benefit of the taxpayer, not for
the taxpayers' loss, ultimately." In addition, he notes,
taxpayers have also been the source of support for his laboratory
at NIH.

He expresses exasperation with persistent critics who insist that
he has yet to pay his debt for the alleged mishandling of HIV in
his lab.

"Yes, I could have been more generous at the time with the
French," Gallo acknowledges. "But I've lived through that, and I
think I've paid for it sufficiently. Now, it's getting a bit
bizarre, isn't it?

"I feel I've gone through hell and back. I don't need much more
of it. I want to work."

Backers In Baltimore
Joining Gallo in the Baltimore venture as associate directors
will be William Blattner, chief of the viral epidemiology branch
of the National Cancer Institute, and Robert R. Redfield, a
leading clinical AIDS investigator at Walter Reed Army Medical
Center. Redfield is the principal investigator in Phase II trials
of a therapeutic vaccine for HIV infection based on the virus
protein gp160 and manufactured by MicroGeneSys Inc. of Meriden,
Conn.

In 1992 and 1993, Redfield himself was investigated for and
cleared of charges of scientific misconduct by the United States
Army for allegedly presenting a misleadingly positive analysis of
early data on the vaccine at the annual international AIDS
conference in Amsterdam in 1992. Also in 1992, the gp160 vaccine
became the subject of controversy when MicroGeneSys successfully
lobbied Congress to allocate $20 million for its testing. The
legislation called for the trials unless NIH, the Food and Drug
Administration, or the Department of Defense determined that they
should not be done. Then-NIH director Bernadine Healy complained
that the appropriation improperly circumvented peer review.
However, a panel headed by Anthony Fauci, director of the
National Institute of Allergy and Infectious Diseases, later
recommended that clinical trials of the gp160 vaccine go forward,
with modifications.

A crucial supporter of the new institute is Gallo's new boss,
Edmund C. Tramont, director of the Medical Biotechnology Center
at the University of Maryland at Baltimore. In 1990, as a
virologist at Walter Reed Army Research Institute -- where he was
Redfield's supervisor prior to the gp160 controversies -- Tramont
participated in the preliminary inquiry of misconduct charges
against Gallo as part of a group led by Jules Hallum, then
director of NIH's Office of Scientific Integrity. The inquiry
found insufficient evidence to support the charge that Gallo had
misappropriated the French virus, and Tramont has been critical
of subsequent investigations ascribing culpability to Gallo.

Tramont disputes the suggestion by Hagins and others that money
is Gallo's primary motivation in creating the institute. He
claims that the 58-year-old scientist's main aim in establishing
the new institute and its affiliated biotechnology company is to
create an active, ongoing scientific legacy.

"Gallo recognizes his age, and what he really wants to do is
leave in place a structure that will be able to do excellent
research in this arena after he's gone," Tramont maintains.
"That's what's driving him most. If he is successful with the
company that is built on his science -- and remember that over the
last decade or so, his inventions have grossed over $1 billion --
he
will then be able to put those royalties into a foundation."

Such a foundation could provide money for institute research in
the future, he says.

An existing Gallo initiative, his annual scientific meeting -- held
in the past in Bethesda, Md., and attended by hundreds of the
world's prominent AIDS researchers each fall since the mid-
1980s -- will take place in Baltimore in the future.

Division Of Labor
The new institute will have a tripartite structure, reflecting
the areas of expertise -- basic research, epidemiology, and
clinical studies -- of Gallo, Blattner, and Redfield, respectively,
according to Tramont and institute members.

"Each one of us brings a different set of skills that are very
complementary to each other," says Blattner. "My own goals are to
develop a program of epidemiology that will focus on
understanding the risk factors and the correlates of infection
that will facilitate the basic science mission of developing a
vaccine against HIV, for example." Epidemiological studies will
also aid in the discovery of new disease-causing viruses for
possible study at the institute, Blattner says.

"Gallo will now have a clinical arm, too, which he never had
before," Tramont notes. "That is what Redfield is going to run."

"Redfield is a superb experimental clinical virologist, which I
need and am not," confirms Gallo. "We plan to outreach into
community hospitals in the Baltimore area. We will also be
involved in public health education and training programs in the
minority community."

One early project at the institute, according to Gallo, will
likely involve his laboratory's recent discovery that a
pregnancy-related hormone may have therapeutic effects on
Kaposi's sarcoma, one of the afflictions associated with AIDS.

The institute's scientific strengths and those of the university
will also dovetail well, university administrators maintain.

"The school of medicine has always had a very strong program in
infectious diseases, right from its founding days, and we have an
internationally known center for vaccine development," remarks
David J. Ramsay, president of the University of Maryland at
Baltimore and a physiologist. "Also, Baltimore has quite a large
AIDS population. So, it seemed to us that Gallo and his coworkers
would fit in nicely and augment those areas."

In the last five years, the university's medical school has grown
from an institution with about $20 million in research funding to
one that now has close to $100 million, medical school dean
Wilson points out. "But viral studies was not a niche we had
planned to carve out for ourselves, even though HIV is something
we've been involved in," Wilson says.

"So, this will bring a broader viral approach into the medical
school that we had not planned on and will dramatically
supplement some of the HIV studies we're already involved in."

Weighing The Risks
University, state, and city officials recognized that bringing
Gallo to Baltimore represented a potential political risk. Most
say that they felt able to extend an invitation to Gallo because
of two events related to his long-running misconduct imbroglio
that they feel put the issues  surounding him to rest. A number
of scientists agree with this view.

The first was the late-1993 decision by the Office of Research
Integrity in the Department of Health and Human Services to drop
government charges against Gallo. ORI had found Gallo guilty of
misconduct in 1992, and he had appealed the finding to a
departmental appeals board. After Mikulas Popovic -- who performed
central HIV experiments in Gallo's lab and was similarly
charged -- was exonerated by the board, ORI chose not to pursue its
case against Gallo. Having failed to meet the standards of
evidence required by the board in the Popovic case, ORI officials
acknowledged they could do no better in the Gallo case.

The second event was the July 1994 renegotiation of HIV blood
test royalties between NIH and the Institut Pasteur. Initially,
the agreement called for the U.S. and France to keep the first 20
percent of royalties from the countries' respective sales of
blood test kits. Of the remaining pool of royalties, the World
AIDS Foundation received 25 percent and the two countries split
the rest evenly. Under the new agreement, both countries still
get to keep the first 20 percent, but France now receives 50
percent of the remaining pool, the U.S. 25 percent, and the
foundation 25 percent. As the U.S. sales of test kits -- and thus
the initial royalties -- have greatly outdistanced France's, the
new agreement is expected to eventually equalize each country's
share.

In considering whether to contribute city funds to the project,
Baltimore Mayor Kurt L. Schmoke consulted marine biologist Rita
Colwell, president of the University of Maryland Biotechnology
Institute. The Biotechnology Institute is the parent organization
for Tramont's Medical Biotechnology Center, within which Gallo's
new institute will reside, administratively. Colwell also is the
current president of the American Association for the Advancement
of Science.

"Yes, the mayor did call me," Colwell recounts. "I advised him
that Gallo was an extremely good scientist and that, considering
the fact that he was at NIH in Maryland and wanted to go to
Baltimore, I would encourage it. As best I could determine in
talking to a number of people, including representatives from
NIH, [the misconduct investigation] had been closed. There had
been statements [against Gallo], but they had not been borne out.

"It was a controversy between scientists. Montagnier and Gallo
have come to an agreement [to be called codiscoverers of HIV],
and Gallo still has a lot of very exciting research going and
will be making major contributions."

Even so, a few discontented voices could be found on an Internet
discussion group devoted to scientific misconduct issues (send
message "subscribe scifraud" to listserv at uacsc2.albany.edu).

One was A.C. Higgins, moderator of the group and an associate
professor of sociology at the State University of New York,
Albany. In late May, when news of Gallo's institute was
announced, Higgins wrote, "This message will be delivered, loud
and clear, to young men and women entering science: the spoils go
to the corner-cutter in science."

Gallo's supporters, however, maintain that his scientific
contributions have been significant and that he should be allowed
to continue his work.

Max Essex, a professor of virology at the Harvard School of
Public Health, contends the new institute will be good for all
involved parties and help promote research to counter AIDS:
"Regardless of what anyone would say positively or negatively
about Gallo, I think everyone would agree that he's had
remarkable vision for new discoveries."


(The Scientist, Vol:9, #15, pg.3 , July 24, 1995)
(Copyright, The Scientist, Inc.)

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