With New Virology Institute, Gallo May Make A Fresh Start In Baltimore

By Franklin Hoke
The Scientist, Vol:9, #15, pg.3 , July 24, 1995

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@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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