Chernobyl ‘Hero’ : Dr. Gale--Medical Maverick
Since his first official house call to the Soviet Union in the spring of 1986, Dr. Robert Peter Gale, the 42-year-old UCLA bone-marrow transplant specialist, has become nothing short of an international celebrity.
As the physician who led the international “rescue team” that helped treat victims of the Chernobyl nuclear plant accident, Gale has been a darling of the news media for two years. He has been interviewed by Barbara Walters, made guest appearances on the “Donahue” and Larry King shows and been featured in Time, Life, Vanity Fair--even Pravda--to name a few.
Along with author Thomas Hauser, Gale has written a book, “Final Warning: the Legacy of Chernobyl,” with an initial printing of 100,000 copies, and is now on a 10-city promotion tour. Ove1914729576delivered at least 100 Chernobyl lectures--often receiving $5,000 an appearance. He has been approached by actors like Dustin Hoffman interested in dramatizing the events of his life.
Yet there is something about the Chernobyl effort that is not mentioned in Gale’s book nor in the numerous interviews he has given since the summer of 1986. According to documents recently obtained by The Times, Gale designed and helped carry out experimental treatments on at least three Soviet citizens with a genetically engineered drug that had never before been tried on human subjects, nor approved for human testing.
It is an incident that Gale refuses to discuss in detail. But, according to letters written in 1986 from the drug’s manufacturer to the Food and Drug Administration, the patients received an experimental substance called granulocyte macrophage colony stimulating factor, or GM-CSF, in hopes that it would help them recover infection-fighting white cells that had been destroyed by exposure to radiation.
It was a bold and unconventional step--some might say a risky one--especially because it was taken under such sensitive political circumstances.
It is not clear what role the FDA or, for that matter, the Soviet government may have played. In any event, the report suggests that the drug did little either to help or hurt the patients. What the incident does clearly reveal, however, is something of the way Gale approaches medicine.
Widely regarded as a brilliant physician, Gale charts his own course. As unafraid of crossing forbidding international boundaries for his work as he is doing battle with the administration of his own university, Gale himself acknowledges that there is considerable truth to his reputation as a man who plays by no one’s rules but his own.
By his own telling, he represents a controversial side of medicine that tries constantly to push forward the conventional boundaries of medical practice. This has brought Gale more attention than most physicians and scientists receive in a lifetime. But it also has gotten him into a good deal of trouble.
In the early 1980s, he was the subject of investigations by both the government and his own institution for allegedly using experimental treatments on dying patients without proper authority and without demonstrating that he had fully informed patients of what he was doing. Although Gale has argued that the treatments were “not experiments at all” but the “best available therapy” for his patients, he was nonetheless reprimanded by the government for his activities and until March of this year was subjected to random federally mandated audits of his patient records.
Until July, 1986, he, along with some other UCLA researchers, also were under a 16-month order by the Food and Drug Administration to halt all use of experimental drugs from the National Cancer Institute after an investigation that uncovered a number of record-keeping and safety violations in connection with human drug trials.
In a more recent but as yet unpublicized round of trouble with UCLA, Gale was investigated again in 1986 for failing to follow one of the most fundamental practices of his profession--filling out the charts of his patients as he saw them. It was, Gale said, an “unfortunate consequence” of the public attention he was receiving after Chernobyl.
Although his intelligence and his skills as a physician have never been called into question nor has there ever been evidence that he has misdiagnosed or mistreated patients, Gale’s departure would not be “unwelcome” among some faculty members, said Albert A. Barber, UCLA’s vice chancellor for research.
There are, Barber said, “plenty of people over at the Medical School” who say frankly--but privately--that they think Gale should have been fired long ago from the university where he has been conducting research and caring for patients for 18 years.
Few of Gale’s detractors, however, will criticize him publicly. Also, most UCLA administrators have been circumspect in dealing with Gale, saying they are in part culpable for his problems and perhaps even enjoying some of the benefits that his fame has brought UCLA’s way.
Loses Position Nonetheless, Gale was long ago replaced as head of UCLA’s bone marrow transplantation unit and no longer oversees multimillion-dollar government research grants at UCLA, according to Dr. David W. Golde, chairman of UCLA’s division of hematology and oncology.
Although Gale retains his $98,300-a-year post as an associate professor of medicine, he says he has been blocked from promotion to full professor, a step that in the normal course of things would be long overdue.
Gale himself is largely unconcerned by all of this trouble, which he characterizes simply as “harassment . . . an endless barrage of harassment.”
Seeming almost to delight in his reputation as a medical maverick, he acknowledges he has been at odds with UCLA and government funding agencies for some time, but dismisses much of it as the envy of other doctors. “To me, it’s not very important,” Gale said. ". . . But there’s not much they can do to me or I to them.”
What Gale can do, he says, is attend to his own more pressing agenda: finding what he hopes will be one of the first cures for cancer.
It was a warm winter afternoon in Los Angeles recently when Gale and his 38-year-old Israeli wife, Tamar, arrived at a reception for Yitzhak Shamir, the prime minister of Israel.
If not the center of attention at fashionable Westside parties, the Gales had become frequent and apparently welcome additions to the usual lineup of stars in this city’s long list of the rich and famous.
“Dr. Gale, I’d like you to meet my daughter,” said an attractive middle-age woman. “She’s one of your fans.”
Gale, gray-haired but boyish looking, had smiled shyly as he is wont to do at social occasions.
“I didn’t know I had any fans,” he demurred.
“Everyone knows that ‘s not true. Where was it that we saw each other last, anyway?” the woman asked, turning to Gale’s wife. “I suppose it was when the king of Spain was in town, wasn’t it?”
Time to Move On
Forty-five minutes of banter and hand pumping and the doctor had had enough. It was out the front door and on to the next activity.
Now, back at a UCLA parking structure and apparently eager to return to his office at the university’s bone marrow transplantation unit, Gale climbed out of the family van, gave his wife a quick goodby kiss and jumped into his own car--a red 1961 Mercedes-Benz convertible bearing the custom license plate RPG.
The top down, Gale sped the wrong way down a lane of parked cars. Amused by the fearful look of his fellow passenger, Gale flashed his most charming grin.
“You pay attention to that,” he said, pointing defiantly at the huge “Wrong Way” sign overhead, “and you’ll never find a cure for cancer.”
By his own telling, Robert Peter Gale is not a man who likes doing things by other people’s rules.
It is one of Gale’s self-described “affectations,” for example, that, instead of wearing shoes and socks, he likes to wear wooden clogs. He wears them in the operating room; he wears them at social functions. He even wore them, he is fond of pointing out, when he went to the Kremlin to meet with Soviet leader Mikhail S. Gorbachev in 1986.
Such an outward sign of defiance marks an inward “unwillingness,” as he calls it, “to compromise” his own standards for those of anyone else.
Gale likes to tell a story about when he was in Brazil treating patients and trying to get antibiotics and other pharmaceuticals shipped in from the United States. The drugs finally arrived only to be mislaid. Meanwhile, the customs official on duty was closing shop for the weekend. Gale not only forced the official to reopen his office, he also personally searched for the missing drugs until they were found and dispatched to the hospital.
“I find this kind of thing maddening,” Gale said, recalling the situation. “Now I can either wait for the bureaucracy or I can get in the car . . . and go do battle with the customs official myself. That’s, of course, what I did. You can imagine that this kind of behavior doesn’t make you very popular.
“If you were to take these personality traits that I have . . . this unwillingness to compromise . . . (and) put them in someone less intelligent than I am, you could have a problem. . . .
“In another profession,” Gale said, smiling, “these traits might be considered a personality defect.”
His friends and acquaintances find these traits admirable. “He’s the most extraordinarily modest man . . . considering his accomplishments,” said actor Michael York, who has become quite friendly with the Gales in the last few years. “What courage he has . . . a man so settled with a wife and family . . . to shoot off to the other side of the world.”
Gale’s detractors--and there are surely as many of them--do not find his personality quite so endearing. “To say he is despised around here would be an understatement,” quipped one of his closest associates at UCLA.
“He has a compulsion to make himself bigger than he is,” remarked another colleague, one who has worked with Gale for years. “In a way it’s very sad because he would be famous anyway.”
Whatever criticism comes his way, Gale seems invariably prepared to handle it. In fact, he seems to encourage it.
On one hand, he is highly conscious about his own health. He begins each day with a brief series of Canadian Air Force exercises, followed by a 30-minute jog or swim. He insists that restaurants serve him bagels without butter or cream cheese, because, he explains, “they are the only bread I know of that is made without shortening. . . . And since every American male is at risk for heart disease, it seems a sensible thing to do.”
Tanned on Television
On the other hand, he spends more time in the sun than can possibly be good for anybody. Deeply tanned even in mid-winter, he tells, with considerable delight, a story about a recent trip to Washington where he was appearing on a televised “cancer summit” between the United States and the Soviet Union. Before the shooting began, Gale said, an official of the National Cancer Institute came up to him and insisted that Gale be more heavily made up than any of the other participants to disguise the color of his face because an oncologist who was so unmindful of the connection between prolonged exposure to the sun and skin cancer would surely give the lay public the wrong impression.
Gale is even inclined to a rebellious and eccentric view of his own religion. In deference to Tamar, who is his second wife, he speaks Hebrew at home with his children. The boy, Elan, 4, and the girls, Shir, 9, and Tal, 11, all have dual Israeli-American citizenship and “may one day have to fight in the Israeli army. Since they could be killed,” Gale said, he has spent considerable time showing his children examples of persecution of Jews, taking them, for example, to the sites of concentration camps in Europe.
He also makes a point of celebrating Purim, one of the minor Jewish holidays that goes unnoticed by most American Jews, simply because, he explained, “it is an example of the first recorded attempt at genocide.” But he shuns what he calls “the big leaguers” the High Holidays, Rosh Hashana and Yom Kippur, which emphasize morality and self-examination and celebrate God’s role as master of the universe.
Gale counts among his friends and the people he truly admires men who have been equally resistant to the rules that society has tried to impose on them. The person that Gale most often mentions is Dr. Armand Hammer, the celebrated international industrialist, art collector and philanthropist who paved the way for Gale’s 1986 trips to the Soviet Union.
“It’s probably dangerous for me to say I like men like Armand Hammer,” Gale said recently. “After all, Hammer is thought by some to be a flagrant self-promoter.” But, Gale continues in an obvious dig at the UCLA administration, “I cannot do as . . . some administrators . . . do. . . . I cannot compromise my support for someone just because they have been criticized.”
Even in his first years as a young intern at UCLA, Gale played by his own rules.
Having graduated from college and medical school two years earlier than most of his contemporaries, he went through a residency program in internal medicine, a fellowship in hematology and oncology, enrolled as a Ph.D. student in microbiology and immunology and became a member of the Medical School faculty--all within a short time. Only momentarily did he get himself into a jam and that was because a university regulation forbade faculty from getting degrees at their own campuses. Gale said he finessed that easily enough. He simply resigned, got his degree and resumed his job.
“In two years, he accomplished what it takes most people a decade . . . ,” said one of Gale’s long-term associates at UCLA.
Gale grew up in Flatbush, a predominantly Jewish, middle-class section of Brooklyn. He was a good enough student to go away to college at age 16 but was far too small to play football, which he wanted to do. He has one brother, two years younger, who is an experimental psychologist at the Department of Agriculture in Washington. Gale’s father, who changed the family name from Galinsky, had been a Wall Street broker and is now retired. His mother, from whom he believes he got most of his personality traits, died of cancer five years ago.
Gale did his undergraduate work at Hobart College, a small liberal arts school in upstate New York, and received his medical education at the State University of New York at Buffalo, a respectable but unremarkable medical school. Choosing UCLA to begin his medical career, however, was another matter, he said.
Believing it to be “among the foremost medical research institutes in the world,” Gale said he wanted an academic environment where there were relatively few patients to care for and where the opportunities for doing research at the cutting edge of medicine would be plentiful.
He had been at UCLA only a short time when he saw a chance to make a name for himself as well as for the institution. The idea was to do bone marrow transplantations.
Bone marrow is the spongy material inside the bone that acts as the body’s factory of blood, including immunity-producing white cells. Transplanting marrow from a healthy donor to a patient whose immune system had been destroyed by disease or radiation was a procedure first developed shortly after World War II. Because of the risks involved, however, it was being done in the 1970s at only a handful of places, most notably by Dr. E. Donnall Thomas at the Fred Hutchinson Cancer Research Center at the University of Washington in Seattle.
For Gale, the appeal of bringing a program like the one at Seattle to UCLA was enormous. It was dramatic, it was controversial. And, it was a relatively new, high-tech approach to some very old problems in medicine--namely a possible way of curing leukemia and other blood disorders.
From early in his career, blood diseases had been Gale’s primary interest and he was particularly interested in cancer of the blood--or more precisely, cancer of the bone marrow. He felt, as do many other researchers, that this form of cancer would be the first to be cured. The reason is simple. “You can take blood out of the body, study it, manipulate it, treat it,” Gale explained. “You can’t do those things quite so easily with a lung or a liver or a breast.”
A bone marrow transplant is a relatively easy process. A small quantity of marrow simply has to be drawn from a donor with large needles inserted into the bones of the pelvis. It is a painful though safe operation during which the donor is generally put under general anesthetic. Once the healthy marrow is obtained, it is filtered and then dripped into the bloodstream of the patient, in a process not unlike that of a blood transfusion.
The most difficult part is often finding a donor whose tissue matches that of the patient. Only a person with an identical twin is guaranteed a perfect match; a patient with only one sibling has a one in four chance of finding a suitable donor; someone looking for an unrelated donor faces odds closer to one in 10,000.
What happens after the transplant is complete is even more complex and requires luck as well the skills of a talented physician.
In the first days and weeks after the transplant, there is the worst danger of infection. Until the new immune system takes hold, the transplant patient has no protection against the outside world. Bacteria from the touch of a family member or from the taste of fresh fruit can prove deadly. In some cases, the new marrow will be rejected and the patient will be left utterly vulnerable to the most benign virus or bacteria.
And there is a further risk as well--something that was named graft-versus-host disease. In an ironic and ugly twist of nature, the new immune system can turn against the patient, attacking the body as if it were a mass of foreign tissue. What happens in such cases, as one of Gale’s colleagues puts, can be quite “unsightly.” The patient whose transplant fails will undergo what is all too often a grotesque and hideously painful death. Experts say a fifth to a half of the patients who go in for a bone marrow transplant will die sooner than they would have had they not had the transplant.
Unfortunately, for many victims of leukemia or other blood diseases, a bone marrow transplant may be their only hope for long-term survival. For the young Dr. Gale, it was the beginning of a very short road to fame.
And fame is what he got, in April, 1986.
As Gale tells the story, he was at home shaving one morning when he heard a fragmentary news report on the radio about a serious accident at a Soviet nuclear power plant north of Kiev. He briefly contemplated the matter. A radiation accident. Burns. Radiation sickness. If the accident were serious enough, the victims would face more than skin ailments, hair loss and vomiting; their bone marrow would be destroyed as well.
So he picked up the phone and called Hammer, who was chairman of President Reagan’s Advisory Committee on Cancer and, Gale knew, a longtime intimate of the Soviet leadership. Gale had met Hammer in passing in 1978, and got to know him better in 1984 on a medical trip to Israel.
These people in the Soviet Union, Gale told Hammer, may need bone marrow transplants. They may need his help, he said.
Within weeks, Gale’s assistance had been offered and accepted, as had the help of Gale’s boss at UCLA, Dr. Richard Champlin; Paul I. Terasaki, a UCLA tissue-typing expert; Dr. Yair Reisner, an Israeli collaborator of Gale’s who specializes in treating marrow to prevent rejection; and numerous American corporations and individuals who contributed millions of dollars worth of equipment and pharmaceuticals to help with treatment of the victims.
But everybody remembered Gale. He was the one who had organized the “international rescue team.” He was the one who was recognized on Soviet television as the American “hero.” He was the one who charmed reporters by recounting how he had had bagels flown from home to help him through the ordeal.
Today, Gale says the trip was as much of a political mission as it was a medical rescue--the first time a Western physician was invited by the Soviet Union to help cope with a disaster since World War II. In all, according to Soviet physicians, only 13 bone marrow transplants and six fetal liver cell transplant operations were done and some of them were completed before Gale and his colleagues even arrived. But Gorbachev had thanked Gale personally and the Soviet doctors invited him back.
A month later, Time magazine would report that Gale “entertains the prospect of earning both the Lenin and the Nobel peace prizes, but admits, ‘I’d like to get the Nobel--in medicine.’ ”
But that was not quite the response that UCLA was entertaining at the time.
By his own recounting of what happened in the spring of 1986, Gale did not receive the calls of congratulations from the UCLA administration that he might have expected. He did not receive the letters of commendation that he might have hoped for. There was virtual silence.
But, with all the tumult going on at the Medical School upon his return, the silence from Gale’s colleagues might have been hard to notice. TV crews, photographers, reporters--all were clamoring for his attention, Gale said, as he made his rounds as the attending physician on one of the cancer wards that month, a duty he and most every other doctor at UCLA has to fulfill once or twice a year, the rest of the time being devoted to research, occasional lectures and their own patients.
More quietly, there was action of another kind under way. It took place in closed-door sessions, but virtually everyone in UCLA’s School of Medicine knew about it and talked about it incessantly among themselves, according to those who were there at the time.
In the crush of attention after Chernobyl, it seems that Gale failed to dictate notes in the charts of the patients he was seeing. Other doctors and nurses noticed it and complained. Administrators and senior faculty contemplated what to do.
‘Breach of Ethics’
“It was widely regarded,” said one senior faculty member who had been in on some of the discussions, “as a serious breach of medical ethics.”
Charts are the way doctors communicate with one another about patients. They provide the detailed history of what procedures have been done, what tests have been run, what medications have been ordered and what has been administered. In the middle of the night, in the middle of a crisis, when the attending physician is not there or is busy with someone else or simply does not remember what has gone before, the charts are the critical guide to what can and cannot be done next to treat the patient, perhaps to save a life.
Having discovered what happened, or more precisely what failed to happen, during the month of June, administrators in Gale’s division took the matter before a meeting of senior faculty in the summer of 1986. According to several people who were there, the meeting had been called to consider Gale’s pending promotion from associate to full professor--a position that he was, at least on paper, more than qualified to fill. The matter was also turned over to an ad hoc ethics committee for investigation, officials in the administration have confirmed.
Recalling the situation recently, Gale said he had “of course” kept private notes on all his patients on index cards that he carried around in his pocket and eventually he did get around to dictating notes for the charts. Moreover, he argued, his failure to do this in a timely fashion happened only because of the unusual circumstances following his return from the Soviet Union.
“It’s not ideal,” Gale said recently, “but under the circumstances it was reasonable. Certainly the important thing is having seen the patients every day and having made the critical decisions.”
No Action Taken
Since it indeed appeared to be a one-time infraction of the rules, the ethics committee concluded that nothing should be done, according to Roy T. Young, who was until recently acting chairman of the UCLA Department of Medicine.
Moreover, those faculty members and administrators who were charged with considering Gale’s promotion concluded, at least for the time being, that Gale would not be made a full professor.
Votes by the senior faculty and ultimate decisions by administrators on promotion are confidential personnel matters, so the precise reasons that Gale’s promotion was held up have never been made public. But that wasn’t the first time Gale had been accused of overlooking university rules. Nor would it be the last.
Before he went to Moscow, Gale, by dint of his own personality and the volume of his writing, had already been a highly visible physician in his field.
“He has a very high profile,” said Dr. James O. Armitage, an oncologist and bone marrow specialist at the University of Nebraska. “Everyone knows of him. . . . He’s one of the smartest people in medicine. And he may be the best writer.”
Not only has he published in the best journals--Nature, Science, Lancet, the New England Journal of Medicine--he has written scientific articles at such a rate to astound even some of his prolific colleagues. “On the average of one article a week,” Gale said recently as he leafed through the 30-plus pages of his curriculum vitae.
“Three-hundred-seventy-six actually, as of Friday . . . another 53 in press, another 22 in process,” Gale said.
His special interests have been in treating various forms of leukemia with bone marrow transplantation. But he has also made inroads into the treatment of other blood disorders, such as aplastic anemia, a fatal disease in which the normal cells of the bone marrow literally disappear.
Realizing the limitations of standard chemotherapies and even the more radical bone marrow transplants, he, along with other researchers, have recently focused their attention on trying to understand the basic molecular underpinnings of certain cancers. In at least one form of leukemia, Gale and an Israeli colleague have written probably the most definitive article on the basic biology of the disease.
His Particular Gift
Gale’s most notable contribution has not been in the new assays he has designed or in the experimental treatments he has tried, many of his colleagues say. Rather, it has been his ability to make connections between the laboratory and the clinic and among various disciplines; to take the results of other people’s work, compare them, analyze them and make sense of all the contradictory data, often presenting definitive judgments about what all the research means for the actual practice of medicine.
“I am not the best molecular biologist in the world. . . . Someone who is as smart as me and had no other responsibilities could be a better physician. . . . My expertise, if I have one . . . is synthesis. . . . I see myself as a catalyst . . . putting together people who don’t see what it is they have in common and tackling an interesting question,” Gale said.
Dr. Mortimer Bortin, director of the International Bone Marrow Transplant Registry, credits Gale with making the registry what it is today, an extremely important resource for gathering and analyzing information from 150 transplant centers worldwide.
He certainly has long been a master at capitalizing on his successes.
In 1973 when Gale was just 28 years old, he performed his first bone marrow transplant on a 12-year-old boy dying of aplastic anemia. Two years later, he held a press conference to present the child to the world, along with a 48-year-old leukemia patient who had been transplanted only six months before. To this day, many of Gale’s colleagues at UCLA think that the publicity and optimism surrounding these two patients was unwarranted, given the risks inherent in the procedure.
The boy’s father, Ray Barba Sr., does not see it that way and is willing to have himself and his healthy, handsome son (who is now 28 years old) brought out for display “anytime Dr. Gale wants to call.”
In the summer of 1980, Raymond G. Schultze, who was then associate dean of UCLA’s Medical School, wrote a letter to the dean concluding that, in his opinion, the bone marrow transplant unit at UCLA, of which Gale was then director, was “guilty of violations of the regulations governing human subjects’ protection.”
The violations, he wrote, were “flagrant and may well be deliberate.”
“In my judgment,” Schultze concluded, “this behavior is detrimental to the School of Medicine and potentially this campus of the university.”
According to documents obtained from the government under the federal Freedom of Information Act, Schultze, who is now a vice chancellor and director of the UCLA Medical Center, was talking about allegations that Gale and other members of the bone marrow transplant unit had conducted experiments on patients without proof that the patients had full knowledge of what was being done to them and without approval of the university committee that oversees research on human subjects.
Word of the allegations reached the federal National Institutes of Health after an article on Gale’s troubles written by Paul Jacobs appeared in the Los Angeles Times on Dec. 27, 1980. In 1981, the NIH began investigating.
Whether the experimental treatments had worked or not (they were later proved to be not as effective as some researchers had hoped), NIH warned Gale that he must have approval from an established body of his peers before proceeding with any further experiments. It was also about this time that Gale relinquished his administrative duties.
Gale took then, as he does now, strong exception to these views. He always informs patients, he said, and none of the procedures called into question were “experiments” to his way of thinking. Even though they might have been new and largely untried, they were still the best treatment available for hopelessly ill patients, Gale said at the time.
“It’s a matter of intent,” Gale argued recently. Physicians, particularly talented physicians like himself, Gale said, must have sole authority to make decisions about patient care; such decisions should never be left in the hands of a committee.
To this day, few people at UCLA or at NIH have been persuaded by Gale’s arguments, according to Barber, UCLA’s vice chancellor for research.
The Medical School, in addition, has responded to other allegations against Gale, including one investigated recently that the parents of a boy who had been given an experimental fetal liver cell transplant in the late 1970s had never been informed of what was being done to their son. Again, an ad hoc ethics committee was put together and again an investigation undertaken.
The committee determined, according to Young, then chairman of the Department of Medicine, that Gale had not been in the wrong, that there had been consent.
What is somewhat more clear, at least to Gale’s critics, is the extent to which he has taken credit for things that he may not always deserve. His detractors are angered, for example, when they read in his new book, “Final Warning,” that Gale, who was long ago relieved of all administrative duties, says he is “director of UCLA’s program in transplantation biology"--a position that Dr. Richard Champlin said he has held since 1983.
“It’s a little difficult to explain,” Gale replied. He said that was an unofficial title he made up before the book was written and now no longer uses.
He also acknowledges that some Soviet doctors have also tried to distance themselves from him and discredit the effectiveness of bone marrow transplantation in the treatment of the Chernobyl victims.
Little Value Noted
In a report issued the summer after the Chernobyl accident, Soviet medical authorities concluded that the bone marrow transplants turned out to have little practical value and probably hastened the death of at least two patients. In future nuclear accidents, the Soviet doctors concluded, bone marrow transplants would benefit only a small number of patients exposed to a narrow range of radiation doses.
Gale does not entirely disagree with their assessment but he dismisses some of their thinly veiled criticism as mere political posturing by Soviet doctors who may be jealous of all the attention that he, as an American physician, has gotten. For instance, he said, the report overlooks the fact that the treatment was given only to patients who had no chance of surviving without it.
When he established his international “rescue team” to treat victims of the 1986 Chernobyl accident, Gale said, he knew it would be only a matter of time before it--and he--would be called into action again.
Indeed a call did come in the fall of 1987.
In September, there had been a bizarre and terrible radiation accident in Goiania, a small city in central Brazil. Two scavengers making their way through an abandoned medical clinic had come across a stainless steel cylinder, part of a forgotten cancer therapy machine. The device had been pried open and its contents, a luminescent blue powder, widely dispersed. People had rubbed it on their bodies and danced. They had used the glowing granules as night lights. Some actually ate it. In all, 244 people in Goiania came into contact with what authorities identified as a deadly radioactive isotope, cesium-137.
By the time Gale entered the picture, according to one of the physicians who was there, Clarence Lushbaugh of the Radiation Emergency Center Training Sites in Tennessee, several dozen victims had been hospitalized and 12 of the sickest patients had been airlifted from Goiania to a Brazilian Navy hospital in Rio de Janeiro. There the victims were treated by Brazilian military doctors and a radiation response team assembled by the International Atomic Energy Agency in Vienna. The team included two American doctors, Lushbaugh and another radiation expert affiliated with the World Health Organization, whom the Brazilian government had requested by name. Gale was not one of them.
Used Tourist Visa
Gale had gone to Brazil not on a government visa, but on a tourist visa. And, he later said himself, he had gone not at the request of the military doctors in charge but at the invitation of a personal friend, Dr. Daniel Tabak, director of the Brazilian National Cancer Research Center.
Tabak’s reason for wanting Gale, Gale said, was his access to the experimental drug GM-CSF. The drug, which some researchers believed could be of use in treating radiation victims, was being produced in the United States but was also available in West Germany where Gale happened to be at the time attending a scientific meeting.
Gale not only used the drug but took more credit for his activities than some of the Brazilians doctors seemed to think he deserved, according to various accounts that appeared in both the U.S. and Brazilian news media. Concerned about adverse publicity surrounding the visit, the UCLA Department of Medicine wrote letters recently both to Gale and to the head of the Brazilian hospital where the patients had been treated seeking details of Gale’s work.
Neither the department nor Gale has made public the letter or Gale’s reply, although department chairman Young said Gale’s response was “totally inadequate” and “didn’t clarify anything.”
As far as Gale is concerned, there is nothing to clarify. He brushes aside the adverse publicity as little more than petty rivalries among physicians and interagency jealousies among various branches of the Brazilian government.
As for as his use of GM-CSF, he said he obtained the substance from Europe and used it in South America, and thus was under no obligation to get approval from UCLA’s Human Subjects Protection Committee, as some of his colleagues have suggested. What’s more, Gale said, he was “probably” under no obligation to get approval from the U.S. government either, although, because “regulations in this area are somewhat unclear,” he did write a letter to the Food and Drug Administration informing them of his activities in Brazil.
Viewed as a Repetition
What troubles some people at UCLA is that Brazil was apparently not the first time Gale had used GM-CSF. According to letters and documents from the U.S. manufacturer of GM-CSF to the FDA, obtained by The Times, the first use ever of the drug was in the summer of 1986 after the other U.S. doctors had gone home and Gale had returned to the Soviet Union for a follow-up visit.
In the first letter, dated May 22, Sandoz Research Institute made an emergency “compassionate need request” on behalf of Gale for the use of GM-CSF. Such requests are permitted by FDA rules, although this came even before Sandoz had submitted results of animal tests to the agency in advance of seeking permission to begin human trials on the drug. Up to that point, the substance, which was derived from human cells, had been used only in experiments with monkeys, although it is now undergoing trials on cancer patients and AIDS victims.
It is not clear whether the agency replied to Sandoz or in what fashion, since the FDA is forbidden from commenting on the letters by laws protecting the proprietary rights of drug companies. The Soviet doctors involved could not be reached for comment.
However, in a follow-up letter dated Aug. 13, Sandoz told the FDA that it had supplied GM-CSF to Gale “for the experimental treatment of a minimum of three patients hospitalized with radiation-induced myelosuppression associated with the nuclear eruption at Chernobyl, U.S.S.R.” The company had received the “first preliminary report . . . from Dr. Gale” and, according to its synopsis of the findings, the drug had had little effect on the patients.
The official from the manufacturing company who wrote the letters has also refused to comment, saying only that “certain agreements” had been made that the matter would not be made public and that “Gale had been party to those agreements.”
Gale has never mentioned the use of the drug in either his scientific or popular writings on Chernobyl. When advised that The Times had obtained the letters from the manufacturer to the FDA, Gale declined to comment in detail.
“I cannot for my own benefit put other people at risk; I can take the heat,” he said. ". . . But keep one thing in mind. Obviously any drug would have to be given by Soviet physicians. I couldn’t ever go in and just set up operations. The hands-on work would have to be done by the Soviets.”
Wherever he goes, there are people who want to rub shoulders with Dr. Robert Peter Gale--people who seem to think they may benefit from his brilliance and his ability to make things happen. But there are others who want to distance themselves from him. The problem is that Gale’s notoriety and style run counter to some of the cardinal rules of medicine: that the business of doctoring should be a quiet, painstaking enterprise, one in which the patient is of utmost consideration and protocol is followed meticulously.
There is, of course, another side to medicine as well. It is that research at the cutting edge is fiercely competitive and inherently filled with risks. And there is what one UCLA professor calls a “good deal of strive and public backbiting, despite whatever image it is we would prefer to maintain.”
But Gale stands out in what is surely an almost uncanny ability to turn even the most adverse situation into a new opportunity. AFter the NIH reprimand, for example, Gale went to Israel for a yearlong sabbatical to retool himself as a molecular biologist. When UCLA tried to reduce his visibility on campus by eliminating his administrative duties, Gale took his interests in bone marrow transplantion to the International Bone Marrow Registry.
Gale has also become interested in the business side of medicine. As a paid consultant, he has advised a number of companies on how to set up clinical trials to test new drugs and what might be fruitful avenues of research in years to come.
For Gale, though, the most interesting question remains to be how to cure cancer, particularly leukemia, the cancer that he is now convinced more than ever will be the first to succumb to medical advances.
“Setting high goals is dangerous because sometimes you fail, but it has to be done,” he writes in “Final Warning.”
“What I’d like most is for someone to give me a large chunk of space and money, and tell me, ‘Do the job!’ I’d set up my own unit, take 10 very good people--I know who the best players are--and in five to 10 years we’d have a cure.”