Feud Over X-Ray Test Safety Divides VA Hospital Staff

A bitter feud, complete with charges of a cover-up, has erupted at a Southern California veterans hospital over allegations that dozens of patients taking part in research there have been exposed to risky dosages of radiation without their knowledge.

The controversy has pitted the top radiation safety officer and others at the Veterans Affairs medical center in Loma Linda against a cadre of doctors with a long list of research projects to their credit who say they have engaged in no ethical or medical improprieties.

The central allegation: that research participants over the last several years have been exposed to multiple rounds of radiation testing--of little or no medical benefit to them--and were not informed about the potential risks.

The two sides have agreed on little in the dispute. Among the contested issues:

* Were the patients subjected to dangerous levels of radiation?

* Were the patients fully informed of the potential risks of the research?

* Was an in-house review of safety concerns conducted impartially?

Those raising the red flags include a handful of specialists at the hospital.

A renowned radiologist worries that the radiation testing conducted on the eyes of research participants could cause cataracts. Another doctor refused to perform kidney exams on some study participants because of their frail conditions. A third physician said she quit her project because she “could not in good conscience” ask patients to submit to the risks of radiation exposure.

Fueling the imbroglio is Moussa Raiszadeh, who has a PhD in radiopharmaceutical science and is an unwavering whistle-blower on radiation safety issues.

His complaints have sparked an inquiry from the VA inspector general’s office in Washington, which said this week that it will send investigators to Loma Linda to explore the research allegations and other issues.

Seeking to quiet the controversy themselves, hospital officials Wednesday asked a physicist at the VA’s central office to review the research documentation. A hospital spokeswoman said, however, that the review would include no interviews with doctors, researchers or patients.

Raiszadeh has butted heads before with higher-ups during his seven-year tenure as the hospital’s radiation safety officer. And when his bosses retaliated by stripping his office of support staff, federal investigators ordered the hospital to pay him because it had created a “hostile work environment.”

Raiszadeh says he was further emboldened to play hardball because a federal review of the hospital in 1992 faulted the facility--and his own office--for radiation safety shortcomings.

So when Raiszadeh discovered last year that four radiation research studies involving patients were being conducted in his own building without his knowledge and approval, he pounced.

He reviewed the research protocols that outlined the study procedures. He examined the patient consent forms. And focusing on one specific study, he bluntly told administrators in a memo that the patients “did not have a clue” what was being done to them.

In short order, the four projects--two involving work on kidneys, another on tear ducts and a fourth on breast cancer--were halted by Raiszadeh and the head of the hospital’s radiation safety committee.

In challenging the propriety of the studies, Raiszadeh targeted two of the most prominent doctors at the facility. One heads the medical radiation department; the other chairs the hospital’s human research committee.

The incensed research teams reviewed one another’s work and concluded that Raiszadeh was misinterpreting protocols and data for procedures that were out of his professional expertise. He should stay the watchdog over occupational hazards of radiation use at the hospital--things like fickle X-ray machines and the tracking and disposal of radioactive materials, they said. In fact, they and federal regulators acknowledge, Raiszadeh does an outstanding job at that.

The hospital director agreed with the doctors, scaling back Raiszadeh’s authority to review X-ray research. In an interview, Director Dean Stordahl said that on matters of radiation testing on humans, he deferred to the expertise of MDs over a PhD.

Almost everyone hoped that the issue would die in-house. No patients have gotten ill from the research, the doctors say, and the VA didn’t need more bad publicity, given earlier revelations that its hospitals and other federal institutions had conducted secret radiation tests on patients after World War II.

The whole episode at the seemingly bucolic Jerry L. Pettis Memorial Veterans Affairs Medical Center--the flurry of angry memos, cold stares, tense exchanges and accusations between professionals--was, in the words of one hospital official, the sad result of “an unfortunate morass of misunderstandings.”

How Much Is Too Much?

The full risks associated with radiation exposure remain in some dispute in the scientific community. Some specialists assert that the dangers posed by repeated, low-dosage radiation in diagnostic procedures is fairly minuscule. It could be no more dangerous, they say, than living beneath power lines or in a high-altitude city like Denver.

But Raiszadeh, focusing chiefly on research using computed tomography, or CT, testing, to analyze kidney functions, thought he needed to blow the whistle.

Patients in that test, he said in a memo to the hospital brass, would be subjected to three “unnecessary exposures” of radiation, just for research’s sake. More troubling, Raiszadeh charged that patients were being subjected to seven times more radiation than the protocol called for because of researchers’ miscalculations.

For one test, he said, radiation reached a level of 5,900 mRads, which experts say is the equivalent of 230 routine chest X-rays.

The researchers bristled at Raiszadeh’s conclusions, saying he was miscalculating the figures. “In radiology, we were flabbergasted to read this thing,” one principal researcher said of the memo.

However, one pioneering British researcher, who reviewed Raiszadeh’s charges at The Times’ request, said she was shocked by what she read.

“This seems astonishing to me,” said Dr. Alice Stewart, a radiation epidemiologist credited with linking low-dosage X-rays on pregnant women to leukemia in their children. “How could these people have planned an experiment and not even consulted the radiation people to see if they were working in safe limits?”

She agreed with Raiszadeh that the Loma Linda researchers were using “an absurdly high dose” of radiation.

Closer to home, Raiszadeh found support from Dr. Thu-Anh Hoang, a Loma Linda VA neuroradiologist who was a principal investigator in one of the kidney studies.

In a memo to the head of radiology, she said she quit the project partly because of concerns that an older, slower scanner was spitting out higher dosages of radiation on patients who already were being subjected to multiple rounds of X-rays.

She also complained that the amount of contrast fluid--a toxic dye pumped into the veins to track circulation--exceeded standard levels.

Concerns about the amount of radiation being directed at patients have also been raised by Dr. Ross Adey, a radiation expert who has since retired from the VA as its head of research. While serving on a committee that reviewed the tests, he concurred with colleagues in blessing the tear duct study.

He says now that he has “very mixed feelings” about that decision because of the possibility of patients developing radiation-induced cataracts.

“More and more,” he said in an interview, “the evidence is pointing to the idea that there is no threshold [for safety] with ionizing radiation. It’s cumulative, and there is no necessarily safe dose.”

But other doctors at the Loma Linda VA--including members of the human research committee, which reviewed the projects--dismiss concerns that radiation levels administered during the hospital’s research were unsafe.

“Clearly there is no evidence supporting the . . . allegation that human subjects had been exposed to either unnecessary or excessive radiation,” the committee concluded.

A Question of Consent

The issue of radiation dosage--a dizzying discipline of arcane measurements--is probably lost on patients who must rely on doctors’ warnings and advice about what is in store for them.

To that question, Raiszadeh and others believed that the patients in these research studies were not properly informed of the amount of radiation they were being subjected to so they could intelligently give their consent.

Indeed, in the patient consent form for the tear duct study, there is no reference at all to the dangers of radiation noted in the section titled “Potential Risks of Study.” Although the VA notes in other reports that “radiation is generally acknowledged to be harmful,” the only risk noted in the tear duct study is the possibility of swelling or redness of the eyes caused by a testing fluid.

That omission bothers some doctors, including Stewart, the British researcher.

The fact that exposure to radiation can increase the chance of cancer many years later “should have been made clear,” she said.

Hoang, the Loma Linda doctor who quit her research project, voiced similar concern. Knowing what she knew about the work, “I could not in good conscience obtain an informed consent from the patient in that context,” she wrote in a hospital memo.

A doctor who left the VA last year after participating in the research said that even when some patients seemed willing to join the project, he felt compelled to intervene. He refused to test three kidney patients who he said were too frail to withstand the exams.

He said that when he voiced his concerns to researchers, “they raised hell.”

The radiologist, who requested anonymity, said that he began briefing participants on his own about the potential dangers of the studies--and that a few would-be participants then dropped out.

“You’re scaring the patients,” he quoted one of the researchers as protesting. That doctor--Paul Hammond, a kidney specialist who heads the human research committee--said he had only vague recollection of the exchange but acknowledged: “That is the sort of debate that goes on between professional people.”

Although some doctors worry that patients were given insufficient information on the research project, one hospital employee said some seemed to have been given none at all.

The employee, who is familiar with the research testing process and did not want to be identified, said that two patients arrived without having even signed consent forms and that five others out of the group of 20 or so seemed to have no understanding of what they were participating in, based on their discussions.

Another patient, Jim Long, a 52-year-old veteran of the Vietnam War, said he knew he was a “guinea pig” of sorts in a kidney study. He said he was nervous, but the doctor “put my mind at ease completely.”

When told by a reporter that some doctors have raised concerns about the exposure levels, Long became alarmed. “It bothers me,” he said. “If it’s gonna hurt me, what’s the deal?”

Defenders of the research say the radiation dosages used in the tests are so low as to not require mention in the patient consent forms.

Asked why the risk of radiation exposure was not mentioned in one detailed consent form, one key researcher responded: “There was none.”

Review Panel’s Makeup

One of the hottest arenas of conflict is whether the allegations of risky radiation and inadequate consent were thoroughly investigated by the hospital.

Raiszadeh thinks not. “They investigated themselves,” he said. “They are trying to cover it up.”

The human research committee, which reviewed the matter, was headed by Hammond, who played a role in two of the controversial research projects.

To assist, he invited four “independent experts” to serve as consultants. Not only were all four employed by the hospital, but three were directly involved in the research and were asked to review one another’s work. The fourth was Dr. Samuel Ing, who was asked to assess the tear duct study that his boss in nuclear medicine helped pull together.

While Ing blessed his superior’s work, he said in an interview that the review was a “rush job” done in a single morning and agreed that the appearance of professional conflict could taint his conclusions.

“I would have chosen somebody else [to do the review],” he said. “It would have been more objective, wouldn’t it?”

Asked whether he felt pressured to bless the research, Ing responded: “If I didn’t come up with a positive finding, it wouldn’t have been used.”

Raiszadeh bristled that the research he questioned was reviewed by the very group of doctors who were doing the research.

But Hammond, the committee head, has not given an inch to Raiszadeh, and is said to be bitter over Raiszadeh’s persistence. “No patients have had excessive radiation exposure at all,” he said. “We want to put this to sleep because it’s a nonissue.”

Stordahl, the hospital director, agrees.

“The issue about the four research projects is closed in my mind,” he said.

Previous Shortcomings

The issue is not closed in the minds of federal inspectors who in past years have chastised the hospital for shortcomings in its research and radiation safety practices, according to audits obtained under the Freedom of Information Act.

Five years ago, investigators determined that the facility had suffered “a breakdown” in its radiation safety program. Inspectors cited improper storage of radioactive waste, improper calibration of X-ray machines and failure to check the integrity of safety equipment.

“As a result, the facility cannot ensure that radiation exposure to patients and employees is minimized,” the audit concluded, saying improvements were essential.

The next year--1993--Raiszadeh complained to the Nuclear Regulatory Commission about new safety problems at the hospital. The hospital brass, Raiszadeh said, punished him for his efforts by stripping him of his only two employees and otherwise intimidating him in his work.

He complained to federal authorities and, in 1995, the U.S. Labor Department concluded that hospital administrators did appear to create “a hostile work environment” for Raiszadeh.

Moreover, Labor Department investigators found that hospital officials then apparently tried “to mislead us and Dr. Raiszadeh” about how his authority was undercut. The VA was ordered to restore Raiszadeh’s authority and pay him compensatory damages.

The hospital has been scolded for problems beyond those involving radiation.

A 1993 audit by the VA inspector general disclosed a wide range of abuse by an unidentified genetics researcher. He began the project before it was approved, and many of the people who took part in it never gave proper consent, the report found.

The VA’s medical director pledged at the time that human research participants would be given the appropriate medical information and give their consent before such work proceeded.

Raiszadeh, however, does not think much has changed. And the current controversy is particularly frustrating because, he said, he is attempting to follow the inspector general’s recommendation that he broaden his oversight.

“If I was adequately convinced that patient safety . . . was safeguarded, I would have dropped this issue on the first day,” he said. “I want to do my job. If I don’t report this, there is no one else who would.”

Times medical writer Thomas H. Maugh II contributed to this story.

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Charges of Radiation Exposure

Moussa Raiszadeh, radiation safety officer at the Veterans Affairs hospital in Loma Linda, has charged that patients there have been exposed to multiple rounds of radiation for research, without being informed of the potential risks involved.

In a Jan. 28 memo to the hospital director and chief of staff, Raiszadeh aired his concerns over a series of human research projects, reserving his harshest criticism for a study comparing how different forms of radiation can be used to diagnose kidney ailments.

The hospital’s human studies subcommittee (HSS) refuted the allegations by Raiszadeh, the hospital’s radiation safety officer (RSO), in a March 20 memo, saying it had explored the charges and found them baseless. Raiszadeh claims the committee’s review was biased because of the investigators’ own involvement in the research.