Get unlimited digital access to baltimoresun.com. $0.99 for 4 weeks.
Health

FDA investigating radiation overdoses

When Alain Reyes' hair suddenly fell out in a freakish band circling his head, he was not the only one worried about his health. His co-workers at a shipping company avoided him, and his boss sent him home, fearing he had a contagious disease.

Only later would Reyes learn what had caused him so much physical and emotional grief: He had received a radiation overdose during a test for a stroke at a hospital in Glendale, Calif.

Other patients getting the procedure, called a CT brain perfusion scan, were being overdosed, too—37 of them just up the freeway at Providence St. Joseph Medical Center in Burbank, 269 more at the renowned Cedars-Sinai Medical Center in Los Angeles and dozens more at a hospital in Huntsville, Ala.

The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months the agency has yet to provide a final report on what it found.

But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage.

The review also offers insight into the way many of the overdoses occurred. While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them.

The Times found the biggest overdoses at Huntsville Hospital—up to 13 times the amount of radiation generally used in the test.

Officials there said they intentionally used high levels of radiation to get clearer images, according to an inquiry by the company that supplied the scanners, GE Healthcare.

Experts say that is unjustified and potentially dangerous.

The FDA was unaware of the magnitude of those overdoses until The Times brought them to the agency's attention. Now, the agency is considering extending its investigation, according to Dr. Alberto Gutierrez, an FDA official who oversees diagnostic devices.

Growing number of cases

So far, the number of patients nationwide who got higher-than-expected radiation doses exceeds 400 at eight hospitals, six in California alone, according to figures supplied by hospitals, regulators and lawyers representing overdosed patients. A health official in California who played a leading role in uncovering the cases predicts that many more will be found as states intensify their search.

The FDA acknowledges, that the number does not capture all the overdoses.

Even when done properly, CT brain perfusion scans deliver a large dose of radiation—the equivalent of about 200 X-rays of the skull. But there are no hard standards for how much radiation is too much.

For a year or more, doctors and hospitals failed to detect the overdoses even though patients continued to report distinctive patterns of hair loss that matched where they had been radiated. After the FDA issued a nationwide alert asking hospitals to check their radiation output on these tests, a few hospitals continued to overdose patients for weeks and in some cases months afterward, according to records and interviews.

Four of the hospitals involved were identified in recent months: LAC + USC Medical Center, where one patient received seven and a half times the amount generally used; Bakersfield Memorial Hospital, where 16 people received up to five and a half times too much; South Lake Hospital in central Florida, where an unknown number of patients received 40 percent more than usual, and an as yet unidentified hospital in San Francisco, government officials said.

None of the overdoses can be attributed to malfunctions of the CT scanners, government officials say.

At Glendale Adventist Medical Center, where Reyes and nine others were overdosed, employees told state investigators they consulted with GE last year when instituting a new procedure to get quicker images of blood flow, state records show. But employees still made mistakes.

As a result, hospital officials said, a feature technicians thought would lower radiation levels actually raised them. Cedars-Sinai gave a similar explanation.

The FDA, in trying to assess the scope and cause of the overdoses, has had to rely on state radiation control officials for information. But if the state of Alabama is any indication, the agency is not getting a full picture.

A Huntsville Hospital spokesman, Burr Ingram, said that about 65 possible stroke patients there had been over-radiated. Lawyers representing patients say the number of overdoses is closer to 100.

Nonetheless, Alabama officials say the number is actually zero since the state does not define an acceptable dosing level. "No such thing as an overdose," said James L. McNees, director of Alabama's Office of Radiation Control.

A hospital's low moment

One day last August, the radiation safety officer at Cedars-Sinai, Donna Early, decided she had to act.

It was a low moment for such an esteemed institution. Patients were being over-radiated during CT brain perfusion scans, hospital officials concluded, and it was Early's job to tell county health officials.

The genesis of Early's alert was an event on the morning of July 4, when a 52-year-old executive producer of films, H. Michael Heuser, arrived in the emergency department with stroke symptoms.

A "code brain" was immediately called, signaling a life or death situation. A blood clot in the brain can be dissolved with medicine, but doctors must do it within several hours, before brain cells die from a lack of oxygen. So Heuser was rushed into a room with several CT scanners, where he underwent one brain perfusion study and at least one more later. A CT perfusion scan, which lasts about 45 seconds, can identify a stroke through a series of blood flow images.

Heuser did have a stroke, from which he would recover. But other parts of his body inexplicably began to break down.

"I had a full body rash, my whole body, legs, armpits, bottom, my back, with these red welts," Heuser said.

It burned and itched. Then clumps of hair began to fall out. "I went completely bald in a perfectly symmetrical 4-inch wide band that extended from ear to ear all the way around my head," he recalled. The hospital, he said, responded by offering him a hair piece.

Finally, a doctor was so struck by the unusual nature of Heuser's hair loss that he took a picture. A second patient reported similar hair loss. Eventually, the hospital made the connection, and on Aug. 28, Early called country health officials, records show. From then on, as the accounting of overdoses reached 269 over a period of 18 months, Heuser would be known in government reports simply as "Patient 1."

To this day, no one at Cedars-Sinai knows who programmed the scanners that delivered the overdoses, officials there say. But in written statements to The Times, hospital officials said they had figured out how they might have occurred.

Normally, the more radiation a CT scan uses, the better the image. But amid concerns that patients are getting more radiation than necessary, the medical community has embraced the idea of using only enough to obtain an image sufficient for diagnosis.

To do that, GE offers a feature on its CT scanner that can automatically adjust the dose according to a patient's size and body part. It is, a GE manual says, "a technical innovation that significantly reduces radiation dose."

At Cedars-Sinai and Glendale Adventist, technicians used the automatic feature—rather than a fixed, predetermined radiation level—for their brain perfusion scans. But a surprise awaited them: when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose—it raised it.

As a result, patients at Cedars-Sinai received up to eight times more radiation than necessary, while the 10 over-radiated at Glendale received four times too much, state records show.

GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had "limited utility" for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain.

GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens.

But representatives of both hospitals said GE trainers never fully explained the automatic feature.

Manufacturers say they will address some of these issues in newer models.

Form letter, no apology

Huntsville Hospital informed patients that they had been overdosed in a two-page form letter that included no apology. The word radiation was mentioned once—in the ninth sentence.

"We have identified a few patients, including you, who received a scan in which the dosage level was elevated," stated the letter, dated Dec. 11, 2009.

The acknowledgment by hospital officials that 65 people were over-radiated has come slowly.

After the California overdoses became public, Huntsville officials reviewed their testing and determined that their use of higher doses to get clearer images was not a mistake and was, in fact, appropriate, according to the GE inspection report. Therefore, they concluded that they had no overdoses.

State and federal officials said they did not investigate Huntsville, because there were no equipment malfunctions or because the dosing decisions were considered part of the practice of medicine. As a result, the only public accounting of the number of overdoses in Huntsville has come from the hospital, not government inspectors.

By contrast, California officials conducted investigations, released inspection reports and have cited at least four hospitals for failing to safely irradiate patients.

Because Huntsville Hospital officials declined to be interviewed, it is unclear how they determined who had been over-radiated, when the overdoses started or why patients with sudden hair loss did not arouse more suspicion.

Huntsville Hospital officials said they did not routinely record radiation dose levels before 2009. Ingram, the spokesman, said the hospital did keep information needed to calculate the dose, but he declined to say whether officials had gone back to determine doses for all patients who had brain perfusion scans.

The form letter Huntsville sent to overdose patients appears to play down the damage high doses can inflict. The hospital told patients that hair loss and skin redness might occur, but would go away. "At this time, we have no recommendations for you to have any follow-up treatment," the letter said.

Health experts elsewhere have warned of possible eye damage, in addition to the higher risk of cancer and brain damage.

Copyright © 2015, The Baltimore Sun
Related Content
Comments
Loading