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.
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.