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, California.
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, Alabama.
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The big question
The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration (FDA) 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.
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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.
Role of manufacturers
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 New York 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.
FDA initially unaware
The FDA was unaware of the magnitude of those overdoses until The New York 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.
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.
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. None of the overdoses can be attributed to malfunctions of the CT scanners, government officials say.
No full picture
At Glendale Adventist Medical Center, where Reyes and nine others were overdosed, GE instituted a new procedure to get quicker images of blood flow. But employees still made mistakes.
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. New York Times News Service