Patient Privacy Issues at Heart of Vaccine Safety Inquiry
An aggressive effort by Rep. Dan Burton (R-Ind.) to investigate whether childhood vaccines can cause autism has set up a political showdown over the medical privacy of 8 million HMO patients, more than 6 million of them Californians.
Scientists said Thursday that the public-private research partnership set up to protect all Americans from deadly diseases and bioterrorist attack could be undermined if Burton subpoenaed the project’s huge database.
Rep. Henry A. Waxman (D-Los Angeles) urged Burton in a letter Thursday “to reverse course.”
But Burton made no such promise. “While I am not poised to issue a subpoena at this time, I will not foreclose my right to do so at some point if events warrant such action,” he said in a response.
Burton’s letter criticized the vaccine project’s methods. He said he was waiting to see if the “research procedures” to be used in a compromise offered by the Centers for Disease Control and Prevention would be acceptable.
The CDC has said it could allow independent researchers to analyze the project’s data at the National Center for Health Statistics in a way that would not violate patient confidentiality. The partnership is called the Vaccine Safety Datalink Project.
Burton, who has a grandchild with autism, has conducted numerous hearings on vaccine safety as chairman of the House Government Reform Committee. Vaccine safety researchers and government scientists said Burton’s continued involvement could have an “incredibly broad impact” on public health.
“These issues need to be resolved in the scientific arena, not the political arena,” said Dr. Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins University in Baltimore.
Burton first asked the CDC in November 2000 to turn over the vaccine project’s records.
CDC officials refused, citing the strict privacy agreements it has with eight large health-maintenance organizations and the HMOs’ confidentiality contracts with their members.
Since 1991, the project has used the HMOs’ computerized medical records to watch for vaccine-related health problems and improve the safety of the 12 vaccines, delivered in 20 shots, administered to most American children by their second birthday.
Large databases have always been needed for public health research, “but with Sept. 11 and the threat of bioterrorism and the need for vaccines [for] anthrax and smallpox, it’s even more critical,” said Dr. Steven Black, co-director of the Kaiser Permanente Vaccine Study Center in Oakland.
Burton’s campaign has set up “a lose-lose situation for the country,” said Dr. Robert Chen, chief of vaccine safety and development activity for the CDC’s National Immunization Program. If the confidentiality of the patient records is breached, he said, HMOs would no longer participate in the vaccine safety project and public health would suffer.
Burton first rejected the CDC’s offer to set up an outside, confidential process to allow independent researchers to analyze its data.
In February, almost a year after the private Institute of Medicine found no link between autism and the measles-mumps-rubella vaccine, Burton’s committee drafted a subpoena for “all records collected” by the CDC’s vaccine safety project. The CDC and the National Institutes of Health have begun their own studies to determine if the MMR vaccine can sometimes cause autism, a severe and increasingly common developmental disorder.
While autism’s cause is unknown, most scientists believe there is a genetic basis for the disability, which afflicts about 1 million American children and adults.