BAD MEDICINE By Annette Stark

BAD MEDICINE
A new federal law has UC campuses reluctant to provide researchers with crucial patient data
By Annette Stark

http://www.lacitybeat.com/cms/story/detail/bad_medicine/1399/

John Ott formed Stand Together in the Fight in 2001, one year after his nine-year-old daughter was diagnosed with brain stem tumors, a rare brain tumor with an historically poor prognosis. It accounts for more than 10 percent of all childhood brain tumors, and Ott's daughter died within eight months of being diagnosed. And within three years, so did three other children in his Huntington Beach neighborhood. "All our families lived off the same street," Ott says. "Three of us still do."
Since founding the cancer advocacy group with neighbor Susan Junghans - whose child was also one of the four - Ott has worked to provide financial and emotional support for families dealing with this disease, as well as raising money for a cure. But, since April 2003, Ott has joined fellow cancer advocates in another fight - to insure that the California Cancer Registry continues to provide immediate information about cancer patients to researchers, as it has for the last 16 years.
To cancer advocates, this has now become an onerous task as a result of interpretations of patient privacy rights contained in the Health Insurance Portability and Accountability Act (HIPAA), a federal law passed in 2003. Since then, an increasing number of University of California campuses have become reluctant to comply with the Cancer Registry's requests for relevant data. On September 26, the San Francisco Chronicle reported that "citing the privacy rule, at least 17 Bay Area hospitals have imposed restrictions on the state Cancer Registry's accustomed rapid access to patient records."
The California Cancer Registry was created by an act of the state legislature in 1985, stipulating that all cancer cases must be reported to the Department of Health within six months of diagnosis for the purpose of providing qualified researchers with information to track incidents of the disease, study effective treatments, and locate patients who would be willing to participate in studies.
As cancer advocates indicate, HIPAA should not conflict with the Cancer Registry; HIPAA distinctly specifies that cancer is reportable, and excludes data mined for research from patient privacy protections. "There's a whole protocol for reporting and it's our position that it satisfies all legal and ethical privacy concerns," says Jim Knox, vice president of advocacy for the American Cancer Society. "To my knowledge there has never been a breach or a lawsuit."
"It worked without incident," says Dr. Dennis Deapen, who heads the Los Angeles Cancer Registry and is also president of the North American Association of Central Cancer Registries. "California researchers could identify new cases within four weeks of diagnosis, and most patients contacted were eager to participate."
"The people who turn down being in a study are few and far between," says Lloyd Morgan, a brain tumor survivor and activist with the Brain Tumor Action Network. "This is someone's last contribution, a chance to help."
Especially with cancers that might be genetically based, patients are eager to participate in research that might help other family members, particularly their children.
Despite this, Deapen says, "researchers requesting rapid access to data at UC hospitals have been turned away."
To those who devote their lives to studying diseases that can kill within three months of diagnosis, Rapid Case Ascertainment (RCA) is key. Scientists must have access to patient information cases where the prognosis is poor. "RCA is the gold standard for epidemiological work," Morgan says. In the event researchers would be denied rapid access, many with these kinds of cancers will have died before they can even become part of a study."
As regards patient privacy, Deapen maintains that the law is "wonderfully clear."
"It's appropriate about the balance between protection of privacy and how research must occur. We worked hard in L.A. to explain this to the hospitals."
But cancer advocates had their worst fears confirmed when a version of HIPAA panic turned up in Los Angeles in May of 2004, when West Hills Hospital denied Deapen access to non-cancer patient information he had previously mined for quality control - in other words, to ascertain that a hospital had not mistakenly omitted cancer patients in their lists. "They cited HIPAA as the reason, even though I communicated to them that this activity is in full compliance with state and federal law."
Unlike the 17 UC hospitals, West Hills has not changed its policy regarding rapidly reporting cancer patients. "Our issue is that we don't want anybody to have access to patients with other diseases," emphasizes Jessica Blue, West Hills' HIPAA officer and director of medical records. "We are happy to allow [Deapen] information. But there is a need-to-know provision from HIPAA and we feel that this surpasses his need to know."
Blue was unaware of the controversy that was brewing up north, but to Deapen, West Hills was the red flag signifying that other California hospitals were now getting on board with policies implemented by UC's. HIPAA privacy officer Dr. Maria Faer, who Deapen claims first misinterpreted HIPAA laws and now refuses to admit she got it wrong. Deapen says, "Dr. Faer continues to be the person in the UC system who is requiring the denial of access."
"I'm still trying to figure out what Dr. Faer's agenda is," Ott says. "I'm baffled about what she is trying to accomplish. It's like she wanders around, does her own thing and doesn't have to report to anyone."
Faer has explained that her agenda is privacy, telling the Chronicle of concerns about patients potentially being contacted by a researcher and learning they have cancer before being told by a diagnosing physician.
It's ludicrous, Morgan says. "It would be malpractice for a doctor to not have told the patient as soon as a diagnosis was confirmed. Also, you couldn't end up on the list unless there was a confirmed diagnosis."
When contacted by CityBeat, Faer insists that her concerns are misunderstood. "We want a time lag of four to six weeks from the point of biopsy by the treating physician," she says, "to make sure that a patient has had sufficient time to meet and confer with her physician."
The list of those who "misunderstood" includes the American Cancer Society, Brain Tumor Action Network, hundreds of cancer patients who faxed concerned letters to UC President Dynes, and numerous research scientists such as Deapen who says Faer just doesn't get it. "We already explained to her that the process for us to mine this data takes six weeks after diagnosis, under maximum speedy conditions."
While Faer admits she doesn't know of any reported privacy breaches, she maintains it's an irrelevant concern. "The electronic age exists and you don't put laws in place because there has been a breech. You put laws in place to prevent it. And I have asked over and over for examples of where research has been prohibited or harmed, and it hasn't."
According to Burt Cohen, director for the California Office of HIPAA Implementation, the state and the university have been talking about a simple proposal for making this all work. "I've been following it, and my understanding is that there has recently been an agreement." Cohen reveals.
Activists say the absolute necessity for all RCA to thrive has them holding their breath about any possible agreements in the works. To date, Morgan's list of studies that have been harmed, or delayed, or grants that were not applied for as a result of UC's policies, totals 54. CanCORS (the federal colon cancer study) is one glaring example. "The federal government picked the type of patients they wanted as a national total for this research and asked for scientists to compete," Deapen explains. "Five centers won, including mine, and Dr. Dee West in Northern California, who partnered with Harvard. Two of the five centers are in California. So the fact that they have been unable to identify patients in Northern California from those UC hospitals means the government isn't going to get their national total, the statistics they paid for, because one person at UC made the decision not to comply."
Published: 11/18/2004