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Medical privacy law said to be chilling cancer studies Scientists fight for fast access to patient files

Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)


Posted on: 09/26/2004

Medical privacy law said to be chilling cancer studies Scientists fight for fast access to patient files

Sabin Russell, Chronicle Medical Writer
Sunday, September 26, 2004

For 16 years, California's Cancer Registry has been dutifully logging the names and addresses of all state residents who come down with the dreaded disease, their type of cancer and whether they live or die.

Researchers at universities across the country mine that data, searching for clues to cancer's causes and possible cures. Using registry records, the scientists call patients, recruiting them for surveys, studies and even clinical trials comparing new drugs or therapies.

Since April 14, 2003, however, a new federal law designed to protect the privacy of medical records has made it harder, if not impossible, for medical researchers in the United States to troll through patient charts, whether they are trying to unravel the riddle of cancer or studying complications in childbirth.

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 door kind of slammed in our face," said Dr. Dee West, chief scientific officer for the Northern California Cancer Center, which collects data in the Bay Area for the state registry.

In the view of some researchers, this interruption in the flow of information has irreparably harmed major cancer studies -- including a $35 million National Cancer Institute project comparing outcomes and quality of life of colon and lung cancer patients. Enrollment of Bay Area patients has slipped off schedule, while money to cover recruiting efforts is running out. "I'm not sure we will be able to complete the study," said West.

The problem is not limited to cancer studies, or to California.

"What we have on our hands is a mess," said Dr. Roberta Ness, who heads the epidemiology department of the University of Pittsburgh Graduate School of Public Health.

At the American College of Epidemiology annual conference in Boston earlier this month, Ness led a forum on the effect the privacy rule is having in the field. "In the research community, it's an incredibly widespread concern," she said. "I think the public is almost entirely unaware of it."

Ness has felt the impact of the privacy rule on her own studies of preeclampsia, a dangerous condition in pregnancy that can threaten the life of both mother and newborn.

It used to be that Ness could station research assistants at medical clinics, where they would flip through patient records for women who might qualify for a study. Today, access to the records is blocked, and researchers can only contact patients referred by clinics after they have signed a package of legal documents so imposing that many women, according to Ness, refuse to even read it.

Before the privacy rule came into effect, Ness was enrolling 10 women a week. "During the first four months, we were shut down altogether. Now we are enrolling five a week -- half speed," she said.

Susan Ehringhaus, attorney for the Association of American Medical Colleges, said three-quarters of the researchers polled in a recent survey reported that both patient recruitment and access to data had been affected by the privacy rule.

In the Bay Area, the controversy centers on a process that allows epidemiologists to inspect pathology reports quickly after a cancer diagnosis. The process, formally known as "Rapid Case Ascertainment," is aimed at picking up cases of the most aggressively fatal tumors -- such as brain tumors and lung and pancreatic cancers.

"We study a disease that kills you in three months. If we wait a year, we won't have any subjects to study," said UCSF cancer epidemiologist John Wiencke.

He worries that privacy concerns will jeopardize a forthcoming survey, set to begin in December, of African American lung cancer patients. The purpose of the $7.5 million study, another National Cancer Institute project, is to search for reasons why blacks in the Bay Area have a higher risk of lung cancer than other racial and ethnic groups in the region.

Dr. Dennis Deapen, president of the North American Association of Central Cancer Registries, said Rapid Case Ascertainment is "the gold standard" for cancer epidemiology.

"If you miss the rapidly fatal patients, you miss the patients of most concern," he said.

Yet to the chagrin of many of its world-renowned researchers, UCSF became the first California institution to block rapid access to patient records, citing the privacy rule. The administration's policy was quickly embraced by the University of California Office of the President, which ever since has been battling the state Cancer Registry -- and many of its own scientists. UC officials argue that the privacy rule no longer allows the registry "unfettered access" to patient records at its medical school hospitals.

"We're putting our patients as our priority," said Maria Faer, who is responsible for compliance with the statute throughout the UC system.

Faer contends that, in a new age of electronic medical records, there is a risk that a cancer patient might learn of his or her diagnosis first from a medical researcher recruiting for a study, rather than from a doctor. She wants to negotiate what she calls "a reasonable lag time" -- barring contact until four to six weeks after diagnosis -- to assure that such an accidental disclosure does not happen.

UC lawyers also maintain that there is nothing in state law that requires university hospitals to provide cancer records in less than six months, and that the Cancer Registry has no right to review the charts of patients who do not have cancer -- something the Cancer Registry has done routinely when it conducts "quality control" audits to be sure a hospital is accurately reporting all cancer cases.

"We don't want to cripple research," said Faer. "The question is, how can we do this better, and make sure our patients can be protected?"

Critics say the notion that a researcher would deliver the bad news of a cancer diagnosis is purely hypothetical.

In practice, physicians are contacted before any effort is made to recruit a patient. "Researchers have been very good about protecting privacy," said Dr. Robert Hiatt, director of population sciences at UCSF. "This is a case of fixing something that was not broken."

William Wright, chief of cancer surveillance for the state Department of Health Services, said the registry needs to perform periodic audits of all patient charts to be sure that all cancer cases are being counted.

"It's not good enough for scientific work," he said. "Things have to be verified."

In an exchange of letters with the UC legal staff, state health department attorney Roberta Ward wrote in January that the Rapid Case Ascertainment program preferred by researchers did not conflict with either federal or state laws. Richard Campanelli, director for Civil Rights at the federal Department of Health and Human Services, who is responsible for compliance and enforcement of the privacy rule, also sees no problem.

Campanelli said there is nothing in the federal rule that would block Rapid Case Ascertainment: "It was designed so that it would permit research to go forward, and would protect privacy."

In her letter, Ward warned UC that the state health department is authorized to levy fines of $500 a day against individuals or institutions that deny the Cancer Registry access to a patient's record.

Alarmed by the specter of one giant arm of state government imposing penalties on another, the state health department and UC officials have been engaged in extensive discussions of the issue -- without resolution.

Responding to complaints from constituents, Rep. Barbara Lee, D-Oakland, requested an explanation of the controversy from UC President Robert Dynes.

In a July 22 response, Dynes defended the university's stance, writing that the federal law has "caused institutions and individuals to question historical practices that could be in violation of patient privacy." The university's objections to allowing rapid access to patient records, he said, "have been both legal and ethical."

University administrators deny that research has been harmed. Faer acknowledges that there was a delay in the reporting of cancer cases from UCSF, but said that medical center is currently providing a list of cases to the registry well within the six-month time frame that she maintains is set by law.

Kaiser Permanente, with 11 hospitals in the Bay Area, also has refused to allow the Cancer Registry direct access to its medical records, but is voluntarily reporting all cancer cases every two weeks. Dr. Phil Madvig, associate executive director of the Kaiser Permanente Medical Group, said there were both legal and social obligations to provide cancer data to the state.

However, he said the Cancer Registry's demand to review all pathology records oversteps its authority.

"The broad review of data is not something they are entitled to," he said. "It violates the privacy of patients who do not have cancer."

Several Bay Area hospitals, citing the privacy rule, have taken similar stands, including Good Samaritan Hospital in San Jose and Alta Bates Summit Medical Center in Berkeley.

Officials at Good Samaritan insist they are submitting cancer pathology reports promptly to the Cancer Registry, but acknowledge they no longer allow the state to view all records directly. Alta Bates Summit also said it is cooperating; according to the Northern California Cancer Center, the Berkeley hospital provides timely access to pathology reports, but not to the addresses and telephone numbers of patients named on those charts.

"There is a state mandate to report, and a federal mandate to protect privacy. That's kind of a Catch-22," said Pam Davis, director of oncology services at Alta Bates Summit. "The reason these issues have come up is that we are all trying to do the right thing."

Under pressure from researchers and patient advocacy groups, the state health department's patience appears to be wearing thin. "The law is extremely clear on this. The state or its representatives are to be allowed access to these cancer records," said Dr. Kevin Reilly, deputy director for prevention services.

Faer's office at UC had submitted a draft agreement to the state that would lay out conditions under which the Cancer Registry could obtain records promptly. But Reilly called such an agreement "unnecessary." He said that if the state cut a deal with one institution, it would have to negotiate similar deals with every hospital in the state.

"We do understand that the law allows for fines, and we will consider pursuing those avenues if need be," he said. "We want to resolve this as soon as possible."

Reilly's sense of urgency is shared by Lloyd Morgan, a brain tumor survivor. The retired Berkeley electronics engineer knows firsthand the emotions of a getting a medical death sentence. Miraculously, after emergency surgery nine years ago, he recovered.

"People with a brain tumor are at great risk of dying shortly, and they desperately want to understand what happened to them," said Morgan. "The last contribution you can make in your life may be to participate in a study."

This week's question:
Should researchers' previous access to private medical records be restored?
-- Yes. Adjust for the privacy law's unintended negative effect.

-- No. Law strikes a balance with an acceptable cost.

Vote at

Last week's results:

Is John Kerry on the right track in his condemnations of President Bush and his policies?

-- He's hitting the mark and using the right tone.3%
-- He needs to specifically outline his policies and attack less.19%
-- He needs to turn up the heat on the president even more.78%
Total votes: 1,874

E-mail Sabin Russell at

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