October 26

University of California Seeks to Ease Curbs on Patient Protection in Research – LA Times

August 7, 2002

University of California Seeks to Ease Curbs on Patient Protection in Research – LA Times


Thanks to a series of articles, in the San Francisco Chronicle and Los Angeles Times, the public has been made aware about the back-door efforts to pass a bill in California that would circumvent federal regulations and state law requiring court appointed surrogates for research involving incapacitated patients. As Sunday’s front page article in The Chronicle noted:

“By considering the legalization of proxy consent by relatives, state legislators are grappling with one of the most sacred principles that have governed research on human subjects since the end of World War II….the Nuremberg Code established that no human being should undergo experimentation without giving fully informed consent.”

The bill, AB2328, would allow surrogates–who have no legal authority or responsibility– to give consent to medical experiments on behalf of an incapacitated relative. Both federal regulations and California law protects such persons from unwanted research that may be contrary to their best interest. California’s Medical Experimentation Act requires that only a “legally authorized representative” may give consent to research that is expected to “maintain or improve” the condition of the incapacitated individual. However, an investigation by the Office of Human Research Protection (OHRP) found that the University of California, San Francisco violated informed consent requirements –both of federal regulations and state law. The experiment compared two methods of air ventilation.

At the start of the experiment the investigators on the basis of studies of animals and human cases had reason to believe that one–

low volume ventilation–would save more lives than high volume. From OHRP’s criticism, it appears that those who consented on behalf of acutely ill patients were not informed that the researchers believed one treatment to be superior to the other. The OHRP letter of finding did not address the basic ethics of conducting the study, given the strength of prior knowledge, or permitting 37 patients in the high volume control group more than in the low volume experimental group to die before terminating the study.

Following OHRP’s letter of finding (Feb 8, 2002) UC counsel advised a moratorium on all research consented by surrogates. [See The Alliance for Human Research Protection (AHRP) website for our complaint and links to documents:
http://www.researchprotection.org/index.html ]

Most of those who are clamoring to amend California law in order to facilitate

easier recruitment of patients through proxy consent, have financial stakes in

biomedical research and are financially tied to the pharmaceutical / biotech industry.

San Francisco Chronicle, SPECIAL REPORT: Experiments on Humans: August 4, 2002: Business of clinical trials soars, but risks unknown Medical studies give new hope to patients, yet. By Tom Abate

Aug. 5, 2002: Rules for clinical trials are confusing, inconsistent No single agency regulates medical research on humans, putting millions of volunteers at risk. By Tom Abate.

Aug. 6, 2002: A split verdict on clinical trials Studies offer hope — and raise a series of ethical questions. By Bernadette Tansey.

July 28, 2002: Patients’ rights: Doctors improperly got consent for study, feds say. By Bernadette Tansey.
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2002/07/28 /MN119229.DTL


http://www.latimes.com/features/health/medicine/la-me-uc7aug07.story?coll=la %2Dhealth%2Dmedicine

THE LOS ANGELES TIMES UC Seeks to Ease Curbs on Patient Research Health: A bill has passed Assembly. Critics say the university has failed to protect earlier subjects. By CHARLES ORNSTEIN and REBECCA TROUNSON TIMES STAFF WRITERS

August 7 2002

The University of California and several health groups are lobbying the Legislature for more leeway to enroll incapacitated patients in research studies.

But patient activists say the UC system doesn’t deserve this new authority because of its previous lapses in protecting human research subjects in medical experiments. And bioethicists worry that the legislation could place patients at risk for exploitation.

The bill, which passed the Assembly and is headed to the Senate as early as today, would allow certain relatives, from spouses to the closest available family member, to approve studies involving patients unable to give consent. Such patients might include victims of strokes or Alzheimer’s disease, or those in comas.

The university, along with such groups as the American Heart Assn. and California chapters of the Alzheimer’s Assn., said more flexibility is needed to advance treatment of life-threatening diseases and injuries.

The bill’s advocates also seek greater clarity: The consent laws are open to interpretation.

Federal law allows any “legally appointed representative” to give consent on behalf of an incapacitated patient, leaving interpretation of that term to individual states. California law is more restrictive, giving authority only to those appointed by the courts or legally approved by the patients before incapacitation. The state’s definition may or may not include close relatives.

The situation is “a bit of a mess,” said Regis Kelly, executive vice chancellor of UC San Francisco.

Individual UC campuses and other research institutions interpret the laws in various ways. In April, acting on legal advice, UCLA issued a moratorium that bars researchers from enrolling patients in studies if they cannot give consent. But other UC campuses allow such research if a relative consents.

Questions about the precise meaning of the law have arisen as research institutions nationwide have come under fire in recent years for controversial studies, some of which have led to deaths.

The California bill would create a list of relatives who could give consent for a patient who is incapacitated.

“If we could make somebody better or give them relief, why wouldn’t we want to do that?” asked Assemblywoman Dion Aroner (D-Berkeley), who co-authored the bill.

But Aroner, whose mother had Alzheimer’s disease, said after conferring with patient advocates that “there are some issues here that need to be dealt with still. It’s not a black-and-white issue.”

Some patient advocates are suspicious. “This is like a grab for more power” by UC, said Vera Hassner Sharav, president of the Alliance for Human Research Protection. “In fact, they haven’t earned it at all. They haven’t complied with the existing regulations and law.”

She and other critics said the UC system has a history of violating the rights of patients involved in research.

In 1994, UCLA was reprimanded by federal officials for failing to get proper informed consent from patients enrolled in a clinical trial of a new anti-schizophrenia drug. One patient committed suicide.

The next year, three doctors at UC Irvine were accused of taking the eggs and embryos of patients without their consent and implanting them in other women, some of whom gave birth.

Since June 2001, the U.S. Office of Human Research Protections has criticized UCLA, UC Irvine and UC San Francisco for minor instances of failing to inform subjects of their risks in experiments.

UC officials said they have made every attempt to rectify past problems, and the federal office has expressed satisfaction with each campus’ efforts.

“If you go back a few years anywhere in the country, [the protections] would not meet the standards of today,” said William Parker, vice chancellor for research at UC Irvine. “We’ve made improvements since then.”

Sandra Fried, a UC lobbyist and analyst in Sacramento, said the university and other sponsors of the legislation have tried to address opponents’ concerns. They have made several changes, including eliminating patients involuntarily committed to mental hospitals as research subjects.

With opponents who remain, she said, “I think we’ve gotten down to a philosophical difference as to whether human beings should be involved in this kind of research at all.”

The American Stroke Assn. is a strong advocate of the bill, saying that the ability to get patients the most up-to-date treatment is urgently needed.

“When a patient presents at the emergency room, the most appropriate treatment for that patient is often still in an experimental state,” said Marc Burgat, a legislative advocate for the stroke association in Sacramento.

“We would like to have the law very specifically clarified,” Burgat said.

But Bob Aller, whose son participated in the schizophrenia study at UCLA in 1990, said he still doesn’t trust UC researchers. During the study, Aller’s son Greg, who had been taken off antipsychotic medication without his knowledge, came to believe voices in his head that ordered him to kill the former president, Aller has said.

“The lessons learned and the integrity for the individual … don’t seem to be taken to heart really,” said Aller, who with his son is suing the university for not properly advising Greg Aller of potential risks in the research.

The case, closely watched by researchers, is set for trial in January.

Bioethicists said it is premature to change the California law. So far, they said, studies have shown that family members and doctors are poor predictors of what treatments patients actually want.

“What gives me pause is that there has not been any real public discussion of whether this is something that society wants to sanction or not,” said Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia Medical School.

Another bioethicist, George Annas of the Boston University School of Public Health, would insist upon a host of changes in the proposed law.

One would be that every incapacitated patient have an independent physician who agreed that the study would not cause harm.

And the legislation should prevent relatives from being paid “to volunteer somebody else for an experiment,” Annas said.

Bioethicists said UC is not the only university system to be criticized for research protections.

Alleging serious violations, the federal government in the last three years temporarily suspended all research involving humans at several schools, including Duke University and Johns Hopkins.

“Some of the most advanced research centers seem to have the worst problems, probably because they have some of the most aggressive researchers going after diseases,” said USC bioethicist Alexander Capron.

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