Medical research reform weighed

Senate panel pledges stronger protections for experiment volunteers

April 24, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

WASHINGTON - Senators vowed yesterday to seek legislation that would strengthen federal protections for volunteers in medical experiments, saying they are concerned about reports of flaws and loopholes in existing regulations.

"If patients fear that their safety is not adequately protected in medical research, the cures of the future will be placed in jeopardy," Sen. Edward M. Kennedy, chairman of the committee on Health, Education, Labor and Pensions, said during a hearing on the issue yesterday.

The Massachusetts Democrat is working with Sen. Bill Frist, a Tennessee Republican, to draft a bill that would strengthen federal oversight of experiments, compel disclosure of conflicts of interest and require full disclosure of risks to study subjects, according to aides.

Their effort has been driven by a recent series of scandals at academic medical centers, including the death in June of a healthy 24-year-old in an asthma study at the Johns Hopkins University and the death in 1998 of an 18-year-old volunteer in a gene therapy trial at the University of Pennsylvania.

"Congress has made clear its commitment to biomedical research," said Frist, the Senate's only physician. "However, until recently, there has been too little attention paid to protecting the individuals who are the focus of this critical research."

The Maryland General Assembly recently made a similar push for greater accountability in medical experiments, approving a bill that compels universities to publicly disclose the minutes of their scientific review boards.

Witnesses at yesterday's hearing described a system of reviewing experiments nationally that is overwhelmed, inconsistent and often poorly equipped to protect the 2.3 million people a year who volunteer for clinical trials.

Federal laws have loopholes that do not require researchers to disclose their own financial conflicts of interest to volunteers or review boards, according to testimony from critics of the current system. An unknown number of deaths and injuries in experiments go unreported, and existing regulations do not fine or penalize scientists who break safety rules, critics said.

Moreover, the university review boards designed to scrutinize experiments are overwhelmed with work, critics added, and provide little or no monitoring of experiments to make sure researchers perform them as approved.

Cherlyn Mathias, a nurse who worked as a research coordinator at the University of Oklahoma in 1999 and 2000, said she believes safety violations and cover-ups are common among researchers.

She told the committee she was forced out of her job more than a year ago after she complained to federal authorities about a series of problems in a melanoma cancer vaccine trial.

Mathias said a researcher she worked with failed to seek review board approvals and exaggerated promises of a cure for melanoma when he described the study to volunteers. He also let subjects inject themselves with the experimental vaccine and store it at dangerously warm temperatures in their home refrigerators, Mathias said.

"By the time I blew the whistle in June of 2000, the university had formed a committee that included the dean of the medical college," said Mathias. But "the committee was engaged in acts of cover-up instead of promptly reporting as required by the federal regulations."

Mathias, now manager of the clinical trials department for the Harris Methodist Fort Worth Hospital in Texas, said the University of Oklahoma has since made several improvements to strengthen its oversight of experiments. But she said that problems still haunt research around the country. Even in her new job in Texas, Mathias said, she feels unhealthy financial pressure to meet quotas of enrolling certain numbers of volunteers in clinical trials per month.

"My performance is based on how many people I enroll in clinical trials," said Mathias. "It's a situation that creates conflict."

Marjorie Speers, former acting director of a group of scientific ethics experts called the National Bioethics Advisory Commission, said a national system of accreditation should be created to make sure that researchers receive education on federal safety rules and comply with them, or else risk professional censure.

"It is ethically indefensible to not fully protect volunteers in research," said Speers, leader of a nonprofit organization called the Association for the Accreditation of Human Research Protection Programs.

Charles A. Johnson, a representative for the Biotechnology Industry Organization, a technology industry trade group, also supported federal legislation, but as a way of eliminating what he called a confusing patchwork of federal and state regulations that sometimes conflict. The system would work better if the federal government created a single, streamlined set of regulations that would override the sometimes widely varying and overly restrictive state laws, said Johnson, an associate director of Genentech Inc. of San Francisco.

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