How lobbying killed new state regulations
Seattle Times political reporter
OLYMPIA - After testimony last year from The Fred Hutchinson Cancer Research Center, other Washington medical facilities and biotechnology companies, lawmakers stopped a proposal that would have given more independence to the boards that review controversial and experimental medical treatments.
This week, following reports of potential conflicts of interest in clinical trials at "The Hutch," a key lawmaker who last year was convinced the legislation wasn't necessary now says she'll push for the reforms.
"They were really insistent that this would interfere with their ability to do research," said Senate Health Care Committee Chairwoman Pat Thibaudeau, D-Seattle. "Maybe we should have interfered a little."
"I'm not interested in tarnishing the very, very, good name of Fred Hutchinson," Thibaudeau said. "But I think we need to take a very hard look at this."
In addition to the bill she introduced this week on Independent Review Boards, Thibaudeau said she will introduce another in response to this week's news about the Hutch to address the broader conflict-of-interest issues.
That bill, which Thibaudeau is still circulating among senators for co-sponsors, would require medical facilities to disclose any financial interest in a drug or treatment given to a patient.
The lobbyist for the center said yesterday that the world-renowned facility had not opposed the bill last year but had just pointed out potential problems and conflicts.
But lawmakers say it was, in part, the reputation of The Hutch that helped stop the bill and other measures regulating human research and experiments.
"They were like Mother Teresa when they came in here; like they were doing the Lord's work," said Sen. Jim Hargrove, D-Hoquiam. "It was very hard to do anything they disagreed with because they were supposed to be snow-white."
Criticism of the bill took two approaches: Regulation could chill, or even kill, the state's booming research industry, and state regulation would duplicate or conflict with federal rules.
But at the time, state lawmakers had in hand a federal investigation that said the lack of more independent members on review boards nationwide made them "clearly inadequate" and that participation in the Institutional Review Boards, or IRBs, by researchers with financial interests "undermines a perception of impartiality."
The June 1998 report by the inspector general of the Department of Health and Human Services said there were "danger signs that inhibit IRBs from operating with sufficient independence."
The Seattle Times reported this week on two failed clinical trials in which The Hutch and its doctors had financial ties to some of the drugs being tested.
Patients were not told of those ties, nor were they fully informed of the experiments' risks.
Legislation that would have forced changes in the membership of Institutional Review Boards arose from lawmakers' study of DNA research and the privacy of medical information.
Last year, there were bills that would have, among other things, tightened privacy provisions, broadened informed consent for DNA research and prohibited genetic discrimination.
None of the bills was approved.
Institutional Review Boards are required by law for any federally funded medical experiment involving humans.
The boards are supposed to make sure that human subjects of experiments are treated in an ethical and humane manner, are fully informed, and that the potential benefits of the experiment outweigh the risks.
Last year's IRB bill would have required:
• More than one board member not affiliated with the institution. The same person could not qualify as the non-scientific and outside board members.
• Scientists to compose at least one-third of the members on the board, but no more than two-thirds.
• Invalidation of any vote of a board member with a "property or fiscal interest" in the research being reviewed.
Criticism of the bill was mostly aimed at its potential conflict or duplication of federal regulations. The bill's sponsor, Sen. Darlene Fairley, D-Lake Forest Park, said the state measure was designed to tighten conflict-of-interest provisions and to guarantee a broader representation on IRBs.
At a hearing in January 2000, Mike Ryherd, The Hutch's contract lobbyist in Olympia, told lawmakers that changes to the IRB regulations were unnecessary because federal law adequately covered most of the center's work.
"This bill may not apply to federally funded institutions and it may in fact be in conflict," Ryherd said. "While we agree that there are potentials for some of the conflicts you said, that you have pointed out, we feel that the federal legislation, which is already in place, is more comprehensive and more broad."
During the hearing by the Joint Committee on DNA Research, co-chairwoman Sen. Rosa Franklin, D-Tacoma, told Ryherd that she was surprised the committee had received no written testimony opposing the bills.
"When I heard from staff that no one had really responded, I said, 'Oh they like it very well, we'll move on,' " Franklin told Ryherd at the hearing.
Ryherd responded, "That's a very dangerous assumption."
But in an interview yesterday, Ryherd said the center had not opposed the legislation and should not be blamed for stopping the measures.
"We never said we were opposed to the legislation," Ryherd said. "We said either it was not necessary because it duplicates federal laws that were already in place, or some of the legislation was badly drafted, and that there was language that needed to be cleaned up."
He said legislation dealing with medical research is very complicated and often can have unintended consequences.
Hargrove, chairman of one committee that heard some of the research bills but not the IRB measure, said The Hutch did its part to defeat all the medical-research bills.
"What they did was come in and poop all over it and say things like, 'We don't think those bills are necessary.' How do you interpret that? It's all semantics."
Lawmakers also heard warnings last year from the Washington Biotechnology and Biomedical Association, which represents private bio-tech companies and government-backed research centers, including the Hutchinson Center.
The Hutch, association lobbyist Enid Layes told lawmakers last year, "is spinning off new companies almost on a daily basis."
But the strong growth in the industry might be stymied, she said, by new state laws.
"Medical research is heavily, heavily, regulated by the federal government," Layes said. "It is a long, laborious process to bring a new medical treatment or a new drug to market, and there are many, many hurdles.
"We don't need, frankly, more state laws that put more hurdles in our way."
This was persuasive to some lawmakers.
Rep. Al O'Brien, D-Mountlake Terrace, said at the same hearing last year that Oregon lost much of its research industry after new state laws were passed.
"We better be careful," he told lawmakers. "We all don't know what is going on."
This week, O'Brien said he hadn't heard anything new about The Hutch or medical research to change his mind. He pledged to stop any attempt by Thibaudeau to pass legislation this session.
"I think what we read this week was all about history," O'Brien said of The Times' series. "I don't think any of that is going on now and we shouldn't rush to do something."
Other lawmakers remain angry at the heavy lobbying against regulations on medical research. They say that this week's news about The Hutch's potential conflicts make it clear the legislation was needed.
"If I were able to dance, I'd be dancing around this place going, 'Told you so, told you so,' " said Fairley, who walks with crutches.
Fairley said Fred Hutchinson officials were clear that they didn't feel the legislation was necessary.
"They constantly came to me and said, 'This does not happen. It is not a problem. We're scientists. We're doctors. We do good for humanity. How dare you question us?' "
David Postman can be reached at 360-943-9882 or firstname.lastname@example.org.