October 26

Critics of NIH Studies Prompt Senate Hearing – WashPost

Critics of NIH Studies Prompt Senate Hearing – WashPost

Mon, 19 Jan 2004

Accountability is a controversial concept for officials at the National Institutes of Health (NIH). Dr. Elias Zirhouni, director of NIH, is scrambling to explain recent revelations of impropriety: First, the agency approved taxpayer money for highly questionable research projects, most of which involve the recording of risky, unsafe sexual practices. Despite protestations by NIH, the value of these projects–to anyone but the investigator-recipients of NIH grants–is highly questionable.

The second in this “one-two punch has put the NIH on the defensive.” Revelations by The Los Angeles Times that NIH researchers have been double dipping– against government regulations, is reverberating. Dr. Zirhouni claims he has found no evidence that any NIH decisions have been influenced by collaboration with drug companies. Really? Does it not occur to Dr. Zirhouni that as the director of NIH he is hardly disinterested? He is, therefore, not an impartial investigator of conflicts of interest.

Rick Weiss reports (below) that some “NIH-watchers” said the agency will survive the new scrutiny relatively unscathed. “But many predicted that the controversy will prompt new and perhaps overdue restrictions on deals between companies and NIH officials who control the flow of funds, and possibly changes to make all deals more open to the public.”

Let’s hope the latter will prove correct. Scientists, like all mortals, need to be held accountable.


Critics of NIH Studies Prompt Senate Hearing

By Rick Weiss

Under pressure from conservative activists and members of Congress, officials at the National Institutes of Health are scrambling to respond to allegations of improper funding and financial conflicts of interest that will be the focus of a Senate hearing scheduled for Thursday.

This week’s hearing and another being planned in the House reflect an uncomfortable shift of political winds for the venerable research institute and its director, Elias A. Zerhouni, who took the reins of the agency in May 2002.

Last year, the agency enjoyed its fifth consecutive major funding increase, to $27 billion, capping an ambitious plan launched in the Clinton administration to double its budget over five years. During that period, the agency retained the political goodwill of the Bush administration and Congress despite a contentious national debate over human embryo cell research — and even increased its stature by providing leadership in the emerging field of biodefense.

But a recent one-two punch has put the NIH on the defensive. Late last fall, a conservative religious group released what it said was evidence that the NIH was financing scientifically useless studies of morally repugnant behavior, triggering a congressional inquiry. In December, an article in the Los Angeles Times suggested that improprieties were occurring in collaborations between NIH scientists and drug companies. Those claims prompted a fresh round of congressional questions.

“I’ve been a very strong advocate for increasing NIH funding,” said Sen. Arlen Specter (R-Pa.), who will lead Thursday’s hearing. “I want to find out what’s going on.”

Zerhouni said last week that he had completed an internal investigation of all the grants challenged by the Washington-based Traditional Values Coalition as a waste of taxpayer dollars and found all to be of legitimate public health value.

He also said in an interview that he has found no evidence that any NIH decisions have been influenced by collaboration with drug companies, though he will soon announce a panel of outside experts to examine those allegations.

Several NIH-watchers said they are convinced the agency will survive the new scrutiny relatively unscathed. They said that the claims of unworthy grants are political and easily rebutted on scientific grounds, and that no proof of financial wrongdoing has emerged.

But many predicted that the controversy will prompt new and perhaps overdue restrictions on deals between companies and NIH officials who control the flow of funds, and possibly changes to make all deals more open to the public.

“If you take public funds, you have an obligation to have everything you do be transparent,” said Alan I. Leshner, president of the American Association for the Advancement of Science and a former chief of the National Institute of Drug Abuse.

The NIH has a long history of having to defend itself against allegations of funding unworthy research — claims most colorfully made by Sen. William Proxmire (D-Wis.) and his Golden Fleece Awards in the 1970s.

The most recent round erupted last fall, when Rep. W.J. “Billy” Tauzin (R-La.) and others questioned more than 200 NIH grants, many focusing on sexual behavior. The list was provided by Andrea Lafferty, executive director of the Traditional Values Coalition.

Among those targeted were a study of the sexual habits of older men, a study of gay and lesbian Native Americans who believe they have both male and female “spirits,” and a study of sex workers, known as “lot lizards,” who frequent truck stops.

“We’re shaking the NIH tree,” Lafferty said last week, “and a lot of rotten fruit is falling.”

But a thorough review, Zerhouni said, has concluded that in every case “the grants are extremely relevant to our public health needs.”

One study that stirred controversy, awarded to a researcher at the Kinsey Institute at Indiana University, called “Mood Arousal and Sexual Risk Taking,” addresses an important but poorly understood issue in the age of AIDS, NIH officials said: Why is it that many people, despite knowing better, take enormous sexual risks once they become aroused?

The question is important, experts said, because educational programs designed to reduce risky sexual behavior typically appeal to the rational mind, which is not necessarily in charge at such times.

“People may know perfectly well that something is risky — that they shouldn’t have sex with this person or they shouldn’t have sex without a condom or they shouldn’t have sex at all,” said Christine A. Bachrach, who directs the NIH program that funded the grant. “But many people do it because they get swept off their feet, or they do something they shouldn’t do in the heat of the moment.”

The study uses videos, questionnaires and other methods to identify the psychological mechanisms that might be better targets for safe-sex messages.

A second study that drew derisive comments focused on gay, lesbian, bisexual and transgender Indians — an underserved group heavily stigmatized in their own culture and at greater risk of AIDS, NIH officials said. Native Americans have a 50 percent higher prevalence of AIDS than white Americans, yet almost nothing is known about the risky behaviors, in part because the culture has been distrustful of whites. The funded study is led by a university researcher who is Choctaw.

A third grant, for $1 million over four years, is collecting information, never gathered before, about the sexual habits of the nation’s nearly 4 million truck drivers and the prostitutes who frequent truck stops — a population that, according to preliminary results, is significantly contributing to the spread of AIDS in the United States.

Referring to the criticism of the studies, Leshner said, “Here we have people saying, ‘I don’t like how that disease was contracted, so I don’t want to study that disease.’ It’s equivalent to sticking your head in the sand. It’s very important that the scientific community rises up and objects to the imposition of ideology in these areas.”

At Thursday’s hearing, Zerhouni is also to address the growing number of collaborations between NIH scientists and private companies and the implications of those deals.

The collaborations — which typically involve corporate payments to NIH scientists for expert advice — have been explicitly encouraged by Congress since the 1980s to speed translation of federally funded research into medical products. The collaborations must occur on personal time and must be reviewed by federal ethics officers to ensure they do not pose a conflict of interest.

The number of such collaborations has grown over the years, with 242 active last week, according to NIH documents. Among the issues that Zerhouni is assessing is whether it is adequate for NIH institute chiefs, who control the government purse strings, to simply recuse themselves from funding decisions involving the companies they have deals with. With corporate relationships growing more complex, institute chiefs might not realize that these companies may own or control other companies or research groups that are competing for NIH grants those chiefs oversee.

All NIH researchers must disclose to federal ethics officials the details of their collaborations, but only those with salaries above a certain cutoff must make the disclosures public. One contentious aspect is an exception to that rule: NIH scientists who have been placed in a special higher salary class known as Title 42, used to retain highly valued scientists, are for the most part exempt from making public disclosures.

Zerhouni said he is not wedded to that system of reduced disclosure.

Also problematic, Zerhouni said, is that the current disclosure options are “all or nothing.” Those who do disclose side deals must make public every detail of their finances — a daunting and invasive requirement.

Zerhouni said he would rather err on the side of more openness because the key to maintaining public trust “is to ensure transparency, full disclosure and independent review.”

But he and many other scientists stated emphatically that it would be tragic if Congress banned NIH-corporate collaborations, which not only help companies and the public but also educate federal scientists about how their work can fit into the real world.

“To retreat entirely to the point where government scientists shouldn’t work with industry would be very bad,” said Harold Varmus, president of Memorial Sloan-Kettering Cancer Center in New York and Zerhouni’s predecessor. “There are too many mutually beneficial relationships between government and industry to do that.”

© 2004 The Washington Post Company

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