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Bernadine Healy : The Head of NIH Defends Medical Reseach on the Front Lines

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<i> Janny Scott is a medical writer for The Times. She interviewed Bernadine Healy during the director's recent visit to Los Angeles</i>

When Bernadine Healy became director of the National Institutes of Health 15 months ago, she took over an agency ominously adrift: The world’s leading center for biomedical research seemed to some to be in danger of being nickel-and-dimed into mediocrity.

Morale among its 4,000 resident scientists was flagging. Funding had failed to keep up with the accelerating pace of science. Charges of scientific misconduct dogged a top AIDS researcher. Politics, some believed, were shaping science in worrisome ways.

Into that environment came Healy, the 47-year-old cardiologist and head of the research institute at the respected Cleveland Clinic Foundation, a Republican and self-described feminist, the first woman to head the $9-billion federal agency in its 104-year history. Within a month of taking office, she initiated the biggest study of women’s health ever attempted, a 10-year, $500-million project. Then she embarked upon developing a strategic plan, expected to prove a powerful weapon in the battle for a bigger NIH budget.

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But last August, Rep. John D. Dingell (D-Mich.), whose committee oversees the NIH, accused Healy of “derailing” investigations of misconduct charges against two prominent scientists and “emasculating” the investigating staff.

Not one to shrink from a fight, Healy called the charges “preposterous.” She flatly denied trying to influence either case. Then she accused her own agency’s ethics arm, the Office of Scientific Integrity, of ignoring its own guidelines.

Now Healy finds herself up against Nobel laureate James D. Watson, who resigned this spring as head of NIH’s project to map all human genes, saying he was forced out over his opposition to the agency’s attempt to get patents on man-made copies of thousands of gene fragments.

Healy says Watson left for far different reasons--conflict-of-interest questions raised about his ownership of stock in biotechnology companies. And she has denied charges that the patenting attempt will scare companies away from crucial research into gene-based therapies.

A slim, striking woman with oft-remarked-upon blonde hair, Healy graduated with honors from Vassar College and Harvard Medical School. She lives during the week at NIH in Bethesda, returning to Cleveland on weekends to be with her husband and two daughters, ages 6 and 13.

Question: Dr. James Watson, who resigned this spring as head of the human genome project, has described the NIH’s gene-patenting plan as “sheer lunacy.” Critics say it will discourage biotech companies from developing gene-based therapies. Are they right?

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Answer: As far as I witnessed it, this had nothing to with his resigning and if he were going to resign over that, it would have been many months ago. . . . I view Dr. Watson’s perspective on (gene) patenting a valid one that must be part of the present airing of this issue.

Q: But you feel NIH is right to file for these patents?

A: NIH, as a matter of interim policy, has decided that it should file for patents. . . . We have a series of complicated issues that must be explored before we know whether or not it is in the best interest of the public, of science, or of industry to hold patents on full genes or gene fragments. NIH’s primary goal here is to see that we can develop products that will be beneficial to the public, that we will advance the very powerful science surrounding the understanding of the human genome.

Also, we believe we have a responsibility to protect the interests of the American taxpayer if it turns out that this knowledge is powerful in the development of American industry. At the present time, we do not know whether or not the holding of patents is pro-competitive or anti-competitive in terms of American industry. . . .

One thing that I have determined from industry, however, is that across the spectrum of opinion, virtually all say it was appropriate for NIH to file in the face of uncertainty.

Q: Competition for limited federal research money has meant that a declining percentage of worthy grant applications to NIH are being funded. What effect will this have on biomedical research?

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A: I don’t think biomedical research in the United States can continue its preeminence at home and abroad if we continue to turn down 75% of meritorious research that comes before us. At the present time, we are not funding as much excellence as we are funding. That means numerous opportunities are not being pursued that need to be pursued. Something has to be done. Obviously, that something requires a broader consensus beyond the scientific community.

Q: How can you build that?

A: If we can accomplish one thing directed toward that issue, it would be to elevate NIH and biomedical research as a priority for the American public. One, and primarily one, because it is of great importance to their health. Secondly, NIH is of growing importance to this nation’s economy. That cannot be minimized.

Q: With access to abortion diminishing, what do you intend to do at NIH to encourage the development of new contraceptives?

A: I think NIH has an obligation to address the whole field of reproductive biology and contraceptive research. We have not seen any major breakthroughs in the area of contraception or of protection, of women in particular, against sexually transmitted diseases in 20 or 30 years. NIH has an obligation as part of its mission to address this--and indeed we are elevating that as an NIH priority. We are obliged, nevertheless, under law, to restrict some of our activities insofar as they might touch on abortion.

Q: Is there any philosophical resistance to contraceptive research?

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A: Absolutely not. And I think it is truly unfortunate that sometimes contraception and abortion are linked together. The only way they are linked, to my mind, is that abortion is a failure of contraception. If we should be on common ground for anything, we should all be together that we need more effective means of contraception. That would overnight eliminate the abortion debate.

Q: The Administration squashed a survey of teen-age sex that you had approved. What can you realistically hope to accomplish in that area?

A: Well, I was overruled on that particular study. However, there are many other dimensions to exploring the important area of sexual behavior. We believe that there is room for bio-behavioral studies that would touch on areas of sexually transmitted diseases and teen-age pregnancy, and NIH is committed to pursuing them. But we have to do it within narrower guidelines.

Q: What do you mean, under narrower guidelines?

A: . . . We can try and respond to some of their objections. And then do what we think we can get approval for. For example, there was some language in those questionnaires which the Administration felt to be offensive and were part of the reason why we were overruled. The Institute of Child Health and Human Development is looking at ways of making that language more acceptable so that the same data can be obtained and some of those objections can be met.

Q: Many people say morale is low .

A: Morale is a problem. I think perhaps one of the most important reasons for declining morale is the feeling and the perception that biomedical research today is neither valued nor seen as a high and compelling national priority. If we are truly going to deal with the morale issue in such a way that the life of a scientist is seen as a positive life, it is seen as a socially responsible vocation, it is seen as a career in which there is great opportunity to do good . . . it will require a major cultural change to achieve that.

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Q: What specific steps would help?

A: I think it’s going to take a lot more than money. We need to have a sense that there is great opportunity in science, and have the excitement of that opportunity conveyed to young people. I think we do have to address some of the public-trust issues that have eroded the sense of scientific pursuit as a profession of dignity with high goals associated with it. We do have to tackle with the regulatory environment surrounding science and, I think, make sure that the scientific community’s voice is appropriately heard, that they are party to the debate. They may not be able to dominate the debate, particularly when you are dealing with issues that transcend science--like issues of animal rights, socially contentious issues, moral or ethical issues. But I think the scientist ought to be viewed as a respected and vital part of the policy debate. I think there are issues of academic freedom that have to be addressed, particularly for scientists who work for the government.

Q: You seem to suggest the position of scientists in society has been degraded.

A: Let’s say that we have downplayed or devalued the importance of intellectual pursuit in this country in general. What we see in education--the fact that we’ve allowed our educational systems to deteriorate--is but another example of the devaluation of intellectual pursuit. Science and the pursuit of discovery perhaps is one of the most powerful aspects of intellectual pursuit. It is, in many ways, a celebration of what the human intellect can do.

I think it has suffered from this global devaluation of this as a national good, a heroic pursuit. I think that the only way to address it in a truly effective way is to make that diagnosis: That this is a problem of national values, this is not just the problem of one unhappy scientist sitting in Bethesda complaining about back pain. And it’s going to take a lot of heavy-hitting people in their bully pulpits taking this issue on as a matter of importance for all of us.

Q: In light of the difference between the salaries for senior NIH positions and for comparable jobs in academia and industry, what can you do to attract top scientists?

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A: Create an environment of excitement and discovery that makes the intellectual rewards so compelling that the differential in salary is not a deterrent. Traditionally, when scientists and MD scientists pursue careers in research, they always know that they’re going to have less financial reward. That was known 20 and 30 years ago. “Arrowsmith” knew that. But what is it that will make an MD scientist willing to take lesser financial reward? It’s that there are other rewards that are viewed as of higher value. . . . We’re talking about scientists getting a reasonably good income, maybe not a great income, but having great rewards intellectually, emotionally and the career satisfaction factor, I guess.

Q: Have you had any second thoughts about how you handled the confrontation with Rep. Dingell?

A: . . . My relationships with Chairman Dingell are not my finest hour. I believe that they can and must get better. And I am willing to work with him in making them better for the interest of NIH. . . . I do believe that oversight committees have a responsibility to oversee agencies and I am willing to see that that oversight mechanism works. But if there are misunderstandings, I believe it is also my obligation to do what I can do to correct them. I’m amazed that doing that is interpreted is interpreted as “confrontational.”

Q: What is the future of the Office of Scientific Integrity?

A: I think it’s already gotten much better under the leadership of Dr. Jules Hallum. He has instituted better systems for separating investigation from adjudication, for having teams of investigators, for having better procedures relating to confidentiality, for tight adherence to guidelines that govern investigations. I also think OSI will be better because of the restructuring that we have proposed--namely to elevate OSI out of NIH, to give it more independence of the scientists it must investigate; secondly, to provide the opportunity for a hearing conducted by someone trained in adjudication, namely an administrative law judge, and to also explore crisper definitions for what constitutes scientific misconduct and a statute of limitations for misconduct investigations.

Q: Gen. Colin Powell is said to have greeted you upon your arrival in this job saying, “Welcome to the NFL.” What have you learned in the past year about football?

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A: I learned that there is a lot of wisdom in football that I have used in this job . . . (including) the notion of having a strong offensive team and a strong defensive team. I’ve said this before but in Washington, sometimes there’s an attitude that doing a good job in Washington is all playing defense. But if you’re going to get anything done, you have to have an offensive strategy. And I guess the last thing I’ve learned is that being on the 5-yard line is not a touchdown. I’ve learned that many times.

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