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Making Her World Work:The Nominee For FDA Commissioner

Medical Device & Diagnostic Industry
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An MD&DI September 1998 Column

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An interview with Jane E. Henney, MD, vice president of the University of New Mexico Health Sciences Center and nominee for FDA commissioner.

The office of FDA commissioner is one of the most complex, high-profile, and potentially contentious positions in government—and one of the most important. A successful candidate must bring an unusual combination of scientific, managerial, and political expertise to the post and be prepared to enact and carry out critical policy decisions in the media glare of today's fast-changing, dynamic health-care environment.

Jane E. Henney, MD, the nominee for FDA commissioner awaiting an upcoming confirmation hearing in the Senate, may not be particularly well-known to the medical device industry, despite a wide ranging resume that includes prominent academic and public service appointments. It's safe to say that interest in her background and views has increased dramatically since President Clinton picked her to lead the agency into the next century.

In the following interview with MD&DI, conducted in July 1997, Henney recounts the evolution of her career and outlines her approach to running organizations and pushing change through even the most resistant roadblocks. This discussion took place prior to Henney's nomination for commissioner and was conducted by Steve Halasey, former MD&DI executive editor and current editor of IVD Technology.

You began your career with nine years of service at the National Cancer Institute (NCI), leaving as deputy director. What kind of foundation did that experience provide for your career?

Working at NCI was an extraordinary experience. I was there from 1976 through 1985, and I had the good fortune to move up through the ranks reasonably rapidly. But the last five years, when I was deputy director, taught me a tremendous amount.

I was trained as a medical oncologist and had been involved in clinical research and clinical research issues. But seeing cancer research issues from the perspective of the director's office gave me a much better appreciation for all the research going on in biology, cancer etiology, cancer control, and epidemiology.

I was also working for a director, Vince DeVita, who gave me a tremendous amount of latitude in representing the institute and strengthening its internal and external operations. So although I wasn't performing research, I got to observe research close-up and initiate a number of extramural programs.

Some of those programs were classic, hard-core research, and some were designed to ensure that all of NCI's clinical protocols were known and available to the community physicians and patients who needed them. We made research data and information available nationwide on a real-time basis to people who needed it and developed the database at the National Library of Medicine that's become known as the PDQ [patient data query] system.

How did you come to leave NCI for your next position at the University of Kansas?

My undergraduate background was in education, and I had always seen myself becoming part of an academic institution. But through my experience at NCI, I learned that I had both an appreciation and a talent for administration, so I started directing my career more toward the work of academic administration.

What were you involved in at the University of Kansas?

I was specifically charged with helping to develop and create centers of excellence in the areas of aging, cancer, and environmental and occupational health. It was challenging to recruit the leadership for each of those centers and to set up the framework in which they would work.

After I had been there for a year, the dean of the medical school took another position, and the chancellor and a group of faculty asked if I would take over as interim dean. Perhaps naively, since I was not tenured at the time, I agreed. But it turned out to be a wonderful experience, so I've never been sorry that I did it. The things that came up during that year taught me a great deal.

After that I moved into the vice chancellor's position, taking on increasing job roles that spanned the university. I really enjoyed the range of interdisciplinary and multidisciplinary projects that I was able to observe and create from that vantage point, more than just line administration of a single school.

How did you come to leave the University of Kansas for your stint at FDA?

There's nothing that gets your attention quicker than a little pink slip with a phone message saying that the commissioner of FDA wants to talk to you as soon as possible. And that's how it started. At the time, I didn't know David Kessler from Adam. So my first thought was, "Oh God, what have we done now? Who hasn't filed what report? Or what screwup has gone on in our clinical operation? How are we going to handle this one?"

I returned the call, but Dr. Kessler was out. So I spoke with his senior executive secretary, who simply told me that "he really wants to talk to you." Well, we had three or four of these go-arounds, so by the time he finally got me on the phone I was ready to confess to anything.

So I was more than a little surprised when the conversation went something like this: "Hello, Dr. Henney. I don't think we've ever met, but I really want to come out to Kansas City and talk to you about a job." And I said, "I've got a job; I'm employed." He said, "No, no. I don't think you understand. I really want to come to Kansas City and talk to you about a job." I said, "No, I don't think you understand. I'm employed. I'm very happy with academic administration. I'll probably want to pursue a government career again some day, but not now. I'm on a different path." And he said, "No, I understand, but I really want to come to Kansas City to talk to you about a job." So finally I said, "Well look, you can come to Kansas City and I will talk to you, but just so you know, I'm not interested in coming back into career service at this point."

I guess that first conversation should've told me that David Kessler is very persuasive. He came, we had a six-hour conversation, and, as you know, I went back.

What was it that convinced you to take the position at FDA?

The job he was describing was something that really caught my fancy: being the agency's chief operating officer. During the time I was there—a little over two years—we recruited new directors to almost every center. The other major challenge was the National Center for Toxicological Research in Jefferson, AR. We needed to reorient that center and use it as a resource for the integrated missions of the agency.

Because there are so many interesting issues going on all the time, FDA is an agency where you can easily get pulled into areas of interest rather than maintaining your focus on primary responsibilities. You have to remain disciplined about your job. There were a few specific issues that I got involved in, but I was much more expected to be the day-to-day operations person.

When you were at FDA you were involved in negotiations for international harmonization, an area that remains important for the device industry. Would you elaborate on your experience in that area?

When I came on board, the push toward international harmonization—not only in devices but also in drugs—was causing tremendous disagreement between this country and Europe and among all of the European countries. The European Economic Community was still coming together, and there was a lot of discontent over who would control what and which country's standard should become the European standard. I never spent much time worrying about how we would harmonize with Europe, because they still needed to harmonize with one another first.

When we began to work on the North American Free Trade Agreement (NAFTA), we were fortunate because the agency already had a fairly strong bilateral agreement with Mexico, which served as a good starting point. The lead individual for Mexico was a wonderful rheumatologist, and together we set concrete goals for ourselves and then began working through them. One of the key issues was what pesticides could be used on crops grown for export to the United States. We worked closely with the Environmental Protection Agency (EPA) on that question, because EPA hadn't yet established its standards in that area. These meetings were the most productive international negotiations in which I've been involved.

We later invited Canada to join in the meetings, and that filled out the three countries that eventually signed NAFTA. I was only at the agency for one meeting of the three countries. Although there were differences of opinion, I had a strong belief that the groups would be able to work through many issues affecting the public health.

As deputy commissioner for operations, you had a chance to see the agency's full spread. How does the device center look from that perspective?

Like the drug center, the device center had its own importance and its own set of issues. Members of the device center had a lot of expertise and experience to bring to the table, so it was always important to make sure that the center was represented and that nothing done by the commissioner's office would adversely affect it.

How do you go about giving people a sense of an organization's mission and getting them to help accomplish that mission?

An organization's mission has to come from the top. People down at the bottom can feel it, but they can't change it. But you can't influence how an entire organization sees things unless you have a global view of the organization. So when I was at FDA, I tried to make sure that more people had a broader view, if not of the whole agency, at least of their center's field operations. To accomplish this, we made it possible for agency staff to trade places. A district director of seafoods from Seattle, for instance, would spend a couple of months working at headquarters in Rockville. Or a deputy director from headquarters, someone who had always been in headquarters, would take over as regional director in Boston, working the docks and seeing the real-time impact of policies.

I don't know how to measure the difference, but these trades definitely changed our conversations about and appreciation for the work of another major part of the agency. People began to know who was out in the field, how they thought about problems, and what was going to happen. It's hard to conduct those kinds of minisabbaticals, because people are away from their families for extended periods. But when we made them available, people started to ask if they could participate, and we were able to involve senior leadership in at least eight to 10 such sessions. Quite frankly, I like it as a training model.

Another technique that I've used here at the University of New Mexico (UNM) is to add to people's portfolios an issue normally outside their day-to-day responsibilities. That gives them a good, strong leadership position for a part of an organization but also allows them to think more globally about the whole health sciences center. That technique can be used to good benefit in an institution that needs to be sure its line organizations are running with good quality but also needs to have cohesiveness in the broader organization. None of these techniques guarantee success, but they're the kinds of things that I try to build in with some degree of intent.

Why did you leave the agency?

Commissioner Kessler always knew that I would eventually want to go to an academic institution. I probably looked at two or three different institutions, but New Mexico is unique in many, many respects. It's particularly known, I think, for its innovation in a number of realms. When I came, there was an opportunity to be a part of an organizational change, to set a new direction, and to establish an organization for the future. I found people who already had a sense of readiness and who were already constantly innovating in their labs and in their curricula. Faculty and staff are not afraid to try something and if it doesn't work to try something else. Many academic institutions are not like that; they are much more bound to their traditions. So I felt like I could really make a difference here, and that this institution and its health sciences center could really make a difference in the health and well-being of the people of the state.

Did your experience with interdisciplinary and outreach programs at the University of Kansas make it easier to handle the organizational and programmatic changes you've made here at UNM?

Actually, in that respect I've been fortunate in almost every position that I've had. Even at NCI, where cancer was the common denominator, a lot of the programs had traditionally been interdisciplinary. A lot of the work that we supported looked at cancer from its most basic cellular level all the way through a continuum of clinical issues. And at FDA a lot of our work involved trying to get different disciplines to focus on a single problem.

Do you find interdisciplinary programs more difficult than working along the more established boundaries, or are they easier because they take the unbeaten path?

I like them because they are taking an uncharted path. There are always very high expectations, but since nobody has ever done what you're doing before, you're your own benchmark. You can make as much of a difference as the effort you put in.

Sometimes the biggest challenge is to capture and focus everyone's energies, so that you don't try to do so many things that you can't get any one thing done. Administratively, that takes a different skill base, but it's much more fun to apply focus than it is to try to create energy. If you've got good innovators among the faculty and staff, you can try new things in new ways to create a supportive environment. And that can make for a very dynamic place to work.

BIOGRAPHY


Jane E. Henney became the first appointed vice president of the University of New Mexico (UNM) Health Sciences Center in July 1994. She received her bachelor's degree in biology from Manchester College (North Manchester, IN) and earned her MD at the Indiana University School of Medicine (Indianapolis).

In her current position, Henney is responsible for the operation of the UNM School of Medicine, the Colleges of Nursing and Pharmacy, University Hospital, Mental Health Center, Cancer Research and Treatment Center, Children's Psychiatric Hospital, and Carrie Tingley Hospital. Her faculty appointment is in the UNM School of Medicine, where she is a professor in the department of internal medicine.

Immediately prior to her appointment at UNM, Henney served as deputy commissioner for operations at FDA (1992–1994). Her other past academic administrative positions have included vice chancellor for health programs and policy at the University of Kansas and acting director of the University of Kansas Mid America Cancer Center (1985–1992). She also served as interim dean of the School of Medicine at the University of Kansas (1987–1989). From 1976 to 1985, she held various positions at the National Cancer Institute (NCI), ending as deputy director (1980–1985).

In addition to being an active member of various professional societies, Henney is also president of the United States Pharmacopoeial Convention, a member of the advisory committee to the director of the National Institutes of Health (NIH), a member of the board of directors of the Lovelace Respiratory Research Institute, a member of the board of trustees at Manchester College, and a member of the board of directors for the Kansas State University Cancer Center. She also serves as an advisory member of the committee Quality of Life at the End of Life for the Commonwealth Fund, as a consultant to the W. K. Kellogg Foundation, and as a principal on the Council for Excellence in Government.

What does it take to keep hitting the same wall until it crumbles?

You've got to find allies. But in some places they're hard to find because they have to fight against the established culture. Even in an organization like UNM, which is trying to experiment, pilot, and innovate, there are some programs that run a fairly traditional path.

Businesses become successful because they learn how to improve their product and implement continual quality improvement. But when businesses like that crash, it's usually right after their very best year. And managers are often left wondering what happened. One view is that individuals within such companies generate an abundance of ideas that can't find a home within the organization. So these employees leave, creating new companies and new products that eventually overtake the original company and its products.

To avoid this pattern, it's essential to capture skills within the organization, making sure that the quality of the traditional product keeps improving but fostering innovation as well. That applies equally well in an academic setting. We all have to be looking constantly for ways to improve our programs.

How do you view the relationship between academic medicine and medical technology?

The two worlds of biomedicine and device engineering are just now starting to realize that they need to have a stronger relationship. Health sciences centers have much to offer industry, especially in terms of a tremendous patient base, and industry needs that resource to test its products before releasing them to the market. Health sciences centers also offer a wealth of faculty who perform clinical research.

Unfortunately, the clinical researcher is a commodity that is not as numerous as one would like. But at UNM, for instance, we have a clinical research center that has been continuously funded for the past 25 years. And within that unit we are training faculty and students who know how to do clinical research. That is a tremendous asset to those in the device world and other industries that want to have access to partnerships. We also have established clinical trial centers—sort of turnkey operations—so that when a pharmaceutical or device company needs to conduct clinical research we can offer a wide array of services that are already there and available.

Every faculty member, every investigator who works on a medical technology, has the desire to translate that technology into a real product. They're not conducting research just for the sake of discovery. They need to know how to take their great discoveries, get them into an incubator, get the venture capital, and finally get them to the market. They want their work to make a difference, so they know it's got to go that way. It's very important for the institution to lead the way through that route, and we try to do it through technology cooperations and other sorts of partnerships. But it's equally important that commercial firms come back in and tap into the resources that are available within an academic health center. That kind of technology transfer is incredibly important. I hope we do that to some degree, but I don't know that either academic health centers or industry has systematically taken advantage of that opportunity.

How is it that the pharmaceutical industry has developed a stronger working relationship with academic medicine than the medical device industry has been able to do?

The device and pharmaceutical industries are two very distinct cultures. Companies in the pharmaceutical industry are not only larger, they are oriented differently. Ultimately, the work that they do is rooted in academic biomedicine, and structurally and organizationally they are much more akin to the academic community. So they are comfortable with us, and vice versa.

Of course, there is still a huge difference. Pharmaceutical companies are very market driven, and their research is very directed. A faculty researcher who was suddenly dropped into a pharmaceutical company and told to work under its rules would very likely get whiplash from the culture shock. And there is a similar culture clash when pharmaceutical houses come into the university setting; they have a certain mode of operating that doesn't quite blend. Still, there is more similarity than difference.

The most distinctive characteristic of device companies is not so much their size as their roots. Device firms tend to have their roots in engineering fields and not so much in biomedical fields. So the orientations of device companies and academic health centers are very different. But I see that they are starting to work together, to the benefit of both parties.

The device industry is scientifically driven, but it's a different kind of science from what clinicians are used to. Engineers and bioengineers consider a different set of issues, and some of the things that physicians think are obvious, they don't consider at all. If you're designing an implantable device, for example, physicians will immediately want to consider what body systems the device might unintentionally affect. That might not be high on the list of considerations for engineers.

Similarly, academic medical researchers are stretching their capabilities to consider engineering factors. We know that we can't develop new technologies using the language of the biological sciences alone. Physicians often don't realize the possibilities of the structural sciences. They don't know how big we might be able to dream in terms of structures and devices that may be created. So both groups need to have a really strong understanding in order to strengthen both their sciences. That's a gap that has not been bridged well enough yet.

How do you see the advance of technology contributing to improved medical care?

I believe people are still going to need health professionals who can care for them and integrate information and technology so that they can be used appropriately.

In terms of technology, I'm not sure I know what will drive us. Three things that will be influential are the ability to do things more noninvasively, the capacity to intervene genetically in mammals, and the tremendous change that information technology is going to bring about for both of those things.

More things will be understood about the human genome, and that will bring both disruptions and benefits for health care. There is certainly disruption in knowing that someone may be predestined to some terrible disease or condition, but there is also the potential for developing new methods of treating or curing those conditions. There will be fear and anxiety about these new technologies, but in time we will deal with those issues.

The next five years are going to be revolutionary for information technology. When I think about the computer, which is a relatively recent innovation, and the things that it has changed in our daily lives, I think it's surely going to have an effect on health care. It's going to be hard to sort and integrate all the information that we will have at our disposal. Professionals already have a lot of information, but making sense of it is the real challenge.

Everybody's worry and fear about current technology is that it will simply give us more of the end-of-life suffering that we don't want. And that concern may bring about a rebalancing of our thinking about medical technologies. Certainly this is a societal issue that is now being examined, and we will need to determine what technologies we really want, and what we want them to do. In the past, I think, technologies tended to be geared toward prolonging life. But perhaps the next generation of technologies will focus on improving the quality of our lives.

What changes do you foresee in the international scope of medicine or the international use of medical technologies?

The whole nature of our increasingly small world has tremendous implications for health, both in terms of our ability to be aware of a wide variety of health issues and our effectiveness in dealing with those issues. Because of global travel, with air transport bringing all kinds of products and people into this country, many of the health issues that we have traditionally ignored could easily be our problems soon. As we begin to see increased outbreaks of diseases that we've never had to deal with on a day-to-day basis, our health issues are going to change. The diseases we have to be aware of and prepare for are going to be much more complex than in the past. Antibiotic resistance, for instance, is going to present a powerful challenge to the pharmaceutical industry and to the health-care community in general. It will be interesting to see what kind of technologies will be developed to address that situation. In addition, with continuing population growth, there are going to be so many of us that our sheer numbers will drive industry to create new technologies.

Few countries enjoy the access to medical technologies that we have in the United States. Do you see that changing in the future?

I think access is always going to be uneven because it is driven by the sheer wealth of the country. The strength of the argument for taking technologies into underdeveloped countries depends on the specific technology. Some technologies are too expensive for folks to afford, and some bring about radical consequences that would really not make good sense.

Henney is married to Robert Graham, MD, who currently serves as executive vice president of the American Academy of Family Physicians (Kansas City, MO). They maintain residences in Placitas, NM, and Kansas City, MO.


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