Mona Sarfaty

This is an interview with Mona Sarfaty, on July 16, 2008, in Philadelphia. Why don’t we start at the beginning? Tell me when you first met Edward Kennedy, and what were your first impressions of him.

My very first meeting was after I had been interviewed as a possible new health policy staff member. I went through the process and I was about to be offered the job, and they wanted the Senator to meet me before they offered it. At that point, I went to his office and was introduced. I sat down and chatted for a little while, and of course, I was thrilled at the idea that I would work on health policy in the Senate, on Senator Kennedy’s staff. It was really a thrilling moment for me, and I’d say he was very welcoming and gracious. It was a memorable moment, the first of many.

How did you come to be interviewed for the position? What was your background that led you to that point?

That’s an interesting story. I was at Georgetown University at the time, in the Department of Family and Community Medicine. I was a faculty member, and I was teaching family medicine residents. We had preceptors who came over in the afternoons to help teach the residents when they were seeing patients. David Sundwall, who was one of Senator [Orrin] Hatch’s chief staff people, precepted on the same afternoon that I did. We spent a lot of time chatting with each other about health policy issues when we weren’t talking to the residents, and he learned something of my background.

I had been involved in health policy and politics before I ever came to the Washington area, when I had done my residency in San Francisco. The position in Kennedy’s office became open unexpectedly. Somebody had been hired and then left to take another job, so they were looking for somebody in a hurry. I guess they put the word out and David Sundwall told them that he was working with me and he thought that I would be an interesting possible candidate for the job. So I went in, I met with David Nexon, they asked me to submit a writing sample about some policy issues, which I did, and we talked about my background and involvement and so forth, and they offered me the job.

Were you filling, in essence, the physician’s slot? He’s always had a physician.

I was actually, yes. They were definitely looking for a doctor, and they always had at least one physician on the staff. That was a part of the modus operandi of the office, and the person who had left was a physician, so they were definitely looking for another doctor. I’m not sure there had ever been a woman physician before; I might have been the first. I don’t know if that was intriguing or inspiring or something that they needed to think twice about, but they did end up offering me the job.

How did your work, filling the designated physician slot, differ from what other people did? Did you also have the responsibilities as some of the other physicians have had, of medical care and medical advice for Kennedy and for Kennedy’s extended family?

That’s a good question. By the time I got there, it was some years into his tenure in the Senate and several positions later. You would have to look back and see how many doctors had worked in the office before. I think the Senator himself was much less likely to look for his own medical advice from his physician on staff. In addition, when I began working there, Larry Horowitz, who was one of the early doctors, was still there. He was the administrative head at the time. Larry had a long-standing relationship with Senator Kennedy, and if there were medical questions, he probably asked them of Larry, and I didn’t get involved in his medical care at all.

But he did suggest to other members of the family and family friends, and even other members of the Senate or their family members or staff that they call me to ask medical questions. I would make contact with physicians around the country who might be helpful to whatever case or situation people were presenting to me. I might find them physicians, or I might give them a little advice about finding the help they needed over the phone, and so I did play a medical role there in the office, definitely.

Larry left not that long after you came. There was a long-standing relationship with Larry and Kennedy, but at that point you were the only physician. It did not transfer to you, to take over the function that Larry had filled?

Some of the early docs even traveled with him as he toured in Massachusetts and other areas, and they were standing by in case anything should happen. So there was much more of that kind of relationship I guess, as a personal physician, in addition to a staff member or policy expert. In my case, it was much less so with regard to the Senator’s own personal health care. I really did focus on health policy. I provided advice, as I said, to other staff, and family members and other Senate offices. I would find physicians in Chicago or New York or California if people were looking to find experts around the country or if people were looking for just the right physician expert. But with regard to the Senator himself, no. I didn’t really provide personal medical care.

Did you come in under Tom Rollins?

Tom Rollins joined the staff and became our committee director after I began. Kitty Higgins was the staff director when I joined. When I became a staff member, there were only two of us in the health office. It was David Nexon and myself, and that was 1986. It was late spring or early summer of ’85, and it wasn’t until ’87 that the Democrats then took control of the Senate and we were in the majority. Kennedy got two-thirds of the committee staff funding and we were able to hire more staff. During the first year and a half, it was just David and me. He did all the financing and I did most of the rest, with his guidance of course, since he had already been there for a few years.

After the Democrats took back the Senate, who did Kennedy bring in to increase the size of the health staff?

Walter [Sheridan] the investigator moved in and became a part of the health staff, and he was assigned to do some investigating that had to do with health—maybe FDA [Food and Drug Administration] issues. During 1987, I spent most of the year focusing heavily on the HIV [human immunodeficiency virus] epidemic. Michael Iskowitz was hired to work on that issue with me. And then Terry Biern (an AIDS [acquired immune deficiency syndrome] activist) was hired as well. The three of us spent a tremendous amount of time on AIDS. The first comprehensive bill passed in late 1988. Then the Ryan White Care Act came afterward.

In late 1985, early 1986, when David and I were by ourselves, and even later when we were in the majority, we brought in a lot of Robert Wood Johnson Fellows. We must have had five or six fellows who were either Robert Wood Johnson Fellows or were details from the federal government, at high levels of experience and responsibility. So we immediately increased our staff, but not with hired staff people. It’s actually somewhat difficult to remember exactly who were the staff people, since everyone was doing serious legislative development work.

One fellow was Mary [O’Neil] Mundinger, who worked on nursing training. She later became the Dean of the Nursing School at Columbia. She went on to work at the federal Office of Disease Prevention and Health Promotion. Mark Manley was a preventive medicine resident from Hopkins. He developed prevention programs for us and then went on to work at the NIH [National Institutes of Health]. A fellow from the American Association for the Advancement of Science worked on scientific integrity issues. Dick Rieselbach, who was a Dean of the Medical School at the University of Wisconsin, joined us and developed the Geriatric Training Program. Bob Vollinger went on to work at the Office of Tobacco Education at the NIH.

So we had fellows basically, for the first 18 months, and then when the new staff members began to come on board. At the beginning, some of the fellows were more like active staff members than the staff. Stephen Keith, an African American physician, joined us. Kennedy put affirmative action into effect. He felt very strongly that if we made diversity an objective, we would find people who had the credentials and could join our health policy staff, particularly African Americans, who he wanted to hear from. So we started searching for the right staff member. Stephen Keith joined us, and started working on quality issues. Some people moved from other offices into our office.

Ron Weich, a lawyer, was hired to work on the war on drugs. Deb Sutinen was there at the time as an administrative person, and Wanda Dawkins was another lively administrative presence.

Over the next six years, we had a lot of people come and go. Mike Iskowitz joined the staff. He worked a tremendous amount on AIDS policy. I spent an entire year working on AIDS policy and initiated the focus on AIDS. Toward the middle of 1987, Michael joined the staff, and then Terry Beirn also came on for a year. He came from an AIDS activist perspective, and he brought a lot of energy to our AIDS effort and connected us to other outside groups. Michael, Terry, and I then worked together on AIDS policy. I planned the first couple of hearings and we laid a lot of groundwork and put together the first bill, which addressed prevention and treatment. We later expanded the focus to health service and care of people with AIDS. Altogether we had about 5-6 hearings on AIDS.

Darrel Jodrey joined us as a fellow initially to work with David on Medicare, and then she was hired as a full-time person. Ron Weich joined us as mentioned.

Yes.

As I said, we immediately brought five fellows into the office, and they worked intensely in specific areas. Whereas a lot of the staff people would come in and they’d get two or three areas they had to cover, the fellows were working in depth. They were very senior people, and they were working in depth on particular policy developments or policy analyses.

From the time you came in, what was your basic portfolio and how did it differ from what David did?

David did all the financing issues: the health reform, health financing, healthcare for all Americans, the health provisions as they had to do with requirement of employment, health benefits, Medicare. Those were all David’s areas, and I handled everything else.

Did he do COBRA [Consolidated Omnibus Budget Reconciliation Act]?

Yes, he did COBRA also, because that was a health insurance area. There were other issues that were continued from previous work. An example of that would be biomedical ethics. Kennedy had a long-standing interest in biomedical ethics, and I picked that up and continued to work on it. The “scientific integrity issue” as it was called at that time became a hot area because Congressman [John] Dingell held hearings that implicated David Baltimore, a famous Nobel Prize winning scientist. Senator Kennedy had a long-standing interest in biomedical research, and I also picked that up and continued to work on it. For instance, we did a hearing on the National Cancer Act. Every year we’d make recommendations on the appropriations for the NIH, and we reauthorized the legal authorities and programs every three years, and created new ones.

So you handled that?

Yes. I picked up the biomedical research, and he also had a long track record of involvement with the pharmaceuticals—FDA and pharmaceutical regulation—and I also picked that up. Drug export became a hot issue. This issue was whether approval of drugs by other countries would make it permissible for U.S. companies to export U.S. manufactured medications to these other countries. U.S. jobs were thought to be at stake. Those were the areas that I inherited. He also had a long-standing involvement in access to care through Medicaid, Medicare, and government supported options like community health centers, rural health centers, and the National Health Service Corps. He had been an advocate and supporter of the programs that were extending health service delivery sites around the country, so I picked all of that up.

We continued working on all of those and began to look for new and exciting policy areas. Tobacco was a pressing one. HIV was unaddressed at the time and almost a taboo subject in 1986. There had been no hearings on the Senate side on AIDS in the middle of 1986. The epidemic was already several years old, but there hadn’t been a single hearing and it was a taboo subject, and so that was a target that we wanted to address. The Senator was very concerned and interested.

Did he stake it out and say that he wanted to address it?

Yes, he did. He recognized its importance very early, especially since it was early on viewed as a plague and the victims were being treated like lepers. In addition, Senator Kennedy has a really keen ear and a keen eye for an idea whose time is coming. He was always open to hearing from his staff about things that we thought were pressing or looming on the agenda, issues that just really needed attention.

At the beginning of every year, before the beginning of the new Congress, he would put out the word to his staff that he wanted to prepare for the new Congress and that we should submit ideas about what we thought should be addressed. We would send all that material in—we’d have discussions amongst the staff and with our staff directors, and there’d be almost a competition of ideas and brainstorming. From that, we would factor out what we thought were the best or the most important things to address, or the areas where we could do the most good and we could make the most difference. We would send those all along, and then the Senator would sit down and talk about them, and sometimes he’d call some of us together to flesh the ideas out a little bit more, so he could hear more from us about why we wanted to address those issues. From that would come a list of priorities, and then he and we would decide which priority we were going to focus on.

That happened every Congress, and sometimes that happened every year. The big things start at the beginning of the Congresses, but each year is also a new year of new opportunity, depending on how much is carried over from the prior year. If there’s not much carry over because the work’s been done, then you have more time to initiate new topics in the second year of the Congress.

What were the issues that emerged with the FDA?

Well, let me mention one thing. Because the Democrats were taking over the Senate majority in ’87, this was a very exciting watershed, so we actually had a lot of discussion about where we were going to focus. Right up front, at the beginning of the year, we had a health goals hearing: we were attempting to establish some goals for the new Congress. The goals were: expanded access to care for the uninsured, better Medicare protection for the elderly, care for pregnant women and kids, biomedical research and health promotion, and disease prevention. Around those five priority areas, we had various people come in at the hearing to lay out some ideas, and then we developed a whole series of more specific focus areas within those goals. It was a pretty rational process, almost like strategic planning, that went on at the beginning of that year. It was highly organized.

That’s often not too well understood—how do issues become issues? There actually was a process to figure that out, and in this case, there was prework and discussion and vetting between the staff and the Senator, and then we brought in outside experts to comment on all of that, and from that came a number of things that we subsequently worked on. In health promotion and disease prevention, for instance, HIV was a huge issue. We didn’t want to ignore that. We wanted to get the Senate going, doing something, and that fit in perfectly with health promotion and disease prevention.

Tobacco, which had been a major focus before, also fit in perfectly in health promotion and disease prevention. I think tobacco policy was one of those ideas whose time had come. A number of us realized that all of the work, the scientific work, had been done, and the interest groups and associations were reasonably unified in their concern about it and their desire to do something. There were enough political figures who were beginning to tune in and realize that this was important, that it was a great story to tell and really important progress to be made. Since all the elements had come together perfectly, it was an excellent time to work on tobacco. It came to a head several years later, but key legislative work started then.

How did Kennedy feel about tobacco?

That’s a good question. Like everybody else, once he realized what a scourge it was, and that a thousand people a day were dying because of tobacco-related illness, and that it was something that was entirely preventable, and that the product itself was addictive, he was convinced that this was something that we needed to work on, and that if we did make some progress, it would have huge implications for the health of the country. All that prework— everything that was needed to show the harmful effects—had been done already, so the evidence was there and the information was there. All the arguments had been marshaled. He was open minded and willing to pursue things that were going to make a difference to the health of the people of the country or even the world. He became completely convinced.

Now, he personally smoked a cigar now and again, and that was always a subject of some mirth amongst the staff. In fact, in 1987, the second health goals hearing was held on January 15th, which is the day before I delivered my second child. I was sitting behind him at the hearing as Surgeon General Everett Koop was testifying. Kennedy pulled out a cigar and lit up and started to smoke. Here’s Koop, who is the country’s leading voice on the dangers of tobacco use, and Kennedy’s sitting there smoking his cigar, so I learned forward and I said, “Senator, the Surgeon General is here. Do you think maybe it’s a good idea to put the cigar out?” He said, “Aww” and he put out his cigar in the ashtray and said, “Can’t a fellow have any fun?” But he put it out and that was the end of it.

Aside from the fact that you were very pregnant, sitting behind him.

Well, at the time, a lot of the implications regarding smoking and pregnancy were not realized. It wasn’t proved until later that smoking by the pregnant woman, and even secondhand smoke, could have an impact on the fetus. The data about secondhand smoke was quite fresh.

Oh, really?

Yes.

What was the status of the tobacco lawsuit at this point? Is that still off in the future or had it already started?

There had been a liability project that had started earlier in the ’80s, but none of the liability suits really worked, and so it wasn’t until ’93 that the Supreme Court finally ruled, in the Cipollone [v. Liggett Group] case, that the warning labels on the cigarette packages did not protect the cigarette industry from liability. Once that happened, it opened up the floodgates, but it took quite a while to get to that point.

This was a good six years before that?

Yes. Right.

So he really was in advance—The ducks may have been lined up, but the legal system hadn’t caught up to the change.

Absolutely. I’d say he really got that ball rolling in the Senate, on tobacco. There had been some earlier things that had happened—in 1970, remember, there was the ban on TV advertising. At that time, the Fairness Doctrine was in effect, and some of the organizations like the American Cancer Society, the American Heart Association, and the American Lung Association had started to get counter ads onto television against the cigarette ads, and the counter ads looked like they were being quite effective. So the tobacco industry didn’t really oppose the efforts to get their advertising off the air. They realized that if they got their advertising off, they would get the counter advertising off, and maybe it would just be a wash. But they cleverly slipped in a preemption on state regulation of advertising. When their TV advertising was banned, they preempted any state regulation of advertising, which was a very clever move.

That was 1970, and then they started to promote all those events on TV anyway—NASCAR races and every kind of sporting event on television. They got all of their logos and product names back on TV even though they weren’t advertising. There were also additional labeling bills. The first required label, “The Surgeon General Has Determined That Cigarette Smoking is Dangerous to Your Health,” had come in ’65. The labels were updated after that and there were rotating warning labels added. There had been a little policy activity in Congress, but not a whole lot. So when he picked it up in the mid-’80s, it really made a big difference.

How was it conceptualized to tackle the tobacco problem?

Well, we did a lot of work. I did a lot of work on exactly how we should approach it. One of the first things we considered came from one of the members of Congress, Mike Synar I believe, who recommended that tobacco advertising be completely banned. He was planning to introduce this in the House and Kennedy considered introducing it on the Senate side. I think that was 1987. We thoroughly researched it. Tom Rollins was there at the time and he was close buddies with some constitutional experts. We looked at the advertising budget—how large it was and how much of a difference we thought it really made in people’s decision to take up the smoking habit. Ultimately, we thought it might be effective policy, but we decided not to do it because we recognized that legally we would not be able to get it through, and that it would become a constitutional issue and just wasn’t going to be fruitful.

Would the votes have been there?

That’s a good question, hard to say, probably not. Later on, the Clinton administration tried to put through an advertising ban, and it did not get through the Supreme Court, so that judgment was correct. It just wouldn’t have passed muster.

We were researching other possible approaches, and we became very interested in prevention and education and smoking in the schools. We were still looking at the advertising issue and whether there was some way that we could address advertising, which was ubiquitous, especially in poor and minority communities, and whether there were other ways that we could address that. We started to look at some of the things that were toxic about cigarettes, and the issues about what is actually in cigarettes that people don’t realize that they’re taking into their lungs, and we got into a right-to-know approach. So we developed all of those areas of policy and recommended that we establish some kind of a center in the federal government that would take responsibility for supporting education in the schools and public education, and that might even be able to take some public dollars and do counter advertising. Then we recommended that some of the preemption on state regulation of advertising be lifted. One of our first bills actually tried to lift the preemption so that states at least could take action and try to limit the ubiquitous advertising they were facing.

We suggested greatly strengthening the warning labels and making them larger, because the warning labels were so tiny on the packages that they were insignificant, and very difficult to see. Canada had labels that were about 20 percent of the package size, so we proposed that we have much larger labels, with much clearer, simpler statements of the danger, and also made it clear that the product was addictive.

Little by little, we put together this whole policy plan, which eventually was introduced as a piece of legislation, and then we held hearings on it. We never actually did get that bill passed, but in the process of holding hearings and publicizing the approaches, a great deal more activity was stimulated.

By whom?

Tobacco continued to grow as an area of public health interest. The Surgeon General’s Office started to put out a report every single year on tobacco, so one year there was a report on tobacco cessation, another year was on tobacco addiction, another year was on secondhand smoke, another year was on women and smoking. There hadn’t been annual reports of any significant size, and the Surgeon General’s Office began to put out these reports that looked at different aspects of the smoking and tobacco use problem every single year. In addition, the CDC [Centers for Disease Control and Prevention] began to focus more on school education, and they developed some education programs that got into the schools, and they evaluated them and they found that these programs were effective.

The advertising issue continued to be vetted and discussed, and when the Clinton administration came in, they put through something that would have allowed the FDA to regulate advertising. That was what the Supreme Court nixed when they made their decision. So that whole notion of trying somehow to limit advertising continued under discussion as a focus of interest, and people kept coming up with new variations on policy proposals. We also, in our bill, tried to work on tobacco through worksite wellness, so there was a little grant program in there that would have supported businesses to try to discourage smoking amongst their workers. That was one of the things that got the whole smoke-free buildings issue moving.

As you know, there’s currently a tobacco bill working its way through Congress. This is 2008, and we introduced the original bill in 1990, so this is 18 years later. It takes a while for major policy changes to happen, but the thing about Kennedy’s office and the hearings and the bringing together of groups, is that nationwide, it gave all of this a mighty shove. At its best, this is one of the things that the policy process does. It does several things, but this is definitely one of them. The EMTALA [Emergency Medical Treatment and Active Labor Act] bill that opened emergency rooms is an example of another way to achieve progress through Congressional activity.

Who was your target audience? Was it other Senators? Was it the media? Was it the public? Was it the executive branch?

Our target audience always had two parts, and it was always about the public. It was always clear that we wanted to get good coverage for our subject matter, and we thought long and hard about how to tell a story that the public could comprehend. The other important audience was the Senate. We were always trying to create a record that made a very strong case for our policy proposals, so that later on, when we tried to get these proposals through as bills, we could point to our hearing record and say, “If you need the evidence that what we’re saying is true or that what we recommend could be effective, here it is. It’s in the hearing record. It’s printed by the Government Printing Office [GPO]. It’s available as a little booklet. Every member of the Senate and every staff person can get one, and so we want to make sure that was available to you.”

We always had those two audiences. Now of course, if we could get the administration on our side as we tried to move things through, that would always bring more votes. I don’t think they were a principal audience, but they were potential allies.

Well, initially you had Koop.

For tobacco.

For tobacco, yes.

Yes, we did, it’s true, and tobacco was one of those issues in which you didn’t have some of the ideological opposition that other issues seemed to bring with them.

Just regional.

Just regional opposition, and it was powerful, there’s no question about it, and it brought big money. There were very powerful financial interests that opposed any tobacco regulation or legislation.

When did the ban on smoking in airplanes go through, and how?

You’d have to check the date, the exact date, but it was about 1988 or ’89, I think. That was a result of a suit brought by the flight attendants against the airlines, who felt that they were being subjected to the dangers of secondhand smoke on their job and wanted to be protected.

What was Kennedy’s role in the Congressional action on it? Because if I recall, it went through by bylaw rather than by Executive order. Did Kennedy play any role?

Yes, it did. I think he spoke on it. He was not the person who introduced that bill. I believe it passed first as an amendment to another bill on the House side. He may have been a cosponsor. It didn’t originate in our office, but he was a supporter, and I’m sure his support carried weight. That was a very exciting development because it was really the first time that smoking was banned by federal law, across the board, for a particular type of environment. That was a precedent.

The focus really was more on the health piece and using the hook of our health costs and the costs of the health system going up because of the dangers of smoking, because of people’s behavior?

Well, no. The cost was definitely a piece of it, but we were losing about 360,000 people a year to tobacco, a thousand people a day. The carnage was tremendous, and of course along with that went significant costs, $100 billion per year to be exact. Not only was there a lot of carnage, but there was a lot of carnage for groups that didn’t previously face the risk. Women, for instance, had not been a group who had smoked in large numbers, and about that period, in the mid-’80s, the number of women who were dying from lung cancer—that had been relatively small some years before—grew tremendously, and lung cancer became the biggest killer of women in addition to the biggest cancer killer of men. I know that definitely impressed people. As one of the groups said, it was the only product that was deadly when used exactly as intended. That logic was very powerful.

When we realized we had good proof that it was addictive—because by then it had been scientifically demonstrated that it was an addictive product—that put it in a context which was very unacceptable. There was nothing nefarious, and any fair-minded person would see it as nefarious, to sell a product that was addictive, especially at a time when we were facing the national drug emergency.

It was 1986 that we had the national war on drugs, and every committee in the Senate had been involved in helping to develop some aspect of the legislation for the war on drugs. So our committee worked on the treatment of addiction. The committees that focused on criminal law worked on the criminalization issues. Those that worked on transportation, across state lines, worked on those issues. But every single committee in the Senate was involved in coming up with a part of that national drug act in 1986. We had evidence that tobacco really and truly was addictive, and suddenly it put it in a whole new context. Here’s an addictive product that’s being legally sold, that is deadly, that’s going to kill one-quarter of the people who take up the habit. And yes, it was costly, but I don’t think that was the principal reason. I guess it was one of the reasons, but it wasn’t the only reason.

At this early stage of the fight against tobacco, was there any discussion of giving the FDA the power to regulate tobacco as a drug?

Yes, we did look into that, and we had discussions with the FDA. We talked to people at the Agency for Toxic Substances as another possible place to put a regulatory operation. We did look extensively into it, and at the time we decided that it wasn’t a good fit for the FDA. I think that was the judgment at the time.

Why did it become a good fit later? Change of leadership of the FDA? Change of mentality?

At the time, the FDA had not been at all involved in this issue. Later on, when David Kessler became Commissioner, he was very interested and did some investigative work that ended up also having a great impact on the development of the issue. I don’t know if you talked with him already about this whole revelation about the industry importing a biologically engineered tobacco plant from Brazil, which was specifically engineered to be able to deliver more nicotine and be more addictive. It was the subject of a 60 Minutes report. Talk about something that was a smoking gun. That was the smoking gun.

So to speak. [chuckle]

And at that point, all of the heads of the tobacco companies were called to testify before the Oversight and Investigations Committee on the House side, and there’s that famous picture of them all standing up and raising their right hands.

Really something.

So Kessler was interested, and that made a big difference.

On the FDA, talk about the shift when Kessler comes in as Commissioner. What were the issues that you were dealing with, with the FDA, when you first came there, and then how did that change with Kessler?

The first big issue was biotechnology and the export of U.S. pharmaceuticals, and the loss of U.S. economic interests because of barriers to export of drugs. Drug export was something that I must have spent six months on when I started. There were always many overlapping issues.

Genentech was especially concerned that it was going to have to begin to license its products abroad, because it otherwise couldn’t export them, and if they licensed their products abroad, then the jobs would have to go abroad. If we changed the laws to make it possible to export some of the drugs, then the development and the jobs could remain in the U.S. and just the drugs would be exported. But in order to set up that system, we had to look at all of the world’s drug approval agencies and to try to understand which ones were qualified to be able to make a domestic decision. So we did come up with a bill and it passed, and it did reform the drug export rules at the time. It was later reformed again, so it works differently now than it did then, but that stayed in place for some years.

After that, we had a whole series of disputes. It seemed like we were often resolving disputes between companies that alleged that they had been, in one way or the other, cheated out of a patent, or that a rival company had been allowed to market the same drug under a different name. One dispute was over a drug that had only one amino acid different and was seen as a different drug so that both drugs could be approved simultaneously. One company might have lost patent exclusivity because of that. There were a lot of disputes between companies and they would come to Congress to relieve. We also had specific issues, such as the Tylenol poisonings, which occurred while I was there. That was a fire that had to be put out. From that came new practices and regulations on packaging and sealed containers and things like that.

How much of that came out of Congress and how much out of the executive branch, and how much out of the industry itself?

I think most of that was proactively initiated by the industry, but it may also have worked its way into FDA regulation. The industry was terribly damaged by the poisonings, and they wanted to develop a mechanism to protect their product and to prove to the consumer that the product was safe, so they came up with all kinds of packaging protections and seals and things. We held hearings on it. It gave everybody an opportunity to air the problem and the potential solutions and to learn exactly what had happened. Some of these voluntary solutions went into effect, but whether the FDA followed that up with regulations so that it would spread to the entire industry, I’m not sure. It’s very possible that they did. Once other companies realized that their products were vulnerable to that kind of tampering, many of them wanted to take action.

With regard to the FDA, the user fee issue was one we looked into. There was a lot of concern that the FDA budget didn’t match up to its responsibilities. That was something that came up over and over again because the agency was given a lot of responsibility, and every time something went wrong, it was given more responsibility. They greatly needed increased funding and they weren’t getting it from the appropriations subcommittee that was responsible for it, which is the Agriculture Subcommittee.

For some reason the FDA appropriations don’t go through a health subcommittee, they go through the Agriculture Subcommittee. Probably because it’s food rather than cosmetics, the Agriculture Subcommittee has somewhat less appreciation—or had somewhat less appreciation—for the public health mission. So the FDA wasn’t getting the support that it needed. This idea of a user fee had been kicking around some years before, so the notion wasn’t original on our parts. But we picked it up and we researched it, and we tried to figure out how we could make it work. The bill did finally pass, and it went into effect.

This was user fees for companies who were attempting to get approval of drugs?

Yes, so they all had to pay for the privilege of being regulated by experts. That was what the notion was.

Were generic drugs an issue in those years?

No, but another issue that came up was the food supplements. The food supplement industry launched a mighty campaign and spent huge numbers of dollars in support of the campaigns of some committee members, and it was able to get through a bill that deregulated food supplements. From that came your general nutrition stores and all of these other commercial outlets for myriad food supplements. I won’t say anything more about that. There’s a lot of concern on the public health side and the medical side about food supplements. They are unregulated. Some tragedies have occurred because of it.

Well, there’s a long history of Congressional attempts to regulate vitamins and food supplements, all of which tend to fail because for some reason, the industry manages to—I don’t know whether they garner grassroots support, but it doesn’t get through, and it ties people up in knots.

Yes. This actually even loosened it up further, so it made it possible to get some other items, which are really essentially drugs. But if they’re in the form of “food supplements,” they don’t have to be regulated. That’s an area of concern.

What else was going on with regard to the FDA? There was more biotechnology work which came later, and Mark, whose last name I’m also not going to remember, picked that up eventually. I worked on the FDA for several years, and then in 1988 and ’89, I started focusing in a lot more on public health; access, tobacco, HIV, and biomedical research, and some of the other things I just let go.

I have to mention some of the things we did in graduate medical education because so many of these little things seem so insignificant when you look at the Senate agenda, but when you look out at the world, they are so important. One example of that was—in ’86 I believe it was—when Dick Rieselbach was the fellow. He was a Dean from the University of Wisconsin Medical School. He came in greatly concerned about geriatric education and the fact that we really needed geriatricians and there were very few in training and little money to train them. So he worked for a whole year on a proposal to develop geriatric training programs and to have the Health Resources Services Administration support the geriatric training programs. He left before we ever got it passed, but we continued to work on it. We eventually got that passed and now there is direct support for graduate medical education in geriatrics. We still need many more geriatricians, but at least we have that significant start and we have some out there.

We now have baby boomers starting to turn 60, and over the next 15 to 20 years, they’re going to be 60 to 80. It’s a huge piece of the population, and the need for geriatrics is greater than ever. So if we didn’t have that innovating going on in the mid-’80s, we’d be in a more difficult place today in figuring out how to meet those needs.

Were you there when David Kessler came in as head of FDA?

I was, yes. I was at that hearing. In fact, I think I staffed the Senator. Several of us staffed him during that hearing, and we each came up with questions that were relevant to the areas that we were working on.

Did he bring a new approach to the FDA?

I’m not sure that that was so apparent on the Congressional side, but it was apparent on the FDA side. He was a Republican but he was more bipartisan, he was more open. He was less ideological. He wasn’t stuck in any kind of traditional ruts in terms of what he was willing to address, and he was willing to be more proactive. All of those things, I think, characterized his interest.

He also came in with a very strong focus on food safety and on the truth in food claims, and food labeling became something that the FDA got involved in. We had been a little involved in it before, mainly because of the interest of Senator [Howard] Metzenbaum from Ohio. Metzenbaum had gone to the floor of the Senate several times with food labeling proposals, and they never managed to get through. Then they got various agencies involved—the Department of Agriculture and then eventually the FDA. I guess Kessler gave that a lot of attention, and from that came a very viable food labeling system, which is the one that we have in effect today.

Kessler looked at packages of orange juice and soup and was disturbed by the misleading claims or statements on the packages. He sought to clean that up, and that went very nicely with the interest in food labeling and letting people know what exactly they were eating, what the content was, what the fat content was especially. So that was something that was achieved during his tenure. And then he got very interested in tobacco as well, and really advanced the cause of tobacco control.

Why don’t you talk about that first year of working on AIDS, before Michael Iskowitz came in.

In 1987, the Democrats were now the majority in the Senate. We had managed to have a hearing in the fall of ’86 on AIDS, which was a breakthrough, because there had been no prior hearings despite the fact that there was interest. We worked with Senator Hatch’s staff person, David Sundwall, who was an open-minded, and I think very public-health-minded, individual. We finally got Senator Hatch to agree that this was something that should be addressed, so we had that hearing in the fall of ’86.

Then, in preparation for 1987 and the health goals hearing, we realized that HIV was something that we really wanted to address, that it was an epidemic that had tremendous potential significance not only in the United States but worldwide. We began to try to figure out what to do about it—what kind of role the Senate and Senator Kennedy could play and what kind of proposals we could make that were within the jurisdiction of our committee, that would really be of help, and for which we could get support, so we started to do a lot of research. We talked to people around the country who were addressing AIDS, including public health departments and medical centers. We talked to some of the public health experts, epidemiologists who had been following this and who could help us predict what we were going to see some years down the line and what we would need to address it. There were some individuals who were personally very concerned and who you might call “friends of the office,” who were extremely well informed and who made themselves available, dropped by frequently, and had valuable perspective on it.

Who were some of those?

I knew you were going to ask me that, and I’m blocking right now on the names.

Mathilde Krim?

No, it wasn’t Mathilde Krim. She may have been talking to somebody, not really to me. It was Professor Bill Hazeltine. He was from Harvard Medical School, he was a researcher, and he really had his mind wrapped around the larger picture in a way that was very helpful. We also had access to people like Tony Fauci from the Infectious Diseases Institute. So from many discussions, including people from health departments in the country that were seeing a lot of HIV and AIDS, we started to develop a sense of what was needed. Margaret Fishel was an example. At about the same time, Surgeon General Koop had sent out his Surgeon General’s Report on AIDS. I think that was also ’88. I don’t think he had talked about it in the Congress at that point. I think this hearing we invited him to was his first opportunity to address that. He was a very strong voice and we had his input, and he was emphasizing education.

The education piece, the prevention piece, was one that the public clearly needed to know about, because it was possible to prevent AIDS, but people didn’t know how it was spread and how to prevent it. We wanted to get that information out just like Koop had tried to get it out, so we tried to get it out through the hearing, and then we sought to get it out through legislation, through an education program that would further disseminate this information.

We were very concerned about the medical care for people who had AIDS, and also where they were being treated and whether they could all be treated in highly specialized centers. It was still new enough at the time that only a limited number of places had experience with it and were in a position to know what to do or to recognize it. There needed to be dissemination of information amongst physicians and academic medical centers about the problem and how to address the infections that occurred, so we tried to give some help through legislation to try to support the care effort by providing some funding for research and medical care, and especially for research initially. There was research to treat it, research to prevent it, and also research on how to take care of it, so we introduced a bill that had prevention education and research as the main focus. This was in ’87. Actually, there was a smaller bill introduced in ’86, I think just a prevention and education bill. And then in ’87 we included prevention education research. There was a little bit of interest in care, but it was later on, with the Ryan White Bill, that we really addressed the care issues.

The care piece.

Yes. In ’87, my life as a staff member was very involved with meeting with people, talking to people, trying to learn enough about the issue to help guide the Senator on what needed to be done, what we could do, what was the priority, how to get the word out, who to bring in. It was really policy development, policy analysis, and that year was full of endlessly talking to people who were from different parts of the country, from different parts of the health structure, the preventive people in the health departments, and at the CDC. There were research people at the NIH and at some of the medical schools, the treatment people at the medical schools, and the education folks.

What about AIDS activists?

We did begin to talk to the AIDS activists, but I think it was really when Terry Beirn came on that we got a lot more involved with the AIDS activists. To his credit, Kennedy wanted to bring an AIDS activist into the office, and Terry Beirn was that person. He was an AIDS activist. He joined us and he got us to think a bit more broadly about some of the things that we would do that addressed the problems raised by the AIDS activists. They had tremendous concern about decentralizing the treatment of people with AIDS, putting more services in the community, making them more accessible to people where they lived, as opposed to them having to leave their home communities and go to referral centers. Some of that structure was added to our legislation.

Did you deal with the community-based clinical trials issue?

Yes. The community-based clinical trials also opened up the clinical trials to people who wouldn’t necessarily be in the academic medical centers or at the NIH, but who were in the community itself. That was also one of the innovations that came from that increased dialogue with the AIDS activists, and that was eventually factored into that same bill, I think, in ’88. So all of the work of ’86, ’87 and ’88, finally came together in Senate Bill 1288. It was the Health Omnibus Programs Extension [HOPE] Act of 1988 for programs with respect to Acquired Immune Deficiency Syndrome. We finally passed that in November of ’88. It took two and a half years to get a bill through, but it did get through and it was the first comprehensive AIDS legislation, and it had all of that in it.

How did it come about that Michael Iskowitz was hired?

We wanted to get somebody who would spend more time focusing on AIDS because I spent so much of my time in 1987 working on AIDS, and I had a lot of other things that were supposed to be areas of responsibility. In fact, I was associate director for health in that year, working with David, and we still had this sort of rough division of the world, where he did all the financing and the coverage and I did everything else. So we were looking for somebody who would really pick up the AIDS issue and work it intensely. Michael came along. We interviewed him, David took it from there to the committee director, who was still Tom Rollins at the time, and the Senator, and then Michael was hired.

There was so much going on. It’s just mind boggling when I think back on it. There were two big things that happened in ’86 that became leading edge events for things that continued to be dominant policy areas for the next ten years or more. One of those was child health. It was in ’86 that we introduced the first Medicaid expansion, and although David usually handled the financing things, because it was children’s health, I got very involved in that. The Institute of Medicine report on prenatal care had come out just a little before that. It gave cost benefit data that showed that every dollar spent on prenatal care saved about $2.60. I remember clearly our poster that had the money painted on it to illustrate the savings. I can see Senator Kennedy pointing at it at the press conference announcing the introduction of the bill.

Senator Kennedy—with [David] Durenberger, who was on the Finance Committee and therefore able to take this to the committee of jurisdiction—and some other Senators introduced this bill that made all pregnant women and infants covered by Medicaid, up to 100 percent of the federal poverty level, regardless of where they lived in the country. Before that time, pregnant women and infants were covered by Medicaid only if they were below the Medicaid level by the state definition, which could have been set over a range of levels. This bill said that if you were at 100 percent of the federal poverty level, then you would be covered by Medicaid if you’re a pregnant woman or an infant. That was a huge breakthrough. It created a federal standard for care for pregnant women and infants, a federal income floor for pregnant women and infants. Shortly after that, we began to try to raise that level and phase it in until it was much higher, and by 1990, there was a provision that raised, on a phased-in basis, coverage for kids up to 100 percent, to age 18. And it became an option for states to go right up to 185 percent.

So between 1986 and 1990, we went from this new notion that we should have an income floor, under which we will provide care to all pregnant women and infants, to a phase-in basis for children all the way up to age 18. It was under 100 percent of the poverty level and states had the option of going to 185 percent if they wanted, and the feds would match their spending. This really formed the basis for what later became the CHIP [Children’s Health Insurance Program] program.

And how did the S-CHIP program differ from that?

In ’96, they separated Medicaid from welfare. Before that, a lot of states said that when you get on welfare, then you get Medicaid, so the welfare income level was not necessarily set at 100 percent of the federal poverty level. It was set wherever the states wanted to set it, and some of them were very low—35 percent of the federal poverty level. So in ’96, when they did away with welfare and they created that aid for needy families—

Welfare to Work.

Yes, Welfare to Work. It separated out Medicaid and that had to be conferred independently. Then Medicaid was separate with 100 percent for pregnant women, infants, and kids up to age 18, and then it was a very logical step to just separate the program entirely and to make it the CHIP program.

So the actual underpinnings for what became the CHIP program were set considerably earlier, and all the CHIP program did was to separate it from welfare?

Yes, I think the foundation was being put in place. In ’86, when they established a floor, they said that every state must observe the floor—no more of this “30 percent of the poverty level and that’s what gets you Medicaid.” Instead, if you’re a pregnant woman or infant at 100 percent of the federal poverty level, you are going to get healthcare. From there, the ages were increased each year, up until about 1990, at which time ages six to 18 were phased in over several years.

When that finally stopped being phased in—it may have been just before CHIP happened—by the time CHIP formed, there was a whole program out there that offered mandatory Medicaid for kids up to the age of 18 and for pregnant women who were below 100 percent of the federal poverty level, which is now about $40,000 for a family of four. Furthermore, if individual states want to, they can go up to a much higher level—up to 185 percent of the poverty level—with their individual Medicaid programs, and we’ll match them. The CHIP program tried to raise it to 300 percent this last year, and that was what [George W.] Bush vetoed. But yes, the principles and the mechanisms were set in motion.

I would say that Kennedy had a huge role in determining that direction nationwide, a huge role in determining the tobacco direction, and in getting the AIDS policies moving in the right direction. I have to say that’s the case with the homeless also, because the McKinney Homeless Act passed during that same ’86–’87 period of time. I was not involved in that, but it provided a whole range of services for the homeless, including healthcare services for the homeless, which are still providing care all over the country. Cities and states all over the country are drawing on that McKinney program.

This was a very busy time, and there are a lot of things that took place in that time period. Kennedy obviously was very active, having just taken back the chairmanship.

Extremely active. Very ambitious, and very determined to accomplish something, so he empowered the staff. We worked for him. He listened to us. He was a tireless champion. It was a time of tremendous energy and devotion and achievement, achievement in the sense that there was so much launched during that period of time. To me it was a leap forward for public health, it was like the 60s was for coverage, with the founding of Medicare and Medicaid. I really believe that. With all these areas of policy, it had a similar determining impact. It shaped health policy for years to come.

How did Tom Rollins’ style of leadership for the committee differ from Nick Littlefield’s, who came in relatively soon thereafter?

Tom was actually a lot more willing to bring the expert staff into direct contact with the Senator. He was more conscious of what he knew and what he didn’t know, and he really sought to allow a very free flow of ideas—well, not a completely free flow of ideas, but to allow a flow of ideas—between the Senator and his staff. The whole operation greatly thrived under that kind of leadership. Between Kennedy’s executive style and Rollins’ willingness to have the expertise flow directly to the Senator, it allowed the process to be very open and to really draw on great energy and good ideas.

Nick Littlefield was much more apt to want to handle a lot of that interchange with the Senator by himself, so although there was still a fair amount of contact with Senator Kennedy— especially for some of us who had been around for a while—in general, I’d say it was a more closed process. I don’t know whether that was Nick or whether it was Kennedy during a different period of his life. I really couldn’t tell you. He could have easily said, “Look, I’m tired of talking to all these people, please just come here and tell me what I need to do.” When we were there, it was ’88, and he celebrated 25 years in the Senate. He just celebrated his 75th birthday, so he was about 55 at that time. By the early ’90s, he was almost 60. I have no idea whether it was Nick or the Senator. It seemed to me that it was Nick, but I don’t really know.

Why did you leave?

It was a very hard decision. My first child was born in ’85 and my second child was born in ’87. I cut back my hours first, just so I could spend more time with my kids, and then I kept reducing my time and for a while there I was going 50 percent, 30 percent, then 20 percent. I felt like I had to go because you can’t do health policy in a part-time way in Washington, and I really wanted to spend more time with my children. I was still working there 10 percent and everybody was joking that I would never really leave because I would just keep halving the percentages. When I did actually leave, it was very hard to go, and I felt somewhat bereft, because I really did love working there. But it was not really compatible for the kind of mother that I wanted to be at that point in my life.

Well, this has been terrific. There’s so much that went on in those years—just a very busy time. Anything else you want to add?

I’m sure there’s a great deal more I’d want to add. Also, just to give some sense about how much interplay there was between us and the biomedical research enterprise. We were talking to the institute directors at the NIH all of the time. They would come to us with their problems and their concerns, and we would try to figure out whether there was some way that the Senate could help them or Senator Kennedy could help them with their interest for the upcoming reauthorization that happened every three years. I went through two or three authorizations while I was there, and with every reauthorization, there were some little adjustments that the institute directors were seeking in their legislative authorities that would help them to be able to expand into areas of research where they weren’t previously expanded, or would define their role a little bit better to help protect them within the NIH structure, or would bring some of the interest groups into the public light so that the public would realize that there was a lot more interest in these areas of research.

They clearly are political people, the folks who get those jobs as institute directors. They were in a sensitive position because they were administration appointees. They never testified. The head of the NIH testifies, but technically, they’re still appointees, so there were some political concerns that they had to be aware of. And yet, they were much closer to their own individual institutes and the agendas and the dollars and what was and wasn’t happening. Clearly, when it came to the reauthorization times or the appropriations, the NIH directors always had very definite interests that they wanted the Senate to know about, and for them to be able to get that word into the process was a dance, a delicate dance in which they had to be very aware of protocol. And yet, they definitely wanted to make sure that information transfer occurred. We were working on those kinds of issues at that time.

We also established the NIH Foundation. That was a proposal developed by Wright Williamson, who was on detail from the National Institute of Mental Health. He was an administrator from the Institute of Mental Health who came to work in the Senate on our committee for a year and who worked with me. Senator Kennedy liked the idea. I think the idea had come originally from the Institute of Medicine. They recommended it in a report as a possible way to improve the functioning of the NIH, and we thought this recommendation was viable. Then Wright Williamson worked on it and we worked it into a really great proposal. Kennedy was excited about it and thought it could bring some private money into the NIH and that it could help support things that the institutes were limited to do, and we got that passed. It finally passed in 1990, and now it’s a very active foundation that brings together private money and public money and helps to spawn new approaches, some public/private partnerships that might not otherwise get support. So we did that.

It also demonstrates how effectively Kennedy and his staff use fellows.

Yes.

Bringing fellows in and working on specific issues that they can then apply their expertise to, and they get something very concrete accomplished, even if it’s not within the tenure of when they’re there.

Each fellow had a project that they worked on while they were in the Senate, and I’d say two-thirds of them ended up as viable legislation.

That’s great.

So it was a great experience for them and it was great for the office.

More hands, more work, more accomplishments, more expertise.

It always amazed me that folks from such high levels of training and responsibility would come in and find it so fascinating and be so inspired to work on these proposals. It was a constant reminder of how all of the tremendous expertise and knowledge on the outside may have great difficulty working its way onto the inside unless you provide avenues by which it can come in. One of the differences between a really effective legislator and one who’s not so effective is exactly that—how you set up the avenues through which these ideas can come into the Senate.

There’s a lot of noise, there are a lot of sharp elbows, there’s a lot of what didn’t used to be called bribery—but I guess now is seen as bribery—in the sense that it used to be perfectly OK to go out to lunch and to be taken out to lunch. I remember David used to say, “The person who said there is no free lunch never worked on Capitol Hill,” because there were as many free lunches as you had time for. People used those free lunches to get access, so you had to work your way through the free lunches and the elbowing and the calls and the badgering and the constant visits by all of the lobbies that have time and money and try to figure out what really is worthwhile to do and whether it can be done and how it can be done.

All of that is not easy, and Kennedy is so successful in part because of the mechanisms that they have in the office for getting good ideas in and making sure that the staff has time to develop those ideas and to research them. And they bring the political people together with the subject experts to figure out how to do it and how to utilize the rules and the structure of the Senate and of the whole Congress to make it happen. You know, they are skilled at those strategic things.

And you can’t underestimate the effect that it has when these people come in, to be able to take the knowledge that they gain of Congress back to the agency people. That’s critically important because many of them don’t have that knowledge, so the more exposure that they can get, the more useful it is for everybody.

You mean in terms of the details, the folks who come through.

The details or even the agency heads. The level of interaction—It’s very much two- way and it’s a very important two-way.

Yes, no question about it. Amongst the Senators, too. One of the things that Kennedy did—in ’87, he had a dinner at his house. This is when we were just starting to work on HIV, and Tom Rollins and I went, and there were about five other Senators there—Senator [Christopher] Dodd and Metzenbaum and Dale Bumpers from Arkansas—and we just had a dinner to talk about AIDS. Kennedy had a lovely meal, we ate out on the terrace, and he invited them into the library and he gave a tour of the family icons and collections. He was extraordinarily gracious and a terrific host. We all had dinner together and then we talked about AIDS.

So that was a real effort, just to provide information to his colleagues in a relaxed setting in which they could be very open about speaking their mind and having a chance to think through what it was all about, what it meant, what needed to be done. He is an extraordinarily talented politician, person, and policymaker, using every single one of the means at his disposal to convince his colleagues as well as people in the executive branch and from the agencies of things that he had come to believe in, of his convictions.

Interesting years, weren’t they?

Fascinating, completely fascinating. And I’m sure there’s so much more I could tell you. At a health goals hearing that I talked about—we had two at the beginning of ’87. Tip [Thomas P.] O’Neill came to one of the early goals hearings and that was a thrill for me, to meet Tip O’Neill. I have a picture of myself—somewhere, I guess in my other office—walking with Kennedy and Tip O’Neill. Here is this guy who had been Speaker of the House for 25 years and he was an icon and a character and sort of a bird of a feather for Kennedy because they both had come from old Irish political families. He had just been to Ireland and he was talking about his trip and some of his experiences. He was invited over by Kennedy to speak on a subject that Kennedy knew was of interest to him, and of course to have Tip O’Neill from the House come over and address a subject of interest—right at the beginning of the year—it was going to have an impact and the potential to get things done in the House.

Everything that we did there was intended to educate, convince, build a case, bring coherence to a discussion—it’s just part and parcel of what goes on there—and that also is why it’s such a thrilling experience for people who have that interest. I take it from everything I saw and everything I’ve heard since that Kennedy is that person and he loves the policy process, that he’s deeply motivated by it and tremendously energized by it, and is tireless in pursuing it. Many of the folks who end up working for him and really pursuing the goals are like him in that way. I think people recognize that similarity and then respect each other for it and feel a kinship because of it.

Well, this has been terrific. You’ve really illuminated a very important period.