“It Isn’t Always Fun.” – The NHLBI Advisory Council, 1989-93
National Heart, Lung, and Blood Institute, Advisory Council, 1989-93
In the fall of 1988, Claude Lenfant, Director of the National Heart, Lung, and Blood Institute (NHLBI), approached me at an American Heart Association meeting and asked if I would serve on the Institute’s Advisory Council. I accepted with enthusiasm, understanding the usual qualifications — the appointment required approval at the level of the Bush Administration, the FBI, etc.
My major activities as Division Head and in the joint community projects of Minnesota, Stanford, and Pawtucket were all winding down. And epidemiological studies and preventive trials were falling on lean times and hostile attitudes. For example, Dan Steinberg, who headed up the NHLBI Task Force on Atherosclerosis, made this sardonic comment to me in the hall of Building 31 at NIH: “You guys in epidemiology have done your bit, Henry. Now we have more interesting and important things to do.” The report of his Task Force was uniquely and uncharacteristically out of balance. For the first time since these reports were initiated in the early 1970s, there was hardly a line about needed epidemiological or prevention researches, only recommendations for bench and clinical pursuits.
I assumed that I was appointed to the Advisory Council to represent epidemiology and preventive research disciplines, succeeding Jerry Stamler in that unofficial, perhaps token role. At the moment I entered the fray, Claude Lenfant and much of the Council were infuriated by what they considered the effrontery of a huge budget proposal just submitted by the principal investigators for the Treatment of Mild Hypertension Study, the TOMHS II trial. I don’t recall the exact amount but at that juncture it was thought “obscenely large” in view of the major budget struggles going on in the Institute. Lenfant, along with the natural enemies of prevention studies, used this visceral reaction to advantage and whipped up Council resistance to “these expensive epidemiological studies and trials” in general. I didn’t relish being identified as the “clinical trials person” coming on the Council during this turbulent time, but I remarked in my personal notes at the time that if this were the case then I darn well better get good at it.
At any rate, my arrival in 1989 seemed a propitious time for new thought, action, and whatever clout might be assembled at the national level for prevention researches. The Council’s review process for major grants was not as formal as that for study section but proposals for population studies and trials were my main assignments, along with generally “defending the faith” in open debate. I enjoyed the challenge but it wasn’t always fun.
How the Advisory Council Operates
The Council pattern of operation soon became clear. Departmental and Branch Heads at NHLBI did their homework well and served as lead-off commentators for applications before the entire Council. Much depended on the effectiveness of their opening presentations. The best-prepared person of all, besides Ron Geller, Executive to the Council, was always Claude Lenfant, himself. He had heard all the issues beforehand and had usually arrived at his judgment before the Council met. Depending on the importance and the level of funding, he would make his support or lack of support clear at the particular moment in deliberations that he considered most appropriate. He may also have lobbied his viewpoint beforehand with the “Gang of Four,” four Council members appointed by him to a special review committee that meets the day before the Council to discuss policy and Institute direction, or to ponder specific grants representing major policy or funding issues.
I do not imply that Claude Lenfant “fixed” the decisions of the Council. In fact, I was eventually appointed to the Gang of Four and found its deliberations quite open. We were always able to give evidence for our support or otherwise on a given issue. In a democratic parliamentary Council, Lenfant had the skills and means of getting his way, but it was not impossible on occasion to sway debate against his view.
NHLBI Advisory Council in 1991. Claude Lenfant, Director,
Of several significant events and confrontations during my term on the Council, and the many anecdotes about them, only a couple of the more dramatic are recounted here.
Sunset on Stanford
Lenfant had initiated an on-going process to assure the “sunset” of expensive special centers of research (SCORS), epidemiologic studies, trials, and public health demonstrations when the Stanford Five Cities Study came up for renewal. The debate he invited in open session of the Council was tending toward the view he had made abundantly known, that these large “community things” must soon reach an end and their funds be redistributed to the Institute’s new and more urgent priorities.
I regret that I did not record my comments to the Council on the beleaguered Stanford program. Staff and colleagues seated in the jury around the grand table were kind enough to indicate later that my arguments had been persuasive. I argued that the project was a “must-fund” if the historically appropriate balance of Institute researches among the major disciplines was to be maintained. And I emphasized that the renewal, for data analysis, was necessary if the Institute were to realize the considerable investment already made in the Stanford program. At the end of my statement, Claude called for a vote of the Council and it approved the extension, against Lenfant’s wishes.
I expected no gratitude for carrying out my proper function on the Council and I received none. But I sensed that I had expended a great deal of social currency in my vigorous support of the Stanford project renewal.
A Dastardly Leak
A major confrontation in the Council came over my primary scientific review of a sterling application from Darwin Labarthe of the University of Texas at Houston for a study of adolescents in an up-scale population of Houston with a comparison group of children in Japan. Interesting epidemiological and endocrinological markers of maturation were being compared in cross-section and over time. This, too, somehow got on the Director’s personal docket for rejection, presumably for its cost, despite a superb scientific review score from the study section.
On the morning after the evening Council discussion on the project, when its troubled plight had become clear to all, a special urgent message arrived in Lenfant’s office from the project’s principal investigator in Houston. It contained more than the usual forceful arguments and documentation of strengths of the project. There were also veiled threats that the investigators might appeal or even by-pass the Council and go to Congress if it were not passed based on its unchallengeable scientific priority score.
The arrival of this letter at that crucial juncture seemed more than coincidence. A leak to the principal investigator from the Council or staff about the precarious state of the grant was thought a strong possibility. As the primary reviewer of the proposal, I felt myself a prime suspect for the leak, though this was never openly addressed.
In renewed debate that morning, I attempted to articulate the many strengths of the Houston study. In due course, again to Lenfant’s chagrin, the Council voted to approve it. But the issues among the principal investigator, University of Texas lawyers, Lenfant, the Institute, and Congress, continued for more than a decade. It appeared to me that the Institute struck back by imposing stringent requirements for inclusion of minority populations in the Houston study. [My view expressed to the Council at the time was that this clear need for research among minority populations would better be accomplished by the Institute defining specific questions and providing specific funding for such studies, within strong designs and among appropriate populations, rather than by imposing minority quotas on any and all population studies in which overall design and operation might easily be jeopardized.]
After a series of unpleasant exchanges between Houston and the Institute, the Japanese population was axed and its support diverted to a new population of African-American children required to be recruited in Texas, effectively destroying this particularly fruitful collaboration of the U.S.-Japan Health Treaty, one which Lenfant had once been pleased to display as a model of research interchange. Damning articles then appeared in The Journal of NIH Research, with threats from the Texas Congressional delegation and lawyers for the University of Texas, with an equally vigorous editorial reply from Lenfant. In the long run, the effectiveness of leadership in epidemiological and community studies from the University of Texas at Houston’s School of Public Health suffered greatly. Along with the national diversion of funds from epidemiologic research in general, this particular case produced a serious conflagration in which everyone was burned. NHLBI attitudes and control over epidemiological studies hardened. And the Texas School of Public Health in Houston is still trying to recover, more than a decade later. Its once-effective team in epidemiology has dispersed to the winds.
Head-to-Head with Lenfant
A more personally traumatic and dramatic Council experience for me was in a head-to-head confrontation with Claude Lenfant during a 1991 meeting. Prior to that meeting he had solicited advice of Council members about deteriorating relationships among Institute staff and the community of cardiovascular investigators. The litany of complaints included, among others:
• suffocating control by NHLBI of epidemiological projects and preventive trials (e.g. their being forced into the cooperative-agreement mold from their origins as R0-1 investigations, that is, grants originated and directed by the principal investigators);
• sometimes arbitrary exercise of scientific direction by Project Officers over the principal investigator;
• the need for a study to pass muster under the Institute’s vague policy priorities even before submission of proposals (at the funding level of $500,000 or greater);
• limitation of 10 percent for automatic increases in funding beyond the first budget year. (This failed to recognize the natural progression of any major epidemiological study, which starts gradually with recruitment, followed by development of program and testing of protocols, requiring a modest first-year budget, and then, over several active recruitment and study years, a need for much more than the ceiling 10-percent budget increase, before dropping off again at the end for a period of analysis and publication.)
But the more distressing issue in the “Epi” community was the culture of increasing NIH control. Under the guise of fiscal and quality control, young NHLBI project officers also had administrative and scientific control over investigators, including veto power. The staff’s scientific ambitions, plus NIH career requirements for them, forced them, in the view of some, into an unacceptable conflict of interest. As administrators assigned to support a project, they were at the same time directing and profiting academically from it. Young USPHS officers were thrust into a climate fully comparable to that in academia, requiring research leadership and first-authored publications, creating a clear conflict of interest. Some of the project officers acted supportively; others acted immaturely and arrogantly. Some were even abusive of their already excessive authority over the extra-mural investigators. The investigator community was intimidated, their work and role degraded.
Addressing this latter delicate issue, to which our attention had been solicited by Lenfant, I composed and presented before the Council a short satirical parody that I intended and hoped would illustrate in a light vein the concern and disgruntlement of the investigative community trying to deal with increasing NHLBI control and with the Young Turks who wielded it. This message, which I unfortunately did not keep, was delivered to the Council with a broad smile. It was received by Lenfant with icy fury.
I have never in my professional or personal life received such a dressing down. Lenfant rose in wounded defense of his staff and made a number of uncomplimentary declarations, put always in the third person, about “anyone” who would present such views. I was so bowled over by the tone and intensity of his personal attack that I could barely breathe or, for that matter, even look up from my papers. I wish I had had the presence of mind to say simply, “Dr. Lenfant, this is the message you invited. I am a simple messenger.” But instead I was silent, unable to move, much less respond to his tirade.
My message clearly did not deserve such a terrible response even if it were inappropriate. The episode was acutely embarrassing for all present. John Clement, distinguished senior council member and retiring head of the Cardiovascular Institute at the University of California in San Francisco, got to Lenfant that same evening with the remark I would have wanted to make. He told me that he said something like: “You weren’t listening, Claude. And you shot the messenger besides.”
Lenfant came to me early the next day before the Council reconvened to apologize and he offered to make his apology public if I wanted. I said that would not be necessary.
Unfortunately, Claude Lenfant had not heard. Seven years later, the identical observations and sentiments were brought to his attention, forcefully and formally, by Francis Abboud in a major policy letter from the ad hoc committee Lenfant himself appointed to examine unhappiness in the scientific community over NIH/NHLBI policy and practice.
The question today, in 2003, is whether any policy addressing the obsessive NIH/NHLBI control and obvious staff conflict of interest has been changed. Or has the improved funding position of NHLBI generally, the temporarily bigger piece of the pie for everyone, reduced tension all around? [I am too far removed to know.]
Someone with the putative management style of the “new” (in 1999) Internal Revenue Service Director would work. At least the new policy purportedly in place at the IRS could well be advanced at the NHLBI: “The customer comes first.”
Ancel Keys Lecture: The Three Beauties
In the fall of 1991, the tension between the NHLBI and the community of prevention scientists had become acute. When invited to give the second Ancel Keys Lecture (Geoffrey Rose gave the first) at the Anaheim annual Scientific Sessions, I chose to address the concerns of the epidemiologic community and spent (squandered?) the opportunity on that subject rather that address more interesting scientific issues. In a broad review of the crisis, I outlined the situation in the epidemiologic community, first reviewing the contributions of epidemiology to the overall understanding of cardiovascular diseases. Then I spoke of the deteriorating traditional balance of researches, bench, clinical, and epidemiologic (“The Three Beauties”) that had made NHLBI the leader among federal institutes. I ended my commentary with a series of recommendations about the rising tide of concerns and resentment among the investigative community and about “fair and balanced” funding and administration of epidemiological studies.
Dr. Lenfant was not present at the Keys lecture but some of his staff took away an impression that I had given the Institute a drubbing. They relayed that attitude to Lenfant and he immediately related his pique to me. I responded by sending him an audio tape of my lecture and shortly thereafter a printed copy, gently defying him to find anything unfair or derogatory in it. It dealt with documented facts and with the Institute’s articulated policy and function, much of which was leading to diminution of the research infrastructure and morale in cardiovascular disease epidemiology and prevention.
I understand that things have been more quiet in the decade since I stepped down from the NHLBI Advisory Council in 1993. This would be fine if there were balance among research activities and funding within the Institute. Instead, the control by ambitious “yea-sayers” to the Director has seemed to go on. Meanwhile, the traditionally sound, supportive, fair and disinterested expert administrators of the halcyon days of NHLBI either retired or disappeared from the scene, the likes of Jerry Green, Eleanor Darby, Ruth Heglyi, Gardner Macmillan, Paul Leaverton, Bill Harlan, Manning Feinleib, James Schreier, Beth Schucker, etc. These and other “greats” over the years recognized where the intellectual leadership lay and devoted their careers selflessly to the support of investigators. Prevention, nevertheless, still got attention from Lenfant, who retired in 2003. He knew very well that balance, or the appearance thereof, among bench, clinical, and population studies, and particularly the applied studies of epidemiology and clinical trials, is popular with Congress and is therefore healthy for his Institute’s national position and funding.
Despite our mutual, sometimes sharp disagreements, Claude Lenfant invited me as one of the keynoters for his fine show on the 50th Anniversary Conference of NHLBI, held in 1998. There I laid out concerns over what I find a backlash and backsliding in preventive and epidemiological research and in health behaviors and risk nationwide, against a backdrop of leveling off in cardiovascular disease risk factors and death rates and an apparent rise in stroke death rates. It is reported on good authority that Lenfant listened carefully to my talk.
Having served the longest tour of any NIH institute director, Lenfant will be remembered for carrying high the banner of Heart, Lung, and Blood, and in the epidemiological community for his testy, barely tolerant view of epidemiology and prevention researches. This attitude was illustrated by his remark on the evening of my retirement from the Advisory Council of NHLBI: “Now, Henry Blackburn retires. If he had his way we would be called the ‘National Institute of Cardiovascular Disease Prevention!’”
Gramm-Rudman economics were hitting NIH hard in the early ’90s. There was acknowledgment among all cardiovascular disease investigators on the Council that competition was greater, the supply of trainees and junior faculty diminished, and the salary differentials and economic situation serious, within an overall shrinking environment of funding. Projections were made for a shocking NIH pay line: only 12 percent of approved grants would be paid in the coming year’s awards of new and competing grants!
In the stunned ambiance of the Council, after hearing this awful news, I raised the simple-minded idea that “long-term solutions depend on long-term projections,” remarking that the Council seemed continuously in the process of wrestling with the effects of its past short-term solutions, which often raised NHLBI fixed costs (lengthened grant periods, increased merit awards, program projects, and SCORS, plus inflation). Might long-term projections be made and provided to the Council on the impact of recommended caps and constraints that we were even then putting into place? When, if ever, would we catch up?
[I wonder whether there is still no policy or on-going mechanism at NIH or OMB to analyze and project estimates of the economic impact of Council decisions as they are implemented.]
Lenfant then went on to other policy areas painful for him and the Institute, indicating that the continued “cloud over the Institute” from Congress had shifted from the issue of the implantable artificial heart to that of cholesterol control in the population. He asked for our help in the latter matter. [The earlier “cloud over the Institute” had come from the Institute’s sound scientific policy decision to focus on ventricular assist devices rather than on the totally implantable artificial heart. The policy had been held up to Lenfant in withering sarcasm from Senator Ted Kennedy, who spoke for his high-tech Massachusetts constituency working on the total artificial heart. A large cloud over the Institute, indeed!]
Pediatric Epidemiology of CVD Risk Factors:
U.S. and Japan
As I mentioned earlier, the May 1990 assembly of the NHLBIAdvisory Council considered a grant request of the above title from Darwin Labarthe and colleagues at the University of Texas at Houston School of Public Health. I was its primary reviewer before the Council, and, as had the Epidemiology and Disease Control (EDC) study section before us, I gave the proposal high marks on its science. But Lenfant, for reasons still obscure, was dead set against it from the outset, despite its strengths of preoccupation with poorly studied adolescents and a natural collaboration of the U.S.-Japan Health Treaty.
Questions were raised by EDC reviewers, who had otherwise been enthusiastic about the study, over the cost of the Japanese cohort and the absence of a U.S. minority population in the design. Anticipating in my review that these issues might be raised, I outlined arguments against the budding NIH policy and the Congressional mandate to enforce quotas on any and all population studies.
I opined that it would clearly be desirable to have similar information in minority groups of this country; distinct scientific questions exist for Hispanics and Blacks in respect to adolescent precursors of obesity, insulin activity, glucose tolerance, body composition, diet, and blood pressure. But the review of any given proposal requires a sensitivity to the environmental setting, feasibility, and cost. The U.S. and Japan studies were in place, their communities organized, preliminary data collected.
I went on to argue along these lines: feasibility in an epidemiological study requires a defined community, prior work experience in it, an established identity for the study, adequate sample size, and reasonable homogeneity within, not among, the populations compared. Adding a minority population on this ongoing project would at least double its cost. I proposed that it is needed and appropriate that NIH stimulate, organize, and support definitive studies in which cultural differences among minorities may play a role in disease susceptibility but that it may not be appropriate for NIH to fail to support well-designed studies seeking fundamental answers applicable across cultures because of absence of a given minority population within the plan or purview of the investigators. In other words, addressing such particular questions by particular designs in particular populations should be an overall program priority of the Institute. But downgrading the priority of a current proposal mainly because of failure to include those minority questions in the project would seem to impair the progress of science for all, minorities included.
My peroration proved mere blowing in the wind; it was unacceptable, politically incorrect. If I were to continue more of that sort of argument I would surely see my southern heritage being brought up and my being labeled Bourbon Bigot. Clearly, politics influences science much like religion influences politics.