Medical Scientists and the Marketplace

THE OPEN MIND
Host: Richard D. Heffner
Guest: Dr. David Blumenthal
Title: Medical Scientists And The Marketplace
VTR: 1/30/02

I’m Richard Heffner, your host on The Open Mind … and my guest once again today is Dr. David Blumenthal, a distinguished Harvard Medical School Professor of Medicine and Professor of Health Care Policy.

Dr. Blumenthal is also Executive Director of The Commonwealth Fund Task Force on the future of Academic Health Centers, and his research interests prominently include the determinants of physician behavior and the extent and consequences of academic-industrial relationships in the health sciences.

Now some time back, in my guest’s study of “Entrepreneurs in Academe”, the statement appears that “Many scientists still believe that the search for truth is inconsistent with any interest in profiting from ideas.”

Yet these days, when medical researchers and practitioners alike seem more and more to participate in profits, when scientific discoveries are patented and research endeavors are so often underwritten by giant pharmaceutical companies that now advertise and promote even their prescription drugs directly to the public, commerce rather than science seems to be in the catbird seat. So that I wonder and would ask what Dr. Blumenthal’s fix is on all of that.

BLUMENTHAL: Well, it’s a big question. And I guess there are two perspectives on it that I think are both important to keep in mind and encapsulate the dilemma that we face. On the one hand the ideal of science is precisely what you’ve discussed, which is disinterested pursuit of knowledge, letting the research dictate where you go. And share the results freely and openly with your colleagues, with the public and with companies, whoever else wants to make use of them without the hope or the intent, and with very little likelihood of realizing any personal financial gain.

That ideal has served us well as an ideal for many years. At the same time, the American public finances most of the research that takes place in universities in this country and it does so with a very utilitarian purpose. It wants knowledge generated that will be used for their benefit. That’s the reason that they allow their tax dollars to go in those directions, that’s the compact that they have with our nation’s universities and our nation’s scientists.

Well, how do we get that information into use? Universities don’t have manufacturing sites, they don’t have the wherewithal to produce and market drugs. We have to do it through, in this country, a private enterprise called the pharmaceutical industry, which itself contributes substantial funds to the development of this new knowledge and its perfection for use.

Well, you have a necessity for a scientist to make that information useful, to present it in a useful form. The process of technology transfer necessitates some contact between these two sectors. The academic sector, the ivory tower and the commercial enterprise of drug production and distribution.

The most effective way of providing technology transfer is direct interaction. When companies fund research in universities they not only get the intellectual property that results, they get the unwritten information, the know-how that makes it easier to produce the new pharmaceuticals that are, that, that capitalize on that new knowledge.

So you have to have some contact and once the contact is available, all kinds of relationships occur. Some of them inevitable. Some more troubling than others. So we, we go back and forth in this country between complaining about the conflicts of interest on our scientists and then complaining that knowledge doesn’t get out and used fast enough.

There’s a famous story of Lyndon Johnson, never one to understate or under demonstrate a point, arriving by helicopter at the National Institutes of Health in Bethesda, Maryland, and in a sense, dropping out of the sky to proclaim that NIH scientists were sitting on all kinds of useful knowledge that they were keeping to themselves and not getting out to the public.

Well, that message back in 1965 has had a long tail and we continue to remember, the university community continues to remember that we are accountable for making sure that what we discover is used effectively.

HEFFNER: That’s a very eloquent statement. How would you criticize it?

BLUMENTHAL: The requirement to use knowledge effectively?

HEFFNER: Well … well, you put it that way.

BLUMENTHAL: From Lyndon Johnson’s point of view?

HEFFNER: How would you criticize the whole rationale that you have just offered? I didn’t say “rationalization”, but rationale.

BLUMENTHAL: Well, I think that the major issue here is whether the public will continue to have faith in our bio-medical enterprise.

HEFFNER: If …

BLUMENTHAL: If relationships … commercial relationships are perceived to be excessive. And I think that’s the … in a sense the fundamental goal, the fundamental value that we rest this whole enterprise on is that trust. If that trust is eroded than the money will not flow and the progress won’t continue. So I think it’s absolutely essential that the academic community behave in a way that preserves that trust. And constantly be vigilant about it. And that mean constant self-monitoring. And constant, sort of monitoring of the public’s perceptions of the academic community.

HEFFNER: Of course when Robert Merton sums up …

BLUMENTHAL: MmmHmmm.

HEFFNER: … that social contract that you refer to, the assumption is … and I have to ask you whether it’s your assumption, that that is to some extent beyond the capacity of mere mortals.

BLUMENTHAL: I think it’s fair to say that Merton’s ideals were never observed widely. It was the, it was an aspiration, rather than a description of the world. But they are useful for providing goals and internal values. For professionalizing science to a certain set of rules and socializing science to a certain set of rules. So even if the rules aren’t always obeyed, there’s I think great value in continuing to hold them up as ideals.

HEFFNER: But how strongly will we be … what will be the measure of our strength in holding up those ideals if we have made quite as many changes …

BLUMENTHAL: MmmHmmm.

HEFFNER: … as we have made in the basic assumption of what the relationship is between science, the truth, knowledge …

BLUMENTHAL: MmmHmmm.

HEFFNER: … and commerce?

BLUMENTHAL: I think that there are lots of dangers and that we need to manage those dangers. We need to manage them much more self consciously than we have up to now. The university community needs to do that. The government needs to help them do that. And I think if we go about our business with integrity and vigilance that we can sustain the relationships that we need and ought to have with the commercial sector without undermining either the progress of science or the public’s trust. And I think some of the essential elements in that are first of all to assure the public that when they are participants in research that conflicts of interest won’t be tolerated.

That is that when the research involves human participants whose individual lives are potentially affected by decisions that researchers made in the course of a clinical experiment, that that researcher is not going to be diverted or affected by any kind of personal financial interests.

And I think that’s one of the absolutely first thing that we have to do collectively. One that we have not yet done in universities. One that the Federal government has not yet insisted on. And I think we will ultimately get to. So that’s the first thing that has to be done.

The second thing that has to be done is we need to know what university researchers’ interests are. They need to be disclosed to the university for … so they can be managed. And so that things that are troublesome can be identified. And I think there are some kinds of relationships that are sufficiently troublesome that they need to be monitored and tracked and scrutinized more closely than they have been in the past.

And those, I think, pertain particularly to situations where people can benefit from the premature release of information. That is benefit personally and financially. There’s been a lot of discussion in the news recently about companies that by-pass the peer review of literature and release their findings directly to the press in press releases. Sometimes before, obviously before they’ve been validated by the scientific community or had the scrutiny that is given in a peer review process.

HEFFNER: Am I wrong in assuming that I have seen more and more of that recently?

BLUMENTHAL: It certainly appears that way. I can’t tell you we can measure it, but it certainly appears that way. And I think it has to do with the epic of the nineties. The availability of venture capital to start lots of new bio-technology companies, as well as the incredible store of new knowledge that has been developed over the last 20 years in the biological revolution, making it … creating commercial opportunities. And the relaxation of the prohibition, internal prohibition that scientists have felt about being involved in new companies.

HEFFNER: Isn’t that what classically has been described as “the slippery slope” … you start down it …

BLUMENTHAL: Yup.

HEFFNER: … and you slip further …

BLUMENTHAL: Yes.

HEFFNER: … further and further.

BLUMENTHAL: Well, the world is made up of line-drawers and people who try to manage without lines. And I think if you … I think there are some lines to be drawn. And I think they are most importantly around circumstances were individual identifiable people are at risk. There are some small companies with … which benefit enormously from the involvement of university scientists, which contribute value and which, I think ought to be able to consult and use the services of university scientists. I think we just have to define the circumstances in which that’s possible.

HEFFNER: What, what is your own feeling about advertising to consumers directly and the … even in the area of prescription drugs?

BLUMENTHAL: My own personal view is that it’s a worrisome trend in many ways. I see no way to change it, at this point given the rulings that the Federal Trade Commission has made about this being protected speech, in effect.

Part of me feels that the antidote is probably not to restrict the drug companies … use of the airwaves, but to have alternative sources of information that are just as appealing. And less interested. More dis-interested. We can …the American public is … avidly devours information about health. They don’t rely exclusively on television, they get information from the Internet, from magazines and the newspapers, every, every major daily American newspaper has a health section once a week that goes into great detail.

I think we need to make sure that Americans have access to balanced … a balanced portfolio of information. And that if it’s becoming unbalanced because one particular source of information is dominant that other sources become available that are just as powerful.

HEFFNER: I talked about the “slippery slope” before. I quote again my favorite passage from Milton, “Whoever knew truth put to the worst in a free and open encounter.”

BLUMENTHAL: MmmHmmm.

HEFFNER: The only trouble is there are so few free and open encounters. In fact there are no free encounters …

BLUMENTHAL: MmmHmmm.

HEFFNER: … they are paid for and we’re now talking about major corporate interests that have unlimited …

BLUMENTHAL: MmmHmmm.

HEFFNER: … amounts of money … you have to bring to the attention of the public prescription drugs.

BLUMENTHAL: MmmHmmm.

HEFFNER: How do you fight that? Or how do you, never mind fight it … how do you counter, or balance that with other information?

BLUMENTHAL: MmmHmmm.

HEFFNER: How do you do it?

BLUMENTHAL: Well, it’s a good question. I can’t say that I have the, the full answer. I think that one, there are relatively few forces in our lives, in the lives of Americans that have the power to counter those kinds of messages. And perhaps the only one is government, which can accumulate resources and use them to educate people about the reality of the situation.

And maybe the tobacco counter advertising is an example that we need to keep in mind. Now that was funded through a tobacco … has been funded through a settlement and through tobacco taxes. And it may be that some time in the future we’re going to need some kind of publicly available information funded from some source of tax revenue, whether it’s a sales tax, or some other source, that is available to educate the public in an unbiased way about the pros and cons of medications, life style change, smoking, driving and use of seat belts … a whole range of things that are important for the public to keep in mind.

HEFFNER: Well I know that there are some physicians, perhaps many who say they’re delighted with the fact that major pharmaceutical companies advertise the way they do because they bring the attention of the public to bear upon a number of diseases …

BLUMENTHAL: MmmHmmm.

HEFFNER: … and upon their possible treatment. Do you …

BLUMENTHAL: I think that may be … may turn out to be true. I think that the.. there are certainly people who are under treated for common illnesses. Under-treated for high blood pressure, under treated for high cholesterol and to the extent that these advertisements do curry those people to seek attention and get treated, there may be a positive health benefit. I think that if we could assure that that was the major or dominant effect of this advertising, then there would be a lot more comfort with it.

HEFFNER: ‘Cause you don’t believe that, do you? I know I don’t.

BLUMENTHAL: I don’t know. And I think that we still have to define the risks and benefits of this advertising phenomenon. And there are studies going on to do that. Right now. And we are actually participating in some of those studies. I do think that there will turn out to be health benefits. Because there is a health content to those ads. There will also be, I think, some excessive use of medications and …

HEFFNER: What about by …

BLUMENTHAL: By …

HEFFNER: … in part by advertising.

BLUMENTHAL: That’s right. And we’re going to have to see to what extent that occurs as opposed to the other more, more useful benefits. These are things that can be empirically assessed. And the pharmaceutical industry I’m sure believes that the positive outweighs the negative …

HEFFNER: Why do you say that?

BLUMENTHAL: … well, because I hear them say it.

HEFFNER: Oh, well … would they say otherwise?

BLUMENTHAL: No, well, that’s why I assume that they believe it.

HEFFNER: Now, now let me question you on that. You mean belief is not associated with profit, but it’s associated with …

BLUMENTHAL: Well, I shouldn’t attribute … I guess belief is too strong a statement. That’s certainly what …

HEFFNER: They say.

BLUMENTHAL: They contend. Yes.

HEFFNER: Let’s go back a minute to this question of conflict of interest. How would you go about dealing with it?

BLUMENTHAL: Well, I think we need to educate young scientists about it.

HEFFNER: You mean educate them that it’s a “no-no”?

BLUMENTHAL: Educate them about the risks and benefits. And about the ethical issues that come up in the context of conflicts of interest. And help them sort out the complex ethical issues that arise in the settings, in settings where they have relationships with outside companies. I think we need to have a strong, clear university policies about what’s acceptable and what’s not acceptable and then to make sure that relationships are disclosed so that when conduct is suspicious then it can be recognized. And I think the Federal government needs to provide a floor under this by setting standards for what people involved in Federally funded research can or cannot do. And what universities ought to be doing.

HEFFNER: Do you think that the Federal government could get away with that in our present lassize faire frame of thinking, way of thinking?

BLUMENTHAL: I think the Federal government could get away with it if the university community fails to police itself. And so far, in my view, the university community has not done an adequate job of policing themselves.

HEFFNER: What are its … community … what are its responses to your recognition of what needs to be done? Any at all?

BLUMENTHAL: There’s a lot of activity right now within the university community to look at these issues. I think that it’s … they are moving toward some voluntary standards that they will collectively agree on. And I think that’s fine. What I’m concerned about is whether the voluntary standards will, in fact, be observed.

HEFFNER: What’s your bet?

BLUMENTHAL: My bet is that there will be some institutions that go off the farm, human nature and its interests being what they are.

HEFFNER: Some, you say.

BLUMENTHAL: Yes. Well I think there are some that have shown a great deal of leadership. I’m please to be part of a university, Harvard University, that has quite strict, clear guidelines for what’s acceptable and what’s not.

HEFFNER: Is that because it’s the strongest and the richest university in the country?

BLUMENTHAL: I don’t think it’s exclusively that. I think it has to do also with leadership on the part of Presidents and Deans. Because Harvard is not immune to the competition that goes on among elite schools for eminent scientists. It doesn’t have a lock on all the talent in the country and competes with the likes of Stanford and Hopkins and Columbia and other places …

HEFFNER: Princeton, don’t forget Princeton.

BLUMENTHAL: Yeah, Princeton. Though Princeton doesn’t have a medical school.

HEFFNER: [Laughter] I know, I wasn’t talking about medicine.

BLUMENTHAL: [Laughter]

HEFFNER: … except the tough medicine Harvard is …

BLUMENTHAL: Yeah.

HEFFNER: … taking. Overall, I, I did a very, very … played a dirty trick on you and I asked you to make a statement of a position and then asked you to criticize it, too.

BLUMENTHAL: MmmmHmmm.

HEFFNER: Where do you come out?

BLUMENTHAL: I think I come out where I’ve been sitting in our conversation. And that is saying that we need a set of standards that are common to the nation’s universities, that allow interaction, but draw some lines about interactions that are not acceptable. That create conflicts of interest that are not acceptable. And I think that set of interactions, mostly concerns clinical research where human, human beings participate and are vulnerable. And I think there can be more flexibility in research where there are humans immediately at risk, but there still needs to be a set of standards that define responsible conduct.

HEFFNER: Would you do me a favor and go through that again for me because I’m not sure I, I understand where conflict of interest is … where you would not consider …

BLUMENTHAL: MmmHmmm.

HEFFNER: … what I would call conflict of interest, “conflict of interest.”

BLUMENTHAL: Well I think that it … that companies ought to continue, will have to continue to fund research in universities. I don’t think the Federal government has the resources to develop all the work that’s potentially applicable.

HEFFNER: So, it’s a pragmatic approach on your part.

BLUMENTHAL: That’s right. So I think that University Professors ought to be allowed to work with companies, to do their research and to make their research useful to the public. I don’t think we can accomplish our common goals without that.

HEFFNER: And to profit thereby?

BLUMENTHAL: And to profit. Because I don’t think they’ll support the work unless they have the opportunity to profit from it. There was a period before these relationships were as common as they are now in which the Federal government claimed ownership of all the intellectual property that resulted from the research it funded. And most of that property, intellectual property was never exploited. And that’s a loss to everyone. So I think that the pure ideal of separation has to back off in the name of getting useful knowledge out to help people.

HEFFNER: And Merton’s presentation of what the ideal of science is. What happens to that?

BLUMENTHAL: Well, I don’t see that Merton … that scientist’s receipt of research funding from industry makes them inherently corrupt or interested or leads them to profit.

HEFFNER: But they’re not as disinterested.

BLUMENTHAL: They’re not as dis … well, they may not be as disinterested. I do think that the amount of money that they can personally gain from those interactions needs to be monitored.

HEFFNER: Limited?

BLUMENTHAL: Ah, I think it needs to be limited where … and actually shouldn’t exist at all for clinical research. Some of the kinds of work that we’ve just been discussing …

HEFFNER: Right.

BLUMENTHAL: …. shouldn’t involve personal income. It’s a tougher, and I frankly don’t know what the answer is … in the situation where someone’s doing test tube research that has no immediate clinical application. And a company funds it. And what other relationships ought to be permitted. I think there are ways to allow those relationships without allowing bias to be a major problem in the work that results. And I think that has to do with making sure that any equity isn’t sold until the product, until the result of that work is actually on the market and being used, or has FDA approval.

HEFFNER: As I said to you before, before we went on the air, I come from the age of Arrowsmith and it’s all such … spoken in a foreign tongue.

BLUMENTHAL: MmmHmmm.

HEFFNER: But I do understand the challenges you face in your research and I thank you for once again joining me on The Open Mind.

BLUMENTHAL: You’re very welcome.

HEFFNER: And thanks, too, to you in the audience. I hope you join us again next time. If you would like a transcript of today’s program, please send four dollars in check or money order to: The Open Mind, P. O. Box 7977, F.D.R. Station, New York, New York 10150

Meanwhile, as an old friend used to say, “Good night and good luck”.

N.B. Every effort has been made to ensure the accuracy of this transcript. It may not, however, be a verbatim copy of the program.