The following is a close approximation of a talk DrRich gave to a gathering of some of the world’s most promising young cardiac electrophysiologists, in Nice, France, on June 15, 2010. He was asked to talk to these young physicians about physician-industry relationships. The organizers of this gathering apparently did not know, as anyone who reads this blog would know, that DrRich should never, ever be allowed an opportunity to influence promising young physicians. But, what’s done is done.
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A worldwide controversy is now roiling over the appropriate relationship between physicians and industry. Superficially at least, this controversy has to do with the undisputed fact that a physician’s relationship with industry can unduly influence his or her behavior.
That is, this controversy is said to be related to the conflicts of interest (COI) that are always inherent, to some degree, in such relationships.
I believe there is a deeper, and far more disturbing, reason behind this controversy, and I will address it in a short while. But let’s first talk about COI, because it is ostensibly the chief concern, and it is in fact a very important issue.
A COI is present when an individual has a sacred, fiduciary duty (i.e., a duty of trust) to Entity A, but then develops a secondary relationship with Entity B, which (by creating self-interest, competing loyalties, or even just an inability to be objective), threatens to interfere with the primary duty to Entity A.
Physicians, especially academic physicians, have (at various times) at least three primary fiduciary duties that must take priority. These are: a duty to patients when practicing medicine; a duty to students (i.e., actual students, colleagues, or the public) when teaching; and a duty to society (and truth itself) when conducting medical research. It is clear that ties with specific companies and their products can easily create important COI that may interfere with each of these primary fiduciary duties, and it is equally clear that physicians have commonly allowed this interference to happen.
Far more often than we like to imagine, doctors have allowed bias to creep in when recommending a course of action for their patients, in imparting knowledge to trainees, colleagues or the public, or when designing, analyzing or reporting results of clinical trials. And typically, most doctors who exercise inappropriate bias have convinced themselves that they are really acting in the best interests of their patients, students or society at large. For it is quite difficult to be objective about one’s own COI.
And there is no question that industry has become adept at the gentle art of creating COI among physicians (subliminally whenever possible), and have carefully incorporated the creation of such conflicts into their business models.
Obvious abuses we have all seen include doctors “shilling” for companies or their products at national meetings; clinical guidelines committees seeded with biased members; unbelievable amounts of money (well above “fair market value) being paid to key doctors for consulting services; long advertisements disguised as CME events; and ghost-writing scientific papers, then recruiting prominent physicians to sign on as “authors” after the fact. There are many others.
Such ongoing abuses of our fiduciary duties ought to be deeply embarrassing to us in the medical profession.
And if it’s not embarrassing, it is at least becoming painful. In the US, physicians who are discovered doing some of these things are being called out publicly, being investigated by Congress if not the Justice Department, losing their prestigious academic positions, and having their reputations destroyed. It is hard to be sympathetic toward them.
Despite all the negative attention – both public and legal – that such COI have brought to our profession in recent years, many of us continue to have tin ears. A recent example, which has caused a stir in the blogosphere if nowhere else, happens to relate to the EP community. (Thanks to Larry Huston of Cardiobrief who did the heavy lifting on this one. )
Recently, the ACC/HRS collaborated in the launch of a new website, called AFibProfessional.org, which is described as “a unique collaboration to address atrial fibrillation for the cardiology community.” The site has only one corporate sponsor – Sanofi, the maker of Multaq.
At the time of launch, all the content on this new website consisted merely of old, recycled material from older ACC and HRS websites, with a single exception. The single exception was a slide lecture by a prominent electrophysiologist, who we all know and love, on “Managing Atrial Fibrillation.” This lecture makes a strong case for the off-label, off-guideline use of Multaq. The lecture was posted without any COI disclosure statements, though the lecturer, it turns out, has significant financial ties to Sanofi. When the matter became a public issue, the lecture was pulled from the site, and the ACC promised to investigate. A few days later, the investigation apparently completed to the ACC’s satisfaction, the lecture was reposted, this time with a COI disclosure.
While one hesitates to suggest malfeasance here, it certainly looks bad. For the ACC and HRS to co-sponsor a brand new website that , by all appearances, is chiefly a vehicle for advertising Multaq suggests, if nothing else, that we in the medical profession, and our professional organizations, still don’t get it. If we don’t police our own COI, it will be policed for us.
What remedy should be applied? A reasonable approach would be to recognize that physician-industry ties will always bring at least some COI, and to manage the problem by strictly limiting inappropriate COI, and fully disclosing any that remain.
Accordingly, a number of groups – most prominently the Institute Of Medicine – have recently made formal, and tough, recommendations regarding physician-industry relationships. The final “rules” under which we will all have to live are still being negotiated.
But it is highly likely that they will include many if not all of the following:
- Doctors should not accept any gifts, no matter how small, from industry. These include trivialities such as pens and notepads, and more substantial gifts such as meals and travel.
- Doctors should not give presentations in which content is controlled or influenced by industry.
- Doctors should not consult for industry without a written contract, nor should they receive more than “fair market value” for consulting activities.
- Doctors should not accept drug samples from industry.
- Doctors who have a financial interest in a product or company should not participate in clinical trials in any capacity that involve that product or company, including patient enrollment, data collection, analysis or reporting.
- Doctors who have industry ties should not participate in the development of clinical guidelines.
- Medical schools and professional organizations should not accept direct funding, or attributable funding, for CME.
- Any interaction with industry will be fully disclosed, and made publicly available.
What this “full disclosure” will look like can be seen in the Physician Payment Sunshine Act, a law which is pending in the US. Under this act, all “transfers of value” totaling $100 or more in a year to any physician will be reported by each company to the government annually, along with each physician’s identifying information. Such “TOV” includes food, trinkets, entertainment or gifts; travel; consulting fees or honoraria; funding for research or education; stocks or stock options; ownership or investment interest, and any other economic benefit. This information will be posted on a public, searchable government website. Companies will be fined $10,000 for each incident of an unreported TOV.
You younger physicians will be spending your careers in a COI environment that is significantly different from that which we, your elders, have experienced. Activities that have been acceptable, and even encouraged, will now cause you to be publicly stigmatized, or worse. This matter is in great flux, and you need to pay close attention to it as the rules are changing. In the meantime, you need to choose your interactions with industry very carefully, and very circumspectly.
Everything I have just discussed assumes that the real issue regarding doctor-industry relationships is COI. Indeed, everything I have discussed assumes a particular way of looking at industry relationships, which I will call Theory A. Theory A, goes as follows:
- Medical progress is Good, and benefits mankind.
- Industry is responsible for a high proportion of medical progress.
- Industry-driven progress requires the active participation of physicians.
- Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.
If you subscribe to Theory A you believe that, because well-managed physician-industry relationships benefit mankind, these relationships are good. So, fundamentally, it’s the management of these relationships which is at issue. These beneficial relationships produce unavoidable COI, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.
On the surface, at least, that’s what the debate is about – where to draw the necessary limits. But just below the surface, the debate is about something else entirely. Beneath the surface, Theory A is rejected outright.
Today we hear prominent voices telling us that merely managing COI does not go far enough. No amount of COI is acceptable, and ALL physician-industry ties should be prohibited. Among these is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of COI is not to have them at all.” For these voices, Theory A simply does not apply. Rather, (I submit) they subscribe to Theory B:
- The greed of medical industry creates excessive costs, and produces far more harm to society than good.
- Physician-industry alliances strengthen industry, and increase the harm.
- Therefore, crippling these unholy alliances is critical to the interests of society.
A corollary of Theory B is that it can only be the State’s job to cripple these alliances.
Proponents of Theory B, noting, not incorrectly, that medical industry is chiefly concerned with profits rather than the public good, conclude that industry will always behave in ways that are counter to the interests of society. While many proponents of Theory B will agree that industry provides at least some benefits, they are convinced that these benefits are far outweighed by the harm they produce. Therefore, Theory B proposes to stifle, if not cripple, medical industry. And a very useful strategy for achieving this goal is to de-legitimize any practical relationships whatsoever between medical industry and physicians.
Proponents of Theory B rarely say what their real goal is. Most of them give lip service to Theory A. One must discern their real motives from their behavior.
Much of that behavior, in practical terms, has to do with controlling the flow of information. Let industry develop whatever it wants (perhaps), but don’t let profit-drunk industry – or its greedy physician spokespersons – instruct doctors and patients on who gets to use industry’s products, or when and how.
That kind of information can only be managed by unbiased sources. Proponents of Theory B invariably refer to government-appointed panels of experts to determine which products of industry are good and bad, and to manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed.
Inherent in this viewpoint is the notion that the State is an honest broker, with no bias of its own, except to do what is best for the population. The State, in its disinterested beneficence, is the only civil entity which can pass judgment on which medical information is suitable for general consumption.
But even as a general proposition, no government is an unbiased and honest broker. Politics, according to Harold Lasswell, an early Progressive political scientist, is determining who gets what, when and how. Government officials do not cancel their own human nature when they put on a government name tag. As they go about the business of determining who gets what, when and how, they inevitably – and most often intentionally – create various favored constituencies, fiefdoms, and clienteles to suit their own goal. That goal is to consolidate and expand their own authority. In this way, in the exercise of its political mandate the government always creates co-dependencies, and determines winners and losers. So even in the general case, the government cannot be an honest broker.
But with regard to healthcare, government bias goes far beyond the general case. Healthcare spending is the chief problem governments face today. In the US, projected Medicare expenditures over the next 30 – 40 years will be $35-55 trillion. Numbers like this are deeply destabilizing, and simply cannot be abided, and promise nothing but chaos, revolution, and societal disintegration.
To the State, controlling healthcare spending is an existential problem, a matter of life and death, an issue that justifies any solution that has even a slight chance of working.
Why is the cost of healthcare rising so rapidly? Fundamentally, it is medical progress. Medical progress has greatly increased overall healthcare expenditures. Simply consider, for instance, the many fatal illnesses we have converted to chronic, and chronically expensive diseases – coronary artery disease, kidney disease, HIV/AIDS, various forms of cancer, and heart failure, to name a few. Medical progress has made great strides in early detection and prevention, and preventive medicine always increases the cost of care. And thanks at least partly to medical progress, life expectancies are on the rise, and people have many more years to consume healthcare.
Medical progress is very expensive, and the more we have of it the more it costs. The State can only look at medical progress and say, “Medical progress is killing us.”
But it is not politically feasible to come right out and say that stifling medical progress is necessary to the survival of the State. Rather, the State must assert that what it is stifling is greed.
Hillary Clinton gave us the State’s operative formulation in 1993: “There are just too many greedy doctors using too much expensive technology.” So, to control costs, the State must control the doctors; and the State must control the technology, which is to say, industry.
I submit that an underlying theme within the debate over doctor-industry relationships is a desire to greatly slow or even stop the real threat to the State: medical progress, and the vast expenditures which medical progress produces.
The State has several means for stifling medical progress. The State can institute increasingly oppressive regulations, which can have the effect of hamstringing industry, but more importantly, has the effect of converting industry to a client of the State, dependent on the State’s favors for its success. The State can demonize industry, trying to convince the public that drug companies and medical device companies are evil entities that would just as soon harm them as help them, and indeed, without the strong hand of the State would prefer to distribute pain and suffering as the more favored pathway to windfall profits. But more to the point of today’s discussion, the State can stifle the doctor-industry relationships that are so critical in steering medical progress in a clinically relevant direction.
So the interests of industry must be represented as being fundamentally counter to the interests of society, and the doctors who have relationships with industry must be painted as their evil (or, at best, deluded) minions.
Yes, industry is biased, and industry will act on that bias whenever they can get away with it. Industry just can’t help itself. That’s just the way it is.
But the State is also biased. And the State will also act on that bias whenever they can get away with it. The State can’t help itself. That’s just the way it is.
Industry will try to exercise its influence over us by data-driven persuasion, and when that fails they will try to sweeten the persuasion, perhaps even with subtle or not-so-subtle bribes.
But the exercise of persuasion is even more dangerous when done by the State. While the State may also try to influence us with data-driven persuasion, it is very quick to resort instead to propaganda (i.e., the art of information-control by which the unwashed masses are told only what the specialized classes have determined is best for them), and when that fails, the State will resort to its ultimate form of persuasion – the enforcement of new and suppressive regulations at the point of a gun.
So, while industry is indeed biased, and needs to be kept at arms length, de-legitimizing industry altogether would be disastrous. It would create an open field for extraordinarily powerful forces which are at least as biased, but in the opposite direction. If we value medical progress, we need the balance that industry provides – and that includes not only industry’s products, but its voice.
Medical progress driven by industry-physician collaboration is good for mankind. But that collaboration inevitably creates conflicts. We physicians need to control those conflicts, or the collaboration will be forcibly terminated altogether. Our professional history to date is bleak in this regard, and we only have one chance left to get it right, if that.
But in controlling our COI, we should not allow ourselves to be pushed too far. We should agree to reasonable limits on conflicts, and on full disclosure of any conflicts that remain. But we should draw the line when we are urged to forgo all relationships with industry altogether. We must recognize that industry and its selfish goals provide a necessary counterbalance to even more powerful forces whose goal is to stifle medical progress.
I don’t ask that you accept my synthesis of this problem at face value. I simply ask that you listen to what I am suggesting, and observe for yourself what is happening out in the wild. Then challenge yourself to come up with a better explanation for what you see happening out there. I sincerely hope you can, as I would much rather that my conclusions were not true. So if you do come up with a better explanation, I will greatly appreciate hearing about it.
DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.