Data, dollars, and drugs - Part IV: Solutions
How can we solve the drug industry/academia problem?
Posted Jan 05, 2009
My previous three posts have described the context of the problem. Now let's look at proposed solutions.
Those who view the pharmaceutical industry (PI) as simply evil often argue for complete disengagement. Let us put a huge fosse between our pure castle of medicine and those corporate Huns. Yet major problems arise with this solution: In clinical research, the problem would be how to get funding for studies. Unless the NIMH steps in to provide such funds (see below), fewer studies would be done, and despite some junk research, important knowledge would be lost. In medical education, if there was no industry support, then hospitals and medical schools would have to fund lectures; they show no sign of doing so and are not likely able to do so given their economic problems in our health care non-system. If such funding is not provided, fewer lectures will be given by experts traveling to distant places, and again, despite some junk talks, important knowledge will not be propagated. In drug development, if academics were to be uninvolved, the PI would proceed without any such input and academics would lose the ability to influence research programs up front; we could always criticize drugs studies after the fact, as we often do, but input into large studies before they begin would be more effective.
Complete disengagement would seem to lead to the loss of important benefits, along with the removal of some harm. It would seem more rational to revise our approach about how and why we engage with the PI. As academics, our goal should not be to care about, or want to propagate, profits for the PI; they can do this on their own, and do not need our advice. Our goal should be only one thing: to get the best research done for our patients and to have the best knowledge spread for their benefit. I agree that the status quo is unacceptable, partly because many academics seem to care about helping the PI to greater profits (I have seen such advice myself at PI advisory boards given by academic experts). But complete disengagement is a prescription for surgery with a high mortality rate. Critical engagement, with no interest in helping the PI itself, would seem a better solution.
The role of the NIH
It seems to me that a more rational approach to reforms would start by asking two questions: What does the PI do well? And what does the PI do poorly? What they do well: They do a good job with manufacturing and distributing drugs, marketing them, and with conducting short-term studies. What they do poorly: Innovation with new drug mechanisms; comparisons of medications with each other; and long-term studies. It might make sense to have the NIH step in to conduct studies in those aspects that the PI handles poorly. In fact, the NIMH recently did this with the recent large multicenter grants given for treatment trials of schizophrenia (CATIE), bipolar disorder (STEP-BD), and unipolar depression (STAR*D). The results of these studies are groundbreaking, refuting some common treatment assumptions, and will likely play out for over a decade in psychiatric practice.
Yet there are no follow ups to these large NIMH funded clinical studies on the horizon. For at least another decade, we may have no reliable new large scale information on the topics mentioned (e.g., long-term outcomes, head to head comparisons) to inform clinical practice. This is the kind of knowledge practitioners need. With the exceptions above, the NIMH has avoided funding much clinical research, in the belief that the PI is available to fund such studies. Instead most NIMH funding has gone to basic science research, which is viewed as needing such funds more critically. This imbalance needs to be redressed, which means, for all critics who are also taxpayers, more money from the citizenry to meet these health care needs. (Or perhaps a reallocation of what is already collected towards the relatively neglected field of NIH-funding for clinical research).
Cleaning up our own ship
Any solution to the current dilemma has to go beyond policy prescriptions for Congress, the NIH, and hospitals. We need to also turn inward. If we dare judge others, then we have to also judge ourselves.
We might begin by judging how we understand psychopharmacology. Too often psychiatrists now practice as if psychopharmacology is simply a matter of giving pills for symptoms. 82% of patients who enter a psychiatrist's door leave with a prescription. We practice what Osler called " a penny-in-the-slot sort of practice, in which each symptom is at once met with its appropriate drug." We have begun to lose the idea that we should treat diseases, not symptoms; that Hippocratic tradition that frowned on symptom management because it causes more harm than good; that sensibility to realizing that all drugs are harmful, and that they should not be presumed safe until proven harmful, but vice versa. Our profession has quickly gone from a psychoanalytic nihilism about drugs to a Prozac high. We need to get our bearings, not to ban drugs, but to use them less frequently, and more effectively, than we are. No doubt the pharmaceutical industry finds our pharmacological naivete useful, and exploits it, but we are to blame, not they.
As academics, we need to set a better examples. Leaders, like department chairmen and prominent researchers, should not enrich themselves on pharmaceutical income. Academic leaders should refuse authorship of ghost written articles in peer reviewed journals. Private practice psychiatrists need to see fewer patients and spend more time with them. Universities need to fund education, the APA needs to bring influence to bear on the PI, directly or indirectly through public education, to reduce biased marketing, and the NIMH needs to fund more clinical research. Academia needs, above all, to make space for criticism of itself; critics should not be marginalized, even if they prove extreme or wrong on certain matters; truth is corrected error, and without debate no truth can emerge. Yet sensationalism, designed to profit the book or newspaper industries, should also be discouraged.
Complex problems usually do not have simple answers. It seems that critiques of the PI are partially correct and partially not; simple solutions fail. Perhaps some of our dilemmas are not simply ethical, or economic, or a matter of laying blame, but rather based on our own confusion about what psychiatry is all about.