"He who controls the narrative, controls the debate."
It was after retiring when I first became aware of how unreliable the information I had about the psychiatric medications I was being asked to prescibe as a volunteer physician had become. So I went to the medical resources traditionally available to me. I bought the latest textbooks, read the PDR, began to read review articles and the original articles reporting on the clinical trials of the drugs themselves. I got to know ClinicalTrials.gov and Drugs@FDA. I read the blogs available at that time – furious seasons, soulful sepulcher, carlat, etc. And I read about Conflicts of Interest and learned about Speaker’s Bureaus, Key Opinion Leaders [KOLs], and Senator Grassley’s findings of payola. It was a sadly disillusioning landscape.
That had never happened to me in Medicine. I had the conviction that when I hit a bump in the road I could hit the books and find my way. And this time it didn’t happen. I couldn’t find an anchor, some still point that I could count on. In a forty year medical career, I had counted on the academic literature to be a guide and it just wasn’t there this time. The chairman of the department I was affiliated with was removed from his post for unreported pharmaceutical income. The same was true for the President of the American Psychiatric Association. Such goings on in Medicine were unparalleled in my experience.
Flash forward six or seven years. It’s taken me that long to accept that things just aren’t like they used to be. In the past, I could count on the academic medical literature because of a covenant of integrity that was part of medicine’s academic tradition – embedded in its historic narrative. But there’s something now that really is different, and I credit Alastair Matheson for making it clear, though he did it in slightly different context [see rebranding…]. This is now part of academic medicine’s narrative:
"Conflict of Interest is not a problem if it is acknowledged."
That’s what is different now. And by the way, it’s an absurd declaration. Of course it’s a problem. How could it be otherwise? In the past, that covenant of integrity was the unseen force that allowed me to count on the literature. It’s not there any more, or maybe sleeping very soundly. And the time for lamenting its absence or trying to force it to come back has passed. It’s a time to accept that we’re in a different place now, and have to make adaptations to the world we actually live in. To hold people accountable directly. That false statement is currently controlling the narrative. That’s why we need for the FDA to actively certify, actively offer surveillance, actively intervene. The implicit checks and balances of historic medicine are no longer operating as they have in the past.
Mickey,
Conflict of interest (COA) is just another politicized fact of life. It is just a matter of whether it is:
1. Illegal.
2. Unethical
3. Bad public relations
As far as I can tell, lying is central to the human condition and COA is just another variation on that theme.
With that level of importance, why would we expect it to go away with a simple set of rules?
With regard to Big Pharma and COA, I think that you can probably do just as well controlling your own behavior rather than counting on mixed or questionable research results.
Isn’t it general social context that is important? My guess is that before antibiotics we -MD internists– didn’t have much of an income . the Post world war 11 period floated all boats but i think md practitioners did well, however substantially better than research MDs. Somewhere-my guess is in the 70s Pharma discovered real profitability and research MDs somewhat after became in high demand with soaring salaries and for many increased pressure to maintain their high standard of living. Upward mobility meant the middle class could now emulate the decadent rich .This impacted scientific honesty ,with particular reference to the KOL model.
Unfortunately this is all speculation but some earnest sociologist probably could find out if my income speculations are approxmately correct. Whether an attitudinal shift is a result of upward mobility would be harder to estimate, but it sounds to me like Veblen.
After WWII medical students and residents with families used the public housing units in my city and it was considered a good deal
Many of those residents and students were vets and some had undergone very tough times
When I worked at a teaching hospital several decades after my father
I was appalled at the medical student and resident thinking regarding future work
Many were in it for the money and status and there were occasions when poor patients did not get a complete physical exam
Some students even decided that they did not like working with sick people and choose more isolating specialities.
I don’t think this was an exception after seeing what now has occurred
It seems as if the trauma of war gave my father’s generation a more nuanced and compassionate outlook that – and living through the Great Depression also influenced how the interacted with their patients
The other factor would be the known culture
Everyone knew each other whether this was from an African American or White perspective
This goes along with all the professions
We and they all lived side by side
No isolating gated communities , no social invisibility for the doc and patient
Church, Store, Post Office were all potential meeting places
No hiding.
These are all factors for your campaign now regarding clinical trials
All ripples in the pond -scum scarred as it is as an American way of life
The BBC reported in 2014 that the 10 biggest drug companies spent $100 billion dollars on marketing a year. If we add in all the rest of the drug companies and their marketing expenditure, that probably comes in at $200 billion a year, or half a billion dollars A DAY!.
This amount of money allows you to buy a lot of things. It even allows you to buy the philosophy, the epistemology of an entire field. It allows you to buy the assumption that “A conflict of interest in not a problem if it is acknowledged.”
It allows you to buy the minds of an entire generation of physicians, and the patients they treat. And everything those physicians learn, will be filtered through, and shaped by, that mindset.
“It even allows you to buy the philosophy, the epistemology of an entire field. It allows you to buy the assumption that “A conflict of interest in not a problem if it is acknowledged.”
You may be mistaking physicians for Congress.
The notion that physicians are in lockstep with Big Pharma is seriously overblown as are the benefits to Big Pharma for any affiliation. Physicians are in lock step with managed care companies and PBMs because they control physician income directly by denying payment or indirectly by wasting huge amounts of time if the physicians don’t do exactly what they want them to.
And as anyone should know – MCOs and PBMs are proxies for the failed government theory of managed care.
So far that government-business affiliation has adversely affected the philosophy and epistemology of two generations of physicians. That is the real tragedy here – not advertising from Big Pharma.
The problem on a practical level of substituting regulation for enforcement is basically that the 5-10% who are going to cause problems either way will figure out an end-around while the basically honest majority has to waste time, effort and put up with needless roadblocks. TSA is a perfect example of this. The opioid crisis and upcoming overreaction to it will be another. If you interview the doctors within a 20 mile radius of my office, the same five or six names would keep coming up as the main culprits. I’m kind of sick of being hassled for someone else’s misdeeds (I don’t even have triplicates to make the problem go away). Mangled care is another example. If they would have just asked doctors and nurses in the eighties to identify the problem children, we wouldn’t all have to put our heads down on the desk for the entirety of recess.
I think the problem with bad research is much more related to poor design and poor talent than overt malice and the problem with malice and malicious COI occurs with or without government (see AGW). That’s difficult to overcome. I don’t know how you undo a generation of Powerpoint brainwashing. I also don’t know how you do with snotty elites who believe in nonsense such as “settled science”.
Thank you Dr. O’Brien for stating what is driving so many dedicated physicians out of medicine … “the 5-10% who are going to cause problems either way will figure out an end-around while the basically honest majority has to waste time, effort and put up with needless roadblocks.”
If the government were serious about weeding out Medicare frauds, work comp cheats and opioid mills, it would be the easiest thing to do. Just talk to the people in the community (nurses and doctors) who know where the bodies are buried. The same names will always come up. I’ve read that Medifraud investigations cost 5x what they recover. It doesn’t have to be that way…unlike academics, docs in private practice tend not to be so tolerant of sloppiness and unfair competition, unless the miscreants are noncompetitors in the same group, and even then that situation usually blows up because of perceived group liability risk.
That won’t work with research corruption as well because there will be an institutional backlash to calling a prestigious academic colleague out.