Not long back, I departed a pharma-sponsored research project. I based my decision to leave in something I occasioned over a decade ago. I thought it was time to share the episode and the lessons learned given the attention being paid to physician conflict of interest nowadays (as well as the annual Open Payments review and dispute period approaching).
When I finished training, very few docs practiced hospital medicine—or even knew what the term hospitalist meant. Several forward-thinking medical centers hitched their wagons to the hospitalist model, as did some astute information technology and staffing companies.
However, few healthcare players embraced the hospitalist movement in a serious fashion like the pharmaceutical industry. They realized hospitalists prescribed a narrow band of products, in big lots, within a centralized location. The higher ups in the pharma sector saw the benefits in directing reps our way.
Throughout history, physicians have treated patients for conditions that generations of their professional successors later deemed figments of their (the physicians’) imaginations. The list is long, but in just the last 100 years, it has included such disorders as female hysteria, homosexuality, moral insanity, neurasthenia, and vapors, among many others. The consequences of such diagnoses were not trivial, and in some cases, patients were stigmatized, ostracized, subjected involuntarily to a variety of noxious treatments, and even incarcerated because of them. Yet we now believe that each of these conditions was a fiction, and they are absent from today’s textbooks.
Something similar may be afoot in the profession of medicine today. The affliction is known as conflict of interest, and medicine is thought to be suffering a pandemic of it. In fact, its proponents argue that no physician is safe. Its symptoms among researchers are a tendency to conduct investigations and publish results that are biased, and among clinicians, to prescribe tests and therapies that their patients do not really need. The underlying cause of the condition is thought to be financial inducements from industry, which lead these gullible physicians and scientists to betray their personal and professional integrity without even knowing it.
For example, industry funding of research might lead physician-scientists to bias their results in ways that line the pockets of pharmaceutical companies and medical device manufacturers. Likewise, the presence of industry representatives in offices and hospitals might lead physicians to write inappropriate prescriptions for industry-promoted drugs. If physicians are presented with a gift such as a pen, a notepad, a book, or a free meal from an industry representative, they might be more inclined to use that company’s products in their practice. The implication? Physicians are insufficiently self-aware and trustworthy to put patients’ interests above their own.
So much media and journal space has been devoted to financial conflicts of interest, particularly within and related to pharma and device manufacturers, that to write any more about it may be redundant. On this site we have also intermittently addressed COI from other perspectives, such as financial interest of the members of the American College of Radiology in maintaining mammography screening status quo, thinly veiled in its own version of the pernicious “death panel” language. We have also spoken a bit about the non-financial COI. And even though we are so very much aware of COI’s potential to lurk around every corner, there are still some surprises.
Take the sacred cow of “quality improvement” in healthcare. Even the name, much like the “pro life” moniker, suggests that it is untouchable in its purity and nobility of purpose. So necessary is it because of the epic magnitude of morbidity and mortality attributed to healthcare itself, that the billions of dollars spent on it seem unquestionably justified. Indeed, much like our public education system, the QI movement garners higher and higher allocations simply due to the sheer face validity of the assumption that more of it is better.
An Archives of Internal Medicine article (Conflicts of Interest in Cardiovascular Clinical Practice Guidelines) is getting a lot of notice this month. In essence, many of the physicians who develop guideline that influence practice patterns and payment decisions have conflicts. The authors recommend only allowing those without conflicts to write the guidelines.
A year ago in Time to deal with medicine’s dirty little secrets?, I wrote about a variety of practices that are relatively well-known in the health care field but would be shocking to outsiders. Industry often takes the blame for “aggressive marketing tactics,” and no doubt some of that is deserved. But physicians are also culpable.
The open secrets include the ghostwriting of journal articles by industry sponsors, physicians and academic medical centers holding ownership stakes in companies whose products they are researching, the clinical role sometimes played by orthopedic sales reps, and perhaps the most egregious example: physicians who set guidelines having financial relationships with the companies that benefit from how those guidelines are set.
Now we have a new example, which is even more serious than usual. A recent New England Journal of Medicine article blames Eli Lilly for overzealous promotion of Xigris. According to the Boston Globe:
Eli Lilly and Co. funded medical guidelines created for the treatment of [sepsis] in an effort to boost sales of a drug with questionable benefits. The allegation was made by senior scientists at the National Institutes of Health. [They] said Lilly tried to shape the guidelines for use of the drug Xigris by sponsoring a three-pronged marketing campaign
The first two phases are by now almost standard practice in the industry:
Lilly paid a task force to spread the word that hospitals were rationing Xigris because of its cost, which forced docs “to decide who would live and who would die”
Lilly “orchestrated” the development of practice guidelines to treat sepsis that called for early use of Xigris (an example of the phenomenon I have described before)
But then Lilly allegedly took a third step, which was a little shocking even to me:
Now, Lilly is sponsoring lobbying efforts to turn the guidelines into quality standards. Hospitals that follow such quality measures receive higher payment from insurers.
What’s happening here? Basically, an influential group of doctors is being lazy and greedy, and Lilly is enabling their behavior. The doctors put their fingers in the cookie jar and Lilly keeps restocking it. The public is paying for the cookies –in the form of higher product sales and sub-optimal health care– and should get fed up!
I have no problem with companies using legal means to promote their products, even if their tactics are “aggressive.” They owe it to their shareholders to maximize return on investment. But it isn’t in their long-term interest to push things as far as the medical profession often lets them.
Industry leans on the reputations of individual physicians (aka “key opinion leaders”), medical societies (aka guideline writers), and journals to legitimize their marketing messages. It’s up to the medical profession to scrutinize industry claims and issue independent guidelines and quality standards. Sometimes these claims hold up and deserve to be propagated. Sometimes they don’t. If the docs and journals don’t do their jobs they deserve to lose credibility.
It’s hard to know the extent to which medical guidelines are already corrupted. The situation is a bit like the incident when the Chinese President’s plane was refitted. In the process of fixing up the plane someone inserted a bunch of listening devices (presumably at no extra charge). When the Chinese checked out the plane and realized it was bugged they had to rip the whole thing up. That’s something like what is going on within the major payers. They’ve stopped treating journal articles and guidelines as objective and have started doing their own analyses. But do we really want to leave health care decisions just to them?
Here’s some free advice to the different players in health care:
Industry: Feel free to market your products and services aggressively, but don’t take things too far. If you do you’ll end up killing the goose that lays the golden eggs. No one will trust doctors, guidelines or journals anymore
Physicians: Remember that pharma and device companies are not stupid. If they spend money supporting your research or sending you to conferences or sponsoring continuing medical education it’s because they expect to get a return on their investment. It’s awfully hard to remain objective in such instances. Your job is to adopt the best medical practices and put the patient first –sometimes that requires expensive new treatments and sometimes old, cheap standbys are better
Payers: Go ahead and challenge the objectivity of journal articles and guidelines. On the other hand, don’t pretend that low cost is always synonymous with best treatment. Expect physicians to keep you in line on that.
Patients: You need to look out for yourself. Find a good, honest physician. Take a look at who’s sponsoring the educational materials you receive. Ask your physician about alternative treatments and do some research yourself
I want to digress from our recent focus on methods and talk a bit about conflict of interest (COI for short). There has been a lot in the press lately about doctors taking money from the biopharmaceutical manufacturers, and doctors inserting unnecessary hardware into patients’ hearts and spines. All of this has been happening against the background of a low hum of an ongoing discussion of what constitutes a COI, how much is too much and for what (for example, can a doc who takes research and education dollars from a manufacturer with an interest in anticoagulation sit on a committee that develops the guidelines for prevention of thromboembolic disease?), and how to mitigate these ubiquitous and pesky COIs.
In some ways watching this discussion has been amusing, while in others it has been downright sad. Medical journals, while insisting that advertising money is OK to take (presumably because the editorial and marketing offices are separated by some sort of a fire wall), though professional societies should not be able to take this tainted education money. Professional societies, on the other hand, are running away from the accusations by tightening their continuing medical education (CME) criteria and scrambling to replace the lavish budgets derived from pharma to develop their coveted evidence-based practice guidelines. And while all the pots are calling all the kettles black, academic researchers are being barred from collaborating with the industry on research projects, and industry researchers are being precluded from presenting their data at professional society meetings. While all the time the public is being whipped into lather about these alleged systematic transgressions, and forced to cheer for the ensuing retribution.