How Conflict of Interest Became a Health Care Urban Legend

Screen Shot 2014-06-20 at 6.30.35 PMThroughout 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.

These putative dangers have attracted the attention of a number of organizations that have taken it upon themselves to protect patients and the public.  For example, consider this piece of advice from the Accreditation Council for Continuing Medical Education, which oversees the content of education programs for practicing physicians.  An online questioner asked whether it would be permissible for an educator to request suggestions on topics or speakers from an industry representative.  The ACCME not only responded in the negative, but also said that such requests are essentially nonsensical, since it would be impermissible to act on any response.

CME providers cannot receive guidance, either nuanced or direct, on the content of the educational activity or who should deliver that content.  If the provider implements the suggestions of a commercial interest, then this undermines the independence of the educational activity from the commercial interest.

However, the organization makes clear, this does not prevent the educator from accepting money from industry.  It is permissible to take money, but not advice.

There are numerous problems with this line of reasoning.  First, why would industry, which is an important funder of continuing medical education, continue to incur such expenses if they do not offer any hope of financial return?  Second, why would anyone suppose that scientists and physicians, who are among the most trusted and respected professionals in our society, cannot distinguish between education and advertising, or resist the latter’s undue influence on their decision making?  Third, how strong is the evidence that industry educational initiatives have undermined the quality of scientific research or led physicians to betray their patients’ trust?

Let’s focus on this third question.  In the June issue of International Journal of Clinical Practice, investigators at Boston’s Brigham and Women’s Hospital, Harvard Medical School, and the Carolinas Medical Center state in unequivocal terms that there is “no solid evidence of harm” concerning financial conflicts of interest.  In fact, they say that even proponents of tighter controls on conflicts of interest “admit that no data are currently available to ascertain the truth or falsehood of the statement [that] physicians make prescribing decisions that conflict with the best interests of their patients.”  They go on to argue that such restrictions probably produce more net harm than good for patients.

How could such restrictions harm patients?  First and foremost, they threaten to impede the exchange of new information between biomedical professionals and industry.  Beneficial new tests, drugs, and procedures often take longer to reach patients if industry is not engaged in helping to promote them.  Likewise, physicians’ efforts to innovate are impeded when they cannot interact meaningfully with the firms that develop, market, and distribute products commercially.  Most of the important innovations in medicine in the past 100 years – insulin for diabetes, angioplasty for opening up blocked blood vessels, and CT scanners for diagnosis of disease – were the product of such collaborations.

The authors of the Clinical Practice article go on to argue that stringent conflict of interest policies have also diverted resources away from research, clinical care, and medical education and toward offices and organizations that develop and enforce such policies.  There are direct effects in terms of diverted personnel, time, and money, but there are also indirect effects, such as the development of a culture in which potential collaborators interact much less frequently, know one another less well, and increasingly regard one another with an attitude of suspicion.  It is difficult to form a productive working relationship with someone whose very presence is prohibited.

The authors also argue that the proponents of stringent conflict of interest policies are undermining the intellectual integrity of the same professions they are policing.  Because there is no solid evidence that patients have been harmed by such conflicts, policy makers must resort to arguments that cannot withstand close intellectual and scientific scrutiny.  Some critics of such policies have even accused proponents of engaging in a new form of McCarthyism, creating a presumption of guilt based strictly on association.  “If you are caught talking with the wrong person or engaging in the wrong kind of discussion,” they seem to say, “we will punish you, whether we can prove that any harm has resulted or not.”

If such conflict of interest policies are so seriously at odds with the facts, how did matters progress to this point?  The answer, the authors suggest, is what behavioral economist and Nobel Laureate Daniel Kahneman has labelled an “availability cascade.”  So many people have given speeches and published articles decrying the dangers of conflicts of interest that the majority of professionals have simply assumed that there could be no basis for doubting their dangers.  As a result, interactions between biomedical professionals and industry have become some of the most strictly regulated forms of speech and association in our society.

This cultural transformation has broader implications that extend far beyond the boundaries of biomedical science, clinical medicine, and the pharmaceutical and medical device manufacturing sectors of our economy.  It threatens both public esteem and the professional self-regard of researchers and clinicians, by calling into question their judgment and ethics.  Without doubt, money can corrupt, and there are egregious cases of physicians who have been corrupted by money, but it is a mistake to subject every physician to stifling policies and regulations in response to the abuses of a few outliers.  And we should not overlook the fact that such policies represent a rather strident assault on civil liberties.

In short, there is good reason to raise three questions about the putative pandemic of conflict of interest afflicting contemporary biomedical science and medicine: Is it as widely prevalent as commonly supposed, are its consequences really so severe as its proponents have argued, and most significantly, does it in fact exist, at least in the sense that patients and physicians are being harmed?  Strange as it seems, it is quite possible that this scourge of biomedicine is more bogeyman than real threat.  As a result, many of the preventative and therapeutic responses being mounted against it, like the bloodletting of days of yore,  are likely doing more harm than good to the very people they aim to protect.

14 replies »

  1. I guess I wasn’t either smart enough or a good enough doctor to be “bribed.”

    All I ever got was a few free pens (mostly the 39 cent variety), and occasionally a turkey sandwich in return for listening to a colleague drone for an hour about COX-2 selectivity.

    Why didn’t I get to play golf in Hawaii or Europe? Geez. I’m pissed.

  2. This is a naive and outdated issue trying to pose as a newly pandemic pharmaceutical conspiracy with doctors in general. Listen it might have been popular 15years ago, but its not anymore. Drug reps come to our office on a daily basis, pushing this and that. Because most of my Pts are HMO insurance plans they really don’t pay for anything but generics and an occasional crestor. When a drug rep pushes for androgen replacement therapy or a new asthma medication, or a new med for overactive bladder, I always ask is it a tier 1 (usually the insurance company- humana, wellcare, freedom, united healthcare, etc- will pay all of it if a Tier 1 medication) , and or is it expensive for the Pt. Higher Tier meds 2 or 3 – are usually very expensive for the Pts. Most Pts on HMOs don’t usually want to pay beyond 10 dollars per Rx let alone 400 dollars on just one Rx- like cialis or a new irritable bowel syndrome medication, or respiratory inhaler like – eg. xopenex. And the authorization game does not play well with MDs and their staff. To get an authorization by phone can take as much as 30-45 minutes on the phone just for one patient per Rx. When you have 200 patients a week it becomes astronomically non-productive and would require an extra staff of 20 people working around the clock just to get the Pt pay a discount- if it gets approved. Ain’t gonna happen. Thats why doctors will write for cheap and approved tier one meds first. (because ciprofloxacin still saves lives).

  3. The human operating system is analog. There are hundreds of biases that are irrational (see book; The Rational Animal). All people, irrespective of their profession are influenced by these biases; however, it appears we’re holding doctors to different standards that everyone else (esp. politicians who just need to say sorry). If we’re going to expose the main issues here, let’s go to all the advocacy groups that are imposing their will on the medical profession and do a deep dive on their conflicts of interest. Once the mirror is directed at these individuals and groups, only then will the hypocrisy be exposed.

  4. Not egregious cases of industry misconduct, but in fact an industry norm-widespread practice. We will have tons of data shortly when the Sunshine Act (part of ACA) disclosures are finally made public.

    What you will learn is that the pharmaceutical manufacturers spend many hundreds of millions on “honoraria” for CME programs for drugs which are thinly disguised bribes to their “influencers” to “educate” their colleagues on these drugs. Glaxo Smith Kline made headlines last December by unilaterally discontinuing this practice, in anticipation of widespread negative publicity and, perhaps, diminishing returns from the practice.

    You will also see thousands of instances where procedure oriented docs, notably orthopedic surgeons, neurosurgeons and cardiologists are paid, in many cases, six figure “consulting fees” to “advise” the device manufacturers on improving their products. Some of these folks actually render advice; most are actually rewarded for their loyalty, and for resisting their hospitals’ efforts to narrow the selection of these virtually identical devices to achieve discounts. You will likely find not a single instance where a procedure oriented doc has more than one such relationship with a device manufacturer.

    The practice is called “physician preference marketing” and it has been the key to margin preservation for many of these firms. There have been repeated public scandals about improper payments in the orthopedic device market, as recently as last month. Physician preference marketing is narrowing in effectiveness as more procedure oriented docs, notably cardiologists, become hospital employees, and hospital supply chain folks make the vendor selection decisions.

    You don’t know what you don’t know. . .

  5. I would agree that that fact that Eli Lilly and others promote their medications and these medications are of great value. But I also know that the number of drugs that have trivial changes made to their delivery system at coincidentally the same time that their pattents expire and these “new” drugs fill physician sample closets has an adverse affect on prescribing patterns of physicians. If the egregious cases of misconduct were rare we probably would not be having this discussion, but they are common place inspite of industry “voluntary” guidelines. The WSJ has a nice piece on the use of Epogen in cancer patients today and while this is mostly a fee for service issue and possible abuse. Take a look at the quote from it. I wonder how much he was paid to co-write this article. http://www.lakesidemedicalmusings.com, my blog, discusses the fee for service nightmare that continues to inflate medical costs with limited patient benefit.

    Ralph Boccia of Bethesda, Md., says he is among “real believers in the benefits” of the drugs for cancer patients. The oncologist, who co-wrote Amgen-sponsored research supporting Aranesp’s use in cancer patients, used Procrit on 24% of patients and Aranesp on 19%. He says his usage reflects his practice’s growth and that he follows the guidelines but considers the safety concerns overblown.

  6. There are egregious cases of misconduct, but we should not fall into the trap of supposing that drug or device manufacturer spending proves that patients, physicians, or payers are being cheated. The mere fact that in the 1920s and following Eli Lilly and Company promoted insulin does not establish that the huge increases in insulin sales harmed anyone. In many cases, such expenditures serve a useful and even necessary educational function, allowing new drugs and devices to benefit patients in a more timely fashion. Moreover, we need more, not less, collaboration between physicians and industry, and our current preoccupation with conflicts of interest is undermining this.

  7. If it were only, pens and pads that caused a conflict of interest. It is golf trips to Europe, huge unearned consultant fee. The conflict in interest in medicine has exploded to the point that the general public is losing confidence in what we prescibe and offer. Fee for Service is one of the biggest conflicts of interest in medicine and one of the most expensive. Take a look at my fee for service posts on my blog: http://www.lakesidemedicalmusings.com It is not a pretty picture.

  8. This is a remarkable communication from a thoughtful member of a profession that’s waged a semi-successful thirty year war against conflicts of interest in medicine, namely the self-referral to imaging services by physicians (orthopods, cardiologists, e.g.) that own their own imaging equipment. Granted, this has been an evidence-based crusade: self-referring docs use anywhere from two to five times as much imaging as docs who refer their imaging to radiologists, or facilities. Is that what Dr. G is looking for here.
    Well let the health services research begin. . .

    Why indeed would drug companies waste scarce funds paying “honoraria” for high prescribing opinion shapers in medical communities to lecture colleagues in the local fine dining establishment about the merits of drugs they adore if it didnt’ generate predictable and non-incremental product sales? Why did they cease buying docs fancy trips overseas, or other more obvious costly inducements?

    Is it simply “politics” that is causing the Chinese government to crack down on massive and systematic bribery of underpaid Chinese physicians by pharmaceutical manufacturers seeking to influence their prescribing decisions?

    Why indeed would device manufacturers pay low to mid six figure “consulting” fees to their high utilizers to use their stents/coils/implants if it had no effect -for example, in preventing the hospitals or systems where they do their surgery or interventions from standardizing (e.g. narrowing) their device purchasing decisions?

    These are businesses doing the bribing, and the fact that some manufacturers seem to be caught repeatedly and sign consent decrees that say, basically,
    “we didn’t do anything wrong . . . and we won’t do it again”. or pay multi hundred million dollar fines for inappropriate marketing practices. Why would they continue cutting corners and risking criminal penalties . . if it wasn’t influencing sales.

    This argument is sophistry. That stench in the air is the smell of physicians pandering to commercial interests and selling out their patients for extra income. So what is Dr. Gunderman asking for: peer reviewed studies? Give me a break please.

    Wake up and smell the stench. . .

  9. I’d like to see the same degree of conflict of interest oversight for hospital administrators, health policy experts and health care journalists.

  10. Good docs relate to patients like family. Also they know that one bad review of their services on the Net can bring disaster in their practice. They largely are immune to the hype, accordingly. But it is fun and informative to listen to the enthusiasm and the keen arguments of Pharma. The degree of attention to this conflict of interest is about right. Let it be. Having speakers list conflicts with industry during their intro’s and ditto for journal papers seems proper.

  11. Another masterpiece in common sense by Dr. Gunderman.

    The notion that MDs can be influenced by free pens and notepads is laughably absurd and tragically misses the most sinister of all biases: ideological bias.

    As Schumpeter famously warned “the first thing a man will do for his ideals is lie”.

    That, and the fact that researchers often have their own biases when their pet ideas are on parade (see the letters to the editor about the study that showed that Checklists may not be Vishnu’s tenth reincarnation), means that concentrating on piddly financial incentives whilst ignoring other non-financial biases is like fretting about breezes and ignoring gale storms.

    That this passes for policy makes an utter mockery of our desires to rationally plan society.

  12. Excellent argument. To paraphrase a famous epidemiologist: “Whose conflict of interest is it anyway?” The best example I can think of is the recent and ongoing FDA approvals of opioid medications against the recommendations of their own scientific committee. That committee contains physicians and scientists who are carefully vetted for conflict of interest. The lesson there is clear – at any point conflict of interest becomes relative and the usual highly conflicted political and regulatory bodies take over.

    I would add a fourth question – are conflict of interest arguments used basically to silence and manipulate physicians? Nobody seems to question the relationships that other non-medical academic departments have with industry. In many cases other professional societies want the input of industry whenever they attempt to set standards. The notion that physicians need to be treated differently because they treat patients doesn’t have any traction with me.