Twilight of the Anechoic Effect? - New England Journal of Medicine Article Discusses Previously Taboo Topic of Bad Corporate Health Care Leadership

We have often complained of the anechoic effect, that the issues we discuss on Health Care Renewal often do not seem to be considered topics of polite conversation.  Any discussion that might question the brilliance, integrity, dedication, or selflessness of the leaders of health care organizations seems particularly taboo. 

So a major aim of this blog has been to discuss the numerous publicly available examples of leadership that is ill-informed, uncaring about or hostile to the values of health care professionals, incompetent, self-interested, conflicted, or outright corrupt, and of governance that lacks accountability, transparency, integrity, honesty, or ethics.  We have postulated that such problems with leadership and governance are not only causes, but the major causes of the increasing dysfunction of our health care system.  That discussing these issues is simply not done in many contexts, including academic health care, medical and health care journals, and health policy fora has only accelerated health care dysfunction.

The New England Journal on Punishing Health Care Fraud

Therefore, I note with some surprise that the New England Journal of Medicine just published an article (online first) that implicitly challenged the leadership of some large health care organizations. [Outterson K. Punishing health care fraud - is the GSK settlement sufficient.  N Engl J Med 2012; 367: 1082 - 1085.  Link here.]

The article summarized the record settling legal settlement agreed to by GlaxoSmithKline (see this post).  It noted that the company pleaded guilty to three criminal charges.  It then noted that while this was the largest recent legal settlement by a pharmaceutical company, "it would be a mistake to assume that GSK was an outlier in the global pharmaceutical and medical-device industries. Indeed, many of the major companies have settled with the Department of Justice in recent years."  It included a table of the largest pharmaceutical company settlements with the US government from 2009 to now.

Based on this background, the article dared to question whether such settlements deter bad behavior:

But questions remain about the efficacy of fines and corporate integrity agreements in deterring corporate misbehavior. The 2012 fines against Abbott Laboratories and GSK represent a modest percentage of those companies' revenue. Companies might well view such fines as merely a cost of doing business — a quite small percentage of their global revenue and often a manageable percentage of the revenue received from the particular product under scrutiny. If so, little has been done to change the system; the government merely recoups a portion of the financial fruit of firms' past misdeeds.

Even more daring was its challenge to top executives of pharmaceutical corporations,

One partial solution would be to impose penalties on corporate executives rather than just the company as a whole. Boston whistleblower attorney Robert M. Thomas, Jr., embraces this approach: 'GSK is a recidivist. How can a company commit a $1 billion crime and no individual is held responsible?'

A Taboo Broken

Having blogged on Health Care Renewal for nearly eight years, I recall very few, if any instances in which leaders of health care organizations were described as deserving punishment, or perhaps even guilty of crimes within large circulation medical journals, and within the New England Journal of Medicine, the most prominent US journal in particular. While discussion of misbehavior within health care organizations has slowly been seeping into the medical and health care literature, delicate phrasing has often been employed that leaves unclear whether top executives have any accountability for this behavior. (For example, while the Lancet editorial on the GSK settlement condemned "GSK's fraud," accused GSK of "actively encouraging off-label prescription," and asserted that "GSK and other drug companies have come adrift from standards of the societies they seek to serve," it never said anything about GSK's leaders or whether they in paticular had anything to do with the company's bad behavior. [Anon. Moral decaly at GSK reaps record US$# billion fine. Lancet 2010; 380: 2. Link here.])

So it is a big step for the NEJM to publish an article that suggests corporate executives might deserve penalties. I hope that this publication might lead to a bit of discussion of these issues within the larger medical and health care communities, the vast majority of whom have likely never heard of this blog and may have never seen anything other than an occasional news article in local media questioning the leadership of large health care organizations.

Things are Even Worse

Unfortunately, I need to end with the observation that the problems are even worse than what the NEJM article implies. Legal settlements of allegations of bad behavior by large health care organizations are much more numerous than those mentioned in this article (look here for examples).

Many of the largest and most prestigious organizations actually have histories of multiple settlements, guilty pleas, and related legal and governmental findings. For example, look here for Pfizer's record, here for Johnson and Johnson's record, here for Abbott's record, and here for Wellpoint's record. Pfizer was even found by a jury to be a racketeering influenced and corrupt organization (RICO)(see post here).

Despite these records of recidivism, no leaders of these companies have paid any individual penalties, and none of these organizations have had any restructuring or leadership changes imposed. This is even more disturbing when this kid-glove treatment of misbehavior by big health care organizations is contrasted with the severe penalties imposed on individuals or leaders of small companies found guilty of health care fraud (look here).

You Heard It Here First

However, in 2003 we first published documentation of individual physicians' concerns that ill-informed, incompetent, self-interested, or even corrupt leadership was threatening their core values [Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130. Link here.] Furthermore, since 2008 we have been stating that corporate fines do not deter bad behavior.

It is not that law enforcement does not have the power to seek penalties on individuals. As we noted here, a Supreme Court case from 1943 empowered the government to seek penalties against responsible corporate officers (the "responsible corporate officer doctrine") who were in a position to stop a fraud that resulted in a guilty plea or conviction, particularly for the selling of misbranded or adulterated drugs into interstate commerce under the US Food and Drug Act.  (This was exactly the situation dealt with by the GSK settlement.)  Despite a threat made in 2010 by the chief counsel of the Inspector General's office of the US Department of Health and Human Services to use such legal authority to "get high level executives out of companies," nothing of the sort has happened.

So now that it is no longer taboo to question the pretensions of some leaders of health care organizations to near divine purity, let me state as I did in 2008,

As long as health care leaders can shrug off the consequences of unethical behavior merely as acceptable costs of doing business, absent any serious attempts to get health care organizations to enforce internal codes of ethical behavior or to avoid hiring ethically challenged leaders, the procession will likely continue. The effects will be continually rising costs, declining quality, shrinking access, and rising numbers of demoralized health professionals.

As I wrote in 2009,

Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.

Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

• Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
• The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
• Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.
  

You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.

This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:

HOWW TOOOO ….

The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice.

Three day course teaches you:

How to relate to the patient, evaluate, test and diagnose

How to use solutions, mixtures, methods, supplies and equipment

How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI

How to design and organize your office

How to hire and fire staff and to computerize

How to use public relations and marketing

How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies

Manuals included…

Each attendee receives one set of training materials, including:

Protocol Manual

Physicians Manual

Office Procedure Manual

Forms Book

Marketing Manual

Patient Results Manual

Employee Manual

Audio tapes

and other related material.

Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO). But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine:

Six Ways to Earn Extra Income From Medical
Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in.

So what are those ‘6 avenues’? Let’s see:

• Work with Attorneys
• See Nursing Home Patients
• Serve as a Medical Director
  

So far, so not necessarily bad…

• Team Up with Pharmaceutical Companies
  

What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:

Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape:

Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.

What it all comes down to is this:

Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.

Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:

I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well.

True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.”

Oh yeah: what were the other 2 “avenues”? Those would be:

• Become a Media Personality
• Consult for Wall Street

The Editorial that Wasn't: Evidence for Systematic Research Manipulation Undetectable by Critical Review

Woe to those of us who have been advocates for evidence-based medicine.  A short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values.

Evidence-based medicine is based on some key assumptions.  One is that a systematic review will reveal all the results of research studies that are relevant to the issue at hand.  A second is that while the research studies may be flawed and imperfect, they are reported honestly.

Unfortunately, as we have repeatedly discussed, there is more and more evidence that a systematic review will not reveal all relevant results, because research studies may be suppressed, perhaps often, when their results are unfavorable to vested interests.  (Look here for further discussion.)  There is also considerable anecdotal evidence that the design, implementation, and analysis of research studies may be manipulated to make the results more likely to favor vested interests.  (Look here for further discussion.)

An article by Vedula et al just published in the renowned New England Journal of Medicine suggests that such manipulation might be systemic, and that the reporting of manipulated studies may not clearly show what manipulation was done. (1)

To summarize, the authors got access through legal proceedings to internal study protocols and research reports from clinical trials sponsored by Parke-Davis (later merged into Pfizer Inc) of gabapentin (Neurontin) for a variety of clinical problems other than seizures.  Gabapentin was originally marketed as an anti-seizure drug, but Pfizer later "admitted guilt for off-label marketing."  (We discussed the stealth marketing campaign for Neurontin here.)  Vedula et al compared the primary outcome variables specified in the original research protocols, internal research reports, and any publications of the trials' results.  They identified 21 trials, 13 of which were published.  For 12 of the 13, the authors had access to the internal protocol, report, or both.  The main results were:

For 8 of the 12 published trials, there was a disagreement between the definition of the primary outcome in the protocol and that in the published report.... Sources of disagreement included the introduction of an entirely new primary outcome in the published report (in the case of 6 trials); failure to distinguish between primary and secondary outcomes in the published report, even though the protocol did distinguish between them (2 trials); relegation of a primary outcome in the protocol to a secondary outcome in the published report (2 trials); and failure to include in the published report one or more primary outcomes specified in the protocol (5 trials).

Furthermore, it appeared that failure of published articles to clearly and fully report results in terms of the original, pre-specified primary outcome variables occurred when these comparisons were not favorable to gabapentin. As the authors summarized:

Thus, trials with findings that were not statistically significant (P≥0.05) for the protocol-defined primary outcome, according to the internal documents, either were not published in full or were published with a changed primary outcome.

As shown in Figure 3, all the changes that took place between what was specified in the protocol, what was known before publication (as presented in the internal company research reports), and what was reported to the public led to a more favorable presentation in the medical literature of gabapentin's efficacy for unapproved indications.

They concluded:

We are concerned that the reporting practices observed in our analysis do not meet the ethical standards for clinical research or maintain the integrity of scientific knowledge. Fair and honest treatment of patients enrolled in clinical trials of any kind requires full, open, and unbiased reporting. Journal publication, a formalized platform for scientific discourse and dissemination of knowledge, should not be used as a marketing tool for off-label drug use.

Reporting biases such as those we describe here increase the likelihood that interventions will appear to be effective when they are not. Such biases can lead to the omission of negative findings in systematic reviews of intervention effectiveness and in evidence-based guidelines. For example, the 2005 Cochrane systematic review regarding the effectiveness of gabapentin for acute and chronic pain concluded that it is effective on the basis of published findings and should now be updated with the inclusion of unpublished information made available through litigation.

I believe that the article by Vedula et al is particularly important because it shows what appears to be systematic manipulation of the analysis and reporting of multiple clinical trials of the same drug (but for different indications) that had the effect of making the drug appear efficacious when it likely was not. Furthermore, the manipulation was concealed. The published research articles did not completely describe what the intended primary efficacy outcome variables were, did not provide results in terms of these variables, and instead provided results only in terms of variables that were chosen post-hoc as new primary outcome variables.

To address that latter point, I independently reviewed three of the research publications cited by Vedula et al.(2,3,4) All three were noted to have reported significant results favoring gabapentin in terms of a primary efficacy outcome variable that was not identified as such in the corresponding studies' original research protocols or reports (see the supplementary data provided with the New England Journal article.) Per my review, none of the three published articles offered any hint that what they reported as primary outcome variables were not the variables originally chosen in that capacity, nor did they identify what those original primary outcome variables were, or how comparisons made using them turned out.

The implications of the article by Vedula et al are very important. Hence, I was surprised that the article appeared without an accompanying editorial to discuss these implications, and that its publication did not generate much media interest.

So that gives me an opportunity to comment further.

One could start with the implications for evidence-based medicine. As noted above, a short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values. Evidence-based medicine depends on critical, rigorous review, but the review process is generally done under the assumptions that research publications honestly describe what was done and what its results were. The review process was never designed to detect dishonest reporting or find information that was deliberately concealed. Manipulation of research (design, analysis, and implementation), concealment of that manipulation, and outright suppression of research threaten the foundations of evidence-based medicine. Yet the article by Vedula et al is part of a growing body of evidence that such manipulation, concealment and suppression are widespread, and done to serve vested interests, often commercial.

That is a huge problem for proponents of evidence-based medicine, but also for physicians who want their practices to be based on science, for patients who want their care to be based on science, and for all those in society who see the advancement of medical science as a way to improve peoples' lives.

As senior author Professor Kay Dickersin noted in an interview with Bloomberg "The trouble is, as a scientist, the publication has always been held up to me as the truth. It's the scientific record. What this study indicated is we can't believe that record."

Furthermore, to be a bit more concrete, most physicians, patients, and policy makers depend on what appears to be honest clinical research to make decisions about individual care and health policy. Deliberate and deceitful manipulation of clinical research to favor sponsors' products has likely lead to excessive use of and payments for drugs and devices that are less effective than advertised, if not useless or dangerous. Thus, it is likely that such manipulation is partially responsible for ever increasing health costs and poor health outcomes.

Finally, we need to start thinking about how we can detect and compensate for manipulation of clinical research in the past, and deter such manipulation in the future. One possible deterrent would be, as was noted by Vedula et al, detailed clinical trials registries that contain complete information about trial protocols.  For this to be effective, there need to be mechanisms to assure compliance, and penalties for non-compliance.  Moreover, since clinical research is now global, the registries must have global scope, and enforced assurance of compliance must also be global.

Registries might decrease future manipulation and suppression of research.   No one has suggested, as far as I know, a systematic way to detect and correct for previous manipulation. It would require a major, global investigative effort to uncover manipulation, and it would be a major scientific and policy endeavor to reveal most suppressed research and correct most manipulations.

However, before anything is done, patients, physicians and policy makers must acknowledge and understand the problem.  Yet it seems that even discussing these may be topics that are very uncomfortable for some of us. The longer we shrink from addressing them, however, the worse will be the results for patients, physicians, science and society.

References


1. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored tirals of gabapentin for off-label use. N Engl J Med 2009; 361: 1963-1971. Link here.


2. Mathew NT, Rapoport A, Saper J et al. Efficacy of gabapentin in migraine prophylaxis. Headache 2001; 41: 119-128. Link here.


3. Vieta E, Goikolea JM, Martinea-Aran A et al. A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. J Clin Psychiatr 2006; 67: 473-477.  Link here.


4. Caraceni A, Zecca E, Bonezzi C et al. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the gabapentin cancer pain study group. J Clin Oncol 2004; 22: 2909-2917. Link here.