While on a brief vacation on lovely Cape Anne, Massachusetts, one of my daily automated Google searches provided an article of local interest. The person nominated to be CEO of the local hospital system had been at the center of controversy while in his previous position as leader of a hospital system in Cincinnatti, Ohio. When I got back, I put some relevant terms into Google, and lo and behold, came up with one of the more complicated and colorful, if unhappy stories about problems with health care leadership and goverance I’ve seen lately. So, to the tune of “lions and tigers and bears, oh my….”

Let me begin with some background, and then to try to tell this story chronologically, noting issues as they came into public view. Northeast Health System is a regional hospital system in northeast Massachusets. It includes Addison Gilbert Hospital in Rockport, BayRidge Hospital in Lynn, and Beverly Hospital. Now bear with me through the amazing details.

Leadership Lacking in Transparency

The system’s leadership seems to have recently inspired more than its share of controversy. Hints about the nature of the leadership problem appeared in an editorial in the Gloucester (MA) Daily Times in April, 2008.

Once again, Northeast Health System, the Beverly-based corporation that owns Gloucester’s Addison Gilbert Hospital, is trying to have it both ways.

When it wants public support — including public money — it casts itself as serving the public. When it doesn’t want the public looking into its affairs, it retreats behind the ‘private corporation’ wall.

That’s not acceptable.

The latest example is Northeast’s refusal to provide statistics on its diversion rate of patients from Addison Gilbert to Beverly Hospital during the past three years.

Although the editorial granted that the diversion statistics might not prove to be that alarming, but

If there’s not a problem here, the corporation is simply creating needless concern about it by its failure to be forthcoming.

Unfortunately, this is a continuing pattern for Northeast CEO Stephen Laverty, who apparently sees no problem with accepting subsidies of $500,000 from the say for two years running — subsidies secured in part through Tarr’s efforts — but then ignoring reasonable requests for information about the corporation’s operations, specifically as it pertains to Addison Gilbert.

Statistics on diversions should not be high-level trade secrets. Laverty must make Northeast more transparent.

Doctors Vote No Confidence

The pot really started to boil in May, 2008. At that point, as reported by the Boston Globe, its medical staff voted “no confidence” in CEO Stephen R Laverty:

In a private meeting, doctors at Beverly Hospital have taken a vote of no confidence in its chief executive, Stephen R. Laverty, citing frustration with his management.

The unusual step, made three weeks ago and acknowledged by hospital officials this week, was prompted by Laverty’s alleged lack of communication and support in current years, said several physicians who attended the April 29 meeting at the hospital.

‘There is been a lot of cumulative dissatisfaction with how the doctors have been dealt with over a period of years in a variety of departments,’ stated Dr. Harriet A. Bering, an oncologist who was at the meeting. ‘People had the same frustrations with incidents in which they had not been included in the decision-making process.’

A vote of no confidence, oh my. The article wasn’t very specific about what lead to such an unusual step, but did note that doctors “accumulated grievances during Laverty’s tenure. For instance, they stated they were not properly consulted a few years ago when Beverly Hospital ended a successful cancer treatment program with North Shore Medical Center….” So this part of the story points to a hospital system management that does not see the need to communicate with and be transparent to dedicated health care professionals.

The Pregnancy Pact

In June, 2008, a story about a high school’s unexpectedly high pregnancy rate and allegations that girls there entered into a “pregnancy pact” got international attention. The latter allegation was not proven, and even though initial coverage did locate the story in Gloucester, MA (e.g., see the story in Time), the role of Northeast Health System was more obscure. Later we learned, in October, 2008, as reported in the Gloucester Times,

Addison Gilbert Hospital risked losing the state grant that pays for the operation of the Gloucester High School Health Center this spring when hospital leaders were reluctant to allow confidential access to birth control at the clinic, according to its former staff.

Debate about prescribing contraceptives erupted within a health center advisory board working on a response to the rise in teen pregnancies in Gloucester this year and turned public when the medical director and nurse practitioner resigned because representatives of Northeast Health Systems, the company that owns Addison Gilbert and runs the clinic, wouldn’t think about adding confidential prescription of contraceptives to the care offered.

A pregnancy pact, oh my. But this part of the story talks to system management that seems unsympathetic to the concerns of its health professionals.

Nurses Vote No Confidence, and Allege a Punitive Culture and Intimidation; Vice President Accused of Art Theft

Also in October, 2008, the nurses also voted no confidence, again per the Gloucester Times in an editorial that provided more hints about the nature of the system’s leadership problems,

Conflicts between Northeast Health System CEO Stephen Laverty and his subordinates are, unfortunately, nothing new.

By now, in fact, they have taken on a weary familiarity. After persistent rumors of unrest, a group of subordinates goes public with their frustration and resentment of the CEO. This past week, it was the nurses union, with members at both Beverly Hospital and Gloucester’s Addison Gilbert Hospital, that took a ‘no confidence’ vote in Laverty.

The union is now trying to pressure the board of trustees to fire him, saying Laverty has created a ‘punitive organizational culture (with) … oppressive management practices.’ And a 2005 Beverly Hospital citation by OSHA, which surfaced along with the nurses’ discontent, gives credence to that claim.

The nurses, of course, are not alone. This past April, it was physicians who took a no confidence vote. In 2006, the Massachusetts Nursing Association filed a formal complaint against Laverty for entering operating rooms unannounced to observe surgeries.

Yet, the response from Laverty is always the same — no response. And his spokespeople offer little more than vague references to ‘challenges’ and ‘competing agendas,’ concluding with how proud they all are of themselves.

The editorial allowed, “It’s also true that, in any big business, especially one as competitive as health care, there are sure to be conflicts between management and labor.” However,

Still, it has to concern the Northeast trustees that every time there is trouble or unrest, Laverty is at the center of it.

It should concern them that morale continues to sink under his style of leadership, which most subordinates agree is a mix of arrogance and intimidation. Effective leaders don’t assert their authority by demeaning their subordinates. They lead by building people up, not tearing them down. They lead by inspiring, not breeding resentment.

The truth is, Northeast still inspires shaky confidence among Cape Ann residents for a variety of reasons, including the corporation’s out-and-out refusal to share numbers regarding the number of ambulance transport “diversions” from Addison Gilbert to Beverly — and, more recently, Northeast’s stewardship over Addison Gilbert’s wonderful endowment of artwork.

The recent arrest of a former Beverly Hospital associate vice president — a reported friend of Laverty — on charges of stealing donated art and antiques worth more than $200,000 from the hospital, hardly inspires confidence. And public confidence is one of the most important assets any health care institution has, since its patients are entrusting their health and livelihoods to it.

At times like this, when the public starts asking questions about problems, Northeast officials tend to retreat behind the ‘private corporation’ wall. It is true that Northeast isn’t part of the public sector. But it regularly seeks donations from the public. It has received at least $1.5 million in state money, supposedly to support its services to the public, but somehow still finds enough money to pay Laverty well more than $600,000 a year.

The trustees surely should not take the nurses vote as the only credible word on Laverty. But they need to take it, along with other continuing conflicts, very seriously.

Another no confidence vote, a punitive organizational culture and oppressive management, arrogance and intimidation, and art theft, oh my. So here we have much more detail about bad management, punitive, oppressive, arrogant, and ruling by intimidation. We also have allegations of criminal behavior by top managers.

Wait, what was that, a vice president of the system arrested for stealing art from it? In November, 2008, the Boston Globe suggested Laverty’s imminent departure, and added more about the art theft.

The current situation comes after years of increasing resentment between Laverty and hospital staff. His internal relationships at the hospital were also damaged by his longstanding association with Paul G. Galzerano, Beverly’s former associate vice president for support services. Galzerano sometimes argued with staff members, according to longtime employees, and often threatened them based on his close association with Laverty, according to former nurses.

Galzerano, who left the hospital last year, was arrested in October by Groveland police, who alleged he stole paintings, a grandfather clock, and furniture from Beverly Hospital. The items were found in his home, according to police, who alleged they were stolen when the hospital was undergoing renovations. Galzerano could not be reached for comment yesterday.

Threats by allegedly an art thief, oh my.

Birthing Center Threatened with Closure

But Laverty’s departure didn’t end the controversy. Also in November, 2008, the Boston Globe reported,

A proposal to cease all deliveries at the North Shore Birth Center in Beverly - one of only two hospital-affiliated centers statewide that offer natural birth options - has ignited a passionate protest from women across the region.

With a debate and potential vote by Beverly Hospital’s board of trustees expected Tuesday morning, women have been picketing the hospital, circulating fliers, writing letters to board members, blogging and organizing on Facebook, where more than 500 members have already signed on to the campaign.

Service cuts, oh my. After the art work was stolen, the system decided to cut costs by reducing an apparently very popular service.

Specialty Service Cuts, Bed Cuts, and Board Conflicts

An eloquent letter to the Cape Anne Beacon in January, 2009, (and an abbreviated version in the Gloucester Times) by Ms Beverly Quint of Drumlin Road, Rockport, provided much more detail about the legacy of the leadership and governance problems at Northeast Health Systems:

Since November, I’ve heard a number of people say on line at the market, or greeting one another for coffee or waiting for a movie to start, ‘Thank goodness he’s gone. Now we have the ability to get somewhere without the worry.’

At first I thought they might be speaking about the presidential election, but it became clear that most of them felt that anyone leading the country at this time was not expected to perform feats of magic. Then I wondered if they were speaking about Father Time, himself, the old guy with the flowing robe and the long beard. It has, in fact, been a year of plunging confidence and quiet desperation. No, people were talking of neither of these; people were and are talking about the exit of Stephen Laverty, the much-criticized CEO of Northeast Health Systems, the corporation that 14 years ago merged with Addison Gilbert Hospital, our community hospital.

I wish I could share my neighbors’ rejoicing at Mr. Laverty’s exit, but I’m more worried than ever about the potential loss of our hospital, the lifeline for Cape Ann citizens, isolated as we are from the mainland, connected by two not-always-reliable bridges. Here’s why I’m more worried than ever:

When NEHS announced its merger with AGH, it declared that the merger would benefit both celebrations. Almost immediately, NEHS began to dismantle AGH, service by service. Nor has NEHS ever made available to the community a detailed record-keeping of its use of $2 million given by the state Department of Public Health for the protection of emergency surgical and anesthesiologist services at AGH. Here it should be added that NEHS has never given a detailed bookkeeping to the community of other sums taken from AGH, in the form of income from investments, real estate and an art collection estimated at $4 million.

Having downsized AGH’s bed capacity by refusing to use the beds on Steele Two and having sent patients to Beverly for each or no reason and having closed several departments, what remains in Gloucester is a shell. Even as such, we have the ability to still call it our community hospital so long — and only so long — as it provides eight services all under one roof, eight services essential for retaining its license. Now even that status for AGH is at risk. And that is why I am more worried than ever. If those eight services go, we lose all — and now they’re being plucked at by NEHS. We are at the tipping point, with or without Stephen Laverty.

Let me give you a few examples. One of the eight services essential to our hospital’s survival is the availability of a surgeon 24/7. Instead, NEHS, without announcing it, sends any patient whom they think might need surgery to Beverly Hospital. Till Jan. 1 of this year, we had only one general surgeon based on Cape Ann. Now, again without publicizing it, he will not be available on call for emergency services.

The same is true of anesthesiologists. Without publicizing it, NEHS has not recruited anesthesiologists for AGH, even as it has not recruited surgeons for AGH. This, despite the previously mentioned $2 million received from DPH for bolstering those specialties.

Availability of hospital beds is another of the eight essential services required for AGH to stay alive, but NEHS refuses to open medical-surgical beds on Steele Two, sending patients away from their families, over the bridge instead.

NEHS has also not made an effort to insist that specialists, such as pulmonologists, see hospitalized patients at AGH, but are insisting that patients, instead, be moved to Beverly. As a by-product, this means that patients’ family members — many elderly, many handicapped, many who don’t drive —are deprived of a closeness, something that can be emotionally important to patients’ recovery.

For starters, the present board of trustees needs to be questioned on the very high percentage of trustees who are doctors and executives employed by NEHS.

Cuts in surgical and anesthesia services, cuts in beds, shifting of medical sub-specialty services, and conflicted board members, oh my. So whatever the management is doing, it isn’t increasing services. Also, Ms Quint’s letter recommended that conflicted governance may be enabling bad management.

Can It All Be Blamed on the Previous CEO?

In another letter published only last month, in August, 2009, Ms Quint recommended that things hadn’t changed much under an interim CEO,

Not only has the Board of Directors of Northeast ignored a petition by 8,000 Cape Ann residents begging Northeast to disclose its plans and make a commitment in writing. Not only has Northeast ignored a petition by Rockport residents at Town Meeting to be more interactive in commitment to this issue.

Not only has it ignored Rockport selectmen’s request to report at regular meetings to which the public could have input.

Not only has it snubbed overtures by state Sen. Bruce Tarr to meet regularly with his Task Force, it has systematically downsized, downsized, downsized Addison Gilbert.

Some of this has been ascribed to the particularly tyrannical nature of former Northeast CEO Stephen Laverty. Yet here is a most current example that belies Mr. Laverty’s personality as the supreme cause of the problems. On July 28, Dr. Henry Ramini, interim replacement for Mr. Laverty, spoke to Rockport selectmen on the status of Addison Gilbert. Did you know Dr. Ramini would be there? Nobody seemed to know.

Even the selectmen — one of whom, I comprehend, had been on vacation — seemed unprepared to publicize Dr. Ramini’s appearance. What I later learned from people who happened to hear Dr. Ramini was that he’s a much kinder, gentler appearing person than his predecessor. However, the content of his presentation was not particularly reassuring: He urged the town of Rockport to be nice to any future doctors who might deign to seek employment here.

Again, the recommendation is that there are systemic problems with governance and leadership

“An Ugly Set of Facts”

And that’ll bring us up to the story that my automated search produced. The candidate to be the new Northeast Health System CEO also has his issues. Per the Gloucester Times from August, 2009,

The man in line to become the next CEO of Northeast Health System is leaving behind a crumbling hospital system in Ohio that has been plagued by lawsuits and controversy.

Supporters of Kenneth Hanover state he does not deserve blame for the breakup of the Health Alliance, a $1.4 billion corporation that he served as president and chief executive officer.

But in two court decisions, judges ruled that the Health Alliance and Hanover failed to live up to a legal obligation to act for the benefit of two of its hospitals, improperly used ‘enormous sums’ of money to fight the lawsuit and gave bonuses to physicians to prevent them from working at those hospitals.

‘The record is replete with evidence that the Alliance breached its fiduciary to (The Christ Hospital),’ Judge Ralph Winkler wrote in his decision last year for the Ohio Court of Appeals.

Considering the turmoil surrounding Laverty’s tenure at Northeast Health System, it might seem surprising that the organization would replace him with a man with such a controversial background of his own.

The breakup of the Health Alliance became so acrimonious that the Ohio attorney general’s office stepped in. In July 2007, in the midst of the legal battle, the chairman of Christ Hospital wrote a letter calling for Hanover to be replaced.

Monica Rimai, the interim president at the University of Cincinnati and a former Health Alliance board member, acknowledged that the lawsuit and the breakup constitute ‘an hideous set of facts and we lost.’

Robert Weigel, chairman of Fort Hamilton Hospital, which is in the processing of withdrawing from the Alliance, said Hanover is “one of the smartest men I know.” He also stated Hanover has a forceful manner than can rub some people the wrong way.

“I have a lot of respect for his abilities and his thinking, but he can be tough to deal with,” stated Weigel….

An hideous set of facts about the new CEO, oh my. One wonders if the NEHS board had investigated its new CEO candidate’s previous performance. On the other hand, maybe the board is most comfortable with CEOs that are “tough [for others] to deal with.”

Pregnancy pacts, art theft, no confidence votes, punitive corporate culture, threats and intimidation, shut wards and clinics, slashed services, oh my. You just can’t make this stuff up.

On a slightly more sober note, the curious case of Northeast Health Systems is a good example of how governance and leadership can go wrong, and the downstream effect on health services.

Reorganizing the colorful facts above, we seem to start with poor governance, possibly by a conflicted board (per Ms Quint). That board seems most comfortable with aggressive leaders who seem more intent on imposing their will on dedicated, professional staff, rather than working collaboratively, and hiding behind a veil of corporate secrecy, rather than providing the transparency appropriate for a not-for-profit organization whose mission is to to serve the community. Meanwhile, services of all kinds decline, while the community that once supported the organization now regards it with suspicion and alarm.

The current debate about health care reform has focused - to the extent it has focused on anything - on financing and insurance. As we have stated many times before, we can’t fix the health care crisis simply by changing financing mechanisms or money flows.

We can only improve health care by improving the leadership and governance of health care organizations, and by rethinking the size and scope of health care organizations. The most crucial part of health care is what goes on between individual health care professionals and individual patients. Yet our system is composed of endlessly enlarging bureaucracies run by self-interested, often clueless, and sometimes dishonest, if not criminal leaders. This must change, unless we want this crisis to get much, much worse.

The title of this post is a weakly satirical bow to the Rudyard Kipling novel set partially in Gloucester, MA.

[Source : Health Care Renewal]

Roy Poses’ post “Again, Defending Conflicts of Interest with Logical Fallacies” and a similar piece by Dr. Howard Brody over at Hooked: Ethics, Medicine, and Pharma were written by them with no foreknowledge by me of their planning, writing, or posting. I state this up front, because I’ve a very important observation to add after reading them.

The name of the subject of those posts, Dr. Larry Hirsch, seemed immediately familiar to me, for good reason:

Dr Hirsch was an employee at Merck & Co from 1988-2006 and managed the Medical Communications Department [at VP level - ed.] for clinical research publications from late 2001 to mid-2006.

He was VP of Clinical Drug Development, Clinical Trial Registration and Publication, as per his LinkedIn bio.

I was Director of Published [i.e., scientific] Information Resources and of The Merck Index of Chemicals, Drugs and Biologicals in Merck Research Labs from mid 2000-late 2003.

The name stood out due to my recollections of meetings I attended with Dr. Hirsch. The topic was whether, and how, Merck clinical trials results should be made available to the public. Being knowledgeable in electronic health records and biomedical information management, my input was sought.

I’m, as is Dr. Poses, quite sensitive to logical fallacies. In my case, this sensitivity arises from early medical mentorship under the aegis of Dr. Victor P. Satinsky, cardiovascular surgeon, inventor (of the Satinsky clamp and other heart surgery-enabling devices) and polymath, and leader of the Hahnemann Medical College and Hospital’s NSF-funded summer science programs.

Dr. Satinsky stressed “critical thinking … always … or your patient’s dead” to his students; most still probably recall those words, repeated time and again. He would cut down poor arguments and logical fallacy directly and even confrontationally when he encountered them.

I recall Dr. Hirsch making reasonable arguments about the issues in publicizing clinical trials data, both pro and con, and even more importantly I left the meetings with a sense that such matters were in able hands. Dr. Hirsh was well able to synthesize information such as I presented and make rational arguments in response. I didn’t sense a fool in any way, shape or form.

Hence, my surprise and disappointment in the logical fallacies observed and defined by Dr. Poses and Dr. Brody in Dr. Hirsch’s Mayo Clinic Proceedings article regarding the effects of conflict of interest.

This raises a number of questions:

• Have Dr. Hirsch’s personal feelings simply clouded his judgment over the conflict of interest issue, resulting in a somewhat hysterical tone and logical swiss cheese, the holes as catalogued by Drs. Poses and Brody?

• Alternatively, are the logical fallacies deliberate and purposeful, as is done in propaganda written to confuse the audience and steer them erroneously towards a point of view that is not in their own ideal interests? (Such behaviors, of course, depend on an elitist belief that the audience - in this case, doctors, regulators and the public - lacks abilities to detect such flaws, or put more bluntly, as Dr. Satinsky might have stated, is stupid and gullible.)

• Although this is less likely, there’s been enough ghostwriting going on in this industry that the following question must be asked: who, exactly, wrote the Mayo Proceedings article in question? Could it have been, or could there have been contributions from, an unattributed “communications specialist”, i.e., a non-scientist skilled in political spin while less skilled in logical argumentation?

• Are the reviewers and editors of the Mayo Clinic Proceedings able to critically review submitted pieces and themselves perform the analysis that Dr. Poses has performed? As a peer reviewer for scientific publications myself, I would likely have opined that such a piece was unsuitable for publication in its present form due to its flaws in reasoning.

I do not opine on the answers to these questions, but I do feel great disappointment that they even need to be asked. Dr. Satinsky, one of many medical giants of the past, must be rolling in his grave.

– SS

[Source : Health Care Renewal]

The latest version of the argument that we are all getting too worked up over conflicts of interest in health care has appeared, this time in a scholarly, peer-reviewed journal. (Hirsch LJ. Conflicts of interest, authorship, and disclosures in industry-related scientific publishing: the tort bar and editorial oversight in medical journals. Mayo Clinic Proc 2009; 84: 811-821. Link here.) The major point of the paper seems to be that payments to physicians, particularly academic physicians by pharmaceutical, biotechnology, and device companies are necessary for medical progress, so instead of perseverating about them, we all should pay far more attention to the evil of payments made for expert testimony by physicians who serve as expert witnesses in litigation against such companies.

In the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody addressed this main argument, while dismissing the bulk of the article as merely “illogic and innuendo.” I think that Dr Brody failed to grasp the educational opportunities that the Hirsch article presented. It offers a true cornucopia of logical fallacies, making it best teaching material for the sort of course in logic and evidence that should be taught in all our medical schools, but is not.

So let me use this “teachable moment” to address just some of the many logical fallacies that Dr Hirsch so enthusiastically employed, in order of their first appearance in his article.

Appeal to Ridicule

There is a politically correct herd mentality that ascribes to the concept that objectivity is forsaken by medical companies that seek profit (and by their employees) because of ‘conflict of interest.’

Also,

These overt restrictions on researcher communications in this day’s climate of political correctness on COI are causing more than policy debates among various stakeholders….

In both these examples, concerns about conflicts of interest are deemed mere “political correctness.” Thus, this is an appeal to ridicule.

Yet this day there is a McCarthyesque reaction to the term, conflict of interest, with an unstated presumption of guilt until proven innocent.

Here instead the term of ridicule is “McCarthyesque.”

Straw Man Fallacy

There is a politically correct herd mentality that ascribes to the concept that objectivity is forsaken by medical companies that seek profit (and by their employees) because of ‘conflict of interest.’

This single sentence employed two fallacies for the price of one. I would challenge Dr Hirsch to provide a credible example that any thoughtful figure in the conflict of interest discussion has dismissed the objectivity of all for profit health care corporations, and all of their employees. He apparently has constructed a straw man argument which he has attributed to his opponents, one that’s either to strike down than their real arguments.

Appeal to Authority

Previously, the president of the Association of American Medical Colleges emphasized that the term indicates a state of affairs and not a behavior, that COIs are ubiquitous, and that despite their inaccurate portrayal by the media, COIs don’t indicate the occurrence of any improper behavior, much less scientific misconduct, analogous to a say of potential energy

If he stated it, was he right? Is he still right today? Obviously, because someone with a distinguished title expresses an thought does not mean it is true. Thus, this is an appeal to authority. (Note: since the reference appended to this sentence appears to have nothing to do with the content of the sentence, it isn’t even clear that the authority in question made such a statement. Link here.)

Appeal to Common Practice

Publication bias (preferential publication of studies with positive outcomes vs trials with negative, neutral, or ambiguous outcomes) has been reported for more than 2 decades,….

Publication bias clearly extends to government- and nonprofit-funded research….

The thrust here was clearly that publication bias is general and has been around for a long time, so why worry? This is an appeal to common practice, which equates a statement that a pheonomenon is general with the assertion that it is reasonable, justified, ethical, optimal, etc.

Special Pleading

For the 2008 article that was critical of Merck’s authorship practices by Ross, Hill, Egilman and Krumholz, the entire disclosure statement was, ‘All of the authors have been compensated for their work as consultants at the request of plaintiffs in litigation against Merck & Co, Inc, related to rofecoxib.’ Only in the middle of the Comment (Discussion) portion of the article was it mentioned that the authors had served as paid expert witnesses for plaintiffs’ attorneys in rofecoxib litigation. The terse disclosure statement seems at odds with JAMA’s said policy in its Instructions for Authors that financial COI disclosure must be complete. Regardless, the information provided hardly conveyed that, as of January 2007, Krumholz had received more than $300,000 for his consulting from plaintiffs’ attorney Mark Lanier (no relationship to Mayo Clinic Proceedings Editor-in-Chief William L. Lanier, MD), which only became public in a letter to the editor of BMJ that responded to a previous article critical of Merck by Krumholz et al.

Krumholz’ remuneration seems substantial until it is compared to that of another coauthor of the JAMA authorship report,16 David Egilman. Egilman has testified for Mr Lanier and other attorneys in more than 100 tort cases (nearly always for plaintiffs) for approximately 2 decades and, by his own estimate, has earned $20 to $25 million for such testimony.

[Note: this discussion appeared in the midst of a long tirade against the editorial policies and practices of JAMA, especially in relation to controversy about the drug rofecoxib (Vioxx), the now withdrawn Merck Cox-2 inhibitor. Dr Hirsch apparently was responsible for Merck’s publication policies about this drug. Further note that there are major questions about whether the figures supplied by Dr Hirsch are correct. Appended to the post in Dr Brody’s blog post is a categorical denial by Dr Krumholz that he was paid, as asserted by Dr Hirsch, over $300,000, and evidence against the assertions by Dr Hirsch about Dr Egilman’s pay.]

While Dr Hirsch alleged that the disclosures by the authors of this article were incomplete, he did not compare them to the disclosures made by authors of other articles in JAMA. In fact, I have never seen an article in JAMA which included disclsoure of dollar amounts, and couldn’t find any such disclosure in spot checks of the latest issue.

On the other hand, here is the disclosure Dr Hirsch made in his own article:

Dr Hirsch was an employee at Merck & Co from 1988-2006 and managed the Medical Communications Department for clinical research publications from late 2001 to mid-2006. He currently is employed at a medical device and technology company that has no financial interest in any matters related to rofecoxib or the resulting tort litigation involving Merck & Co. Dr Hirsch owns mutual funds with stock from a variety of pharmaceutical and device companies, including Merck, and some shares of Merck and other medical product companies.

He did not disclose dollar amounts connected with any of these activities. He wouldn’t name his current employer on the grounds that it has no interest in rofecoxib and related litigation. However, his article is ostensibly about the broader issues of conflict of interest, authorship, etc which may relate to the interests of Becton Dickinson, which currently employs Dr Hirsch in the capacity of Worldwide Vice President of Medical Affairs, BD Diabetes Care. He didn’t name the “medical product companies” whose shares he owns.

Thus, Dr Hirsch argued that Dr Krumholz and Dr Egilman were wrong not to disclose the details of their financial arrangements with plaintiffs’ attorneys (setting aside the likely inaccuracy of Dr Hirsch’s contentions about the specifics of these arrangements), although the detail they provided in their disclosures was similar to that provided by other JAMA authors, and even though Dr Hirsch didn’t find it necessary to himself disclose in such detail. Thus, Dr Hirsch was advocating a double standard, and in this case, his argument amounts to a special pleading, since the standard he advocated for others wasn’t the same he felt obliged to uphold.

Appeal to Fear

[standards regarding COI] are beginning to affect the willingness of prominent researchers to interact with industry in any manner that involves even minimal compensation for their time and efforts.

Also,

There are serious negative implications for the future of medical product development if top academic researchers are shamed into ceasing any type of compensated interactions with industry.

Dr Hirsch implied that medical progress would be greatly endangered if industry no longer paid practicing doctors and full-time academics to work on the side, and that such payments would no longer be possible were COI disclosure stipulations to be made more strict. Such dire warnings, without evidence to support them, amount to appeals to fear.

Summary

So Dr Hirsch has provided yet another example of an apologia for conflicted physicians and academics based on a panoply of logical fallacies. We have offered several other examples of fallacious defenses of conflicts of interest, compiled here.

It is sad to see logical fallacies so cavalierly employed. There frequent, sometimes strident use in current health policy suggest the need to superior train health care professionals in logic and the use of evidence.

I’m still awaiting a defense of the sorts of conflicts of interest that we frequently discuss on Health Care Renewal that is based on logic and evidence, but it may be that no one can produce such a defense.

Meanwhile, we continue to advocate that at the very least, medical academics, medical academic institutions, and other health care not-for-profits or NGOs should reveal in detail what payments they get from companies selling health care products or services, and how these payments could relate to the companies’ marketing or lobbying efforts. In the US, some such disclosure would be mandated by the proposed “Sunshine” legislation now being considered by the US Congress. (By the way, note that this problem is hardly confined to the US, and needs global, not just American attention.)

However, physicians (at least doctors in full-time private practice, academic positions, and employed by mission-oriented not for profit organizations) should go further, and consider whether receiving industry money is worth the ongoing damage it does to our professionalism and our professional reputations. Medical schools, universities, health care foundations, disease advocacy groups, and other health care not-for-profits and NGOs should also go further, and think about whether receiving industry money is worth the ongoing damage it does to their missions, and their institutional reputations.

[Source : Health Care Renewal]

Yale-trained Medical informatics specialist with experience in pharma. Creative in thought and application to the point where I have the ability to spin anything to the liking of senior management. Will utilize Yale education to the fullest in misusing research funds in providing generous compensation to friendly doctor advocates for company drugs and for compensating ghostwriters. Will employ skills in data modeling and medical decision making to conceal negative research results and put a pretty veneer on even the worst debacles for marketing purposes. Will hire the finest generalist staff from McDonald’s and supply them with a Process Manual in adverse events detection and reporting, to minimize the chances of problems being discovered prior to major profits being generated. Will utilize creativity to simply make stuff up about new uses for drugs. Finally, will ensure only the tastiest of rotisserie chicken and sides in company cafeteria to improve corporate morale during layoffs as a result of upcoming merger.

[Source : Health Care Renewal]

Re the $2.3 billion dollar Pfizer settlement, in the headlines today…

Health Care Renewal readers learned about it in February, here.

At the time, we mentioned how tiny coverage the news had received, a manifestation of the anechoic effect.

We said this about it then:

We’ve posted about numerous settlements of charges of misbehavior by drug, device, insurance and other health care organizations. Stacking them all up suggests the magnitude of bad behavior by the leaders of health care organizations. Yet it’s not clear that all these monetary penalties are discouraging bad behavior.

In nearly all cases, the monetary penalties accrue to the organization as a whole, not to the individuals whose behavior incited the settlement. And I have not so far ever heard of a case in which the organization which has to pay a settlement turns around and enforces a penalty upon the responsible leaders. Thus, the deterrent effect, even of large penalties, is thus diffuse. An executive, knowing that bad behavior may increase short term profits, and hence may markedly increase his or her compensation in the short run, might be undeterred by the threat of a future settlement that he or she does not have to pay. Instead, the settlement may come out of the pockets of stock-holders, employees as a whole, customers, clients, or patients, or the public.

If we want to prevent health care leaders from continuing “childish” behaviors, allowing health care to “spin out of control,” (as per President Obama’ inaugural address, see post here), we must do a better job of enforcing negative consequences, as the mom of any five-year old will tell us.

Rest assured we’ll have more to say about this topic, now that it is in the headlines.

[Source : Health Care Renewal]