Embedded Networks of Influence in Health Care: An Illustrative Case

At the 12th International Anti-Corruption Conference (IACC), sponsored by Transparency International, one of the plenary sessions was devoted to the topic of "embedded networks of influence."  The session description included this description of the topic as:

the major stumbling block in the fight against corruption, namely, the power of 'embedded networks' in advancing personal or group interests through state institutions. The extent of their power can create what is known as “state capture” meaning democratic governance failure. It will take a close look at the influential role of private sector, especially of the multinational private sector.

A recent investigative report in the Chronicle of Higher Education illustrated a striking case of how one key individual has affected health care through multiple connections to what can be regarded as embedded networks of influence, thus tying in to many of the topics we have discussed on Health Care Renewal.

The article focused on the University of Miami and its current President, Donna Shalala. Let me summarize the set of relevant topics in roughly chronological order and note how the article links them to President Shalala.

Speech Codes and Restrictions on Free Speech within Academia

As I wrote in my 2003 article, (Poses RM. A cautionary tale: the dysfunction of the American health care system.  Eur J Int Med 2003; 14: 123-130.  Link here), speech codes and other restrictions on free speech within academia created the framework for the suppression of clinical research that may offend those with vested interests:

Failure of universities to champion the academic freedom of their clinical researchers may stem from their abandonment of their own academic core value of free enquiry. There is abundant evidence that universities may restrict expression and limit academic freedom. In The Shadow University, Kors and Silverglate charged that 'universities have become the enemy of a free society.' Universities have punished faculty and students who raised unpopular viewpoints.

In the Chronicle,

Ms. Shalala, ... was previously president of Hunter College of the City University of New York and chancellor of the University of Wisconsin at Madison....

The Shadow University, the pioneering work on challenges to individual rights by leaders at academic institutions, dealt with Ms Shalala's role as a leading early proponent of silencing speech that offended academic leaders.

Wisconsin chose to enact a speech code. On March 29, 1990, the Wisconsin ACLU joined a suit against the university, announcing that the important moral goals of toleration and equal opportunity 'can be accomplished through means other than the creation of rules which infringe upon the fundamental freedom to express ideas.'

The speech code was drafted with the help of UW-Madison Law School professors Richard Delgado, Gordon Baldwin, and Ted Finman.... On June 9, 1989, upon recommendation by Chancellor Shalala, it was adopted by the Board of Regents...."

The speech code was soon declared unconstitutional by a federal court, which held:

the policy was unconstitutional precisely because 'the UW rule regulates its speech upon its content.'

Ms Shalala then:

recommended a new code to the regents in the spring of 1992, which they adopted in March.

However,

Faced with another lawsuit, the regents reversed themselves

For these and similar efforts, as discussed by Evans and Novak in 1993, Ms Shalala was dubbed "the Queen of PC" [political correctness].

Speech codes and other restrictions on free speech in the academic setting seem mainly to be used to target speech that administrators find offensive, including speech critical of management practices. This is echoed in the Chronicle story, which suggested how fearful University of Miami faculty now are of criticizing Ms Shalala:

Others, including several current and former faculty members, outline their complaints in far more detail. But they do so anonymously, saying they don't want to tangle head-on with such a politically powerful president.

Ms Shalala's prominence in academics, probably more due to rather that in spite of her hostility to free speech and free enquiry, may have enabled her to join another and even more powerful network of influence, this one at the center of the US political world.
 
The Rise of Commercial Health Insurance 

In Deadly Spin, former CIGNA executive Wendell Potter documented how clever and unscrupulous use of public relations and marketing techniques enabled commercial health care insurance and managed care companies to increase dominance of US health care, while allowing health care costs to soar, and denying access to larger numbers of patients. 

The Chronicle article briefly alluded to Ms Shalala's role in the rise of for-profit health insurance.  Despite being labelled "farthest to the left and most controversial of all President-elect Clinton's Cabinet appointments," again per Evans and Novak, Ms Shalala departed the University of Wisconsin in 1993 to become US Secretary of Health and Human Services. In that role, she presided over the administration's failed attempt at health care reform, as Potter wrote,

When President Bill Clinton was forced to give up on comprehensive health care reform in 1994, the damage was far more extensive than anyone could have imagined - the administration's defeat emboldened health insurance companies to totally redefine the mission and methods of an industry that now strands nearly fifty million people without insurance.

As I outlined..., insurers knew after the Clinton disaster that the coast was clear for them to abandon nonprofit practices, long-standing commitments to public service, and traditional insurance models and turn instead to satisfying Wall Street investors' desire to make money, by limiting spending on health care.

Note that my only quibble with what Wendell Potter wrote is that it may be that the insurance companies' top executives, rather than their stockholders who benefited the most from these changes, as we will address below.

Ms Shalala remained Secretary of HHS until 2001, but after the failure of the health care reform proposal in 1994, her department apparently did nothing to try to ameliorate the changes to health care that Potter described above.

Bloated Executive Compensation Disproportionate to Any Measure of Organizational Performance

We have frequently discussed how health care leaders now seem entitled to get huge amounts of compensation disproportionate to their organizations' performance and their responsibility for it. 

Despite Ms Shalala's reputation in the 1990s as an extreme leftist, upon leaving her role in the Clinton administration, she almost immediately embraced the for-profit corporate model of health insurance. In a notable example of what now is called the "revolving door" that went unnoticed at the time,  Ms Shalala went from would be regulator of commercial managed care to leader of commercial managed care.  As noted by the Chronicle:

Debates over ethical boundaries are not new to those involved in the university's growth surge. Ms. Shalala was on the compensation committee of the board of the health insurer UnitedHealth Group when it was caught in one of the nation's largest-ever stock-options scandals. She also received low-cost loans in 2002 as part of a favors-for-politicians scandal at Countrywide Financial Corporation.

Both Ms. Shalala and [University of Miami medical school dean] Dr. Goldschmidt have served on the boards of companies directly or indirectly affected by the university's business decisions. The university had $30-million in annual business with UnitedHealth Group when Ms. Shalala was on its board.

Note that Ms Shalala served as Secretary of Health and Human Services from 1993 to 2001, (see this list), then joined the board of UnitedHealth Group within months (see this article.)

We discussed in considerable detail the ethical failings of UnitedHealth Group while Ms Shalala had fiduciary responsibility as a board member for its conduct. A particularly striking failing was how the board of directors granted sufficient back-dated stock options to the company's former CEO to make him a billionaire on paper.  The resulting scandal was followed by his resignation.  Later, Dr McGuire was forced to give back some the options.  The final settlement of the fiasco cost UnitedHealth $895 million, and Dr McGuire $30 million and the cancellation of 3.6 million stock options.  As we most recently summarized here, former CEO William McGuire was one of the top 10 best compensated CEOs of the first decade of the 21st century, despite the company's multiple ethical failings. 

Conflicts of Interest, Especially Involving Key Opinion Leaders who Promote Marketing Objectives Cloaked in Academic Respectability

We have extensively discussed the web of conflicts of interest that now pervades health care. For academic health care leaders, the most intense kind of conflict of interest may be created by service on the board of directors of a for-profit health care corporation.  Note that corporate directors, as we have discussed previously, have a fiduciary duty to exhibit "unyielding loyalty" to the stockholders of the company and their interests  [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.].  We first started to discuss the intense conflicts of interest generated when leaders of academic medicine are also members of boards of directors of for-profit health care corporations in 2006.  The issue really made the big time in 2010 when the New York Times published a front page article in its Sunday Business section about whether university presidents who also were corporate directors were part of an "academic-industrial complex."  As we noted above, Ms Shalala's service on the board of UnitedHealth Group created such a conflict, and she apparently presided a similar board level conflict of interest affecting her medical school dean. 

A particularly pernicious kind of conflict of interest may be created when a company selling health care goods or services pays an academic to become a "key opinion leader."  Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There are documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

The Chronicle recounted how Ms Shalala also was linked to one of the better known examples of industry paid KOLs:

Dr. Goldschmidt did not fully report the income from such corporate associations on the medical school's financial-disclosure Web site, even while promoting the site as evidence of his faculty's commitment to openness. He also brought to Miami a repeat violator of financial-conflict-of-interest standards, Charles B. Nemeroff, to serve as a professor and chairman of the department of psychiatry and behavioral sciences.

In a companion article, the Chronicle summarized Dr Nemeroff's career thus:

Dr. Nemeroff had quit as chairman of Emory University's psychiatry department in December 2008 after the university received complaints about his secretly receiving money from GlaxoSmithKline and other pharmaceutical companies while helping promote their products.

We (Dr Bernard Carroll more than yours truly)  have posted previously about Dr Nemeroff's exploits, including those at the University of Miami, numerous times. 

The Fall of Municipal Hospitals, the Rise of For-Profit Hospitals

We have frequently discussed how the leaders have undermined health care organizations' core missions, and particularly how hospitals and hospital systems have strayed from their patient care mission to make more money. The Chronicle suggested how Ms Shalala's leadership of the University of Miami has enriched the institution's teaching hospital at the apparent expense of the local municipal hospital system:

Another set of problems, cited by current and former university faculty and Jackson staff members, stems from the 2007 takeover of a facility that became the University of Miami Hospital, across the street from Jackson. The purchase has greatly expanded the university's ability to direct many of the area's most profitable patients and procedures to the new facility and to other university-owned hospitals, further worsening Jackson's own considerable budget woes.

In addition,

The university's patient-enrollment practices were part of the problem. The inspector general of the U.S. Department of Health and Human Services and the U.S. Attorney's Office for the Southern District of Florida are looking into the question of whether university doctors routinely enrolled Jackson patients in research projects without telling the hospital.

In a 2008 letter from Jackson officials to university leaders, Nathan Anspach, who was vice president for physician services at the hospital, described a series of failed efforts 'to stop new clandestine research' at Jackson by university doctors.

Meetings with university officials aimed at stopping the practice 'went badly,' Mr. Anspach wrote, and Dr. Goldschmidt, the medical-school dean, was 'outwardly annoyed' by Jackson's requests for information that would help it identify research patients in the building.

Ms. Shalala was copied on at least some of the correspondence, including a 2006 letter in which Marvin O'Quinn, then-president and chief executive of the Jackson Health System, which runs Jackson Memorial, warned Dr. Goldschmidt about the legal risks of submitting claims for patient care that should be covered by a medical study.

The current director of compliance at Jackson Health System, Diana Salinas, said the allegations are a matter of investigation by the two federal agencies. Ms. Shalala and Dr. Goldschmidt told The Chronicle that they were unfamiliar with the matter. 'This must not be a very big issue,' Ms. Shalala said, 'because none of the Jackson senior leadership has ever brought it up with me.'

Finally,

And the departing chief executive of the Jackson Health System, Eneida O. Roldan, whose appointment two years ago was supported by the university, said medical-school officials made clear from the start 'that they were going to take cardiology across the street.'

Ms. Dixon-Shim, of the support-workers' union, is among those who say they've seen it happen. 'Most of the indigent patients, they're staying at Jackson,' she says. 'But most of the private patients, the physicians are taking them over to their area' at the university-owned hospitals.

Note that we previously discussed how Jackson's financial troubles lead to a bid by for-profit Steward Health Care to take it over.

Summary

So, through her mutiple roles that allowed her to serve at several key nodes of networks of influence in health care, one person has been linked to multiple dysfunctional aspects of US health care that arguably have been responsible for our increasing costs, declining access, and poor quality.  Note that these multiple roles seem to have been logically and even ideologically inconsistent, suggesting that multiplying her roles within the  networks may have been more compelling to her than logical or ideological rationales for particular actions.

We have discussed before, the leadership of health care organizations has become incredibly interrelated, interlocked, and incestuous. It appears that top leaders of various health care organizations may be more familiar with and identify more with each other, and with other hired executives and managers, than with their organizations, their organizations' missions, and their organizations' professionals, staff, students, clients, and patients.  It now appears reasonable to characterize the relationships among health care leaders as embedded networks of influence. 


So to repeat- I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, the anechoic effect mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience.

Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

UCB Settles, Pleads Guilty

Tromp, tromp, tromp.... the legal settlements keep marching along.  This latest story was reported by Reuters and Bloomberg.  The basics were, per Reuters:

The American unit of Belgian pharmaceutical company UCB SA (UCB.BR) pleaded guilty on Thursday and will pay $34.4 million to settle criminal and civil charges that it illegally promoted a drug for migraines.

The company pleaded guilty to one count of promoting the epilepsy treatment drug, Keppra, in the United States in 2004 for migraine treatment without the necessary approval from the Food and Drug Administration, the U.S. Department of Justice said.

One atypical element here is that the company actually pleaded guilty to a crime.

Another slightly off-key note came from the description of the activities constituting the illegal marketing, per Reuters:

The company was accused of promoting Keppra with posters that claimed it was safe and effective for migraines and cited studies that it also claimed were independent -- but in fact were sponsored by UCB, according to the Justice Department.

In those posters, UCB failed to disclose that its own trials had failed to demonstrate the drug was effective for migraines or that it had backed the studies, the agency said.

Furthermore, per Bloomberg,

UCB’s marketing included sponsorship of doctor-paid 'studies,' posters, publications and oral presentations about the supposed benefits of using Keppra to treat migraines. Prosecutors said UCB failed to disclose that a 2000 study showed that Keppra was not effective in preventing migraine.

So the company did not deny accusations of deceptive marketing, and the suppression of a clinical study that failed to conform to marketing objectives.

But most of the rest followed the usual routine.

The settlement involved some sort of promises of better corporate behavior in the future, per Reuters:

As part of the settlement, the company agreed to implement procedures and reviews to avoid and detect any future similar conduct. As a result, UCB will not face probation, according to the plea agreement filed in court.

The penalty for the company was a fine that appeared to be big:

UCB will pay about $8.6 million in criminal fines and forfeiture and another $25.8 million to settle parallel civil allegations involving false claims submitted to U.S. federal healthcare programs, according to the plea agreement.

However, it was a pittance compared to the revenues generate by the product whose marketing was illegal, per Bloomberg:

Keppra, with 942 million euros ($1.37 billion) in sales last year, is the company’s top-selling drug, according to data compiled by Bloomberg.

The spokesperson for the government basically said, "that ought to teach them," again per Bloomberg,

'UCB put its pursuit of profits ahead of its obligations to patients,' Ronald C. Machen Jr., U.S. attorney for the District of Columbia, said in an e-mailed statement. 'Today’s guilty plea and UCB’s $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety.'

However, the company's leaders did not seem the least bit fazed, or contrite for that matter, per Reuters,

'We are pleased to have resolved this matter and look forward to continuing to work with the many organizations with whom we partner to advance our mission of transforming the lives of people living with severe diseases,' said Greg Duncan, UCB's president for North American Operations.

The contrast between the crime his company admitted, involving deceptive marketing and the suppression and a study that failed to fit marketing objectives, and the high minded mission seemed to cause Mr Duncan no cognitive dissonance. Or perhaps "transforming the lives of people" was meant more ironically?

Left unsaid in the brief news reports was whether any individual who authorized, directed, or implemented the bad behavior, including, in this case, the deceptive marketing and suppression of clinical research, would pay any sort of penalty. It seems safe to assume that no one will go to jail, pay a fine, lose a job, or even be demoted.  Why the US Department of Justice thought that a small fine and no individual penalties would change corporate behavior, when the profits to be made are so large, in the absence of even a little bit of contrition by corporate leaders, was not exactly clear.

So on and on the march goes. The parade of settlements, sometimes even involving guilty pleas of criminal convictions, now indicates how low the ethical standards of health care organizations have fallen. However, the lack of any consequences to individuals suggests that they have no incentive to rise.

Again, despite promises of tougher treatment of individuals involved in health care corporate misbehavior from the government (see posts here and here), the same old script plays out again and again.

So I get to say twice in two days,,,, pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.


So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

The Stealth Marketing of Medical Devices: The Biotronik Example

We have frequently discussed the use of organized, deceptive stealth marketing campaigns to influence physicians to prescribe pharmaceuticals. Now more information is coming to light about similar campaigns to influence physicians to use particular medical devices

As reported in the New York Times, based on documents supplied apparently by a corporate whistleblower, here are some tactics used by a small German device manufacturer, Biotronik:

Seeding Trials

These are ostensibly clinical trials, but designed more to market than to discover meaningful data. We have discussed them in the context of drug marketing.

The message from cardiologists was loud and clear, according to a top executive at a heart device company. The doctors wanted implant makers to produce more clinical trials of devices to help them generate income from research fees.

To compete, 'we must be able to 'answer the bell,'' wrote Thomas V. Brown, an executive vice president at the American subsidiary of Biotronik, a small German firm that makes pacemakers and defibrillators.

Mr. Brown’s charge came in an e-mail last year to fellow Biotronik executives, one of scores of documents involving the company that offer a portrait of an implant industry where producers seek to influence the brand of device that patients receive long before a diagnosis.

The documents show, for example, that device makers recruit not only implant specialists as consultants but also general cardiologists who refer patients. Those cardiologists, called feeders in one of the documents, can benefit by enrolling the referred patients in a company-financed study that can pay a cardiologist up to $4,800 a patient.

A lawyer representing Biotronik, Christopher Myers, said Mr. Brown’s e-mail was sent around the same time that some Biotronik sales officials were asking the company to design 'unscientific studies' to compete with producers offering sham studies 'as a means of funneling money to doctors.'

Influencing Device Choice by Making Referring Doctors Consultants

The Times report stated that the company's recent increase in sales was due to

the company’s success in developing relationships with doctors who, in turn, can influence which brand of device a patient gets.

Here is an example of one type of such a relationship:

The company’s relationship with a general cardiologist in Tucson, Dr. Monty C. Morales, is the subject of several memos.

In mid-2008, Biotronik retained Dr. Morales as a consultant under an arrangement that paid him up to $2,000 a month, company records indicate. And about that same time, Dr. Morales, who does not implant devices, expressed strong opinions about the implant brand his patients should get, according to a report apparently written by a sales representative for a Biotronik distributor called Western Medical.

In that memo, Dr. Morales is described as saying that he would not refer patients to an implant specialist in his same Tucson-area practice, Dr. Darren Peress, unless Dr. Peress started implanting Biotronik devices.

'Currently, Peress does not get any of Morales’ business,' the memo stated. 'Monty will strongly support use and send Peress business if he uses Biotronik.'

Also,

Among the Tucson-area implant specialists to whom Dr. Morales apparently referred his patients was Dr. Benigno F. Decena III, the Western Medical report indicates. Internal Biotronik sales data indicates that Dr. Decena’s usage of the company’s products rose sharply in 2009.

During the 12-month period from February 2009 to January 2010, the monetary value of the Biotronik devices used by Dr. Decena reached $1.1 million, an eightfold increase from the previous 12-month period, data shows.

Influencing Device Choice by Making Device Implanters Consultants

Here is a more direct example of making physicians consultants to influence them to then themselves implant more product.

The Times recently detailed in an article how four implant specialists in Las Vegas sharply increased their use of Biotronik devices in mid-2008, about the same time they became consultants. Those doctors said that it was the quality of Biotronik’s devices, not the payments they had received, that had influenced their choice of implants. Whatever the reason, Biotronik’s revenues apparently skyrocketed. By early 2010, the cumulative monetary value of company devices used by those four physicians alone reached about $16 million, internal Biotronik sales data indicates. [Note: see our post by Cetona on this here.]

The documents point to similar outcomes elsewhere.

An implant specialist in Fullerton, Calif., Duane E. Bridges, became a consultant to Biotronik in mid-2008, company records indicate. The monetary volume of company products used by Dr. Bridges from early 2008 to early 2009 reached about $360,000, then jumped to $1.6 million over the next 12-month period, a greater than fourfold rise, the company data indicates.

Dr. Bridges did not respond to comment; also a lawyer, Anthony Willoughby, who said he represented Dr. Bridges could not be reached for comment.

Another implant specialist who became a company consultant in mid-2008, Dr. Michael Brodsky of Irvine, Calif., increased the dollar value of Biotronik devices he used over those two periods, Biotronik data indicate. The value of company products used by another specialist who became a Biotronik consultant in mid-2008, Dr. Prash Jayaraj of Burbank, Calif., also doubled, company data indicate.

Cultivating Nepotism

Finally, here is the use of influence via creating family members' conflicts of interests.

a widely used industry practice: the hiring by a device maker of a doctor’s spouse or other relative. For example, in plotting strategies to gain sales at one California hospital, Biotronik officials suggested that an implant specialist, whose son and wife both worked for a competitor, might be wooed if Biotronik offered him concessions 'such as studies or even the hiring of his son,' according to an internal company report.

Another company document discussed how the revenues of a sales official sharply dropped after his father, an implant specialist, died unexpectedly in an airplane crash

Summary

Thus, the set of documents the Times obtained suggested that one small device company used a set of tactics to increase sales by influencing doctors to use its products.  The tactics employed included seeding trials, hiring referring doctors as consultants to influence proceduralists to whom they referred to use the company's products, hiring proceduralists directly as consultants to influence them to use the products, and hiring relatives of doctors to influence them to use the products or persuade others to use the products.

There is every reason to suspect that such systematic stealth marketing campaigns are prevalent throughout commercialized health care. We have mainly discussed them in terms of the promotion of pharmaceuticals. The examples above suggest they may be used as often to promote medical devices. There is every reason to think they may also be used to promote other health care goods or services.

This latest set of examples brings up two important points.

Physicians, other health care professionals, and health care academics are frequently employed as consultants. These relationships seemed to be looked up on with much favor not only by those directly involved, but also by the supervisors of those involved who are academic or hospital/ health system employees. Even people who find fault with certain kinds of conflicts of interest affecting health care professionals seem less concerned about consulting relationships  For example, the often cited article by Brennan et al which called for more stringent academic policies on conflicts of interest, including banning small gifts from industry, would allow consulting as long as it were governed by a contract with "specific deliverables," (See our post here.)

Yet we have seen repeated examples of consultancies which seem more designed to market products than actually provide specific consulting advice. We also recently have seen how consulting relationships can cloak third-party strategies used in stealth advocacy campaigns (see post here). So all this would suggest that one should be very skeptical about any consulting relationships by health care professionals or academics unless the reason for and nature of the consulting is very clear, and very clearly not related to marketing or public relations.

Finally, note that many apologists for conflicts of interest affecting health care professionals and academics argue that these relationships are inevitable byproducts of the collaboration with industry needed to drive innovation (e.g., see this post.) We have argued that collaboration does not require industry to pay its professional or academic collaborators. The example above shows how conflicts of interest may be created deliberately by commercial firms for marketing purposes. Such relationships do not appear to be "collaboration" necessary for "innovation."

Health care professionals and educators should think again about whether accepting gifts or money from organizations which sell health care products or services is worth the doubts that such incentives create.  Even if the relationship was not designed to promote a product or service, the desire for continued payments and gifts can influence professional decisions or academic opinions.  Worse, the increasing evidence about the prevalence of stealth marketing and advocacy suggests that any gift or payment not clearly in reciprocity for a very well defined technical service is likely to be a deliberate part of such a campaign.  Is the money really worth the doubts about professionalism and trustworthiness it may create? 

Has the Heart Rhythm Society Become More Like a Marketing Firm?

ProPublica's and USA Today's joint investigation of one medical society's ties to industry has created a stir.  (The full ProPublica version is here.)  It's worth doing a little reading between the lines to see its further implications.

The Basic Story

The story focused first on the annual meeting of the Heart Rhythm Society (HRS), a sub-specialized medical society for cardiologists who specialize in electrical or rhythm disorders.  The meeting seemingly has become a giant marketing opportunity, supported by $5 million in industry money, in which practically every flat surface became a medium for advertising.  (The ProPublica article included multiple pictures of branded items from carpets in the exhibit halls to the backs of the seats in shuttle buses.) Also,

St. Jude Medical adorns every hotel key card. Medtronic ads are splashed on buses, banners and the stairs underfoot. Logos splay across shuttle bus headrests, carpets and cellphone-charging stations.

At night, a drug firm gets the last word: A promo for the heart drug Multaq stood on each doctor’s nightstand Wednesday.

Then reporters Charles Ornstein and Tracy Weber looked at the HRS as a whole, noting that half the society's total income comes from industry, and "Twelve of 18 directors are paid speakers or consultants for the companies, one holds stock, and the outgoing president disclosed research ties, according to the society’s website, which does not specify how much they receive."  Furthermore, "Two of the society’s biggest funders — Boston Scientific and St. Jude Medical — have paid millions since 2009 to settle federal allegations that they improperly paid kickbacks to unidentified physicians to use their cardiac devices. Neither company admitted wrongdoing."

The article raised tantalizing questions and implied others, but despite the reporters' best attempts, leaders of the HRS and their defenders failed to address them.  Their failure to grapple with the real issues is to me the most disturbing part of the story.

Why Take the Money?

ProPublica published a companion piece consisting of questions to and responses from the HRS President, Dr Douglas L Packer, and President-Elect, Dr Bruce L Wilkoff. The first response was the rationale for taking the money:

Advances in electrophysiology depend on a collaborative relationship between physicians and industry....

Later,

It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials.

This response is very common from physicians and other health professionals defending relationships with industry. Note that this response, similar to previous ones, is off the point. The issue is not all relationships with industry. It is about relationships in which industry pays people, or in this case, a group of people for purposes not always clear, but when clear are related to marketing. Payments from industry to physicians and health professionals are not necessary for collaboration. If the goal is innovation and development of therapies, how is that supported by payments to a medical society to provide marketing opportunities?

Why Subject the Meeting Attendees to All That Advertising?

Much of the money received by the society was obviously for marketing purposes. The effect of these payments was the advertising barrage noted above. So the obvious questions are: is it beneficial for the society to expose its members and other meeting attendees to all this marketing?  Should making its members accessible to marketing be a major part of the society's activities?

When questioned by ProPublica, the organization's leadership evaded:

Q. Items at your conference—from key cards to newspaper wraps—are available for sponsorships. What is the purpose of these sponsorships? Does the livelihood of the organization depend on them? Do the ads have an impact on what your members buy and use in their practices?

A. The Heart Rhythm Society offers sponsorship opportunities at the annual scientific sessions to provide advertising opportunities for participating exhibitors. Approximately 50 percent of the revenue for the annual scientific sessions is generated by industry in a combination of exhibit space rental (largest), sponsorship/promotional advertising opportunities, unrestricted educational grants and exhibitor office suites. The society does not collect data or ask attendees if sponsorship or advertising impacts their purchase decisions.

Very few people quoted in the ProPublic series ventured to defend the marketing onslaught. There was only this. In a newer follow up article, Chris Ornstein quoted meeting attendees with similar sentiments:

'I’ve always been rather offended that people who aren’t doctors think I’m susceptible to bribes and corruption,' [Raleigh, NC electophysiologist Dr Mark] Englehardt said. 'A lot of what you learn about products is from people that sell the products. … You have to learn it somewhere.'

Note that the good Dr Englehardt lead off by invoking a straw-man fallacy. Being influenced by advertising is not the same as taking bribes. No one accused those attending the conference of taking bribes. More importantly, his argument in favor of advertising invoked a false dilemma (or false dichotomy). There certainly are sources of information about products, and particularly about electrophysiologic devices, beyond manufacturers' advertising.  The choice is not simply ignorance versus advertising.

Others merely sought to minimize the harms of exposure to so much advertising. For example, one of the HRS' defenders, who not coincidentally runs a much larger medical society, which also has had its issues with its extensive ties to industry, (look here) said:

The 'circus element' of the exhibit booths doesn’t unduly influence attendees, [CEO of the American College of Cardiology Jack] Lewin said. 'I don’t buy a soft drink just because of the advertising… I buy it because I like it.'

Maybe not, but the analogy may not be apt. Furthermore, we have seen a stream of physicians, other health professionals, and academics deny that they are influenced by marketing or monetary incentives. It is hard to believe, however, that industry would spend so much trying to influence opinions without some evidence that the money provides some results. In addition, most people seem to lack insight about what influences their opinions, especially when consciously admitting such influence might threaten their self-image.

On the other hand, the follow-up article also noted:

Some doctors acknowledged that the corporate barrage must have some effect. 'I hope not, but I’m certain that it does,' said Dr. Christopher Conley of Nashville, Tenn. 'I’m sure the companies do their own research. They wouldn’t be here, they wouldn’t be putting all this money out if it didn’t influence people.'

It seems obvious that all the advertising was meant to sell products. It seems unlikely that marketers spend so much money without some reason to believe it would have an effect. Even if it had little effect, was there any benefit to selling all that marketing space that would counter-act one glaringly obvious harm? By raising so much money from such obvious and widespread marketing, the Cardiac Rhythm Society meeting is liable to be viewed more as a marketing event than a serious scientific or professional venue.

Is It a Professional Society, or a Marketing Firm?

As noted above, accepting so much money for such a large marketing presence at its national meeting makes the Heart Rhythm Society appear to resemble a marketing firm.  Other information revealed by ProPublica increases the apparent similarity. 

Societies are groups of people who gather for a common purpose.  Medical societies ought to be groups of doctors who gather for common purposes, usually including promoting their own professional interests and upholding professional values.  They typically used to convene meetings for educational or advocacy purposes, and publish journals or other media.  Thus their typical sources of revenue could be dues, meeting registrations, and subscription and similar fees. 

However, as noted above, half of the Heart Rhythm Society's budget comes from industry, specifically "from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms," according to ProPublica.  The picture was similar in 2009.  I reviewed the organization's most recent (2009) financial disclosure (990 form) filed with the US Internal Revenue Service and made available to the public by Guidestar.  In that year, the organization's total revenues were $14,772,708.  Revenues from "grants and sponsorships" were $4,061,883 and from annual meeting exhibits were $3,065,750, for a total of $7,127,633.  So only about half of the society's revenues came from traditional sources, including meeting registration ($4,749,974) and dues ($1,513,361).  Given that some of the registration fees doubtless came from industry attendees, and some product sales ($212,298) and royalties ($511,760) also came from industry sources, the organization's revenue makes it appear at least at least as much like a marketing firm as a medical society. 

Note that one group of beneficiaries of this industry largess was the organization's paid managers.  The 990 form listed eight executives who made over $150,000 a year in the worst years so far of the Great Recession.  Its CEO received total compensation of $532,691.  His compensation used 3.6% of the organization's total revenue. 

Moreover, the majority of the Heart Rhythm Society's board and officers have major ties to manufacturers of drugs and devices used in the diagnosis and treatment of heart rhythm problems.  As noted above, 12/18 directors were found to have ties to the companies which advertised at the meeting.  Perusal of disclosure forms which the Society, to its credit, does make public here, revealed only three of 20 officers and directors who had nothing to disclose in 2011-12. The current President, Dr Douglas L Packer, had two pages of disclosures, including 10 different device or biotechnology companies from whom he got "significant" (over $10,000) grants or royalty income.  Many other board members and officers had "significant" financial relationships, consulting/ honoraria, speakers' bureau membership, equity interests, with drug, biotechnology, or device companies which make products relevant to cardiac rhythm disorders.
 
The leaders of the society asserted their ability to "manage" industry relationships:

Due to thorough policies and procedures in place for working with industry, the Heart Rhythm Society is comfortable identifying and managing various interactions with industry. Additionally, the society seeks multiple supporters for its educational programs in order to avoid the perception that programs are tied to a specific company. The society has sufficient measures in place to prevent undue influence from industry or introduction of industry bias into HRS-sponsored educational programs, research, scientific documents and policy initiatives.

Later, when directly questioned about the implications of receiving half the organization's funding from industry, they evaded again:

Q. Some researchers on conflicts of interest say that when a medical society receives half of its funding from industry, it is codependent on them and therefore will—consciously or not—avoid criticizing the products they make. How would you respond?

A.  The Heart Rhythm Society’s first and foremost concern is to provide effective and appropriate treatment options to our patients.  It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials. For this reason, we believe that interacting with industry is not inherently wrong with the correct measures in place to mitigate the possibility of conflicts of interest.

Moreover, the Society maintains a neutral position on all products and services offered by industry. The U.S. Food and Drug Administration is our source for information about new products, safety alerts and drug recalls.

Half of the organization's revenues come from industry, and the organization is willing to expose its meeting attendees to a barrage of advertising to obtain most of these revenues. Providing such advertising does not seem to maintaining "a neutral position." Do its leaders really mean that this proportion of support has no influence on them or how the organization is run? Nearly all the organization's officers and directors have their own financial relationships with industry. Do they really think that these relationships have no effect on their thinking? Would the leaders be indifferent to losing half of the organization's financial support and their own personal financial relationships with industry? If they would not be indifferent to this eventuality, can they argue they are uninfluenced?  Would the organization's CEO, whose compensation is over 3% of the organization's total revenue, be indifferent to a decrease of 50% in that revenue?  If not, could he be uninfluenced by the source of this revenue?

Summary: Why Pay Dues to a Marketing Firm?

As health care dysfunction has gotten worse over the years, as costs rise, access falls, and quality stagnate, as physicians are subject perverse incentives and deceptive marketing, as the medical research literature has been suppressed and manipulated, there have been surprisingly few responses from medical societies.  The case study provided by ProPublica of one such society suggests one reason why.  Medical societies seem to behave increasingly like marketing firms.  The majority of their revenue may not come from their members.  They may be willing to subject their members to a flood of marketing to make more money.  Their leaders may have extensive relationships with industry.  Their paid managers may be dependent on industry revenue for out sized compensation.

If medical societies have come to resemble marketing firms, is it any wonder that they have not spoken up against the commercialization of health care, even when the result has not been good for physicians' core values?  But in that case, why would physicians who care about their patients and their core values want to belong and pay dues to marketing firms?  Inquiring minds want to know....

Maybe physicians should only join medical societies that really act like medical societies.

For further discussion in the blogsphere, see this post by Merrill Goozner on the GoozNews blog, this post by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, this post by Daniel Carlat on the Carlat Psychiatry blog, and this post by Paul Thacker on the Project on Government Oversight blog.

Who Is Really "Bullying?" - Academic Leaders and the Stifling of Critics of Conflicts of Interests

Universities, which are supposed to discover and disseminate knowledge, ought to be the foremost defenders of free speech and a free press.  However, in the past decades, university executives have become notorious for trying to control speech that offends their political sensibilities (for numerous examples, see the FIRE - Foundation for Individual Rights in Education web-site.) 

It seems that academic leaders get even more upset when their or their faculties' conflicts of interest are criticized, as demonstrated by updates about two important cases we have discussed.

Columbia University

We recently posted about reactions at the university to revelations in the movie "Inside Job" that the Dean of the Business School and one of its prominent professors failed to disclose pay they received that might have motivated their enthusiastic promotion of economic policies that helped contribute to the Great Recession. 

These reactions occurred six months after the movie came out.  A Columbia Spectator student columnist asked why it took so long:

Why have students waited until April to address the consequences of “Inside Job” when the film was released in October? Why has our reaction been delayed by seven months?

Her postulated answer:

Why should Columbia need an outside documentary to point out its ethical failures?

Embedded in the Spectator news article about the film—published April 15— is a quote from University Senator Liya Yu that offers a frightening answer to our question about the delayed student reaction. 'I think people in the Business School haven’t responded because they are afraid,' Yu was quoted saying. 'If you are the dean of a school, obviously all the students are going to be dependent on you for their careers and futures. It’s hard for them to do anything.' I think this explanation extends to students beyond those currently enrolled in the Business School. In fact, its implications pose a threat to student journalism as a whole. For the first time in history, everything that a student journalist writes during his or her time in college is published on the Internet. This is a good thing for many reasons: It increases readership, allows writers to cross-reference easily, etc. But it also creates a permanent, compromising memory that is available forever to anyone who seeks it.

From the moment the college application process began, we were told that the content of our Facebook profiles could be used against us in admissions. We have learned to censor our traceable online behavior so as not to compromise our professional or educational prospects. Unfortunately, this has led to journalistic over-caution. We fear that anything we say now will be used against us later. And maybe it’s true. After all, not enough time has passed for us to take a careful account of the degree to which students’ first publications can affect their futures. Even editors have advised me to mitigate the strongest claims in my columns for fear of consequences to come. Perhaps they are right. But the most insidious kind of censorship—the hardest to recognize, the hardest to combat—is self-censorship, the persistent imaginative failure that prevents us from even recognizing what we should be writing about.

In the Internet age, bravery in student journalism is not trailing a military unit on the Iraqi front lines. Rather, it is the willingness to address controversial issues as they surface, not once these points of view have become popular. Our brand of fear—which is frankly selfish—censors our thoughts almost unnoticed. Next time, let’s skip the delayed reaction. I for one hope to do better.

So students may fear challenging conflicted faculty or administrators for fear of immediate academic punishment and future harm to career prospects in a society in which criticism of acquisitive leaders is decreasingly tolerated.

University of Minnesota

Earlier this year we posted about the troubling case of the death of an ostensibly voluntary participant in a clinical trial at the University of Minnesota years ago.  A particular concern was whether the money they received from the trial's sponsor influenced faculty and university leaders to overlook problems that might have put patients at risk in a trial whose main goal was marketing, not science.

The case got recent attention in an article by Dr Carl Elliott, a university professor of bioethics, and a letter he signed with other faculty requesting a new university inquiry into the case.  Not only did the university administration rebuff this request, but it now seems to be looking for ways to deter any future criticism of the institution's human research.  As reported in the Chronicle of Higher Education,

At the prompting of the University of Minnesota's general counsel, a committee of the University Senate has taken up the question of how faculty should collectively respond to "factually incorrect attacks" on particular faculty research.

Some faculty members say that direct appeal from the general counsel, Mark B. Rotenberg, is an attempt to quiet some faculty members' criticism of drug trials conducted at the university, including one seven years ago in which a participant, Dan Markingson, committed suicide. Before they took up the general counsel's question at a meeting this month, members of the university's Academic Freedom and Tenure Committee were provided with copies of material related to that case, including a letter sent by eight bioethicists to the Board of Regents last fall, asking it to appoint a panel of outside experts to examine the ethical issues raised by the death.

Committee members discussed with two administrators who attended that meeting, on April 8, whether faculty members have a responsibility to respond to attacks on fellow faculty members, according to minutes from the meeting; failure to do so, one professor said, could be seen as parallel to 'bullying.'

Professor Carl Elliott, who wrote the Mother Jones article that brought the recent unpleasantness of the Markingson case back into the public view, was concerned:

In an interview, Mr. Elliott said the general counsel's actions are troubling. Instead of fostering an open discussion about research practices, Mr. Rotenberg, and by extension the university administration, is attempting to use the faculty senate as a 'stalking horse' for intimidation and punitive action, Mr. Elliott said.

It defies common sense that Dr Elliott, representing only his own intellect and knowledge of ethics, was the "bully" in this case, while Mr Rotenberg, representing the university hierarchy, and the faculty members who ran the trial in which Mr Markingson died were the victims. As University of Minnesota faculty member Karen-Sue Taussig, a medical anthropologist, said per the Bioethics Forum:

I was worried the committee might be being used to intimidate a member of the faculty who was critical of the University. It seemed to me that there was a logical inconsistency in the University counsel's position: he did not provide any evidence that any individual faculty member felt chilled by Carl's work, yet his bringing up the issue clearly posed the threat of chilling Carl's speech. . . . In short, I was concerned about the possibility of an Orwellian attempt to invoke academic freedom in order to chill academic freedom.

By the way, there is also nothing to suggest that Dr Elliott's work was "factually incorrect."  Per the Bioethics Forum:

Philosopher and historian of science Ken Waters, who also attended the second meeting, was just as concerned. 'The University's general council planted a false question, the implicature of which [the committee] seemed to be uncritically accepting (that Carl was advancing factually incorrect claims),' he wrote to me in an e-mail. 'And in planting the question, the counsel was trying to turn the tables and squelch my colleagues' academic freedom by somehow suggesting that they were impinging upon the academic freedom of others.'

In the 1980s and 1990s, university administrators tended to attack speech they felt was hurtful to minorities and women, using speech codes (again as has been amply demonstrated by FIRE). Now they seem most sensitive to speech critical of their own exercise of power, and of the cozy financial relationships that generate conflicts of interest and threaten the academic mission.  Furthermore, now that it has become fashionable to decry "bullying," "anti-bullying" initiatives may become the chief way to quell criticism that make academic leaders uncomfortable.

Summary

At one time, university administrators and favored faculty justified attacks on free enquiry, a crucial part of the academic, by claiming a higher political or social purpose.  Now they seem to be willing to trash the core values of academia to stifle critics of their own actions, especially those involving lucrative conflicts of interest.   Such actions may be a major cause of the anechoic effect.
Increasingly, academic institutuions seem to be run more for the personal benefit of their leaders and their cronies than to discover and disseminate knowledge.  True health care reform would return academic medicine to its fundamental purpose, and return its leadership to those who would uphold the mission rather than fill their pockets.  

Hat tip to Ed Silverman in the PharmaLot blog re the University of Minnesota case.  See also comments by Prof William Gleason in the Periodic Table blog, e.g., here and here, and by Gary Schwitzer in the HealthNewsReview blog.

RUCing About - Conflicts of Interest Affecting the Members of the RBRVS Update Committee

Since 2007, we have been writing about the secretive RUC (RBRVS Update Committee), the private AMA committee that somehow has managed to get effective control over how Medicare pays physicians. The RUC has been accused of setting up incentives that strongly favor invasive, high technology procedures while disfavoring primary care and other "cognitive medicine." Despite the central role of (perverse) incentives in raising health care costs while limiting access and degrading quality, there was surprisingly little discussion about the pivotal role played by the RUC until the formation of the "Replace the RUC" movement (see post here). 

Recently, the leaders of Replace the RUC scored a journalistic coup by putting the current list of RUC members publicly on-line.  As we have discussed, previously the membership of this committee was kept very obscure, although the committee argued it was not exactly secret. 

Some Google searching suggests one possible reason that the RUC was in no hurry to disclose its own membership.  It appears that many of the RUC members have significant conflicts of interest with respect to their roles as de facto setters of the rates at which physicians are paid by the government.

The RUC Members and Their Financial Relationships

Below is the list of the current RUC membership (from this link), and relevant conflicts of interest obtained by Google searching.  Note that for each member, I first give the name, affiliation relevant to the RUC, location, and first year of membership as provided by the link above.  Then I list relevant financial relationships that appear to present conflicts of interest.

- Barbara Levy, MD

Chair, RVS Update Committee
Federal Way, WA 2000

Consultant/Advisory Boards: Conceptus; AMS; Covidien; Halt Medical; Gynesonics; Idoman Medical (hysteroscopic surgery and sterilization, endometrial ablation, electrosurgery, vaginal hysterectomy) per UptoDate

- Bibb Allen, Jr., MD
American College of Radiology (ACR)
Birmingham, AL 2006

- Michael D. Bishop, MD
American College of Emergency Physicians (ACEP)
Bloomington, IN 2003

- James Blankenship, MD
American College of Cardiology (ACC)
Danville, PA 2000

Lecture fees from Sanofi-Aventis per New England Journal of Medicine

- Robert Dale Blasier, MD
American Academy of Orthopaedic Surgeons (AAOS)
Little Rock, AK 2008

- Joel Bradley, MD
American Academy of Pediatrics (AAP)
Brentwood, TN 2008

Medical Director, Americhoice by UnitedHealthcare, per AAP conference brochure

- Ronald Burd, MD
American Psychiatric Association (APA)
Fargo, ND 2006

- William F. Gee, MD
American Urological Association (AUA)
Lexington, KY 2010

Member, Physician Advisory Board, Aetna per Aetna

- John O. Gage, MD
American College of Surgeons (ACS)
Pensacola, FL 1991

- David F. Hitzeman, DO
American Osteopathic Association (AOA)
Tulsa, OK 1996

- Peter A. Hollmann, MD
CPT Editorial Panel (AMA/CPT)
Providence, RI 2003

Medical Director, Blue Cross and Blue Shield of Rhode Island, per RI Medical Society

- Charles F. Koopmann, Jr., MD
American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
Ann Arbor, MI 1996

- Robert Kossmann, MD
Renal Physicians Association (RPA)
Santa Fe, NM 2009

Member of Advanced Renal Technologies Advisory Board, Network 15 Medical Advisory Board, Baxter Home Dialysis Advisory Board, Fresenius Medical Advisory Board per Renal Physicians Association

- Walter Larimore, MD
American Academy of Family Physicians (AAFP)
Colorado Springs, CO 2009

- Brenda Lewis, DO
American Society of Anesthesiologists (ASA)
Cleveland, OH 2009

- J. Leonard Lichtenfeld, MD
American College of Physicians (ACP)
Atlanta, GA 1994

Member, Physician Advisory Board, Aetna per Aetna

- Scott Manaker, MD, PhD
American College of Chest Physicians (ACCP)
Philadelphia, PA 2010

Consultant to Pfizer and Johnson and Johnson. Owns stock in Neose Technologies, Pfizer, Johnson & Johnson, and Rohm and Haas per Chest

- Bill Moran, MD
Practice Expense Review Committee
Oklahoma City, OK 2000

- Guy Orangio, MD
American Society of Colon & Rectal Surgeons (ASCRS)
Atlanta, GA 2009

- Gregory Przybylski, MD
American Association of Neurological Surgeons (AANS)
Edison, NJ 2001

Stock Ownership: United Healthcare (300 shares);  ...  Scientific Advisory Board: United Health Group (B, Spine Advisory Board) per NASS meeting

- Marc Raphaelson, MD
American Academy of Neurology (AAN)
Leesburg, VA 2009

personal compensation for activities with Jazz Pharmaceuticals and Medtronics as a speakers bureau member or consultant per AAN

- Sandra Reed, MD
American College of Obstetricians and Gynecologists (ACOG)
Thomasville, GA 2009

GlaxoSmithKline Consulting, $1750 in 2009, $1500 in 2010 per ProPublica Dollars for Docs search through here

- Daniel Mark Siegel, MD
American Academy of Dermatology (AAD)
Brooklyn, NY 2003

Vivacare Dermatology Advisory Board, 2006 – present. Photomedex Scientific Advisory Board, 2006-present, Ad Hoc consultant to ClickDiagnostics, per Encite CV
DermFirst-Shareholder, Logical Image – Consultant, Vivacare - Consultant per MOHS Surgery

- Lloyd S. Smith, DPM
Health Care Professionals Advisory Committee
Bethesda, MD 2007

- Peter Smith, MD
Society of Thoracic Surgeons (STS)
Durham, NC 2006

Eli Lilly, Consulting, $1500 in 2009, $1990 in 2010 per Pro Publica Dollars for Docs search through here
Advisor or consultant to Bayer per Medscape

- Susan Spires, MD
College of American Pathologists (CAP)
Lexington, KY 2007

- Arthur Traugott, MD
American Medical Association (AMA)
Champaign, IL 2006

- James Waldorf, MD
American Society of Plastic Surgeons (ASPS)
Jacksonville, FL 2008

- George Williams, MD
American Academy of Ophthalmology (AAO)
Royal Oak, MI 2009

Advisory Team, RetroSense Therapeutics
Shareholder and consultant for ThromboGenics Ltd. and holds intellectual property on the use of plasmin per Review of Opthamology
Alcon Laboratories, consultant, lecturer; Allergan, consultant, lecturer; Macusight, consultant, equity owner; Neurotech, consultant; Nu-Vue Technologies, equity owner, patent/ royalties; OMIC- Ophthalmic Mutual Insurance Company, employee; Optimedica, consultant, equity owner; Thrombogenics, consultant, equity owner per AAO meeting
Pfizer, “Professional Advising,” $5534 in 2009 per Pro Publica Dollars for Docs search through here

Summary

There you have it.  A substantial proportion, almost half, 14 of 29 members of the RUC have financial relationships with pharmaceutical companies, biotechnology companies, device companies, companies that directly provide health care, and health care insurance companies. 

As we have noted in our previous discussions of the RUC, that committee has been accused of being the de facto controller of how the US government pays physicians.  In that role, it has been accused of favoring procedural care rather than cognitive or primary care by increasing the relative financial incentives for the former over the latter.  This may be one of the most important reasons for the expensive, high-technology, procedural-heavy style of care in the US, which has likely been a major driver for increasing costs, declining access and stagnant quality.

It seemed obvious that a committee dominated by a majority of physicians who perform procedures would tend to favor bigger financial incentives for procedures.  But now it appears the committee also includes a substantial number of people who work part-time or have ownership interests in companies that also stand to benefit from increasing use of procedures.  Procedures drive increased consumption of drugs, supplies and devices, and lead to larger revenue for hospitals and clinics.  Thus these financial relationships could reasonably be suspected of even further distorting the committee's decision-making in favor of procedures.

I was surprised how many RUC members have financial ties to health care insurance companies.  Such companies are not usually thought of as beneficiaries of high-technology, procedural care.  However, if one conceives of their revenue as a percentage of health care costs, perhaps they are.  Furthermore, one can only wonder if the links between the RUC and health care insurance companies have anything to do with how such companies have apparently unquestioningly adapted the RBRVS system controlled by the RUC?

The prevalence of conflicts of interest among RUC members highlight the need for a more accountable, transparent and honest system to manage how the government pays physicians, and a need for more transparency and accountability in the relationship among the government, health care insurance, and physicians.

 As we have previously noted,  there are still many unanswered questions about the RUC:

- How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
- Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
- How did the RUC become de facto in charge of this process?
- Why does the AMA [keep the membership of the RUC so opaque, and] give no input into the RUC process to its general membership?
- Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
- Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?

Stay tuned, maybe these will be answered in our life-times....

Khadafy's Academic Mercenaries' Health Care Connections

We just discussed Henry Kissinger as an early example of the intellectual mercenary, and recent striking examples of academic mercenaries,particularly the Harvard University-derived Monitor Group's academically disguised public relations work for Libyan tyrant Moammar Khadafy.

We concluded that academic mercenaries help foster the corporate culture in which health care is now immersed.  However, it also appears they may have direct influence on health care. 

Monitor Group Leadership

Consider for example the main figure in the Monitor Group - Khadafy scandal.  According to a Boston Globe article, Michael Porter developed the Monitor-Khadafy connection:

Monitor’s work in Libya began when Michael Porter, a Harvard Business School professor who is among the country’s top theorists on management strategies, received a call from Saif Khadafy around 2001, according to Porter. Saif, a Western-leaning doctoral student who US officials hoped would become the next leader of Libya, asked for his expertise to help change Libya’s battered, Soviet-style economy.

(Saif, of course, later sided with his father in brutally putting down anti-government protesters.)

According to his official Harvard biography, Michael Porter also has a big interest in health care:

Since 2001, Professor Porter has devoted considerable attention to competition in the health care system, with a focus on improving health care delivery. His work with Professor Elizabeth Teisberg, including the book Redefining Health Care: Creating Value-Based Competition on Results (Harvard Business School Press, 2006), is influencing thinking and practice not only in the United States but numerous other countries.

In fact, the New England Journal of Medicine published his four-page commentary on "value-based" health care reform in 2009 [Porter ME. A strategy for health care reform - toward a value-based system. N Engl J Med 2009; 361: 109-112. Link here.]

The journal required that he disclose financial relationships with other health care organizations, including

receiving lecture fees from the American Surgical Association, the American Medical Group Association, the World Health Care Congress, Hoag Hospital, and the Children's Hospital of Philadelphia, receiving director's fees from Thermo Fisher Scientific, and having an equity interest in Thermo Fisher Scientific, Genzyme, Zoll Medical, Merck, and Pfizer.

The Boston Globe article identified two more Monitor leaders who helped develop the Libyan connection:

Porter brought in Monitor, a firm he had helped found, along with other associates including former Harvard professors Mark Fuller, who is now the firm’s chairman, and Joseph Fuller, who works at Monitor and also collaborates on research with some Harvard professors.

Mark Fuller, the current CEO of the Monitor Group, who wrote to the Libyan government proposing to counter its "deficit of positive public relations" as described by Mother Jones, per the New Profit Inc web-site is:

a Member of Harvard University's Major Gifts Steering Committee, a Member of the [Harvard] Board of Overseers' Committee on University Resources,...

Joseph Fuller was an unsuccesful candidate for the Harvard Board of Overseers in 2010. His biography for that candidacy also stated:

He and his wife, Ruthanne Schwartz Fuller, MBA ’83, served on the HBS Board of Dean’s Advisors and Joe on the Harvard College Fund and the FAS Undergraduate Education Planning Committee.

So of the three Monitor Group leaders who developed the stealth public relations campaign for Khadafy, the leader who set up the relationship with Libya has a professed interest in health care, published on health policy in a prominent journal, and has financial ties to multiple health care organizations. The two others have leadership roles within their own university which are likely to affect its medical and health care spheres

Monitor's Hired Academics

Furthermore, of the seven outside academics the Monitor Group paid to help promote the Khadafy regime per the Mother Jones article, three had health care connections. 

Richard Perle is on the board of directors of New Health Sciences Inc, a biotechnology company.

In 2008, Francis Fukuyama was elected a member of the Board of Trustees of the Rand Corporation, which does substantial health care research.

Benjamin Barber's own biography claims he has been on the National Advisory Board of American Health Decision Inc since 1992.

Summary

As we noted before, severe problems with the leadership and governance of health care seem not to be only due to specific deficiencies within health care, but may also be influenced by larger societal problems.  The leadership of many organizations seems to have been given over to self-serving opportunists with no fixed values or loyalties. David Halberstam described Henry Kissinger as a prototype of these "wildly ambitious agents of opportunity," also as:

the free agent—the professional political player who brilliantly manipulated the press, played both sides of issues, and put his own agenda ahead of all others.

We discussed examples of such free agents who cloaked themselves in the mantles of two formerly prestigious academic institutions, Columbia and Harvard Universities. Both universities have medical schools, teaching hospitals, and considerable influence within medicine and health care. So it seems likely that the free agency of faculty outside of medicine and health care could influence how things are done within medicine and health care. Furthermore, we have demonstrated that many free agents whose focus may not primarily be on health care and medicine may have wide-ranging activities including some that directly affect medicine and health care.

The pervasive nature of free agents, or agents of opportunity within academia, government, and the rest of society shows why it has been so hard to challenge the threats to core values created by conflicts of interest in medicine and health care. The conflicted already hold much of the power within the larger society in which medicine and health care operate. They are unlikely to favor restrictions on their brother and sister free agents within the medical and health care sector.

So our effort to address concentration and abuse of power in health care, and promote accountability, integrity, honesty, and ethics in health care leadership and governance must necessarily take into account these issues in society at large. The bad news is that the problems are much bigger than we first imagined. The good news is that we have potential allies facing similar problems throughout the world.

But it is now really clear that to truly reform health care, we must improve the accountability, integrity, honesty and ethics of not only health care leadership and governance, but of all organizational leadership and governance. That should keep us busy for a while.

Henry Kissinger, Iceland's Promoter, Khadafy's Apologists, and the Rise of the Academic Mercenary

In which we discuss how medical academic mercenaries (like the key opinion leaders paid to promote drugs and devices cloaked in their academic and professional credentials) now appear to be just part of a larger problem.
Henry Kissinger

Almost 17 years ago, an article by David Halberstam in Vanity Fair(1) should have warned us of the rise of the academic and intellectual mercenary.  However, back in those go-go years of the new gilded age, most of us were not listening. 

Halberstam focused on Henry Kissinger, once a protege of New York Governor and then US Vice President Nelson Rockefeller, who became the infamous President Nixon's National Security Advisor, then Secretary of State:

Kissinger’s capacity to be all things to all campaigns—an overt Rockefeller man, a semi-overt Humphrey man, and a covert Nixon man—reflects the emergence of the rootless operator in the modern superstate. Kissinger was the first—though there were others to follow—of the wildly ambitious agents of opportunity set loose in the wilds of Washington and other capitals. They are interchangeable men, singular in their ambitions, unhampered by traditional loyalties or affiliations. They are men so cool and detached in their geopolitical views that they sometimes seem to be part of a new international elite, readily transferable to the governments of allies and adversaries alike.

Two recent dramatic stories show how prevalent academic mercenaries, another breed of "rootless operators," or "wildly ambitious agents of opportunity," have become.

Promoting Iceland: Columbia Professors' "Inside Job"

The Academy Award winning documentary film, "Inside Job," suggested that one cause of the Great Recession was the wrong-headed deregulation of the financial industry deceptively promoted by academics who failed to disclose they were being paid by those who stood to benefit from deregulation.  (See our post here.)

Reconsideration of the roles of two of the academics cited in the film who are faculty at Columbia University shed more light on how public policy was influenced by academics hired to do public relations. The Columbia Spectator just published a three- part series on the local controversy with global implications.

At least a few Columbia faculty realized that it did not look good for their colleagues to do public relations while pretending they were delivering disinterested academic opinions:

[Columbia Economics Department Chair Michael] Riordan added that it is important that Columbia protect its reputation and the public’s trust in its professors’ expert opinions.

'What does the university stand for but if not for the quality of the ideas that come out of that university?' he asked. (2)

Also,

Teachers College professor Kathleen O’Connell ... called the film 'appalling' and said that 'the Columbia professors were even more appalling.' She said she was especially surprised considering Hubbard and Mishkin have both had high-ranking government jobs—Hubbard was at one time a top economic adviser to former President George W. Bush, and Mishkin was a governor of the Federal Reserve.

'I was shocked at the lack of ethics that they displayed. They are in really powerful positions—they have been in powerful positions in the Federal Reserve and the President’s economic advisors,' O’Connell said.(3)

However, there was much resistance to change. Just as we have seen in arguments about conflicts of interest affecting medical faculty, there were those who denied that being paid to consult could affect any faculty member's thinking about the source of the payment:

But some, including Business School professor and University Senator Frank Lichtenberg, oppose the disclosure of consulting to the University. Lichtenberg said that many factors besides money can influence professors’ academic opinions.

'There are lots of other sources of bias and non-neutrality in academia anyway,' Lichtenberg said. 'People often have predispositions for or against different hypotheses, and unfortunately, those sometimes prevail.'

Some professors question whether paid consulting positions influence researchers at all. Business School professor Bruce Greenwald said that the economists featured in 'Inside Job' have 'long espoused and long promoted' pro-market ideas and would have made the same arguments regardless of financial ties.(4)

So we have economists denying the effect of economic incentives?

Beyond that, there were arguments that public disclosure of conflicts of interest would violate faculty members' privacy.

But full public disclosure is not likely to gain much traction in the debate over a University-wide policy. Steele said that it is not necessary to publicly release disclosures made privately to University officials.

'I don’t think that the public needs to have access to forms that people fill out and all the materials that go into that,' [Provost Paul] Steele said. 'That would be onerous at least, and there might be other objections … that you are invading people’s sense of privacy and freedom.'(2)

I suppose that would have made some sense if the faculty member had not made any public pronouncements that could have been influenced by the undisclosed conflicts. However, the contention in "Inside Job" was that conflicted academic economists publicly advocated on behalf of their undisclosed clients. For example,

In 2006, the Iceland Chamber of Commerce paid Columbia Business School professor Frederic Mishkin $134,858 to co-author a report on Iceland’s economy and banking systems. In the report, titled 'Financial Stability in Iceland,' Mishkin painted a bright picture of the country’s economic future, but he did not disclose who was paying him to write it.

'Although Iceland’s economy does have imbalances that will eventually be reversed, financial fragility is not high and the likelihood of a financial meltdown is very low,' Mishkin wrote.

Two years later, Iceland’s economy collapsed. Its major banks failed, its currency lost much of its value, and thousands of its citizens lost their jobs. The New York Times wrote at the time that, to Icelanders, 'the collapse came so fast it seemed unreal, impossible.'(2)

Harvard Professors' Paid Apologia for Moammar Khadafy

Praising Iceland's economy was one thing. Praising brutal Libyan leader Moammar Khadafy as democratic was another.

In March, 2011, Mother Jones disclosed(5) how a consulting group run by Harvard professors was hired in part to burnish the image of Moammar Khadafy, who since has ordered brutal attacks on protesters within his country.

In February 2007 Harvard professor Joseph Nye Jr., who developed the concept of "soft power,' visited Libya and sipped tea for three hours with Muammar Qad'afi. Months later, he penned an elegant description of the chat for The New Republic, reporting that Qaddafi had been interested in discussing 'direct democracy.' Nye noted that 'there is no doubt that' the Libyan autocrat 'acts differently on the world stage today than he did in decades past. And the fact that he took so much time to discuss ideas—including soft power—with a visiting professor suggests that he is actively seeking a new strategy.' The article struck a hopeful tone: that there was a new Qaddafi. It also noted that Nye had gone to Libya 'at the invitation of the Monitor Group, a consulting company that is helping Libya open itself to the global economy.'

Nye did not disclose all. He had actually traveled to Tripoli as a paid consultant of the Monitor Group (a relationship he disclosed in an email to Mother Jones), and the firm was working under a $3 million-per-year contract with Libya. Monitor, a Boston-based consulting firm with ties to the Harvard Business School, had been retained, according to internal documents obtained by a Libyan dissident group, not to promote economic development, but 'to enhance the profile of Libya and Muammar Qadhafi.' So The New Republic published an article sympathetic to Qaddafi that had been written by a prominent American intellectual paid by a firm that was being compensated by Libya to burnish the dictator's image.

Monitor also sponsored trips to Libya for scholars from other universities who also later wrote positively about Khadafy's and his reign over Libya, presumably after they had received their large consulting fees.

The Boston Globe reported(6) in more detail about a proposal by Monitor to write a laudatory book about Khadafy:

It reads like Libyan government propaganda, extolling the importance of Moammar Khadafy, his theories on democracy, and his 'core ideas on individual freedom.'


But the 22-page proposal for a book on Khadafy was written by Monitor Group, a Cambridge-based consultant firm founded by Harvard professors. The management consulting firm received $250,000 a month from the Libyan government from 2006 to 2008 for a wide range of services, including writing the book proposal, bringing prominent academics to Libya to meet Khadafy 'to enhance international appreciation of Libya' and trying to generate positive news coverage of the country.

As further documented in the Globe article, it was very clear that Monitor was paid not just to provide consultation, but to do public relations work on behalf of the Khadafy regime.

Yet an article in the Nation(7) made it clear that the prominent academics it hired did not disclose who paid them, or the purposes of those payments:

Joseph Nye of Harvard’s Kennedy School wrote in The New Republic in 2007 that Muammar Qaddafi was interested in discussing 'direct democracy.'

Anthony Giddens of the London School of Economics wrote in the Guardian the same year that Libya under Qaddafi could become 'the Norway of North Africa.'

Benjamin Barber of Rutgers University wrote in the Washington Post, also in 2007, that Libya under Qaddafi could become 'the first Arab state to transition peacefully and without overt Western intervention to a stable, non-autocratic government.

Great minds think alike? Actually, no: all were being paid by Libyan money, under a $3 million per year contract with a consulting group which promised to 'enhance the profile of Libya and Muammar Quadhafi' in Britain and the US.

One more thing: none of them said in The New Republic, the Guardian, or the Washington Post that they were being paid by Libyan money.

So here again we have the elements of what Wendell Potter (see this post) called the "third party strategy." A public relations company hires outside "experts" with veneers of academic or professional credibility to promote the interests of its clients, without disclosing that the "experts" have become paid flacks. Again, this is bad enough when it is done on behalf of health policies favorable to commercial insurance companies. It is worse when it is done on behalf of brutal dictators.

More recently, the Globe discovered(8) that the Monitor Group negotiated with the head of the Libyan intelligence service who had been implicated in various violent acts,

He is Moammar Khadafy’s brother-in-law and his most trusted aide, convicted in absentia for the 1989 bombing of a French airliner and implicated in the 1996 massacre of 1,200 Libyan political prisoners.

But in 2006, Abdullah Al Sanusi was also the man who arranged the services of a noted Cambridge consulting firm in a very different project: revamping Libya’s reputation on the world stage.

Sanusi, a longtime head of Libya’s intelligence services, oversaw initial negotiations with the Monitor Group, which was vying for a contract with Libya to bring prominent Americans to speak to Khadafy as part of an effort to improve ties and nudge the pariah country toward reforms.

'We believe that your commitment to creating a program of mutual education and relationship building with the Unit ed States remains of critical importance at this turning point in Libyan history. We remain privileged to be trusted with this work,' Monitor’s chief executive, Mark Fuller, and project director, Rajeev Singh-Molares, wrote to Sanusi in 2006.

However, so far, Harvard leadership has if anything been more defensive about its faculty members' stealth public relations work for a brutal dictator than was Columbia's leadership about its faculty member's stealth public relations work for Iceland. As reported(9) again by the Boston Globe,

A prominent Harvard professor and former university administrator urged Harvard President Drew Faust during a faculty meeting yesterday to express 'shame'’ on behalf of the university at the disclosure of financial ties between a senior academic and Libyan dictator Moammar Khadafy.

Saying nothing would send the wrong message to students, giving them the impression that personal financial gain could come at the expense of ethical conduct, said Harry Lewis, a computer science professor who formerly served as undergraduate dean.

'Shouldn’t Harvard acknowledge its embarrassment, and might you remind us that when we parlay our status as Harvard professors for personal profit, we can hurt both the university and all of its members?' Lewis asked Faust at the monthly gathering of the arts and sciences faculty.

Faculty meetings are closed to outside media, but Lewis provided the Globe a written transcript of his statement, which he sent to Faust several days ago.

Faust — who, according to Lewis, told him she did not want to be 'scold in chief' — said she supports the wide discretion of faculty members to pursue the directions of academic inquiry and outside engagements they choose.

How low once proud institutions have fallen was demonstrated by a Harvard President who could not bring herself to "scold" faculty who were paid to provide public relations for a brutal dictator while hiding behind their Harvard titles.  Her action was not just "a weak standard for an institution of global leadership,"(10) but failed to erase "a distinctive odor, one that emanates from the corruption of academic reputation."(11)

Summary

Since before we first started this blog, we wondered somewhat despairingly how medicine, and particularly academic medicine, had become so badly lead.  Since the global economic collapse/ Great Recession it belatedly became clear that health care has just been swept along by the waves that drove larger social, economic and political institutions.  In particular, when we wondered how conflicts of interest had become so pervasive in medicine, we did not realize how pervasive conflicts of interest and corruption had become throughout the world.  The fact that leaders of previously revered educational institutions like Columbia and Harvard still cannot bring themselves even to admit the need to disclose conflicts, much less "scold" people for selling out to brutal tyrants indicates how deep the rot has gone.

Fixing the great problems of health care will require fixing the greater problems of society at large.  We must learn to discredit, not honor the "wildly ambitious agents of opportunity" that have been sent out to dominate the new gilded age.   


References


1.  Halberstam D. The new establishment: the decline and fall of the Eastern Empire. Vanity Fair, October, 1994. Link here.
2. Poliak S. 'Inside Job' prompts new look at conflict of interest policy. Columbia Spectator, April 13, 2011. Link here.
3. Poliak S. After documentary, B-school rethinking ethics. Columbia Spectator, April 15, 2011. Link here.
4. Poliak S, Roth S. 'Inside Job' sparks three separate reviews of disclosure policy. Columbia Spectator, April 14, 2011. Link here.
5. Corn D, Mahanta S. From Libya with love. Mother Jones, March 3, 2011. Link here.
6. Stockman F. Local consultants aided Khadafy. Boston Globe, March 4, 2011. Link here.
7. Wiener J. Professors paid by Qaddafi: providing 'positive public relations.' The Nation, March 5, 2011. Link here.
8. Stockman F. Top Khadafy aide helped craft deal with local firm. Boston Globe, March 30, 2011. Link here.
9. Jan T. Harvard leader confronted on professor's ties to Libya. Boston Globe, April 6, 2011. Link here.
10. Anonymous. Yes, Harvard chief should scold profs who worked for Khadafys.  Boston Globe, April 11, 2011.  Link here.
11.  Barrett PM. The professors and Qaddafi's extreme makeover.  Bloomberg BusinessWeek, April 6, 2011.  Link here.