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Showing posts with label conflicts of interest. Show all posts
Showing posts with label conflicts of interest. Show all posts

Friday, March 25, 2011

The Institute of Medicine Releases Reports on Practice Guidelines and Systematic Reviews Which Generate Few Echoes

Two days ago, the prestigious US Institute of Medicine released two reports on important health care issues, clinical practice guidelines and systematic reviews.  Systematic reviews of the relevant clinical research have been advocated by evidence-based medicine proponents as the appropriate basis for clinical and policy decisions.  Clinical practice guidelines have been advocated by many health researchers, policy makers, and clinicians as the best way to encapsulate the evidence to inform clinical and policy decision making.  Both reports suggested series of standards for how systematic reviews and clinical practice guidelines should be developed. 

These topics are of general importance to clinicians, health services researchers, and health policy makers.  The Institute of Medicine, part of the US National Academy of Sciences, is one of the most authoritative sources of opinion on medicine and health care.  Therefore, one would think that these reports would have gotten wide notice, and would hardly required Health Care Renewal to create some echoes.

However, a Google News search today produced only six "hits" relevant to these reports, including the original press release.  All are in specialized medical/ health care news outlets.  None are in the national media, and none are from major medical/ professional journals or societies. 

Let me suggest a theory about why these two major reports have generated so few echoes so far.  Let me quote from the summary of the report on clinical practice guidelines:
Most guidelines used today suffer from shortcomings in development. Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process. To be trustworthy, clinical practice guidelines should:
� Be based on a systematic review of the existing evidence;
� Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
� Consider important patient subgroups and patient preferences, as appropriate;
Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest;
� Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of recommendations; and
� Be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations.
Additionally, as reflected in the committee�s standards for developing trustworthy clinical practice guidelines, guideline development groups optimally comprise members without conflict of interest. The committee recognizes that in some circumstances, a guideline development group may not be able to perform its work without members who have conflicts of interest�for example, relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the guideline. Therefore, the committee specifies that members of the guideline development group who have a conflict of interest should not represent more than a minority of the group.

So it seems that the report on clinical practice guidelines emphasized two issues highly relevant to Health Care Renewal, the need for transparency in guideline development, and the need to avoid conflicts of interest affecting the development process. The two first standards for guidelines are about transparency and minimization of conflicts of interest.  Similarly, the report on systematic reviews also included fairly tough standards to minimize conflicts of interest.

We on Health Care Renewal go on and on about the need to maximize transparency in health care, and particularly in health care leadership and governance, and about the need to disassemble the now pervasive web of conflicts of interest that has entangled health care.  However, as we know, these are not popular topics among the leadership of health care, which includes many individuals who have greatly benefited from lack of transparency and pervasive conflicts of interest.  We know these topics make these leaders, and many of those who report to, or work or associate with them very uncomfortable.

So unfortunately, I am not surprised that the two new and likely authoritative reports from the Institute of Medicine, despite that organization's prestige, have started off relatively anechoic.  It also unfortunately likely that they will remain relatively anechoic. 

In 2009, the IOM issued an authoritative report on conflicts of interest in medicine and health care which suggested fairly tough standards to decrease such conflicts and their influence (also see post here).  Since 2009, I just found 53 citations to that report in the medical literature using the ISI Web of Science, for a rate of 27/year.  In 1999, the IOM issued a report on medical errors, "To Err is Human."  Since then, it has received 1374 citations, a rate of 115/year. 

As we noted above, the topic of conflicts of interest seems to make the powers that be in health care very uncomfortable.  In contrast, "To Err is Human" was widely interpreted to mean that physicians make a lot of dangerous errors, and the best way to decrease them is to impose more controls by bureaucrats, managers, and executives (even if that was not its intent).  Thus, that report could be twisted to fit the talking points of the powers that be, and hence has been anything but anechoic.

So while Health Care Renewal is hardly a powerful tool for creating publicity, I thought we should try to get the word out about the new IOM reports on clinical practice guidelines and systematic reviews.  Every little bit helps.

Meanwhile, the deathly quiet reception these reports have gotten so far emphasizes the need to combat the anechoic effect.  As long as the powers that be can command billions of dollars to influence the health care conversation through their marketing, public relations, and lobbying departments, expect the discussion not to question what they do, and how they benefit from the status quo to the financial and health detriment of patients and the population.

We will not be able to truly reform health care until we can speak openly about what threatens health care values and what needs to be done about these threats.

Wednesday, March 23, 2011

Despite Poor Financial Results, Diminishing Pipeline, Multiple Settlements of Legal Cases, Outgoing Pfizer CEO Got Over $24 Million

It is the season for share-holders' meetings of big US publicly held corporations, and as the proxy statements prepared for these meetings, prepare for more eye-popping, jaw-dropping examples of executive compensation. 

Pfizer's 2010 CEO Compensation
The AP (via the Wall Street Journal) just noted the compensation given to Jeffrey Kindler, the outgoing (in 2010) CEO of Pfizer, Inc, the world's largest pharmaceutical company:

Former Pfizer Inc. Chairman and CEO Jeffrey B. Kindler may have left the world's largest drugmaker abruptly last December, but he didn't leave empty-handed thanks to a compensation package valued almost $22 million.

Kindler received a 60 percent increase last year over his 2009 compensation, according to an Associated Press analysis of a Pfizer regulatory filing Tuesday.

The New York-based drugmaker gave Kindler a salary and performance-related bonus totaling $4.9 million, a $4.5 million severance payment and more than $12 million in stock and option awards. The company also will continue his health coverage for 12 months 'at active employee rates,' the filing said.

In fact, perusal of the new 2011 Pfizer proxy statement shows that Kindler, who stepped down on 5 December, 2010, made even more based on Pfizer's own calculations, $24,688, 849. Curiously, Ian Read, the CEO after 5 December, and previously Group President, Worldwide Pharmaceutical Business, received $17,396,112, despite only being CEO for 26 days.

Pay for What Kind of Performance?

These opulent pay packages stand in contrast to Pfizer's performance under Kindler and its financial results in 2010:
Kindler was ousted by Pfizer's board unexpectedly Dec. 6 after four years of languishing share prices and several failures of promising drugs in late testing, including a successor to cholesterol fighter Lipitor, the world's top-selling drug. Pfizer will lose U.S. patent protection in November for Lipitor.

Also,
Pfizer's 2010 net income fell 4 percent to $8.26 billion, or $1.02 per share. Revenue totaled $67.81 billion, up 36 percent, thanks to $18.1 billion from sales of Wyeth products.

Its stock price slipped 4 percent to close 2010 at $17.31, while the Standard & Poor's 500 index climbed 12.8 percent.

Furthermore, the compensation given the former and current CEO also stood in sharp contrast to Pfizer's amazing track record of recent unethical behavior.   Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).  Pfizer was involved in three other major cases from then to early 2010, including two involving settlements of fraud charges, and one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).   Just yesterday a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).

Despite Pfizer's recent dismal financial performance, clotted drug pipeline, and unfortunate ethical/ legal track record, the company's board compensation committee reported thus:
The Committee believes that Pfizer�s executive compensation program implements and achieves the goals of our executive compensation philosophy. Pfizer�s executive compensation philosophy, which is set by the Committee, is to align each executive�s compensation with Pfizer�s short-term and long-term performance and to provide the compensation and incentives needed to attract, motivate and retain key executives who are crucial to Pfizer�s long-term success.
Who Provided "Stewardship" of Pfizer?
So I had to ask: who were these people who thought that compensation of over $24 million was somehow "aligned" with declining profits, declining revenues, little output of new drugs, and multiple legal settlements of charges like fraud and violating the RICO act?

Here is a list of Pfizer's board of directors in 2010, and some relevant affiliations, taken from Pfizer's web-site, and where indicated, elsewhere (color coding to be explained below)

- Dennis A. Ausiello, M.D. -
Jackson Professor of Clinical Medicine at Harvard Medical School and Chief of Medicine at Massachusetts General Hospital since 1996.
Member of the Institute of Medicine....
Director of TARIS BioMedical, Inc.
(per Research!America bio) advisor to drug delivery and biosensing start-up companies Entra, BIND Biosciences, and Seventh Sense Biosystems, Inc., to drug-discovery startup companies Promedior and Pulmatrix, to Proventys, an evidence-based medicine delivery system, and to Ore Pharmaceuticals and Polaris, investment and venture capital companies working in the biotech and device area.

- Michael S. Brown, M.D. -
Distinguished Chair in Biomedical Sciences since 1989 and Regental Professor since 1985 at the University of Texas Southwestern Medical Center at Dallas.
Member of ... the Institute of Medicine,....
Director of Regeneron Pharmaceuticals, Inc.

- M. Anthony Burns -
Chairman Emeritus since 2002, Chairman of the Board from 1985 to 2002, Chief Executive Officer from 1983 to 2000, and President from 1979 to 1999 of Ryder System, Inc., a provider of transportation and logistics services.
Life Trustee of the University of Miami.

- Robert N. Burt -
Retired Chairman and Chief Executive Officer of FMC Corporation, a chemicals manufacturer, and FMC Technologies Inc., a machinery manufacturer....
Life Trustee of the Rehabilitation Institute of Chicago

- W. Don Cornwell -
Chairman of the Board and Chief Executive Officer of Granite Broadcasting Corporation from 1988 until his retirement in August 2009 and Vice Chairman until December 2009.
(per Wallace Foundation web-site) He previously served as vice president, investment banking division, of Goldman Sachs.

- Frances D. Fergusson, Ph.D. -
President Emeritus of Vassar College since 2006 and President from 1986 to 2006. Served on the Mayo Clinic Board for 14 years, the last four years as its Chairman, and as President of the Board of Overseers of Harvard University from 2007 through 2008.

- William H. Gray III -
Co-Chairman of GrayLoeffler, LLC (formerly the Amani Group), a business advisory and consulting firm. Chairman of the Amani Group from 2004 through September 2009.
Currently Director of ... J. P. Morgan Chase & Co.

- Constance J. Horner -
Guest Scholar from 1993 until 2005 at The Brookings Institution....

- James M. Kilts -
Founding Partner, Centerview Partners Management, LLC, a private equity firm, since 2006.
(Per Centerview Partners web-site) Centerview Partners' investment banking advisory business serves some of the largest companies globally in a broad range of industries, with particular expertise in Food & Consumer Products, Financial Institutions, General Industrials, Healthcare, Media & Entertainment ....
The firm has executed many significant transactions in recent years, including:
Altria's $113 billion spin-off of Philip Morris International, its $62 billion spin-off of Kraft and its $11.7 billion acquisition of UST...
Facet Biotech's $722 million sale to Abbott Labs;
OSI Pharmaceuticals' $4.0 billion sale to Astellas Pharma;

- George A. Lorch -
Chairman Emeritus of Armstrong Holdings, Inc., a global manufacturer of flooring and ceiling materials,....

- John P. Mascotte -
Retired President and Chief Executive Officer of Blue Cross and Blue Shield of Kansas City, Inc.,...

- Suzanne Nora Johnson -
Retired Vice Chairman, Goldman Sachs Group, Inc.,...
Director of American International Group, Inc., .... Board member of the American Red Cross, The Brookings Institution, ... and the University of Southern California.
(per Milken Institute web-site) on the board of numerous not-for-profit organizations, including ... RAND Health ....
She is on the Advisory Board of Councilors of Harvard Medical School

- Ian C. Read -
President and Chief Executive Officer since December 2010.

- Stephen W. Sanger -
Chairman of General Mills, Inc.
Currently Director of ... Wells Fargo & Company.

- William C. Steere, Jr. -
Chairman Emeritus of Pfizer Inc. since 2001.
Currently Director of Health Management Associates, Inc.
Director of the New York University Medical Center ...; and Member of the Board of Overseers of Memorial Sloan-Kettering Cancer Center.

Of Pfizer's 14 directors (excluding its CEO), seven have or had leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities. Three have or had leadership positions at other influential non-profit health care organizations. 


Two had leadership positions at potentially competing pharmaceutical or biotechnology companies.

Two had leadership positions at companies that finance pharmaceutical, biotechnology and other health related companies.

One had a leadership position at a health insurance company.

One had a leadership position at a for-profit hospital operating company.

Four had leadership positions in financial services corporations, including some that were implicated in the global financial collapse, and/or required massive federal bail-outs to avoid collapse.

It seems that every time we look at the boards of directors or trustees who are supposed to provide stewardship to a troubled health care organization, we see a similar pattern.  Just as we recently said about the Johnson and Johnson board, ....
 
Summary
 
So here we have the latest striking case that indicates the confluence of forces that can lead to health care dysfunction. Not only has the compensation given to health care leaders got so large that it is per se a cause of increased health spending, but also, and more importantly, such compensation often provides perverse incentives that perpetuate mismanagement, raising costs and lowering quality. This situation appears to be enabled by governance (or "stewardship") by individuals who are often fellow members of the CEOs' club, and hence who may feel more sympathy with the executives they are supposed to supervise than the stockholders whose financial interests they are supposed to protect, or the public whom the companies' products and services are supposed to benefit. Moreover, these individuals often have conflicts of interest which may mitigate against objective scrutiny of the executives they are supposed to oversee. Finally, these individuals often may come from corporate cultures which do not espouse the values that we in health care are supposed to uphold. (See this post and its links for other examples of the sorts of people who are supposed to provide stewardship to health care organizations.)


So to repeat once more-

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.

ADDENDUM (23 March, 2011) - See also comments by Merrill Goozner on the GoozNews blog.

Friday, March 18, 2011

Conflicts of Interest, Government Leaders, and Private Health Care Organizations

There seems to be a small surge of stories about conflicts of interest regarding health care affecting government leaders who can affect health care. 

The Institute of Medicine defined conflict of interest in medicine as "circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest."  So we will summarize these stories by first showing what each leader's secondary interests are, and then show how they may influence carrying out his leadership responsibilities.  (We used "his" because all examples are of male leaders.)

Florida: Governor Scott and Solantic

Rick Scott, the new Florida Governor, apparently still has strong ties to a for-profit chain of urgent care centers, as reported by the Palm Beach Post:
As Florida Gov. Rick Scott reorganizes health agencies, cuts spending and pushes for new free-market health policies, his ownership of Solantic, the urgent care chain, increasingly poses conflict of interest questions.

Solantic co-founder Karen Bowling says Scott has taken steps to distance himself from the chain. He stopped regular business calls with her after he was elected.

'I don't talk to him anymore. Not since November. Really not much since April,' Bowling said.

Scott left the privately held company's board of directors in January 2010, during his campaign.

But the most important step the governor must take to avoid a conflict of interest, some ethics experts say, is to divest his Solantic interests.

In January, Scott did transfer his Solantic stock - to his wife.

There were obvious questions raised whether this transfer mitigated the conflict of interest:
Scott's efforts to distance himself appear to be designed to meet the letter of Florida ethics laws, if not the spirit.

They may not succeed if challenged, warned legal and ethics expert Marc Rodwin, a law professor at Suffolk University who is the author of several books on health care and conflicts of interest.

'Placing his ownership in the name of his wife is not an effective way to control for conflicts of interest and not generally accepted because they are personally related,' Rodwin said.


Rodwin said Scott's blindness to Solantic's daily business decisions likewise does not relieve his conflict.


'His family still benefits from it,' he said.

There are a number of issues before Florida government about which there appears to be a risk that Governor Scott's actions could be unduly influenced by his family's ownership interest in Solantic:
From the moment he was elected, Scott has said government has no business providing primary care.


His budget proposal eliminated state support for the clinics. The county's health department director warns that may leave 30,000 adults without a medical home.

Scott's decisions as governor are likely to affect Solantic in other, perhaps more significant ways.

Scott's budget would curb growth in Medicaid spending, the state-federal safety net insurance program, by requiring most recipients to join private HMOs. Solantic accepts Medicaid HMO reimbursements, but not state Medicaid, so adding clients could broaden the clinics' customer base.

But the greatest benefit for Solantic could come from Scott and other Republican governors' lobbying efforts in Washington.

They want the Obama administration to give states waivers from the Affordable Care Act, and provide them with a massive block grant to expand health coverage in the way they deem best for their states. Money slated to go to business' health insurance tax credits and lower income consumers' insurance subsidies could pay for the grants - to the tune of billions.

Obama has said he's willing to give the states waivers on a speeded-up timetable. His administration Thursday published new rules on how states could get that waiver.

Scott's health policy adviser Michael Cannon, an economist with the Cato Institute in Washington, favors giving consumers health vouchers that they would use either as cash for direct-pay medical care or to buy insurance.

The possible effect on Solantic and similar clinics could be huge, said Rodwin, the legal ethics expert.

'You have a major owner-operator of a set of clinics on the state level, and a major policy figure on a state level, making major changes that affect whether that kind of business will thrive or not, what their competition will be, and really reforming the whole health sector,'  Rodwin said. That's in my view a very dangerous role.'

Note that this is not the first whiff of scandal regarding Rick Scott's leadership role in health care.  As the article noted, Scott:
resigned as CEO of Columbia/HCA amid a federal billing fraud investigation. Columbia/HCA ultimately agreed to the nation's largest Medicare fraud settlement, a $1.7 billion criminal and civil penalty.

Although the company had admitted to criminal wrongdoing, Scott himself was never charged, and he has denied knowledge of the illegal activities.

Scott left Columbia/HCA with more than $5 million in severance and $300 million worth of stock and options.
See our most recent detailed post on Mr Scott's history here.

Massachusetts: House Health Finance Committee Chair Walsh and Health Care Industry Lobbyists

The newly appointed chair of the Massachusetts House committee on health care finance has strong relationships to health care industry lobbyists, according to an editorial in the Boston Globe:
Speaker Robert DeLeo has chosen a health-finance committee chairman, Steven M. Walsh of Lynn, whose family is to lobbying what the Mannings are to NFL quarterbacking. Walsh�s father-in-law represents the state�s health insurers, while his uncle�s firm blocks and tackles for Steward Health Care, new owners of the Caritas chain of Catholic hospitals.

Again, there are a number of issues before the Massachusetts legislature about which there appears to be a risk that Representative Walsh's actions could be unduly influenced by his family's lobbying work:
Next to the budget, the thorniest issue the Legislature will deal with this year will be changes in health care financing. Lawmakers will consider bills that may completely change how health care providers are paid. That shift � from fee-for-service payments towards a system based more on per-capita reimbursements � will set off a free-for-all among insurers, doctors, and hospitals.

So,
Walsh�s admirable efforts ... [to improve legistlation regarding lobbying] don�t erase the conflict of interest he faces on health care issues. Walsh can try to separate family feelings and events from his official role, but the companies paying his uncle�s firm and his father-in-law are still expecting them to use every opportunity to make the strongest possible case for their clients. And it�s no exaggeration that these clients � the state�s insurers and its newest hospital chain � have hundreds of millions of dollars at risk in the new payment system Walsh will be vetting.

Perhaps if the stakes were lower or the relationships more distant, Walsh could chair the health-finance committee without risking public confidence. But as it is, he will be in a position of representing the taxpayers� interests against those of his close relatives.
Note that we discussed Steward Health's possibly revolutionary role in commercializing physicians' practices here, and how a former Massachusetts government health care agency official exited via the revolving door to join Steward Health Care here.
New York: Governor Cuomo's Advisor and Major Hospital Systems

New York Governor Andrew Cuomo has a close advisor whom he just appointed to a "Medicaid redesign team" whose clients include large academic medical centers/ hospital systems, per the New York Times:
When Andrew M. Cuomo married Kerry Kennedy in 1990, Jeffrey A. Sachs served as an usher. When Mr. Cuomo�s daughter Michaela was born, he asked Mr. Sachs to be her godfather. When his marriage fell apart years later, Mr. Cuomo stayed in Mr. Sachs�s triplex near the United Nations.

Since Mr. Cuomo�s election as governor last fall, Mr. Sachs, 58, has taken on a powerful role among his health care advisers as the administration confronts crucial decisions, including how to overhaul New York�s $53 billion Medicaid program.

But at the same time, Mr. Sachs, known to many in Albany as 'Andrew�s best friend,' is working as a paid consultant to some of the biggest players in the New York health care industry, including Mount Sinai Medical Center, NYU Langone Medical Center and the state�s largest association of nursing homes, all of which have financial interests at stake in the coming Medicaid changes.

Mr. Sachs, whose firm is named Sachs Consulting, has never registered as a lobbyist, which would require him to divulge his clients and fees to the state ethics commission.

Again, there are a number of issues before New York government about which there appears to be a risk that Governor Cuomo's actions could be unduly influenced by his friend, advisor, and committee member's consulting relationships with major hospital systems.
Mr. Sachs was also an early advocate of the �Wisconsin model� of Medicaid, under which the governor would set a target for spending reductions and then appoint a task force of industry stakeholders to apportion the cuts. The approach has political appeal for the governor, in that it entices would-be opponents of spending reductions to participate in the plan rather than protest it. But it also endows the unelected team members with immense power.

Mr. Sachs made recommendations to Mr. Cuomo and his aides about whom to appoint to the Medicaid team, which Mr. Cuomo formed through an executive order in January. During the transition, Mr. Sachs also helped assemble a four-person policy team to begin meeting with state agencies about the best approach to reducing Medicaid spending

Moreover, the Times article recounted cases in which Mr Sachs appeared to influence policy in ways that benefited his consulting clients. For example:
While he was helping Mr. Cuomo assemble his health care staff, Mr. Sachs�s name arose in an unusual personnel matter, one that held great interest for one of his clients, NYU Langone Medical Center.

For at least a year, NYU Langone had had strained relations with Dr. Harold S. Koplewicz, a well-known psychiatrist who founded the hospital�s child psychiatry center but left in 2009 to start a competing research and clinical center.

Relations worsened because Dr. Koplewicz, who also served as director of the Nathan S. Kline Institute for Psychiatric Research, a state-run psychiatric center in Rockland County that also has a research affiliation with NYU, refused to allow NYU to screen those he hired at the institute, among other issues.

During an October meeting between Mr. Sachs and Dr. Koplewicz, Mr. Sachs suggested the doctor resign from the Kline Institute, people briefed on the meeting said. Should he lobby too aggressively to keep his job, Mr. Sachs warned, Mr. Cuomo, then widely expected to win election, might choose to close down the institute.

In a later meeting in December, Michael F. Hogan, state commissioner of mental health, told Dr. Koplewicz that he had been warned by Mr. Sachs that his reappointment by Mr. Cuomo would be jeopardized if Dr. Koplewicz did not resign, according to the people briefed.

Afterward, Dr. Koplewicz wrote Dr. Hogan a letter detailing his accomplishments as director of the institute and complaining of the pressure being exerted by Mr. Sachs.

'As you explained � and I appreciate your candor � you have been pressured by NYU through Jeff Sachs to have me resign as a condition for your reappointment as commissioner of mental health,' Dr. Koplewicz wrote in the letter.

In a response sent the following day, Dr. Hogan did not dispute Dr. Koplewicz�s account but suggested that he had been insufficiently cooperative with NYU and the Office of Mental Health.

'Accordingly, your service as director, Psychiatric Research Institute, will end effective Jan. 13, 2011,' Dr. Hogan wrote.

Dr. Koplewicz and Dr. Hogan both declined to comment, though neither disputed the authenticity of the letters.

This case is particularly disquieting because of Governor Cuomo's former role as a tough state attorney general who targeted white collar crime.

Summary

US health care is hugely complex. The interests of its increasingly large commercial players can be strongly affected by the actions of government at local, state and national levels.

We have previously discussed the pervasiveness of conflicts of interest throughout health care. It should come as no surprise that there are important conflicts affecting government leaders who have power over health care issues.

Although there may actually be more laws and regulations about conflicts of interest affecting government leaders than about those affecting, say, leaders of academic medical institutions, the increasingly incestuous nature of health care leadership seems to add impetus to entwine the system in ever increasing strands of conflict.

So, I humbly suggest, as a variation on a theme I have sounded before, that governmental leaders who have power over health care should put the health of patients and the population first, and should not have relationships that risk this mission in service of private gain.  Furthermore, leaders of civilian health care organizations, especially of hospitals, hospital systems and physicians' groups whose mission is also to improve care of individuals and society, should not seek to entangle government leaders in conflicts meant to serve private financial interests. 

Wednesday, March 16, 2011

Despite Recalls, Legal Settlements, Guilty Plea, Johonson & Johnson Board Paid CEO $29 Million, Says He "Met Expectations"

For our latest story about the tremendous disconnect between the pay and performance of leaders of health care organizations, we turn to Reuters

Astronomical Pay

Despite having a very bad 2010, Johnson and Johnson continued to reward its CEO royally:
After a year in which Johnson & Johnson's product quality control was deemed such a shambles that the U.S. government will oversee some plants, the board had praise for Chief Executive William Weldon and awarded him almost $29 million in overall compensation.

The once golden reputation of the diversified healthcare giant was severely tarnished by seemingly endless recalls of widely used consumer products as well as recalls of medical devices and products from other units in 2010.

U.S. consumer product sales fell by more than 19 percent in 2010 and the company's 2011 forecast for earnings growth of only 1 percent to 3 percent fell shy of Wall Street projections.

Weldon's compensation was trimmed 7 percent, but in what appears to be a disconnect with the reality of its situation, J&J's (JNJ.N) board, in a year-end regulatory filing, said his performance 'generally met expectations' despite a year in which 'operational sales declined and fell below the goals for the year.'

'The board believes that Mr Weldon provided strong leadership during a very demanding year and has worked to resolve multiple challenging issues and position the company for future growth,' it said in the filing.

The rash of consumer medicine recalls in 2009 and 2010 were largely responsible for the first back-to-back years of company sales declines since World War Two.

Last week, U.S. health regulators filed a consent decree against J&J's McNeil consumer unit that will put some of its manufacturing plants under government supervision for at least five years.
The McNeil unit has recalled more than 300 million bottles and packages of Tylenol, Motrin, Rolaids, Benadryl and other products in the past year over faulty manufacturing and quality control problems.
The recalls cost the company $900 million in sales last year and hurt earnings, and Weldon was called to testify before Congress about problems that left pharmacy and supermarket shelves without Children's Tylenol.

But Weldon's 2010 compensation fell just 7 percent to $28.7 million from the $30.8 million he received in 2009. His performance bonus for 2010 was down 45 percent to $1.98 million.
The Wall Street Journal article on Weldon's pay also mentioned that Weldon also received " perquisites and other benefits in 2010 [which] included personal use of company aircraft, valued at $89,796; a car and driver for commuting and other personal transportation valued at $29,635; and a nominal amount of home security system monitoring fees."

The 2011 Johnson and Johnson proxy statement also noted that the other four of the five most highly paid Johnson and Johnson executives received compensation valued from $5,632,285 to $8,851,965 in 2010. In particular, Ms Colleen A Goggins, who retired under fire as head of the embattled Johnson and Johnson consumer group, walked away with $7,738,614 in 2010.

Other Aspects of Bad Company Performance

The WSJ Health Blog has been keeping an eye on the running total of Johnson and Johnson recalls. On 9 March, 2011, the list included 18 separate recalls of various different drugs and devices since July, 2009, from over-the-counter cold medications to sutures and hip replacements.

While suffering such a massive breakdown of the ability to perform the company's most basic function, to supply pure, unadulterated medicines and well-made devices, the company has also suffered from ethical lapses which were not listed in the Reuters article. In 2010, these included a jury verdict that the company had committed marketing fraud in its promotion of the atypical anti-psychotic drug Respirdal (see post here), and a guilty plea to a misdemeanor for and civil settlement of charges of "misbranding" Topamax by Johnson and Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals (see post here).

Of course, we once speculated that the Johnson and Johnson CEO commanded such astronomical pay in part based on his ability to influence US government health policy in favor of his and his company's interests (see this post).

Who Made Up the Board Who Was Responsible?

Responsible for the astronomical amounts paid to Mr Weldon despite his company's ongoing inability to make pure, unadulterated medicines, and to other executives who presided over the company's recalls, guilty plea, and legal settlements was the company's board of directors.  Its members are listed below.  For explanation of the color coding, see the explanation below:
  • Mary Sue Coleman - President, University of Michigan.
  • James G Cullen - Retired Chairman and CEO, Bell Atlantic Corp
  • Ian E L Davis - Senior Advisor, Apax Partners; Former Chairman and Worldwide Managing Director, McKinsey & Company, non-executive director, BP plc
  • Michael M E Johns - Chancellor, Emory University, Past Chair of the Council of Teaching Hospitals, member of the editorial board, JAMA, chair of the publication committee, Academic Medicine
  • Susan L Lindquist - Member and Former Director, Whitehead Institute for Biomedical Research, Co-Founder of FoldRx Pharmaceuticals, Inc, a subsidiary of Pfizer Inc.
  • Anne M Mulcahy - Former Chairman and CEO, Xerox Corp, director of the Washington Post Company, previously director of Citigroup Inc, and Federal National Association (Fannie Mae)
  • Leo F Mullin - Retired Chairman and CEO, Delta Airlines, director of Education Management Corporation
  • William D Perez -Senior Advisor, Geenhill & Co, Inc, Trustee of Cornell University and Northwestern Hospital
  • Charles Prince - Senior Counselor, Albright Capital Management LLC, Retired Chairman and CEO, Citigroup
  • David Satcher - Director, Center of Excellent on Health Disparities, Director, Satcher Health Leadership Institute and Poussaint-Satcher-Crosby Chair in Mental Health, Morehouse School of Medicine, and trustee of the Kaiser Family Foundation
Of Johnson and Johnson's 10 directors (excluding its CEO), four have leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities.  Of these, two also had leadership positions at other influential non-profit health care organizations, including medical journals, a teaching hospital association, and a charitable foundation.

One had a management position at a competing pharmaceutical company.

Four had leadership positions in  financial services corporations, including some that were implicated in the global financial collapse, and/or required massive federal bail-outs to avoid collapse.

Three had had leadership positions in other organizations now under fire , that is, McKinsey, for the role of one of its former executives in an alleged insider trading scandal (e.g., latest coverage in the NY Times); several for-profit higher education companies caught up in allegations of luring students destined to fail in order to collect tuition funded by government loans;  and BP, under investigation for its role in a massive oil spill.

Summary

So here we have the latest striking case that indicates the confluence of forces that can lead to health care dysfunction.  Not only has the compensation given to health care leaders got so large that it is per se a cause of increased health spending, but also, and more importantly, such compensation often provides perverse incentives that perpetuate mismanagement, raising costs and lowering quality.  This situation appears to be enabled by governance by individuals who are often fellow members of the CEOs' club, and hence who may feel more sympathy with the executives they are supposed to supervise than the stockholders whose financial interests they are supposed to protect, or the public whom the companies' products and services are supposed to benefit.  Moreover, these individuals often have conflicts of interest which may mitigate against objective scrutiny of the executives they are supposed to oversee.  Finally, these individuals often may come from corporate cultures which do not espouse the values that we in health care are supposed to uphold.  (See this post and its links for other examples of the sorts of people who are supposed to provide stewardship to health care organizations.)

So to repeat once more-

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.

ADDENDUM (17 March, 2011) - Also see comments on by Jim Edwards on the Placebo Effect blog: "heads he wins, tails shareholders lose," as do patients and doctors. 

Monday, March 14, 2011

Some Dare Call It "Corruption" - the Massachusetts Blue Cross Blue Shield Golden Parachute Scandal Continues

We have discussed many cases of health care organizations' leaders reaping rewards disproportionate to any concept of their performance, and especially to any concept of the effect of their conduct on patients' or the public's health.  Most of these cases have been pretty anechoic, but for some reason, the case of the huge golden parachute given to the outgoing CEO of Massachusetts Blue Cross Blue Shield despite a tenure  marked by financial losses and no particularly brilliant advances in patients' care or outcomes, (see this post) continues to generate responses. 

One editorial suggested that should the non-profit health insurance company continue to pay so lavishly, it should lose its tax exemption.  Another noted that the company should start putting its stakeholders, defined as its policy-holders "first and its funding of overly generous compensation packages to board members and outgoing CEOs somewhere far below."  Finally, an editorial in the local Providence Journal used the "c" word, "corruption," to define the company's and its CEO's behavior.

So it should not be surprising that defenders of the company have appeared.  The Boston Globe published an article which featured attempts to minimize the importance of the CEO's golden parachute. Further analysis of the points are in order.

Executive Salaries are a Minimal Component of Cost

The article quoted an expert who asserted executive salaries are not themselves a big component of cost:
The outcry grew big enough to force Blue Cross board members to vote to suspend their own payments and to lead the insurer to make promises to curb excessive payouts to executives. There�s just one problem: Those steps will do little to fix soaring health care costs.

'I have the same outrage,' Stuart H. Altman, a national health policy professor at Brandeis University, said about Blue Cross�s payments. But, 'We need to put executive pay and board salaries in perspective. It is not the major force, or even close to the major force, in driving up health care costs.'
My comment is that just because administrative costs are not the largest component of health care costs does not mean they do not drive health care costs.

As I have argued before, the biggest problem created by excess compensation for health care organizations' leaders is not the amount of money they get, per se.  The problem is the effect of the perverse incentives created by the money.  One concern is that people paid that much may make decisions that support their pay in the short-term, but damage the organizations' mission in the long-term.  Another is that the sorts of people attracted by the possibility of big pay packages are those least likely to uphold the mission in the first place.  Another is that the huge disparity between the pay of the top leaders and of everybody else is demoralizing for the relatively poorly paid staff who actually must do the work.

Finally, it may be worth quoting the former President of Princeton University, just interviewed about what academic leadership was like in the days before giant pay packages:
I�m not a fan of huge salaries for presidents of academic institutions. These are hard jobs. But people don�t really do them for the money. What kind of message do you really want to convey concerning the nature of the institution and its leadership? I always thought that it was important to convey a message of we�re all in this together. If you as president earn so much more than everyone else, it�s hard to argue that we�re all in this together.
Focusing on Executive Compensation Distracts from the Real Issues

The final argument in the Boston Globe piece was that huge executive compensation just is a distraction from the real issues:
Yet [current Massachusetts Blue Cross Blue Shield CEO Andrew] Dreyfus said he is concerned that the focus on executive and director pay will distract insurers, providers, and policy makers from addressing factors driving health care costs higher. Those factors range from an aging population to increases in obesity to expensive tests, drugs, and treatments that cure diseases and prolong lives.

'If you had a dozen health economists sitting in this room and you asked them what�s driving health care [costs], you know executive and board compensation wouldn�t be at the top of the list,' he said. 'It would be chronic illness and prices of hospitals and doctors and medical advances and discoveries and technology.'

That list of the "real" drivers of health care costs sounds very familiar.

Wendell Potter's Deadly Spin, is an expose of how how insurance and managed care corporations' public relations departments used deception, propaganda, and outright disinformation campaigns to make sure health policy supported the companies' interests.

Potter wrote (p.110) about how PR campaigns were designed to distract the public and policy makers from the industry's responsibility for health care dysfunction:
Rather than admit responsibility for the failures, insurance executives pointed the finger of blame at their customers, the 'consumers' of health care, and, of course, the providers of care. In introducing the concept of their new silver bullet - consumer driven health care - insurance executives claimed that the 'real drivers of health care costs' (one of my CEO's favorite expressions) were the people who sought care when they really didn't need it and the doctors and hospitals who were all too willing to provide this unnecessary care. Sure, the aging population and expensive new technology were also factors, but the main culprits were people who just didn't realize how expensive health care had become.
I color coded the factors listed by the current Blue Cross CEO as the real "drivers" of health care using the same colors with which I coded Mr Potter's list the specific distractors created by insurance company executives to deflect attention from the companies' inability (and probable) disinclination to control costs.
So it appears that Andrew Dreyfus is working from the same playbook that Wendell Potter described, down to the "drivers of health care costs" terminology. 

Summary

The Massachusetts Blue Cross Blue Shield kerfuffle seems to be enlarging into a good case to teach about what health care dysfunction is really all about.  It shows how the leaders of large health care organizations seem to be putting their self-interest ahead of the missions they are supposed to uphold.  Without governance structures that hold them accountable for upholding these missions, they have set up perverse incentives to pay themselves very well regardless of the effects of their actions on patients' or the public's health. 

So it appears, as the Providence Journal editorial asserted, that the leadership of health care organizations is increasingly corrupt, at least using the Transparency International definition of corruption, abuse of entrusted power for private gain. 

True health care reform would make leaders of health care organizations accountable for upholding their missions, and for patients' and the public's health.  Leaders of health care organizations ought to get reasonable incentives for improving health, but not incentives so large as to demoralize the people who actually do the work and take care of the patients. 

Post Script: More Undisclosed Conflicts of Interest

It is obvious why Andrew Dreyfus, the new CEO of Massachusetts Blue Cross Blue Shield might quote the health insurance industry public relations party line about drivers of health care costs that conveniently do not include insurance company practices and executive compensation. 

It was not obvious when reading the Boston Globe article why Professor Altman might be susceptible to that party line.  Perhaps his conclusions were only based on his scholarship.

However, the Boston Globe article failed to disclose Prof Altman's part-time jobs.  As per this 2010 proxy statement, he is a member of the board of directors of Lincare, a company that provides respiratory care services, including disease management, and of Aveta Inc, a privately held health insurance company.  Prof Altman's total compensation from Lincare in 2009 (per the latest proxy statement available, i.e., that issued in 2010), was over $1.7 million.   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.].  Given Prof Altman's membership in the board of directors of a health insurance company, and his towering compensation as a director of a health care company that may need to maintain good relationships with health care insurers, it would seem that he has multiple financial relationships that could lead to sympathy with the health insurance industry's public relations party line.

So it seems that regardless of the intent of the reporter who wrote it, the latest Boston Globe article about the Massachustts Blue Cross Blue Shield CEO golden parachute scandal ended up being an apologia for excess compensation of health care insurance executives that followed the script written years ago by health care insurance corporate public relations.

So I need to add another conclusion.  The discussion of health care policy needs to be informed by disclosure of the financial interests of those participating, particularly those participating as experts in the media.   True health care reform would lead to such disclosure.  However, in our currently dysfunctional health care environment, be very skeptical about the interests of "health policy experts" who seem eager to support the powers that be.

Tuesday, March 1, 2011

Once More with Feeling: Another Defense of Conflicts of Interest Based on Logical Fallacies

Despite increasing recognition of the adverse effects of health care professionals' and health care institutions' conflicts of interest on health care, such financial relationships continue to have their prominent defenders.  The latest example was an article in Medscape General Surgery by Frank J Veith MD, entitled "Physicians and Industry: Fix the Relationships, but Keep Them Going."  Dr Veith is a prominent vascular surgeon who "received numerous awards and honors as a leader, outstanding teacher, and innovator in vascular surgery," according to New York University

We have noted before how defenders of conflicted professionals and professional societies often employ logical fallacies to support their arguments.  Some recent examples were discussed here, by a prominent ostensibly libertarian attorney and law professor; here, published in a well-known medical journal by the former director of "medical communications" for a large pharmaceutical firm; and here, by the president of a large medical society, published again in a well-known medical journal.

Dr Veith seems to be continuing that tradition. His approach emphasized frequent repetition of the same fallacious argument.

Straw Man: "Totally Interrupt All Doctor-Industry Relationships"

Dr Veith's main argument seemed to be with attempts to prevent physicians from having any relationships with industry, presumably including not just financial relationships, but professional collaborations or even personal friendships.  For example, he wrote about
a recent initiative to completely sever the relationship between industry and doctors has gained traction. This initiative has been supported by several states, including Massachusetts and Vermont, and universities, such as Harvard, Stanford, the University of Massachusetts, and the University of Michigan, which have enacted draconian laws or policies designed to separate doctors and industry and to interrupt any relationship between them.

Furthermore,
Even many individual physicians have sanctimoniously jumped on the bandwagon and written articles or opinion pieces attacking the evils of any relationship between industry and doctors, suggesting the severance of any such relationships.

Then later, Dr Veith wrote,
We should establish rules to prevent or minimize the abuses, but we should not totally interrupt all doctor-industry relationships. To do so is wrong-headed and would eliminate the many beneficial effects that accrue to medical care and society from these relationships. It would be throwing the baby out with the bathwater.

Finally, he concluded thus,
These will be far better solutions than completely eliminating all industry-doctor relationships.... Such safeguards will be better than the present trend for institutions and governments to enact strict measures to separate physicians from industry.


Despite making this argument at least four times, the problem is that Dr Veith provided no citations, much less evidence that such "draconian" policies have been enacted or even advocated.

There have been new policies on conflicts of interest suggested or adopted by some organizations. None, to my knowledge have been exactly "draconian."

For example, Harvard University does have a new policy on conflicts of interest. Maybe Dr Veith was referring to it above when he mentioned Harvard. However, in an interview about the new policy involving university leaders published in the Harvard Gazette, the Vice Provost of the University said,
The University is not designed to be an ivory tower isolated from the world. So the trick is to be able to have a robust system for affording faculty opportunities to engage with the commercial world and at the same time not threaten in any way their own fundamental integrity or that of Harvard.
That hardly sounds like a policy that completely severs all relationships between faculty and industry.
So Dr Veith's main premise seems to be based on a multiply repeated straw-man argument. He argued again and again against a policy that no one seems to be advocating. (And even I, as a hard-liner about conflicts of interest, have never advocated a complete interruption of all relationships of any kind between all physicians and all of industry.)

Appeal to Fear: You Will be "Blighted"

Perhaps just to spice things up, Dr Veith warned of the dire consequences of the "draconian" policies that no one was advocating:
Those institutions that choose such inquisitional approaches will be blighted and suffer competitive disadvantages.

Dr Veith had asserted multiple benefits of continuing relationships among physicians, health care institutions, and commercial firm. He presented no evidence to support his assertions, most of which can be questioned (see below). His warning that institutions will be "blighted" was based on his assertion that the stringent policy no one advocated would eliminate these unproven benefits, hence his warning of  something so severe as "blight" seemed to be an appeal to fear.

Ad Hominem: "Sanctimonious" Physicians Leading a "Witch Hunt"

As noted above, Dr Veith referred to anonymous physicians who "sanctimoniously jumped on the bandwagon," thus leading to
The initiative to separate industry from physicians and surgeons [which] has taken on the trappings of a witch hunt.

And again,
Their leaders should recognize this and resist the temptation to join the separation witch hunt....

My interpretation is that this was an implied set of ad hominems. Those who supposedly advocated the "draconian" policy were made out to be "sanctimonious" witch hunters. After just having seen "The Crucible," I could also argue that the use of the term "witch hunt," with its current extreme emotional references (apparently to a case in which presumably innocent people were hanged), amounted to an appeal to emotion and an appeal to fear.

Summary

I must admit Dr Veith's entire set of arguments was not completely based on logical fallacies.  However, the rest of his arguments hardly appeared even-handed.  He presented a series of assertions about the benefits of such relationships, including that they "foster innovation and development," that "industry-sponsored medical education helps to keep physicians informed about new developments," that industry sponsored education about devices prevents "difficult and dangerous" practices, and helps physicians use devices "better and more safely."  He provided no evidence in favor of these claims, and seemed to ignore arguments about the hazards of payments to physicians biasing their clinical practice, teaching and research.

I should also note that these arguments were made by a physician who appears to have his own personal financial relationships with industry.  In the Medscape article, Dr Veith "disclosed no relevant financial relationships."   However, as a member of the editorial board of Medscape General Surgery, Dr Veith "disclosed the following relevant financial relationships: Owns stock, stock options, or bonds from: Vascular Innovations, Inc."  Furthermore, the disclosure summary for the iCON2011 conference includes the following for Dr Veith, "Honorarium/Expenses: Cook Medical, Cordis, WL Gore, Medtronic." Finally, Dr Veith apparently runs the Veith Symposium, which in 2010 acknowledged the following commercial sponsors: Aastrom, Abbott Vascular, Aptus Endosystems Inc, Atrium, Bard Peripheral Vascular, Boston Scientific, Cook Medical, Cordis Cardiac and Vascular Institute, Delcath Systems Inc, Gore, Hansen Medical, Lombard Medical Technologies, Maquet, Medtronic, Organogenesis Inc, Sanofi-Aventis, St. Jude Medical, Tenaxis Medical, Triavascular, Vascutek Terumo.

So Dr Veith's article continues the tradition of defenses of physicians' and health care institutions' conflicts of interest based on logical fallacies and unbalanced and unsupported assertions.  Also, note that all the examples of such defenses we have discussed were made by people with their own financial relationships with drug, device, and/or biotechnology companies, although some of them disclosed these relationships.  I have yet to see a defense of such conflicts based on logic and evidence, or a defense of such conflicts made by someone who has absolutely no conflicts of his or her own. 

The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them.  I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone, much less someone who does not have such relationships.

I will note that the defenses of conflicts of interest begin to seem drearily similar.  Not only do they often use the same logical fallacies, but they repeat the same stale and unsupported arguments about the benefits of financial relationships with industry: that they foster "innovation," and that they provide better educational opportunities than unconflicted programs and educators.  We now know that the managed care industry has engineered stealth health policy advocacy campaigns that furnish talking points to "third parties" which may get caught up in the larger policy discourse (see posts here and here).  I wonder whether some such stealth health policy advocacy campaign by pharmaceutical, device and/or biotechnology companies seeded the discourse about conflicts of interest with some of the logical fallacies and unproven assertions that have become so familiar. 

We need to elevate our discourse about health care policy.  People involved in health policy discussions should at least disclose their conflicts of interest when making their points.  We should be very skeptical of  arguments and look carefully for the evidence and logic that supports them.  When we find that evidence and logic is lacking, be even more skeptical about who benefits from them. 

Tuesday, February 15, 2011

The University of Minnesota, Where Nothing Can Go Wrong, Go Wrong, Go Wrong...

As noted on the Periodic Table blog, the administration of the University of Minnesota continues to believe all is well with its clinical research activities.  A recent internal review said there was nothing more to investigate about the unfortunate death of a psychiatric patient years before. So should we all be relieved?

It will take an extensive review of the case to ultimately suggest we should not at all be relieved.  The case raised important concerns about the validity of clinical research, and whether it violates the trust of its patient-subjects.  These concerns had not been addressed before the university's most recent review, and thus seem even more pointed after its recent non-investigation.

Background: the Untimely Death of Dan Markingson

In May, 2008, the (Minnesota) Pioneer Press ran a series of articles about the untimely death of Dan Markingson which occurred while he was enrolled in a randomized trial sponsored by AstraZeneca (the CAFE study) at a site at the University of Minnesota.  The first article in the series made the following major points:

Mr Markingson had given his consent to be enrolled despite evidence that he was actively psychotic
He started having visions of killing his mother in the storm. Markingson was taken Nov. 12, 2003, to Regions Hospital in St. Paul, but it had no open psychiatric beds. He was then transferred to the University of Minnesota Medical Center, Fairview.

Weiss said discussions about research started right away at the hospital. Markingson was placed in Fairview's Station 12, a new unit at the time created to treat psychotic patients and screen them for research. Olson and Dr. Charles Schulz, head of the U's psychiatry department, helped launch the unit in part to enhance the hospital's startup schizophrenia program and meet the U's mandate to bring in more research dollars.

Olson first recommended on Nov. 14 that a Dakota County District Court commit Markingson to the state treatment center in Anoka because he was not fit to make decisions about his care. He wrote to the court that Markingson was convinced his delusions were real and that he wasn't mentally ill.

The doctor changed his opinion about the commitment in less than a week, telling the court Markingson had started to acknowledge the need for help.

Reversals by patients are common, Olson explained in an interview with the Pioneer Press last month. Schizophrenics often arrive for treatment with delusions and denial but change their outlook while hospitalized.

A judge agreed Nov. 20 with Olson's new recommendation, requiring Markingson to follow the doctor's treatment plan. The next day, Markingson signed a consent form to be part of a national anti-psychotic drug study, Comparison of Atypicals for First Episode, or CAFE.

His mother's multiple complaints that while in the study, Markingson was not getting better and not getting proper treatment were ignored
Weiss' letters to Olson and Schulz, who was a co-investigator in the study, urged them to consider different treatment options for her son, which would have disqualified him from the study. But the doctors were unconvinced by her pleas.

In particular, she wrote with strange prescience,
'Do we have to wait until he kills himself or someone else,' she asked three weeks before his suicide, 'before anyone does anything.'
There was evidence that Markingson was not getting optimal treatment

In retrospect, it was not even clear that Markingson was taking his study medications prior to his suicide:
An autopsy showed no medication in Markingson's bloodstream, and a coroner's photo showed a sealed bottle of his medication. Had he been taking his drugs?

Study officials could have been fooled. They only counted drugs left in pill bottles instead of testing blood levels in patients.
Suggestions that financial conflicts of interest influenced trial investigators' actions

The initial news article raised questions whether the study investigator had been unduly influenced to keep Markingson in the study by financial concerns:
CAFE was an early opportunity at the U for Olson to add research experience to his academic credentials. The U had recruited him in 2001 for his expertise in schizophrenia.

It was a slow start. Olson recruited one patient in 2002, and CAFE study leaders considered dropping him altogether, according to monthly recruiting summaries. Olson and the university had been dropped from a previous study because of low recruiting numbers, the doctor later said in his court deposition.

Exchanges between local and national study officials made it clear that there was pressure for results and a 'risk' that the study would be shut down if it didn't recruit enough patients.

Note that:
As Subject 13, Markingson was worth $15,000 to the U, with some of that going to Olson's salary and the psychiatry department. Switching or adding medications could have disqualified Markingson and halted payments to Olson and the department from AstraZeneca.

Overall, the study offered $327,000 to the U and an opportunity to raise the profile of its schizophrenia program.

An accompanying Pioneer Press article indicated that both Dr Olson, and the Chair of Psychiatry, Dr S Charles Schulz, were receiving considerable financial support from AstraZeneca and other pharmaceutical companies at the time of the study.
Olson received $220,000 from six companies since 2002, including $149,000 from AstraZeneca, according to the state records. Schulz received $562,000, including $112,000 as a researcher and consultant to AstraZeneca.

Olson said his AstraZeneca money went straight to the U but did support his salary. Markingson's full participation in the yearlong study meant up to $15,000 for the university.
Did the lawsuit's results indicate nothing was wrong?

Mr Markingson's mother sued the University of Minnesota and AstraZeneca, but (per the first Pioneer Press article),
The lawsuit ended this year after a judge ruled that the university had statutory immunity from such lawsuits and that AstraZeneca shouldn't stand trial because there was no convincing proof that its drug caused Markingson's death. Weiss settled with Olson, the only defendant left. She said she was granted $75,000, which went entirely toward legal bills.
Note that the results did not address the university's or its administration's role.

Dr Carl Elliott Takes Another Look

Thus the case appeared to end, with no real reconsideration of how medical schools' dependence on commercial funding of clinical studies, and how individual faculty members' financial relationships with drug, device, and biotechnology firms may affect research done on human beings.

However, in September, 2010, Mother Jones published an article by Dr Carl Elliott, a University of Minnesota bioethicist, which raised further questions about the case.
I talked to several university colleagues and administrators, trying to learn what had happened. Many of them dismissed the story as slanted and incomplete. Yet the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan's death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs

Major design defects of the CAFE study:
It barred subjects from being taken off their assigned drug; it didn't allow them to be switched to another drug if their assigned drug was not working; and it restricted the number of additional drugs subjects could be given to manage side effects and symptoms such as depression, anxiety, or agitation. Like many clinical trials, the study was also randomized and double-blinded: Subjects were assigned a drug randomly by a computer, and neither the subjects nor the researchers knew which drug it was. These restrictions meant that subjects in the CAFE study had fewer therapeutic options than they would have had outside the study.

In fact, the CAFE study also contained a serious oversight that, if corrected, would have prevented patients like Dan from being enrolled. Like other patients with schizophrenia, patients experiencing their first psychotic episode are at higher risk of killing themselves or other people. For this reason, most studies of antipsychotic drugs specifically bar researchers from recruiting patients at risk of violence or suicide, for fear that they might kill themselves or someone else during the study. Conveniently, however, the CAFE study only prohibited patients at risk of suicide, not homicide. This meant that Dan�who had threatened to slit his mother's throat, but had not threatened to harm himself�was a legitimate target for recruitment.

As Dr Elliott noted, this appeared to be yet another example of manipulation of clinical research designed to make the sponsors' products look better, a topic we have frequently discussed on Health Care Renewal:
A 2006 study in The American Journal of Psychiatry, which looked at 32 head-to-head trials of atypicals, found that 90 percent of them came out positively for whichever company had designed and financed the trial. This startling result was not a matter of selective publication. The companies had simply designed the studies in a way that virtually ensured their own drugs would come out ahead�for instance, by dosing the competing drugs too low to be effective, or so high that they would produce damaging side effects. Much of this manipulation came from biased statistical analyses and rigged trial designs of such complexity that outside reviewers were unable to spot them. As Dr. Richard Smith, the former editor of the British Medical Journal, has pointed out, 'The companies seem to get the results they want not by fiddling the results, which would be far too crude and possibly detectable by peer review, but rather by asking the 'right' questions.'

This was likely what was going on with the CAFE study:
Although the documents unsealed in the Seroquel litigation do not specifically mention the CAFE study in which Dan was enrolled, they do suggest that AstraZeneca planned to establish Seroquel as the "atypical of choice in first-episode schizophrenia,' according to a 2000 'Seroquel Strate'y Summary.' A later document titled 'Seroquel PR Plan 2001' discusses the agenda for an advisory panel meeting in Hawaii. Among the potential topics were the marketing of Seroquel to first-episode patients, adolescents, and the elderly. The document refers to these populations as "vulnerable patient groups."

Even more alarming are internal documents suggesting that AstraZeneca was designing clinical trials as a covert method of marketing Seroquel. In 1997, when Dr. Andrew Goudie, a psychopharmacologist at the University of Liverpool, asked AstraZeneca to fund a research study he was planning, a company official replied that 'R&D is no longer responsible for Seroquel research�it is now the responsibility of Sales and Marketing.' The official also noted that funding decisions would depend on whether the study was likely to show a 'competitive advantage for Seroquel.'
Were study subjects protected?
So, as Dr Elliott wrote,
Many clinical studies place human subjects at risk�at a minimum, the risk of mild discomfort, and at worst, the risk of serious pain and death. Bioethicists and regulators spend a lot of time and energy debating the degree of risk that ought to be permitted in a study, how those risks should be presented to subjects, and the way those risks should be balanced against the potential benefits a subject might receive. What is simply assumed, without much consideration at all, is that the research is being conducted to produce scientific knowledge. This assumption is codified in a number of foundational ethics documents, such as the Nuremberg Code, which was instituted following Nazi experiments on concentration camp victims. The Nuremberg Code stipulates that an 'experiment should be such as to yield fruitful results for the good of society,' and 'the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.'

But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to 'generate commercially attractive messages'?

Conflicts of interest
Of course, university faculty pushed to bring in more external funds to support their careers (see this post) by university leaders with their eyes on the bottom line may not be too critical of the intricate designs of the studies they need to do to continue their academic careers, and whether such studies are really meant to promote science and improve patient care, or position products in the marketplace, especially when the same companies are paying them as consultants, speakers, etc.

In fact, Dr Elliott found reasons to make such concerns specific to the case of Mr Markingson's untimely death:
Olson had another financial reason to maintain good relations with AstraZeneca. According to a disclosure statement for a 2006 conference, he was a member of the AstraZeneca 'speaker's bureau,' giving paid talks for the company. He had similar arrangements with Eli Lilly and Janssen, the makers of the other atypicals being tested in the CAFE study, as well as Bristol-Myers Squibb and Pfizer. In addition, Olson was working as a paid consultant for Lilly, Janssen, Bristol-Myers Squibb, and Pfizer.

Bioethicists Demand an Investigation

So eight University of Minnesota bioethicists, including Dr Elliott, wrote a letter to the University administration demanding an investigation, as reported in December, 2010, by the Minneapolis- St Paul Star-Tribune,
In a letter to the board Monday, the professors questioned whether U psychiatrists lacked ethical judgment in enrolling the victim, Dan Markingson, a schizophrenic who may have lacked the wherewithal to consent to research. They also questioned whether financial incentives from AstraZeneca, the drugmaker funding the study, presented conflicts for the researchers, Dr. Stephen Olson and Dr. S. Charles Schulz.

At the time, the administration promised a serious response:
U leaders will take the letter seriously and take the protection of human research subjects seriously, said the U's general counsel, Mark Rotenberg.

But then almost immediately indicated its bias:
'The fact that this is tragic doesn't mean the treating physicians did anything wrong,' he said.

What, Us Worry?

It did not take long for Mark Rotenberg to decide that there was nothing more to worry about. As reported in February, 2011, by the Pioneer Press:
in a Monday letter to Elliott and colleagues, the chairman of the U's board of regents wrote 'we do not believe further university resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies.'

'Our general counsel has provided us with the extensive reviews of this case that were performed over the years by a number of independent experts and governmental units,' chairman Clyde Allen Jr. said in the letter. 'Each and every one of these reviews resulted in the same conclusion: there was no improper or inappropriate care provided to Mr. Markingson, nor is there evidence of misconduct or violation of applicable laws or regulations.'

Of course, since Mr Rotenberg is responsible for, among other things, reducing the university's legal liability, one could see how he might not want to delve further into this case.  As we noted earlier, it is not clear that previous "exhaustive" investigations asked the questions that needed to be asked, or had access to all the relevant data.  The issues are not whether their was criminal conduct, or even civil liability, but whether the university is presiding over good science and protection of research subjects?

So we should be worried, of course, that commercial firms sponsor research on human beings mainly to serve marketing objectives, and that university faculty and administrators go along, allowing their formerly prestigious universities' names to be added to the research in exchange for the money they so much want to keep themselves living in the style to which they are accustomed. We ought to be particularly worried when these universities seem to forget about their mission to find and disseminate new knowledge in favor of defending the work that continues to bring in the money.

Thus, physicians, researchers, patients, and the public ought to be very skeptical about clinical research sponsored by commercial firms with vested interests in the research turning out a particular way, and even about research not sponsored by such firms, but done by researchers who have personal financial ties to such firms. Worse, patients ought to be extremely skeptical about the motives of researchers who want to enroll them in trials when the researchers have financial ties to commercial firms whose products could be promoted through such trials, and especially when such firms are sponsoring the trials.

As a long-time advocate for evidence-based medicine, whose advancement depends on the continuing creation of valid research evidence from clinical research, it is heart-breaking to have to make these recommendations, but they will be necessary until there is better assurance that clinical research is being done to advance science and patient care, not the commercial interests of the sponsors and the researchers.

Until academic medicine becomes more open about how and why it is doing clinical research, such skepticism is warranted.

However, I will end with a ray of hope. If the administrators and faculty do not get it, the student journalists do. Read these words in an editorial in the Minnesota Daily:
Of course, the University has maintained neither it nor anyone involved in the case did anything wrong, an odd claim to make after the Minnesota Legislature unanimously passed a law that prohibits exactly what happened and named the law after Markingson.

The University seems to think that because it was not held liable in court for Markingson�s death, it did nothing wrong. This is false; it is a cynical excuse to keep corporate drug money flowing into the University.

The regents� decision fundamentally undermines our mission: Supposedly, the University is 'dedicated to � the search for truth.' But the letter makes it clear that corporate research cash is more important to the University than patient safety and transparency.

Refusing to set up an independent investigation is a willfully ignorant attempt to sweep the Markingson case under the rug and damages the integrity of the entire University.

Perhaps it is time for the state legislature to take another look at this issue.

True health care reform would separate clinical research, that is, research done on human beings, from the commercial interests of health care corporations and the people who work for them.

ADDENDUM (18 March, 2011) - See this post by Naomi Freundlich on the Health Beat blog.

Tuesday, February 8, 2011

After Publicity About Losses from Corruption, Now Will Any Health Charities Start Anti-Corruption Initiatives?

Over the last few weeks a series of stories appeared about how corruption siphons off money from worthy global health initiatives. 

Corruption Depletes Global Fund to Fight AIDS, Tuberculosis and Malaria

The story that first got attention was from AP:
A $21.7 billion development fund backed by celebrities and hailed as an alternative to the bureaucracy of the United Nations sees as much as two-thirds of some grants eaten up by corruption, The Associated Press has learned.

Much of the money is accounted for with forged documents or improper bookkeeping, indicating it was pocketed, investigators for the Global Fund to Fight AIDS, Tuberculosis and Malaria say. Donated prescription drugs wind up being sold on the black market.

The fund's newly reinforced inspector general's office, which uncovered the corruption, can't give an overall accounting because it has examined only a tiny fraction of the $10 billion that the fund has spent since its creation in 2002. But the levels of corruption in the grants they have audited so far are astonishing.

A full 67 percent of money spent on an anti-AIDS program in Mauritania was misspent, the investigators told the fund's board of directors. So did 36 percent of the money spent on a program in Mali to fight tuberculosis and malaria, and 30 percent of grants to Djibouti.

In Zambia, where $3.5 million in spending was undocumented and one accountant pilfered $104,130, the fund decided the nation's health ministry simply couldn't manage the grants and put the United Nations in charge of them. The fund is trying to recover $7 million in 'unsupported and ineligible costs' from the ministry.

The fund is pulling or suspending grants from nations where corruption is found, and demanding recipients return millions of dollars of misspent money.

'The messenger is being shot to some extent,' fund spokesman Jon Liden said. 'We would contend that we do not have any corruption problems that are significantly different in scale or nature to any other international financing institution.'

To date, the United States, the European Union and other major donors have pledged $21.7 to the fund, the dominant financier of efforts to fight the three diseases. The fund has been a darling of the power set that will hold the World Economic Forum in the Swiss mountain village of Davos this week.

It was on the sidelines of Davos that rock star Bono launched a new global brand, (Product) Red, which donates a large share of profits to the Global Fund. Other prominent backers include former U.N. secretary-general Kofi Annan, French first lady Carla Bruni-Sarkozy and Microsoft founder Bill Gates, whose Bill and Melinda Gates Foundation gives $150 million a year.
Corruption Depletes Health Alliance International

At about the same time, the Seattle Times reported fraud losses at another global health project:
Health Alliance International (HAI), which was begun in 1987 by North American doctors and nurses to support the fledgling government in Mozambique, has played a leading role in HIV treatment.
Focused on strengthening health systems of impoverished and fragile nations, it was awarded the Doris Duke Charitable Foundation's Africa Health Initiative grant, a seven-year $10 million program to help government-run health facilities use data to improve services. The UW departments of Global Health and Industrial Engineering are partners in that project.

All but 7 percent of its funding came from the U.S. government, and more than 90 percent of its work was in Mozambique, according to HAI's 2009 annual report. Gloyd said the alliance increased the number of people receiving antiretroviral drugs from about a couple dozen in 2003 to more than 50,000 this year.

In late 2009, the alliance applied for what would have been its biggest grant ever � $100 million in funding from USAID over the next five years.

Early last year, its application was selected as the best technical proposal. But in the midst of the administrative review in June, a tipster reported problems in an organization employed by HAI.

One such program hired local community organizations in Mozambique for home-based nursing care and delivery of basic medical kits. The alliance did an internal audit and discovered irregularities.

'Their own accounting for those kits was quite inadequate, and that came back to bite us,' Gloyd said.

HAI shared the findings with USAID and put forth a plan to resolve the issues. But at the end of August, USAID rejected the group's grant application.
How Big Is Corruption?
There was actually considerable dispute about the significance of the fraud discovered at the Global Fund. On one hand, the losses were a very large proportion of the grants investigated. On the other hand, the total amounts were a very tiny proportion of the total of the fund's outlays. As summarized by William Savedoff in the Center for Global Development's Global Health Policy blog:
While readers might finish the AP article mistakenly thinking that $14 billion has been stolen (that is, two-thirds of $21.7 billion), it would also be a mistake to read the Global Fund press release and believe that only $34 million is gone.

What we�re missing is a way to assess how representative these cases may be. If the Global Fund�s detection system is 100% effective, then these cases are isolated and it is a tiny problem. If the detection system only picks up 50% of cases, then instead of a tiny problem, we�ve got a small one. But if the detection system only finds 5% of cases then�despite the mistaken deduction from the AP article�we really would have a massive billion-dollar corruption problem.

The Global Fund should be praised, not slammed, for its investigations and for its openness. But, it also needs to be challenged to find a way to estimate how representative these cases may be.

At any case, the Global Fund has promised "new anti-corruption measures," per the AP again.
A $21.7 billion global health fund and the U.N.'s main development arm launched new anti-corruption measures Friday in the wake of intense scrutiny from donors and stories by The Associated Press detailing fraud in their grants.

Chief among The Global Fund to Fight AIDS, Tuberculosis and Malaria's new measures are plans to create a high-profile panel of experts to examine the fund's ability to prevent and detect fraud in its grants.

'Programs supported by the fund have saved seven million lives and are turning back the three disease pandemics around the world,' said the fund's executive director, Dr. Michel Kazatchkine. He said the fund has 'zero tolerance' for fraud and corruption and was 'responding aggressively when instances of fraud or misappropriation are detected.'

That is nice, but I submit these stories are a reminder of how anechoic health care corruption is, and how few and ad hoc are the few efforts made to fight it. Much of the coverage of the corruption affecting the Global Fund had a breathless quality as if the authors were shocked, shocked that there could be corruption in health care.

In fact, many people more distinguished than yours truly have been warning about health care corruption for years. In particular, in 2006, Transparency International's Global Corruption Report, asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  It also noted how diverse is health care corruption:
In the health sphere corruption encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, the diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. It is not limited to abuse by public officials, because society frequently entrusts private actors in health care with important public roles. When hospital administrators, insurers, physicians or pharmaceutical company executives dishonestly enrich themselves, they are not formally abusing a public office, but they are abusing entrusted power and stealing precious resources needed to improve health.

It further stated how serious the consequences of corruption may be:
Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly....


The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted public health services.


Corruption affects health policy and spending priorities.

On this blog, our limited resources make us focus mainly on the US, and sometimes other English-speaking countries. Yet we now have in our archives some amazing stories that document various forms of corruption, including numerous allegations of corporate misbehavior ending in legal settlements, outright fraud, and other crime. Also, as we have noted before, the US Institute of Medicine has defined conflicts of interest
Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.

Given that Transparency International's definition of corruption is
abuse of entrusted power for private gain

One can easily argue that in health care, conflicts of interest defined as above create risks of abuse of power by health care professionals influenced by the private gains provided by their secondary interests. On Health Care Renewal, we have provided a massive set of examples of individual and institutional conflicts of interest. There is evidence that about two-thirds of medical academics(1) and academic leaders(2) have significant conflicts of interest. The huge prevalence of conflicts suggests the risk of major corruption.

Corruption and Conflicts of Interest as Anechoic

So what we all should be shocked, shocked about is how little has been done to fight health care corruption, whether in Mozambique or the US.

Note that the Gates Foundation is a major donor to the Global Fund. It has a number of disease or condition specific initiatives, and a global health policy and advocacy initiative. But it has no initiative to fight corruption and conflicts of interest, or, to put it in positive terms, to promote accountability, integrity, transparency, honesty and ethics.

The Doris Duke Charitable Foundation funds Health Alliance International.  It funds medical research, and has a specific focus on African health care research.  However, it also has no initiatives to fight corruption and conflicts of interest, or improve accountability, integrity, transparency, honesty and ethics in health care.

In fact, one could look in vain for any initiatives about or funding for anti-corruption, or pro-accountability, integrity, transparency, honesty and ethics by any major US charity with health care interests.

One can  find very few significant efforts to discuss, teach about, or research ways to fight corruption, or to promote accountability, integrity, transparency, honesty and ethics by academic health care institutions.  (See this post for how difficult it was to find academic institutions' initiatives to resist conflicts of interest.)  One can count the conferences, meetings, symposia, and courses on such topics on one's fingers. When I last looked, I could count only a single course on fighting corruption at any US medical or public health school ( at Boston University, by Prof Taryn Vian).

Given the scope of corruption, we should be shocked, shocked at how anechoic it is, and how our respected health care institutions, particularly academic institutions and health care charities have ignored the problem.

So will the Global Fund's losses to corruption inspire the Gates Foundation or any of its major donors to start an anti-corruption initiative? Or even have an anti-corruption symposium? So will the Health Alliance International's losses so inspire the Doris Duke Charitable Foundation?  Will these cases inspire any foundation, or academic health care organization to do anything to fight corruption and conflicts of interest, and to promote accountability, integrity, transparency, honesty and ethics in health care?

I am not holding my breath, but I live in hope.

Of course, one reason we started Health Care Renewal was to make these issues less anechoic. So hear we go again.

PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information.

References

1. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician�industry relationships. N Engl J Med 2007; 356:1742-1750. (link here)

2. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. (link here)

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