Thursday, November 29, 2012

"The Scent ... of a Casino" - Clinical Research Results as Fodder for Insider Trading

"The scent and smoke and sweat of a casino are nauseating at three in the morning. Then the soul-erosion produced by high gambling - a compost of greed and fear and nervous tension - becomes unbearable and the senses awake and revolt from it." - Ian Fleming.  Casino Royale.  1953

A major theme of this blog has been threats to the integrity of clinical research.  When I started out as a young naive academician in medicine, I viewed clinical research through the lens of evidence-based medicine, as primarily a means to develop better evidence to aid in the care of patients, and secondarily a way to advance science and public health.  Yet in the past 20 to 30 years, clinical research has become commercialized.  Now most randomized controlled clinical trials are done to support the licensing of drugs and devices for particular indications.  Furthermore, clinical research has become de facto a primary avenue of marketing of drugs and devices.  So we have discussed endlessly how clinical research has been manipulated by those with vested interests in selling drugs and devices, and may be suppressed when even such manipulation fails to produce results desired by commercial sponsors.

If that was not bad enough - and it is - now there is evidence that clinical research has become the roulette wheel in an investment casino.  This is the lesson provided by new US government charges that giant hedge fund SAC Capital used insider knowledge to trade drug company stocks.

Let me try to provide a narrative of the key elements of the case.

The Key Players

Matthew Martoma was a " former student at Harvard Law School, ... [who] co-wrote papers on medical ethics before seeking a business degree at Stanford University and joining a little-known Boston hedge fund."  Then, "in 2006, at age 32, Martoma made it to SAC Capital Advisors LP and gained the attention of the firm’s billionaire owner Steven A. Cohen."(1)

Dr Sidney Gilman is

an 80-year-old neurologist with expertise in neurodegenerative disorders, including Alzheimer’s disease. According to his biography on the University of Michigan website, Gilman first served on the faculty at Harvard and Columbia and then had a long and distinguished career at the University of Michigan, where he was the chair of the department of neurology for many years. He is a member of the Institute of Medicine of the National Academy of Sciences and a past president of the American Neurological Association. In other words, he’s a bigshot.

Gilman moonlighted as a consultant, working for an expert networking firm, where he provided advice to the financial industry (and which eventually led to the insider trading case), and for Elan Pharmaceuticals. In addition to his consulting for Elan, he also served as the chair of the Safety Monitoring Committee for a phase II clinical trial of a highly promising (at the time) Alzheimer’s drug, bapineuzumab, under development by Elan and Wyeth.(2)

The owner of SAC Capital, a hedge fund worth $14 billion, is Steven A Cohen, "a prodigious art collector, an investor in the New York Mets, a supporter of Mitt Romney’s presidential campaign."  His "career ... has reached mythic status on Wall Street. Over the last 20 years, Mr. Cohen has amassed a multibillion-dollar fortune by posting returns averaging 30 percent a year. SAC has grown into a firm with about 1,000 employees around the world."(3)

The Maneuver

Per the NY Times(4), 

The doctor met Martoma as a consultant for an expert- networking firm based in Manhattan and had sessions with Martoma from mid-2006 to July 2008, according to the government.

Gilman worked for Gerson Lehrman Group’s Scientific Advisory Board starting in 2002,... 

Also according to the NY Times(5)
Dr. Gilman’s consulting work for Mr. Martoma earned him about $108,000, according to court filings. Based in part on Dr. Gilman’s leaks about positive developments related to the clinical trials of a new Alzheimer’s drug, SAC accumulated a roughly $700 million position in the stocks of Wyeth and Elan, according to the government.

The S.E.C. said that the fund’s owner, Mr. Cohen, took a large position in Wyeth and Elan in his personal portfolio based on Mr. Martoma’s recommendation. Mr. Cohen maintained his holdings even though there was significant internal debate about the wisdom of such a large position in the drug makers, the government said.
Furthermore, per Larry Husten writing in Cardiobrief(2),

 While serving on the Safety Monitoring Committee of the trial, from the summer of 2006 through mid-July 2008, Gilman had access to the safety (but not the efficacy) data from the trial. Throughout this period he leaked the positive safety information to his contact at SAC (the enormous hedge fund), which then began to accumulate a large position in both Elan and Wyeth.

So, allegedly based on information from Dr Gilman, the high-ranking academic physician doubling as a data monitoring committee chair for a drug trial, paid for these services by Elan, SAC Capital and Mr Cohen made a large investment in Elan and Wyeth, the companies sponsoring the trial.

But then, again per Husten(2),

 Later in June, Elan chose Gilman to present the full trial data at ICAD. Gilman did not become privy to this data until the middle of July when Elan gave him the full results of the trial. The results, in sharp contrast to the earlier view in the press release, were decidedly negative, offering little hope that the drug would be considered effective. Gilman apparently understood this, because he immediately gave the results to the hedge fund, which then rapidly and dramatically reversed its long position on Wyeth and Elan.

Specifically, per the New York Times(5), after

Dr. Gilman told Mr. Martoma that patients were experiencing serious side effects, prosecutors say. Afterward, Mr. Martoma e-mailed Mr. Cohen, telling him 'it’s important' that they speak. They spoke on the phone for nearly 20 minutes, the government says, and Mr. Martoma told his boss that he was no longer 'comfortable' with the investments.

The following day, SAC reversed course. Mr. Cohen’s head trader sold the firm’s entire inventory of roughly 10.5 million shares of Elan and about seven million shares of Wyeth, the government said. Once it had dumped the shares, SAC built a short position in the two stocks, betting their value would drop.

According to the S.E.C., the trader, Mr. Cohen and Mr. Martoma kept the sales confidential. The trade, wrote the head trader in an e-mail to Mr. Cohen, 'was executed quietly and efficiently over a four-day period through algos and darkpools' — referring to trades using algorithms and to trading platforms that do not have the same reporting requirements as the stock exchanges — 'and booked into two firm accounts that have very limited viewing access.'

After the companies announced the results of the trials, Elan’s stock fell about 42 percent and Wyeth’s about 12 percent.

The trading allowed SAC to avoid about $194 million in losses and earn about $83 million in profits on Elan and Wyeth, according to prosecutors.

At the end of 2008, Mr. Martoma received a bonus of about $9.3 million, the S.E.C. said.

So, having bet heavily on Elan and Wyeth based on Dr Gilman's initial information that the trial was showing positive results, SAC Capital and Mr Cohen then bet heavily against these companies based on Dr Gilman's new information that the trial would end up not showing such results.  Because they had this information allegedly before it was made public, these bets yielded huge profits.  Mr Martoma, the conduit between SAC Capital and allegedly Mr Cohen, made millions.  Dr Gilman made over a hundred thousand.

The Charges

Per Bloomberg(4),

Martoma, 38, was accused by prosecutors in Manhattan federal court with playing a lead role in what they called the most lucrative insider-trading scheme in history, given the $276 million profit he allegedly helped the hedge fund achieve.
The government started off taking a tough approach, per the NY Times(5),

FBI agents arrested Mr. Martoma, 38, early Tuesday morning at his home in Boca Raton, Fla. He was released on bail after making an appearance in Federal District Court in West Palm Beach. Mr. Martoma, who has been unemployed since leaving SAC in 2010, is expected to appear in federal court in Manhattan on Monday and enter a plea.

 In addition, Dr Gilman, per Bloomberg(1), "has entered into a non- prosecution agreement with prosecutors in which he agreed to testify before a federal grand jury and to forfeit $186,761, money which he was paid by Elan for his consulting work."

Mr Cohen has not been charged.  However, according to John Cassidy writing in the New Yorker(6),

the complaints do assert that Cohen, identified as 'Portfolio Manager A,' personally authorized many of Martoma's trades, and pocketed the bulk of the profits they generated.  In a statement accompanying the indictment [US Attorney Preet] Bharara was careful to state that S.AC., and by extension Cohen, reaped enormous rewards from the criminal wrongdoing, even though they weren't being charged.
the complaints do assert that Cohen, identified as “Portfolio Manager A,” personally authorized many of Martoma’s trades, and pocketed the bulk of the profits they generated. In a statement accompanying the indictment, Bharara was careful to state that S.A.C., and by extension Cohen, reaped enormous rewards from the criminal wrongdoing, even though they weren’t being charged.

Read more:
In addition, there is now some likelihood that there will be legal actions against SAC Capital.  The company has reportedly received a "Wells notice" that the SEC is considering pursuing such action.  In addition, according to the New York Times(7), "an additional action against SAC, or even Mr. Cohen, could involve accusations of fraud based on the so-called control-person liability theory, meaning that it was in 'control' of Mr. Martoma when he engaged in insider trading."
the complaints do assert that Cohen, identified as “Portfolio Manager A,” personally authorized many of Martoma’s trades, and pocketed the bulk of the profits they generated. In a statement accompanying the indictment, Bharara was careful to state that S.A.C., and by extension Cohen, reaped enormous rewards from the criminal wrongdoing, even though they weren’t being charged.

Read more:


At one point, I would have simply regarded the trial of bapineuzumab as a clinical scientific experiment meant to determine if a promising new therapy would work for the important clinical problem of Alzheimer's disease, and incidentally as means to learn more about the biology of that disease.  More recently, I would have regarded the trial as primarily a means for Elan and Wyeth to persuade the US Food and Drug Administration to approve this drug as a treatment for this disease, and then if so, a means for these companies to market it.  I would have been skeptical about the value of the clinical evidence supplied by the trial to support use of this drug, but would not have dismissed this evidence out of hand.

Now it appears that a major role of this trial was to be a roulette wheel in a Wall Street casino.  Big bettors on this wheel included people who may have had advance knowledge about the slot in which the ball would land.

Ideally, clinical research ought to be done by people who have no particular interest in the results turning out one way or the other.  Obviously, clinical investigators as humans may have opinions about how studies might turn out.  However, they should not be in positions to gain or lose money according to the results, or to be intimidated by those with interests in having the studies obtain particular results. Our current system in which many clinical studies are funded by organizations with interests in how the results turn out has lead to numerous cases of manipulation of study results, and sometimes suppression of studies whose results could not be manipulated successfully in the desired direction.  Such threats to study integrity make it difficult to make the best clinical decisions for individual patients, distort health policy, and break the trust of patients who volunteered to participate in the studies.

Now it appears that short-term stock trading that bets on the results of clinical research, sometimes informed by insider information about these results, could be another powerful external influence on clinical research that could additionally threaten its integrity.  Furthermore, as we speculated seven years ago (see this post and links backward), fear of insider trading may be making clinical research more opaque, and this opacity may allow even more control of research by sponsors (companies funding it) rather than investigators.

We have previously suggested that real consideration ought to be given to taking clinical research out of the hands of organizations, particularly health care corporations, that have vested interests in the direction of the results.  Knowledge that clinical research is increasingly becoming a casino for stock traders and hedge funds, and that research results are becoming the stuff of insider trading should further prompt this consideration. 

1.  Burton K, Kishan S, Van Voris B. Cohen's 'Elan Guy' Martoma dropped ethics for hedge fund.  Bloomberg, Nov 23, 2012.  Link here.  
2.  Husten L. The doctor and the center of the insider trading scandal.  Cardiobrief, Nov 27, 2012.  Link here.
3.  Lattman P. S.E.C. weighs suit against SAC Capital.  New York Times, Nov 28, 2012.  Link here.
4.  Van Voris B, Hurtado P. Insider crackdown uses SAC manager in health-care pivot.  Bloomberg, Nov 21, 2012.  Link here.
5.  Lattman P. Insider inquiry inching closer to a billionaire.  New York Times, Nov 20, 2012.  Link here.
6.  Cassidy J. It's time for Obama to bite the hedge-fund sharks.  New Yorker, Nov 21, 2012.  Link here.
7.  Lattman P. S.E.C. weighs suit against SAC Capital.  New York Times, Nov 28, 2012.  Link here

Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled "Medicare Is Faulted on Shift to Electronic Records" observes that:

The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators [the report from HHS OIG is here - ed.] ... Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions. [I note that meeting EHR "meaningful use" standards does not necessarily signify better care; the "standards" are experimental - ed.]

Hospitals and doctors are lying about their EHR efforts, in order to gain incentive payments, it seems.

In an article "IG says program is 'vulnerable' to abuse, better oversight needed", Fred Schulte at the Center for Public Integrity notes:

... the Centers for Medicare and Medicaid Services has since paid out more than $3.6 billion to medical professionals who made the switch without verifying they are meeting the required quality goals, according to a new federal audit to be released today

Observes the CEO of the American Health Information Management Association:

“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. 

More Horse and Buggy than Model T.  At least the Model T was reasonably dependable. 

Also mentioned is this:

House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.

In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.”

I was taught "first, do no harm."  Fairness to patients injured and killed by this technology in its present "Horse and Buggy" state (buggy being a particularly apropos term) seems not a matter of particularly high concern to HHS.   A suspension of incentives would slow the adoption rate down, necessary in order to "get the bugs" out of the technology before mass deployment and develop safety, validation and surveillance standards (currently non-existent), as I wrote in my Oct. 24, 2012 "Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems."

This is despite the fact that FDA, IOM and others have indicated the level of harm is not known, due to systematic impediments to diffusion of that knowledge (see IOM statements in the midsection of my post on health information technology hyper-enthusiasm at this link, and an internal FDA memo on HIT safety at this link). 

HHS seems to care not about health and human services, or at best to be severely misguided.  "Cybernetik Über Alles" seems their current credo.

-- SS

Tuesday, November 27, 2012

What If the Institute of Medicine Wrote a Report and Nobody Followed it? - the Case of the Standards for Developing Trustworthy Guidelines

For over 20 years, clinical practice guidelines (CPGs) have been touted to improve health care quality and control costs.  Enormous numbers of guidelines have been developed, but with seemingly little impact on health outcomes.  While some of those leading health care organizations have predictably blamed individual practitioners for obstinately ignoring or challenging guidelines, there is increasing evidence that maybe the guidelines themselves are part of the problem.

 An Example of a Guideline that Apparently was Not Trusted

One example Dr Wally Smith and I have taught in our recurring mini-course on why physicians fail to follow guidelines (and otherwise appear not to practice in accord with others' wishes) is that of the guidelines on management of depression in primary care.  Most existing guidelines urge physicians to screen patients for (presumably mild-to-moderate) depression and treat them aggressively, with emphasis on the use of the newer anti-depressants.  These guidelines, in turn, were based on numerous published randomized clinical trials that showed that these drugs were safe and efficacious.  Yet multiple studies showed that physicians failed to follow these guidelines, and various attempts to improve their adherence did little.  So for years the assumption was that physicians at best experienced practical and system barriers to follow these guidelines, and at worst were ill-informed or irrational. 

However, information that came out gradually during the early part of the 21st century suggested that perhaps the problem was within the guidelines, not the health care professionals.  First, documents produced during New York Attorney General Eliot Spitzer's lawsuit against GlaxoSmithKline about the marketing of one of these drugs (Paxil, paroxetine) suggested that the company had suppressed clinical trial data that reflected poorly on the drug (See Kondro W.  Drug company experts advised staff to withold data about SSRI use in children.  Can Med Assoc J 2004; 170: 783.  Link here.)    These suspicions were later fleshed out  by consideration of documents further disclosed in litigation (e.g., see this post and its links).  Then several studies, most particularly that by Erick Turner and colleagues, showed that numerous trials of new anti-depressants had been suppressed, that is, never published (Turner et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358:252-260.  Link here).  When the results of these trials were added to those that were published, the efficacy of anti-depressants was no longer so clear.  So maybe the guidelines that physicians did not follow were not trustworthy, and should not have been followed in the first place.

Would IOM Standards to Improve Guideline Trustworthiness Help?

So in 2011, the prestigious Institute of Medicine released a report on the development of  better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust.  Link here.)  We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect. 

A few weeks ago, an article appeared documenting a study meant to assess the the trustworthiness of clinical practice guidelines published soon after the IOM report.  Its title telegraphs the results. ( Kung J, Miller RR, Mackowiak PA. Failure of clinical practice guidelines to meet Institute of Medicine standards: two more decades of little, if any progress.  Arch Intern Med 2012.  Link here.)

Methods and Results

The investigators selected a random sample of 114 individual guidelines available during June, 2011 stratified by 26 clinical topics. The versions of the guidelines used were those archived in the National Guideline Clearinghouse (NGC) maintained by the Agency for Healthcare Research and Quality (AHRQ).

The goal of the study was to "examine adherence to the IOM standards" by guidelines published after the standards were published.  Actually, the study only assessed adherence to 18 of the 25 standards espoused by the IOM (because the remaining seven were "too vague and subjective to be analyzed.")

Furthermore, the criteria used to determine if a specific guideline met each of the three items above were rather lax:

In evaluating each guideline summary, care was taken to be as liberal as possible in considering that a standard was met when the individual guideline summary provided any information pertaining to that particular standard.

Nevertheless, using these lax standards to only evaluate adherence to 18/25 guidelines, the authors found that "the overall median number of IOM standards satisfied (out of 18) was 8 (44.4%) ....  Fewer than half of the guidelines surveyed met more than 50% of the IOM standards."

An examination of the details of the study's methods reveals things are even worse than that.

Analyzing the Study's Methods to Find that Things Are Worse Than They Seem

Review of the study's methods show that they provided a very optimistic view of adherence to the IOM standards.  As noted above, the study did not look for adherence to all of the IOM standards.  Moreover, those they did consider were simplified and made less rigorous.  For example, Standard 2 from the IOM on management of conflict of interest (COI) was:

Management of conflict of interest (COI)

Prior to selection of the Guideline Development Group (GDG), individuals being considered for membership should declare all interests and activities potentially resulting in COI with development group activity, by written disclosure to those convening the GDG.
- Disclosure should reflect all current and planned commercial (including services from which a clinician derives a substantial proportion of income), non-commercial, intellectual, institutional, and patient/public activities pertinent to the potential scope of the CPG.

Disclosure of COIs within GDG
- All COI of each GDG member should be reported and discussed by the prospective development group prior to the onset of their work.
- Each panel member should explain how their • COI could influence the CPG development process or specific recommendations.

- Members of the GDG should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG recommendations.

- Whenever possible GDG members should not have COI.
- In some circumstances, a GDG may not be able to perform its work without members who have COIs, such as relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the CPG.
- Members with COIs should represent not more than a minority of the GDG.
- The chair or co-chairs should not be a person(s) with COI.
- Funders should have no role in CPG development.

However, the study boiled all this down to three items:
-  COIs stated
-  Chair has COI
-  Co-chairperson has COI

Thus the study did not address standards requiring full and complete disclosure (not just some disclosure) of all COIs; consideration of how the COIs might influence the particular guideline; divestment of specific types of conflicts of interest, that is, financial investments, and cessation of participation in marketing activities or advisor boards; minimization of conflicts of all members of the committee; and barring of participation of funders in guideline development.

Even so, the guidelines assessed did a very poor job upholding even these few liberalized standards regarding conflicts of interest.  Of the guidelines assessed, less than half, 46.8% provided ANY disclosure of conflicts of interest.  Those written by sub-specialty societies were particularly opaque in this regard.  Less than one-third, 29.3%, provided any disclosure.  Thus the majority of guidelines assessed were not at all transparent about conflicts of interest affecting the guideline development process.

Furthermore, of the 46.8% of all the guidelines which made any disclosures of conflicts of interest, 71.4% admitted their chair people HAD a conflict of interest.  Thus, only (0.468 * [1 - .714]) = 13.3% provided assurance that they fulfilled the single requirement (from standard 2.4 above) that the chair person did not have a COI.  For the guidelines written by sub-specialty societies, by a similar calculation, only 12.2% provided an assurance that the chair had no COI.  (The proportions providing assurance that the co-chair people had no COI were even lower.)  Thus the vast majority of guidelines did not clearly follow two straight-forward standards for minimizing the effects of conflict of interest, that the guideline committee chair and co-chair should not have any relevant conflicts. 

Given the miserable results concerning even minimal adherence to some of the IOM report's conflict of interest standards, it is likely that almost no published guidelines from 2011 came close to fulfilling the full set of IOM standards.  Despite the best efforts of the IOM, it appears that guideline developers have not progressed at all towards providing trustworthy guidelines. 


An editorial (Shaneyfelt T. In guidelines we cannot trust.  Arch Intern Med 2012) accompanying the article by Kung and colleagues summarized its results thus:

The same problems that have plagued guideline development continue to plague guideline development; namely, their variable and opaque development methods, their often conflicted and limited panel composition, and their lack of significant external review by stakeholders throughout the development process.   As a result, the trustworthiness of guidelines is limited.

While guidelines may have seemed to be a promising method to improve health care in the early 1990s, they have failed to live up to that promise.  Shaneyfelt was not optimistic they would improve in the future:

I am not optimistic that much will improve.  No one seems interested in curtailing the out-of-control guideline industry.

On the other hand, in my humble opinion, it is not that on one is interested in better guidelines.  It would clearly be in the best interests of patients and the public, and of health care professionals who care about the quality of their practice and the outcomes of their patients to curtail that industry.  The issue is why patients', the public's, and professional's interests were ignored.

Neither Shaneyfelt nor Kung et al discussed why there has been so little attention to patients' and the public's health, and to health care professionalism in all this.  For a quick answer, we do not have to look far on Health Care Renewal

In fact, the IOM report on guideline development from 2011 was a serious challenge to the powers that be in health care.  In particular, it challenged the cozy relationships that had grown up among the organizations that undertook guideline development and the health care professionals on guideline panels on one hand and organizations that stand to gain were specific guidelines to favor their products, services, and agendas on the other.  The standards mandated transparency and honesty about conflicts of interest affecting guideline committees and the organizations which assembled them, and if upheld would have greatly reduced these relationships.

Now it turns out that the guideline standards have been honored mainly in the breach.  Of course, these standards, while increasing trustworthiness, would have cost a lot of medical societies considerable commercial funding, and would have cost a lot of health care professionals on guideline panels considerable personal wealth.  These standards would probably also have cost a lot of companies whose products and services were addressed by guidelines to lose revenue.  So it is not surprising that the IOM standards were ignored.  Their implementation would have cost too many people who are financially benefiting from the status quo too much money.  And these people, that is, leaders of professional societies dependent on commercial outside funding, health care professionals and academic used to financial support from commercial interests, and health care corporations are good at making sure their interests are not ignored, even if their interests conflict with those of patients, the public, and well-intentioned health care professionals.  

So, the flouting of the well reasoned IOM guideline standards adds one more reason for patients and the general public to distrust modern health care and all those who "deliver" it, even to distrust well-intentioned health care professionals who have not been able to distinguish themselves from their colleagues who are too happy to help commercial interests while taking commercial money.  If health care professionals want to regain the public's trust, they could do worse than publicly declaring their intention to show that their practice in the future will be guided by trustworthy guidelines based on clinical research evidence and knowledge of biomedical science, drawn up by health care professionals independent of commercial interests.

Friday, November 23, 2012

Should Health Care be a "'Commodity, Subordinate to the Laws of the Market?" - a Powerful Rebuttal

In the US, it has become the accepted wisdom that health care is now an industry, not a calling or a profession, and the health care it produces is a commodity, not a human service. 

The Conventional Wisdom

For example, earlier in 2012 we quoted Dr Ralph de la Torre, the CEO of Steward Healthcare (formerly the Caritas Christi health system, a Catholic health care system whose take-over by Cerberus Capital Management, a private equity firm, was arranged in part by Dr de la Torre [see posts here]):

In deference to those who love the individual hospital, you have to look back at America and the trends in industries that have gone from being art to science, to being commodities. Health care is becoming a commodity. The car industry started off as an art, people hand-shaping the bodies, hand-building the engines. As it became a commodity and was all about making cars accessible to everybody, it became more about standardization. It's not different from the banking industry and other industries as they've matured. Health care is finally maturing as an industry, and part of that maturation process is consolidation. It's getting economies of scale and in many ways making it a commodity

More recently, Human Events, which describes itself as "the nation’s first conservative weekly," featured a description of a new book by one Edmund L Valentine, "CEO of the Stamford, Conn.-based MMC International, a health care consulting firm, which emphasizes its expertise in the pharmaceutical and device manufacturing fields.  In it, Mr Valentine stated that one should:

treat health insurance as a commodity, where companies only compete based on their reputation and price.
but presumably companies should not compete based on the effects of their products on the health of those who buy them.

Furthermore, he supported

the further industrialization of healthcare, ...

'Industrialization created our great economy,' he said. 'Allow the market and competition can fix the inefficiencies in the system.'
This ignored the arguments going back to the work of Kenneth Arrow that health care cannot be an ideal market (see this post), and all the data suggesting that in the last 20-30 years, when the market fundamentalists became so influential in US health care, costs have risen continuously and quickly without commensurate gains in access or quality.    These are just the latest of many examples of the business people who now run health care justifying approaching it as just another business.

A Strong Rebuttal of the Argument that Health Care is an Industry that Produces a Commodity  

For quite a while, Dr Arnold Relman has lead a relatively lonely quest to restore medicine as a profession and health care as a calling  (see posts here, here and here).  He noted that at one time, the notion that "the practice of medicine should not be commercialized, nor treated as a commodity in trade.'" was considered very mainstream.  (The quote came from the mid- twentieth century AMA code of ethics.)  We have done what little we can to support him.  However, the opposition to the new normal of health care as an industry that produces a commodity has paled compared to the conventional wisdom favored by rich executives and supported by billions of dollars of marketing, public relations, and lobbying budgets.    

However, this week strong support for health care as professions, as a calling, and hospitals as serving a mission just appeared in a big way in a major address to a health care meeting in Europe.  First, in the context  

during the current economic crisis "that is cutting resources for safeguarding health,"...   Hospitals and other facilities 'must rethink their particular role in order to avoid having health become a simple 'commodity,' subordinate to the laws of the market, and, therefore, a good reserved to a few, rather than a universal good to be guaranteed and defended,'  

'Only when the wellbeing of the person, in its most fragile and defenseless condition and in search of meaning in the unfathomable mystery of pain, is very clearly at the center of medical and assisted care' can the hospital be seen as a place where healing isn't a job, but a mission,

  The speaker thus directly challenged the current notion that health care is a commodity, and those who work in health care have jobs, not callings or missions. 

While the speaker was in fact a retired distinguished professor from a European university, but before any market fundamentalists start thinking he could be pilloried as some radical European academic, note the following.

The conference was the XXVI International Conference of the Pontifical Council for Health Care Workers, and the speaker quoted above was Pope Benedict XVI

Thus there is some very distinguished, albeit not numerous support for the ideas that held sway before market fundamentalism took over much of health care, the ideas that medicine is a profession and a calling, and hospitals should be mission oriented organizations, and that health care professionals and institutions should put patients' health and welfare first, very far ahead of short-term revenue and the accumulation of wealth by health care organizational leaders. 

Tuesday, November 20, 2012

Why Did the Global Fund Fire its Inspector General?

The Global Fund to Fight AIDS, Tuberculosis, and Malaria continues to struggle with the issue of health care corruption, an issue we noted here and here in 2011. 

Now as a news story in Nature put it,

It has been a rough couple of years for the Global Fund to Fight AIDS, Tuberculosis and Malaria, the world’s largest funder of international health programmes. Since its creation in 2002, the organization, based in Geneva, Switzerland, has channelled US$24.7 billion to delivering disease-control measures such as drugs, diagnostics and bed nets, saving millions of lives. But the global financial crisis has hit the fund hard, and its troubles mounted in 2011 when allegations of corruption among its grant recipients tarnished its reputation and alarmed donors.

Last week, the Global Fund tried to move on, announcing a new leader and unveiling major changes to its funding programme.
The Nature news story suggested that the troubles of the Fund all seemed so unfair.  After all,
the fraud allegations, ... [were] largely rehashed audits already made public by the fund itself. A retrospective audit published in July this year suggests that the allegations may have been overblown. It found that, in a sample of grants worth $3.8 billion that were awarded from 2005 to 2012 in 27 countries, just 0.5% of grant funding was lost to outright fraud. Experts say that figure is not exceptional for funding programmes in poor nations that often struggle with corruption.
Yet the Nature story suggested that the Fund's intrepid new later "could signal a fresh start, and has been broadly welcomed," leaving the impression that all things may turn out well.

Firing the Inspector General

However, the Nature story left out one nagging detail.  At the same time the Fund board announced the appointment of Dr Mark Dybul as its new director, it also announced that it had fired the Fund's Inspector General.  A report in the Financial Times only included,

It also dismissed John Parsons, its inspector general. Some directors believed Mr Parsons had been too outspoken in conducting public audits that sparked criticism of relatively small amounts of mismanagement and corruption.
The impression left was that Mr Parson was mainly guilty of rocking the boat.

The New York Times version, which started by recounting the hiring of Dr Dybul, also made it sound that Mr Parsons was generating too much bad publicity,

The fund also dismissed its inspector general, John Parsons, on Thursday, citing unsatisfactory work.

Mr. Parsons and Dr. Kazatchkine had privately clashed. Mr. Parsons’s teams aggressively pursued theft and fraud, and found it in Mali, Mauritania and elsewhere. But the total amount stolen — $10 million to $20 million — was relatively small, and aides to Dr. Kazatchkine said the fund cut off those countries and sought to retrieve the money. The aides claimed that Mr. Parsons, who reported only to the board, went to news outlets and left the impression that the fund was covering up rampant theft.

The fuss scared off some donor countries....
The AP version also cited the Board's accusation that Mr Parson's performance was "unsatisfactory," but included,

The inspector general's office is supposed to function independently. It was created in 2005 at the urging of the fund's biggest donor, the United States, which has contributed $7.3 billion to date.

The board held a contentious closed-door session with Parsons on Wednesday then deliberated into the night after he stormed out.

The board chairman, Simon Bland, and the head of its audit committee, Graham Joscelyne, each said they were unconcerned whether U.S. lawmakers might perceive the firing as an infringement on the office. Joscelyne would not elaborate on what Parsons did wrong but cited several reviews of him that were not disclosed.

In its latest 6-month progress report, Parsons' office said it had a growing caseload of 142 active investigations, up more than 70 percent from just two years ago.

Summary and Comment

We posted about the allegations of corruption at the Global Fund here and here in 2011.  At that time the scope of the problem was  unclear.  Now, at least according to the latest news report, it still is not clear.  On one hand, maybe no more than 0.5% of the budget was compromised.  On the other hand, would that caseload of 142 active investigations reveal more? 

Even less clear is the reason that Investigator General Parsons was fired.  The Board did not clarify what about his performance was unsatisfactory.  The AP report implies that doing too little was not the issue.  Most disturbing is lack of any mention of a possible replacement.

As we mentioned previously, the authoritative 2006 Global Corruption Report from Transparency International stated that corruption is a major global health problem.  Furthermore, Transparency International's IACC (International Anti-Corruption Conference) in Brasilia just wrapped up.  It's final declaration included,

We call on leaders everywhere to embrace not only transparency in public life but a culture of transparency leading to a participatory society in which leaders are accountable.

We call on the anti-corruption movement to support and protect the activists, whistleblowers and journalists who speak out against corruption, often at great risk.

It is up to all of us in government, business and society to embrace transparency so that it ensures full participation of all people, bringing us together to send a clear message: We are watching those who act with impunity and we will not let them get away with it.

Yet, corruption as a global health problem is still mostly ignored. In particular, global health aid programs almost never include pro-active measures to address corruption. In this case, the Global Fund, the world's largest source of such aid, was initially pushed into defensively addressing corruption, but now seems not to be so transparent about the problem. In my humble opinion, unless more transparency soon becomes evident, donors may continue to find reasons not to support the fund.

So the leaders of the Global Fund might want to consider becoming more transparent, and making some assurances that they are not out to get whistleblowers, including their own internal watchdogs.  At this point a more pro-active approach might be too much to ask for. 

Friday, November 16, 2012

"Why Do We Always Need to Blame Somebody?" - An Investment Banker Pushes Back Against Health Care Leadership Accountability

One of the many dramatic stories generated by the destructive Hurricane Sandy illustrated, oddly enough, the influence of big finance on American academic medicine.

Vivid video showed patients being carried down darkened stairways after flooding and a power failure at Langone Medical Center in New York (for example, see this CNN story.)  Amazingly, all the patients survived, thanks to heroic work by health care professionals and first responders.  CNN noted, "Some 1,000 staff members -- doctors, nurses, residents and medical students -- along with firefighters and police officers evacuated the patients."

The medical center suffered significant damage beyond that caused by the blackout.  A New York Times story about the problems was entitled, "A Flooded Mess that was a Medical Gem."  It noted the hospital's basement flooding destroyed major equipment like MRI machines, a linear accelerator and a gamma knife.  An animal research facility was destroyed and most of the animals died.  A renovated lecture hall and the library were ruined.

What Went Wrong?

However, soon after the debate began about why the hospital flooded and power failed.  A Bloomberg story stated,  

New York University Langone Medical Center, the 705-bed hospital in lower Manhattan that assured city officials it was ready for Hurricane Sandy, stood dark and empty a day after the storm rolled through.

That story raised questions whether hospital leadership gave adequate priority to infrastructure like generators, or put too much emphasis on spending likely to produce more rapid rewards.

Blame is being placed on the building’s outdated backup power system, which has raised concern that aging infrastructure at U.S. hospitals has created a risk for similar outages that jeopardize patient care.

'Hospitals are careful to get the latest and greatest medical equipment, but then they don’t spend on the infrastructure,' Michael Orlowicz, a principal at consulting company Lawrence Associates LLC, said....

A story on ProPublica (available on Salon) noted,

Experts say such failures are troubling but not entirely surprising. Dr. Arthur Kellermann founded the emergency department at Emory University and headed it from 1999 to 2007. Now, he’s Paul O’Neill-Alcoa Chair in Policy Analysis at RAND Corporation think tank.

The other night, as the NYU evacuation was unfolding, he tweeted, 'Hospital preparedness and well-functioning backup systems are a costly distraction from daily business, until they are needed. Like now.'

In an email interview with ProPublica, Kellermann elaborated: 'I have no doubt when the hospital assured the Mayor that their backup systems were ready, they believed they were. They were wrong. What I find most remarkable about this story is that [more than seven] years after Hurricane Katrina, major hospitals still have critical backup systems like generators in basements that are prone to flooding.'

Similarly, a Reuters story included another quote from Dr Kellermann,

'I've been asking hospitals to look at their own survivability' after a natural or manmade disaster, 'and I just can't get it on their radar screens,' said Dr. Art Kellerman,...
It added,

For hospital administrators trying to keep their institutions in the black, disaster-resistant infrastructure is expensive and lacks the sex appeal of robotic surgery suites and proton-beam cancer therapy to attract patients.

'People don't pick hospitals based on which one has the best generator,' Kellerman said. 

The notion that hospital leaders may put short-term revenue ahead of long-term infrastructure development, even when such development might be critical for patient safety, should not surprise Health Care Renewal readers.  Hospitals are often lead or influenced by those who believe maximizing short-term revenue should be the main goal of all management, an over-generalization of the idea promoted in business schools for a generation that business leaders should maximize "shareholder value," which has come to be defined as short-term stock price (see this post).

  Who Defended the Disaster Planning

 In response to this or anticipated criticism, leaders of Langone Medical Center deployed.  Not unexpectedly, one was Richard Cohen, the vice president for facilities, as reported by ProPublica, via the Huffington Post,  
After Hurricane Irene, officials at NYU Langone Medical Center spent several million dollars protecting its backup power system from flooding, according to Richard Cohen, vice president of facilities operations.

The hospital removed a fuel tank and a set of emergency generators at street level and chose to depend on what Cohen termed an 'extremely modern, extremely reliable' system of rooftop generators.

The hospital also built a new, flood-resistant house for pumps that draw fuel from the hospital's sealed underground tank and feed it to the generators that make electricity when New York City's power fails.

One vulnerability remained, and it proved to be the system's Achilles Heel. A portion of the hospital's power distribution circuits, which direct the generated electricity out into various areas of the hospital, were located in the hospital's basement.

'It's like what happens when you have a flood in your basement and the electrical panel is in your basement,' Cohen said.

Oops.  Why a crucial component of the system meant to protect the back up power system from threats including flooding was placed in an area at risk from flooding was not clear.   Only one story I could find (in the NY Times) included a response by the Dean of the Medical School and CEO of the Medical Center Dr Robert I Grossman.

At this point, Dr. Grossman said, he could only theorize as to why the generators had shut down. All but one generator is on a high floor, but the fuel tanks are in the basement. The flood, he said, was registered by the liquid sensors on the tanks, which then did what they were supposed to do in the event, for instance, of an oil leak. They shut down the fuel to the generators.

Oops again.  Why an effort to flood proof the hospital included an undeground fuel tank which could not be operated if water got near it was also not clear. 

The most voluble defender of the hospital's management proved to be one Mr Kenneth Langone.  As noted in a blog post in the Wall Street Journal, Mr Langone is the medical center's "board chair and benefactor."  In fact, as the NY Times reported in 2008,

Kenneth G Langone, a billionaire financier and founder of Home Depot, is giving another $100 million donation to New York University Medical Center, matching the one he made anonymously in 1999. 

In return, the university plans to name the medical center the N.Y.U. Langone Medical Center,....

The WSJ blog post asserted,

Langone said the hospital 'frequently' tested its generators and they had passed the tests, and the hospital was prepared for a 12-foot storm surge. 'We anticipated 12-foot surges, which we knew we could handle. We got 14-foot surges,' he said.

Some of the hospital generators were in the basement, which flooded. Langone acknowledged that the generators were 'not in the right location,' but that was an artifact of aging facilities undergoing an extensive upgrade. 'They’ve been there for years,' he said of the generators in the basement. As part of a $3.2 billion modernization, NYU Langone was planning on buying new generators and locating them in better locations than the basement, Langone said.

Oops one more time.  Mr Langone seemed to only offer inertia as an excuse for why some generators remained in the basement after an effort to flood proof the back up electrical system.
Langone was quoted in the CNN story mentioned above,

Kenneth Langone, the chairman of the hospital's board of trustees who also happened to be a patient there until he was discharged Tuesday morning, said that regulations require the generators to be tested regularly and that they've worked every time.

Langone said the hospital is in the midst of an 'enormous' building campaign. The generators are going to be replaced in a renovation, he said.

In a Bloomberg story, Langone was quoted again,
'We believed the machines would work, and we believed everything we were told about the scope and size of the storm,' Langone said.

 In that story, he tried to deflect attention from tha apparent infrastructure failure, and presumably the responsibility of the organization's leadership for it, to the efforts of health professionals,

'The backup generators failed, it’s that simple, but the story here is the magnificence of the effort of all of our people and what they did,' Langone, 77, said yesterday....

He also defended the relatively silent Dean and medical center CEO,

'What this dean has done is nothing short of spectacular, in every respect,' Langone said of Grossman. 'So last night God decides to give us a test and our machines failed.'

The story ended with yet another of his attempts to deflect attention to management's responsibility,

'Machines fail, airplanes take off in great shape and they have malfunctions,' Langone said. 'Why do we always need to blame somebody for something that could just have happened? Why not write a story about what people did because things happened? Let’s be a little positive once in a while.'

And in the WNYC News Blog, Langone appeared yet again with this apologia, 

He said hospital pumps failed, because they were overwhelmed by an event that was 'unprecedented' and 'an act of god.'

'The generators are on the seventh floor, and the fuel supply is in cement vaults in the basement, where they're supposed to be according to code,' Langone said. 'Moisture sensors shut down the pumps, but they did what they're supposed to do.'


Certainly the survival of all the former patients at Langone Medical Center due to brave efforts by health care professionals and first responders ought to be celebrated.  From the discussion so far, it is not clear whether the infrastructure failures were unavoidable due to the scope of a huge natural disaster, or whether the failures were the results of poor planning and insufficient attention to and investment in infrastructure.  Celebration of personal and professional dedication, however, ought not to distract from determining what lessons could be learned about making health care infrastructure safer in cases of natural disaster. 

It also ought not to distract from concerns about management accountability.  In this day and age, it is not surprising that no executive at Langone Medical Center would accept any responsibility for an effort to protect its electrical back-up power from flooding that included an underground fuel tank which would be shut down if any water affected it.  However, these executives are rewarded handsomely supposedly for their "spectacular" leadership.  (Dean Grossman received $1,744,780 in the 2010-2011 period according to the NYU Hospitals Center 2010 form 990.  That document listed four other executives who made over $1 million.)  One would think they would at least try to substantively address how their patients got put into such a precarious situation.

It is surprising that the silence from management was supplanted by the opinions of a very wealthy board chairman who paid hundreds of millions for some of the improvements to the hospital that were destroyed by the storm, but improvements that may not have included fully flood proofing the hospital's back up electrical system.  Why he may well be disappointed about the loss of what he spent so much to build, it is not clear why his opinions about technical aspects of disaster preparation should replace responses from those who were responsible for disaster preparedness.  After all, Mr Langone, while very wealthy, has no evident expertise in engineering, science, or anything pertaining to protecting infrastructure from natural disasters.  (Mr Langone's biography showed his background seems to be only in investment banking and finance.)  One wonders whether Mr Langone's prominence in the discussion suggests how influential the views of investment bankers, versus those of health care professionals, engineers and scientists, have become in the operation of health care systems.

Again, it appears that the culture of finance has intruded progressively into the cultures of health care and academics during an era in which finance has been increasingly irresponsible, as shown by the global financial collapse and our current economic woes.  Instead, true health care reform would develop leadership and governance that upholds health care professionals' values rather than worshiping short term revenue.

Wednesday, November 14, 2012

Will the Circle be Unbroken? - Hospital Executive Compensation Continues to Defy Gravity and Logic

A report from Health Leaders Media, a prominent media site about health care management, shows how non-profit hospital executive compensation continues to levitate.  In general,

For not-for-profit CEOs nationwide the median total cash compensation (base plus incentives) increased 3% to 6.7% over last year, and these organizations' senior leadership teams gained similar pay increases,...

The specifics included

Health system CEOs' median base salaries increased to $717,500 (2012) from $650,000 (2011), while independent hospital CEOs' median base salaries rose to $506,100 from $472,000 during that period, according to IHS. Comparatively, Sullivan, Cotter and Associates shows the base pay for system CEOs nationwide increased while the TCC declined slightly—base pay increased to $334,700 from $325,000, while TCC decreased to $411,100 from $412,100 from 2012 to 2011, respectively. Unlike their health system counterparts, independent hospital CEOs' base pay and TCC climbed between 2011 and 2012—base pay went up to $530,000 from $504,000 (a 4.9% gain) and TCC jumped 4.3% to $600,000 from $574,000.

The report also showed that pay increased for some species of top executives.  CIOs (chief information officers) did the best,

Nationally, system CIOs received one of the largest TCC increases year over year, according to Sullivan, Cotter and Associates (5.8%). IHS reported a median base salary increase of (3.5%).

These increases ought to be compared to the base rate for the population.  In September, the Census Bureau reported that median family income dropped in 2011 (per the New York Times):

 Median household income after inflation fell to $50,054, a level that was 8 percent lower than in 2007, the year before the recession took hold.

The actual decline from 2010 to 2011 was 1.5% (look here).

So executive compensation in health care continues to defy gravity, even as the income of the typical family does the opposite. 

Will the Circle be Unbroken?

Conveniently, the day before, another well regarded site for hospital management information, Becker's Hospital Review, provided a rationale for current health care executive compensation, based on a blog post from Integrated Healthcare Strategies, which claims to be one of the largest US healthcare consulting firms.

The Review article first noted that "executive compensation is a delicate subject," without explaining why it was more delicate than the compensation given to other people.  It then answered the question its title posed, "are hospital executives paid too much?"  In summary,

compensation levels are currently appropriate, on the whole, because employers are generally keeping them on the job with such consistent pay levels.

The syntax is a little difficult, but I believe the translation is the circular cliche, "it is what it is."  More formally, this appears to be a version of begging the question, or circular reasoning.

The Integrated Healthcare Stragies blog post by David Bjork, "thought leader," Senior Vice President and Senior Advisor, who authored two books on executive compensation in health care, rotated this again.
ARE EXECUTIVES PAID TOO MUCH?  The short answer is no. Executives are not overpaid. If they were, employers would not willingly pay them as much as they do.
And again

the intrinsic value of a job can be quantified. Economists and most workers judge the value of a job by how much it pays. A job is worth what an employer is willing to pay an employee to do it, or what an employee is willing to accept as payment for the job. Virtually no one doubts that principle—except when it comes to executive jobs.

Have we got that?  Bjork argued that executive pay is self-justifying.  All executives are worth what they are paid because that is what they are paid.

Another way to understand the fallaciousness of this argument is to try to apply it to jobs other than executive positions.  Presumably, it would mean that everybody's pay is appropriate, and hence nobody's pay could ever be changed.  But one's head begins to hurt just trying to think about this.

Yet those were the main arguments that Mr Bjork made to justify his contention that

There is no rational basis for the view that executives should not be paid as much as they are paid, just a personal attitude, generally held by someone who is paid less.

A Side Trip to the Fallacy of Composition

Mr Bjork did make an attempt to supplement that argument.  For example, he wrote "labor market forces drive pay for executives," without explaining how much they do so, or the nature of the market for executive pay.  Later, he wrote,

Hospitals and health systems continually look for ways to reduce their costs. When they come across jobs that cost more than they are worth, they eliminate the jobs and either eliminate the work, redistribute it to other employees, or outsource it to cheaper labor. They view executive jobs the same way. When hospitals and health systems find an executive job that seems to cost more than it is worth, they eliminate it if they can and redistribute the work to other managers.

Let us unpack this a bit.  First, hospital and health systems are organizations composed of humans.  They do not look for anything, but the executives who run them may certainly look for ways to reduce costs and eliminate apparently unnecessary jobs.  Confusing hospital executives with the organizations they run appears to be a version of the fallacy of composition, which "arises when a person reasons from the characteristics of individual members of a class or group to a conclusion regarding the characteristics of the entire class or group (taken as a whole)."

Taken literally, this paragraph suggested that executives could decide their own jobs "cost more than they are worth," and then fire themselves and give their work to someone else.   

Nonetheless, were this targument to be true, it in fact contradicts the conclusion based on this argument that appeared two sentences later
Therefore, executives must be worth what they are paid, because employers keep them on the job and willingly continue to pay what¬ever they are paid.

Note that this conclusion is yet another restatement of the circular argument above.  . 


We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  In our latest example we find some particularly ripe repitition of a fundamentally fallacious argument to support ever rising compensation for health care executives.  It is distressing that the arguments were made by a prominent health care management consultant and published author on the subject of health care executive pay, and was picked up without question by a prominent health care management media site.  It suggests, like other posts we have written about the generous use of logical fallacies to protect the powers that be, that these eminences really may have not the slightest idea what they are doing, and have truly risen to their level of incompetence, if not ridiculousness; or else, they do know what they are doing, but have nothing but contempt for the reasoning powers of anyone outside their circle, and feel no need to justify their actions to such hoi polloi.

The sheer foolishness of arguments made to protect the status quo ought to lead the rest of us, particularly health care professionals, to question that status quo further. 

The ability of top executives of many, probably most health care organizations to collect bloated paychecks out of proportion to, if not despite their performance attracts the wrong people to lead these organizations, and provides incentives for even the right people to lead badly.

Until we make health care leaders accountable, and until their incentives reflect their ability to uphold the health care mission, expect more unaccountable leadership that subverts the health care mission, and hence continually rising costs, declining access, and deteriorating quality.

Friday, November 09, 2012

Why It's Crazy to Want Your Most Confidential Information Put into An Electronic Medical Records System

Besides the reasons I outlined in posts retrievable by these query links (link, link), there's this from

Microsoft warns of first critical Windows 8, RT security flaws

It's been less than a month since Windows 8 and Windows RT-powered Surface tablets were launched and went on sale, but Microsoft is already warning that the two next-generation operating systems contain critical security vulnerabilities that are due to be patched this coming Tuesday.

Among the various flaws, versions from Windows XP (Service Pack 3) all the way through to Windows 8 are affected, including versions of the Office suite, and versions of Windows Server. Released only in September, Windows Server 2012 requires patching to maintain maximum security.

The latest vulnerabilities include three critical security vulnerabilities for Windows 8, and one critical security vulnerability for the Surface-based Windows RT operating system. These flaws are considered "critical" and could allow remote code execution on vulnerable systems.

I note that Windows XP was released worldwide for retail sale on October 25, 2001, which was more than eleven years ago.  That security vulnerabilities are still being patched in 2012 is stunning.  Also, many enterprise information systems and most hospital clients (workstations) run on Windows-based servers and Windows installed local machines (UNIX, MacOS and other OS's are very rare on general-purpose hospital workstations).

From a Microsoft website here:

This partial list includes many very large HIT sellers.  There are many others as well.

By simple reckoning, it's likely we'll be seeing critical security vulnerabilities in Windows 8 - in 2023.

It goes without saying that these security problems will continue to be exploited by identity thieves, medical information merchants, and others with no rights to "protected" information.

In my opinion, the (still not yet realized) convenience of being able to have one doctor transmit your record to another, thus avoiding a FAX machine, the Postal Service or the telephone, and the trillion-dollar "solution" to the nearly non-existent problem of being found unconscious in some foreign land with no ID, no companions, and some hidden, critical medical condition not findable on physical exam and bloodwork, EKG, x-rays etc. that will cause death if not treated in minutes, is not worth the risk of having one's most private information spilled all over the Internet.

EHR's should not be accessible on networks beyond a physician's office or the robustly encrypted network of a hospital, and the information security personnel kept on very short leashes, for the foreseeable future.

I am unwilling to cede my own privacy to cybernetic utopians who ignore alarming evidence - plain to see at the aforementioned query links at the top of this post - nor can I in good faith recommend doing so to the public in 2012.

Considering the information in the many posts at the aforementioned query links (as here: link, link -- be aware you need to hit "older posts" at the bottom of each page to see all of them), that position is straightforward.

-- SS

11/9/2012 Addendum:

Also see my Oct. 2012 post "Computer Viruses Are 'Rampant' on Medical Devices in Hospitals."

-- SS

Thursday, November 08, 2012

For Whom Does the Center for the Protection of Patient Rights Advocate?

We have occasionally discussed the cases of  some patient advocacy organizations which seem to be influenced by substantial financial support from the health care industry.  For example, look here and here.  Related are "astroturf" organizations, which promote policies that may be favored by their industrial sponsors (e.g., here.)

Background on the Center for Protection of Patient Rights

The topic of this post is the Center for Protection of Patient Rights, which may have started out as something like an astroturf organization, but seems to have become something even more interesting.  The Center, which, by the way, seems not to have a web-site, was the subject of an investigative report in the Los Angeles Times in May, 2012.  Here is the article's description of how the Center began,

The Center to Protect Patient Rights was created in April 2009, just as the debate over the healthcare bill was heating up. The group's mission was to 'protect the rights of patients to choose and use medical care providers,' according to its corporate paperwork, filed in Maryland.

While never surfacing publicly, the center sent more than $10 million in its first year to groups such as Americans for Prosperity, which took a lead in protesting the measure.

'I think they saw what we were doing and liked it,' said Tim Phillips, president of Americans for Prosperity, which got $4.1 million. He said he did not know the source of the center's funding and declined to comment on whether it still supports his group.

So this group supported an advocacy position about health care reform, so perhaps it could be considered an astroturf organization, were we to know it was funded by the health care industry.  Many astroturf organizations do reveal support from particular corporations.  However, at the time the Los Angeles Times published the report, the source of the Center's funding was unknown. 

Secretive Leadership

Furthermore, while astroturf organizations may be eager to get more public notice, presumably so they can further their advocacy, the Center seemed oddly secretive.  Its executive director and president is one Sean Nobel.  However, as the LA Times article noted,

Noble did not respond to repeated phone calls and emails. Courtney Koshar, a Phoenix anesthesiologist and the organization's only other director, did not respond to requests for comment. And a Phoenix doctor who once sat on its board said he couldn't remember who asked him to join.

'I honestly played very little role,' said Dr. Eric Novack, who headed an organization called the US Health Freedom Coalition that received nearly its entire budget — $1.7 million — from the center to help pass a state ballot measure that aimed to block President Obama's healthcare overhaul.

Support for Political Organizations, not Health Care Advocacy

Even more curiously, despite its name, the most of the Center's spending was not for advocacy about health care reform, but went to organizations that  seemed to have little or nothing directly to do with health.  As the Times reported,

During the 2010 midterm election, the center sent more than $55 million to 26 GOP [Grand Old Party, that is, Republican Party] -allied groups, tax filings show, funding opaque outfits such as American Future Fund, 60 Plus and Americans for Job Security that were behind a coordinated campaign against Democratic congressional candidates.
It seemed that these grants were used for nothing that directly related to health.  For example,

The largest share of the center's money went to American Future Fund, a Des Moines-based group started by onetime GOP congressional aide Nick Ryan. The fund, which ran campaigns against two dozen Democrats in the 2010 election cycle, spent $23 million that period, tax filings show, with nearly $13 million coming from the center.

Its biggest target was an up-and-coming Iowa Democrat, Rep. Bruce Braley. In August 2010, American Future Fund launched an ad falsely claiming that Braley supported building a mosque at the former World Trade Center site in New York — the beginning of a $2-million fusillade that included radio ads, robo-calls and nine mailers.

A list of the recipients of the Center's 2010 grants was also publised in the LA Times here.

Where Did the Center Get its Support?

Just before this week's US election, the plot thickened.  The LA Times reported that because of the Center's obviously political activities in California, an effort was made to determine its source of funding, but that came up short.

After a frantic court battle, state election officials succeeded Monday in forcing an Arizona group to disclose the identities of contributors that provided $11 million to a California campaign fund.

But the revelations added little clarity for voters. The mystery donors turned out to be other nonprofits, whose individual contributors remained secret.

The money started with the Virginia-based Americans for Job Security and was transferred to a group called the Center to Protect Patient Rights. Over the course of a few days in October it was sent to the Arizona group, Americans for Responsible Leadership, and then transferred again to California.

Finding the source of the money 'becomes daunting,' said Derek Cressman of Common Cause, an activist organization that filed the original complaint about the donation. 'How many layers can you drill through?'

Note that in 2010, the Center for Protection of Patient Rights gave money to the Americans for Job Security, but in 2012, the latter organization gave money to the former - curiouser and curiouser. 

Allegations of Illegalities, Including Money Laundering

It turns out the Americans for Job Security has been in trouble before for activities that seemed contrary to state election law:

Americans for Job Security, one of the nonprofits involved in the $11-million donation, was investigated by Alaskan officials for its role in a 2008 mining referendum.

Authorities concluded that the organization's 'sole purpose is to allow individuals and corporations to financially support various causes without having to disclose that financial support.'

That investigation showed how a wealthy landowner sent $2 million to the group, which then funneled most of it back to Alaska to try to fend off construction of a mine near the landowner's property.

Americans for Job Security agreed to a settlement, paying a $20,000 fine and pledging 'not to engage in similar activity' again in Alaska.

In addition, the Mercury News reported allegations that the fund transfers by the Committee for the Protection of Patient Rights were illegal.
two conservative groups, Americans for Job Security and the Center to Protect Patient Rights, are part of a tangled web of so-called dark donors who operate largely out of public view, shielded by their status as nonprofit advocacy groups that are supposedly not involved primarily in politics.

While the groups have been identified, however, individual donors who have bankrolled them remain a mystery.

But 'this isn't going to stop here,' said Ann Ravel, chairwoman of the Fair Political Practices Commission, the state's political watchdog. 'They admitted to money laundering. We agreed to do this without an audit because we wanted to get information to the public before the election. But we in no way agreed this would preclude further action.'

The FPPC determined that the Arizona group, Americans for Responsible Leadership, had violated California campaign law.

Money laundering -- sending money through multiple sources to conceal the original donor -- is a misdemeanor. But a conspiracy to commit money laundering is a felony. It was not clear Monday whether the FPPC or the state Attorney General's Office will pursue criminal charges.


So the answer to the question posed in the title of this post is unknown.  At this point, there is nothing public that indicates for whom the Center for Protection of Patient Rights advocates.  However, it is hard to conceive that its advocacy is for patients. 

So rather than merely being an astroturf organization (a health care policy advocacy group funded by industry money), the benignly named Center for the Protection of Patient Rights appears to be a dark money group whose goals may have allegedly included money laundering to facilitate vast monetary influence on political campaigns by people and organizations whose identities remain secret.

We have often discussed the role of deception in health care, including stealth marketingstealth public policy advocacy, and stealth lobbying.  Now we see health care being used as a vehicle for political deception, stealth political campaigns being disguised as stealth public relations campaigns.  The convolutions of the deceptions induce dizziness. 

Of course, this is the opposite of the sorts of transparency health care professionals and academics ought to support, and patients and the public ought to demand.  How will we ever improve health care when health care organizations are used to hide layer upon layer of deception?

Real improvements in health care require health care leadership dedicated to transparency, honesty, and accountability.