Who Is Now Scolding the "Pharmascolds?"

Ah, there they go again. This week, the Wall Street Journal published an op-ed by David A Shaywitz and Dr Thomas P Stossel whose title says it all, "It's Time to Fight the 'Pharmascolds.'"
On the Hooked: Ethics, Medicine and Pharma Blog, Dr Howard Brody provided a pithy point by point response to Shaywitz and Stossel, which is very much worth reading. But given the sweeping nature of Shaywitz and Stossel's arguments, and the prominent forum in which they appeared, I thought I could add to the discussion.

Shaywitz and Stossel's main point was that "relationships between university researchers and medical product companies are under relentless attack by critics who portray these associations as a morality play in which noble academics struggle to resist the dark, corrupting influence of industry." They castigated

the disproportionate influence of a coterie of prominent critics we have previously dubbed 'pharmascolds,' who routinely vilify the medical products industry and portray academics working with it as traitors and sellouts. These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists. Their condemnation of anyone's legitimate profit -- it's all 'corruption' in their book -- has in fact materially enhanced their own careers. They extrapolate from occasional behavioral lapses in industry -- which is equally, if not more prevalent, in universities -- to demonize the market and portray scientific medicine as an ascetic religion, which it is not.

I can't claim to be "prominent," and my career has certainly not been "materially enhanced" so far by my writing on Health Care Renewal, but I am sure some of what my colleagues and I have written puts us at least in the company of more prominent "pharmascolds," in Shaywitz and Stossel's book.

However, their arguments seem to be based on a slippery slope, or, on over-generalization of criticism of certain kinds of relationships among certain people and organizations under certain circumstances.

In particular, I see nothing wrong, in general, with "relationships" among academics and industry. However, there are specific kinds of conflicts of interest in academic medicine that ought to cause concern. So let me take this opportunity to first postulate a simple definition of conflict of interest in this context, and provide specific examples of the sorts of conflicts that ought to be troubling.

Definition: An individual conflict of interest occurs when a person with entrusted responsibility has another interest that may conflict with the proper exercise of that responsibility.

Examples of conflicts of interest relevant to academic medicine include:

- A physician entrusted to take the best possible care of individual patients receives payments from a drug manufacturer which might bias his or her decisions to use that company's drugs even for patients for whom these drugs would not be the best possible treatment.
- A clinical teacher entrusted to honestly impart information, skills, and judgment receives payments from a drug manufacturer which might bias his or her teaching in favor of that company's products
- A clinical researcher entrusted to discover and disseminate the truth based on research on human beings receives payments from a drug manufacturer which might bias the design, implementation, analysis or dissemination of studies on humans in favor of that manufacturer's products, or against its competitor's products
- An administrator entrusted to uphold the mission of the academic institution receives payments from a drug manufacturer that might bias his or her management decisions in favor of that company's interests, but against the institution's mission
- An academic entrusted to provide honest, clear health policy advice receives payments from a drug manufacturer that might bias his or her advice in favor of that company's interests

On the other hand, I do not have a problem with true collaboration among academics and industry that does not involve industry paying the academics money, or paying the academics' institutions money for which the individuals receive credit. One can envision all sorts of collaborations that do not involve one party paying the other.

Furthermore, I do not necessarily have a problem with industry paying an academic in the course of the conduct of basic science, that is in this case, science that does not involve research done on humans. Shaywitz and Stossel seem most concerned with the damage "pharmascolds" might do to basic and translational research. They warned of dire results from barriers that might mainly be designed to discourage the sorts of conflicts of interest listed above, but would damage the progress of basic science and translational research. For example, they warn

each new barrier -- such as the National Institutes of Health's ban on paid consulting for industry -- erected between publicly funded researchers and companies, especially cash-strapped start-ups where many of the breakthroughs occur, slows the progress of potential treatments.

There is the germ of an important idea in there. In fact, many medical academics simultaneously wear many hats. So someone who sees patients in practice, and teaches students about clinical medicine may also do bench research in the laboratory. Banning such an individual from receiving consulting payments from drug, biotechnology, device and other companies to prevent bias in his or her patient care or teaching might conceivably adversely affect his or her biomedical research. How to handle such trade-offs has not been widely discussed, but needs to be.

But the notion that all relationships among medical academics and industry are meant to promote science and find new cures for disease, but not to market products or influence policy in favor or industry, is at best naive.

So Shaywitz and Stossel's dire warnings that seemed based on this notion seem as naive as the notion they attribute to their opponents, that all relationships among academics and industry are evil.

Finally, Shaywitz and Stossel did some scolding of their own, addressed to medical academics who do not stand up for their relationships with industry

When challenged by reporters, most academic consultants to industry refuse to comment or offer a meek explanation, instead of retorting that industry pays them because they add critically important value. This evasion has only emboldened industry critics, disheartened company employees, and caused even allies to wonder if there really is something to hide.

They concluded with plea that academics with industry relationships stand up for these relationships, to wit,

For the sake of the many patients whose diseases require innovative treatments -- and for the medical philanthropists determined to make it happen -- it's time for the leaders of the medical products industry to take pride in their purpose and start fighting back.

They are entitled to their opinion, of course. However, there is just a whiff of hypocrisy emanating from this.

Just below it, Dr Stossel identifies himself as "a professor of medicine at Harvard and a fellow at the Manhattan Institute," which is surely true.

But it is also surely incomplete. As we have posted before, Dr Stossel himself has multiple relationships with industry, some of which he has revealed in other venues.

As we wrote in 2007, in a commentary in the New England Journal(1) in which Stossel attacked the rigorous conflicts of interest rules that were once again imposed on the US National Institutes of Health (NIH), Stossel disclosed

having received consulting fees from ZymeQuest, owning stock options in ZymeQuest and Biogen, and having pending and issued patents, owned by Brigham and Women's Hospital, some of which are licensed to ZymeQuest.

In another paean to a laissez-faire approach to conflicts of interest in Perspectives in Biology and Medicine(2), Stossel also disclosed that he

is a member of the Board of Directors of Zymequest Inc, and the Scientific Leadership Advisory Board of Merck & Co. The author is a founding scientist of Critical Biologics Corporation and a consultant to Boston Scientific, Inc., and Gerson-Lehrman, Inc.

In a commentary in the British Medical Journal(3) arguing once again that concerns with conflicts of interest have gone too far, he disclosed, he

is on the boards of directors and owns stock options in ZymeQuest and Critical Biologics Corporations, and his employer has licensed intellectual property to these companies, which may result in his receiving milestone payments, royalties and in the stock options having financial value. He receives fees for speaking to corporations and other organisations on the topic of conflict of interest. He has served on scientific advisory boards for Biogen, Dyax, and Merck.

So maybe Dr Stossel should take his own advice, and proudly declare his complex relationships with industry in the course of yet another of his arguments that any criticism of any relationships among medical academics and industry under any circumstances will deprive humanity of future cures of dread diseases. As long as medical academics with relationships to industry, of all kinds and in all contexts, fail to disclose such relationships when they might be germane to the topic at hand, others will continue to wonder if they indeed do have something to hide.


References

1. Stossel TP. Regulating academic-industrial research relationships - solving problems or stifling progress? N Engl J Med 2005; 353: 1060-1065. Link here.
2. Stossel TP. Regulation of financial conflicts of interest in medical practice and medical research. Perspect Biol Med 2007; 50: 54-71. Link here.
3. Stossel TP. Has the hunt for conflicts of interst gone too far? - Yes. Brit Med J 2008; 336: 476. Link here.

BLOGSCAN - A Not So Tough Policy on Industry Interactions

On the Carlat Psychiatry Blog, Dr Daniel Carlat dissected Johns Hopkins' heralded new "tough" policy on interactions with industry. It turns out to be not so tough, banning only the smallest gifts, but failing to ban various kinds of larger payments that cause more intense conflicts of interest. Dr Carlat summarize the policy as mainly designed to generate "good PR."

Hedge Fund U

We previously posted about how the Bernie Madoff scandal shed light on problems in the governance and leadership of one major university (which includes a well-known medical school). Yeshiva University, which includes the Albert Einstein College of Medicine, reportedly lost more than $11o million of its investments with Madoff. Not only was Madoff on the university's board of trustees, but also the chairman of the board's investment committee was hedge fund leader Ezra Merkin. Merkin invested the university's money in his own hedge funds, which, in turn, turned over the money to Madoff.

This week, Merkin, who like Madoff has left the Yeshiva board, was charged with civil fraud. As reported by the Wall Street Journal,

J. Ezra Merkin, a money manager who funneled $2.4 billion from universities and nonprofit organizations into Bernard Madoff's firm, was charged Monday on allegations he "betrayed hundreds of investors" by repeatedly lying to them about how he invested their money.

Mr. Merkin, a New York philanthropic leader and the former chairman of finance company GMAC, raised billions of dollars for his three hedge funds, telling clients he was managing the money himself. But instead, according to a civil fraud complaint filed by New York state's attorney general, Andrew Cuomo, Mr. Merkin collected hundreds of millions of dollars in fees over more than a decade while weaving a 'panoply of lies' to conceal that he was channeling much of his clients' funds to Mr. Madoff.

'Merkin held himself out to investors as an investing guru...In reality, Merkin was but a master marketer,' Mr. Cuomo said in the complaint.

Mr. Merkin, who met Mr. Madoff in 'the very late 1980s, maybe 1990,' according to his testimony, has emerged as a prominent figure in the Madoff scandal because of his stature among charities, universities, funds and even sophisticated value investors. Many of his clients were entities he courted through his social ties among monied New Yorkers. Mr. Merkin sat on the boards of some charities whose money he managed.

The sales pitches for Mr. Merkin's three funds -- Ascot Partners LP, Gabriel Capital Corp. and Ariel Fund Ltd. -- included promises that he actively managed their funds, according to the complaint.

Mr. Cuomo said the Ascot fund was formed by Mr. Merkin in 1992 as a 'feeder' fund for Mr. Madoff. It grew to hold $1.8 billion from 300 investors by the end of December 2008. Mr. Madoff pleaded guilty last month to using the money in a Ponzi scheme, where funds from new investors were used to pay existing ones.

About 85% of investors in the Ascot fund didn't know their money was flowing largely to Mr. Madoff, Mr. Cuomo's complaint said. In two meetings with Ascot investors in his offices at 450 Park Ave. in Manhattan, it says, Mr. Merkin pointed through a glass partition to a trading area and said his staff 'right here' was doing the work of managing their money.

Mr. Merkin collected an annual fee from Ascot's investors amounting to 1% to 1.5% of the fund's total assets, which included the fictitious Madoff returns, Mr. Cuomo's complaint said. By 2008, Mr. Merkin was collecting about $25.5 million a year from managing Ascot -- generating management fees of about $169 million from Ascot from 1995 to 2007, the complaint says.

Mr. Merkin told investors that 60% of his Ascot fund was comprised of money that came from his personal family trusts, the complaint alleges. But all told, Mr. Merkin invested personally and through family trusts and foundations $7 million in Ascot through 1998, and less than $2 million over the following 10 years.

Seeing how readily Madoff's institutional investors, in particular, the leadership of Yeshiva University were bamboozled, I thought maybe it was time to see who that leadership actually was.

Yeshiva's current Board of Trustees is listed here on the University web-site, but without any detail about the people whose names appear there. A bit of Google searching revealed that the group included, besides Merkin and Madoff,

- Morry J Weiss (chairman), who is on the advisory board of Primus Venture Partners, a private equity firm
- Sy Syms (vice chairman), who is on the board of the Israel Discount Bank of New York
- Alan E Goldberg (treasurer), who is co-managing partner and co-founder of Lindsay Goldberg, a private equity firm
- Israel A Englander, who is co-founder if I A Englander & Co, a financial derivatives trading firm, and founder of Millennium Partners, a hedge fund (also note that Millennium Partners and Mr Englander personally settled lawsuits in 2005 that charged they used an elaborate scheme using market timing, as per this NY Times story)
- Ruth L Gottesman, the spouse of David Gottesman, the founder and senior managing director of First Manhattan Company, an investment adviser, (and also a former chairman of the Yeshiva University board)
- Lance L Hirt, another partner at Lindsay Goldberg, a private equity firm (see above)
- Michael Jesselson, the president of Jesselson Capital, an investment company
- Henry Kressel, a partner and senior managing director of Warburg Pincus, a venture capital company

So, before the resignation of Madoff and Merkin, nine of the 40 officers and trustees of Yeshiva University were in finance, all in leadership positions (and the board also included the spouse of another financial leader). Most were not in retail banking or retail stock brokerages, but in the more exotic areas of finance that are most associated with the global economic collapse, including derivative trading, hedge funds, private equity, etc.

On one hand, it would appear that a board so heavily stocked with finance leaders ought to have been sophisticated enough to do the due diligence their role required in evaluating the university's investments. On the other hand, perhaps the enrichment with finance people created a clubby atmosphere that discouraged questioning their fellow financiers too closely.

That almost 25% of Yeshiva University's board was composed of finance leaders is striking, given that the US Bureau of Labor Statistics estimates that less than 6% of employed people work in finance. But note that we previously found that 50% of the Harvard Fellows (the equivalent of their board of trustees' executive committee), and 69% of Dartmouth College's charter (self-appointed, as opposed to elected by alumni) trustees were leaders in the financial sector. This is somewhat anecdotal evidence, but it suggests that leaders of finance are much more prevalent among the top leadership of elite US institutions of higher education than would be explained by their prevalence in the population.

This raises the question of why financial leaders seem to have become so prevalent in academic leadership. This question is important, since this prevalence seems to have increased in a time when the culture of the leadership of the financial sector seemed to become more and more alien to the values that academic leaders ought to support, culminating in a global financial collapse that many blame on the sector leaders' arrogance, greed, and sometimes outright corruption.

At least it seems a reasonable hypothesis that some of the problems of academia, and particularly the problems of medical academia, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission.

We hope that there will be more interest in who now leads academia, especially medical academia, how they got there, and what they have wrought.

Masochism, Medicine and Clinical IT: How Physicians Can Be Beaten Over and Over, and Still Come Back For More

At "Health Care Information Technology Vendors' Hold Harmless Clause - The Largest IT Industry Abuse Ever?" I pointed out that physicians and patients have become the unconsented experimental subjects of the IT industry.

Even worse, Tuskegee Study style, the risk is on the docs and patients, while the purveyors of the technology in question enjoy contractual freedom from liability and contractual protection from relevations of product risks and defects (see the remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009;301(12):1276-1278).

Could this situation get any worse?

It's worse.

Here is a tale about the companies that medicine will be dependent upon for EHR's and other clinical IT - now by force of government (financial at first, but I would not at all rule out punitive licensure and other measures as a possibility in the future for "EHR noncompliers"):

Chi-Town Daily News
Billing glitch led to mental health closures
Alex Parker / Staff Writer

April 07, 2009

The Chicago Department of Public Health lost more than $1 million in state funding by failing to fix computer problems with its [Cerner-developed] billing system, public records show, sparking a funding crisis and the scheduled closure of four South Side mental health centers today.

City officials have previously blamed the closures in large part on state budget cutbacks.

But a trail of official paperwork, obtained by the Daily News through the Freedom of Information Act, shows that the department’s new computerized billing system was so flawed that patient bills weren’t submitted to the state for six months in 2008.

Where have I seen the name of that company before regarding HIT difficulty? While not about billing per se, I saw the name in the UK House of Commons Public Account Committee's Conclusions and recommendations of The National Programme for IT in the NHS: Progress since 2006 :

The termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option being considered for new deployments is for Trusts to have a choice of either Lorenzo provided through CSC or the [Cerner] Millennium system provided through BT. There are, however, considerable problems with existing deployments of [Cerner] Millennium and serious concerns about the prospects for future deployments of Lorenzo. Before the new arrangements for the South are finalised, the Department should assess whether it would be wise for Trusts in the South to adopt these systems. Should either of the Local Service Providers take on additional commitments relating to the South, the Department should take particular care to assess the implications of the extra workload for the quality of services to Trusts in the Local Service Providers' existing areas of responsibility.

... The Programme is not providing value for money at present because there have been few successful deployments of the [Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

The problems with billing modules are not limited to one company. Yale had problems with another HIT billing vendor leading to a Justice Department investigation and a multimillion dollar fine, as did Drexel University with AllScripts and its subcontractor Medicomp, civil complaint in PDF here. I know about the former because I was there, I know about the latter only by circumstance even though I was there, reading about it at the HIT gossip site HisTalk.com from an anonymous commenter. Who knows how many other such situations exist, information flow censored by the aforementioned HIT vendor/purchaser nondisclosure clauses?

The Chicago article continues:

The city's current-year state payments are based on monthly reimbursements for service. When the state received no bills from the city for the last four months of the previous fiscal year, it amended the contract it had with the city to reflect the city's apparent lesser need for funds.

The city's public health chief, Terry Mason, declined to answer questions for this article. Carlo Govia, CDPH’s chief financial officer did not respond to a request to be interviewed. Nor did Cerner Corp., the Kansas City, Mo.-based company that developed the city's software.

The centers, which serve about 2,000 people, are scheduled to close today ... “These people are telling us in here that it don’t matter if we live or die,” says Helen Morley, a patient at the Beverly-Morgan Park facility.

Death by defective IT? It's not as if the problems were discovered suddenly:

The city first notified the Illinois Department of Human Services officials about the plan to switch from a state billing system to the Cerner system on Feb. 11, 2008 -- just over two weeks before the new system would be turned on. Shortly thereafter, the state warned that problems could arise if the city's system was unable to communicate with the state's computers.

“March 1st is right around the corner, and if the software is not programmed to work correctly with Springfield’s system, claims and service reporting will not be accepted,” says a Feb. 22 letter from Peggy Peterson, the chief DHS liaison to the city's public health department.

But the city began using the new system. [typical of asinine bureacratic edict - but could there also have been conflicts of interest, such as those with decision making authoirty being given financial stakes in this system's success? - ed.]

Problems ensued. On April 29, Peterson warned, “I can not stress enough the importance of continued and timely submission to DMH of all FY08 service reporting and billing via whatever software is functional.”

In the same email, she noted that the state began reducing monthly allocations based on billing in January, docking 10 percent of CDPH’s monthly service stipend, and would continue doing so if billing did not reach 100 percent. The city, she said, could risk more than $334,000 if it did not resolve its billing issues

In June, Peterson wrote that the state had received no billing since mid-March, shortly after the city began using the new system. A city official replied that the Department of Public Health and Cerner were working to fix the problems.

On June 9, Peterson again recommended that the city return to billing with the state system. She noted that the state had already docked the city $334,059 since February.

The next day, Mason wrote to DHS officials saying the transition to the Cerner system “to date, has been unsuccessful.” He said the city could not use the state system or manually submit bills because all of the city’s patient information resided in the new computer system.

... In August, the state wrote the city to say that it would withhold payment of $1.2 million that had been budgeted for Chicago mental health services. The funds were placed into a reserve fund, with no assurance the city would ever receive them.

A subsequent state letter advised the city that $99,000 of that cut was due to overall budget shortages affecting all mental health operators. The letter said $1,163,514 was due to the city's failure to submit bills to the state.

On Sept. 16, Peterson wrote a top city official to express “grave” concern about the city's inability to submit billing records since discontinuing its use of the state software in March.

Around the same time, records show that of the 14,261 claims submitted to the state, 95 percent were rejected for missing data.

Mason appealed the decision in late September, acknowledging in a letter to the state that billing had been a problem: "... Service reporting data and billing information has not been submitted for a period of six months."

He chalked the failure to file billing records up to the transition to the new computer system.

Mason's letter also said the state's decision to withhold money would "place the City of Chicago in an unfair position and result in the closure of multiple mental health facilities.”

Also in September, the city began using the state's billing system again. It was eventually able to submit records for about 90 percent of its outstanding bills from fiscal year 2008, but by that time the state had already decided not to allocate the money to the city.

On Oct. 31 the state wrote to say that the city's funding would not be restored.

DHS spokesman Tom Green says the decision to cut funding was based solely on the city's inability to provide billing data.

“The City did not provide adequate billing information to justify continuing to pay them the full amount," he says. "The Division of Mental Health chose not to allocate funding where it was not being spent effectively."

What a stunning and spectacular debacle. This, my friends, is the type of technology hospitals and physicians are now being pressured to adopt en masse by 2014.

Fortunately, in a surprise announcement, Chicago mayor Richard M. Daley said at a press conference that the plan to close four of Chicago’s city-run mental health clinics was put on hold for the moment, pending "investigation." All I can say is "amazing."

Can the dependence by physicians on HIT companies by government edict get any worse than this?

Indeed. It gets worse still:

Medical Economics
The problem with EHRs and coding
Apr 3, 2009
By: Deborah Grider, CPC, Robin Linker, CPC, Susan Thurston, CPC, Stephen Levinson, MD

... most physicians include among their highest priorities the goal of compliant evaluation and management (E/M) coding. Physicians believe they have a right to expect that these sophisticated and costly systems will ensure that they achieve compliant documentation and coding, thereby "making any E/M problems go away."

However, something has gone awry to create an environment that leaves well-intended physicians victimized when government audits reveal their software systems have allowed—even facilitated—submission of non-compliant and potentially fraudulent claims for E/M services. In the midst of increasing storm warnings of non-compliant designs, physicians are increasingly vulnerable to severe financial penalties.

This devastating storm has been developing for many years, often bolstered by an unintended lack of effective policies from several organizations that should have the best interests of physicians, patients, and the healthcare system at their core—organizations such as CMS, the Certification Commission for Healthcare Information Technology (CCHIT), and the U.S. Department of Health and Human Services (HHS), as well as EHR software vendors and physician training institutions (for more information).

With watchdogs like these, who needs enemies? Is this technology designed to help clinicians take care of their patients, or is this technology and its purveyors trying to kill people after driving clinicians to mental collapse - or to jail?

... Analyses of problems with EHR systems by physicians and their practice managers consistently reveal that the overwhelming preponderance of their challenges relate to the rarely discussed data-entry characteristics of the electronic history and physical (H&P), not to the heralded data-storage and retrieval features of their systems. One physician personally reported that "The software forces me to enter clinical information in a preloaded format; when I see a patient three weeks later, I cannot find any individualized details of the previous visit or understand why I did what I did."

Too often, these problems have proven insurmountable. At the Second HIT Summit in 2005, Mark McClellan, MD (then the administrator of CMS), reported "40 percent of attempted implementations fail." According to the April 1, 2006, issue of CIO Magazine, "The [Health and Human Services] department itself has acknowledged that the failure rate for EHR system implementation is 30 percent to 50 percent. Some healthcare network providers claim it is as high as 70 percent."

During the last several years, a significant number of articles have pointed out compliance problems intrinsic to the majority of current EHR systems. Chief among these relate to coding engines that fail to consider medical necessity, which CMS describes as "the overarching criterion for payment," and certain types of data-entry functionality that result in "cloned documentation," in which the records of every visit read almost word-for-word the same except for minor variations confined almost exclusively to the chief complaint.

The problem that physicians face is that most current EHR system designs have failed to incorporate protections to ensure the correct use of these shortcut tools. Without such "error proofing," it is not feasible for physicians, while concentrating on patient care, to differentiate the settings in which these various tools can be used compliantly from those circumstances in which their use could lead to pliant or even fraudulent documentation.

Guess who would be responsible for that?

("A computer is never put on trial.")

The Medical Economics authors are compliance experts who were called in to assist different physician groups during federal and state audits of those groups' EHRs, conducted either by individual Medicare Carriers, Recovery Audit Contractors (RACs), or the Office of the Inspector General of the HHS.

In each of the four cases, the audits revealed pliant E/M claims that were submitted as a consequence of physicians using their EHRs in accord with their particular designs for E/M documentation and coding. During audits the following was found:

• All of the systems had designs that failed to meet all of Current Procedural Terminology's and Documentation Guidelines for Evaluation and Management Services' published requirements for compliant documentation of medical history, physical examination, medical decision-making, and nature of the presenting problem(s) (which is the E/M system's measure of medical necessity)
• Each of the systems included three or more types of data-entry functionality that has been consistently identified as having the potential to promote non-compliant or even fraudulent documentation
• The E/M coding engines of all four systems failed to consider the three levels of risk in decision-making, failed to consider medical necessity in determining appropriate code levels, and failed to recognize the critical role of medical necessity in guiding medically indicated levels of care, documentation, and coding.

How, exactly, is such software supposed to help physicians?

This Medical Economics article concluded with a dire warning about a converging perfect storm, sounding similar to my own warnings at this blog. The article is worth reading in its entirety at this link. This all seems more like torture than the revolutionizing of healthcare via IT.

It seems physicians can be beaten over and over, not complain very much, and still come back for more. Being forced to use health IT may yet prove to be the most poster perfect example of physician learned helplessness and physician expected helplessness, ever.

Can it get worse than that?

Probably. See this post on government promoted, perhaps soon-to-be-government-mandated EHR computational alchemy, turning medical lead into gold, postmodern style.

-- SS

Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?

Have we suffered a complete breakdown in the scientific method with regard to EHR and other clinical IT?

I read announcements like this with trepidation:

http://govhealthit.com/articles/2009/03/31/sebelius-confirmation.aspx
“The goal,” Sebelius said, “is to provide every American with a safe, secure electronic health record by 2014." The nominee also endorsed efforts to use data gleaned from electronic medical records to conduct “comparative effectiveness research" (CER) to provide information on the relative strengths and weaknesses of alternative medical interventions to health providers and consumers.”

Recovery Act funds have been allocated to NIH specifically for comparative effectiveness research. NIH has further specified the definition of CER as:

"[A] rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy."

NIH states that such research may include "the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER."

The problems I foresee concern the word "rigorous" as in the above definition.

The use of EHR data to reliably detect uncommon (but strong, discrete) early warning signals from a single drug or treatment -- to then be subject to more rigorous study with reasonable controls -- is itself a Medical Informatics "Grand Challenge." An example would be finding VIOXX's association with myocardial infarction earlier than we did, via an EHR-based automated postmarket surveillance process.

Doing this is a "grand challenge" due to the nature of EHR data, which is as far from "clinical trials clean" as possible. It is what might be called highly uncontrolled. The statistical methods needed to reliably pull signals out of the muck for even a single drug are still exploratory, the problems formidable if one wants to stay scientifically sound. I wrote about the experimental nature of such efforts a few years ago here, and believe an effort got underway at U. Indiana/Regenstrief to test such methodologies for postmarket surveillance about the same time.

Now we have had what appears to be a leap of faith and logic of irrationally exuberant proportions, and probably a deviation from sound science as well. The government has announced enthusiasm for EHR data-based comparative effectiveness research (CER) not to aid science, but to cut costs (implying skipping the rigorous confirmatory phases) through elimination of more costly drugs and treatments deemed less effective or at effectiveness parity compared to less expensive choices. Following this thinking, perhaps in the future a metric will be developed for an "acceptable" improved benefit/cost ratio for expensive drugs that are better than cheaper alternatives?

This overconfidence in EHR data is of concern. To detect relatively less concrete (i.e., than major ADE) "outcomes differences" between two or more drugs or treatments via EHR data - did treatment A lower blood pressure more than drug B, did drug C lessen depression more than drug D - rises to the level of "grand overconfidence in computing." To accomplish this task with reasonable scientific certainty from reams of EHR data, originating from different vendor systems, input by myriad people of different backgrounds with differing interpretations of terminologies (students/MD's/RN's etc) under different pressures (time, reimbursement maximization), and so forth, seems a stretch. What will the p values and predictive values be for such studies? Yet our incoming HHS secretary touts such methods?

Ironically, the gold standard in medical science is the controlled clinical trial, yet EHR-based comparative effectiveness research itself as a research methodology, now touted by our government, seems to have gotten a pass.

Even what I would consider minimum requirements for scientific treatment comparisons, such as well designed and reasonably controlled registries as developed here for interventional cardiology, with hundreds of granular, finely defined and "tuned" data elements, appear to be bypassed in EHR "miracle claims." Such precise registries take months or years to develop, implement, and train users to interact with properly. Further, such registries are not portable and must be created for individual medical domains and subdomains. Uncontrolled EHR data is no substitute for such efforts.

The following question arises:

Where are the comparative effectiveness studies that compare 1) EHR-based comparative effectiveness studies of drugs and treatments to 2) controlled clinical trials-based comparative effectiveness studies?

In other words, where are the meta-clinical trials that compare EHR data mining-based comparative effectiveness research as a methodology, vs. the "traditional" gold standard methodology of controlled clinical trials to compare drugs or treatments? How do we know EHR-based CER studies will not produce GIGO that will cause harm through ham-fisted elimination or defunding of useful treatment options?

While there are initial efforts underway to increase understanding of CER, e.g., "Broad Challenge Area 5" (PDF) of the NIH RC1 Challenge Grants in Health and Science Research, ominously, there is a lot of potential advantage to be had with terabytes of uncontrolled data and a political agenda.

I fear that what will come from "comparative effectiveness research" that draws upon uncontrolled EHR data will be politics masquerading as comparative effectiveness research. Good luck to private practitioners and medical innovators. Good luck, pharma. Good luck, patients.

This movement towards EHR uncontrolled data alchemy represents a further deviation from medical science towards the Syndrome of Inappropriate Over-Confidence in Computing (a.k.a. SICC Syndrome) writ large.

It seems the IT industry has now rendered a scientific approach to HIT and its use obsolete. We see this "post scientific era" phenomenon in the takeover of clinical IT by vendors who contractually demand suppression of sharing of problems, we see it in a remarkably uncritical push for EMR's by 2014 now involving force of government (only financial at present, but will punitive licensure issues and other measures be off the table?) despite a growing body of literature advising caution, we see a consortium of big business/payers/vendors/myriad secondary feeder organizations gunning full blast for this technology without consideration of the possible downsides.

Biomedical informatics, a scientific discipline (at least those parts of it not yet compromised by conflicts of interest), as a relevant field is very much a minority player in today's health IT.

Even the contributions from experts and pioneers in the field of Biomedical Informatics, in the form of the Jan. 2009 National Research Council's report that "Current Approaches to U.S. Health Care Information Technology are Insufficient" (here) has not had much impact.

I see Biomedical Informatics' death as a relevant discipline that anyone of importance pays attention to, not too far down the road as well.

-- SS

Addendum April 20:

We've seen this phenomenon in our economy. WSJ "Information Age" writer L. Gordon Crovitz notes:

... In a paper for the scientific journal of the Royal Society back in 1994, Harvard economist Robert Merton wrote that "any virtue can become a vice if taken to extreme, and just so with the applications of mathematical models in finance practice." We know even better now that some risks can be calculated and thus reduced, while some unknowns cannot be turned into probabilities. "The mathematics of the models are precise, but the models are not, being only approximations to the complex, real world."

I believe EMR data at best is a very loose approximation to the real world. It contains many "unknowns" regarding quality and reliability that cannot be turned into probabilities no matter how fancy the math. Asking too much of EHR data becomes a vice, not a virtue.

-- SS

Who Is Warning Us About the Perils of a Government-Run Public Health Insurance Plan?

There has been considerable discussion lately about whether the US government should offer a publicly run health insurance plan similar to the current Medicare program for the elderly and disabled. A recent report has thrown a bit of cold water on the idea, as noted in this AP article:

A public health insurance option for middle class families could help cover the uninsured but it may well put private insurers out of business, a respected consulting firm concluded in a study released Monday.

The report by the Lewin Group, a numbers-crunching firm that serves government and private clients, said it all depends on details that lawmakers are far from deciding. Nonetheless, the report could provide ammunition for critics who say a public plan would move in the direction of government-run medicine.

President Barack Obama and many Democrats want to create a government insurance plan to compete with private plans that now cover about 170 million Americans. The issue is major sticking point for Republicans and the insurance industry.

The Lewin study found that if such a plan were open to all employers and individuals, and if it paid doctors and hospitals the same as Medicare, the government plan would quickly grow to 131 million members, while enrollment in private insurance plans would plummet.

'The private insurance industry might just fizzle out altogether,' said John Sheils, a Lewin vice president and leading author of the study.

By paying Medicare rates the government plan would be able to set premiums well below what private plans charge. Monthly premiums for family coverage would be $761 in the government plan, compared with an average of $970 in private plans, the study estimated. Employers and individuals would flock to the public plan to cut costs.

This new report by the Lewin group also provided more ammunition to politically conservative commentators opposed to a public health insurance plan, e.g., see this link.

I am not going to comment on the substance of the report, or the argument over the merits of a public health insurance plan, save to note that in my humble opinion, the biggest danger of such a plan would be to further exaggerate differences in payments made to primary care and other "cognitive" physicians and to physicians who mainly do procedures. We have posted before (e.g., here) on how Medicare has come to fix payments to favor procedures and disfavor primary care and other cognitive services. Increasing the number of patients covered by Medicare or a Medicare-like plan, without changing the current Medicare payment system, would only make these discrepancies worse. Note that this potential problem with the public health insurance plan was not mentioned in the Lewin Group report.

Perhaps the nature of the Lewin Group influenced what this report did and did not emphasize. The group was described above as an independent consulting firm. Its web-site says it is "a premier national health care and human services consulting firm." It also claims:

The Lewin Group is committed to independence and integrity in our work. We combine professional expertise with extensive knowledge and a rigorous approach to analyzing and solving problems to deliver value to each of our clients and to the larger community as well.

That's a somewhat self-contradictory assertion. It seems that delivering "value" to specific clients might be hard to do while maintaining "independence."

Perhaps considering the nature of the Lewin Group's clients would clarify things. The group says its clients include "hospitals, health systems and providers;" "payers / insurers;" and "pharma/bio/device." The middle group seems most germane to a debate about The services provided to them include:

The Lewin Group helps payers and insurers succeed in complex government, commercial, and long-term care markets.

Based on our more than 20 years of experience, The Lewin Group offers our clients detailed understanding of the competitive marketplace and the expectations of purchasers. Based on rigorous, data-driven research, we provide our clients with actionable information grounded in practical, real-world advice.

Our understanding of public policy through our work with government entities, including Medicaid and SCHIP, helps us understand how policies are shaped and how they impact our clients. With this insight, we help our clients strategize and succeed in public programs and new product offerings.

So, the Lewin Group specifically offers to help insurers succeed in a complex market partially controlled by government. Maybe this orientation had some influence on the report they published now being used to support arguments for private, commercial health insurance.

Finally, who owns the Lewin Group? The description provided in the news story above suggests it is independent, and perhaps is even not-for-profit. Per Lewing Group web-site, it is neither:

The Lewin Group is an Ingenix company. Ingenix, a wholly-owned subsidiary of UnitedHealth Group, was founded in 1996 to develop, acquire and integrate the world's best-in-class health care information technology capabilities.

Ingenix has been in the news lately. See our posts here, here, and here about legal settlements of charges that large health care insurance companies used a database created and allegedly manipulated by Ingenix to underpay out of network claims. So, the Lewin Group is a part of Ingenix, an organization that just settled claims that it manipulated data about insurance payments.

Furthermore, Ingenix is in turn part of UnitedHealth. It is amazing how often UnitedHealth's antics have provided grist for the Health Care Renewal mill. See this post for a summary of the company's more recent escapades.

For balance, I must note that the Lewin Group web-page asserts:

The Lewin Group operates with editorial independence and provides its clients with the very best expert and impartial health care and human services policy research and consulting services.

But again, note that the focus is on making clients happy, not providing the public with unbiased knowledge.

So a report being used to support arguments against government-run health insurance was published by a subsidiary of one of the largest commercial health care insurance companies and managed care organizations, a subsidiary that just settled charges that it manipulated data to increase insurance company profits.

With a new administration in the White House, there is new interest in health care reform. It is not surprising that this has inspired some vigorous discussion. Nor is it surprising that some of the discussion comes from those with vested interests to protect. They have, of course, every right to make their views known. But it would be a more honest discussion if everyone were willing to put their vested interests on the table.

In Defense of Psychiatric Diagnoses and Treatments

In Defense of Psychiatric Diagnoses and Treatments

The Boston Globe is out today with a story about conflicts of interest involving American Psychiatric Association guidelines for treating depression, mania, and schizophrenia – disorders for which the market in medications is said to be $25 billion annually. Conflicts abound, it seems, and the consequent implication is that industry influence has led to guidelines that “focus heavily on medications and give relatively little attention to nondrug treatments.”

The lead author of a forthcoming analysis, Lisa Cosgrove from the University of Massachusetts is quoted in the Globe as saying “…the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." Maybe so, but it’s not just psychiatry. And this new study should not be taken to invalidate psychiatric diagnoses or to undermine the efficacy of psychiatric treatments.

The existence of disease is not predicated on having a biological test. It’s nice when we do have one, but there are many disorders throughout medicine, not just in psychiatry, for which there is no conclusively defining biological test. Think migraine. Think multiple sclerosis. Think chronic pain.

There is a distinguished tradition of clinical research, going back to the late 1950s, wherein disorders like depression, mania, and schizophrenia were studied for their genetic profiles, their clinically meaningful subtypes, their biological correlates, and their responses to treatments. This bottom-up approach yielded useful theories, which in turn led to better theories and to new treatments for depression, mania, and schizophrenia. Like any other branch of science, clinical science has a self-correcting function that distinguishes it from pseudo-science and propaganda. So, we welcome new theories even though most will not survive, and we welcome new diagnostic proposals and we welcome potential new treatments. All are subject to the test of independent confirmation, and nobody is surprised when many fall away.

Since around 1990 that tradition has been corrupted by Pharma and Pharma’s money. There is no shortage of examples regularly in the news. Academic key opinion leaders lost their ethical compass and, with or without a figleaf, devolved into spokespersons for industry. One is reminded of Julien Benda’s term la trahison des clercs. Instead of moving on from undistinguished and problematic new drugs, key opinion leaders work with the marketing departments of Pharma to promote and defend the brand. Remember the PsychNetters? Of course, psychiatry is not the only medical specialty corrupted in this way. Stents, anybody? Orthopedic devices, anybody?

Lost in the marketeering and propaganda since around 1990 is the discipline of clinical therapeutics. As one commentator put it, if there is no way to confirm biologically the existence of disease, then “…we cannot confirm with much confidence that this or that treatment treats mental disease.” It actually is possible to identify effective treatments for mental disease. We did it with lithium. We did it with the early antidepressant drugs. And we did it with the early antipsychotic drugs. There was room for improvement in all of these, but make no mistake – they were dramatic positive developments. Most of the work in the past 20 years, however, put marketing first and clinical therapeutics second. Humbug aside, the goal was not to improve the management of depression or mania or schizophrenia but to jump whatever bar the FDA was setting in order to get a product on the market. Indeed, the really hard clinical research issues were studiously avoided. Along the way, the clinical research enterprise became dominated by academic and for-profit contract research organizations in which, to put it gently, standards of recruitment of patients apparently suffered, so that response rates in placebo-treated patients skyrocketed. As a result, proving that a drug does work became harder, and the overall drug advantage over placebo in treating depression came into serious question. In effect, the corruption of clinical research standards has brought us to an epistemologic quagmire about the efficacy of today’s most popular antidepressant drugs.

As for the charge that psychiatrists and primary care physicians just throw drugs at mental health problems, that is nothing new. It is a reflection of the professional pragmatism that permeates medical practice. Think back to the 1950s when the new wonder drugs called antibiotics were handed out like Pez, mostly for people who did not really need them and who would not benefit from them. The working principle was misguided simplicity and pragmatism, which minimized and discounted the risks. Even today the over-use of antibiotics remains a public health concern. Just as in the 1950s patients with nonspecific upper respiratory symptoms were “given the benefit of the doubt” and were prescribed an antibiotic on the reasoning that it might help them while probably not hurting them, so today patients with nondescript depressive or anxiety symptoms are prescribed an SSRI drug on the same reasoning. The cost of this approach in wasted money, in unnecessary side effects, and in unproductive clinical management is non-trivial.

So, the issues are more nuanced than today’s Boston Globe story would suggest. For good and for ill, psychiatry is not so very different from the rest of medicine. Corruption and compromise respect no subspecialty boundaries. We can have reliable and valid knowledge of disease without a biological test. We can show efficacy of treatments for disorders that lack a biological test. But when simplistic pragmatism and cutting corners dominate in therapeutics and in clinical trials, then we are in trouble.