Despite Recalls, Legal Settlements and Guilty Pleas - A $143.5 Million (or Perhaps $197 Million) Golden Parachute for the Former Drug Representative Who Is Now CEO of Johnson and Johnson

After 30 separate product recalls since 2009, and multiple legal settlements and guilty pleas, we noted that the former pharmaceutical representative who is now the CEO of Johnson and Johnson will be retiring. 

The $143.5 Million (or Perhaps $197 Million) Golden Parachute

The Wall Street Journal just reported his retirement will come with an immense golden parachute:

Johnson & Johnson Chairman and Chief Executive William Weldon stands to collect pension benefits and deferred compensation currently valued at $143.5 million after his retirement, according to new details released by the health-care conglomerate.

The details were:

Mr. Weldon, who will be succeeded as CEO by Vice Chairman Alex Gorsky, stands to collect benefits from two main sources. The present value of his accumulated pension benefits is $48.4 million, portions of which are paid out as a monthly annuity for life, according to Wednesday's filing with the Securities and Exchange Commission.

His pension's value places Mr. Weldon well into the top 10% of CEOs of Standard & Poor's 500 companies, said Paul Hodgson, chief communications officer and senior research associate at GMI Ratings, which tracks corporate-governance information.

Mr. Weldon also has amassed $95.1 million in nonqualified deferred-compensation plans. This represents parts of his salary and bonus that had been deferred in prior years, as well as company contributions to savings plans. Portions of Mr. Weldon's deferred compensation have been recorded each year as part of his total annual pay.

Of the $95.1 million, more than $70 million represents Mr. Weldon's accumulated balance from a legacy cash-incentive plan that J&J has discontinued and replaced with a new executive-compensation plan. This sum would be paid to Mr. Weldon at retirement, J&J said. All deferred compensation is subject to taxes.

Actually, an argument that the $143.5 million figure is an major under-estimate appeared in the Shearlings Got Plowed blog:

The MSM reports calculate only the cash values for soon to be Ex-CEO Weldon, not the present value of his stock options, at today's NYSE closing price for J&J of $65.08. So, that -- plus the vesting of his February 2012 JNJ RSUs and Stock Option awards [see page 45 of the link (but such amounts are ommitted from the year end 2011 proxy, on which the WSJ relied)] -- add about $53.47 million to the Weldon walkaway haul.

Thus, Mr Weldon's golden parachute may be as big as $197 million.

The Board's Justification for the Riches

Of course, the Johnson and Johnson board justified the latest additions to Mr Weldon's wealth, as reported by the WSJ:

In a regulatory filing Wednesday, the board said Mr. Weldon 'successfully managed our company through a challenging economic environment in 2011,' with solid financial results and advances in J&J's pharmaceutical pipeline.

The board added that while J&J made progress in addressing manufacturing-quality issues in 2011, 'continued focus is needed to address critical product supply and quality issues that impact our responsibility of being able to deliver products to patients and customers who need them.'

Johnson and Johnson's Recent Record

The board's upbeat assessment sharply contrasts with Johnson and Johnson's actual recent record.

As we discussed recently, Johnson and Johnson seems to have lost the ability to manufacture high quality products. It has had to make 30 separate product recalls since 2009. The latest was Liquid Infant Tylenol. (The current WSJ Health Blog list of recalls can be found here.)  This seems to be more than a "rough patch," which is how the WSJ article described the manufacturing problems.

In addition, the WSJ article failed to mention that Johnson and Johnson also has an amazing recent record of ethical lapses and guilty pleas, including:
- Convictions in two different states in 2010 for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax in 2010
- Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see this link for all of the above)
- Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post here)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
- More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see this BusinessWeek story.)

Meanwhile, an article from the Wharton Business School suggested that the problems at Johnson and Johnson stemmed directly from former drug representative Weldon's management approach, which put short term revenues, "making the numbers," ahead of everything else, apparently including good manufacturing practices, or ethical business practices:

[University of Michigan Ross School of Business Professor Erik] Gordon argues that CEO Weldon's relentless focus on the bottom line -- the company's website touts its record of 27 consecutive years of adjusted earnings increases and 49 consecutive years of dividend increases -- is the reason for the current woes. 'Bill Weldon sets the priorities and the culture for the company,' says Gordon. And the problems, from overly aggressive marketing to underinvestment in safety and quality systems, reflect 'people trying to get their bonuses, hit their numbers and keep their job.'

No doubt the global economic collapse in 2008 put renewed pressure on managers at multinationals like Johnson & Johnson. John Kimberly -- a Wharton management professor and executive director of the Wharton/INSEAD Alliance who has worked with J&J executives in Europe since the late 1990s -- says he detected a shift among those managers starting in 2008. 'I got the sense that there were some things happening at corporate, and that messages were being sent about the need to deliver profitability,' Kimberly notes. 'It seemed as though the people I was working with were feeling pressure from above to pay closer attention to the bottom line. It was a palpable, tangible change.'

Wharton's Donaldson gives J&J management credit for the aggressive steps the company is now taking to overhaul its manufacturing processes and plants. But he also notes that the balance between profits and patients is a tricky one. Managers at J&J, he says, 'are juggling a lot of balls. In the credo, they say they put patients first and stockholders further down the line. But there is a red ball that every manager knows about, [which is] profit -- and they don't let that red ball drop.' Figuring out how to serve patients well and still deliver for Wall Street is not easy. 'J&J believes they can do both those things,' Donaldson says. 'But if the weight of one side of that formula gets too heavy, the entire structure collapses.'

Summary

The ongoing news from the once proud Johnson and Johnson, whose credo famously states:

We believe our first responsibility is to doctors, nurses and patients, to mothers and fathers, and all others who use our products and services. In meeting their needs, everything we do must be of high quality.

suggests that instead, the company's first responsibility is now to the hired managers, to obey their dictates no matter how they undermine the credo, and most importantly, to pay them so much as to make them some of the most wealthy people in the world. Johnson and Johnson has become exemplary, not of putting patients or health care professionals first, but of how hired managers took over health care, and turned it to their own advantage.

So should we trust Johnson and Johnson to do better, now that another former pharmaceutical representative will be its new CEO?

The case of Johnson and Johnson indicates why we need a huge change in how health care organizations are lead.

Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

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

EHRs and test ordering: Health Affairs authors reply to ONC

At my March 9, 2012 post "Increased Lab Ordering with EHR's?" I refuted ONC's response to a Harvard-based research study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that may contradict the notion that HIT reduces medical costs.

Now the authors themselves have responded to ONC. There are many similar themes in their response. I've bolded them below:

The Effect Of Physicians’ Electronic Access To Tests: A Response To Farzad Mostashari

March 12th, 2012
by Danny McCormick, David Bor, Stephanie Woolhandler, and David Himmelstein

Our recent Health Affairs article linking increased test ordering to electronic access to results has elicited heated responses, including a blog post by Farzad Mostashari, National Coordinator for Health IT. Some of the assertions in his blog post are mistaken. Some take us to task for claims we never made, or for studying only some of the myriad issues relevant to medical computing. And many reflect wishful thinking regarding health IT; an acceptance of deeply flawed evidence of its benefit, and skepticism about solid data that leads to unwelcome conclusions.

Dr. Mostashari’s critique of our paper, will, we hope, open a fruitful dialogue. We trust that in the interest of fairness he will direct readers to our response on his agency’s site. [If not, HC Renewal posts get highly ranked by Google - ed.]
Our study analyzed government survey data on a nationally representative sample of 28,741 patient visits to 1187 office-based physicians. We found that electronic access to computerized imaging results (either the report or the actual image) was associated with a 40% -70% increase in imaging tests, including sharp increases in expensive tests like MRIs and CT scans; the findings for blood tests were similar. Although the survey did not collect data on payments for the tests, it’s hard to imagine how a 40% to 70% increase in testing could fail to increase imaging costs.
Dr. Mostashari’s statement that “reducing test orders is not the way that health IT is meant to reduce costs” is surprising, and contradicts statements by his predecessor as National Coordinator that electronic access to a previous CT scan helped him to avoid ordering a duplicate and “saved a whole bunch of money.” A Rand study, widely cited by health IT advocates including President Obama, estimated that health IT would save $6.6 billion annually on outpatient imaging and lab testing. Another frequently quoted estimate of HIT-based savings projected annual cost reductions of $8.3 billion on imaging and $8.1 billion on lab testing.
We focused on electronic access to results because the common understanding of how health IT might decrease test ordering is that it would facilitate retrieval of previous results, avoiding duplicate tests. Indeed, it’s clear from the extensive press coverage that our study was seen as contravening this “conventional wisdom”.
Nonetheless, Dr. Mostashari criticizes us for analyzing the impact of physicians’ electronic access to imaging and test results, but not other aspects of electronic health record (EHR) use. We did, however, analyze the relationship of EHRs to test ordering in a subsidiary analysis. While physicians use of a full EHR was associated with a 19% increase in image ordering, as we noted in the paper this finding was not statistically significant. While we cautiously (and properly) interpreted this as a “null” finding, these data are inconsistent with Mostashari’s optimistic view that use of a full EHR reduces costs.
He asserts that our 2008 data are passe, and that health IT meeting today’s “meaningful use” criteria definitely saves money. The data we analyzed were the latest available data when we initiated the study. While the proportion of outpatient physicians utilizing health IT has grown since 2008, we are unaware of any “game changing” health IT developments in the past four years that are would produce substantially different results if the study were repeated today. The EHR vendors that dominated the market in 2008 remain, by and large, today’s market leaders, and their products have undergone mostly modest tweaks. Mostashari’s contention that 2012 EHRs – incorporating decision support and electronic information exchange – save money in ways not possible in 2008 should be tested through additional research but remains merely a hypothesis. We hope that some day his predicted savings can be achieved.
Dr. Mostashari offers his own explanation for our findings, suggesting that doctors who are inclined to order more tests are also inclined to purchase health IT for viewing test results electronically rather than on paper. He offers no evidence for this assertion and ignores the fact that we explored (and rejected) this explanation by analyzing subgroups of doctors who are unlikely to be the decision maker for IT purchases – e.g. employed physicians, those working in an HMO setting etc. In other words, electronic access to results predicted more test ordering whether or not the ordering physician was responsible for health IT purchases.
He incorrectly states that our analysis did not take into account patients’ severity of illness, physicians’ level of training, and the nature of physicians’ financial arrangements. In fact, we reported subsidiary multivariate analyses that included several serious diagnoses; all of our models included physician specialty (which we specified in several different ways); and all models included adjustment for an extensive list of indicators of financial arrangements (e.g. whether the physician owned the practice or was an employee; the type of office; whether the practice was owned by a hospital; whether the physician was a solo practitioner; whether the physician’s compensation was based, in part or whole on “profiling”; and whether the practice was predominantly prepaid). We also performed a series of subsidiary analyses that explored whether physicians with a proclivity to “self refer” patients for imaging tests accounted for our finding; they didn’t.
Dr. Mostashari criticizes us for failing to assess whether health IT improved the quality or appropriateness of care. Of course, these were not the topic of our research. Those are different studies for a different time. However, we would note that other large-scale studies have found no, or trivial quality improvements associated with HIT outside of a few flagship institutions^4-6.
Dr. Mostashari’s strongest claim is that observational studies like ours (and most other health policy studies, including some by Dr. Mostashari himself) cannot prove causation. This is surely true. As long time teachers of evidence based medicine we took care to couch our conclusions in cautious terms, stating only that “Computerization, whatever its other benefits, remains unproven as a cost control strategy.”
But Dr. Motashari is less cautious, asserting that the case for HIT is closed. The paper he cites to buttress this claim (authored by members of his own agency) culled studies reporting any impact of HIT on virtually any aspect of care, and accepted authors’ claims of benefit without regard to study quality or statistical niceties. Thus, a focus group’s impressions of benefit are accorded the same weight as nationwide studies of Medicare data showing virtually no impact of computerization on quality measures. Reports of a reduction from 70% to 38 % in “missed billing opportunities” or a $7,000 reduction in office supply costs are among the 92% of studies judged “positive”. While the literature review he cites is interesting, nothing in it contradicts our findings.
Dr. Mostashari is also correct in reiterating that randomized trials are the best way to assess health IT. In fact, no randomized trial has ever been published that examines patients’ outcomes or costs associated with off-the-shelf health IT systems that dominate the U.S. market. No drug or new medical device could pass FDA review based on such thin evidence as we have on health IT. Yet his agency is disbursing $19 billion in federal funds to stimulate the adoption of this inadequately evaluated technology. Dr. Mostashari is perhaps the only person in our nation who commands the resources needed to mount a well done randomized controlled trial to fairly assess the impact of health IT, and the comparative efficacy of the various EHR options.
Finally, Dr. Mostashari’s unbridled faith in technology is mirrored by his belief that ACOs are the next panacea for health costs and quality. That health policy flavor-of-the-month also remains wholly unproven.

I think readers comparing my response to the authors', and who are familiar with the many posts at HC Renewal going back to 2004, will recognize the themes I have bolded in the author's response to HHS.

-- SS

Nancy Finn, author of "e-Patients Live Longer", openly calls for unethical medical experimentation without consent

My construct of the "Ddulite" orientation largely driving health IT is not merely a theoretical construct. Ddulites (derived from the term "Luddite" with first four characters reversed) are:

Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

Here is an example of this disposition on display:

In a March 14, 2012 Pittsburgh Post Gazette article "Digital ease may complicate health care" by Bill Toland about the recent controversy caused by a Harvard study showing EHR's may actually increase test ordering thus raising, not lowering, medical costs, Nancy Finn, a medical consultant and author of "e-Patients Live Longer" is quoted as saying:

... In an ideal world, management would know if a software suite is going to improve health outcomes before it's rolled out, said Nancy Finn, a medical consultant and author of "e-Patients Live Longer." Unfortunately, though, uncertainty is built into the process.

"The only way to know [the systems] are inefficient and flawed is to deploy them, then correct them as we go," she said. [That is, they are experimental - ed.]

"That is the way that all of the new innovative technologies have worked over the years. We have to take the risk, and then improvements get made."

This statement in highly alien to medical ethics.

She is explicitly stating that this technology is experimental - "The only way to know [the systems] are inefficient and flawed is to deploy them" - and then states "We have to take the risk" where the "we" are unconsenting patients, i.e., not afforded the opportunity for true informed consent, and 'investigators' also often coerced to use these systems, i.e., clinicians themselves.

Never mentioned are the downsides of experimental technology such as health IT: patient injury, death, litigation against physicians and other clinicians entrapped into "use error" (errors promoted by the common mission hostility of today's health IT), or led into errors by poor software quality causing data corruption, misidentification or outright loss, and additional issues described by FDA (link) and others. Nor are ethical issues considered.

NO, Ms. Finn: "We" do NOT have to "take the risk."

There are scientific methods for improving experimental technologies such as "controlled clinical trials" with informed consent, opt-out provisions and built-in protections for patients and investigators.

The "trial and error", "learn-as-we-go", "computers' rights supercede patients' rights" approach you suggest, while perhaps appropriate for mercantile computing, is highly inappropriate for healthcare.

Such issues, I had believed, had been settled after WW2.

There is nothing to argue, and nothing to discuss.

-- SS

Logical Fallacies in Defense of the European Society of Cardiology's Lenient Approach to Conflicts of Interest

The European Society of Cardiology just published its recommendations for interactions between medical societies and industry.(1)   The report emphasized the supposed benefits of industry relationships and funding, and suggested few restrictions on current practices.  Like other defenses of leniency towards conflicts of interest, its arguments seemed to rest on a series of logical fallacies.  

Wonderful "Innovations ... Through Productive Collaboration" - Appeal to Belief and the Fallacy of Division

The report made several arguments about the benefits of professional - industrial interaction.  These included:

In recent decades, cardiology has been a fast-moving medical speciality. Many advances have come from basic and clinical research conducted by universities and by pharmaceutical and medical device companies. Innovations have been realized in part through productive collaborations between clinicians, academia, and industry. Such links are essential and need to be encouraged and supported by appropriate investment if medical progress is to be sustained.

The notion that interactions between physicians and industry is a source, perhaps the most important source of wonderful "innovations" is often used to justify the sorts of interactions, involving payments by industry to academia and physicians, that are now prevalent. In this report, this first appears as an assertion without any evidence to justify it.

Later, the report noted:

The Association of American Medical Colleges has stated that there are benefits from effective partnerships between industry and academic medical centres.

This statement came with a citation, to a 2008 report entitled "Industry Funding of Medical Education."(2) This AAMC report, in turn, contained many similar assertions, e.g.,

An effective and principled partnership between academic medical centers and various health industries is critical in order to realize fully the benefits of biomedical research and ensure continued advances in the prevention, diagnosis, and treatment of disease.

However, the AAMC report also failed to cite any evidence in support of these assertions.

There are two major problems with these assertions, which form the foundations of both reports. The first is they do not seem to have a clear evidence base.

While the notion that current research efforts marked by substantial interaction between physicians, academia and industry are producing wonderful innovations is appealing, what evidence there is suggests that clinically important innovation is rare. For example, I quote a 2009 review of global drug discovery by Light(3) on whether new drugs represent advances over older treatments:

the best evidence of clinical quality comes from systematic efforts to assess therapeutic advantage and adverse effects compared with existing drugs. A detailed analysis of therapeutic quality in new drugs over the past twenty years found that 14 percent of all new chemical entities are either therapeutic breakthroughs or substantially superior to existing medications. Likewise, a comprehensive review of all new drugs approved between 1989 and 2000 in the United States concluded that 14.8 percent were new chemical entities that provided significant clinical improvement, and a Canadian review board concluded that 10.7 percent of new chemical entities in 2000–2004 did so.

Thus while many new drugs are introduced, only a few introduced recently were chemically unique or had effects different than older treatments.  I would argue that most of these will prove not to be truly clinically innovative, in that good clinical research will not show that they produce substantial improvements in clinical outcomes without major adverse effects for a good number of patients with not uncommon problems.  (It is not hard to think of really important innovations developed before the era of major industry-academic-physician interactions: antisepsis for surgery, anesthesia for surgery, antibiotics, hormone replacement therapy with insulin, thyroid hormone, etc, smallpox vaccination, polio vaccination, etc, etc)  However, it is actually very hard to think of more than a handful of new drugs or devices discovered in the last 20 years which were that hugely innovative.  (The closest might be multi anti-viral drugs used to treat HIV, and Gleevec for chronic myelogenous leukemia.)  If there has been very little really important innovation in the last 20 plus year era of enhanced industry-academic-physician interactions, these collaborations could not have produced tremendous innovation. 

So the report's arguments rests on an assertion that is not clearly justified, and which appears to be at best a huge exaggeration. Resting an argument on a belief that is not further supported by evidence amounts to a obvious logical fallacy.  It is an appeal to belief.

Furthermore, while both reports emphasize physician-industry collaboration or interaction, there are many ways interaction or collaboration can occur without involving substantial payments by the latter to the former. It is possible for two people or organizations to work together without one paying the other.  Yet both reports use the broad assertions about interaction and collaboration to justify interactions and collaborations in which industry makes substantial payments to physicians or academic institutions. This appears to be an example of the fallacy of division, that is, an unjustified assertion that "what is true of a whole must also be true of its constituents."

CME Would Wither if Financing Were Reduced, and Industry is the Only Possible Source of Such Money - A Slippery Slope and a False Dilemma

The ESC report made the argument that without industry funding, CME would wither. For example,

Should Europe choose to follow the strategy proposed in the USA, severing links between industry and medical societies, CME could be severely compromised. Relying completely on public funding is not a viable option for Europe at the moment. The removal of industry support for medical associations would be followed by increased fees and reduced attendance at congresses especially by clinical trainees and young fellows. It is the view of the ESC that in the absence of alternative funding, or until alternative funding is identified, maintaining links with industry is appropriate....

The argument is that CME would fail if financial support for it would be reduced, and that industry is the only possible source of financial support at the current level. The notion that CME must inevitably fail if financing of it were reduced is a slippery slope fallacy, that is, a statement that a inevitably causes b when such inevitability is not proven. Why could not adequate CME be done at a lower cost, even if the result were less luxurious? Furthermore, the notion that industry is the only source of funding is a false dilemma fallacy. In fact, there are other possibly sources of funding. Given that physicians are among the world's best paid professionals, why could they not pay for their own CME?

"Conflicts of Interest are Unavoidable and ... They Cannot Be Abolished" - False Dilemma

The third major argument on which the report bases its recommendations is encapsulated above, and was buttressed by:

The risk of bias in medical education is not restricted to activities that are supported by industry. It can affect any type of scientific communication, even an educational meeting organized independently by a university or medical association.

Underlying these assertions seem to be extremely broad definitions of bias and conflicts of interest, coupled with unwillingness to see a distinction between trivial and serious varieties of each. This again appears to be a false dilemma. The distinctions should be between no conflicts, trivial conflicts, and serious conflicts, not between no conflicts and any conflicts, even if trivial.  This also could be called an example of how "the perfect is the enemy of the good."  Even if perfectly preventing all conflicts of interest is impossible, does this imply that preventing serious conflicts of interest is not worthwhile.   

Summary

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.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, here,  here, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.

So we add to our ongoing series how, based on a series of logical fallacies, the European Society of Cardiology provided a series of recommendations that allowed nearly any kind of relationship among CME speakers and selection committees and industry, as long as the relationships were disclosed.  The only relationships banned were those "which would represent a significant conflict of interest" for the Chairperson of a Congress Programme Committee.  Similarly, the only stipulations for the society's cardiology journals were that interests affecting editors and editorial board members must be declared, and board members and reviewers should decline reviews of manuscripts "relating to topics, drugs, or devices, in which they have significant commercial of academic interests."  The rules for guideline committees were somewhat more rigorous, but "receipt of consultancy fees or fees for lecturing would not debar an individual from being a member of a committee but must be fully disclosed."

It is discouraging that the web of conflicts of interest that currently enmeshes much of academic medicine and many medical professionals is so heavily defended.  It is more discouraging that its defenders include so many prominent academics and practicing physicians.  It is more discouraging that so many well trained people resort to logical fallacies to make their arguments, and do so in prestigious scholarly journals.

Our continuing series about how logical fallacies are used to support the status quo and the powers that be in health care suggests, if nothing else, that health care professional education ought to include courses in logic.

Finally,  in 2011, I noted, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  Last month, however, I discussed how the leader of one of the most acclaimed US medical schools made an argument in support of conflicts of interest based on logical fallacies,  Now we have just seen such arguments made by the leaders of European cardiology.  The new paper suggested that disclosure is the best way to manage conflicts of interest.  True to this belief, the paper included a disclosure section that took up an entire journal page.

It seems likely that number and magnitude of ongoing commercial interests so disclosed may have influenced the content of the position paper.  Yet while it may be unsurprising, it is most disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care.

The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA(4):

Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.

True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals, others who make decisions about patients' or the public's health, and academic health care institutions. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

References
1. ESC Board. Relations between professional medical associations and the health-care industry, concerning scientific communication and continuing medical education. Eur Heart J 2012; 33: 666-674. Link here.
2. Association of Americian Medical Colleges. Industry Funding of Medical Education. Washington, DC: AAMC, 2008. Link here.
3. Light DW. Global drug discovery: Europe is ahead. Health Aff 2009; 28: w969-w977. Link here.
4. Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link here.

A Case Demonstrating Links Between Poor Governance, Conflicts of Interest, and Excess Executive Compensation at a Hospital System

The Salinas Valley Memorial Healthcare System in California first appeared on our radar in 2011 for not only giving an improbably large severance package to its CEO, but doing so two years before he actually retired.   At the time, hospital "officials" gave the usual sorts of justifications we see for huge executive compensation packages.  They suggested the CEO is brilliant, in particular, "gifted and experienced," and that to retain him they needed to pay "private sector-level benefits."  Then it turned out the system was rapidly raising the compensation of other executives while laying off employees who actually took care of patients. 

A Government Audit

Because the system, despite its title, is actually a local government agency, these controversies triggered not only outrage, but also a state audit.  The Los Angeles Times described its results. 

The audit found that the Salinas Valley Memorial Healthcare System regularly did business with firms that the board and top officials had financial stakes in — in some cases in apparent violation of state conflict-of-interest laws.

The report stated that Salinas Valley lacks sufficient safeguards against making decisions that violate conflict-of-interest laws, and that the district therefore can't guarantee 'that it's board members and executives do not experience personal financial gain from its transactions with businesses.'

The audit found 11 instances between 2006 and 2010 in which board members had reported economic ties — including stocks, salaries and other types of payments — to vendors with which the district did business.

Not all the cases represented violations of conflict-of-interest rules, state auditors said, but in two cases they found that officials may have broken the law.

One case involved former Chief Executive Samuel Downing, who had $50,000 in investments with 1st Capital Bank, an institution Salinas Valley and the executive agreed to deposit $1 million into.

In another case, the hospital made $5.6 million in disbursements to Rabobank, where a board member, Harry Wardwell, serves as a regional president and receives a salary of more than $100,000, according to his most recent statement of economic interest.

A San Jose Mercury News article listed some other problems found by the audit:

· Absence of a formal executive compensation policy despite paying its top administrators at the upper end of the industry scale. Downing received a nearly $5 million retirement payout, and other executives received generous pay topping out at $341,000 per year. The reported also cited supplemental pensions, which have been discontinued.

· Violations of state open-meeting laws as the board approved executive pay.

· Failure to ensure all employees who are required to file statements of economic interest had done so.

· Absence of a duly approved, legally binding conflict of interest code, which must be approved by the county Board of Supervisors. The report noted the hospital board instituted a properly approved code in December.

· Lack of proper documentation on the selection process for no-bid contracts, necessary to ensure the hospital gets the best value for its money. The report found only one of eight contracts reviewed during the audit included such documentation.

· Need for better oversight of hospital funding of community events, including the rationale for why and how they benefit Salinas Valley Memorial, to adhere to the ban on making gifts of public money. The report found the board delivered $54,000 to California Rodeo Salinas without any evidence it had considered how it furthered its public purposes.

Conclusions

First, this case should not be viewed as an indictment of hospitals run by local governments.  Rather than indicating that bad behavior is particularly likely at such hospitals, the fact that questionable behavior came to light at such a hospital is more likely due to better regulation of such hospitals leading to more transparency about them compared to other hospitals.  The regulations and laws governing the operations of non-profit hospitals not run by government agencies, or for-profit hospitals vary from US state to state.  To my knowledge, rarely do states strictly regulate conflicts of interest affecting, or require much transparency about governance at hospitals that are not government run.  There is a similar lack of state regulation of for-profit hospitals, and federal regulation of either non-profit or for-profit in these areas.  Thus it is extremely rare to see an audit or report about any non-governmental hospital like the one about Salinas Valley Memorial Healthcare.  Without the greater transparency produced by such investigations, there is little data about whether the practices seen at Salinas Valley are common at other hospitals, be they government run, non-profit and private, or for-profit.   

However, while this is just one case, it does allow an interesting comparison.  We have discussed the usual "talking points" proffered by management and boards to explain outsized compensation packages in health care.  They often include statements about the brilliance of the executives in question, almost never with any supporting evidence, and the need to pay "market" rates.  Although these, and other talking points may seem implausible, they are hard to challenge, because hospital and other health care organizations are usually able to conceal the processes which actually lead to compensation decisions. 

However, in this case there is documentation of problems with governance processes which may have plausibly enabled unjustified levels of compensation.  Failure to maintain processes to disclose and deal with conflicts of interest could increase the likelihood that conflicts would occur.  A board that included individuals who may have been personally profiting from their board membership might be inclined to go along to get along with the CEO.  Meeting in secret despite an open meeting law would prevent discovery of cronyism.

This case therefore suggests that governance that lacks transparency, accountability and integrity may lead to self-interested, conflicted leadership that responds to perverse incentives.  Such leadership is likely to pay more attention to its own interests than the health care mission, short-changing patients' and the public's health.

So once more with feeling.... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

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

Head of Lobbying Firm with Health Care Clients Walks Through Revolving Door into Executive Branch

A Washington Post op-ed described the latest case of a revolving door frequent flier, or perhaps frequent revolver, with health care connections. I will try to piece it together chronologically.

The story revolves around one Steven Ricchetti. His earlier career trajectory was:

Blue Cross Blue Shield, then the Democratic Senatorial Campaign Committee, then the Clinton White House, then lobbying, then back to the Clinton White House, then more lobbying, this time starting Ricchetti Inc. with his brother, Jeff. (A call seeking comment from Ricchetti Inc. wasn’t returned.)

Most recently, he "was tapped to be counselor to Vice President [Joseph] Biden."

His recent clients were"Fannie Mae, General Motors, the American Hospital Association, and Eli Lilly," obviously includeingtwo prominent health care organizations.

Previously he had represented

AT&T, Reed Elsevier, Pfizer, Sanofi-Aventis, Siemens, Sirius XM, Amgen, Boston Scientific, America’s Health Insurance Plans, eBay, Dow Chemical, the U.S. Conference of Catholic Bishops, among others, according to the Center for Responsive Politics. Cumulatively, they paid Ricchetti and his firms millions.

Eli Lilly, Pfizer, Sanofi-Aventis, Amgen, and Boston Scientific are obviously "pure" health care corporations. Reed Elsevier has a publishing subsidiary with important medical titles. Siemens Healthcare is an important part of that company. The links above are to our relevant posts about these firms, some of which describe various ethically questionable behavior.

Note that Mr Ricchetti's appointment apparently circumvented the President's previous statement that "lobbyists 'will not run my White House.'" He

achieved this feat — getting around the ban on lobbyists serving in the administration — by using one of Washington’s most-honored traditions: the loophole. Just as Obama won the presidency, Ricchetti de-registered as a lobbyist for his various clients. But he remained president of the lobbying firm that continued to work for many of those same clients, as well as a few more, such as the American Bankers Association.

While Mr Ricchetti is no doubt an intelligent and hard-working man, could not someone who was not so strongly financially tied to the leadership of some of the US' most ppowerful health care corporations be found who was well-qualified for this position?

Pending the answer to that question, which I do not expect to receive, this story becomes our latest example of the coziness between political and government leadership on one hand, and the leadership of large health care organizations, and those they choose as representatives.

We have seen all sorts of permutations of revolving door stories involving people with strong ties to the largest health care organizations. The implication is that both health care's private sector and the government functions meant to provide or regulate health care do not operate at arms' length, and in fact seem to be run by a group of insiders who overlap both, and may be more attuned to their self-interest and patients' and the public's health.

Health policy in the US has become an insiders' game. Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction.

Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox. We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.

Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality

One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians.

At "Health IT: Ddulites and Irrational Exuberance" and related posts (query link) I've described the phenomenon of the:

'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.'

I have called this personality type the "Ddulite", which is "Luddite" with the first four letter reversed. I have also pointed out that the two are not exact opposites, as the Luddites did not endanger anyone in trying to preserve their textile jobs, whereas the Ddulites in healthcare IT do endanger patients.

Yet, in the 20 years I've been professionally involved in health IT, I have frequently heard the refrain, usually from IT personnel and their management, that "Doctors resists EHRs because they are [backwards, technophobic, reactionary, dinosaurs, unable/unwilling to change, think they are Gods, ..... insert other slanderous/libelous comment].

I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at HIMSS), at government meetings (e.g., GS1 healthcare), and others.

The summary catchphrase I've heard and seen (even in the comments on this blog) is that doctors are "Luddites" while IT personnel are forward-thinking, know better than doctors, and are "Modernists."

This slander and libel of physicians and other clinicians needs to stop, and the entire issue needs to be reframed.

Doctors are pragmatists. When a new technology is rigorously shown to be beneficial to patients, and (perhaps more importantly) rigorously shown not to be of little benefit or worse, significantly harmful, doctors will embrace it. There are countless examples of this that I need not go into. They also have responsibilities, obligations, ethical considerations, liabilities, and other factors to consider in their decisions:

Pragmatism (Merriam-Webster):

: a practical approach to problems and affairs

The reality is not:

Luddite doctors <---- are in tension with ----> Modernist IT personnel

but is:

Pragmatist doctors <---- are in tension with ----> Ardent technophiles (Ddulites)

The technophiles' views may be due, on the one hand, to ignorance of medicine's true complexities and "innocent" overconfidence in technology. Unfortunately, it is a gargantuan leap of logic to go from "well, computers work in tracking FedEx packages and allowing me to withdraw money from my U.S. bank when I'm abroad, to "therefore with just a little work they will transform medicine."

Anyone familiar with even the most fundamental issues in Medical Informatics is aware of this. (This is the problem with "generic management" of healthcare IT - healthcare amateurs are unfamiliar with these issues.) Due to the complex, messy social, scientific, informational, ethical, cultural, emotional and other issues relatively unique to medicine, that leap from banking/widget tracking/mercantile computing --> medicine is probably more naive than the leap in logic, for instance, that would have a person believe since a hot air balloon can go high in the sky, it can take a person to the moon, as I observed here.

On the other hand the technophile's expressed views can also be a territorial ploy with full awareness of, and reckless disregard for, the consequences of technology's downsides.

(The CIO where I was a CMIO was well-known to be an aficionado of Sun Tzu's "Art of War" in his corporate politics - the polar opposite of a 'team player.' I might add that the doctors were fully expected to be 'team players'.)

Part of the struggle between the health IT industry and medical professionals has also been control of information flow about HIT.

This has been brought to the fore by my observation of the almost uniformly negative comments on today's HIT at the physician-only site Sermo.com. Sermo is populated, I might add, not by computerphobes but by physicians in a wide variety of specialties using computers for social networking. These comments will hopefully soon be published.

(They are not dissimilar to the many comments I reported in my Jan. 2010 post "An Honest Physician Survey on EHR's", although some might call the sponsor of the latter survey, AAPS, biased. I do not think the same can be said of Sermo.com, an open site for all physicians.)

I have mentioned on this blog the numerous impediments to flow of information about health IT's downsides, and these impediments are well described, for example, in the Joint Commission Sentinel Events Alert on Health IT (link), the FDA Internal Memorandum on H-IT Safety (link) and elsewhere (such as at link, link).

The Institute of Medicine of the National Academies noted this in their late 2011 study on EHR safety:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”

I note that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398.

Pragmatist physicians are quite rightly very wary of the technology as it now exists.

Ultimately, even when information on HIT risks or defects does surface, it is highly inappropriately labeled as "anecdotal" (see this post on anecdotes for why this behavior is inappropriate).

This "anecdotalist" phenomenon occurs right up to the HHS Office of the National Coordinator for Health IT (ONC), as I described in my post "Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector" and elsewhere.

Therefore, another part of reframing the pragmatism vs. technophilia issue is for clinicians to put an end to censorship of HIT adverse experiences.

I have the following practical suggestions, used myself, to start to accomplish the latter goal.

These suggestions are in the interest of protecting public health and safety:

When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

• Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).

• Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

• Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at http://www.jointcommission.org/report_a_complaint.aspx . Also consider writing the JC senior officers (link to officer's list), whose awareness of HIT issues I can personally attest to via our correspondences.

• Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. An example of such an adverse event report I filed myself (when the involved hospital refused) is at this link in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.

• Inform the State Medical Society and local Medical Society of your locale.

• Inform the appropriate Board of Health for your locale.

• If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."

• Inform a personal attorney.

• Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.

• As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:

"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."

• If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.

• As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.

-- SS

Increased Lab Ordering with EHR's?

ONC has once more proffered typical politically-motivated spin with regard to the Harvard study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that I wrote about at "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access."

That study had the rather tame, reasonable conclusion:

... These findings raise the possibility that, as currently implemented, electronic access does not decrease test ordering in the office setting and may even increase it, possibly because of system features that are enticements to ordering. We conclude that use of these health information technologies, whatever their other benefits, remains unproven as an effective cost-control strategy with respect to reducing the ordering of unnecessary tests.

The ONC response (posted here at present) to such a mild conclusion about an experimental technology seemed very splenetic.

As I mentioned at the aforementioned post, ONC has thrown good science under the bus before, for political purposes in my view:

... On the other hand, coming from a political office that clearly does not understand how to conduct qualitative research and creates political promotion pieces masquerading as "research", such a statement is not surprising. See "ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" at this link, where essential research methodologies were thrown under the bus for publication in Health Affairs.
At least the deviations from rigorous research methodologies were admitted:

“... Our findings must be qualified by two important limitations: the question of publication bias [e.g., bias in evidence selection - ed.], and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.”

Unfortunately, the media, politicians, financial decisionmakers and others are likely not to really comprehend, in-depth, the full significance of that sentence.

I am in the unfortunate situation of again having to stuff ONC's - um, stuff - back into the bull.

First, hat tip to Histalk where I found the link below:

National Coordinator for HIT Farzad Mostashari, MD takes issue with the recently published report that found doctors with online access to patients’ charts ordered more tests. Mostashari disputes the study, which raised questions as to whether or not EHRs cut costs. Mostashari’s contends that the study was based on 2008 data and before the start of the Meaningful Use program and thus does not address certified EHRs’ capabilities for data exchange and clinical data support.

The fatal passage in the linked ONC piece at http://www.healthit.gov/buzz-blog/meaningful-use/study-facts/ is this:

"Also, the study data were from 2008, before the passage of the HITECH Act and the linking of payment incentives to the meaningful use of EHRs."

This seems a variation of the typical excuse-making in IT - "they were using v. 1.0; it's all fixed in the later version."

The outcomes of (Orwellian-named) "Meaningful Use" (MU) have not been studied, to my knowledge. Futher, the criteria chosen for "Meaningful Use" were primarily best guesses as to what could be beneficial. ("Meaningful Use" should have been more accurately termed "good faith use.")

Claiming that 2008 data on EHR-related test ordering is invalid because "Meaningful Use" was not in effect at the time is, in fact, jumping to an unsupported conclusion that "Meaningful Use" will counter whatever multiple medical/social factors caused the increased ordering in the first place -- because, of course, MU is "Meaningful" and deterministically guaranteed to work out, nationally, as planned, among all outpatient and inpatient settings.

This seems a form of "begging the question":

Begging the Question is a fallacy in which the premises include the claim that the conclusion is true or (directly or indirectly) assume that the conclusion is true. This sort of "reasoning" typically has the following form.

- Premises in which the truth of the conclusion is claimed or the truth of the conclusion is assumed (either directly or indirectly).
- Claim C (the conclusion) is true.

This sort of "reasoning" is fallacious because simply assuming that the conclusion is true (directly or indirectly) in the premises does not constitute evidence for that conclusion. Obviously, simply assuming a claim is true does not serve as evidence for that claim. This is especially clear in particularly blatant cases: "X is true. The evidence for this claim is that X is true."

I note that the MU criteria are themselves evolving and not finalized. Making predictions about the future is the domain of fortune tellers with crystal balls, not scientists:

Health IT WILL reduce costs and improve caregivers’ decisions and patients’ outcomes. It is written in the stars!

ONC seems to think it is capable of such certainty, as I wrote in mid-2010 at "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records":

... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

In its current piece, ONC goes on to state:

Reducing Test Orders Is Not the Way that Health IT Is Meant to Reduce Costs

The ultimate impact of EHRs on reducing cost will be through improvements in the coordination and quality of care, and the prevention of unnecessary and costly complications and hospitalizations. [Note the mysterious disappearance of the word "tests" - ed.] Providers who are embracing new delivery and payment models such as Accountable Care Organizations and Patient-Centered Medical Homes know that meaningful use of EHRs is a critical foundation for being able to improve quality while reducing cost.

That is, simply, a lie. Reducing test utilization has long been claimed as a benefit of EHR's.

For example, from http://www.healthit.gov/patients-families/benefits-health-it:

EHRs reduce unnecessary tests and procedures. Have you ever had to repeat medical tests ordered by one doctor because the results weren’t readily available to another doctor? Those tests may have been uncomfortable and inconvenient or have posed some risk, and they also cost money. Repeating tests—whether a $20 blood test or a $2,000 MRI--results in higher costs to you in the form of bigger bills and increased insurance premiums. With EHRs, all of your care providers can have access to all your test results and records at once, reducing the potential for unnecessary repeat tests.

It is also another example of "moving the goalposts", a defense often used by those without a sound argument; by politicians; and sometimes by - scoundrels.

(I observed another "moving of the goalposts" at my aforementioned post "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access." In that post I observed Michael Furukawa, a health economist in the ONC office, stating that the researchers’ focus was not "deep enough" to support the study’s conclusions. He wrote: “The data are sound, the methods are appropriate, but the focus is limited,” he said. “They only looked at one piece of health IT.”)

Well, yes, and the piece they looked at should set off red flags that the assumptions about health IT and savings might be erroneous - not generate excuses that the goalposts were too close, and need to be moved further away.

This is not to mention that it appears most healthcare errors have little to do with documentation, as I outlined in my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?"

I particularly take issue with the ONC statement that:

... this was not a randomized trial, but an observational study (the National Ambulatory Medical Survey) that was not designed to answer the question of cost, or associations between EHRs and quality. As a result, many other variables that could affect physician behavior could not be examined in this study

Yet in the aforementioned ONC "predominantly positive results" literature survey described at this link, ONC "implicitly gave equal weight to all studies regardless of study design or sample size." Their review thus included qualitative studies that were probably not meant to be evaluative, and observational studies subject to severe methodological bias, yet all were weighted equally. Further, studies contradicting the 'narrative' of health IT efficacy and beneficence such as in this list appear to have been excluded.

This appears a prime example of, at best, "the pot calling the teakettle black", and raises doubts as to ONC's objectivity and perhaps even intellectual honesty. Of course, they are a political office with a mission, so perhaps this can be understood. (Not excused, but understood.)

ONC also views risk management-critical reports of health IT-caused harm as "anecdotal", a scientific and ethical faux pas (or is it willful blindness?) of major proportions.

As I wrote at my April 2001 post "Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector":

... This view [of negative HIT reports being 'anecdotes'] extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:

Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.

(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")

The definitive take-down of the "anecdote" canard is at this link.

One could wonder if a criteria for work at ONC is a Ddulite disposition ('Luddite' with first four characters reversed):

Ddulites: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

Instead of logical fallacy and "spin", perhaps the ONC would be better served by sponsoring some (independent, objective) researchers to actually conduct research supporting their claims about the effects of the "Meaningful Use" program.

Finally, perhaps ONC should ask my mother what she thinks about EHRs. She has specially-acquired firsthand expertise. They can find her here.

-- SS

Addendum 3/9/12:

At my Feb. 2011 post "Does EHR-Incited Upcoding (Also Known as "Fraud") Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance " is another side effect on costs of EHR's in inpatient settings, specifically, the ED.

-- SS

Addendum 3/11/12:

Another article in 2010 by Himmelstein, Woolhandler & Wright had reached related conclusions:

Hospital Computing and the Costs and Quality of Care: A National Study

David U. Himmelstein, MD, Adam Wright, PhD,Steffie Woolhandler, MD, MPH

The American Journal of Medicine Volume 123, Issue 1 , Pages 40-46, January 2010

Background

Many believe that computerization will improve health care quality, reduce costs, and increase administrative efficiency. However, no previous studies have examined computerization's cost and quality impacts at a diverse national sample of hospitals.

Methods

We linked data from an annual survey of computerization at approximately 4000 hospitals for the period from 2003 to 2007 with administrative cost data from Medicare Cost Reports and cost and quality data from the 2008 Dartmouth Health Atlas. We calculated an overall computerization score and 3 subscores based on 24 individual computer applications, including the use of computerized practitioner order entry and electronic medical records. We analyzed whether more computerized hospitals had lower costs of care or administration, or better quality. We also compared hospitals included on a list of the “100 Most Wired” with others.

Results

More computerized hospitals had higher total costs in bivariate analyses (r=0.06, P=.001) but not multivariate analyses (P=.69). Neither overall computerization scores nor subscores were consistently related to administrative costs, but hospitals that increased computerization faster had more rapid administrative cost increases (P=.0001). Higher overall computerization scores correlated weakly with better quality scores for acute myocardial infarction (r=0.07, P=.003), but not for heart failure, pneumonia, or the 3 conditions combined. In multivariate analyses, more computerized hospitals had slightly better quality. Hospitals on the “Most Wired” list performed no better than others on quality, costs, or administrative costs.

Conclusion

As currently implemented, hospital computing might modestly improve process measures of quality but does not reduce administrative or overall costs.

-- SS

EHR Musings From a Pediatrician

I am reproducing with the author's permission a post from Sermo.com. The author is a pediatrician. Sermo is a physician-only online community.

Emphases mine:

EHR Musings
March 06, 2012
Author Specialties: Pediatrics

Let me preface my comments by saying that I LOVE TECHNOLOGY. I am a geek at heart and live to use all kinds of gadgets. I was actually looking forward to going EHR. These comments apply to someone with an existing mature practice that needs to be converted to EHR. For a doc starting out new, things are infinitely simpler. I am a Pediatrician in solo practice.

It has been 6 months since we started using [EHR name redacted - ed.] and dove all in to the EHR realm. They have not been a happy 6 months. I am working a lot more and enjoying it less. My days do not end with the last patient, far from it.

This is my opinion:

Pros: 1) You can always find the chart. 2) In the case of [EHR name redacted - ed.], since it is web based, I can work at home and access records from anywhere. It is also free and never has to be updated. 3) At the end of the day I remember the patients better. I can also send messages to the staff within the EHR for follow up calls, things I might have forgotten , etc.

That is pretty much it.

Cons: 1) Documenting will add 1-2 hrs to your day. Since a lot of the documenting consists of templates you or the EHR created, it results in charts that all look very similar and there is a tendency to overdocumenting. I daresay it gets in the way of patient care. 2) You will have to drastically change your workflow. If you walk in the room with a laptop or tablet, you will wind up interacting with the tablet and not the patient. If you jot down notes, and then go out of the room to chart or look up things in the chart you will walk 10 miles a day and take up precious minutes. 3) I actually find it harder to keep track of things as growth charts, immunization records, prior labs, previous medical diagnosis and things I need to follow up. Why? Because I now have 2 charts for each patient. The new electronic chart and the digital copy of the paper chart. In the case of newborns things are better because there is no old record. 4) Once you sign a chart it is often impossible to add a note to some parts of the chart to explain an error. For example if the MA switches the weight and the height and I do not notice prior to signing, the growth chart looks like a roller coaster and I can't change it.

Then there are the quality of life issues. I no longer have any time to do anything out of the office at lunch time. It is usually spent finishing the "documenting" from the AM so I don't have as much to do at the end of the day. I get frustrated by the inability to come up with a better workflow after 6 months. I have tried various different methods and none seem better than the other.

Then there is the issue of the e prescribing. Any of you that are doing this can "attest" ( nice play on words ) to the fact that you can write 5 paper prescriptions in the time you can do an e Rx. E prescribing would be a cinch in rural Arkansas, where your patients have only 4 Pharmacies to choose from. In Orlando with a 300 pharmacies or so, and dealing with young parents of kids it is a nightmare. They change pharmacies more often than I change clothes in a week. They tell you to send it to one pharmacy and later complain because they made a mistake and gave you the wrong pharmacy. It is such a hassle for the staff, that they beg me to give them paper scripts so they don't have to deal with the calls. Notice I have not said anything about the Rx's that never reach their destination !

BTW, if and when I receive the incentive money I will know that I have earned every penny of it and then some.

If you are still reading at this point, you can tell I AM PRETTY FRUSTRATED. And we all owe this to those wonderful folks in Washington DC whose lives are devoted to coming up with ideas to mess with our lives even more. ARGH !!!!!!!!!!!!!!!!!

I would love to hear comments. Just venting has made me feel better. Of course it is now 10:50 EST and I have 7 more charts to do.

I post this with no additional comments.

-- SS