A Confidentiality Clause or an Oath of Fealty?

The advancement of modern scientific medicine depends on the search for and dissemination of truth. Academic medicine, like the rest of academia, ought to be based on openness, transparency, and academic freedom. The 1940 American Association of University Professors (AAUP) Statement of Principles on Academic Freedom and Tenure opened with:

The common good depends upon the free search for truth and its free exposition.

Yet we have written about dark clouds of secrecy spreading over medicine and health care. The increasingly powerful leaders of health care increasingly use opacity and secrecy to keep what they are doing out of the public eye. We have frequently discussed the anechoic effect, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations.  People may feel it is unseemly to speak badly of renowned institutions such as hospitals and universities.  People with conflicts of interest may not be inclined to criticize those who pay them.  Now people employed by contemporary health care organizations may have to pledge theri silence to keep their jobs.

The latest story in this regard comes from Virginia Commonwealth University (VCU), which includes VCU Health Systems, and MCV Hospital and Physicians.  (Full disclosure: I was a VCU full-time faculty member from 1987-1994, and still am on the adjunct faculty.)  In 2008, the VCU President resigned after the university's secret research contract with a tobacco company, and the President's own position on the board of directors of another tobacco company were revealed (see blog post here and others here).

Michael Rao, the President since 2008, is now under outside review after it was revealed that he required his staff to sign a secrecy pledge.  The story appeared in the Richmond Times-Dispatch:

Virginia Commonwealth University President Michael Rao asks employees who work in his office to sign an unusual confidentiality agreement that bars them from talking about what they observe about him or his family.

The prohibition goes beyond the standard agreement that university employees sign acknowledging that they can't disclose personal or proprietary information.

The agreement, a copy of which was obtained by the Richmond Times-Dispatch, covers interactions at Rao's office and at his residence. It bars disclosure not just to the news media, family or friends, but also to colleagues, 'clergy and attorneys, or to any other person not otherwise identified.'

'I agree that any such disclosure in violation of this nondisclosure agreement could result in irreparable damage and harm to VCU, President Rao, and/or his family'" the agreement states. 'Any such violation or anticipated violation' would entitle Rao to seek 'injunctive relief' in Richmond or Henrico County circuit courts.

VCU spokeswoman Pam Lepley said she could not comment immediately yesterday.

Several current or former employees of the president's office confirmed that they had been asked to sign the agreement, including Kimberley Busch, Rao's former scheduler.

She described it as a 'what happens in the president's office stays in the president's office' agreement.

The newly uncovered confidentiality clause provoked strong criticism:

Raymond D. Cotton, a Washington attorney who specializes in higher-education governance, said such a confidentiality agreement is highly unusual and goes against the culture of openness and transparency in higher education.

'There is this concept of academic freedom that is broader than the First Amendment,' he said.

In fact, since Virginia Commonwealth University is a state-supported institution, the confidentiality clause may be unconstitutional, as reported by WTVR:

Kent Willis with the Virginia American Civil Liberties Union said the agreement doesn't pass constitutional muster.

'A public employee, no matter where they are in the government, has a right to speak out on matters of public concern,' Willis said. 'That's a U.S. Supreme Court case, it's guaranteed to every public employee by the First Amendment to the Constitution.'

Willis said there are numerous legal issues raised by the contract. But, he said, the bottom line problem with the contract 'is the attitude. This is a contract that says 'I'm not transparent. I don't want you to know what is going on. I'm running a closed shop.''

Times-Dispatch columnist Michael Paul Williams wrote:

VCU, we have a problem. This confidentiality agreement does not inspire confidence. The lack of transparency only gives the appearance that someone's hiding something.

He also further quoted Kent Willis:

Rao's contract 'fails to address this whistle-blower right and could create conflicts for employees, who are silenced by the employment contract,' yet have a constitutional right to speak out on some matters, Willis said.

And as Willis points out, even if a person's constitutional right trumps the contract, how many employees are willing to take that risk?

'Particularly disturbing is the prohibition against talking to an attorney,' he said. 'If an employee believes something illegal is going on at work, an attorney is precisely the person he or she should be talking with.'

We just posted about how a pharmaceutical company included a confidentiality clause in a consulting contract, suggesting the deliberate creation of a conflict of interest in order to prevent criticism of the company's products or practices. 

However, in several ways, the present example is more insidious.  First, it involves a university, whose mission is to discover and disseminate the truth.  Thus, as noted above, the confidentiality agreement subverts the university's core mission.  Second, it was required of full-time employees who wanted to keep  their jobs, making choose between secrecy and unemployment.  Third, it was particularly harsh, addressing incipient as well as actual disclosure, and including injunctive relief as well as the threat of  termination.  Fourth, it protected not just the organization and its products, but personally protected the organization's leader and his family.  It was not just a contract, but an oath of fealty, as if the CEO were nobility, or even royalty.

The good news is that this confidentiality agreement now sits in the glare of sunlight.  One does wonder, however, how many other such agreements are already in force so that the would be nobility who now run too much of health care to avoid any embarassing revelations about what their leadership really is about.

We are a long way from the transparency that true health care reform requires. 

Citizen Journalism: Why I Blog on Healthcare Informatics

I am teaching my current students about alternate media, a.k.a. citizen journalism, also known as "blogging", in a course on organizational and social aspects of healthcare informatics.

I am using a (de-identified) personal experience as an example of why alternate media is valuable in getting "inconvenient" memes into circulation.

In addition to recent articles such as "The Problems with Peer Review" (in the British Medical Journal by Mark Henderson, Science Editor, the Times, London. BMJ 2010;340:c1409), "Ghostwriting at Elite Academic Medical Centers in the United States" (LaCasse & Leo, PLoS Medicine, February 2010, Volume 7, Issue 2) and others about ghostwriting and other ills affecting the conventional biomedical literature, I provided my students the personal example below.

I thought the example might be interesting to blog readers as well.

Here is the example I used with my students:

Regarding a paper I wrote a few years ago and that I ultimately simply posted on Scribd, "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" (link), an anonymous peer reviewer had this to say when I submitted it to "journal XYZ":

Comments to the Author

This paper addresses a potentially important issue but adds little that is new or that goes beyond what a reader might find in a major city newspaper. Proposing a classification of sources of UC and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field.

This was certainly an ironic if not bizarre comment. A paper on a scarcity of data on unintended consequences of health IT due to a "closed culture" in the HIT industry does not add anything new "beyond what one might find in a major city newspaper?"

Unfortunately, the anonymous peer review process does not allow me to ask what newspaper this reviewer reads, but it was clear to me this reviewer was 1) attempting to prevent the paper's publication and 2) "moving the goalposts" to delay it or have the focus on scarcity removed by seeking for me to "propose a classification of sources of UC" (tangential or even irrelevant to the paper's topic).

I felt it likely the review of a revised paper by this reviewer would have led to negative comments on any proposed classification schema.

Worse, was this, in a dialog via several emails I've condensed for readability. It is very likely it came from the same reviewer above:

EDITOR OF JOURNAL XYZ: I suggest Scot that you modify this into an editorial. One reviewer recognized the writing and asked me if this may have been pre-published on a blog. Any possibility for that?

In other words, I was being accused by the anonymous reviewer of possibly violating the ethics of journal publication and the contract I signed to not pre-publish (the journal has exclusive rights).

My response:

SS: No, this work was entirely original, written from a clean slate, and was not pre-published on a blog. I would think the reviewers would know me better than that in terms of integrity.

The editor shot back:

EDITOR: My response as well. Good - looking forward to the edits. Happy snow day

I reminded the editor:

SS: Not to mention the extensive footnotes showing where I sourced my material. In an age of search engines, I have to ask the following:

- was the person who raised this concern so technologically limited they were unable to search themselves to answer their own question?
- did this person have such a lack of trust they felt compelled to make such a statement?
- did this person raise this due to bias against the fundamental thesis of the paper?

I think it's fair to say there is very, very strong pushback against articles such as this being published. I have to consider whether it's worth my while to continue, or to withdraw the paper.

At which point I received the following revealing comment from the editor:

EDITOR: I think, Scot, that you have a talent for sniffing out problems, dangers, risk, failures and by addressing them in your head on ways, you are likely to make enemies. You are doing a valuable job, but you have to realize that people are threatened by you. That's why the respond in this manner. Not that it is excusable, but it is understandable.

I decided it was not worth revising the paper due to that reviewer's comments and the editor's observations, and therefore disseminated the paper via the Healthcare Renewal blog and Scribd.

(I note that "making enemies" by directly confronting possible risks of a new technology in healthcare suggests skewed priorities among those so affected.)

While I believe the current Wikileaks web exposures have gone insanely too far, as those incidents involved exposure of sensitive material held illegally that could people to be harmed, damage international relations, and cause other unforeseen ill effects, the web has proven valuable for dissemination of one's ideas that have not been able to escape the gravity of the sometimes "peer review Black Hole."

-- SS

Prominent Health Care Policy Advice from People Sans Health Care Expertise

It is two days after the US Thanksgiving holiday, and one thing I am thankful for is the continued hilarity generated by health care corporate CEOs who pretend to be health care experts.  Of course this all really is not so funny, because the bogus expertise appears not in MAD Magazine, but in the most respected media outlets with the most influence over health care policy.

 This week's example comes from the Wall Street Journal's vaunted CEO Council.  A summary of its health care panel appeared early this week in that newspaper.

The panel included Angela Braly President and CEO, Wellpoint Inc., William A. Hawkins Chairman and CEO, Medtronic Inc., and Klaus Kleinfeld Chairman and CEO, Alcoa.  Angela Braly, a lawyer with no obvious record of direct experience in health care or related fields (see her bio here), received total compensation from WellPoint of more than $13 million in 2009, while presiding over various snafus and ethical missteps (most recently here, and with a further catalog here.)   William Hawkins, who has an undergraduate degree in engineering, and an MBA, received total compensation from Medtronic of over $9 million in fiscal 2010.  His direct involvement in health care or related fields apparently ended after his undergraduate years, when he was said to have done research in pathology (see his bio here).   He presided over Medtronic's settlement of thousands of patients' lawsuits that alleged injuries due to a faulty lead on one model of a Medtronic implantable cardiac defibrillator for over $200 million.  The company's other recent questionable activities may be found here.  Dr Kleinfeld's doctorate is in strategic management, but he has no obvious health care background (see his bio here.)   (The panel apparently had a "subject expert," Dr Risa Lavizzo-Mourey, a physician who is now CEO of the Robert Wood Johnson Foundation, but she was not quoted directly in the WSJ edited transcript.)

So what could we expect from a panel on health care that included no one with direct experience or expertise in health care, but two CEOs who managed to become extremely wealthy courtesy their employment by health care companies? 

Here is Ms Braly on changing incentives:

This really gets to the fact that right now we have a fee-for-service payment system, so we pay for quantity rather than quality. And very importantly, we think we need to redesign the way in which we reimburse for health care.

So,

Reimbursement could come in the form of accountable care organizations or patient-centered medical homes or pay-for-performance or risk sharing. There are a number of ways—and we didn't want to be completely prescriptive in terms of what that reimbursement formula would be.

The issue is not quantity versus quality, but cognitive, including primary care vs procedures. Ms Braly completely ignores how the government takes only the advice of the RUC to set physician payments, and how her company just apes that example (see posts here). Ms Braly also completely ignored how her company could actually try to change reimbursement on its own. There is no law that says it must follow the example set by Medicare.

So what she said about changing "delivery incentives" is just nonsense, to use a polite term.

Then we have Dr Kleinfeld ostensibly on transparency, but really on thinking about health care as if it were done on a production line:

Let me first talk about the transparency aspect. It was very informative to hear from those that are in the industry how big a variation you have in practices across the board.

If I were to look at a set of factories that make the same thing, and one does it in five days and the other one in 10 days, and the one that does it in five days is cheaper than the one that does it in 10 days, why would I not bring everybody down to the five days?

So the question is, what hinders the health-care industry from applying the same mechanics? There was agreement that today for every important disease category there are also quality indicators that are accepted that you could use to see what is the quality delivered.

Once you control the process, once you bring the quality up, the costs go down.

Dr Kleinfeld does not seem to realize that health care involves taking care of unique patients. Even when patients have common problems, they have unique mixtures of other medical problems and personal characteristics. The physician's most basic pledge is to do what is best for each individual patient. Treating them as if they were identical widgets on a production line makes absolutely no sense.  One cannot apply the "same mechanics" that apply on a production line, because actually taking care of patients is not done, and does not at all resemble what happens on a production line. It goes without saying that Dr Kleinfeld seems to have no idea how complex and fraught with error the process of measuring quality in health care actually is.

His remarks again, to put it politely, were nonsense.

Finally, there was Mr Hawkins in a similar vein:

Contrary to popular belief, we actually have very good medical care in this country, and with the proliferation of evidence-based medicine, we have determined that there are best practices for how we can treat hypertension or some of the neurodegenerative diseases or diabetes. And the reality is, as you look across different systems, there's a lot of variability in what people are doing.

We talked about the importance of publishing or being very clear about what are the best practices for dealing with hypertension, and then making sure that we have the means by which people will be held accountable moving forward in that area.

Maybe we should acknowledge that at least Mr Hawkins tried to concentrate on hypertension, which may have a slightly more secure evidence base than some other conditions. But the implication still is that there are "best practices" when the complexity of real patients in a real health care context makes figuring out what really is best for individual patients very challenging. Maybe that is why we used to try to leave such decisions up to doctors, other health professionals, and their patients.

However, it seems that the CEOs of big health care corporations seem to feel the need to justify their ridiculous total compensation by opining on health care topics that are completely beyond their experience, training, and expertise. The real problem is that probably because of the assumption that those huge salaries must correlate with huge expertise and intelligence, their opinions are taken seriously. The quotes above did not come from MAD Magazine. They came from a highly respected and prestigious conference sponsored by and whose results were published by the Wall Street Journal.

To truly reform health care, we need to stop pretending that general business or law training makes someone a health care expert, and that being paid a lot of money by a health care corporation makes one a bigger health care expert.   We need to go back to developing health care policy with the help of people who actually know something about health care, and who are not paid by particular health care corporation to support their vested interests. 

ACO = Arrogant Clinical or Aggressive Care Oligopoly?

In the 1970s, it was managed care organizations.  In the 1990s, it was vertically integrated health care systems.  In the 2010s, the fashionable concept for improving health care, apparently beloved by left-wing policy wonks and right-wing health care executives is the "accountable care organization." (ACO).  Development of the ACO is funded by the recently passed US health care reform legislation.  The official definition of ACO from the US Center for Medicare and Medicaid Services is: 

An Accountable Care Organization, also called an 'ACO' for short, is an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it.

Oddly enough, that seems like it could also describe a 1970s managed care organization, or a 1990s vertically integrated health care system. The only real difference is the idea that the ACO would be paid fees for service. All these similar concepts embody the notion that health care needs to be highly organized into big, bureaucratic organizations to improve quality and access while controlling costs.

Back in August, we warned:

There seems to be a strange and increasing alliance between politically- correct academic theorists and proponents of raw economic power. The theorists' notion of "accountable care organizations" seems to have become a great foil for would-be monopolists, yet the theorists have done nothing to show how their creation would really bring "power to the people." Meanwhile, maybe 'ACO' should stand for 'aggressive care oligopoly.' Meanwhile, be extremely skeptical of the latest health care fad, especially when it is supported both by academics and CEOs.

I am not sure you really heard it here first, but you did hear it here early. Now, three months later, our doubts have become main-stream.

Revisiting Sutter Health

n California, National Public Radio continued to document the increasing market dominance of the Sutter Health system (which we discussed in August here) as it marches toward becoming an ACO:

Through new construction and expanding its doctors' groups, Sutter Health is enhancing its position as one of the most dominant hospital systems in California. In addition, Sutter is further ahead of many competitors in fashioning itself into a so-called accountable care organization, responsible for coordinating care between hospitals, specialists and primary doctors.

A companion article gave examples of how this emerging ACO is becoming increasingly oligoplistic:

Hospital prices in the Sacramento region are among the highest in California, driven in large part by the negotiating clout of the hospital chain Sutter Health.

Over the last decade and a half, Sutter has gradually accumulated hospitals and amassed a roster of doctors who contract exclusively with the company. Sutter is now one of the largest hospital chains in California with 24 acute care hospitals.

'In this Roseville market, which is a big suburban area, the hospital is Sutter,' says John Murray, a veteran insurance broker. 'It's a lock right now. Because Sutter dominates the market, major insurance companies, like Blue Cross and Aetna, can't sell policies that exclude Sutter hospitals and doctors. That dependence means the hospital chain can dictate high prices.'

Concerns about Sutter's market dominance are also increasing:

'As Sutter gets bigger,' says Anthony Wright, executive director of Health Access California, a nonprofit advocacy group based in Sacramento, 'it can dictate higher prices and is less accountable for ensuring good quality because it has a lock on certain markets.'

Doubts in the New York Times

In the New York Times, Robert Pear reported:

When Congress passed the health care law, it envisioned doctors and hospitals joining forces, coordinating care and holding down costs, with the prospect of earning government bonuses for controlling costs.

Now, eight months into the new law there is a growing frenzy of mergers involving hospitals, clinics and doctor groups eager to share costs and savings, and cash in on the incentives. They, in turn, have deployed a small army of lawyers and lobbyists trying to persuade the Obama administration to relax or waive a body of older laws intended to thwart health care monopolies, and to protect against shoddy care and fraudulent billing of patients or Medicare.

Consumer advocates fear that the health care law could worsen some of the very problems it was meant to solve — by reducing competition, driving up costs and creating incentives for doctors and hospitals to stint on care, in order to retain their cost-saving bonuses.

'The new law is already encouraging a wave of mergers, joint ventures and alliances in the health care industry,' said Prof. Thomas L. Greaney, an expert on health and antitrust law at St. Louis University. 'The risk that dominant providers and dominant insurers may exercise their market power, individually or jointly, has never been greater.'

Skeptical Liberals and Libertarians
Amazingly, while ACOs seem to be supported by many left-wing policy wonks and right-wing health care executives, they have also rapidly engendered skepticism from both liberals on the left and libertarians on the right, and from within government and the private sector. For example, at the end of the NY Times article we find:

Dr. Donald M. Berwick, the administrator of the Centers for Medicare and Medicaid Services, hails the benefits of 'integrated care.' But, Dr. Berwick said, “we need to assure both patients and society at large that destructive, exploitative and costly forms of collusion and monopolistic behaviors do not emerge and thrive, disguised as cooperation.”

Dr Berwick is a well-known advocate of innovative approaches to improve the quality of care, but was tarred as a raving left-winger when he was nominated to his current position.

On the other hand, in the New York Post was an op-ed by Dr Scott Gottlieb:

I warned that the creation of 'accountable care organizations,' which put hospitals in control of all the doctors in their outlying areas, would lead to concentrated power over the provision of medical care -- turning physicians into salaried employees and reducing consumer choices.

Furthermore, he wrote:

Since the ACOs will have local monopolies, they'll also have little incentive to compete for more patients in an open marketplace. Yet this is the only incentive that would spur an ACO to truly innovate and improve its delivery of medical care and offer better services.

Private health plans vie to contract with the best doctors and hospitals, creating market prices for services and competition to improve outcomes. If the ACOs squeeze out this competition, the result will be a de facto 'single payer': Every market will be controlled by a single ACO,....

Dr Gottlieb writes frequently about health care and policy issues, and is a "resident fellow at the American Enterprise Institute."

Missing the Main Point: Doctors vs Business Executives as Leaders
At least it did not take long this time for the fundamental flaws in the latest fashionable health care reform effort to get attention. It is really striking that this time around, skepticism is coming from both liberals and libertarians.  Maybe we all have learned something from the failures of managed care and of vertically integrated hospital systems.

A Washington Post op-ed by Steven Pearlstein hinted at one fundamental problem with the ACO concept.

Most reformers believe ...that the best way to deliver affordable quality care is through organizations such as the Mayo Clinic, which coordinate physician and hospital services under one roof and are paid not on the basis of how many procedures they do but on the quality of the care they provide. These organizations tend to rely on salaried doctors, make extensive use of electronic medical records and evidence-based 'best practices,' and, in effect, take on much of the risk traditionally borne by insurers. Several provisions of the new health-care reform law encourage the formation of such 'accountable care organizations.'

Somehow, however, the supposed health care reformers seemed to have overlooked a crucial fact about the Mayo Clinic they are using as a model. The Mayo Clinic traditionally was basically a large physician group practice. It was run by physicians. Even now, the Mayo Clinic's CEO is a physician (Dr John H. Noseworthy) who had a substantial clinical and academic career. The CAO is a nurse, and the three top Vice Presidents are physicians.  I submit the fact that the organization was run by physicians, physicians who once swore to put their patients' clinical care ahead of all other considerations, was crucial to the Clinic's success in taking care of patients as well as maintaining its finances.

However, nearly all of the would-be ACOs we hear about now are centered on big hospital systems, run by business executives who have never taken care of patients, and never swore to put patient care ahead of anything. For example, the most advanced degree possessed by the CEO of Sutter Health is a Master's in Health Administration (see here). Sutter Health does not make biographical information about its top executives particularly easy to find, but according to the most recent (2008) 990 form posted on Guidestar, of its 19 top executives, only 2 had MD degrees. As we have seen time and again on Health Care Renewal, such executives have become extremely good at becoming rich in their jobs. (For example, according to the 2008 990 form, of those 19 executives, all had total compensation greater than $200,000, 16 had compensation greater than $500,000, and 9 had compensation greater than $1 million.) When things go wrong, these royally paid executives may take their golden parachutes and open the exit door, and jump on the slide.

The advent of ACOs reminds me of the advent of managed care. The original managed care organizations, exemplified by Kaiser - Permanante, were also not-for-profit large group practices run by physicians. However, the "managed care organizations" that evolved out of the 1970s law, favored by our glorious former President Nixon, were for-profit corporations run by business executives. Somehow, when legislators seek to promote better health care, the legislation they right often get the crucial details wrong.

The one good thing about ACOs seems to be that they have galvanized liberals and libertarians alike to worry about big, collective, bureaucratic health care organizations run by executives with no clear commitment to putting care of individual patients first.

ADDENDUM (26 November, 2010) - See also comments by David Williams on the Health Business Blog.

Of Drug Talks, Deception, and Denial

A month ago, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records. 

Since then, a series of local or regional news organizations have reported on physicians in their areas.  These reports (all listed below as "references" in somewhat chronological order ) further explained how these "drug talks" are just marketing exercises, and how some of the physicians involved rationalized making money hawking drugs.

Physicians as Marketers

Considered together, the articles documented how the drug talks served marketing rather than educational needs.

Doctors are the Most Influential Speakers

As noted previously, corporations and the doctors they hire chronically characterize the doctors' talks as educational. However, from New York City,(9)

[Dr Stephen] Friedes said drug companies can’t use sales reps to give the same speeches. Instead, they need doctors to serve as speakers because the presentations are more believable when they come from an expert’s mouth. And that’s why companies will pay the biggest bucks to get the biggest experts to read their slides.

Paying Doctors Who Already are Prolific Prescribers

From Chattanooga, Tennessee(7), came pulmonologist Daniel Smith's acknowledgment that the corporations choose speakers who they already know favor their products:

He emphasized that his use of GlaxoSmithKline's Advair inhaler began long before he started speaking for the company.

'The assumption is if the doctor didn't have the relationship, he wouldn't prescribe the medication,' he said.

Also, as reported from Des Moines, Iowa(8):

Several doctors said drug company representatives asked them to become paid speakers because sales records showed the physicians often prescribed the companies' products.

'They're like, 'We noticed you're using a lot of our drugs, would you mind telling other doctors why?' ' said [Sioux City internist Dr Mark] Carlson, who emphasized that he prescribes the medications he believes work best.

Furthermore, from New York City(9) :

First, the industry says it picks the doctors who are the most knowledgeable about the drugs. But [Dr Richard] Schloss said Pfizer first picked him because he was a high prescriber of Geodon.

'What they do is they get the pharmacy records, and they know who’s prescribing what,' said Schloss, 'and they can come in and say, ‘I see you’re prescribing, you know, a lot of, in this case, Geodon. What do you like about it?’ And you if say nice things, they say, ‘Will you be interested in speaking for us?’'

Payments Influence Behavior

Even though health care corporations may select speakers who already favor their products, probably to reinforce this pattern, that does not mean that such payments do not induce even more enthusiasm. From Chattanooga, Tennessee(7), obstetrician-gynecologist Kirk Brody

said he hasn't actually spoken on behalf of a drug company for eight years or so. He quit after one year when he realized the drugs he lectured about ended up popping into his head when it came time to prescribe, he said.

'I felt like it was probably influencing my prescription habits,' he said. 'If you're out there singing the praises of something, you tend to believe it. It was just an ethical problem.'

Also, from New York City(9):

[Dr Richard] Schloss said he agreed to be a speaker because he genuinely believes in Geodon, and he enjoys teaching. But even he admitted the speaking has actually changed the way he prescribes.

'You know, I may use Geodon maybe 10 percent more than I did before I was a speaker,' said Schloss. 'I use it 10 percent more because I’ve spoken about it so many times....'

"Push Poll"

From New Hampshire(1), Dr. Leonard Korn, president of the New Hampshire Psychiatric Society, described how the drug talks resembled a "push poll" (biased poll meant to sell a viewpoint)

'We sat there being educated by their people and they sent us a check,' he said, recalling the usual fee was about $500.

The doctors would then give feedback about the positive and negative aspects of a particular medication and of drugs made by competitors.

'It was a bit like a focus group ... except a focus group is not really promoting its product,' he said. 'This is much more like a push poll.'

His concern is that such events can influence doctors, even subconsciously, to choose that company's drug.

Why Hide the "Education?"

If the physicians' talks are educational, as some of the speakers and their corporate pay-masters assert, why should they be hidden from the media. However, as reported from Des Moines (Iowa)(8):

The companies say they favor openness. 'We believe transparency is critical to rebuilding trust in our industry, and Lilly seeks to continue to be a leading voice and example in transparency efforts in the biopharmaceutical industry,' said J. Scott MacGregor, a spokesman for Eli Lilly.

In that spirit, The Des Moines Register asked MacGregor and his counterparts at the other two leading companies to let a reporter observe one of their doctor-education sessions. All three declined.

'It would be inappropriate for you to attend an event,' AstraZeneca spokeswoman Katie Lubenow said. She said the sessions are open only to medical professionals.

Also, from New York City(9):

But for talks that are supposed to be purely educational, there seems to be a lot of secrecy. WNYC called the seven companies in the ProPublica database, and asked if it could observe a presentation. Each company declined. And none would send copies of their slides. [Columbia Unviersity urologist Franklin] Lowe wouldn’t provide a copy either. He said the slides were company property and he could get into trouble if he passed them out.

Physicians' Rationalizations for Getting Paid to Give Pharmaceutical Talks 

Denial: Industry Sponsored Talks are Educational

Despite the evidence above and elsewhere that pharmaceutical companies pay physicians to give talks to market their products, not to altruistically provide unbiased education, many physicians asserted what they were doing is educational. Those providing the rationalizations included high ranking academics. For example, from New Hampshire(1):

Dr. Craig L. Donnelly, chief of the child psychiatry section at Dartmouth-Hitchcock Medical Center, said he views such appearances as part of his mission to educate the next generation of physicians.

Donnelly is the second-highest earner on Pro Publica's list for New Hampshire, earning $136,578 from Eli Lilly in 2009 and the first quarter of 2010.

When he gives talks, Donnelly said in an e-mail, he advocates not for one particular drug but for a "full range of treatment options," including non-pharmacological ones.

'When I speak to colleagues, I am putting my reputation on the line,' he said. 'I genuinely believe that these talks provide educational value to my colleagues in primary care, above and beyond the informational component on the particular drug topic.'

Denial:  Physicians are Not Chosen to Speak Because they Favor the Product

Despite the evidence above and elsewhere that corporations pick physician speakers who already favor their products, from San Francisco, California(10), former Stanford faculty member psychiatrist Manoj Waikar said:

he does not disclose what drugs he prescribes to pharmaceutical companies so they hire him for his expertise, not because of his prescribing patterns.

He seemed unaware that the companies already have easy access to data about his prescribing habits.

Rationalization: The Need for "Collaboration" Implies the Need to Get Paid for Marketing

Furthermore, even academics who were uncomfortable with industry supported talks recited the mantra that academic-industrial "collaboration" is needed to provide "innovation." This begs the question of why such "collaboration" needs to include payments by industry to academia for marketing, or in fact any activities other than pure research. For example, from an article specifically about the Dartmouth-Hitchcock Medical Center in New Hampshire(2), Dr James L. Bernat, a DHMC neurologist and chairman of the bioethics committee,

said the relationship between medicine and industry can be 'synergistic and useful' for both groups. But he said, 'There are potential conflicts of interest that can occur ... that need to be identified, mitigated and prevented.'

Also, co-chair of the hospital's integrity and ethics task force Dr. Carl DeMatteo, an infectious-disease physician and chief quality and compliance officer,

said academic physicians who share their research with pharmaceutical or medical-device companies 'can bring forward treatments and cures to the public that can make a real difference in people's lives.'

The latter, of course, is mainly an argument for publication and dissemination of basic science research, not for academic physicians working with drug, device or other companies on evaluating the products those companies have a vested interest in, much less involving academics in marketing.

Universities are always promoting academic-industrial collaboration, but never seem to explain why such collaboration requires academics to be paid to give talks, or for that matter, for ill-defined consulting work.  They talk about the benefits of research as a monolithic whole, rarely explaining why it is good for industry to sponsor and control human research meant to evaluate the products in which companies have vested interests.

Reasoning from a Biased Sample: Multiple Conflicts as De-Biasing

Physicians asserted that being paid by multiple corporations is reduces bias in favor of a particular drug, ignoring the possibilities that multiple conflicts of interest might bias in favor of expensive drugs vs generics, in favor of drug therapy vs other approaches, or even in favor of aggressive vs conservative therapy. For example, from Erie, Pennsylvania(3), a report quoted Dr Gurjaipal Kang,

'I don't feel there is a conflict of interest,' Kang said. 'I speak for competing drug companies. I speak about some drugs that I don't often prescribe.'

Also, from Vancouver, Washington(4), a quote from Dr Jeffrey L Hansen, psychiatrist:

'I don’t believe it influences my prescribing practices because I work with a number of companies,' Hansen said. 'I want to make sure that no matter who’s sponsoring my speaking the message is the same.'

Denial: Conflicts of Interest Do Not Influence Behavior

Many doctors simply asserted that being paid to give a talk does not influence their prescribing. This begs the question of whether they were hired to speak to reinforce their pre-existing preference for the products of their employers. It also seems to simply deny that financial incentives matter, a position supported by common sense, and underlying essentially all of economics. For example, from Syracuse, New York(5), the chief of urology at Crouse Hospital, said

'Morally my goal is to treat the patient with the best medications I know of,' Albala said. 'I find it hard to believe some people would write a (prescription for) a medication just because they are a speaker.'

'I would be happy to do these gratis,'....

Note, of course, that despite the last assertion, he was apparently even happier to get paid. Dr Albala was the top recipient of drug company honoraria in the Syracuse region, getting $180,200 from GlaxoSmithKline.

False Dilemma: If It is Not Illegal, It Must be Good

An old argument in politics and business is the assertion that one's behavior is good as long as one has not been convicted of a crime.  An analogous argument made by physicians is to claim that compliance with local administrative processes certifies one's actions as ethical. For example, from Durham, North Carolina)(6), Duke Medicine oncologist David Rizzieri,

asked whether the substantial sums he has received from drug companies could lead to ethical issues, Rizzieri replied, 'I respect this concern and feel the multiple layers of oversight and conflict of interest management planning ... help assure appropriate application and presentation of the data.

Rationalization: Entitlement

Physicians may feel that because of the hardships they have endured, especially during training, they are entitled to be rewarded, apparently no matter what the circumstance. So, from Durham, North Carolina,(6) a medical student noted:

There is certainly a sense that once you go through medical school and you go through residency, you're kind of entitled to these gifts from industry, or to be paid well enough for speaking

Also, from Chattanooga, Tennesse(7), local pulmonologist Daniel Smith sarcastically asserted:

We're considered experts in our field. I guess we're supposed to spend hours and hours of time educating other doctors for free

This, of course, begs the question of who should be paying.

Appeal to Common Practice: Pharmaceutical Paid Talks are Part of the Culture

Some in the academic world seemed to assert that since the talks are common practice, they must continue.  From Durham, North Carolina(6), Ross McKinney, director of Duke's Trent Center for Bioethics, Humanities and History of Medicine, said

the new policies will also have to consider the existing culture among doctors.

'It is hard to set restrictions when that is the existing culture. This isn't the Mayo Clinic where everybody is just a salaried employee,'....

Summary

There is a growing body of evidence that pharmaceutical companies, and presumably other for-profit health care corporations, may pay physicians to give talks to help market their products, not to altruistically support unbiased education.  Physicians may command more respect than sales people.  The companies may choose those who are already known to favor their products.  While the speakers may influence other physicians, payments to them may reinforce, if not enhance their favorable stance towards the companies' products.  The setting of the talks may be designed to favor their marketing purpose.  Pharmaceutical companies and the physicians they pay may be wary of letting skeptics witness these talks because they have the above considerations to hide.

However, it seems that many physicians who give the talks, and sometimes the academic institutions with which they are affiliated, are in denial about the nature of these talks.  They are quick to rationalize what they do, sometimes with the help of logical fallacies.

I submit that physicians and health professionals should shun commercially sponsored talks as deceptive marketing.  Physicians who give such talks are at best naive, and at worst complicit in the deception.  Deceptive marketing is never good, but is particularly upsetting and dangerous when it is used to sell products that have serious health consequences. 

ADDENDUM (24 November, 2010) - See this related post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

References


1.  Wickham SE. Three Doctors paid $100,000-plus by drug companies. New Hampshire Union-Leader, Nov 8, 2010.  Link here.
2. Wickham SE. Dartmouth-Hitchcock takes fresh look at such payments. New Hampshire Union Leader, Nov 8, 2010. Link here.
3. Bruce D. Drug companies pay Erie doctors to speak about their drugs, devices. Erie (Pennsylvania) Times-News, Nov 8, 2010. Link here
4. Lasher B. Pharmaceutical industry spends millions on doctors: Clark County doctors got $190,000 over 18 months. Vancouver (Washington) Columbian, Nov 7, 2010. Link here.
5. Mulder JT. Drug makers pay 51 central New York doctors nearly $1 million to talk about their products. Syracuse (New York) Post-Standard, Nov 7, 2010. Link here.
6. Chen M. 'Dollars for Docs' hits home. Durham (North Carolina) Herald-Sun, Nov 13, 2010. Link here.
7. Bregel E. Prescription for concern: pharmaceutical companies' payments to doctors raise questions amid soaring U. S. drug costs. Chattanooga (Tennessee) Times- Free Press. Nov 14, 2010. Link here.
8. Leys T. 121 Iowa physicians collect from drug firms. Des Moines (Iowa) Register, November 14, 2010. Link here.
9. Chang A. Physicians on pharma's payroll: educators or marketers? WNYC, November 18, 2010. Link here.
10. Colliver V. Disciplined doctors receiving pharmaceutical funds. San Francisco (California) Chronicle. Nov 18, 2010. Link here.

EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)" at this link.

It is an interesting interview. I certainly find the recognition of need for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare.

It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders.

Here's an explanation by Dr. Fotsch:

... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of medical society executives, professional liability carriers, and liaison representatives from the FDA. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint.

In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were concerns from the liability carriers that there was no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records.

[Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.]

They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that medical societies had similar concerns.

[That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.]

Rather than have each of them create a system, the Alliance took on a role of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. That’s how it came into play.

Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought [I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.], but now it’s up and available.

While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics:

Fotsch:

… Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, turns out to be some form of user error.

[What about contributory or causative designer error? – ed.]

“I didn’t know it would do that"

[Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed]

... or “I didn’t know that it pre-populated that"

[Why did it pre-populate? Was that inappropriate for the clinical context, such as in this example?]

... or “I didn’t know I shouldn’t cut and paste"

[Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.]

... or “I wasn’t paying attention to this"

[Perhaps due to distractions from mission hostile user interfaces? -ed]

... or maybe the user interface was a little confusing

[What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.]

Actual software errors appear to be the exception rather than the rule as it relates to EHR events.

["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?]

That’s at least as I understand it.

[Understand it from whom? Hopefully not from me or my extensive website on the issues - ed.]

In summary, a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to facilitate error, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute.

These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked eight part series on mission hostile health IT:

From "GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE"
ESD-TR-86-278
August 1986
Sidney L. Smith and Jane N. Mosier
The MITRE Corporation
Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.

... SIGNIFICANCE OF THE USER INTERFACE

The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.

Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.

In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort.

In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing.

I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases.

For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting.

I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise.

-- SS

Addendum 11/28/10:

This passage ends the main essay at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" and is quite relevant here:

... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), http://www.bmj.com/cgi/content/full/320/7237/768:

Summary points:

• Two approaches to the problem of human fallibility exist: the person and the system approaches
  

• The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness

• The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects

• High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.

-- SS

Former KV Pharmaceutical CEO and Chairman Banned from Government Business

Early this year we noted that a subsidiary of KV Pharmaceutical, Ethex, pleaded guilty to two felony counts, and paid a fine in response to charges "stemming from its failure to make and submit to the U.S. Food and Drug Administration a report on its discovery of undistributed pills that 'failed to meet product specifications,' ...."   At the time, we noted that this was yet another marcher in the parade of legal settlements affecting health care organizations.  In this case, as in many others, despite the acknowledgement that unethical actions, worse, crimes were committed, no person appeared to suffer any penalty or negative incentive.  As usual, we argued that settlements like this would be perceived by unscrupulous leaders as mere costs of doing business, and would not deter future bad behavior.

That was then, and this is now.  Bloomberg just reported:

KV Pharmaceutical Co. said Marc Hermelin resigned as a director and will sell his controlling interest after being banned from doing business with the U.S. government for two decades. KV rose in New York trading.

Hermelin left the board on Nov. 10 and will sell his shares, said Catherine Biffignani, vice president of investor relations, in a telephone interview today. Hermelin, 68, had been fired as chairman and chief executive officer of Bridgeton, Missouri-based KV in December 2008. He held about a 52 percent voting stake, either in his own name or through trusts, according to a company filing on May 7. KV didn’t specify the timing of the stock sales.

The ban takes effect tomorrow.

This was really news. As the article noted:

Hermelin will become the first drug-company owner or executive barred from doing business with the government in an antifraud push involving Medicare, the insurance program for seniors and the disabled, and Medicaid, the health program for the poor, according to the Health and Human Services Office of Inspector General’s website.

We just discussed an indictment of a former GlaxoSmithKline executive. Now we have a KV Pharmaceutical executive banned from doing business with the government. So all of a sudden, it looks like the US government has realized that when health care organizations violate the law, their executives do not have complete impunity.

Of course, things immediately became more complicated. The St Louis Post-Dispatch just reported:

In yet another major shakeup, KV Pharmaceutical's board chairman, a member of its audit committee and its chief financial officer quit this week.

The chairman and audit committee member charged that KV's newly elected board can't provide the independent oversight the company needs. The new board had been elected last Thursday.

The CFO, John Stamp, quit on Monday and has not been replaced, the company said in a regulatory filing released Wednesday afternoon.

KV also revealed that the new board had terminated interim CEO David A. Van Vliet. The company last week announced that Van Vliet had been replaced but gave no details.

What seems to be going on here is resistance to the continued control of the company by the family of the now banned former CEO:

In their resignation letters, board chairman Terry Hatfield and audit committee member John Sampson said they had 'serious concerns regarding the ability of the newly constituted board and senior management to provide the required independent oversight of KVs business during this critical time in the company's history.'

They noted that only three of the board's seven nominees for board seats were elected at KV's annual meeting last Thursday. The remaining elected members were candidates proposed by shareholders.

The family of the firm's founder, Victor Hermelin, retains 52 percent of the Class B shares, which have super voting rights, according to the company proxy issued in May.

Among those re-elected to the board was Marc Hermelin, son of the founder, who was ousted as CEO in 2008. Also re-elected was David Hermelin, the son of Marc Hermelin and a former director of corporate strategy who retained his seat on the board.

David Hermelin was among the board's nominees. Marc Hermelin was not.

As soon as the government appears to get somewhat serious about imposing negative consequences for bad behavior in health care, one can expect that the leaders of organizations who have personally profited from bad behavior in the past will try to come up with work-arounds.

Nonetheless, it may be that if health care leaders realize they do not have complete impunity, and they may be held responsible for the bad behavior of the organizations they lead, they may behave better. One can hope.

One can also hope that increasing evidence about the bad behavior of leaders of health care organizations will lead to increased unwillingness by health care professionals to go along with, or at least ignore such bad behavior that compromises their own professional values.

Insurers Test Data Profiles to Identify Risky Clients

Stories like this one today at the WSJ disturb me.

“Insurers Test Data Profiles to Identify Risky Clients”
Wall Street Journal
Nov. 19, 2010

From that story:

Life insurers are testing an intensely personal new use for the vast dossiers of data being amassed about Americans: predicting people’s longevity.

Insurers have long used blood and urine tests to assess people’s health—a costly process. Today, however, data-gathering companies have such extensive files on most U.S. consumers—online shopping details, catalog purchases, magazine subscriptions, leisure activities and information from social-networking sites—that some insurers are exploring whether data can reveal nearly as much about a person as a lab analysis of their bodily fluids.

In one of the biggest tests, the U.S. arm of British insurer Aviva PLC looked at 60,000 recent insurance applicants. It found that a new, “predictive modeling” system, based partly on consumer-marketing data, was “persuasive” in its ability to mimic traditional techniques.

The research heralds a remarkable [alarming? -ed.] expansion of the use of consumer-marketing data, which is traditionally used for advertising purposes.

Read the entire article.

The reason I find this article disturbing is that it can and probably should be looked at as another example of technophiles and opportunists with no knowledge of (or lack of caring about) Social Informatics, a decades-old discipline with a focus on studying the unintended consequences of new information and communications technologies (ICT's), enabling our society to move one step closer to centralized control.

Social Informatics (SI) refers to the body of research and study that examines social aspects of computerization, including the roles of information technology in social and organizational change, the uses of information technologies in social contexts, and the ways that the social organization of information technologies is influenced by social forces and social practices.

Stories such as the above WSJ story, and others in their running series on Internet privacy, also dampen my enthusiasm about the possibility that electronic medical information will be kept private, confidential and secure.

-- SS

GAO report: - Health Care Delivery: Features of Integrated Systems Support Patient Care Strategies and Access to Care (such as HIT)

A new GAO report has appeared entitled "Health Care Delivery: Features of Integrated Systems Support Patient Care Strategies and Access to Care, but Systems Face Challenges." (Hat tip: saw this in story by Inga at HerTALK).

The report is available at these links:

GAO-11-49 November 16, 2010
Highlights Page (PDF) Full Report (PDF, 33 pages) Accessible Text

One of those strategies, of course, is healthcare IT:

IDSs in GAO's sample reported that using electronic health records (EHR), operating health insurance plans, and employing physicians all support strategies to improve patient care. An EHR contains patient and care information, such as progress notes and medications. Some IDSs said that using EHRs supports their patient care strategies such as care coordination, disease management, and use of care protocols by increasing the availability of individual patient and patient population data and by improving communication among providers.

Some might take this report as "proof" that healthcare IT is ready for national rollout.

However, the following passage lends doubt to that interpretation, in the form of a significant "however" (a common word seen in reports about healthcare IT, along with terms such as "but", "except", "in some cases", "in the next release", the ever-valuable term "glitches", and other similar hedge terms).

… However, the information we present is from the perspective of the IDSs in our sample. We relied on data obtained through the Web-based data collection instrument, interviews with system representatives, and published studies and did not conduct independent analyses of the effectiveness of strategies.

This report suffers a serious flaw: potential (or might I say likely) self-reporting bias.

Caveat emptor.

-- SS

Avatar fails. (No, not the Cameron movie, but yet another lousy EMR system implemented by amateurs.)

A story "Designed for Efficiency, New Computer Software at Health Dept. Misfires" by The Bay Citizen senior writer Katharine Mieszkowski appeared in the New York Times today regarding San Francisco's Dept. of Public Health.

"Misfires?"

That's a mild term indeed. In the realm of incendiary comments in the interest of patient care:

In this story, mental health and social workers, and the disadvantaged people suffering mental illness, drug addiction, etc. that these professionals attempt to raise up from misery one difficult step at a time, are being used as unconsenting experimental subjects and free software debuggers and beta testers:

This story follows a script very familiar to Medical Informatics professionals:

• Poorly designed and implemented healthcare IT causes clinical and other chaos;
• Vendor and implementation leaders claims "glitches" and "teething pains" and blame the users for inexperience and/or incompetence;
• Vendor promises relief in the "next version";
• These principals hope it all "goes away" until the system implodes on itself and needs replacement, starting the cycle anew, and/or-
• The principals hope newspapers stop paying attention to the chaos caused by the IT and the users simply surrender, and let the information systems control them, rather than the other way around.

Considering the patient population involved here, one might wonder if the project leaders have any more compassion than the machines they proffer:

New York Times
Designed for Efficiency, New Computer Software at Health Dept. Misfires
By KATHARINE MIESZKOWSKI
November 18, 2010 (from the Bay Citizen)

In July, the San Francisco Department of Public Health started using an $11.2 million electronic medical records system, Avatar, that was designed to streamline billing and improve care for tens of thousands of clients. Thus far, however, it has brought administrative chaos to the mental health and substance abuse services in the city.

Documents obtained by The Bay Citizen under a California Public Records Act request show that shortly after installing Avatar, providers struggled to use the new software, causing health officials to lose track of millions of dollars of services.

Officials are scrambling to fill in the missing data to meet deadlines to qualify for reimbursement from the state.

In addition to mere financial chaos:

... Problems related to the conversion to Avatar delayed for months the payment of about $450,000 to individual therapists, Anne Okubo, the health department’s deputy financial officer, told the San Francisco Health Commission on Tuesday night. The department was forced to use a third party to make the payments, which are still incomplete.

In addition, some therapists and social workers report that the demands of the new software have cut into the time they spend with patients, eroding the quality of care.

In an Aug. 19 e-mail headed “problems with Avatar,” Steven Schreibman, a social worker at Sunset Mental Health, a city-run clinic, wrote that the software required “excessive time charting and performing data entry” and had led to “shorter sessions with clients” and “delays in our capacity to accept new clients.” [This is not news to anyone familiar with poorly designed, mission hostile healthcare IT - ed.]

The customary excuses were presented. Growing pains, ignorant users:

Senior health department officials and Netsmart Technologies, Avatar’s developer, said the problems were glitches that were to be expected as the city made the transition to a more efficient record-keeping system.

“We knew it was going to be rough initially, because there is a learning curve,” said Jo Robinson, who heads the Community Health Behavioral Services division, where Avatar was introduced.

Kevin Scalia, a Netsmart Technologies executive vice president, said that he does not see this as a big problem. “From our point of view,” he said, “everything is going swimmingly.” [Translation - they're making good money - ed.]

Here's the key passage:

Department managers told the Health Commission that Avatar would lead to “improved client care” and had “positive fiscal impacts,” but they acknowledged there had been problems.

In September, the department compared the cost of mental health and substance services reported by the hospital, clinics and organizations in March, before the software was put into use, to those reported in July using the new system.

The data showed that the mental health services reported had plunged 55 percent. Substance abuse services reported fell 32 percent. The large discrepancies caused alarm because they indicated that providers were having problems using the software, according to documents and interviews. [I can also predict they've had problems _providing_ those services under the time duress added by the software - ed.]

As someone who was once a Medical Review Officer for drug testing in the public transit industry, and a colleague of the company's Employee Assistance Program liaison, I can assure readers that implementation of health IT will not effect a one-third reduction in drug abuse problems and recidivism.

After a month of use:

A month later, as more providers gained access and proficiency with the software, the picture improved, but significant discrepancies remained.

Some data modeling issues are apparent:

But some organizations worry that the services they are providing will not be fully reflected in the new system.

Here's a reverse twist on HIT vendor "Hold Harmless" clauses:

At the Health Commission meeting, Estela Garcia, executive director of the Instituto Familiar de la Raza, a community organization that provides mental health services, asked the commission to protect organizations like hers from any financial liability related to Avatar.

“I want a hold-harmless policy until the system is fully up and running,” Ms. Garcia said.

How long that will take is unclear. One mental health program director, who would not allow his name to be used because it could jeopardize his relationship with the department, said his staff had gone to repeated training sessions to try to get up to speed.

“Avatar turns out to be a total disaster,” the program director said. “What is going to happen to contracted agencies if their billing is short at the end of the fiscal year as compared to the terms of their contract, because they can’t master Avatar?”

As in typical in health IT, system users are afraid to speak candidly:

A psychologist who works with a community organization under contract to the city, who spoke on the condition of anonymity because he was afraid of losing his job, said he used to do all his charting and billing on paper and was told that the new system would be more efficient. So far, that has not proved to be the case, he said.

“We are seeing the same number of patients,” he said, “but we are providing substantially less service to them, because the time we are now spending just to do the billing alone, not to mention the record keeping, it’s become the majority of our time.”

Labor unions are taking a look:

Greg Cross, a field representative for Service Employees International Union Local 1021, which represents hundreds of social workers, psychologists and counselors who work for the city, said he had met with officials to discuss Avatar’s impact on workload as well as performance expectations.

I invite SEIU Local 1021 and national SEIU leaders to read this blog, and review my academic site on HIT failure here, to better understand why these debacles repeatedly occur.

At the Health Commission meeting, Fred McGregor, the health department’s senior information technology manager for community programs, said that the department was aware that providers find the demands of Avatar “a little onerous” and that it was working on a redesign to make clinical assessment more efficient.

A "little onerous"?

"Working on a redesign to make clinical assessment more efficient"?

What about getting it right the first time, based on the significant amount of literature that exists on proper IT design?

I, for one, am tired of hearing this corporate mumbo-jumbo every time another health IT system impairs users.

What is needed here is a full scale investigation and evaluation of the competence and expertise of the project leaders, designers, and implementers to be experimenting in the complex field of healthcare information technology.

Mr. Schreibman, the social worker, made it clear in his August e-mail that change was needed quickly.

“The kind and amount of work skill involved using this software represents a change in our job description,” he wrote. “This is not the job we accepted when we chose to do clinical work for the city.”

In other words, they did not accept a job as data entry clerks and directors of workarounds to the mission hostile user experience presented by poorly designed healthcare information systems.

I note that missing in this story are the human tragedies (such as pain & suffering, injury, death) these IT "glitches" may have caused.

Until the memes of complete health IT beneficence and "anyone can do it" are soundly pounded into the ground and out of the heads of hapless politicians, healthcare leaders, and IT personnel, this type of mishap will continue.

Sadly, health IT mishaps are likely to be occurring on a national scale, soon, in a neighborhood near you, thanks to the timelines and penalties expounded in the HITECH act. HITECH was an integral part of the legislation known as the ARRA (American Recovery and Reinvestment Act of 2009).

-- SS

Who You Gonna Call? - How Should a Young Academic Respond to a Proffered Conflict of Interest?

To prepare a workshop on conflicts of interest in health care, I wrote a case of a faculty member offered a proposition that might provide a conflict of interest:

Consider a health care researcher called by a commercial health care corporation's marketing department. The department representative proposes paying the researcher as a consultant to write a scholarly article on a specific policy topic of interest to the company. The implication is that the article should be favorable to the interests of the corporation in this arena. The corporation would be delighted to give the researcher editorial and staff assistance in writing the article and getting it published.

Who you gonna call?

The researcher is concerned that getting this consultancy might be a conflict of interest. What organization (e.g., appropriate professional society, unit within his or her academic institution, other academic unit, independent not-for-profit organization or NGO, or government agency) should the researcher contact for support and help? Please give at least one specific example, (preferably including a URL), with a brief justification of why that organization might be helpful.

I sent the case to a few hundred people on our combined mailing list, to see how they might answer.  Responses came from medical academics, with a sprinkling of practitioners, a journalist, and a well-informed lay-person.

Sources of Information: Is It a Conflict of Interest?

Nearly everyone thought it would be unethical for a young academic to be paid as a consultant to write a health policy review policy by a company with a vested interest in the subject, and with editorial and staff support coming from the company.

I implied (but did not make clear) that the faculty member felt uncomfortable with the situation, was looking either for advice and information, or actual support not to accept a conflict of interest that he or she might have felt pressured to take on.

People suggested some sources of information. Most appeared to be useful, but most also were specialized (by clinical specialty, directed at journal editors, directed only at conflicts related to pharmaceuticals, etc)  Those particularly worthy of mention include:
- The Prescription Project's site on medical school conflict of interest policies
- The World Association of Medical Editor's (WAME) site on conflict of interest in scholarly publication
- The PharmedOut.org general resource site
My personal preference for a single source of general information on COIs is the 2009 US Institute of Medicine report on same.  (I will add all these links to our side-bar, and note that there are some other relevant links there.)

The IOM definition of conflict of interest is:

Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.

Primary interest include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients.

So the offer in the above case clearly seemed to present a conflict. The situation presented in my case seemed to present the potential to violate the report's recommendations 5.1 that bans scientific publications "that are controlled by industry," or that "contain substantial portions written by someone who is not identified as an author...."

Note, however, that even the IOM report seems not to question the idea that "collaborations between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies can benefit society — most notably by promoting the discovery and development of new medications and medical devices that improve individual and public health."  It has never been clear to me that collaboration requires payment by one party to the other, or that academic medical institutions ought to be developing drugs and devices (as opposed to discovering knowledge that commercial firms might later use to do so.) Furthermore, the IOM report, while it is moderately tough and comprehensive, did not recommend that detailed public disclosure of all relevant conflicts by all parties to them, or an outright ban on all of the sorts of conflicts that many might think are objectionable.

Support to Resist the Proffered Conflict

Suggested sources of help resisting pressure to assume an unwanted conflict of interest included local sources: mentors, grants and contracts offices, local conflict of interest/ ethics committees, compliance departments, and research officers. Some people thought their local versions of the above might be helpful. No person seemed sure that any of these options would clearly lead to support if the academic was being pressured by his or her academic superiors.

However, I have big concerns about the availability of even these sorts of local support.  We know COIs are very prevalent among individual academics.  About 60% of all academics, and of department chairs have important conflicts according to two articles by Campbell et al.(1-2)  So it might be hard for the young academic to find a mentor or university officer who was not already conflicted.

We also know that medical schools and academic medical centers see commercializing their discoveries as taking precedence over their traditional mission of seeking and disseminating knowledge, and providing and improving patient care and public health.  For example, in 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development…."[caps added for emphasis] Furthermore,

Academic medicine… finds itself struggling to create a precarious equipoise between the world and values of commerce and those of traditional public service….

Also

In our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of academic inventors in the commercial venture; put simply, no participation, no money. It is this demand … that has driven the dramatic increase in medical faculty entrepreneurship.

I have seen university conflict of interest policies that include such verbiage in their introductions. The impression is that most academic medical institutions now think that is their mission, maybe their overriding mission, to develop and commercialize drugs and devices.

So it might also be hard for the young academic to find a local academic unit that is not affected by institutional conflicts of interest. Indeed, none of the people on our list was sure that their institutions had local authorities or units that could help the young academic in the case above avoid the proffered conflict of interest.

A few people suggested external sources of support: e.g., a small medical society, an association of journal editors, a bioethics center. But they too were ambivalent about how helpful they might be. The small medical society would only be helpful for its few members, and the person who mentioned it doubted it could provide more help that citing its own COI policy. The journal editors and their organizations might only be helpful about how the proffered conflict might affect the ability of the faculty member to get the resulting study published. The bioethics center appeared to have heavy institutional conflicts of interest of its own. No one could suggest an independent organization likely to provide effective support to resist COIs to a wide spectrum of academics (or other health care professionals, etc)

Summary

So this exercise did reinforce one of the assumptions I made when writing the case. Young academics at most US (at least) institutions may have little local support for resisting the extant pressure to become conflicted. There are NO generally useful and effective external sources of such support.

I would point out that with all its limitations, the IOM report still called on academic institutions to develop clear guidelines for COIs (3.1, 3.2); ban people with COIs from research on humans (that is, from all clinical research) (4.1); develop educational programs on COIs (5.2); participate in developing continuing medical education that is free of industry influence (5.3); set up a committee on COIs at the board of trustees level (8.1). It also called on the US government to promote research about COIs (9.2).

As far as I can tell, that was all pretty much wishful thinking. Despite the prestige of the IOM, almost none of these recommendations have been implemented. (I have heard so far of one university that seems to have implemented watered down versions of some of the IOM recommendations in their own policy. I would love to be told there are more extensive implementations of these recommendations. If there are, please show me the specifics.)

Furthermore, there seems to be no effective support for the reduction of COIs from accrediting organizations, professional societies, or foundations that fund health care initiatives. (Again, I would love to be told I am wrong, but if I am, show me the specifics.)  Of course, it appears that most professional societies get extensive support from commercial sources, particularly drug, device, and biotechnology companies, and their leadership often have their own financial relationships with for-profit health care corporations.  Foundations that support health care and medicine may have leaders with similar relationships, and may have endowments disproportionately invested in health care corporations.   

Given the pervasive nature of personal and institutional COIs throughout health care, which we have documented on Health Care Renewal , I was saddened, but not surprised by the responses to my query. So many people and so many institutions are making so much money from their industry payments. They will nearly all have excuses so that they can keep accepting the money. Young faculty are unlikely to be able to resist the prevailing culture, especially when it affects so many of their colleagues and supervisors.

I know that the people on our email lists are more aware of this than most. But we all should be saddened and ashamed that so little progress is being made.

Will academic medical institutions ever again put seeking and disseminating new knowledge, and providing and improving patient care and for the public health ahead of trying to be ersatz drug and device companies?

Will professional societies ever again put put their members' core values ahead of pleasing their corporate funders?

Will health care foundations ever again put rescuing health care's core values ahead of bland projects meant not to offend health care corporate leaders?

References


1. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. (link here)
2. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. (link here)
3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. (link here)