WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE?

Ghostwriting Charges and Stonewalling at the American Psychiatric Association

The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass.

The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a denial of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.

The coup de grâce was administered by blogger Daniel Carlat’s withering review of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed before, because it misses the ethical forest for the legal trees.

Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics.

Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been posted today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency.

For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what.

Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt reply from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.

Post Title → WHO YOU GONNA BELIEVE?

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

JAMA is out today with a Commentary by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defense of seven academic psychiatrists on whom an ethical searchlight has been trained for the past several years by Senator Grassley and others. With ludicrous optimism and a series of straw man discussions, Dr. Insel makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.

Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced? Why does an NIH Institute Director presume to speak for academic psychiatry? Where are the leaders of the major professional and scientific organizations like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry? Why are they not stepping up publicly to the plate? Perhaps they are confounded by the awkward fact that some of the seven individuals are current and past presidents of these very organizations. Even the Institute of Medicine of the National Academy of Sciences has not sanctioned those of the seven who are Institute members.

Why is an NIH Institute Director downplaying the gravity of the ethical controversies surrounding these compromised individuals like Charles Nemeroff at Emory (now at Miami), and Alan Schatzberg at Stanford? To hear Dr. Insel tell it, all they did was fail to disclose income from pharmaceutical companies. That is not the half of it. Readers can look here and here for much more detail on the activities of Nemeroff and Schatzberg. If Dr. Insel chose to remain ignorant of or to overlook the history of false claims on behalf of pharmaceutical corporations or the concealment of consulting relationships or the complaisance with ghostwriting or the patently misleading “educational” presentations or the cashing in through stock sales or the editorial self dealing, then Dr. Insel’s fitness to serve as an NIH Institute Director needs to be reviewed.

Surely Dr. Insel knows that Nemeroff and the others worked mainly with the marketing personnel within pharmaceutical companies. Nemeroff’s staggering schedule of promotional talks for GlaxoSmithKline, released by Senator Grassley, is testament to that. So is Nemeroff’s record of priming the pump for himself with GSK by giving the corporation unpublished research data from NIMH-funded projects at Emory. In turn, GSK and its medical education communications company, Scientific Therapeutics Information, Inc., incorporated Nemeroff’s privileged material in the training manual for PsychNet – a speaker program designed to build advocacy for GSK’s antidepressant drug Paxil. These issues go well beyond just failing to report income. They signify the corruption of academic psychiatry. Doesn’t Dr. Insel understand that?

In his Commentary, Dr. Insel reported no financial disclosures. This is a good example of the problem that Dr. Insel doesn’t see. Many readers will interpret this Commentary from the Director of NIMH as the opening move in the attempted rehabilitation of Charles Nemeroff by his friends and cronies. Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about. Quis custodiet ipsos custodes?

Maybe Dr. Insel should stick to his knitting and resist the impulse to speak for academic psychiatry as a whole. A good place for him to start looking hard would be at the productivity and accounting of the once vaunted Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Principal Investigator Charles B. Nemeroff; 5U19MH069056). One never knows what one will find when the rocks are turned over.

Post Title → DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (query link).

One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry.

One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review" (BMJ 2010;340:c1344).

Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the Philadelphia Inquirer:

"We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.

From the BMJ article itself, free full text available as of this writing at link above:

For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.

The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing.

Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's.

As to results (see the full article for statistical details I am omitting here):

Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.

While causality is not proven, these results are still stunning. Per the Inquirer's summary:

... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found.

Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.

The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy).

The authors observe that:

In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest.

Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements:

Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.]

One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist.

... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]

So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue.

Finally, the pharmaceutical company's view, also published in the Inquirer article cited above:

A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site.

"It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure."

"Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view.

The Mayo researchers wisely conclude:

Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.

Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers.

We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues.

These practices also simply need to be abolished, for as I have written before on these pages ("Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already.

-- SS

Post Title → Study: Researchers with Glaxo ties favored Avandia

Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:

Switch to electronic records alarms Jefferson Regional physicians

By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Friday, October 30, 2009

Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety.

In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians."

Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed.

"It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."

Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying.

I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns.

Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions:

• How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?

• Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?

I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations.

HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason.

On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer.

This is especially true when conflicts of interest exist.

According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.

I find this an interesting finding. After a short Google search, the following appeared:

Western Pennsylvania Hospital News

20 Years of Hospital Information Technology
by John Fries
(December 2005)

... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System.

At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades.

The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy.

This raises a number of questions:

• Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?
• Who did/does the Site Executive report to?
• Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?
• What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?

These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest.

I have noted that a Congressional investigation of the health IT industry is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys.

Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."

He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns.

This is typical of the Wild West environment of Health IT.

-- SS

Post Title → Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF?

Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously described, Stossel is planning the inaugural meeting next week of a group to counter those he calls pharmascolds. The group is named ACRE – Association of Clinical Researchers and Educators. Here is its website: http://www.acreonline.org/ For months, Stossel has been warning of the dire negative consequences that will result from tightened conflict of interest policies, but he has not presented any persuasive examples of damage to “productive relationships between industry and physicians involved in clinical research and educational outreach.” At the same time, Dr. Stossel has conveniently overlooked the shenanigans of the bad actors whom Senator Grassley exposed. Dr. Stossel is a blowhard, as I have described here before.

But wait! ACRE has found something! A News item in the July 2009 issue of Nature Medicine (“Conflict of interest rules seen by some as too stringent”) quoted one of the participants in the upcoming ACRE conference. Avi Markowitz, chief of oncology at UT Medical Branch, Galveston, came up with this example: Patients taking a Sanofi Aventis chemotherapy product may experience peripheral neuropathy, which can cause unpleasant sensations in the hands and feet. ‘Sanofi Aventis had been providing Markowitz and his UTMB colleagues with free blankets and gloves for those patients. Last fall, however, the university adopted stricter rules banning industry freebies. Now, Markowitz can’t even accept the unbranded blankets and gloves that Sanofi Aventis has offered to provide.’ Reading between the lines, it is a good bet that these items originally were branded.

Whatever. And never mind that the patients receiving chemotherapy at UTMB are doubtless billed a hefty facility fee that must include comfort items like blankets and gloves. Since when does a chief of oncology need to beg for these basic patient care provisions from drug companies?

Is this all that ACRE can come up with? The ACRE homepage warned sternly of “restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.” Does Thomas Stossel’s whining and catastrophizing through ACRE come down to piffling items like blankets and gloves for chemotherapy patients? That’s it? Where’s the beef?

At least ACRE has the good sense not to include on its program the smooth operators whom Senator Grassley outed – like Nemeroff at Emory, Schatzberg at Stanford, Kuklo at Walter Reed, Keller at Brown, Biederman at Harvard. Not even Stossel has been brazen enough to try to defend them.

The Nature Medicine News item does close on a helpful note: 'Stossel would like to see abuses involving financial conflicts of interest treated more like cases of scientific misconduct. Rather than forcing everyone to abide by prohibitive rules, he says administrators should focus on weeding out those who misbehave.' I say Amen to that, even if it is a day late and a dollar short.

We have arrived at our present state of discomfiture because the leaders of academic institutions and professional societies looked the other way for too long. They failed to do their job of reining in the ethical outliers. Grassley had to do it for them. As a result, the rest of us will be burdened with new regulations for years to come. Those who did speak up years ago were ignored or demonized. As the saying goes, every group gets the leadership it deserves. Those in academic medicine had better not count on Stossel and ACRE to lead them out of the wilderness.

Bernard Carroll.

Post Title → STOSSEL and ACRE: WHERE'S the BEEF?

Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, No. 3934, STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of healthcare IT not "certified" (i.e., feature-qualified) by the industry-founded and connected group "Certification Commission for Healthcare Information Technology" (CCHIT). The Bill calls for monetary civil penalties for such sale or use:

A civil penalty or civil fine is a term used to describe when a state entity or a governmental agency seeks monetary relief against an individual as restitution for wrongdoing by the individual.

I previously wrote about CCHIT in a series of linked posts that start here: A very troubling post about the CCHIT (Certification Commission for Healthcare Information Technology).

I have now written the following open letter to Mark Leavitt, MD, PhD, Chairman, Certification Commission for Healthcare Information Technology.

To: "Mark Leavitt"
Date: Sunday, June 07, 2009 02:10PM
Cc: Robert O'Harrow, Jr., Washington Post, and various AMIA working group mailing lists (CIS - clinical info systems, POI - people & organizational issues, OS - Open Source, and ELSI - Ethics, Legal & Social Issues)

June 7, 2009

Mark Leavitt, MD, PhD
Chairman, Certification Commission for Healthcare Information Technology
www.cchit.org
[6/8/09 - contact info from www.markleavitt.com removed per critique in response below -ed.]

Re: NJ HIT Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17

Dear Mark,

The NJ Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17, calls for making it a violation of law to sell HIT not "certified" by CCHIT . Penalties are called for. The bill states:

... No person or entity, either directly or indirectly, shall sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by the Certification Commission for Healthcare Information Technology.

As used in this section, "health information technology product" means a system, program, application, or other product that is based upon technology which is used to electronically collect, store, retrieve, and transfer clinical, administrative, and financial health information.

b. A person or entity that violates the provisions of subsection a. of this section shall be liable to a civil penalty of not less than $1,000 for the first violation, not less than $2,500 for the second violation, and $5,000 for the third and each subsequent violation, to be collected pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

I and others find this bill remarkable. It really calls into focus the HIT community's concerns about CCHIT and its political connections, especially pursuant to the article " The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records " of May 16, 2009 in the Washington Post by Robert O'Harrow Jr.

I therefore seek answers to the following questions:

1. Do you approve of the proposals in the bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM ?

2. Did you, or anyone in a governance or leadership position at CCHIT, play a role in sponsorhip of this bill, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

3. Did anyone with governance or leadership roles in CCHIT's founding or affiliated organizations (e.g,, HIMSS, CITL, and others) or business associates of such people, play a role in the bill's sponsorhip, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

4. Did anyone (person or company) in the HIT industry, broadly speaking, who could directly profit from such a bill becoming law play a role in sponsorhip of, or advocacy for this bill?

I believe candid and transparent answers to these questions are important in giving the HIT community confidence that CCHIT primarily serves the public interest, not interests of an HIT lobby.

-- SS

6/8/09

Dr. Leavitt has candidly responded. I take his word on these issues at face value, having done business with him a bit over a decade ago (supporting the purchase of his company's EHR, Logician, for Christiana Care over the opposition of the IT department which preferred another vendor):

From: "Mark Leavitt"
Date: 06/08/2009 02:51AM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Scot,

Here are the answers to your questions:

1. No, I do not approve of this legislation -- which I'm reading for the first time in your email. Our goal, stated in almost every presentation I've given, and to which I've adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. The bill does not fit that model at all, and it is a bad idea.

2. Neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings.

3. Trustees, Commissioners, and Work Group members serve in a volunteer capacity at CCHIT. We require disclosure of conflicts of interest, but we do not monitor all activities in their 'day jobs' or other volunteer roles. "HIMSS, CITL, etc" are not affiliated with CCHIT, and we don't know about all their advocacy activities. I'm not privy to the information you seek.

4. This question presumes that I would know everything that "anyone in the HIT industry, broadly speaking" has done regarding the bill. Naturally I do not have that knowledge either.

Now that I've responded, the AMIA listserve members can stop reading here, while I go on to chat with Scot.

Scot, in 15 years of medical training and practice followed by 25 years of healthcare informatics, I've encountered very few people -- and certainly no university professors -- who acted so disrespectfully toward me. Being a veteran of health IT, it's easy to find people who have worked with me or know me well, and to ask them about my integrity. Or to talk to some of the other 50 or so Commissioners who've served or the hundreds of work group volunteers. Shouldn't an informatics scientist do a modicum of research before undertaking a potentially harmful procedure such as attacking a person's or organization's reputation? Reading a news article by Mr O'Harrow does not qualify as due diligence. Would you let your informatics students get away with that before recommending a major, potentially disruptive or destructive IT project?

From your own blogging I see that your "early medical mentor, cardiothoracic surgery pioneer Victor P Satinsky, MD, believed in public embarrassment as a tool to fight bureaucracy and discrimination ." Well, that helps me understand. And your blogging about your frustration when you sought employment with a commercial EHR vendor http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html explains even more. Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. I would be pleased to engage in a civil, rational debate with you along the lines of "EHRs -- do the benefits outweigh the risks?" C'mon out to the farm here sometime -- you know the address, and the dog's friendly -- or we could do it on the web.

Finally, my apologies to everyone on the mailing lists that Dr. Silverstein chose to include in his investigative journalism broadcast. If you object to his use of AMIA mailing lists for this kind of activity, you could let him know.

Mark Leavitt, MD, PhD
Chairman, CCHIT

My response was simple:

To: "Mark Leavitt"
Date: 06/08/2009 05:24PM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Mark,

I thank you for the answers to my questions.

> Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists.

Mark, that information came from your page at http://www.markleavitt.com/ which I found on a google seach for "Mark Leavitt." Image attached. I believed that to be your professional contact info.

As to the rest of your response, you appear to attempt to discredit my arguments through ad hominem. I refer you to this page:

http://www.nizkor.org/features/fallacies/ad-hominem.html

Translated from Latin to English , "Ad Hominem" means "against the man " or "against the person."

An Ad Hominem is a general category of fallacies in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making the claim , her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim ). Second, this attack is taken to be evidence against the claim or argument the person in question is making (or presenting). This type of "argument" has the following form:

1. Person A makes claim X.
2. Person B makes an attack on person A.
3. Therefore A's claim is false.

The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not (in most cases) have a bearing on the truth or falsity of the claim being made (or the quality of the argument being made).

Ad hominem, sadly, is not debate.

Neither is appeal to authority .

Scot

Truth be told, I actually offered no arguments in my email message. I was asking very probing questions with concern they would be ignored, or responded to with "spin" as here, and their tone offended him. Fair enough.

I was a bit disappointed, however, by the "The lady doth protest too much, methinks" ad hominem embellishments to an otherwise candid and convincing response.

Such are the risks of directness and disruptive innovation, however.

-- SS

6/9 Addendum:

Additional views on the NJ Bill are at ePatients.net at "David Kibbe & Mark Leavitt:Openness vs. Opacity" and "Dossia, Microsoft HealthVault & Google Health: Illegal in NJ?". There are some now-familiar themes regarding CCHIT civility in those posts.

6/10 Addendum:

As a result of a link sent by a commenter, I am adding the post "The Kibbe/Leavitt Rumble in the High Tech Jungle!" to the list of interesting views in the 6/9 addendum above.

Post Title → Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences issued a report of its Committee on Conflict of Interest in Medical Research, Education and Practice. The report is comprehensive, even exhaustive, running to 353 pages. Gardner Harris in the New York Times today calls it “scolding,” “stinging,” and “damning.” The recommendations go well beyond any proposed in the recent past by medical schools or by other professional organizations. The NYT quoted David Rothman, president of the Institute on Medicine as a Profession at Columbia University: “With the I.O.M.’s endorsement, issues that were once controversial now are indisputable. Conflicts of interest in medicine are no longer acceptable.”

It will take some time for the field to digest the scope of the IOM recommendations. It will take even longer for the new standards to be implemented. For now, I offer just a few observations.

First, if the IOM hopes for maximum credibility then it might ought want to do some housecleaning. A few years ago I fired a shot across the bow of the IOM concerning COI. [Can the Institute of Medicine Review the FDA? Nature Medicine 11, 369 (1 April 2005) doi:10.1038/nm0405-369] Nothing much changed, and in the following years, national scandals erupted involving several of the issues I had highlighted. Prominent IOM members, who were well known to be poster boys for COI, were exposed by Senator Charles Grassley (R-Iowa). Their embarrassing behaviors included incomplete financial disclosures and noncompliance with NIH policy on financial conflict of interest. The exposés included Emory’s Charles Nemeroff and Stanford’s Alan Schatzberg. In both cases, administrative rearrangements have now been implemented. The case of Dr. Nemeroff has been referred by Senator Grassley to the Inspector General of the Department of Health and Human Services. It is perhaps no accident that Dean Claudia Adkison of Emory and Dean Philip Pizzo of Stanford were included as external reviewers of the draft IOM report. Their insights would have been invaluable.

Another ongoing embarrassment for the IOM is Lester Crawford. He was the FDA Commissioner who resigned abruptly in 2005 and later pleaded guilty to criminal conflict of interest. He had been charged with falsely reporting information about his stock holdings in companies he was in charge of regulating. He received a sentence of three years of supervised probation and a fine of about $90,000. He is now senior counsel with a health care lobbying firm in Washington, DC. The Institute of Medicine does not help its image by continuing the membership of such a compromised individual.

As the Emory-Nemeroff and Stanford-Schatzberg cases unfolded it appeared that the respective institutions had themselves contributed to the problems, either through inaction or through studiously nontransparent procedures on disclosure. Stanford, for instance, apparently did not require faculty members to report the proceeds of stock sales, and when challenged the university invoked on-line financial reporting services and SEC filings as a sufficient substitute. Not surprisingly, because Stanford didn’t know about Dr. Schatzberg’s realized gain of some $109,000 from sale of founder’s stock in his biotech start-up company, Corcept Therapeutics, this information was not reported to NIH.

Recommendation 4.1 One of the IOM’s recommendations applies particularly to the Stanford-Schatzberg case. Recommendation 4.1 addresses the boundary between academia and commerce in the case of research involving human subjects. Here is the specific language:

“Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).

Last year I posted several times about this issue in the Stanford-Schatzberg case. It is gratifying now to see the IOM affirm the importance of the boundary. The activities declared off-limits by the IOM include not only “recruiting subjects; obtaining informed consent; assessing the clinical end points;” but also “analyzing data; or writing the results, conclusions, and abstracts for publications reporting the findings of the study.” (page 4-17). In Stanford’s earlier plan for managing the conflict and protecting the integrity of the research, Dr. Schatzberg was free to engage in the latter group of activities. Indeed, his hands were all over the project when it came to responding to scientific critiques, managing the climate of professional opinion, attacking and threatening critics, promoting his company’s interest through review articles and press releases, slipping unpublished and non-peer-reviewed commercial data into academic reviews, and generally conducting commercially slanted public relations through academic outlets.

When Stanford adopts the IOM recommendations, such activities will be blocked. As I stated last year, “Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be.”

We should congratulate the IOM committee members for their work, and we hope to see the field embrace their recommendations.

Bernard Carroll.

UPDATE 04-30-2009: The link provided earlier for the IOM report document is no longer operative. Here is where to go now for a copy of the report. This time it will cost you.

http://www.nap.edu/catalog.php?record_id=12598

Post Title → INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

Does Pharma Want its Researchers to Believe They Are Next to God?

In "Drug Maker Told Studies Would Aid It, Papers Say" (New York Times, Mar. 19, 2009), the Times discusses the case of psychiatrist Dr. Joseph Biederman. Dr. Biederman outlined plans to test Johnson & Johnson’s drugs including risperidone/Risperidal in presentations to company executives and seemed to guarantee positive outcomes for his studies of the drug, raising questions about his research.

Biederman has become a key witness in a series of lawsuits filed by state attorneys general claiming that makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines. His work helped fuel a rapid rise in the use of these medicines in children. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but about $200,000 of this income to university officials.

However, if a passage about Dr. Biederman's testimony in court is correct, I believe pharma should consider whether it wants to use someone who believes they are next to God in any capacity whatsoever.

There are certain damning statements that, once made by a person, cast a deep shadow over a person's character. I believe this one, if true, may rise to that level:

In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.

“What’s after that?” asked a lawyer, Fletch Trammell.

“God,” Dr. Biederman responded.

“Did you say God?” Mr. Trammell asked.

“Yeah,” Dr. Biederman said.

One does not usually joke in deposition.

I've been Yale faculty, and would never, ever have made anything even approaching such a comment, least of all in a deposition about drug issues affecting kids.

Let alone the the palm-greasing he was afforded, could Dr. Biederman's apparently hyperinflated ego have clouded his judgment and scientific objectivity?

In drug R&D, that is inherently an extremely dangerous proposition.

Where children are concerned, catastrophic might be a more apt term.

-- SS

Post Title → Does Pharma Want its Researchers to Believe They Are Next to God?

Cerner board member as Healthcare Czar

President Obama has declared that National Electronic Health Records are essential to curing healthcare's ills.

From MSNBC:

WASHINGTON - President Barack Obama will name former Clinton administration health official Nancy-Ann DeParle on Monday to lead the newly created White House Office on Health Reform, a U.S. official said.

DeParle, a former administrator of what is now the Centers for Medicare and Medicaid Services, will lead the White House office charged with coordinating Obama's ambitious healthcare reform efforts with Congress.

From the NY Times:

WASHINGTON — In picking Nancy-Ann DeParle to champion an overhaul of the nation’s health system, President Obama selected someone with deep roots in the Washington bureaucracy, an intimate familiarity with health policy and respect on both sides of the political aisle — not to mention degrees from Harvard Law School and Oxford University.

But in putting Ms. DeParle in charge of an issue that has bedeviled presidents for decades, Mr. Obama also chose to overlook Ms. DeParle’s business ties to companies that have a direct stake in the health care debate.

From Cerner Corp, one of the largest vendors of Health IT:

Nancy-Ann DeParle was appointed to Cerner Corporation's Board of Directors in May 2001.

From the former head of the UK's Connecting For Health National HIT program:

"Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that Cerner has put in recently is appalling ... Cerner and prime contractor Fujitsu had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."

From The National Programme for IT in the NHS: Progress since 2006 - Public Accounts Committee, Jan 2009:

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

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

This appointment appears to my untrained eye, on the surface, to be a problem, even with typical promises that these conflicts of interest will not affect decisions.

From the NY Times article:

White House officials said Ms. DeParle was severing ties with those companies and would recuse herself from participating in any matter that was “directly or substantially” related to former clients or employers.

That is a relief - somewhat. This HIT company is likely to make huge profits in coming years. Will Ms. DePerle give up all financial stakes in this company and industry she and/or her family may hold such as stock, options and other tangibles?

In a more general sense, can we as a country really trust such statements from business and government leaders any more? Should we?

The Washington and San Francisco Examiners have it about right in this common sense-filled editorial in which I am cited (I played no part in its appearance):

America’s foray into HIT will likely be a miss

Examiner editorial 3/2/09

There is a provision of the $878 billion stimulus package rushed through Congress for $20 billion to develop a centralized national health information technology system. Proponents claim HIT will save $77 billion during the next 15 years and greatly reduce medical errors. Who could possibly object to that?

Well, for starters, ask health care providers in Britain’s National Health Service, who have been trying to get their HIT system to work properly for the past five years. The cost of NHS’ HIT has escalated to six times the original estimate — the U.S. equivalent of $18.4 billion — to serve just 30,000 physicians in 300 state-run hospitals, a fraction of the health care providers in the United States.

In January, Public Accounts Chairman Edward Leigh reported to fellow members of Parliament that essential systems are late or, when deployed, do not meet expectations of clinical staff. HIT is such a mess that Leigh recommended funding alternative systems if matters don’t improve within the next six months. But even if HIT is eventually junked, British taxpayers will still have to pay for it.

The National Academies of Science noted that much of the electronic medical data collected in the U.S. is used mainly to comply with regulations or to defend against lawsuits, rather than to improve patient care. A large 2003-04 study of 1.8 billion ambulatory patients discovered that the use of electronic health records provided no difference in 14 of 17 quality-care indicators, produced significantly better care in just two and worse care in one. And, a summary of 33 studies done in Europe between 1985 and 2009 found that HIT actually causes a significant number of medical errors.

After spending billions of dollars during the past three decades, only 4 percent of U.S. physicians have a fully functional HIT system, according to Drexel University biomedical informatics professor Scot Silverstein — and its not because doctors don’t want to use technology. These expensive systems are just not designed for their extremely complex and highly specialized needs. In an open letter to President Barack Obama, Silverstein said HIT is an experiment that’s unproven on a large scale. Computers in hospitals have also been linked to the spread of MRSA, a deadly antibiotic-resistant staph infection. Yet, the same federal government that can’t keep its own military veterans’ medical records secure is bound and determined to spend $20 billion in a top-down, centralized effort that has a very good chance of messing up yours.

This raises several questions:

• Was Ms. DeParle as a board member at Cerner acting definitively when complaints such as those from the UK came in? And perhaps do a google search on terms such as healthcare IT failure?
  

• Will Ms. DeParle support or oppose needed federal regulation of an industry in which she holds (held) a Board Membership?
  

• With (former) board members of HIT companies whose products apparently caused the UK's CfH program to cry "uncle" now in positions of ultimate power over U.S. healthcare, and with an administration locked into irrational exuberance over HIT, should physicians in the U.S. also look forward to a forced cybernetic dystopia as at my series starting here?

Finally, this is not a piece against our President. He is not, nor expected to be, an expert in information technology and healthcare informatics. I actually feel sorry for him.

I feel sorry for him in letting reactionary and opportunistic corporate elements of the healthcare IT ecosystem lead him to make calls for full national HIT, along with penalties for nonadoption of this experimental and often defective technology, on the hyperaggressive, absurd and in fact damaging timeframe of five years, by 2014. See "Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless?" by Ford et al. And parroting the industry line, declaring with full confidence that Health IT will improve quality and decrease healthcare costs.

The evidence on both issues is, let's just say, far more contradictory and questionable than the evidence that VIOXX kills people.

-- SS

Post Title → Cerner board member as Healthcare Czar

Computer Bites Human? Healthcare IT Blamed in Patient Death at UPMC

Just as I'm finishing my semi-tongue in cheek post "Another Human Bites Dog Story? Health Affairs Briefing on Healthcare IT Challenges" on a remarkable new phenomenon of increasing candor from major organizations about the dangers of poorly conceived and implemented health IT, this tragic story crosses my inbox.

My comments are in [bracketed red italics]:

UPMC records blamed in death
By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Wednesday, February 11, 2009

The son of an 89-year-old woman who died on UPMC Montefiore's roof in freezing temperatures charged in court papers Tuesday that a new and untested electronic medical records system was a major factor in her death.

The complaint filed in Allegheny County Common Pleas Court claims the University of Pittsburgh Medical Center implemented the records system at Montefiore a little more than a month before Rose Lee Diggs' death, despite warnings from staffers that it was deficient.

[if you want to know how such warnings from medical personnel can possibly be ignored, read "Why was this site created?" in the introduction to my website on health IT failure - ed.]

Diggs, a survivor of multiple strokes and under treatment for dementia, was under the care of medical staff struggling with a system that "they were not properly trained on," placing patients "at a severely increased risk of harm and death," the lawsuit states.

[Imagine a jet pilot distracted by clunky, ill designed instruments designed for a submarine, say, by people with no aeronautical background, with skimpy training, and the resultant consequences - ed.]

UPMC spokesman Frank Raczkiewicz said he could not comment because hospital attorneys had not seen the complaint. He noted the hospital implemented an alert system following Diggs' death "to quickly find patients who wander from their units."

Family attorney Rob Peirce charges in the lawsuit that UPMC ignored warnings that the records system could put patients at risk because the health conglomerate has an ownership interest in the company, Cerner Corp., that developed the records system

[Healthcare Renewal, of course, has great disdain for such conflicts of interest and how they ultimately affect healthcare professionals and their patients - ed.]

Security and Exchange Commission records show UPMC received 74,787 shares of Cerner stock in 2005. UPMC and Cerner have been involved in joint efforts to sell the recordkeeping system to health care facilities in the United Kingdom.

[Note: Cerner Millenium has not performed well in the UK, see this post and its report from the UK House of Commons, Public Accounts Committee, Items 5 and 6 - ed.]

Cerner, which is not named as a defendant in the lawsuit, did not respond to a request for comment.

Diggs wandered from her 12th floor hospital room about 5 p.m. Dec. 2, passing through three doors that should have been locked or outfitted with an alarm, up a flight of stairs and through a boiler room to the hospital roof. According to the lawsuit she was found dead, wearing only a hospital nightgown and slippers.

[Very tragic - ed.]

The lawsuit charges that UPMC officials, following the discovery of Diggs' body about 8 a.m. the next day, attempted a cover-up by removing faulty locks in the midst of a criminal investigation. That investigation by Allegheny County District Attorney Stephen A. Zappala Jr. and Pittsburgh police continues.

"UPMC's main objective was to destroy or tamper with important evidence in order to exculpate itself as opposed to the safety of Mrs. Diggs," the family claims in the lawsuit, which charges that UPMC waited an hour before notifying police after staffers found Diggs.

[if this is true, management changes such as in my first human bites dog posting "Physicians' Unexpected Un-Helplessness: Executives Invited To Leave Nashville-Based Healthcare System" may be in order - ed.]

... In a state report recently made public, UPMC was cited for the malfunctioning door locks and failing to develop a care plan to specifically deal with Diggs' documented history of wandering.

The lawsuit claims a freeze on overtime, and the virtual elimination of a program to provide round-the-clock monitoring of patients with ailments such as dementia, occurred at the same time the recordkeeping system was implemented Oct. 24.

[I would like to know if any clinical or informatics persons made the connection as to the dangers of the temporal issue here, a real no-brainer except to those suffering either terminal Syndrome of Inappropriate Overconfidence in Computers, or terminal stupidity, and if such persons were ignored - ed.]

Sad story ... and nearly unbelievable if true. Then again, the foundational story behind my HIT difficulties website as mentioned above, written up in depth here, could have had equally adverse consequences, especially in an ICU of all places. (Imagine my horror when that administration would not support me, a clinician medical informaticist, against an arrogant, ignorant and lazy business IT department.)

This story is especially tragic since we already knew Bad Informatics Can Kill. Bad informatics in the company of overwork and cutbacks is simply homicidal in my view.

It's also sad that my ten year old website on HIT difficulty and failure, Lorenzi & Riley's book on managing organization change in health informatics, Koppel's articles on CPOE and barcoding, and many other works were publicly available that should have served as cautionary tales on such matters ... if they'd been taken seriously.

Perhaps this lawsuit and others (yet) unknown is a reason for the puzzling change of heart on the proscribed topic of HIT failure that I observed at the aforementioned human-bites-dog story?

-- SS

Post Title → Computer Bites Human? Healthcare IT Blamed in Patient Death at UPMC

Has Bioinformatics Hit A Hard Wall of Stagnation?

Is the field of bioinformatics in trouble?

I ask this due to two disturbing trends. The first is the misuse of bioinformatics for "dubious" purposes. The second is, has bioinformatics itself reached a wall of stagnation due in part to disciplinary insularity and resultant inadequate collaboration with its medical counterpart?

Terminology note: Bio-informatics is the application of IT to the field of molecular biology, as opposed to the broader Bio-medical Informatics. Biomedical informatics includes both bioinformatics and my field, Medical informatics, which deals with application of IT to patients, along with fields at different granularities such as public health informatics. See a diagram of these relationships in the PDF article here.

On the first issue, consider the following:

In "A Professor and an Anti-Aging Tonic", Roy Poses commented on an academic who may have violated the trust of patients by getting entangled with commercial interests, in this case with what seems a magic potions operation. He wrote:

Academics have long been trusted to seek and disseminate the truth in a spirit of free enquiry. Academics who use their reputations to sell products, and take advantage of their reputation thus to enrich themselves, violate this trust. When the academics who do so are medical academics (even if they are not physicians), they also violate the trust of patients.

I will make observations about this story from different angles than Poses', that of misuse of a scientific discipline itself, and that of stagnation and insularity within that discipline, namely, bioinformatics.

In the WSJ story, it is noted that the protagonist, Harvard Medical School professor Dr. David Sinclair has a PH.D. in biochemistry and molecular genetics but isn't a medical doctor.

Also noted in the article:

In obtaining the backing of Dr. Sinclair this summer, Shaklee scored a coup. Dr. Sinclair knows resveratrol; in 2006, he led a study showing the molecule could counteract the ill effects of overfeeding laboratory mice. One notable benefit: resveratrol let overweight mice live about 114 weeks on average, compared with 102 weeks without the chemical.

Ph.D. in biochemistry and molecular genetics, and tests in mice.

If it works in mice, it's only a sign that human testing is then merited, of course. Well known from drug trials is that what works in animals often does not work, or can even be harmful to human subjects. Yet here we went from mice to people directly. A misuse of a scientific discipline, by either the company or the scientist, or both. Abracadabra!

Abracadabra!

This is indeed an unusual example. However, it seems many bioinformatics findings touted in the press and in biotech prospectuses are of associations that probably merit far more skepticism than received. When I see reports in the news that certain genetic markers are "associated with disease X", for example, especially in animal models, my wishful thinking radar (and/or fraud radar) lights up. See, for example, "Why Most Published Research Findings Are False" by John P. A. Ioannidis, PLoS Medicine, 2005 August; 2(8): e124 (full text and PDF available free here). Ioannidis writes:

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.

The article is worth reading in its entirety.

On the second issue, that of stagnation and insularity of bioinformatics:

Molecular genetics and bioinformatics are fields I am familiar with, having been a co-PI of IT in a genetics and birth defects collaboration with a desert kingdom where consanguinity rates are high, some years ago.

As a result of this background and obervations I made in collaborating with molecular and clinical geneticists, in 2002 I wrote the following, published in the journal Bio-IT World:

Bio-IT World
Aug. 13, 2002
Medical Informatics MIA

I enjoyed reading the article "Informatics Moves to the Head of the Class" (June Bio·IT World). Thank you for spotlighting the National Library of Medicine (NLM) training programs in medical informatics and bioinformatics, of which I am a graduate (Yale, 1994).

Bioinformatics appears to receive more media attention and offer more status, career opportunities, and compensation than the less-prestigious medical informatics.

This disparity, however, may impede the development of next-generation medicines. Bioinformatics discoveries may be more likely to result in new medicines, for example via pharmacogenomics, when they are coupled with large-scale, concurrent, ongoing clinical data collection. At the same time, applied medical informatics, as a distinct specialty, is essential to the success of extensive clinical data collection efforts, especially at the point of care.

Hospital and provider MIS personnel are best equipped for implementing business-oriented IT, not clinical IT. Implementing clinical IT in patient-care settings constitutes one of the core competencies of applied medical informaticists.

Informatics specialists with a bioinformatics focus — even those coming from the new joint programs — usually are not proficient in hospital business and management issues that impede adoption of clinical IT in patient care settings. Such organizational and territorial issues are in no small way responsible for the low utilization of clinical IT in patient care settings.

It will be important for medical informaticists focused in the clinical domain and bioinformaticists specializing in the molecular domain to collaborate with other specialists in order to best integrate clinical and genomic data. ...

Scot Silverstein, MD
Director, Published Information Resources & The Merck Index
Merck Research Laboratories

The key phrase is "It will be important for medical informaticists focused in the clinical domain and bioinformaticists specializing in the molecular domain to collaborate with other specialists in order to best integrate clinical and genomic data." In fact, the "with other specialists" was added to my original to appease others within the company who reviewed this letter for publication.

The Sinclair anti-aging matter reminded me of this issue. Here, we have a nonclinical molecular scientist experimenting on cells from animals, and apparently either he and/or the company extended these observations to possibilities in people, without involvement of clinician and/or Medical Informatics expertise. This is the issue I raised in my Merck letter.

There was no such collaboration at Merck. There is none at many universities, including my current one (the Ivies may be an exception; I enjoyed such collaboration a number of years ago as a Medical Informatics postdoc and then faculty at Yale School of Medicine). Colleagues report there was no such collaboration at GSK, or Wyeth, or several other pharmas.

I've also noted such organizations paradoxically don't even recognize Medical Informatics as an essential specialty e.g., "Why Pharma Fails", "CRO's: We don't need medical informatics here", "We don't need medical informatics here Part 2" and "GSK, Avandia and Medical Informatics: More on Why Pharma Fails."

I fear in the field of Bioinformatics, the lack of collaboration with Medical Informatics occurs frequently, and in fact billions of investor dollars might be going down the drain in the pursuit of cybernetic in-silico miracles as a result.

An observer and commentator with relevant industry and academic experience, Felix Fulmer, observed in addition to the misuse of bioinformatics, this second and even more critical issue. He surmises that perhaps bioinformatics itself has reached a point of stagnation, even when used with the best of intentions but without medical input:

People in specialized disciplines ignore closely related fields, often out of arrogance. They may suffer of professional disciplinary "blinders", and bioinformatics is a prime example.

Doesn't it seem that Bioinformatics has hit a hard wall of stagnation? There have been tens if not hundreds of billions of dollars invested in this area, and yet lately there have been few truly revolutionary, tangible products on the medical shelf as a result. Pharmas are re-evaluating their approaches to bioinformatics, in fact, and numerous restructurings (example) have occurred in what seems an increasingly desperate attempt to leverage this discipline beyond the 'interesting journal article.'

The bioinformatics field may need intentional, massive, deliberate involvement of medical informatics personnel in order to continue achieving the benefits it promises, rather than casual and semi-serious involvement as we see so far.

We can observe that in computer science there is not much to be learned from medical informatics. In fact, it would be somewhat strange if computer scientists became interested in medical informatics for anything other than an application of their research.

On the other hand, that "management science" shows no interest in medical informatics is not surprising since management science has taken the arrogant stance that it alone is a fundamental discipline requiring no input from others; that everything is a widget and everyone is a resource to be dealt with in exactly the same way with minimal input from specific domains. Management has a "domain agnostic approach" to practice. So if computer and management science don't collaborate with medical informatics, it is understandible.

But bioinformatics should certainly be aware of the vital necessity for the strongest of collaborations with medical informatics professionals.

I issue a challenge to any bioinformatics professional who reads this blog to tell me why medical informatics is not an essential discipline to work alongside in discovery of new cures. As a sign of disciplinary insularity, however, I will unfortunately bet that few if any bioinformatics professionals actually read this clinically related blog or blogs on related topics such as medical informatics.

(A corollary of the same phenomena of misuse of experimental fields such as bioinformatics, disciplinary insularity and overconfidence in computing is the use of informatics as a substitute for biological testing altogether. I wrote recently about that issue in "A 21st Century Plague? The Syndrome of Inappropriate Over-Confidence in Computing." I observed via "New Drugs, Virtual Tests", Wall Street Journal, Dec. 17, 2008, that the U.S. Food and Drug Administration plans to use "new computer technology" to simulate how some drugs in development are supposed to work, helping researchers and regulators spot safety and effectiveness issues before late-stage tests on humans are completed.)

As a final aside, perhaps VC's (venture capitalists) ought to take far more care when investing in bioinformatics. They should become better informed (e.g., by reading my site on difficulties in health IT due to failures of collaboration between technologists and clinicians), and invest in cross-disciplinary - not monodisciplinary - endeavors, because monodisiplinary approaches to medicine have probably been plowed dry.

There is likely little to be reaped, nor anything of truly major significance done by lab scientists alone. The low hanging fruit is all gone.

Once an oil field is dried up, it does not matter how many more wells one drills nor how deep one goes. One must accept that a field is dried up, and go elsewhere. Bioinformatics may be in denial and not willing to admit this understandable but unfortunate reality.

Final note: an excellent powerpoint presentation entitled "Seven Deadly Sins of Bioinformatics" by Prof. Carole Goble at the Univ. of Manchester, UK can be seen at this link.

Addendum: I've noted some comments at Reddit.com on this posting. Examples:

• Uh, yeah. Some professor (who isn't even a bioinformaticist) may or may not have endorsed a sketchy nutritional supplement with exaggeration of his own results, so clearly the entire field is "in trouble".
• Has Bioinformatics Hit a Hard Wall of Stagnation? No.

And these at The Life Scientists:

• That blog post is all over the place - a lot of incoherent ranting, I don't see the main message.
• Main messages - bioinformatics is stagnant (nor argument for it) and isolated from medical informatics (again no argument).

It is unclear whether the posters were bioinformaticists. However, it seems they do not fully understand how to proffer logical argumentation, nor respond to the challenge I plainly posted above.

Jan 8 - an interesting and useful discussion is now seen at the above Reddit site.

-- SS

Post Title → Has Bioinformatics Hit A Hard Wall of Stagnation?