Sham Studies and the Commercial IRBs that Approve Them, and Sham IRBs and the Government Department that Registers Them

We have occasionally posted about the activities of for-profit contract research organizations (CROs). These are commercial entities that conduct human research, including clinical trials for pharmaceutical, biotechnology and device companies. More clinical research is being done by such CROs rather than by academic investigators. CROs seem to operate under the radar of most physicians, academics, and policy makers, but sometimes stories surface that raise questions about them.

For example, we discussed the trials by SFBC International (now PharmaNet Development Group) in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post here and links backward); and the trial by Parexel International in London that put most of its subjects in intensive care (see post here, with links backward). Last year, as we discussed here, two articles questioning the ethics of research done under the auspices of CRO appeared in two major medical journals.

In academia, human research is supposed to be overseen by institutional review boards (IRBs). Research done by CROs is also supposed to be overseen by IRBs, but the IRBs that do so are often also commercial. Despite concern that commercial IRBs may be tempted to lower their standards to get more business, commercial IRBs have flown even lower under the radar than have CROs. However, last week, a story appeared about how a "sting operation" tested one commercial IRB with amazing results. Here are excerpts from the article by Alicia Mundy in the Wall Street Journal,

The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.

Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

'We realized it was a terrible risk for the patient … It is the worst thing I have ever seen,' an Argus IRB reviewer said, according to a slide shown at the hearing.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, 'Adhesiabloc.'

The GAO also ran an experiment to see if the US Department of Health and Human Services (DHHS)would register a truly dubious commercial IRB

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included 'April Phuls' and 'Timothy Wittless,' which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.

On one hand, these anecdotes suggest, along with the stories discussed above, that CROs and the commercial IRBs that are supposed to oversee them deserve further scrutiny. Beyond that, one wonders if it is good for society for human research, including experiments involving drugs and devices, to be done by commercial firms dependent for their income on the companies that make these drugs and devices, overseen by other commercial firms also dependent on these same companies. The fundamental conflict is embodied by Coast IRB's self-description:

as an advocate and a catalyst for an ever-stronger pharmaceutical industry, ethically and economically.

which also

recognizes the vital importance of our role in protecting individuals in all clinical studies and in continuously raising the bar on professional standards.

How can the company be an "advocate" for the industry while simultaneously protecting the people exposed to the industry's still experimental drugs?

See also comments on the GoozNews blog.

Will The True Incidence of Healthcare IT-Caused Patient Adverse Outcomes Please Stand Up?

The article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278 (JAMA) has caused much discussion in healthcare IT circles.

I have become aware of discussions centered on issues such as:

• The factors besides vendor design flaws and defects that contribute to the unsafe and ineffective use of health information technology,

• The degree of effect caused by end user organization customizations,

• whether a focus on legal or regulatory action is misplaced

• Whether such regulation could "stifle innovation", and

• Other interesting and stimulating related issues.
  

These discussions miss the forest for the trees, unfortunately.

They are all speculation.

I could just as easily - as a thought experiment - argue and rationally support a point of view that vendor defects, shortcomings, ill conceived user interfaces etc. are the greatest cause of HIT problems, that a sole focus on regulatory action is the best path, and that regulation would not stifle innovation but promote it by forcing complacent, lazy companies protected by the current status quo to become competitive, to hire the very best and brightest and most experienced who they now forgo as "too disruptive, too expensive, lack the latest programming skills", etc.

None of this speculation really matters in the big scheme of things.

What does matter is the fact that we now have before us a "grand confounder" - the anechoic effect caused by vendor contracting - that throws into doubt existing assumptions about HIT-caused errors.

Who among us can now say what the number of physician observed defects really is, what the rate of HIT error really is?

I've had several of my colleagues already tell me since the Koppel article that they know of HIT caused errors and even patient adverse consequences, but they are afraid to speak out. What is the morbidity and mortality change associated with use of HIT vs. paper?

Who really knows?

There is a significant, perhaps high likelihood that the current state of HIT contracting, and the muting effect it creates, combined with fear of retaliation by potential objective HIT reporters (a.k.a. whistleblowers) makes any such estimation highly questionable at best.

Speculation is irrelevant. What we need is a return to the rigor of medicine - to science - in HIT itself.

That can only happen in an environment where users are free(er) to share their observations and findings about HIT problems.

Such one-sided, safety adverse HIT contractual clauses must end.

-- SS

The Retirement of a Generic Manager

A frequent theme on Health Care Renewal has been the adverse effects of health care leadership by generic managers with no background or experience in health care, and no intuitive understanding of its values. This type of leadership arose after some health care economists called for abolishing the supposed physicians' "guild," and transferring power over health care to managers as a way to control health care costs. This has not lead to control of health care costs.

The recent coverage by the New York Times of the sudden retirement of the CEO of General Motors suggests that the notion that organizations should be run by generic managers is one whose time ought to be past. Wagoner presided over a dramatic decline in the fortunes of GM.

Mr. Wagoner presided over some of the biggest losses in G.M. history. In 2002, the company had predicted that it would earn $10 a share by the middle of the decade.

Instead, G.M. lost $30.9 billion in 2008, when its per-share loss translated to more than $50 a share. G.M. stock, an economic bellwether that sold above $35 only three years ago, closed Friday at $3.62; it has fallen as low as $1.27 in the last year.

In 1994, when he took charge of G.M.’s North American operations, the company made up 33.2 percent of auto sales in the United States.

Last month, G.M. represented only 18.8 percent of American car and truck sales....

The problem may have been, in part, that Mr Wagoner was never a "car guy."

'It’s a pretty unceremonious ending,' said John Casesa, an industry analyst and managing partner of the Casesa Shapiro Group. 'G.M. lost its way in the ’70s, but the company didn’t know it until 20 years late. The hole was much deeper than he realized when he became C.E.O.'

And, Mr. Casesa said, Mr. Wagoner’s finance background might have been a poor fit: 'The most successful auto companies are run by people who came out of the revenue-generating functions — manufacturing, design, marketing — making cars and selling cars.' Mr. Wagoner, the analyst said, 'skipped the whole apprenticeship that most auto C.E.O.’s experience.'

The notion that a finance guy should run a car company makes not much more sense than the notion that a finance guy (or marketer, accountant, or lawyer) should run a hospital or a drug company. Yet now most health care organizations are run by such generic managers. Is it any wonder that while such generic managers have made a lot of money, they have been unsuccessful in controlling health care costs, much less solving any other aspect of the the health are crisis?

Hedging the Future of the FDA?

A little while ago, we discussed the Obama administration's nomination for Commissioner of the US Food and Drug Administration (FDA), Dr Margaret Hamburg, focused on her current position as a director of Henry Schein Inc, a large distributor of medical products, including drugs and devices. There is another aspect of her nomination worthy of discussion, but which has not been publicly discussed. It has appeared almost as a footnote in a few reports of her nomination. For example, at the end of an article in the Chicago Tribune,

Hamburg is married to Peter Fitzhugh Brown, an artificial intelligence expert who is executive vice president and director of Renaissance Technologies, a privately owned hedge fund.

In this time of financial meltdown, hedge funds are more frequently mentioned in the press. Hedge funds are a relatively new, and generally opaque presence in the financial world. Hedge funds apparently buy and sell stocks, bonds, commodities, financial instruments, and use a variety of investment strategies. Since health care accounts for over $2 trillion of the US economy, it seems possible that hedge funds might be involved in stocks, bonds, and the finances in general of health care corporations. We therefore wondered Mr Brown's position at the hedge fund management company Renaissance Technologies might have something to do with health care, particularly with health care corporations that make products regulated by the FDA. It turns out that this question has no simple answer.

Hedge funds are often described as secretive and lightly regulated. This seems accurate, as it is not easy to find out much about their operations, strategy, holdings, or leadership. My usual Google searching tricks did not turn up much useful about Renaissance Technologies.

Most helpful was a 2008 article in Bloomberg News, which labeled the company as "the world's largest hedge fund manager." It was managing $35.4 billion in assets in September, 2007.

The Bloomberg reporter's attempt to find out something about the company's strategies was a failure, summarized by his conclusion, "nobody knows precisely how the firm makes its millions." When the funds founder, Jim Simons, was asked what he can say about his trading strategy, he answered, "not much." The instruments he trades? - "everything." The strategies he uses? - "a lot."

The only publicly available information about the company's holdings is in its 13F filings with the US Securities and Exchange Commission (SEC). The 2009 filing, covering 2008, is here. The filing only covers long stock holdings at the end of the year. Lacking a research staff, I have not been able to go through the voluminous report in detail, but do note that the company at times invested in health care corporations from A ([Abbott Laboratories, valued at $88,909,000) to Z (Zimmer Holdings, $7,858,000).

I had little luck finding out the role of Mr Brown within the company, and whether he has any personal responsibility for making decisions about investments in any health care corporations. But I did find that a prominent Renaissance Technologies fund, the Medallion Fund, worth $6 billion in July, 2007, is owned mostly by Renaissance Technologies employees, presumably including Mr Brown, not outside investors, "Medallion stopped taking new money from outside investors in 1993 and returned pretty much the last of their capital 12 years later. Today, the fund is run almost exclusively for the benefit of the Renaissance staff." Furthermore, most of Renaissance Technologies is now owned by its founder and a few top officers, including in particular, Peter Fitzhugh Brown, who the Bloomberg article reported as owning "5-10 percent."

So, does Mr Brown's position in and partial ownership of Renaissance Technologies amount to a conflict of interest with respect to his wife's proposed position as Commissioner of the FDA? It is not clear. Mr Brown works for a company that manages billions of dollars, and likely a good chunk of that money is invested in instruments related to health care corporations. Mr Brown now presumably a goodly number of shares of the company's premier fund, and owns a substantial minority interest in the company as a whole. Hence he indirectly probably owns a substantial amount of such instruments. Whether he has any direct decision making responsibility for the buying and selling of such instruments is unclear.

Therefore, it seems that Dr Hamburg actually has a "potential conflict of interest" arising out of her husband's role in Renaissance Technologies. In academic conflict of interest policies, that phrase often appears without a definition, perhaps to soften the words so often applied now to medical academics. But this seems to be a real instance in which it should be used.

The shadows cast by the increasing opacity of the world of finance, now dominated as never before by organizations such as hedge funds that control large pools of investment about which regulations compel little disclosure, now seem to be darkening health care.

In my humble opinion, the Senate hearings on Dr Hamburg's confirmation ought to determine whether this potential conflict is more than that. Furthermore, we need a broader dialogue about how to dispel the shadows and secrecy that the dark arts of finance have spread to health care.

The Political Incorrectness of Discussing Conflicts of Interest in Medical Academia

From today's Boston Globe,

Tufts University has withdrawn an invitation for a top aide to US Senator Charles E. Grassley to give the keynote speech at a conference on conflicts of interest in medicine and research, leading one conference organizer to pull out and question the university's commitment to academic freedom.

The University-wide Committee on Ethics rescinded the invitation on March 13, according to e-mails obtained by the Globe. The messages said top Tufts officials refused to allow other administrators to be panelists at the meeting if Grassley's aide spoke, saying it was inappropriate to do so while Grassley is investigating ties between a Tufts professor and the drug industry.

The senator, a Republican from Iowa, sent a letter on Feb. 17 to the president of Tufts, Lawrence S. Bacow, requesting detailed information on the relationship between a 'Dr. Boucher' and the pharmaceutical industry, including the amount and dates of all industry payments between January 2006 and December 2008. Dr. Helen Boucher is an infectious diseases specialist at the Tufts medical school.

Spokeswoman Christine Fennelly first said in an e-mail that when Grassley declined the invitation, 'it was decided to refocus the symposium on a smaller scale, where the panelists would be faculty from Tufts University and affiliated faculty from Tufts Medical Center.'

Later, when told that Krimsky's e-mails explicitly said the speaking offer was rescinded, she said the invitation to Grassley's aide had been withdrawn. 'Indeed . . . the administration felt it prudent to not engage someone from the Senator's office while we respond to the Senator's inquiry,' she wrote.

One only has to browse the FIRE (Foundation for Individual Rights in Education) web-site to see the sad state of free speech and academic freedom in American universities. Most of the cases they discuss seem to involve barriers to presenting politically incorrect viewpoints on campus. FIRE has presented several cases involving dis-invitation of speakers with such views.

On the other hand, on Health Care Renewal we have discussed our share of cases involving free speech and academic freedom in academic medicine. Most of these cases seem to involve barriers to presenting research results that turn out unfavorable to vested financial interests, particularly interests served by the promotion of particular health care products, like drugs or devices, or services.

This case appears to be something of a hybrid. Like a number of cases discussed on the FIRE web-site, it involves the dis-invitation of a campus speaker whose viewpoint might not fit with that of the powers that be on campus. However, instead of causing offense because of his political positions, Mr Thacker seemed to cause offense because he has been involved in investigating conflicts of interest affecting medical academics. Thus, it seems that discussing such conflicts of interest has become politically incorrect. This seems to be a fairly blatant instantiation of the anechoic effect.

See also comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

ADDENDUM (31 March, 2009) - also see comments on the Effect Measure Blog.

This Former Chief Medical Informatics Officer is Feeling a Bit Betrayed

In thinking further about the "hold harmless" and "defects gag clause" originated by Health IT vendors and agreed to by hospital executives as I described at Have Hospital Executives Violated Their Fiduciary Responsibilities by Signing Such Contracts?, I can state I feel a sense of (past) betrayal.

Only now thanks to a Penn sociologist and a software consultant (plus the fortitude of JAMA, under some criticisms recently on other matters, in publishing this article) do we formally find out that hospitals have been literally "dumping" on physicians by signing contracts with the HIT vendors leaving the docs "holding the bag" for software errors and malfunctions, and gagging their organizations from openly talking about defects and problems. In other words, physicians hold the risk, everyone else holds the money.

Actually, since EMR mostly benefits the payers, I'd more correctly say hospital administrations have largely sold physicians down the river, an act that echoes of contempt and betrayal let alone breach of fiduciary responsibility and the Joint Commission standards I believe apply as in the post linked above.

It's not as if hospital administrations cannot negotiate these issues, nor are they forced to sign such provisions if vendors refuse to negotiate. They could send such vendors out the door. If this had been done as a routine by hospital executives, the health IT vendors would have been forced to give in years ago. Health IT was and is not mandatory for operations; the latest survey in NEJM indicates only ~9% of hospitals are using EMRs.

I also believe possible claims of ignorance and/or "we didn't read the fine print" don't fly. Hospital execs have the responsibility and duty to research such issues and read the fine print, or at the very least counsel did. In effect, at best the spinelessness of hospital administrations over the years may have spoiled the vendors to expect such concessions. (One also wonders about special "incentives" that might make hospital administrations weaker than they might otherwise be on such issues.)

Now I better understand perhaps why as CMIO/Director of Informatics at Christiana Care Health System in the late 1990's I never got to see the HIT contracts. I likely would have been a lot less eager to try to "sell" the EMR idea to the medical staff if I had been aware of the "vendor held harmless" provisions they faced if a software design problem or glitch in these immensely complex devices contributed to patient harm. I also feel betrayed in my CMIO role by not being informed of these contract provisions.

I wonder how many former and present CMIO's out there are now thinking along the same lines.

Ironically, as a Group Director at Merck Research Labs two years later I did review my department's informatics contracts, in fact I was required to, all several million dollars' worth, and in fact was involved in vendor negotiations (I had a personal grant of authority of $100,000 for smaller contracts). Pharma truly reveals hospitals for the IT backwater they are.

Finally, there appears to be a mainstream media boycott of the Koppel/Kreda article. As of 1:30 PM EST March 26, Google news shows almost no coverage except JAMA, ZDNet and Fox Business News. With Google web search, I find mostly copies of the U. Penn press release, and links to a few blogs, including this one.

I've previously noted this fascinating, Google-revealed phenomena about media noncoverage of politically inconvenient stories.

I've contacted the WSJ who printed my editorial letter on Health IT last month. Perhaps they'll get the scoop on the issues raised by Koppel and Kreda.

-- SS

Health IT "Hold Harmless" and Defects Gag Clauses: Have Hospital Executives Violated Their Fiduciary Responsibilities By Signing Such Contracts?

July 2009 - Note: also see my letter to the editor in JAMA on this same topic, "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", published July 22, 2009, available online at this link.

Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses as revealed by the JAMA article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians by Koppel and Kreda:

Have hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well?

Fiduciary (fidOO'shēe"rē), in law, a person who is obliged to discharge faithfully a responsibility of trust toward another. Among the common fiduciary relationships are guardian to ward, parent to child, lawyer to client, corporate director to corporation, trustee to trust, and business partner to business partner. In discharging a trust, the fiduciary must be absolutely open and fair. Certain business methods that would be acceptable between independent parties dealing with one another “at arm's length” may expose a fiduciary to liability for having abused a position of trust.

Hospital management conduct is not bound by traditional business law only, just as physicians and other clinicians hold additional obligations. In both cases, obligations go beyond that of, say, a manager or worker at a McDonald's or a Wal-Mart. In healthcare there are "special" third parties involved with critical rights and responsibilities, namely, patients and clinicians.

At Health Care Information Technology Vendors' "Hold Harmless" Clause I expressed great concern about the remarkable revelations in Koppel and Kreda's expose of arguably unethical and clearly inexcusable contracting practices by healthcare IT producers and vendors.

The vendors have declared themselves off limits from liability even if patients die as a result of software defects and malfunctions, pushing that liability onto clinicians. Vendors have simultaneously declared themselves the Ministry of Information, Soviet style, on such defects.

I also expressed my concern that the contractual suppression of information dissemination on health IT problems and defects may be one reason websites on health IT difficulties, such as the site I started in 1998 (in fact cited by Koppel and Kreda) remain uncommon on the Web. This is despite my documentation of continued, ongoing, world wide interest in this topic (see my 2006 AMIA abstract on this issue here, PDF, and poster here, PPT).

It is not just the vendors who may be acting against the best interests of medical science and patient safety, however.

It also seems to me that hospital executives, boards and counsel have fiduciary responsibilities, as well as obligations under principles of due diligence, Joint Commission and other regulatory guidelines, etc. to protect not just patients from defective technologies but also to protect their staffs from unfair risks and legal liabilities. I note that these health IT contracts have apparently been signed willingly by hospital executives, against the best interests of patients and medical staffs. Nobody is holding a gun to their heads, and nobody is forbidding negotiation of terms.

As a former CMIO/Director of Informatics I would never have signed such a contract. Period. (Of course, CMIO's and Directors of Informatics don't generally sign or even see health IT contracts, as they are Chiefs and Directors of Nothing.)

Have hospital executives, boards of directors and counsel been violating their responsibilities and obligations every time they've signed a healthcare IT "hold vendors harmless, it's all on your docs" and "shhhh! keep the defects secret" contract? Have they abused their positions of trust?

NIH research leaders and grant reviewers, as an example, consider seriously any problems with research that might place not just research subjects but also investigators at risk, medically, legally and otherwise. I perform this function on NIH study section panels.

Let's look at the Joint Commission Hospital Accreditation Program Leadership Chapter, and its standards for hospital leadership (link, PDF):

Leadership
LD.01.03.01

Standard LD.01.03.01
The governing body is ultimately accountable for the safety and quality of care, treatment, and services.

Rationale for LD.01.03.01
The governing body’s ultimate responsibility for safety and quality derives from their legal responsibility and operational authority for [organization] performance. In this context, the governing body provides for internal structures and resources, including staff, that support safety and quality.

The governing body has a legal responsibility for safety and quality, not just a moral obligation. One of the "internal structures" is healthcare IT that is safe and effective and that does not expose patients or staff to undue risks.

How does signing "hold harmless" and "defects gag order" clauses with an HIT vendor serve such a purpose, exactly?

Hospital executives know, should know, or should have known that such provisions would remove incentives for health IT vendors to produce the best products and to correct deficiencies rapidly, thus increasing risk to patients and clinicians.

Elements of Performance for LD.01.03.01
5. The governing body provides for the resources needed to maintain safe, quality care, treatment, and services.

One of those resources is health IT.

Standard LD.02.01.01
The mission, vision, and goals of the [organization] support the safety and quality of care, treatment, and services.

Rationale for LD.02.01.01
The primary responsibility of leaders is to provide for the safety and quality of care, treatment, and services. The purpose of the [organization]’s mission, vision, and goals, is to define how the [organization] will achieve safety and quality. The leaders are more likely to be aligned with the mission, vision, and goals when they create them together. The common purpose of the [organization] is most likely achieved when it is understood by all who work in or are served by the [organization].

How is a contract with an HIT vendor that calls for hiding defects in health IT and exposing staff to liability for defects in same serving the above purposes?

Standard LD.02.03.01
The governing body, senior managers and leaders of the organized medical staff regularly communicate with each other on issues of safety and quality.

Does that include communication on health IT defects? Can a medical staff member ask to see a database of such defects when the hospital has signed a nondisclosure of defects agreement with an HIT vendor?

Rationale for LD.02.03.01
Leaders, who provide for safety and quality, must communicate with each other on matters affecting the [organization] and those it serves.

I ask the same question as above.

Standard LD.03.01.01
Leaders create and maintain a culture of safety and quality throughout the [organization].

Safety for whom, exactly? Patients, or patients and staff?

How is exposing professional staff to undeserved liability from defective health IT serving the creation of a culture of safety and quality for them? How is suppressing information on health IT defects and problems helping patient safety and care quality?

How is lack of seeking informed consent on health IT use from patients whose care is mediated by health IT devices with known but undisclosable defects creating a culture of quality?

How is hiding such defects creating a culture of quality in the community's other hospitals, that may be considering purchase of the very same health IT?

Standard LD.03.04.01
The [organization] communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, [patient]s, families, and external interested parties.

Rationale for LD.03.04.01
Effective communication is essential among individuals and groups within the [organization], and between the [organization] and external parties. Poor communication often contributes to adverse events and can compromise safety and quality of care, treatment, and services. Effective communication is timely, accurate, and usable by the audience.

Are physicians and nurses explicitly informed by administration that clinicians are liable for bad outcomes due to software problems? Are they informed of the gag clause? Are patients informed of unremediated health IT defects existing at time of service?

This standard seems a veritable smoking gun regarding breach of fiduciary responsibility and Joint Commission obligations when hospital leadership signs agreements specifically excluding the sharing information about health IT defects and complaints. It is already known that hospitals maintain lists of health IT defects, some in the thousands of items. A number of the defects rise to the level of creating considerable risk to patients, and nobody is in a hurry to remediate them. (See my proposed although somewhat tongue in cheek "HIT Informed Consent" that describes some of these known defect categories here).

Standard LD.04.04.03
New or modified services or processes are well-designed.

... 3. The hospital's design of new or modified services or processes incorporates: Information about potential risks to patients.

4. The hospital's design of new or modified services or processes incorporates: Evidence-based information in the decision-making process. Note: For example, evidence-based information could include practice guidelines, successful practices, information from current literature, and clinical standards.

How does the contractual inability to communicate about health IT defects, which its executives willingly sign, serve this purpose?

Standard LD.04.04.05
The [organization] has an organization-wide, integrated [patient] safety program.

... 12. The hospital disseminates lessons learned from root cause analyses, system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation.

Disseminates lessons learned, except when the HIT contract they've signed with a vendor forbids it, that is.

The practices of the health IT industry, and the dealings of the hospital leadership with that industry, may in fact be a scandal of national (or international) proportions.

I urge physicians and concerned others reading this to read the Univ. of PA press release "Why Are Healthcare Information Manufacturers Free of All Liability When Their Products Can Result in Medical Errors?" here, obtain the JAMA article by Koppel and Kreda, and call their congressional and other representatives to have these self-serving industry practices that ignore protection of patients and practitioners from undue jeopardy stopped.

I also believe any clinician under lawsuit related to hospital HIT malfunction, and/or patients harmed, should consider suit against the management that signed the contracts allowing the defective IT's entry into the hospital and mandated clinicians to use the HIT.

I, for one, already have begun discussing these issues with my representatives in Washington, and they've expressed great surprise at these revelations.

-- SS

BLOGSCAN - The Mysterious Disappearance of a Report Critical of Industry Funding of CME

On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed the mysterious disappearance of a report by the AMA's Council on Ethical and Judicial Affairs (CEJA) which recommended the end of commercial funding of continuing medical education (CME). The report was tabled, and is now no longer available on the AMA web-site. (Although, it has not completely vanished off the webs. See the comments on Dr Carlat's post.) Meanwhile, the AMA has posted a series of "fact sheets" from their National Task Force on CME Provider/Industry Collaboration which seem notably friendly to "collaboration" among educators and industry.

Health Care Information Technology Vendors' "Hold Harmless" Clause - The Largest IT Industry Abuse Ever?

Dear fellow physicians, nurses and other clinicians:

You thought frivolous medical malpractice suits were a problem?

Guess what:

It's worse. Along with your patients you are nonconsented beta testers and experimental subjects of the health IT industry, and potential victims of the computer industry's arrogance and dysfunction.

In the remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that:

Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [Yes - we're all knowing magicians with the power to read minds, infer incorrect lab values via therapeutic touch, and possess encyclopedic knowledge in our heads at all times. This raises the question: if we are that omniscient to be able to identify and correct software faults with 100 percent accuracy to avoid patient harm, then why do we need electronic medical records at all? - ed.]

Also see the Univ. of Pennsylvania press release "Why Are Healthcare Information Manufacturers Free of All Liability When Their Products Can Result in Medical Errors?" here.

In the new Koppel and Kreda JAMA article we also learn that:

HIT implementations are massively complex, and are fraught with delays, errors, resistance, work process redesign, frustration, and outright failure. Healthcare facilities cannot predict the myriad scenarios in which software failures could result in patient harm and liability, and they are not likely to be knowledgeable a priori about frequent vendor updates.

We additionally learn that:

The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults.

[This is simply astonishing. In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects, while clinicians -- through their ingenuity, their labor in finding defect workarounds, and their liability -- serve (as I've written) as captive beta testers and an insurance company for HIT vendors - ed.]

These observations are nothing short of astonishing. They do help explain, however, the near silence of hospitals and their executives regarding healthcare IT faults, an observation I made in this 2006 AMIA presentation about the scarcity of such information:

Access Patterns to a Website on Healthcare IT Failure (Abstract [pdf], Poster [ppt].)

The Joint Commission also made this observation in their Dec. 2008 Sentinel Events Alert on Health IT:

There is a dearth of data on the incidence of adverse events directly caused by HIT overall.

The new JAMA article may also explain why HIT is so often done so poorly as to present a mission hostile user experience, as I started to write about a decade ago at my healthcare IT difficulties website here, as I outlined in an eight part series starting here, as the American College of Physician Executives noted here, as the National Research Council noted here ("Current Approaches to US Healthcare IT are Insufficient"), and as many others noted as well:

Healthcare IT News (3/10, Merrill) reported, a survey conducted by the American College of Physician Executives found "that although more physician leaders are using healthcare information technology, they still find it clunky and unresponsive to their needs." The survey of 1,000 ACPE members "revealed that the biggest source of frustration is a lack of input from physicians when designing and implementing healthcare information technology systems. Many said involving clinicians at the planning stages would pre-empt many of the problems that crop up later." One respondent noted that "systems are chosen according to administrative criteria rather than what physicians need."

Without accountability, a manufacturer is unmotivated to produce quality products at the expense of profits. They become complacent and lazy. This is an excellent reason why major HIT applications are as abhorrent as they are and violate so many fundamental principles of human computer interaction and resilience engineering.

It can also explain why talent management within the vendors is biased against hiring medical informatics experts, who would resist intellectual laziness of their non-informatics profit oriented (and unaccountable) counterparts.

Koppel and Kreda note that such stipulations defeat patient safety efforts and are contrary to the principles of evidence based medicine. I can add that such stipulations are contrary to the principles of good engineering.

These stipulations further instantiate my observation that health IT lacks the rigor of medical science itself, its major Achilles heel. This is one reason why I believe a national HIT initiative at this point in time is going to be, as in the UK, nothing short of an expensive debacle.

The existence of "hold harmless" clauses and gag orders raises many questions:

• Clinical supervisors of other physicians are indeed practicing medicine. Are Health IT vendors in fact practicing medicine by cybernetic proxy via these IT systems?
• Aren't the vendors' own claims of revolutionary healthcare quality improvements mediated via EMR's, alerts and reminders, clinical decision support, etc., malfunctions of which physicians may be held liable, prima facie evidence that the vendors are in fact practicing medicine by proxy?
  
• Should not these purveyors of cybernetic (i.e., virtual) medical devices be held accountable for their products, as in the pharmaceutical and the non-cybernetic (i.e., physical) medical device industries?
  
• How did such a situation regarding critical healthcare devices arise?
• In what other healthcare or other technology intensive industries, if any, do similar conditions exist, and what are the repercussions?
  
• How long has this situation existed?
• Why is it tolerated by clinicians?
• Why is it tolerated by clinical leaders?
• Why is it tolerated by medical professional societies, such as the AMA, the ACPE, etc., supposedly representing their members' interests?
• Why is it tolerated by hospitals and their executive leadership and boards of directors?
• Why is it tolerated by IS departments in hospitals?
• Why is it tolerated by hospital general counsel?
• Are there possible civil tort/RICO (racketeering)/criminal implications regarding patients injured by defective health IT where defects were known but not disclosed?
• Is not such a protective arrangement prima facie evidence that this technology is indeed experimental, with patients and clinicians as unconsented experimental subjects?
  
• Why is it tolerated by our government?

Regarding the last point, the Obama administration has promised an atmosphere of national accountability and responsibility. Why, then, has it simultaneously employed the coercive force of government (payment penalties for HIT non adopters after the absurdly short period of five years from now, 2014) to push an exploratory medical device from an unaccountable industry of unproven ROI at a cost of tens of billions of dollars on to the medical profession? This reality raises another question as I suggested in my WSJ Letter to the Editor of February 18, 2009. I wrote:

Dear Wall Street Journal:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

In other words, was the administration misled by the health IT industry? I believe it might have been.

As an example, Mr. Obama's healthcare IT policy campaign adviser per the WSJ Glen Tullman, CEO of HIT vendor AllScripts and Board member of the industry-created government contractor CCHIT ("Certification Commission for Healthcare IT"), probably didn't tell Mr. Obama his company was selling goods that did not function properly. (Here is a link to my organization's Civil Complaint against AllScripts, PDF). We apparently cannot know how many other organizations had their own complaints that might not have made it into litigation, due to the aforementioned gag orders. (Ironically, I found out about the lawsuit at my own organization only through an anonymous comment at the HIT gossip site HISTalk.)

Incidentally, by matter of pure speculation, I was not permitted involvement in that implementation despite having been a pioneering CMIO at a larger healthcare system years prior and the only formally educated medical informaticist at my organization. My writings on health IT dysfunction were well known to the IT staff and likely the vendor after a short web search; it would have been in the vendors' interests to keep me away from sales and implementation of known deficient health IT. Again, this is simply speculation.

On the other hand, I am aware of major healthcare organizations with "portfolios" of hundreds or thousands of issues and defects awaiting remediation, and CMIO's struggling against cavalier bureaucracies who want the doctors even in critical care areas to live with the problems, and vendors who are not in a hurry to fix their products.

Some of the problems rise to the level of critical with regard to patient safety. Under contract, the problems cannot be disclosed to the public, to patients whose care might fall under the aegis of these systems, or to other healthcare organizations seeking the same systems. I hope to be a plaintiff's witness when the inevitable lawsuits for patient injury place such capricious vendor, hospital and IT leadership on the witness stand.

Finally, in fairness the JAMA article discusses issues beyond the vendors' control such as misuse or poor training done by the host organization using the IT.

Possible remedies to the situation of unaccountability for the outcomes of HIT misdesign, malfunction and other defects are outlined in the article. See it or the press release at the above links if you lack JAMA access.

As I've written numerous times on this site, due to the implications and especially now due to the revelation that the scarcity of adverse events information related to HIT is probably by design, I favor stringent health IT regulation as in pharmaceutical IT.

Whatever happens, however, I know this. For the sake of patient safety:

This sorry, abusive and inexcusable travesty must end ... now.

Finally, to health IT vendors, as my early medical mentor, pioneering cardiovascular surgeon and educator Victor P. Satinsky, MD might have said:

If you can't take the heat of the responsibilities of clinical medicine, then get out of our kitchen.

-- SS

JAMA Editors Try Attacking the Messenger

Early this month, yet another story surfaced about allegations of undisclosed conflicts of interest affecting the author of a highly publicized clinical trial. This story has now taken such an odd twist that it seems worth discussing in some detail. Let me first try to present some relevant facts, derived from published articles, mainly peer-reviewed, which do not seem to be in dispute, in chronological order.

2005 - In a multi-author review article on mood disorders in the medically ill, Dr Robert G Robinson, of the University of Iowa, disclosed that he served on the speakers bureau of Forest Laboratories.(1) In an article in Stroke: Clinical Updates, he made a similar disclosure.(2)

28 May, 2008 - Dr Robinson was the first author of an article published in JAMA that described a randomized controlled trial comparing placebo, problem-solving (cognitive talking) therapy, and escitalopram (Lexapro, Forest Laboratories) in the prevention of depression in patients who have had strokes.(3) Patients who received placebo had a higher rate of depression (11 major, 2 minor cases, 22.4%) than patients who received escitalopram (3, 2, 8.5%) or who received problem-solving therapy (5,2, 11.9%). At the end of the article, Dr Robinson disclosed, "over the past 5 years, Dr Robinson reports serving as a consultant to the former Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company," but made no disclosure about any financial relationship with Forest. In a news article published the day before, Dr Robinson was quoted as saying, "I think every stroke patient who can tolerate an antidepressant should be given one to prevent depression," but did not advocate the use of problem solving therapy.(4)

15 October, 2008 - In a letter to JAMA, Lacasse and Leo asked whether Robinson et al had done an analysis directly comparing problem-solving therapy and escitalopram, and noted that the reported incidence data for stroke in the two treatment groups suggest that the difference in treatment results "does not appear to be either clinically or statistically significant."(5) Robinson et al responded that there was no statistically significant differences between the groups.(6)

5 March, 2009 - In a rapid response section in the British Medical Journal, Leo and Lacasse raised their concerns about the interpretation of the results of the 2008 trial, and also stated that "during a subsequent internet search we were surprised to learn that four years previously the lead author had been listed on the speaker's bureau for Forest. The omission, however innocent or mistaken, is disturbing; neither the JAMA article nor subsequent media accounts noted that the lead author had served on the speaker's bureau for the manufacturer of Lexapro."(7) Their citation was to our reference 2.

11 March, 2009 - In a letter to JAMA, Robinson and Arndt reported that the financial disclosure for their 2008 article was incomplete, "resulting from erroneous recollection of the appropriate dates for speaking presentations sponsored by pharmaceutical companies...."(8) Dr Robinson disclosed receiving honoraria for two presentations in 2004, and serving on the Forest Laboratories speakers bureau "in 2004 and perhaps 2005." No editorial comment accompanied this letter.

So far, this seems to be a familiar story about an author who seemed to be excessively enthusiastic about a product of the company with whom he had had a financial relationship, but reluctant to disclose this relationship. But wait,

20 March, 2009 - A rather extraordinary editorial was published electronically in JAMA on 20 March, 2009.(9) Let me review its main points, section by section.

After acknowledging the attention conflicts of interest now receive, and briefly describing the 2008 study and the subsequent letter by Lacasse and Leo, the editorial stated that JAMA editors had received a communication from Leo on or after 16 October, 2008 which "indicated he had evidence that Robinson had not reported in his article that he had served on the speakers bureaus for pharmaceutical companies."

The editorial then devoted several paragraphs explaining the "due diligence" JAMA editors used to investigate this "allegation." They noted the "sensitive nature of these investigations," which required them to conduct them "confidentially," and again insisted "these investigations into undisclosed conflicts of interest are time-intensive and require careful attention." Thus, from the time Leo sent his "allegations," (apparently 16 October, 2008), it took until 31 January, 2009 to get a letter from Robinson et al acknowledging his undisclosed conflicts, and until 11 March, 2009 to publish it, a total of five months.

However, the concerns with confidentiality, and the repeated emphasis on the need for unusually painstaking investigation seemed disconnected to the particular case. It is clear that it may take quite a bit of time and effort to investigate some allegations of undisclosed conflicts of interest, especially when the allegations are vague, but the alleged conflicts are severe. However, in this case, it should have taken trivial effort to find Dr Robinson's previous, published disclosures. (It took me about 5 minutes of internet searching to find the two 2005 articles.) Once (easily) discovered, the disclosures in the 2005 articles starkly contrast with the disclosures, or lack thereof in the 2008 article. Furthermore, since these disclosures were already in the public domain, there should have been no concerns with confidentiality.

Nonetheless, the editors then asserted:

While the confidential investigation of unreported conflicts of interest is under way, we consider involvement of third parties— such as Leo had done by his posting on the BMJ site and by contacting the media—to be a serious ethical breach of confidentiality that not only potentially damages our ability to complete a fair and thorough investigation (of the specific issue that Leo had brought to our attention), but also potentially damages JAMA’s reputation by the insinuation that we would fail to do so.

This makes no sense. There was no need for confidentiality, because the allegations were not based on whistle-blowing or confidential information. They were based on published articles, articles which clearly disclosed Dr Robinson's financial ties to Forest Laboratories. Anyone who bothered to do a simple Google search could have found that Dr Robinson's disclosure in his 2008 JAMA article did not agree with his disclosure in several 2005 articles. Lacasse and Leo used no confidential information whatsoever in making their allegations. Actually, they were not making "allegations," but simply pointing out that an author had published statements which were inconsistent. Since Lacasse and Leo were simply pointing discrepancies among published articles, how could they have breached "confidentiality," ethically or not?

Second, there was no need for a complex or prolonged investigation. The discrepancies were apparent as soon as one viewed the published articles side by side.

The third point was a non sequitur, and a classic example of blaming the messenger for the message. JAMA had published an article. Other journals published other articles. Publishing these articles put them in the public domain. If comparison of these articles in the public domain were to reflect badly on on of their publishers, it would not be the fault of making the comparison.

Regardless of the illogical nature of their concerns with non-existent confidentiality, assertions that it takes a long, complex investigation to demonstrate the obvious, and their aspersions on the messenger for the message, the JAMA editors then revealed that:

A telephone conversation intended to inform Leo that his actions were inappropriate transformed into an argumentative discussion, as Leo continued to refuse to acknowledge any problems with his actions, even after he was informed that the investigation was completed and was advised to read the upcoming March 11 issue of JAMA (where the letter of explanation and apology from Robinson and the formal correction were in press).

Furthermore, the editors proposed punishing Leo, first by effectively banning him from publishing in the pages of JAMA,

Leo also was informed that, if his actions represented his apparent lack of confidence in and regard for JAMA, he certainly should not plan to submit future
manuscripts or letters for publication.

Then, by complaining to his supervisor

However, since Leo apparently did not appreciate the serious implications of his actions, despite our attempts to explain, we felt an obligation to notify the dean of his institution about our concerns of how Leo’s actions were potentially damaging to JAMA’s reputation. We sought the dean’s assistance in resolving this issue involving a member of the faculty of his institution, to assure there would be no need to publicly identify that faculty member. No dean wants his or her institution implicated in a publication reflecting improper behavior by a faculty member.

Finally, they seemed bitterly offended that the British Medical Journal would publish anything that disagreed with anything printed in JAMA:

In addition, we were dismayed that BMJ would post the article by Leo with the allegations against Robinson and the negative insinuations about JAMA, without at least contacting JAMA to verify the veracity of the report.

Again, rather than raising unsubstantiated allegations, Leo and Lacasse's letter to the BMJ simply showed the discrepancy between the disclosures in Robinson and colleagues' 2008 JAMA article and those in one of his 2005 articles. Both articles are publicly available. What useful information about the letter above and beyond that provided by viewing the discrepant articles could the JAMA editors have provided?

While the JAMA editors castigated Leo for unethical behavior, and sought to punish him for it, they said nothing negative about Robinson. Yet it was Dr Robinson who was supposed to disclose his conflicts to JAMA, but who managed to forget conflicts that he had disclosed before. Why would would it be more unethical to point out publicly available evidence about failure to disclose conflicts of interest than to conceal these conflicts in the first place?

This story is saddening. JAMA has published many important and useful articles on conflicts of interest, and other matters relevant to Health Care Renewal. We have probably favorably cited more editorials by JAMA on these topics than those in any other journal. Yet now the journal's leadership seems to have somehow lost their way. Instead of trying to constructively respond to criticism, they now seem intent on punishing the critics. I hope they find their compass soon, before an important medical institution really is irreparably damaged.


Note: another detailed analysis of this case is here in the Hooked: Ethics, Medicine and Pharma blog. Here is Professor Leo's response to the JAMA ediorial.

ADDENDUM (24 March, 2009) - see also the extensive analysis of this case on the Respectful Insolence blog, and the comments here on the Effect Measure blog, here on Gooznews, and here on KevinMD.

References

1. Evans DL, Charney DS, Lewis L et al. Mood disorders in the medically ill: scientific review and recommendations. Biol Psychiatry 2005; 58: 175-189. [Link here.]
2. Robinson RG, Zorowitz RD. Pseudobulbar affect and stroke. Stroke: Clinical Updates 2005; XV (Jan-Feb). [Link here.]
3. Robinson RG, Jorge RE, Moser DJ et al. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA 2008; 299: 2391-2400. [Link here.]
4. Elias M. Study: antidpressants help stroke victims. USA Today, May 27, 2008.
5. Lacasse J, Leo J. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1757-1758.
6. Robinson RG, Jorge RE, Arndt S. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1758-1759.
7. Leo J, Lacasse J. Clinical trials of therapy versus medication: even in a tie, medication wins. Brit Med J, 2009: 338: b464. [Link here.]
8. Robinson RG, Arnd S. Incomplete financial disclosure in a study of escitalopram and problem-solving therapy for prevention of poststroke depression. JAMA 2009; 301: 1023-1024. [Link here.]
9. DeAngelis CD, Fontanarosa PB. Conflicts over conflicts of interest. JAMA 2009; 301: [Link here.]

Let's Deregulate Pharmaceutical Information Technology

... after all, a full Electronic Medical Record/Order Entry/Decision Support system is far more complex, with potential for far more immediate patient impact, then pharma's research IT systems. Yet the former is unregulated.

PhRMA, you should start lobbying to create your own private Certification Commission For Pharmaceutical IT (CCPIT) now. You can start certifying all your IT by going through a checklist of features, and avoid those pesky FDA inspections just as hospital do!

Seriously, my views are identical to that of Hoffman and Podgurski.

They expressed their views in the article "Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems", Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1, and now have summarized and amplified them in the short piece "Why Electronic Health Record Systems Require Safety Regulation", Bioethics Forum, Sharona Hoffman and Andy Podgurski, March 20, 2009.

Emphases mine:

...In light of these risks to patient care, federal regulations must establish rigorous quality control mechanisms. Currently, initial approval of EHR systems is conducted by a certification program operated by the Certification Commission for Health Information Technology, a private, industry-based organization. Our review of the certification criteria revealed that they are inadequate to ensure the safety and efficacy of EHR systems . For example, testing is conducted in just one eight-hour period , and the criteria do not explicitly address important issues such as safety and usability.

We believe that EHR systems should be scrutinized through a careful premarket approval process, including field testing at several facilities for at least six months. We also recommend local system oversight committees, based on the IRB model , that would oversee field testing and conduct postmarketing monitoring throughout the life of the product. Adverse event reporting would be mandated under this system to ensure that problems are detected and addressed swiftly and that the government intervenes when necessary to safeguard patient welfare.

Federal regulations should also require that all EHR systems meet specific quality standards. Audit trails and capture-replay capabilities should be required to facilitate discovery of both system and user errors, much as black boxes allow the reconstruction of conditions that led to aviation incidents .

... Because EHR systems will manage patient care to a significant degree, they must be subject to government oversight akin to the highest level of scrutiny required, in principle, by the Food and Drug Administration for complex medical devices ... Federal regulations should establish appropriate oversight and quality control through EHR system standards, approval processes, and ongoing monitoring requirements. It is only with careful oversight that providers can be assured of investing in high quality EHR products. And it is only with appropriate safeguards that the benefits of this very promising technology will be maximized–that health outcomes will improve and risks as well as costs will decline.

I do not think these suggestions are unrealistic.

After spending considerable time in pharma, to be consistent I say either we discontinue FDA regulation of pharma clinical IT, or we continue to regulate pharma's IT and add the even more complex provider healthcare IT to the pool of regulated medical devices.

-- SS

BLOGSCAN - The Over-Selling of Seroquel

The anonymous blogger on the Clinical Psychology and Psychiatry blog has been hard at work on the story of how research on Seroquel (quetiapine, by AstraZeneca) was manipulated and oversold. His latest effort is here. Once again, a major theme is how a "key opinion leader," that is, a prominent medical academic lavishly paid as a consultant or speaker, became overly enthusiastic about his employer's product. Unforunately, academic medicine is now rife with well-paid key opinion leaders. I suspect many may have cause in the future to feel sheepish about their former enthusiasms. Meanwhile, beware marketers in academics' clothing.

Putting a New Schein to the FDA?

When the national discussion seems preoccupied with the bonuses at AIG, the nomination of a new leader of the US Food and Drug Administration did not seem to get the attention it may have deserved. Last week, the president nominated Dr Margaret Hamburg to this position. As reported by the Los Angeles Times,

President Obama has decided to nominate former New York City Health Commissioner Margaret Hamburg to head the Food and Drug Administration, turning to a onetime Clinton administration official to help right the beleaguered regulatory agency, a source briefed on the choice said Wednesday.

Hamburg, 53, a physician who has worked extensively on bioterrorism issues, is a senior scientist at the Nuclear Threat Initiative, a Washington-based foundation focused on threats from nuclear, biological and chemical weapons.

Though less experienced as a regulator, Hamburg has extensive government experience. She served as health commissioner in New York for six years in the 1990s before becoming assistant secretary for planning and evaluation at the Department of Health and Human Services in 1997.

Tucked away at the end of the LA Times story, and not emphasized in other news articles, was a salient fact:

She sits on the board of medical supply distributor Henry Schein Inc., but would have to surrender the position if confirmed by the Senate.

Many now believe the FDA is in crisis, having failed to protect the people from unduly hazardous drugs and devices, and becoming too cozy with drug and device companies, which it may not regard, instead of the population as a whole, as the agencie's clients. Would Dr Hamburg's current position with Henry Schein Inc, however, jeopardize her ability to restore peoples' trust that the agency will put their interests, rather than those of health care corporations first?

Henry Schein Inc is a large distributor of health care supplies, including drugs and devices. For an example of its very extensive catalog, look here. Henry Schein makes its profits by selling the products that the FDA regulates, particularly drugs and devices. In her role as director of Henry Schein, Dr Hamburg had a legal responsibility to enhance the finances and profits of the company and its stockholders. As we have discussed many times previously, a corporate director has a legal obligation to advance the profits and financial fortunes of the corporation he or she serves. As Robert AG Monks put it, corporate directors are supposed to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]

As compensation for that loyalty, corporate directors are usually exceedingly well-paid for the nominal hours they spend in their meetings.So, according to the company's 2008 proxy statement, Dr Hamburg owned the equivalent of 63,472 shares of stock (current value, at the price of $37.32, via Google Finance, $ 2,368,775.04). Her total compensation in 2007 for her position as director was $249,151.)

Given that Dr Hamburg has spent over five years living with the obligation for unyielding loyalty to the interests of Henry Schein, and has become what many people would consider rich in the process, how easy will it be for her to turn to becoming a strict regulator of the products her former company used to sell? Time will tell. But this is the second nomination to a major health care post charged with improving the health of all citizens that has gone to someone currently obligated to protect the interests of corporations that now profiting from today's health care milieu. Let us see if this will lead to the change we need in health care.

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

A few not so random thoughts on Healthcare IT

A few thoughts for a Wednesday morning:

• I had recently written on some (probably) minor issues about CCHIT, the Certification Commission for Healthcare Information Technology. However, I have more substantive concerns. I would like to know how CCHIT functions differently from a fictional "Drug Certification Commission." Imagine such a Commission founded by PhRMA and other pharmaceutical industry advocates, partly staffed at high levels by pharmaceutical executives, and "certifying" drugs for consumer purchase simply on the basis of their being manufactured under cGMP guidelines (current good manufacturing processes). Imagine this Commission declaring drugs "certified" without clinical trials, impartial regulatory oversight, postmarketing surveillance and in the face of equivocal studies and outright unfavorable studies showing increased risk of adverse events. How is CCHIT conceptually and substantively different from this fictional drug certification commission?
  

• I would also like to know how the irrational exuberance over Health IT, vastly accelerated for reasons unclear to me by the "Economic Stimulus Bill", differs from the Madoff scandal. The "Bernard Madoff" version of HIT reality promotes the point of view that even in the face of flimsy and/or contradictory evidence, billions of dollars in investment in today's HIT is guaranteed to reap massive rewards, no matter what. Worse than Madoff's scam, those clinicians who don't invest will be penalized. In effect, the government has now taken over Madoff's Acme Anvil EMR Securities, Inc. and is forcing everyone to invest - or else.
  

-- SS

A Primer On Why We Have Busywork Generators Masquerading as EMR's: Health IT Reality vs. the Bernard Madoff Version

As many have now observed, electronic medical records products on the market are clunky, fail to support the cognitive and workflow needs of clinicians, contribute to clinician cognitive overload and increased clerical work burden, and may be harming patients at a rate far higher than, say, VIOXX, which was summarily withdrawn from the market to be followed by billions of dollars of lawsuits.

Health IT can indeed improve healthcare quality, reduce costs and achieve other benefits claimed of it, but only if it's done well. There is tremendous underlying social and technical complexity underlying those two words "done well", and unfortunately in 2009 most health IT is simply not done well. Yet the technology is actually worshipped in what I see as a Bernard Madoff syndrome, an irrational exuberance in IT for reasons not entirely clear to me considering the existing objective evidence.

The motivation to learn how to truly "do HIT well" before embarking on a multi-billion dollar HIT adventure is sorely lacking -- our current approaches being inadequate per such authoritative sources as the National Research Council. In my transit authority safety officer-trained mind, I sense a train wreck approaching. Further, a federally pushed national HIT initiative using billions of dollars, dollars that might be better spent to prevent events like this hospital closure in an underserved area, is premature.

In regard to doing HIT well, usability and usefulness of EMR's have been largely stifled by traditional approaches to Health IT. Those approaches fail to adhere to "innovation" - innovation, that is, compared to traditional IT practices - that was called for by the pioneers beginning in the 1950's and 1960's. (Should I really use the term "innovation" if it's been called for now for over forty years?)

Dr. Don Lindberg in 1969:

"... computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information" (Lindberg DAB: Computer Failures and Successes, Southern Medical Bulletin 1969;57:18-21).

Others such as Morris Collen, Octo Barnett, et al. published guidelines on how to best implement clinical IT that if followed would have alleviated many of the problems we have today. Sadly, they published their ideas starting in -- and perhaps even before -- the 1960's.

The recommendations of the pioneers are documented in "A History of Medical Informatics in the United States 1950-1990", by Morris Collen MD, section 3.4. For example, Octo Barnett's clinical IT "10 Commandments" (written in 1970) as reproduced in Collen's book on page 169, as well as 1960's and 70's material by Lindberg, Lamson, Collen, Davis, Baker, and numerous others address many of the substantial problems that plague health IT today.

What we largely have today are "busywork generators masquerading as EMR's."

I've only begun to illustrate some of the mission hostile user experiences presented by major vendor "CCHIT Certified" EHR's at this eight part series.

Below is a suggested reading list on the problems we have today.

Anyone contemplating policy work in health IT should be intimately familiar with these works, as they illustrate the true HIT environment in 2009, not the Bernard Madoff "unlimited returns no matter what" version.

What these articles do not illustrate is the common atmosphere of irrational exuberance and complacency now prevalent about HIT, with healthcare organizations and physicians now being pushed forcefully to adopt these technologies or suffer payment penalties they can ill afford:

Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.

National Research Council report. Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, Jan. 2009

The National Programme for IT in the NHS: Progress since 2006, Public Accounts Committee, January 2009. Summary points here.

Common Examples of Healthcare IT Difficulties (website). S. Silverstein, MD, Drexel University College of Information Science and Technology.

Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278

Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1

Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies, Ball et al., Methods Inf Med 2008; 47: 4–7,

IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers, JAMA Mar. 4, 2009, p. 919-920.

Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512

Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3.

Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423

The Computer Will See You Now, New York Times, Armstrong-Coben, March 5, 2009,

Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop. Journal of the American Medical Informatics Association. Bonnie Kaplan and Kimberly D. Harris-Salamone (preprint, doi:10.1197/jamia.M2997)

Bad Health Informatics Can Kill. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405

High Rates of Adverse Drug Events in a Highly Computerized Hospital, Nebeker at al., Arch Intern Med. 2005;165:1111-1116.

"Dutch nationwide EHR postponed: Are they in good company?", ICMCC.org, Jan. 24, 2009

“Avoiding EMR meltdown.” About a third of practices that buy electronic medical records systems stop using them within a year, AMA News, Dec. 2006.

"The failure rates of EMR implementations are also consistently high at close to 50%", from Proceedings of the 11th International Symposium on Health Information Management Research – iSHIMR 2006

"Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from A Commonsense Approach to EMRs, July 2006

Adverse Effects of Information Technology in Healthcare. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports.

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007

This is a short list, but if there were such articles about VIOXX or Phen-Fen and pharma or the government not just approved but demanded they be used, (figuratively) there would have been heads rolling.

There were outspoken people challenging the Bernard Madoff scheme ...

... Concerns about Madoff's business had surfaced as early as 1999, when financial analyst-whistleblower Harry Markopolos informed the SEC that he felt it was legally and mathematically impossible to achieve the gains Madoff claimed to deliver. Others felt it was inconceivable that his growing volume of accounts could be competently serviced by his documented accounting/auditing firm, a three-person firm with only one active accountant.

... but they were just disruptive, negative, bad people.

-- SS