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.

Preventing Tooth Decay

Meet Sir Edward Mellanby, the discoverer of vitamin D. Along with his wife, Dr. May Mellanby, he identified dietary factors that control the formation and repair of teeth and bones. He also identified the cause of rickets (vitamin D deficiency) and the effect of phytic acid on mineral absorption. Truly a great man! This research began in the 1910s and continued through the 1940s.

What he discovered about tooth and bone formation is profound, disarmingly simple and largely forgotten. I remember going to the dentist as a child. He told me I had good teeth. I informed him that I tried to eat well and stay away from sweets. He explained to me that I had good teeth because of genetics, not my diet. I was skeptical at the time, but now I realize just how ignorant that man was.

Tooth structure is determined during growth. Well-formed teeth are highly resistant to decay while poorly-formed teeth are cavity-prone. Drs. Mellanby demonstrated this by showing a strong correlation between tooth enamel defects and cavities in British children. The following graph is drawn from several studies he compiled in the book Nutrition and Disease (1934). "Hypoplastic" refers to enamel that's poorly formed on a microscopic level.
The graph is confusing, so don't worry if you're having a hard time interpreting it. If you look at the blue bar representing children with well-formed teeth, you can see that 77% of them have no cavities, and only 7.5% have severe cavities (a "3" on the X axis). Looking at the green bar, only 6% of children with the worst enamel structure are without cavities, while 74% have severe cavities. Enamel structure is VERY strongly related to cavity prevalence.

What determines enamel structure during growth? Drs. Mellanby identified three dominant factors:

1. The mineral content of the diet
2. The fat-soluble vitamin content of the diet, chiefly vitamin D
   
3. The availability of minerals for absorption, determined largely by the diet's phytic acid content
   

Teeth and bones are a mineralized protein scaffold. Vitamin D influences the quality of the protein scaffold that's laid down. For the scaffold to mineralize, the diet has to contain enough minerals, primarily calcium and phosphorus. Vitamin D allows the digestive system to absorb the minerals, but it can only absorb them if they aren't bound by phytic acid. Phytic acid is an anti-nutrient found primarily in unfermented seeds such as grains. So the process depends on getting minerals (sufficient minerals in the diet and low phytic acid) and putting them in the right place (fat-soluble vitamins).

Optimal tooth and bone formation occurs only on a diet that is sufficient in minerals, fat-soluble vitamins, and low in phytic acid. Drs. Mellanby used dogs in their experiments, which it turns out are a good model for tooth formation in humans for a reason I'll explain later. From Nutrition and Disease:

Thus, if growing puppies are given a limited amount of separated [skim] milk together with cereals, lean meat, orange juice, and yeast (i.e., a diet containing sufficient energy value and also sufficient proteins, carbohydrates, vitamins B and C, and salts), defectively formed teeth will result. If some rich source of vitamin D be added, such as cod-liver oil or egg-yolk, the structure of the teeth will be greatly improved, while the addition of oils such as olive... leaves the teeth as badly formed as when the basal diet only is given... If, when the vitamin D intake is deficient, the cereal part of the diet is increased, or if wheat germ [high in phytic acid] replaces white flour, or, again, if oatmeal [high in phytic acid] is substituted for white flour, then the teeth tend to be worse in structure, but if, under these conditions, the calcium intake is increased, then calcification [the deposition of calcium in the teeth] is improved.

Other researchers initially disputed the Mellanbys' results because they weren't able to replicate the findings in rats. It turns out, rats produce the phytic acid-degrading enzyme phytase in their small intestine, so they can extract minerals from unfermented grains better than dogs. Humans also produce phytase, but at levels so low they don't significantly degrade phytic acid. The small intestine of rats has about 30 times the phytase activity of the human small intestine, again demonstrating that humans are not well adapted to eating grains. Our ability to extract minerals from seeds is comparable to that of dogs, which shows that the Mellanbys' results are applicable to humans.

Drs. Mellanby found that the same three factors determine bone quality in dogs as well, which I may discuss in another post.

Is there anything someone with fully formed enamel can do to prevent tooth decay? Drs. Mellanby showed (in humans this time) that not only can tooth decay be prevented by a good diet, it can be almost completely reversed even if it's already present. Dr. Weston Price used a similar method to reverse tooth decay as well. I'll discuss that in my next post.

Preventing Tooth Decay

Meet Sir Edward Mellanby, the discoverer of vitamin D. Along with his wife, Dr. May Mellanby, he identified dietary factors that control the formation and repair of teeth and bones. He also identified the cause of rickets (vitamin D deficiency) and the effect of phytic acid on mineral absorption. Truly a great man! This research began in the 1910s and continued through the 1940s.

What he discovered about tooth and bone formation is profound, disarmingly simple and largely forgotten. I remember going to the dentist as a child. He told me I had good teeth. I informed him that I tried to eat well and stay away from sweets. He explained to me that I had good teeth because of genetics, not my diet. I was skeptical at the time, but now I realize just how ignorant that man was.

Tooth structure is determined during growth. Well-formed teeth are highly resistant to decay while poorly-formed teeth are cavity-prone. Drs. Mellanby demonstrated this by showing a strong correlation between tooth enamel defects and cavities in British children. The following graph is drawn from several studies he compiled in the book Nutrition and Disease (1934). "Hypoplastic" refers to enamel that's poorly formed on a microscopic level.
The graph is confusing, so don't worry if you're having a hard time interpreting it. If you look at the blue bar representing children with well-formed teeth, you can see that 77% of them have no cavities, and only 7.5% have severe cavities (a "3" on the X axis). Looking at the green bar, only 6% of children with the worst enamel structure are without cavities, while 74% have severe cavities. Enamel structure is VERY strongly related to cavity prevalence.

What determines enamel structure during growth? Drs. Mellanby identified three dominant factors:

1. The mineral content of the diet
2. The fat-soluble vitamin content of the diet, chiefly vitamin D
   
3. The availability of minerals for absorption, determined largely by the diet's phytic acid content
   

Teeth and bones are a mineralized protein scaffold. Vitamin D influences the quality of the protein scaffold that's laid down. For the scaffold to mineralize, the diet has to contain enough minerals, primarily calcium and phosphorus. Vitamin D allows the digestive system to absorb the minerals, but it can only absorb them if they aren't bound by phytic acid. Phytic acid is an anti-nutrient found primarily in unfermented seeds such as grains. So the process depends on getting minerals (sufficient minerals in the diet and low phytic acid) and putting them in the right place (fat-soluble vitamins).

Optimal tooth and bone formation occurs only on a diet that is sufficient in minerals, fat-soluble vitamins, and low in phytic acid. Drs. Mellanby used dogs in their experiments, which it turns out are a good model for tooth formation in humans for a reason I'll explain later. From Nutrition and Disease:

Thus, if growing puppies are given a limited amount of separated [skim] milk together with cereals, lean meat, orange juice, and yeast (i.e., a diet containing sufficient energy value and also sufficient proteins, carbohydrates, vitamins B and C, and salts), defectively formed teeth will result. If some rich source of vitamin D be added, such as cod-liver oil or egg-yolk, the structure of the teeth will be greatly improved, while the addition of oils such as olive... leaves the teeth as badly formed as when the basal diet only is given... If, when the vitamin D intake is deficient, the cereal part of the diet is increased, or if wheat germ [high in phytic acid] replaces white flour, or, again, if oatmeal [high in phytic acid] is substituted for white flour, then the teeth tend to be worse in structure, but if, under these conditions, the calcium intake is increased, then calcification [the deposition of calcium in the teeth] is improved.

Other researchers initially disputed the Mellanbys' results because they weren't able to replicate the findings in rats. It turns out, rats produce the phytic acid-degrading enzyme phytase in their small intestine, so they can extract minerals from unfermented grains better than dogs. Humans also produce phytase, but at levels so low they don't significantly degrade phytic acid. The small intestine of rats has about 30 times the phytase activity of the human small intestine, again demonstrating that humans are not well adapted to eating grains. Our ability to extract minerals from seeds is comparable to that of dogs, which shows that the Mellanbys' results are applicable to humans.

Drs. Mellanby found that the same three factors determine bone quality in dogs as well, which I may discuss in another post.

Is there anything someone with fully formed enamel can do to prevent tooth decay? Drs. Mellanby showed (in humans this time) that not only can tooth decay be prevented by a good diet, it can be almost completely reversed even if it's already present. Dr. Weston Price used a similar method to reverse tooth decay as well. I'll discuss that in my next post.

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

Skin Texture, Cancer and Dietary Fat

Richard and I exchanged a series of e-mails last week in which he remarked that Thai people generally have nice skin, which is something I've also noticed in Thai immigrants to the U.S. I believe you can often tell what kind of fat a person eats by looking at their face, especially as people age or bear children.

People who eat predominantly traditional fats like butter and coconut oil usually have nice skin. It's smoother, rosier and it ages more gracefully than the skin of a person who eats industrial fats like soy and corn oil. Coconut is the predominant fat in the traditional Thai diet. Coconut fat is about 87% saturated, far more than any animal fat*. Coconut oil and butter are very low in omega-6 linoleic acid, while industrial vegetable oils and margarine contain a lot of it.

I saw a great movie last week called "The Betrayal", about a family of Lao refugees that immigrated to the U.S. in the late 1970s. The director followed the family for 23 years as they tried to carve out a life for themselves in Brooklyn. The main fats in the traditional Lao diet are lard and coconut milk. The mother of the family was a nice looking woman when she left Laos. She was thin and had great skin and teeth, despite having delivered half a dozen children at that point. After 23 years in the U.S., she was overweight and her skin was colorless and pasty. At the end of the movie, they return to Laos to visit their family there. The woman's mother was still alive. She was nearly 100 years old and looked younger than her daughter.

Well that's a pretty story, but let's hit the science. There's a mouse model of skin cancer called the Skh:HR-1 hairless mouse. When exposed to UV rays and/or topical carcinogens, these mice develop skin cancer just like humans (especially fair-skinned humans). Researchers have been studying the factors that determine their susceptibility to skin cancer, and fat is a dominant one. Specifically, their susceptibility to skin cancer is determined by the amount of linoleic acid in the diet.

In 1994, Drs. Cope and Reeve published a study using hairless mice in which they put groups of mice on two different diets (Cope, R. B. & Reeve, V. E. (1994) Photochem. Photobiol. 59: 24 S). The first diet contained 20% margarine; the second was identical but contained 20% butter. Mice eating margarine developed significantly more skin tumors when they were exposed to UV light or a combination of UV and a topical carcinogen. Researchers have known this for a long time. Here's a quote from a review published in 1987:

Nearly 50 years ago the first reports appeared that cast suspicion on lipids, or peroxidative products thereof, as being involved in the expression of actinically induced cancer. Whereas numerous studies have implicated lipids as potentiators of specific chemical-induced carcinogenesis, only recently has the involvement of these dietary constituents in photocarcinogenesis been substantiated. It has now been demonstrated that both level of dietary lipid intake and degree of lipid saturation have pronounced effects on photoinduced skin cancer, with increasing levels of unsaturated fat intake enhancing cancer expression. The level of intake of these lipids is also manifested in the level of epidermal lipid peroxidation.

Here's a quote from a study conducted in 1996:

A series of semi-purified diets containing 20% fat by weight, of increasing proportions (0, 5%, 10%, 15% or 20%) of polyunsaturated sunflower oil mixed with hydrogenated saturated cottonseed oil, was fed to groups of Skh:HR-1 hairless mice during induction and promotion of photocarcinogenesis. The photocarcinogenic response was of increasing severity as the polyunsaturated content of the mixed dietary fat was increased, whether measured as tumour incidence, tumour multiplicity, progression of benign tumours to squamous cell carcinoma, or reduced survival... These results suggest that the enhancement of photocarcinogenesis by the dietary polyunsaturated fat component is mediated by an induced predisposition to persistent immunosuppression caused by the chronic UV irradiation, and supports the evidence for an immunological role in dietary fat modulation of photocarcinogenesis in mice.

In other words, UV-induced cancer increased in proportion to the linoleic acid content of the diet, because linoleic acid suppresses the immune system's cancer-fighting ability!

It doesn't end at skin cancer. In animal models, a number of cancers are highly sensitive to the amount of linoleic acid in the diet, including breast cancer. Once again, butter beats margarine and vegetable oils. Spontaneous breast tumors develop only half as frequently in rats fed butter than in rats fed margarine or safflower oil (Yanagi, S. et al. (1989) Comparative effects of butter, margarine, safflower oil and dextrin on mammary tumorigenesis in mice and rats. In: The Pharmacological Effects of Lipids.). The development of breast tumors in rats fed carcinogens is highly dependent on the linoleic acid content of the diet. The effect plateaus around 4.4% of calories, after which additional linoleic acid has no further effect.

Conversely, omega-3 fish oil protects against skin cancer in the hairless mouse, even in large amounts. In another study, not only did fish oil protect against skin cancer, it doubled the amount of time researchers had to expose the mice to UV light to cause sunburn!

Thus, the amount of linoleic acid in the diet as well as the balance between omega-6 and omega-3 determine the susceptibility of the skin to damage from UV rays. This is a very straightforward explanation for the beautiful skin of people eating traditional fats like butter and coconut oil. It's also a straightforward explanation for the poor skin and sharply rising melanoma incidence of Western nations (source). Melanoma is the most deadly form of skin cancer. If you're dark-skinned, you're off the hook:

I believe the other factor contributing to rising melanoma incidence is sunscreen. Most sunscreens block sunburn-causing UVB rays but not melanoma-causing UVA rays. The fact that they allow you to remain in the sun for longer without burning means they increase your exposure to UVA. I've written about this before. Sunscreen also blocks vitamin D formation in the skin, a process that some researchers believe also promotes cancer. I'll end with a couple more graphs that are self-explanatory (source). "PUFA" stands for polyunsaturated faty acids, and primarily represents linoleic acid:





*Not only do Thais have clear skin, they also have clear arteries. Autopsies performed in the 1960s showed that residents of Bangkok had a low prevalence of atherosclerosis and a rate of heart attack (myocardial infarction) about 1/10 that of Americans living in Los Angeles.

Skin Texture, Cancer and Dietary Fat

Richard and I exchanged a series of e-mails last week in which he remarked that Thai people generally have nice skin, which is something I've also noticed in Thai immigrants to the U.S. I believe you can often tell what kind of fat a person eats by looking at their face, especially as people age or bear children.

People who eat predominantly traditional fats like butter and coconut oil usually have nice skin. It's smoother, rosier and it ages more gracefully than the skin of a person who eats industrial fats like soy and corn oil. Coconut is the predominant fat in the traditional Thai diet. Coconut fat is about 87% saturated, far more than any animal fat*. Coconut oil and butter are very low in omega-6 linoleic acid, while industrial vegetable oils and margarine contain a lot of it.

I saw a great movie last week called "The Betrayal", about a family of Lao refugees that immigrated to the U.S. in the late 1970s. The director followed the family for 23 years as they tried to carve out a life for themselves in Brooklyn. The main fats in the traditional Lao diet are lard and coconut milk. The mother of the family was a nice looking woman when she left Laos. She was thin and had great skin and teeth, despite having delivered half a dozen children at that point. After 23 years in the U.S., she was overweight and her skin was colorless and pasty. At the end of the movie, they return to Laos to visit their family there. The woman's mother was still alive. She was nearly 100 years old and looked younger than her daughter.

Well that's a pretty story, but let's hit the science. There's a mouse model of skin cancer called the Skh:HR-1 hairless mouse. When exposed to UV rays and/or topical carcinogens, these mice develop skin cancer just like humans (especially fair-skinned humans). Researchers have been studying the factors that determine their susceptibility to skin cancer, and fat is a dominant one. Specifically, their susceptibility to skin cancer is determined by the amount of linoleic acid in the diet.

In 1994, Drs. Cope and Reeve published a study using hairless mice in which they put groups of mice on two different diets (Cope, R. B. & Reeve, V. E. (1994) Photochem. Photobiol. 59: 24 S). The first diet contained 20% margarine; the second was identical but contained 20% butter. Mice eating margarine developed significantly more skin tumors when they were exposed to UV light or a combination of UV and a topical carcinogen. Researchers have known this for a long time. Here's a quote from a review published in 1987:

Nearly 50 years ago the first reports appeared that cast suspicion on lipids, or peroxidative products thereof, as being involved in the expression of actinically induced cancer. Whereas numerous studies have implicated lipids as potentiators of specific chemical-induced carcinogenesis, only recently has the involvement of these dietary constituents in photocarcinogenesis been substantiated. It has now been demonstrated that both level of dietary lipid intake and degree of lipid saturation have pronounced effects on photoinduced skin cancer, with increasing levels of unsaturated fat intake enhancing cancer expression. The level of intake of these lipids is also manifested in the level of epidermal lipid peroxidation.

Here's a quote from a study conducted in 1996:

A series of semi-purified diets containing 20% fat by weight, of increasing proportions (0, 5%, 10%, 15% or 20%) of polyunsaturated sunflower oil mixed with hydrogenated saturated cottonseed oil, was fed to groups of Skh:HR-1 hairless mice during induction and promotion of photocarcinogenesis. The photocarcinogenic response was of increasing severity as the polyunsaturated content of the mixed dietary fat was increased, whether measured as tumour incidence, tumour multiplicity, progression of benign tumours to squamous cell carcinoma, or reduced survival... These results suggest that the enhancement of photocarcinogenesis by the dietary polyunsaturated fat component is mediated by an induced predisposition to persistent immunosuppression caused by the chronic UV irradiation, and supports the evidence for an immunological role in dietary fat modulation of photocarcinogenesis in mice.

In other words, UV-induced cancer increased in proportion to the linoleic acid content of the diet, because linoleic acid suppresses the immune system's cancer-fighting ability!

It doesn't end at skin cancer. In animal models, a number of cancers are highly sensitive to the amount of linoleic acid in the diet, including breast cancer. Once again, butter beats margarine and vegetable oils. Spontaneous breast tumors develop only half as frequently in rats fed butter than in rats fed margarine or safflower oil (Yanagi, S. et al. (1989) Comparative effects of butter, margarine, safflower oil and dextrin on mammary tumorigenesis in mice and rats. In: The Pharmacological Effects of Lipids.). The development of breast tumors in rats fed carcinogens is highly dependent on the linoleic acid content of the diet. The effect plateaus around 4.4% of calories, after which additional linoleic acid has no further effect.

Conversely, omega-3 fish oil protects against skin cancer in the hairless mouse, even in large amounts. In another study, not only did fish oil protect against skin cancer, it doubled the amount of time researchers had to expose the mice to UV light to cause sunburn!

Thus, the amount of linoleic acid in the diet as well as the balance between omega-6 and omega-3 determine the susceptibility of the skin to damage from UV rays. This is a very straightforward explanation for the beautiful skin of people eating traditional fats like butter and coconut oil. It's also a straightforward explanation for the poor skin and sharply rising melanoma incidence of Western nations (source). Melanoma is the most deadly form of skin cancer. If you're dark-skinned, you're off the hook:

I believe the other factor contributing to rising melanoma incidence is sunscreen. Most sunscreens block sunburn-causing UVB rays but not melanoma-causing UVA rays. The fact that they allow you to remain in the sun for longer without burning means they increase your exposure to UVA. I've written about this before. Sunscreen also blocks vitamin D formation in the skin, a process that some researchers believe also promotes cancer. I'll end with a couple more graphs that are self-explanatory (source). "PUFA" stands for polyunsaturated faty acids, and primarily represents linoleic acid:





*Not only do Thais have clear skin, they also have clear arteries. Autopsies performed in the 1960s showed that residents of Bangkok had a low prevalence of atherosclerosis and a rate of heart attack (myocardial infarction) about 1/10 that of Americans living in Los Angeles.

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