Tuesday, April 22, 2014

A Tangled Web of Perversity by a Healthcare Company Owner - Subpoenaing Emails of Law Student Critics at NYU Law School, Where He is a Trustee

At Healthcare Renewal, we are largely calling for removal from healthcare of perverse managers and perverse management practices. 

One of those practices is the attempted silencing of critics.

I have first hand experience with a perverse but unsuccessful attempt myself, where the apparently (and IMO, and as protected by the 1st Amendent) megalomaniacal management of a once-reasonable hospital (I did my residency there 1985-7) sought to abridge my 1st Amendment rights regarding care of my late mother.  See my August 11, 2013 post "Who Would Have Thought, Comrades, That The Most Severe Form of Attempted Internet Censorship Could Originate in a Community Hospital, Abington Memorial, That Alleges Itself A Non-Profit Public Servant?" at http://hcrenewal.blogspot.com/2013/08/who-would-have-thought-comrades-that.html.

This recent story, however, is simply stunning in the audacity of its principal regarding "shutting up" critics, this time two law students at a law school of which he is a Trustee:

Law School Trustee's Company Chills Critical Speech With Subpoena For Students' Personal Emails

A New York University trustee has found a way to chill speech critical of him and the [healthcare] companies he owns: subpoena the personal emails of two particularly outspoken opponents.
A New York University Law trustee's company wants two students to hand over their personal emails after they circulated a letter criticizing him, according to a subpoena.

The law students, second-year Luke Herrine and first-year Leo Gertner, were targeted after they helped circulate a letter denouncing NYU Law School trustee Daniel Straus, who owns Care One Management, a home health aide and nursing home company embroiled in a labor dispute.
The two students started a petition asking for the removal of Straus from the Board of Trustees, pointing out that a law school should probably be associated with someone who respects the law, something Straus' companies seem to have trouble doing. His two companies, CareOne (http://care-one.com/) and HealthBridge Management (http://www.healthbridgemanagement.com/), have been cited at least 38 times by the National Labor Relations Board for violating federal labor laws. In addition, HealthBridge was held in contempt of court for refusing to allow 600 workers to return to their jobs at their pre-strike pay levels.

"A law school should probably be associated with someone who respects the law" seems an oxymoron, not to mention protected speech under the First Amendment of the U.S. Constitution: http://en.wikipedia.org/wiki/First_Amendment_to_the_United_States_Constitution.

CareOne's current legal battle with a local labor union, Service Employees International Union (SEIU), something that has dragged on for years at this point, has seemingly turned into a convenient way for Straus to get back at his critics. Of course, CareOne claims otherwise.
CareOne spokesperson Deborah Maxson said the deadline for the requested information is April 25.

Straus is not a party to the lawsuit and is not managing the litigation,” Maxson said.
Straus may not be a party to this lawsuit, but these are his companies, and there can be very little doubt that Straus would prefer the ongoing criticism of his business efforts be halted. If CareOne wants to use the excuse that Straus isn't a "party" to this lawsuit, then it needs to extend that same courtesy to the two students, who also aren't a "party" to the ongoing legal fight.

But they're defenseless students, and in healthcare matters, dissing a high-ranking healthcare management  person seems to be a crime that such persons cannot seem to tolerate.  (I won't get into the psychopathological issues that may come into play).

Then there's the content sought by the subpoenas. This, too, mentions Straus directly, even as CareOne claims this has nothing to do with him. According to a letter sent by the Board of Trustees to NYU administration, this is what CareOne is hoping to obtain:
The subpoenas requested information regarding any contact the students may have had with SEIU and any activity they may have engaged in, such as protests or meetings, relating to Mr. Straus or CareOne...”
If Straus isn't "party" to this lawsuit, why does CareOne need information relating to Straus? Beyond that, the information requested bears all the hallmarks of trying to use the power of the court to silence free speech. Protests and meetings, both activities covered by the First Amendment, are mentioned specifically by the subpoena.

Perhaps some members of the generation after the "Greatest generation" have such low self-esteem that they have to bully mere students into submission.

For what it's worth, NYU has stepped up and has provided the students with the pro bono help of one of the school's lawyers. It also issued a very carefully-worded defense of the students, no doubt mindful of Straus' $1.25 million annual endowment.
The Law School is not a party to the litigation between Care One and SEIU, and will remain uninvolved in it," the school wrote in a statement to DNAinfo New York sent Thursday. "We vigorously support the right of our students to express their views and to organize and participate in lawful demonstrations and other protest activity, at the same time that we acknowledge that parties to litigation are permitted, subject to applicable rules and judicial oversight, to gather evidence in support of their case."
Further statements reiterated NYU's support for its students' rights but also noted it considered Straus to be an "upright and honorable person."

That said, it seems that there is a clear -- and somewhat massive -- conflict of interest for Straus to remain on the board of trustees at NYU Law at the same time he's using the legal process to demand the email contents from two of its students.

Conflicts of interest are nothing new to healthcare.

As is noted by the students' new petition demanding the withdrawal of the subpoenas, this sort of activity, undertaken by a "victim" of criticism, will discourage others from approaching anything remotely controversial.
Forcing students to turn over emails and other private communications in litigation that does not concern them can chill free speech on campus and make students think twice about raising their voice about controversial issues. This is antithetical to NYU's mission of open academic inquiry and commitment to the public interest.

That's assuming the mission of NYU and other universities still remains "open academic inquiry."  Many have begun to doubt that, and with good reason; e.g., see http://www.bloombergview.com/articles/2014-04-22/free-speech-zones-and-other-college-lies as just one example.

Rather than address these concerns, Straus is allowing (or directing) his company to shut down his critics by seeking personal communications from non-party NYU students. Straus also has additional leverage with the university should this fail to keep future criticism at bay. Of course, there's always a chance NYU will side with the students and decide that Straus' companies don't really reflect the culture it's trying to instill in its students. But until this all plays out, we're just witnessing the sort of tactics deployed by entities who would rather shut people up than address their concerns.

I note the following statement on the web page of Care One Management:

"With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.

With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities."

With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.
With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.
- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf

With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.
With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.
- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf

With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.
With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.
- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf P { margin-bottom: 0.08in; }A:link { }
In healthcare, I remind, the "shut people up" mentality results in patient injury and death.  It seems to me that this Trustee is not just setting a bad example for the legal profession, but it also throws the management of his healthcare organizations into question.

-- SS

Wednesday, April 16, 2014

Knee Deep in the Hoopla - "A Triumph of Medical Technology" Sans Evidence of Superiority from Published Randomized Double Blind Controlled Trials

With the publication of several new articles in the prestigious New England Journal of Medicine, the buzz about Sovaldi (sofosbuvir - Gilead), a new oral treatment of hepatitis C, has become feverish.  The drug had been hailed as near miraculous, and the only debate has been about its near stratospheric cost (look here). 

This week, of all weeks, however we should be extremely skeptical about expensive drugs promoted as the cures of our most feared ills.  This week a series of articles appeared in the British Medical Journal showing that there was no evidence to support the clinical value of the  antiviral drugs stockpiled for governments as proof against dreaded influenza epidemics (look here to start).  

The Latest Buzz

As we posted earlier, the discussions contrast the ostensibly near miraculous aspects of the drug's performance with its extremely high price.  For example, a few days ago the Los Angeles Times reported,

In a series of clinical trial results, a new generation of antiviral medications was able to clear the liver-ravaging virus from virtually all patients' bloodstreams in as little as eight weeks. Even in patients with the most stubborn infections, the new drugs were capable of suppressing the virus completely at rates well over 90%. The treatments, however, come with a steep price tag.


The new medications are 'a triumph of modern medical technology,' said Dr. Jeffrey Tice, a UC San Francisco physician who was not involved in any of the clinical trials.

Accompanying the research reports in the New England Journal was a commentary by Dr Raymond T Chung and Dr Thomas F Baumert.  Its title proclaimed Sovaldi and similar drugs also to be part of "The Arc of Medical Triumph."(1)  Buried in the commentary's supplementary material was a link to disclosure forms that showed that:

Dr Chung reports grant support from Gilead Sciences [the manufacturer of Sovaldi], Mass Biologics, Vertex and Merck, and personal fees from Abbvie, Enanta and Idenix.

Note that Abbvie and Merck are also at work on antiviral treatments for hepatitis C.


Dr Baumert reports several patents ... and pending patents [apparently that could be conflicts of interest]

It is clear that there have been major scientific advances in the characterization of the hepatitis C virus, and development of multiple new antiviral agents which promise to treat that infection.  Furthermore, clearly there is reason for hope for treatment of hepatitis C that prevents its long-term complications and averts premature death. (Of course, that hope could be a bit stronger in the hearts of those who have financial relationships with the corporations that stand to profit from sales of these drugs.)

But it is not obvious that there is sufficient clear evidence from clinical research, particularly from double-blind randomized controlled trials (RCTs), that shows the newest treatments will provide triumphal benefits to patients that outweigh their possible harms.

One Published Unblinded RCT Compared Sovaldi to Peg-Interferon

In our previous post, written after the immense price of the new drug in the US became apparent, we questioned whether the evidence from controlled trials then available would justify the hype, and the high price.

We looked at what appeared to be the then single best available study. The most prominent randomized controlled trial of Sovaldi for patients who had not had previous therapy for hepatitis C that had been published by March, 2014, appeared in the New England Journal of Medicine in May, 2013.(2)   While it provided some reason for hope, it did not provide clear evidence that Sovaldi was a miracle drug.

The study showed that Sovaldi plus ribavirin produced the same rate of sustained virologic response (SVR), 67%, as did the previously accepted standard treatment, peg-interferon plus ribavirin, again 67%.  (SVR means that the hepatitis C virus has become undetectable in the patient's blood, and is believed, but not proven to represent a cure.)

While Sovaldi had lower rates of unpleasant side effects than did peg-interferon, these rates were not negligible. For example, the rate of nausea after peg-interferon was reported to be 29%, but after Sovaldi it was still 18%.  Given that the trial was unblinded, and that some of these side effects have a subjective element, these figures could have been biased due to patient expectations that the new drug would have fewer side effects.

Furthermore, Sovaldi appeared to produce higher rates of severe adverse effects (3%) than peg-interferon (1%).  However, the article did not mention any deaths in either treatment group.  When I later reviewed the  supplemental data available on the web from the May, 2013 article, I found that buried within this information were the facts that two people died during treatment with Sovaldi, and one after treatment with peg-interferon.  So, the rate of  severe adverse effects or death after Sovaldi treatment was more than double (9/256 ) than that after peg-interferon (4/243).  It is very curious and concerning that the authors chose not to mention deaths of study subjects in the paper that reported their trial results.   

Finally, the trial, like just about all previous trials of treatment of hepatitis C, did not follow patients long-term, and hence could not show whether treatment actually resulted in better clinical outcomes, for example, longer survival, decreased rates of severe liver disease, etc.  We thus concluded that there really was no clear evidence that Sovaldi was really a miracle drug, which could cure more people, in fact, nearly everyone, compared to standard therapy, yet with fewer side effects and more safety.

Any Evidence from Other Controlled Trials?

We looked through the newly published articles, the articles they cited, and the official US label for sofosbuvir to see if there is any other evidence from controlled trials to support the triumphant claims about sofosbuvir.  To simplify this casual, not systematic review, we only looked at articles about patients who had not been previously treated for hepatitis C.

The drug label mentioned a controlled trial that compared sofosbuvir to placebo.  The POSITRON study (study 107) was a trail that compared Sovaldi and ribavirin to placebo in patients who are "interferon intolerant, ineligible or unwilling."  The overall SVR in the treated group was 78%.  The label did not mention adverse effects rates in this trial, and as far as I can tell, it was not published.  Again, while the SVR was good, it was NOT over 90%.  As far as I could tell, the results of this study have not otherwise been published. 

The new studies in the New England Journal, and the studies cited by one of them were NOT double-blind randomized controlled trials of sofosbuvir versus some other treatment, or versus placebo for that matter.

For example, the study by Afdhal et al in the New England Journal considered sofosbuvir in combination with another new drug from Gilead, ledipasvir.  However, this was an open label (unblinded) study that compared patients given different durations of treatment with both sofosbuvir and ledipasvir with or without ribavirin.  It did NOT directly compare sofosbuvir (or ledipasvir) to any other treatment, or to placebo.(3) Another study by Sulkowski et al in the NEJM focused on previously treated patients.

Cited by Afdhal et al were studies by Osinusi et al (an unblinded study that compared different doses of ribavirin given to patients also who all received sofosbuvir)(4); Lawitz et al (an unblinded study that compared different durations of treatment for both sofosbuvir and ledipavir with or without ribavirin)(5); and Gane et al (a study that compared various drugs again all added to sofosbuvir)(6).  Again, NO study compared sofosbuvir to any other treatment, or to placebo.

Thus so far I have been unable to find any additional studies that compared Sovaldi (sofosbuvir) to any other potential treatments for hepatitis C.  Without a comparison to another treatment, it is not possible to tell whether the high rates of patients whose blood tests show no detectable hepatitis C virus in the short-term after treatment were due to the excellence of the treatment, or due to selection of patients with particularly good prognoses.   Recall that there is evidence that some patients with hepatitis C spontaneously clear their blood of hepatitis C, and become spontaneously cured (see our previous discussion, and particularly the study by Seeff et al[7]). 

There is evidence that the studies above may have been designed to only include patients with the best prognoses.  They generally were designed with very complicated, restrictive and subjective inclusion and exclusion criteria that could have eliminated all but the healthiest patients.  For example, according to the study protocol found in the supplementary material for the study by Afdhal et al, patients with "clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol" would have been excluded, as would have "subjects currently under evaluation for a potentially clinically-significant illness (other than HCV)...."

So, while many articles about sofosbuvir (Sovaldi) have appeared recently, in my humble opinion they do not provide strong clear evidence that this drug is extremely effective and remarkably safe, i.e., that the drug is a "triumph" that will cure nearly everyone without risk or harm to them, and therefore warrants a princely price.


While the buzz about Sovaldi intensifies, there still seems to be little clear evidence to justify extravagant claims made for it, or the extravagant price demanded for it.  Yet there seems to be a bandwagon building to somehow pay whatever it takes to provide the "triumph" of medical science to every patient who needs it.  At the current price, that should make the CEO of Gilead even richer (increases in the stock price after the $84,000/ course drug price was announced already turned him into a billionaire on paper, look here.)  As noted above, it is not clear what benefits such a costly policy would bring to patients, and at what risks.

We have discussed how our current policy of letting corporations sponsor and run the clinical research meant to assess their own products has lead to widespread manipulation of research to make their products look better, and sometimes suppression of research that cannot be manipulated into making their products look good.  This should make health care professionals, policy makers, and the public extremely skeptical of every over-hyped new "innovation."  So far, there seems to be no public skepticism about this latest, and seemingly most expensive pharmaceutical "triumph."

The US health care system, and to some extent the health care systems in most developed countries are experiencing ever higher prices.  Much of these prices' effects seem to drive up remuneration of health care executives and managers, but whether they buy better care or outcomes for most people is not so clear.  The ever rising prices seem to be buoyed by endless enthusiasm for new tests, treatments, programs, and unbridled faith in the benefits of all new technology.  It is not clear how much of that is due to evidence, how much is based on ideology and unquestioning faith in technological progress, and how much is driven by marketing and public relations, which not always may be entirely honest and free from deception.

Evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients.  The skepticism EBM should engender could lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. If only such skepticism were easier to find.

1.  Chung RT, Baumert TF.  Curing chronic hepatitis C - the arc of medical triumph.  N Engl J Med 2014:  Link here.
2.   Lawitz E, Mangia A, Wyles D et al.  Sofosbuvir for previously untreated chronic hepatitis C infection.  N Engl J Med 2013; 368: 1878-1887.  Link here.
3.  Afdhal N et al.  Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.  N Engl J Med 2014: Link here.
4.  Orinusi A Meissner EG, Lee YJ et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.  JAMA 2013; 310: 804.  Link here.
5.  Lawitz E, Poordad FF, Hyland RH et al.  Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised phase 2 trial.  Lancet 2013; 383: 515.  Link here.
6.  Gane EJ, Stedman CA, Hyland RH et al.  Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection.  Gastroenterology 2013.  Link here.
7.  Seeff LB, Hollilnger B, Alter HJ et al.  Long-term mortality and morbidity of transfusion- associated non-A, non-B, and type C hepatitis: a National Heart Lung and Blood Institute Collaborative Study.  Hepatology 2001; 33: 455-463.  Link here.

ADDENDUM (21 April, 2014) - Also see the post on "breakthrough cures?" by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog

CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives?

If this is true, the EHR hyper-enthusiasm problem is even worse than I believed.

From the April 2014 newsletter of the American Association for Physicians and Surgeons (http://www.aapsonline.org/index.php/about_us/), an organization that is dedicated "to preserving the sanctity of the patient-physician relationship and the practice of private medicine":

CMS Claims to Have No Information on EHRs

On Mar. 14, 2014, the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare and Medicaid Services replied to a Freedom of Information Act (FOIA) request sent Apr. 4, 2012:  The American Recovery and Reinvestment Act of 2009 (ARRA) created the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.  While our Office of E-Health Standards and Services works to implement the provisions of the ARRA, we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."

However, that doesn't stop our government from spending billions of taxpayer dollars on them, when, in fact, we do know of harms they cause.  One can reasonably assume their primary interest is in bookkeeping.

With FDA, it's even worse.  Rather than stopping at admitting they simply don't know due to admitted impediments to knowing, they simply leap to a conclusion that the technology is of 'sufficiently low risk' not to warrant their regulatory attention, even if such systems meet the statutory requirements to be a medical device and thus fall under the Food, Drug & Cosmetic Act.

See my Apr. 9, 2014 post "FDA on health IT risk: We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" and its ten-point (and non-comprehensive) summary of risks: http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.  Another FOIA request is surely needed...

More generally, I know from personal development and implementation experience that when "done well", that is, when good health IT and good implementation practices are offered and with patient safety as a priority, health IT can save lives and improve care.  It's just that the commercial for-profit health IT sector does not meet those expectations, due largely to its leadership model from the merchant-computing culture.  Instead, bad health IT is the norm.  From my academic site at http://cci.drexel.edu/faculty/ssilverstein/cases/:

Good Health IT is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

 I am seeking source material from the AAPS and will post it.

-- SS

Monday, April 14, 2014

Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another article in its series on the high cost of US health care.  This one, focused on the care of type 1 diabetes mellitus and other chronic diseases, shines some light on the business management practices that now determine how our health care system functions, or not, and implies who benefits the most from them.

Planned Obsolescence Disguised as Innovation

The article first discussed the brave new world of type 1 diabetes treatment.  The introductory theme was:

Today, the routine care costs of many chronic illnesses eclipse that of acute care because new treatments that keep patients well have become a multibillion-dollar business opportunity for device and drug makers and medical providers.

Much of modern diabetes treatment seems to depend on medical devices and disposable medical supplies:

That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments, borrowing business models from technology companies like Apple: Each pump and monitor requires the separate purchase of an array of items that are often brand and model specific.

A steady stream of new models and updates often offer dubious improvement: colored pumps; talking, bilingual meters; sensors reporting minute-by-minute sugar readouts. [Diabetes patient] Ms. Hayley’s new pump will cost $7,350 (she will pay $2,500 under the terms of her insurance). But she will also need to pay her part for supplies, including $100 monitor probes that must be replaced every week, disposable tubing that she must change every three days and 10 or so test strips every day.

Of course, the device and supply manufacturers claim that the high prices reflect the value of the wondrous new innovations:

Companies that produce the treatments say the higher costs reflect medical advances and the need to recoup money spent on research.

Yet now the Times reporter was able to find physicians who claim the "innovations" are really just the latest version of planned obsolescence:

Diabetes experts say a good part of what companies label as innovation amounts to planned obsolescence. Just as Apple customers can no longer buy an iPhone 3 even if they were content with it, diabetics are nudged to keep up with the latest model.
For example,

Those companies spend millions of dollars recruiting patients at health fairs, through physicians’ offices and with aggressive advertising — often urging them to get devices and treatments that are not necessary, doctors say. 'They may be better in some abstract sense, but the clinical relevance is minor,' said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center.

'People don’t need a meter that talks to them,' he added. 'There’s an incredible waste of money.'

Pharmaceutical companies have also discovered this model.

insulin ... has been produced with genetic engineering and protected by patents, so that a medicine that cost a few dollars when Ms. Hayley was a child now often sells for more than $200 a vial, meaning some patients must pay more than $4,000 a year.

In particular,

Synthetic human insulin is safer for patients, who sometimes developed reactions to animal insulin. But it is made by only three companies: Eli Lilly, Sanofi and Novo Nordisk. Manufactured in microbes, each one’s product has minor dissimilarities that reflect the type of cell in which it was made. Since the companies owned the cell lines, it is nearly impossible for other companies to make exact copies or even similar versions that would be cheaper, even once the patents expire. And the pharmaceutical companies defend the patents ferociously.

What’s more, the three companies continued to refine their product, adding chemical groups that made the insulin absorb somewhat more quickly or evenly, for example. They are called insulin analogues, and their benefits are promoted tirelessly to doctors and patients.

Of course, the pharmaceutical companies also claim that it's all about innnovation,

Dr. Todd Hobbs, chief medical officer of Novo Nordisk, defended the rising prices of insulin, linking them to medical benefits. 'The cost to develop these new insulin products has been enormous, and the cost of the insulin to the consumer in developed countries has risen to enable these and future advancements to occur,' he wrote in an email.
 Not everyone is convinced,

'The insulins are tweaked for minor benefits that may help a small number of patients with difficult-to-control diabetes, and result in major price increases for all,' [Kings College, London, UK Professor] Dr. Pickup said. Because of analogues, he added, Britain’s National Health Service has had to spend 130 percent more on insulin in the past five years.

In the United States, said Dr. Zonszein at Montefiore, the price of Humalog, Lilly’s analogue insulin, was typically two to four times that of its older human insulin line, called Humulin. 'There is not a lot of difference between Humulin and analogues,' he said, but he noted that Humulin was getting 'hard to find.' Sanofi Aventis has stopped selling its older product in the United States, and Mr. Kliff, the financial analyst, said other companies were likely to follow suit, effectively forcing patients to use the costlier versions.

The arguments about valuable innovation also do not explain why the prognosis of diabetes in the US does not seem to reflect all the money we spend on the disease,

Complication rates from diabetes in the United States are generally higher than in other developed countries. That is true even though the United States spends more per patient and per capita treating diabetes than elsewhere, said Ping Zhang, an economist at the Centers for Disease Control and Prevention.

The high costs are taking their toll on public coffers, since 62 percent of that treatment money comes from government insurers. The cumulative outlays for treating Type 1 and Type 2 diabetes reached nearly $200 billion in 2012, or about 7 percent of America’s health care bill.

So to summarize, there is considerable evidence that companies that make drugs and devices to manage type 1 diabetes constantly provide "innovations," yet most are minor changes that encourage obsolescence of previous products, but do not provide important increases in benefits or reductions in harm for patients. 

Oligopoly Disguised as a Free Market

Many in the US sing the praises of our supposed free-market health care system.  As noted above however, the insulin market is an oligopoly, dominated by three companies.  The diabetes device market is also dominated by a few companies, and in particular, the insulin pump market is dominated by a single company,

Medtronic is the dominant insulin pump manufacturer, serving 65 percent of American patients and the majority of those worldwide. Though smaller companies sell cheaper pumps, it is hard to make inroads: Once familiar with the Medtronic system and its extensive support network for troubleshooting problems, patients are reluctant to switch. Doctors are leery of prescribing equipment from a new company that may be out of business in a year; their office computer may not sync with the new software anyway.

Of course, Medtronic public relations will justify it all again based on innovation,

Medtronic declined to talk about specific prices, but said a core tenet was to make only 'a fair profit.' Amanda Sheldon, a spokeswoman, added: 'We are committed to reinvesting in research and development of new technologies to improve the lives of people with diabetes, and our current pricing structure ensures that we can bring new products to market.'

The article also discussed the prices of treating chronic diseases other than diabetes.  For example, see how a nominally non-profit hospital priced treatments for chronic diseases,

Dr. Kivi was on high doses of steroids for debilitating joint pain that left him unable to walk at times.

But when his last three-hour infusion at NYU Langone Medical Center’s outpatient clinic generated a bill of $133,000 — and his insurer paid $99,593 — Dr. Kivi was so outraged that he decided to risk switching to another drug that he could inject by himself at home. 

However,  this pricing appears to have been facilitated by the hospital's increasing market domination generated by its purchase of physician practices,

He had moved his care to NYU Langone to follow his longtime doctor, who had moved her practice from a nearby hospital where the same infusion had been billed at $19,000. The average price that hospitals paid for Dr. Kivi’s dose of Remicade late last year was about $1,200, according to Medicare data.

So in summary, a few companies now dominate the production of drugs and devices for the management of diabetes, and a few large hospitals may increasingly dominate the treatment of particular chronic diseases.  Such oligopolists are able to increase prices without improving treatment to or outcomes of patients.

Enrichment of the Oligarchs

This example shows how the current US health care system is dominated by huge organizations, mostly for-profit corporations but including some nominally non-profit corporations that act similarly.  They loudly proclaim innovation, but much of that innovation seems to provide few benefits to patients, and actually appears to be planned obsolescence.  The result is high and ever-rising prices. So if patients do not benefit from this, who does?

It does not appear to be the health care professionals,

Meanwhile, as the price of supplies rises, endocrinologists remain among the lowest-paid specialists in American medicine, meaning severe physician shortages in many areas and long waits to see a doctor.

We  have seen other examples of how leaders of the big health care organizations have become as rich as royalty.  Therefore, let us consider the pay of the leaders of the organizations mentioned above.  I will focus on the two US based corporations, Eli Lilly and Medtronic, and the New York hospital, NYU Langone Medical Center.

Eli Lilly

According to the company's 2014 proxy statement, the 2013 total compensation of its five highest paid hired executives was

- John C Lechleiter PhD, CEO                                      $11,217,000

- Derica W Rice, CFO                                                   $5,176,822

- Jan M Lundberg, PhD, EVP, Science and Technology   $4,774,535

- Michael J Harrington, General Counsel                          $3,174,222

- Erico A Conterno, President Lilly Diabetes                    $3,009,041

Note that all of these executives save Mr Harrington have also amassed more than 100,000 shares of company stock, and Dr Lechleiter has amassed more than 1,000,000.

It should be no surprise, given our recent discussion (e.g., here) of the currently symbiotic relationship among top health care corporations and academic medicine, that several of the members of the Lilly board of directors that has exercised stewardship over the company, and is thus responsible for these gargantuan compensation packages and the business practices discussed above are top academic leaders.  These include,

- Alfred G Gilman, MD, PhD, Regental Professor Emeritus, recent (until 2009) executive vice presdient, provost, and dean of medicine, University of Texas Southwestern 

- William G Kaelin Jr, MD, Professor of Medicine, Associate Director of Basic Science, Dana-Farber Cancer Center, Harvard University

- Marschall S Runge MD, Executive Dean and Chair of the Department of Medicine, University of North Carolina Medical School

- Katherine Baicker PhD, Professor of Health Economics, Harvard University School of Public Health  (I must note that Prof Baicker is also - amazingly - on the Medicare Payment Advisory Committee, MEDPAC).

- Ellen R Marram, Trustee, New York-Presbyterian Hospital

- Ralph Alvarez, President's Council, University of Miami

- R David Hooper, Trustee, Children's Hospital of Colorado

- Franklyn G Pendergast MD PhD, Professor, Mayo Medical School

All but the newest directors were paid at least $250,000 a year by the company (and thus by the executives the directors are supposed to supervise), and all but the newest directors had accumulated tens of thousands of shares of stock or the equivalent as pay for their services.


Similarly, according to the company's 2013 proxy (the latest now available), CEO Omar Ishrak made $8,975,866 in 2013, and the next four highest paid executives all made over $2,500,000 each.   Mr Ishrak owned or could acquire the equivalent of more than 500,000 shares of stock, and the other top paid executives owned of could acquire from over 100,000 to over 1,000,000 shares of stock.

Again, the executives were nominally supervised by a board of directors that included an academic and non-profit leader, Dr Victor J Dzau, MD former chancellor for health affairs at Duke University, and president-elect of the Institute of Medicine (note that we discussed Dr Dzau's conflicts of interest most recently here).  It also included a former government leader, Michael O Leavitt, former US Secretary of Health and Human Services; and a hospital leader, Preetha Reddy, Managing Director of Apollo Hospitals Enterprise Limited (India). 

NYU Langone Medical Center

The Medical Center's 2011 US form 990 is old, but the latest available, and is remarkably obscure, omitting, for example, mentioning the titles of any of the people listed as highest paid officers and employees.  The current CEO, was listed as receiving total compensation of just over $2.000,000.  Four individuals then received over $1,000,000.  The 990 form also mentioned that the Medical Center provided some individuals with first class travel, tax gross-up payments, housing allowances, and reimbursement for personal services.  Neither the 990, nor the center's web-site makes all the possible conflicts of interest of its trustees obvious.   

So in summary, the large organizations, for-profit and non-profit, that are able to greatly increase their prices through planned obsolescence disguised as innovation, and oligopoly disguised as free markets, are able to make their top executives very rich, and also enrich those who are supposed to exercise stewardship over them. 


An extensive journalistic investigation revealed how certain aspects of chronic care in the US health care system are dominated by a few large organizations.  These organizations are able to charge very high prices, mainly through market domination, and with the aid of marketing and public relations that tout planned obsolescence as valuable innovation.  The leaders of these organizations have become wealthy, often fabulously so.  This state of affairs has not been challenged by those who are supposed to provide stewardship, including many prominent academics.

The US health care system is the most expensive, on a per capita basis, in the world, and far more expensive than that in any other developed country.  Yet there is no evidence that its results are superior to those of other countries.  What evidence there is suggests in fact that our results are mediocre at best.

The current example suggests how the US system differs from those of other countries.  It has an ostensible free market focus.  Yet the system appears more to be an oligopoly, with most of its market components dominated by a few large organizations, run as an oligarchy, by a small, overlapping in-group of managers, executives and their cronies, with elements of corporatism, that is with the cooperation of, rather than regulation by government entities and leaders

A real free market health care system would include a level playing field.  This could only be achieved by the government acting as a fair umpire, not a crony.  Anti-competitive practices would have to end.  Oligopolies would have to be broken.  Deceptive marketing and public relations would have to be exposed.  Leaders would have to be made accountable, especially for putting patients' and the public's health ahead of their own enrichment.  All this would be horribly difficult, as the oligarchs have amassed much money and control, and would oppose, possibly violently, any effort to challenge them.  If we do not challenge them in the US, however, not only will our health care continue to become ever more expensive, less accessible, and less beneficial to patients, but we will all cease to be citizens of one of the first real democracies, and end up serfs instead. 

Friday, April 11, 2014

Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning.

Press reports say she is resigning in large part due to the Exchange Website debacle.   This from the New York Times:

Health Secretary Resigns After Woes of HealthCare.gov

... Officials said Ms. Sebelius, 65, made the decision to resign and was not forced out [Yeah, right - SS]. But the frustration at the White House over her performance had become increasingly clear, as administration aides worried that the crippling problems at HealthCare.gov, the website set up to enroll Americans in insurance exchanges, would result in lasting damage to the president’s legacy.

It's not as if there's no literature out there on how to create good health IT.  Doing so is not a state secret.  Simple (and free, unlike the hundreds of millions spent on incompetent beltway-bandit 'consultants') Google searches on the term "healthcare IT failure" or similar return ample resources that could have prevented the "lasting damage to the president's legacy."

Way to go, Ms. Ex-Secretary.  Another health IT amateur bites the dust, as my early computer mentor, Philadelphia's George Washington High School math instructor Fred Holzwarth (http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf) would have said.

However, even worse ... far worse ...

Under this Secretary of the Department of Health and Human Services, the principal watchdog agency over medicine and medical device safety under her aegis, the FDA, found that:

... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.

Thus, patients are condemned to injury and death, probably at ECRI Deep Dive study levels [1], for the foreseeable future (see my post on that FDA decision at my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

This is especially outrageous at the time massive investigations are ongoing about the 13 deaths caused by apparent coverups of a faulty General Motors ignition switch.

It was your FDA agency, Ms. Ex-Secretary.  You own that decision.

Good Riddance, indeed.  

The person at this link: http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html would certainly agree, if she were alive; she is not thanks to the very devices your FDA just perversely found to be of "sufficiently low risk."

-- SS


[1]  In 9 weeks in 36 PSO-member hospitals, 171 IT mishaps sufficient to cause harm were voluntarily reported; 8 injuries occurred, some severe, and 3 deaths may have been the result.  See http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

Wednesday, April 09, 2014

FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post "An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT" (http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html) I wrote:

David Bates, Chair, ONC FDASIA Health IT Policy Committee
via email
Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent.

The resultant April 2014 report is out: "FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework."  It is available at http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf.

The report is an academic idealist's and industry's dream.  It is a patient's nightmare.

Instead of regulation, the report recommends the creation of a nebulous "Health IT Safety Center" (pgs. 16 and 25) as a "public-private entity with broad stakeholder engagement, that includes a governance structure for the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts.In other words, a toothless organization without true regulatory authority.

The recommendations of the Health IT Policy Committee have apparently been taken seriously by FDA. 

This FDA announcement recently appeared (FDA is part of HHS):


HHS News Release
For Immediate Release: April 3, 2014

Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication

HHS today released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

... As proposed in the draft report, posted on the ONC, FDA and FCC websites, there would be three health IT categories, based on function and level of risk, that focus on what the product does, not on the platform on which it operates (mobile medical device, PC, or cloud-based, for example).

The first category, products with administrative health IT functions, poses little or no risk to patient safety and as such requires no additional oversight. They include software for billing and claims processing, scheduling, and practice and inventory management.

The second category, products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them. Instead, the draft report proposes relying primarily on ONC-coordinated activities and private sector capabilities that highlight quality management principles, industry standards and best practices.

The characterization of these admitted medical devices as "sufficiently low risk" is in my opinion grossly negligent (if not criminal).

For instance, GM concealed an ignition flaw that resulted in 13 deaths.  Look what's happening now in that sector.  Revelations of corporate wrongdoing and Congressional investigations:


U.S. Agency Knew About G.M. Flaw but Did Not Act
MARCH 30, 2014

Federal regulators decided not to open an inquiry on the ignitions of Chevrolet Cobalts and other cars even after their own investigators reported in 2007 that they knew of four fatal crashes, 29 complaints and 14 other reports that showed the problem disabled air bags, according to a memo released by a House subcommittee on Sunday.

Then in 2010, the safety agency came to the same decision after receiving more reports that air bags were not deploying.

The memo also revealed that General Motors approved the faulty design of the switch in 2002 even though the company that made the part, Delphi, warned the automaker that the switch did not meet specifications. This followed a warning the year before — when the Saturn Ion was being developed — but G.M. said that “a design change had solved the problem,” according to the memo.
Continue reading the main story
Related Coverage

The striking new details in the memo bolster the contention that both G.M. and the National Highway Traffic Safety Administration, more than previously acknowledged, ignored or dismissed warnings for more than a decade about a faulty ignition switch that, if bumped, could turn off, shutting the engine and disabling the air bags. General Motors has recalled nearly 2.6 million cars and has linked 13 deaths to the defect.

13 deaths, and we get this:

A House subcommittee, which gathered more than 200,000 pages of documents from G.M. and 6,000 pages from the agency, will hold a hearing on Tuesday. Mary T. Barra, General Motors’ chief executive, and David Friedman, the acting administrator of the safety agency, are scheduled to testify. Both are also scheduled to testify before a Senate panel on Wednesday.

“The problems persisted over a decade, the red flags were many, and yet those responsible failed to connect the dots,” Fred Upton, a Republican of Michigan and the chairman of the House Energy and Commerce Committee, said in a statement.

The most damaging finding in the memo concerned the four fatal crashes that went unheeded by regulators.

In a presentation dated Nov. 17, 2007, the safety agency’s investigators reported to its Office of Defects Investigation on the fatal crashes, as well as broad range of complaints and other reports about cars shutting off.

“The panel did not identify any discernible trend and decided not to pursue a more formal investigation,” the House memo said. The findings reinforce an analysis by The New York Times published March 8 that found the agency had received more than 260 complaints about Cobalts, Ions and other cars in the recall, citing potentially dangerous shutdowns.

While GM is being grilled and raked over the coals, the health IT industry is likely going to get the healthcare industry's most generous and unprecedented special regulatory accommodation by FDA due to its products being deemed of "sufficiently low risk" (?) not to merit attention.


The FDA statement is particularly reckless, perhaps criminally so, given the following ten points.

I add that the following are just highlights off the top of my head, and non-inclusive of all known facts on health IT risk:

(1)  FDA's own 2010 "Internal Memo on HIT Risk", "not intended for public use" but exposed by Center for Public Integrity investigative reporter Fred Schulte (http://www.publicintegrity.org/authors/fred-schulte) when he was with the Huffington Post Investigative Fund (as described at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html), stated:

...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications.

They then go on to categorize the known risk factors and the impediments to knowing about their occurrence: 

Limitations of the MAUDE search and final subset of MDRs include the following: 

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including
...(a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
...(b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
...(c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

In other words, FDA does not know the level of risk due to systematic impediments to information diffusion.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  Download the full PDF by clicking here.

I think it axiomatic to state that it is, at best, seriously misleading to now state a technology is of "low risk" while internally having admitted that the risk level is not known due to impediments to that knowledge.  That situation has not changed since this memo's internal FDA dissemination, and its disclosure by Schulte.

This is inexplicable on its face on scientific grounds.

(2)  FDA CDRH Director Jeff Shuren MD, JD's own statement that the known risks are "the tip of an iceberg" at the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010, where the topic was "HIT safety" (The text is available at this link):

...... In the past two years, we [FDA] have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Considering the admitted impediments to information diffusion, it's likely even at this point that FDA knew the number of injuries and deaths was far larger than GM's mere 13 ignition defect-related deaths.

(3)   FDA's MAUDE (Manufacturer and User Facility Device Experience) database is a voluntary medical device defects reporting system, but is not specifically purposed for health IT and is almost unknown to typical health IT users as a resource for reporting flaws. 

MAUDE reports show health IT devices are literally festooned with an incredible number of flaws, as if they come from dirt-floor-covered software sweatshops with little oversight.

These are defects that have made it into live hospital and caregiver devices, and have led to reported harms and death (see http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html).

The voluntary nature of this MAUDE reporting by just a few HIT sellers, and lack of knowledge of it by health IT users as a resource, cannot fail to lead to the conclusion that the problems are far worse than this limited dataset indicates.

(4)  The prestigious U.S. Institute of Medicine of the National Academies (http://www.iom.edu/), perhaps the top scientific authority in this country, also admitted the risk levels of health IT were unknown due to systematic impediments to knowing.  IOM noted this in their late 2011 study on EHR safety:

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

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks.

The IOM did note, contrary to FDA's current finding that these systems are of "sufficiently low risk", that:

These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:

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

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

IOM could not have stated the reality more explicitly than via their statement "the magnitude of the risk associated with health IT is not known."

(5)   Surely FDA (and the FDASIA committees responsible for the new Report) are aware of  the ECRI Institute's Deep Dive study results from a study they carried out within their PSO-member hospitals (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).  I would call 171 voluntarily-reported health IT-related mishaps in 36 hospitals over 9 weeks, with 8 injuries and 3 possible deaths, an alarming study.

I certainly would NOT aver that this technology's risk level is of "sufficiently low risk" to not warrant formal regulation by a body skilled in software regulation, as is FDA., e.g., for medical devices and for IT used in pharmaceutical clinical trials data management and drug manufacturing.

See for example "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm.

(I would really not enjoy being in a position to have to make such an averment about "sufficiently low risk" under GM ignition investigation-like conditions... )

(6)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of the data reported by the medical malpractice insurer CRICO, that insures the Harvard medical community (see http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html):

... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database [from numerous sources] and found 147 cases in which EHRs were a contributing factor. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.  ... Half of the 147 cases resulted in severe injury.  [Death numbers are unstated - ed.]

Note that these numbers were an examination of lawsuits filed; most medical malpractice never gets to the point of an actual filed lawsuit due to the unfavorable economics of the medical malpractice industry.  Perhaps 5% of actual events ever get filed, thus CRICO's data is also a "tip of an iceberg."

(7)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of mass risk introduced by faulty systems such as in the incident in Rhode Island, at Lifespan Healthcare (http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), where thousands of prescriptions were altered by faulty HIT without physician knowledge.  Suffixes for the long acting version of a drug (e.g., "XL" or "XR") were dropped:

PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is shocked to hear a Lifespan computer glitch caused thousands of patients to receive the wrong types of medication. [Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and the WaPo - ed.]

Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health.

The DOH is investigating after learning patients who were supposed to receive medications taken once a day instead received medications meant to be taken more than once per day.  [In other words, they were taking short acting drugs on a long-acting once a day schedule, thus being massively under-dosed - ed.]

(8)  The FDA (and the FDASIA committees responsible for the new Report) surely cannot be unaware of all of the "glitches" reported on in-situ health IT systems, as cataloged at this blog under the tag "glitch" and as of this writing numbering 25 posts, some including patient deaths.  See the results of the query link: http://hcrenewal.blogspot.com/search/label/glitch.

(9) Surely FDA (and the FDASIA committees responsible for the new Report) cannot be unaware that FDA itself had to recall health IT with flaws "serious enough to cause patient death":

FDA recall.  McKesson Anesthesia Care – Patient Case Data May Not Match Patient DataUse of this affected product may cause serious adverse health consequences, including death. 

FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems

FDA recall:  An ED EHR "Glitch" That Mangles Prescriptions

(10)  FDA (and the FDASIA committees responsible for the new Report) are surely not unaware of my own report to its MAUDE database (because the hospital denied my request to issue the report itself) of a fundamental defect in a widely used health IT system, Eclipsys Sunrise, that nearly caused the death of my mother... AFTER she was seriously injured due to a flaw in an ED's EHR that did lead a year later to her death:


Event Date 06/12/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other,Life Threatening,Required Intervention
Event Description

The eclipsys sunrise clinical manager emr/cpoe is in use at (b) (6) hospital. This system appears to have a serious deficiency: an apparent lack of date constraint validity checking when users are seeking information on prior medication orders and administration. (b) (6), (b) (6) was admitted (b) (6) 2010, for cerebrovascular problems. Famotidine iv was started prophylactically to prevent gastric problems, but was discontinued and changed to protonix a few days later due to suspicion of causing severe agitation and confusion, causing her to pull her lines. Around (b) (6) 2010, patient was transferred to physical therapy floor in the hospital. Hospital considers such a transfer to be a "discharge" and "readmission. " however, patient did poorly, had to be sent back to med-surg floor several days later. Due to having pulled a percutaneous endoscopic gastrostomy tube -peg tube-, she was started on TPN on (b) (6) 2010. In the first bag of tpn solution was 40 mg. Famotidine. Patient's mental status began deteriorating and she began to get very, very agitated and confused once again. Eclipsys sunrise problem/bug was noted when son, a physician informaticist -and author of this report- noted the 40 mg famotidine in the tpn bag, and reported to the floor rn that this was contraindicated. The rn pulled up the medication order and administration records on the eclipsys sunrise clinical manager system to confirm famotidine had been administered previously. Famotidine was shown only as being ordered for tpn on (b) (6), but not prior. The rn selected a date constraint entry box, at which time a calendar widget popped up. The rn set the date constraint back to (b) (6), then (b) (6), then (b) (6) 2010, but the use of the famotidine at that time did not appear. Son of patient demanded the famotidine be stopped anyway, which it was, and that an allergy entry be entered. However, it was fortunate son was a physician and remembered the name of the medicine. In tracing this error today, it was found that the data from admission on (b) (6) to "discharge" to physical therapy floor (b) (6) 2010, was unavailable since it was considered a "prior admission" although the patient had never left the hospital physically. The sunrise system, however, failed to flag the (b) (6) 2010 date constraint entries as 'out of bounds' for the current admission. The validity of the date constraints was not checked, preventing the rn user from realizing he should have called up the prior admissions records. If son of patient had not been a physician, famotidine might have been continued and patient might have suffered more severe consequences than she did after the 40 mg was given in the first tpn bag. As it was, she spent the next three days in a severe delirium and is only slowly recovering. That the eclipsys sunrise ehr did not alert its user that the date constraints they set for seeking medication ordering and administration data were out of bounds -beyond the range of the current "admission" -is a significant and severe oversight and/or bg, and a danger to patients not fortunate enough to have a physician informaticist son closely monitoring their care.


Note that these ten points themselves, all I had time to write about this morning, themselves represent a "tip of the iceberg" regarding health IT risks.

In my opinion it's immensely reckless for FDA to make a statement that "products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software ... are of sufficiently low risk" so as to not warrant formal regulation that is already in place for other healthcare software sectors.

Fortunately, the public gets to comment via this announcement:

Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments

I feel, however, that the decision is a given, and that the health IT industry has such regulatory capture that public comments will be ignored.  (Not that I won't try.)


I ponder what ever happened to the inquiry responses about health IT defects and harm sought by the Senate Finance Committee, as reported in the Washington Post:

Electronic medical records draw frequent criticisms
By Alexi Mostrous
Washington Post Staff Writer
Sunday, October 25, 2009


... the Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.

On Oct. 16, the panel wrote to 10 major sellers of electronic record systems, demanding to know, for example, what steps they had taken to safeguard patients. "Every accountability measure ought to be used to track the stimulus money invested in health information technology," said Sen. Charles E. Grassley (Iowa), the panel's ranking Republican.

The results of that request seem to have gone to the recycle bin.

-- SS

Thursday, April 03, 2014

Finally, An Article in a Large Circulation Medical Journal with Systematic Data about Leaders of Academic Medicine Conflicted by their Service on Health Care Corporate Boards

Background - a New Species of Conflict of Interest

Since 2006, we have posted repeatedly about  what was then a new species of severe conflicts of interest.  This occurs when leaders of academic medical institutions or other health care non-profit organizations or non-governmental organizations (NGOs) also serve as members of boards of directors of for-profit corporations  whose products and actions have major effects on health care.

Most recently, we discussed the cases of the current CEO of the National Quality Forum and past CEO of the American Board of Internal Medicine who was found to be on the board of for-profit hospital group purchasing organization Premier Inc, and had been on the board of its privately held but for-profit predecessors.  We then discussed the case of the incoming president of the US Institute of Medicine and former Chancellor of Health Affairs at Duke University who was on the boards of Alnylam Pharmaceuticals, Medtronic and Pepsico.  We next discussed the case of the current Dean of medicine at the University of Illinois who is on the board of Novartis. 

We also recently posted about the first time these sorts of severe conflicts of interest issue have been addressed in a large circulation medical journal.  A commentary in JAMA called for many such conflicts to be banned.

A Small Study of the Prevalence of a New Species of Conflict of Interest

Now JAMA has just published a research letter which examined the prevalence of board members of large, for-profit, publicly held pharmaceutical companies who also were among the leadership of academic medical centers. [Anderson TS, Dave S, Good CB et al. Academic medical center leadership on pharmaceutical company boards of directors.  JAMA 2014; 311: 1353-5.  Link here.]

The authors looked at public data about 2012 board membership of the 47 biggest publicly held companies based on global prescription drug sales. They tabulated those who were also leaders at (apparently only US) academic medical centers. 

The most important findings were:
- 19/47 companies (40%) had at least one board member who was a leader of an academic medical center (AMC)
- 16/17 US based companies had at least one board member who was also a leader of a US AMC
-  pharmaceutical company board members included 2 university presidents, 6 deans of medicine, 6 hospital or health system executives, 7 clinical department chairs or center directors
-  28 board members were also members of boards of trustees or directors of US hospitals, medical schools, or their parent universities.


We have been trying to raise awareness of this issue since 2006.  Now we have some idea of the size of the problem.

Keep in mind that this study did not attempt to determine the prevalence of academic medical center leaders on boards of smaller pharmaceutical companies, privately held companies, biotechnology or device companies, or other health care and health care related companies (e.g., for-profit hospital systems, health insurance companies, for-profit contract research organizations, for-profit medical education and communication companies, large companies with major health care components, etc, etc, etc)  It also did not attempt to determine the prevalence of leaders of other important health care non-profit organizations (e.g., hospitals and hospital systems, insurance companies, professional societies, patient advocacy groups, accrediting boards, etc, etc, etc) on health care or related corporate boards.  It also did not address leaders of health care organizations outside of the US.  So this study likely greatly underestimates the overall prevalence of and the number of people involved in what we first called a "new species of conflict of interest."

But it is a start.  And publishing it in JAMA will begin to make more health care professionals, policy makers, and researchers, and more of the public at large aware of the problem.

As I said before, it is very nice to see that the issue of what we once called a new species of conflict of interest finally has made the big time.  Whether it now gets any more traction remains to be seen.  Unfortunately, since conflicts of interest can be so profitable for the directly affected parties, I fully expect they will continue to oppose any restrictions.  The money they have made will likely be used to deploy marketing and public relations personnel and legal counsel to counter any attempts to try to make this aspect of health care more honest.

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.

For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.

Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.

ADDENDUM (3 April, 2014) - see also comments by Paul Levy on the Not Running a Hospital blog, on the 1BoringOldMan blog, and by Ed Silverman (welcome back!) on the WSJ Corporate Intelligence blog