Hoffman and Podgurski: A relatively lawless industry and "meaningful use" of health IT, with safety as an afterthought

In their article "Meaningful Use and Certification of Health Information Technology: What About Safety?" (free PDF here), Sharona Hoffman (Professor of Law and Bioethics and Co‐Director of the Law‐Medicine Center, Case Western Reserve University School of Law) and Andy Podgurski (Professor of Electrical Engineering and Computer Science, Case Western Reserve) make an important case for what I've previously described as "putting the cart before the horse."

At my Oct. 1, 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC" I argued that the IOM was only called in to study HIT safety after plans for national rollout were put into law, and a "stimulus to adoption" (with penalties for refusniks) financed at the cost of tens of billions of dollars.

I found this approach to HIT and the sequencing of events - the development of "meaningful use" criteria before usability and safety criteria - quite cavalier.

Hoffman and Podgurski go a step further.

They begin:

In the summer of 2010, the Department of Health and Human Services (HHS) published three sets of regulations to implement ARRA. This article briefly describes and critiques the regulations, arguing that (1) they fail to appropriately address HIT safety and (2) further steps must be taken to protect patients and serve public health needs in the new digital era.

After a brief review of the Meaningful Use and "Certification" (a.k.a. features qualification) regulations and programs, they go on to critique those regulations and programs as a "step towards comprehensive oversight", but a very deficient step considering the ambitions and timelines of the HITECH act and the federal government.

They aptly note (along with with footnotes):

... While advocates argue that computerization will reduce errors, numerous recent reports have demonstrated that the opposite can be true. Hospitals have experienced incidents in which doctors’ orders were posted to the wrong patient charts and electronic drug orders were not delivered to nurses who needed to dispense them to patients. A published 2009 review of almost 56,000 CPOE prescriptions found that approximately 1% of them contained errors. Patients who do not receive needed medication or whose treatment is otherwise mismanaged because of software or usability problems can suffer catastrophic consequences.

General system safety is a property that is attainable only through rigorous processes for development and evaluation. [Evaluations of the kind the healthcare IT industry seems to have steadfastly circumvented and avoided - ed.]

However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. [In other words, they are essentially meaningless in terms of HIT safety - ed.]

Furthermore, ATCBs [ONC 'Authorized Testing and Certification Bodies'] will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions. [In other words, a preflight checklist will be conducted of aircraft that have rarely or never actually flown, to declare them flight ready for the amateur pilot - ed.]

They note the obvious:

Meticulous testing of EHR products is critical to their safety. Because of the government’s lucrative incentive payments, many new vendors may attempt to enter the market and to quickly produce EHR systems whose quality is unproven and perhaps dubious.

A key passage in this article is this:

Admittedly, clinical evaluation of new products poses challenges for vendors who would need to find facilities willing to accept the administrative burdens of assessing systems that may ultimately fail. [In other words, it will cost them to improve the safety of their products, a core competency they should have developed decades ago - ed.]

Such facilities would also experience delays in receiving incentive payments because they would use uncertified systems during the evaluation period. However, certification of HIT that has not been thoroughly evaluated is no more responsible than approval of medications or devices that have not been carefully scrutinized by the FDA

"No more responsible than approval of medications not scrutinized by FDA" is quite on target. I personally would use a stronger term than deficient responsibility, however: deliberate reckless indifference to health IT safety seems more descriptive.

The authors do note that:

The delegation of EHR approval responsibilities to ATCBs will ease HHS’s regulatory burdens and likely supply an adequate pool of experts for HIT testing. HHS is authorized to monitor ATCBs through on‐site visits, reports, and review of documentation. It remains to be seen if these measures will ensure that ATCB members are qualified, competent, and free of conflict of interest. These issues will become more critical if HHS eventually requires rigorous clinical testing of EHR systems as described above.

Considering the track record of the pharma and medical device industries as presented in many case examples at this blog, "qualified, competent, and free of conflict of interest" is a tall order indeed for the health IT industry and its "certifiers."

The authors again state the obvious (albeit an "inconvenient truth"):

... it is naive to assume that any use of HIT is better than no use of HIT. [This warning echoes the "use equals success" fallacy as described by Karsh et al. in their recent JAMIA article described here - ed.]

EHR systems constitute complex technology that can introduce errors as well as prevent them. Medical errors can occur because of computer bugs, computer shut‐downs, or user mistakes that may be attributable to a flawed user interface. Through communication tools, electronic ordering, decision support features, and data management, EHR systems will guide many aspects of patient care. Treatment success will often depend on their proper functioning.

They conclude:

HHS’ new regulations constitute positive first steps and a laudable reversal of a relatively lawless approach to EHR system design and deployment. Previously, the only certification program was offered by the Certification Commission for Health Information Technology, a private industry group that was not subject to regulation.

I used terms such as "wild west", "out of control" and "pre-Flexnerian" to describe the HIT industry. That an attorney would use the term "lawless" seems quite fitting to describe similar observations.

Finally, they state:

Still, much more work must be done to protect public health in the digital era. We urge that future meaningful use and certification criteria and the post‐2011 permanent certification program be more attentive to safety issues.

EHR system approval should be no less rigorous than the FDA’s process for drug and device approval because HIT is as safety‐critical for patients. A prime criterion for certification should be a documented history of safe operations in a number of clinical environments.

The federal government would be wise to focus less on the speed of EHR adoption and more on product quality. Only through sufficient safeguards for EHR system safety can this technology fulfill its promise to dramatically improve individual and public health outcomes.

In my opinion, the HITECH timelines are far too ambitious (I sense a similar sentiment "between the lines" in the above passage). Perhaps it's time for those timelines to be revisited.

A new Congress should take that on, or defund HITECH and rewrite it to prevent patient harm and AHLTA and UK NPfIT-like debacles, to save billions of taxpayer dollars we really don't have to spare at the moment.

-- SS

GlaxoSmithKline Subsidiary Pleads Guilty to Manufacturing Adulterated Drugs: Three Strikes and ...?

Paxil

First there was Paxil (Seroxat in the UK, or paroxetine), the anti-depressant whose marketing lead GlaxoSmithKline (GSK) to settle allegations of fraud brought by then New York Attorney General Elliott Spitzer in 2004.  That case included allegations of suppression and manipulation of clinical research, and was discussed in great detail in the book Side Effects by Alison Bass.  We posted about various aspects of this case, e.g., more recently here, here, and here. 

Avandia

Then there was Avandia (rosiglitazone), the anti-diabetic drug whose use was just restricted by the US Food and Drug Administration.  This GlaxoSmithKline product inspired a "spin cycle" which provided us with endless grist for the Health Care Renewal mill.  A good summary of the case appeared in September in the British Medical Journal (Cohen D. Rosiglitazone: what went wrong: Brit Med J 2010; 341: 530-534.  Link here)  Once again, it appears that research was suppressed and manipulated (e.g., see here), Avandia critics were attacked by "experts" whose financial relationships with GSK were not always obvious (e.g., see here), and there were allegations that GSK executives tried to intimidate those who disagreed with them (e.g., see here and here). 

Adulterated Drugs

And now it is adulterated drugs.  Here is the version from Bloomberg:

GlaxoSmithKline Plc, the U.K.’s largest drugmaker, will pay $750 million to settle a U.S. whistleblower lawsuit over the sale of defective drugs.

Glaxo and the U.S. Justice Department announced the agreement yesterday, resolving a false-claims lawsuit first filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the London-based company.

'This is not something I wanted to do, but because of patient safety it was necessary,' Eckard, 51, told reporters following a Justice Department press conference in Boston. As a whistleblower, she will receive $96 million from the settlement money.

Glaxo was accused in court papers of selling tainted drugs under false pretenses. The medicines, made at a Glaxo plant in Cidra, Puerto Rico, were misidentified as a result of product mix-ups, according to papers filed in federal court in Boston. The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet. [Note that this is a combination drug that includes Avandia - ed]

The settlement includes a criminal fine and forfeiture totaling $150 million and a $600 million civil settlement under the False Claims Act and related state claims, the Justice Department said in a statement.

'We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers,' Carmen M. Ortiz, the U.S. Attorney in Boston, said at yesterday’s news conference.

SB Pharmco Puerto Rico Inc., a Glaxo unit, agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs made at the now-shuttered plant, the Justice Department said. Glaxo said in July it had agreed in principle with the U.S. to pay 500 million pounds ($791 million) to resolve the investigation.

'We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality,' PD Villarreal, a Glaxo senior vice president, said in an e-mailed statement.

Eckard’s take is the largest ever for a single whistleblower, said Patrick Burns, spokesman for Taxpayers Against Fraud, a nonprofit Washington group that publicizes the use of legal means to combat fraud against the U.S. The federal government will receive $436.4 million from the settlement and participating states will split as much as $163.6 million, the Justice Department said.

Other drugs made at the plant include Kytril, an anti- nausea medication, and Bactroban, an ointment used to treat skin infections, the Justice Department said.

'The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,' the government said in court papers.

The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.

It seems that not only questions about GSK sponsored clinical research about and GSK marketing of Paxil and Avandia, but the company has problems even supplying tablets that contain the pure drugs at the right dose.
Summary and Discussion

First, this is another dreary marcher in the parade of legal settlements that we have now been chronicling for years. This case has some particular features. It included a guilty plea to a crime. Although the allegations included fraud, the fundamental problem seemed to be the selling of adulterated, impure drugs.

So my first comment is that this is the latest instance of a major pharmaceutical company not being able to fulfill its most basic responsibility and reason for being, the manufacture of pure, unadulterated drugs. We previously discussed problems with adulterated drugs made by Baxter International and Johnson and Johnson. We have discussed, seemingly endlessly, how big health care corporations, including but certainly not limited to pharmaceutical companies, have engaged in various sophisticated deceptions involving marketing and clinical research to sell more products at higher prices. Now it seems that while these companies have put so much of their resources into marketing and public relations, not necessarily in honest ways, they have neglected to put the necessary expertise and resources into their most basic manufacturing functions.

So while drug industry sycophants prattle on endless about life-saving innovations, not only have industry marketing and research become less trustworthy, but now we cannot even trust the companies to supply the drug that is on the label in a pure form at the labelled dose.

My next comment is that this is the third big case involving GlaxoSmithKline reported in the last few years. (Although, like the previous cases, the events that lead to recent relevations actually occurred over the last 10+ years.) This would suggest that there is a serious problem with the culture, leadership, and governance at this corporation.

Maybe one reason such problems are allowed to fester is that in the current case, like the last two involving GSK, and as is typical for the legal settlements and crimes we have discussed before, no individuals who authorized, directed, or implemented the problematic behavior seem to have suffered any negative consequences or paid any penalty. In fact, the Guardian just pointed out:

Five of the six senior GlaxoSmithKline executives cited by a whistleblower as part of a cover-up of contamination problems at the group's Puerto Rico factory are understood to still be employed by the pharmaceuticals company.

Cheryl Eckard, who was sacked by the company as a quality control manager in 2003 after repeatedly raising her concerns with a series of GSK executives, received a $96m (£61m) reward this week as part of a $750m criminal and civil settlement between US regulators and the company.

Her evidence stated that she believed company executives refused to acknowledge the gravity of the production violations – which included the wrong strength of pills being shipped – because it would delay the approval of two new drugs by the US Food and Drug Administration.

The court documents allege that Eckard, who had recommended the factory be shut until the issues were resolved, communicated the quality violations at the plant in Cidra to David Pulman, president of global manufacturing and supply; Janice Whitaker, senior vice president of global quality; Peter Savin, vice president of global quality assurance; Diane Sevigny, director of global quality assurance, risk management and compliance; and Jonathan Box, vice president of manufacturing and supply for North America.

All five executives are believed to be still working for the London-listed company, while Pulman is also a member of the company's 18-strong corporate executive team, which includes chief executive Andrew Witty.

As we have said endlessly, penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue. 

When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards.  Further, expect organizations that did not uphold high standards in one instance to fail to uphold them in other instances.

See also comments on the Postscript blog.

THAT'S EDUCATION!

THAT’S EDUCATION!

You can’t make this stuff up.

This week I received a cheerful E-mail from a well known academic key opinion leader or KOL. Only the E-mail didn’t really come from Dr. Ian Cook at UCLA. It really came from a company called PeerView Institute for Medical Education. The E-mail offered on-line CME content with the topic Essential Aspects to Building a Therapeutic Alliance Between Patients and Practitioners for the Treatment of Mood Disorders. Whenever I see an anodyne title like that I know there’s trouble ahead.

The content came in the form of a dialogue between Dr. Cook and another well known academic KOL, Dr. Michael Thase from Penn. Beneath two prominent corporate logos, a disclosure stated This activity is supported by educational grants from AstraZeneca LP and Lilly USA, LLC. Another disclosure stated This CME/CNE/CPE activity is jointly sponsored by Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. The program also states This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. Purdue University College of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians.
I happen to know Dr. Cook and Dr. Thase, so already I am thinking why are these productive academic researchers from first tier universities doing a yawner CME gig like this? Then I get it. Most academic physicians have been told by now that they may no longer speak for hire at dinners and events sponsored by Pharma. You know, the sort of thing that Charles Nemeroff tried to pass off as CME-like, only Senator Grassley wasn’t buying it. So now the action has moved to commercial CME activities that carry the imprimatur of ACCME, thus confirming the principle that the flow of marketing money must find an outlet.

My jaundiced view of ACCME’s performance and credibility is a matter of record. For that matter, I am on record with a jaundiced view of the entire CME business. Here is what I said back in 2008.

…Continuing Medical Education (CME) is a second front in the campaign to expand (drug markets). The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content. The KOLs are chosen for their willingness to be “on message” for the corporate sponsor. If they go “off message” they know they will not be invited back. The talk of “unrestricted grants” is window dressing. The MECC also secures the imprimatur of a nationally accredited CME sponsor, typically an academic institution. The sponsor is paid to certify that the CME program meets the standards of the Accreditation Council on Continuing Medical Education (ACCME). Everybody turns a buck: the MECC and its staff are handsomely paid (CME is now a multi-billion dollar business); the KOLs are generously rewarded with honoraria and perquisites; the academic sponsor is well paid by the MECC; the ACCME receives dues from the academic sponsor; the audience obtains free CME credits rather than having to pay for these required educational experiences; and the corporate sponsor gets what it considers value for its marketing dollar.
So, I approached this free on-line CME offering with a good deal of skepticism. Most of the content was pedestrian and scripted – not because these KOLs couldn’t have done better but because someone at the MECC scripted it for them. Someone at the MECC also put the slides together, about which more in a moment. The material was formulaic, a succession of clinical banalities accompanied by Power Point slides that said everything and nothing. I cannot imagine that a physician would learn anything substantive from these educational tropes.

The impresarios at PeerView Institute for Medical Education, funded by Lilly and AstraZeneca, came through with the desired spin. The corporate sponsors obtained the soft messaging they wanted. Their products olanzapine and quetiapine were not promoted overtly, but it was surely gratifying that the content emphasized the accepted place of such second generation antipsychotic drugs as a class in mood stabilization for bipolar disorder and in augmentation for nonresponsive major depression. This soft messaging was delivered with the appearance of authority, within a package of algorithms, strategies, Venn diagrams, and measurement tools that featured potential upsides but gave hardly a nod to the worrisome side effects of such drugs, especially in depressed patients . And it surely was no accident that the sponsors’ drugs appeared as exemplars in slides and in the follow-up questions – another form of soft messaging.


Finally, I came upon incontrovertible evidence that these KOLs did not prepare the educational content of the program. A slide that discussed antidepressant drug options contained a panel dealing with the MAO Inhibitors (MAOIs). This class of antidepressant drug appeared in the 1950s, and MAOIs still have a limited place in clinical practice. The information given about the MAOI drugs in the enduring material (slide) of this program, however, is dated, inaccurate, and dangerous. Here is the relevant section of the slide.

CLASS
MAOIs (eg, benmoxin, hydralazine phenelzine, pheniprazine)

EFFICACY
↓ efficacy compared to TCAs 4

COMMON SIDE EFFECTS
• Drowsiness, dizziness, loss of visual acuity, GI side effects, insomnia, irritability 4

What’s wrong with this? Plenty. Benmoxin has never been marketed in the US and was discontinued in Europe many years ago. Hydralazine is not an MAOI but an antihypertensive agent. Pheniprazine was discontinued many years ago due to marked toxicity. Meanwhile there is no mention of tranylcypromine or selegiline or moclobemide, which are in current use. The listing of hydralazine, which has no antidepressant activity, is especially dangerous. Likewise, the laundry list of side effects manages to omit the single most important problem with the MAOI class – potentially lethal dietary and drug interactions.

There is only one way to say it – this educational content is incompetent, reckless, and dangerous. I know both the KOLs well enough to be certain they would never develop such educational content themselves. So, who did develop it? Some functionary at PeerView Institute for Medical Education, who had no clue what s/he was doing. Compounding the problem, the Purdue University College of Pharmacy waved through this incompetent material for CME credit. If the Purdue University College of Pharmacy wants to provide continuing education for pharmacists, fine. But I draw the line at allowing an institution that does not train physicians to provide continuing education for physicians. I do not understand why this is permitted by ACCME. On the evidence of this program, the Purdue University College of Pharmacy lacks the expertise to provide continuing education for physicians.

The standard is simple. The standard is not ‘we try to ensure accuracy’… the standard is we get it right – that’s what our role models teach us in medical school and residency training. These KOLs are accountable for the reckless errors in this content because they allowed their names to be featured as the authorities. Plainly, they did not develop the educational content and they did not take the time to review the enduring materials as their accountability required.

Why have the deans of US medical schools not banned academic physicians from participating in such commercial CME gigs? It is no secret how phony these events are. Why not help these busy academic clinical scientists to maintain their focus by limiting them to educational programs at academic medical centers and at meetings and functions genuinely sponsored by professional medical societies? As the present example shows, anything else is business as usual under cover of a fig leaf.

I want to be clear that I have enjoyed friendly relationships with Ian Cook and Michael Thase for a long time. It’s not personal, it’s about standards and it’s about tradecraft. If academic KOLs are too busy to maintain standards and tradecraft then they should pass up these educational charades. For shame, guys.

Bernard Carroll

RUC It Up - How the US Government Fixes Physicians' Payments Becomes Less Anechoic

We have frequently posted, first here in 2007, and most recently here and here, about the little-known group that controls how the US Medicare system pays physicians, the RBRVS Update Committee, or RUC. 

Since 1991, Medicare as set physicians' payments using the Resource Based Relative Value System (RBRVS), ostensibly based on a rational formula to tie physicians' pay to the time and effort the expend, and the resources they consume on particular patient care activities.  Although the RBRVS was meant to level the payment playing field for cognitive services, including primary care, vs procedures, over time it has had the opposite effect, as explained by Bodenheimer et al in a 1997 article in the Annals of Internal Medicine.(1)  A system that pays a lot for procedures, but much less for diagnosing illnesses, forecasting prognoses, deciding on treatment, understanding patients' values and preferences, when procedures and devices are not involved, is likely to be very expensive, but not necessarily very good for patients. 

As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.


To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation. Their names do not appear. A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it. Thus, the RUC membership as at best relatively opaque.

To expand on the ultimate point, as Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."

The fog surrounding the operations of the RUC seems to have affected many who write about. We have posted (here, here, here, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC. Up until now in 2010, after the US recent attempt at health care reform, the RUC seems to remain the great unmentionable. Even the leading US medical journal seems reluctant to even print its name.

That has just changed.  A combined effort by the Wall Street Journal, the Center for Public Integrity, and Kaiser yielded two major articles about the RUC, here in the WSJ (also with two more spin-off articles), and here from the Center for Public Integrity (also reprinted by Kaiser Health News.)  The articles cover the main points about the RUC: its de facto control over how physicians are paid, its "secretive" nature (quoting the WSJ article), how it appears to favor procedures over cognitive physician services, etc.

So the RUC has suddenly become less anechoic.

However, despite the best efforts of some very good investigative reporters, there still are important unanswered questions, questions we have raised before:

• How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
• Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
• How did the RUC become de facto in charge of this process?
• Why does the AMA keep the membership on the RUC so opaque, and give no input into the RUC process to its general membership?
• Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
• Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?

Without discussing how the incentives for physicians became so unbalanced, do we really expect we can fix them?  If we do not fix them, do we really think we can "bend the cost curve?"  If we do not control our costs, do we really think that we will be able to make good health care accessible for all?  At least now I can say that the issue may really be in play for health care professionals, health care policy experts, and the public at large.
See also comments on other blogs: DBs Medical Rants, GoozNews, and Managed Care Matters.

ADDENDUM - Additionally, see comments on the Retired Doc's Thoughts blog, and the Running a Hospital blog.

References
1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.)

2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (Link here.)

Not "the Best and the Brightest" - Drug Marketers and the Creation of "Thought Leaders"

A combined investigative reporting effort by Pro Publica, partnering with the Boston Globe, Consumers Reports, the Chicago Tribune, National Public Radio, the Public Broadcasting System on seven major pharmaceutical companies' payments to doctors who make speeches on the companies' behalf has gotten a lot of press.  It inspired several separate reviews by news organizations in Colorado, Illinois, Minnesota, Ohio,Washington, etc on local doctors who were paid to talk.  Many of my fellow health care skeptic bloggers, including the Carlat Psychiatry Blog, Hooked: Ethics,Medicine and Pharma blog, the Health Beat blog, have been all over this story.

Yet I think it is reasonable to underline three important points.

Not the Brightest

Pharmaceutical and other health care corporations are fond of saying that the doctors they hire to give talks are the "best and the brightest," thought leaders respected by other physicians.  In fact, the lead article by Pro Publica suggested that some of these supposed "best and the brightest" have dubious credentials, indeed.

Some were not board-certified, and lacked credentials suggesting great expertise:

Among the top-paid speakers, some had impressive resumes, clearly demonstrating their expertise as researchers or specialists. But others did not –contrary to the standards the companies say they follow.

Forty five who earned in excess of $100,000 did not have board certification in any specialty, suggesting they had not completed advanced training and passed a comprehensive exam. Some of those doctors and others also lacked published research, academic appointments or leadership roles in professional societies.

In summary,

Pharma companies often say their physician salesmen are chosen for their expertise. Glaxo, for example, said it selects 'highly qualified experts in their field, well-respected by their peers and, in the case of speakers, good presenters.'

ProPublica found that some top speakers are experts mainly because the companies have deemed them such. Several acknowledge that they are regularly called upon because they are willing to speak when, where and how the companies need them to.

Not the Best

Worse, some of the pharmaceutical paid speakers had records of ethical problems.

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.


More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

The Pro Publica story lead with three disturbing anecdotes:

The Ohio medical board concluded [1] that pain physician William D. Leak had performed 'unnecessary' nerve tests on 20 patients and subjected some to 'an excessive number of invasive procedures,' including injections of agents that destroy nerve tissue.

Yet the finding, posted on the board’s public website, didn’t prevent Eli Lilly and Co. from using him as a promotional speaker and adviser. The company has paid him $85,450 since 2009.

In 2001, the U.S. Food and Drug Administration ordered [2] Pennsylvania doctor James I. McMillen to stop 'false or misleading' promotions of the painkiller Celebrex, saying he minimized risks and touted it for unapproved uses.

Still, three other leading drug makers paid the rheumatologist $224,163 over 18 months to deliver talks to other physicians about their drugs.

And in Georgia, a state appeals court in 2004 upheld [3] a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. The anesthesiologist had admitted giving young female patients rectal and vaginal exams without documenting why. He’d also been accused of exposing women’s breasts during medical procedures. When confronted by a hospital official, Taylor said, 'Maybe I am a pervert, I honestly don’t know,' according to the appellate court ruling.

Last year, Taylor was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June.

It also included:

The Medical Board of California filed a public accusation against psychiatrist Karin Hastik in 2008 and placed her [8] on five years’ probation in May for gross negligence in her care of a patient. A monitor must observe her practice.

Kentucky’s medical board placed Dr. Van Breeding on probation [9] from 2005 to 2008. In a stipulation filed with the board, Breeding admits unethical and unprofessional conduct. Reviewing 23 patient records, a consultant found Breeding often that gave addictive pain killers without clear justification. He also voluntarily relinquished his Florida license.

New York’s medical board put Dr. Tulio Ortega on two years’ probation [10] in 2008 after he pleaded no contest to falsifying records to show he had treated four patients when he had not. Louisiana’s medical board, acting on the New York discipline, also put him on probation [11] this year.

Yet during 2009 and 2010, Hastik made $168,658 from Lilly, Glaxo and AstraZeneca. Ortega was paid $110,928 from Lilly and AstraZeneca. Breeding took in $37,497 from four of the firms.

The Biggest Prescribers = "Thought Leaders"

An accompanying NPR story suggested that most physicians are recruited as speakers because they are big prescribers of the drugs the companies want to market, with the expectation that they will be even bigger prescribers once they start giving paid talks. Furthermore, the companies' representatives use a carefully programmed psychological strategy to allow the physicians they recruit to think they are being paid as "thought leaders" to give educational talks.

Drug companies train representatives to approach a narrow set of doctors in a very specific way, using language that deliberately fosters this idea that the doctors who speak are educators, and not just educators, but the smartest of the smart.

For example, every drug representative interviewed for this story used the exact same phrase when approaching a doctor with a pitch to become a speaker: Each doctor approached to speak was told that he was being recruited to serve as a "thought leader."

This phrase, Webb says, seems to have incredible psychological power.

'When you do say 'thought leader' I think it's a huge ego boost for the physicians,' Webb says. 'It's like a feather in their cap. They get a lot from it.'

This is because most doctors have a very specific idea in mind when you ask them what constitutes a thought leader. Most doctors, including Clawson, cite two important qualifications. 'First, the other doctors in the community respect that person's opinion,' Clawson says. 'And the other way to become a 'thought leader' is to become an academic researcher and try to push the bounds of science further, and then by definition you're a thought leader.'

But some drug representatives, like Maher, have a more cynical view of why drug companies choose the doctors they choose. It's not about how well respected the doctor is, according to Maher; it's about how many prescriptions he writes.

'I think nowadays a thought leader is defined as a physician with a large patient population who can write a lot of pharmaceutical drugs. Period,' she says.

These "thought leaders" may find it comfortable to think that they are paid as experts to give educational talks, but really, they are paid to persuade themselves to prescribe more. If audiences prescribe more, it's just a bonus.

This doesn't mean that every doctor recruited is not a high-quality doctor. Many are. But every representative NPR spoke to had a stable of stories about profoundly unimpressive doctors that they'd recruited as thought leaders essentially for the same reason that a robber robs a bank: because that's where the money is.

The fact is that the top 20 doctors in a representative's territory prescribe the vast majority of the medication. According to Webb, the top 20 percent prescribe as much as the lower 80.

So if you want to sell more of your product, and every representative is required to sell more, those are the physicians to target.

Which brings us to the hard reality about doctor speaking: Although doctors believe that they are recruited to speak in order to persuade a room of their peers to consider a drug, one of the primary targets of speaking, if not the primary target, is the speaker himself.

That's where reps look for a real increase in prescriptions — after a speech.

Here's how the money works out, at least for Webb. It's hard to know whether he's typical because there haven't been any published studies of this subject. But according to Webb, he would give a high-prescribing doctor about $1,500 to speak. And following that speech, Webb would see the speaking doctor write an additional $100,000 to $200,000 in prescriptions of his company's drug.

Webb points out that the people recruited to speak are almost always high prescribers with incredibly high patient populations. 'That much money, easily,' he says. 'So yeah, it was a good return on investment.'

The article also suggested that most of the paid "thought leaders" do not realize on a conscious level how they have been bought.

Dr. James Dickie, an endocrinologist in Westminster, Md., was very clear that his prescription-writing was unaffected by speaking. 'Absolutely not. The physicians who are in the audience may notice it if they have been educated to that drug and the benefits of that drug — they may see an increase in writing. But specifically in my own? I don't believe so.'

When NPR told Dickie about the findings learned from drug reps like Maher and Webb, he seemed genuinely surprised and disturbed and began to wonder out loud if he was, in fact, affected.

'It would really bother me,' Dickie says. 'Because I perceive myself as always prescribing in the best interest of my patient, and even unconsciously if I was unduly influenced, that would really bother me. I usually pride myself on keeping up my guard to prevent undue influence.'

But Maher says it's almost impossible for a doctor to keep up his guard. She points out that before doctors speak to their peers about a drug, they review slides provided by the company and talk to the company medical officers. And this process, she says, focuses the doctor on the most positive aspects of a drug.

'What is happening is that you are being manipulated to talk about the drug out loud,' Maher says. 'Kind of like talking themselves into knowing that what they were saying, were actually believing. And if they believed what they were saying, then they would write more drug.'

Summary

Marketers, especially but not only pharmaceutical marketers, have become very adept at using psychology to manipulate their targets, so that marketing campaigns have begun to resemble disinformation campaigns.  Pharmaceutical marketers in particular have used their ability to convince physicians that they are "thought leaders," (or "key opinion leaders") to get physicians who are already favorably inclined toward their products to prescribe even more.  It is a bonus for the companies if these physicians can also persuade other physicians to prescribe more.  The fact that these supposed "thought leaders" have become real leaders of medicine, to a great extent on the basis of marketers' decisions (also abetted in the academic setting by medical schools' and academic medical centers' love of "external funding," including the sort supplied by marketers to "thought leaders", see this post) is the perhaps unintended but unhappy consequence.  Thus the leaders of medicine and health care are more and more those doctors who are most compliant with and least questioning of pharmaceutical (and other health care) companies' marketing. 

No wonder the leadership of medicine has been so passive as health care has become more dysfunctional.

What is to be done?

-  Physicians and others who are paid to give talks by commercial firms must read the series of articles noted above. 
-  We need to be very skeptical of all "thought leaders" and "key opinion leaders," especially if it is not clear whether they were first dubbed as such by marketers rather than by their own achievements.
-  We need as rapidly as possible to mandate full disclosure of all payments by health care corporations others with vested interests in promoting products or services to physicians, academics, and others with decision making ability or influence in medicine and health care.
-  Hopefully full disclosure of the scope of the thus revealed conflicts of interest will persuade health care professionals and society that we need to eliminate such conflicts, allowing professionals to eventually return to their once respected status as those pledged to put their patients' (rather than their financial backers') interests first. 

JAMIA: Health information technology: fallacies and sober realities

A superb, well-researched, and I believe watershed position paper in JAMIA was just published. I will briefly cover its major points due to current time limitations (ironically, I have an elderly health IT-injured relative to tend to). However I did want to make readers aware of the paper.

The paper nukes the health IT industry myths, memes and cavalier business practices that I find so disappointing.

The article organizes many of the themes around HIT myths, irrational exuberances and marketing memes into one coherent position paper (unfortunately, free fulltext is not yet available online that I can locate, but if you can obtain the article, it is a must-read):

J Am Med Inform Assoc. 2010 Nov 1;17(6):617-23.

Health information technology: fallacies and sober realities (link)

Karsh BT, Weinger MB, Abbott PA, Wears RL.

Department of Industrial and Systems Engineering and Systems Engineering Initiative for Patient Safety, University of Wisconsin, Madison, Wisconsin, USA.

Abstract

Current research suggests that the rate of adoption of health information technology (HIT) is low, and that HIT may not have the touted beneficial effects on quality of care or costs. The twin issues of the failure of HIT adoption and of HIT efficacy stem primarily from a series of fallacies about HIT. [Not discussed are the origins and maintenance vectors of those fallacies, a topic for significant research itself - ed.] We discuss 12 HIT fallacies and their implications for design and implementation. These fallacies must be understood and addressed for HIT to yield better results. Foundational cognitive and human factors engineering research and development are essential to better inform HIT development, deployment, and use.

PMID: 20962121 [PubMed - in process]

The article presents a series of HIT "fallacies" akin to the logical fallacies lists often referenced at this blog including:

THE ‘RISK FREE HIT’ FALLACY
THE ‘HIT IS NOT A DEVICE’ FALLACY
THE ‘LEARNED INTERMEDIARY’ FALLACY
THE ‘BAD APPLE’ FALLACY'
THE ‘USE EQUALS SUCCESS’ FALLACY
THE ‘MESSY DESK’ FALLACY (i.e., the fallacy that medicine is neat and linear)
THE ‘FATHER KNOWS BEST’ FALLACY
THE ‘FIELD OF DREAMS’ FALLACY
THE ‘ONE SIZE FITS ALL’ FALLACY
THE ‘WE COMPUTERIZED THE PAPER, SO WE CAN GO PAPERLESS’ FALLACY

I will write more about the paper in a future posting. However, readers of this blog, where I've covered these issues, can probably ascertain the meanings of these fallacies regarding health IT without further explanation.

Addendum 10/29: This is not just a "what is wrong with health IT" paper. The paper points out that insufficient contextual research has been conducted to support effective commercial HIT design and implementation despite decades of exemplary research on these topics, and suggests a path to remediation.

At the most fundamental level, HIT must be focused on transforming care and improving patient outcomes and must be designed to support the needs of clinicians and their patients. For example:

• The needs of users and the complexities of clinical work must be analyzed first, followed by evaluation of the entire scope of potential solutions, rather than examining the current array of available products and characterizing the needs that they might meet.
• Appropriate metrics for HIT success should not be adoption or usage, but rather impact on health.
  
• The ‘comparative effectiveness’ perspective must also be applied to HIT - what is the return-on-investment of each HIT initiative compared with alternative uses of these funds?
  
• There must be substantive collaboration with those who can contribute unique and important expertise such as human factors engineers, applied psychologists, medical sociologists, communication scientists, cognitive scientists, and interaction designers.
• During HIT development, vendors and healthcare organizations must focus on more meaningful measures of design success: clinician and patient ease of learning, time to find information, time to solve relevant clinical problems, use errors, accuracy of found information, changes in task and information flow, workload, situation awareness, communication and coordination effectiveness, and patient and clinician
  satisfaction.
• We must also consider the likely undesirable consequences of current policies and regulations on HIT advancement, e.g., hold harmless clauses.
  

If you have access to JAMIA via a library, I recommend downloading the article and reading it.

What will be interesting is the healthcare IT industry and government response, and the response of those with financial interests in pushing for rapid HIT diffusion along HITECH timelines (the "Bullet train out of the station with only a quarter mile of track" fallacy...)

-- SS

10/31/10 addendum

For a pro-industry alternate view on the importance and credibility of this article, see the Review posted on the HisTALK site by its owner at Monday Morning Update 11/1/10, approximately at the halfway mark.

My major concern with the review is not just on its internal logic and anti-academic, academics-automatically-hate-business bias (having been employed in academia, the healthcare IT industry and in Big Pharma myself, I see multiple perspectives).

... The authors of this paper are academics. I like their objectivity, but I’m left with the feeling that they are disillusioned about this fact that is distasteful to them: both healthcare and healthcare IT are businesses that, rightly or wrongly, make decisions based on their own self-preservation, not high-minded academic ideals. [Such as the Hippocratic oath - ed.]

My other concern is the review's taking on the JAMIA article in isolation, ignoring the increasing body of other literature up to the National Reseaarch Council (quoted at the beginning of the Karsh article) shedding doubt on HIT beneficence, effectiveness and ROI, and the statements of the Healthcare IT industry itself such as:

HIMSS's former Chairman of the Board Barry Chaiken admitting the technology remains experimental:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better;

and a HIMSS task force itself admitting in this 2009 PDF report that:

"Electronic medical record (EMR)!adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available";

It seems that from the ethical point of view, when industry leaders themselves express doubts in their own products, the responsible position is to err on the side of caution.

-- SS

Concerns about adoption of Electronic Health Records, as expressed at a meeting of the U.S. House of Representatives Committee on Science & Technology

Even within the Medical Informatics community, it is not common to hear major real-world issues that must be faced before national health IT can become a (safe, effective) reality presented candidly.

I therefore found this candid presentation by a fellow Medical Informaticist, Dr. Richard Gibson, refreshing. (Dr. Gibson was in Medical Informatics fellowship training at U. Utah at the same time I was in my postdoctoral fellowship at Yale.) He presented on issues related to standards for the most part, but also presented some serious caveats as I reproduce below. The caveats will sound familiar to readers of this blog.

The head of ONC, Dr. Blumenthal, was present at this meeting. I hope he will heed Dr. Gibson's words on the difficulties of health IT and cease to present clinical IT as a deterministic solution to healthcare's ills, including definitive statements on unknowns or debatable topics, and even false statements such as these (released for political reasons, of course):

In the NEJM:

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes [actually, may - we do not yet know - ed.] . Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.


From the HuffPo Investigative Fund:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. [False- ed.] And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

Dr. Gibson's testimony on EHR adoption concerns was as follows:

Medical Informaticist Dr. Richard Gibson on Health IT
U.S. House of Representatives Committee on Science & Technology
Subcommittee on Technology & Innovation
Sept. 30, 2010
(Full PDF transcription here).

... CONCERNS ABOUT ADOPTION OF ELECTRONIC HEALTH RECORDS

Adoption of EHRs is a Prerequisite for Interoperability

We have an enormous effort still ahead of us. Before going on to the specific standards that are the topic of today's hearing, we need to acknowledge that the standards have relatively little application unless individual healthcare providers have electronic health records in the first place. Most of the more than 400,000 Eligible Professionals still need to acquire an electronic health record, and most of that effort will be in small physician offices. CMS has estimated the five-year cost of acquiring an electronic health record for an eligible professional to be $94,000. EHR incentive plans through Medicare and Medicaid will cover 47 to 67% of that estimated cost. As a general rule, EHRs still do not allow providers to see more patients in a day, spend more quality time with their patients, or guarantee better or more consistent health outcomes for their patients. [This raises the question of what then, exactly, do EHR's do? - ed.] In short, even with the generous EHR incentive program, there still may not be a sufficient financial rationale for individual providers or small practices to invest in electronic health records.

Implementing an EHR is Stressful for the Provider

Implementing electronic health records in small physician offices is not like purchasing a copy machine or a fax machine. In addition to the great capital expense, the EHR is markedly disruptive to both the clinical and administrative functions of the office. Every provider, medical assistant, receptionist, and billing staff member needs to change the way they do their work. Even with excellent training, it usually takes 2-12 months before providers are fully comfortable on their new tools. On a new EHR, each office visit takes longer - this means increased waiting times for patients or a fewer number of patients per day for the provider. It is not uncommon for providers on a new EHR, after a full 8-10 hour day of seeing patients, to finish their charts on the computer at home for three or four hours in the evening [potentially introducing inaccuracy into the record as a result of the long delay between visit and documentation - ed.] Even those providers who believe in the patient care benefits of an EHR are exhausted by the process in the first year. [Do exhausted clinicians make more, or less errors? - ed.]

EHRs Viewed Unfavorably by Many Providers Because of Administrative Documentation

Many providers who do not yet have EHRs in their office have commented to me how much they dislike the output received from many other physician office EHRs or from hospital EHRs. They specifically complain about how many pages these EHR reports require and how difficult it is to find the small bit of useful clinical information within. Upon investigation, most of this low-value verbosity comes from physicians documenting specific history and physical exam findings required to support their billing. Also, as medicolegal requirements ratchet up, clinicians feel a need to document with a date-time stamp every single finding and every single item of data that they have reviewed. The existing cumbersome EHR reports impair the clinical process and can put the patient at risk by making important information obscure. Clinicians criticize the EHR for this clumsy reading even though the cause lies with our current payment and administrative systems, and not the EHR itself [I would challenge this assertion; computers generate reports according to human-created scripts, and scripts could be created to generate clinically meaningful reports - ed.] , which is otherwise widely agreed to be highly legible. [An apropos term is "legible gibberish" and I recently paid almost $1000 for appx. 2,800 pages of it from an Eclipsys system, documenting two and a half weeks of care of my EHR-injured mother. The output was simply awful - ed.] Most clinicians would prefer to go back to simpler charting that more closely reflects their thought process. These EHR changes will need to await payment reform.

IT Professionals with Multiple Skills Needed for EHR Implementation

Another challenge in implementing electronic health records in small provider offices is the lack of technical expertise and support for the office. The providers are busy with a full schedule seeing patients. Medical assistants are putting patients in rooms or they are continuously on the phone with patients. Front office staff members are trying to make appointments and handle incoming calls. The billing staff is overwhelmed with insurance paperwork. Most providers and staff, especially those in small practices, don’t have time to become fluent in the use of the new system, much less become expert in training others to use the system. Typical small physician implementations start two to three months before the expected launch date of the software. All current paper-based workflows need to be examined and re-designed for the new software. This requires analysts who are not only familiar with software but familiar with the healthcare office process. [It also requires competent people with a service attitude, further limiting the pool of available personnel - ed.] Bringing the majority of the 400,000 Eligible Professionals up to speed on an EHR in the next several years will be challenged by a lack of IT implementation professionals.

EHR Technical Requirements Can Be Challenging for Smaller Practices

Small physician practices are already spending 40-60% of their net revenue on overhead. Space in small physician offices is at a premium and providing a physically locked computer space within the physician office is difficult. Physician offices do not typically have the technical expertise to manage the computers in the clinical areas as well as the office computer network and the larger computers that act as servers and tape backup for the EHR software. Hosting provider EHRs on centralized servers supporting multiple practices may address this concern, but many of the currently used office EHRs are not yet ready for this step-up in technology. Many small towns do not have local computer hardware professionals to support physician offices. The Regional Extension Centers (RECs) exist to assist physicians in this context but even with generous funding, the RECs will be challenged to meet the enormous demand in the next several years. [Considering the "wicked" nature of health IT and the organizational and social issues involved, I would say the RECs will be "overwhelmed to the point of paralysis" - ed.]

I agree with nearly all of Dr. Gibson's positions. I feel they are very helpful in terms of clarifying others' understanding of some inconvenient truths about HIT.

I am disappointed, however, that we even need such testimony before Congress to clear up misconceptions and irrational exuberance about EHR's in the year 2010, when these issues became obvious to objective and unconflicted observers many years ago.

The culture of HIT appears stagnant. Unfortunately cultural reform takes far longer than technological reform.

Yet HIT cannot reform medicine until HIT itself and our societal attitudes and approaches to it are reformed. Hopefully this speech will be a part of initiating the needed reform.

-- SS

History Repeats, and Repeats: McKesson Settles

Here a settlement, there a settlement, everywhere a settlement....  And the march continues, as reported by the New London (CT) Day,

Pharmaceutical distributor McKesson Corp. will pay Connecticut $15 million for 'illegal and deceptive practices' that inflated drug costs for both individual consumers and state-funded programs, Attorney General Richard Blumenthal announced Tuesday.

The settlement calls for $9 million to be used for reimbursing Connecticut's Medicaid program and $3 million for ConnPace, a state program that provides drug coverage for seniors. In addition, $2.3 million will be paid as a civil penalty and $700,000 will go into the state's drug-assistance program for AIDS patients.

Blumenthal had charged in a lawsuit that San Francisco-based McKesson conspired with First DataBank - which publishes average wholesale prices of drugs - to increase the amounts Connecticut paid for brand-name remedies by about 25 percent over usual wholesale costs. Previously, the prices had been 20 percent above wholesale.

McKesson used the increase to sweeten the 'spread' - the amount of profit - that could be taken by pharmacies, thereby increasing its share of the market, he said.

'McKesson manipulated the drug market - conspiring to inflate costs for hundreds of drugs and exploiting public programs that serve our most vulnerable citizens,' Blumenthal said in a statement.

Having been posting on this blog for nearly five years, it is interesting that viewed over time, patterns emerge suggesting that certain organizations have chronic problems with bad behavior. Last year, we noted that a former McKesson Chairman of the Board was convicted of five counts of securities fraud arising from actions occurring in the early part of the 21st century. Five former McKesson executives had already pleaded guilty to related crimes. Last year, Bloomberg called this scandal "one of the largest white-collar crimes."

This pattern may go back a lot longer that the turn of the last century.  Amazingly, the same company, McKesson, was involved in one of the biggest frauds of the great depression era. From the Wikipedia entry,

The McKesson & Robbins, Inc. scandal of 1938 was one of the major financial scandals of the 20th century. The company McKesson & Robbins, Inc. (now McKesson Corporation) had been taken over in 1925 by Phillip Musica, who had previously used Adelphia Pharmaceutical Manufacturing Company as a front for bootlegging operations. Musica, a twice-convicted felon, used assumed names to conceal his true identity in taking control of the two companies: Frank D. Costa at Adelphia Pharmaceutical and F. Donald Coster at McKesson & Robbins. Although he was successful in expanding the company’s legitimate business operations, Musica recruited three of his brothers, also working under assumed names, one outside the company and two inside it, to generate bogus sales documentation and to pay commissions to a shell distribution company under their control. Eventually, McKesson & Robbins treasurer Julian Thompson discovered the distribution company was bogus. It was eventually determined that about $20 million of the $87 million in assets on the company’s balance sheet were phony.

In December 1938, the Securities and Exchange Commission (SEC) opened an investigation and Musica was arrested. Only after he was booked, fingerprinted and released on bond did the authorities realize that 'Coster' was in reality Musica. His bond was revoked and he committed suicide before he could be rearrested.

The McKesson & Robbins scandal led to major corporate governance and auditing reforms. The SEC required that public companies have audit committees of 'outside' directors and that the appointment of auditors be approved by the shareholders. The American Institute of Accountants (now the American Institute of Certified Public Accountants) adopted audit standards requiring that auditors verify accounts receivable and inventory.

So I guess in some ways it should not be a surprise that a company involved in one of the biggest financial scandals of the depression era, and then one of the biggest white-collar crime of the early 21st century, should now be involved in a comparatively small settlement involving allegations of over-charges for drugs.

Given that in this latest case, the settlement was small, and there were no negative consequences for any individual who authorized, directed, or implemented the alleged market manipulation, it seems doubtful that it will have any lasting effect on corporate leadership of the corporate culture.

McKesson's long and chequered history suggests some sort of chronic affliction of its corporate culture.  It also suggests a rationale for requiring heath care organizations to have ongoing, active organizational ethics policies.  

Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts

I have written frequently about the pipe dream of secure national electronic medical records, such as in February 2010 at my post "Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?", my post "Networked, Interoperable, Secure National Medical Records a Castle in the Sky?", as well as "Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?" and others.

I was also quoted on July 30, 2010, in a Philadelphia Inquirer story about the theft of a laptop computer with data on 21,000 patients from Thomas Jefferson University Hospital here, and also interviewed August 2 by local NPR station WHYY-91FM, where I stated:

"There is almost no excuse for unencrypted data to be sitting on any computer at a hospital or any organization," said Scot Silverstein, a Drexel University expert on health-information technology.

In the latest health-data-on-computer-theft-of-the-week, the Inquirer ran this story today about a local theft ten times as large as July's:

Medical-data breach said to be major

By Jane M. Von Bergen, Inquirer Staff Writer, Thu, Oct. 21, 2010

A computer flash drive containing the names, addresses, and personal health information of 280,000 people is missing - one of the largest recent security breaches of personal health data in the nation.

"We deeply regret this unfortunate incident," said Jay Feldstein, the president of the two affiliated Philadelphia companies, Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan.

The breach, which involves the records of Medicaid recipients, is the first such Medicaid data breach in Pennsylvania since at least 1997, according to the state's Department of Welfare, which has oversight.

There is little more I can add to my prior postings on this issue except the words of privacy advocate, psychiatrist Dr. Deborah Peel:

The security failure, one of the several largest in nearly two years, involves nearly two-thirds of the insurers' subscribers. It became known only after The Inquirer requested information Tuesday evening. The insurers said the drive was missing from the corporate offices on Stevens Drive in Southwest Philadelphia. It noted that the same flash drive was used at community health fairs.

"That seems grossly irresponsible," said Dr. Deborah Peel, a Texas psychiatrist who heads Patient Privacy Rights, an advocacy group.

"Why would you be hauling around private patient information to a health fair," she said. "I can't imagine what they were thinking, taking this data out of a locked room at company headquarters.

"What's tragic is that this is a particularly vulnerable group of people," Peel said. "They tend to be vulnerable to identity theft, vulnerable to discrimination." Medicaid recipients are low-income people.

As to encryption (a built-in feature of the upper tier versions of Windows and of Mac OS X):

They [the companies] would not comment on the riskiness of taking the drive to health fairs, nor would they say whether the data on the drive was encrypted.

Highly likely translation: no.

The companies issued an apology:

"At Keystone Mercy Health Plan and AmeriHealth Mercy Health Plan, our number one priority is our members. Since reporting this unfortunate incident to the Department of Public Welfare, we have actively and responsibly executed a multifaceted plan to inform those affected, while also evaluating and enhancing our security measures to ensure this does not happen again."

[Did any employee have their "privileges revoked" -- the medical term of art for a physician who is 'fired' -- I wonder? - ed.]

Perhaps the executives in charge of this data, as well as the IT department, should read stories like the aforementioned July 30, 2010 story.

However, I fear there are those who are ineducable or hopelessly irresponsible when it comes to acting cautiously and responsibly regarding computer-based medical information, in the poorly bounded, complex, unpredictable world of healthcare.

That is not to even mention deliberate theft for personal gain.

This is why the dream of secure national electronic medical records seems a pipe dream for the foreseeable future.

-- SS

10/23 Addendum

in an updated story, the Inquirer reports the data was indeed unencrypted, although the companies claimed an encryption project was in progress.

"Toxic and Dangerous?" - The Watchdog vs Medtronic's Man at the VA

An odd story that appeared earlier this month linked several people we have discussed on Health Care Renewal.

On one hand, we posted about how Dr David Polly, a spine surgeon at the University of Minnesota, testified before the US Congress in support of research on treatments of bone injuries afflicting US soldiers.  He did not then reveal that he had been paid more than one million dollars for consulting by Medtronic, the manufacturer of a bone growth product used to treat such injuries, also the source of payments of his expenses for the trip to Washington.  At the time, we suggested this case was a reminder to be skeptical about academics who are really stealth health policy advocates for industry.

On the other hand, in a post about renewed payments by makers of artificial joints to orthopedic surgeons after the US government advocated a series of deferred prosecution agreements as a cure for such apparent conflicts of interest, we quoted Dr Charles Rosen, "Nothing will change until someone goes to jail. It’s a big game."

The link between them appeared in two related articles.  First, the Minneapolis Star-Tribune reported on the appointment of another Medtronic consultant to a top leadership post in the US Department of Veterans Affairs:

In a Sept. 28 letter to Veterans Affairs Secretary Eric Shinseki, Sen. Charles Grassley asks whether Dr. Stephen Ondra's 'policy advice and decisions at the VA are vulnerable to potential conflicts of financial interest' given his prior relationship with the Fridley-based medical technology giant.

Ondra and Medtronic mutually severed their financial relationship in July 2008. But just prior to that, Medtronic paid him $3.6 million in royalties related to spine-surgery instruments, according to financial disclosure forms he submitted to the VA.

It appears that Medtronic lobbied hard for the appointment of its former consultant:

While noting that Ondra is not a Medtronic employee, Grassley characterized the surgeon's relationship with the company as 'unambiguous and substantial.' Further, Grassley notes that Ondra 'was able to penetrate the political establishment at its highest level to obtain a senior position at the VA' because of his previous ties to the company.

The details are:

Ondra's candidacy for his current post was supported by Medtronic Chief Executive William Hawkins III, who wrote a letter of recommendation to Secretary of Defense Robert Gates on his behalf. This was at the suggestion of Dr. S. Ward Casscells III, who was then assistant secretary of defense for health affairs, according to a series of internal e-mails obtained by the Star Tribune.

'I have known Dr. Casscells for many years and was comfortable in approaching him on this topic,' Hawkins wrote in a Jan. 16, 2009 e-mail to the then-head of Medtronic's $3.5 billion spine device business, Steve La Neve. (La Neve left that position earlier this year in a corporate reorganization.)

La Neve replied a day later that Ondra wanted to meet with him or with Hawkins before a reference letter was sent, 'so that it can capture his work on appropriate industry-physician relationships and transparency.'

(It is not clear whether the last sentence above is meant to be an ironic pun about regulatory capture.)

A post on Pharmalot explains what Dr Ondra's first priority was once he got his government job:

Within a few days, however, Ondra objected to the proposed nomination of another spine surgeon, Charles Rosen, as US Surgeon General. Why? As founder of the Association of Medical Ethics, Rosen publicly questioned consulting ties between doctors and device makers and, for his trouble, allegedly suffered retaliation by members of the American Academy of Orthopaedic Surgeons (see this). In a January 21, 2009 email exchange with Davd Polly, a University of Minnesota professor who was another Medtronic consultant, Ondra acknowledged never having heard of Rosen, but reacts viscerally to a recent story in The Orange County Register that details Rosen’s self-appointed role as a watchdog.

'Since this individual is toxic and dangerous I would leave nothing to chance,' he responds to Polly, who had forwarded the newspaper story to Ondra. Polly, by the way, is a nationally known spine surgeon who came under congressional scrutiny for his work several years ago for the device maker, something that Rosen had criticized (look here). 'This moment in history is too important to our country to let such a disreputable and dangerous person continue his self-promotion crusade,' Ondra continues. 'I would encourage you and any other physicians and citizens to weigh in on this to HHS and public health.'

Got that?  Medtronic pays Dr Ondra millions.  Medtronic pushes for Dr Ondra's appointment to a top VA leadership position.  Once in that position, Dr Ondra confers with another million dollar Medtronic consultant, and then works to block the appointment as Surgeon General of a known foe of the cozy web of conflicts of interest that afflicts medicine.  Thus do conflicts of interest work to promote the capture of government by special interests. 

The Pharmalot post concluded with this opinion:

'It’s obvious that Dr. Ondra benefited from his relationship with Medtronic. And since he worked to kill off the nomination of Chuck Rosen, Medtronic’s main critic, I can see how Medtronic benefited from Dr. Ondra,' says Paul Thacker, a former Grassley staff investigator and US Army specialist. 'What I don’t understand is how I and other veterans have benefited from all this back-door dealing. What’s in it for us?'

That is a good question. It appears that nothing was in it for veterans, or the US public. But everything was in it for Medtronic and the doctors it pays so well.  I would submit that it is the readiness of big health care corporations to create conflicts of interest that seduce physicians to put their loyalties to their corporate sponsors ahead of the public interest that is toxic and dangerous.

This convoluted story suggests the urgent need for full disclosure of all relationships between physicians and others who make decisions and wield influence in health care on one hand, and health care organizations on the other hand.  If physicians want their health policy efforts to be met with anything other than guffaws and cynical eye rolls, they need to seriously consider swearing off the sorts of cushy corporate relationships that Dr Ondra and Dr Polly embraced.