Bank Bailout Puts £12.7bn NHS Electronic Medical Record Project In Jeopardy

What health IT mismanagement could not accomplish, perhaps international financial mismanagement will. Could this happen here?

This story reflects a veritable cornucopia of the issues I write about at Healthcare Renewal and at my site on HIT failure, with the added spice of the World Financial Debacle That Keeps On Giving, er, Taking.

Bank bailout puts £12.7bn NHS computer project in jeopardy

John Carvel, social affairs editor
The Guardian, Wednesday October 29 2008

The future of the NHS's £12.7bn computer programme was in doubt last night after its managers acknowledged further delays in introducing a system for the electronic storage and transmission of patients' records.

Connecting for Health, the NHS agency responsible for the world's biggest civil IT project, said it was no longer possible to give a date when hospitals in England will start using the sophisticated software that is required to keep track of patients' medical files.

Christine Connelly, the Department of Health's recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care.

She will have to find compelling arguments to stop the Treasury earmarking health service IT as a candidate for cuts to compensate for the billions spent on the bailout of the banks. However, the high cost of cancelling contracts with IT suppliers may be a factor saving the programme from cancellation.

In May the National Audit Office said the project was running at least four years late, but still appeared to be feasible. It has since been beset by a series of further setbacks.

The agency fired Fujitsu, the contractor responsible for building the patient record system in the south of England. It asked BT to take over the work, but has not yet agreed a price.

In London, attempts to install the system at the Royal Free hospital and Barts caused weeks of confusion and disruption. Other trusts that were next in line were so alarmed that they pleaded for postponement.

In the north, the first installation of the Lorenzo version of the software at Morecambe Bay was repeatedly delayed.

A Connecting for Health spokesman said parts of the programme are working well, with doctors and patients already noticing the benefits.

But he added: "The programme is one of the largest IT change programmes in the world and it is inevitable that such transformation will present challenges."

"Challenges."

You don't say?

One wonders if some of those "challenges" might have been minimized or avoided through some simple measures. Such as a google search by project leaders and politicians.

Jon Hoeksma, editor of E-Health Insider, a website that has specialised in tracking Connecting for Health, said: "Contracts [for the patient care record] were let in 2003 and they were supposed to be completed by 2010. But the best estimates now are that the software will not be ready until well into the next decade.

I believe the estimate of widespread U.S. electronic health records by 2014 are just a little overoptimistic ...

On the world financial mess, that's another matter entirely. Unfortunately, Medical Informaticists don't have the technology yet to perform Brain Transplants.





-- SS

Surveillance On the Average Joe: Another Blow To Patient Confidence In Electronic Medical Records?

In 2006 I'd commented on Healthcare Renewal about the Wall Street Journal story "Spread of Records Stirs Patient Fears of Privacy Erosion", by Theo Francis, published Dec. 26, 2006.

As I wrote at "Another Electronic Medical Record Horror Story" here, a patient, Patricia Galvin, was betrayed after medical information she thought was confidential about her psychotherapy was divulged to an insurance company.

I also penned a Letter to the Editor at the WSJ, published on Dec. 30, 2006 (viewable here as published, second letter from top; and as submitted, in the blog post above). I had noted that:

In the UK, the ambitious Connecting for Health (CfH) national EMR project and plans for a central clinical database have been met with stiff resistance from patient advocacy groups. Plans to upload medical records onto the central clinical database will put patient confidentiality at risk, the UK [1] . Professor Ross Anderson, Professor of Security Engineering at Cambridge University and one of the founder members of privacy advocacy group http://TheBigOptOut.org made the telling point that people should opt out of inclusion in the national database, if only to wait and see if their government delivers the ‘protections’ that it is promising - and if it does, to see if they are sufficient and effective [2]

[1] “CfH report confirms confidentiality risk,” The Register, Nov. 27, 2006, http://www.theregister.co.uk/2006/11/27/care_record_conf/

[2] http://www.nhsconfidentiality.org/?p=37

The issues of 2008 U.S. politics aside, I believe another blow to patient confidence in EHR has just occurred, I'm afraid:

Agency Head Defends "Joe" Searches
Columbus Dispatch
Oct. 30, 2008

A state agency has revealed that its checks of computer systems for potential information on "Joe the Plumber" were more extensive than it first acknowledged .

Helen Jones-Kelley, director of the Ohio Department of Job and Family Services, disclosed yesterday that computer inquiries on Samuel Joseph Wurzelbacher were not restricted to a child-support system.

The agency also checked Wurzelbacher in its computer systems to determine whether he was receiving welfare assistance or owed unemployment compensation taxes, she wrote.

Jones-Kelley made the revelations in a letter to Ohio Senate President Bill M. Harris, R-Ashland, who demanded answers on why state officials checked out Wurzelbacher.

Harris called the multiple records checks "questionable" and said he awaits more answers. "It's kind of like Big Brother is looking in your pocket," he said.

If state employees run checks on every person listed in newspaper stories as buying a business, "it must take a lot of people a lot of time to run these checks," he said. "Where do you draw the line?"

The checks were run after the news media reported that Wurzelbacher was considering buying a plumbing business with more than $250,000 in annual income, Jones-Kelley wrote.

... Jones-Kelley wrote the checks were "well-meaning" ...

Apparently a statement was made by Ohio officials that this type of checking was done on anyone who "comes into public attention" or words to that effect.

Ohio Senate President Bill M. Harris sought answers on why state officials checked out Wurzelbacher. Harris called the multiple records checks "questionable" and said he awaits more answers. "It's kind of like Big Brother is looking in your pocket," he said.

I would agree with that assessment.

I believe nearly every U.S. citizen who's awake and conscious has heard of this by now, and very many people abroad are aware of this as well.

This raises several key questions.

• How will this event and others that come to light affect confidence in EHR privacy and confidentiality by the "average Joe" who might fear intimate details might be divulged about them if they are shown on the evening news regarding something controversial or in the newspaper? (For example, did someone check my background after my WSJ editorial above was published?)

• Of what use are "guarantees of medical records privacy" if government officials themselves decide that they are justified for whatever reason and "well meaning" in peeking at a person's records - especially for reasons as dubious as in the Wurzelbacher example?

• Were medical records breached in Mr. Wurzelbacher's case? Although I am unaware of any evidence of this, I would place the likelihood at "very concerning" considering what is already known.

I believe this incident may have serious repercussions upon patient confidence in electronic record privacy, with a resultant harder time in diffusing this technology for clinical care and research.

I, for one, already feel less confident in my assertions that EHR data, especially data in governmental systems, is "safe."

-- SS

How Pharmaceutical Companies Disguise Promotion of Off-Label Drug Uses

An article just published in PLoS Medicine [Fugh-Berman A, Melnick D. Off-label promotion, on-target sales. PLoS Med 2008; 5(10): e210 doi:10.1371/journal.pmed.0050210] just cataloged methods used by pharmaceutical companies to promote medications for "off-label" uses. These main points are worth reviewing:

Use of "Key Opinion Leaders" -

Off-label campaigns are launched outside of the sales force.

Nationally known, influential academic physicians help 'word-of-mouth' or 'buzz' marketing. These 'thought leaders' or 'key opinion leaders' (KOLs) support labeled marketing efforts as well, but they are considered crucial for the promotion of off-label uses. Industry-paid KOLs are never company employees. Rendering purportedly independent opinions, via articles and lectures, KOLs are able to elude laws against off-label promotion.

Note that this supports the notion, raised elsewhere, that "key opinion leaders" are paid mainly for marketing purposes, and chosen for their sympathy to marketing objectives. Many KOLs, however, themselves assert that they are paid because of their expertise and brilliance. This suggests that deception is at the root of the concept of "key opinion leader."

"Publication Strategies" to Generate Influential Publications Whose Industry Origins are Disguised -

The 'publication' strategy ... stimulates off-label prescribing by using research 'to disseminate the information as widely as possible through the world's medical literature'. Clinical studies provide key references for the industry-produced reviews and commentaries, signed by KOLs, used for promoting off-label sales. Case studies about off-label uses may be solicited; physicians may be paid for combing patient medical records for cases that help industry goals. A physician—or a medical writer—will write up the case or case series, which may be submitted for publication or presented as a meeting abstract. Industry-sponsored reprints may be included in continuing medical education (CME) activities sponsored by medical education companies (MECs), often distributed by direct mail.

Note again that KOLs are intrinsic to the "publication strategy." The existence of this strategy suggests that physicians need to be extremely skeptical of even apparently academic publications in scholarly journals.

Leveraging Abstracts and Meeting Presentations -

Posters and abstracts presented at medical meetings create buzz, especially if a press release garners media attention. Meeting abstracts and posters are considered cutting-edge, but the information is almost always incomplete and usually lacks peer review.

Abstracts or posters may be 'published' in conference proceedings, medical journals, 'throwaway' journals, or industry-sponsored medical journal supplements. These industry-generated, non-peer-reviewed, covert promotional pieces are now citable items that are provided to physicians by a company's medical affairs office to support off-label use, and can be referenced in peer-reviewed articles, ads, and other marketing materials.

This strategy and the one above remind physicians not to assume anything about the origins of what they read. Much of the information placed before physicians for apparently educational purposes may really be meant to market products. Also note that compilations of presented abstracts usually provide not even rudimentary information about authors' financial relationships or conflicts of interest.

Bleed-Through from Unaccredited "Drug Talks" to Accredited Continuing Medical Education -

MECs know that accredited CME programs funded by unrestricted grants must favor marketing messages. The easiest way to accomplish this goal is to use company speakers trained for unaccredited (non-CME) promotional presentations.

Physician-speakers are trained in presenting unaccredited talks, sometimes called 'dinner talks' or 'lunch-and-learns.' This training, using company slides, often occurs at resorts. Some speakers are genuinely unaware of the marketing messages they are responsible for disseminating. For example, messages that a certain disease is underdiagnosed, undertreated, or more serious than commonly believed can bolster a company's marketing goals even if drugs are never mentioned.

Physicians trained in unaccredited talks may present the same talk at a CME event. Most industry-paid physicians believe that they maintain intellectual independence. Presenting different statements in different settings would create cognitive dissonance. Psychologically, it is easier to believe that what one is saying is scientific and accurate, and thus to say the same thing at accredited and unaccredited programs.

This strategy is striking in its ingeniousness, but also its audacity. Again, it challenges the assertion, which I have heard often from KOLs, that they cannot possibly have been influenced by what they were paid, or who they were paid by to give their talks.

Using Obligations Generated by "Unrestricted Educational Grants" -

'Unrestricted' grants provided to departments at academic medical centers for grand rounds and lunch conferences depend on a sense of obligation rather than a quid pro quo. When lists of recommended speakers are supplied to organizers, it is unstated, but nonetheless understood, that company-paid speakers will be included in the lecture series.

Of course, many medical schools, hospitals and academic medical centers, and physicians' societies deny that "unrestricted educational grants" could possible affect the content or direction of their educational offering. Again, physicians must maintain extreme skepticism, asking "who benefits" about every lecture or presentation they attend, and about every article they read.

Use of Compendia and Drug Indices-

Compendia are compilations of drug information that include both on-label and off-label uses. Medicare, Medicaid, and many other insurers will cover off-label uses of reimbursable drugs included in major compendia, including the American Hospital Formulary Service–Drug Information (American Society of Health-System Pharmacists), the US Pharmacopoeia–Drug Information (Micromedex, a division of the Thomson Publishing Company), and DRUGDEX. Pharmaceutical companies strive to establish good relationships with compendia staff, and may assign an employee as the designated compendia contact. The pharmacists who write compendia listings are very busy, and are usually delighted to receive organized packets of scientific articles, abstracts, and contact information. Using company-provided articles (which always contain marketing messages) saves time; all of the company's assertions for off-label use may be transferred intact to the final product. Companies celebrate new compendia listings because expanded insurance coverage ensures more sales.

Drug information listings, similar to compendia, usually solicit company input and review. Although companies do not pay for listings, they may offer to buy hundreds or thousands of reprints for sales staff. In any case, it makes sense to contribute to entries that show company data in the best light.

Dr Fugh-Berman continues to raise disturbing points about how medical education and publishing has become entwined with industry. Physicians who read and view uncritically, and who place their trust in seemingly authoritative figures, risk being seduced by those more interested in selling products than in making sure each patient gets the most beneficial and least harmful management.

See also comments on the Carlat Psychiatry Blog.

Do Healthcare Organizations Truly Want Electronic Health Records To Succeed?

As readers here know, I have written frequently about the seemingly paradoxical problems commonly experienced by healthcare organizations in their clinical IT (EHR, CPOE, Decision Support, etc.) projects, including at my academic site on this topic.

It seems as if organizations do not learn from and do not want to learn from one another, or from the wisdom of decades of experience of the informatics pioneers, in literature that is widely available to anyone with a computer and just a little sense of due diligence and/or curiosity. As I've written at this blog, organizations also seem to resist formal medical informatics expertise.

Simple, formulaic, well known "best practices" approaches (e.g., appointment of executive "champions", permitting enduser and stakeholder involvement at all phases, and other "sterile technique in surgery" commonsense platitudes) are inadequate for HIT management.

Many business IT personnel in healthcare settings have not quite figured out how to apply true best practices known from decades of medical informatics, social informatics and healthcare IT management research in the complex, poorly bounded, conflicted, highly variable, uncertain, and high tempo work domains (per Nemeth & Cook, pdf here) of clinical settings, and resist such wisdom for traditional MIS approaches suitable in traditional business. Yet, clinical IT and business IT appear to be distinct subspecialties of IT, requiring different approaches to system design, implementation and lifecycle.

Perhaps more importantly, those same business IT personnel often seem to lack knowledge about how to effectively manage what might be called "worst practices" of various stakeholders that nullify the benefits of any best practices that are employed.

Why do these "worst practices" misbehavior situations arise? (See the addendum for some examples that anyone working in HIT will find familiar.)

Further, in every account of health IT difficulty I've encountered, it seems the same "Keystone Kops" organizational players mismanage clinical IT projects at great expense - expense which healthcare organizations can ill afford.

The following question must be asked. Why is this so regarding a technology so highly touted and so purportedly desired by all?

Computers and EHR’s have been widely touted as being the key to a literal cornucopia of medical benefits: better and cheaper healthcare, reduced errors, evidence-based, genetically tailored medicine, and other cybernetic miracles.

Yet, many clinical information systems don't reflect the health care professional's hectic work environment, with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead, they are designed for people who work in calm and solitary environments, with resultant poor usability [1]. A leading computerized practitioner order entry (CPOE) system was found to actually facilitate medication error risks [2]. As implemented, EHR’s were not associated with better quality ambulatory care [3]. Expensive, clinician morale-damaging failure and de-installation of EHRs are not uncommon [4]. National EHR efforts such as in the UK have self-admittedly made serious errors and needlessly wasted billions of dollars [5]. The U.S. Office of the National Coordinator for Health IT (ONC) recognizes that a major barrier to wide adoption of this technology is a high failure rate for EHR implementations [6].

Finally, diffusion of EHR’s after 30-plus years of effort and billions of dollars spent remains limited. As per the 2008 statistics in the prestigious New England Journal of Medicine, just four percent of physicians in the U.S. reported having an extensive, fully functional electronic-records system, and just thirteen percent reported having a basic system. Most hospitals are also lacking the technology to any meaningful extent [7].

I have thought hard about what the large scale "metaproblems" for this seeming paradox might be, other than just mismanagement secondary to stupidity of the type that's put this country in some dire financial jeopardy recently. I also thought about a line I often tell my students (itself borrowed from somewhere) that there are no true paradoxes, just false assumptions.

As an example of yet another situation - actually a continuation of a situation - that brought a possible new "meta-explanation" of Healthcare IT chaos to mind (which I disclose below), I present Act III of my own experience.

I then present my thoughts on an a possible explanation for the "paradox" of widespread HIT problems.

-----------------------

Drexel EHR Debacle, A Tale in Three Acts:

Some time ago I wrote at Healthcare Renewal here that at my own organization I was excluded from the EHR project of the Faculty Practice Plan after the original CIO left (I had only attended a few meetings at her invitation at that point). Let's call this "Drexel EHR Debacle, Act I."

Fast forward two years to Act II. Due to design failure of the E&M ('evaluation and management') component of the system, the component that was supposed to "reduce administrative costs" via helping automate and optimize billing functions -- but instead raised costs by a few million dollars to manually correct errors the E&M coder was creating! - the result was a multimillion dollar lawsuit (link to Civil Complaint PDF here ) by Drexel against the EHR vendor AllScripts and Allscript's partner Medicomp Systems. The latter advertised itself as a "corporation specializing in the development of point-of-care tools for Electronic Medical Records ... to help overcome physician resistance to adoption" (!). What was unfortunate is that I possibly might have prevented the problems had I been involved, as I had seen a similar issue at Yale years prior that actually did lead to a Justice Dept. investigation and fines for billing irregularities ( link ). My assistance was not sought, even after I volunteered to help Drexel in the lawsuit against the vendor.

Now, fast forward another two years to the current time, and what I call Act III of this debacle.

I have recently been informed of issues such as this: that the EMR allegedly cannot be used by senior executives to gauge the productivity of salaried physicians and that the senior people feel they do not have a quality system (yet who selected it in the first place?) The end users were apparently not utilized to make the decision nor to beta test or write user requirements, and in retrospect senior leaders are doubting the system was needed at all for ambulatory. No pilot was conducted. After go live the Compliance Officer apparently felt that the system as implemented did not meet federal guidelines and reversed some of the features.

In order to process an encounter a physician cannot just check that they treated the patient for certain conditions; they must also check that they "did not treat" the following conditions. A total of over 70 clicks on a single page. Attendings are having to do this at night at home. Complaints are ignored. The mobile notebooks do not work properly and the system allegedly goes down frequently. Local IT support is minimal since the system is apparently an ASP model. Change management processes were not fully vetted and a plan was not executed and no one knows the right channel for getting problems addressed.

And on and on it goes.

I once again volunteered my help, and received initial interest and an invitation to a lunch meeting with the project leads. However, once I reminded that I am now an adjunct, and no longer an Asst. Professor FTE (by my own choice due to dysfunction) and therefore I would be charging a consulting fee, interest stopped. The lunch meeting was paradoxically cancelled by an AA with an indefinite statement about it being rescheduled at some time in the future. That was a few weeks ago.

(Sadly, one of the reasons I resigned my asst. professor position after only two years and voluntarily remained as a non tenure track adjunct is that without a hospital -- Drexel has no hospital of its own; Hahnemann is Tenet-managed and has not done well financially in the competitive Philadelphia medical environment and is not a fertile place for informatics research -- and with the medical college EMR project I'd hoped to use as the backbone for funded research basically brain damaged and clinician confidence affected, perhaps irreparably, I saw little chance at winning increasingly competitive NIH funding for research, and therefore no chance to secure tenure. Better to be in a non tenure track position in such an environment, I felt.)

-----------------------

Now as to the "meta issues" that might be playing out, here and elsewhere:

I've recently read the following online somewhere regarding discussion of the media and its biases:

I learned a long time ago that when people or institutions begin to behave in a matter that seems to be entirely against their own interests, it’s because we don’t understand what their motives really are .

I have always assumed that, at least organizationally speaking, healthcare organizations wanted their EHR projects to succeed. While I have encountered individuals who seemed to want specific projects to fail, usually due to territorial or other fairly obvious political issues, I always thought a reasonable assumption about HC organizations is that they want clinical IT projects to succeed.

What if that is a false assumption?

What if there are a critical mass of people in many healthcare organizations who, while afraid to express it openly, are in opposition to the inconveniences, costs, political battles, loss of power, fear of loss of ability to conceal substandard performance (a fear both at the practitioner level and the management level), etc., such that on balance what the organizational motives "really are" are to cause EHR to fail?

This could explain the prevalence of the "large scale problems" noted, and explain resistance regarding hiring of the most qualified in clinical IT (i.e., formally trained medical informatics experts), who might actually be correctly perceived as the best people to make this technology work.

Finally, the national push to EHR that started a few years ago with ONC and the "2014 goal" should have had the effect of a large increase in the desirability of people with formal informatics training. However, if the assumption that organizations want EHR to succeed is not correct, then a federal mandate might only increase the resistance to the best talent in empowered operational roles, out of resentment towards the mandate at the very least.

So, my question is: do healthcare organizations really want clinical IT to succeed, and are many of the "problems" seen that are often identified as "sociotechnical complexities" in reality the outcome of simmering opposition to EHR's and other clinical IT, and the often nasty issues they create for everyone in a healthcare organization?

I am myself skeptical about this possibility, but again, there are no paradoxes, only false assumptions.

If the assumption about organizations wanting clinical IT success is even in part false, then those pressuring the healthcare industry to computerize as a means to save costs and improve quality may be barking up the wrong tree.

-- SS

Notes:

[1] Most hospitals don't use latest ordering technology. Oregon Health & Science University, http://www.eurekalert.org/pub_releases/2003-11/ohs-mhd112403.php (accessed Oct. 25, 2008)

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

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

[4] Medical Records Institute, as reported in Modern Healthcare, October 30, 2007. http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20071030/FREE
/310300002/0/FRONTPAGE (accessed Oct. 25, 2008)

[5] Granger [UK] says he is 'ashamed' of some systems provided. E-Health Insider, 10 Jul 2007, http://www.e-health-insider.com/news/item.cfm?ID=2854 (accessed Oct. 25, 2008)

[6] Current Market Barriers and Challenges to Widespread Adoption of Health Information Technology. U.S. Office of the National Coordinator for Health Information Technology (ONC), http://www.os.dhhs.gov/healthit/barrierAdpt.html (accessed Oct. 25, 2008).

[7] "Electronic Health Records in Ambulatory Care - A National Survey of Physicians", NEJM 359:50-60


11/10/08
Addendum

In summarizing these issues, blog founder Roy Poses made an astute observation:

MedInformaticsMD came up with a novel hypothesis about why the EMR, and other health care IT applications, often seem so jinxed. Perhaps many (presumably thoughtful and intelligent) people within health care organizations are very skeptical of these applications because of problems such as security flaws, user unfriendliness, conflicts with work flow, etc, etc. However, since it is politically incorrect to express their skepticism openly and frankly, they resort to passive aggressive opposition.

A review of the manifestations of passive aggressive behavior is quite interesting in that regard:

Common signs

There are certain behaviors that help identify passive-aggressive behavior.

• Ambiguity
• Avoiding responsibility by claiming forgetfulness
• Blaming others
• Chronic lateness and forgetfulness
• Complaining
• Does not express hostility or anger openly (e.g., expresses it instead by leaving notes)
• Fear of authority
• Fear of competition
• Fear of dependency
• Fear of intimacy (infidelity as a means to act out anger): The passive aggressive often can't trust. Because of this, they guard themselves against becoming intimately attached to someone.
• Fosters chaos
• Intentional inefficiency
• Making excuses
• Losing things
• Lying
• Obstructionism
• Procrastination
• Resentment
• Resists suggestions from others
• Sarcasm
• Stubbornness
• Sullenness
• Willful withholding of understanding

These behaviors are quite familiar to those working in healthcare informatics.

-- SS

NIH Management Reprimanded Scientific Review Administrator Who Advocated Transparency About Conflicts of Interest

In the "early days" of Health Care Renewal, i.e., in 2006, we posted a lot about the story of wide-spread conflicts of interest affecting top leaders at the US National Institutes of Health (NIH). After the NIH conflict of interest rules were relaxed in the mid-1990's, some top NIH managers received five- and six-figure consulting payments from pharmaceutical and biotechnology companies. Some failed to disclose these payments, even when writing journal articles favoring the products of the companies for which they worked.

Since then, NIH Director Zerhouni made the organization's conflict of interest policies much more stringent, although not without opposition from some of his staff (see post here).

More recently interest has focused on two cases. Dr Trey Sunderland, a leader within in the National Institute of Mental Health (NIMH), part of the US National Institutes of Health (NIH), provided tissue samples to Pfizer Inc while receiving consulting fees from the drug company. (See posts here, here, and here.) Sunderland pleaded guilty to "criminal conflict of interest," (see post here). We also posted about a "footloose and fancy-free" NIH institute director here.

Yet while all this was going on, it appears that NIH management was punishing not the conflicted, but those within the NIH who dared to complain about how the organization handled this conflicts. A few days ago, Ed Silverman reported on his blog PharmaLot about how a former NIH scientist who was reprimanded because he wrote letters to scholarly journals and newspapers advocating that the organization do better at disclosing conflicts of interest affecting its own personnel, and researchers who get NIH grants. As reported on PharmaLot,

Three years ago, Ned Feder began complaining publicly about what he perceived as the National Institutes of Health’s failure to monitor conflicts of interest involving academic researchers, who receive government grants for drug research while simultaneously getting paid by pharma for consulting, research or speaking.

And so the scientific review administrator, who at the time worked for the National Institute of Diabetes and Digestive and Kidney Diseases, began writing memos to NIH officials and then letters to various publications - Nature, The Scientist and The Los Angeles Times - to raise public awareness. “A proposal to require readily accessible financial disclosure will probably be fought tooth and nail by those who benefit from leaving things as they are: some university researchers and administrators, officials at the NIH and scientists in the industry,” Feder wrote in a September 2005 letter to Nature....

What was the NIH’s reaction? Feder was reprimanded for signing his letters as an NIH employee....

Looking at the document to which PharmaLot linked, Feder was reprimanded for "failure to follow management instructions." His specific offense was that he provided a "reference to your NIH affiliation in signature blocks for your personal publications." What apparently so troubled NIH management was, for example, some of the statements that follow

[There was] the embarrassing failure by the US National Institutes of Health (NIH), during the past year, to disclose information about NIH scientists serving as paid consultants to private companies. Having been a scientist at the NIH since 1967, as a physician, a cell biologist and now a science administrator, I must add that the habit of non-disclosure continues, making further embarrassments likely.

In articles published since December 2003, the Los Angeles Times has given ten specific examples of NIH scientists with financial conflicts of interest. However,
details of hundreds of others remain hidden, and the extent of the damage caused since 1995 is unknown.

He concluded,

The NIH’s defensive approach — one congressman called it stonewalling — has proved a disastrous miscalculation. If the NIH does not unflinchingly seek the facts and release them, they may come out anyhow in other ways. Then the NIH’s reputation, already at the lowest point in its history, will suffer further.

Note that the letter above [Feder N. NIH must tell whole truth about conflicts of interest. Nature 2005; 434: 271.]was written before the allegations about Sunderland, who eventually pleaded guilty, appeared.

Feder's second letter to Nature in 2005 [Feder N. Public disclosure could deter conflicts of interest. Nature 2005; 437: 620.] correctly predicted what would happen to Feder, himself

A proposal to require readily accessible financial disclosure will probably be fought tooth and nail by those who benefit from leaving things as they are: some university researchers and administrators, officials at the NIH and scientists in industry.

So while the conflicts on interest continued, those advocating transparency about financial relationships were punished.

Note that Feder's second 2005 letter was about how

NIH-funded researchers are required to provide details of any consulting arrangements to their universities, which in turn approve or veto the plans. This information is confidential and usually cannot be seen by the public.

What Feder advocated was that

The NIH could require grantees to make public disclosures of their paid arrangements with pharmaceutical, investment and other companies, as well as their ownership of stock and stock options, as a condition of having their medical research funded by the government.

So this letter from 2005 presaged the scandals of 2008, for example, how US Senator Charles Grassley has found that prominent researchers failed to disclose large payments from pharmaceutical companies that they received while doing NIH funded studies on drugs made by these same companies (see post here).

The unfortunate story of the punishment of Ned Feder is a reminder how deeply the culture of "get mine first" has infiltrated the culture of the leadership of our once most respected health care institutions. To promote research to serve science and the public rather than the needs of vested interests, we will have to make a big change in this corporate culture.

BLOGSCAN - Annals of Stealth Marketing

On the Reidbord's Reflections blog, Dr Steven Reidbord recounted how he was invited to speak at a big and glitzy event, part of the national tour for "GOAL" (go on and live). He was first enthused, but when he found that the event was sponsored by a pharmaceutical company, and organized by a public relations firm, he realized he had been "duped" and backed out, to the great annoyance of his chairman, who saw the event as worthwhile "public outreach." Add this to the annals of stealth marketing. Hat tip to the Carlat Psychiatry Blog.

A Tall "Cap" for GSK's Payments to Key Opinion Leaders

With a hat-tip to PharmaGossip, the Financial Times reported (link here, requires subscription) that,

GlaxoSmithKline is to make public the level of advisory fees it offers to doctors and medical academics, and will strictly cap the payments they can receive in the US to $150,000 (£88,000) a year each.

Andrew Witty, chief executive of the UK-based pharmaceutical company, said he was introducing tougher new rules to impose a cap "without exception" on such payments and promised to publish the amounts.

So let's see, if it is news that the "cap" of payments to physicians (presumably fees for "consulting," and honoraria for giving talks), then it is likely that GSK was paying at least some physicians more than $150,000 a year for these purposes. We have discussed, along with many others, the large fees GSK and other pharmaceutical companies were paying to one particular "Key Opinion Leader," who apparently failed to accurately report these payments even while he was leading an NIH grant designed to evaluate a drug made by GSK.

As evidence accumulates that the amounts paid some academic physician "Key Opinion Leaders" by pharmaceutical (and other health care) companies equal some academic physicians' salaries, it becomes harder to argue that these payments are just compensation for some straightforward and occasional services rendered. Furthermore, it becomes harder for those receiving the payments to argue that the amounts received could not possibly have ever had the slightest influence on their professional judgment, what they taught their trainees, or what they wrote or spoke about in academic and health policy fora.

With more pressure on health care companies to disclose payments to "Key Opinion Leaders," I wonder whether the details of such disclosure will start to illustrate that disclosure alone is not an adequate way to "manage" such "conflicts of interest?"

If This is How WellPoint Has Managed Its Investment Portfolio....?

Among other news outlets, the Indianapolis Star reported that giant health care insurance company/ for-profit managed care organization WellPoint has had trouble with its investment portfolio:

WellPoint is like many other investors these days: Its portfolio took a sizable hit from the financial crisis.

The Indianapolis-based health insurance giant saw its quarterly profit fall 5.4 percent, dragged down by investment losses.

The company Wednesday reported a profit of $820.7 million for the third quarter ending Sept. 30. That's down from a profit of $868 million a year earlier. WellPoint's quarterly revenue of about $15 billion also was down slightly from a year ago.

WellPoint said that those results included pre-tax investment losses of $562.6 million, or 71 cents a share. Of those losses, $229.5 million came from investments in mortgage lenders Fannie Mae and Freddie Mac and $88.5 million from bankrupt Lehman Brothers.

A long time ago, the argument was made that managed care organizations would be better able to manage care than would health care professionals. This seemed to come out of thinking prevalent towards the end of the 2oth century that professional managers and executives somehow could manage any kind of endeavor better than people who were trained in the context in which the endeavor operated. The 21st century seems to be on its way to correcting that notion.

The current example suggests that the businesspeople now in charge of health care insurance and managed care (and most other kinds of health care organizations) are not even good at managing how they invest their financial researces. Investment management is clearly much closer to what ought to be the core expertise of businesspeople than health care. If they cannot manage their investments well, is it any surprise that they have not managed health care well? (And we have had occasion, most recently here, to write about WellPoint's less than stellar management in areas that more directly impact patient care.)

Another Misuse of EBM

We agree with Roy Poses' comment on the recent JAMA article about EBM, particularly regarding some of its unfortunate "misuses." In the article that stands as the defining credo of Health Care Renewal, Roy wrote:

Most physicians believe that medicine should be based on science. Evidence based medicine, (EBM) ‘‘the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients’’ [74], is a refinement of this view. Meanwhile, the scientific basis of medicine is under increasingly severe attack.

We'd like to take this opportunity to identify a misuse of EBM that, ironically, contributes to the attack on the scientific basis of medicine, and that authors Montori and Guyatt didn't consider--probably because they are unaware of it. We explain it in the following letter, submitted to JAMA in response to their article. We discuss it at more length on the other blog to which we contribute, Science-Based Medicine, referenced from the letter:

To the editor:

In their recent article, “Progress in Evidence-Based Medicine,” Drs. Montori and Guyatt include important caveats about misuses of EBM. They mention trials funded by industry. They list several, documented problems with such trials, and correctly warn that these can result in erroneous interpretations by “unsophisticated users of the medical literature.” They correctly worry about “abandoning appropriate skepticism.”

There is a related misuse of EBM that leads to erroneous interpretations even by sophisticated authors, and that calls attention to systematic problems in EBM: trials of highly implausible hypotheses. Thus, regarding the homeopathic preparation Oscillococcinum, the Cochrane Collaboration writes:

Though promising, the data were not strong enough to make a general recommendation to use Oscillococcinum for first-line treatment of influenza and influenza-like syndromes. Further research is warranted…[1]

The data, however, are not promising, and further research is not warranted. The reason is that for highly implausible treatments, existing knowledge easily trumps modestly “positive” trial data. In the case of homeopathy, each of its tenets has been more than adequately disproved, and its claim that the potency of a “remedy” increases with each dilution of the original substance, continuing well past the point at which not a molecule of that substance remains in the preparation, contradicts physical reality.[2]

Such considerations reveal at least two, related problems with the evidence of EBM as it pertains to clinical trials. The first is explicit: by relegating “physiology, bench research or ‘first principles’” to Level 5 of its “Levels of Evidence” hierarchy, EBM fails to acknowledge that consistency with firmly established knowledge is a necessary, even if insufficient, basis for accepting a hypothetical treatment as effective.[2]

The second problem is part of the culture, if not the letter of EBM: by eschewing Bayesian in favor of “frequentist” statistics, its practitioners can excuse themselves from justifying estimates of prior probability, and erroneously conclude that trial data tell us more about reality than they do.[3-5]

In January, 2008, several colleagues began the blog Science-Based Medicine, referenced below.* The name, which could just as well have been “knowledge-based medicine,” is a frank recognition of the EBM weaknesses described above. Because of our interests, Science-Based Medicine’s content is predominantly, though not entirely, concerned with implausible health claims. Its larger message, however, is that these claims call attention to fundamental ways in which EBM can be improved, such as to justify its own claim to being an arbiter of real evidence.

Kimball C. Atwood, IV

Wallace I. Sampson

10/19/2008

* Steven Novella, David Gorski, Harriet Hall, Wallace Sampson, Kimball Atwood

[1] Vickers A, Smith C. Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.: CD001957. DOI: 10.1002/14651858.CD001957.pub3.

[2] Atwood K. Homeopathy and Evidence-Based Medicine: Back to the Future Part V. Science-Based Medicine 2008 (Feb. 8). http://www.sciencebasedmedicine.org/?p=42. Accessed October 19, 2008

[3] Atwood K. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine.” Science-Based Medicine 2008 (Feb. 15). http://www.sciencebasedmedicine.org/?p=48. Accessed October 19, 2008

[4] Goodman SN. Toward evidence-based medical statistics. 1: The P value fallacy. Ann Intern Med. 1999;130:995-1004.

[5] Goodman SN. Toward evidence-based medical statistics. 2: The Bayes factor. Ann Intern Med. 1999;130:1005-13.

"Misuses of EBM"

In an excellent article(1) just published in JAMA on progress in evidence-based medicine, Montori and Guyatt devote a section to the misuses of EBM, worth quoting in its entirety herewith emphasis added.

An analogy can be made between EBM and nuclear fission: it can be very powerful when used appropriately and dangerous when used inappropriately. The term evidence-based precedes many recommendations, guidelines, and algorithms that are not transparently linked to the underlying evidence base and do not represent the results of a systematic and critical appraisal of that evidence. It sometimes appears as if using the term obviates the need to describe the quality of underlying evidence, the magnitude of effects, or the applicability of any of the results in the context, values, and preferences of the patients.

This is particularly problematic because the EBM era has coincided with a dramatic increase in the for-profit funding of research. Researchers funded by industry interpret their results differently and in favor of the industry product relative to not-for-profit funding. Problems associated with industry funding include use of inappropriate control interventions, surrogate outcomes, publication and reporting bias, and misleading descriptions and presentations of research findings—all forms of corrupting the evidence base. Unsophisticated users of the medical literature, assuming that medical editors, peer reviewers, and topic experts have now become familiar with the tenets of EBM, may trust these corrupted research reports and advocate for their application in practice.

Many medical schools and training programs, in a form of premature closure, are moving away from teaching the fundamentals of careful evidence appraisal to emphasize the implementation of evidence. The intent of this new focus is to produce high-quality, safe, and low-cost care (ie, Accreditation Council for Graduate Medical Education competencies of systems-based practice and improvement and practice-based learning14). However, abandoning appropriate skepticism regarding the effectiveness of these interventions may lead to large investments in quality-improvement, safety, and efficiency activities that fail to yield the expected benefits.

We are truly making progress when there is now such public recognition of threats to evidence-based medicine, and thus to the rational and compassionate practice of medicine based clinical knowledge, and on both critical review of the best available clinical evidence, and sensitivity to patients' values.

I should underline the points made in the last paragraph quoted. It is distressing that what little progress in making evidence-based medicine part of medical education we made in the 1980s and 1990s is being wiped out. But what should we expect of medical schools staffed by faculty and faculty leaders who mostly are paid by the companies that make the drugs and devices that are the subject of their teaching and research?(2-3) And what should we expect of medical schools that now depend on large infusions of money from these same companies? Truly rigorous EBM might actually show that some of these "innovative" drugs and devices are not quite as good as the marketing says. So teaching same may distress the faculty's employers and the university's benefactors.

If we expect the teaching of rational and compassionate medicine that puts the benefit of patients first, we need medical schools and medical faculty who are not paid by companies whose first priority is increasing profits by selling as many drug doses and devices they can.

References

1. Montori VM, Guyatt GH. Progress in evidence-based medicine. JAMA 2008; 300: 1814-1816. Link here.

2. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link here.

3. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. Link here.

Ascension Health's Descent Away from its Mission

This week, the Wall Street Journal continued its series on US not-for-profit hospitals and health systems with a story about how Ascension Health is abandoning inner-city Detroit for the more affluent suburbs,

Ascension Health, the country's largest nonprofit hospital system, says its mission is to serve all, 'with special attention to those who are poor and vulnerable.' But in this city, where one in four people don't have health insurance, it's become harder for the poor and vulnerable to find Ascension.

Last year, Ascension's local subsidiary closed Riverview Hospital, the third hospital it has shut down in Detroit in the past 10 years and the only hospital that remained on the city's blighted east side. Meanwhile, 30 miles away, in a suburb of multimillion-dollar homes, Ascension is opening a new $224 million hospital.

Ascension's approach to the Detroit market is an increasingly common strategy among nonprofit hospital systems: Close money-losing facilities in poor areas where a large share of patients are uninsured, and build or refurbish hospitals in affluent places where people have private insurance coverage.

Before its closing, Riverview was one of the few remaining hospitals in the Detroit city limits. Of the 42 hospitals that dotted this 139-square-mile city in 1960, only four are now left. At the same time Detroit's hospitals have dwindled, its number of uninsured has grown. An estimated 200,000 of the city's 800,000 residents have no health insurance.

Located in one of Detroit's poorest wards, Riverview sits among empty buildings on East Jefferson Avenue, a thoroughfare sprinkled with subsidized senior housing, empty and overgrown lots, partially burned homes, and graffiti-stained shops.

Even in a struggling city, Riverview's neighborhood stands out for its abysmal statistics: Thirty-four percent of the population lives below the poverty line, infant mortality is more than double the national average and the rate of AIDS deaths is five times higher, according to Richard Lichtenstein, an associate professor at the University of Michigan's School of Public Health. Its poor patient base made Riverview a perennial money-loser.

The closing of Riverview Hospital by Ascension Health seems to be a product of Ascension's current business strategy.

Shutting down unprofitable operations and expanding profitable ones is a common business maneuver, but nonprofit hospital systems aren't ordinary businesses. They're required to provide benefits to their communities, such as free care for the indigent, in exchange for the billions of dollars in annual tax exemptions they receive.
Ascension, which is affiliated with the Roman Catholic Church, says its more profitable subsidiaries can't be used to subsidize those that are struggling. 'Such an approach would mean that needs in other communities may not be met,' says Ascension spokeswoman Trudy Barthels. The 38 subsidiaries, which Ascension calls 'health ministries,' operate with a large degree of independence and have to be 'self-sustaining,' she says. Ascension adds that it ties how much capital it allocates each subsidiary, in part, to its profitability.

How Ascension Health regards its individual hospitals is similar to how many academic hospitals now regard their departments and divisions. Each sub-unit is regarded as semi-independent, and responsible for bringing in its own revenue.

That makes sense, to a limited degree, if one regards each sub-unit as a separate production facility in a business.

BUT IT MAKES NO SENSE to run a not-for-profit health care organization in this manner. A not-for-profit first and foremost is supposed to fulfill its mission, not make a profit (hence, the term "not-for-profit.) Thus, in a not-for-profit, each sub-unit should be viewed in terms of how its work fulfills the total mission.

Thus, it might make sense for a hospital system whose mission is to care for the poor to allow certain sub-units to run at a financial loss if they are important to this mission. It might also make sense for an academic medical center whose mission is to provide education and research to allow certain sub-units to run at a financial loss if they are important to this mission.

So what is Ascension Health's mission? It is:

Rooted in the loving ministry of Jesus as healer, we commit ourselves to serving all persons with special attention to those who are poor and vulnerable. Our Catholic health ministry is dedicated to spiritually centered, holistic care, which sustains and improves the health of individuals and communities. We are advocates for a compassionate and just society through our actions and our words.

The hospital system states that:

We are called to:

Service of the Poor — generosity of spirit, especially for persons most in need

The abandonment of Riverview, apparently on financial grounds, appears to be in stark contrast to that mission.

Furthermore, per the WSJ, Ascension Health seems instead to be devoted to increasing its bottom line, and rewarding its top leader sufficiently to make him rich:

Net income at Ascension, which owns 67 hospitals located mostly in the Midwest, South and Northeast, nearly tripled to $1.2 billion between 2004 and 2007 thanks largely to investment gains. With financial markets struggling over the past year, Ascension reported net income of $351 million for the year ended June 30.

Ascension is also a well-oiled money machine with sterling credit ratings. Its cash and investments totaled $7.3 billion for the year ended June 30, including about $1 billion restricted to self-insurance trust funds or limited by donors for specific uses or to be maintained in perpetuity. Ascension's chief executive, Anthony Tersigni, earned $2.4 million in total compensation in 2006, according to the hospital system's latest filing with the Internal Revenue Service. Ascension declined to provide more recent compensation figures.

It appears that Ascension Health displays the most "generosity of spirit" to its own CEO.

I am not a Catholic, so perhaps am less qualified to comment than others. But it seems there ought to be some special place, not a comfortable one, reserved for organizations that promise service to the poor while raking in billions, and paying their leaders millions.

This appears to be a classic, and tragic example of mission-hostile management by the leadership of once proud not-for-profit health care organizations. It suggests why we need a wholesale reassessment of how such organizations are lead.

Is it any wonder that health care costs rise while access falls when those pledged to increase access mainly seem to be about increasing their own bottom line?

BLOGSCAN - An Industry Sponsored "Scholarly" CME Journal?

On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed a new apparently scholarly peer-reviewed journal devoted to studies of continuing medical education. However, the journal seems to be funded by a group of pharmaceutical companies, published by a medical education and communications company (MECC), and edited by the Vice President of a for-profit medical education assessment company. A majority of the editorial board appear to work for the pharmaceutical industry, MECCs, and related businesses.

The Nemeroff Case vs the Anechoic Effect

The saga of Dr Charles Nemeroff was most recently discussed on Health Care Renewal here and here. We had first posted about his failure to disclose relevant conflicts of interest relating an article he wrote for a journal he also edited here. Other posts about Nemeroff's questionable behavior are here, here. Nemeroff has also starred in numerous posts on the Clinical Psychology and Psychiatry Blog, amongst others.

Now the tale of how Nemeroff raked in hundreds of thousands of dollars as a paid speaker on behalf of drug marketers, and denied these earnings while he ran a US government funded project meant to evaluate some of the products of his commercial sponsors, has splashed across major newspapers. There has been a lot of good discussion about the case in the blogsphere. (We await, of course, discussion in scholarly medical and health care journals, if it ever appears.)

I am a bit surprised that, in defiance of the anechoic effect, this case has now inspired some pithy commentary in the editorial pages of major media outlets. Particularly vigorous was Judith Warner writing admittedly for her blog, but a blog sponsored by the New York Times.

Yet the story of Nemeroff, who earned $2.8 million in fees from 2000 to 2007, and had at one point consulted for 21 drug and device companies simultaneously, wasn’t really a departure from the news of the week – or of this whole benighted era – at all.
It was, rather, yet another iteration of the ever-unfolding saga of greed and how the deregulation of absolutely everything has brought our country to this painful season of reckoning. Because Nemeroff’s story – which is hardly unique – belongs uniquely to this time in our nation’s history.

It is a product of legislative and cultural changes that have altered the practice of medicine, the work of research universities and the relationship between those universities and industry. And it is marked, like so much of what’s gone off the rails in our era, by the failure of our government to step in to protect citizens.

Nemeroff didn’t bring down any banks, didn’t freeze the American credit markets, hasn’t plunged the world economy into recession. But his extensive, excessive and untransparent ties to the pharmaceutical industry are all too common, unfortunately, among his cohort of 'thought leaders' in psychiatry and other medical specialties. And these relationships have led to a dangerous crisis of confidence in the basic integrity and validity of America’s medical research.

Her discussion of the history behind the Nemeroff case is of interest,

How did all this happen?

It’s a familiar story: About three decades ago, it became possible to make serious money as a university researcher. Not that the money was so bad before, of course. It was respectable. But it wasn’t Wall Street-type money.

That changed in the early 1980s with the passage of legislation that allowed universities to patent their publicly funded research results and then grant exclusive licenses to pharmaceutical companies. The public-private wall came down. The universities received royalties on the drugs, and the royalties were split between the researchers and the departments. Start-up companies were spun off and sold. University researchers became, essentially, partners to industry.

The change wasn’t just structural, however. There was a cultural shift, a kind of boundary melt.

'Greed became respectable,' Angell, a professor of global health and social medicine at Harvard Medical School and the former editor in chief of The New England Journal of Medicine, recalled. 'There used to be a sort of tension between doing well and doing good for medical researchers. If they wanted to make a lot of money in a high-risk sort of job they could work for industry. If they wanted to do important, exciting research they stayed in academia and they had a comfortable life but not great wealth.'

'Before 1980, they were aware of this tension,' she said. 'Before 1980, those who went into industry were held in some disdain. With Reagan, all this changed. There was a strong feeling that the world divided into winners and losers. In medical research this just has had enormous implications.'

It’s had enormous implications for our world generally. On Wall Street, change had to come via catastrophe. Let’s hope it won’t take a disaster to bring sense back to medicine.

We have said similar things on Health Care Renewal.

I must add, however, that I think the cultural change went beyond just making greed respectable. It also somehow made deception respectable, even in the context of academic institutions that are supposed to be about discovering and disseminating the truth. So it not only became acceptable for top academics to earn hundreds of thousands in consulting fees and honoraria for talks. It became acceptable for those academics to give their talks and write articles while cloaked in their academic respectability, and without revealing that they were being paid extremely generously by drug marketers to help them hawk drugs. It became acceptable for these academics to let drug, biotechnology and device companies tell them how their clinical research would be designed, implemented and reported, but the academics still took credit for being pretend "principal investigators," and "first authors." It even became acceptable for academics to let these companies make the slides for their talks, and provide ghost-writers for their articles, but the academics still acted like they were speaking their own words of wisdom, rather than signing off on pitches authored by marketers.

Also, an unsigned editorial in the New York Times declared,

We’ve long feared that the integrity of medical research is being eroded by conflicts of interest and manipulation of scientific data. Still, it was disheartening to learn that one of the nation’s most prominent psychiatrists has taken large, undisclosed payments from a drug company whose products he evaluated and that another company manipulated studies to make a drug look far more beneficial than it actually is.

It also linked the Nemeroff case to the allegations that Pfizer marketers manipulated the reporting of clinical research to make it appear more favorable to their drug, Neurontin, as we discussed in this post.

In addition, an editorial in the Atlanta Journal-Constitution began to suggest solutions,

It now seems pretty clear that researchers at major universities — including the head of psychiatry at Emory University — failed to properly disclose their financial ties to drug companies. And evidence of that failure suggests academic medical centers are not capable of policing their faculty’s potential conflicts of interest.

These recent disclosures are more evidence that the requirements for reporting payments from the drug industry — in essence an honor system that relies on the researchers to tell their universities what they are earning — are simply inadequate. At a minimum, Congress should approve Grassley’s proposal requiring annual disclosures by companies of payments of $500 or more to researchers, a suggestion several pharmaceutical manufacturers have voluntarily adopted.

But much more needs to be done. The culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing. Disinfecting it may result in a temporary reduction in the amount of money going into research and continuing physician education. But in the long run, the nation’s medical schools will want to enhance the reputation of faculty members who are doing quality, independent research unencumbered by questions about whether they are protecting the lives of patients or protecting their own wealth.

This was echoed by an op-ed in the same newspaper by Peter Lurie and Jonas Hines from Public Citizen,

The problem is the notion that disclosure alone is a panacea for conflict of interest. Disclosure amounts to an evasion of responsibility because the consumer of the disclosed information then becomes responsible for interpreting it. Is a talk by a presenter who has received $30,000 from a sponsor twice as tainted as one by a presenter who has accepted $15,000?

Certain relationships are so egregious that no amount of disclosure will suffice. For instance, investigators in clinical trials should have no direct financial interest in the products they are investigating.

There should also be a low ceiling on total external payments to academics. What assurance did Emory have that Nemeroff was fulfilling his responsibilities as department chair if he was continually jetting off to extol Paxil’s virtues?

Congress is considering bills that would create a database of drug and device companies’ payments to physicians. But the legislation has been watered down to garner support from drug companies and organized medicine. Meanwhile, some leading medical schools, such as the universities of Pennsylvania and Massachusetts, are taking the initiative, implementing stringent policies that restrict the relationships between physicians and industry.

But these efforts remain voluntary and compliance is likely to be spotty. To restore public trust, doctors will have to “just say no” to drug company trinkets, medical schools should keep companies out of clinics and insulate company-funded research from meddling, and government must develop policies that stamp out the worst excesses. Mere disclosure will not suffice.

On the other hand, the President of Emory University wrote,

The federal government has ... long understood the importance of well-managed collaboration between private industry and the academy. From such collaborations have come many of the biomedical discoveries that have improved human life and alleviated suffering in the past 20 years.

It is also essential, however, to manage properly any conflicts of interest that might jeopardize the scientific validity of the results of these collaborations.

As we have said before, requiring full and detailed disclosure of conflicts of interest affecting physicians, medical academics, and health care decision makers would begin to make the public and the medical profession aware of the magnitude of the conflicts of interest problem. What should be disclosed is not merely the existence of a relationship, but the size of payments and the nature of the activities that were done to earn that payment. Even for a simple talk, it is very different for someone to say, for example, "This talk was supported by GSK," than to say, "I was paid $3500 plus all expenses by the marketing department of GSK for this talk meant to help market Paxil." Given the fragmentary nature of the disclosure now usually made, it is particularly outrageous when influential figures in health care fail to provide even limited information.

That being said, I fully agree (and have said before) that even full disclosure is not a way to adequately "manage" many conflicts of interest. Disclosure does not remove the subconscious influence and confusion that conflicts may create, especially conflicts involving substantial sums of money. In fact, there is evidence that disclosure may give some of the conflicted a license to slant their speech and writing even more heavily (see this post). There is also evidence that people who receive disclosures do not know how to interpret them, and may fail to allow for the degree of influence the disclosed conflict may have on the conflicted.

So I agree that we ought to put an end to most of the financial relationships between health care academics whose teaching could sway audiences to use specific products and services, and who do research evaluating specific products and services, and the companies who supply those services and manufacture those products. Although it is true that collaboration between academics and industry can yield innovation, one can collaborate without being paid off by one's collaborators. As long as academics are paid on the side for nebulous consulting work and to give talks for "education" arranged by marketers, trust in them as finders and disseminators of truth will continue to erode. That is bad for academics, bad for health care, and very bad for patients.

Did Pfizer Marketers Suppress and Manipulate Clinical Studies of Neurontin?

Here we go again. Multiple media sources reported on allegations that Pfizer Inc, the world's largest pharmaceutical company, attempted to manipulate and suppress clinical research results unfavorable to one of its products. Per the Wall Street Journal,

Pfizer Inc. marketers urged the suppression of medical studies that reached unfavorable conclusions about the effectiveness of the company's big-selling drug Neurontin [gabapentin], according to internal Pfizer documents submitted in a lawsuit against the company.

In 2004, Pfizer's Warner-Lambert unit pleaded guilty to felony charges that it promoted Neurontin for uses not approved by the Food and Drug Administration, including bipolar disorder and chronic nerve pain. The FDA originally approved the drug as an antiseizure treatment for epilepsy and in 2002 for one kind of pain related to shingles.

Pfizer paid $430 million to resolve the charges and reimburse state Medicaid programs for unapproved, or off-label, uses of Neurontin. Pfizer said it made sure there was no improper marketing after it purchased Warner-Lambert in 2000. Pfizer has booked about $12 billion in Neurontin sales since then and, though the drug is now subject to generic competition, it remains a strong seller.

Documents and emails released this week in the case in U.S. District Court in Boston suggest Pfizer's marketers influenced the drug's scientific record to boost sales at least until 2003 by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions.

Here are the details about how one study of gabapentin was allegedly suppressed.

According to documents in the Boston case, a European study done in the late 1990s by Warner-Lambert to measure Neurontin's use for diabetic nerve pain produced consternation at Pfizer after it failed to find a significant effect. 'I think we can limit the potential downsides of the ... study by delaying the publication for as long as possible,' wrote Michael Rowbothan, then Neurontin's marketing team leader, in a 2000 email sent after Pfizer bought Warner-Lambert. He added that 'it will be more important to how WE write up the study.'

The study's scientific manager, Beate Roder, wrote in an email to employees after Pfizer agreed to buy Warner-Lambert that she had been instructed "that we should take care not to publish anything that damages Neurontin's marketing success." Neurontin has been widely prescribed for diabetic nerve pain, according to market researchers.

In 2002, Angela Crespo, then Neurontin's senior marketing manager, emailed an outside firm that was contracted to write up the study's results: "We are not interested at all in having this paper published because it is negative!!" Pfizer declined to make the three employees in the emails available for interviews.

The company's writeup of the study was subsequently rejected by two medical journals. Some of the reviewers for these journals said the company was putting too rosy a spin on the results, the court documents show. The paper was never published, although Pfizer later summarized some of the study's results in a broad review published in 2003 in an obscure medical journal, Clinical Therapeutics.

The New York Times had some more detail,

In one example, the experts concluded that Pfizer had deliberately delayed release of a study that showed the drug had little effect against pain that is a complication of long-term diabetes, even as the outside researcher who was a lead investigator for the study, Dr. John Reckless of Bath, England, pushed to publish the unflattering findings on his own. Dr. Reckless’s office said Tuesday that he could not be reached for comment.

According to one September 2000 e-mail message by a Neurontin team leader at Pfizer, “The main investigator in the U.K. (Dr. Reckless) is keen to publish but this will have several ramifications.” The team leader later wrote, “I think we can limit the potential downside of the 224 study by delaying publication for as long as possible.”

Another series of e-mail messages had the subject line “Spinning Serpell,” a reference to an investigator on the study, Dr. Michael Serpell of Glasgow, Scotland. In the e-mail exchange a senior marketing manager for Pfizer and a professional medical writer discussed how to cast the results in a more favorable light for a poster presentation at a medical conference, the experts concluded.

“If Pfizer wants to use, present and publish this comparative data analysis in which two of the five studies compared make the overall picture look bad, how do we make it sound better than it looks on the graphs?” the medical writer asked.

In summary,

One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.”

Dr. Dickersin, the Johns Hopkins expert, said that of 21 studies she reviewed, five were positive and 16 negative, meaning they did not prove the drug was effective. Of the five positive studies, four were published in full journal articles, yet only six of the negative studies were published and, of those, two were published in abbreviated form.

This case is important in that it reveals the extent of involvement of Pfizer marketers in the how and whether clinical research is reported, and the effects of that involvement in terms of how often negative studies are suppressed. The specific tactics pushed by the marketers appeared to have included having professional ghost writers spin the data so that a negative study will "sound better than it looks," delaying unfavorable results, and when all else fails, suppressing the most unfavorable studies entirely. In the case of gabapentin, which does not seem to be a very good drug, this meant suppressing about two-thirds of the negative studies, which outnumbered the positive studies by a three to one ratio.

This unfortunately is another blow to the current paradigm of evidence-based medicine. The EBM paradigm calls for physicians to make optimal decisions for individual patients based on their knowledge of the clinical context, the patients' values and wishes, and a critical review of the best relevant evidence from clinical research. For the paradigm to work, the assumptions are that all relevant research can be found, and that the research studies, while imperfect, were not intentionally designed or reported to deceive the reader. Yet the case of gabapentin adds to fears that relevant evidence that is unfavorable to the interests of the drug, device, or biotechnology company which sponsored the work is likely to be suppressed by that sponsor, and that commercially sponsored research is often deliberately manipulated to make its results appear more favorable.

Also, as Professor Dickersin noted (reported by the WSJ), "in exchange for being experimented upon in trials, patients are told they are contributing to human knowledge. To withhold negative results from the public breaks that ethical obligation to such patients...."

The practical lessons:
- As we have said many times, physicians, patients, and policy-makers need to be extremely skeptical about the clinical research evidence base.
- On a policy level, if providers of health care goods and services are to continue to be allowed to sponsor clinical research that evaluates their products, no one from their marketing departments should be allowed any influence on such research
- However, since it may be impractical to prevent such influence, a more draconian but effective approach would be to ban such commercial firms from any direct involvement in human research meant to evaluate their products.

FDA Evaded Bidding Process to Hire Public Relations Firm Which Also Works for PhRMA

Last week, the Washington Post reported the unusual - shall we say - way that the US Food and Drug Administration went about setting up a public relations campaign to respond to some negative criticism it has been getting. Here is the background.

The U.S. Food and Drug Administration had an image problem. For months last year the agency had been pummeled by Congress for poor inspections of tainted vegetables, drugs and other products.

FDA leaders decided to hire a contractor for a public relations campaign that would 'create and foster a lasting positive public image of the agency for the American public,' according to agency documents.

How they went about doing this was out of the ordinary.

Tasked with the public relations job was Mildred Cooper, a temporary FDA consultant hired on a two-year contract to advise FDA Commissioner Andrew C. von Eschenbach and other officials. Hired in March, Cooper became an FDA civil servant.

Cooper, who had worked on Capitol Hill and in public affairs for the Federal Emergency Management Agency and Defense Department, called a friend at Qorvis [Communications Inc], which specializes in corporate communications.

Before she joined the FDA, Cooper had worked with Qorvis as a public affairs executive at Luna Innovations, a company that sells medical devices and other products and whose clients include the Defense Department.

'I had experience with Qorvis,' she said in an interview. 'We thought they could help with our communications effort. . . . It was a matter of efficiency.'

She was referred to Don Goldberg, who helps lead Qorvis's crisis communications practice and had once served as part of President Clinton's crisis management team.

Qorvis also represents PhRMA, the drugmakers trade group.

The people involved seemed to have formulated a way to get around the usual government bidding process.

Goldberg discussed the project with [James] Dunn, a business consultant working with Qorvis, e-mails show. They decided to arrange for Qorvis to come into the project through ANI, the Alaska newspaper company, which runs several weeklies and a small public relations office.

Dunn, who works for a firm called Red Team Consulting, told The Post he had experience with the set-aside rules for Alaska Native corporations because he had worked for one as chief operating officer.

ANI, it turns out, is

a firm owned by an Alaska Native corporation that does not have to compete for federal work because it qualifies for special set-asides.

Then,

Other e-mails show that Cooper apparently allowed Qorvis to tailor terms of the contract known as the scope of work.

During most of these discussions, ANI itself was out of the loop.

no one from ANI appeared to be a part of the contract discussions, according to the e-mails. On Feb. 13, Goldberg forwarded a note to Cooper from 'the ANI team contact.' That day, the contact, Washington public relations veteran Aaron Guiterman, wrote to Goldberg, Qorvis and ANI that 'the most likely next step with the FDA is for ANI to submit a proposal.'

In a brief interview, Guiterman said he was not permitted to speak about the contract.

The final result was

On July 23, after more deliberation, the FDA issued a $300,000 purchase order for the public awareness campaign, with ANI listed as the contractor. An FDA official said ANI had pledged in writing to do more than half the work.

Two parts of this are remarkable, of course. One is how a government contract to a big Washington PR firm was arranged without any public bidding or scrutiny. The second was that the company chosen for this contract to improve the image of the FDA, the agency responsible for regulating pharmaceutical companies, went to a firm which also worked for PhRMA, the pharmaceutical industry trade organization. Could this excess coziness of some FDA officials with the pharmaceutical industry, which the agency is supposed to regulate, be evidence of "regulatory capture?" On a policy level, it seems that the US needs to have a much clearer separation between the FDA and the targets of its regulation.

Hat tip to the WSJ Health Blog.