SSRIs, Stealth Marketing, and Public Radio

We have previously posted about instances of stealth marketing in public television (here and here.) Now Shannon Brownlee and Jeanne Lenzer have published "Stealth Marketers: Are Doctors Shilling for Drug Companies on Public Radio" in Slate. Their take-home message was:

A few weeks ago, devoted listeners of public radio were treated to an episode of the award-winning radio series The Infinite Mind called 'Prozac Nation: Revisited.' The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.

The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, had the air of quiet, authoritative credibility. Host Dr. Fred Goodwin, a former director of the National Institute of Mental Health, interviewed three prominent guests, and any radio producer would be hard-pressed to find a more seemingly credible quartet. Credible, that is, except for a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac.

We don't know just how much funding or when the show last received it, since neither Goodwin nor the show's producers responded to repeated requests for interviews.

In addition,

Goodwin is on the board of directors of Center for Medicine in the Public Interest, an industry-funded front, or "Astroturf" group, which receives a majority of its funding from drug companies.

Regarding the financial ties of panelist Peter Pitts

CMPI President Peter Pitts was one of Goodwin's three guests for 'Prozac Nation.' We don't know which companies fund his group because when we asked him, Pitts said, 'I don't want to go into that.'

Pitts has another title that might have been relevant to The Infinite Mind; he is the senior vice president for global health affairs at the PR firm Manning Selvage & Lee, which represents Eli Lilly Inc., GlaxoSmithKline, Pfizer, and more than a dozen other pharmaceutical companies. Yet on the show, Pitts was identified only by his title as 'a former FDA official.'

Regarding Dr Andrew F Leuchter:

a professor of psychiatry at UCLA who has received research money from drug companies including Eli Lilly Inc., Pfizer, and Novartis.

Finally, regarding Dr Nada Stotland:

Nada Stotland, president-elect of the American Psychiatric Association, has served on the speakers' bureaus of GlaxoSmithKline and Pfizer.

Note that neither Dr Goodwin nor the show's producers agreed to be interviewed by Brownlee and Lenzer.

In my humble opinion, it's great that more and more instances of apparent stealth marketing are being exposed in the media.

It may be that the people introduced as distinguished experts on this show who asserted that the suicide risks of antidepressants were overblown were not the least bit influenced by their financial ties to pharmaceutical companies which make antidipressants. Or maybe they were influenced?

But at least they should have revealed these ties to their listeners. Maybe had the show's producers felt compelled to reveal such conflicts of interest, they might have thought about at least adding some experts who did not have such ties.

Finally, as we have said before, physicians and researchers who are in a position to influence how the media discusses medicine and health care should, at a minimum, fully and completely disclose any financial arrangements they have with organizations with vested interests affected by such media discussions.

ADDENDUM (12 May, 2008) - See also this post by Ed Silverman on PharmaLot, and especially the voluminous and vociferous comments.

BLOGSCAN - LSD and the Corruption of Medicine

On the Scientific Misconduct blog, Dr AubreyBlumsohn has a series of posts (here, here, and here) about a case he considers a major precursor to some of the problems we often discuss: research misconduct, conflicts of interest, and secrecy involving government, foundations, pharmaceutical corporations, teaching hospitals and medical schools, and doctors. The case is not one I would have thought about in this regard. It is about how the US Central Intelligence Agency (CIA) conducted clandestine testing on uninformed, often civilian subjects of psychedelic drugs such as LSD over 30 years ago, under the MK-ULTRA code-name among others. What is particularly relevant, and not widely known, is how the agency funneled funding through not-for-profit foundations, some generally well reputed; how the funds went to prestigious academic medical institutions; how large pharmaceutical corporations cooperated by providing the drugs; and how much of the research was done by well-known academic physicians and researchers.

Payments for the Patient-Centered Medical Home Mired in the RUC

We have posted a number of times, (most recently here, and see links to earlier posts) about the RBRVS Update Committee's (RUC) responsibility for Medicare's relatively poor reimbursement of primary care and other "cognitive" physicians' services compared to procedures. This imbalance has rippled through all of US health care, affecting how private insurers and managed care organizations reimburse physicians, and generally how the US systems favors procedures over talking, examining, thinking, diagnosing, prognosticating, deciding, and prescribing and super-specialization over generalism and primary care.

The RUC ostensibly is just an advocacy group sponsored by the American Medical Association, yet it seems to be the only source of outside input about physicians' reimbursement used by the US Center for Medicare and Medicaid Services (CMS). Given this influence, it is dismaying that it is secretive, unrepresentative, and unaccountable. Neither its membership nor proceedings are public. It is dominated by proceduralists and sub-specialists. It is unaccountable to US physicians, much less the general public.

CMS in its wisdom also put the RUC in charge of figuring out how physicians' practices participating in trials of the patient-centered medical home (PCMH) would be paid. The PCMH has gotten a lot of buzz lately. It purports to be the modern way to characterize a well-functioning primary care practice. Various powers that be that now want to support primary care seem only interested in supporting such care that fits the PCMH model. Yet putting the RUC, which seems to be the single most important cause of the decline of primary care, in charge of payment for this new version of primary care, appears to be a great case of putting the fox in charge of the hen-house. On the Retired Doc's Thoughts blog, Dr James Gaulte first pointed this out.

The RUC just released its report on how physicians providing medical homes ought to be paid. Now, on the Happy Hospitalist blog, this post dissected how the RUC came up with its recommendations, in all their mind-numbing detail. That blog summarized the results as "punching primary care in the face," and furthermore,

The payment rates that are recommended are insulting and downright degrading. Do they think nobody is paying attention? These people have no business trying to create public policy.

Unless I'm completely off base in my interpretation, if I was an outpatient doc, I would run faster than Forest Gump from this proposed financial disaster.

This is a reminder of what can go wrong with a "single-payer health care system," which is what Medicare is. When the government sets what physicians are paid, which is what happens in Medicare, (and de facto happens for our entire health care system, as private insurance companies and managed care organizations seem to slavishly follow the CMS' lead as engineered by the RUC), the government ought to provide a rational, transparent, accountable method of doing so. The current RUC based system is the opposite, irrational, opaque, and unaccountable. If we don't fix it, we can kiss primary care goodbye, with all the negative consequences that would entail. And further woe unto us if the calls for health care reform lead to "Medicare for all," with the RUC based system intact.

Earthlings and Htraesians: The Parallel Worlds of Medicine and Healthcare Information Technology

5/12/08 A preliminary note:

To those who linked here from the May 12, 2008 HISTalk post that said this...

From Blogreader: "Re: advance degree. See this [Healthcare Renewal] post." ... [the post author] doesn’t usually have good things to say about CIOs and IT departments, so if you don’t want to start your Monday morning sputtering and flinging your coffee at your monitor, don’t click the link. He often makes harsh observations from the context of "the IT people didn’t hire me, so they must be insular fools who hate doctors" angle, but he does make an occasional point.

My actual observation and that of many of my colleagues is that IT leaders, for reasons outlined in empirical research such as in the field of social informatics, don't often hire qualified medical informaticians and/or other physicians into anything but "internal consultant" roles, and their skills are severely underutilized as a result. In fact, such experts when properly empowered reduce clinical IT project costs and timelines by 25 to 75 percent. Since most healthcare organizations can ill afford IT misadventure (many organizations can barely afford care for the underprivileged), this is a rather important point. Since patient lives are also at stake, I'm glad I make an "occasional point" (e.g., based on my experiences saving lives) relevant to the biomedical and informatics-centric knowledge gaps of most health IT leaders. I'm still waiting for someone to reasonably defend the decisions made in the linked ICU case history.

I also welcome comments on this post in the blog comments section, but please stick to these guidelines ...

Now, here is the posting that prompted the above response from the HISTalk blog editor:

Over a decade ago I wrote that my fledgling website on health IT difficulties in large part originated from my personal observations of hospital "I.S." (management information systems) computer personnel leading clinical computing projects and wielding considerable authority over clinicians on decisions affecting medical environments and resources. (The current website version is here.)

I also observed difficulties among the IS personnel in functioning as true team members and collaborators on clinical teams, due to a rigid focus on "business process" and questionable management fads over the clinician goal of "getting results."

These observations led to the questions "who are these personnel, and what exactly is their expertise and educational bona fides? What metrics are applied to ensure such personnel are competent with complex clinical IT in patient care settings?"

I feel the questions in 2008 remain unsatisfactorily answered, and the that answers would likely raise serious concerns among those who believe good, appropriate education and credentialing is inherent to the rigor required for excellence in all aspects of health care. Surely, we as a nation can do better than a 115-question multiple choice exam where 15 questions are giveaways.

Unfortunately, in those days before blogs and before truly widespread internet access, the capability to inform the public, media and governmental authorities about this issue was limited.

That has changed.

I am a strong believer in physicians taking leadership roles in HIT, especially physicians with education and expertise crossing medicine and information technology. An example of such specialists are those with formal medical informatics postdoctoral training, but numerous other examples exist.

Further, in the pharmaceutical industry where I ran a department in the division of Research Information Systems, business IT and scientific IT have long been partitioned and populated by people who generally have the most focused (and especially cross-disciplinary) experience regarding each domain. This was due to a realization that this partitioning was consistent with the mission and with best scientific principles.

In the healthcare provider sector, no such wisdom appears to have developed, and to my knowledge is not even being explored. In fact, quite a different situation exists. My eyebrows were recently raised via reading the apparently patronizing words of a non-medical CIO, Denis Baker, of Sarasota Memorial Hospital, a major medical center on the Gulf Coast of Florida. Baker had this to say regarding physician leadership of HIT in an interview on the HIStalk blog here:

... "I think that physicians bring a certain aspect to the job, but I don’t think they necessarily know how a hospital works. I think they know how their practice works and how they interact with the hospital, but I don’t think they absolutely know what nursing does, or any of the ancillary departments, and what they do." - Denis Baker

I was further startled via a response to my HC Renewal post "On the Pitfalls of Going Electronic: Should Physicians Reject Hospital EMRs" about the recent NEJM editorial on the risks of going electronic. In that post I reproduced the Sarasota CIO's statement as exemplifying one reason why physicians do not hold appropriate leadership roles in HIT. I received the following comment, apparently from another non-medical CIO named Mark Harvey:

Quite an interesting post. If awards (or certifications) existed for hubris and paranoia, the author would certainly qualify ... Who are the “crafters” of the notes and letters in question? Oh, right, it is those “seasoned professionals” who have had their thinking impaired by the insidious EMR ... the responsibility for that documentation [on an EMR] rests upon the professional who is crafting it.

In other words, the customer of IT is responsible for the problems the IT facilitates. You can read the full comment at this link; Mr. Harvey's comment is #7 down the list and my lengthy reply follows.

Now, while being paranoid doesn't mean they're not out to get you, I can assure readers that paranoia is not one of my problems. If it were, I wouldn't be writing blog posts critical of a whole sector of healthcare, now, would I?

(In case you did not notice, that last paragraph was written tongue in cheek.)

Seriously speaking, it is unlikely Mr. Harvey actually read most of my post with its myriad hyperlinks; my critique of questionable aspects of the credentialing process for IT workers in healthcare may have set him off for reasons more clear if you read my reply - and his title.

This all reminds me of comments I saw years ago from the HIT/CIO world about HIT leadership as reproduced in the aforementioned post, and below as well from recruiters such as Hersher and Goodman.

In trying to unify my observations, I am postulating that HIT has created for itself its own closed society with its own value system, credentialing, culture, and power stuctures, which piggyback off the hard labor of clinicians.

The culture of this closed society is at great odds with that of the community it ostensibly serves, medicine. More on why this society is "closed" later.

For the purposes of the comparisons that follow I shall call the medical community "Earth" and the closed HIT society "Htrae" for reasons having to do with the parallel yet opposite cultures. I've written about Htrae before in my posts "Leadership Position in Health Informatics: MD's Need Not Apply" and "Hospital IT: Amateurs welcome":

In the Bizarro world, a cube-shaped planet known as "Htrae" ("Earth" spelled backwards), society is ruled by the Bizarro Code, which states "Us do opposite of all Earthly things! Us hate beauty! Us love ugliness! Is big crime to make anything perfect on Bizarro World!". In one episode, for example, a salesman is doing a brisk trade selling "Bizarro bonds. Guaranteed to lose money for you". Later in this episode, the mayor appoints Bizarro #1 to investigate a crime, "Because you are stupider than the entire Bizarro police force put together". This is intended and taken as a great compliment.

IT personnel may believe the opposite designations are the appropriate ones, but since I am the writer I get to choose the taxonomy :-)

Htrae

I shall now compare the culture of "Htrae" (HIT) and "Earth" (medicine). Because it's hard to produce a grid on blogger, I shall do it via a list:

1. On formal education:

On Earth, it was decided via the Flexner Report of 1910 that standards for medical education and credentialing had to be scientific and rigorous. Prior to then, anyone could start a medical school or "hang out a shingle", and predictable, disastrous results followed. After that report and certainly now, physicians must complete rigorous academic and applied training (med school, residency, postdoctoral fellowships, etc.), and take rigorous multi-day exams (national boards, specialty boards, subspecialty boards, etc.) in order to receive credentials and licensure.

On Htrae, the creed is something like this:

"I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers.

Healthcare MIS recruiter Betsy Hersher of Hersher Associates , Northbrook, Illinois, agreed, stating "There's nothing like the school of Hard Knocks ."

In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues ," according to Goodman. (Who's Growing CIO's, Healthcare Informatics, Nov. 1998, p. 88).

In other words it was decided that in HIT, education and credentials were optional, since "a degree doesn't get you anything" and "there's nothing like the school of hard knocks" for CIO leadership and HIT talent, anyway.

A parallel and somewhat bastardized system of getting letters after one's name was created. One can become a "Certified Professional in Healthcare Information and Management Systems" (CPHIMS) through a 115 question multiple choice exam (15 questions are "discounted" to boot).

The series of FCC amateur radio communications exams I took, from "novice" to "general" to "advanced" to "extra" class, were far more rigorous, including electronics theory and math, radio propagation, international radio laws and regulations, safety, etc., plus copying progressively increasing speeds of morse code at higher exam levels, culminating in flawless copy of 20 words per minute for the "extra." Ham radio, of course, is just a hobby generally not affecting people's lives.

In fact, I would make the case that the mirror parallel for the bachelor's degree between Earth and Htrae is that on Earth a bachelor's degree is mandatory for progess to the next level; on Htrae "equivalent experience" (as in "bachelor's degree or equivalent experience", whatever that means) is seen in want ads.

The mirror parallel for the Master's degree is the alphabet soup represented by titles such as "CPHIMS."

The mirror parallel for the Doctorate is "X years experience with vendor product Z." More on that below.

Licensure? Anyone can "hang out a shingle" as an HIT expert.

2. On leadership criteria

On Earth, specialized postdoctoral training in Medical Informatics is funded by The U.S. National Institutes of Health (NIH) at a number of universities, and is provided by other universities via internal funds as well to help improve informatics research and practice such as here (I attended the former and architected the latter).

On Htrae, training is optional. People at all levels in HIT come from a myriad of backgrounds. I've seen healthcare CIO's with no degree, degrees in business of various types or operations engineering, and rarely a higher degree - and rare as hen's teeth, an MD.

3. On hiring

On Earth: One generally gets a medical position through proof of medical education and specialty training, letters of recommendation from senior medical mentors, a check of malpractice claims, and other factors to assure as best as possible the person being hired is competent and ethical. One can generally then adapt to the medical environment into which one is hired; one can move from, say, a clinic or office to an academic or non-academic hospital, and vice versa, depending on one's specialty.

On Htrae: I periodically receive emails like this one, received today, from recruiters:

I have an up and coming project with one of our healthcare clients looking for consultants with both McKesson and Cerner experience. I just wanted to check your status to see if you are available for contract work or know of anyone else currently looking. This project will be starting in about 3-4 weeks and will run 6-12+ months. Please feel free to contact me if you are looking for a position with a healthcare client on the West Coast.

My colleagues and I have been told countless times that "we don't have enough experience" for HIT work because we lacked "experience" in the, say, Acme Anvil EMR. Although we had meta-experience (e.g., formal informatics and CS education, done EMR design, led implementation projects for other vendor's products, understood the unique aspects of HIT environments that lead to success or failure, etc.), because we'd not had "experience" with the Acme Anvil EMR, we were unsuitable.

Now, this is akin to being told that a senior automotive engineer for Ford does not have enough experience to design door locks for General Motors.

In HIT this is a strategic error of major proportions due to the history of HIT difficulties and failure, poor acceptance, and costs.

(Other bizarro world things happen on Htrae as well, such as not knowing what you don't know and not caring that you don't know what you don't know, as in here, and not wanting too much talent in an organization because that's a bad thing in complex, expensive areas prone to mayhem like HIT.)

Let's face it, although Htrae seems to regard "experience with a vendor product" much as medicine considers advanced training and/or a PhD, gaining expert-level experience for leadership of projects of any specific vendor EMR product takes a person such as myself and other medical informaticists perhaps several weeks or a month. I know this because in the"olden days" a decade ago when Htrae was solidifying out of the firmament, I did just that.

... On the other hand, it would take an IT person "considerably longer" to attain a good working knowledge of a medical specialty.

4. On being a closed society:

On Earth: anyone can join the club, if they are academically able to get good grades, prove motivation, and endure training (that sometimes is as rigorous as Marine training, I might add, especially internships).

On Htrae: note the above job solicitation in #3. Where might I go to "get experience" with McKesson? Unlike VisTA, they are a proprietary company producing proprietary products. If "experience with McKesson" is a criteria for hiring, and the only way to get "experience with McKesson" is by getting a job where one works with McKesson products, then we have a little bit of an exclusionary problem (I've often thought this a potentially fruitful conundrum for enterprising government officials on the rise, or even litigation attorneys, to exploit).

5. On knowledge of healthcare:

On Earth: Physicians in the U.S. train via four years spent in medical school, two in a hospital/clinic setting, where they interact extensively with all members of the healthcare clinical team - doctors, nurses, ancillary healthcare personnel, etc. During the three to four year residency, that interaction and interdependency becomes even more intense. During subspecialty training (e.g., ICU medicine, surgical subspecialties, etc.), even more so.

On Htrae: Once doctors get out on their own, in the words of that loveable Htrae imp from the Fifth Dimension, Mister Mxyzptlk, they forget all that and become ineligible for HIT leadership:

... "I think that physicians bring a certain aspect to the job, but I don’t think they necessarily know how a hospital works. I think they know how their practice works and how they interact with the hospital, but I don’t think they absolutely know what nursing does, or any of the ancillary departments, and what they do." - Mr. Mxyzptlk

6. On responsibility and accountability:

On Earth: Physician hurts patient through negligence or perceived negligence. Case goes before M&M conference at very least. More likely, physician gets sued, physician has to spend time in court, physician's name gets entered into national practitioner database, malpractice insurance goes up, physician's reputation is harmed, license can be revoked. With enough cases, physician may be booted out of the job.

On Htrae: Failure leads to promotion or a move to another organization, with no accountability. I can personally think of several CIO's and other HIT workers where this applied.

In one particularly egregious case, a competent cardiac services line manager had to take an inadequate HIT worker out to lunch to "apologize for being so mean" (i.e., demanding results in a life-or-death cath lab). The cardiac manager was eventually booted; the IT person was promoted.

There is another branch of computing that is not on Htrae: computer science. CS is a very academic field. I've often thought that hospital staff and even executives may mistake the business-computing/management information systems (MIS) personnel who inhabit the IS departments to be computer scientists, and treat them accordingly (i.e., with overconfidence in their abilities outside pure business-oriented IT).

However, computer scientists they are not. Business IT personnel do, in fact, generally find computer scientists unsuitable to work in MIS departments (is that a surprise?) As a result, computer scientists are having difficulties getting jobs in recent years. In fact, many more with CS degrees have been applying to my college, Drexel's College of Information Science & Technology, than in past years as a result.

Several additional comparisons may be seen poster-style in a presentation I gave to the IEEE Medical Technology Policy Committee late last year (4 Mb zipped Powerpoint file is here).

In conclusion, with the massive cultural divide between Earth and Htrae, I have but two questions:

1. Why is it demanded of Earthlings that they use products developed and controlled by Htraesians in life-or-death environments?

and

2. Why would anyone expect the products of Htraesians to perform adequately in Terran environments?

-- SS

Another Conflicted Defense of Conflicts of Interest

It seems to be the season for defenses of financial relationships among medical academics and health care corporations to appear in the media. The latest example appeared last week in the Boston Globe as an op-ed [Shaywitz DA, Auseillo DA. Scientific research with an asterisk. April 29, 2008.]

Like other articles in this genre, the authors incorporated a number of logical fallacies into their arguments.

In particular, they attacked a series of straw-men. Consider, to start,

The notion that academic researchers who partner with industry are intrinsically tainted reflects a misunderstanding of the importance and quality of industry research, and the role industry plays in bringing new drugs to the patients who need them.

The straw-man above is in italics. The argument is much more broad than most of the critiques of academic-industry relationships of which I am aware. Most critiques refer not to
"industry" in general, but to particular kinds of industry, usually pharmaceutical, biotechnology, or medical devices. Most critiques refer not to all "researchers," but to those who do clinical research (involving live patients), not basic biomedical research. Most critiques refer not to all "partnerships," but to partnerships that involve industry paying the academic institution and/or the researcher. Furthermore, most critiques are not of a general "taint," but of specific effects of such conflicts of interest.

For example, what we have said on Health Care Renewal is that clinical research (as opposed to basic biomedical research) supported by companies whose products or services are being evaluated by the research tends to be biased. Research sponsors may find ways to manipulate the design, implementation, analysis, and/or reporting of the research in ways that increase the likelihood of results favorable to their products or services. Research sponsors may suppress research whose results are not so favorable. Thus, we most recently recommended considering the requirement "that all clinical research be conducted at true arm's length from organizations and people with vested interests in promoting particular products or services assessed by such research."

The article contained other versions of this straw-man, e.g.,

Unfortunately, industry critics often lose sight of the big picture, and routinely stigmatize pharmaceutical researchers and their academic collaborators.

However, the criticisms of which I am aware were of specific researchers and/or research projects, not all "pharmaceutical researchers and their academic collaborators."

Furthermore,

Senior university researchers who might contribute considerable wisdom to drug discovery efforts are reviled in the press if they associate with industry in any way....

Again, I have not heard academics criticized for simply associating with industry in any way shape or form. We and others have criticized specific kinds of association in specific circumstances. For example, we and others have criticized senior academics who are paid by industry speakers' bureaus to give talks that are thinly-disguised marketing pitches, especially when the slides for these talks are provided by the companies' marketers, and the talks are reviewed by company representatives. (See, for example, the case of "Dr Drug Rep," and the case of an academic physician serving as a "front man for the drug.")

The article actually opened with an even grander straw-man,

Consider an academic scientist - we'll call him Louis - who receives funding from the beverage industry, the textile industry, and the livestock industry, and ultimately generates profound new scientific insights, beneficial both to the sponsoring companies and to the world as a whole. Are these accomplishments diminished because the work was industry funded? Should Louis - Pasteur - have an asterisk next to his name?

Well, of course not. Note how this argument was picked for emotional appeal. Who would dare insult the great Pasteur? In fact, this is a tremendously stretched analogy. Pasteur was an academic, but not a physician. Although my knowledge of his work is elementary, it appeared almost none of his extensive research would now be called clinical, except his experimental inoculation of a single human against rabies done late in his career. He did do applied research, but on plants and animals. He was never funded, as far as I can tell, by a company which produced medicines or medical devices. I cannot find any evidence that he was ever paid by a company to evaluate that company's products.

While shredding these straw-men, the authors also made assertions that are simply unsupported by evidence. For example,

There is a need for more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.

Even more striking,

Pharmaceutical research is tightly regulated, and industry-sponsored clinical studies are typically performed in a rigorous, consistent, and transparent fashion that would be the envy of many academics.

Obviously, although some industry-sponsored clinical research is doubtless excellent, this assertion ignores the many cases of manipulation and attempted suppression of research that have come to light in the last few years. A few of the most recent examples discussed on Health Care Renewal were the manipulation of the reporting of Study 329 (of paroxetine), and manipulation of the mortality results from trials of rofecoxib.

At this point, it would surprise no one that both of the authors of this op-ed work directly or indirectly for industry. The Boston Globe article identified Dr Shaywitz as a "management consultant." According to a post by Ed Silverman on PharmaLot, Dr Shaywitz works for the Boston Consulting Group, whose clients include pharmaceutical companies. Dr Ausiello was identified as a member of the board of directors of Pfizer Inc. An earlier post on PharmaLot had also noted he is "on the advisory boards of Promedior, Proventys and Pulmatrix."

As Collier noted, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.] Maybe this is why someone as distinguished as Dr Ausiello (who is also physician-in-chief of the Massachusetts General Hospital, and Jackson Professor of Clinical Medicine at Harvard) would sign onto such a series of unsupported arguments. The failure of the conflicted defenders of academic medicine's financial entanglements with health care corporations to be able to made evidence-based, logical arguments is in itself an argument against such conflicts of interest.

Blaming "Some Dude" for Contaminated Heparin

It is time to update the story of the contaminated heparin. A summary of the story to date is below (in smaller type.):

- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.
- Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."


We most recently commented on this case here. There have been some major developments since.

• The US Food and Drug Administration (FDA) inspected the Changzhou SPL plant, finding "significant deviations" from good manufacturing practices.(1) The FDA warning letter asserted "your firm lacked an adequate evaluation of the effectiveness of critical processing steps designed to remove impurities, and critical process parameters were not well defined or controlled." Also, "you received lots of material from an unacceptable workshop vendor that were used in your API [active pharmaceutical ingredient]." In addition, "Your system for evaluating suppliers of crude heparin material is ineffective to ensure that materials are acceptable for use." Finally, "Equipment used to manufacture heparin sodium USP is unsuitable for its intended use."(2)
• Scientific Protein Laboratories (SPL) provided a statement that "the contaminant found in certain lots of finished heparin product was not introduced in the manufacturing process at Changzhou SPL or SPL." Furthermore, "it is now clear that the suspect contaminant was introduced earlier in the supply chain in China and was widespread throughout the unrelated Chinese supply chain of many companies."(1)
• Baxter International claimed it had inspected the Changzhou SPL plant, per the Wall Street Journal, but a senior congressional investigator said, "Baxter conducted one audit of the Chinese plant, in September 2007, and concluded the plant was acceptable."(3) Furthermore, the New York Times reported that "the company sent one person who spent one day in the plant, Mr. Nelson said. Five months later, the F.D.A. discovered myriad problems, he said. 'It really is impossible for a plant to have fallen that far out of compliance in five months,' Mr. Nelson said."(4)
• The FDA seemed to concur that the contamination began in China before the heparin was supplied to Changzhou SPL. Per the Washington Post, "new evidence that links hundreds of serious adverse reactions and scores of deaths among patients given the blood thinner heparin to a man-made contaminant introduced during production in China. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said that the contaminant has been traced to 12 different Chinese companies and has been found in heparin batches shipped to 11 nations, all of it from China."(5)
• However, Chinese officials disputed the conclusion that the contamination came from China, and instead suggested it occurred in SPL's plant in the US. Per the Washington Post, "Jin [Shaohong, an official with the Chinese National Institute for the Control of Pharmaceutical and Biological Products] said the Chinese government was conducting its own investigation of the heparin issue, which would include a visit today to Baxter's New Jersey processing plant, where officials hoped to collect additional samples of the tainted drug. He said the allergic reactions could have been created by impurities introduced when the imported raw heparin was refined by Scientific Protein Laboratories (SPL) of Wisconsin and then prepared for distribution in New Jersey."(5)
• Per Forbes, The CEO of Baxter International, Robert Parkinson, "said at a congressional hearing that it wasn't responsible for contaminated batches of Heparin, an anticoagulant used mostly in hospitals, and that it may have been a deliberate contamination." In particular, he said, "we're alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result."(6)
• Per the Chicago Tribune, the CEO of Scientific Protein Laboratories said "Chinese authorities have blocked his company's efforts to inspect suppliers that might have introduced foreign material into the company's heparin.'We started an inspection, but at a certain time the Chinese authorities took over a very significant inspection, and felt we should not be interfering with an inspection by the Chinese authorities,'..."(7)
• Congresspeople blamed the FDA. According to the Wall Street Journal, Rep. John Dingell (Democrat - Michigan) said, "Our citizens can no longer trust their food, drugs, or medical devices are safe when the FDA says they are."(3)

So, everyone is to blame, and practically every organization involved blames another one.

Congress blames the FDA, but congress is responsible for funding the FDA insufficiently for it to inspect all the foreign plants that now supply active pharmaceutical ingredients to the US, and for funding the FDA with "user fees" that may have lead many in the FDA to view the drug companies, rather than the American public, as their clients.

The FDA blames Changzhou SPL and its suppliers, but the FDA is responsible for the safety and purity of US drugs, and therefore has responsibility for the entire supply chain responsible for drugs prescribed in the US.

Baxter International blames nefarious contaminators, but Baxter is responsible for making sure that the drugs it sells are pure and safe.

Scientific Protein Laboratories blames the contaminators, and the Chinese government for blocking attempts to inspect its suppliers, but SPL is responsible for making sure the active pharmaceutical ingredient it sells to pharmaceutical companies are pure and safe.

The Chinese government blames the American companies, but the Chinese government ought to be responsible for products exported from its country.

I could not find any evidence that any leader of any involved organization assumed any responsibility for anything that went wrong during this fiasco. It reminded me of stories that when adolescents are caught by the US police, they often blame their offense on "some dude," otherwise not identified.

This case is an amazing example of global health care dysfunction. Each organization listed above, of course, bears some but not all responsibility. Although the leaders of these organizations are supposedly chosen because of their ability and willingness to take responsibility (and the leaders of the US corporations are paid very handsomely supposedly for taking such responsibility), all they have done so far is try to avoid responsibility, and blame "some dude" for the problems.

And this goes on in an era where physicians are constantly badgered about how they must be responsible, be accountable, and be paid for their "performance."

When we get some adult leadership of health care organizations who are willing to take responsibility and be accountable for their organizations' actions, maybe we will have a more functional health care system. Such leaders might find out that bearing responsibility and being accountable would involve putting patients before profits, or ego. (I also bet adult leaders with more secure egos might be willing to work for less than the millions a year now required by the "imperial CEOs" of US health care corporations.)

Finally, as a reminder of the consequences of the current dysfunction, the death toll for the case of the contaminated heparin is now estimated to be 81.(4)

References

1. Japsen B. FDA: heparin supplier's Chinese factory 'unsuitable.' Chicago Tribune, April 21, 2008. Link here.
2. FDA. Letter to Dr Yan Wang, General Manager, Changhzhou SPL Company, Ltd. April 21, 2008. Link here.
3. Favole JA, Boles C. Lawmakers seek heparin answers from FDA and Baxter officials. Wall Street Journal, April 29, 2008. Link here.
4. Harris G. Heparin contamination may have been deliberate, F.D.A. says. New York Times, April 30, 2008. Link here.
5. Kaufman M. New data link heparin deaths to Chinese batches, FDA says. Washington Post, April 22, 2008. Link here.
6. LaMotta L. Heparin: the plot thickens. Forbes, April 29, 2008. Link here.
7. Japsen B, Greising D. Baxter CEO tells congress heparin tampering was deliberate. Chicago Tribune, April 29, 2008. Link here.

Is the HIMSS "Certified Professional in Healthcare Information and Management Systems" stamp substantive, or just alphabet soup?

This post might be subtitled "when spending millions on health IT, why spend thousands on true healthcare informatics education when you can get a 'Certified Professional' credential to hang on your office wall, cheap?"

Imagine your reaction to a web page for a major HC organization that said this:

Certification as an expert in medical devices available. No domain-specific, specialized educational requirements. Short multiple choice test where many wrong answers "forgotten" is only requirement. You will be identified as an elite member of the healthcare device team after receiving our certification. Send $xxx dollars to ...

Such a scam would likely invite a governmental investigation.

Electronic medical records and other clinical IT are, in fact, virtual clinical devices that happen to reside on computers.

Their impact on medical care and education can be profound, as pointed out in papers by Ross Koppel at Penn, Pamela Hartzband, M.D. and Jerome Groopman, M.D. at Harvard, and many others around the world such as at Bad Health Informatics Can Kill and my own growing aggregation of HIT stories at "Sociotechnologic Issues in Clinical Computing: Common Examples of Healthcare IT Difficulties."

Yet, the vendor-friendly organization HIMSS (The Healthcare Information and Management Systems Society) offers such a certification in health IT. HIMSS identifies itself as "the healthcare industry's membership organization exclusively focused on providing leadership for the optimal use of healthcare information technology and management systems for the betterment of healthcare."

Here are the details on their certification as a Certified Professional in Healthcare Information and Management Systems (CPHIMS):

The Healthcare Information and Management Systems Society (HIMSS) has launched a professional certification program for healthcare information and management systems professionals. An individual who meets eligibility criteria and successfully completes a qualifying examination is designated a Certified Professional in Healthcare Information and Management Systems (CPHIMS).

CPHIMS status provides both internal and external rewards. As a Certified Professional in Healthcare Information and Management Systems, you:

• Distinguish yourself from your peers as certified in healthcare information and management systems;
  
• Expand your career opportunities;
  
• Signal that you have mastered proven, broad-based concepts through successful completion of the Certified Professional in Healthcare Information and Management Systems Examination;
  
• Provide yourself with skills and tools to help you make a difference in your career, your organization, and your community;
  
• Enjoy the pride of recognition of knowing that you are among the elite in a critical field of healthcare; and
  
• Have a premier credential based on a sound assessment to distinguish yourself in an increasingly competitive marketplace.
  
  

Here are the eligibility standards:

• Baccalaureate degree plus five (5) years of associated information and management systems experience*, three (3) of those years in healthcare.
  
  
• Graduate degree plus three (3) years of associated information and management systems experience*, two (2) of those years in healthcare.
  
  
• *Associated information and management systems experience includes experience in the following functional areas: administration/management, clinical information systems, e-health, information systems, or management engineering. [Is that vague and non-specific enough? - ed.]
  

And now, the certification instrument:

The CPHIMS credential is awarded to individuals who demonstrate eligibility for the Certification Program and who successfully complete a qualifying examination. The examination consists of 115 multiple-choice test items, presented during a 2-hour session. Scoring is based on 100 items pre-selected for desirable psychometric characteristics. The additional 15 test items are included as pretest items. Performance on pretest items does not affect a candidate’s score.

It is remarkable to me that there are no specific educational requirements relevant to HIT, such as a certificate in health informatics, informatics fellowship, or clinical medicine experience of any kind. In my humble opinion a 115-question multiple choice test does not qualify a person as an expert in anything. Further, it seems to me that any "15 test items" a test taker got wrong might simply be discarded, further diluting such a test's relevance at best, and a rather dubious manner of scoring an exam in healthcare at worst.

Also omitted is the calibre of one's "experience." What, exactly, did you do? Were you successful? Were you an asset? Or, did you set projects back? Did you contribute to failure?

I'd though the importance of formal education in healthcare had been resolved by the 1910-era Flexner Report. I guess I am mistaken.

The sequential FCC exams I took to achieve a ham radio license - a mere hobby - were far more exacting. And at the time there was an applied exam as well; I had to be able to receive Morse Code at twenty words per minute to achieve the "Extra class" license.

I won't even compare to medical board exams.

To this NIH postdoctoral fellowship-educated HIT professional, CPHIMS certification sounds more like a "credentials mill" operation than a legitimate eduational and certificational process.

An attempt to introduce such a certification process at any institution of higher education, such as the one in which I teach about clinical IT, would get laughed out of a Faculty Senate's Committee for Academic Affairs or similar curriculum-approval body. It might even harm the school's accreditation.

Could you imagine such a certification process for some other medical process or technology, e.g., fluoroscopy equipment or EKG machines?

Discouraging pursuit of formal informatics education increases HIT problems and delays, raises costs, and facilitate failures. Does the availability of "instant credentials" discourage acquiring a substantive health care informatics background, diluting the availability of true expertise in this difficult field?

Is such health IT certification somewhat of a fraud, a ploy to allow undereducated people an opportunity to add "alphabet soup" to their resume in order to secure positions in health IT, or is it legitimate certification?

I report, you decide.

-- SS

"Selective Reporting of Study 329"

A new study in a rather obscure journal has revealed more about the now infamous study 329. [Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008; 20: 73-81. Link here.]

For the background, let me take the easy way out, and quote Ed Silverman from PharmaLot:

Back in 2001, an infamous study was published in the Journal of the American Academy of Child and Adolescent Psychiatry that declared Glaxo’s [GlaxoSmithKline, GSK] Paxil antidepressant - called Seroxat in the UK - [paroxetine] was “generally well tolerated and effective for major depression in adolescents.” Known as study 329, the findings were used to widely promote the drug, which became a huge seller.

Of course, the study was later held in disrepute after it was learned the results didn’t tell the whole story. In fact, 329 was one of three studies cited by former New York Attorney General Eliot Spitzer, who filed a suit charging Glaxo with “repeated and persistent fraud,” alleging the drugmaker had promoted positive findings, but hadn’t publicized unfavorable data (back story).

As it turns out, study 329, ... already had a sordid history that included ghostwriting charges (here’s some background)....

We did cover this issue in the past (here) on Health Care Renewal.

Furthermore, we can now turn to the Clinical Psychology and Psychiatry Blog for an analysis of what is new about the study by Jureidini et al. The main points were -

The study report (in the Journal of the American Academy of Child and Adolescent Psychiatry) featured results of manipulation of the measures used to assess efficacy to make the drug appear more efficacious:

• Study 329 was designed to employ 8 measures of drug efficacy. It turned out that paroxetine was not statistically significantly superior to the comparator using any of these 8 measures.
• After the study was underway, the authors added a bunch of new measures, including new instruments, and modifications of instruments used in the original 8 measures. Only when using some of these new measures did the drug exhibit any efficacy.

To summarize how the Clinical Psychology and Psychiatry blog put it:

Devising various cutoff scores on various measures on which victory could be declared, as well as examining individual items from various measures rather than entire rating scales, the authors were able to grasp and pull out a couple of small victories. In the published version of the paper, there is no hint that such data dredging occurred. Change the endpoints until you find one that works out, then declare victory.

Worse, the study report simply omitted mention of the data that serious adverse events were more common in patients treated with paroxetine than with placebo, making the drug appear safer than it really may be. Jureidini et al noted that the following phrase,

worsening depression, emotional lability, headache, and hostility were considered related or possibly related to treatment

was omitted from the published report. Furthermore, per Jureidine et al,

Suicidal thoughts and behavior were grouped under the euphemism of 'emotional lability'

Yet the final JAACAP paper only stated,

Only headache (1 patient) was considered by the treating investigator to be related to paroxetine treatment

Jureidini et al concluded,

The published conclusions of study 329 and information provided by GSK to health professionals understated adverse effect rates and emphasized post-hoc measures that were not consistent with the unpublished, protocol-defined primary and secondary outcomes.

The article by Jureidini et al adds to our understanding of the various devious ways commercial sponsors of clinical research and the supposedly independent academic investigators who collaborate with them may manipulate the design, implementation, analysis and reporting of clinical studies to make the sponsors' products look better.

As we have said again and again, patients and physicians require the best possible information about benefits and harms of treatments to make the best decisions about such treatments. When those with vested interests in supporting a particular treatment distort the information available to make such decisions, they risk harming patients. In addition, manipulation of clinical studies violates the trust of study participants who thought they were taking part to advance science or health care.

The ongoing revelations about study 329 unfortunately remind doctors and patients who skeptical they must be about how well drugs and devices really are supported by clinical research. Combined with numerous other reports of manipulation and suppression of research, they suggest that:

• medicine, and particularly academic medicine ought to do a far better job of policing itself to ensure the integrity of clinical research
• pharmaceutical, biotechnology and device companies lead by businesspeople and lacking strong corporate cultures and explicit codes of conduct supporting ethical conduct may not deserve our trust
• government regulation of drug and device companies need to be far more stringent
• consideration ought to be given to require that all clinical research be conducted at true arm's length from organizations and people with vested interests in promoting particular products or services assessed by such research
  

I must note that there is also a local angle to this. As Jureidini et al wrote, "in 1992 Martin Keller MD, Chairman of Psychiatry at Brown University, Rhode Island and colleagues successfully proposed to SKB [SmithKline Beecham, the predecessor of GSK] a multi-site study of a selective serotonin reuptake inhibitor and tricyclic antidepressant in adolescent major depression."

As PharmaLot reported, "The latest study prompted a complaint concerning possible scientific misconduct to be leveled against study 329’s lead author, Martin Keller, a psychiatry professor at Brown University, by David Egilman, a clinical associate professor in community health at Brown. We are awaiting a reply from Keller and Brown provost David Kertzer, who was sent the complaint by Egilman. UPDATE: A Brown spokesman declines to comment."

As I noted in my previous blog post, I am currently on the voluntary faculty of Alpert Medical School of Brown University. I am a former full-time faculty member, and an undergraduate and medical school alumnus of Brown. I am saddened to see the ongoing damage to the reputation of the institution from this case. I do believe that Dr Egilman's complaint warrants full, open, and transparent investigation.

The AAMC Report on Medical Schools' Industry Relationships: A Glass Half Empty

The Association of American Medical Colleges (AAMC) just unveiled a report on relationships among academic medical institutions and the pharmaceutical, biotechnology, and device industry. The report was notable in its toughness in certain areas, laxity in others, and for what it did not mention, and what kinds of conflicts of interest it actually encouraged.

Where it was tough:

• It advocated banning "acceptance of any gifts from industry by physicians and other faculty, staff, students, and trainees...."
• It considered "industry supplied food and meals" as "personal gifts" which should be therefore banned (but see below).
• It advocated prohibiting "physicians, trainees, and students from directly accepting travel funds from industry." (But see below.)
• It advocated prohibiting "physicians, trainees, and students from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any part, industry or otherwise."

Where it was lax

• It did not ban interactions among physicians, faculty, staff, students and trainees and pharmaceutical or device representatives (sales people), only restricting such interactions to "nonpatient care areas and nonpublic areas," "by appointment or invitation of the physicians." Furthermore, it suggested that "involvement of students and trainees in such individual meetings should occur only for educational purposes."
• It allowed "industry representatives who wish to provide educational information on their products" to do so "by invitation in faculty-supervised structured group settings"
• It allowed "access by device manufacturers' representatives" if they are "appropriately credentialed."
• It allowed participation in industry funded continuing medical education (CME) programs as long as they are accredited by the Accreditation Council for Continuing Medical Education (ACCME)
• It allowed industry-sponsored food and meals as long as they are part of ACCME accredited CME.
• It advocated that "participation by ... faculty in industry-sponsored speakers' bureaus" should be "strongly discouraged," but not prohibited.
• It allowed industry to reimburse travel "for legitimate reimbursement or contractual services."

What it encouraged:

• It acknowledged "the value of permitting academic medical center faculty to interact appropriately with industry." It deemed appropriate "faculty participation on industry boards of directors and scientific advisory boards," and faculty "services provided through professional service agreements and consulting contracts," as long as they are "in full compliance with the policies of the medical center and applicable law," and compensated according to "fair market value." It did not require, or even suggest disclosure of such financial relationships.

What it did not mention:

• Institutional conflicts of interest, in general.
• Industry manipulation or suppression of clinical research, and how contracts between academic medical institutions and industry allow such manipulation.
• Some specific kinds of financial relationships between faculty and industry, including faculty holding executive positions with or founding health care corporations, and faculty receiving royalty payments.

In my humble opinion, at best this report, which I suspect will be highly influential, is a glass half empty.

There is reason to ban gifts and food to trainees, and physicians. Such gifts imply the need for reciprocity, and hence may be influential beyond their monetary value. See our posts (here, here, and here) on how gifts are used for marketing purposes by pharmaceutical representatives.

Yet given the evidence (see posts above) that the goal of pharmaceutical (and biotechnology and device) representatives is to market product, not provide education, the report's allowance of "educational" activities by such representatives is at best disingenuous.

Furthermore, given the evidence that industry sponsored CME is likely to be biased in favor of the sponsoring companies' products and services (see posts here, and here, and numerous posts on the Carlat Psychiatry Blog and the Hooked: Ethics, Medicine and Pharma blog ), and the logic behind this assertion, the report's allowance of such "educational" activities is also at best disingenuous.

I believe that the report's failure to address the issue of manipulation and suppression of industry funded research is astonishing given how obvious such problems have become. (Try searching these topics on this blog, to begin with.)

Finally, the report's encouragement of certain often lucrative financial relationships (such as consulting, service on advisory committees, and service on boards of directors of health care corporations), while it ignored other lucrative relationships (service as a corporate executive, founding of health care corporations, and receipts of royalties) suggests cynicism and hypocrisy.

First, even though small gifts may have influence beyond their monetary value, very large payments are likely to be more influential. Even without empirical research, common sense suggests that a faculty member who receives tens of thousands of dollars for consulting or serving on an advisory committee or speakers' bureau is likely to look favorably on his or her corporate part-time employer, and its products or services. Furthermore, serving as an executive of a corporation, and particularly serving on the board of directors of a corporation should demand loyalty to the corporation, and such loyalty can be enforced in court. Surely such loyalty is likely to be much more powerful than warm feelings generated by the receipt of a free pizza.

If there is a reason to ban gifts of pens, coffee mugs, or pizza slices due to the concern that such gifts may influence trainees and physicians' behavior, there is more of a reason to ban service on speakers' bureaus and advisory committees, consulting contracts, and particularly service as company executives, and on boards of directors.

Otherwise, we may well see the spectacle of a the director of a health care corporation punishing a medical student for accepting a pen with that corporation's logo on it.

And a postscript - It appears that this report may be so ambivalent about conflicts of interest because several of its authors were affected by such conflicts. On the PharmaLot blog, Ed Silverman reported that three authors are on the boards of directors of large health care corporations, and three other authors had significant financial relationships with health care corporations. None of these relationships were disclosed in the report. The report did disclose that four other authors were not academics or medical college administrators, but CEOs of pharmaceutical or biotechnology corporations. Why the AAMC saw fit to ask such people, who are obviously likely to be more loyal to their corporations than to academic medicine, is a mystery yet to be solved.

Note, see somewhat more optimistic opinions about this report on the Carlat Psychiatry Blog and the Hooked: Ethics, Medicine and Pharma blog. Also, a New York Times editorial accused of the AAMC of "flinching" from banning service on speakers' bureaus, and industry supported CME, but did not mention the report's support of consulting, service on advisory committees and boards of directors, service as a corporate executive, etc. But I agree with its general conclusion, "Patients need to be assured that their doctors are prescribing what’s best for them, not what’s best for companies. "

ADDENDUM (30 April, 2008) - See also coverage in the Gooznews Blog, in which Merrill Goozner noted that the report "stopped short of calling for prohibiting faculty members from consulting or speaking on behalf of drug and device companies, or for eliminating industry’s role in financing continuing medical education (CME)." On the other hand, the Postscript blog by the Prescription Project noted the AAMC report without much comment.

ADDENDUM (30 April, 2008) - On theRetired Doc's Thoughts blog, Dr James Gaulte is also skeptical, "My non-insider take is that there will be a flurry of high profile (within the institutions at least) announcements of 'no more free lunches' and much self congratulation and talk of professionalism but somehow I doubt the faculty will give up the lucrative lecture gigs although a veneer of word smithed propriety and oversight will be grafted onto it."

BLOGSCAN - "Regulatory Capture," Heparin and the FDA

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody discusses the recent case of toxic heparin (see our most recent post here) in terms of "regulatory capture" of the US Food and Drug Administration (FDA). Regulatory capture occurs when a regulatory agency starts to view those whom it is supposed to regulate as clients (rather than viewing the general public as its client). More comments on this issue by Dr James Gaulte can be read on the Retired Doc's Thoughts blog.

BLOGSCAN - Disease Mongering and Indefinite Use of Smoking Cessation Pharmaceuticals

On the Bioethics Forum, Dr Adriane Fugh-Berman and Dr Douglas Melnick discuss what appears to be the latest example of disease-mongering. An article in the Annals of Internal Medicine, written by authors with ties to companies that make pharmaceuticals for smoking cessation, argued that tobacco addiction should be reclassified as a chronic disease, such that patients should be expected to be on smoking cessation products indefinitely. Such indefinite use, of course, is unsupported by clinical evidence, but would create a huge new market for these drugs.

Pharma Union cowed into submission?

In various posts including this one, I've commented on the environment of cutbacks, quality issues, and fear that seems to permeate pharma.

Now a labor union leader at Merck has responded to the Philadelphia Inquirer article "FDA report shows problems at Merck vaccine plant." He writes in a letter to the editor:

Concerns at Merck

The article "FDA: Problems at Merck's vaccine plant" (Inquirer, April 24) indicated the concerns raised after an inspection at our facility, Merck's West Point site. We, the United Steelworkers Union members, are dedicated to the creation of quality products through all phases of the manufacturing process. We are committed to following FDA guidelines, industry standards, and the FDA's Good Manufacturing Practices, all of which are the foundation for a successful pharmaceutical and vaccine production plant.

The company has implemented new ideas on how to function at our site. The expectation placed on our members is that they are required to do more with less. This business philosophy is not unique to large corporations but it is new to the pharmaceutical industry. Our members have worked diligently to ensure that the demands that have been placed on them have been met. They also want to ensure that their jobs are secure, but the article has raised concerns for them and their families about the future.

Phil Hughes
Vice president
United Steelworkers Local 10-0086
North Wales (PA)

This somewhat cryptic letter can be interpreted in a number of ways. A clear message is that the union members are being asked to "do more with less", implying overwork. This seems an explanatory theme in the FDA 483 Inspection Report referenced in the Inquirer article, a copy of which I have obtained. There are, in fact, phrases in paragraphs of that FDA inspection report that do not belong in the same paragraph, such as:

5. SOP 1330, Headquarters Review of Lot Numbers for Product Quality Complaints (PQCs), dated 14 May 2007, states that all deaths and life threatening adverse experiences [with vaccines] require lot checks with batch record review. This is not always performed.

and

Rejects from the first pass through the inspection equipment are sent through the inspection equipment a second time and only those that are rejected a second time are discarded. [Four examples involving vials of Varivax, Zostavax and ProQuad follow.]

What is most concerning about the union leader's letter to the editor, however, is this:

They [our union member Merck employees] also want to ensure that their jobs are secure, but the article has raised concerns for them and their families about the future.

I ask why an article such as the one published in the Inquirer would raise concerns for Merck unionized workers about their "future" (i.e., jobs).

Is the union concerned about retaliation in the form of layoffs for the substandard report? Since it's unlikely Merck vaccine sales will be affected by easily correctable FDA inspection problems, and since it's also unlikely Merck Vaccine Division will go out of business, being touted as it is by Merck management as a significant source of company income (e.g., via the new Herpes vaccine), the fear of layoff retaliation appears possible.

I can only say that if the unions are so concerned and so milquetoast in their approach to employee overwork via mild-mannered letters to the editor, imagine what the non-unionized employees must be feeling.

Finally, I once worked as Medical Programs Manager for the regional transit authority in Philadelphia. The leader of its biggest union, Transport Workers Union local 234, would likely have had quite a different response in the Inquirer to the problems caused by his employees being made to "do more with less" in a life-critical operation.

When I first met Mr. Lombardo it was at a medical department meeting where he was banging his fists on the table, shouting at the doctors for f***ing around with his employees via workers comp denials, drug tests, etc. At the time I thought this behavior frightening and unprofessional, but now I see its value.

I wish I'd had a union leader will testicles representing me in my past few positions.

-- SS

On the Pitfalls of Going Electronic: Should Physicians Reject Hospital EMRs?

Yes, I believe they should, and with a spine, especially when they're lousy and their design and implementation have been led by people with superficial "certification" and/or no clinical credentials whatsoever. And sometimes no discernible IT credentials, either, unless you consider the "school of hard knocks" a credential.

(More on the credentials issue below. Also see my website "Common Examples of Healthcare IT Difficulties" for more on these issues.)

A viewpoint article was just published in the NEJM by Harvard physicians Pamela Hartzband, M.D. and Jerome Groopman, M.D. entitled "Off the Record — Avoiding the Pitfalls of Going Electronic" (NEJM 358:1656-1658, April 17, 2008).

The authors note:

... The ultimate goal of the electronic medical record — a technological solution being championed by the Bush administration, the presidential candidates, and New York Mayor Michael Bloomberg, as well as Google, Microsoft, and many insurance companies — is to make all patient information immediately accessible and easily transferable and to allow its essential elements to be held by both physician and patient. The history, physical exam findings, medications, laboratory
results, and all physicians' opinions will be collected in one place and available at a single keystroke. And there is no doubt that these records offer many benefits. We worry, however, that they are being touted as a panacea for nearly all the ills of modern medicine. Before blindly embracing electronic records, we should consider their current limitations and potential downsides.

As we have increasingly used electronic medical records in our hospital and received them from other institutions, we've noticed several serious problems with the way in which notes and letters are crafted. Many times, physicians have clearly cut and pasted large blocks of text, or even complete notes, from other physicians; we have seen portions of our own notes inserted verbatim into another doctor's note. This is, in essence, a form of clinical plagiarism with potentially deleterious consequences for the patient.

Residents, rushing to complete numerous tasks for large numbers of patients, have sometimes pasted in the medical history and the history of the present illness from someone else's note even before the patient arrives at the clinic. Efficient? Yes. Useful? No. This capacity to manipulate the electronic record makes it far too easy for trainees to avoid taking their own histories and coming to their own conclusions about what might be wrong. Senior physicians also cut and paste from their own notes, filling each note with the identical medical history, family history, social history, and review of systems. Though it may be appropriate to repeat certain information, often the primary motivation for such blanket copying is to pass scrutiny for billing. Unfortunately, these kinds of repetitive notes dull the reader, hiding the important new data.

Writing in a personal and independent way forces us to think and formulate our ideas. Notes that are meant to be focused and selective have become voluminous and templated, distracting from the key cognitive work of providing care. Such charts may satisfy the demands of third-party payers, but they are the product of a word processor, not of physicians' thoughtful review and analysis. They may be "efficient" for the purpose of documentation but not for creative clinical thinking.

In effect, the doctors have keenly observed that not only do EMR's impair documentation and thinking by seasoned professionals, especially those pressed for time, but the use of these technologies impairs the training of the next generation of physicians. I benefited much through learning how to properly document medical observations, findings, differential diagnoses, treatment plans, and other high level cognitive processes. IT designed by non clinicians with the maintenance of payor profit as a principal motivator may be, in effect, causing a further dilution in the quality of medical training. Social informatics predicts such unexpected adverse outcomes of any new information and communications technology (ICT).

However, the current environment of irrational exuberance over Health IT, as well as the potential for capital transfer from the healthcare to the IT and payer sectors and the motivators and conflicts this generates among hospital management, consultants, regulators and others, has had a marked blinding effect.

The NEJM authors also note:

Similarly, electronic medical records can reproduce all of a patient's laboratory results, often dropping them in automatically. There is no selectivity, because it takes human effort to wade through all the data and isolate the information that is pertinent to the patient's current problems. Although the intent may be to ensure thoroughness, in the new electronic sea of results, it becomes difficult to find those that are truly relevant.

A colleague at a major cancer center that recently switched to electronic medical records said that chart review during rounds has become nearly worthless. He bemoaned the vain search through meaningless repetition in multiple notes for the single line that represented a new development. "It's like `Where's Waldo?'" he said bitterly. Ironically, he has started to handwrite a list of new developments on index cards so that he can refer to them at the bedside.

...The worst kind of electronic medical record requires filling in boxes with little room for free text. Although completing such templates may help physicians survive a report-card review, it directs them to ask restrictive questions rather than engaging in a narrative-based, open-ended dialogue. Such dialogue can be key to making the correct diagnosis and to understanding which treatment best fits a patient's beliefs and needs.

... These problems, we believe, will only worsen, for even as we are pressed to see more patients per hour and to work with greater "efficiency," we must respond to demands for detailed documentation to justify our billing and protect ourselves from lawsuits. Though the electronic medical record serves these exigencies, it simultaneously risks compromising care by fostering a generic approach to diagnosis and treatment.

I agree with these assessments, especially for hospital based enterprise EMR's forced on doctors by management.

Physician leadership of HIT projects would be of great benefit. However, here's what typical healthcare organizational leaders have to say about physician leadership of HIT initiatives, in this case Denis Baker, the CIO of Sarasota Memorial Hospital, a major medical center on the Gulf Coast of Florida in an interview here:

I think that physicians bring a certain aspect to the job, but I don’t think they necessarily know how a hospital works. I think they know how their practice works and how they interact with the hospital, but I don’t think they absolutely know what nursing does, or any of the ancillary departments, and what they do.

Worse, as far as I can tell, the CIO making that statement appears to lack formal education in medicine, information systems, information technology and biomedical information science i.e., informatics. (I was unable to find any such credentials but will correct this if mistaken.)

Stereotypes of physicians do not come any more patronizing than that.

Oh, wait ... yes they do.

His statement is little different than a decade ago when I wrote this essay about stereotypes and observed others in influential positions holding marginalizing views of physicians - and indeed of professional education of any kind:

Several healthcare MIS Recruitment firms have published interesting views on healthcare MIS leadership, views that most clinicians will not identify with. " I don't think a degree gets you anything ," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers.

Healthcare MIS recruiter Betsy Hersher of Hersher Associates , Northbrook, Illinois, agreed, stating " There's nothing like the school of Hard Knocks ." (Who's Growing CIO's, Healthcare Informatics, Nov. 1998, p. 88).

In seeking out CIO talent, recruiter Lion Goodman " doesn't think clinical experience yields [hospital] IT people who have broad enough perspective . Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues ," according to Goodman.

It appears there's been little change in ten years.

Oh, wait ... yes there has been "change."

"Specialists" and "managers" in HIT projects now undergo certification by vendor-centric groups such as the Health Information Management Systems Society HIMSS.

Here's a description of the value of certication as a HIMSS Certified Professional in Healthcare Information and Management Systems (CPHIMS):

CPHIMS status provides both internal and external rewards. As a Certified Professional in Healthcare Information and Management Systems, you:

• Distinguish yourself from your peers as certified in healthcare information and management systems;
• Expand your career opportunities;
• Signal that you have mastered proven, broad-based concepts through successful completion of the Certified Professional in Healthcare Information and Management Systems Examination;
• Provide yourself with skills and tools to help you make a difference in your career, your organization, and your community;
• Enjoy the pride of recognition of knowing that you are among the elite in a critical field of healthcare; and
• Have a premier credential based on a sound assessment to distinguish yourself in an increasingly competitive marketplace.

Wow! "You are among the elite" after taking this exam!

Here are the eligibility standards:

Baccalaureate degree plus five (5) years of associated information and management systems experience*, three (3) of those years in healthcare.

Graduate degree plus three (3) years of associated information and management systems experience*, two (2) of those years in healthcare.

*Associated information and management systems experience includes experience in the following functional areas: administration/management, clinical information systems, e-health, information systems, or management engineering.

And now, the certification instrument:

The CPHIMS credential is awarded to individuals who demonstrate eligibility for the Certification Program and who successfully complete a qualifying examination. The examination consists of 115 multiple-choice test items, presented during a 2-hour session. Scoring is based on 100 items pre-selected for desirable psychometric characteristics. The additional 15 test items are included as pretest items. Performance on pretest items does not affect a candidate’s score.

That is the certification that will be used to hire more "experts" in HIT.

This is pathetic. My exams to become a licensed ham radio operator were more challenging. I consider such a credential unmeritorious at best, fraudulent at worst. (I haven't even inquired as to costs.)

However, medical credentialing exams are just a bit more thorough.

By several orders of magnitude, that is.

In conclusion, medicine is in very sad shape when in an era of out of control technology costs ($100 million for an EMR?), unclear benefit and irrational exuberance over HIT it's demanded of physicians that they use tools designed by business IT personnel, processes and methodologies best known for failure, produced by an industry rife with conflicts, whose leaders often lack substantive credentials, patronize those who do, produce ill-conceived and/or shoddy products whose use is mandated by non-clinician hospital managers and that as the NEJM writers note, impair medical practice and education.

-- SS