Wednesday, October 31, 2007
The University of Delaware, a large, state-supported US university, which includes a College of Health Sciences, recently instituted a new "treatment"program for university students, described in the draft of a detailed report. [Following page references are from that report.] (References to the program, also described as a curriculum, as a "treatment" are on page 8, 10, and 14) Subjects will be exposed to educational and behavioral interventions, the latter described in one document as that which will "leave a mental footprint on their consciousness." An example of one behavioral intervention requires subjects to line up, then step forward or backward in response to questions about their social identities [see p. 2 of this letter.]. The program will be subject to "action research" [p. 3], which "is generally distinguished by being practioner based, focused on actual existing practices, and using data to improve existing practices," [p. 4] and possibly also "summative, research style studies" [p. 3] Outcomes to be assessed include "behavioral changes in reaction to ... educational strategies." [p. 5] Data collection methods include "surveys, formal inteviews, focus group[s]" [p. 11] Subjects with the worst outcomes in particular groups would be individually identified, and subject to additional interventions [see p. 3 of this letter.] The investigators claimed the research "would qualify for an exemption from full [institutional review] board review." [p. 12]
So far, this sounds unremarkable, but, just has been extensively reported by the Foundation for Individual Rights in Education (FIRE), the subjects of this "treatment" program are all students living in all University of Delaware dormitories, not patients with any defined conditions or diseases. Furthermore, as the FIRE case file makes very clear, participation is mandatory. Not only is consent not required for participation, students must participate in the "treatment" and in the associated "action research" study whether or not they want to.
As FIRE noted in a letter to university president, there are a set of objections to all this based on the content of the intervention, which seems to designed to inculcate political beliefs, rather than to educate, and which requires students to affirm beliefs they may not actually hold. For a government institution to expose students to what seems to be mandatory political indoctrination, and to require students to express beliefs which are not theirs raise major constitutional issues.
Setting those aside, this program seems to profoundly violate some fundamental values of health care and of human research. Except in very particular cases of incompetent patients or patients who are at immediate risk of harming themselves and others, no one should be subject to a treatment without his or her consent. In such a situation, compelling subjects to participate in associated research is equally unethical.
Some may argue that the university's description of this project as "treatment" was metaphor or rhetorical excess. However, the repeated use of that term, plus description of the project in behavioral terms, and the clear human research component invite viewing the project as a treatment intervention and associated human research plan.
For an American state university to have gone so far in a plan for mandatory behavioral "treatment" of students without their consent is chilling. It is a reminder that something has clearly gone very wrong in health care and academia, and that the problems are clearly not at all limited to the for-profit corporate sector.
ADDENDUM (3 November, 2007) - the University of Delaware has cancelled its mandatory "treatment" program, as covered by FIRE.
We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Most recently, we found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), and that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here).
In response to this debacle, the New Jersey State Commission of Investigation (SCI) investigated financial practices at multiple state institutions of higher education, including UMDNJ. As compiled from articles in the (central New Jersey) Home News Tribune, and the (North Jersey) Record, the main points were
- Even after all the scrutiny given to UMDNJ, the SCI found new problems there, for example, its report alleged "a contract for janitorial and housekeeping supplies wasted $1 million over six years at UMDNJ because of overbilling. The vendor also gave liquor, meals and Yankees tickets to key UMDNJ staff." [Home News Tribune] "The company even sprang for $800 in food costs for a 60th birthday party for ... [the head of ] UMDNJ's office of supplier diversity and vendor development." [Record] Also, a construction company founded by a former UMDNJ plumber billed more than $2.8 million over seven years. The work was overseen at UMDNJ by the former plumbing partner of the construction company boss. The company built the UMDNJ official "a 400-square-foot wooden deck on his Oxford, N.J. home, free of charge. Three years later, when [he] ... decided to convert the deck into a sunroom, [the company owner] ... paid the bill."
- There were "questionable payouts to employees, including $3 million in bonuses in 2004 to UMDNJ administrators and lump-sum payments to departing officials." [Home News-Tribune]
- However, similar problems were found at other institutions. For instance, the report alleged Rutgers University paid for expensive trips, meals, and alcoholic beverages. Also, "vast amounts of money were moved through 'emergency accounts' including a $5,000 liquor bill for an anniversary celebration at the Camden campus." [Record]
- The report found instances of excessive political influence on the academic institutions, even though they had been freed from centralized state supervision in 1994. For example, "One former trustee at The College of New Jersey said he was told then-Gov. James E. McGreevey wouldn't reappoint him because 'he criticized the administration's approach to the New Jersey business community concerning taxes.' A Ramapo trustee said he resigned after state officials tried to make then-Sen. Joseph Doria Jr., D-Hudson, president of the college. [Home News-Tribune]
Although some may argue that New Jersey has uniquely bad problems, this report raises the possibility that sleazy accounting and budgeting practices may be widespread at US academic institutions, particularly but not exclusively those involved in health care. The finances of US private not-for-profit academic health care institutions are generally completely opaque. Almost never do such institutions publish detailed budget, or subject themselves to outside audits. This opacity may make it easy for such practices to flourish.
(For those who don't believe that statement, try to find a clear, detailed budget for any local health care not-for-profit. Further, try to find the results of any outside audit of any such institutions. You may need to dig much deeper than the usual glossy institutional publications and their state-of-the-art web-sites. Let me know of any success.)
Given that tuition for higher education, including health care professional education, and the costs of health care have been rising much faster than inflation for a long time now, there is reason for concern that a good chunk of the cost increases are due to questionable payments and financial practices. But until the organizations involved make their finances public and allow detailed audit, that is all conjecture.
WHAT CAN BE DONE:
Insist that your local hospitals, academic medical centers, medical schools, and universities make public detailed budgets, and subject their budgets to periodic audits. "Sunlight is the best disinfectant." But expect lots of resistance...
Tuesday, October 30, 2007
Sunday, October 28, 2007
The Funding of "the Mysterious Human Heart" and the Mysterious Financial Arrangements of its Medical Advisors
Indeed, the PBS Ombudsman was already involved in this case. In his column, Michael Getler wrote,
The main sponsors of the series ... [were] Medtronic, a medical technology firm; AstraZeneca, a pharmaceutical company....
Bruce Halford of Stockton, N.J., wrote to say:
'Medtronic’s role as a principal underwriter of ‘The Mysterious Human Heart’ seems to violate PBS’ perception test for program funding. In Episode 2 of the series, viewers are told that the best treatment for certain potentially deadly heart arrhythmias is an implantable pacemaker. Who’s the leading manufacturer of such devices? Medtronic, of course. But viewers are never told about potential problems with those devices.... In addition, viewers of the episode are not informed about possible financial ties between the series’ on-camera experts and Medtronic, or with another major underwriter, AstraZeneca, which markets a full line of drugs for cardiovascular problems. No question, securing funding for this kind of series is a major challenge. But what’s happened to PBS’ pledge to prevent a blatant corporate tie-in from compromising the editorial content of such a high-profile project?'
The next day, Jeffrey Chester, director of the Center for Digital Democracy, and an ever-vigilant observer of PBS funding arrangements, wrote to ask 'how PBS (and presenting station Thirteen/WNET in New York) sought and publicly promoted the involvement of Medtronic and AstraZeneca as underwriters? As you know, both Medtronic and AstraZeneca have major commercial interests involving heart disease related medical issues, through technology and pharmaceuticals respectively.'
Gettler asked William Grant, director of science, natural history and features programs at WNET [the station that produced the show] about all this, and he denied that specific Medtronic and AstraZeneca products were promoted in the series, or that the companies "had any editorial involvement whatsoever."
Gettler got a response from the program's producer, David Grubin, which included the statement that the program "was never meant to be an investigation of the pharmaceutical or medical device industry."
Gettler ended up concluding that "the responses, especially from PBS, did not address the real conflict, criticism, and questions at issue here" including "the seeming inappropriatement of funders for a number of programs and the residue of dobut that leaves in the mind of some viewers even though one may not see or sense any hint of influence."
In looking over the show's web-site, I discovered another issue not addressed yet by the Ombudsman.
The show's content advisers appear to be Peter Libby, MD, Chief of Cardiovascular Medicine at the Brigham and Women's Hospital in Boston, Massachusetts, Mallinckrodt Professor of Medicine at Harvard Medical School, and director of the D.W. Reynolds Cardiovascular Clinical Research Center at Harvard; and Douglas P Zipes MD, Distinguished Professor of Medicine, Pharmacology and Toxicology at Indiana University, and Director of the Cardiology Division and Krannert Institute of Cardiology. What the web-site, and probably the show did not mention is that
- Libby has received grant support from, consulted for, and served on a speakers' bureau for AstraZeneca (see this link).
- Zipes has received consulting fees or honoraria worth more than $10,000 from Medtronic (see this link).
Thus the show's content was influenced by people with significant personal financial relationships with AstraZeneca and Medtronic.
Again, as noted above, there is nothing to suggest that the show's content directly promoted particular products. But by increasing awareness and concern about cardiovascular disease, and emphasizing its treatability, the show could still have served a marketing purpose for companies that make drugs and devices used to treat cardiovascular disease.
Furthermore, although the show did apparently disclose its funding from Medtronic and AstraZeneca, it did not disclose the funding received by some of its medical advisors from the same company.
One can only wonder why the people who put the show together happened to pick for its two principle medical advisors people who had financial ties with the two sponsoring companies?
I will conclude with a quote from PBS guidelines for funding (as noted by Gettler):
Steps must also be taken to avoid the public perception that program funders have influenced professional judgments. Should a significant number of reasonable viewers conclude that public television has sold its professionalism and independence to its public funders, whether or not their conclusions are justified, then the entire program service of public television will be suspect and the goal of serving the public will be unachievable....
I would also add that at a minimum, 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 (29 October, 2007) - See additional comments by Ed Silverman on PharmaLot.
Thursday, October 25, 2007
Arbitrator Margaret Kern said the hospital ruined any chance for a fair election by intimidating union supporters and spreading misinformation.
She ordered the hospital to pay SEIU $2.3 million, to cover its organizing expenses and $2.2 million to about 1,700 hospital employees eligible to vote in the election. The second figure is the amount Yale-New Haven paid to IRI Consultants to Management Inc., the company it hired to coordinate its campaign against the union.
'Employees were deprived of the right to truthful information, the right to do their job uninterrupted by solicitation, and the right not to participate in captive audience meetings,' wrote Kern.
The New Haven Register reported that after a long standing labor dispute, Yale-New Haven Hospital and the union agreed
not to disparage each other and to conduct a factual campaign. The hospital also committed to not initiate one-on-one conversations with workers; not conduct mandatory meetings; not use consultants to abrogate the agreement, while also promising to abide by the arbitrator’s rulings.
Kern found Y-NH violated all these points, conducting 98 mandatory meetings where workers were forced to listen to managers’ 'feelings and fears' about the union and misrepresentations about the hot button issue of union dues.
She said there was strong evidence that the consultants were keeping a running count of the workers’ leanings and that the violations were not the work of a 'few rogue managers.'
'The employer’s conduct here was a methodical dismantling of the terms and commitments of the election principles agreement,' Kern said.
I can understand that the hospital may have had rational reasons not to want the union to organize its workers. But it seems to make some promises Yale-New Haven makes in its mission statement, including
To provide sensitive, high quality, cost effective health care services to all patients, regardless of ability to pay.
To serve the community as a public health advocate and provide support and services which respond to the area's health care needs through health education, health promotion and access to care.
ring pretty hollow, after the hospital has been found to be "intimidating union supporters and spreading misinformation."
Would you trust a hospital management who spreads "disinformation" as part of a labor dispute to really support the best patient care, teaching, research, and community service?
Spreading disinformation also does not exactly fit with Yale University's motto, "lux et veritas," light and truth.
This seems to be another example of mission hostile management, this time by the leaders of one of America's premier medical centers.
Wednesday, October 24, 2007
BLOGSCAN - Conflicts of Interest Affecting the Institute of Medicine's New Panel on Conflicts of Interest
Tuesday, October 23, 2007
Battle over a key heart procedure (link)
By Josh Goldstein
Tue, Oct. 23, 2007
Is cardiac angioplasty without surgical backup safe? A S. Jersey dispute is part of a major study.
Last year, more than 16,000 patients in the eight-county Philadelphia area had cardiac angioplasty to treat heart disease - many for elective, non-emergency procedures.
Five years ago, virtually no angioplasties were performed at hospitals that did not have on-site open-heart surgery available, in case something went wrong. Last year, more than 700 were done at hospitals without such surgical backup.
The question of whether that was safe is roiling the cardiology establishment in South Jersey, where Virtua-West Jersey Hospital Marlton is participating in a major study that seeks to find the answer.
South Jersey's three hospitals with open-heart programs - Cooper University Hospital, Deborah Heart and Lung Center, and Our Lady of Lourdes Medical Center - are campaigning to block Virtua from expanding into the profitable angioplasty market.
The procedure, in which a tiny balloon is used to open blocked heart vessels, can generate hospital fees ranging from nearly $17,000 to more than $25,000, according to the federal Centers for Medicare and Medicaid Services.
"This is an issue because it is cardiac care and it is lucrative," said James P. Dwyer, Virtua's chief medical officer. [indeed - just a bit of conflict of interest and bias is created by that fact - ed.]
Currently, 23 states allow at least some hospitals to perform angioplasty without surgical backup. The new study at the center of South Jersey's cardiac wars is a nine-state look led by Johns Hopkins University.
Dwyer said the protocols for the research were "appropriate scientifically" and had proper safeguards to protect patients.
At the Christiana Care Health System a decade ago, I led data modeling of invasive cardiology and its procedures down to an extremely fine-grained level of several hundred data elements. I also led development of an information system utilizing this data that could easily show that there were occasions where "the unexpected happened." It took several days just to develop the terminology and dataset on failed angioplasties, what happened to the stent, and what happened to the patient. Ruptured coronary artery, dissection, stent lost in body, and acute myocardial infarction were just a few examples of what can (and does) happen, even under the best of conditions where the patient appears stable and the coronary lesion uncomplicated and easy to approach via catheter.
Without cardiac surgical backup, a patient with an "unexpected event" would have to be rushed by ambulance to the nearest cardiac surgical facility. Until the friendly Asgard provide us with beaming technology, that means time - and the amount of time from the potentially catastrophic invasive cardiology adverse event to the thoracic incision is itself subject to unpredictable variables.
It doesn't matter how good the invasive cardiology team is, either. These events do happen, and there is nothing that can be done about some of them without "open access."
In effect, performing invasive cardiology procedures without onsite cardiac surgical backup is simply asking the patient the question "do you feel lucky?"
The study's opponents contend it is an end run around a New Jersey law that requires hospitals to demonstrate a community's need and to get approval from state regulators before expanding into high-end medical services.
Jan Weber, chief of the division of cardiology at Our Lady of Lourdes, said there was no demand for the expanded services. Few residents of the Garden State live more than 30 minutes from a hospital with an open-heart program, and if the procedures are spread out among many hospitals, the quality of care will suffer, Weber said.
"Our primary concern has been safety," he said.
There has been little controversy in Pennsylvania, where 11 hospitals, including five in Philadelphia and its western suburbs, have permission to perform angioplasty without surgical backup.
I was actually unaware of this. I consider it cavalier at best. Profitable, but quite cavalier.
In heart care, time is critical, and having surgical care available on-site can save lives, said Joseph E. Parrillo, chief of medicine at Cooper.
"You lose heart muscle for every minute of delay," he said. "If that rare emergency case is your wife or your mother, then do you say, 'Too bad?'"
Arup K. Roy, a doctor of internal medicine, says no. Roy contends that his father died as a result of complications from an angioplasty at Virtua.
In an Oct. 14 letter to the New Jersey Department of Health and Senior Services and others, Roy said a series of missteps at Virtua led to his 84-year-old father's death.
Community hospitals are "not capable to handle these sorts of complex procedures, and down the road they will kill more people like my father," Roy said during an interview last week.
I agree with that assessment and sympathize with Dr. Roy. My own father died as a result of malpractice at a large hospital that was fully equipped to do every intervention - but could not diagnose bilateral golfball-sized renal adenocarcinomas in over two years and fourteen trips to the urological O.R. Doing risky procedures in secondary facilities is asking for trouble.
Virtua officials expressed sympathy for the doctor's grief, but insisted that the medical record did not support his conclusion that angioplasty triggered a dissected aortic aneurysm (sic) and caused his father's death.
A dissecting aortic aneuryism is a tear in the layers of the aorta, the body's main artery, creating a "false space" where blood can travel, distort the anatomy, and result in blockage of blood supply to major organs. It is a dire condition and true medical emergency, but can be treated surgically. (The hospital denied there was a dissecting aneurysm, claiming death was due to cancer, but this is to be further investigated.)
Thomas Aversano, the Hopkins interventional cardiologist who is leading the study, said the continued rise in heart disease made it necessary to turn more community hospitals into centers that excel at cardiac care.
The debate reflects not just economics, but a longstanding tension between cardiovascular surgeons, who do open-heart surgery, and interventional cardiologists, who do angioplasty.
"It is difficult in the absence of angioplasty to recruit and or retain the best cardiologists," Aversano said in an interview.
It may be necessary to turn more community hospitals into centers that "excel at cardiac care," but is doing so at the expense of the uncommon patient who dies due to delays in surgical intervention an ethical way to go about it?
Aversano said he would "absolutely" have an angioplasty at one of the hospitals participating in his study.
That's perhaps easy for a Johns Hopkins interventional cardiologist to say, and I'll bet he'd do it - as a last resort. I'd rather suspect he'd primarily desire to be transported to the nearest full-service facility first, unless really in dire straights. On a personal note, when I was faculty at Yale and needed radioablation of my Bundle of Kent, damned if I was going to have it at a secondary facility. My choice was Yale-New Haven Hospital...
Others were not so sure [about angioplasty at a smaller hospital]. "I live in New Jersey, but no, I would not allow myself to have an angioplasty at a smaller hospital until we have proven it is safe," said David L. Fischman, co-director of the cardiac catheterization lab at Thomas Jefferson University Hospital.
That is indeed a more cautious approach. The problem is that it can never be "proven" to be "safe" for those patients who get into serious trouble and die due to time delays to surgery.
The automobile industry once had an analogous ethical dilemma re: the costs of fixing exploding fuel tanks vs. costs of litigation over people injured and killed by same. Does "Pinto" ring any bells?
The financial analysis that Ford conducted on the Pinto concluded that it was not cost-efficient to add an $11 per car cost in order to correct a flaw. Benefits derived from spending this amount of money were estimated to be $49.5 million. This estimate assumed that each death, which could be avoided, would be worth $200,000, that each major burn injury that could be avoided would be worth $67,000 and that an average repair cost of $700 per car involved in a rear end accident would be avoided. It further assumed that there would be 2,100 burned vehicles, 180 serious burn injuries, and 180 burn deaths in making this calculation. When the unit cost was spread out over the number of cars and light trucks which would be affected by the design change, at a cost of $11 per vehicle, the cost [of fixing the design flaw] was calculated to be $137 million, much greater then the $49.5 million benefit [through decreased payouts for driver death and horrendous burn injury - ed].
One can only wonder if such "scientific" (i.e., amoral) financial analyses inform decisionmaking about permitting angioplasty at facilities that do not offer cardiac surgery.
Friday, October 19, 2007
The "Director of Informatics" role has been transformed into numerous fancy sounding titles including "CMIO" (Chief Medical Informatics Officer), "VP of Informatics", "Senior Informatics Specialist", etc. However, as I wrote several years ago:
Rule 3 [for CMIO's]: Avoid 'internal consultant' positions, a way for organizations to get expert help cheap (i.e., at your expense, with limited career advancement opportunities).
Career advancement routes for "Directors of Medical Informatics" are not yet well-defined. A candidate for such a position should consider the issue of career advancement very carefully and raise questions about it before accepting these positions.
If you start as an 'internal consultant', an organization may be strongly motivated to let you remain as an internal consultant. Good external consultants are very expensive. Unfortunately, an 'internal consultant' position does little for a person's career advancement.
Such roles usually have no direct reports (i.e., MIS, performance improvement, or other people reporting to you). It must be remembered that the number of direct reports a person has had is a key factor evaluated for advancement in healthcare management roles. Internal consultant roles are therefore not good long-term prospects for clinical people who have made the sacrifices to become informatics specialists.
In addition, informaticists should think carefully about organizations that believe informatics physicians do not need, or should not have, direct reports. This may be a litmus test of the true beliefs of the organizational leaders about informatics.
In the worst case, 'internal consultant' can become 'glorified errand runner.' Such glass ceilings are best avoided.
Rule 5: Avoid project management roles that lack clear, direct control of resources. "Doctors don't manage projects" is a corollary of "doctors don't do things with computers." Unfortunately, without direct control of resources (such as hiring, firing, and budgets), a person is an 'internal consultant', not a leader, despite any titles or representations to the contrary. This can be referred to, in a term coined by a friend, as a "Director of Nothing" position. This reduces effectiveness and certainly reduces job satisfaction and career-advancement opportunities.
Here’s another new job posting ad that speaks for itself. In one possible area of improvement, the posting does not try to hide the fact that it has no direct reports:
Description: Senior Medical Informatics Research Scientist
The organization recognizes that Informatics capabilities linked to Delivery System business processes:
• Enables enhanced medical cost management through timely identification of actionable drivers
• Improved quality of care for members
• Improved provider performance
• And improved organizational effectiveness through data driven business management.
In this role, YOU WILL:
• Provide vision, leadership and execution of health services research projects to help meet business objectives.
• Work in collaboration with the Director of Advanced Analytics.
• No direct reports but would have ability to collaborate with analysts on specific projects.
• Work with clients across different business units to address some of the most complex analyses facing the company.
A challenging role with a diverse set of projects varying from health economic modeling, provider assessment strategy (P4P), population segmentation for targeted health management programs (case mgmt, disease mgmt and preventive health), predictive modeling, and disease registries/models of disease progression. Specific projects will depend upon prior experience and skill set.
Of course, it could be argued that some informatics clinicians would find having “no direct reports” to be attractive.
However, I then ask – what is the background of the person who the “senior scientist” reports to, why is the job title “senior scientist,” and how is the “junior scientist” role structured?
Additionally, this position is likely in an insurance company. Those companies have a history of layoffs as in most big organizations. What is the position security here? What are the job advancement opportunities? (Perhaps “Super Senior Scientist”?)
Perhaps most importantly, what are the capabilities, if any, to develop analytics and algorithms fair to practitioners as well as payors without interference from above, and of the incumbent to challenge unscrupulous or unfair data manipulation that might favor the payor over the provider, and still remian employed?
On a related note with regard to hospitals and the new "Chief Medical Informatics Officer" title that seems to have appeared out of nowhere in recent years, it seems to me that hospitals have skirted the issues outlined above and kept health IT management authority "closely held" to the traditional players, i.e., IT and CIO/COO/CEO, and 'friendly' vendors.
It appears the old role of "Director of Informatics" has now been given a shiny "C"-level title - "CMIO"; however, it seems the thinking about the role's specifics has not really changed in a decade. In review of job descriptions and in actual interviews I've had recently, as well as via discussions in my professional society, it seems the role is still viewed as an "internal consultant" position (irrespective of what it's called), whose role is in large part to placate doctors into EMR use of which many are skeptical, not a true "C" level officer role with control of management and resources and a career path into higher levels of healthcare management .
In essence, the title "CMIO" itself may be a new designation for "Chief of Nothing", a title that costs healthcare organizations exactly - nothing - to hand out. It could be construed as a title that masks the lack of power-sharing by traditional healthcare executives with clinicians, especially informatics-credentialed ones.
I ask the hard questions, you decide.
Thursday, October 18, 2007
If Congress overrides President Bush’s veto of the State Children’s Health Insurance Program, a little-known provision of the original House bill could be revived.
As written, the provision would allocate $300 million to create a Center for Comparative Effectiveness that would test whether newer, more expensive drugs work better than their older and cheaper counterparts. Medicare would use the center’s findings to help decide which drugs to cover. If the center found that a newer, pricier pill was no more effective than the older, cheaper version, Medicare would probably refuse to pay for it.
This sounds reasonable. But it will most likely result in Medicare covering fewer breakthrough medicines, which would, in turn, force doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.
Why? Drugs must be tested on large, representative populations that must be monitored for years. Because conducting these studies is so tricky, their findings are regularly overturned or modified by further research. In fact, some are so off the mark that doctors ignore them.
But if Medicare starts using flawed studies like these to determine its list of covered drugs, doctors will have to give them respect they probably don’t deserve. There’s also an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying. The more drugs the government classifies as 'wasteful,' the more money it saves.
We have previously posted about comparative effectiveness research, that is, clinical research that compares the plausible management options that might be used to treat particular patients with particular problems. Such research could help physicians pick the best option for particular patients. Yet research directly comparing plausible options has not been done for a large number of important clinical problems affecting many types of patients. Why not? Most research about drugs or devices is currently sponsored, that is, paid for by the companies that make them. Such companies seem primarily concerned with doing the research required by the US Food and Drug Administration (FDA) and other such national regulatory bodies to get their products approved. After that, they are unlikely to fund studies that do not have a really good chance of showing that their products in a favorable light.
Comparative effectiveness research is coming in for more public criticism, and that criticism is showing up in more widely read publications. We posted about two previous examples, one published in the Wall Street Journal (see post here), another in the Washington Times (see post here). In my humble opinion, neither made a lot of sense, and Pitts' latest salvo against comparative effectiveness research, in what many people feel is the US "newspaper of record," does not make much more sense.
Pitts' main concerns amounted to two slippery slope arguments linked together. The first argument went from the reasonable proposition that comparative effectiveness research is difficult, and hence at times may be done badly, but slid down the slope to the implication that most such studies are flawed. The second argument started with the not so obvious assumption that Medicare will, out of ignorance or worse, choose to consider "flawed" studies, and slid down the slope to the conclusion that physicians will be forced to "respect" its bad judgments.
Pitts' next argument focused on the faults of one alternative, so as to avoid comparison with an even worse alternative. That government funded research could be biased by the government's motivation to save money is not an unreasonable concern. But Pitts failed to compare it to the current alternative, research on drugs or devices sponsored by their manufacturers which may be even more biased by the companies' desire to show their products in a favorable light (see relevant posts here, here, and here.)
Readers might better be able to evaluate Pitts' argument if they knew what sort of vested interests he might have. The New York Times did identify Pitts as the leader of not-for-profit organization which received pharmaceutical industry funding. Yet even with this this disclosure, this article, like two previous critiques of comparative effectiveness research that appeared in nationally influential newspapers, did not reveal all of its author's relevant financial interests.
Peter Pitts, as we have noted before when he publicly criticized Dr Steve Nissen during the Avandia affair (see post here), and when he warned against restricting people with conflicts of interest from FDA advisory panels (see post here), holds down the day-job of Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. As Senior Vice President for Global Health Affairs, Pitts is presumably responsible for all these accounts. Thus, his livelihood seems to depend largely on his ability to convey the pharmaceutical industry's point of view.
It is disappointing that a newspaper as influential as the New York Times would publish a health policy article without disclosing all the author's relevant financial interests, particularly one so relevant and direct.
Fostering more stealth health policy advocacy in ever more influential venues will just make the already confusing clamor about health care and its reform even muddier.
ADDENDUM (19 October, 2007) - Our post above, Pitts' op-ed article, and the general topic have collectively attracted quite a lot of interest in the blogsphere. See comments by Merrill Goozner on Gooznews (which come from a very interesting journalistic angle), Joe Paduda on Managed Care Matters, and the anonymous "Jack Friday" on PharmaGossip. The issue was picked up by PRWatch as well. Pitts reprinted his op-ed on DrugWonks. The latter blog also now features a rebuttal directed to supporters of comparative effectiveness research, not clearly directed at the post above, but which does include a link to Health Care Renewal, and a really strange question about the treatment of hypertension and congestive heart failure (which I will probably have to address, since it's directed directly to me).
Wednesday, October 17, 2007
Let me summarize the methods. The authors sent a paper-and-pencil survey to all chairs of medicine, psychiatry, two randomly selected clinical departments, microbiology, and one randomly selected non-clinical department at all 125 US allopathic medical schools and the 15 hospitals with the largest amount of NIH funding. The survey was sent in 2006. The response rate was 67%, and was almost the same for clinical and non-clinical chairs. The surveys asked about the chairs' personal relationships with industry in the previous year, and about the chairs' departments' institutional relationships with industry in the previous year.
The results were striking. The proportion of chairs reporting personal relationships were (in percentages, for all chairs, and when the difference between clinical and non-clinical was statistically significant, for that breakdown):
- Company officer or executive: 7% (same)
- Member of board of directors: 11%
- Paid consultant: 27%
- Member of scientific advisory board: 27%
- Member of speakers' bureau: 14% (21% clinical, 2% non-clinical)
- Founder of company: 9%
The proportion of chairs receiving particular types of funds or gifts was:
- Research funding: 21%
- Personal compensation for writing: 3%
- Personal compensation for participating in CME: 19% (26% clinical, 6% non-clinical)
- Personal compensation for participating in meetings, conferences: 28%
- Equity of stock options for professional service or intellectual property: 6%
- Personal royalties, patent licenses, etc: 11% (7% clinical, 20% non-clinical)
- Personal gifts: 1%
- Travel or other personal expenses related to meetings or conferences: 16%
A total of 60% of department chairs reported at least one of the above relationships with industry.
The proportion of chairs reporting that their departments received specific types of resources or funds from industry was:
- Research equipment: 14% (17% clinical, 10% non-clinical)
- Unrestricted funding for operations: 13% (19% clinical, 3% non-clinical)
- Research support: 9%
- Support for trainees: 14%
- Money from licensing or transferring intellectual property: 20% (16% clinical, 27% non-clinical)
- Support for research seminars: 28% (36% clinical, 13% non-clinical)
- Support for fellowship training: 25% (37% clinical, 2% non-clinical)
- Support for CME: 46% (65% clinical, 3% non-clinical)
The proportion of chairs reporting that their dDepartments received discretionary funds to support specific activities were:
- Faculty bonuses: 0.5%
- Food, berverages: 38% (51% clinical, 12% non-clinical)
- Travel and meetings: 22% (30% clinical, 8% non-clinical)
- Journal subscriptions: 6% (8% clinical, 2% non-clinical)
- Software: 3%
- Research equipment or infrastructure: 12%
- Clinical equipment: 3% (4% clinical,1% non-clinical)
A total of 67% of chairs reported their departments received at least one kind of support.
The article properly noted that social desirability bias may have prompted some people with extensive relationships with industry not to respond, and some respondents to under-report their relationships. Hence, the proportions above should be regarded as lower bounds on the actual proportions.
This article was covered in a variety of wire service reports, which contained some interesting commentary.
The study's lead author, Eric Campbell, said (per HealthDay, via the Washington Post):
There is not a single aspect of medicine in which the drug companies do not have substantial and deep relationships, affecting not only doctors-in-training, resident physicians, researchers, physicians-in-practice, the people who review drugs for the federal government and the people who review studies.
Drug companies have relationships with everyone. They're involved in every aspect of medicine. Someone has to decide which of these is OK.
I believe there's very little reasonable justification for why drug companies should be involved in the education of medical students. What knowledge do they have that is not currently available in the biggest medical schools in the country?
Dr David Korn, Senior Vice-President for Biomedical and Health Sciences Research of the American Association of Medical Colleges, was more circumspect, and somewhat defensive.
I think the paper is a very valuable contribution, in that it provides what's probably the first comprehensive documentation of the extent of relationships that involve department chairs, and department chairs are certainly the key agents of overseeing and maintaining the day-to-day operations of a medical school or teaching hospital.
The extent of the relations is not surprising.
Supported research is fulfilling a social mandate. After all, the public support of NIH [U.S. National Institutes of Health] funding is really driven by the desire to see practical results . . . and the only way those practical results can come to pass is by having productive relationships between the discoverers of new information and the organizations that our country has established to determine whether that information can be developed into useful products for public health.
Not surprisingly, Alan Goldhammer from Pharmaceutical Research and Manufacturers of America (PhRMA), defended industry involvement with department chairs and their departments, saying "the study results don't mean these relationships are a problem. He said it makes sense to reach out to academic heads because they have the most expertise." (per the Associated Press)
But Jerry Kassirer, formed editor of the New England Journal of Medicine, thought they were a real problem (again, per the Associated Press),
I was appalled by the results.
No one knew that so many chairs of medicine and psychiatry were paid speakers. We've never had that data before.
I agree with Dr Kassirer and Dr Campbell. There is no educational need for academic medical leaders to have personal financial relationships with health care corporations. There is a rationale for medical schools and their faculty to collaborate with employees of such corporations in the conduct of research. However, there is no need for faculty, their leaders, and their departments to be paid by such corporations in order to conduct valid research.
Instead, the financial relationships revealed in the study by Campbell et al threaten the tripartite mission of medical schools. Medical schools' missions include providing the best possible care for their patients, teaching future generations of physicians and other health care professionals, and doing biomedical and clinical research.
Providing the best possible patient care requires deciding which tests or treatments are most likely to help and least likely to harm individual patients. Such decisions should not be biased by physicians' relationships with the companies that make tests and treatments.
Teaching future generations of health professionals should involve preparing them to make such decisions. Such teaching, again, should not be biased by the faculty's or their supervisors' relationships with the companies that make tests and treatments.
Performing valid clinical research that properly respects research subjects should mean conducting research designed, implemented, analyzed, and disseminated so as not to be biased towards a particular test or treatment because of the researchers' relationships with the companies that make them.
The data in the study by Campbell et al suggests there is a huge risk that medical schools' missions are being compromised by their faculty leaders' relationships and by departmental relationships with health care corporations.
Furthermore, the extensive personal relationships of department chairs with such corporations may suggest to their faculty and students that they ought to be particularly friendly to certain health care corporations, and at least not criticize such corporations and their products, and certainly not complain about any related conflicts of interest on the part of their supervisors.
This may explain why medical schools have been so reluctant to teach about the ethics of health care, and thus fail to prepare physicians for the threats to their values that they may encounter in the real world (see post here).
To preserve their missions, medical schools should ban personal financial relationships among their faculty, particularly their leaders, and pharmaceutical, biotechnology, and device manufacturers and other for-profit health care corporations.
Until they enact such bans, patients, physicians, policy-makers and the public at large will wonder about the extent that medical schools' missions are compromised by faculty leaders' personal relationships and the schools' institutional relationships with these for-profit health care corporations.
Tuesday, October 16, 2007
Senators have earmarked more than $40 million for health care projects at college and university systems they attended — more than one-fifth of all money being sought through a special federal program to help the country's uninsured, records show.
Records also show that the average grant to the senators' schools was more than three times the average amount of money given to other schools under the Health Resources and Services Administration (HRSA) program, where increasing earmarks have attracted concern from federal officials and government watchdogs.
The Times came up with some good examples of Congressman and Senators arranging earmarks for their alma maters.
- Senator Byrd (D- West Virginia) and Mountain State University -" In one of the largest Senate earmarks through the Health Resources and Services Administration (HRSA), Sen. Robert C. Byrd, West Virginia Democrat, wants $3.6 million to build an 'allied health technology tower' at the 4,422-student Mountain State University, which the Democrat attended when it was Beckley College, Senate records show." The earmarks included "$1,575,000 for a virtual-colonoscopy outreach program, $1,575,000 for a bioengineering institute and $3,250,000 for construction of a patient care and clinical training site."
- Senator Shelby (R - Alabama) and the University of Alabama - "The largest Senate earmark through HRSA provides $11 million for the University of Alabama. Requested by Republican Sen. Richard C. Shelby, a 1957 graduate of the university, the earmark provides 'construction, renovation and equipment' for a new health services building."
In general, earmarks directed toward alma maters were larger than those directed elsewhere, "Overall, the average Senate HRSA earmark was worth less than $500,000, documents show. But the 25 earmarks by senators to their old schools had an average worth of almost $1.7 million."
The article noted that earmarked money is provided without any attempt at an outside review of clinical, scientific, or educational merit.
Earmarks are a way for members of Congress to send federal money for specific projects. But a recent program assessment by the U.S. Department of Health and Human Services and the Office of Management and Budget has raised questions about past years' congressional HRSA earmarks, which more than doubled from 451 projects in 2003 to 932 in 2005.
'Earmarked projects often serve local interests and do not fulfill national priorities or needs,' the assessment stated. 'Earmarks do not necessarily reflect a community's most pressing needs.'
'The HRSA earmarks awarded to universities or other research institutions are not based on scientific merit or any competitive process.'
It's nice that our US legislators want to contribute to their alma maters. But directing federal money preferentially to the schools they attended appears to be yet another example of pervasive conflicts of interest in health care (albeit an example, for once, that has nothing to do with pharmaceuticals, biotechnology firms, and device manufacturers). Each such conflict has the potential to waste health care dollars and make incentives in health care more perverse.
Note: for a previous example of how the US congressional earmark process seemed to distort health care priorities and funding, see this post.
Monday, October 15, 2007
The background is that several UK hospitals have been having increasing problems with hospital-acquired infections such as those due to C. difficile. A recent report cited particular problems run by the Maidstone and Tunbridge Wells NHS Trust. As reported by the Telegraph,
The hospitals had filthy wards and vulnerable elderly patients were told to soil their beds because nurses were too busy to help them.
Targets and financial problems within the health service led to staff shortages and overcrowded wards which contributed to the spread of the infection, the report found.
Between April 2004 and September 2006, 1,176 patients contracted C.diff at the three hospitals and 345 died. Some patients with curable conditions died after contracting the bug.
The commission found the bug definitely or probably caused the deaths of 90 of them and was likely to have contribu ted to the deaths of another 255. In only 14 cases was it felt the bug had not been a factor in the death.
So what happened to the chief executive of the trust?
Rose Gibb left her job as chief executive of the Maidstone and Tunbridge Wells NHS Trust, in Kent, days before a damning report revealed at least 90 patients in its care had been directly killed by clostridium difficile.
Miss Gibb was allowed to leave her £150,000 post by "mutual agreement" last Friday, meaning she was eligible for £250,000 in severance pay....
It turned out that there were allegations that the chief executive had covered up this and other problems.
It has also emerged that Miss Gibb ... tried to cover up the extent of the C.diff outbreak.
Doctors at the Maidstone and Tunbridge Wells NHS Trust told The Daily Telegraph that Miss Gibb had deliberately withheld information about the extent of the outbreak, even from fellow board members.
Junior doctors were also allegedly ordered not to put clostridium difficile on death certificates.
The Telegraph has also learnt that Miss Gibb was blamed for allegedly failing to sort out dirty wards at two other hospitals and was involved in a secret pact to try to ensure her previous hospital was not blamed for failings in the 2000 case of Victoria Climbie, who died after appalling abuse at her home.
Miss Gibb was one of six signatories to a letter from health chiefs to Haringey council in which they allegedly agreed not to criticise each other over failures to spot the signs of abuse before the eight-year-old died, though Miss Gibb was not working at the hospital at the time of Victoria's death.
Several editorialists also suggested deeper systemic problems. Charles Moore wrote in the Telegraph.
We all complain about the "target culture" that made administrators in Maidstone ignore actual human suffering before their eyes. But if you have a top-down system of healthcare, targets are the inevitable response to whatever is the latest disaster.
In this case, one of the targets was to cut waiting times in Accident and Emergency to four hours .... In this world without choice, each claim of need jostles against another: either faster A&E, or cleaner bed-pans, but not both.
This is all, morally, wrong. It turns the patient from being the entity for which the service exists into a nuisance. Each new patient is just an added cost and each dead patient is an administrative convenience.
And Minette Martin wrote in the Times,
It all sounds too familiar to a US reader.
Government has almost overwhelmed the NHS with money, protocols, guidelines, employment procedures, information technology – much of it clearly disastrous and with perverse consequences. The whole point of this tyranny of inspection, infection control teams, recording, box-ticking and, above all, the imposition of targets, was to make things better in the health service.
Maidstone and Tunbridge Wells NHS Trust was obsessed with government waiting time targets and financial targets, to the neglect of infection control.
In the US, the large organizations that now run health care, including in this case, government agencies, managed care organizations and health insurers, and pharma/ biotech/ device manufacturers have also pushed "protocols, guidelines," and "information technology" which risk "perverse consequences." (See this post on the "pay for performance" movement, for example.) And we have worried that focus on a few easily measured targets will distract from the more important parts of medicine and health care.
In the US, it also seems true that there is no pay for performance for health care leaders. When misdeeds are discovered, it is the organization as a whole, rather than the leaders responsible, who pays the penalty (see this recent post). Inept leaders retire with huge golden parachutes.
Finally, it seems that health care leaders in both countries are too quick to hide their problems, and threaten any possible whistle-blowers.
The similarities are striking, even though the UK has a National Health Service, and the US has a mosaic of private and public health care.
So perhaps UK and US doctors ought to get together and discuss how to fix this mess.
Friday, October 12, 2007
First, medical schools and post-graduate training programs do not teach physicians how to cope with the current health care environment.
Medical training programs do not provide young physicians basic information about doctors' options in the workforce -- for example, the pros and cons of private practice vs employment -- nor is there any effort to explain to them the larger economic forces at work in healthcare in the United States, so physicians do not understand the competitive forces that are shaping today's radically changing economic climate.
Doctors, having received no training in adapting to the current market conditions that are occurring rapidly around them, are ill-equipped to function in this radically changed economic -- and ethical -- landscape.
Beyond the basics of medical economics, young physicians are generally not introduced to the regulatory and political environment in which they will have to practice.
Medical training is inculcating a culture among physicians that may be deepening their woes and contributing to the decline of the profession.
Helplessness can be trained into individuals when, regardless of repeated best efforts that should be rewarded, no reward is forthcoming; as a result, the individual eventually learns to give up and sinks into a lonely feeling of futility and malaise. It would appear that collectively the medical profession has mastered this art and is suffering the symptoms en masse.
Unfortunately, medical training is helping to create the foundation for the profession's helplessness. Regardless of the new limitations on work hours, conditions in many training programs remain reminiscent of medieval, monastic, ascetic orders. Self-deprivation -- especially sleep deprivation -- continues to be viewed as a necessary virtue, especially during subspecialty training. Learning is still most often imposed on the basis of the model of strict authoritarian discipline, with a high degree of emphasis on shame and fear of failing. Good patient care is so expected of trainees that it is rarely rewarded. Residents' pay is usually set at bare subsistence levels or below, so there is no financial reward for the hard work of medical training, and indeed most medical graduates emerge with huge school loan debts.
Psychologically, young physicians often expect residency and fellowship to be the crowning experience of their long educational path. Since they were 5 years old, these young people were told that they were the brightest and the best, a message that was socially reinforced as they successfully progressed through school, college, and medical school. Everything about their experience reinforced their belief in the Puritan work ethic: If you work hard and do well, you will be rewarded -- until they reach residency, a point at which rewards are so few and far between that they begin to believe that if they work hard and do well they will be resented.
Young physicians become so well trained in deferring gratification that many give up on ever getting any meaningful rewards for their sacrifices. With their resilience worn away, many just give up the fight. A dispirited acceptance of one's individual fate seems to be the dominant mood of physicians nowadays rather than a motivated mobilization toward a better lot for the individual practitioner and the profession as a whole. Most doctors focus so hard on trying to provide good patient care -- ie, taking care of others -- that they forget, or have no energy, to take care of themselves. Thus, when some doctors propose positive collective action, they are usually quickly quieted by a few naysayers whose negativity taps into the helplessness learned so well during medical training. The progress of the profession is being effectively paralyzed by its own failure to teach leadership and the skills of self-survival.
Strong stuff, that.
There are, of course, two obvious solutions.
The first is to teach medical students and house-staff about the realities of the professional world they will inhabit. In my humble opinion, this would include teaching about evidence-based medicine and technology assessment so that they have some framework to evaluate the maelstrom of marketing, propaganda, disinformation, and intimidation and coercion that they will encounter. This would certainly also include discussion of health care ethics, i.e., the issues that we discuss on Health Care Renewal. This sort of teaching need not focus too much on how to recognize conflicts of interest and corruption (which is pretty obvious), but should focus on helping the learners resist these "dark arts." (This should be distinguished from traditional biomedical ethics courses, which mainly focus on analyzing difficult clinical decisions, important, but not the same thing.)
Note that efforts to teach even the rudiments of evidence-based medicine have not gone very far. We can also surely expect a lot of resistance to teaching about the sorts of ethical issues that appear on Health Care Renewal. After all, that might make certain medical school, academic medical center, and university leaders, starting with those who also sit on the boards of directors of public for-profit health care corporations, uncomfortable. In fact, I know of no US medical school that requires any education in any such issues. Further, Bonds noted,
One attempt to institute a seminar-style course in 'real-world' healthcare economics at a major State University School of Medicine was met with a refusal to fund even the modest travel stipends for the national experts lined up to teach the course.
The second solution is to change the culture of medical education itself. We need to lessen the crushing sleep deprivation and the long work hours which still occur when the work-week is limited to "only" 80 hours. We need to make teaching more collegial and less authoritarian. That may require actually paying medical school faculty to teach in clinical settings. (In many schools, the first priority is on faculty raising external funds for the school through research and patient care.) This may also require banning the conflicts of interest that let faculty work as much for pharma/ biotech/ device companies as they do for the medical school, e.g., as noted here. None of that will be easy either, especially because such changes would obviously disrupt some economic relationships that are very lucrative to certain people.
Nonetheless, physicians are going to have to unlearn their helplessness if they expect to do anything about the mess that is health care today. They certainly ought to feel obliged not to let the next generation of physicians be taught to be helpless as well.
Thursday, October 11, 2007
In this feature, which so far has run daily over three days in a "this day in history" format, Blumsohn summarizes important cases of "corruption and poor leadership in science and academia in general, editorial misconduct, the forgotten lessons we should not forget...." Some of these cases are still on-going, but many have been subject of the anechoic effect.
The Scientific Misconduct Blog is here. The three Memory Hole features so far are:
Illusions of Due Diligence (8 October)
When While is Black and Black is White (9 October)
A Society of Sheep (10 October)
These are must-reads. I imagine posts that will appear in the future will be even more important.
Dr. More referenced my site and has an excellent summary of the reasons why healthcare IT projects "go bad." It is clear this is an international phenomenon unrelated to the type of healthcare system (e.g., socialized vs. private sector model), and that the root causes are similar.
The reasons cited by Dr. More from his website are (emphases mine on the key phrases):
1. Many believe a key point is that managerial and organisational instability is a major cause of failure. I agree this is really important and, indeed, when one reflects on the Public Health Sector it is really a relative rarity to have an Area Health Service CEO or CIO serve out their full five year contract. This flux is due, in part at least, to a combination of Government and Ministerial changes, changing policy priorities, some being perhaps promoted beyond their capabilities and the unexpected events that precipitate management change. Conducting any significant project in the absence of continuing stable senior management support is a recipe of disaster.These reasons are well-stated. Healthcare organizations should heed them.
2. Especially in the public sector, there is often a disconnect between the managerial responsibility placed on a project manager and the freedom to act they are accorded. At times this leads to the “wrong” staff being retained in roles for which they are no longer suited, to the detriment of the project as a whole. The disconnect (and budget inflexibility) also often leads to difficulty in attracting and retaining suitably skilled staff as well as excessive delay in staff acquisition. The other problem that is almost universally encountered in Hospital projects in my experience is the “drip feed” of funds and the difficulties in getting suppliers paid. More than once I have seen competent project managers just resign in disgust when they realise they have neither the spending authority, money or the staff to deliver the project they are required to make happen.
3. Because executive health-care management are often uncomfortable regarding many aspects of Health IT, frequently associated with a fairly limited understanding of what is required, at an executive level, for project success, the quality of project sponsorship and support is less than is needed. Senior executives, like everyone else, prefer to stay within their “comfort zone” and, if the Health IT project is not within that zone, real difficulties are almost inevitable. The project manager has a difficult responsibility to carry the project sponsor along on the journey, and to make it clear what they must do for the project to be a success on their watch!.
4. Clinicians inevitably see a new system as a very low priority in their “caring for their patients” activities. This will lead to all sorts of difficulties with change management, training and effective use of a new system, unless both executive management are fully committed and real “clinician” evangelists and enthusiasts are recruited to work with their peers.
5. Involvement of all relevant categories of clinicians in the selection and later configuration of systems is crucial. The clinicians really have to be confident the system will work for them and be convinced of its value and utility or the project will be at extreme risk before it even starts.
6. There is a real tendency to underestimate the complexity of and the effort required to implement say a new laboratory or patient management system – to say nothing of clinician facing systems such as Computerised Physician Order Entry or Computerised Nursing Documentation which involve virtually all key staff changing the way they work. Careful planning and an really adequate emphasis on education and change management are vital as is developing real clinician ownership of the project.
7. It is clear that all organisations need to develop organisational competence and teamwork with Health IT. I think the best way to do this is to choose one or two easily “doable” projects and get them done on time and within budget. Only once this capability is proven should an organisation try the larger and more complex implementations. Success, as they say, builds on success.
8. It is clear that when implementing systems in hospitals size really does matter. It is a relatively straightforward process to put basic systems in a 100 bed regional hospital in 3-6 months with very little difficulty. The 1000 bed tertiary teaching referral hospital is a horse of a totally different colour. The budget is likely to be in the millions, the complexity of what is needed much higher and the work practices more entrenched. All this means both risk and duration are much higher. Additionally these organisations cannot be fed a ‘one size fits all’ solution. The systems that are deployed must not only be flexible but be flexibly implemented in consultation with ALL involved.
9. It is vital to work hard to develop an open and frank relationship between the system vendor and the organisation which is implementing the new system. No contract will prevent a disaster but work on ensuring a constructive, frank and balanced relationship will make a huge difference.
It was recently once again driven home that this does not occur often enough, even in very large medical centers. I’ve left the Director of the Institute for Healthcare Informatics position I’ve held for the past few years and am now adjunct faculty. The reasons why are at this link on the Healthcare Renewal blog at "Medical Informatics still round peg in square hole?"
As a result, I'm seeking applied Chief Medical Informatics Officer (CMIO) positions once again. I just completed two full rounds of interviews at a prestigious hospital system that recently experienced a decline in its clinical quality stats. The organization feels the quality stats themselves were inaccurate, in part due to lack of good healthcare IT.
From what I was able to gather, their leadership was displeased. Board members were seasoned executives from a heavy-manufacturing industry that is extremely dependent on information technology and concurrent supply chain data. These executives ordered the organization to move quickly on EHRs.
The organization is thus planning to implement EHRs for a large number of skeptical physicians, most of whom are not employed by the hospital, plus integrated systems drawing on EHR data to automate quality reporting to regulatory agencies and to support ongoing, funded clinical drug and device trials.
I was interviewed by the usual mix of clinician eager adopters, clinician skeptics, knowledgeable executives, skeptical executives who knew little about clinical IT, IT personnel who seemed overconfident, and those who were clearly frightened by the prospect of being held accountable for a project of this magnitude. In the end, I did not get the position due to the organizational leaders being adamant the incumbent CMIO needed to also practice medicine.
I'd thought this issue had been settled after the first round of interviews, leading to the invitation for round two. This line of questioning was revisited, however, in round two in a group interview setting. The group interview was attended by a number of people with whom I'd already discussed this issue via individual meetings in round one. This suggested my time was being wasted and was rather annoying, especially considering that I'd had to fly cross-country not once but twice to an organization not in consensus about a very basic hiring requirement. I asked myself what other major executive disagreements about the role might exist that were not being expressed. (One fundamental principle I'd penned a decade ago in an essay "Ten critical rules for applied informatics positions: what every CMIO should know" was the importance of executive consensus.)
It is not as if such a role would have ample free time where the incumbent would be idly sitting at their desk unless this time were absorbed seeing patients in the clinic. It is my opinion that healthcare organizations requiring that a CMIO practice medicine part-time either believe the CMIO role is not truly strategic and critical, or they believe the task at hand for the incumbent is easy and can be accomplished essentially by a part-time CMIO.
Ironically, I was told during my interviews that a CMIO they'd hired a few years ago had left, in part due to being overextended. I was also told that some of the clinical IT problems I'd solved as a CMIO in the past were problems this organization had not been able to solve around the same time period.
Regarding underestimation, this organization appeared to have little idea of the difficulties they are getting into. This is even after I, an experienced ex-CMIO, tried to explain this to their leadership, among other methods via recommending my web site on health IT failures.
I should also point out that another indication that this organization didn't know what they didn't know came quite early. I was informed that the organization had selected their EHR vendor prior to seeking a medical informatics expert. This implies they really did not understand what a medical informatics specialist does and can do, which is far more than being a tactical "EHR implementation assistant." It also left open the possibility that the selection process may have been "biased" (e.g., via IT domination of the process, back room dealing, etc.)
If this was the case, the risk is that the informatics incumbent might find themselves performing "damage control" to force-fit a square peg into a round hole, i.e., forcing an EHR product with suboptimal "fit" down the throats of (appropriately) resistant clinicians.
I've been there, and done that. It is not rewarding and I actually had decided not to take the risk, even before the organization decided they wanted an (effectively) part-time CMIO who also saw patients.
What more can I say?
Gerard M. Martineau was the bag man of Blue Cross [and Blue Shield of Rhode Island] and CVS — but he was 8 million bags short.
Now, the former Rhode Island House majority leader is the second ex-legislator, after John Celona, to admit to selling his office in the federal State House corruption probe known as Operation Dollar Bill.
As part of a $900,000 corruption scheme that the longtime Woonsocket Democrat has admitted to, Martineau sold 10 million bags to Blue Cross & Blue Shield of Rhode Island — but fewer than 2 million bags were ever manufactured, according to court documents filed yesterday by federal prosecutors.
Besides inflating invoices for phantom bags, Martineau also admitted using his power to act favorably on legislation that benefited CVS and Blue Cross, most notably by thwarting pharmacy-choice legislation that both companies opposed from 1999 to 2002, when he left the General Assembly after 16 years.
While Martineau was doing the companies’ bidding at the State House, he was paid $715,000 in commissions by CVS and $175,500 by Blue Cross for paper and plastic bags, according to charges filed in federal court yesterday.
Martineau, who co-chaired a working group of state health officials, lawmakers and lobbyists that led to his sponsorship of landmark health-insurance reform in 2000, also admits that he failed to disclose his financial ties to Blue Cross and CVS while he sat in a position to influence hundreds of health-care bills.
The main focus of Martineau's now admittedly illegal enterprise was health care legislation.
On March 1, 1999 — weeks after the introduction of pharmacy-choice legislation opposed by CVS and Blue Cross — someone at CVS wrote Martineau that the company was examining its plastic-bag contracts and invited him to submit a contract proposal. That same day, Martineau told a newspaper reporter that he had changed his opinion on pharmacy-choice legislation, and now believed it was unnecessary.
In April, CVS invited Martineau to submit another proposal, this time for paper bags. The same day, the House Corporations Committee voted 17-0 against four pharmacy-choice bills. Martineau, the information says, 'opposed that legislation and used his power, influence and authority as Majority Leader to influence the vote in the Corporations Committee to help obtain that result.'
In the following months, the information says, CVS awarded paper and plastic bag contracts to manufacturers in Canada and New Jersey. In each case, Martineau’s Upland Group received commissions.
Over the next three legislative sessions, in 2000, 2001 and 2002, Martineau thwarted pharmacy-choice legislation and also used his influence to affect several other bills of interest to CVS, including fair pricing for prescription drugs, pharmaceutical assistance for the elderly and competition from mail-order and Canadian pharmacies.
Martineau was also doing business with Blue Cross. In 1998, when he was chairman of the House Corporations Committee, Martineau solicited bag business from an unidentified Blue Cross executive who had come to the State House to lobby him on legislation. Although Blue Cross did not use bags, Martineau proposed that the insurer place advertisements on bags and distribute them for free to about 29 independent pharmacies that had become part of Blue Cross’ exclusive pharmacy network — a network administered by CVS.
The first order, Martineau proposed, should be for 1 million bags, at $19,500 per million. Blue Cross hired him, the information says, 'without comparing prices, obtaining other bids, analyzing the effectiveness of the advertising approach, determining specifically where the bags were to be delivered or assessing the need for the quantity of bags proposed.'
Blue Cross issued its first purchase order, for 1 million bags, on Jan. 5, 1999 — the first day of the legislative session. On Jan. 27, about a week after the insurer issued a $19,500 check to Martineau’s company, Martineau met, as the majority leader, with lobbyists for Blue Cross and CVS to discuss pharmacy-choice and other health-care legislation.
Over the next few years, a pattern emerged. Blue Cross lobbyists would meet with Martineau to discuss legislation, he would support their agenda and he would sell them bags. In 1999, when Blue Cross was experiencing financial difficulties, Martineau was the primary sponsor of a Health Conversion Act that would have facilitated the sale of Blue Cross to a for-profit company. A Blue Cross lobbyist referred to the act as 'The Martineau Conversion Bill.'
On May 1, 2000, a Blue Cross executive sent Martineau a list of 'those House bills which are of significant concern.' In 2002, Martineau sponsored legislation delaying rate restrictions on small employers — 'our number one priority,' according to a Blue Cross report.
This, of course, is just the latest story about conflicts of interest and corruption in health care in this small state. One state senator is already in jail for selling his office to local health care organizations, particularly, a local medical center (see post here). The CEO and one other former executive of that medical center were also convicted of mail fraud (see post here), and the medical center is now operating under a federal deferred prosecution agreement (see post here), and under new management.
But lest anyone scoff that this sort of corruption is merely a Rhode Island problem, I would point to similar cases in other US states (e.g., UMDNJ, the largest medical university in the country, is also operating under a deferred prosecution agreement, as summarized in this recent post). It is also worth revisiting Transparency International's 2006 Global Corruption Report which asserted health care corruption is a global problem that has raised costs, denied access, and hurt quality worldwide.
One particularly important element of this current case is, I believe, its links to health policy, rather than the day to day operation of health care. Although the state legislator may have been just seeking to feather his own nest, he did so by influencing bills which affected health policy at least state-wide, and formed part of a larger mosaic of health policy making. To some extent, the defeat of pharmacy-choice legislation, which would have disrupted the cozy business relationships among specific insurers and specific pharmacies, seems to have occurred because of Martineau's sale of his office.
One wonders how much health policy in a larger sense has ended up mainly serving private interests?
Another particularly important element of this case is how it has not been discussed in a health care context. Other previous cases in the state that had large effects on health care also have largely not been discussed in their health context, and have never had visibility in the medical or health care literature. Justice then and now was primarily pursued by the civil authorities charged with enforcing the law in general. There was no framework for enforcement or ethics that seemed to bear directly on the health care issues involved.
This points out some important voids in health care. Health care organizations (like Rhode Island Blue Cross, and CVS in this case), generally:
- Do not have explicit ethical codes that apply to their management as well as to their rank-and-file.
- Do not have inspectors general, ombudsmen, or the like to help enforce such codes.
- Do not have specific protection for whistle-blowers.
- Are not required to have leaders who are licensed, or have met any specific competency or ethical standards.
- Are not required by government or accrediting bodies to adhere to a higher standard of ethics than any other organizations, e.g., a higher standard than applies to garbage-hauling companies.
Is something wrong with this picture?