Follow Up on Alleged Conflicts of Interest Affecting the FDA Panel on Cox-2 Inhibitors

Bloomberg reported that an FDA spokesperson claimed that "the advisory committee members were screened for conflicts of interest according to the same strict guidelines FDA applies to all its advisory committees." Furthermore, she claimed that all relationships among panel members and health care companies were disclosed verbally prior to the meeting. Yet this disclosure has not otherwise been made public. Nor has the roster of the committee. Finally, the FDA has not yet responded to any of the specific allegations of conflict of interest made by the New York Times.
Senator Charles Grassley (R-Iowa) commented to the LA Times,"the votes of the joint advisory committee are now, justly or unjustly, tainted."
Given all the concerns about conflicts of interest affecting first the NIH, and now the FDA, one would think that the agency would have made a stronger effort at least to disclose any panel members' possible conflicts of interest. And as Merrill Goozner, of the Center for Science in the Public Interest, said, "I don't believe this country is so small the FDA can't find unconflicted scientists who have the requisite expertise."

New Poll Shows Public's Distrust of Pharmaceutical Companies

Of related interest is a recent poll reported by the Washington Post show that many people now mistrust the pharmaceutical industry. 70% said drug companies put profits ahead of developing new drugs, and 40% had no trust in direct to consumer advertising.
The latter figure is an important counterpoint to those who argue that pharmaceutical companies are so omniscient that their marketing efforts unfailingly manipulate doctors and patients (as some did back on the hcrenewal email list some time ago). In fact, these data, if accurate, suggest that direct to consumer advertising is beginning to backfire.
So patients are beginning to realize how they are caught in cross-fires amongst large and powerful organizations. Pharmaceutical companies are only one type of such organization.

More Conflicts of Interest: This Time on the FDA Cox-2 Panel of Experts

I was on the road this week (and air travel was not exactly on schedule due to the latest "snow event,") so I apologize for being a bit behind.
However, there still may be some who have not heard of this one.
The NY Times reported that 10 out of 32 members of the recent, highly-publicized US Food and Drug Administration (FDA) panel on Cox-2 inhibitors had financial ties to Merck, Pfizer, or Novartis, the makers of the internationally best known drugs in this class. These apparent conflicts were not publicly disclosed prior to the panel's deliberations, and apparently would have remained unknown had not the Times investigated.
The problem, again, is not so much conflicts of interests, but efforts to hide such conflicts. It is true, of course, that it may be increasingly difficult to find "experts" on a particular drug who have not had financial dealings with the makers of that drug. But, if such experts are reluctant to publicly disclose such dealings, then their advice is suspect. So now the question is: were this panel's findings made in the interests of patients and science, versus the financial interests of the some of the participants, and of those who paid them?

Pain-pill advisers had ties to makers

This article is not likely to inspire consumer confidence in the impartiality of the FDA's committees on life-and-death drug adverse events matters.

-- SS

Pain-pill advisers had ties to makers
Ten of the 32 consulted for the firms in recent years. Such ties are common, contentious.
By Gardiner Harris and Alex Berenson, New York Times News Service
http://www.philly.com/mld/philly/news/nation/10987547.htm?1c
Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records.
If the 10 advisers had not cast their votes, the committee would have voted 12-8 that Bextra should be withdrawn and 14-8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9-1 to keep Bextra on the market and 9-1 for Vioxx's return.
... Ten members of the panel have worked in some capacity in recent years for Merck, the maker of Vioxx; Pfizer, the maker of Celebrex and Bextra; or Novartis, which is applying to sell Prexige.
In their votes, the members with financial ties to the companies were 10 times more likely to favor the drugs as those without such ties.
(See link for remainder of article).

HELLO ... it's for the doctors

In the latest example of clinical information technology mismanagment, this time on a national scale, the BBC has posted a story on the continued decline in confidence by the UK's GP physicians in the national electronic medical records efforts. Tens of billions of dollars are at stake because "the government (a.k.a. governmental officials and IT leaders) had failed to engage with GPs over the upgrade."

For all the non-medical officials and IT managers involved in this initiative, a word of advice: HELLO ... it's for the doctors.

I have very little else to add to what I've already written at my website on Healthcare IT failure. Except that perhaps there should be stringent educational requirements and formal licensing processes for anyone given a leadership role (e.g., just for argument's sake, control of 5 or more people and a budget exceeding $500,000) in a healthcare computing environment. Also, this license should be subject to forfeit upon findings of significant clinical IT mismanagement. In the medical world, patient mismanagement is known by the more common term "malpractice."

We follow stringent accrediting and licencing processes in medicine and in allied health professions. Why are so-called "computing professionals" in healthcare not under similar requirements? Who, exactly, has granted them this privilege?

Doctor IT upgrade support 'falls'

http://news.bbc.co.uk/1/hi/health/4245695.stm

The £6.2bn overhaul of the NHS IT system could be undermined by declining support among doctors, a survey says.

Just one in five GPs are enthusiastic about the upgrade - down from more than half last year. Support among hospital doctors fell from 75% to 51% during the same period, medical pollsters Medix found.

The 10-year IT programme will give patients electronic health records and allow them to book hospital appointments of their choice online.

The findings come after a National Audit Office report warned last month that the government had failed to engage with GPs over the upgrade which is supposed to revolutionise the NHS for the 21st century.

And last year Computer Weekly magazine said the costs of the National Programme for IT could exceed £30bn.

The Medix poll of 900 doctors, co-sponsored by the Guardian and Computer Weekly, also found GPs felt the new system was less important than they did a year ago.

And 70% of GPs and 42% of non-GPs felt the electronic records would be less secure than paper-based systems.

And just 5% of all doctors said consultation on the upgrade had been adequate.

Medix concluded: "It will be a major challenge to overcome the distrust and cynicism that seems to be replacing enthusiasm in the minds of many doctors. That challenge must surely be addressed urgently."

'Depressing'

Dr Paul Cundy, chairman of British Medical Association's GP's committee on IT, told BBC News the findings were "deeply depressing".

"At the end of last year GPs were given a demonstration of how the new system would work and it was clear it was not good enough.

"It was meant to be an all singing, all dancing system but it is not up to scratch. "Since then GP enthusiasm for the project has plummeted."

A spokesman for the NPfIT accepted there needed to be more consultation with doctors. "The national programme recognises that clinical engagement is essential.

"Medix says that a reinvigorated engagement programme may well rebuild enthusiasm for NPfIT which has the potential to be a success. That is exactly what we have embarked on.

"We know there has been some discontinuity in our clinical engagement.

"But we have recently adopted a new approach, appointing a number of senior clinicians to lead this engagement work."

I'm not sure what the 'scare quotes' around the word 'falls' in the title are meant to signify (i.e., Doctor IT upgrade support 'falls' ). However, the statement "we know there has been some discontinuity in our clinical engagement" is truly scary. Scare quotes belong around the "some discontinuity" phrase if anywhere.

-- SS

Do Physicians Have "the Knowledge to Run These Hospitals?" - Maybe More than Do MBAs

In the LA Times, a story about how a group of doctors took over a struggling hospital, previously run (nearly into the ground) by Tenet. Midway Hospital Medical Center had once been owned and run by physicians, and in the middle of the 20th century, its patients included Hollywood celebrities. Like many other hospitals, it was sold in the 1980's to corporate owners, and wound up in the 1990's as a Tenet hospital losing more than $9 million a year.
Of course, leaders of local health care organizations expressed concerns. One, described as the executive director of a local health care not-for-profit, asked "do these people [the physician owners] have the staying power, the resources and the knowledge to run these hospitals?"
Actually, it looks like the physicians had a lot more knowledge than the former adminstrators.
The most interesting part of the story is how the new physician owner-operators were able to immediately spot ways to save money and/or improve quality. Some examples:

• The hospital had been paying top dollar for two different "ulcer medications," because it could not order either in large quantities. Review by the physician owners found that the medications were similar, so they persuaded their fellow physicians to managed with just one of them, and ordered that one in bulk, reducing the price by about 90%.
• The hospital had been paying much more for one medical device than it could charge for it. The physician owners got its supplier to reduce its price, simply by suggesting they might shop around for a new supplier.
• The physician owners were able to assemble paper charts in a uniform manner by using simple color-coded tabs, making it easier to find clinical data.

It's kind of ironic, isn't it, that the physicians seem better able to find easy ways to save money without compromising care than Tenet's high-powered, and highly-paid executives?
But again, the question is, how many of the managers and executives who run large health care organizations actually know much about health care on the ground? And in the absence of such knowledge, can they determine whether any drug, device, or service is under-, fairly, or over-priced relative to its cost of production? Furthermore, can they determine the relationship of the price to the value (benefit/harm) it bestows on the patient? The answers appear to be "not many," "no" and "no."
(See my previous postings on the issue of health care managers' and bureaucrats' inability to judge price in relationship to cost and to clinical value here, here, and here.)

How Intrusive Should Employee Health Programs Be?

We had previously posted about Weyco, the company which fired workers who would not submit to testing to see if they were smoking after-hours.
Today the Washington Post reported on a growing number of firms which are developing increasingly intrusive efforts supposedly to improve their employees' health. One example is PacifiCare, the West Coast managed care organization. The current PacifiCare health promotion program is strictly voluntary, but includes, for example, the availability of computer software into which the employee enters a record of his or her entire dietary consumption and exercise. However, the program's leader, Dr. Sam Ho, PacifiCare's Chief Medical Officer, reportedly said that "the company plans to introduce modifications to make it stricter in the next few years. Parts of the program may become mandatory, and there may be monitoring of reported indicators of health such as weight loss and exercise."
Other examples include "a Florida sheriff's office is requiring some applicants to take a polygraph test with questions about their smoking habits. Omaha-based Union Pacific Corp. last fall stopped hiring smokers in seven states."
But, as Lewis Maltby, President of the National Workrights Institute, asked, "do we really want employers conducting an extensive sruvey of employees' every unhealthy lifestyle choice? Do you really want your boss asking you what you eat and what you do for recreation?"
Again, some of this reflects a fundamental confusion. Because of US tax law and history, employers often pay for health insurance on behalf of their employees, using presumably dollars that would have gone into the employees' salaries instead. But some employers now thinks this makes them responsible, not just for paying for health care, but for their employees' health in its entirety.
I submit that large corporations, no matter how well intentioned, cannot possibly make better health care decisions for their employees than their employees could make for themselves. And not all may be so well-intentioned.

Stem Cells for Every Ailment

Although we hear a lot about the rising costs and stagnant quality of health care, the health care policy literature is nearly silent about the role of quackery in increasing costs and causing bad outcomes for patients. The Los Angeles Times has a poignant report about one particular health care fraud, and its effects on the desparate patients who turned to it.
This fraud capitalized (literally) on the rising interest in stem cells. A company called BioMark Inernational, originally located in Florida, and prominently located on the web, touted stem cell infusions for a variety of illnesses, including amyotropic lateral sclerosis (ALS). The LA Times story focusses on one ALS sufferer who got two stem cell treatments, convinced that it was his only hope. After spending a lot of money, and after his preoccupation with finding a miraculous cure drove a wedge between him and his family, he died less than a year after his first treatment.
The article documented how BioMark was founded by Laura Brown, a former fashion model, and Steve van Rooyen. Neither had any biomedically related training. BioMark's advisory board included reputable physicians and scientists who never agreed to serve on it. BioMark started its operations in the US, but after the Food and Drug Administation (FDA) raided its offices, it transferred its site for stem cell injections to Canada, then to Mexico, and set up offices in London. Patients from the US, and probably other countries, are still journeying to Mexico and paying $10,000 for stem-cell injections. The elaborate BioMark web-site is still operational here. It still claims: "They [stem cells] have been documented as effective treatment for most all degenerative conditions as well as injuries. This is due to their capacity to regenerate the blood system, as well as every single organ, tissue and cell system in the human body. " And it still claims that stem-cells can treat a broad variety of illnesses, including ALS.
A stronger and more international effort to shut down quackery like this would more than repay the initial investment, not only by saving money spent on such worthless treatments, but also, and more importantly, by preventing the the shattered hopes that are the human costs of quackery.

The return of VIOXX?

In a surprising announcement late Thursday, a Merck executive hinted that the company may begin reselling Vioxx -- a painkiller that generated billions of dollars in sales -- after yanking it off the market last September due to cardiac risks.

While this is an interesting development, I'm wondering what clinician would take the risk of prescribing a drug that was on again-off again in terms of recall. Even pharmacists could get drawn into litigation on cases of people who were prescribed a once-recalled drug and then suffered a cardiac event. The possibilities for litigation seem endless.

It would, at the very least, require extensive surveillance of the COX-2's as a whole, the kind of surveillance that current systems (such as FDA Medwatch) are likely incapable of. A more proactive system would be needed, such as the EMR on a wider scale, perhaps on a pilot basis for surveillance reporting at a number of large medical centers.

Feb. 19 - addendum:

Panel OKs Merck's Vioxx Return to Market

This panel's decisions raise some interesting informatics and legal questions in my mind.

Should clinicians be required to submit outcomes data to the manufacturers on patients for whom they prescribe COX-2 drugs? There still is significant debate on the the cardiovascular risks of these drugs.

Should specific guidelines for prescribing these drugs be crafted to create a standard of practice? Without this, I would fear that clinicians might be at risk unless they document carefully that they explained to patients that these drugs may be risky, and that the true risk is still under debate.

If I were still in practice, I'd require patients to sign a waiver releasing me from liability before I'd prescribe under these circumstances. But that's just the 'Medical Informatics' me remembering the former 'Medical Programs Manager/Substance Abuse Review Officer for a Huge City Transit Authority With Litigation Left-and-Right' me.

-- SS

Holding Psychiatric Patients Against Their Will: "Disturbing Reminder of the Company's Dark Past"

Per reports in the South Florida Sun-Sentinel and the Miami Herald, Florida Medical Center, in Lauderdale Lakes, has been accused of involuntarily holding numerous patients against their will, even though the patients, often elderly, were not a danger to others, but were mainly "confused, paranoid, [or] agitated." The hospital, owned by Tenet, also has been accused of preventing patients who had been admitted voluntarily from leaving. This is one of the uglier stories about hospitals trying to keep their census high that I have seen. But, as this report from thestreet.com notes, Tenet, under its old name of National Medical Enterprises, settled similar charges that it had confined psychiatric patients against their wishes. As a dissident Tenet shareholder group said, this is a "disturbing reminder of the company's dark past."

FDA Whistleblower to Air New Pain Drug Analysis

... and needs senatorial protection to do so.

http://biz.yahoo.com/rb/050217/health_painkillers_1.html

Reuters
FDA Whistleblower to Air New Pain Drug Analysis
Thursday February 17, 2:35 am ET By Susan Heavey

WASHINGTON (Reuters) - A veteran U.S. Food and Drug Administration scientist will unveil new data on Thursday before an expert panel charged with determining whether pain relievers similar to Merck & Co. Inc.'s now-withdrawn Vioxx should remain on the market.

David Graham, associate director for science and medicine at the FDA's Office of Drug Safety, will present a safety analysis that he says is larger than any previous related study. Graham is regarded as a maverick for his forthright criticism of the FDA's ability to monitor the safety of drugs once they are on the market.

... On Thursday, Graham will present data culled from California's Medicaid program, called Medi-Cal, that looked at more than 15,000 heart attack patients. The study is awaiting publication, and FDA officials had previously said they prefer that only published data be presented. Graham, who has sought legal counsel from a whistleblower protection group, said earlier this week he would not present the analysis at the meeting because he felt intimidated by supervisors.

He changed his mind after FDA Acting Commissioner Lester Crawford sent a letter saying there would be no reprisal. "I want to assure you that Dr. Graham is free to present from his Medi-Cal study ... without any concerns of retaliation from any FDA employee," Crawford wrote. The letter, provided to Reuters, was sent to Senate Finance Committee Chairman Sen. Charles Grassley, who has defended Graham since the scientist testified at a November hearing.

Intellectual diversity in the pharmaceutical industry and regulatory agencies? Sure. If it's guaranteed by the threat of jail for retaliation against those with opinions outside the main$$tream.

It has been said that today's pharmaceutical industry is having pipeline problems due to "having already picked the low-hanging fruit," despite their research labs spending billions of dollars annually. I have another theory. It may be that the industry has become infected with greedy non-medical MBA's and intellectual lightweights who have then brought in kindred at all levels of leadership. These leaders so bog down creative processes with bureacratic nonsense and create such an anti-intellectual atmosphere, that creativity has suffered severely.

Uncensored commentary on the Yahoo finance message boards on pharma investing, and on independent pharma sales/marketing sites such as www.cafepharma.com , is often quite interesting in this regard.

Creativity is the key resource in an industry such as this. Some pharmas are getting the message and are creating somewhat more independent islands of research in their labs, e.g., GlaxoSmithKline's CEDD's (Centers of Excellence for Drug Discovery).

Others are lumbering on with management models firmly anchored in the past or in the "management mysticism" fads of the consultant du jour. In my opinion, without an environment resembling that in academia, with central activities focusing on the library (both physical and virtual) and with freedom to pursue scientific leads without interference by non-science bureacrats demanding a short-term "return on investment", research labs in pharma may be becoming no more than cookie-cutter bakeries with less chance of innovation than a high school chemistry lab.

As for bioinformatics saving the day, my views on that are here.

-- SS

Are Older Doctors Dumber?

The results of a systematic review in the Annals of Internal Medicine have created headlines around the US. Most, like this one from the Boston Globe (Greater Risk Seen With Older Doctors), suggest that older doctors are, well, dumber than younger ones. My wife, seeing the headline, and observing that I had progressed to a certain age, said this morning, "shouldn't you look into this one." So I did.

The study in the Annals of Internal Medicine [Choudry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of health care. Ann Intern Med 2005; 142: 260-273] searched the literature search to find 62 articles that analyzed physician knowledge or performance according to the the physicians' age. Summaries of the 62 studies were broken down by study purpose: 12 involved written tests of knowledge; 17, adherence to guidelines or practice standards for diagnosis, screening, or prevention assessed by self-report, e.g., by surveys or interviews; 7, adherence to such standards assessed by chart audit; 5, adherence to guidelines or practice standards for treatment assessed by self-report; 13, adherence to guidelines or practice standards for treatment assessed by chart audit; and 7, directly measured patient outcomes.

The review did not screen out articles of poor methodologic quality, or rate the methodologic quality of any article. So it did not eliminate articles whose specific standards for physician performance were not evidence-based, such as tests of knowledge not related to the physicians' practices. Furthermore, it included articles regardless of their study architecture, age, sample size, patient selection criteria, whether and how they controlled for patients' characteristics, and effect size and its precision. Thus, this review's results could well have been biased by poorly designed or performed studies, and studies which are unlikely to generalize to modern physicians.

I did not have time to re-review every article, but a quick perusal made me more concerned that the most striking results showing older physicians performing worse were contributed by the methodologically weakest articles. For example, of the 13 articles that looked at adherence to standards for treatment by chart audit, only 6 showed what the authors called a consistently negative effect of increasing age. Of these,

• one was published 34 years ago, and included only 37 physicians;
• one, of treatment of depression, did not account for the severity of the patients' symptoms, and had a very small effect size (OR=1.12, CI 1.01, 1.24);
• one used a standard of care for inappropriate drug selection that might be debated;
• one used that same standard, did not adjust for patients' clinical characteristics, and had a very small effect size (OR=1.14);
• one was published 21 years ago, and used practice standards defined by consensus, not evidence; and
• one was published 20 years ago, included only 66 physicians, and again used practice standards defined by a panel, not evidence.

The article failed to acknowledge the methodologic weaknesses of the studies it summarized. But I am very concerned that its conclusions were biased by these weakness. Thus I think its basic conclusion, that older doctors are dumber, is not strongly supported by the evidence.

Yet an accompanying commentary, [Weinberger SE, Duffy FD, Cassel CK. "Practice makes perfect" ... or does it? Ann Intern Med 2005; 142: 302-303.], hailed the article as showing that physicians "must embrace the concepts behind maintenance of certification, which provides an opportunity to prevent the outcomes demonstrated...." Since Choudry's review did not include any studies of recertification, I think this conclusion goes even farther beyond its data.

Even though physicians seem beset on all sides by powerful organizations, sometimes that stand to profit by reducing physician autonomy, I believe that our professional values mandate serious, ongoing examination of our own performance. (I have actually published a few studies which do just that.) However, the principles of clinical epidemiology apply to such studies just as they apply to studies of patients. We do no one any favors by rushing to negative conclusions about physician performance without examining the strength of the relevant evidence.

Blind leading deaf: U.S. to create oversight board to alert public on new drugs

Is the article below, "U.S. to create oversight board to alert public on new drugs", an example of the blind leading the deaf? An apparently toothless board that is to be part of the FDA seems more likely to be ineffectual than useful.

Philadelphia Inquirer, Wed, Feb. 16, 2005, excerpts:
http://www.philly.com/mld/philly/news/nation/10909214.htm?1c

WASHINGTON - Amid concern that the government has not done enough to ensure the safety of prescription medications, the Bush administration announced yesterday that it was setting up an oversight board to more quickly inform the public of side effects after a drug goes on the market.

Health and Human Services Secretary Mike Leavitt said the Drug Safety Oversight Board, to be part of the Food and Drug Administration, would consist of scientific experts from throughout the government. The board would be responsible for monitoring reports of potentially hazardous drug reactions and posting that information on a Web page. Its role would be largely advisory. It would not have power to take a drug off the market or change the circumstances under which it was sold, though it could make recommendations on these issues to senior FDA officials
...
Representatives of the pharmaceutical industry reacted cautiously yesterday, arguing that drugs' potential side effects should be weighed against benefits in any review process. "It is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk," the main industry trade group, Pharmaceutical Research and Manufacturers of America, said in a statement.

Being part of FDA is bad enough. However, there is an even more important issue than organizational reporting and governance for such a board. The issue is summarized by the "law" in the book The House of God : The Classic Novel of Life and Death in an American Hospital by Samuel Shem which I paraphrase as "you can't find a fever if you don't take a temperature." Pharma has been doing a rather deficient job of taking that temperature, to the point of congessional investigations and massive personal-injury and wrongful-death class action lawsuits.

For example, regarding the Pharmaceutical Research and Manufacturers of America's statement regarding the importance of "making regulatory decisions based on sound science and carefully considered judgments", there is a major problem. Reliance on small clinical trials and voluntary reporting of adverse effects of "blockbuster" drugs taken by millions via the FDA Medwatch system -- where no report gets filed if an event is not recognized as possibly drug-related (e.g., a myocardical infarction in a patient taking a COX-2 inhibitor up to a few months ago) -- is neither sound nor "considered judgment" in my opinion.

As to pharma's seriously taking into account other types of data such as from payors in producing a "risk portfolio" for a drug that includes multiple study types, or making serious efforts to support the implementation of full EMR's that can start providing better, regular data flows that might be helpful in identifying adverse events before they become public health debacles, there seems insufficient effort.

Pharma also seems to ignore the field of Medical Informatics that was designed and funded by NIH for the purpose of expanding use of technologies such as EMR, among others. That I and others in Medical Informatics cannot seem to secure employment at present in pharma (not for lack of trying), and that I was laid off from a pharma instead of, say, a non-medical person with a bachelor's degree in computers making nearly as much as an M.D. with postdoctoral certification in Medical Informatics and clinical computing, speaks to the third component of the "blind, deaf and..." triad.

In fact, in one pharma I know where the information scientists reported to the IT personnel (a major structural misalignment not uncommon in industry), the term "medical informatics" did not appear at all in their controlled vocabularies. Further, terms describing the core competencies of information professionals such as library scientists, informaticists, and the like, were simply absent from the Human Resources taxonomy of skills used for performance review and for hiring. Terms describing computer programming and project management skills were abundant, of course.

In other words, this pharma was blind to information management professionals and their skillsets in hiring, promotion, and performance review.

Pharma prides itself on being an "information intensive" industry. And my name is Mata Hari.

-- SS

UTMB Emergency Department to Send Less Sick Patients "Elsewhere"

A new sign of how hospitals are turning away from their traditional mission in response to financial pressure: The Houston Chronicle reported that the University of Texas Medical Branch (UTMB) at Galveston will start pre-screening patients who go to their Emergency Department (ED), and will turn away patients deemed not sick enough to need emergency care. Such patients will apparently be told how to get care "elsewhere." The article did not address how difficult it might be to get to "elsewhere," or how rapidly they might be seen there.
This policy should be distinguished from the on-site services many EDs maintain (sometimes called walk-in, fast-lane, or the like) to see less sick patients in settings that are less intense than the regular ED, but are located in proximity to it.
The policy was inspired by how the University of Colorado Health Science Center in Denver ED has operated, not without controversy, since 2002.

The NIH: "We Have a Systemic Problem"

We have written a lot about the conflict of interest scandals at the NIH. (See below for links to related posts on Health Care Renewal, plus a citation of a newspaper op-ed.)

We have also noted several times how little discussion there was of this story in the medical and health care literature, and even what is now called the main-stream media (MSM). This appeared to be an example of what Russ Maulitz called the anechoic effect, the silence that greeted any story about concentration and abuse of power in health care.

Thus, I was gratified to see an interview published in yesterday's Los Angeles Times which provided a lot of support to our viewpoint on this scandal. Here are some particularly pithy quotes:

• "If you are weighing in on behalf of the public, I want you to be there on behalf of the public. Don't tread [trade] on your prestige, position, in a way that pretends to be completely objective."
• "I came to the conclusion that we have a systemic problem. They were not just isolated events. They reflected a complete set of rules that had been adopted over the years, which had transformed the culture..... if that's the case, let's bring back the culture to where it needs to be: that is, public first."
• "No limits on stock. No limits on money. No limits. Where were all those holier-than-thou intellects?" "This issue was standing between the history of the NIH and its future."

What is most striking is that the interviewee was the current Director of the NIH, Dr. Elias Zerhouni. Clearly, having the public support of Dr. Zerhouni for unconflicted, ethical leadership of the NIH is a big step forward. The interview also marks a significant crumbling of the anechoic effect (to badly mix metaphors).

Dr. Zerhouni's approach also stands in stark contrast to how leaders of other major health care organizations have reacted to allegations of uninformed, incompetent, self-interested, or even corrupt leadership. The usual way of doing business has been to circle the wagons, deny the problems, and, if pushed very hard, purge the most visible culprit and then declare the problem resolved.

Concentration and abuse of power in health care are widespread problems, as perusal of recent posts on Health Care Renewal demonstrates. We need all the support we can get for informed, competent, honest and ethical leadership of health care organizations. We can now use Dr. Zerhouni as a good example, and hope we can count on his support for the reform of leadership of other organizations.

Previous Posts and One Article

End of the Anechoic Effect: Editorial Reaction to the New NIH Rules

Pogo at the NIH

NIH Seeks Higher Standard: Better Late Than Never

Ban on Federal Scientists' Consulting Nears

Yet More Conflicts of Interest at the NIH

Few Echoes from Allegations of NIH "Appearance of Corruption"

The Anechoic Effect and Conflicts of Interest at the NIH

More Outrageous Conflicts of Interest at the NIH

Poses RM. Corruption, incompetence in health care. Providence Journal, December 17, 2003.

"A Vested Economic Interest" in the Outcome of the Battle Over Angioplasty

Re: my discussion earlier of price versus value, see this article in the Boston Globe about how community hospitals are battling for authorization to do angioplasty in the Boston area. (Regulations now prevent hospitals who don't have facilities to do coronary artery bypass grafts from doing angioplasty, based on the concern that such hospitals would be unable to cope with acute adverse events from the procedure.)
The chief of interventional cardiology at the Beth Israel Deaconess Hospital said, "we have to realize that we have a vested economic interest in the outcome [of the debate about which hospitals can do angioplasty]" He then noted that about 40% of the $17K - $20K that hospitals get from Blue Cross for the procedure is profit.
This is an example of how insurance and managed care companies do not have a clear idea of the actual costs of an imporant, expensive service they pay for. Whether they have a better idea of its value to the patient is questionable.
Rather than leaning on primary care physicians to reduce utilization of such expensive services, wouldn't it make more sense to bargain down the hospital's profit margins to something less than 40%?

Study Finds Doctors with EHRs Have More Complete Patient Information

An interesting article pointing out the true information-intensive nature of healthcare. I agree that EMR's "alleviate but do not solve the problem" but point out that this observation is what medical educator and activist Dr. Victor Satinsky would have called an observation by a "master of the obvious." There may never in our lifetimes be a complete unified registry (either virtual or physical) of all healthcare information on everyone.

However, the EMR is a key component whose implementation must not be delayed and costs increased by hospital politics (a.k.a. mismanagement), IT/clinician/executive territorial and ego battles, incompetence, unscrupulous software vendor business practices (e.g., the HBOC medical software company scandal of several years ago), and other biomedical IT sociotechnical issues and dysfunction.

-- SS

Study Finds Doctors with EHRs Have More Complete Patient Information

February 3, 2005
By M.L. Baker

Patients' care may be adversely affected by missing information in as many as 220 million patient visits each year, according to a study published by the Journal of the American Medical Association this week. Electronic medical records alleviate but do not solve the problem.

Though missing information is blamed in about 16 percent of medical errors, this is the first survey to document how frequently primary care clinicians lack information during office visits. Information was missing in one of seven visits. Clinicians estimated that the missing information was likely to adversely affect the patient's medical care and could cause delayed care or redundant services 60 percent of the time. In 45 percent of the visits, the clinician reported spending five or more minutes unsuccessfully searching for the information, time that could have been spent with the patient.

Only about 7 percent of physicians, physicians' assistants, and nurse practitioners reported having full EHRs (electronic health records), but this group was 60 percent more likely to have complete information. Doctors' offices in rural areas, which tend to rely on a smaller number of vendors for laboratory results, were 48 percent more likely to have complete information.

Don Mon, vice president of practice management at the American Health Information Management Association, said that clinicians with EHRs probably had more complete information because the system actively prompts physicians to collect information.

Clinicians reported that most (52.3 percent) missing information was outside the medical practice but inside the United States. However, information was just as likely to be missing if a practice had electronic access to a primary hospital.

Nevertheless, Mon said that the study pointed to the need for a national health information network so that different systems could communicate. "Hospitals might have an electronic record and a physician might have an electronic record, but we don't have the means to exchange them. They are acting like islands."

In an editorial accompanying the study in the JAMA, Nancy Elder and John Hickner wrote, "There are thousands of electronic databases, even within the same community, that cannot communicate with each other." In addition, clinicians who reported having hybrid or partial EHRs were just as likely to have missing information as those without such systems.

New patients were more than twice as likely to have missing information as patients who were returning to the same doctors' offices. Information was three times more likely to be missing for patients with five or more medical problems, and 80 percent more likely to be missing for recent immigrants.

The survey did not ask clinicians whether any information was missing, but asked specifically whether information important for patient care and known to exist was missing during the visit. Information that was not in a patient's file when a doctor visit began was not counted as missing if it was located before the visit ended. In 36 percent of visits with missing information, clinicians or staff had spent more than five minutes looking for information while the patient was in the office.

The survey, led by Peter Smith at the University of Colorado Health Sciences Center, was conducted for 1614 visits with 253 physicians, physicians' assistants or nurse practitioners at 32 clinics. Laboratory results were reported missing most often, in about 6 percent of visits, followed by letters and dictations, history and physical examinations, radiology results and medications.

Forbidden Knowledge, with Irony

Science just published a qualitative research article about scientists' "self-censorship." The term we have used before for this behavior is "suppression of research." A news summary is here, and the article is here but requires a subscription. (The citation is Kempner J, Perlis CS, Merz JF. Forbidden knowledge. Science 2005; 307: 854.)
Many of those interviewed for the study were from the life sciences, although none were apparently physicians. The article's introduction mentioned "social control of scientists," particularly regarding studies of "human cloning and embryonic stem cell creation," and certain "government sponsored research." It cited examples of the latter included studies of gay men and prostitutes and of sexual behavior more broadly, and about potential bio-terror agents. The sorts of topics the scientists considered "sensitive" included "human cloning, embryonic stem cells, weapons, race, intelligence, sexual behaviors, and addictions, as well as concerns about using humans and animals in research."
It's an interesting article that adds to our knowledge about suppresion of research.
However, I was startled to find almost no discussion of suppression of research about commercial products due to pressure from those with financial interests in the products. Clearly, this is a prevalent problem in health care, complicated, in some famous cases, by the quickness with which universities and teaching hospitals have succumbed to such pressure.
It is also ironic that most of the examples seemed to be of pressure from groups that may have had a right-wing tinge, e.g., pressure against stem-cell research, or studies of sexual behavior. Of course, as quick perusal of the FIRE web-site shows, at universities much of the pressure on free speech and academic freedom comes from the other end of the political spectrum.
Perhaps the authors' emphasis mainly reflected their small, and probably not very generalizable study sample.
But it seems even more ironic that a report from university researchers on suppression of research seems to leave out some of the most salient sources of pressure on academics to suppress. But maybe this just adds to their own argument.

Caught in the Cross-Fire: Merck Tried to "Neutralize" Vioxx Opponents

Here is a new kind of example of how physicians have been caught in cross-fires between competing interests.
The NY Times reported today about some newly obtained documents about how Merck marketed Vioxx. Particularly striking were references in them to the need to "neutralize" physicians who Merck marketers perceived were Vioxx opponents. To quote the Times, "In the 'neutralize' documents written by a Merck marketing executive, company officials identified dozens of influential but 'problem' physicians whom [sic] the company believed had either a negative view of Merck or Vioxx or were active boosters of Celebrex. To win them over, the documents show, Merck officials planned to offer them carrots like clinical trials, posts as consultants, or give them grants." A form that Merck used internally to request payments for doctors asked for "Expected Outcome/ Return on Investment."
When I first read the headline, I feared "neutralization" meant something even more sinister. But the reality was bad enough. This is a vivid case of how when physicians are caught between powerful organizations, here, competing drug companies, the patients' interests seem to come last.

Lo Bat for Implantable Cardiac Defibrillators

Medtronic warned physicians today about the possibility of battery failures in one of its models of implantable cardiac defibrillators (ICDs), 87,000 of which were manufactured before 2003. The market for these devices has recently expanded, since Medicare approved their prophylactic use for patients with congestive heart failure. Medicare planned to pay from $28 to $36K for the device, and the procedure to implant it.
I believe (but cannot find evidence at the moment to prove) that the price of the actual ICD is around $25K. If so, given that its circuitry cannot be that complex in this day and age, one would think that this would have been enough to buy an extremely reliable battery.
This reinforces the questions I recently raised about the pricing of medical devices versus their value to the patient.

"FTC Seeking to Break Apart Hospital Merger"

Its about time that the government started paying attention to the concentration of power within hospital groups, and, of course in ever larger merged insurance companies and managed care organizations.

An Interesting Report from Boston University on Controlling Health Care Costs

An interesting report on entitled "Health Costs Absorb One-Quarter of Economic Growth, 2000 – 2005" from the Boston University School of Public Health has received a little notice in the press. It's long, so I haven't been able to review it in detail, but it makes some pretty good points (although also seems to leave out some important issues that get discussed on Health Care Renewal.)

• It suggests that waste, bureaucracy, and fraud account for large proportions of health care costs. The data that justifies this assertion, however, is not immediately obvious.
• It notes that prices are much too high, but seems to imply that this is a generalized pheonomenon. The example it uses, for example, is a general comparison of drug costs in the US and Canada. The report does not seem to grapple with discrepancies of price and value, for example that some drugs seem inordinately expensive compared with their benefit/harm ratio, while others may be quite cheap. Such discrepancies between price and value, of course, seem to occur for all kinds of health care products and services.
• Its discussion of waste, fraud, and bureaucracy skirts the issue of ill-informed, incompetent, self-interested, and even corrupt leadership of health care organizations. For example, its discussion of fraud seems to focus mostly on that perpetrated by individual providers on insurance companies. How the Allegheny bankruptcy (here, on p. 5) , or the conflicts of interest at the NIH would have fit into this framework aren't clear.
• It recognizes that physicians actually make most of the important health care decisions for individual patients, and hopes that better informed, more evidence-based decision making will help. In fact, it puts most of the onus of controlling costs on physicians, while acknowledging that this is quite a burden, and that physicians will deserve considerable help with it. However, given its failure to deal with the issue of whether the pricing of particular items is excessive, it is not clear how it expects physicians to control costs, no matter how well they are educated in evidence-based medicine, if they do not understand and cannot influence pricing. Nevertheless, the report's approach to physicians is more sympathetic and understanding of the issues physicians face than much of what has been written about health care policy

All in all, this is a thoughtful work that deserves careful reading and response.

UC faulted for paying millions in bonuses

These are private-industry-level bonuses. One can argue that such bonuses are needed to retain top talent, but teaching hospitals do not have the income of, say, A Hewlett-Packard, IBM or Pfizer.

Do teaching hospitals needs to rethink their executive compensation? I'll bet most line clinicians and patients would agree.

-- SS

Excerpts:

The University of California gave nearly $2.4 million in bonuses to 65 top executives at its five teaching hospitals in 2004, with 11 administrators receiving more than $50,000 each. The bonuses averaged $36,000 and reached as high as $82,000, according to a report to the UC Board of Regents that was made public Wednesday by an employee union.

... the largest bonus went to UC Davis Medical Center chief executive officer Robert Chason. It totaled $82,000 -- 20 percent of his annual salary of $410, 000. At UC Davis Medical Center, 12 health care executives shared bonuses totaling $526,803.
At UCSF, chief executive Mark Laret received a $79,495 bonus, 18.3 percent of his $434,400 salary. The bonuses for UCSF executives totaled $583, 740.

"At every level of our organization, UCSF Medical Center strives to compensate its employees at the median of the market," Laret said in a statement released Wednesday. "UCSF Medical Center leaders receive their compensation in two parts -- a base salary plus an at-risk incentive based on performance. At this time, including both parts of their compensation, UCSF Medical Center leaders are paid well below the market for comparable academic medical centers."

According to university documents, the bonuses were approved in October by UC President Robert Dynes and were outlined to the Board of Regents last month.

The regents did not discuss the payouts publicly, and one reached Wednesday said he objects to the bonuses.

"I am very disappointed with the bonuses that UC has given its health care executives," said Regent Ward Connerly, whose term on the board expires March 1. "There is a pattern of indifference among some of our more elite people at UC to the plight of our lower-paid employees and to the appearance that some of these bonuses are obscene. This indifference is not confined to health care executives."

... Medical center workers say the bonuses are a slap in the face. Many have gone without raises for several years and are anticipating salary increases of just 3 percent this year. "They keep telling us how little money they have ... but they always seem to have money for people they want to give raises to, and it always seems to be people at the top," said Jeff Cox, a lead building maintenance worker at UCSF. "It says that I don't matter. It is hurtful."

... "We think that the money could have been better spent on patient care and low-wage workers and maintaining the quality of services," said Faith Raider, a union spokeswoman. "We have seen a lot of cutbacks in staffing and services, and we think this money could have gone to that."

Jennifer Lilla, president of the University of California Student Association and a biomedical sciences graduate student at UCSF, said the money also could have been used to offset cuts in student aid.

"That is half of the money we are trying to get returned to the financial aid pool,'' Lilla said. "Yes, it made a difference in a handful of people's lives, but it could have made a difference in literally thousands of students' lives had it been diverted elsewhere.''

CRO's: we don't need Medical Informatics here

After being laid off from a major pharma as part of a large reduction in force, in recent months I've spoken to major CRO's (Clinical Research Organizations) about opportunities in Medical Informatics. CRO's are companies that conduct clinical trials for pharmas under contract as well as perform other drug development-related activities.

Here are some of the responses I've received:

A senior executive for Biometrics and Data Management at a large CRO with operations in my vicinity: "There's nothing in your resume of value to a clinical research organization." This was repeated even after I verbally reviewed my background with said individual. (A truly stunning and unforgettable rebuff, the likes of which I'd never heard before.)

Unknown hiring manager at another large CRO (via a recruiter): "Just wanted to follow up with you about the [management] position. They sent us an e-mail today communicating that you are a great candidate but just a little too heavy on the Informatics side for this position."

So, ironically, one CRO finds nothing of value in the background of a seasoned Medical Informaticist, and another finds "too much" Informatics for a management opportunity. How, one might ask, can someone be "too heavy" on the informatics side in an organization whose lifeblood is clinical data management?

Here is the NIH on the value of Medical Informatics, on which they and other organizations spend tens of millions of dollars annually on training programs and research:

Clinical care, biomedical research and education, and public health administration can be improved by the inclusion of informaticists (in-context information specialists) into work and decision settings. Informaticists are information specialists who have received formal graduate training and practical experience that provides a cross-disciplinary background in both medical science and information science. Their cross training provides a unique perspective on the acquisition, synthesis and application of information to problem solving and program development in clinical and biomedical areas.

Do I sense a disconnect here? This experience reflects only two CRO examples, but if this reflects the same kind of trend I've observed in the provider sector, it makes me less incredulous that the pharmaceutical industry is facing significant challenges regarding clinical trials results and post-marketing surveillance, to the point of class-action personal injury lawsuits and Congressional investigation. It may reflect a significant underutilization of talent.

The reasons for an apparent blindness to Medical Informatics by providers, pharma and possibly CRO's may reflect lack of knowledge of the field, occupational jealousy or territorial issues by personnel who are unidisciplinary, or basic reactionary thinking.

In any case, the repeated observations of healthcare's data management difficulties reflect a significant gap in healthcare leadership's thinking on these issues, in my opinion.

-- SS

Another Homicide

There seems to be a tiny time-cluster of health care officials facing homicide charges, a new low for health care. (See the previous posting about, among other things, the conviction of a VA research coordinator for negligent homicide.) The Chicago Sun-Times reports that Director of Communications and Policy for the STD/HIV/AIDS Division of the Chicago health department was charged with murder for "allegedly commandeering a cab and repeatedly running over the 61-year old driver."

Malpractice Crisis in Ireland: Physicians to Vote On Industrial Action

Although this blog has had a distinctly American flavor, we believe that the general problems we discuss know no national boundaries. (By the way, we'd be happy to welcome some bloggers from outside the US.)
For example, those who think that the malpractice insurance situation is bad in the US should see stories here and here from Ireland. Although Ireland has a national health service, Irish hospital-based physicians (consultants) still face the risk of malpractice law-suits. Now Irish hospital consultants are ready to vote for an "industrial action," i.e., a doctor's strike, over malpractice insurance issues. Apparently, the Irish government developed a new system of malpractice coverage, but which did not include coverage for liabilities incurred before last February. The former source of many physicians' coverage of this "tail" (in the US parlance), is no longer available. So physicians have no source, other than own pocket, of payment for expenses occured to defend lawsuits arising from events before last February, and no insurance for any damages they might have to pay.

CVS tied to R.I. lawmakers

I am aware that Rhode Island has had its share of healthcare problems in the insurance sector. Here's another angle to the dangers of allowing those involved making a living from healthcare parasitically to curry favor from those who set or enforce the rules for society (i.e., politicians, also usually with no healthcare credentials).

I am the son of a small, independent pharmacist in Philadelphia who opened his first store in the early 1950's. I worked for my father as a teen and literally watched the takeover of his profession by large corporate interests as chain drugstores started dotting the landscape, including directly across the street from his venerable Lumar Pharmacy, Somerton (far Northeast Philadelphia).

-- SS

CVS tied to R.I. lawmakers
The drugstore chain's dealings led to the state Senate president's resignation.

By Michael Mello, Associated Press

PROVIDENCE, R.I. - From the University of Rhode Island's sparkling Ryan Center, named after CVS Corp.'s top executive, to the familiar red signs that dot the landscape, the nation's second-largest drugstore chain is a clear economic force in the nation's smallest state. Yet CVS's behind-the-scenes political clout may be even stronger.

A furor has erupted at the Statehouse over the recent disclosure that CVS - Rhode Island's largest private employer - had secret business dealings with some lawmakers.

The uproar has spurred the resignation of the state Senate president and led to an investigation by the Rhode Island attorney general - himself a former CVS lobbyist.

Activist groups are demanding tighter disclosure laws. Others want to replace the state's part-time legislature with a full-time one, so that lawmakers are less likely to hold down outside jobs that could create conflicts of interest.

Republican Gov. Don Carcieri, meanwhile, wants a special commission to investigate corporate influence in government.

"We have a huge crisis of confidence in the public's mind," he said last week. The governor's concern goes beyond CVS to recent ethics complaints involving other firms, including Blue Cross & Blue Shield of Rhode Island, the state's largest insurer.

Also, two executives connected to the Lincoln Park dog track and gambling hall have been indicted on charges of conspiring to pay a bribe of up to $4.5 million to the House speaker's law firm in 2000 and 2001 for help in winning approval for more video slot machines and blocking a proposed casino. Rep. John Harwood, who is no longer speaker, has denied any wrongdoing and has not been charged.

Few, if any, companies are as tightly woven into the fabric of the state as CVS. Cofounded by Woonsocket native Stanley Goldstein, CVS opened its first store in 1963 in Lowell, Mass. The Fortune 100 company now has about 4,200 stores in 32 states and the District of Columbia. It has dozens of stores in the Philadelphia area. Its corporate headquarters are in Woonsocket, and it employs about 5,200 people in Rhode Island. CVS has long been lauded for its philanthropic efforts, including an annual charity golf tournament. The company and its chief executive officer, Tom Ryan, donated at least $4 million to help build the state university's sports arena.

But critics say the goodwill generated by the company's good citizenship has been erased by the secret business relationships with Democratic Senate President William Irons and Sen. John Celona, who was chairman of a committee overseeing the health-care industry. "I can't trust them," Democratic State Sen. Leonidas Raptakis said of CVS. "Why didn't they come out and tell the public of this hidden agenda?"

Irons, an insurance broker, received $70,000 in commissions over two years as the broker on a CVS employee health-insurance policy, according to federal documents.

And Celona acknowledged he was being paid $1,000 a month by CVS as a consultant when a bill opposed by CVS died in his committee. The bill would have relaxed the exclusive relationship Blue Cross has with CVS and certain other pharmacies, and allowed patients to get their prescriptions filled at drugstores including Walgreens.

Celona has since stepped down from the chairmanship, and CVS's competitors are again pushing the bill.

CVS said in a statement that it violated no state laws but is adopting new procedures that "will hold CVS to a higher standard of conduct than that required by Rhode Island state law or regulation."

Some of the financial arrangements were brought to light by the Providence Journal. Because Rhode Island lawmakers are part-time, they are not barred from working for CVS or any other company. Lawmakers must report the names of their employers, though not the exact amounts they are paid.

Celona and Irons could be fined for not disclosing their business relationships. Criminal investigators are looking deeper, to see if businesses have bought influence with lawmakers. Celona and Irons both declined interview requests.

Rhode Island Attorney General Patrick Lynch is heading the investigation along with state police. He has resisted calls to remove himself and appoint a special prosecutor because of his own past connections to CVS.

CVS also is named in an ethics complaint against Republican State Rep. William McManus, a business analyst for the company. McManus is accused of improperly speaking against a bill to allow the sale of medications imported from Canada.

The Rhode Island legislature typically meets six months a year in the late afternoons, and includes teachers, lawyers, restaurant owners, firefighters, insurance agents and farmers. Most of the lawmakers make $12,063 a year.

Democratic Sen. Joseph Polisena said Rhode Island needed a full-time legislature. "As we have seen in a number of instances, there can be unfortunate results when members of the part-time General Assembly serve two masters - the citizens in their districts and their regular, full-time jobs," he said.

But having full-time legislatures can lead to complaints, too - namely, that the lawmakers are too focused on reelection.

"If it is their primary source of income, then it becomes a job that's important for them to hold onto, then they'll make decisions in the interest of getting reelected," said Karl Kurtz of the National Conference of State Legislatures.

"There is Always a Hidden Agenda" - Alleged Cover Up of Research Abuses at the VA

In January, we posted the story of malfeasance at the Stratton Veterans Affairs (VA) Medical Center in Albany. Today, the NY Times published a major piece of investigative reporting on the affair, which now appears to be larger and more troubling than it did last month.
Then, the focus was on research coordinator Paul Kornak. Kornak was apparently hired despite having lost medical licenses in several states due to forged credentials, and a felony fraud conviction in Pennsylvania. Although Kornak apparently never completed medical training, the Stratton VAMC allowed him to perform physical examinations and identify himself as "doctor." The FDA found that Kornak had falsified patients' medical records in several drug studies, allowing patients to enroll in studies even though they should have been excluded. Kornak plead guilty to fraud and negligent homicide for the death of one patient in a chemotherapy study.
However, problems at Stratton predated Kornak's arrival. In the 1990's, two pharmacists repeatedly complained of major violations of research protocols, including enrollment of patients without consent, enrollment of patients who should have been excluded, and giving patients treatments not included in protocols. In response, the pharmacists were targeted by VA internal investigations, although none ever found any wrong-doing. An investigation of research at the hospital, conducted by Dr. Thomass Ferro, was allegedly rigged by administrators to find nothing wrong. Said Dr. Ferro, "there is always a hidden agenda to exonerate or convict in these internal investigations. In this case it was to exonerate." So Ferro did a cursory investigation, and even after he then "watered down" his finidings, his superiors edited his report to remove even "minor discrepancies."
Furthermore, how the VA responded on the national level to the problems at Stratton was even more troubling. When problems there first were noticed in 2003, the new VA Chief of Research and Development, Dr. Nelda Wray, ordered a nation-wide review of VA research. She halted research altogether at Fargo, ND, where there were problems with the Institutional Review Board. She ordered credentials checks on and ethics training for all researchers. But by2004, Dr. Wray, in turn was accused of ethics problems, and was forced out of her position. Her lawyer charged the investigation was "an easy and convenient way to stop sorely needed reforms."
Some major points:
- The response of the VA to staff complaints about research at the Stratton VAMC was apparently to punish the whistle-blowers, and cover up the complaints. This is all too reminiscent of the cases of physicians punished for complaining about quality, detailed in the landmark investigative series in the Pittsburgh Post-Gazette, The Cost of Courage.
- This response allowed wrong-doing to continue, resulting in, according to a court of law, the death of at least one patient.
- Thus, this case suggests how bad leadership of a medical organization can not only harm the research process, or suppress research results, but also directly harm patients.
- Furthermore, the allegations made by Dr. Wray's lawyers, if true, suggest that the problems go much deeper, or higher than the administration of one VA hospital.
Coupled with all the other stories we have been reporting, about not only the VA, but the NIH and the FDA at the federal level, about numerous for-profit companies, and not-for-profit hospitals and managed care organizations, this underscores how we need to get serious about restoring integrity to the leadership of health care organizations.

End of the Anechoic Effect: Editorial Reaction to the New NIH Rules

The announcement of the change in NIH conflict of interest rules has created quite a bit of press, maybe finally signaling the end of the "anechoic effect" for this particular story. Oddly enough, the old way of doing business at the NIH has found a few prominent apologists, echoing the troubling reaction by NIH staff I discussed yesterday.

For example, see the commentary by Steven Pearlstein in the Washington Post. Here are a few quotes with my comments.
"A Massachusetts politician once told me, over lunch at Boston's Locke-Ober cafe, that most systems work best when lubricated with a bit of moral ambiguity."
As a Rhode Island resident, I didn't think this was a promising start for a discussion of ethics and research. The moral ambiguity of many politicians has fueled considerable cynicism about politics in general.
"I'm not sure I see the wisdom of drawing a 'bright line,' ... between NIH scientistis doing basic research and commercial enterprises that build upon that research. "
This is a false dichotomy, but seems to be a prevalent argument against the new standards. The false dichotomy is between major financial entanglements with pharma and biotechnology firms and no contact at all with such firms. NIH staff don't need to be paid huge consulting fees over and above their full-time salaries, or hold stock or collect stock options in pharmaceutical and biotech companies to work collaboratively with industry.
"What purpose is served by preventing them (NIH staff) from making a buck by sharing that informal knowledge with profit-making companies?"
The purpose is not having them feel beholden to the profit-making companies for all those bucks they make on the side. But again, why should people who work full-time for the NIH, and get six-figure salaries from the government, need to also "make a buck" from these companies?
"A surprising number of people violated those [existing] rules [requiring disclosing conflicts of interest]. But rather than coping with that by dealing harshly and publicly with a few of the worse offenders, the NIH brass have now caved in to pressure from Capitol Hill to prohibit drug and biotech-related investments and commercial entanglements by their researchers."
It is true that no one has yet dealt harshly with the NIH leaders who made the most money from consulting fees and stock options while supposedly working full time for Uncle Sam. Actually it is not true that the rules prohibit biotech-related investments by NIH staff, since they can still invest indirectly through, for example, mutual funds. Why is it bad in this case to listen to the opinion of Congress?
"But the right question is not whether we should stomp out every last bit of such 'corruption,' but whether the price is worth it. Having a fuzzy line, and giving administrators some flexibility in enforcing it, was probably better for medicine, better for the biotech industry, and certainly better for the Washington economy."
There has been very little research on the effects of conflicts of interest and corruption affecting the leaders of health care organizations, so there is no good data about what might be good for "medicine" or the public. However, it seems reasonable to hypothesize that commerical entanglements are bad because they may sway such NIH leaders, who have considerable power over what science gets done and how it is reported, in favor of their outside benefactors, leading to biased science, biased interpretation of science, and biased science policy. Furthermore, the knowledge that some NIH leaders may be beholden to commercial vested interests outside of the NIH threatens the credibility of all NIH sponsored research, the credibility of the NIH research priorities, and the credibility of NIH efforts to translate and disseminate research results. Finally, knowing that some NIH leaders are financially benefiting from conflicts of interest may clearly demoralize NIH staff, NIH-supported scientists, and researchers seeking NIH support who do not have such conflicts.

Similar was the commentary in Forbes by Thomas P. Stossel MD.
"In the real world, these restrictions (on conflicts of interest) address nearly nonexistent scientific corruption and ultimately impede medical progress by depriving pharmaceutical companies of access to biomedical scholars."
See my comments above. Since there have been few relevant studies, it's not clear how much corruption there is. Again, biomedical companies can easily get access to and collaborate with scholars without paying them personally for consulting or handing them stock options.
"How did financial conflicts-of-interest rules get to be such a big deal? One reason is that the gatekeepers of the medical literature believe it is. Editors of high-profile medical journals vilify the pharmaceutical industry..."
Funny, I have seen criticism that medical journals have been too cozy with that industry. Note that for Stossel the bogey-man seems to be journal editors, while for Pearlstein it was "Capitol Hill."
"The public wants trustworthy science, and it can get that without new ethical rules. Even more, it wants results - lives saved - and it can't get those if commercial sponsorship of research is made difficult, if not impossible."
Again, why should the public will find research more trustworthy if the researcher is getting paid on the side by industry? Again, note the false dichotomy. Industry can certainly sponsor research done at academic organizations by research grants without paying researchers consulting fees in addition to their full-time salaries.

For contrast, see the editorial in the Philadelphia Inquirer. My favorite quotes were:
"The NIH staffers' outside work involved paid consulting, teaching, speaking or writing for private health-care firms - with drugmakes bankrolling many of the deals. Financial arrangements like these, allowed since, 1995, pose a huge conflict for all the 6,000-plus NIH scientists. How so? Because NIH officials' day jobs position them to promote or aid these firms through grants, contracts, and approvals."
"As a group, NIH scientists pulled in millions of dollars in consulting and other fees. With that kind of money at stake, to whose interests were they most attuned - the publics', or their second employers'?
"Institutes' officials must monitor whether an exodus of talent occurs. If so, the correct remedy is better pay - not watering down ethical core standards."
'Nuff said.

Major medical center thrashes for clinical IT leadership

Major medical center in Philadelphia, Temple University, thrashes around for clinical IT leadership.

This ad, regarding a "a seven-year, enterprise-wide Information Technology strategic plan" for clinical IT and process redesign, was posted again on the job exchange area of the American Medical Informatics Association. It has many hallmarks of the lack of awareness of sociotechnical issues in clinical IT and of the role of Healthcare Informatics professionals in studying and preventing costly errors experienced by other medical centers, and of facilitating change.

"The ideal candidate will have a Bachelor’s degree; a Master’s is preferred [in what, exactly, is unclear-SS]. Significant IT skills [why don't I see "Medical Informatics" or clinical medicine training anywhere? - SS] with 8-10 years in managing a CIS Implementation Process in a large, complex academic medical center or multi-hospital health system is also required....The Director must have a demonstrated, successful track record in Operations Improvement, Clinical Work Redesign, Benchmarking and results monitoring as well as strong project management skills. The ability to conduct educational training and coaching on project management, change management and Operations Improvement analysis is also essential."

This position also has the hallmark of a "Director of Nothing" position, lacking executive presense and credibility with medical staff - especially tough medical specialists such as surgeons, invasive cardiologists, and the like:

The Operations Improvement Director/Clinical Work Redesign will provide support, leadership and guidance to all system entities’ OI Teams during the implementation process. He/she will serve as a Team Leader and Major Change Agent leading multiple Redesign Teams.

With a bachelor's or master's degree in field that is unspecified, such a person is likely going to have a very hard time convincing the medical staff of several major academic hospitals to acquiese to major work changes affecting how they practice medicine, for example. A summary of some of these issues is at the page "Ten critical rules about job structure and reporting for applied informatics positions", authored by me in 1998 or so.

My background was, for example, deemed unsuitable for this role when I inquired last year, despite the fact that I'd successfully led evaluation, acquisition and implementation of both vendor-acquired clinical IT (e.g., the Logician EMR), and personally led custom development of advanced subspecialty IT (e.g., in Invasive Cardiology), in large (1500 bed) multi-hospital medical centers. The rejection was on the basis of "not having enough clinical process redesign experience." Not even called for an interview; the rejection was paper-based.

Others with formal training and experience in Healthcare Informatics, with training and background similar to mine, were likely also rejected. This posting is a repeat on a primary site for NIH-program Informatics recruiting, namely, the website of the American Medical Informatics Association.

It is a sad phenomenon to watch this apparent thrashing, essentially reflecting an "informatics immaturity", over and over again throughout a period dating back at least 12 years in my case, when I was an NIH Postdoctoral Fellow in Medical Informatics. Perhaps I should not complain. The pioneers in clinical IT began noting these issues 30+ years ago.

It's also possible that resumes of those with formal Medical Informatics credentials scare the daylights out of some people in large medical centers -- for example, IT personnel with no clinical training or experience, and "Medical Instamaticists" (e.g., clinicians whose credentials in information technology amount to novice or intermediate-level tinkering as per this taxonomy of informatics skills).

The NIH has tried to introduce a cadre of specialists to make EMR implementation more efficient but even after more than a decade of dedicated funding for programs at some of the country's best universities, the word has not gotten out as well as it should have. In the end, patients (and taxpayers) pay the price for errors in clinical IT implementation - sometimes spectacularly so.

As Roy Poses' correspondent notes below regarding leadership of Independence Blue Cross of Pennsylvania:

"What you're seeing is typical of most businesses. This seems to me to be the result of some myopic views taught in B-schools; "you don't have to know 'THE' business, just how to run 'A' business." Similarly, some folks think just because they can "do anything," they can run a business. I'm trying to convince them that "it ain't necessarily so."

This myopia seems to permeate down far below the C-officer level in the so-called "healthcare system" in the U.S.

I hope I'm wrong, but the Internist-learned pattern detection algorithms in my grey matter sense a long and arduous implementation process at Temple. That public money may be spent on this seven-year project (Temple University is a state-funded school) is a real issue.

-- SS

Pogo at the NIH

If we, as health professionals, want health care to be more honestly and rationally managed, we must be prepared to do our best to conduct ourselves honestly and rationally. Of course, dealing honestly with others is a fundamental value for physicians, and is codified in, for example, the AMA Principles of Medical Ethics, and the ACP-ASIM-ESIM Physician Charter.

Today's Washington Post has a disturbing report about NIH staff reactions to the new ethics policy, (first reported on Health Care Renewal here and here.) According to the Post, "nary a positive word had been uttered about the new policy, and there was more vented spleen around than a busy medical center like the NIH might normally see in a year." For example, Chief of Clinical Bioethics Ezekiel Emanuel "fumed" that his secretary would have to sell her stock, (presumably because the rules require that lower-ranking NIH employees limit individual stock holdings in drug, biotechnology, and similar companies to those valued at less than $15,000), and later asked "if we want to reassure the public, why don't we apply these [rules] to everyone who gets an NIH grant." There was indignation that the rules didn't apply to other federal departments, like Energy, Agriculture, and Defense, and that they didn't apply to grant reviewers.

These comments seem to reflect a troubling lack of knowledge about how the NIH funds research outside of its walls. Hardly any individuals get NIH grants. The money goes to their institutions. Many research universities have had strict conflict of interest policies in place for quite a while. NIH grant reviewers have also had to follow strict conflict of interest rules going back to at least the 1980's. These rules, unlike those that applied to NIH full-time employees, were never, to my knowledge, relaxed.

The comments also seem to exaggerate the hardships imposed by the new rules for NIH full-time employees. NIH employees are not being asked to give their stock holdings away. They are being asked to sell them, and they get to keep the money. Nor are they being barred from most kinds of investment. They can own stock in any kind of company that is not directly involved with pharma, biotech, and the like, and they can own any mutual fund or other diversified holding.

But it is most discouraging to hear high level NIH employees, and particularly their head of bioethics, complain that they should only be subject to the lowest common denominator of ethical rules, rather than at least acknowledge the need to set an example after their organization has been tarred by scandal.

As Pogo said, "we have met the enemy and he is us."

NIH Seeks "Higher Standard" - Better Late Than Never

Finally, the headline reads "NIH Seeks 'Higher Standard.'" More than 13 months after the Los Angeles Times published its first investigative report detailing serious conflicts of interest affecting top NIH leaders, NIH Director Elias Zerhouni has decided the time has come to provide "at least one source of public health information in the country that can be completely trusted," and "we need to hold NIH and ourselves as scientists at NIH to a higher standard, because we do have national public health responsibilities." Of course, prior to the alteration of the NIH rules and disclosure requirements about possible conflicts in the 1990's, the NIH was a completely trusted source of science. But for 13 months, Zerhouni and his organization fought restrictions on outside income for full-time government employees, even as it was revealed that some NIH leaders were making hundreds of thousands as "consultants" to pharmaceutical and biotech companies. See our previous discussions here and here. But now, at least Zerhouni admits "I've changed my mind." Better late than never....

Revisiting: More Tuition, But Less Teaching

We are not the only ones talking about how tuition rises while instruction suffers. Here is an interesting blog discussion of the problem as it afflicts undergraduate education. Note the question whether "costs can be controlled by stripping away all the ancillary stuff - the health centers, the multi-cultural institutes, the student life programming. Tuition in this model would be used for basically one thing: to provide instruction." I was arguing that the first priority of tuition for medical school is also to "support instruction." However, does anyone know how much of the medical schools' budgets go for such ancillaries? Or how much goes for instruction? I have never seen the former addressed. There is suggestive data that the answer to the latter is not as much as you would expect.

A New CEO for Independence Blue Cross

Independence Blue Cross (IBC) of Pennsylvania just announced the appointment of a new CEO after the untimely death of its former leader, G. Fred DiBona Jr. His Philadelphia Inquirer obituary summarized his career before he started at Blue Cross:

In 1976, at the age of 25, he was appointed to the Philadelphia Zoning Board of Adjustment, quickly rising to become its chairman. Two years later, Mr. DiBona was named head of the Philadelphia Port Corp. He led the agency for four years and was appointed president and chief executive officer of the Greater Philadelphia Chamber of Commerce in 1983. During his three years there, membership rose to 5,000 from 1,800. From the chamber, he moved in 1986 to Pennsylvania Blue Shield....

The new CEO is Joseph Frick. His brief bio in the IBC press release includes:

Frick, 52, had been Senior Vice President - Human Resources and Administration since 1997. In this capacity, he was responsible for corporate planning and business development, as well as IBC's Human Resources and Administrative services functions. He joined IBC in 1993 as Vice President, Human Resources, after spending almost six years in several HR positions at Philadelphia Newspapers Inc. (PNI). Before coming to PNI, Frick spent 13 years at Westinghouse Electric Corporation in various training and development, quality control and planning positions.

Thus IBC, a huge health insurer and managed care organization with 3.5 million subscribers and $10 billion in revenue, will have had two successive CEOs with no demonstrable experience "on the ground" in health care. I received a comment on this issue from a correspondent with considerable relevant insurance and managed care experience:

What you're seeing is typical of most businesses. This seems to me to be the result of some myopic views taught in B-schools; "you don't have to know 'THE' business, just how to run 'A' business." Similarly, some folks think just because they can "do anything," they can run a business. I'm trying to convince them that "it ain't necessarily so."

It makes you wonder how much better off we all would be if such large health organizations had leaders who actually had experience in health care. We can only hope that Mr. Frick at least gets some input from people with real "on the ground" experience.

Ban on Federal Scientists' Consulting Nears

An article in the NY Times today on a forthcoming ban on consulting arrangements for NIH employees.

Whether hard action occurs and is strictly enforced over the long haul remains to be seen. These type of scandals tend to burn brightly for awhile, then turn to more lukewarm efforts once out of the public spotlight.

February 1, 2005
Ban on Federal Scientists' Consulting Nears
By GARDINER HARRIS

The National Institutes of Health and the Office of Government Ethicsare expected to announce a ban today on private consulting arrangements between scientists at the institutes and pharmaceutical and biotech companies.

The ban comes in the wake of damaging revelations that some government scientists leveraged their positions at the institutes to gain lucrative consulting contracts with such companies, arrangements that sometimes overlapped with their government work.

Dr. Elias Zerhouni, director of the institutes, emphasized in an interview last year that only 369 of the institutes' 6,000 scientists had consulting arrangements with such companies from 1999 to 2004. More than 80 percent of these scientists received $5,000 or less from outside consulting, Dr. Zerhouni said.

"I want to dispel the notion here that every scientist at N.I.H. has consulting arrangements with 10 companies," he said in the interview.

Dr. Zerhouni had hoped for months to preserve scientists' right to engage in some of these activities, saying a ban would turn the institutes into "a convent," which, he said, was not in keeping with Congress's insistence that its research lead to cures.

But a series of articles in The Los Angeles Times detailing the conflicts between some N.I.H. scientists' public and private work and several hearings by the House Energy and Commerce Committee forced Dr.Zerhouni to retreat and finally propose late last year a ban on outside consulting activities. Since the ban was a change to government policies, it required approval from the Office of Government Ethics. That office is expected to announce today that it has approved such a ban.

Representative Diana DeGette, a Democrat from Colorado and a member of the House Energy and Commerce Committee, released a statement yesterday saying that the institutes' new consulting guidelines would be "a major step toward restoring public confidence in our nation's premier research institution."

Studies show that researchers who accept money from private companies are less likely than others to share the results of their work with their colleagues. Such researchers are also more likely to focus on commercially applicable studies, said Dr. David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospitalin Boston.

Mildred Cho, associate director of the Center for Biomedical Ethics at Stanford University, said that academic researchers increasingly collaborated with drug and biotech companies, and that the growing number of consulting relationships between N.I.H. researchers and companies had simply reflected that trend.

"What's different about this," Dr. Cho said, "is that it involves the government, government research and government funding of research. That represents a crossing of a line that hadn't been crossed before."

The number of cases that have come to light so far are wide-ranging and include top-level administrators and working researchers alike.

Dr. Bryan Brewer Jr., for instance, is chief of the National Heart,Lung and Blood Institute's molecular disease branch. In 2003, he wrote an article promoting the benefits of Crestor, a cholesterol-lowering medicine from AstraZeneca.

The article was published in a medical journal "supplement" that was paid for by AstraZeneca, and Dr. Brewer's N.I.H. title was prominently displayed.

The article failed to mention potentially serious safety problems with Crestor.
In the interview last year, Dr. Zerhouni distanced himself from Dr.Brewer's Crestor article, saying that it was a "marketing effort" and "a product-driven endorsement" that should be banned.

Dr. P. Trey Sunderland, a senior researcher at the National Institute of Mental Health, received more than $500,000 in consulting fees from Pfizer at the same time that he was collaborating with it in his government capacity of studying patients with Alzheimer's disease. Despite rules requiring that government scientists disclose their consulting arrangements to the health institutes, Dr. Sunderland failed to make such a disclosure.

Dr. Zerhouni has described Dr. Sunderland's case as "a way outlier" that is being closely investigated.

Private consulting arrangements between N.I.H. researchers and drug and biotech companies were relatively rare until the 1980's, when they slowly started to grow. They grew quickly after Dr. Harold Varmus, who was the institutes' director in the 1990's, decided to lift the limits on outside income, and administrators loosened disclosure rules about these activities.

When the House began investigating, it asked Dr. Zerhouni to produce a list of agency researchers who were consulting for companies and the amounts they made. At first, Dr. Zerhouni said such a list would be impossible to produce. The committee asked pharmaceutical companies to disclose a list of their consultants at the agency. Finally, Dr. Zerhouni produced a list of consultants.

But the lists produced by the drug companies included dozens of researchers who had not been listed by the institutes. Dr. Zerhouni said some of those names were errors. But, he said, the agency is investigating "30 or 40" people whose outside consulting arrangements were unknown to the institutes, and among them is Dr. Sunderland.

Neither Dr. Sunderland nor Dr. Brewer could be reached. An institutes spokesman also declined to comment.