Thursday, March 17, 2005

Are Older Healthcare Executives Dumber?

I'm not sure any further explanation of the absurd title of this entry is needed in relation to what looks like a really pathetic attempt to self-marginalize the medical profession.

One of the purposes of blogs like this towards absurdities in medicine can be summed up as: if they can't be made to see the light, then they must be made to feel the heat.

-- SS

Are Older Doctors Dumber? - Reloaded

Joe Diaz and I published an e-letter about the Chourdry et al review of physicians' age versus performance. The e-letter was similar to what I had posted last month on this blog.
Coincidentally, or inspired by our letter, a whole host of other e-letters appeared, all sharply critical of the Choudry article. See all the e-letters here.
Some points that they raised were:
  • that the authors of the Choudry et al review may have had conflicts of interest that affected their results, conflicts that were not properly disclosed
  • publishing such an article, disparaging "older physicians with flimsy data," raises questions about the Annals' publishing policies at a time when older physicians are being driven out of practice early by malpractice insurance and reimbursement concerns
  • the article will be used as justification for increasing mandatory re-testing of older doctors, as was advocated by ABIM leaders in an accompanying editorial, even though it provides no evidence that such testing would actually improve performance
  • publishing the article without acknowledging its severe limitations could have grave "incalculable" effects on medicine and medical practice
Have a look.

Tuesday, March 15, 2005

Debate Swirls Around JAMA Article Critical of CPOE

The recent JAMA article on Computerized Physician Order Entry ("Role of Computerized Physician Order Entry Systems in facilitating Medication Errors") seems to have created controversy:


Health-IT World, March 15, 2005
Debate Swirls Around JAMA Article Critical of CPOE
http://tmlr.net/jump/?c=12208&m=2795&p=927207&t=164&a=296

Clinical informatics professionals are defending the efficacy of computerized physician order entry (CPOE) after a widely publicized report indicated that CPOE can introduce a multitude of errors to in-hospital medication processes.

"This article is drawing conclusions that are based on outdated technologies," says Samuel Bierstock, M.D., chief medical officer for IT consulting firm
Healthlink. "These are very old issues."

The article in question is a piece published last week --
Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors -- in the Journal of the American Medical Association (JAMA) suggesting that a "widely used" CPOE system tested at the University of Pennsylvania School of Medicine increased the risks of 22 different types of medication errors over paper-based ordering.

"That CPOE use might increase the likelihood of medication errors was an unanticipated finding," a Penn research team concluded. The researchers based this finding on interviews and surveys of house staff, observation of clinicians and focus groups. Among staff at the university's hospital, 72 percent said they had questions about medications and dosages because the system did not display complete medication lists on a single screen. Also, the report said, "It is easy to select the wrong patient file because names and drugs are close together, the font is small, and, most critical here, patients' names do not appear on all screens."

The researchers surmised there has been limited attention on risks posed by CPOE because most studies on the technology have focused on error reduction. Since the report became public last week, however, national media have seized on the findings to question the wisdom of investing in pricey CPOE systems.

What is not getting a lot of press, health-IT experts say, is the methodology in the JAMA study. "A lot of the things that are brought forward are really simple to avoid," according to Manuel Lowenhaupt, M.D., national practice leader for clinical transformation at
Capgemini. For example, during the survey period, the Penn clinicians were using a TDS 7000 installation, a legacy brand that Eclipsys Corp. (Boca Raton, Fla.) acquired in 1997 and no longer produced. The display was monochromatic and the database was only loosely integrated with other hospital information systems, according to Bierstock, a former Eclipsys executive.

"That fragmentation is not something you should ever build a system to support," Lowenhaupt added.

"CPOE is a tool," according to Lowenhaupt. "The sophistication of the tool in the JAMA article is far from ideal."

Both Lowenhaupt and Bierstock agreed with the JAMA assessment that the organization of work is more important than the technology itself: "CPOE must determine clinical actions only if they improve, or at least do not deteriorate, patient care," the Penn team said.

"I could write a much more damning article about paper processes that exist," Lowenhaupt said. "All of those errors can be addressed and mitigated by designing paper processes correctly. The same can't be said about paper processes."According to Bierstock, "This highlights our need to analyze how physicians think, process and act on data when it's coming to them in a whole new fashion." He added, though, "I don't see it as an indictment of CPOE technology."


Here are excerpts from my response (a derivative of my JAMA response) to Health-IT World, which has published some of my views in the past:

That the specific CPOE instantiation was "outdated" was of little relevance since its "outdated" nature was not the principal cause of its problems. Other clinical IT installations are far from trouble-free, not due to the versioning of the software but due to other sociotechnical and organizational issues. See below.

In fact, the author's JAMA article on Penn's CPOE issues is quite welcome as a start to closing the gaps in understanding widely-unknown problems in the world of clinical IT. Such articles are all too rare; these issues are often highly whitewashed in the industry-led healthcare IT press. There is also resistance to such articles from some academic quarters. However, either an organization is in control of its computing - and studies its IT issues and mistakes - or the IT is in control of the organization. That's an adaptation of an old UNIX adage "either you're in control of your system, or it's in control of you."

According to Manuel Lowenhaupt, M.D., national practice leader for clinical transformation at
Capgemini, a lot of the things that are brought forward are really simple to avoid." I disagree. If this were true, the nearly 6,000 hospital CIO's in the U.S. (not to mention those internationally) would have really plumb jobs. Clinical IT projects are incredibly complex social endeavors in unforgiving environments that happen to involve computers, as opposed to information technology projects that happen to involve doctors.

Those who oppose exposure of clinical IT's flaws, when the critique is geared towards learning and correction , are firmly rooted in a dysfuntional territorial mentality that has no place in a scientific field such as medicine. It may or may not have had its place in "data processing" shops of the past; however, such beliefs have no place in 21st century healthcare.

The Ten Day MBA

On the topic of highly-paid MBA's without scientific or clinical knowledge, training or experience acting as bulls in a china shop in healthcare, I have been reading a book "The Ten Day MBA: A step-by-step guide to mastering the skills taught in America's top business schools" by Steven Silbiger (Quill William Morrow, 1993, rev. 1999). In the introduction, the author, an MBA, relates that "one can grasp the fundamentals of an MBA without losing two years' wages and incurring a $50,000 debt for tuition and expenses."

After working in for-profit industry (Comdisco Healthcare Group) and then managing a 50+ staff Merck pharmaceutical research support department and a multimillion dollar budget - to under 1% of "estimated actuals" (budget allocations) each quarter for over three years running - I can say the information in this book appears quite useful and probably a good summary of the major issues in the MBA's education. I learned a lot of this type of material in just interacting with financial folks and strategic planning committees in running my department.

I cannot imagine a comparable book for the clinical professions. Titles such as "The Ten Day M.D.", "Endocrinology Expert in 30 Days", or "Dummy's Guide to Pediatric Neurosurgery" are simply too absurd to even contemplate. The rigors of medical education, from background sciences (in high school and college), graduate preclinical (basic) sciences, clinical sciences, preliminary clinical training (as a medical student), post-doctoral training (internship and residency), and subspecialty training required to obtain required expertise and licensure, make such a concept ludicrous.

As pointed out in another entry on this blog, "Do Physicians Have "the Knowledge to Run These Hospitals?" - Maybe More than Do MBAs", a typical businessperson without a clinical background is likely overextending their expertise on a regular basis, ultimately at the expense of patient care.

It is my view that in order to hold a high leadership position in a healthcare organization, a person needs a strong business-oriented background but also needs a significant clinical or biomedical science background. A dual background is needed in order to understand the clinical decision making process and not interfere in a deleterious manner through defective decisionmaking.

The fictitious "Ten Day M.D."-level background just won't cut it. In healthcare IT my colleagues and I have encountered the lame CEO, the megalomaniacal micromanaging COO, the scheming and technologically-challenged CIO, the airhead deputy CIO's and technology people, the Catbert-style HR managers, the skinflint CFO and financial managers, and the incompetent or dilettante managers and management consultants (J.D. Kleinke's "Oxymorons" incarnate), enough to make the following deliberately outlandish statement for the sake of argument:

"Healthcare is not likely to make major strides in true quality improvement and cost reduction until the MBA-executive leadership is either educated in medicine and science, or removed from their positions of authority and replaced with those who are."

"Medicine for patients and clinicians" could be an appropriate slogan for healthcare reform.

-- SS

Monday, March 14, 2005

A Million Dollar CEO With More Than an Arm Around "the Medical Expense Trend"

Earlier, I noted how Charles Baker, the CEO of Harvard Pilgrim Health Care, in Massachusetts, scolded employees for their responsibility for rising health care costs. He stated, "if everybody keeps doing what they're doing , we will probably never get our arms around the medical expense trend."
To check Mr Baker's contribution to the "medical expense trend," I found Harvard Pilgrim's 990 forms, which are available on the Guidestar web site.
( Harvard Pilgrim is a not-for-profit organization. All such organizations with revenues greater than $25,000 must file annual disclosure forms with the Internal Revenue Service (IRS). These must list compensation paid to their most highly paid employees. Guidestar maintains an on-line library of these forms, updated at least through 2003.)
Harvard Pilgrim's 2003 990 form showed that Mr Baker's total compensation was $1,045,336.
Maybe Mr Baker has more than an arm around "the medical expense trend."
Do I detect a whiff of hypocrisy here? By what moral authority does Mr Baker get to lecture employees about their responsibility for medical costs while he gets more than one million a year as the CEO of a not-for-profit one of whose ostensible goals is to control health care costs?

Sunday, March 13, 2005

Medical Insta-matics phenomenon?

Re: the post below, Locking the Emergency Department Doors in Toronto : I also note in the bio of Mr. Closson that "he is currently Vice Chair of the Canadian Institute for Health Information."

Is this an example of what I termed the Medical Instamatics phenomenon?

-- SS

Locking the Emergency Department Doors in Toronto

Yet another story about the hospital acute care capacity crunch, but with some new twists...
The Toronto Sun reports that Toronto General Hospital literally "locked the doors to the emergency department," and "posted a sign saying no ambulances or non-life threatening injuries allowed." Tom Closson, Presidnet of the University Health Network, which oversees the hospital, said "We are quite overwhelmed (since Tuesday night) and we have had a lot of sick patients." "Things were out of hand and we decided we couldn't take any more ambulances." He also indicated he wasn't aware of a law that prevented him from closing the ED. On the other hand, an official with the city's Emergency Medical Services said, "our position is Toronto General is still open until we hear differently from the ministry of health and we hope this is not an official policy." He also noted that the number of acute care beds in Toronto has dropped from 8300 in 1993 to 4700 now.
(In the spirit of an earlier post, note that Closson has a Bachelor of Applied Science degree in Industrial Engineering, and an MBA from York University in Ontario. He is a Certified Health Executive as per the Canadian College of Health Services Executives. In this bio from the Ontario Hospital Association, I cannot find any evidence that he ever directly provided health care.)
I guess I can't blame this one on managed care....
Again, the problem of episodic but worsening capacity crunches due to decreases in acute care capacity initiatied in the 1990's no longer seems confined to the US. Here, the rationale often was that efficiencies and preventive measures introduced by managed care would lessen the need for acute care beds. But things did not quite work out that way.
[Thanks to MedPundit for a tip about this.]

"The Way to Save Money and Increase Productivity is to Cut Management Jobs, Not Create Them"

A telling statistic about health care administrators, this time from the UK. A commentary in the Telegraph reported that from 2001-02, the number of doctors and nurses employed by the British National Health Service (NHS) increased 5%, while the number of managers increased by 17%. "The process by which administrators subconsciously create work for each other was described by Cyril Northcote Parkinson back in the fifties. But even he never foresaw the sickness that has come to afflict public organisations." (Parkinson was the author of Parkinson's law, "work expands so as to fill the time available for its completion." See Wikipedia.)
Furthermore, "the BBC [British Broadcasting Corporation] ... seems finally to have grasped that the way to save money and increase productivity is to cut management jobs, not create them. It his about time that the government and NHS grasped it too."
Maybe some big health care organizations in the US, and other countries could learn the same lesson.
Management seems to be the fastest growing part of healthcare in many developed countries.
Of course, this is bad enough even if the bureaucrats ultimately perform competently, albeit inefficiently. Things get worse if they are incompetent, put their self-interest ahead of the organization's mission, or are frankly corrupt.

Saturday, March 12, 2005

Re: Managed Care CEO Blames Patients for High Costs

My additional thoughts on the post below by Roy Poses regarding Harvard Pilgrim CEO Charles Baker's brilliant idea of using patients themselves to "control medical costs" (i.e., increase his organization's revenues), as presented in the Boston Globe:

"To the credit of the [Boston] Globe, the article provided some pithy dissent. Katherine Putnam, President of Putnam Machinery Co, responded that too much "healthcare spending goes to administration, not to providers of care. Furthermore, administration "would be an easy thing to cut."

I think a better piece of dissent came from my alma mater, Boston University:

Alan Sager, a Boston University professor in the School of Public Health, said employees should not be responsible for lowering costs. ''We send doctors to medical school, so they learn what care we need," he said. ''You can't use patients as kamikaze pilots in a cost control war."


An apt description. Sure, let's depend on patients to decide how they can best deny themselves care. Brilliant! Let's examine Mr. Baker's clinical and scientific credentials:

Charles D. Baker is President and CEO of Harvard Pilgrim Health Care, Inc.... before coming to Harvard Pilgrim, Charlie was president and CEO of Harvard Vanguard Medical Associates. Previously he spent eight years in Massachusetts state government, serving as Secretary of Administration and Finance, and Secretary of Health and Human Services during the Weld and Celluci Administrations ... Charlie received a Master’s degree in Management, concentrating in Public Administration and Finance, from Northwestern’s Kellogg School and a B.A. in English from Harvard College.


While I make no specific comments on Mr. Baker, not knowing him, in my exposures to healthcare managers who have no expertise in healthcare sciences or actual patient care experience, my observations have been that of arrogant people who believe an MBA precludes the need for any knowledge of the nuances of healthcare itself in providing healthcare leadership.

This overextension of expertise, based on false assumptions (e.g., that medicine is a widget-making business like McDonald's), and underestimations (e.g., of the complexities of medicine), remind me of potential follies such as a chairman of a Department of Neurosurgery (brain surgery) who's only trained in accounting, or an automobile mechanic only trained in fixing televisions.

For example, I learned quite a lot when I was a senior medical resident. I was faced with three near-simultaneous code 30's (cardiac arrests) in the ICU, during family visiting hours, while a Mennonite minister-in-training was trailing my team. I learned much from when I was part of the resuscitation team on New Year's Eve 1986 when one of my colleagues, Abington hospital's fertility specialist, was brought in with a gunshot wound to the chest from a home intruder. I performed open chest heart massage while the ER trauma surgeons worked frantically in vain (the bullet had severed the aorta) - while having to evaluate and admit nearly thirty other very sick medical patients that same night. And when I, as a doctor, had to report to a clinical colleague who was phoning from his father's funeral that his mother, also my patient, had just passed away moments prior (I spared him this sad news until later, only saying on the phone that there was "no change" in mom's condition.) And when, on a hunch, I repaired a CT scanner via fixing its computer in the wee hours of the night between Sunday and Monday (when the company who made the machine stunningly provided no service) and prevented a lumbar puncture (spinal tap) from being performed on a young, delirious patient who turned out to have a hydrocephalus (massive fluid buildup in his brain) which could have resulted in a fatal brain injury had the spinal tap been done.

Tell me where those with book-study Master's-level degrees in business obtain better judgment on medical affairs than clinicians who've gone through tough doctoral and postdoctoral-level training in the most intense of clinical environments.

In the healthcare information technology (IT) sector, I've personally observed millions of dollars being thrown down the drain needlessly through such arrogance and lack of clinical knowledge in the IT decisionmakers. I've heard about hundreds of millions more from others, including the national press (see my other posts on this blog such as about the University of Pennsylvania CPOE problems for links to such stories). The differences between those specially-trained for clinical IT leadership and those trained in business IT is quite large.

Who can convince me that the decisions by non-medically-trained, business-oriented healthcare executives are any better than that of the CIO's they hire?

Could it be that the MBA club has become a type of cult, and that "MBA Mysticism" and "Management by Magazine" (fad) is harming healthcare -- not to mention other industries?

-- SS

Managed Care CEO Blames Patients for High Costs

Charles Baker, the CEO of Harvard Pilgrim, a large, and heretofore well-reputed non-for-profit managed care organization in Massachusetts (and formerly in Rhode Island, until our local Blue Cross drove them out), "told executives they need to get employees involved in their medical spending decisions," according to the Boston Globe. He also said "if everybody keeps doing what they're doing, we will probably never get our arms around the medical expense trend." "There really has to be some disruptive activity."
My comments: if you want to give employees more involvement in medical spending decisions, that's fine. But will you also give them more involvement in decisions made about where they get their health care coverage, and which physicians and other professionals they go to for their care? Just blaming employees, i.e., people, for rising health care costs comes close to blaming the victim, given the little control that employees have over what sort of health care insurance they can get, and given the restrictive nature of many contemporary commercial managed care plans.
To the credit of the Globe, the article provided some pithy dissent. Katherine Putnam, President of Putnam Machinery Co, responded that too much "healthcare spending goes to administration, not to providers of care. Furthermore, administration "would be an easy thing to cut."
I agree, but by putting administrators (of managed care organizations, of hospitals, of corporations acting as employers, etc., etc.) in charge of cutting costs, can one expect that they are going to cut administrative costs? The implication, of course, is that patients and health care professionals have to have a bigger role in the governance of health care organizations. Otherwise, administrators are going to just continue seeing to their own.
Incidentally, the Globe identified Harvard-Pilgrim CEO Baker as a "possible Republican gubernatorial candidate." That might give voters an opportunity to show what they think of his prescription for cutting health care costs.

Health Canada Official Sentenced for Fraud

Another reminder that the irrestible temptations provided by running a large health care organization with a huge cash flow are not confined to the US, from the Edmonton Sun, and the Globe and Mail...
Paul Cochrane, a former Canadian Assistant Deputy Health Minister, was sentenced to a year in prison for fraud, as part of a plea bargain. Cochrane was in charge of the First Nations and Inuit Health Branch, with a budget of $1.2 billion (Canadian). He inflated funds going to the Virginia Fontaine Addictions Foundation on the Sagkeeng reservation north of Winnepeg from 1994-2000. For example, he unilaterally raised the per diem reimbursement rate paid to one of the foundation's centres, resulting in nearly $1 million in extra revenues. In total, the foundation received about $70 million from Health Canada. In return, Cochrane got "cash, SUVs, $27,000 in exotic travel and NHL tickets." He is still facing charges of tax evasion. Nine others have been charged so far in this ongoing investigation.

Friday, March 11, 2005

Refusing to Hire Smokers to Reduce Health Insurance Costs

Montgomery County, Pennsylvania, is considering whether to stop hiring anyone who smokes, according to the Philadelphia Inquirer. The reason is to save health insurance costs. The Chairman of the County Commissioners, James Matthews, said, "if we can cut down health care cost by not hiring smokers, let's do it. This is not about taking away anything from anybody."
This is another example of the confusions resulting from having employers pay for their employees health insurance (presumably with money that would otherwise have increased their salaries). A small, but growing number of employers obviously assumes that this practice, which arises from history and tax law, gives them a license to either control their employees behavior or exclude employees whose private behavior raises the risk of bad health outcomes.
Of course, if one takes this to the logical extreme, think of all the sorts of people an employer could refuse to hire on the grounds that their private behavior increases their health risks....

Still More Fall-Out from the Bankruptcy of Allegheny: Womens' Medical Center to Close

The fallout from the bankruptcy of Allegheny Health Education and Research Foundation (AHERF) continues even now. The Philadelphia Inquirer reported that Women's Medical Center, formerly part of AHERF, formerly Medical College of Pennsylvania Hospital, is closing. Although some would argue that the hospital was already in trouble when Allegheny acquired it in 1988, there is at least an argument that mismanagement by AHERF, and then the catastropic bankruptcy of AHERF in 1998, the second largest bankruptcy of any kind in the country at that time, were also partially responsible for the end of the hospital. The hospital was originally part of Female Medical College, the first medical school for women in the US, founded in 1850.

Conflicted Leaders Leaving NIH

Three leaders at the NIH whom the Los Angeles Times had reported had major conflicts of interest are going to leave, again according to the Times.
H. Bryan Brewer Jr is leaving the National Heart Lung and Blood Institute (NHLBI). The Times had reported that Brewer received $114,000 in consulting fees from makers of cholesterol lowering drugs, including AstraZeneca, maker of Crestor, from 2001 to 2003. In his NHLBI role, he helped draft guidelines for cholesterol treatment. He wrote an article in the American Journal of Cardiology praising Crestor without disclosing that he had received money from AstraZeneca. Brewer will be going to a "research institute in the Washington area."
Lance A. Liotta, a laboratory chief at the National Cancer Institute (NCI) is also leaving. The Times had reported that Liotta, while working with one company to develop a test to detect ovarian cancer, had received $70,000 from another company making a competing product. Liotta will be going to George Mason University.
Emanuel F. Petricoin III, based at the NIH, but employed by the Food and Drug Administration will also be leaving for George Mason. He had worked with Liotta on the ovarian cancer detection project.
This is an apparent sign that the times they are a-changin' for conflict of interest at the NIH.

Thursday, March 10, 2005

US senator says FDA needs independent safety office

I think Senator Grassley has his priorities correct. As I wrote in a piece "Reflections on the future of drug safety surveillance from the Medical Informatics perspective" , pharmaceutical companies and regulatory agencies that ignore non-RCT data and studies such as retrosepective reviews on a dogmatic basis (due to a belief in the absolute ascendancy of controlled clinical trials) do so at their own peril. Such studies need to be factored into an overall risk portfolio of drugs to be consumed by millions, where even a small risk of major side effects could lead to catastrophe due to volume.

Unfortunately, this change in thinking will apparently not occur from within the industry.

DISCLAIMER: my views on this topic may be shaded due to the fact that various pharmas and CRO's would not hire me into positions involving drug safety and surveillance, or adverse events data analysis because, essentially, they felt I did not have enough experience. Oddly (and there's a lot of oddness in this domain), one major decisionmaker on this issue was himself a former high-level FDA adverse events official now working in pharma. He barely even gave me the time of day even though his staff wanted to hire me badly, if only for improving the primitive system they had for getting to adverse events data that was basically warehoused and rationed by the pharma's IT personnel.

Dr. David Graham of the FDA said the FDA's Office of New Drugs "unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not" [via clinical trials]. That rule does not protect consumers, Graham told the Senate committee. "What it does is it protects the drug," he said.

For those less scientifically-inclined, a somewhat crude and provocative translation of his statement might read: "a drug will be considered safe for consumption by tens of millions of people unless some small clinical trial on a few thousand (or sometimes just hundreds) of random people shows greater than 1-in-20 odds (say, 1 in 10) that the drug's suspected harmful side effects are real, and might actually harm or kill you. And, by the way, if the trial shows the chances at only 1 in 21, hallelujah! Sales! And, the stock price and the value of executive stock options go up!"

These observations have led me to a somewhat master-of-the-obvious hypothesis: that insights into process flaws, inadequate leadership skillsets, and perhaps even corruption in high-stakes industries can be gleaned by who they won't hire.

-- SS

US senator says FDA needs independent safety office
Thu Mar 10, 2005 08:15 AM ET

WASHINGTON, March 10 (Reuters) - The Food and Drug Administration needs an independent drug safety office with the power to order pharmaceutical companies to add warning labels to dangerous medicines, a top U.S. Senate Republican said on Thursday.

Senate Finance Committee Chairman Charles Grassley said he was preparing legislation to establish such an office in response to controversies surrounding Merck & Co. Inc's (MRK.N: Quote, Profile, Research) withdrawn arthritis pill Vioxx and other drugs.

"We need reforms, both administrative and legislative, to bring greater responsiveness and transparency to the FDA," Grassley said in remarks prepared for delivery at a Consumer Federation of America conference.

The new drug safety office "would have an independent director and the regulatory authority to require label changes," the Iowa Republican said.

Grassley and other lawmakers are investigating the FDA's monitoring of drug side effects, which came into question during the past year when two agency scientists said their warnings about drug dangers were ignored or suppressed.

Many critics have called for a drug safety office independent from the FDA's Office of New Drugs, which approves medicines for sale. They argue scientists in the Office of New Drugs may be reluctant to later acknowledge safety problems from medicines they have approved. The FDA responded to criticism by announcing the creation of a drug safety board, but Grassley and others said that board did not appear to have enough independence.

Last week, a top FDA official told Congress that stronger authority over drug warning labels could help ensure important safety information gets to the public quickly.

Grassley said the FDA had done "decades of good work" but became "too complacent" and "too cozy" with drug makers, who in some cases had engaged in fraud.
He said the Justice Department was aware of about 100 whistle-blowers who had made fraud allegations against 200 drug companies.

"In this fraudulent environment, the FDA's mission is more important than ever before. The FDA absolutely has to do a top-notch job on ensuring drug safety," he said.

Wednesday, March 09, 2005

Upenn: Not What The Doctor Ordered

The University of Pennsylvania has penned an excellent article in JAMA (March 9, 2005): Role of Computerized Physician Order Entry Systems in facilitating Medication Errors , Koppel et al (free article). A summary of the article was in today's Philadelphia Inquirer ("Not what the Doctor Ordered"). The authors studied a CPOE system at the Hospital of the University of Pennsylvania operational from 1997 to 2004 -- and since replaced.

Many IT and workflow system-related problems are cited as causing a situation where information technology implemented with the best of intentions was actually causing error. Among the problems cited were "loss of data, time and focus when CPOE is nonfunctional ... crashes are common." "Inflexible ordering screens." "Viewing one patient's medications may require 20 screens." "lack of coordination among information systems [causing antibiotic renewal failure]."

These, among other issues cited, are simply stunning. I was involved in implementing the exact same CPOE system (TDS) at Yale-New Haven Hospital in 1992. It appears that hospital IT is truly an island, with inadequate cross-institutional problem-sharing or corporate memory.

These issues are depressingly reminiscent of similar clinical IT observations I documented via an Internet collaboration with other medical informaticists starting in 1998 at the website "Sociotechnologic issues in clinical computing: Common Examples of Healthcare IT Failure."

Here's an excerpt from the Philadelphia Inquirer article (registration required for full access):

Not What The Doctor Ordered
By Susan FitzGerald, Inquirer Staff Writer
Computerized prescription-ordering systems are promoted as the answer to preventing medication errors in hospitals, but a new study shows the technology also can cause mistakes.

The study at the Hospital of the University of Pennsylvania found that computer systems that allowed doctors to order drugs electronically, rather than writing orders, could lead to a variety of errors, including requesting drugs for the wrong patient or at an incorrect dosage. "What is supposed to be the great solution is itself
a source of errors," said Ross Koppel, a Penn sociologist who led the study.

While computerized systems "do offer some real protection," Koppel said, the study identified 22 types of medication errors that could result from the technology.

I penned a reply to the authors and to JAMA, which I reproduce here:

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

Re: Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors” (JAMA, March 9, 2005)

Dear Dr. Koppel,

As a formally-trained Medical Informatics specialist formerly directing IT implementation in healthcare (Yale-New Haven Hospital, Christiana Care Health System after CIO Ward Keever's departure to HUP, and pharmaceuticals at Merck), I found the article “Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors” (JAMA, March 9, 2005) fascinating. Congratulations on an excellent and useful study.

I would, however, have liked to see a discussion of a critical element that I feel may be at the root cause of many clinical IT problems. The root issue I have in mind was hinted at in the statement “the researchers were not involved in CPOE system design, installation or operation.”

In my 1998 JAMA letter “Barriers to Computerized Prescribing” (JAMA.1998; 280: 516-517), I identified a lack of leadership by clinical experts, especially those with dual formal training in medicine and information technology (i.e., Medical Informatics), in the design, evaluation, acquisition, implementation, revision, and system life cycle processes in clinical IT.

Instead, these processes are customarily led by those of a Management Information Systems (business computing) background in both vendor environments and provider environments. By leadership I mean the direct control of resources, staffing, skill sets, personnel evaluation, and major decisions impacting the practice of medicine. Clinicians as “consultants who know something about computers” is proving an inadequate model for success of complex clinical IT, as your experience suggests. I submit that most, if not all, of the errors you observed from CPOE use had as a root cause an inadequate leadership expertise of the system designers, evaluators and implementers. These personnel did not have bad intentions, of course, but due to a basic misalignment of skillsets required for leadership in clinical IT the observed problems may result.

A stunning example of this phenomenon on a large scale was the recent $450 million hospital IT failure at the Bay Pines, Florida VA Hospital. Half a billion dollars was wasted due to the system designers and implementers admittedly not having sufficient understanding of hospitals and healthcare, a debacle detailed by the Google search http://www.google.com/search?hl=en&lr=&q=Bay+Pines+VA+hospital+computer+system+failure .

On a national scale, the UK’s multibillion dollar national electronic medical records initiative faces similar problems due to “lack of engagement by clinicians in the early stages of the programme” (“NHS joint IT chief resigns after six months in the job”, http://www.computerweekly.com/articles/article.asp?liArticleID=133699 ).

As Joan Ash, Ph.D. noted at Oregon Health & Science University in a 2003 study “Most hospitals don't use latest ordering technology” (http://www.eurekalert.org/pub_releases/2003-11/ohs-mhd112403.php ), "many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead these are designed for people who work in calm and solitary environments … some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician."

Calm and solitary environments, indeed.

How are CPOE and other clinical IT systems that ignore the healthcare workplace's realities finding their way into real products? How is this possible? While the workflow of the National Security Agency might be secretive, the realities of the medical work environment are certainly not. Who are the CPOE designers, exactly, and what are their backgrounds? How could investor dollars have been spent in such a fashion as to ignore the fundamental realities of clinical settings? How could IT companies have designed and implemented systems that "led to a loss of cognitive focus by the clinician" and created error?

Unfortunately, the answer to these questions is that design and implementation of CPOE systems and other clinical IT are being led by Management Information Systems business-computing personnel, who generally design and implement systems for "calm and solitary" business office environments, instead of those with both IT and clinical expertise such as Medical Informatics specialists.

I detailed a number of case studies of healthcare IT failures through inadequate leadership models by business computing personnel at my old website “Sociotechnologic issues in clinical computing: Common examples of healthcare IT failure” at http://home.aol.com/medinformaticsmd/failurecases.htm . You will likely find these cases of interest. The IT model of "If it's information, we do it" starts to fall apart and impede progress in such organizationally and sociologically-complex environments as medicine.

Clearly, clinical IT leadership models are defective and must be changed as an initial step before any of the recommendations you make in your article’s conclusion can be realized.

Sincerely,

Scot M. Silverstein, MD

Former faculty, Yale School of Medicine, Center for
Medical Informatics, Director of Clinical Informatics, Christiana Care Health
System, Wilmington, DE, and Director of Scientific Information Resources &
The Merck Index, Merck & Co., Inc.

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

(In my letter to JAMA, unfortunately, I forgot to include perhaps the most stunning of recent, costly CPOE missteps, "Doctors Pull Plug on Paperless System" at Cedars-Sinai Medical Center in Los Angeles, AMA News, Feb. 17, 2003. An excerpt:


As I wrote above, It appears that hospital IT is truly an island, with little cross-institutional sharing or memory. I sometimes wonder if Gilligan's Island is not an inappropriate metaphor for this phenomenon.

The author's JAMA article is quite welcome as a start to closing the gaps in the world of clinical IT. These articles are all too rare; these issues are often highly whitewashed in the hospital IT press. There is also resistance to such articles from many quarters. However, either an organization is in control of its computing - and studies its IT issues and mistakes - or the IT is in control of the organization. That's an adaptation of the old UNIX adage "either you're in control of your system, or it's in control of you."

Those who oppose exposure of clinical IT's flaws, when the critique is geared towards learning and correction , are firmly rooted in a dysfuntional territorial mentality that has no place in a scientific field such as medicine. It may or may not have had its place in "data processing" shops of the past; however, such beliefs have no place in 21st century healthcare.

It must be remembered that hospitals exist so that clinicians can take care of patients, not so that IT personnel, staff and vendor companies can have easy computing jobs and lucrative contracts.

(Note: I worked with an IBM/370-165 mainframe in the past at the assembly language level. As I recall, the TDS CPOE system ran on an a mainframe successor to the 370's that was of utmost industrial reliability, and the software was accessed via character-based terminal emulators (e.g., VT100) running on PC's. How such a system can have "common crashes" is somewhat of a mystery to me.)

-- SS
"Cedars-Sinai Medical Center in Los Angeles turned off its computerized physician order entry system in January, after hundreds of physicians complained that rather than speeding up and improving patient care, it actually slowed down the process of filling their orders -- assuming those orders didn't get lost in the system ... Cedars-Sinai's decision was extraordinary but not unique. David Classen, MD, of First Consulting Group, says he knows of at least six other hospitals that have pulled paperless systems in the face of physician resistance and other problems ... "They poorly designed the system, poorly sold it and then jammed it down our throats and had the audacity to say everybody loves it and that it's a great system," [Cedars-Sinai physician user Dr. Dudley] Danoff said."

Tuesday, March 08, 2005

Mismanagement: Like Medical School, Like University

Since the blog began in December, 2004, we have posted several stories about woes at the University of Colorado, suggesting poor management in inattention to the core mission of the medical school and academic health center:
  • the crumbling physical plant of the Denver Veterans Affairs Medical Center, posted here in December
  • confusion about plans to build a new VA Medical Center, here in January
  • the University of Colorado Health Science Center policy, instituted in 2002, to turn away less sick patients from the Emergency Department, now being copied by the University of Texas Medical Branch at Galveston, here in February
But these have hardly been the only woes afflicting the University.
  • The football program was rocked by a scandal involving sex and alcohol used for recruitment (see summary with extensive time-line here).
  • The chairman of its ethnic studies program, a tenured professor named Ward Churchill, became notorious after the uncovering of his essay that seemed to approve of the terrorist attack on the World Trade Center on September 11, 2001, and which derided the workers in the Trade Center as "little Eichmann's," i.e., Nazis. Reporters and bloggers discovered that Churchill achieved tenure and a department chair without having obtained a doctoral degree, but partially based on his claim that he is an Indian, which may be false, while he has been accused several times of committing academic fraud.
  • While faculty called for Churchill's academic freedom to be protected, they stood by silently when the University shut down a satiric "affirmative action bake sale."
Yesterday, amidst all this, the President of the University announced her resignation.
One can't help but suspect that there is a linkage between the widely publicized fiascos and scandals on the main campus and the woes of the medical school and academic health center. Why would one expect that an administration that is sloppy about its oversight of and inattentive to its mission on the main campus manage the medical school and the health center any better?

"We Fear to Inform the IT Emperor That Some of His Clothes are Missing"

After hearing a friend of mine rant about how guys in suits are trying to stuff the latest and greatest electronic health record (EHR) down her throat, without concern about the costs she will have to bear, without concern about whether the EHR will decrease or increase her work-load, and without any clear data that the EHR will improve her patient care...
Here are some great quotes from a commentary in the Times (UK) on putting too much trust in information technology (IT). This was not specifically about health care, but was certainly applicable to it.
  • "We are over-reliant on databases, over-optimistic about the electronic age. We do not learn from disappointment: we kid ourselves that every task can be not only eased but replaced by new technology. We turn tools into tyrants. We fear to inform the IT emperor that some his clothes are missing."
  • Per the British Information Commissioner, Richard Thomas, on the National Child Database, which was meant to record education and health information about every child in England and Wales, "it increases the size of the haystack when hunting for a needle."
  • "Ministers - gliding around in chauffeured cars, seeing everything through a filter of paperwork - get distanced from the muddy facts of life. They are seduced by salesmen's PowerPoint, and trustfully plunge into computerised projects without even the basic prudence to set tough penalties if the magic doesn't work."
  • "It is not computer technology itself which is to blame. What does the damage is ministerial ignorance and the nervous desire to be 'modern,' which leads to blind faith in IT and superstitious reverence for its providers. What is dangerous is the erroneous conviction (common to many of us) that once you've made an electronic list you've done the job. You haven't."

Tobacco CEO Quits Cancer Center Board

For a rare look inside the often closed and shadowy world of hospital boards, see the Boston Globe report about the rise and fall of Dana-Farber Cancer Center Trustee Bennett S. LeBow.
LeBow was appointed on January 25, with an official announcement that labeled him as an investor in the "computer industry" who "eventually expanded into other areas." On February 23, the hospital's newsletter described him as a businessman and philanthropist.
In fact, in 1986, LeBow acquired the Liggett Group, Inc., the maker of L&M, Lark, and Chesterfield brand cigarettes. Now his firm, the Vector Group, includes Liggett and Vector Tobacco as subsidiaries. It had 2.4% of the market for cigarettes in 2003.
In 1996, LeBow settled lawsuits filed by state attorneys general, avoiding huge payments by declaring that tobacco is a cancer risk.
On March 7, after the Boston Globe asked about his appointment, LeBow resigned from the Dana Farber Board of Trustees.
Matthew Myers, the President of Tobacco Free Kids, commented, "It's an appointment that on its face is inconsistent with the mission of the organization."

Monday, March 07, 2005

"Crying All The Way to the Bank:" Marketing Old Drugs by Combining Them With New Ones

From the NY Times, Pfizer has come up with a new scheme for marketing cholesterol lowering drugs.
The compnay is running clinical trials on a new drug, torcetrapib, that raises HDL ("good") cholesterol. Thus, the drug holds promise to offer benefits to patients beyond those from the traditional "statin" drugs, which lower LDL ("bad") cholesterol.
The trials apparently only involve a fixed combination of torcetrapib and Pfizer's statin drug, Lipitor. This suggests that Pfizer may only market the new drug in combination with Lipitor. Thus any patient who might benefit from the new drug would be forced to also take Lipitor instead of another statin (or a generic version of Lipitor, which will go off patent in 2010).
There is no reason to think that torcetrapib should work better with Lipitor than any other statin.
Thus the only obvious reason to offer only this fixed combination drug is to maintain the demand for brand-name Lipitor, according to Dr. Michael Crawford, a cardiologist at the University of California, San Francisco.
There are anti-trust laws that may ban companies from "tying" products together or refusing to sell one product without another. But it also seems that if the FDA were to accept Pfizer's application for a combined drug, this action would pre-empt an anti-trust complaint, according to the Times.
It may be a clever scheme to use one drug's novelty to maintain sales of another, older drug. But it clearly would restrict the choices open to doctors and patients, preventing some patients from getting drug combinations that might be cheaper, more effective, or less toxic for certain individuals.
As Dr. Crawford said, "It's an unfortunate decision on Pfizer's part. It's not going to sit well with people. But, you know, they're going to be just crying all the way to the bank."

Sunday, March 06, 2005

Big Medical Organizations Still Don't Understand Why Medical Students Don't Choose Primary Care

In Internal Medicine News Online is this gem of an article about how our fearless leaders are trying to attract more students into primary care fields. According to Michael Whitcomb MD, Senior Vice President of Medical Education for the American Association of Medical Colleges (AAMC), and Steven Weinberger MD, Senior Vice President for Medical Knowledge and Education at the American College of Physicians (ACP), and someone anonymous from the American Academy of Family Practice (AAFP), the reasons students don't go into primary care include:
  • "the way students see primary care"
  • students don't see "the proper management of chronic care patients"
  • "students often don't recognize the gratification of building relationships over many years"
  • students don't have "access to competent role models in family medicine"
Some still-dedicated medical school faculty who toil with ever less support from medical schools (even as tuition rises much faster than inflation) might feel insulted by the leaders of the AAMC, ACP, and AAFP who think they aren't demonstrating "proper management of chronic care patients," and aren't "competent role models."
For a good response see KevinMD:
" Graduates today finish with more debt and higher practice costs than at any time in the history of U.S. medicine, while facing a resource-constraining reimbursement system that has been racheting down physicians' incomes for many years now. Let the researchers puzzle over this: why would anyone want to go into a field where every indication is that the annoying stressors become ever more burdensome while the costs of operating a practice rise relentlessly and reimbursement is nearly flat. "
As Medical Rants put it:
"Understanding student decision making is not rocket science. Kevin does primary care - and he understands what our leaders apparently do not understand. "

Well, actually, Dr Weinberger of the ACP also said that "repairing the payment system, reducing administrative hassles, articulating the value of internal medicine, and redesigning training to better meet the scope of practice" are also important.

But it still seems like the leaders of the organizations that are supposed to support primary care don't understand the pressures on primary care physicians. The rising tide of paperwork and bureaucracy are far more than "hassles." The AAMC, ACP, and the AAFP should fight to support physicians' core values, not merely "articulate" the value of primary care and market it as "attractive"

The relatively small Society of General Internal Medicine recognized that primary care physicians face "chaos," not just "hassles." (Its annual meeting this year has the explicit theme of "Out of Chaos.") But the bigger, powerful, better funded AAMC, ACP, and AAFP still don't get it.

Friday, March 04, 2005

FDA Scolds Drug Companies for Direct to Consumer Advertising

In the Boston Globe, a US Food and Drug Admininstration (FDA) official scolded drug companies for their direct to consumer (DTC) advertising, saying "consider this a heads up. We are very concerned about the direction consumer advertising seems to be taking."
It took them long enough to become concerned.
However, I wonder whether the drug companies will submit voluntarily to more stringent regulation of DTC advertising, or will they argue that it's a violation of their free speech rights. And if they made such an argument, they might be right.
But as something of a free speech absolutist, I believe that the best way to challenge speech with which you disagree is by speaking out against it, not by attempting to silence it.
So I continue to wonder why all those "concerned" about DTC advertising, which ought to include managed care organizations and us physicians as well as the FDA, don't try to communicate directly to the public to counter the DTC advertising with which they disagree.

Thursday, March 03, 2005

Who Paid Those Who Protest the New Stringent Policy Against Conflict of Interest at the NIH?

The LA Times has yet more on the NIH. A committee of dissidents has been arguing that the new restrictions on outside income, consulting, stock options etc imposed by Director Zerhouni are too strict. The group complained that the new regulations "discourage talented, innovative scientists from staying at or being recruited to the NIH." According to the LA Times, committee members include:
"Dr. William E. Paul, chief of the laboratory of immunology at the NIH's National Institute of Allergy and Infectious Diseases. Paul from 2000 to early 2004 accepted a total of $380,000 in fees from Suntory Pharmaceuticals Research Lab and Novartis AG, plus $40,000 in travel expenses from Novartis."
"Howard A. Young, a microbiologist and section chief in the National Cancer Institute's laboratory of experimental immunology. Young received stock options for 500,000 shares from Advanced Viral Research Corp. from 2002 to 2003 to compensate him as a consultant."
"Dr. Harvey J. Alter, a blood-transfusion specialist at the NIH Clinical Center, the world's largest center for medical research on humans. Alter accepted $34,000 from six companies from 2001 to 2003."
"Dr. Steven K. Libutti, a researcher and surgeon with the National Cancer Institute. Libutti accepted $21,000 in consulting fees from two biomedical companies, Peregrine Pharmaceuticals Inc. and Therapro Consulting, from 2003 to 2004."
And two others who got smaller amounts from industry.
So is this committee supporting the ability of the NIH to attract talented scientists, or supporting the ability of its members to make a lot of money?
As long as NIH leaders get large payments from industry in addition to their full-time salaries, their loyalty will thus remain in question. This just once again illustrates the corrosive effect of the payments NIH leaders received on the their perceived trustworthiness.

US FDA official promises early drug risk warnings

My questions about the article below are these:

1. Exactly what "improvements in health and information technology" is Dr. Woodcock referring to? I'm not aware of any recent advancements in information technology that would "address recent concerns over drug side effects." The world of clinical IT issues a lot of press, but not enough substance - and that's in the delivery sector. Pharma seems a decade behind the healthcare delivery sector in my interactions with multiple companies, being firmly stuck in the data processing mentality of yesteryear as opposed to the clinical informatics mentality of the 21st century. An example: pharma computing leadership with management information systems (business computing) skills but no clinical or scientific credentials whatsoever .

2. On the issue of "considering whether longer pre-marketing trials are needed to catch problems earlier," my question is, what, exactly, needs to be considered? If longer (and/or larger) pre-marketing trials are not needed, then how, exactly, would the COX-2, Fen-Phen and pediatric antidepressant suicide problems have been avoided?

3. Regarding Woodcock's "declining to endorse proposals circulating in Congress," and her defense of the FDA's current system for detecting drug risks, how can one be considering changing a system while defending the current system at the same time? This strongly sounds like bureaucratic doubletalk.

There is so much money at stake in this issue, I expect true change to proceed even more slowly than in the provider sector. Much more slowly.

-- SS




US FDA official promises early drug risk warnings
Thu Mar 3, 2005 03:15 PM ET

By Lisa Richwine

WASHINGTON, March 3 (Reuters) - U.S. regulators are moving to get drug safety warnings to patients and physicians earlier, which should limit prescribing and cut the number of dangerous side effects, a top U.S. Food and Drug Administration official told Congress on Thursday. FDA acting deputy commissioner for operations, Dr. Janet Woodcock, said those efforts,
plus improvements in health and information technology, would address recent concerns over drug side effects.

Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) withdrawal of arthritis drug Vioxx in September prompted criticism that the FDA was lax in its oversight.

"We are now ... planning to put information out directly to the public on emerging safety issues" even before the FDA and a manufacturer agree to change the drug label, Woodcock told the Senate Health, Education, Labor and Pensions Committee.

Vioxx was widely prescribed because doctors were unaware of a 2000 study called Vigor that linked the drug to cardiovascular problems, Woodcock told the committee.

"Communications about the findings of the Vigor trial were not effective in reaching prescribers and patients, despite a (2002) label change that was made. Most prescribers really did not know about that finding," Woodcock said.

Merck withdrew Vioxx from the market last year after another study showed the drug increased the chances of heart attacks and strokes.

Pain relieving medicines such as Vioxx are approved after relatively short studies of three to six months of use.

FDA officials are considering whether longer pre-market trials are needed to catch problems earlier, Woodcock said. "It's something we are going to have to wrestle with," she told reporters.

Lawmakers are considering whether to give the FDA new authority or funding, or to change the agency's structure to improve the monitoring of medicines already on the market. The FDA has proposed a new drug safety board, but some lawmakers want a panel completely independent of the agency.

Woodcock declined to endorse any proposals circulating in Congress, and she defended the FDA's current system for detecting drug risks.

"It is really a continuum between pre-market and post-market (reviews).
It is by no means 'we simply forget this drug' after it's been approved," she said.

Sen. Mike Enzi, the health committee's chairman, said he had not decided what type of legislative fix to pursue. But the Wyoming Republican said "doing nothing to address the current controversies is not an option."

On the Web-based health movement: consumers as informed self-care managers

Amplifying the post below, I had written a piece "On the Web-based health movement: consumers as informed self-care managers" back in 1999 and was not sanguine about consumer-driven healthcare. The piece (a fragment of a larger site) is still online at http://home.aol.com/informaticsmd/consumer1.htm

-- SS

Wednesday, March 02, 2005

After "consumer driven health care" implodes, what next?

This week's New Republic has a very thought-provoking article by former NEJM editor Arnold Relman. It takes on some of the issues in health care finance and "market-driven" health care, and discusses why the new fad for CDHC (consumer-driven health care) is likely to end in the same morass of poor quality and shady deals that investor-owned managed care has (as often illustrated on this blog). CDHC is based on the same failure to understand why health care is not just another industry that led to the managed care fiasco. Worth a read, and discussion of his proposed solutions. Maybe the solutions are realistic, maybe not, but at least he has a realistic handle on the problem.

A Health Care System "Better Suited to a Monty Python Movie"

In the US, advocates for a single-payer health care financing system have long cited the Canadian model. And many of these advocates have implied that changing the US health care financing system would cure most of the country's health care ills.
To illustrate that a single-payer financing system has not solved all of Canada's health care problems, see this story in the Globe and Mail.
In Ontario, hospitals often have to guess what the government will set as their budgets, then run for most of the fiscal year based on the guess, only to find out at the end of the year that their guess was wrong. The provincial government may then blame the hospital for running a deficit based on a budget the hospital had never actually seen. So that's one reason why the head of the Ontario Hospital Assocation called for a new system, claiming the current one "would be better suited to a Monty Python movie."
This is just a reminder that organization and governance of health care may be even more important than financing. But in the US, financing receives much more attention.

Managed Care: The Reality

Managed care advocates claimed it would improve quality and reduce costs. Here are two more examples of the reality which proved to be something a bit different.
In today's Boston Globe, an article about increasing be shortages among Boston area hospitals. "By the 1990's, many healthcare specialists predicted that managed care insurance companies would restrict overnight hospital stays well into the future. So, hospitals mothballed beds, and some shut down entirely."
I remember all those predictions. I also remember wondering how managed care would wipe out so much disease that the demand for hospital beds would fall so much. After all, most people go to the hospital because they are sick. Of course, managed care didn't wipe out so much disease...
In today's New York Times, an article on the looming Prilosec shortage. Prilosec is now available over the counter, and demand for it is outstripping supply. Prilosec OTC is much cheaper than Nexium (both made by AstraZeneca), but molecularly, they are mirror images, and there is no evidence of which I am aware that Nexium produces better clinical results, despite all those ads for the new "little purple pill," funded by a massive Astra Zeneca marketing effort (worth US $260 M in 2003, the last year for which data were available.) Compounding the problem is that managed care rarely will pay for perscription Prilosec, which is generally available, because an over the counter version exists. Instead, the same insurers seem willing to pay for much more expensive Nexium.

Tuesday, March 01, 2005

The New England Journal of Medicine Meets Radical Chic

The New England Journal of Medicine rarely prints obituaries. Before this week, its last published obituary was of Francis Crick, who discovered the structure of DNA. During the second half of 2004, the deaths of Sune Bergstrom (1982 Nobel Prize in Medicine for research on prostaglandins), Sir Godfrey Hounsfield (1979 Nobel Prize in Medicine for development of CT scanning), Elizabeth Kubler-Ross (author of On Death and Dying), and Edward Lewis (1995 Nobel Prize in Medicine for research on genes controlling development) went unnoticed.
This week, that is, on February 24, however, the Journal published a page-long obituary of the writer Susan Sontag.
Susan Sontag did write about illness, notably in two books, Illness as Metaphor and AIDS and its Metaphors. However, she was not obviously a central figure in medicine, health care or biomedical research, certainly not on the order of Francis Crick.
She was, on the other hand, intensely political, an extreme, polarizing figure, revered by the "new left," and despised by the right. This was just barely hinted in Rita Charon's obituary: "her provocative positions on national and international policy and on public health debates polarized - and sharpened - the discourse, leading others, if not necessarily to agree with her, certainly to understand more clearly what they themselves sought."
In fact, Sontag has been denounced as an indefatigable anti-American and an admirer of tyranny.
She called American culture "inorganic, dead, coercive, authoritarian," "a cancerous society," and "a criminal, sinister country - swollen with priggishness, numbed by affluence, bemused by the monstrous conceit that it has the mandate to dispose of the destiny of the world" in the 1960's. During the same era, she called the white race "the cancer of human history."
After the terrorist attacks of September 11, 2001, she asked "where is the acknowledgment that this was not a 'cowardly' attack on 'civilization' or 'liberty' or 'humanity'or 'the free world' but an attack on the world's self-proclaimed superpower, undertaken as a consequence of specific American alliances and actions?" Furthermore, "whatever may be said of the perpetrators of Tuesday's slaughter, they were not cowards." On the other hand, she later decried the "jihadist mentality" of the Bust administration.
She discussed "the right way" for Americans "to love the Cuban revolution." She declared "the Cuban revolution is remarkably free of repression and bureaucratization," and that "no Cuban writer has been or is in jail, or failing to get his work published."
She denounced "American aggression" in the Viet Nam war. On the other hand, she applauded North Viet Nam for its treatment of American prisoners of war, "they genuinely care about the welfare of the hundreds of captured American pilots." Furthermore, she enthused she found "North Vietnam to be a place which, in many respects, deserves to be idealized."
Recognition of Susan Sontag, after so many Nobel prize winners went unnoticed, suggests that the New England Journal of Medicine, once the premier American medical journal, and generally consider non-partisan, has been politicized, taken a far-left stance, and jumped head-first into the culture wars.
To use a metaphor from Sontag's hey-day, "I see a bad moon rising, I see trouble on the way."

Monday, February 28, 2005

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."