Monday, January 31, 2005
Friday, January 28, 2005
I think there is plenty of blame to spread around for the Vioxx debacle. Physicians' enthuisiasm for Vioxx and other Cox-2 inhibitors clearly went beyond the evidence. And I think some physicians believed that Cox-2 inhibitors are actually more effective than regular non-steroidal anti-inflammatory drugs (NSAIDS), without evidence to support this belief.
Payers are frustrated that MDs are prescribing drugs patients don’t need, driving up short term costs with no attendant benefit to patients. Meanwhile, these decisions may very well lead to additional costs, as patients suffering cardiovascular events who also took COX-2s for WC injuries seek compensation from their WC payer.
The net - payers see MD prescribing behavior as abdicating responsibility, and increasing payer costs. Frustration is rampant.
However, before 2004, it would have taken some digging to find evidence that suggested Cox-2 inhibitors were actually dangerous. The published VIGOR trial data did show heart attack risk was higher in the Vioxx group, but this could have been due to chance alone. Although the most evidence-based discussions of Cox-2 inhibitors did raise questions about cardiac risk, they offered no definitive conlusions (see the Cochrane Review and ACP Journal Club from 2002.)
Furthermore, even the most evidence-based physician would have had a hard time discouraging a patient absolutely determined to get a Cox-2 inhibitor before 2004, especially in the context of the typical 15 minute visit during which Cox-2 may have been only one of many issues raised. Such patients were not rare, due to vigorous direct to consumer (DTC) advertisements.
Managed care, of course, has to accept some blame for deluging physicians with paper-work and bureaucracy, while cutting reimbursements for office visits, thus making it financially disadvantageous for physicians to spend enough time with patients to discuss benefits and harms of treatments. Managed care, of course, likes to talk about "evidence-based medicine," but has provided little real support for clinical trials, systematic reviews, or educating physicians about evidence-based medicine. And managed care did nothing to counter all those fancy pharamaceutical DTC advertising campaigns that down-played the adverse effects of drugs, including Cox-2 inhibitors.
If managed care organizations really want patients to get the best possible care based on the best possible evidence, they should provide support and incentives for physicians to take enough time with patients, and for physicians to understand, have access to, and be able to use the tools of evidence-based medicine.
 Bombardier C et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-8.
 Garner S et al. Rofecoxib for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev 2002; CD003685.
 Meyerhoff J. Rofecoxib, 25 md/d, was more effective than rofecoxib, 12.5 md/d, or acetaminophen in osteoarthritis of the knee. ACP Journal Club 2002; 137: 26.
Thursday, January 27, 2005
The Detroit News just reported that Weyco, ironically a medical benefits adminstration firm, fired four workers because they refused to be tested to see if they were smoking during off hours. The company already had stopped hiring smokers, and fined workers who continued to smoke. Weyco President Howard Weyers said his motivation included "saving money on the company's own insurance claims," according to Reuters. An editorialist also quoted him as saying, "I don't want to pay for the results of smoking." Next on his agenda, again according to Reuters, is to "tell fat workers to lose weight or else."
The trend is spreading locally in Michigan, as Kalamazoo Community College is refusing to hire smokers to "reduce health care claims by 10 percent," per Sandy Bohnet, its Vice President for Human Resources.
The federal tax laws allow companies, but not individuals to deduct health insurance payments, so employers take money that could have added to employees' salaries to pay directly for their health insurance. Because they "pay" for employees' health insurance, some employers now seem to think they own their employees' bodies.
As a physician, I am no fan of smoking, but firing employees just because they smoke (off the job) just adds insult to injury. Of course, more rational tax laws could let individuals could make their own decisions about health insurance and health-related behavior, and be the ones responsible for their actions.
Wednesday, January 26, 2005
Science, and therefore science based medicine, of course, requires the free communication of research data and results, and the free analysis, interpretation, and discussion of them. The very last place in the world I would have expected to see someone who publicly discussed questionable research methods "overwhelmed with force" is the NIH, formerly one of the world's foremost biomedical research organizations.
This story, coupled with previous stories about major conflicts of interest affecting NIH leaders (see previous posts here and here and here) suggests the NIH badly needs new leadership who will respect its mission.
Tuesday, January 25, 2005
The pharmaceutical companies should provide moneys for drug testing, but have no influence on what studies are done or how they are performed. Only if we have the research at arm’s length from those in position to benefit from the study results can we have ethical evaluation of new drugs. Is this position anti-capitalistic? I argue that the public welfare requires that we have good data on drugs, diagnostic tests, etc.
By Lindsey Tanner
CHICAGO - Merck & Co. forced one of its researchers to remove her name from a study linking Vioxx to heart attacks, then criticized the findings before ultimately pulling the arthritis drug from the market last fall, two of the scientist's colleagues said.
"Even after funding and agreeing with the design of the study, Merck publicly discredited our findings," Drs. Daniel Solomon and Jerry Avorn of Boston's Brigham and Women's Hospital wrote in this week's Archives of Internal Medicine.
Merck spokeswoman Anita Larsen confirmed the company's action, saying Merck believed the study's conclusions "were not supported by the data." The incident came about six months before another study prompted the drugmaker to withdraw Vioxx.
The journal contains several studies about Vioxx and Celebrex, the once popular and heavily promoted painkillers advertised as stomach-friendly alternatives to aspirin. They are under congressional and regulatory scrutiny.
One new report echoes previous data suggesting that in some older patients the drugs might not offer as much protection as thought against gastrointestinal problems. A separate study suggests they have been overprescribed, frequently to patients at low risk for gastrointestinal problems. And other research supports evidence that Vioxx increases some patients' blood pressure.
Vioxx was withdrawn Sept. 30 because of a study suggesting it doubled the risk of heart attack and stroke. Celebrex maker Pfizer Inc. halted its ads last month after a study linked high doses with increased heart and stroke risks.
Both drugs are in a class called Cox-2 inhibitors. The Archives reports, published yesterday, come weeks before a Feb. 16-18 Food and Drug Administration meeting on the safety of all Cox-2 drugs. Also yesterday, the watchdog group Public Citizen petitioned the FDA to immediately remove from the market Celebrex and a related drug, Bextra, because of the potential heart risks.
Critics contend Merck tried for years to suppress Vioxx risks found in numerous studies. The company maintains it has acted responsibly.
The author-removal incident, mentioned in previous news reports, involved a Merck study of more than 50,000 patients age 65 and older taking Vioxx, Celebrex, traditional painkillers, or none of the drugs. The results, published last year in the journal Circulation, showed Vioxx patients faced a higher heart-attack risk than the other groups did.
When the results came in, "Merck required a co-author who was an employee of the company to remove her name from the article immediately prior to publication," Solomon and Avorn said in an Archives editorial.
Solomon identified the coauthor as Merck epidemiologist Carolyn Cannuscio. She did not respond to e-mail and telephone requests for comment.
Sunday, January 23, 2005
This quote appeared in the Milwaukee Journal Sentinel last month, from a press conference Thompson gave after he announced his resignation.
"Out here, in this department, you get an idea and you have to vet it with all the division heads and the 67,000 employees. . . . then it goes over to the supergod in our society, and the supergod is O.M.B. [Office of Management and Budget.] And they turn you down nine times out of 10, just to show you who the boss is. Then it goes to the young intelligentsia of the White House, who don't believe that anything original or good can come from a cabinet secretary. And if you do get by them, it goes to the president. And if the president does agree with it, it goes on to the Congress, and if Congress ever does pass it, it's time to retire."
Similarly, in Houston, a story from the Chronicle about how the new Texas law designed to make mental health care more efficient has resulted in long waiting lists for anyone not overtly psychotic, and an apparent dearth of chronic care.
At the same time, the Chronicle reported how the latest trend in Houston general hospitals is patient amenities. It described, for example, the University of Texas M.D. Anderson's new Ambulatory Clinical Building, "with its commissioned artwork, hotel-like lobby, waiting rooms with wireless internet access and garden terraces."
So we have poverty amidst plenty. In the US, where health care costs increase annually much more than the inflation rate, where we spend more than $1.5 trillion on health care, we cannot provide enough emergency room and hospital capacity for the predictable acute respiratory illness surge in winter. In one city, the wait for an out-patient mental health care appointment for the poor is 3 1/2 months, but a state-supported hospital now displays commissioned artwork and provides wireless internet access? What does this say about the values of our health care leaders?
Friday, January 21, 2005
Why mention this here? Apparently, Massachusetts law requires immediate reporting of infectious diseases like tularemia, yet BU did not report the outbreak to the public health department until November 9. BU has been planning the construction of a Level 4 laboratory to study extremely virulent pathogens at a site in the densely populated South End of Boston. To gain approval for the new laboratory, BU filed an environmental impact report with the state Environmental Affairs department that claimed a perfect safety record for protecting workers against laboratory acquired infections. However, BU failed to update the report with information about the outbreak, despite state environmental regulations that require such corrections.
Finally, as a Globe editorial noted, to sell the laboratory to a dubious public, BU promised maximum opennes and candor. However, BU never notified the public of the tularemia outbreak until the stories appeared in the Globe. At that point, the spin put on the events by BU spokesperson Ellen Berlin was, "It doesn't change our stellar safety record." Moreover, our "first obligation in this incident was to ensure there was no public health risk and to report the incident to ... local, state, and federal public health authorities," although, not apparently, to do so very quickly.
As a Globe columnist pointed out, "Trust is a fragile thing - hard to build, harder still to rebuild." Many large health care organizations need some serious education about what openness and candor really mean.
Forbes.com, Matthew Herper, 01.21.05
NEW YORK - Doers and doings in business, entertainment and technology:
Connecticut Senator Christopher J. Dodd, a Democrat, is proposing a sweeping set
of drug reforms that would give the Food and Drug Administration the muscle to
force pharmaceutical companies to study drug safety after the medicines are
approved. If drug companies ran afoul of the FDA, they might be fined as much as
$10,000 per day. The bill, called the Patient Protection Act of 2005, would have
no effect on the approval process for drugs. Instead, it gives the FDA more
power to regulate medicines after they are approved, filling what he said were
"gaping holes" in the agency's ability to enforce its decisions. "'FDA-approved'
is just about as good a brand as we have," said Dodd. The point of the bill is
to make that brand stronger. He said the bill would "put some real teeth into
Dear Senator Dodd,
The NIH has trained a growing cadre of physician/informatics specialists whose specialty includes electronic medical records; clinical outcome improvement initiatives; biomedical data, information and knowledge management; and optimal approaches to implementing clinical information technology in patient care settings.
For some reason, Sen. Dodd, the pharmaceutical industry nearly ignores this NIH-sponsored specialty. I managed to get in - running a science library while reporting to computer people whose knowledge of medicine did not extend past the local CVS pharmacy - until it was determined that due to budget cuts, first a financial guy and then an IT technologist without a medical background were sufficient for the purpose. I was told by a number of pharma companies that "medical informatics was not needed here", including in an adverse-events reporting department led by a former FDA adverse events official.
It was a peculiar observation that this person's reports, the clinicians and scientists involved in adverse events day-to-day data management, felt 100% differently than their boss. It was also kind of funny when I showed them 10-year-old technology I gave the Saudi Arabians back in 1995. They thought it would be great if they had similar technology - in 2004 - to solve the problems they sometimes had in dealing with data in that good old reliable 1970's format, paper, or else via that other wonder of advanced technology, Microsoft Access.
If I didn't know better, I might think that big pharma is trying hard to avoid incorporating new thinking and doing everything in its power to maintain its ossified practices -- practices that have worked so well in recent years that there are more lawsuits over drug side effects than there are computers in CompUSA.
So, Sen. Dodd, by all means, knock yourself out.
Wednesday, January 19, 2005
Cuts in Ontario
The province of Ontario, Canada planned to lower hospital expenses by moving more patients into improved primary and community care settings. The improvements are not complete, the care as not yet been transferred, yet as the Toronto Star reports, the province is pushing cuts in the hospital budgets now. As this editorial suggests, the result is likely to be drastic nursing shortages and longer queues for care.
An IT Flop in the UK
The UK is spending 6.2 billion pounds sterling to improve its health care information technology (IT). An early, key project was a system to improve general practitioners' (GPs) abilities to refer patients to specialists. By now, this 196 million pounds sterling system was supposed to have scheduled over 200,000 patient referrals. In reality, it has handled 63. It turns out that very few GPs were familiarized with the system, which lead to an "information vacuum." Furthermore, the system was apparently not designed to handle such situations as patients who needed referrals to more than one professional for treatment. (See reports in the Manchester Guardian here and here.)
US VA Researcher Busted
A former cancer researcher at the Stratton Veterans Affairs (VA) Medical Center just plead guilty to negligent homicide, and several other charges, as reported by Newsday. Paul Kornak had proclaimed himself to be a doctor, although he never completed medical school. He was hired by the VA despite a previous criminal record stemming from forgery of a previous medical licensing application. Per the Albany Times-Union, co-workers alleged that they were punished after trying to report irregularities in the cancer research program he ran to hospital administrators. An attempt by hospital pharmacists to involve the Federal Bureau of Investigation was stymied when VA officials told the FBI that one of the pharmacists was under investigation, although he was never charged with doing anything wrong. Kornak was finally tripped up when his commercial sponsor, Ilex Oncology, found more "irregularities" in his reports.
The moral of the stories is that government is not immune to health care mismanagement. Maybe more transparency, accountability, and involvement of medical professionals and the public could prevent some of these problems.
Tuesday, January 18, 2005
Here is a pithy comment from Prof. Norman Levitt, author of Higher Superstition:
"I found this story very disturbing because of its implications for scientific medicine in an era swamped by politicians who are not very bright and "alternative" hucksters who are very adept at taking advantage of that kind of stupidity. I think the chiropractic school at FSU (or any major university for that matter) has to be stopped dead in its tracks. I don't think physicians and scientists should be at all coy about putting forth the argument that there's a vast gulf between science--even highly speculative science--and pseudoscietific dogma of whatever persuasion. It would be too much to expect most pols to become epistemologically sophisticated, of course, but maybe it will penetrate that there are, eventually, painful social and economic costs to trampling on scientific judgment in the name of pet theories."
Monday, January 17, 2005
Today, the NY Times published a news article that seems to suggest something big went wrong at the BMJ. "Dispute Puts a Medical Journal Under Fire," by Barry Meier, asserted "the staid, usually methodical world of medical journals could suffer its own black eye," and that "the incident may prove to be a messy one for the BMJ."
But Meier produced little evidence to support these apparently quasi-editorial conclusions.
Let's go back to the original BMJ article. Its key assertions were that
"confidential drug company documents ... went missing during a controversial product liability suit more than 10 years ago;" "the documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence;" and "Eli Lilly officials were aware in the 1980's that fluoxetine had troubling side effects and sought to minimise their likely negative effects on prescribing."
Meier's NY Times news article reported that Eli Lilly vigorously contested the content of the BMJ article. Specifically, its lawyers "notified the publication that the company considers the article to be 'inaccurate and defamatory,' asserting that the records were not missing and that all their relevant data had been previously submitted to the FDA. Also, Lilly issued an analysis last week of the 52 pages of records that the BMJ had received, which the company said supported its claims." Yet Meier's article does not give any specifics of how Lilly disputed the main points of the BMJ article. So apparently Meier concluded that the BMJ deserved a "black eye" just because Lilly did not agree with it. Why he seemed to think that Lilly was right and the BMJ was wrong, especially without seeing the documents in question, is not clear.
Furthermore, other statements by Lilly, available on its web site, muddy things further.
Lilly's press release of January 4, 2005, asserted that the "documents reveal no new clinical or scientific information," and that "the information in the documents has already been shared with the U.S. Food and Drug Administration (FDA) and other regulatory bodies, published in medical journals, or produced through legal discovery and available for use at various legal trials for more than a decade." Of course, this did really address the BMJ's assertion that specific documents went missing. Furthermore, information produced through legal discovery may not be sufficiently available to physicians to affect their prescribing decisions.
The second Lilly press release of January 13, 2005, contains an assertion by Lilly CEO Sidney Taurel that "it is simply wrong to suggest that information on Prozac was ever missing or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators." Lilly complained about "the media reports stating that Prozac is 12 times more likely to cause suicide than other, older antidepressants" as "patently false." The BMJ news article, however, contained no such claim. Taurel's statement seems to be an attempt to declare guilt by association. (Perhaps Taurel was referring to a document posted by CNN that purports to show a suicide attempt rate of 3.7% for fluoxetine vs. 0.8% for amitryptiline, and 0.2% for trazadone.)
More curiously, the press release stated "Lilly is calling on the BMJ to make the full documents available to the media and other interested parties." However, in its accompanying "analysis", Lilly itself declined to make the actual documents public, stating "due to court orders requiring confidentiality of some of the documents contained within the 52 pages, Lilly is unable to relsease the 52 pages of documents." But then did Lilly mean to call on the BMJ to violate a court order? This statement, of course, also contradicts Sidney Taurel's assertion that all relevant information in the documents was freely available to doctors and regulators. How were doctors supposed to access information that was rendered "confidential" by court order?
Thus, there is nothing I can find so far in Lilly's media barrage that refuted the claim made by the BMJ news article that Lilly had tried to prevent data on adverse effects of fluoxetine from affecting doctors' prescribing decisions. And I cannot figure out why a NY Times reporter decided that it was the BMJ, not Lilly, who figuratively earned a "black eye."
Finally, let me state again, we should not let smoke and mirrors distract us from the fundamental issue that suppressing and/or obfuscating information about adverse effects of drugs is bad for patients, bad for doctors, bad for science, and bad for society.
Saturday, January 15, 2005
BETHESDA, Md. (Reuters) - A U.S. advisory panel on Friday urged regulators to
reject over-the-counter sales of Merck & Co. Inc.'s cholesterol-lowering
drug Mevacor because of doubts the medicine could be used safely without a
An interesting outcome, no doubt affected by the VIOXX controversy and the negative publicity in the form of appearances of conflicts-of-interest between Big Pharma and government regulators.
As a physician, medical informaticist and son of a pharmacist (I'd worked in my father's store throughout high school and into college), I am in agreement with the FDA's decision. Knowing the trouble that patients get into with OTC medications and with prescription ones through misuse, disuse, abuse, etc., selling drugs with the profile of a statin - even with dependence on a pharmacist to play "policeman" or "policewoman" - is a bad idea.
Why not make antibiotics OTC? Why not anticoagulants and antiarrhythics? Anxiolytics? After all, *most* people don't get into trouble with those. Further, why not make chiropractors the gatekeepers on these meds? Or hospital administrators? Where does the slippery slope end?
As I once wrote in a Wall Street Journal letter, if you want to play doctor, then get yourself to medical school.
I also wonder how much of this proposal was a move of desperation led by marketing to generate revenues by a company in financial difficulty, as opposed to the "altruistic" move led by clinical scientists and clinicians it was made out to be by the industry.
DISCLAIMER: Being the only formally-trained Medical Informaticist at this company, who'd provided significant assistance in improving research support but was then summarily laid off by a no-biomedical-credentials computing exec to cut costs when the pipeline suffered difficulties (as a result of decisions made long before my arrival), I would be the first to admit my thoughts on this issue may not be entirely objective.
Friday, January 14, 2005
In today's Forbes article "FDA Fix No. 3: Track Side Effects", however, I was reminded that perhaps my statement was indeed close to the truth. Note the absence of mention of the EMR:
NEW YORK - One of the clearest lessons from the Vioxx debacle is that the
Food and Drug Administration's side effect tracking system is woefully
inadequate. Its current system relies on doctors to voluntarily report when a
drug causes a problem. This works great for finding rare side effects that would
be unlikely to happen without the drug, such as liver or kidney problems or
allergic reactions. But it doesn't work well for picking up common problems such
as heart attacks and strokes--exactly the ills Vioxx and its kin may have
... One solution, proposed by Raymond Woosley, the Vice President for Health
Sciences at the University of Arizona, is to carefully track the first 100,000
patients who take a drug in order to look for higher rates of common health
problems. That might be prohibitively expensive.
A similar idea is to start what are known as patient registries. People who
either take a drug or have a particular disease are put into a database and
monitored for side effects and potential benefits. Richard Gliklich, a Harvard
professor, runs a profitable, closely-held business called Outcome that develops
such prospective databases for big drug companies and organizations like the
American Heart Association. "There are going to be drugs that are going to be
toxic to some segments of the population, and very beneficial to other segments
of the population," he predicts Another fix: make the Office of Drug Safety,
currently part of the FDA, a separate agency.
Experts like comparing such a step to the creation of the National
Transportation Safety Board. The NTSB makes recommendations to the Federal
Aviation Administration, for instance, and thought they are not binding, they
are often followed. In the same way, a separate drug safety office could create
a public watchdog that makes sure studies into side effects of commonly
prescribed drugs are getting done.
Even some drug executives have backed doing more studies of the type done
by FDA safety expert David Graham, who was one of those to warn about Vioxx.
"While I don't think that a separate office for post-marketing surveillance is
likely, a strengthened Office of Drug Safety is almost a certainty," says David
Kessler, a former FDA commissioner who is now a dean at the University of
California, San Francisco. "In the past, we have seen examples of the
accelerated approval of drugs without the appropriate follow-up, and I think
that will be a thing of the past."
In a setting where the NIH has been funding postdoctoral-level training in Medical Informatics to produce EMR experts for well over a decade, and where a long-range national EMR initiative (coined the Decade of Health Information Technology) has been launched in the U.S. by the Department of Health and Human Services to:
"bring information tools to the point of care; build an interoperable health information infrastructure; use HIT to give better access to patients and more involvement in decision making; and improve public health monitoring and quality care assessments with faster application of research advances in actual medical practice",the lack of mention of the EMR as a possible solution for enhancing postmarketing drug surveillance (possible right now, this minute via pilot projects with existing EMR installations) is a strong sign of a pernicious compartmentalization of the pharmaceutical industry from the healthcare delivery sector, and a severe strategic blindness to EMR developments in pharma.
The scarcity in Big Pharma of formally-trained Medical Informatics experts with insights in implementation and leveraging of EMR technology is another symptom of this apparent blindness.
This data becomes all the more alarming when juxtaposed with a recent JAMA editorial [DeAngelis CD. Professors not professing. JAMA 2004; 292: 1060-1.] Its argument was that due to financial pressure, medical school faculty are devoting less and less time to teaching. Particularly, "few medical schools provide adequate, if any, reimbursement for teaching time." So this suggests that medical schools are charging students more and more, while less and less money goes to clinical faculty to teach. But what should tuition pay for, if not teaching? And exactly where are all the tuition dollars going? Methinks there is something rotten here, but not in Denmark...
Thursday, January 13, 2005
This may be one of the fist times this idea has appeared in the general business literature.
As a medical informatics specialist (combining medicine with postdoctoral-level information science and computing training), as well as a former Merck & Co. (MRK ) manager, I view the Vioxx controversy with concern ("How to prevent another Vioxx," News: Analysis & Commentary, Dec. 13). Post-marketing surveillance programs fail to produce any data at all if the practitioner does not realize a problem may be due to a drug -- and this is likely the situation in a majority of cases.
The Food & Drug Administration's moves to improve the way it responds to risks from medical products, including better "data-mining," is a step in the right direction. My concern is that overconfidence in such initiatives may dilute the resolve needed for the fundamental and daunting task of implementing comprehensive electronic medical record (EMR) systems in clinical settings that could provide a solution to long-term postmarketing drug follow-up.
The variety and creativity of the responses is amazing. It's as if hospital management tries very, very hard to prevent themselves from hiring the people who can actually help them avoid typical healthcare IT debacles, for example as chronicled here.
I term this the "1001 Dalmations" phenomenon. One never knows what variation of the same set of spots to expect.
Here's an example that just occurred to a colleague with credentials comparable to my own. He's turned expensive clinical IT chaos and failures into major successes recognized by national figures in subspecialty medicine, implemented complex EMR in a cost-effective, team-building manner along with required work redesign in large multi-hospital academic and non-academic healthcare systems, and actually demonstrated improved outcomes and cost savings for the organizations where he's worked.
A large city hospital system announced a new position:
The informaticist applied to the position, highlighting his having achieved recognized success while saving significant money for the organizations he'd worked for.
Director, Operations Improvement/Clinical Work Redesign
The Director will provide leadership, support, and guidance to the system during implementation of a seven-year enterprise-wide IT strategic plan. He/she provides operational input into the CIS Selection Process. The Director will serve as the primary contact and liaison for CEOs and their leadership teams, providing Clinical Work Redesign content expertise in the specified areas. The Director will be a Team Leader and Major Change Agent leading multiple Redesign teams.
The following "1001 Dalmations" response was received from the recruiter:
Thank you for your message regarding the opportunity for a Director of Process Improvement/Clinical Work Redesign ... [Unfortunately], we are seeking someone who could not only assist in selecting and implementing the system, but who has significant process improvement/clinical work redesign expertise in a very large, complex academic medical center or multi-hospital system. Do you know anyone with those qualifications?One sometimes could believe that seasoned people with formal NIH-based Medical Informatics credentials and superb resumes must come knocking on the CEO's door on a daily basis.
I leave it to the reader to determine what the Informaticist might have responded.
1001 Dalmations is but a specific species or instantiation of the more general phenomenon known as "healthcare mismanagement." Closely related are a variety of stereotypes and politics that impede informatics leadership in hospital settings, not to mention micromanagement of informatics professionals by hospital MBA types, a severe species of mismanagement in its purest form.
Wednesday, January 12, 2005
For example, Dr. Anthony Fauci and Dr. H. Clifford Lane, who helped develop Interleukin-2, have each received more than $45,000 since 1997 in royalties. Meanwhile, they continued to have influence over continuing trials of the drug. Independently concerned about the appearance of conflict of interest, they asked for outside reviews of their work. But when Fauci tried to return his royalties, and to disclose them on a standard government form, agency managers told him he could do neither. Furthermore, in the absence of any NIH policy about disclosing the royalties, neither Fauci nor Lane informed study patients about them.
Again, the NIH is one of the most important biomedical research organizations in the world. It used to have a reputation for impeccable integrity. So I will simply repeat what I said in another post : "In my humble opinion, it is a tragedy and disgrace for the country's and perhaps the world's premier biomedical research organization to be tainted by leaders with the gross sorts of conflicts of interest reported in yesterday's articles. It will take drastic measures to cleanse it. But until it is cleansed, can anyone fully trust its actions?"
Tuesday, January 11, 2005
For example, the latest issue of Health Affairs (not yet on the web) includes a key-note article by David Eddy, [Eddy DM. Evidence-based medicine: a unified approach. Health Aff 2005; 24-9-16], which asserted,
"In 1973 John Wennberg and his colleagues began to document wide variations inWennberg studied, however, rates of particular management options in different geographic areas. He did not control for prevalence of disease in these areas (much less severity of disease, co-morbidity, patient's values, etc.) Therefore, it is going well beyond his data to say the physicians were recommending different things for essentially the same patients.
practice patterns. The implications ... were undeniable: when different
physicians are recommending different things for essentially the same patients,
it is impossible to claim that they are all doing the right thing."
Eddy used this assertion, among others, to justify his idiosyncratic version of evidence-based medicine, which seems to put the interests of "society" in controlling costs and efficiency on par with, or perhaps above, what Eddy called "the narrow viewpoint of an individual physician and patient."
A new study in Medical Care strongly challenges this old, unfounded assumption about practice variation. (viewing online requires a subscription.) [Shwartz M, Pekoz EA, Ash AS et al. Do variations in disease prevalanece limit the usefulness of population-based hospitalization rates for studying variations in hospital admissions? Med Care 2004; 43: 4-11.]
Let me quote liberally from the accompanying editorial [Ashton CM, Pietz K. Setting a new standard for studies of geographic varation in hospital utilizaton rates. Med Care 2004; 43: 1-3]
"For decades researchers analyzing differences in area-specific hospital
utilization rates have worked under the assumption that adjusting geographic
areas for age and sex differences is sufficient to account for any geographic
differences in disease prevalence. Shwartz et al challenged that
assumption and have shown it to be untrue."
"What can be concluded from this research is that geographic differences in
disease prevalence rates exist, even in small geographic areas within a single
state, and that studies of geographic variation in hospitalization rates that
fail to take underlying disease prevalence into account run a serious risk of
coming to spurious conclusions. The findings of Shwartz et al have set a
new standard in variations research."
Congratulations to Shwartz et al for taking this one on. I don't deny that physicians may sometimes make less than optimal, and even irrational decisions. However, let's stop pillorying their decisions based on irrelevant practice variation data. And let's stop using practice variation data to justify putting more control in the hands of bureaucrats and managers who may not be more rational, and who have not taken an oath to put the interests of patients first.
Sunday, January 09, 2005
One example is an argument that was distributed over two other health care blogs. Medical Rants included a post from Managed Care Matters which argued that "the real issue employers have with health care costs is they have NO sense for their return on the investment. " Thus "what employers SHOULD be thinking about is the demonstrated ability of a health care provider to 'deliver' healthy, fully functional employees and families." Of course, it really is the patient who should be concerned about his or her health care provider's abilities. How a corporate benefits manager could figure out the performance of all employees' health care providers, and then sensibly figure out how to improve them, is unclear. A few comments made this point more eloquently.
A more fundamental confusion appears in a story out of Detroit. A local medical benefits administration company, Weyco, Inc. has apparently decided not to hire any new cigarette smokers, and to fire any current employees who refuse to quit. The rationale by the company president, "increasing health care costs were choking his business." I am a strong advocate of quitting smoking, but as the Detroit News editorialist wrote, punishing smoking employees by firing them has surely "gone too far."
Friday, January 07, 2005
In Colorado, there is indignation over the Department of Veterans Affairs (VA) cancellation of plans to build a new hospital integrated with the University of Colorado medical center. Apparently, there was a lot of initial discussion about an innovative, cooperative building, but, as Lawrence Biro, director of the VA Rocky Mountain Health Care Network put it, VA architects are not used to designing integrated facilities. "That's the way VA hospitals are built." As for all the local discussions about the cooperative building, "This is out of my control. Planning of hospitals is driven from Washington." As Colorado Governor Bill Owens said, "apparently the VA can't think outside of the proverbial federal box."
In Florida, a fed-up physician is suing several managed care organizations (MCOs) about how they reimburse out of network physicians. Setting aside the merits of the suit, a telling remark was made by the spokesperson of Neighborhood Health, Bruce C. Rubin, "we've been paying a certain percentage of Medicare for years. It's standard procedure." Thus some Florida MCOs decide how to reimburse simply by paying a fixed proportion of what Medicare pays. So it seems they also can't think outside of the proverbial federal box.
Is it any surprise that large organizations don't make decisions outside of the box? But didn't a lot of people once argue that managed care innovation would reduce health costs while improving quality and access? And didn't others argue that the only way to save US health care is to nationalize health insurance? (The euphemism is "single-payer.")
Thursday, January 06, 2005
There is an ongoing federal investigation into the award of a $49 million contract for radiology services for the new Stoger Hospital of the Cook County health system. The contract first went to DD Industries, a joint venture of Siemens Medical Systems and Faustech Industries. The President of Faustech was politically connected, having made contributions to various County Commisioners. After General Electric sued, claiming the county had violated its bidding procedures in the award to DD Industries, a federal magistrate ruled that Faustech was not a legitimite partner in the deal, but was in it merely to arrange "access to county officials." The story came out when the Cook County Board President, John Stoger, for whom the hospital was named, warned County Commissioners to watch what they say to the Federal Bureau of Investigation (FBI).
This is the second story I have found about the Cook County health system in a month. (See the first story posted here.) This story, about the questionable awarding of a security services contract, seemed to be another reason Stoger did not want his Commisioners talking to federal investigators. He warned them that saying too much could make the FBI "think you're involved deeper than you are."
It makes one wonder how deeply they were involved.
It also makes one wonder what is happening to the morale of all the doctors and other health care professionals who must labor in this system..., and the effects of all this on patients, not to mention the academic mission at Cook County.
It's not that I mean to particularly pick on Cook County, by the way. These sorts of "true crime" reports about various health care organization seem to be appearing daily in the news media (and who knows how many other reports appear in the vast number of media outlets that I don't scan). The news media, however, almost never deal with the effects of these shenanigans and skullduggery on patient care (and teaching and research when applicable). Until physicians, and the larger health community start paying attention to the extent and outcomes of health care mismanagement, we will have little chance of fighting it.
An interesting article on reducing medical errors in hospitals appeared in the Philadelphia Inquirer today. In the article, it is stated that:
A regional effort to prevent hospital patients from being harmed by medication errors has made progress, but more must be done, according to a new report. Launched in February 2001 by the Delaware Valley Healthcare Council and two leading patient-safety organizations, the Regional Medication Safety Program for Hospitals sought to give hospitals the tools needed to reduce mistakes that injure and kill patients. A report on the program being released today concludes that participating hospitals had a 22 percent improvement toward meeting the council's goals.
The article describes the metrics used to arrive at the 22% improvement figure, and goes on to state:
"The implementation of computerized medication orders will reduce errors between 60 and 95 percent when the appropriate pharmacy safeguards are in place," said John J. Kelly, chief of staff at Abington Memorial Hospital. Abington has required that all medical orders be entered in the computer since the system was fully implemented at the Montgomery County hospital three years ago.Disclaimer: Dr. Jack Kelly was my Medical Residency Program Director. He is a superb clinician and in his new role as Chief of Staff, I am certain he will make major strides in quality improvement at Abington Memorial, a truly excellent hospital already.
One problem with such information systems is the cost. Kelly said Abington spent more than $30 million on its project. Thomas Jefferson University Hospital spent $20 million, not including the training and ancillary costs. Main Line Health is in the midst of a 5- to 10-year, $21 million project to add computerized order entry at its three hospitals and its rehabilitation facility. In this region, about one-quarter of all hospitals have such systems. Leapfrog [the Leapfrog Group business consortium] found that 4.4 percent of the nation's 1,257 hospitals that responded to its survey have computerized order entry.
My concern is on implementation costs of these POE (physician order entry) systems. In my website "Common Examples of Health IT Failure" I wrote about some of the factors that cause costs to spiral and projects to encounter costly difficulty and even failure. Factors such as inadequate IT personnel and management consultant experience in complex clinical environments, vendor overpricing and sweetheart ("padded") deals, political and territorial infighting, and poor relations between clinicians, IT staff and hospital executives are examples.
The AMA case study "Doctors Pull Plug on Paperless System" is a poster-child example of these problems. (My response from the medical informatics perspective, "How to Avoid CPOE Failure a Second Time" , appeared in the journal Health-IT World). Unfortunately, there are no metrics to robustly determine whether or not hospital IT staff (usually of a business-IT and not clinical-IT background) are performing in the most cost-effective manner, and/or if hospitals are getting "fleeced" by information technology companies and healthcare IT management consultants.
I suspect they often are, and have seen it in my own experiences. This is an issue that should be addressed before the remaining 78% of the "quality improvement gaps" are addressed. Hospitals, of all organizations, have precious little extra capital and expense in their budgets to pad the incomes of healthcare IT companies, IT vendors and management consultants.
I should also add that the "22% improvement" figure is disappointing considering the time, expenditures, publicity, public pressures, and other factors at play in the hospital/healthcare sector five years after the Institute of Medicine (IOM) landmark 1999 report, "To Err Is Human", which cited 98,000 preventable deaths each year.
Wednesday, January 05, 2005
As others have recently pointed out on this blog, all the pain meds can be bad for us. As it now seems, they aren't particularly good for us either, leaving one to wonder whether the balance does in fact lie on the positive side of the scale. Perhaps the answer is to be a bit less rosy-eyed in our own tendency to overestimate the benefits and underestimate the risks of what we prescribe, and to inform patients honestly about the magnitude of benefit and risk so they can make their own decisions. (That's really what got Merck into trouble over Vioxx: not that it caused harm, but that they knew it and concealed it while simultaneously inflating claims of benefit.) But then if we tell patients "this stuff can eat your stomach, might give you a heart attack, and doesn't really do any more for your knee than those M&M's over there", how will patients respond? People come to us for doctoring, not just technology. The pills we prescribe represent hope: the doctor prescribed them, and they are powerful "medicine" (in the sense that my Chippewa ancestors meant it, not in the sense pharmacists mean it).
If we're addressing people's strongly felt (and I believe absolutely legitimate) need for doctoring by prescribing something that can hurt them, costs a lot, and doesn't really do much, and we're not leveling with them about that, are we committing the quackery we accuse alternative providers of? Hmm. I'm not about to start defending the nutbars of pseudoscience, but if we're scientific we have to apply our standards ourselves too, eh?
I recommend glucosamine a lot lately. It doesn't work any less well than NSAIDs or COX-2s, it doesn't plug arteries or eat gastric mucosa, and it's pretty cheap. At bottom, I have to respect what the patient came to me for. If it's almost a placebo... let's not knock 'em, just pick safe ones.
Golden Parachutes for the TB Sanitarium District Board
Cook County, in Illinois, may be the last to have a separate agency to care of tuberculosis patients. The Cook County Tuberculosis Sanitarium Board, circa 1947, no longer has any sanitariums, but runs four TB clinics. Independent from local public health agencies, it has the power to levy real estate taxes to support itself. It has been charged in the past with some dubious management practices, such as failing to bill insured patients for its services, continuing to levy taxes when its reserve funds exceed its annual budget (per the Chicago Tribune), and paying for its Board Chairman's health insurance despite legal prohibitions (per the Sun-Times). As a recent political battle swirled over whether to fold the agency into the Cook County Bureau of Health, the TB Sanitarium Board voted to award "golden parachutes," according to the Chicago Sun-Times, to outgoing employees and board members, only to have judge hand out a temporary restraining order against it.
Federal Investigations of the Failed Bay Pines VA Medical Center Computer System
The Justice Department and the Veterans Affairs Inspector General have opened criminal and civil investigations of how Department of Veterans Affairs managers had spent over $200 million on the Core FLS computer system, a system which never worked, reported USA Today and the St. Petersburg Times. The Core Financial and Logistic System, developed by BearingPoint (formerly KPMG Consulting), flunked its trial at the Bay Pines VA Medical Center. Per the Tampa Tribune, "CoreFLS was intended to keep better track of hospital supplies and improve financial management. Instead, it led to supply shortages that delayed surgeries and spurred complaints."
More Charges About NIH African Nevirapine Study
A former NIH physician has charged publicly that a study of nevirapine to block maternal-fetal HIV transmission was so sloppily done as to be invalid, but was kept in operation because NIH officials were "so heavily invested in the trial's outcome." Dr. Jonathan Fishbein also charged that the NIH is trying to fire him because he blew the whistle on this study's problems, but the NIH says he performed poorly during his probabitionary period. (AP report available here, as well as many other places.) This story, including the apparent role of political considerations in decisions to keep the research study running, was previously discussed on Health Care Renewal here.
Tuesday, January 04, 2005
As a medical informatics specialist used to designing EMR systems meant to capture clinical information on thousands or tens of thousands of patients (or more) routinely, the Clinical Trials and FDA approval processes seem like fossils from the 1950's.
Prior to FDA approval, Psaty [an epidemiologist and drug-safety specialist who testified at the recent Senate hearings on drug approval] explained, Vioxx had been tested -- at common doses of 12.5 and 25 milligrams -- on just 371 patients for at least one year. The only large study to explore the drug's cardiac risks had yet to be completed.
Clearly, if medicine is to become more data-driven, industry and government can do far better than this.
It might help to clean out some of the deadwood that allow drugs for millions to be approved after tests in hundreds.
According to a study from Baylor College of Medicine, in Clinical Gastroenterology and Hepatology entitled Visible small-intestinal mucosal injury in chronic NSAID users, ibuprofen is unsafe for long-term use. It found that
Some 71% of the NSAID patients showed signs of small bowel injury, compared to just 10% of the controls.According to researcher Dr. David Graham,
"We saw some ulcers and we saw lots of erosions. Anybody who takes aspirin or (other) NSAIDS for a year has a 1% to 4% risk of serious gastrointestinal complications."Unfortunately, that leaves us with just tylenol and various narcotics as pain relievers.
As Thomas Sowell discusses, all decisions have trade-offs between risks and benefits. No choices come completely free of risk.
Where do people not recognize trade-offs? Where they are making decisions for other people. That's where they make unrealistic demands, including demands for "safety." Maybe Vioxx or Celebrex is too dangerous, all things considered. Maybe not. The problem is that all things are not considered.He makes the excellent point that "nothing is categorically safe", and that all of life involves weighing weighing risks, benefits and alternatives. If we really considered absolute safety as our primary objective in life, we'd never get into an automobile. Ever. We would give up chemotherapy, surgery and antibiotics as well, for they have even larger risks than do painkillers.
The recent march against NSAIDs and COX-2 inhibitors is especially foolish, inasmuch as we have frighteningly few pain medicine alternatives.
Next news flash: tylenol, aspirin and narcotics are bad for you!!
Monday, January 03, 2005
Medicine needs to be reorganized more than it needs any scientific breakthrough. The problem is no longer inventing new lifesaving drugs or devices, but getting them to the right patients. Armies of specialists prescribe tons of pricey pills but fail to deliver basic medical care. Patients don't get drugs that could save them, and medical errors crop up with alarming frequency. New computer systems could help. But what we really need is good, old-fashioned doctoring--the kind that takes the time to take care of the whole patient.
Does this mean that the folks in various big health care organizations are going to introspect about how health care (dis)organization and (mis)governance has gotten in the way of primary care and generalism, which is what I think he means to promote?
My summary was: "the AHERF case illustrated a large and powerful health care organization whose governance did not represent key constituencies, and was secretive, unethical, and unaccountable. The human and financial costs of its mismanagement have never been clearly accounted. Yet the case received relatively little publicity and has generated sparse discussion in the medical and health care arena. However, failing to acknowledge cases like this risks their repetition. "
By the way, although space did not permit listing any references, every statement in the case description was derived from the extensive coverage of the case in the media. References are available to anyone interested.