healthy4u

Letter: How The FDA Can Prevent Another Vioxx

A letter from me on the value of EMR in postmarketing surveillance published by <a href="http://yahoo.businessweek.com/magazine/content/05_02/c3915011_mz004.htm">Business Week</a>, January 10: <blockquote>As a medical informatics specialist (combining medicine with postdoctoral-level information science and computing training), as well as a former Merck & Co. (<a href="javascript:" title="javascript: void showTicker('MRK')">MRK</a> ) 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.</blockquote>This may be one of the fist times this idea has appeared in the general business literature. -- SS

Letter: How The FDA Can Prevent Another Vioxx

A letter from me on the value of EMR in postmarketing surveillance published by Business Week , January 10: As a medical informatics special...

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1001 Dalmations

When seasoned medical informaticists apply for hospital-based positions, they are often amazed by the diversity of negative or diversionary responses they receive. These responses are often tied around the themes of "you don't have enough experience", and often originate in the primal fear of the business IT types (who typically lack legitimate qualifications to be leading clinical tools implementations that directly impact clinical practice) protecting their own hegemony in the hospital MIS departments. 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 <a href="http://home.aol.com/medinformaticsmd/failurecases.htm">here</a>. 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: <blockquote>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.</blockquote>The informaticist applied to the position, highlighting his having achieved recognized success while saving significant money for the organizations he'd worked for. The following "1001 Dalmations" response was received from the recruiter: <blockquote>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? </blockquote>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 <a href="http://home.aol.com/informaticsmd/tactics.htm">stereotypes and politics </a>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. -- SS

1001 Dalmations

When seasoned medical informaticists apply for hospital-based positions, they are often amazed by the diversity of negative or diversionary ...

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Yet More Conflicts of Interest at the NIH

Another story, reported by the Associated Press <a href="http://www.boston.com/business/articles/2005/01/11/federal_scientists_stake_in_experiments_disclosed/">here </a>and in more detail <a href="http://www.capitolhillblue.com/artman/publish/article_6009.shtml">here</a>, about conflict of interest at the NIH has surfaced. NIH full-time staff are now legally able to collect royalties on inventions they developed while working for the government, including drugs and medical devices. By 2000, The NIH was supposed to develop a process to assure that NIH researchers would disclose such financial interests to patients in clinical studies. The Secretary of the Department of Health and Human Services at the time, Donna Shalala, promised "that any researchers' finanacial interest in a clinical trial be disclosed to potential participants." But the NIH only got around to actually doing so last week, prompted by an enquiry by an Associated Press reporter about royalty payments and the policy for their disclosure under the Freedom of Information Act. 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 <a href="http://hcrenewal.blogspot.com/2004/12/anechoic-effect-and-conflicts-of.html">another post </a>: "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?"

Yet More Conflicts of Interest at the NIH

Another story, reported by the Associated Press here and in more detail here , about conflict of interest at the NIH has surfaced. NIH full-...

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An Unfounded Assumption About Practice Variation Finally Is Challenged

As I <a href="http://hcrenewal.blogspot.com/2004/12/pitfalls-of-single-disease-solutions.html">mentioned in a previous post</a>, many people interpret the practice variation literature as demonstrating that physicians often make unsubstantiated, even irrational decisions for individual patients. This supposed irrationality is used as justification for all sorts of things. For example, the latest issue of <a href="http://www.healthaffairs.org/">Health Affairs </a>(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, <blockquote>"In 1973 John Wennberg and his colleagues began to document wide variations in 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." </blockquote>Wennberg 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. 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 <a href="http://www.lww-medicalcare.com/">Medical Care </a>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] <blockquote>"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." </blockquote> 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.

An Unfounded Assumption About Practice Variation Finally Is Challenged

As I mentioned in a previous post , many people interpret the practice variation literature as demonstrating that physicians often make unsu...

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Employers' vs Employee's Control of Health Care

In the US, most employers provide employees health insurance benefits. The reasons for this have to do with history and tax law. In World War II, because of wage controls, employers could not bid for scarce employees by offering higher salaries, so they offered other benefits, such as health insurance, instead. Furthermore, employers can deduct employees' health care insurance from their income for tax purposes, while individuals cannot generally deduct what they pay for their own health insurance. This arrangement gives employers, rather than individuals, control over what health insurance options they can choose. It also can even further tilt the balance of power and control over health care to large organizations (large employers) and away from the individuals who actually need the care. Such large organizations may not always make decisions about health care that are best for their individual employees. One example is an argument that was distributed over two other health care blogs. <a href="http://medrants.com/archives/2005/01/02/a-comment/">Medical Rants</a> included a post from <a href="http://www.joepaduda.com/">Managed Care Matters </a>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 href="http://www.medrants.com/wp-comments-popup.php?p=2223&c=1">A few comments </a>made this point more eloquently. A more fundamental confusion appears in <a href="http://detnews.com/2005/editorial/0501/07/D08-53788.htm">a story out of Detroit</a>. 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."

Employers' vs Employee's Control of Health Care

In the US, most employers provide employees health insurance benefits. The reasons for this have to do with history and tax law. In World Wa...

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Can They Think Outside of the "Proverbial Federal Box?"

A couple of brief anecdotes illustrating what happens when large organizations run health care.... <a href="http://www.denverpost.com/Stories/0,1413,36~53~2639623,00.html">In Colorado, there is indignation </a>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." <a href="http://www.miami.com/mld/miamiherald/10584453.htm">In Florida, a fed-up physician is suing </a>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.")

Can They Think Outside of the "Proverbial Federal Box?"

A couple of brief anecdotes illustrating what happens when large organizations run health care.... In Colorado, there is indignation over th...

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How Deeply Involved at Cook County?

<a href="http://www.suntimes.com/output/news/cst-nws-invest06.html">Another story out of Cook County, Illinois</a>... 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 <a href="http://hcrenewal.blogspot.com/2004/12/political-insecurity-at-provident.html">here</a>.) 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.

How Deeply Involved at Cook County?

Another story out of Cook County, Illinois ... There is an ongoing federal investigation into the award of a $49 million contract for radiol...

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