Another Facet of the SSRI Suppression of Research Story

Here is yet another facet of the complicated story about possible suppression of research data about selective serotonin uptake inhibitor (SSRI) anti-depressants.<br />The <a href="http://bmj.bmjjournals.com/cgi/content/full/330/7481/7?ehom">British Medical Journal just received documents </a>from an anonymous source about adverse effects of fluoxetine (Prozac) that went missing for 10 years from the files of the Wesbecker case. Joseph Wesbecker shot and killed 8 people, wounded 12 more, and then commited suicide. He had been taking fluoexetine for one month for his depression. The plaintiffs against Eli Lilly, the manufacturer of Prozac, claimed the company withheld data unfavorable to fluoxetine from the FDA, and that the drug caused Wesbecker's homicidal rage. Lilly apparently won the case, and used the results to argue that Prozac had been proven safe and effective in a court of law. However, the judge later ruled the case "dismissed as settled with prejudice" because he discovered Lilly had secretly settled the case before the jury verdict.<br />Among the newly found documents was an internal company report that showed that fluoxetine lead to a 19% absolute risk increase for activation symptoms. Such symptoms included agitation, panic attacks, and aggressiveness. This information was never provided to the FDA.<br />The increasingly complex story of suppression of SSRI research seems to be part of a growing epidemic of suppression of medical research.<br />Let's say it again. Withholding data from clinical research is unethical because:<br />1. it breaks the promise to research subjects that their voluntary participation has scientific or social value, but undisseminated research has no value; (See <a href="http://jama.ama-assn.org/cgi/reprint/283/20/2701.pdf">Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.</a>)<br />2. it impedes scientific progress;<br />3. it prevents patients from receiving the best possible medical care.<br />But until this unethical behavior starts having negative consequences for its perpetrators, the epidemic of research suppression is likely to continue.

Another Facet of the SSRI Suppression of Research Story

Here is yet another facet of the complicated story about possible suppression of research data about selective serotonin uptake inhibitor (S...

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"A Crumbling, Filthy Mess"

The Denver Post has documented the sad decline of the city's Department of Veterans Affaris (VA) Medical Center. A 2004 inspection report found, <a href="http://www.denverpost.com/Stories/0,1413,36%257E53%257E2623303,00.html">in the reporter's words</a>, the Medical Center to be "a crumbling, filthy mess."<br />Undoubtably, one cause of the problems is a national one, funding for the US national health care system for veterans that has failed to keep up with increasing patient loads. In the 1990's, Congress reduced restrictions on veterans' eligibility for VA care, but failed to allocate funding that kept pace with the increasing numbers of patients in the national health care system. In particular, the Eastern Colorado regional budget in 2004 was less than that of 2002, even though patients and visits have gone up by about 20% in the two years. (See "<a href="http://www.denverpost.com/Stories/0,1413,36%257E53%257E2614222,00.html">Demand Strains VA Sites in State</a>," and "<a href="http://www.denverpost.com/Stories/0,1413,36~53~2625515,00.html">VA Center on a Skid Since 2002</a>." )<br />On the other hand, the series of articles suggest local management problems affecting employee morale. A Denver area VA spokesperson declared, "we have very high patient satisfaction scores," and "our patients really do love coming here." However, one patient, a navy officer, said that VA employees "really seem like they don't want to be there." A technician who refused to let her name be published because of fear of retribution said "it has been dirty here for years. We've been telling them and telling them."<br />Maybe now they will get the message

"A Crumbling, Filthy Mess"

The Denver Post has documented the sad decline of the city's Department of Veterans Affaris (VA) Medical Center. A 2004 inspection repor...

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Pitfalls of Single-Disease Solutions

It has been fashionable for health care managers and health policy types to foist "single-disease solutions" on doctors. The best examples are single-disease management strategies, based on single-disease management guidelines. Such solutions may be attractive in their simplicity, especially to managers who may not understand that patients and health care are actually very complex.<br />To me as a clinician, single-disease management programs make little sense for most of my patients. Patients with one chronic disease usually have multiple chronic diseases. Yet, single-disease management strategies often fail to include adjustments to their management of the target disease that take into account the patient's other diseases, and their treatments.<br />The intellectual heritage of these single-disease solutions seems to be the practice variation studies of the last century. They showed again and again that the rates of use of specific management options varied from place to place. Many of their authors quickly concluded that these variations were due to physicians' capriciousness, not physicians' appropriate responses to variability in patients' clinical characteristics and preferences and values. The unproven argument that practice variation reflected "seemingly random variations" in physicians' strategies was a touchstone for managed care advocates in the 1980's. (The quote was from Paul Ellwood, founder of the Jackson Hole Group, and one of the most vocal managed care proponents. See: Ellwood PM. Shattuck lecture -- outcomes management: a technology of patient experience. N Engl J Med 1988; 318: 1549-1556.)<br />Two important recent articles question single-disease guidelines, and disease management programs and other quality improvement schemes based on them. <a href="http://content.nejm.org/cgi/reprint/351/27/2870.pdf">In today's New England Journal of Medicine is "Potential Pitfalls of Disease-Specific Guidelines for Patients with Multiple Conditions," by Mary E. Tinetti et al</a>. This article elegantly, if somewhat too politely, "raises the question of whether what is good for the disease is always best for the patient." Its starting premise is that many patients, particularly the elderly, have multiple chronic diseases, e.g., 20% of Medicare patients have more than five chronic conditions. However, even the most rigorous evidence-based disease-specific guidelines barely take into account the applicability of the evidence to patients with multiple co-morbid disease, or how the presence of other diseases, and their treatments, might modify the benefits and harms of treatments for the target diseases.<br />Thus, whether the guidelines' recommendations really should apply to patients with other chronic diseases is usually arguable. Nonetheless, such recommendations may be rigidly applied to such patients, because "one of the hallmarks of quality assurance programs is a reduction in the variation of practice patterns among providers," whatever the cause of such variation might be. Again, the notion that variation is bad and must be stamped out at all costs arises from the early practice variation studies, and Ellwood's argument above that practice variation is due to physicians' "randomness."<br />Furthermore, in the second article, Kravitz and colleagues note the problem of "guideline creep: the evolution of genuinely flexible clinical recomendations into more rigid practice standards," (see: <a href="http://www.milbank.org/820403.html">Kravitz RL, Duan N, Braslow J. Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages. Milbank Quarterly 2004; 82: 661-687)</a>. They described how US Department of Veterans Affairs (VA) guidelines advocate screening even for patients "with severe comorbid illnesses or strong preferences against screening, [for whom] the risks of colorectal cancer screening outweigh the benefits." Worse, the VA financially penalizes hospitals with low screening rates, no matter how many of their patients would not benefit from screening. Kravitz et al concluded with sensible recommendations about practice guidelines, notably that guidelines should be "promulgated in a spirit of humility, generally eschewing strong incentives or punitive sanctions, at least until compelling evidence for the absence of significant HTE [heterogeneity of treatment effects] is acquired."<br />One can only hope that the health care managers pause their headlong rush into disease management and other single-disease solutions to adopt such "a spirit of humility."

Pitfalls of Single-Disease Solutions

It has been fashionable for health care managers and health policy types to foist "single-disease solutions" on doctors. The best ...

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House of coxibs: a fragile house of cards

From <a href="http://jama.ama-assn.org/cgi/content/full/293.3.366v1">Arthritis Medicines and Cardiovascular Events—"House of Coxibs"</a> by Eric Topol, M.D., JAMA. 2005;293:(DOI 10.1001/jama.293.3.366).<br /><br /><br /><br /><blockquote><p><em>... Third, there are major concerns about how an entire drug class has gone awry with respect to unleashing significant cardiovascular hazard. A "house of cards" is defined as a flimsy situation that is in danger of collapsing or failing. From the outset, the coxib class of medicines seemed destined for potential collapse. These drugs were <strong>mass-marketed from the moment they were commercially available</strong> in the new world of direct-to-consumer advertising, with <strong>unrealistic expectations about pain relief, marked gastrointestinal protection, and safety</strong>. Rather than a sufficient waiting period after approval to firmly establish safety in the large, representative "real world" population, the unbridled promotion exacerbated the public health problem. This is so poignantly clear for an indication such as arthritis, which is one of the most common conditions requiring medication. <strong>Furthermore, one has to question the wisdom of allowing direct-to-consumer advertising</strong> for lifestyle medications that have no capability of preserving life or preventing major events such as MI or stroke. Here the paradox of actually promoting these events is all the more difficult to accept.</em> </p><p></p></blockquote>Difficult to accept, indeed. I would add that the inability I experienced at one pharma company to secure a few million dollars/year for acquisition of standard informatics tools for R&D, despite rigorous justification, concurrent with spending in the hundreds of millions of dollars/year for direct-to-consumer (DTC) advertising, is an indictment of the business model whereby the <strong>MBA's run the science</strong>.<br /><br /><br /><br />As quoted at Matthew Holt's <a href="http://www.thehealthcareblog.com/2004/12/pharma-industry-veteran-on-don.html">Health Care Blog</a>, one unnamed "<em>Industry Veteran</em>" relates this solution for Big Pharma's current major problems:<br /><br /><br /><br /><blockquote><p><em>Eject from business departments the ignoramus, Ivy League MBAs who know nothing about the industry but feel they can comprehend the universe with spreadsheets.</em> </p></blockquote><p>On a related note, those MBA's and executives, in their dogged pursuit of "efficiency" (a.k.a. increased margins), do not have the expertise and ability to differentiate a haircut from a scalping. I am reminded of the healthcare research IT VP with only a bachelor's in math and master's in computer science from a second-rate school (and no training or credentials in biomedicine) who demanded cuts in expenditures for specialized biomedical knowledge databases serving R&D scientists as an "efficiency measure." The metric of "cost per user per database" was demanded for decisions about cuts. The "most expensive" ones would go. </p><p>However, considering there existed all of the following: 1) individual users of specific databases, 2) groups and teams of users that varied in composition and database selection over time depending on R&D direction, and 3) entirely-automated use by computer applications of the databases to drive user-customizable alerts for individuals, groups and teams in ever-varying and complex patterns, the simplistic metrics requested were, quite frankly, meaningless, damaging and actually deranged from the Medical Informatics perspective.</p><p>Cleverness without wisdom, a hallmark of too many non-healthcare "healthcare business specialists" and the "House of Cards" they engineer, kills companies ... and patients.</p>-- SS<br /><br />

House of coxibs: a fragile house of cards

From Arthritis Medicines and Cardiovascular Events—"House of Coxibs" by Eric Topol, M.D., JAMA. 2005;293:(DOI 10.1001/jama.293.3....

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Few Echoes From Allegations of NIH "Appearance of Corruption"

The recent <a href="http://www.latimes.com/news/printedition/la-na-nih22dec22,1,2808994.story">stories from the Los Angeles Times </a>about severe conflicts of interests affecting senior National Institutes of Health (NIH) staff, and an <a href="http://www.latimes.com/news/printedition/opinion/la-ed-nih23dec23,1,1602999.story">accompanying editorial </a>charging "the appearance of corruption," continue to be curiously anechoic.<br />The Senior Science and Technology Editor of United Press International, Dee Ann Divis, did just <a href="http://www.washtimes.com/upi-breaking/20041228-063926-6519r.htm">summarize</a> how "public faith in the science advice provided by the federal government took several hard hits in 2004, as politics and circumstance converged to undermine further the general credibility of science policy and federal researchers." She cited scientists' complaints about Bush administration influence on federal researchers and science policy, the Food and Drug Administration's (FDA's) "poor handling" of reports of adverse effects of selective serotonin re-uptake inhibitor (SSRI) anti-depressants for children, and its "lax approach" to reports of adverse effects of Cox-2 inhibitors. She thought that the responsibility for these latter problems could be spread around to Congress for its decision to partially fund the FDA with user fees paid by pharmaceutical companies. However, she wrote, "this is not an excuse available to the National Institutes of Health, however, where there appears to be significant financial conflicts of interest among some of the researchers."<br />Meanwhile, <a href="http://www.latimes.com/news/printedition/opinion/la-le-nih28dec28,1,2646992.story">the Director of the NIH, Elias Zerhouni, responded </a>to the LA Times articles, by touting the "stringent rules" that "we are enacting." What was most significant, however, was what his letter did not say. He did not make clear whether these rules are already in effect, and if not, when they will be. Likewise, he called for "a total ban on all outside activities with industry for a full year," but did not mention whether such a ban would actually be put in place. Zerhouni had previously resisted any blanket restriction on consulting, and <a href="http://www.biomedcentral.com/news/20040927/03">the last report I could find on the proposed ban </a>left its enactment in doubt, dependent on approval by (now outgoing) Secretary of Health and Human Services Tommy Thompson, and the Office of Government Ethics.<br />Of course, we are between Holidays, but this does not seem like an appropriate response to the magnitude of the problems reported by the LA Times. The anechoic effect continues?

Few Echoes From Allegations of NIH "Appearance of Corruption"

The recent stories from the Los Angeles Times about severe conflicts of interests affecting senior National Institutes of Health (NIH) staff...

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Political Insecurity at Provident Hospital

<a href="http://www.suntimes.com/output/news/cst-nws-security27.html">From the Chicago Sun-Times</a>: the company that just won a multi-year contract to provide security at <a href="http://www.cchil.org/Cch/providen.htm">Provident Hospital</a>, (an affiliate of Cook County Hospital) has a history of strong political connections and accusations of negligence. Digby's Security Services and the Digby family "have pumped thousands of dollars into the political campaigns of [Cook County Board President John] Stoger, his son Alderman Todd Stroger, and their 8th Ward Democratic Organization as the company made millions off government contracts -- contracts that also have brought it troubles. The firm settled two of the highest profile negligence lawsuits in CTA [Chicago Housing Authority] history, one involving Eric Morse, a boy thrown from a CHA high-rise in 1994, and one involving a child known as Girl X, who was found raped and beaten in a high-rise stairwell in 1997.." "In 2000, the ... Daley adminstration cut off Digby's security contracts at city tow yards after one of its guards admitted to taking bribes to release cars." The lowest bidder on the hospital security contract has filed a complaint that the County manipulated the bidding process so Digby's could win instead.<br />Is this another not very pretty example of health care leaders putting local political concerns ahead of providing the best services at the lowest costs at a muncipal hospital?

Political Insecurity at Provident Hospital

From the Chicago Sun-Times : the company that just won a multi-year contract to provide security at Provident Hospital , (an affiliate of Co...

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King/Drew: "Out of This Mountain of Despair a Stone of Hope?"

An update on the ongoing troubles at the King/Drew Medical Center in Los Angeles.<br /><a href="http://www.latimes.com/news/opinion/la-ed-kingdrew26dec26,0,7046963.story">The Los Angeles Times published an editorial </a>proposing major changes, particularly in the hospital's leadership, to address its ongoing problems. The Times editorial proposed that the hospital's executives should report to a dedicated health authority rather than to the County Board of Supervisors. <a href="http://www.latimes.com/news/local/kingdrew/la-me-kdday1dec05,0,5281026.story">A Times investigative report </a>had suggested that the Board of Supervisors neglected severe quality problems at King/Drew due to fear of the political cost of challenging the hospital's entrenched leadership. The editorial proposed bringing in the University of California - Los Angeles to help run the teaching programs at the hospital. These programs are now run by the <a href="http://www.cdrewu.edu/">Charles R. Drew University of Medicine and Science</a>. On its watch, the surgery, radiology, and neonatology training programs have lost their accreditation, and the <a href="http://www.msnbc.msn.com/id/4780341/">hospital got an overall "unfavorable" rating from the Accreditation Council for Graduate Medical Education (ACGME) </a>. Finally, the editorial proposed restoring the institution's clinical focus on the serious health problems prevalent in its geographic area.<br />(The quote, which appears in the editorial, is of Dr. Martin Luther King.)

King/Drew: "Out of This Mountain of Despair a Stone of Hope?"

An update on the ongoing troubles at the King/Drew Medical Center in Los Angeles. The Los Angeles Times published an editorial proposing maj...

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Bursting the Balloons

Here's yet another story about how health care executives can hide bad news which might have slowed their cash flow, and then delay taking any responsibility for their actions.<br />Based on an ongoing grand jury investigation, The <a href="http://www.boston.com/business/technology/biotechnology/articles/2004/12/26/stents_sold_despite_high_failure_rates">Boston Globe reported </a>how Boston Scientific Corporation continued to ship coronary artery stents in 1998 even though its leaders knew that internal testing showed that 10% of the balloons used to insert the stents were failing. During a conference call, the Boston Scientific CEO admitted "we're shipping adulterated product, and we cannot do that." Instead of halting shipments, and recalling stents already shipped, however, Boston Scientific executives decided to "engage" with the FDA to delay a recall. The company also sent a "Dear Doctor" letter reminding physicians to insert the stents using proper procedures, which implied that stent failures were due to incorrect placement procedures. There was no evidence that this was the case. The letter failed to mention the balloons' 10% failure rate, or that Boston Scientific had made changes to the stent manufacturing process that the FDA had not approved. Meanwhile, Boston Scientific was shipping stents worth about $1.5 million a day, and physicians, unaware of these issues, were continuing to insert apparently defective stents from existing stocks.<br />The criminal investigation of Boston Scientific has gone on for six years without any clear results. The CEO of Boston Scientific, in fact, had predicted that it would be a long time before the company paid any penalty for its actions, "another three or four years and ... Boston Scientific would then settle with a consent decree and a fine."

Bursting the Balloons

Here's yet another story about how health care executives can hide bad news which might have slowed their cash flow, and then delay taki...

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The Anechoic Effect and Conflicts of Interest at the NIH

The <a href="http://www.latimes.com/news/nationworld/nation/la-na-nih22dec22,0,7519657.story?coll=la-home-headlines">articles published by the Los Angeles Times </a>about serious conflicts of interest affecting senior NIH scientists have not yet received much notice. A Google News search reveals two lonely reactions, one a web duplicate of the main LA Times story, and one an audio report on NPR last night.<br />Last year, when the LA Times published <a href="http://www.anderson.ucla.edu/documents/areas/adm/loeb/04a23.pdf">"Stealth Merger: Drug Companies and Government Medical Research," </a>the response was also very slow. It took about a month for major-market east coast newspapers to pick up the story. This seemed to be an example of what my colleague, Russ Maulitz, dubbed the "anechoic effect." Stories about the mismanagement of health care organizations tend to vanish without an echo.<br />Of course, once the Congressional investigations of the NIH started last year, media interest picked up. But, as the investigations faded away, so did attention to them. The bitter irony is that one reason the investigations waned is that their leaders left government to take prominent positions in the industry whose interactions with government they had tried to plumb.<br />Rep James Greenwood, who lead the House Energy and Commerce Subcommittee on Oversight and Investigations, <a href="http://www.house.gov/greenwood/press_releases/2004/pr041115.html">accepted the Presidency of the Biotechnology Industry Organization</a>. Rep. W. J. "Billy" Tauzin, chair of the House Energy and Commerce Committee, now is <a href="http://www.phrma.org/mediaroom/press/releases/15.12.2004.1104.cfm">President and CEO of the Pharmaceutical Research and Manufacturers of America.</a><br />Finally, NIH Director Elias Zerhouni did announce a future <a href="http://www.nature.com/nbt/journal/v22/n11/pdf/nbt1104-1331.pdf">temporary one-year moratorium </a>on NIH officials consulting with industry, but that ban has apparently not yet taken effect. A future one-year moratorium seems hardly adequate as a response to the sorts of conflicts recounted in yesterday's Los Angeles Times articles.<br />Today, a Times editorial, <a href="http://www.latimes.com/news/opinion/la-ed-nih23dec23,0,654183.story">"The Sick NIH "</a> alleged "the appearance of corruption" at the NIH, and called for Zerhouni to resign.<br />One explanation for the anechoic effect is that we revere some of our health care institutions so much we are reluctant to criticize any aspect of them, particularly their leaders. Of course, if we truly revere them, we should defend them from inadequate or worse leadership. Some less than honorable leaders may realize this tendency, and cloak themselves in their organization's revered mantle to avoid justifiable criticism.<br />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?

The Anechoic Effect and Conflicts of Interest at the NIH

The articles published by the Los Angeles Times about serious conflicts of interest affecting senior NIH scientists have not yet received mu...

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More Outrageous Conflicts of Interest at the NIH

A year after their <a href="http://www.latimes.com/news/nationworld/nation/la-na-nihmethodbox7dec07,1,6320617.story?coll=la-headlines-nation">landmark series of articles on conflicts of interest affecting top leaders of the NIH</a>, the diligent <a href="http://www.latimes.com/news/nationworld/nation/la-na-nih22dec22,0,7519657.story?coll=la-home-headlines">investigative reporters at the Los Angeles Times have produced a new series </a>about conflicts of interest affecting senior scientists at the NIH.<br />What they found was as outrageous as what they reported last year.<br />They found that senior NIH scientists were collecting hundreds of thousands of dollars in consulting fees and stock from industry. Some of these researchers never reported what they received. Some were involved in research directly relevant to products marketed by the companies who paid them. Some publicly praised the companies products in their capacity as NIH scientists, without mentioning their ties to the companies.<br />For example, the Times reported three cases.<br /><a href="http://www.latimes.com/news/nationworld/nation/la-na-sunderland22dec22,1,7074780.story?coll=la-home-headlines">Dr. P. Trey Sunderland III </a>received more than $500,000 from Pfizer. He did not report any of this income to the NIH. He was running an NIH study of Alzheimer's disease with which Pfizer collaborated. He publicly endorsed Aricept, made by Pfizer, during a presentation at the NIH, without mentioning his ties to the company.<br /><a href="http://www.latimes.com/news/nationworld/nation/la-na-liotta22dec22,1,2069837.story?coll=la-home-headlines">Dr. Lance A Liotta and Dr. Emanuel F. Petricoin III </a>became paid consultants for Biospect Inc, abiotechnology company working on diagnostic technology. Liotta received about $70,000 from Biospect. Both had previously worked on a project to develop better blood tests for ovarian cancer with Correlogic, a competitor of Biospect. Correlogic tried to set up a cooperative research agreement with the NIH, but after Liotta and Petricoin began consulting for its competitor, found its progress blocked by one bureaucratic obstacle after another.<br /><a href="http://www.latimes.com/news/nationworld/nation/la-na-klein22dec22,0,3481773.story?coll=la-home-headlines">Dr. Harvey G. Klein </a>received about $240,000 in fees plus stock options from five companies in the blood products field. One was Haemonetics, which makes leukocyte filters for blood transfusion. Klein got $60,000 from Haemonetics, plus stock options from 1999 to 2003. Klein publicly backed universal leukocyte filtering of transfused blood in his capacity with the NIH, without mentioning his conflict of interest. Klein also received money from two companies that made red blood cell substitutes. He publicly endorsed such substitutes at an NIH conference, and in a New England Journal article in his capacity with the NIH, without, again, mentioning any conflicts of interest.<br />These conflicts of interest are particularly outrageous because:<br />The NIH is obviously extremely influential in medical research, and the actions of its leaders and top scientists clearly influence medical practice.<br />The NIH used to have such a pristine reputation, and still has rigorous requirements for its small-fry to report conflicts of interest. (For example, I have served on NIH study sections, and am required to disclose even the smallest conflict of interest that could affect my grant reviews, and am barred from reviewing any grant for which I have the slightest conflict of interest).<br />As mentioned in this series, and the previous series, the NIH apparently tried to cover up the changes in its policy in the mid-1990's that allowed researchers and top officials to collect large amounts of money as consulting.<br />And finally, the amounts of money involved are so substantial...<br />Have they no shame?

More Outrageous Conflicts of Interest at the NIH

A year after their landmark series of articles on conflicts of interest affecting top leaders of the NIH , the diligent investigative report...

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NIH: "No one seems to have studied long-term safety of NSAIDS"

In "<a href="http://www.philly.com/mld/philly/living/health/10465103.htm?1c">Naproxen study halted by NIH</a>" (Rick Weiss, Washington Post, Tue, Dec. 21, 2004) it is reported regarding the new findings about naproxen that:<br /><br /><span style="font-family: arial;"></span><br />That's a significant indictment of the way postmarketing surveillance is now conducted by the government and pharmaceutical industry, including the makers of OTC and generic drugs. There's likely little interest in making the significant investments to study OTC and generic drugs such as the NSAIDS, indicating some other mechanisms to accomplish surveillance of present and future "consumer medicines" for uncommon adverse effects (which can cause signficant actual harm through sheer volume of users) would be very helpful.<br /><br />It would also help to study the drugs thoroughly <em>before</em> they become OTC/generic.<br /><br />National-scale EMR, anyone?<br /><br />-- SS<br /><br /><span style="font-family: arial;">Addendum: the Dec. 1, 2004 JAMA article "</span><a href="http://psychrights.org/Research/Digest/Science4Sale/JAMAPostMarketingSurveillance.pdf"><span style="font-family: arial;">Postmarketing Surveillance - Lack of Vigilance, Lack of Trust</span></a><span style="font-family: arial;">" by Fontanarosa, Rennie and DeAngelis discusses the defects in today's postmarketing surveillance processes in some detail.</span> The following passage is particularly interesting:<br /><blockquote>... in some cases, serious adverse drug events are quite uncommon, and detecting them accurately and using them to determine incidence rates can be difficult with the existing passive system for voluntary reporting of adverse drug events. As illustrated in another article in this issue, Graham and colleagues used data from more than 250,000 patients treated with lipid-lowering agents from January 1998 through June 2001 in 11 managed care health plans, and identified 24 patients who were hospitalized with rhabdomyolysis during treatment. By virtue of having data from drug-specific, population-based inception cohorts, the authors estimated an incidence of rhabdomyolysis of 5.34 per 10,000 person-years for cerivastatin monotherapy, and 1035 per 10,000 person-years for combined cerivastatin-fibrate use (ie, risk of rhabdomyolysis of approximately 1 in 10 patients treated with the combined therapy per year).</blockquote>The widepread use of EMR would make such analyses much easier to accomplish, and provide data of significantly greater scope and quality. Are FDA and Big Pharma paying adequate attention?<br /><blockquote><span style="font-family: arial;">"This is a very confusing situation," said Sandra L. Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, speaking to reporters at a hastily convened telephone news conference last evening. Naproxen has been on the market since 1976, Kweder noted, and "this is the first evidence we've seen that suggests there is a risk." She and other officials acknowledged, however, <strong>that no one seems to have studied the long-term safety of naproxen or, for that matter, any of the other popular painkillers</strong> known as nonsteroidal anti-inflammatory drugs.</span></blockquote>

NIH: "No one seems to have studied long-term safety of NSAIDS"

In " Naproxen study halted by NIH " (Rick Weiss, Washington Post, Tue, Dec. 21, 2004) it is reported regarding the new findings ab...

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Vested Interests in Direct-to-Consumer Drug Advertising

As a physician, my blood pressure goes up every time I see the ad about the little purple pill, or the ad involving the guy throwing the football through the old tire (but which is not about throwing, or footballs, or tires), etc., etc., etc. I am convinced that such advertisements provide almost no education to patients. But they probably persuade quite a few to pressure their physicians for drugs that they may not really need, or that may not be the best choices for them. Promoting little purple pills shoves aside the complex balancing of benefits, harms, and costs that should underly choice of therapeutic agents. For how many patients with dyspepsia or GERD will that little purple pill really work better than a generic H2-blocker or proton pump inhibitor?<br />What has made the current news about the Cox-2 inhibitors so troubling is that the drugs were advertised heavily as generally useful for arthritis, and all sorts of aches and pains. Thus, many patients for whom the drugs provided no particular advantage were exposed to their risks of adverse effects. Will the lessons learned from this episode lead to decreased, and/or more informative and realistic direct-to-consumer drug advertising?<br /><a href="http://www.nytimes.com/2004/12/21/business/media/21adco.html?pagewanted=all">The NY Times today reported </a>the extent of vested interests in keeping such direct-to-consumer advertising going. Merck's spending on advertising Vioxx was $78 million a year. Pfizer was planning to spend more than $87.6 million on advertising Celebrex this year until it canceled the campaign. $3.8 million is now spent yearly on all direct-to-consumer drug advertising. This is not a trivial business for advertising agencies. Furthermore, $110 million, about one-third of the advertising revenue of the big three network evening news programs, comes from direct-to-consumer drug advertising. It remains to be seen whether such vested interests will resist down-sizing direct to consumer advertising, or at least making it more realistic and less like "marketing for Cheerios."

Vested Interests in Direct-to-Consumer Drug Advertising

As a physician, my blood pressure goes up every time I see the ad about the little purple pill, or the ad involving the guy throwing the foo...

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The End of Blockbuster Drugs?

In "<a href="http://www.thestreet.com/_yahoo/comment/adamfeuerstein/10200068.html">The End of Blockbuster Drugs</a>", Adam Feuerstein of TheStreet.com writes:<br /><br /><br /><br /><br /><br /><span style="font-family:arial;"><blockquote><p><span style="font-family:arial;">The FDA <a href="http://www.thestreet.com/tech/adamfeuerstein/10044113.html">approved Iressa in 2003</a> under a program that allows drugs for serious, life-threatening diseases like cancer to be approved based on certain surrogate markers for clinical benefit ... Under the so-called subpart H regulatory guidelines, the FDA approved Iressa with the condition that AstraZeneca would run another clinical study to show that Iressa's ability to shrink tumors would lead to improved survival, which is the gold standard in cancer drug efficacy ... </span></p><p>AstraZeneca ran that confirmatory study, and it failed. Now, the FDA has to decide whether to pull Iressa off the market ... <span style="font-family:arial;">The Iressa mess could have been avoided back in 2003 if AstraZeneca had conducted a randomized, controlled study (<em>Randomized Clinical Trial </em>or RCT) of the drug, such as comparing Iressa with a placebo or best supportive care to see if the drug improved survival. If that study had been conducted and the results had turned out as those released Friday, the FDA probably wouldn't have approved Iressa, and therefore, wouldn't be facing a difficult decision today. AstraZeneca could have put together a controlled study of Iressa; after all, that's exactly what OSI and Genentech did.</span><br /><br /><span style="font-family:arial;"><br /><br />My point here is not to be a Monday morning quarterback. Instead, looking ahead, <strong>I think that some top FDA officials will use the Iressa situation to argue even more strongly against the use of single-arm, uncontrolled studies as the basis for future drug approvals</strong>. While everyone wants to see the FDA work quickly to approve life-saving drugs, we should also be concerned when the agency approves drugs that turn out to be nothing more than expensive placebos, and often with dangerous side-effects, to boot.</span></p><p></span></p></blockquote><br /><br />Caution should be exercised along this line of thought regarding use of non-RCT studies. There is a marked asymmetry between evaluating a drug for positive effects vs. evaluating a drug's risk.<br /><br /><br /><br />When a successful RCT shows a therapeutic drug effect at p<.05, this means that there is only 1 chance in 20 (5/100) or less that the drug is actually not useful, the downside being that there's 1 chance in 20 (or less) that the drug is simply a waste of money. This is the basis for using the RCT and setting the confidence level at p<.05 in the drug approval process. <br /><br /><br /><br />However, if some other non-RCT (e.g., a retrospective analysis of insurance company records) suggests adverse effects, but p>.05 , dismissing such an analysis is quite cavalier, as the downside is potentially quite serious. This is especially true in the setting of "blockbusters" with millions of users, where the absolute number of affecteds could be relatively large (e.g., 100,000 MI's and CVA's).<br /><br /><br /><br />The FDA analysis of a Kaiser Permanente database reportedly showing that 27,785 heart attacks and sudden cardiac deaths might have occurred due to VIOXX was controversial. In an <a href="http://www.boston.com/business/articles/2004/10/09/ceo_defends_merck_on_vioxx/">interview in the Boston Globe</a>, Merck CEO Raymond Gilmartin refutes the study's findings because it was based on a review of medical records, not a clinical trial. "You can't take a study like this and take a patient population and extrapolate those kinds of numbers," he said. "It's just not valid to do that." Such retrospective studies are subject to confounding factors in the data.<br /><br /><br /><br /><strong>This does not make such studies automatically wrong, however</strong>, and pharmaceutical companies and regulatory agencies that ignore such studies on a dogmatic basis (due to a belief in the absolute ascendancy of controlled clinical trials) do so at their own peril. (In fact, in this case the retrospective studies were shown to be correct by later RCT's and the resultant VIOXX withdrawal has significantly harmed a company with a century's reputation for excellence.)<br /><br /><br /><br />Such non-RCT, retrospective studies need to be factored into the 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. In recent testimony to the a U.S. Senate committee, 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. "<strong>What it does is it protects the drug</strong>," he said.<br /><br /><br /><br />Let's hope FDA understands the asymmetry between testing drugs for efficacy via small RCT vs. monitoring them for adverse effects in large populations.<br /><br />

The End of Blockbuster Drugs?

In " The End of Blockbuster Drugs ", Adam Feuerstein of TheStreet.com writes: The FDA approved Iressa in 2003 under a program tha...

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Job descriptions as a window into deficient IT strategy

<p>I will periodically post job descriptions showing how business IT thinking applied to clinical or biomedical research computing environments is as appropriate as the tools of psychiatry applied to treat brain tumors, or neurosurgery used to treat neurosis. (Both are medicine, and both are concerned with the same body part - the brain - but....) </p><p>Below is an example of why biomedical research is likely more costly and less productive than it should be. IT support staff with bachelor's degrees are busy supporting <em>visions</em>, following "<em>business process</em>", developing "<em>information architectures</em>" (whatever they are) ... instead of supporting real clinicians and scientists on a peer-to-peer level (which would require more than bachelor's degrees), focusing on results, and communicating in language that their 'customers' can understand.</p><p>What follows is an actual job description from a biomedical research setting:<br /><br /><ul><span style="font-family:arial;font-size:85%;">Director of Research Information Architecture</span> <p></p><p><span style="font-size:85%;"><span style="font-family:arial;"><strong>Job Description: </strong></span><span style="font-family:arial;">The Director of Research Information Architecture reports into the Senior Director of Research Shared Technologies and Services. In this role, the Director leads a team of architects to <em>define and communicate <strong>the vision</strong></em> for <strong>information, technical and solutions architectures</strong> within the organization. Working with the Enterprise Architects and functionally-aligned IS groups, the Director will define and implement processes, products, and services <strong>that support the agreed vision</strong>. This includes compliance and metrics processes, <strong>strategic divisional capabilities</strong>, new technology evaluation and introduction processes, and the definition and implementation of new shared services. As part of these deliverables, clear business value must be demonstrated through the use of business cases and results reporting. </span></span></p><span style="font-family:arial;"><p><span style="font-size:85%;"><strong>Qualifications: Bachelor’s degree (or equivalent)</strong>, and at least 10 years of relevant work experience with a demonstrated record of leadership, knowledge across a number of technology areas, and a business focus. Ability to define, communicate, and obtain agreement, both within the IS groups as well as the business areas, on <strong>strategic architectures and processes</strong>. Strong skills in <strong>business process</strong>, <strong>information</strong>, <strong>technology</strong> and <strong>solution</strong> architectures.<br /><br /></span></p></span></ul><p>As a Medical Informatics specialist, I have little idea what terms such as "information, technical and solutions architectures", "strategic divisional capabilities", and "strategic architectures and processes" mean. Ontologies, vendors, and software apps, perhaps? Armor on humvees? Who knows? Yet, these are the job descrptions of people whom clinicians will depend on to select, implement and manage the clinical IT that medical care provision and medical research is becoming increasingly dependent upon.</p><p>By the way, what is a "Bachelor's Degree equivalent?" Do such terms get used when referring to medical training and degrees?</p><p>-- SS<br /><br /></p>

Job descriptions as a window into deficient IT strategy

I will periodically post job descriptions showing how business IT thinking applied to clinical or biomedical research computing environment...

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Healthcare IT Becomes an Adolescent ... or has it?

By Jim Molpus, for HealthLeaders News, December 16, 2004<br /><br /><br /><br />Healthcare IT Becomes an Adolescent<br /><br /><br /><br />Or has it?<br /><br /><br /><br /><ul><span style="font-family:arial;"></span></ul><ul><span style="font-family:arial;"></span></ul><ul><span style="font-family:arial;"></span></ul><ul><span style="font-family:arial;"></span></ul><ul><span style="font-family:arial;">Healthcare clinical information technology has been a kid for a long time. The parents-vendors, the government, providers and payors alike-have beamed proudly at the thought that this gangly kid would one day contribute to society. But so far the kid has just sort of skated along.</span><br /><br /><span style="font-family:arial;"></span><br /><br /><span style="font-family:arial;">After all, these parents have shelled out a lot of money, worried incessantly and planned diligently to raise the child. Now they are hoping the kid will realize that the time has come to learn how to work as part of a team and just generally grow the heck up ... After years of putting off large IT projects because of concerns about compatibility, cost and integration, some of the largest health systems in the country spent hundreds of millions on products with acronyms like CPOE, EMAR and PACS. Wisconsin-based Aurora Health Care is spending $163 million to create a common electronic medical record for its 14 hospitals. Baylor Health Care System in Dallas is launching a five-year, $119 million IT initiative. Allina Hospitals & Clinics in Minneapolis will shell out some $200 million over four years. And giant Sutter Health in California will spend a whopping $1.2 billion in the next decade.</span><br /><br /><span style="font-family:arial;"></span><br /><br /><span style="font-family:arial;"><strong>On the implementation side, the industry learned from past mistakes, with many large projects making sure to include clinicians in selection and system design issues, and in providing enough support when systems went online.</strong></span></ul><ul><span style="font-family:arial;"><br /><br /></span></ul><br /><br />Where is the evidence that the industry has "learned from past mistakes?" That would imply a significant body of literature on the lessons learned from healthcare IT failure.<br /><br /><br /><br />A google search on "health IT failure", "healthcare IT failure", "healthcare information technology failure", "healthcare IT problems", etc. brings up very little on a worldwide basis.<br /><br /><br /><br />"Including clinicians in selection and system design issues" is so obviously necessary that one has to ask why this hasn't been the case for the <i>past several decades</i>. One can go further and ask if clinicians are being "included" in selection and design issues in superficial ways, not as true leaders, in order to maintain MIS hegemony over this juicy piece of hospital territory.<br /><br /><br /><br />From the same journal, HealthLeaders News, Nov. 2004:<br /><br /><br /><br /><ul><span style="font-family:arial;"><a href="http://www.healthleaders.com/magazine/feature1.php?contentid=59807">Big Spenders</a>: The industry is replete with examples of IT projects that have run over budget, missed deadlines, and either stalled or failed outright. Many computerized order-entry projects founder, according to data compiled by KLAS Enterprises LLC, an Orem, Utah software evaluator. In its analysis of how some 200 hospitals use their CPOE systems, KLAS gave top ranking to Evanston (Ill.) Northwestern Healthcare last spring. But the vast majority of the hospitals surveyed barely registered on KLAS' usage scale, which analyzes how deeply the order systems penetrate a hospital's clinical work flow. In another widely cited example, Cedars-Sinai Medical Center, Los Angeles, scrapped its order-entry effort in 2003 after physicians rebelled.</span></ul><br /><br /><br /><br />Another problem is that there are few if any metrics on the efficiency of healthcare IT implementations. There is also little cross-institutional comparison. How would one tell if a project that is deemed "successful" was implemented at the best possible cost, or filled with costly delays, false go-lives, patchwork, massive additional expenditures, or even outright corruption?<br /><br /><br /><br /><a href="http://www.computerweekly.com/articles/article.asp?liArticleID=133699&amp;amp;liArticleTypeID=1&liCategoryID=6&liChannelID=28&liFlavourID=1&sSearch=&nPage=1#">The experiences in the U.K.</a> suggest healthcare IT is far from being an "adolescent."<br /><br /><br /><br />If the great body of literature that the Healthcare IT industry is using to avoid multimillion dollar mistakes is hiding somewhere, could someone please point me to it?<br /><br /><br /><br />-- SS<br /><br />

Healthcare IT Becomes an Adolescent ... or has it?

By Jim Molpus, for HealthLeaders News, December 16, 2004 Healthcare IT Becomes an Adolescent Or has it? Healthcare clinical information tech...

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Money Trumps Mission

<a href="http://www.nytimes.com/2004/12/19/magazine/19HOSPITAL.html">The New York Times Magazine </a>published an article about how not-for-profit hospitals charge indigent patients their highest rates, and then often aggressively pursue payment. The author, Jonathan Cohn from the New Republic, focused on the Advocate and resurrection not-for-profit, religiously affiliated hospital systems in the Chicago area. Cohn explained how hospitals negotiate with insurers by raising their "rack rates" for services, and then allowing larger discounts. However, uninsured patients are charged the artificially elevated "rack rates," even though most are uninsured because they are poor and can't afford insurance. Furthermore, after charging some of the poorest patients the highest rates, the hospital systems often pursue payment by using collection agencies, filing law-suits, and putting liens on property.<br />This seems to be another example of not-for-profit organizations abandoning their mission in pursuit of money. That these organizations are often lead now by businessmen who command huge salaries ($2.3 million in the case of Resurrection CEO Joseph Toomey) just underlines how far they have strayed.<br />Is this an inevitable consequence of the increased competitive pressure on hospitals? Cohn quoted Jacob Hacker from Yale, "We can't ask nonprofits to be more like for-profits in ways that we like - efficient, responsive, aggressive - without expecting that they will also become more like for-profits in the ways that we don't: rapacious, hardheaded, and, yes, sometimes selfish."<br />But are efficiency and compassion necessarily be opposed? Could better regulation, and better governance and different leadership of non-profits yield organizations that hold to their mission without being fiscally irresponsible? We won't know until these alternatives are thoroughly aired.

Money Trumps Mission

The New York Times Magazine published an article about how not-for-profit hospitals charge indigent patients their highest rates, and then o...

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"Web of Conflicts"

California's new initiative to fund stem cell research has already been mired in politics. The announcement of the new chairman of the committee overseeing the institute has just increased the level of controversy, <a href="http://www.nytimes.com/2004/12/18/national/18stem.html">according to the New York Times</a>. The new chair, Robert Klein, is a wealthy real-estate developer with a law degree, but with no apparent health care expertise. He does have strong ties to the Democratic party, and contributed to the campaigns of three of the politicians, including Republican Governor Arnold Schwarznegger, who supported him for the chairmanship position. Other members of the oversight committee have been criticized for their financial ties to biotechnology and pharmaceutical firms, in a "web of conflicts," per the Foundation for Taxpayer and Consumer Rights. The vice chairman was the founder of Chiron Corp, (which owned the British factory whose production of flu vaccine was shut down this year, leading to the flu vaccine shortage). We shall see how well this committee oversees the spending of $300 million a year on stem cell research.

"Web of Conflicts"

California's new initiative to fund stem cell research has already been mired in politics. The announcement of the new chairman of the c...

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Silencing the "Whistle Punks"

As is mentioned in our blog description (unless it has fallen into another soft-ware black hole, as it does periodically), a major manifestation of the current health care system dysfunction are attacks on free speech and academic freedom in the health care context. The covering up of unfavorable data on selective serotonin uptake inhibitor (SSRI) anti-depressants was only the latest example of this.<br />In trying to preserve the rights of researchers to present their findings, teachers to teach, and clinicians to talk to their patients, and expose quality problems, we can use all the help we can get. But we haven't gotten much help. That's why this story is so relevant.<br /><a href="http://www.nytimes.com/2004/12/18/national/18aclu.html">Today the NY Times reported </a>about troubling problems with the leadership of the American Civil Liberties Union (ACLU), which one might have thought ought to have been a champion for free speech in health care (as well as elsewhere). The pivotal factor was the decision of the ACLU executive director to use sophisticated software to develop detailed data files on everyone who contributed more than $20 to the organization, in apparent violation of the ACLU privacy policy, and worse, apparently in direct contradiction to the organization's core mission, which includes protecting privacy rights of American consumers. For the leadership of a not-for-profit to take actions in direct contradiction to the organization's core mission is a violation of their duty. Furthermore, when the Vice President of the ACLU board, Michael Meyers, found out and objected, the first thing done was to change the privacy policy as posted on the web. Finally, when the Vice President tried to get on a board executive committee conference call on the data mining operation, as was apparently his right, he was thrown off the call.<br />Where did my title come from? The name given to dissident board members like the Vice President by other board members, "whistle punks."<br />No wonder the ACLU has not been of much help on the free speech in health care front.

Silencing the "Whistle Punks"

As is mentioned in our blog description (unless it has fallen into another soft-ware black hole, as it does periodically), a major manifesta...

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Another Cox-2 Takes a Fall

<a href="http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7127484">Hot off the press are wire-service reports </a>that an ongoing trial of Pfizer's Celebrex showed a greater than two-fold increase in risk of myocardial infarction (heart attack) for patients taking the drug versus placebo. Celebrex, like Vioxx, another Cox-2 inhibitor, has been heavily promoted for general use as an analgesic and anti-inflammatory, not just as a niche drug for patients who cannot tolerate standard non-steroidal anti-inflammatory drugs (NSAIDS).<br />In fact, there has been evidence around for a while that both widely used Cox-2 inhibitors had important rates of adverse effects. <a href="http://www.cmaj.ca/cgi/content/full/167/10/1131">A meta-analysis published in 2002 in the Canadian Medical Association Journal </a>warned that both drugs produced statistically insignificant<em> increases</em> in total mortality compared to conventional NSAIDS (whereas, if their main difference with conventional drugs was decreased risk of gastrointestinal side effects, one would expect the Cox-2 inhibitors to yield the same, or lower mortality rates as do regular NSAIDS). ("Statistically insignificant" here means that the differences in mortality could have been produced by chance differences between the patients taking different drugs.) More strikingly, both drugs also produced <em>statistically significant increases</em> in serious adverse events.<br />If nothing else, maybe this will alert the public to be skeptical of all those expensive "direct to consumer" advertisements now epidemic on US television. Such skepticism would make it easier for physicians to persuade their patients that they don't necessarily need the newest, and most heavily promoted drug for every ailment.

Another Cox-2 Takes a Fall

Hot off the press are wire-service reports that an ongoing trial of Pfizer's Celebrex showed a greater than two-fold increase in risk of...

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Conflicts of Interest

Marc on the listserv put up an important link to a paper: <br /><br />"Ethical Guidelines for Managing Conflicts of Interest in Health Services Research" <br /><br />It was the product of <a href="http://www.academyhealth.org/">AcademyHealth</a>, which is "the professional home for health services researchers, policy analysts, and practitioners, and a leading, non-partisan resource for the best in health research and policy." <br /><br />I haven't fully reviewed it. A full PDF is downloadable at the above link. The ethical guidelines committee is made up of lawyers, physicians, PhD's, and others. <br /><br />Egan

Conflicts of Interest

Marc on the listserv put up an important link to a paper: "Ethical Guidelines for Managing Conflicts of Interest in Health Services Res...

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Finally, an Ethical Framework for Academic Health Center Leaders

Some of the intrepid health care renewal bloggers just published an <a href="http:///www.academicmedicine.org/cgi/eletters/79/11/1056">electronic letter </a>in response to a nice <a href="http://www.academicmedicine.org/cgi/content/full/79/11/1056">article by Chervenak and McCullough in Academic Medicine</a>. The article proposed an ethical framework for leaders of academic health centers (AHCs), and is definitely worth reading. Our comment was that it was disturbing that this article, as its introduction pointed out, was the <em>first ever</em> to propose that these leaders should need such an ethical framework.

Finally, an Ethical Framework for Academic Health Center Leaders

Some of the intrepid health care renewal bloggers just published an electronic letter in response to a nice article by Chervenak and McCullo...

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The Drug-Trial Registry

<p><span style=";font-family:Arial;font-size:85%;" >Kudos to Shannon!</span> </p> <p><span style=";font-family:Arial;font-size:85%;" >"The Drug-Trial Registry" at the <a href="http://www.nytimes.com/2004/12/12/magazine/12DRUG.html?oref=login&oref=login">New York Times Magazine</a>:</span><br /><br /><span style=";font-family:Arial;font-size:85%;" >(requires free login)<br /><br /></span></p> <p><span style=";font-family:Arial;font-size:85%;" >Shannon provides a nice snapshot of the issues we have reviewed on the listserv.<br /><br /></span></p> <ul> <li>Problems with negative studies</li> <li>The FDA's role</li> <li>Pharma vs. independent (DTR) database</li> <li>Study phases and data availability<br /><br /> </li> </ul> <p><span style=";font-family:Arial;font-size:85%;" >The exposure in NYTM in and of itself is nice to see. Very broad acceptance will be necesary in order to change the status quo (especially when pharma just hired a new top gun <a href="http://www.bloomberg.com/apps/news?pid=10000103&sid=aPlHzyV2PM98&refer=us">lobbyist</a>).<br /><br /></span></p> <p><span style=";font-family:Arial;font-size:85%;" >Egan</span> </p>

The Drug-Trial Registry

Kudos to Shannon! "The Drug-Trial Registry" at the New York Times Magazine : (requires free login) Shannon provides a nice sn...

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New Worries About Drug Safety

The EMR will likely be of great value in improving the large-scale postmarketing surveillance of new drugs. However, there seems to be a near-complete lack of EMR expertise (especially in Medical Informatics specialists) in the pharmaceutical industry. One must wonder why an important specialty whose training is funded in many Ivy-League universities by NIH for well over a decade, and privately by many other reputable universities, is poorly-represented in industry.<br /><br /><br /><br /><FONT FACE="ARIAL"><UL><A HREF="http://www.forbes.com/healthcare/2004/12/16/cx_mh_1216safety.html">New Worries About Drug Safety</A>: Forbes<br /><br /><br /><br />NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market. <br /><br /><br /><br />The survey, which was obtained by two non-profit advocacy groups, the Union of Concerned Scientists and Public Employees for Environmental Responsibility, under the Freedom of Information Act, has some severe limitations--most notably, that only 47% of the 846 FDA staff who were queried responded to the late-2002 survey. Still, it would seem to boost the case of FDA whistleblower David Graham, who has warned about the current system for insuring drug safety. (See: Face of the Year: David Graham) <br /><br /><br /><br />FDA officials were not immediately available for comment. <br /><br /><br /><br />Graham, a proponent of drug safety, said in testimony before a Senate committee, that the current drug safety monitoring system could not prevent another case like the withdrawal of Vioxx, the Merck (nyse: MRK - news - people ) arthritis drug, that was pulled from the market because it raised the risk of heart attack and stroke with long-term use. The drug had been on the market for five years. <br /><br /><br /><br />...<B>In previous interviews, Graham has outlined the problems with the system. Doctors report side effect voluntarily, and the FDA only finds out about a small fraction--at most one-tenth--of these side-effect cases. This makes it incredibly difficult to figure out how often a problem is occurring. With Vioxx, there was an added problem, because heart attacks and strokes are common in the same arthritis patients who took the drug for pain. Therefore, it's possible they could slip under the radar entirely.</B></UL></FONT><br /><br /><br /><br />At present, the FDA depends on the voluntary participation of clinicians to both <i>recognize</i> and then <i>report</i> the side effects of drugs, such as in the <A HREF="http://www.fda.gov/medwatch/">Medwatch</A> program. Symptoms observed might not be recognized as drug-related. For example, MI's and CVA's in patients taking COX-2 inhibitors would likely not have been recognized as dangerous side effects until recent announcements regarding VIOXX. <br /><br /><br /><br />The scope of the drug surveillance "radar screen" will be expanded exponentially when EMR technology becomes commonplace, providing significantly more data for analysis for possible drug side effects. Pharma needs to pay attention to this technology.<br /><br /><br /><br />In a large pharma company I recently worked for, the field of Medical Informatics was nearly unknown to scientific, information technology, and HR/talent management executives and staff. I was hired only to run a scientific library before being laid off in a large reduction in force. I then was turned down for roles in the adverse events data collection and analysis section, characteristically enough, by a former FDA senior adverse events official retained by the company.<br /><br /><br /><br />-- SS

New Worries About Drug Safety

The EMR will likely be of great value in improving the large-scale postmarketing surveillance of new drugs. However, there seems to be a ne...

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Politics and the NIH Nevirapine Study in Africa

As the White House prepared an initiative to combat AIDS in Africa, <a href="http://www.newsday.com/news/health/wire/sns-ap-aids-drug,0,931517.story?coll=sns-ap-health-headlines">the Associated Press reported </a>that top NIH officials glossed-over severe problems with an ongoing study of nevaripine to prevent maternal-fetal transmission of the HIV virus. An NIH consultant found major problems with a site in Uganda in 2002. Westat Inc., hired to audit the site, found failure to get patients' consents for the study, under-reporting adverse drug events, and administration of wrong drug dosages.<br />But Dr. Edward Tramont, the Director of the AIDS Division of the NIAID, over-ruled objections to continuing the project, "I want this restriction lifted ASAP because this site is now the best in Africa run by black Africans and everyone has worked so hard to get it right..." Further, he wrote it was important to encourage Africans' fight against AIDS "especially when the President is about to visit them." The Deputy Director of the Division, Dr. Jonathan Kagan objected, "we should not be motivated by political gains and it's dangerous for you, of all people, to be diminishing the value of our monitors." Nonetheless, Tramont erased concerns about the Ugandan site from an official report that wound up at the FDA. The NIH never warned the White House.<br />Further documents about this case are available <a href="http://wid.ap.org/documents/nevirapine2.html">here</a>.<br />Here it appears that politics once again trumped good research methods, and possibly patients' safety.

Politics and the NIH Nevirapine Study in Africa

As the White House prepared an initiative to combat AIDS in Africa, the Associated Press reported that top NIH officials glossed-over severe...

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How to prevent vaccine shortages

The economics of vaccines are complex, but in the end differ little from other products. In this article from the <a href="http://www.newyorker.com/talk/content/?041220ta_talk_surowiecki">New Yorker</a>, James Surowiecki notes the difference between "push" and "pull" funding in science. He states<br /><br /><br /><br /><blockquote><I>Instead of deciding in advance which vaccine candidates deserve funding, however, a government could commit itself to paying a reasonable price for whatever vaccine turns out to work, effectively guaranteeing a market for it. Drug companies would thus have an incentive to invest in promising candidates. Rather than pushing vaccines into existence, this approach pulls them.<br /><br /></i></blockquote><br /><br />However, this merely makes complex what is in actuality a fairly simple truism. When the government forces down the price of something in order to make it "cheaper", a shortage is likely (if not inevitable). Instead, if a reasonable price is obtained, the product becomes more available.<br /><br /><br /><br />Government intervention, I would argue, cannot remedy scarcity (except briefly), but it can intensify it.

How to prevent vaccine shortages

The economics of vaccines are complex, but in the end differ little from other products. In this article from the New Yorker , James Surowi...

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Mismanagement Are Us

The media today contains a host of stories about health care mismanagement at all sorts of organizations.<br /><br /><strong>Not for Profit RI Blue Cross Fights to Keep Paying Directors</strong><br /><br />The <a href="http://www.projo.com/news/content/projo_20041215_blue15.eb905.html">Providence Journal reported </a>that not-for-profit RI Blue Cross is fighting in court to continue providing health insurance to its own board members, including the chair, also the head of the RI AFL-CIO, despite a new law that forbids compensation to board members without state approval. RI Blue Cross , which has about 70% of the health insurance market in little Rhode Island, fired its CEO this year after news reports of his huge salary, receipt of a $600,000 no-interest loan which he did not pay back, and, receipt of free acupuncture treatments from a practitioner who wanted to influence Blue Cross reimbursement policies. Meanwhile, Blue Cross was paying health care professionals poorly (often less than Medicare), while hiking premiums at double-digit rates.<br /><br /><strong>"Where's the Outrage Over King/Drew?"</strong><br /><br />King/Drew Medical Center in Los Angeles, run by Los Angeles County, was <a href="http://www.latimes.com/news/local/kingdrew/la-me-kdday1dec05,0,5281026.story">documented by the Los Angeles Times </a>to have a history of medical errors and systemic quality problems, accompanied by high costs, and chronic personnel difficulties, (most strikingly 120 workers' compensation claims involving injuries incurred by falling out of chairs.) Today, <a href="http://www.latimes.com/news/opinion/la-oe-morrison15dec15,0,3878267.column?coll=la-home-utilities">op-ed columnist Pat Morrison wondered </a>at the silence of the politicians responsible for its oversight. Perhaps, they were afraid to criticize "the most symbolic and substantive institution in the black community", (per Asseymblyman Mervy Dymally). Morrison concluded that to politicians, "saving the hospital and its jobs matter more than saving the patients whose lives depend on it."<br /><br /><strong>British Foundation Hospital Trust Loses its Chair</strong><br /><br />The chair of one of the new foundation hospital trusts in the UK was fired by the external Monitor organization after it incurred more than an 11 million pound deficit since April, <a href="http:///www.guardian.co.uk/uk_news/story/0,3604,1373818,00.html">reported the Guardian</a>. The trust's board and the Monitor organization have been exchanging charges about who is to blame. The Monitor accused the trust's board of covering up the deficit, after initially projecting a large surplus.<br /><br /><strong>Medicaid Money Went for Care of Dead People</strong><br /><br />Several state Medicaid organizations were accused of mistaken payments. In Colorado, millions went to pay for care of people who were already dead, <a href="http://rockymountainnews.com/drmn/legislature/article/0,1299,DRMN_37_3400136,00.html">per the Rocky Mountain News</a>. In Washington (state), 1.4 million pills, including the narcotics Vicodin and Percocet, went missing, <a href="http://seattlepi.nwsource.com/local/aplocal_story.asp?category=6420&slug=WA%20Unaudited%20Medicaid">per the Seattle Post-Intelligencer</a>.<br /><br /><strong>Flawed Defibrillator Evaded FDA Scrutiny</strong><br /><br /><a href="http://www.nytimes.com/2004/12/15/business/15device.html?hp&amp;ex=1103173200&en=1acb9230d6a94d4e&ei=5094&partner=homepage">The New York Times reported </a>how defective defibrillators escaped FDA oversight. The former CEO of Access Cardiosystems, locked in a legal battle with the company, notified the FDA late in 2003 of potentially defective products. An initial inspection did not find major problems, but when the company received more reports of problems last summer, the FDA responded failed to send inspectors back. A recall was finally ordered in November, and the company closed its doors, leaving customers, including emergency services units, scrambling to replace their now useless defibrillators.

Mismanagement Are Us

The media today contains a host of stories about health care mismanagement at all sorts of organizations. Not for Profit RI Blue Cross Fight...

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Certification in Health IT: valuable or veneer?

The need for seasoned individuals with formal training in Health Informatics is critical to the success of Electronic Medical Records and related clinical IT initiatives. Numerous universities have created formal training programs in Health Informatics as a result. However, entreprenurial individuals are also attempting to create private training and certification:<br /><br /><br /><br /><br /><br /><ul><span style="font-family:arial;font-size:85%;color:#000000;"><a href="http://www.healthitcertification.com/">Health IT Certification</span></a><span style="font-family:arial;font-size:85%;color:#000000;"> announced today its Common Body of Knowledge Outline for Certified Professional in Electronic Health Records (CPEHR) and Certified Professional in Health Information Technology (CPHIT) training. Health IT Certification provides professional training and certification for those responsible for planning, selecting, implementing, and managing electronic health records (EHR) and other health information technology (HIT).<br /><br /></span></ul><br /><br />Onsite training consists of <a href="http://www.healthitcertification.com/trainingonsite.html">three-day sessions</a> covering a broad range of topics in health informatics.<br /><br /><br /><br /><ul><span style="font-family:arial;font-size:85%;color:#000000;">The certification exam for the CPEHR (Certified Professional in Electronic Health Records) contains 75 multiple choice items from all eight domains in the CPEHR common body of knowledge (I - VIII). Candidates have 90 minutes in which to complete the exam. A passing score of 70 percent must be achieved to earn the CPEHR. The certification exam for the CPHIT (Certified Professional in Health Information Technology) contains 100 multiple choice items from all ten domains in the CPHIT common body of knowledge (I - X). Candidates have 120 minutes in which to complete the exam. A passing score of 70 percent must be achieved to earn the CPHIT.</span></ul><br /><br />One wonders how much critical knowledge can be imparted in a few days compared to several years of study and applied experience in academic training programs. One also wonders how the "diplomas" received from the several-day training courses will affect hiring of personnel into leadership roles in clinical IT, in an industry where cost-cutting seems paramount.<br /><br /><br /><br />Is this another face of the "<strong>Medical Instamatics</strong>" phenomenon, where anyone who has done something IT-related in healthcare might be viewed as an "Informatics specialist"? The Medical Instamatics phenomenon is a subcategory of the dysfunction in medicine where generic managers with no biomedical experience are deemed qualified for leadership roles at the executive level and beyond. <br /><br /><br /><br />-- SS<br /><br /><br /><br /><br /><br />

Certification in Health IT: valuable or veneer?

The need for seasoned individuals with formal training in Health Informatics is critical to the success of Electronic Medical Records and re...

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"Snakes in Suits"

From the <a href="http://www.nytimes.com/2004/12/12/magazine/12PSYCHO.html">"Year in Ideas" special issue of the New York Times magazine</a>, two psychologists, Paul Babiak and Robert Hare, have developed the <a href="http://www.b-scan.com/">"B-Scan," </a>an instrument designed to detect whether the CEO of an organization is a psychopath. The instrument is currently being field tested.<br /><a href="http://www.justice4you.org/corporate_psychos.html">Babiak, as quoted in the Vancouver Sun</a>, "The psychopath is the kind of individual that can give you the good impression, has a charming facade, can look and sound like the ideal leader, but behind the mask has a dark side. And it's this dark side of the personality that lies, is deceitful, is manipulative, that bullies other people, that promotes fraud in the organization and steals the company's money...." He fears that psychopaths are increasingly attracted to the business world because, <a href="http://www.sciencemag.org/cgi/content/summary/303/5658/621c">as per a news report in Science</a>, "the rapid pace of technological change, downsizing, and sudden growth make for a chaotic environment ripe for mistrust and manipulation."<br />Babiak and Hare have a book in the works titled "Snakes in Suits."<br />In the brief news reports available on the web there is nothing specific about the prevalence of such "snakes" in health care. If the hypothesis that a fast-paced, technological, and chaotic environment attracts psychopaths is correct, however, health care should have its fair share.

"Snakes in Suits"

From the "Year in Ideas" special issue of the New York Times magazine , two psychologists, Paul Babiak and Robert Hare, have devel...

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Healthcare Renewal and Clinical Information Technology

Information technology (IT) has long been presented as a panacea to many of healthcare's ills. Saying that "health information technology has the potential to greatly improve health care even as it yields huge savings," HHS Secretary Tommy G. Thompson announced in May 2004 the appointment of a <a href="http://www.hhs.gov/news/press/2004pres/20040506.html">National Health Information Technology Coordinator</a>. This is a new position at HHS, created by President Bush to accelerate and coordinate the nation's health information technology efforts.<br /><br /><br /><br />As a <A HREF="http://members.aol.com/medinformatic1/index_org.htm">Medical Informatics</A> professional with combined training in both healthcare and in information technology, I will comment on the many issues related to computing in clinical settings. The same leadership problems, conflicts and organizational ills that affect healthcare affect clinical information technology itself.<br /><br /><br /><br />The awareness of this issue by the public is limited, however, and publications on healthcare IT often gloss over the <a href="http://home.aol.com/medinformaticsmd/failurecases.htm">profound difficulties and failures</a> that affect care delivery and consume valuable healthcare dollars.<br /><br /><br /><br />As clinical and biomedical IT becomes increasingly more complex, and as it supports increasingly complex medical science, research and practices, the number of ways that failures and mishaps can occur from errors in judgment, inadequate knowledge, mismanagement, and related factors increases markedly. Competence, excellent management, logical decisionmaking, and the wide-angle view of true cross-disciplinary expertise have therefore become imperatives for leadership and success in this field.<br /><br /><br /><br />Unfortunately, the reality in today's hospital and research organization IT departments falls far short of this.As far back as 1969, EMR and Medical Informatics pioneer Donald A. B. Lindberg, M.D., now Director of the U.S. National Library of Medicine at NIH, made the following observation. He wrote that "computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information" (Lindberg DAB: Computer Failures and Successes, Southern Medical Bulletin 1969;57:18-21).<br /><br /><br /><br />Surprisingly, there has been little change in this issue in thirty-five years. Today the IT personnel who often hold leadership roles in EMR and clinical data research initiatives, i.e., control of critical budgets and resources, often have inadequate or nonexistent biomedical experience and insight. Specifically, personnel of an information technology background, with little or no background in the biomedical sciences, often are empowered as enablers, rather than facilitators, of such initiatives. They retain a major say in what is -- and is not -- done, and in the tools provided to perform clinical care and biomedical R&D.<br /><br /><br /><br />Medical Informatics specialists with combined training in healthcare and in information technology - specifically, its implementation and use in clinical settings - can help. However, the field is largely unrecognized in hospitals and industry, and unempowered when it is. Medical informatics professionals rarely, if ever, have leadership authority in clinical IT.<br /><br /><br /><br />From a dual perspective as both a clinician and computer professional, it is evident that this arrangement is faulty, and that critical clinical computing projects benefit greatly from an alternate approach to project preparation, development, implementation, customization and evaluation as compared to management information systems (MIS) projects. Clinical computing and business computing are different, highly distinct subspecialties of computing.<br /><br /><br /><br />I will cover in this blog the many aspects of clinical IT and the need for improvement in its quality and leadership model.<br /><br /><br /><br />It is unlikely that a complex field of endeavor such as healthcare can be improved through tools that suffer the same ills in conception, implementation and use as the field itself.<br /><br /><br /><br />-- SS<br /><br />

Healthcare Renewal and Clinical Information Technology

Information technology (IT) has long been presented as a panacea to many of healthcare's ills. Saying that "health information tech...

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On Mon, 13 Dec 2004, Thompson, Kenneth wrote:<br /><br /><br /><br />> given this, why is it that the best care in american appears to be<br /><br />> delivered by some of the larger systems? clearly there must be some<br /><br />> relationship between central resources and local ones. but how to<br /><br />> optimize that relationship?<br /><br /><br /><br />The particular situation of high-quality care being delivered by large<br /><br />systems points out something much closer to what this listserv is really<br /><br />about: idealism. It has long been observed that certain large systems<br /><br />deliver higher quality care than private practice or even some prestigious<br /><br />hospitals. That was part of the idea behind the Nixon administration's<br /><br />advancement of HMOs (they coined the term, actually - Kaiser et al. were<br /><br />Prepaid Group Practices before that). To understand why it's important to<br /><br />look carefully at which large systems deliver the best care: places like<br /><br />Kaiser, Group Health of Puget Sound, Health Insurance Plan of Greater New<br /><br />York are the classic examples.<br /><br /><br /><br />How do they do it? Health services researchers identified three<br /><br />mechanisms: selective recruitment, group practice effect, and idealism.<br /><br />Selective recruitment because Kaiser would hire only better docs, whereas<br /><br />any schmoe who could make it through med school could hang out a shingle<br /><br />in private practice. Group practice effect is what happens in my office<br /><br />every day: my colleagues and I consult amongst ourselves, keeping each<br /><br />other up on the literature and polishing our knowledge, an effect very<br /><br />difficult to replicate in a one- or two-doc shop. Idealism because of why<br /><br />Kaiser, Group Health, etc. exist.<br /><br /><br /><br />The HMOs that consistently deliver high quality care are what health<br /><br />services researchers refer to as the "HMO Movement" HMOs. Those are very<br /><br />different animals from the "HMO Industry" HMOs. The former exist because<br /><br />they believe in quality and efficiency; their mission is to serve<br /><br />patients, and they were doing it even when the deck was stacked against<br /><br />them. The latter exist because the TEFRA law changes under Nixon made it<br /><br />economically attractive and payers wanted to control costs. Their mission<br /><br />is financial, and as this group has observed repeatedly they approach that<br /><br />mission with all the ethics of Enron or WorldCom.<br /><br /><br /><br />The large systems that deliver high quality care are the "movement"<br /><br />systems, those idealistically-based systems that believe in quality care<br /><br />and have finance people to keep them solvent so they can pursue that<br /><br />ideal. The systems we discuss so often on this group are "industry"<br /><br />systems, run by money people, to whom docs are just the means of<br /><br />production and patients are merely market share.<br /><br /><br /><br />No amount of free market incentive alignment, government regulatory<br /><br />micromanagement, liability threat, or anything else will ever turn the<br /><br />latter into the former. The system behaves in the best interest of<br /><br />patients if and only if people who have ideals and ethics run the system.<br /><br /><br /><br />

On Mon, 13 Dec 2004, Thompson, Kenneth wrote: > given this, why is it that the best care in american appears to be > delivered by some...

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Union Charges Advocate Health Care Skimps on Capital Improvements in Minority Areas

In Chicago, <a href="http://www.suntimes.com/output/news/cst-nws-redline12.html">the Sun-Times reported</a> that the Service Employees Internation Union charged that Advocate Health Care, a not-for-profit hospital system, spends more on capital improvements on hospitals in predominantly white areas than it does on hospitals in areas with larger minority populations. The Union asserted that Advocate is not fulfilling its social mission, and thus questioned whether Advocate should keep its not-for-profit status. The state legislature may investigate. Advocate responded by saying its per-patient spending is higher in areas with larger minority populations.<br />Yet another case raising questions about whether a not-for-profit health care system is true to its mission....

Union Charges Advocate Health Care Skimps on Capital Improvements in Minority Areas

In Chicago, the Sun-Times reported that the Service Employees Internation Union charged that Advocate Health Care, a not-for-profit hospita...

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We're from Medicare and We're Here to Help You

The <a href="http://www.nytimes.com/2004/12/12/politics/12medicare.html">NY Times reported</a> US Government Accountability Office found that about 30% of callers to a help number for Medicare patients got wrong answers to questions about Medicare's new drug benefit, while 10% got no answers at all. For example, in response to a question about whether Medicare would pay for a motorized wheel-chair, the help line operator responded that it would depend on whether the wheel-chair would fit in the patient's car trunk. The real answer was that the decision would depend on the patient's trunk strength, that is, upper body strength. Oops.<br />It turns out that the help-line is not actually run by Medicare, but is out-sourced to Pearson Government Solutions, a subsidiary of Pearson PLC, a corporation based in London that publishes the Financial Times, and Penguin Books. A Pearson spokesperson said the government told him not to answer questions from the press.

We're from Medicare and We're Here to Help You

The NY Times reported US Government Accountability Office found that about 30% of callers to a help number for Medicare patients got wrong ...

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SGIM Clinical Practice Task Force

At its winter board retreat, the board of the Society for General Internal Medicine proceeded with plans to create a brand new movement called the SGIM Clinical Practice Task Force. Listed as part of the "landscape scan" justifying this task force were the diminishing interest in primary care practice, "blaming the victim" (see the August N Engl J Med article by Jordan Cohen and others at AAMC blaming primary care training programs for the diminishing attractiveness of primary care), the existence of forces pitted against generalists' giving high quality care to their patients, including organizational forces such as managed care and large health care organizations, and the growing malaise of battered primary care givers facing increasing unfunded mandates such as "pay for performance". <br /><br /><br /><br />SGIM sees these forces as countering its mission, and is making a plan to ally with other generalist organizations to counter these forces. Dr. Greg Rouan is now in charge of this task force. An eNews went out recently, inviting any SGIM members interested in participating in this task force to register their interest. You can do so by going to www. SGIM.org.<br /><br /><br /><br />Through this and other task forces, SGIM is also seeking to: 1) survey the literature for how generalists vs. specialists manage chronic disease, especially multiple diseases in the same patient; 2) lobby Congress to get better payment for cognitive services for beleagured generalists in the upcoming RUC; 3) explore better models for delivering primary care.<br /><br /><br /><br />Wally Smith, MD<br /><br />Secretary-Elect, SGIM<br /><br />

SGIM Clinical Practice Task Force

At its winter board retreat, the board of the Society for General Internal Medicine proceeded with plans to create a brand new movement call...

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Welcome to HCRENEWAL

Health care around the world is beset by rising costs, declining access, stagnant quality, and increasingly dissatisfied health care professionals. Discussions with physicians and other professionals revealed pervasive concerns that the core values of health care are under seige. Patients and physicians are caught in cross-fires between conflicting interests, and subject to perverse incentives. Free speech and academic freedom are threatened. Psuedo-science and anti-science are gaining ground. Causes include the increasing dominance of health care by large organizations, often lead by the ill-informed, the self-interested, and even the corrupt. (1) However, such concentration and abuse of power in health care has rarely been discussed openly. This blog is dedicated to the open discussion of health care's current dysfunction with the hopes of generating its cures.<br /><br /><br /><br /><span style="font-size:78%;">1. Poses RM. A cautionary tale: The dysfunction of American health care. Eur J Int Med 2003; 14: 123-130.</span><br /><br />

Welcome to HCRENEWAL

Health care around the world is beset by rising costs, declining access, stagnant quality, and increasingly dissatisfied health care profess...

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