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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. 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. 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. The increasingly complex story of suppression of SSRI research seems to be part of a growing epidemic of suppression of medical research. Let's say it again. Withholding data from clinical research is unethical because: 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>) 2. it impedes scientific progress; 3. it prevents patients from receiving the best possible medical care. 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." 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>." ) 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." 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. 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. 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.) 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. 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." 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." 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). <blockquote>... 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 mass-marketed from the moment they were commercially available in the new world of direct-to-consumer advertising, with unrealistic expectations about pain relief, marked gastrointestinal protection, and safety. 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. Furthermore, one has to question the wisdom of allowing direct-to-consumer advertising 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. </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 MBA's run the science. 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 "Industry Veteran" relates this solution for Big Pharma's current major problems: <blockquote>Eject from business departments the ignoramus, Ivy League MBAs who know nothing about the industry but feel they can comprehend the universe with spreadsheets. </blockquote>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. 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.Cleverness without wisdom, a hallmark of too many non-healthcare "healthcare business specialists" and the "House of Cards" they engineer, kills companies ... and patients.-- SS

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. 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." 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. 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. 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. <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. (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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