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Blind leading deaf: U.S. to create oversight board to alert public on new drugs

Is the article below, "U.S. to create oversight board to alert public on new drugs", an example of the blind leading the deaf? An apparently toothless board that is to be part of the FDA seems more likely to be ineffectual than useful. <blockquote>Philadelphia Inquirer, Wed, Feb. 16, 2005, excerpts: <a href="http://www.philly.com/mld/philly/news/nation/10909214.htm?1c">http://www.philly.com/mld/philly/news/nation/10909214.htm?1c</a>WASHINGTON - Amid concern that the government has not done enough to ensure the safety of prescription medications, the Bush administration announced yesterday that it was setting up an oversight board to more quickly inform the public of side effects after a drug goes on the market.Health and Human Services Secretary Mike Leavitt said the Drug Safety Oversight Board, to be part of the Food and Drug Administration, would consist of scientific experts from throughout the government. The board would be responsible for monitoring reports of potentially hazardous drug reactions and posting that information on a Web page. Its role would be largely advisory. It would not have power to take a drug off the market or change the circumstances under which it was sold, though it could make recommendations on these issues to senior FDA officials ... Representatives of the pharmaceutical industry reacted cautiously yesterday, arguing that drugs' potential side effects should be weighed against benefits in any review process. "It is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk," the main industry trade group, Pharmaceutical Research and Manufacturers of America, said in a statement.</blockquote>Being part of FDA is bad enough. However, there is an even more important issue than organizational reporting and governance for such a board. The issue is summarized by the "law" in the book <a href="http://www.amazon.com/exec/obidos/tg/detail/-/0385337388/qid=1108600380/sr=8-1/ref=pd_bbs_1/104-2183119-0448717?v=glance&s=books&n=507846">The House of God : The Classic Novel of Life and Death in an American Hospital</a> by Samuel Shem which I paraphrase as "you can't find a fever if you don't take a temperature." Pharma has been doing a rather deficient job of taking that temperature, to the point of congessional investigations and massive personal-injury and wrongful-death class action lawsuits.For example, regarding the Pharmaceutical Research and Manufacturers of America's statement regarding the importance of "making regulatory decisions based on sound science and carefully considered judgments", there is a major problem. Reliance on small clinical trials and voluntary reporting of adverse effects of "blockbuster" drugs taken by millions via the FDA Medwatch system -- where no report gets filed if an event is not recognized as possibly drug-related (e.g., a myocardical infarction in a patient taking a COX-2 inhibitor up to a few months ago) -- is neither sound nor "considered judgment" in my opinion.As to pharma's seriously taking into account other types of data such as from payors in producing a "risk portfolio" for a drug that includes multiple study types, or making serious efforts to support the implementation of full EMR's that can start providing better, regular data flows that might be helpful in identifying adverse events before they become public health debacles, there seems insufficient effort. Pharma also seems to ignore the field of Medical Informatics that was designed and funded by NIH for the purpose of expanding use of technologies such as EMR, among others. That I and others in Medical Informatics cannot seem to secure employment at present in pharma (not for lack of trying), and that I was laid off from a pharma instead of, say, a non-medical person with a bachelor's degree in computers making nearly as much as an M.D. with postdoctoral certification in Medical Informatics and clinical computing, speaks to the third component of the "blind, deaf and..." triad.In fact, in one pharma I know where the information scientists reported to the IT personnel (a major structural misalignment not uncommon in industry), the term "medical informatics" did not appear at all in their controlled vocabularies. Further, terms describing the core competencies of information professionals such as library scientists, informaticists, and the like, were simply absent from the Human Resources taxonomy of skills used for performance review and for hiring. Terms describing computer programming and project management skills were abundant, of course.In other words, this pharma was blind to information management professionals and their skillsets in hiring, promotion, and performance review.Pharma prides itself on being an "information intensive" industry. And my name is Mata Hari.-- SS

Blind leading deaf: U.S. to create oversight board to alert public on new drugs

Is the article below, "U.S. to create oversight board to alert public on new drugs", an example of the blind leading the deaf? An ...

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A richer Zeitgeist brew

A richer Zeitgeist brew

If you were in India, what would you search for? Inquiring minds from Mumbai to Bangalore wanted to know, so now there's a new Google In...

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UTMB Emergency Department to Send Less Sick Patients "Elsewhere"

A new sign of how hospitals are turning away from their traditional mission in response to financial pressure: The <a href="http://www.chron.com/cs/CDA/ssistory.mpl/metropolitan/3040052">Houston Chronicle reported </a>that the University of Texas Medical Branch (UTMB) at Galveston will start pre-screening patients who go to their Emergency Department (ED), and will turn away patients deemed not sick enough to need emergency care. Such patients will apparently be told how to get care "elsewhere." The article did not address how difficult it might be to get to "elsewhere," or how rapidly they might be seen there. This policy should be distinguished from the on-site services many EDs maintain (sometimes called walk-in, fast-lane, or the like) to see less sick patients in settings that are less intense than the regular ED, but are located in proximity to it. The policy was inspired by how the University of Colorado Health Science Center in Denver ED has operated, not without controversy, since 2002.

UTMB Emergency Department to Send Less Sick Patients "Elsewhere"

A new sign of how hospitals are turning away from their traditional mission in response to financial pressure: The Houston Chronicle reporte...

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The NIH: "We Have a Systemic Problem"

We have written a lot about the conflict of interest scandals at the NIH. (See below for links to related posts on Health Care Renewal, plus a citation of a newspaper op-ed.) We have also noted several times how little discussion there was of this story in the medical and health care literature, and even what is now called the main-stream media (MSM). This appeared to be an example of what Russ Maulitz called the anechoic effect, the silence that greeted any story about concentration and abuse of power in health care.Thus, I was gratified to see <a href="http://www.latimes.com/news/nationworld/nation/la-na-nih12feb12,0,7388584.story?coll=la-home-headlines">an interview published in yesterday's Los Angeles Times </a>which provided a lot of support to our viewpoint on this scandal. Here are some particularly pithy quotes:<ul><li>"If you are weighing in on behalf of the public, I want you to be there on behalf of the public. Don't tread [trade] on your prestige, position, in a way that pretends to be completely objective."</li><li>"I came to the conclusion that we have a systemic problem. They were not just isolated events. They reflected a complete set of rules that had been adopted over the years, which had transformed the culture..... if that's the case, let's bring back the culture to where it needs to be: that is, public first." </li><li>"No limits on stock. No limits on money. No limits. Where were all those holier-than-thou intellects?" "This issue was standing between the history of the NIH and its future."</li></ul>What is most striking is that the interviewee was the current Director of the NIH, Dr. Elias Zerhouni. Clearly, having the public support of Dr. Zerhouni for unconflicted, ethical leadership of the NIH is a big step forward. The interview also marks a significant crumbling of the anechoic effect (to badly mix metaphors). Dr. Zerhouni's approach also stands in stark contrast to how leaders of other major health care organizations have reacted to allegations of uninformed, incompetent, self-interested, or even corrupt leadership. The usual way of doing business has been to circle the wagons, deny the problems, and, if pushed very hard, purge the most visible culprit and then declare the problem resolved.Concentration and abuse of power in health care are widespread problems, as perusal of recent posts on Health Care Renewal demonstrates. We need all the support we can get for informed, competent, honest and ethical leadership of health care organizations. We can now use Dr. Zerhouni as a good example, and hope we can count on his support for the reform of leadership of other organizations. Previous Posts and One Article<a href="http://hcrenewal.blogspot.com/2005/02/end-of-anechoic-effect-editorial.html">End of the Anechoic Effect: Editorial Reaction to the New NIH Rules</a><a href="http://hcrenewal.blogspot.com/2005/02/pogo-at-nih.html">Pogo at the NIH</a><a href="http://hcrenewal.blogspot.com/2005/02/nih-seeks-higher-standard-better-late.html">NIH Seeks Higher Standard: Better Late Than Never</a><a href="http://hcrenewal.blogspot.com/2005/02/ban-on-federal-scientists-consulting.html">Ban on Federal Scientists' Consulting Nears</a><a href="http://hcrenewal.blogspot.com/2005/01/yet-more-conflicts-of-interest-at-nih.html">Yet More Conflicts of Interest at the NIH</a><a href="http://hcrenewal.blogspot.com/2004/12/few-echoes-from-allegations-of-nih.html">Few Echoes from Allegations of NIH "Appearance of Corruption"</a><a href="http://hcrenewal.blogspot.com/2004/12/anechoic-effect-and-conflicts-of.html">The Anechoic Effect and Conflicts of Interest at the NIH</a><a href="http://hcrenewal.blogspot.com/2004/12/more-outrageous-conflicts-of-interest.html">More Outrageous Conflicts of Interest at the NIH</a>Poses RM. Corruption, incompetence in health care. Providence Journal, December 17, 2003.

The NIH: "We Have a Systemic Problem"

We have written a lot about the conflict of interest scandals at the NIH. (See below for links to related posts on Health Care Renewal, plus...

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"A Vested Economic Interest" in the Outcome of the Battle Over Angioplasty

Re: <a href="http://hcrenewal.blogspot.com/2005/02/interesting-report-from-boston.html">my discussion earlier </a>of price versus value, see <a href="http://www.boston.com/news/globe/health_science/articles/2005/02/13/small_hospitals_battle_for_right_to_do_angioplasties/">this article in the Boston Globe </a>about how community hospitals are battling for authorization to do angioplasty in the Boston area. (Regulations now prevent hospitals who don't have facilities to do coronary artery bypass grafts from doing angioplasty, based on the concern that such hospitals would be unable to cope with acute adverse events from the procedure.) The chief of interventional cardiology at the Beth Israel Deaconess Hospital said, "we have to realize that we have a vested economic interest in the outcome [of the debate about which hospitals can do angioplasty]" He then noted that about 40% of the $17K - $20K that hospitals get from Blue Cross for the procedure is profit. This is an example of how insurance and managed care companies do not have a clear idea of the actual costs of an imporant, expensive service they pay for. Whether they have a better idea of its value to the patient is questionable. Rather than leaning on primary care physicians to reduce utilization of such expensive services, wouldn't it make more sense to bargain down the hospital's profit margins to something less than 40%?

"A Vested Economic Interest" in the Outcome of the Battle Over Angioplasty

Re: my discussion earlier of price versus value, see this article in the Boston Globe about how community hospitals are battling for authori...

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Study Finds Doctors with EHRs Have More Complete Patient Information

An interesting article pointing out the true information-intensive nature of healthcare. I agree that EMR's "alleviate but do not solve the problem" but point out that this observation is what medical educator and activist Dr. Victor Satinsky would have called an observation by a "master of the obvious." There may never in our lifetimes be a complete unified registry (either virtual or physical) of all healthcare information on everyone. However, the EMR is a key component whose implementation must not be delayed and costs increased by hospital politics (a.k.a. mismanagement), IT/clinician/executive territorial and ego battles, incompetence, unscrupulous software vendor business practices (e.g., the <a href="http://www.healthdatamanagement.com/html/PortalStory.cfm?type=vend&DID=10279">HBOC medical software company scandal</a> of several years ago), and other biomedical IT <a href="http://home.aol.com/medinformaticsmd/failurecases.htm">sociotechnical issues and dysfunction</a>.-- SSStudy Finds Doctors with EHRs Have More Complete Patient InformationFebruary 3, 2005 By M.L. Baker Patients' care may be adversely affected by missing information in as many as 220 million patient visits each year, according to a study published by the Journal of the American Medical Association this week. Electronic medical records alleviate but do not solve the problem. Though missing information is blamed in about 16 percent of medical errors, this is the first survey to document how frequently primary care clinicians lack information during office visits. Information was missing in one of seven visits. Clinicians estimated that the missing information was likely to adversely affect the patient's medical care and could cause delayed care or redundant services 60 percent of the time. In 45 percent of the visits, the clinician reported spending five or more minutes unsuccessfully searching for the information, time that could have been spent with the patient. Only about 7 percent of physicians, physicians' assistants, and nurse practitioners reported having full EHRs (electronic health records), but this group was 60 percent more likely to have complete information. Doctors' offices in rural areas, which tend to rely on a smaller number of vendors for laboratory results, were 48 percent more likely to have complete information.Don Mon, vice president of practice management at the American Health Information Management Association, said that clinicians with EHRs probably had more complete information because the system actively prompts physicians to collect information. Clinicians reported that most (52.3 percent) missing information was outside the medical practice but inside the United States. However, information was just as likely to be missing if a practice had electronic access to a primary hospital. Nevertheless, Mon said that the study pointed to the need for a national health information network so that different systems could communicate. "Hospitals might have an electronic record and a physician might have an electronic record, but we don't have the means to exchange them. They are acting like islands." In an editorial accompanying the study in the JAMA, Nancy Elder and John Hickner wrote, "There are thousands of electronic databases, even within the same community, that cannot communicate with each other." In addition, clinicians who reported having hybrid or partial EHRs were just as likely to have missing information as those without such systems.New patients were more than twice as likely to have missing information as patients who were returning to the same doctors' offices. Information was three times more likely to be missing for patients with five or more medical problems, and 80 percent more likely to be missing for recent immigrants. The survey did not ask clinicians whether any information was missing, but asked specifically whether information important for patient care and known to exist was missing during the visit. Information that was not in a patient's file when a doctor visit began was not counted as missing if it was located before the visit ended. In 36 percent of visits with missing information, clinicians or staff had spent more than five minutes looking for information while the patient was in the office. The survey, led by Peter Smith at the University of Colorado Health Sciences Center, was conducted for 1614 visits with 253 physicians, physicians' assistants or nurse practitioners at 32 clinics. Laboratory results were reported missing most often, in about 6 percent of visits, followed by letters and dictations, history and physical examinations, radiology results and medications.

Study Finds Doctors with EHRs Have More Complete Patient Information

An interesting article pointing out the true information-intensive nature of healthcare. I agree that EMR's "alleviate but do not s...

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Forbidden Knowledge, with Irony

Science just published a qualitative research article about scientists' "self-censorship." The term we have used before for this behavior is "suppression of research." A news summary is <a href="http://msnbc.msn.com/id/6947844/">here</a>, and the article is <a href="http://www.sciencemag.org/cgi/content/full/307/5711/854">here</a> but requires a subscription. (The citation is Kempner J, Perlis CS, Merz JF. Forbidden knowledge. Science 2005; 307: 854.) Many of those interviewed for the study were from the life sciences, although none were apparently physicians. The article's introduction mentioned "social control of scientists," particularly regarding studies of "human cloning and embryonic stem cell creation," and certain "government sponsored research." It cited examples of the latter included studies of gay men and prostitutes and of sexual behavior more broadly, and about potential bio-terror agents. The sorts of topics the scientists considered "sensitive" included "human cloning, embryonic stem cells, weapons, race, intelligence, sexual behaviors, and addictions, as well as concerns about using humans and animals in research." It's an interesting article that adds to our knowledge about suppresion of research. However, I was startled to find almost no discussion of suppression of research about commercial products due to pressure from those with financial interests in the products. Clearly, this is a prevalent problem in health care, complicated, in some famous cases, by the quickness with which universities and teaching hospitals have succumbed to such pressure. It is also ironic that most of the examples seemed to be of pressure from groups that may have had a right-wing tinge, e.g., pressure against stem-cell research, or studies of sexual behavior. Of course, as quick perusal of <a href="http://www.thefire.org/">the FIRE web-site </a>shows, at universities much of the pressure on free speech and academic freedom comes from the other end of the political spectrum. Perhaps the authors' emphasis mainly reflected their small, and probably not very generalizable study sample. But it seems even more ironic that a report from university researchers on suppression of research seems to leave out some of the most salient sources of pressure on academics to suppress. But maybe this just adds to their own argument.

Forbidden Knowledge, with Irony

Science just published a qualitative research article about scientists' "self-censorship." The term we have used before for t...

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