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End of the Anechoic Effect: Editorial Reaction to the New NIH Rules

The announcement of the <a href="http://hcrenewal.blogspot.com/2005/02/nih-seeks-higher-standard-better-late.html">change in NIH conflict of interest rules </a>has created quite a bit of press, maybe finally signaling the end of the <a href="http://hcrenewal.blogspot.com/2004/12/anechoic-effect-and-conflicts-of.html">"anechoic effect"</a> for this particular story. Oddly enough, the old way of doing business at the NIH has found a few prominent apologists, echoing the troubling reaction by NIH staff <a href="http://hcrenewal.blogspot.com/2005/02/pogo-at-nih.html">I discussed yesterday. </a> For example, see the <a href="http://www.washingtonpost.com/wp-dyn/articles/A62214-2005Feb3.html">commentary by Steven Pearlstein in the Washington Post</a>. Here are a few quotes with my comments. "A Massachusetts politician once told me, over lunch at Boston's Locke-Ober cafe, that most systems work best when lubricated with a bit of moral ambiguity." As a Rhode Island resident, I didn't think this was a promising start for a discussion of ethics and research. The moral ambiguity of many politicians has fueled considerable cynicism about politics in general. "I'm not sure I see the wisdom of drawing a 'bright line,' ... between NIH scientistis doing basic research and commercial enterprises that build upon that research. " This is a false dichotomy, but seems to be a prevalent argument against the new standards. The false dichotomy is between major financial entanglements with pharma and biotechnology firms and no contact at all with such firms. NIH staff don't need to be paid huge consulting fees over and above their full-time salaries, or hold stock or collect stock options in pharmaceutical and biotech companies to work collaboratively with industry. "What purpose is served by preventing them (NIH staff) from making a buck by sharing that informal knowledge with profit-making companies?" The purpose is not having them feel beholden to the profit-making companies for all those bucks they make on the side. But again, why should people who work full-time for the NIH, and get six-figure salaries from the government, need to also "make a buck" from these companies? "A surprising number of people violated those [existing] rules [requiring disclosing conflicts of interest]. But rather than coping with that by dealing harshly and publicly with a few of the worse offenders, the NIH brass have now caved in to pressure from Capitol Hill to prohibit drug and biotech-related investments and commercial entanglements by their researchers." It is true that no one has yet dealt harshly with the NIH leaders who made the most money from consulting fees and stock options while supposedly working full time for Uncle Sam. Actually it is not true that the rules prohibit biotech-related investments by NIH staff, since they can still invest indirectly through, for example, mutual funds. Why is it bad in this case to listen to the opinion of Congress? "But the right question is not whether we should stomp out every last bit of such 'corruption,' but whether the price is worth it. Having a fuzzy line, and giving administrators some flexibility in enforcing it, was probably better for medicine, better for the biotech industry, and certainly better for the Washington economy." There has been very little research on the effects of conflicts of interest and corruption affecting the leaders of health care organizations, so there is no good data about what might be good for "medicine" or the public. However, it seems reasonable to hypothesize that commerical entanglements are bad because they may sway such NIH leaders, who have considerable power over what science gets done and how it is reported, in favor of their outside benefactors, leading to biased science, biased interpretation of science, and biased science policy. Furthermore, the knowledge that some NIH leaders may be beholden to commercial vested interests outside of the NIH threatens the credibility of all NIH sponsored research, the credibility of the NIH research priorities, and the credibility of NIH efforts to translate and disseminate research results. Finally, knowing that some NIH leaders are financially benefiting from conflicts of interest may clearly demoralize NIH staff, NIH-supported scientists, and researchers seeking NIH support who do not have such conflicts. Similar was <a href="http://www.forbes.com/columnists/free_forbes/2005/0214/040.html">the commentary in Forbes by Thomas P. Stossel MD</a>. "In the real world, these restrictions (on conflicts of interest) address nearly nonexistent scientific corruption and ultimately impede medical progress by depriving pharmaceutical companies of access to biomedical scholars." See my comments above. Since there have been few relevant studies, it's not clear how much corruption there is. Again, biomedical companies can easily get access to and collaborate with scholars without paying them personally for consulting or handing them stock options. "How did financial conflicts-of-interest rules get to be such a big deal? One reason is that the gatekeepers of the medical literature believe it is. Editors of high-profile medical journals vilify the pharmaceutical industry..." Funny, I have seen criticism that medical journals have been too cozy with that industry. Note that for Stossel the bogey-man seems to be journal editors, while for Pearlstein it was "Capitol Hill." "The public wants trustworthy science, and it can get that without new ethical rules. Even more, it wants results - lives saved - and it can't get those if commercial sponsorship of research is made difficult, if not impossible." Again, why should the public will find research more trustworthy if the researcher is getting paid on the side by industry? Again, note the false dichotomy. Industry can certainly sponsor research done at academic organizations by research grants without paying researchers consulting fees in addition to their full-time salaries. For contrast, see <a href="http://www.philly.com/mld/inquirer/10811695.htm">the editorial in the Philadelphia Inquirer</a>. My favorite quotes were: "The NIH staffers' outside work involved paid consulting, teaching, speaking or writing for private health-care firms - with drugmakes bankrolling many of the deals. Financial arrangements like these, allowed since, 1995, pose a huge conflict for all the 6,000-plus NIH scientists. How so? Because NIH officials' day jobs position them to promote or aid these firms through grants, contracts, and approvals." "As a group, NIH scientists pulled in millions of dollars in consulting and other fees. With that kind of money at stake, to whose interests were they most attuned - the publics', or their second employers'? "Institutes' officials must monitor whether an exodus of talent occurs. If so, the correct remedy is better pay - not watering down ethical core standards." 'Nuff said.

End of the Anechoic Effect: Editorial Reaction to the New NIH Rules

The announcement of the change in NIH conflict of interest rules has created quite a bit of press, maybe finally signaling the end of the ...

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Major medical center thrashes for clinical IT leadership

Major medical center in Philadelphia, Temple University, thrashes around for clinical IT leadership. <a href="http://www.amia.org/jobexch/jobs/posting.asp?jid=710">This ad</a>, regarding a "a seven-year, enterprise-wide Information Technology strategic plan" for clinical IT and process redesign, was posted again on the job exchange area of the American Medical Informatics Association. It has many hallmarks of the lack of awareness of sociotechnical issues in clinical IT and of the role of Healthcare Informatics professionals in studying and <a href="http://home.aol.com/medinformaticsmd/failurecases.htm">preventing costly errors experienced by other medical centers</a>, and of facilitating change. <blockquote>"The ideal candidate will have a Bachelor’s degree; a Master’s is preferred [in what, exactly, is unclear-SS]. Significant IT skills [why don't I see "Medical Informatics" or clinical medicine training anywhere? - SS] with 8-10 years in managing a CIS Implementation Process in a large, complex academic medical center or multi-hospital health system is also required....The Director must have a demonstrated, successful track record in Operations Improvement, Clinical Work Redesign, Benchmarking and results monitoring as well as strong project management skills. The ability to conduct educational training and coaching on project management, change management and Operations Improvement analysis is also essential."</blockquote>This position also has the hallmark of a "Director of Nothing" position, lacking executive presense and credibility with medical staff - especially tough medical specialists such as surgeons, invasive cardiologists, and the like:<blockquote>The Operations Improvement Director/Clinical Work Redesign will provide support, leadership and guidance to all system entities’ OI Teams during the implementation process. He/she will serve as a Team Leader and Major Change Agent leading multiple Redesign Teams. </blockquote>With a bachelor's or master's degree in field that is unspecified, such a person is likely going to have a very hard time convincing the medical staff of several major academic hospitals to acquiese to major work changes affecting how they practice medicine, for example. A summary of some of these issues is at the page "<a href="http://home.aol.com/informaticsmd/job1.htm">Ten critical rules about job structure and reporting for applied informatics positions</a>", authored by me in 1998 or so.<a href="http://home.aol.com/scotsilv/biography.htm">My background</a> was, for example, deemed unsuitable for this role when I inquired last year, despite the fact that I'd successfully led evaluation, acquisition and implementation of both vendor-acquired clinical IT (e.g., the Logician EMR), and personally led custom development of advanced <a href="http://members.aol.com/scotsilv/invascard.htm">subspecialty IT</a> (e.g., in Invasive Cardiology), in large (1500 bed) multi-hospital medical centers. The rejection was on the basis of "not having enough clinical process redesign experience." Not even called for an interview; the rejection was paper-based.Others with formal training and experience in Healthcare Informatics, with training and background similar to mine, were likely also rejected. This posting is a repeat on a primary site for NIH-program Informatics recruiting, namely, the website of the American Medical Informatics Association. It is a sad phenomenon to watch this apparent thrashing, essentially reflecting an "informatics immaturity", over and over again throughout a period dating back at least 12 years in my case, when I was an NIH Postdoctoral Fellow in Medical Informatics. Perhaps I should not complain. The pioneers in clinical IT began noting these issues 30+ years ago.It's also possible that resumes of those with formal Medical Informatics credentials scare the daylights out of some people in large medical centers -- for example, IT personnel with no clinical training or experience, and "Medical Instamaticists" (e.g., clinicians whose credentials in information technology amount to novice or intermediate-level tinkering as per this <a href="http://home.aol.com/informaticsmd/taxonomy1.txt">taxonomy of informatics skills</a>). The NIH has tried to introduce a cadre of specialists to make EMR implementation more efficient but even after more than a decade of dedicated funding for programs at some of the country's best universities, the word has not gotten out as well as it should have. In the end, patients (and taxpayers) <a href="http://www.sptimes.com/2004/02/19/Tampabay/Senator_hears_out_Bay.shtml">pay the price for errors in clinical IT implementation</a> - sometimes spectacularly so.As Roy Poses' correspondent notes below regarding leadership of <a href="http://hcrenewal.blogspot.com/2005/02/new-ceo-for-independence-blue-cross.html">Independence Blue Cross</a> of Pennsylvania:<blockquote>"What you're seeing is typical of most businesses. This seems to me to be the result of some myopic views taught in B-schools; "you don't have to know 'THE' business, just how to run 'A' business." Similarly, some folks think just because they can "do anything," they can run a business. I'm trying to convince them that "it ain't necessarily so." </blockquote>This myopia seems to permeate down far below the C-officer level in the so-called "<a href="http://www.amazon.com/exec/obidos/tg/detail/-/0787959707/qid=1107466486/sr=8-2/ref=sr_8_xs_ap_i2_xgl14/102-0163203-7198542?v=glance&s=books&n=507846">healthcare system</a>" in the U.S.I hope I'm wrong, but the Internist-learned pattern detection algorithms in my grey matter sense a long and arduous implementation process at Temple. That public money may be spent on this seven-year project (Temple University is a state-funded school) is a real issue. -- SS

Major medical center thrashes for clinical IT leadership

Major medical center in Philadelphia, Temple University, thrashes around for clinical IT leadership. This ad , regarding a "a seven-yea...

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Pogo at the NIH

If we, as health professionals, want health care to be more honestly and rationally managed, we must be prepared to do our best to conduct ourselves honestly and rationally. Of course, dealing honestly with others is a fundamental value for physicians, and is codified in, for example, the <a href="http://www.ama-assn.org/ama/pub/category/2512.html">AMA Principles of Medical Ethics</a>, and the <a href="http://www.mja.com.au/public/issues/177_05_020902/bre10417_fm.html">ACP-ASIM-ESIM Physician Charter</a>. <a href="http://www.washingtonpost.com/wp-dyn/articles/A58845-2005Feb2.html">Today's Washington Post has a disturbing report </a>about NIH staff reactions to the new ethics policy, (first reported on Health Care Renewal <a href="http://hcrenewal.blogspot.com/2005/02/ban-on-federal-scientists-consulting.html">here</a> and <a href="http://hcrenewal.blogspot.com/2005/02/nih-seeks-higher-standard-better-late.html">here</a>.) According to the Post, "nary a positive word had been uttered about the new policy, and there was more vented spleen around than a busy medical center like the NIH might normally see in a year." For example, <a href="http://www.bioethics.nih.gov/people/emanuel-bio.html">Chief of Clinical Bioethics Ezekiel Emanuel </a>"fumed" that his secretary would have to sell her stock, (presumably because the rules require that lower-ranking NIH employees limit individual stock holdings in drug, biotechnology, and similar companies to those valued at less than $15,000), and later asked "if we want to reassure the public, why don't we apply these [rules] to everyone who gets an NIH grant." There was indignation that the rules didn't apply to other federal departments, like Energy, Agriculture, and Defense, and that they didn't apply to grant reviewers. These comments seem to reflect a troubling lack of knowledge about how the NIH funds research outside of its walls. Hardly any individuals get NIH grants. The money goes to their institutions. Many research universities have had strict conflict of interest policies in place for quite a while. NIH grant reviewers have also had to follow strict conflict of interest rules going back to at least the 1980's. These rules, unlike those that applied to NIH full-time employees, were never, to my knowledge, relaxed. The comments also seem to exaggerate the hardships imposed by <a href="http://www.nih.gov/about/ethics/020105COIsummary.pdf">the new rules</a> for NIH full-time employees. NIH employees are not being asked to give their stock holdings away. They are being asked to sell them, and they get to keep the money. Nor are they being barred from most kinds of investment. They can own stock in any kind of company that is not directly involved with pharma, biotech, and the like, and they can own any mutual fund or other diversified holding. But it is most discouraging to hear high level NIH employees, and particularly their head of bioethics, complain that they should only be subject to the lowest common denominator of ethical rules, rather than at least acknowledge the need to set an example after their organization has been tarred by scandal. As Pogo said, <a href="http://www.igopogo.com/we_have_met.htm">"we have met the enemy and he is us."</a>

Pogo at the NIH

If we, as health professionals, want health care to be more honestly and rationally managed, we must be prepared to do our best to conduct o...

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Hungering for the here and now

Got a craving for <a href="http://local.google.com/local?q=spaghetti+bolognese&near=san+francisco">spaghetti Bolognese in San Francisco</a>? Maybe you're on the road and must have <a href="http://local.google.com/local?q=free+wifi&near=chicago">free wi-fi in Chicago</a>, or a <a href="http://local.google.com/local?q=hotels+near+the+beach&near=santa+monica">beachfront hotel in Santa Monica</a>. And Valentine's Day is approaching: time to find the perfect <a href="http://local.google.com/local?q=romantic+restaurants&near=philadelphia">romantic restaurant in Philadelphia</a>. There's been such great demand for Local search results that we've added a Local link on the <a href="http://www.google.com/">Google homepage</a> so you can find nearby businesses around the U.S. and Canada even faster than before. Try it out and tell us how it's working for you. We suggest keeping an eye on Local, too - you'll soon see even more features. Whether you're at home or traveling, you're now one click closer to whetting your appetite. Thai Tran Product Manager, Google Local

Hungering for the here and now

Got a craving for spaghetti Bolognese in San Francisco ? Maybe you're on the road and must have free wi-fi in Chicago , or a beachfront...

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NIH Seeks "Higher Standard" - Better Late Than Never

Finally, <a href="http://www.latimes.com/news/nationworld/nation/la-na-nih2feb02,1,5273080.story?coll=la-headlines-nation">the headline reads "NIH Seeks 'Higher Standard.'"</a> More than 13 months after the Los Angeles Times published its first investigative report detailing serious conflicts of interest affecting top NIH leaders, NIH Director Elias Zerhouni has decided the time has come to provide "at least one source of public health information in the country that can be completely trusted," and "we need to hold NIH and ourselves as scientists at NIH to a higher standard, because we do have national public health responsibilities." Of course, prior to the alteration of the NIH rules and disclosure requirements about possible conflicts in the 1990's, the NIH was a completely trusted source of science. But for 13 months, Zerhouni and his organization fought restrictions on outside income for full-time government employees, even as it was revealed that some NIH leaders were making hundreds of thousands as "consultants" to pharmaceutical and biotech companies. See our previous discussions <a href="http://hcrenewal.blogspot.com/2005/01/yet-more-conflicts-of-interest-at-nih.html">here</a> and <a href="http://hcrenewal.blogspot.com/2004/12/anechoic-effect-and-conflicts-of.html">here</a>. But now, at least Zerhouni admits "I've changed my mind." Better late than never....

NIH Seeks "Higher Standard" - Better Late Than Never

Finally, the headline reads "NIH Seeks 'Higher Standard.'" More than 13 months after the Los Angeles Times published its ...

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