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Open Letter to Dr. Josephine Briggs

Josephine P. Briggs, M.D. Director, National Center for Complementary and Alternative Medicine Dear Dr. Briggs, As you know, we've met twice. The first time was at the <a href="http://www.sciencebasedmedicine.org/?p=4100" mce_href="http://www.sciencebasedmedicine.org/?p=4100">Yale "Integrative Medicine"</a> Symposium in March. The second was in April, when Drs. Novella, Gorski and I <a href="http://www.sciencebasedmedicine.org/?p=4575" mce_href="http://www.sciencebasedmedicine.org/?p=4575">met with you</a> for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of <a href="http://www.sciencebasedmedicine.org/?p=4671" mce_href="http://www.sciencebasedmedicine.org/?p=4671">having to appear 'open-minded'</a> about nonsense. More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the <a href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363" mce_href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363">25th Anniversary Convention</a> of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you'll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group---whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they're "part of your education," as my 91 y.o. mother used to say to me): <a href="http://www.medscape.com/viewarticle/465994" mce_href="http://www.medscape.com/viewarticle/465994">Naturopathy: A Critical Appraisal</a> <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed" mce_href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed"></a> <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed" mce_href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed">Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth</a> The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one. Thus the second article inevitably became the crash course---call it CAM for Smarties---that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents' inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous 'research' (funded---unwittingly, I'm sure---by the NCCAM), bait-and-switch labeling of rational methods as "CAM," vacuous assertions about 'toxins' and "curing the underlying cause, not just suppressing the symptoms," anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more. Please excuse me if this sounds preachy; I admit that it does, but understand that I'm writing in good faith. My own views of "CAM" did not dawn on me overnight, but were the result of years of research. My 'internship,' as it were, consisted of <a href="http://www.sciencebasedmedicine.org/?p=115" mce_href="http://www.sciencebasedmedicine.org/?p=115">sitting on a state commission</a> from the fall of 2000 until the spring of 2002, listening to AANP members (including at least <a href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#shiva" mce_href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#shiva">one </a>with whom you will share the podium), reading about 'naturopathic medicine,' and attempting (unsuccessfully) to engage its advocates in rational discussion. I began that task open to forming opinions based on whatever information became available; by its end it had become abundantly clear that the group is best characterized as a pseudoscientific cult, and nothing since has altered that opinion. Regarding your presence at the convention being tantamount to an endorsement of 'naturopathic medicine,' this is so obviously true that it ought not be necessary to mention it. Previous experience, however, has taught me to expect an air of---please don't take this personally---<a href="http://www.sciencebasedmedicine.org/?p=438" mce_href="http://www.sciencebasedmedicine.org/?p=438">utter cluelessness </a>whenever I've raised such an issue. If you've read the second naturopathy article linked above, you already know that according to proponents, <blockquote>The validity of naturopathic medicine is demonstrated by its support in government (including accreditation of its schools and NIH-funded research), on medical school Web sites, and in other parts of the public domain.</blockquote> An appearance at their annual convention by the most important "CAM" administrator at the NIH surely has the <a href="http://www.naturopathic.org/content.asp?contentid=62" mce_href="http://www.naturopathic.org/content.asp?contentid=62">political arm</a> of the AANP licking its chops. NDs, as they call themselves, are currently licensed in 14 or 15 states and a couple of provinces, and aggressively seek licensure throughout the U.S. and Canada. They appear to wield political clout well out of proportion to their numbers, no doubt thanks in part to the <a href="http://nccam.nih.gov/about/naccam/charter.htm#jump4" mce_href="http://nccam.nih.gov/about/naccam/charter.htm#jump4">legislative language</a> that created the NCCAM's National Advisory Council for Complementary and Alternative Medicine (NACCAM): <blockquote>Of the 18 appointed members...Nine...shall be practitioners licensed in one or more of the major systems with which the Center is involved. Six of the members shall be appointed by the Secretary from the general public and shall include leaders in the fields of public policy, law, health policy, economics, and management. Three of the six shall represent the interests of individual consumers of complementary and alternative medicine. </blockquote>Thus there have been 1-3 NDs on the NACCAM since its inception in 1999, although their numbers in general are, by any measure, miniscule: I reckoned there were about 2500 in the U.S. in 2003; the AANP now places that number at 6000. By comparison, there are about 800,000 MDs and 50,000 DOs in the U.S. NDs <a href="http://www.naturopathic.org/content.asp?pl=16&sl=60&contentid=60" mce_href="http://www.naturopathic.org/content.asp?pl=16&sl=60&contentid=60">claim to be well trained</a> to practice what most people think of as family medicine or primary care medicine, although their version of training is chock full of pseudoscientific nonsense and lacks a true residency program. They began by purporting to use only "natural medicines," but in regions where they've become politically connected they've sought, and been granted, the license to <a href="http://www.oregon.gov/OBNM/rules/850-060-0225.-0226_1.pdf" mce_href="http://www.oregon.gov/OBNM/rules/850-060-0225.-0226_1.pdf">prescribe numerous drugs</a>. Predictably, they've recently begun to <a href="http://www.sciencebasedmedicine.org/?p=143" mce_href="http://www.sciencebasedmedicine.org/?p=143">bump people off</a> with such exotic choices as intravenous colchicine and disodium ethylenediaminetetraacetic acid (that pesky <a href="http://www.ncbi.nlm.nih.gov/pubmed/18596934?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum" mce_href="http://www.ncbi.nlm.nih.gov/pubmed/18596934?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum">TACT </a>drug), in addition to more folksy nostrums such as acupuncture, vitamin B12, and an "herbal tincture" for a teenage girl who would shortly <a href="http://www.seattleweekly.com/2005-06-08/news/death-by-natural-causes.php" mce_href="http://www.seattleweekly.com/2005-06-08/news/death-by-natural-causes.php">die of asthma</a>. I see that your talk is titled "Complementary and Alternative Medicine: Promising Ideas from Outside the Mainstream." I imagine that it will cover some of the material that you covered at the Yale Symposium, where you used the similar phrase, “Quirky Ideas from Outside the Mainstream.” Without reading more into that word substitution than is warranted, let me assure you that there are no promising ideas emanating from naturopathy, even if there are plenty of quirky ones, e.g., <a href="http://www.sciencebasedmedicine.org/?p=62" mce_href="http://www.sciencebasedmedicine.org/?p=62">inflating balloons in the nasopharynx</a> to effect a “controlled release of the connective tissue tension to unwind the body and return it toward to its original design." Regarding the implicit requirement of your office that you appear open-minded even to medical absurdities, you made that clear in <a href="http://nccam.nih.gov/about/offices/od/2010-04.htm" mce_href="http://nccam.nih.gov/about/offices/od/2010-04.htm">your own account</a> of our NCCAM meeting and of <a href="http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=650&Itemid=189" mce_href="http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=650&Itemid=189">another </a>that you'd had a few weeks earlier, involving a group of <a href="http://www.theness.com/neurologicablog/?p=41" mce_href="http://www.theness.com/neurologicablog/?p=41">homeopaths</a> and associated <a href="http://www.theness.com/neurologicablog/?p=40" mce_href="http://www.theness.com/neurologicablog/?p=40">crackpots</a> who called themselves "the leading scientists in the field": <blockquote>Recently, I hosted two meetings with groups that represent disparate views of CAM research. These meetings have given me a renewed appreciation for the value of listening to differing voices and perspectives about the work we do. My NCCAM colleagues and I know there are differing views of the value of doing CAM research. On one side, we have stakeholders who are staunch CAM advocates, and on the other side, we have CAM skeptics. Each group has its own beliefs and opinions on the direction, importance, and value of the work that NCCAM funds. The advocates would like to see more research dollars supporting various CAM approaches while the skeptics see our research investment as giving undue credibility to unfeasible CAM modalities and want less research funding. As I've stated before, our position is that science must remain neutral, and we should be strictly objective. There are compelling reasons to explore many CAM modalities, and the science should speak for itself. (emphasis yours) </blockquote> Certainly science must remain neutral in the face of not-yet-seen data from rigorous studies, but that is different from what you, in your dual roles as "CAM" Explicator-in-Chief and Steward of Public Funds, must remain. You typically face questions that are, for all purposes relevant to the NIH, to modern medicine, and to the American citizenry, already settled---whether by basic science, clinical studies, rational thinking, or all three. I've offered several examples in the two naturopathy articles linked above. Consider homeopathy, a <a href="http://www.homeowatch.org/policy/aanp.html" mce_href="http://www.homeowatch.org/policy/aanp.html">core claim</a> of "naturopathic medicine" and the subject of your meeting with the "staunch CAM advocates." It makes no more sense for you to remain neutral on that topic than it would for the NIMH Director to remain neutral on exorcisms, or for the NCI Director to remain neutral on Krebiozen. Edzard Ernst, a one-time homeopath whose own portfolio of <a href="http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ernst%20E%22%5BAuthor%5D" mce_href="http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ernst%20E%22%5BAuthor%5D">"CAM" investigations</a> dwarfs the entire output of the NCCAM, puts it <a href="http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TDC-4XHJVNN-2&_user=6396456&_coverDate=11%2F30%2F2009&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000069771&_version=1&_urlVersion=0&_userid=6396456&md5=30c4f7ae24e5f3dc1403ca0972baf838" mce_href="http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TDC-4XHJVNN-2&_user=6396456&_coverDate=11%2F30%2F2009&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000069771&_version=1&_urlVersion=0&_userid=6396456&md5=30c4f7ae24e5f3dc1403ca0972baf838">this way</a>: <blockquote>Should we keep an open mind about astrology, perpetual motion, alchemy, alien abduction, and sightings of Elvis Presley? No, and we are happy to confess that our minds have closed down on homeopathy in the same way. </blockquote> Science and skepticism, moreover, are not distinct. Good science involves, first and foremost, skepticism. This is true for the design of any experiment, in which the primary goal is to attempt to falsify the hypothesis, and also for scientific thinking in general. Bruce Alberts, the editor of Science, <a href="http://www.sciencemag.org/cgi/content/full/319/5870/1589" mce_href="http://www.sciencemag.org/cgi/content/full/319/5870/1589">discussed this</a> in a 2008 editorial titled "Considering Science Education": <blockquote>...society may less appreciate the advantage of having everyone acquire, as part of their formal education, the ways of thinking and behaving that are central to the practice of successful science: scientific habits of mind. These habits include a skeptical attitude toward dogmatic claims and a strong desire for logic and evidence. As famed astronomer Carl Sagan put it, science is our best "bunk" detector. Individuals and societies clearly need a means to logically test the onslaught of constant clever attempts to manipulate our purchasing and political decisions. (emphasis added) </blockquote> I believe that you know all this at some level, but that your current job demands that you bend over backward to frame skeptics as extreme---distinguishing them from "neutral" scientists. Thus you, like many <a href="http://www.sciencebasedmedicine.org/?p=150" mce_href="http://www.sciencebasedmedicine.org/?p=150">reporters</a>, have placed skeptics of homeopathy or naturopathy at one end of a contrived belief spectrum, and "staunch CAM advocates" at the other. Please indulge me while I compare this <a href="http://www.sciencebasedmedicine.org/?p=319" mce_href="http://www.sciencebasedmedicine.org/?p=319">version of 'neutrality'</a> with others that exist in the popular domain: <ul><li>Some people feel strongly that the moon landings were a collective hoax. Others feel just as strongly that they really happened.</li><li>Some people believe that the Holocaust didn't happen. Others believe that it did.</li><li>Some people believe that the variety of species on earth is a product of Intelligent Design (ID). Others believe in the theory of evolution by variation and natural selection. </li></ul>This could go on and on, but you probably get the point. The last bullet is more pertinent to your tacit endorsement of the AANP than you might imagine. What follows is a representative <a href="http://web.archive.org/web/20030518030621/http:/www.scnm.edu/news/uploads/ms.pdf" mce_href="http://web.archive.org/web/20030518030621/http:/www.scnm.edu/news/uploads/ms.pdf ">view of herbalism</a> offered by Thomas Kruzel, with whom you will also <a href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#thomas_kruzel" mce_href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#thomas_kruzel">share the podium</a> at the convention (he will discuss "Emunctorology"; don't ask). Kruzel is <a href="http://www.aznma.com/viewbulletin.php?id=115" mce_href="http://www.aznma.com/viewbulletin.php?id=115">Past President of the AANP</a> and the former Vice President of Clinical Affairs and Chief Medical Officer at the Southwest College of Naturopathic Medicine. He was selected Physician of the Year by the AANP in 2000, and Physician of the Year by the Arizona Naturopathic Medical Association in 2003: <blockquote>Herbal Medicine: Naturopathic physicians have been trained in the art and science of prescribing medications derived from plant sources. The majority of prescription drugs are derived as well from plants but are often altered and used as single constituents. What makes herbal medicine unique is that plants have evolved along with human beings and have been used as non-toxic medications for centuries.If there is any problem with herbal medicines it is that unless one knows how to prescribe them, they may not be effective. Herbal medications should be prescribed based on the symptoms that the person presents rather than for the name of the disease. Herbal medications are much more effective at relieving the patients symptoms when prescribed in this manner. When prescribed the medicines act with the body’s own innate healing mechanism to restore balance and ultimately allows healing to occur.What’s nice about plant or herbal medicines is that because they are derived from the whole plant they are considerably less toxic to the body. The plant medicine has evolved to work in harmony with the normal body processes rather than taking over its function as many drug therapies do. Because of this herbal medicines may be taken for longer periods of time without the side effects so often experienced with drugs. </blockquote>You are particularly impressed, I hope, by the magical, ID-like claim that "plant medicine has evolved to work in harmony with the normal body processes." Other curious assertions include the conflation of herbal medicine with the core claims of either homeopathy or the non-existent 'allopathy' (we can't tell which)---"...should be prescribed based on the symptoms..."---demonstrating that the author doesn't know much about even the fanciful methods for which he claims expertise; and the dangerously false statement that medicines "derived from the whole plant are considerably less toxic" (than are well-researched and precisely dosed "prescription drugs").Dr. Briggs, please consider the possibility that you no longer must hide your considerable <a href="http://nccam.nih.gov/about/offices/od/briggsCV.pdf" mce_href="http://nccam.nih.gov/about/offices/od/briggsCV.pdf">scientific prowess</a> in order to be a good NCCAM Director. Your 'stakeholders' include not only very small numbers of naturopaths, homeopaths, and other fringe practitioners, but also far larger numbers of citizens who wonder about the validity of what those practitioners are peddling. It is to those citizens that you should be directing your efforts, which ought to begin with sober, objective, skeptical, scientific considerations of the various claims, the vast majority of which can, like balloons in the nasopharynx, be deflated in milliseconds by anyone with even a modest understanding of nature. They don't require clinical trials.Things are changing elsewhere. My colleague Steve Novella has <a href="http://www.sciencebasedmedicine.org/?p=6146" mce_href="http://www.sciencebasedmedicine.org/?p=6146">just written</a> about substantial efforts to deny insurance coverage for homeopathy in the land of its birth, Germany. In the UK, homeopathy has been far more popular than it is here, even to the point of its being funded by the National Health Service. One of the "staunch CAM advocates" who reportedly attended your meeting by teleconference was <a href="http://www.homeopathyworldcommunity.com/video/everyday-homeopathy-lectures" mce_href="http://www.homeopathyworldcommunity.com/video/everyday-homeopathy-lectures">Peter Fisher</a>, Homeopath to the Queen. Yet both the British Medical Association and the House of Commons Science and Technology Committee have seen through the ruse of pseudoscience that is homeopathy, the former declaring it "<a href="http://www.telegraph.co.uk/health/alternativemedicine/7728281/Homeopathy-is-witchcraft-say-doctors.html" mce_href="http://www.telegraph.co.uk/health/alternativemedicine/7728281/Homeopathy-is-witchcraft-say-doctors.html">witchcraft</a>" and latter making this <a href="http://www.parliament.uk/business/committees/committees-archive/science-technology/s-t-homeopathy-inquiry/" mce_href="http://www.parliament.uk/business/committees/committees-archive/science-technology/s-t-homeopathy-inquiry/">statement</a>:<blockquote>The Committee concurred with the Government that the evidence base shows that homeopathy is not efficacious (that is, it does not work beyond the placebo effect) and that explanations for why homeopathy would work are scientifically implausible.</blockquote>American citizens want and deserve, for their tax money, exactly that sort of definitive evaluation of such claims. Your first responsibility, Dr. Briggs, is to them---it is not to the AANP, other "CAM stakeholders," Tom Harkin, Orrin Hatch, or Dan Burton, and certainly not to the members of the NACCAM. Yes, we "skeptics see [the NCCAM] research investment as giving undue credibility to unfeasible CAM modalities," because the <a href="http://www.csicop.org/si/show/ongoing_problem_with_the_national_center" mce_href="http://www.csicop.org/si/show/ongoing_problem_with_the_national_center">evidence is overwhelming</a> that this is the case. We also see your appearing at conventions of <a href="http://www.sciencebasedmedicine.org/?p=247" mce_href="http://www.sciencebasedmedicine.org/?p=247">pseudomedical pseudoprofessional organizations </a>as giving undue credibility to unfeasible and dangerous claims.Sincerely yours,Kimball C. Atwood, M.D. SkepticThis letter has been cross-posted on <a href="http://www.sciencebasedmedicine.org/">Science-Based Medicine</a>.

Open Letter to Dr. Josephine Briggs

Josephine P. Briggs, M.D. Director, National Center for Complementary and Alternative Medicine Dear Dr. Briggs, As you know, we've met t...

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Duke Scientist Bringing Millions from NIH and Pharma Suspended Over Rhodes Scholar Claims

The New York Times reports that a medical researcher faked claims to being a Rhodes Scholar, and that a major scandal that has erupted. The scenario is very familiar to readers of Healthcare Renewal, with universities collecting millions from public sources and the pharmaceutical industry, turning a blind eye to credentials discrepancies of faculty "taxpayers", and the public possibly put at risk through faulty research and suspect "reviews": <blockquote><a href="http://www.nytimes.com/2010/07/21/health/research/21cancer.html">Duke Scientist Suspended Over Rhodes Scholar Claims</a> New York Times July 20, 2010 Duke University School of Medicine has suspended a researcher and stopped patient enrollment in three cancer studies upon learning of reports that the researcher had overstated his academic credentials. One of the lead investigators on the cancer studies, Dr. Anil Potti, was placed on administrative leave, said Douglas J. Stokke, a spokesman for Duke, while the university investigates allegations that Dr. Potti had falsely claimed that he was a Rhodes scholar. The controversy erupted late last week after <a style="font-weight: bold;" href="http://cancerletter.com/tcl-blog/CL36-27.pdf" title="Article in The Cancer Letter. (PDF)">an article published in The Cancer Letter</a> (PDF), a weekly publication for cancer specialists, reported that Dr. Potti, an assistant professor of medicine, had on occasion exaggerated his credentials. (A spokeswoman at Rhodes House at Oxford confirmed on Tuesday that Dr. Potti had not received the scholarship.) </blockquote> The scientist, Anil Potti, was engaged in cancer clinical trials using questionable and possbily erroneous analytical methods (prediction models). <blockquote>In addition, several dozen biostatisticians and cancer researchers at Harvard, Princeton, Johns Hopkins and other academic institutions are now questioning the methodology behind the three clinical trials, urging a halt to the Duke studies — two on lung cancer and one on breast cancer — in a letter sent to the director of the National Cancer Institute.</blockquote> He'd used the fake credentials to get American Cancer Society money: <blockquote> When questions about Dr. Potti’s credentials became public, the American Cancer Society suspended payments of a five-year, $729,000 grant awarded to Dr. Potti to study the genetics of lung cancer. The society awarded the grant based in part on a résumé from the doctor that included the Rhodes honor, said Dr. Otis W. Brawley, the chief medical officer of the cancer society. </blockquote> According to The Cancer Letter's exposé linked above: <blockquote>A high-profile cancer genomics researcher at Duke University claimed in multiple grant applications that he had been a Rhodes scholar, when, in fact, the Rhodes Trust states flatly that he was not. Documents obtained by The Cancer Letter show that in biographies submitted to NIH, Duke oncologist and genomics researcher Anil Potti claimed variously to have won the prestigious scholarship in 1995 or 1996, depending on the version of the biography. Potti also made the Rhodes claim in an application that resulted in a $729,000 grant from the American Cancer Society. “We don’t have any record that Anil Potti was a Rhodes scholar,” spokesman for the Rhodes Trust said to The Cancer Letter.</blockquote> Assuming the fabrications are proven, a number of questions arise: <ul><li>How can a Duke scientist have gotten away with exaggerated credentials on a CV used in a grant applicationa to NIH, the American Cancer Society, and perhaps other organizations, claiming to be a Rhodes Scholar? </li><li>Did he make similar exaggerations in his application to Duke itself?</li><li>Do the exaggerations made in NIH and/or other federal grant applications constitute a crime, e.g., under Title 18 of U.S. Code, Section 1001 which makes it a federal crime to make a false statement to the government, according to one contributor to The Cancer Letter article? </li><li>Will Duke act on fabrications as criminal matters? </li><li>What were the Duke grants office and/or credentials-checking staff doing during their working hours?</li><li>Why did this exaggeration come out in The Cancer Letter? </li></ul> Patients may be at risk: <blockquote> [MD Anderson Cancer Center biostatisticians] Keith Baggerly and Kevin Coombes said they devoted about 1,500 hours to checking Potti’s and Nevins’s work. These efforts—dubbed “forensic bioinformatics”—resulted in a paper in the November 2009, issue of the Annals of Applied Statistics. “Unfortunately, poor documentation can shift from an inconvenience to an active danger when it obscures not just methods but errors,” the paper stated. “Patients in clinical trials are currently being allocated to treatment arms on the basis of these results.” The two raised questions about Duke’s randomized phase II single-institution trials that used the Nevins and Potti technology to assign patients to treatment (NCT00545948, NCT00509366, and NCT00636441). Baggerly and Coombes argued that these trials “may be putting patients at risk.”</blockquote> Duke initially suspended but then restarted the trials after an "investigation" by outside scientists. However: <blockquote>Experts asked by The Cancer Letter to review these [investigation] documents [obtained under the FOIA] noted that Duke deans Cuffe and Kornbluth were inaccurate in their description of the document’s substance and conclusions when they announced completion of the investigation and resumption of the clinical trials earlier this year. “Having read the committee’s report, we must disagree with Duke’s representation of the committee’s findings,” Baggerly and Coombes said in an email after reviewing the documents released under FOIA. The committee stated that “In our review of the methods … we were unable to identify a place where the statistical methods were described in sufficient detail to independently replicate the findings of the papers,” and further noted that the Duke investigators “really need” to work on “clearly explaining the specific statistical steps used in developing the predictors and the prospective sample assignments."</blockquote> Duke has apparently now decided to stonewall: <blockquote> ... The Cancer Letter sent an email with questions to Potti, his collaborator Joseph Nevins, and Duke administration officials. The questions focused on the Rhodes claim, but also touched on other apparent discrepancies. Responding to everyone on the email CC list, including this reporter, Potti wrote: “Sounds like I need to call him to clarify ...... and probably also talk with you all to clarify. I was a nominee..... and several of the others can also be explained. –Anil.” After that email, Potti and Duke officials didn’t respond to questions seeking details that could substantiate this response. Multiple calls and emails from The Cancer Letter were not acknowledged.</blockquote> One reason is that this escapade appears to have many twists and turns regarding credentials claimed by their researcher in the past. See the full <a href="http://cancerletter.com/tcl-blog/CL36-27.pdf" title="Article in The Cancer Letter. (PDF)">article published in The Cancer Letter</a> (PDF). The tale is stunning. Another reason appears to be this: <blockquote>Genomic research led by the two scientists [Potti and senior collaborator Joseph Nevins] has brought millions of public and private dollars to Duke. The duo’s connections with the industry are considerable. According to a recent disclosure, Potti is a member of the scientific advisory boards of Eli Lilly and Co., GlaxoSmith-Kline, and CancerGuideDx.</blockquote> This also raises the questions: <ul><li>Did Potti misrepresent his credentials to these pharmas?</li></ul><ul><li>Was Nevins aware of these exaggerations himself? </li></ul> Of course this author is familiar with laxity in Duke's management and academics, and their not replying to pointed questions on their failures. Perhaps at the time of this grant application, Duke personnel were busy checking the credentials of the <a href="http://en.wikipedia.org/wiki/Duke_lacrosse_case">Duke Lacrosse team</a>, or of academics such as myself, maligned by Duke professors for having a strong sense of ethics (see link below). I then found myself "stonewalled" by Duke's President <a href="http://www.duke.edu/president/">Richard H. Brodhead</a> on the issues. (See my Jan. 2008 post "<a href="http://hcrenewal.blogspot.com/2008/01/truly-disturbing-lawsuit-against-duke.html">A Truly Appalling Lawsuit Against Duke University</a>" for more on that affair.) -- SS

Duke Scientist Bringing Millions from NIH and Pharma Suspended Over Rhodes Scholar Claims

The New York Times reports that a medical researcher faked claims to being a Rhodes Scholar, and that a major scandal that has erupted. The ...

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The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room

<div dir="ltr">The <a href="http://www.nist.gov/index.html">National Institute of Standards and Technology</a> (NIST) has begun to address deficient clinical IT usability. A PDF with presentations on the topic from the recent NIST conference on HIT usability is <a href="http://www.nist.gov/itl/upload/Final-Agenda-Usability-in-Health-IT-2-2.pdf">here</a> (warning: very large, 26 MB). There is a critical "meta-issue" that's being ignored regarding usability, though, yet it is the elephant in the living room. First, I will detail the elephant, then ask the simple, logical question that arises (the "inconvenient" question that nobody seems to be able to give a straight, non-marketing-spin answer to). </div> <div dir="ltr"> </div> <div dir="ltr">Here are the details of the elephant. First, poor usability ---> increased risk to patients. This is a first principle; it is not open to debate. Now: </div> <div dir="ltr"> </div> <div dir="ltr">If NIST is just now getting involved in "improving HIT usability" (the improvement of which should have occurred at least two decades ago); </div> <div dir="ltr"> </div> <div dir="ltr">While HIMSS's former Chairman of the Board admits the <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html" target="_blank">technology remains experimental</a>: </div> <div dir="ltr"> </div> <blockquote dir="ltr" style="margin-right: 0px;"> <div dir="ltr">... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better; </div></blockquote> <div dir="ltr"> </div> <div dir="ltr">While HIMSS itself admits <a href="http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf"> </a><a href="http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf" target="_blank">in this 2009 PDF</a> that </div> <blockquote dir="ltr" style="margin-right: 0px;"> <div dir="ltr">"Electronic medical record (EMR)!adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available"; </div></blockquote> <div dir="ltr"> </div> <div dir="ltr">While the National Research Council (the highest scientific authority in the U.S.) last year <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">reported that</a> : </div> <div dir="ltr"> </div> <blockquote dir="ltr" style="margin-right: 0px;"> <div dir="ltr">"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt); </div></blockquote> <div dir="ltr"> </div> <div dir="ltr">While it's not just the user experience that's the problem, either... </div> <div dir="ltr"> </div> <div dir="ltr">Insurers are starting to recognize this, e.g., <a href="http://hcrenewal.blogspot.com/2010/07/norcal-mutual-insurance-company.html" target="_blank">"NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks"</a> ; While hospitals and vendors cannot yet manage the technology reliably - how many medical mistakes have/will occur as a result of screw ups <a href="http://hcrenewal.blogspot.com/2010/07/health-it-and-highest-regulatory.html" target="_blank">like this one</a>, now confirmed to have occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.? <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html" target="_blank">This patient</a> won't get a second chance, either. </div> <div dir="ltr"> </div> <div dir="ltr">The above issues are the elephant in the living room. Or, shall I say, in the Boardrooms and meeting rooms where health IT is planned and discussed? <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi372kCKQVR2zneqSKOy61V1bpGev7OclaMtQFd1qq86Elnm_87Jq308yxvhTG3zQFsUPqicO3WbHwA2ZPbIWr2X0vyis_-2D-da5x0p02CFnoeG85MaoBzYQU6pQrWTOK39oUZEvwlt6zm/s1600/elephant-in-the-room.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5496364856603005506" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi372kCKQVR2zneqSKOy61V1bpGev7OclaMtQFd1qq86Elnm_87Jq308yxvhTG3zQFsUPqicO3WbHwA2ZPbIWr2X0vyis_-2D-da5x0p02CFnoeG85MaoBzYQU6pQrWTOK39oUZEvwlt6zm/s320/elephant-in-the-room.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 244px;" /></a>Health IT is great stuff, guys; it might actually work well one day! Let's roll it out nationally and penalize those Luddite doctors who refuse to "use it meaningfully" because it's not very usable. Oh, just ignore that strange creature over there in the corner ... </div></div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> Considering the size and weight of the elephant, here is my question: </div> <div dir="ltr"> </div> <div dir="ltr">Why are we rolling out this technology nationally under penalty of Medicare garnishment? I cannot get a straight, unspun answer to that question. Perhaps we need Bill O'Reilly to ask these questions of health IT officials on his <a href="http://www.foxnews.com/">FOX News</a> program, <a href="http://books.google.com/books?id=b9GRPXrYDPUC&printsec=frontcover&dq=no+spin+zone&hl=en&ei=8ANHTP3CAYL_8Abk6bXhBA&sa=X&oi=book_result&ct=result&resnum=1&ved=0CCkQ6AEwAA#v=onepage&q&f=false">The O'Reilly Factor</a>, where spin is attacked relentlessly (the "No Spin Zone.") -- SS </div>

The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room

The National Institute of Standards and Technology (NIST) has begun to address deficient clinical IT usability. A PDF with presentation...

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Barry Chaiken, MD, MPH: "Let's be patient" with experimental devices that harm patients

At an <a href="http://histalk2.com/2010/07/19/histalk-interviews-barry-chaiken/">interview</a> of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group <a href="http://www.himss.org/">HIMSS</a> and chief medical officer of <a href="http://www.imprivata.com/">Imprivata</a>, a company specializing in healthcare IT security, Chaiken pleads for the following special accommodations for Health IT relative to other medical sectors: <blockquote>... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better. [Why are the health IT applications bad to begin with, I ask? - ed.] </blockquote> I note the following. <ul><li>If 'we're' still learning (and I don't include people with genuine clinical computing expertise in that subgroup, but it does include the plethora of amateurs in the commercial health IT industry), then the technology is experimental.</li><li>Worse, it's unregulated - a major special accommodation in and of itself. </li><li>These sentiments about "being patient" would be appropriate - if the subjects of this experimental technology that vendors need to be "given a chance" to make better were experimental lab rats.</li></ul> Instead, the subjects of the experimental technology are unwitting, unconsenting human beings, who are being used as experimental test subjects for software development, and being put at risk, injured and indeed <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">killed</a> by the disruptions these experimental technologies cause. Under these realities, the position presented by Chaiken is, in my opinion, ethically perverse. That such sentiments come from someone who holds the MD degree and who I assume took the Hippocratic oath in some form is stunning. In the health IT industry, "<a href="http://en.wikipedia.org/wiki/Primum_non_nocere">Primum non nocere</a>" seems to have been replaced with "Kybernetik über alle." Further, the commercial health IT vendors have had the good part of five decades to "get it right." How long is long enough? Their software is unavailable for detailed evaluation and open critique of the user experience by impartial experts, unlike open source EHR's like VistA CPRS, demo version available <a href="http://www.ehealth.va.gov/EHEALTH/CPRS_demo.asp">at this link</a> where anyone can: <ul><li>Download the latest version of CPRS today and get access to new features including graphing functionality</li><li>Use the software as if you were a provider by entering orders, entering documentation, retrieving reports (and graphs) and viewing alerts and notifications that help with decision support</li><li>Learn first hand how VA’s electronic health record system works</li></ul> Personally, I've had to use stealth simply to obtain and post graphical representations of some simply inexcusable commercial HIT interface sins (<a href="http://www.tinyurl.com/hostileuserexper">link</a>). Why should a secretive industry be given additional special accommodation? Dr. Chaiken goes on to state: <blockquote>Let’s hold them accountable if they don’t [make the applications better]. Absolutely, hold them accountable if they don’t; and the marketplace, I hope, will be able to make those choices and hold them accountable when they don’t. But, we’re still learning.</blockquote> Again, I'm not sure who the "we're" refers to, but "holding companies accountable" will not really help victims of the experiments who are seriously injured or killed. A better solution, as I have written on this blog (such as at my Nov. 2008 post "<a href="http://hcrenewal.blogspot.com/2008/11/should-us-call-moratorium-on-ambitious.html">Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans</a>?" and at other sites as well: Protect patients. Constrain the health IT experiment temporally and geographically, and apply the laws, customs and regulations of medical experimentation until this industry "has learned" whatever lessons Chaiken thinks they need to learn, e.g., from decades of Medical Informatics, Social Informatics, Computer Science, HCI and other research. None of these fields - last time I looked - are classified or protected intellectual property. Share information on patient adverse outcomes and near misses, instead of concealing them and contractually gagging users from openly speaking about problems. That would be the ethical approach. Further, how many more decades should we wait for the health IT industry to figure out how to look for better leaders beyond the "school of hard knocks" bias that's existed for at least the past decade? How many substandard health IT leaders were placed in hospitals the past few decades as a result of outrageous attitudes like these below from the major recrutiers, centered on spreading the wealth? <blockquote>I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman. Healthcare Informatics, "Who's Growing CIO's." [No, that line about 'being consumed with patient care issues' as a strike against health IT leadership didn't come from a Scott Adams business-idiot parody cartoon - ed.] </blockquote> As in clinical medicine itself, if you're going to be anywhere near patient care and making decisions affecting its delivery, a degree damn well "gets you something." At about the same time the above appeared in Healthcare Informatics, a generalist IT recruiter wrote me <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/opinions1.htm#anon1">this</a>: <blockquote> ... What is happening to MDs trying to change careers is providing a window into broader issues about professionals in society today - narrow training, pigeonholing in the marketplace, difficulty making lateral and cross-industry transition, what a handicap it is to be creative, entrepreneurial, or cross-disciplinary in the current marketplace, and the wasted intellectual capital represented by the high caliber of individuals who can't find ways to fruitfully plug themselves into the marketplace. I continue to be amazed at this general phenomenon...the remarkable quality of a number of candidates I've met, and the lack of recruiters' ability to get them in the door of good companies. The interesting part of the story is that when I am able to get access to high level execs in some of these companies (not just IT, but devices, pharmaceuticals, etc. also) they are dismayed at the quality of those that they hire. They know that something is wrong in how the recruitment process is working. (eg, one of the major device cos. just devoted the time of 1 FTE in Human Resources to 'finding innovative ways of identifying and recruiting good talent into the company.')</blockquote> Whose fault were the outrageous, deleterious hiring practices prevalent in this industry that contributed materially to its production of substandard products, hiring practices that persist to this day? (See example <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=leadership">here</a>.) Why should we be "patient", and "give them [yet more chances] to figure out the right way to do this", and why should patients permit themselves to continue to be guinea pigs to such a sloppy, cavalier industry? I note that Chaiken's credentials appear to fit the template, as colleague Roy Poses describes at various posts including <a href="http://hcrenewal.blogspot.com/2010/07/not-your-average-joes-health-plan.html">here</a>, of an "executive isolated from the real world of health care" and member of the <a href="http://hcrenewal.blogspot.com/search/label/superclass">superclass</a>. From the interview linked above: <blockquote> ... According to your LinkedIn profile, you’re CMO for Imprivata, CMIO for Symphony Corporation, and CMO of DocsNetwork. You’re on a couple of advisory boards, you own a vineyard, and you just finished your term as chair of the HIMSS board.</blockquote> Perhaps that helps explain the mantra of "computers [and profit] first, patients second." Finally, in answer to my own question above "Why are the health IT applications bad to begin with", I suggest complacency, incompetence, willful ignorance, and negligence (including <a href="http://legal-dictionary.thefreedictionary.com/Criminal+Negligence">criminal negligence</a>) as possible answers. -- SS Addendum: The following in today's WSJ caught my eye ("<a href="http://online.wsj.com/article/SB10001424052748703720504575377061515304900.html">What we've learned from the Gulf spill</a>", Michio Kaku, July 20, 2010): <blockquote>The nagging question is: Why did it take so long? Why couldn't they have capped the leak months ago? For three agonizing months, BP's engineers and executives were essentially making things up as they went along, conducting a billion dollar science project with the American people as guinea pigs. The basic science of stopping oil leaks at 5,000 feet below sea level should have been done years ago.</blockquote> Concepts are similar. With just a few edits, we have this: <blockquote>The nagging question is: Why is it taking so long? Why couldn't they have learned to create useful health IT decades ago? For at least thirty agonizing years, Health IT vendors' engineers and executives were essentially making things up as they went along, conducting a multibillion dollar science project with the American people as guinea pigs. The basic science of producing safe, effective, usable health IT should have been done years ago.</blockquote> -- SS

Barry Chaiken, MD, MPH: "Let's be patient" with experimental devices that harm patients

At an interview of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS and chief medical officer o...

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Not Your Average Joe's Health Plan

A <a href="http://www.denverpost.com/business/ci_15533672">Denver Post article</a> offered a brief glimpse into the health benefits of corporate leaders, on the unusual occasion of a former CEO now in legal fight for the health benefits in the style to which he had become accustomed: <blockquote>Poor Joe. He's not getting the health-care benefits he was promised. His former employer merged with another company, and then another, and then another. And, you know how it goes after a slew of mergers. Suddenly the new, conglomerated monster just doesn't care about retirees any more. Joe isn't going to sit back and take it like an average Joe. He's suing his former employer in U.S. District Court in Manhattan for breach of contract, breach of faith, breach of fiduciary duty and even promissory estoppel.</blockquote> The Joe in question was really: <blockquote>Lord & Taylor's CEO. Joseph E. Brooks of Greenwich, Conn., lorded over a fourfold increase in sales at Lord & Taylor, expanding to 46 from 19 locations. </blockquote> His career and Lord and Taylor's course after that were checkered, perhaps contributing to the current dispute: <blockquote>But that was a long time ago. And Macy's Inc., the current parent company, is resisting some of his medical claims.</blockquote> <blockquote>Brooks didn't get a deal like this from Filene's, where he served as president before joining Lord & Taylor. Or Ann Taylor, where he went on to generate shareholder lawsuits and shopper hate mail after demanding lower prices from suppliers and higher prices from customers, destroying both quality and value at the same time. Brooks also made his son president of Ann Taylor, sparking cries of nepotism. And then his son got snagged trying to slip by U.S. Customs without paying duties on pricey watches and was forced to resign. The senior Brooks subsequently resigned as well. A 1992 Newsday article called him 'as egotistical and extravagant as he was brilliant.'</blockquote>What Health Care Benefits Do CEOs Get? What had Brooks been promised as CEO of Lord and Taylor? <blockquote>In 1983, Lord & Taylor's corporate parent told Brooks it sought to provide 'great comfort to executives knowing that their medical costs are fully reimbursed by the Corporation.' The company told Joe it was a lifetime guarantee. CEOs should never, ever, have to worry about health care.</blockquote> Here are some details about his benefits: <blockquote>And for nearly 27 years, substantially all medical costs have been fully covered, even premiums. We're not just talking doctors' visits, hospitals, medications and tests. We're talking all travel and ancillary expenses associated with care, too. We're talking first-class transportation, accommodations and meals while being treated at the Mayo Clinic and the Duke Diet and Fitness Center. We're talking expenses for a companion or personal aide, too. We're also talking 'cosmetic services (surgery, medications, injections, creams and the like)' dental care, gym memberships, personal trainers, vitamins, massages — all paid by Joe's former employer for the rest of Joe's life. Oh, and if any of these benefits have tax consequences, we're talking gross-up payments to cover that, too.</blockquote>Why should we be concerned about the extravagant health plans given to top corporate executives?  The Implications We <a href="http://hcrenewal.blogspot.com/2009/07/are-health-plans-of-very-rich-different.html">noted in 2009</a> that the Goldman Sachs 2009 proxy statement indicated that top executives of that now controversial company received health plans worth about $40,000 each.  My concern then were not how much the costs of the plans contribute to top corporate leaders' compensation packages. Such packages are generally already so outrageously huge that providing $40,000 rather than $13,000 worth of health insurance is a trivial increase. My concern was not that plan recipients' demands for health care will collectively increase health care costs, because they likely include only a tiny portion of the population. My main concern, instead, was how much these plans further insulate already cocooned top executives from the vicissitudes of daily life, particularly related to coping with our current dysfunctional health care system. What benefits executive health care plans provided were not clear from the 2009 story about Goldman Sachs.  However, this year's case of Joe Brooks does suggest that the plans paid for every expense that could be conceivably health related.  As I worried then, it now does appear that such plans could completely insulate executives from having to deal with the managed care/ health insurance bureaucracy which frustrates patients seeking particular services, but not necessarily the most expensive, or least beneficial services. Furthermore, such plans may completely insulate executives from the various other vicissitudes of managing our currently dysfunctional health care system.  (By the way, that is why it seemed amazing that the CEO of Pfizer had to put up with some of the common vicissitudes when he went to a hospital for an elective procedure, an experience he publicly talked about with an almost charming naivete, given that he runs such a powerful health care organization which has been so influential in shaping our US "health care reform," see post <a href="http://hcrenewal.blogspot.com/2010/06/finding-out-about-health-care.html">here</a>.) Such executives isolated from the real world of health care might thus not have gut level appreciation of how dysfunctional the health care system has become for even insured patients. Since top executives often are disproportionately influential members of the "<a href="http://hcrenewal.blogspot.com/search/label/superclass">superclass</a>," their disconnection from the realities of dysfunctional health care is likely to translate into little real support by the powers that be for meaningful health care reform. There support may be further retarded by the influence of their fellow superclass members whose personal fortunes depend on the status quo in health care. Real improvement of health care may depend on finding leaders who have better understanding of the plight of real people.   Two Postscripts   Note: the <a href="http://www2.goldmansachs.com/our-firm/investors/financials/current/proxy-statements/2010-proxy-doc.pdf">Goldman Sachs 2010 proxy</a> indicates that the executive health plans given to the five most highly paid executives cost up to $56,927.     Also note that despite the effect that executive health plans may have on the thinking of those with the most power to influence health care policy, the plans have been of little interest to health care services and policy researchers.  I have not been able to find a single article in these literatures on the subject.  This appears to be yet another version of the anechoic effect, that certain inconvenient truths (to borrow from former US Vice President Al Gore) are not subjects of polite discussion of health care, lest the results excessively disturb the powers that be.

Not Your Average Joe's Health Plan

A Denver Post article offered a brief glimpse into the health benefits of corporate leaders, on the unusual occasion of a former CEO now in...

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Prosecuting Doctors for Importing IUDs from Canada, but Still No Penalties for Selling Adulterated Heparin from China

Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-gynecologists (OB-GYNs).  The first nuanced summary of the story which just appeared <a href="http://www.projo.com/news/content/IUDS_07-18-10_RDJ7DC7_v22.14cd6b6.html">in the Providence Journal</a>, written by Felice Freyer, suggested how the consequences of possible misconduct in health care depend on the clout of those involved. The Unapproved IUDs Here are the main points. The issue that caused so much local controversy was the use of unapproved IUDs: <blockquote>Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long before the Health Department began its investigation in June.</blockquote> Here is what we know about the actual devices they implanted: <blockquote>An IUD is a T-shaped device that can fit in the palm of a woman’s hand. To prevent pregnancy, doctors insert it into the uterus, where it can stay for years. There are two types available in the United States: the ParaGard copper IUD and the Mirena hormonal IUD. Mirena, the more costly and more popular brand, has a coating of a progesterone-like drug that reduces heavy menstrual bleeding. </blockquote>Unapproved IUDs Made by an American Company in Finland and Sold in Canada Most of the "unapproved devices" the doctors were using were apparently made in Finland by an American company. <blockquote>In most cases, the doctors were using Mirena, which is made at a factory in Finland by an American company, Bayer Healthcare Pharmaceuticals. Only when it comes through approved channels can doctors and patients be assured that a product meets FDA standards. But it is unclear whether Bayer –– or anyone –– makes a version of Mirena that does not meet those standards. </blockquote>The doctors imported the devices from far-away, exotic Canada. <blockquote>Most of the devices apparently came from Canada, where the government negotiates with drug and device makers to keep prices low.</blockquote> There is no reason to suspect the devices were counterfeit, or defective. <blockquote>'If they’re really from Canada and from a reputable pharmacy, it should be exactly the same thing [as the FDA-approved version],' said Sheryl Ruzek, a retired public health professor at Temple University and vice chair of the board of the ECRI Institute, a nonprofit organization that evaluates medical procedures and products. 'My hunch is the patients were not harmed,' she said. </blockquote>Potential Negative Consequences for the Physicians However, the RI physicians are in big trouble for importing them: <blockquote>In Rhode Island, the state boards that regulate physicians, nurses and nurse-midwives are investigating all those involved. If any are found guilty of unprofessional conduct, they could face disciplinary action such as a reprimand or license suspension. The state attorney general’s office has a Medicaid fraud unit, but declined to comment. The U.S. Attorney also had no comment. </blockquote>US doctors in other states have also been importing IUDs, and also are in big trouble: <blockquote>So many doctors were importing IUDs or considering doing so that the American College of Obstetricians and Gynecologists recently took an official stand, issuing an advisory opposing the use of imported devices. In 2006, the California Department of Health found that eight doctors had used imported IUDs in some 850 women. In October 2009, an Arkansas doctor was indicted by a federal grand jury for using non-FDA-approved versions of Mirena. He was charged with violation of the Food, Drug & Cosmetic Act, health-care fraud (for allegedly billing Medicaid for the unapproved devices) and money-laundering (for the way he allegedly handled Medicaid reimbursements). The doctor, Kelly Dean Shrum, has not yet come to trial, but potential penalties include fines and imprisonment. </blockquote> Summary, and the Contrast with the Case of the Adulterated, Fatal Heparin So to summarize, doctors who imported IUDs from Canada that appeared to be identical to those sold with FDA approval in the US, and were made in Finland by an American company at the same factory in which the US approved IUDs were made have gotten into major trouble with state and federal authorities. There is no clear evidence that the IUDs caused any harm to patients. I am not defending the doctors' actions. However, contrast the treatment they are likely to receive with another case we have frequently discussed. We last blogged about the case of Baxter International's adulterated heparin <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>.  In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China.  That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label.  The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA.  The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died.  While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product.  Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product. Yet everyone from state health departments to the federal authorities have jumped into the case of the unapproved IUDs imported, but from Canada, and apparently identical to the IUDs sold in the US.  There is, at least so far, no evidence that the IUDs were defective or dangerous, and no evidence they have harmed patients.  One doctor has been prosecuted for violating the Food, Drug and Cosmetic Act, and for health care fraud and money-laundering.  No one working for Baxter International (or for the identified organizations within its supply chain) has been prosecuted for anything. What the...?   I do not object to discipline and prosecution of individual doctors who appear to have broken the law.  But why are we so vigorously pursuing individual doctors for an apparently technical violation of laws that did patients no apparent harm, when we are not pursuing health care corporate executives for selling adulterated drugs that likely killed patients?  F Scott Fitzergald wrote that the "very rich are different from you and me," and it appears that very rich health care leaders have impunity when it comes to conduct that let patients be harmed and die.  Real health care reform would make top health care leaders as accountable as we now make individual doctors.

Prosecuting Doctors for Importing IUDs from Canada, but Still No Penalties for Selling Adulterated Heparin from China

Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-g...

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The Avandia Spin Cycle Continues Even After the FDA Safety Hearings

We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug.  While Avandia has received considerable media coverage, we focused on two questions: 1 - what are the benefits and harms of rosiglitazone as a treatment of type 2 diabetes, and therefore for which patients under what circumstances should this drug be used? 2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?  (See recent post <a href="http://hcrenewal.blogspot.com/2010/02/bring-back-dsi-avandia-case-as-spy.html">here</a>.)  In particular, the Avandia case has illustrated how those with vested interests in the success of a health care product have done their best to obscure information that might threaten its success, even when doing so obscures the information that physicians and patients need to make the best possible decisions.  At one point, (in 2007, no less) we called this the "<a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">Avandia spin cycle</a>." Avandia once again has been in the news after the US Food and Drug Administration's hearings on the safety of the drug.  These hearings were so well covered in the media that a lengthy summary would be superfluous.  However, their main points demonstrated the persistence of the Avandia spin cycle: - An FDA reviewer felt that "the company's misreadings of the ... Record trial ... were so profound, he concluded, that they 'suggest serious flaws with trial conduct.'" (per Gardiner Harris <a href="http://www.nytimes.com/2010/07/10/health/10diabetes.html">writing</a> in the New York Times) -A former FDA reviewer "withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks." (<a href="http://www.bloomberg.com/news/2010-07-09/glaxo-withheld-avandia-study-former-fda-manager-said-to-testify-in-suit.html">per Bloomberg News</a>) - GlaxoSmithKline's forerunner SmithKline Beecham "secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda."  However, "the study also provided clear signs that it [Avandia] was riskier to the heart.  But instead of publishing the results, the company spent the next 11 years trying to cover them up." (per Gardiner Harris <a href="http://www.nytimes.com/2010/07/13/health/policy/13avandia.html">writing</a> in the New York Times. - "Government experts and a panel of medical advisers repeatedly voiced skepticism on Tuesday about the trustworthiness of GlaxoSmithKline, which makes the controversial diabetes drug Avandia." (per Gardiner Harris again <a href="http://www.nytimes.com/2010/07/14/health/policy/14diabetes.html">writing</a> in the New York Times.) So the Avandia saga has brought to the front pages the concerns we have had with <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of clinical research, especially when pursued by health care organizations with vested interests in the results of specific research projects coming out a certain way, and how they have been enabled by those with <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>.  Doctors thus should be worried whether those of us who try to practice evidence-based medicine have been fooled into practicing <a href="http://hcrenewal.blogspot.com/search/label/pseudo-evidence%20based%20medicine">pseudo-evidence-based-medicine</a>. Those commenting on the story focused on the need for transparency when clinical research is funded and run by the corporations whose products are being evaluated. -  "GlaxoSmithKline, the maker of Avandia, can't be trusted to report adverse clinical results fairly.  The company must be watched like a hawk as additional trials that it sponsors go forward."  (<a href="http://www.nytimes.com/2010/07/15/opinion/15thu1.html">NY Times editorial</a>) -  "What America should demand in return for ... [generous patent] protection is that the FDA be able to make an honest evaluation of the efficacy of drugs.  When drug companies make this impossible by suppressing test results, not only do they violate their fundamental obligation of honesty with the public, their customers and their regulator, but they also break the bargain they have struck in return for the protection of their intellectual capital."  (Former NY Attorney General Eliot Spitzer<a href="http://www.slate.com/id/2260470/"> in Slate</a>.) Instead, as I have written before, maybe we ought to consider whether those with vested interests in drugs or devices ought to be running clinical research meant to evaluate their own products.  Ironically, while this discussion of how the Avandia spin cycle first began to revolve were going on, others were still trying to add revolutions (per minute).  In particular, a Reuters <a href="http://www.reuters.com/article/idUSN1511649320100715">story</a> noted: <blockquote>Three influential groups of doctors who treat diabetes urged patients not to stop taking Avandia, saying on Thursday that while news about the controversial drug may be frightening, it would be worse to suddenly stop taking it.</blockquote> That is odd, given that Avandia has never been shown to improve clinical outcomes for patients with diabetes, and that there are many other drugs that control blood sugar which appear to be safer. But wait, there is more, <blockquote>The Endocrine Society, American Diabetes Association and the American Association of Clinical Endocrinologists worried that patients may be afraid to take Avandia. 'Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,' Dr. Robert Vigersky of the Endocrine Society said in a statement. 'Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short term health problems and could increase the risk of diabetes-related complications in the long term.'</blockquote> Would not it make more sense to advise patients still on Avandia to consult with their doctors urgently about possible alternatives?  Meanwhile, it does not seem irrational to be afraid of taking Avandia, given the increasing evidence about its harms, and increasing evidence that what we know about its harms may be an under-estimate. So I wondered why these august medical societies seemed so unaffected about the doubts about Avandia's safety, and about the evidence offered to support its use that the latest news ought to generate. It turns out that all three of the medical societies get financial support from, -- wait for it --, GlaxoSmithKline. The Endocrine Society lists GSK as one of its <a href="http://www.endo-society.org/industry/CLB_about.cfm">Corporate Liaison Board Members</a>. The American Diabetes Association lists GSK as one of its <a href="http://www.diabetes.org/donate/sponsor/our-corporate-supporters.html">Banting Circle Supporters</a>, that is, those that give at least $1,000,000 a year. The American Association of Clinical Endocrinologists lists GSK as a member of its <a href="http://www.aace.com/org/cap/capdirectory.php">Corporate AACE Partnership</a>. (I was not able to find out the total amount contributed by GSK to either the Endocrine Society or the AACE.) So once again, the loudest voices in support of the product come from those used to, and perhaps dependent on financial support from its manufacturer. As a physician, I have been particularly disappointed that our medical societies, whose missions are ostensibly to support our professional values, seem to act more and more like marketers for the companies whose contributions, rather than members' dues increasingly support them. The cycle keeps spinning. For further thoughts on the latest in the Avandia case, see <a href="http://brodyhooked.blogspot.com/2010/07/side-trip-into-diabetes-selling-wrong.html">this post</a> by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and <a href="http://alison-bass.blogspot.com/2010/07/when-will-big-pharma-learn-story-of.html">this</a> by Alison Bass on the Alison Bass Blog.

The Avandia Spin Cycle Continues Even After the FDA Safety Hearings

We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug. While Avandia has re...

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