Education https://scienceblogs.com/channel/education/feed en On the "integration" of quackery into the medical school curriculum https://scienceblogs.com/insolence/2017/10/11/on-the-integration-of-quackery-into-the-medical-school-curriculum <span>On the &quot;integration&quot; of quackery into the medical school curriculum</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p><a href="https://qedcon.org">QEDCon</a> is fast approaching (indeed, I can't believe I have to leave for Manchester tomorrow night), and because my talk there will be about the phenomenon of "integrative medicine," I've been thinking a lot about it. As I put together my slides, I can't help but see my talk evolving to encompass both "integrative" medicine and what I like to refer to as quackademic medicine, but that's not surprising. The two phenomenon are related, and it's hard to determine which has a more pernicious effect on science in medicine.</p> <!--more--><p>One aspect of quackademic medicine that I probably don't write about as much as I should is the "integration" of quackery into the curricula of medical schools. Part of the reason for that, I suspect, is that I am fortunate enough to be faculty at a medical school and cancer center that remain relatively untouched by the pseudoscience of integrative medicine. True, our medical school does have at least one credulous lecture about "complementary and alternative medicine" (CAM) that the medical students have to imbibe, but it really is pretty close to the bare minimum required by the accrediting agencies. Oh, yes. Proponents of integrative medicine have been so successful that one requirement for accreditation by the Liaison Committee on Medical Education (LCME) is that there be adequate instruction about CAM. Actually, that's not quite true. Among the educational objectives in the LCME requirements is ED-10: "The curriculum of a medical education program must include behavioral and socioeconomic subjects in addition to basic science and clinical disciplines." This is where CAM and integrative medicine are slipped in. That's because the Academic Consortium for Integrative Medicine and Health successfully lobbied the LCME to <a href="https://www.imconsortium.org/docs-public/Major_Accomplishments-May2015.pdf">include CAM in its list of topics addressed</a> in the LCME Medical Education Database relative to accreditation standard ED-10. Unfortunately, how that is done in practice is often in the form of entirely credulous teaching of CAM.</p> <p>Last month, when I wrote about the <a href="http://respectfulinsolence.com/2017/09/19/quackademic-medicine-now-reigns-supreme-at-uc-irvine/">$200 million donation to the University of California, Irvine</a> (UCI) by the billionaire couple Susan and Henry Samueli to create a college of health sciences that will encompass several UCI schools, including its school of medicine and nursing school, dedicated to "integrating" quackery at all levels into medicine thusly:</p> <blockquote><p> The Samuelis’ gift will provide $50 million toward construction of a facility to house the college and $5 million for state-of-the-art technology and labs – forming the foundation of a national showcase for integrative health. It also earmarks $145 million to create an endowment for:</p> <ul><li>Up to 15 faculty chairs across the medicine, nursing, pharmacy and population health disciplines for senior, midcareer and junior faculty with expertise in integrative health</li> <li>Integrative health training and mentoring for interested medical school students</li> <li>Scholarships and fellowships for undergraduate and graduate students planning careers in related fields</li> <li>Innovative curricular development and campuswide interdisciplinary research projects</li> <li>Ongoing clinical services, research and education in the Susan Samueli Integrative Health Institute, including investigations of nonconventional interventions as part of medical treatment and educating medical and lay communities about benefits and risks associated with new healthcare approaches</li> </ul></blockquote> <p>What I didn't talk about so much was number 3: "innovative curricular development." That's CAM-speak for teaching CAM alongside real medicine as though homeopathy has scientific validity. This brings us to an article by noted cheerleader for "integrative medicine" Glenn Sabin, <a href="https://fonconsulting.com/blog/integrative-healths-place-in-medical-school-curricula/">Integrative health's place in the medical school curriculum</a>. If you want to know where Sabin's coming from, consider my previous discussions related to his promotion of alternative medicine, such as <a href="http://respectfulinsolence.com/2016/11/28/the-long-strange-road-to-normalizing-the-integration-of-quackery-with-medicine/">his "history" of the integration</a> of quackery with medicine and his advocacy for <a href="http://respectfulinsolence.com/2017/01/05/selling-an-alternative-medicine-cancer-cure-testimonial-as-an-n-of-1-trial-integrative-medicines-new-propaganda-technique/">anecdotal evidence disguised as "N-of-1 trials" over clinical trials</a> in determining if various alternative medicines "work." He also first got my attention for openly admitting that integrative medicine is <a href="http://respectfulinsolence.com/2011/07/28/on-the-evolution-of-quackery/">a brand, not a specialty</a>. Also consider this <a href="https://fonconsulting.com/blog/integrative-healths-place-in-medical-school-curricula/">paragraph from his latest</a>:</p> <blockquote><p> My colleague, John Weeks, wrote a terrific response in Huffington Post to the media’s shameful coverage of the visionary and game-changing Samueli gift to UCI. He cogently supports his position with actual research, facts, and developments that illustrate just how out-of-touch these dwindling skeptics are—and how a few media outlets took the bait that led them down a narrow-minded narrative centering on one controversial therapy: homeopathy.</p> <p>For me, though, the back-and-forth with the cynics is not worth the expended energy. This is not just about acupuncture or chiropractic or massage or dietary supplements. It’s much bigger.</p> <p>The Samueli gift is about the future of health, led by the doctors of tomorrow, like my nephew, Max, who is in his first year of medical school at George Washington University. </p></blockquote> <p>Homeopathy is not "controversial." It is rank pseudoscience. This is not even in dispute. Just look at the way UCI started <a href="http://respectfulinsolence.com/2017/09/26/homeopathy-at-uc-irvine-it-can-run-but-it-cant-hide/">furiously scrubbing its websites</a> of references to homeopathy as soon as critics started looking at the Samuelis' gift in detail. Clearly, the administration was embarrassed. I also note that one earlier gift agreement between the Samuelis to UCI explicitly mentioned that it was to be used to promote research into homeopathy, among other pseudoscientific modalities and that until recently UCI advertised the services of a naturopath and homeopath on its website. Even proponents of integrating quackery into medicine are embarrassed by homeopathy.</p> <p>When discussing the "integration" of quackery into medical school, I like to discuss another "George" university namely Georgetown. In many ways, it was a "trailblazer" in "integrating" quackery into medicine. I <a href="http://respectfulinsolence.com/2015/07/31/a-portrait-of-quackademia-triumphant-georgetown-university/">recounted its history</a> just a couple of years ago, citing a <a href="https://web.archive.org/web/20031102223020/http://som.georgetown.edu/cam/GUmed.pdf">2003 Georgetown brochure</a>:</p> <blockquote><p> One of the reasons CAM is usually offered as an elective is that there’s just no time or room in U.S. medical schools to fit in one more massive subject,” says Michael Lumpkin, Ph.D., professor and chair of the department of physiology and biophysics at Georgetown. “When the course is an elective, a self-selected group – maybe 10 or 20 students in a class of 180 medical students – will take it,” Lumpkin says. “What we’ve tried at Georgetown is rather than create all new courses, we take relevant CAM issues and modalities and weave them seamlessly into existing courses.</p> <p>The “seamless” weaving of CAM into existing classes includes, for instance, a presentation by an acupuncturist on the “anatomy of acupuncture” in the gross anatomy course for first-year students. The same lecturer explores acupuncture’s application in pain relief in the neuroscience course…</p> <p>Haramati and Lumpkin say Georgetown’s program is distinct from CAM initiatives in other medical schools in two ways: The school is integrating CAM education into existing course work across all four years of each student’s medical education, and the initiative includes a mind-body class to help students use techniques to manage their own health and improve self-care. </p></blockquote> <p>Yes, fourteen years ago, Georgetown was "integrating" pseudoscience into its medical school curriculum at every level, starting from day one. Twelve years later, it was celebrating pseudoscience on the <a href="http://respectfulinsolence.com/2015/07/31/a-portrait-of-quackademia-triumphant-georgetown-university/">cover of the medical school's magazine</a>. That's not all, though. Reflexology is taught as fact, along with prescientific medical systems, such as traditional Chinese medicine (TCM), "energy healing" like reiki and therapeutic touch, and pretty much every "integrative" quackery you can think of. In 2007, Georgetown partnered with the naturopathy school Bastyr University to <a href="http://respectfulinsolence.com/2011/01/26/the-integration-of-pseudoscience-into-me/">train the next generation of integrative medicine practitioners</a>.</p> <p>This is the sort of future of medicine that Weeks and Sabin so strongly desire.</p> <p>It's also not as though George Washington University isn't itself a bastion of quackademic medicine. Three years ago, I <a href="http://respectfulinsolence.com/2014/10/09/quackademic-medicine-marches-on-george-washington-university-and-the-university-of-toronto/">wrote about all the quackery</a> advertised on its website. GWCIM's <a href="http://www.gwcim.com/patient-care/services/#anchor-705">list of services</a> includes acupuncture (of course!), chiropractic, craniosacral therapy, infrared light therapies, glutathione infusions, Myers’ Cocktail, naturopathy (again, of course!), reiki, intravenous high dose vitamin C, and genetic profile results that include “customized interpretation of 23andme.com genetic profile results with specific accent on methylation and detoxification profiles.” It’s a truly horrifying website to contemplate, given how little of it has any resemblance to science-based medicine and how much of it includes outright quackery like reiki. In addition, its website’s descriptions of various alternative medicine modalities are depressingly and similarly credulous. <a href="http://www.gwcim.com/services/acupuncture-and-chinese-medicine/">Acupuncture</a> is described as being used for “for treatment of respiratory, digestive, urinary and reproductive systems, as well as the disorders of muscle tone, hormone production, circulation, and allergic responses” plus “pain relief, gynecological conditions and symptoms, insomnia, anxiety, and to enhance wellness.” <a href="http://www.gwcim.com/services/naturopathic-medicine/">Naturopathy</a> is described as a “comprehensive approach to health and healing that combines modern scientific knowledge with traditional and natural forms of medicine,” with naturopaths addressing “the mental, emotional and physical aspects of an individual, and aim to treat the root causes as well as the symptoms of illness.” According to GWCIM, naturopaths are “trained as primary care doctors at accredited four-year naturopathic medical schools.”</p> <p><a href="http://www.sciencebasedmedicine.org/naturopathy-vs-science-facts-edition/">No</a>. <a href="http://www.sciencebasedmedicine.org/disingenuous-deconstruction-of-a-naturopathic-white-paper/">They</a>. <a href="http://respectfulinsolence.com/2013/10/09/naturopaths-and-vaccines/">Aren't</a>.</p> <p>I also can't help but note that John Weeks' article was really <a href="http://respectfulinsolence.com/2017/09/29/in-which-orac-is-accused-of-having-blood-on-his-hands-for-criticizing-the-samuelis-200-million-gift-to-uc-irvine/">nasty broadside against critics of the Samuelis' gift to UCI</a> in which he accused them of having "blood on their hands." Apparently, Sabin approves of such rhetoric, as long as it's directed against his opponents.</p> <p>Sabin's article is yet another example of how "integrative medicine" rebrands science-based modalities, such as nutrition, exercise, and lifestyle modification as somehow "alternative" or "integrative" and then uses them as the vehicle in which quackery is <em>also</em> "integrated" into medicine, while trying to dismiss anyone who points out the pseudoscience as the "old guard—the few out-of-touch, aging critics pushing back." (I note that Sabin and Weeks aren't exactly spring chickens themselves.) Naturally, he tries to <a href="https://fonconsulting.com/blog/integrative-healths-place-in-medical-school-curricula/">push back against the critics' narrative</a>:</p> <blockquote><p> These same integrative health and medicine naysayers essentially conflate quackery—which ought to be called out and confronted—with the larger, progressive, and impactful, integrative health and medicine movement.</p> <p>Critics also purport that nutrition, physical activity, and stress reduction are already consistently applied (or taught) clinically—that it’s already ‘part of medicine’. These few critics are wrong. Their view is incorrect. Their statements are patently false. We know this because, if these truly preventative measures were applied—if this was remotely the case—our healthcare delivery system would be consistently delivering ‘health care’, not ‘chronic disease care’. </p></blockquote> <p>Proponents of integrative medicine always try to sweep all the quackery their specialty embraces under the rug. <em>Pay no attention to that quackery behind the curtain</em>, they say. <em>We're all about nutrition, lifestyle, and stress reduction</em>. They somehow never manage to address the question: Why is quackery so associated with integrative medicine? If integrative medicine really were about "nutrition, lifestyle, and stress reduction" and nothing else, the quackery would be unnecessary. Homeopathy, naturopathy, acupuncture, "energy healing," functional medicine, bogus allergy testing, and more forms of pseudoscience and quackery than I can list here (but have discussed over the years on this very blog) would not find such a comfortable home in "integrative medicine." That they do fit so nicely in "integrative medicine" is by design, not accident.</p> <p>Consider this. Let's, for the sake of argument, concede that Sabin has a point. Perhaps nutrition, physical activity, and stress reduction are not sufficiently consistently applied in clinical medicine. If that is indeed the case, the answer is to develop strategies to change this shortcoming in medicine. Those strategies, assuming they're science based (as they should be), will not involve embracing pseudoscience and quackery. Sabin and Weeks go on and on and on about promoting the "nutrition, physical activity, and stress reduction" aspect of medicine, but fail to explain why a separate specialty is needed to emphasize these health promotion activities more. That's because they can't. The entire unspoken rationale that they cannot admit is that "nutrition, physical activity, and stress reduction" function, in essence, as a Trojan horse for hardcore quackery. Integrative medicine shows up at the gates of academic medicine looking like ""nutrition, physical activity, and stress reduction," but once the horse is pulled into the ivory tower of academia, out jumps the real quackery, like naturopathy, homeopathy, acupuncture, functional medicine, and the like.</p> <p>Also unspoken is that the reason integrative medicine proponents want so badly to insinuate their specialty and thinking into medical school is because they want "nutrition, physical activity, and stress reduction" forever linked with the quackery that they <em>also</em> champion. At schools like GWU and Georgetown, it's working, too. I fear, however, that UCI will soon far surpass both GWU and Georgetown as bastions of quackademic medicine.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Wed, 10/11/2017 - 03:20</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Wed, 11 Oct 2017 07:20:33 +0000 oracknows 22640 at https://scienceblogs.com John Weeks accuses Orac of having "blood on his hands" for criticizing the Samuelis' $200 million gift to UC-Irvine. Orac responds. https://scienceblogs.com/insolence/2017/09/29/in-which-orac-is-accused-of-having-blood-on-his-hands-for-criticizing-the-samuelis-200-million-gift-to-uc-irvine <span>John Weeks accuses Orac of having &quot;blood on his hands&quot; for criticizing the Samuelis&#039; $200 million gift to UC-Irvine. Orac responds.</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>John Weeks has long been an activist for what is now known as "integrative medicine," earlier known as "complementary and alternative medicine"(CAM). Basically, for many years Mr. Weeks has been at the forefront of encouraging the "integration" of quackery with real medicine and promoting what I like to refer to as "quackademic medicine," a perfect term to describe the increasing encroachment of pseudoscience and quackery in medical academia in the form of—you guessed it—integrative medicine. Despite his having zero background in scientific research or the design and execution of experiments and clinical trials, for some bizarre reason in May 2016 he was appointed editor of the <em>Journal of Alternative and Complementary Medicine</em> (JACM), even though he has zero background in science or medicine of a type that one would expect in a journal editor. Once there, he wasted little time <a href="http://respectfulinsolence.com/2016/10/24/in-which-i-am-compared-to-donald-trump-by-a-pro-quackademic-medicine-activist/">comparing doctors</a> advocating science-based medicine and opposing pseudoscience in medicine to <a href="http://respectfulinsolence.com/2016/10/24/in-which-i-am-compared-to-donald-trump-by-a-pro-quackademic-medicine-activist/">Donald Trump</a>.</p> <!--more--><p>Fast forward a year and a half, when the University of California, Irvine (UCI) accepted a $200 million gift from Susan and Henry Samueli to <a href="http://respectfulinsolence.com/2017/09/19/quackademic-medicine-now-reigns-supreme-at-uc-irvine/">vastly expand the integrative medicine offerings</a> at UCI (which were already quite extensive) in the form of establishing the Susan and Henry Samueli College of Health Sciences, with the current Susan Samueli Center for Integrative Medicine becoming the Susan Samueli Integrative Health Institute. Amazingly, it wasn't just skeptics like <a href="https://sciencebasedmedicine.org/quackademic-medicine-at-uc-irvine/">Steve Novella</a> and <a href="http://respectfulinsolence.com/2017/09/26/homeopathy-at-uc-irvine-it-can-run-but-it-cant-hide/">myself</a> writing negative articles about this development. Michael Hiltzik of the LA Times wrote an article in which Dr. Novella and I were quoted with a lovely headline, <a href="http://www.latimes.com/business/hiltzik/la-fi-hiltzik-uci-samueli-20170922-story.html">A $200-million donation threatens to tar UC Irvine's medical school as a haven for quacks</a>. Elsewhere, Usha Lee McFarling over at STAT News chimed in with a story with a somewhat less critical but still quite unflattering headline, <a href="https://www.statnews.com/2017/09/20/uci-integrative-medicine-gift/">A $200 million gift promotes alternative therapies at a California medical school — and critics recoil</a>. Both articles contrasted the claims by Dr. Howard Federoff, CEO of UC Irvine’s health system that the new institute and college will be rigorously evidence-based with the reality of the homeopathy offered by UCI. Hiltzik, amusingly, pointed out how UCI was trying to s<a href="http://www.latimes.com/business/hiltzik/la-fi-hiltzik-uci-samueli-20170922-story.html">end references to homeopathy on its website down the memory hole</a> and failing miserably. Meanwhile, Rick Seltzer at <em>Inside Higher Ed</em> quoted Steve Novella as he asked, <a href="https://www.insidehighered.com/news/2017/09/26/uc-irvine-under-scrutiny-taking-200-million-school-health-couple-some-say-back-junk">Does $200 million quack?</a> (My answer: Yes. Very loudly.)</p> <p>I, of course, used this observation to point out that UCI has <a href="http://respectfulinsolence.com/2017/09/26/homeopathy-at-uc-irvine-it-can-run-but-it-cant-hide/">long embraced homeopathy</a> and that, because all naturopaths are trained in homeopathy, <a href="http://respectfulinsolence.com/2011/01/28/you-cant-have-naturopathy-without-homeop/">you can't have naturopathy without homeopathy</a>. Those of us who know how deeply "integrated" (couldn't resist) quackery is in naturopathy couldn't help but point out that Dr. Federoff's claim that UCI's new integrative medicine effort will be rigorously evidence-based is complete and utter bullshit unless UCI gets rid of naturopaths, at least as a start. Also, given that the Samuelis are very much believers in homeopathy, so much so that they <a href="http://respectfulinsolence.com/2017/09/26/homeopathy-at-uc-irvine-it-can-run-but-it-cant-hide/">mentioned support for research into homeopathy in one of their gift agreements</a> with UCI in 2004, I highly doubt that UCI could dump homeopathy very easily even if Dr. Federoff wanted to. Indeed, given Dr. Federoff's long history of <a href="http://respectfulinsolence.com/2015/07/31/a-portrait-of-quackademia-triumphant-georgetown-university/">integrating quackery into medicine at Georgetown</a>, which was his gig before he moved to UCI, I doubt that Dr. Federoff is particularly serious about getting rid of the quackery, anyway. It's now too entrenched.</p> <p>This sort of coverage clearly enraged poor Mr. Weeks, who goes to great lengths to project a facade of civility in comparison to all the "anger" he portrays on "our" side. Indeed, his facade slipped so much that he misspelled Mr. Hiltzik's name alternatively as "Hitzig" and "Tiltzig" in a post published—where else?—that original wretched hive of scum and quackery, The Huffington Post, in the form of an article entitled <a href="http://www.huffingtonpost.com/entry/shameful-media-response-to-the-samuelis-visionary_us_59c7d9a0e4b0b7022a646b73">Shameful Media Response to the Samueli’s Visionary $200-Million Integrative Health Investment at UC Irvine</a>, in which he refers to critics of integrative medicine as "antiscience" and as "having blood on our hands." You can get a taste from the introduction:</p> <blockquote><p> The response of the LA Times, STAT, Medpage, and most media to the visionary $200-million integrative health investment of Susan and Henry Samueli at UC Irvine has been a shameful display of media descent into Trump-like, polarizing tweets. Worse yet, the coverage has been a profoundly anti-science. These media, and others, have chosen to provide platforms to a small handful of individuals who for decades have denied the evidence of acupuncture, chiropractic, mind-body and multiple other integrative approaches. </p></blockquote> <p>Mr. Weeks is nothing if not predictable. These days, to him any criticism of integrative medicine is "Trump-like" and "polarizing." This is the <a href="http://respectfulinsolence.com/2016/10/24/in-which-i-am-compared-to-donald-trump-by-a-pro-quackademic-medicine-activist/">schtick he came up</a> with <a href="http://respectfulinsolence.com/2016/11/14/in-which-i-am-compared-to-donald-trump-by-a-pro-quackademic-medicine-activist-again/">last year</a>, before the election and continuing after it. To this recent but now familiar trope, Mr. Weeks adds a new epithet: "Anti-science." In essence, he is doing exactly what climate science denialisms and antivaxers do: Try to flip the narrative and portray themselves as the true defenders of scientific inquiry and their critics as close-minded dogmatic skeptics who will not consider all the evidence. This is, of course, nonsense when antivaxers and climate science denialists do it, and it's no less ridiculous when Mr. Weeks does it. Also, note how Mr. Weeks also tries to minimize the criticism by minimizing the critics, referring to us dismissively as a "small handful of individuals," in order to portray us as being a tiny minority who can safely be ignored. Elsewhere in his article, he refers to Medscape "bleating" out a link to McFarling's article in STAT. (Get it? We're sheeple.) Sadly, Mr. Weeks' tactics are all mind-numbingly obvious, but at this point in his jeremiad, Mr. Weeks turns out to be just getting started. It doesn't take him long to work himself into a fine lather:</p> <blockquote><p> From his LA Times podium, Michael Hiltzig first gives voice to David Gorski and then to Steven Novella, long-time colleagues and back-slapping companions as anti-integrative medicine vigilantes. Hiltzig quotes Gorski first, shaping the Samueli’s investment this way: “The only reason ‘integrative medicine’ exists is to integrate quackery into medicine.” Tiltzig immediately turns to Novella to use the Trumpish, name-calling term that Gorski himself favors: “In a blog post, Novella flayed UCI’s establishment of an integrative medicine curriculum as ’quackademic medicine.’” </p></blockquote> <p>"Back-slapping companions as anti-integrative medicine vigilantes"? I laughed out loud when I read that line. Maybe I should change the name of the blog from Respectful Insolence to Anti-Integrative Medicine Vigilante. On second thought, "Respectful Insolence" rolls off the tongue much more nicely. The whole "vigilante" charge, though, is meant to further demonize Steve and me, who slap each other on the back like dudebros after each new takedown of integrative medicine. Maybe next he'll portray us as bumping chests and shouting. (Seriously, could Mr. Weeks <em>be</em> any more obvious?)</p> <p>The answer, apparently, is no:</p> <blockquote><p> It would be one thing if this were just journalistic laziness. Sure, go ahead and run polarizing copy based on a tweetish view of the universe that makes a story fit for afternoon TV. In fact, however, these media have chosen to trumpet fake news. They promote this polarizing grandstanding rather than honor the emerging scientific consensus that is yet poorly integrated into health professional education and practice - and that utterly backs the Samuelis’ investment and direction at UC Irvine: </p></blockquote> <p>He then cites four references that actually show how deeply embedded quackery has become in medicine, thanks to the efforts of people like Mr. Weeks. For instance, he mentions the <a href="http://www.jointcommission.org/assets/1/23/jconline_November_12_14.pdf">Joint Commission's 2015 revision of its pain management standard</a> that recommends nonpharmacologic approaches to pain, and mentions acupuncture, chiropractic, and osteopathic manipulation. Now, I've discussed many times before how integrative medicine mavens have latched on to the opioid crisis as an opportunity to expand their influence by rebranding CAM/integrative medicine as "nonpharmacologic approaches to pain." Indeed, the National Center for Complementary and Integrative Medicine (NCCIH) enshrined this in its <a href="http://respectfulinsolence.com/2016/04/11/meet-the-new-nccih-five-year-strategic-plan-same-as-the-old-nccam-five-year-strategic-plan/">2016-2021 strategic plan</a>. Ever since the opioid crisis inserted itself into the national consciousness, proponents of integrative medicine have seen a golden opportunity to use it to further the integration of quackery into medicine. Only they want to be seen as science-based; so when programs like the one at UCI are caught advertising The One Quackery To Rule Them All, homeopathy, they scramble to hide the evidence of it.</p> <p>Mr. Weeks makes a great show of mentioning <a href="http://www.mayoclinicproceedings.org/article/S0025-6196(16)30317-2/fulltext">guidelines published by the Mayo Clinic</a>, which, if anything, showed that the "complementary" approaches to pain examined <a href="http://respectfulinsolence.com/2016/09/12/nccih-co-opting-nonpharmacologic-treatments-for-pain-as-being-alternative-or-complementary/">do not have an effect greater than placebo</a>. Truly, it was an awful review article. Predictably, he also mentioned <a href="https://www.acponline.org/acp-newsroom/american-college-of-physicians-issues-guideline-for-treating-nonradicular-low-back-pain">American College of Physicians guidelines</a> for low back pain. I can't help but note that those recommendations characterized evidence base for acupuncture, for example, as low quality evidence, moderate at best, and cited the GERAC Study, which basically <a href="http://respectfulinsolence.com/2007/09/26/yawnanother-acupuncture-study/">showed that acupuncture does not work</a>. Another mixed "electroacupuncture" (which is basically TENS) with acupuncture. Truly this was thin gruel for the ACP. Finally, he referred to the <a href="https://www.nap.edu/download/24781">National Academy of Medicine's review on nonpharmacological approaches to pain</a>. I perused it. It misrepresents the evidence base for acupuncture in a far too favorable a fashion, for instance claiming that recent "reviews and meta-analyses examining the effect of acupuncture on musculoskeletal pain (neck and back pain, osteoarthritis, chronic headache and shoulder pain, fibromyalgia) have found that overall, acupuncture is superior to sham and no acupuncture, but with relatively modest differences between true and sham acupuncture." Yes, the NAM cited the Vickers meta-analysis, which <a href="http://respectfulinsolence.com/2012/09/12/can-we-finally-just-say-that-acupuncture-is-nothing-more-than-an-elaborate-placebo-can-we-2012-edition/">showed that acupuncture doesn't work</a>, with <a href="http://respectfulinsolence.com/2013/03/08/author-of-the-acupuncture-metaanalysis-lambastes-sceptics/">no clinically significant effect on pain</a>, although the conclusion was spun to be the exact opposite. Yes, Mr. Weeks is doing what any "thought leader" in integrative medicine has to do: Exaggerate or even misrepresent the evidence base supporting the quackery that integrative medicine is seeking to add to medicine.</p> <p>Up until now, Mr. Weeks didn't actually piss me off. Rather, he amused me, as he recycled the same tired, dubious arguments that he's always used, complete with his dismissive comparison of critics of integrative medicine to Donald Trump, which he's now done so often that to me it's a cliché. Indeed, I'm half tempted to make a drinking game out of Mr. Weeks' references to Donald Trump as a means of denigrating his opponents: Take a drink each time he compares our writing to Trump or to Tweets. The only problem is that I'd probably be at risk for alcohol poisoning if I were to play that game.</p> <p>Here's where Mr. Weeks actually managed to piss me off. It's hard for an apologist for quackery to do, but Mr. Weeks managed it:</p> <blockquote><p> The roundhouse, condemnatory, “quackademic” perspectives of Gorski, Novella, Caulfield and their like toward complementary and integrative health and medicine need to be treated and dismissed by the LA Times and others as the anti-science that they are. Sure, discussion can be engaged over specific approaches or therapies. Yet giving a platform to this broad dismissal of the Sameulis’ investment is no different than repeatedly quoting non-believers in climate change at the top of an article about a massive, exciting effort to correct human environmental degradation.</p> <p>And while the scale is different, both forms of science denial have blood on their hands. The residual, reactive, medical ideology of these anti-integrative careerists to which the LA Times and others give a platform is a barrier to potentially lifesaving directions toward which the Joint Commission-Mayo/NIH-American College of Physicians-NAM-Attorneys General jointly urge us - and the Samueli investment would propel us. </p></blockquote> <p>Fuck you, Mr. Weeks.</p> <p>Longtime readers know that I pretty much never drop the F-bomb on this blog other than when quoting others, such as <a href="http://respectfulinsolence.com/2014/04/14/jenny-mccarthy-thinks-in-shades-of-gray-or-so-she-thinks/">Jenny McCarthy's famous quote about the MMR and autism</a>. In this rare case, however, I think an exception to that rule is more than justified. When you accuse Steve Novella, Tim Caulfield, me, and those who make the same arguments as we do of having "blood on our hands," telling you to fuck off is the <em>only</em> appropriate reaction. We're doctors. Mr. Weeks is not. We save lives. Mr. Weeks does not. I'm a medical researcher. Mr. Weeks is not. I can deal with his unwarranted attacks on us as "antiscience." I can laugh at them, even. I know we have the data, the science, and reason on our side. Also, contrary to how we are portrayed, we do not dismiss massage, mindfulness, exercise, diet, or other lifestyle aspects of integrative medicine. We merely point out that they are more appropriately a part of science-based medicine and that integrative medicine is "rebranding" them as somehow being "alternative" or "integrative" and then throwing in quackery like acupuncture, reiki, naturopathy, and the like. The purpose, of course, is to legitimize quackery. That's why I say that there is no reason for integrative medicine to exist other than to provide a vessel through which quackery can be integrated into medicine.</p> <p>As for being an "anti-integrative medicine careerist," I view this as a thinly disguised variant of the "pharma shill" gambit, in which Mr. Weeks insinuates that we must be biased because we've made a career out of being "anti-integrative medicine." Would this sort of thing were even possible! Seriously, though, Mr. Weeks should look at my publication record. Only two of my publications indexed on PubMed can be characterized as even being about integrative medicine. However, Mr. Weeks' little tirade has med me think that maybe I should try much harder to publish more of this in the peer-reviewed scientific literature. The reason I haven't is because I'm <em>not</em> an "anti-integrative medicine careerist." Maybe I should become one, except that I'd call it being a pro-science careerist.</p> <p>To get an idea of where Mr. Weeks comes from, he repeats a number of anti-medicine tropes. For instance, he does his best to paint critics of integrative medicine as a discipline as not caring about prevention. That's an old chestnut, because integrative medicine proponents have tried very hard to rebrand any sort of interventions to prevent disease as their bailiwick. He also cites a BMJ paper concluding that medical errors result in 251,000 deaths per year and are the third largest cause of death in the US, clearly having selected that particular paper because it has one of the largest numbers of deaths estimated anywhere in the literature. (<em>Über</em>-quacks Mike Adams, Gary Null, and Joe Mercola would be proud.) <a href="http://respectfulinsolence.com/2016/05/16/do-medical-errors-really-kill-a-quarter-of-a-million-people-a-year-in-the-us/">As I pointed out when this study was published</a> in 2016, the methodology used to calculate this number was highly questionable, at best, and basically custom-designed to inflate the number of deaths due to medical error, particularly through misattribution of the cause; i.e., mischaracterization of complications that had nothing to do with medical error as being due to error.</p> <p>Mr. Weeks then defends the poor, put-upon Samuelis as being philanthropists of the highest order, listing their charitable donations over the last two decades. No one is denying that the Samuelis have made worthwhile charitable donations over the last 25 years. It is not those particular donations that I and people like Steve Novella and Tim Caulfield have a problem with. Rather, it is the Samuelis' repeated donations in the cause of furthering integrative medicine that we criticize. Remember, as has been pointed out in multiple articles, the Samuelis are true believers in The One Quackery To Rule Them All, homeopathy. Does Mr. Weeks think that homeopathy is science-based? I'm sorry, but you cannot credibly claim the mantle of science if you believe in homeopathy. Period. You just can't. You can try, but you will be called out, even laughed at—and deservedly so. Homeopathy is <a href="http://respectfulinsolence.com/2015/04/22/regulating-the-magic-that-is-homeopathy-poor-reporting-interferes/">quackery based on concepts of vitalism</a> and <a href="http://respectfulinsolence.com/2007/05/20/doctor-strange-and-the-only-way-to-make/">sympathetic magic</a>.</p> <p>Mr. Weeks concludes:</p> <blockquote><p> Reporters: stop giving a platform to anti-science. Do us all a favor and get serious, and scientific, about your reporting of an investment of the Samuelis at UC Irvine that - despite this apparently necessary stone throwing - may prove to be the most influential philanthropic investment in the substantial course correction that US academic medicine and medical industry need. </p></blockquote> <p>Actually, that's what I'm afraid of, that the Samueli investment will be the most influential philanthropic donation in medicine. I agree that reporters should stop giving a platform to antiscience. What that means is not at all what Mr. Weeks thinks it means. As much as he thinks otherwise, it is he who is promoting antiscience. Indeed, the reporting on the Samueli donation represents one of the times that the mainstream press that bothered to pay attention to this story actually got it mostly right about integrative medicine. Mr. Weeks doesn't like this, not one bit. That's why he's lashing out now.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Fri, 09/29/2017 - 01:00</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Fri, 29 Sep 2017 05:00:17 +0000 oracknows 22633 at https://scienceblogs.com Homeopathy at UC-Irvine: The administration can run but it can't hide from its history of embracing quackery https://scienceblogs.com/insolence/2017/09/26/homeopathy-at-uc-irvine-it-can-run-but-it-cant-hide <span>Homeopathy at UC-Irvine: The administration can run but it can&#039;t hide from its history of embracing quackery</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Last week, the University of California, Irvine (UCI) announced that Susan and Henry Samueli were donating $200 million for it to set up a <a href="http://respectfulinsolence.com/2017/09/19/quackademic-medicine-now-reigns-supreme-at-uc-irvine/">massive new integrative medicine initiative</a>. The plan would basically transform biomedical sciences and medical education at UCI—and not in a good way. Remember what "integrative medicine" is. What is being "integrated" into medicine is, of course, quackery. Oh, sure, integrative medicine also emphasizes lifestyle modification, such as diet and exercise, but that is part of "conventional medicine" already. There is no good scientific or medical rationale for a separate specialty devoted to just that. What integrative medicine does is that it rebrands perfectly science-based modalities, such as diet and exercise, as somehow "alternative" and then "integrates" quackery, like naturopathy, acupuncture, functional medicine, applied kinesiology, homeopathy, and basically any form of quackery you can think of. Without the quackery, there is no integrative medicine. Worse, the phenomenon has resulted in a most pernicious effect in medical academia, the infiltration of outright quackery into the research and education efforts there, a phenomenon I like to refer to as "quackademic medicine."</p> <!--more--><p>Of course, The Very Serious Academics In Very Serious White Coats who have come to believe in integrative medicine to the point of devoting their careers to it would vehemently disagree with my characterization. I'm referring to the sort of doctors who <a href="http://respectfulinsolence.com/2014/06/10/quackademic-medicine-infiltrates-a-major-cancer-conference/">present at conferences of learned academics</a> and write what they <a href="http://respectfulinsolence.com/2014/12/08/old-wine-in-a-new-skin-the-society-for-integrative-oncology-promotes-integrating-pseudoscience-into-oncology/">claim to be evidence-based care guidelines</a> for breast cancer patients. Perhaps the best thing to mention to rile up serious academic advocates of integrative medicine is homeopathy. Any mention of homeopathy is guaranteed provoke paroxysms of self-righteous denial. "Oh, no," they'll say, "homeopathy is pseudoscience! It's quackery. Integrative medicine is evidence-based, and we would never do anything that isn't evidence-based!" Sadly, as I've pointed out time and time again, <a href="http://respectfulinsolence.com/2011/01/28/you-cant-have-naturopathy-without-homeop/">you can't have naturopathy without homeopathy</a>, as homeopathy is an integral part of naturopathy. As long as you have naturopaths, you will have homeopathy. Oddly enough, many of these The Very Serious Academics In Very Serious White Coats are utterly oblivious to this simple fact, even ones who write <a href="http://respectfulinsolence.com/2014/12/08/old-wine-in-a-new-skin-the-society-for-integrative-oncology-promotes-integrating-pseudoscience-into-oncology/">Very Serious Clinical Guidelines with naturopaths</a> and welcome naturopaths into their Very Serious Medical Society.</p> <p>All of this brings me back to UCI, because yesterday there was <a href="http://www.latimes.com/business/hiltzik/la-fi-hiltzik-uci-samieli-homeopathy-20170925-story.html">a story by Michael Hiltzik</a> for the LA Times about this very phenomenon. Well, not exactly. Rather, it's about the relationship between UCI and homeopathy and how UCI seems rather—shall we say?—touchy about the subject:</p> <blockquote><p> As of late last week, visitors to the website of UC Irvine Health, that institution’s clinical arm, could learn that among its services to patients was “homeopathy.”</p> <p>That was a problem, because homeopathy is a discredited and thoroughly debunked “alternative medicine.” Even Howard Federoff, UCI’s vice chancellor for health affairs, agreed that the scientific basis for homeopathy was “lacking.” The issue is important because the donors of <a href="https://news.uci.edu/2017/09/18/uci-receives-200-million-gift-to-name-college-of-health-sciences-and-launch-major-integrative-health-initiative/">a $200-million gift</a> to UCI’s medical schools, the billionaire couple Susan and Henry Samueli, are sworn believers in homeopathy and supporters of a raft of other “integrative” health treatments. <a href="http://www.latimes.com/business/hiltzik/la-fi-hiltzik-uci-samueli-20170922-story.html">As I reported</a>, some medical authorities have raised questions about whether the Samuelis’ beliefs and their rare generosity will undermine UCI’s explicit commitment to science-based medicine.</p> <p>So it’s interesting that after I raised questions about the treatment’s listing on the website, it mysteriously disappeared. As of this writing, a UCI spokesman hasn’t gotten back to me with word on when it was removed, or whether its removal means that homeopathy no longer will be offered to patients, or merely that UCI is keeping it quiet. The listing was present as recently as last Wednesday, when I asked Federoff about it in connection with my column about the Samueli gift, which appeared online Friday; its presence can be seen on an archived version of the website dated Sept. 19. </p></blockquote> <p>Ah, yes. The light of national attention due to the Samuelis' enormous donation to promote pseudoscience must have rattled UCI. After all, even the most avid proponents of integrative medicine are profoundly uncomfortable with homeopathy, even Dr. David Katz, whose "<a href="http://respectfulinsolence.com/2015/04/13/the-return-of-the-revenge-of-a-more-fluid-concept-of-evidence/">more fluid concept of evidence</a>" led him to try homeopathy in a patient. That's because homeopathy is quackery. Indeed, there's a reason I routinely refer to homeopathy as The One Quackery To Rule Them All. To recap, homeopathy is based on two laws. One states that to treat a symptom you use something that causes that symptom. The other states that a homeopathic remedy becomes stronger with dilution. Neither are based in evidence. Indeed, many homeopathic remedies are 30C or greater in dilution, where C is a 100-fold dilution. Thus 30C means diluting the solution 100-fold thirty times, which results in a dilution of 10<sup>-60</sup>. Given that Avogadro's number is on the order of 6 x 10<sup>23</sup>, a 30C dilution is more than 10<sup>36</sup>-fold greater, which means that it's incredibly unlikely that a single molecule of original remedy remains. Most homeopathic remedies are just water or ethanol diluent. Even the most die-hard advocate of quackademic and integrative medicine has to admit that, which is why even they are so uncomfortable when homeopathy is brought up and so loudly and self-righteously deny that integrative medicine would ever have anything to do with homeopathy.</p> <p>Amusingly, Hiltzik noted a web page that looked very, very familiar to me, that of <a href="http://www.sscim.uci.edu/dayna-kowata.asp">Dayna Kowata, ND, LAc</a>. Yes, she's a naturopath and acupuncturist. She also expresses an interest in homeopathy. What's so familiar about Not-a-Dr. Kowata? Well, I used her UCI webpage in talks about quackademic medicine several years ago, and I've even <a href="http://respectfulinsolence.com/2015/07/06/the-triumph-of-new-age-medicine-part-deux-courtesy-of-the-atlantic/">mentioned her</a> on two different occasions on this very blog, albeit <a href="http://respectfulinsolence.com/2014/03/27/quackademic-medicine-at-an-nci-ccc/">not by name</a>. At the time, I didn't know that Susan Samueli is strong believer in homeopathy, but I do now. I wonder what Ms. Samueli will think if Dr. Federoff actually does eliminate homeopathy from UCI. I rather suspect that she won't be happy.</p> <p>I particularly wonder this based on the <a href="http://files.onset.freedom.com/ocregister/ocwatchdog/uci_samueli_PRA2800-01-009.pdf">original gift agreements between the Samuelis and UCI</a> when the Samuelis first founded the Susan Samueli Center for Integrative Medicine (SSCIM) at UCI. The original gift was $20 million in 1999. Now here's where it gets interesting. In 2003, the board of directors of the Samueli Center was formally founded in the UCI College of Medicine. You can read the whole thing if you like, but this is the key paragraph:</p> <blockquote><p> The proposed Center will build on the considerable knowledge and experience of its faculty to study the efficacy of various therapeutic modalities considered to be part of complementary and alternative medicine, including herbs and homeopathic medicine, as they relate to areas such as cardiovascular, autoimmune and neuromuscular diseases, cancer treatment and prevention; and menopaus and ageing. In addition, the proposed center will foster UCI's emergence as a leader in the area of acupuncture by supporting basic and clinical research into the mechanism of action and the efficacy of acupunctxure as a modality. The proposed Center will encourage and foster multidisciplinary studies that involve appropriate faculty from across the campus as well as from other institutions. </p></blockquote> <p>That's right. Homeopathy was baked into the Samueli Center from near the very beginning. I can't help but wonder what would be found in the formal gift agreement for the Samuelis' $200 million donation. Perhaps a Freedom of Information Act request would shed some illumination on this question. On the other hand, I note that homeopathy was only mentioned in one of the gift agreements. Perhaps then, as now, UCI and the Samuelis learned that homeopathy brought too much embarrassment to the university—and rightly so—and that's why homeopathy hasn't been mentioned in any of the Samuelis' gift agreements since 2003. Alternatively, most of the gift agreements after that had to do with setting up fellowships and endowed chairs and gave UCI administration the latitude to use the gifts for whatever purposes it judged most consistent with the wishes of the donors.</p> <p>Contrary to what Dr. Federoff claims, quackery is deeply embedded at UCI. It's the <em>raison d'être</em> for the SSCIM. He might be in denial about it, but it's true. That's why I was amused to read Hiltzik's observation:</p> <blockquote><p> The on-again-off-again appearance of homeopathy on UCI’s website and among its clinical offerings underscores the difficulties the university may face in navigating the inconsistencies between the world view of its biggest donors and its explicit commitment to rigorous scientific standards in its medical teaching, research, and clinical treatment. The Samuelis, after all, will have their names on UCI’s main on-campus medical building, and their gift will endow up to 15 faculty members, all of whom will have to demonstrate some “expertise in integrative health.”</p> <p>We reported over the weekend that “integrative health” is interpreted by many in the medical profession as code for introducing unproven and debunked nostrums into a curriculum that should be based exclusively on scientific evidence. Although Federoff says science will govern at UCI, that hasn’t necessarily been the case at the Susan Samieli Center, which was established in 2001 with a $5.7-million donation from the couple and will be converted into the Susan Samueli Integrative Health Institute and absorbed into the university’s entire medical complex under the terms of the gift. </p></blockquote> <p>I can't help but note that Dr. Federoff <a href="https://news.uci.edu/2015/03/11/dr-howard-federoff-named-uci-vice-chancellor-for-health-affairs-and-dean-of-medicine/">came to UCI from Georgetown University</a>. Why is that significant? Georgetown was one of the "pioneers" (if you will) in quackademic medicine. Basically, Georgetown was the first to "integrate" quackery into all phases of medical education beginning in the first year of medical school, with acupuncturists giving lectures in gross anatomy class. <a href="http://respectfulinsolence.com/2006/11/20/not-so-stealthily-sneaking-cam-into-the-1/">I kid you not</a>. By the time Dr. Federoff left Georgetown in 2015, <a href="http://respectfulinsolence.com/2015/07/31/a-portrait-of-quackademia-triumphant-georgetown-university/">quackademia reigned supreme at Georgetown</a>, even to the point where Georgetown credulously teaches homeopathy to its medical students. Dr. Federoff was there when it began and took hold. You'll pardon me if I call bullshit on his claims that the SSCIM will be rigorously based in science. It won't. That's not what the donors want, and that's not what the culture at UCI will support. Thanks to the Samuelis and the credulous culture they have built at UCI and fueled by the enormous $200 million gift given by the Samuelis, quackademic medicine will reign more supreme than ever at UCI and serve as an example for the metastasis of the cancer that is integrative medicine.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Tue, 09/26/2017 - 00:01</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Tue, 26 Sep 2017 04:01:40 +0000 oracknows 22630 at https://scienceblogs.com Quackademic medicine now reigns supreme at UC-Irvine https://scienceblogs.com/insolence/2017/09/19/quackademic-medicine-now-reigns-supreme-at-uc-irvine <span>Quackademic medicine now reigns supreme at UC-Irvine</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>It's not infrequently that, whenever I complain about the increasing infiltration of quackery and pseudoscience into medicine, I sometimes lament that skeptics and supporters of science-based medicine are massively outgunned, because we are. Thus, we have the continued growth of what I like to refer to as "quackademic medicine," the infiltration of pseudoscience into medical academia in the form of whole divisions, departments, and institutes dedicated to studying fairy dust like acupuncture, naturopathy, and other "unconventional" treatments that are then "integrated" into medicine. It's not for nothing that I refer to "integrative medicine" as integrating quackery with medicine.</p> <p>Unfortunately, I was reminded yesterday of what an uphill battle it is to counter the increasing pseudoscience in medicine when I learned that wealthy donors Susan and Henry Samueli just donated a whole bunch of money to the University of California, Irvine (UCI) to establish an <a href="https://news.uci.edu/2017/09/18/uci-receives-200-million-gift-to-name-college-of-health-sciences-and-launch-major-integrative-health-initiative/">institute dedicated to pseudoscience</a>:</p> <blockquote><p> The University of California, Irvine today announced the largest gift in its history: $200 million from Susan and Henry Samueli, longtime campus supporters, to name a first-of-its-kind College of Health Sciences focused on interdisciplinary integrative health. The far-reaching donation – the seventh-largest to a single public university – positions UCI as a bold, new leader in population health, patient care, education and research.</p> <p>“This gift catalyzes UCI’s belief that human health and well-being requires a science-based approach that engages all disciplines in caring for the whole person and total community,” said Chancellor Howard Gillman. “Susan and Henry Samueli’s dedication, their vision for what is possible and their deep generosity will help UCI set a standard that, over time, other medical centers in the U.S. can follow.” </p></blockquote> <p>Thanks to the Samuelis, unfortunately UCI has long been a prominent force in the brave new world of integrative medicine. Now, it appears to be taking this "integration" a step further, by "integrating" the pseudoscience across not just the new institute. Behold:</p> <blockquote><p> The Susan and Henry Samueli College of Health Sciences will be the first university-based health sciences enterprise to incorporate integrative health research, teaching and patient care across its schools and programs.</p> <p>Integrative health redefines the relationship between the practitioner and patient by focusing on the whole person and the whole community. It is informed by scientific evidence and makes use of all appropriate preventatives, therapeutic and lifestyle approaches, and healthcare professionals and disciplines to promote optimal health and wellness.</p> <p>The existing Susan Samueli Center for Integrative Medicine will become the Susan Samueli Integrative Health Institute and will focus on improving medical care by supporting multidisciplinary research, education, clinical service and community programs. Faculty and students in computer science, engineering, social sciences, business and other areas will collaborate within the institute to study the future of human health. </p></blockquote> <p>Of course, the whole paragraph about integrative health "redefining" the relationship between the practitioner and patient by focusing on the "whole person" is the usual blather that quacks everywhere. As I've said so many times before, it is not necessary to "integrate" pseudoscience into medicine in order to take care of the "whole patient." A good science-based primary care doctor takes care of the "whole patient," with no need to resort to appealing to magic like acupuncture, reiki, reflexology, homeopathy, and the like. And if you don't think this is about all of the forms of quackery I just mentioned, take a look at <a href="http://www.latimes.com/local/lanow/la-me-uc-irvine-donation-20170918-story.html">how the Samuelis became interested in "integrative" medicine</a>:</p> <blockquote><p>Susan Samueli caught a cold while visiting France more than three decades ago. Instead of the usual medicines, a friend suggested aconite, a homeopathic remedy derived from a plant in the buttercup family.</p> <p>She was cured — and became a lifelong advocate of homeopathy and other alternative healing methods to complement conventional medicine. Her husband, Henry — the billionaire co-founder of Broadcom, the Irvine semiconductor maker — says he was initially skeptical but found the integrative health approach helped him easily shake off colds and flus and kept their children healthy without antibiotics.</p> <p>Now the couple’s passion for integrative health has led to the largest donation ever made to UC Irvine.</p></blockquote> <p>As an origin myth, This is just downright silly. Colds are self-limited, and the homeopathic remedy Mrs. Samueli took almost certainly had no effect on the course of her cold. She just got better, as the vast majority of otherwise healthy adults with colds do. As for Mr. Samueli's apparent belief that homeopathy and other "integrative" approaches helped him shake off colds and flus, the same thing is going on. Colds are self-limited. So is the flu for most people, although what most people call the "flu" isn't really the flu but much milder "flu-like illnesses" caused by other viruses. (The real flu can easily knock you on your posterior for a week or even more.) Basically, this story is a load of confirmation bias and good old-fashioned regression to the mean being confused with therapeutic effect. Yet, that's all it takes for otherwise intelligent people to become believers. Humans are pattern-forming animals. If we take something and then get better we'll say that what we took caused us to get better, whether it really did or not.</p> <p>Of course, supporters of "integrative medicine" will no doubt become indignant at my description of their favored new medical specialty. They will point to how diet and exercise are an important part of integrative medicine, how integrative practitioners emphasize prevention and healthy lifestyle. The problem, of course, is that diet, exercise, healthy lifestyles, and prevention are all part of conventional medicine. There is no need for a separate specialty for them, any more than there is a need for a separate specialty in order to take care of the "whole patient." The reason "integrative medicine" exists is not to promote science-based prevention, lifestyle, and exercise interventions, but rather to provide a vessel into which quackery can be poured and mixed with the science-based care until it becomes difficult to tell which is which. That's the idea, whether physicians who have become integrative medicine practitioners will admit it to themselves (or others) or not.</p> <p>So here's how this next stage of "integration" will go. The Susan and Henry Samueli College of Health Science will eventually include the existing Samueli Center plus the following schools at UCI:</p> <ul><li>School of Medicine</li> <li>Sue &amp; Bill Gross School of Nursing</li> <li>School of Pharmacy (currently the Department of Pharmaceutical Sciences)</li> <li>School of Population Health (currently the Program in Public Health)</li> </ul><p>And here's where the money will go:</p> <blockquote><p> The Samuelis’ gift will provide $50 million toward construction of a facility to house the college and $5 million for state-of-the-art technology and labs – forming the foundation of a national showcase for integrative health. It also earmarks $145 million to create an endowment for:</p> <ul><li>Up to 15 faculty chairs across the medicine, nursing, pharmacy and population health disciplines for senior, midcareer and junior faculty with expertise in integrative health</li> <li>Integrative health training and mentoring for interested medical school students</li> <li>Scholarships and fellowships for undergraduate and graduate students planning careers in related fields</li> <li>Innovative curricular development and campuswide interdisciplinary research projects</li> <li>Ongoing clinical services, research and education in the Susan Samueli Integrative Health Institute, including investigations of nonconventional interventions as part of medical treatment and educating medical and lay communities about benefits and risks associated with new healthcare approaches</li> </ul></blockquote> <p>That last bullet point is critical. The whole point of "integrative medicine" is to integrate "nonconventional interventions as part of medical treatment." That means quackery. There is no other reason for integrative medicine. Just think about the evolution of the naming of integrative medicine. First, it was known as alternative medicine. But "alternative" implied that the "nonconventional interventions" weren't medicine (or weren't good medicine, which they weren't). So the name evolved to "complementary and alternative medicine," or CAM. However, that wasn't good enough either, because the name mean that the quackery was "complementary" to real medicine. It wasn't real medicine itself (or at least it wasn't as effective or important as real medicine). It was just "icing on the cake." So a new name was coined, "integrative medicine," in which all the quackery was (and still is) portrayed as co-equal with conventional medicine and "integrative medicine" as "the best of both worlds."</p> <p>And here we are. A wealthy couple has donated $200 million to a public university to promote their vision of pseudoscience, and the university has eagerly accepted, even though it will utterly reshape its medical school and all its biomedical sciences for decades to come.</p> <p>I find it helpful to look at what UCI's Samueli Center already offers. I first took note of the school just shy of 10 years ago, when I added the Susan Samueli Center for Integrative Medicine as part of an <a href="http://respectfulinsolence.com/2007/11/14/i-fought-the-woo-and-the-woo-won-or-its/">early version</a> of my <a href="http://respectfulinsolence.com/2007/11/18/the-woo-aggregator/">Academic Woo Aggregator</a>.Really long time readers of this blog know that for a time I maintained a list of medical schools that had embraced quackademic medicine. I only maintained the list for a relatively brief period of time, not because I didn't think it was a worthwhile endeavor, but rather because there were just too many schools for me to keep track of alone. Quackademic medicine has become the norm, not an outlier. It's schools like mine, where I'm faculty, that have little or no quackademic medicine that are the outliers.</p> <p>So what does Samueli Center offer? It's basically the <a href="http://www.ucirvinehealth.org/medical-services/susan-samueli-center-integrative-medicine">same slate of "integrative medicine"</a> that most quackademic "integrative medicine" centers offer:</p> <ul><li>Acupuncture &amp; traditional Chinese medicine</li> <li>Ayurvedic therapies</li> <li>Functional medicine</li> <li>Massage therapy </li> <li>Meditation</li> <li>Mindfulness </li> <li>Nutritional counseling</li> <li>Physical medicine &amp; rehabilitation</li> <li>Preventive cardiology</li> <li>Sports medicine &amp; osteopathic manipulation</li> <li>Tai chi</li> <li>Vitamin infusion therapy</li> <li>Women's health</li> <li>Yoga</li> </ul><p>Of course, traditional Chinese medicine and Ayurvedic medicine are prescientific systems of medicine based on mysticism and vitalism. <a href="http://respectfulinsolence.com/2017/03/01/disruptive-functional-medicine-at-the-cleveland-clinic-disrupting-medicine-by-mixing-quackery-with-it/">Functional medicine</a> is a bit of "make it up as you go along" quackery that combines the worst of conventional medicine on steroids (e.g., <a href="http://respectfulinsolence.com/2016/12/05/what-functional-medicine-really-is/">massive overtesting</a>) with quackery. Vitamin infusion therapy, of course, is also not scientifically supported. As for the rest, Tai Chi and yoga are nothing more than exercise. Massage therapy makes people feel better, but specific therapeutic claims are to be treated with skepticism.</p> <p>If you want to get an idea of the level of pseudoscience going on here, it's useful to look at what UCI says about various modalities. For instance, "functional medicine" turns out to be <a href="http://www.ucirvinehealth.org/medical-services/susan-samueli-center-integrative-medicine/functional-medicine">all about naturopathy</a> as well:</p> <blockquote><p> Functional medicine, which is based on naturopathic principles, takes a more comprehensive approach. At the Susan Samueli Center for Integrative Medicine, our highly trained naturopaths:</p> <ul><li>Identify and treat the root causes of illness</li> <li>Harness the healing power of nature</li> <li>Treat the whole person</li> <li>Emphasize disease prevention</li> <li>Encourage self-responsibility for health</li> <li>Explore alternatives to drugs and surgery</li> </ul></blockquote> <p>And, based on functional medicine, UCI might offer:</p> <blockquote><p> Based on your individual needs, we develop a treatment plan which may include:</p> <ul><li>Detoxification</li> <li>Dietary and lifestyle changes</li> <li>Exercise therapy</li> <li>Herbs and dietary supplements</li> <li>Homeopathy</li> <li>Manipulative therapies</li> <li>Psychotherapy and counseling</li> <li>Stress reduction</li> </ul></blockquote> <p>There you go. "Detoxification" is virtually always the purest of quackery. Then, of course, there's homeopathy, or, as I like to call it, The One Quackery To Rule Them All. If you don't know why that's the case, I refer you to any of a number of my previous posts, like <a href="http://respectfulinsolence.com/2012/09/18/a-misguided-defense-of-the-one-quackery-to-rule-them-all/">this one</a>.</p> <p>Of course, one aspect of "integrative medicine" is bias. Basically, its adherents don't ask whether it will help patients and result in better outcomes. Rather, they confidently predict that they will be <a href="https://news.uci.edu/2017/09/18/uci-receives-200-million-gift-to-name-college-of-health-sciences-and-launch-major-integrative-health-initiative/">vindicated in their beliefs</a>:</p> <blockquote><p> “As a preventive cardiologist and researcher, I cannot stress enough the critical need for society to adopt a truly integrative approach to health, whether we are talking about community health, nutrition, prevention or appropriate medications. It must start with those who provide care and guidance,” said Dr. Shaista Malik, director of the Susan Samueli Center for Integrative Medicine and the endowed chair of integrative medicine. “Through this exciting new college, we will demonstrate to everyone involved in the health system – from patients to providers to policymakers – the value of an integrative approach.” </p></blockquote> <p>And:</p> <blockquote><p> Fundamental change in thinking about healthcare and how it’s delivered will take time, a steady stream of new evidence and strong academic leadership. The Samuelis’ transformational gift is the first step toward creating an expanded health sciences campus, integrating the affiliated schools and programs of the college as well as new teaching, research and clinical spaces.</p> <p>“Susan and I have supported healthcare research for nearly 20 years, and over that time, we have seen a significant expansion of the scientific evidence demonstrating the value and efficacy of integrative health. This evidence base is critical as UCI – a young, innovative institution – takes this big and influential step,” said Henry Samueli, Ph.D., an engineer and co-founder of Broadcom Corporation. “We are very excited for the UCI College of Health Sciences to become a national model for integrative health. We believe this model will eventually become the standard approach for promoting health and well-being in our society.” </p></blockquote> <p>That's right. Adherents of "integrative" medicine "believe" that it will eventually become standard of care. What evidence do they base this belief on? Certainly not on evidence. I do note that advocates of integrative medicine are quite honest about their goals, as you can see from this article in the the <a href="http://www.latimes.com/local/lanow/la-me-uc-irvine-donation-20170918-story.html">LA Times</a>:</p> <blockquote><p> The Samuelis said they hope their financial support for research will help build evidence for alternative therapies that would convince insurers to pay for them, thus letting more people benefit. Acupuncture, for instance, has been widely documented to ease migraines, according to Howard Federoff, a specialist in neurodegenerative disorders and UC Irvine’s vice chancellor for health affairs. But not all health plans cover the treatment. </p></blockquote> <p>No, acupuncture is nothing more than a <a href="http://www.dcscience.net/2013/05/30/acupuncture-is-a-theatrical-placebo-the-end-of-a-myth/">theatrical placebo</a>.</p> <p>When I say that skeptics and supporters of science-based medicine are at a profound disadvantage, this development at UCI is exactly what I'm talking about. What we have is a ragtag band of physicians and skeptics alarmed at the infiltration of pseudoscience into medicine versus very wealthy believers like the Samuelis willing to donate far more money than we can imagine. Sure, we have science on our side, but will it matter?</p> <p>We have to make it matter.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Tue, 09/19/2017 - 00:55</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Tue, 19 Sep 2017 04:55:38 +0000 oracknows 22626 at https://scienceblogs.com Shame! Another front in the libertarian war on the FDA: Rational Vaccines' unethical offshore herpes vaccine clinical trial https://scienceblogs.com/insolence/2017/08/29/another-front-in-the-libertarian-war-on-the-fda-rational-vaccines-unethical-offshore-herpes-vaccine-clinical-trial <span>Shame! Another front in the libertarian war on the FDA: Rational Vaccines&#039; unethical offshore herpes vaccine clinical trial</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>I've caught a fair amount of flak over my opposition to so-called "right-to-try" laws. Right-to-try laws have proliferated throughout the US like so much kudzu over the last three and a half years, to the point where 37 states now have some version of these profoundly anti-patient laws on the books. At the federal level, three weeks ago the Senate passed a federal version of right-to-try, with the House scheduled to take up the bill when Congress returns from recess next week. Granted, it's watered down and therefore less horrible than the <a href="http://scienceblogs.com/insolence/2017/04/24/congress-is-back-in-session-and-sneaking-the-cruel-sham-that-is-right-to-try-in-a-must-pass-bill-is-on-the-agenda/">original version</a>, which Senator Ron Johnson (R-WI_ has been <a href="http://scienceblogs.com/insolence/2016/09/30/a-victory-and-a-more-substantial-defeat-for-the-cruel-sham-known-as-right-to-try/">trying to pass</a> for <a href="http://scienceblogs.com/insolence/2016/09/06/right-to-try-goes-federal-thus-far-unsuccessfully/">two years</a>, but it's <a href="http://scienceblogs.com/insolence/2017/08/04/the-cruel-sham-that-is-right-to-try-is-that-much-closer-to-being-law/">still plenty bad</a>. In this post and a post later this week, I'm going to show you more circumstantial evidence that I was right all along. The first example you've almost certainly heard of, namely the offshore testing of a new herpes vaccine funded in part by <em>über</em>-Libertarian Peter Thiel. The second you probably haven't heard of, and I'll save it for later, given how long this post is.</p> <!--more--><p>But first, you need to understand what I mean about right-to-try. Basically, right-to-try laws rest on the false premise that the FDA is so slow and so bureaucratic that cures are being kept from terminally ill patients, or at least drugs that might hugely extend their life expectancies. The situation is presented as so dire that "right-to-try" is necessary, which basically allows terminally ill patients to bypass the FDA and receive experimental therapeutics from companies developing them without having to go through the FDA's Expanded Access program (which basically does the same thing, providing access to experimental therapeutics before they are FDA-approved). It's an idea promoted by a Libertarian think tank, the Goldwater Institute, and the branding has been very successful, to the point where, politically, opposing right-to-try is viewed as the equivalent of taking the terminally ill's last chance away from them, wanting them to die horribly, all while pissing on an apple pie and burning an American flag. (I exaggerate, but not by much.) The Goldwater Institute and right-to-try advocates achieved this effect by cynically parading families of patients with terminal illnesses who were convinced that right-to-try would give their loved ones a shot at life in front of legislators, making it very difficult for them to vote no. Meanwhile, industry and medical groups that might have been able to persuade lawmakers that right-to-try is a terrible idea that is bad for patients, despite the optics created by the Goldwater Institute were cowed and remained silent until very late. For example, the American Society of Clinical Oncology (ASCO), an society to which I belong, spent the last three and a half years saying basically nothing. It was only four months ago that ASCO finally issued a <a href="http://www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/2017-Access-to-Investigational-Drugs-Position-Statement.pdf">statement opposing right-to-try</a>, when it was <a href="http://scienceblogs.com/insolence/2017/08/04/the-cruel-sham-that-is-right-to-try-is-that-much-closer-to-being-law/">basically far, far too late</a>.</p> <p>I've also caught flak for characterizing right-to-try as being part of a broader war against the FDA (indeed, as part of a broader war against regulation in general) by libertarian-leaning free market fundamentalists, some of whom claim (literally) that the FDA is <a href="http://scienceblogs.com/insolence/2014/10/28/ebola-right-to-try-laws-and-placebo-legislation/">killing people</a>. Lots of people. <em>How can you say that?</em> proponents of right-to-try would ask, drawing themselves up in their best self righteous fury. <em>This is about helping terminally ill patients!</em> Maybe. But, as I've said before, the FDA already has a Compassionate Use program that <a href="https://med.nyu.edu/pophealth/sites/default/files/pophealth/Proposalsforimprovingexpandedaccess.pdf">achieves the same purpose</a> and rarely turns requests down, a program that's been improved over the last couple of years to be speedier and more responsive, with much less application time. Consistent with its libertarian origins, right-to-try tries to cut the FDA out of decisions between a drug seller and patients, but at the cost of eliminating many protections for patients. For instance, unlike the case in "expanded access" or "compassionate use," the institutional review board (IRB), an ethics panel that oversees clinical trials does not oversee patients in right-to-try. There is no financial help; so only patients whose families are rich or can raise a lot of money fast are likely to be able to benefit. Even worse, as I've described, most right-to-try bills not only do not require insurance companies cover experimental therapeutics (and why should they?), but allow insurance companies not to cover charges for complications from using experimental therapeutics. However, perhaps the most egregiously false argument made by right-to-try advocates is that the laws' allow use of experimental therapeutics after they've been "proven safe" through phase I testing. Yes, you read that right. As I’ve discussed multiple times, there is the requirement that the drug or device has only passed phase 1 trials, which, given how few drugs that have passed phase 1 actually make it through to approval, is a really low bar, especially since most phase 1 trials involve fewer than around 25 patients.</p> <p>Although not commonly seen as such, right-to-try laws are of a piece with libertarian and radical fundamentalist free market views, some of which claim that the FDA is basically unnecessary or that its role should be vastly constrained. You can see it all there: Minimal requirements for safety testing (phase I), no ethical oversight, the decision entirely up to the company and patient, and, of course, the patient is totally on his or her own. People with such views were even in consideration for the post of FDA Commissioner, for example, two cronies of the aforementioned Peter Thiel, both of whom believe that the FDA stifles their holy grail of "innovation." The first was <a href="http://scienceblogs.com/insolence/2016/12/09/fixing-the-fda-by-appointing-a-commissioner-who-doesnt-believe-in-the-fdas-mission/">Jim O'Neill</a>, who has advocated that the FDA test new drugs only for safety, not efficacy, thus returning the FDA to its pre-1962, pre-thalidomide role. The second was <a href="http://scienceblogs.com/insolence/2017/01/16/next-up-on-the-trump-fda-crazy-train-a-man-who-thinks-that-a-yelp-like-system-will-do-better-than-the-fda-at-maintaining-drug-safety/">Balaji Srinivasan</a>, a Silicon Valley entrepreneur who advocated basically doing away with the current system of FDA regulation and replacing it with online reviews, basically a Yelp or Über for drugs and medical devices. When asked "How do you prevent quacks?" Srinivasan replied, "Scaled Internet reputation systems. Works at massive scale in other areas." So clueless were both of these men that it was a relief when a relatively normal Republican pharma shill named <a href="http://scienceblogs.com/insolence/2017/07/06/president-trump-appears-poised-to-betray-the-antivaccine-movement-again-suckers/">Scott Gottlieb</a> was ultimately appointed. He was the "least bad," most conventional choice, someone any conservative Republican administration might have appointed. Yes, he wants to "streamline" the process by which, for example, vaccines are approved, but he's actually pretty conventional. He's even decided to <a href="http://www.npr.org/sections/health-shots/2017/08/28/546719842/fda-cracks-down-on-stem-cell-clinics-selling-unapproved-treatments">http://www.npr.org/sections/health-shots/2017/08/28/546719842/fda-crack…</a>.</p> <p>Stymied at the FDA, apparently Peter Thiel is now <a href="https://www.statnews.com/2017/08/28/herpes-vaccine-trials-thiel/">waging his war on the FDA by other means</a>:</p> <blockquote><p> Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine.</p> <p>The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.</p> <p>Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.</p> <p>“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.” </p></blockquote> <p>Indeed it is. What Peter Thiel and Rational Vaccines, a company founded by Agustín Fernández III and William Halford (formerly of Southern Illinois University who died recently of cancer) did and are doing is patently unethical—shockingly, horrifyingly so. The very function of the IRB is to protect human subjects in clinical trials. Usually, when a clinical trial is proposed, it goes through two committees, first the scientific review board, or SRB, which determines whether the trial is scientifically justified and soundly designed. The second is the IRB, which is charged with protecting the human subjects. Its function is to examine the clinical trial design and to determine whether it is ethical and whether the risks to human subjects do not outweigh the potential benefits; e.g., that there is <a href="http://scienceblogs.com/insolence/2010/09/20/balancing-scientific-rigor-versus-patien/">clinical equipoise</a>. Once it approves the trial, the IRB continues to monitor the trial, examining reports of adverse events, both serious and minor, and sometimes demanding changes in the trial or even canceling it if it judges that there are too many adverse events or that one group is doing so much better than the other group that it would be unethical to continue the trial. These protections for human subjects flow from the <a href="https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html">Belmont Report</a> and the <a href="https://ori.hhs.gov/education/products/ucla/chapter2/page04b.htm">Common Rule</a>, both of which were designed to prevent the abuse of human research subjects like what the Nazis did and underlie all the federal regulation regarding human research protection. Unfortunately, these protections are not universal, as they only apply to organizations with federal funding (such as universities) or entities applying for FDA approval for one of its investigational drugs or devices.</p> <p>Like right-to-try, Peter Thiel's and Rational Vaccines' offshore clinical trial of a new herpes vaccine is an attack on the FDA. Libertarians and free market fundamentalists <a href="https://www.statnews.com/2017/08/28/herpes-vaccine-trials-thiel/">even admit as much</a>:</p> <blockquote><p> The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.</p> <p>“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.” </p></blockquote> <p>These are exactly the sort of arguments made by right-to-try advocates. Indeed, as I've often pointed out, state-level right-to-try laws are completely toothless because federal law supersedes state law and the FDA regulates drug approval. The real reason for their existence is to put pressure on the FDA and to pressure federal legislators to pass a federal law. Sadly, it appears to have worked, as I doubt that the House will block the right-to-try bill passed by the Senate earlier this month. It will very likely become law next month.</p> <p>There's also the same sort of snake oil being used to push this approach to Rational Vaccines' approach, which before this trial had <a href="https://arstechnica.com/science/2017/08/bucking-fda-peter-thiel-funds-patently-unethical-herpes-vaccine-trial/">resulted in a previous small preliminary trial</a>:</p> <blockquote><p> For the initial trial, Halford and Rational Vaccines co-founder Fernández were unable to get federal funding or IRB approval, which oversees human safety. After testing out the vaccine on themselves for safety, they moved the trial to the Caribbean island. They flew 17 patients with pre-existing genital herpes cases there to get three shots of the vaccine. Halford reported that they experienced on average a three-fold reduction in days with symptoms on followup at four to six months after vaccination. Overall, the pair claimed that the trial and self-tests proved the safety and promise of the vaccine.</p> <p>But when Halford attempted to publish the results, scientific reviewers were <a href="https://liveherpesvaccine.files.wordpress.com/2016/12/peer-review-of-halford-manuscript-dec-2016.pdf">ruthlessly critical</a> of the data and lack of safety precautions. One reviewer concluded: “This manuscript is partly a vision, partly science, and partly wishful thinking.” </p></blockquote> <p>I read the <a href="https://liveherpesvaccine.files.wordpress.com/2016/12/peer-review-of-halford-manuscript-dec-2016.pdf">reviews of the manuscript</a>, and I've rarely seen such critical comments from reviewers, ever. Interestingly, the authors apparently tried to slip their clinical trial data into a Perspectives article, rather than as a scientific or clinical report, and they inserted all sorts of extraneous rants and proselytizing into the manuscript, such that Reviewer 2 proclaimed it "part autobiography, part criticism of the herpes vaccine field, part description of autoinoculation studies with the author’s herpes vaccine candidate vaccine, part advertisement for the author’s vaccine company, and part description of preliminary results of a phase I trial." One reviewer explicitly wondered if this was "an end run around the FDA."</p> <p>Why, yes. Yes it was and is. Very obviously so. So is the current trial. Even so, it's hard to see how this works. Both Both Office for Human Research Protections (OHRP) and FDA regulations explicitly require that clinical trials used in support for an application to approve an investigational new drug (IND) be approved and monitored by an IRB. Even Dr. Gottleib can't change that without changing the regulations (a long and onerous process), and I doubt that even he would want to try, his prior advocacy of "streamlining" the drug approval process notwithstanding. Thus, like state-level right-to-try laws, this stunt by Thiel and Fernández is designed to put pressure on the FDA and lawmakers.</p> <p>If you don't believe me, <a href="https://www.statnews.com/2017/08/28/herpes-vaccine-trials-thiel/">listen to Fernández</a>, a former Hollywood filmmaker, himself:</p> <blockquote><p> Even so, Fernández, a former Hollywood filmmaker, said he and his investors plan to submit the trial data to the FDA in hopes of getting the vaccine approved for treatment. If the FDA does not respond favorably, he said, the company will continue its trials in Mexico and Australia. Fernández said he hopes to set up an IRB for these next trials. No matter what, he plans to manufacture the vaccine offshore. However, without U.S. approval, the challenges to market such a vaccine in the United States remain significant. </p></blockquote> <p>Manufacture and sell the vaccine offshore no matter what the FDA says? This is what quacks do.</p> <p>Perhaps the worst thing about this is the involvement of the Southern Illinois University. Not only does SIU make excuses, it basically tries to wash its hands of the whole thing, even after having published a <a href="https://www.siumed.edu/pr/highlights/game-changer-herpes-vaccine-shows-promise.html">glowing press release about the research</a>, promoting it despite how utterly unethical the research was. Now, here's what SIU says:</p> <blockquote><p> Nonetheless, Southern Illinois University officials said they had no legal responsibility to ensure safety measures were in place because the university has an arms-length relationship with Rational Vaccines. Fernández said the company licensed two patents related to the vaccine from the university.</p> <p>“SIU School of Medicine did not have any involvement in Rational Vaccines’ clinical trial,” said Karen Carlson, the university’s spokeswoman. “But we are confident that as the chief scientific officer of Rational Vaccines, Dr. Halford followed safety protocols appropriate to the clinical trial.”</p> <p>But other researchers said they were appalled by what they described as the university’s complicity in ignoring more than 70 years of safety protocols. </p></blockquote> <p>As am I. For shame, SIU:</p> <blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr" xml:lang="en">Hey <a href="https://twitter.com/SIUC">@SIUC</a> there's only one thing to say... <a href="https://t.co/u0si3ALnzn">https://t.co/u0si3ALnzn</a> <a href="https://twitter.com/hashtag/bioethics?src=hash">#bioethics</a> <a href="https://twitter.com/hashtag/research?src=hash">#research</a> <a href="https://twitter.com/hashtag/vaccine?src=hash">#vaccine</a> <a href="https://t.co/sk2xZ2OXJo">pic.twitter.com/sk2xZ2OXJo</a></p> <p>— Alison Bateman-House (@ABatemanHouse) <a href="https://twitter.com/ABatemanHouse/status/902202627995389954">August 28, 2017</a></p></blockquote> <script async="" src="//platform.twitter.com/widgets.js" charset="utf-8"></script><p> One can only wonder whether the feds can do something about SIU's involvement in this, given that the university receives federal funding. Of course, in the anti-regulation governmental era that President Donald Trump has ushered in, I doubt that the FDA or the OHRP will do anything at all, even though SIU richly deserves it for its lack of ethics and disingenuousness. <a href="https://arstechnica.com/science/2017/08/bucking-fda-peter-thiel-funds-patently-unethical-herpes-vaccine-trial/">For example</a>:</p> <blockquote><p> However, after questions about the lack of IRB approval (a federal requirement), the spokesperson said that the university would “take this opportunity to review our internal processes to ensure we are following best practices.” </p></blockquote> <p>Yeah, I hope so. Because clearly SIU wasn't following "best practices" before. Remember OHRP and FDA regulations apply to any faculty of any university receiving federal funds, regardless if the faculty member used federal funds to carry out a clinical trial. SIU dropped the ball here, big time.</p> <p>There is a multi-pronged war being waged on the FDA by ideological and business interests whose belief in the free market (and profit) as the adjudicator of the value of all things has deluded them into believing that all federal regulation is harmful and represents an undue brake on "innovation," which basically seems to mean whatever people like Peter Thiel want to do to make money, regardless of scientific plausibility and ethics. (The passage of the <a href="http://scienceblogs.com/insolence/2016/12/08/the-21st-century-cures-act-passes-turning-the-fda-into-a-puppet-of-the-pharmaceutical-industry/">21st Century Cures Act</a> is a less egregious <a href="http://scienceblogs.com/insolence/2015/08/17/the-21st-century-cures-act-old-vinegary-wine-in-a-new-bottle/">example</a> of another front in this war.) If Thiel and Fernández get away with not just taking their clinical trials offshore (which many drug companies do) but of so blatantly flouting FDA and OHRP regulations by not forming an IRB for these trials (which basically no drug company seeking to market a drug in the US does) and manage to win FDA approval for their vaccine, it will be a stake in the heart of the FDA, which is exactly what Thiel wants.</p> <p>[Next time, to conclude this two-part series: If a federal right-to-try law passes, here's what's likely to be next.]</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Tue, 08/29/2017 - 03:00</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Tue, 29 Aug 2017 07:00:15 +0000 oracknows 22613 at https://scienceblogs.com A new nomenclature for auricular acupuncture: The ultimate in Tooth Fairy science https://scienceblogs.com/insolence/2017/08/25/a-new-nomenclature-for-auricular-acupuncture-the-ultimate-in-tooth-fairy-science <span>A new nomenclature for auricular acupuncture: The ultimate in Tooth Fairy science</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p><a href="http://www.dcscience.net/Colquhoun-Novella-A&amp;A-2013.pdf">Acupuncture is nothing more than a theatrical placebo</a>.</p> <p>I wish I could take credit for the term "theatrical placebo" to describe acupuncture, just as I wish I could take credit for coining the term "quackademic medicine" to describe the unfortunately increasing infiltration of quackery into academic medical centers and medical schools and as I wish I could take credit for the term "<a href="http://skepdic.com/toothfairyscience.html">Tooth Fairy science</a>" to <a href="https://sciencebasedmedicine.org/therapeutic-touch-pseudoscience-the-tooth-fairy-strikes-again/">describe</a> doing scientific studies on a phenomenon that has not been proven to exist, but alas I cannot. I can, however, use the terms as I see fit, even if it might annoy some believers in acupuncture and other alternative medicine modalities that have no definable, demonstrable effect on any disease or medical condition detectable in randomized controlled clinical trials.</p> <!--more--><p>I can take credit, however, for pointing out that the history of "traditional Chinese medicine" was <a href="https://sciencebasedmedicine.org/retconning-traditional-chinese-medicine/">retconned by Chairman Mao Zedong</a>. (I don't think anyone thought to borrow a term from comics and TV to describe the rewriting of history that Mao did to portray TCM as somehow being a single unified ancient and powerful system of medicine, so that he could sell it to his people (and later the world) as a viable alternative to "Western" medicine that should in fact be "integrated" into it. It's a <a href="http://scienceblogs.com/insolence/2017/01/23/first-china-next-the-world-the-chinese-government-gives-a-big-boost-to-traditional-chinese-medicine-just-like-chairman-mao-did/">process that's still going on today</a>. Indeed, as I like to say, Chairman Mao was the father of "integrative medicine," at least with respect to "integrating" TCM into science-based medicine despite the lack of evidence that much, if any, of it worked, except for the <a href="http://scienceblogs.com/insolence/2015/10/12/the-nobel-prize-versus-traditional-chinese-medicine/">occasional lucky guess</a>.</p> <p>However, as ridiculous as acupuncture can be, with its basis in ideas rooted in prescientific vitalism that claim that sticking needles into anatomically nonexistent "meridians" can somehow redirect the flow of "life energy" (qi) to heal, there is a form of acupuncture that is even more ridiculous than that, and it's auricular acupuncture. Basically, the idea behind auricular acupuncture is that there is a homunculus of the human body on the external ear, usually with the head near the earlobe and the feet near the triangular fossa (the upper part of the ear). Basically, in auricular acupuncture, an acupuncturist sticks smaller, shorter needles into the external ear, the location determined according to the homunculus to target the organ or body part that is diseased or in pain. This mapping generally corresponds to similar maps developed for that other form of homunculus-based quackery, reflexology. These are a couple of excellent examples of Tooth Fairy science, in which one studies the amount of money the Tooth Fairy leaves per tooth or the phases of the moon when she is most likely to come but never bothered to show that the Tooth Fairy exists in the first place. In this case, it is the existence of a homunculus mapping different organs to areas on the external ear that has never been demonstrated.</p> <p>Sadly, auricular acupuncture is the preferred form of acupuncture that's been adapted to "<a href="https://sciencebasedmedicine.org/acupuncture-invades-the-military/">battlefield acupuncture</a>" (I <a href="http://scienceblogs.com/insolence/2008/12/22/battlefield-acupuncture-revisited-only-t/">kid you not</a>), where our military (yes, our military) is training medics and other healthcare providers in its ranks to use auricular acupuncture right on the battlefield. Meanwhile, military hospitals and the <a href="http://scienceblogs.com/insolence/2017/01/27/quackery-at-the-va-our-veterans-deserve-real-medicine-not-fake-medicine/">VA medical system</a> are rapidly <a href="http://scienceblogs.com/insolence/2017/03/29/the-quackery-that-is-battlefield-acupuncture-continues-to-metastasize/">adopting the same quackery</a>.</p> <p>Here's an example of such a homunculus (click to embiggen):</p> <p><a href="/files/insolence/files/2017/08/fig1.jpg"><img src="http://scienceblogs.com/insolence/files/2017/08/fig1-271x450.jpg" alt="" width="271" height="450" class="aligncenter size-medium wp-image-11017" /></a></p> <p>Of course, alternative medicine being alternative medicine and quacks being quacks, there is no evidence for the above homunculus, and other maps have appeared, some quite complex, like this one:</p> <p><a href="/files/insolence/files/2017/08/Homu1.jpg"><img src="http://scienceblogs.com/insolence/files/2017/08/Homu1-350x450.jpg" alt="" width="350" height="450" class="aligncenter size-medium wp-image-11018" /></a></p> <p>So naturally, given the rapidly expanding complexity of their quackery, the quacks practicing auricular acupuncture need a new homunculus. They need a new system that can incorporate the rapidly expanding list of areas to map to the ear. Not surprisingly, there are quackademic medical "researchers" who are more than willing to provide just such a system. Behold, published online ahead of print in that repository of quackademic medicine, <em>The Journal of Alternative and Complementary Medicine</em>, a "study" that provides just what cutting edge auricular acupuncture researchers need, a <a href="http://online.liebertpub.com/doi/abs/10.1089/acm.2016.0351">New Universal Nomenclature of Auriculotherapy</a>. (No, I didn't capitalize that. The authors did. Humble, aren't they?) The authors, David Alimi, MD, and Jacques E. Chelly, MD, PhD, MBA, are both based at the University of Pittsburgh, in the Departments of Anesthesia (Alimi and Chelly) and Orthopedics (Chelly). I do find it appropriate that Dr. Chelly has an MBA, because, of course, the business possibilities for auricular acupuncture are endless.</p> <p>So what is the justification for needing a new system of nomenclature for auricular acupuncture? I'll let Alimi and Chelly explain:</p> <blockquote><p> Auricular acupuncture (Auriculotherapy) has gone through the centuries, and, in particular, the last 40 years, going from traditional to modern. By word of mouth, from empirical practice to efficient medicine, it was slowly approved, thanks to neuroimaging progress, and has become, at least, a part of neuroscience.</p> <p>Since the rediscovery of Auriculotherapy by Paul Nogier in 1957 in Lyon (France), and his brilliant vision of a fetus curled up in the ear pavilion, presaging the understanding of his somatotopic bases, modern neuroscientific knowledge has allowed us, as neurophysiologists, to bring understanding of the neurophysiological bases of its action.</p> <p>Since this scientific certification, its development, universal propagation, and academic education have never stopped developing, just like the multiplication of clinical and experimental study publications.</p> <p>After Dr. Paul Nogier's initial cartography of the ear, multiple cartographies have been developed by different authors/countries/schools. Until recently, the construct of these cartographies was anatomically based. Basically, the ear was divided in anatomic zones (helix, Antihelix, Tragus, Lobule, etc.) and each zone was subdivided in areas. This led to the description of each point by a letter referring to the zone and a number referring to an area within the zone.</p> <p>The World Health Organization (WHO) recognized it in 1987 and developed its first International Nomenclature in 1990 (Fig. 1). Its continuous development currently requires an update of its international standardization. </p></blockquote> <p>The WHO? Et tu, WHO? Sadly, it's true. The WHO did come up with a nomenclature for auricular acupuncture, which was <a href="http://apps.who.int/medicinedocs/documents/s7144e/s7144e.pdf">published in 1991</a>. It's a simultaneously depressing and hilarious read, pure pseudoscience, a blot on the WHO forever. Fortunately, I haven't been able to find anything on the WHO website like it that's more recent, other than a couple of papers that have references about auriculotherapy or auricular acupuncture in them.</p> <p>But what about Paul Nogier? Who is he? Or, rather, who was he, given that he died over 20 years ago? Well, helpfully, there is a website that tells all about him and how he "discovered" auricular acupuncture. I got a bad feeling about Nogier from the very first paragraph:</p> <blockquote><p> The XIXth and the XXth centuries were the centuries where the chemistry was omnipotent and where the medical therapy was based upon this chemistry. For every disease, a chemical drug. For every symptom, a molecule. It was very rare in the XXth century that someone explored new physical paths for therapy. Dr. Paul NOGIER, who received a formation as an engineer, looked at the individual with an eye of a physicist. He understood that the biological systems were not only sensitive to active chemical substances but also to physical stimulations. Therefore he systematically tried to find physical therapies to be used in the treatment in order to avoid the secondary effects of the chemical drugs. As soon as he graduated in medicine in Lyon, he focused his interest on homeopathy, as the homeopathic granule liberated from any chemical substance, finds its action through the physical electromagnetic information. Afterwards, he studied manual medicine and later acupuncture. </p></blockquote> <p>Yep. Even though he was a physician, Nogier was a practitioner of The One Quackery To Rule Them All, homeopathy. He was also into other forms of woo, like "energy medicine." Indeed, he <a href="http://www.mylighttherapy.com/nogier-frequencies.html">claimed to have discovered</a> "through painstaking research with the subtle energies of the body" three frequencies that "stimulate the creation of our body tissues." His "finding" with respect to this was described by Dr. Charles McGee, who attended one of Nogier's lectures in 1975:</p> <blockquote><p> He must have been astounded by the orderliness of a pattern he discovered. He found that specific body tissues were in resonance with specific frequencies according to their embryologic origin. … I believe this single finding will one day be recognized as one of the greatest discoveries of medicine, possibly worth a Nobel Prize for Nogier. </p></blockquote> <p>Vibrations. It's always the vibrations with quacks. I know I've said that before. Maybe I should say: <em>Le vibration. C'est toujours le vibration</em>. Oddly enough, poor Dr. Nogier died without ever being awarded a Nobel Prize.</p> <p>Vibrations or not, this next part will sound very familiar to those of you familiar with the history of chiropractic and how D.D. Palmer "discovered" chiropractic:</p> <blockquote><p> In 1951, Paul NOGIER received in his consultation a patient, who explained to him that he was relieved from a sciatica pain by a cauterisation on the ear carried out by a quack in Marseille, Madame BARRIN. Following this observation, Paul NOGIER examined the external ear and tried to understand why this strange cure took place. It will take him more than 30 years to ascertain the mechanisms of the ear properties. </p></blockquote> <p>Yep. A patient with a "miracle cure," although this miracle cure isn't as impressive as what Palmer claimed, the <a href="https://en.wikipedia.org/wiki/Chiropractic#History">cure of someone almost deaf by a "pop" in his spine</a>. Poor auricular acupuncture. It can't even come up with an impressive origin story, either. However, just like every good quack who invented a medical treatment (or, in this case, almost a system of medicine) out of whole cloth, Nogier has been portrayed as laboring many years to figure out that there supposedly exist points in the ear like acupuncture that appear as soon as "pain or functional disorder is provoked" in the body. Supposedly, these points can be detected either by pain sensitivity or with equipment designed to detect electrical impulses in the skin. According to Alimi and Chelly, it is known (obligatory Game of Thrones reference) that the surface of the external ear carries areas of lower resistance that appear in the case of the presence of a functional disorder. It is (also) known that "every point on the ear corresponds to a well defined part of the body" and that a "real cartography is present on the ear."</p> <p>Using that idea as a jumping off point, man, oh, man can the adherents of auricular acupuncture do up some sciencey quackademic medicine studies to justify their woo! In this case, Alimi and Chelly reported on how they used electronic database searches from 1958 to 2012 to find different formulations of Auricular Acupuncture Points (AAPs). They then claim to have studied brain dissections and to have "proved the neurophysiological correlations existing between auricular displays and their brain correspondences." Hilariously, they claim to have found that the middle of the corpus callosum (the structure that connects the two hemispheres of the brain) is the "epicenter of the somatotopic organization of the brain homunculus." Funny, but that's news to neuroscientists, I'm sure! In any case, the authors used this risibly unbelievable analysis to propose a new way to divide up the ear for purposes of auricular acupuncture. It involves a semicircle of an angular value of 180°, which they divided into 20 equal angles (that is, 9°. The called this the “Segmentogram,” which covers the totality of the surface of the auricle. Overall, this system divides the lateral ear in 189 areas and the medial ear in 89 areas. It's easier just to look at the illustrations (click to embiggen):</p> <p><a href="/files/insolence/files/2017/08/figure4.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure4-450x379.jpeg" alt="" width="450" height="379" class="aligncenter size-medium wp-image-11019" /></a></p> <p><a href="/files/insolence/files/2017/08/figure5.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure5-443x450.jpeg" alt="" width="443" height="450" class="aligncenter size-medium wp-image-11021" /></a></p> <p>And these areas of the ear supposedly map to organs and body parts (click to embiggen):</p> <p><a href="/files/insolence/files/2017/08/figure7.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure7-450x342.jpeg" alt="" width="450" height="342" class="aligncenter size-medium wp-image-11022" /></a></p> <p><a href="/files/insolence/files/2017/08/figure9.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/08/figure9-450x389.jpeg" alt="" width="450" height="389" class="aligncenter size-medium wp-image-11020" /></a></p> <p>It's really complicated; so it must be right, right?</p> <p>Wrong.</p> <p>There are no neuroanatomic correlates to suggest that there is any sort of mapping between body parts and organs to specific areas on the external ear. This is the ultimate in Tooth Fairy Science, which is basically doing studies on a phenomenon that has not yet been shown to exist. Sadly, there's a lot more where that came from in quackademic medicine.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Thu, 08/24/2017 - 21:44</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Fri, 25 Aug 2017 01:44:03 +0000 oracknows 22611 at https://scienceblogs.com “He couldn’t tolerate injustice”: Remembering Dr. Herbert Needleman https://scienceblogs.com/thepumphandle/2017/07/26/he-couldnt-tolerate-injustice-remembering-dr-herbert-needleman <span>“He couldn’t tolerate injustice”: Remembering Dr. Herbert Needleman</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>My favorite way to capture students’ attention about lead poisoning is to tell them about <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1497712/pdf/16134577.pdf">Dr. Herbert Needleman and his use of children’s baby teeth</a>. In the late 1960's, Needleman recruited school teachers in Chelsea and Somerville, MA to collect their young students’ deciduous teeth when they fell out. It was a non-invasive way----no needlesticks, no bone biopsies---to get data on lead burden in children.</p> <p>Needleman’s team analyzed the teeth for lead which helped them establish a population distribution of tooth lead levels. (It did not exist up to that time.)  In 1972, <a href="https://www.ncbi.nlm.nih.gov/pubmed/4550400">he published</a> the findings as lead exposure prevalence among the school children in the journal <em>Nature</em>. He built on that research with his investigations of the relationship between children’s lead levels and IQ. That research also involved school teachers. The landmark paper: “<a href="https://www.ncbi.nlm.nih.gov/pubmed/763299">Deficits in psychologic and classroom performance of children with elevated dentine lead levels</a>,” was published in the <em>New England Journal of Medicine</em> in 1979.</p> <p>In an <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1497712/pdf/16134577.pdf">interview with historians</a> David Rosner and Gerald Markowitz, Needleman reveals his enthusiasm for scientific inquiry rich with community involvement:</p> <blockquote><p>“We had posters placed around the city in store windows. My secretary’s husband was a commercial artist. He drew us a tooth that looked like Mickey Mouse. It had a missing tooth, and it said, “I gave.” …We gave as a reward a little kit—toothbrush, toothpaste—and a badge."</p> <p>“The teachers were wonderful. They each had a shoe box filled with coded envelopes. On the envelope was a diagram of the human mouth with a big smile. They would look in the kids’ mouth, find the space, and then mark the space on the envelope.”</p></blockquote> <p>At the time of Needleman's initial work in the late 1960's, children with a blood lead level of 60 <em>u</em>g/dL of blood were considered to have lead poisoning. His work was instrumental in identifying the relationship between lead exposure and intellectual impairment, school performance, and behavior disorders. By 1980, the threshold for childhood lead poisoning was 30 <em>u</em>g/dL of blood. Needleman's inquiries with colleagues continued and their findings were essential in securing greater protections for the public from lead, including action by the EPA and Congress to ban lead in gasoline, paint, plumbing, and other uses. The CDC's <a href="https://www.cdc.gov/nceh/lead/acclpp/blood_lead_levels.htm">current action level</a> for blood lead in children is 5 <em>u</em>g/dL of blood and the recognition that no level is considered safe.</p> <p>Needleman published more than 60 papers about the adverse health effects of lead. His research, however, threatened the economic viability and public image of makers and users of lead. Needleman was vigorously attacked for his work by EI DuPont, the Ethyl Corporation, and others. Assertions of scientific misconduct by Needleman were hurled by scientists on the industry's payroll. The accusations led to investigations by the National Institutes of Health and the University of Pittsburgh where Needleman was a professor of child psychiatry and pediatrics.</p> <p>Needleman discussed the professional assault <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1497712/pdf/16134577.pdf">in an interview</a> with Rosner and Markowitz, in particular, the University's practice of holding academic integrity proceedings behind closed doors. Needleman said:</p> <blockquote><p>"The major issue was having an open hearing. I knew that if we went in to executive session, I was through—I mean, just judging by the report that the inquiry committee wrote. I campaigned to get it open, and the university faculty senate was behind me 100%. It became a big issue here. The chancellor was challenged in public. About 400 scientists from around the country petitioned. The hearings were then declared open, at which point Sandra Scarr and Claire Ernhart [researchers for the lead industry] said they would not come. They did not want to be questioned in public."</p></blockquote> <p><a href="http://pediatrics.aappublications.org/content/90/6/977">Needleman wrote</a> about the experience in "Salem comes to the National Institutes of Health: Notes from inside the crucible of scientific integrity," for a 1992 issue of <em>Pediatrics</em>.</p> <p><a href="http://www.mountsinai.org/profiles/philip-j-landrigan">Philip Landrigan</a> collaborated frequently with Needleman. Landrigan <a href="http://www.post-gazette.com/news/education/2017/07/20/Dr-Herbert-Needleman-pittsburgh-lead-exposure-children-low-IQ-behavior-problems/stories/201707200108">told Sean Hamill</a> of the <em>Pittsburgh Post-Gazette</em>:</p> <blockquote><p>“It was a terrible time in his life. The people who raised the questions used a small discrepancy to undermine him. More than 90 percent of the scientific community had long accepted his findings and the only people who didn’t were on the payroll of the lead industry.”</p></blockquote> <p>Historian <a href="http://www.post-gazette.com/news/education/2017/07/20/Dr-Herbert-Needleman-pittsburgh-lead-exposure-children-low-IQ-behavior-problems/stories/201707200108">Rosner remarked:</a></p> <blockquote><p>"He accomplished a lot. He suffered a lot. And he inspired a lot of people. His main goal was to inspire a generation of researchers, and he obviously has done that. He was just a great man.”</p></blockquote> <p>A testament to Needleman's inspiration comes today from the front lines. Upon his death, pediatrician Mona Hannah-Attisha, who exposed the lead-poisoning epidemic in Flint, Michigan tweeted:</p> <blockquote><p>"So much of our knowledge about lead and children flows from Dr. Needleman's work and tenacity. He was attacked, fought back, and forced change. RIP."</p></blockquote> <p>Needleman's fierce advocacy for children went far beyond lead. A <a href="https://www.nrdc.org/experts/david-wallinga-md/herb-needleman-md-advocates-life-well-lived">tribute written by David Wallinga</a> describes Needleman's role on an EPA advisory committee examining exposures to pesticides.</p> <p>His son, Joshua Needleman, MD, <a href="http://www.post-gazette.com/news/education/2017/07/20/Dr-Herbert-Needleman-pittsburgh-lead-exposure-children-low-IQ-behavior-problems/stories/201707200108">said his father's passion</a> for social justice grounded all of his work.</p> <blockquote><p>“He just couldn’t tolerate injustice and could not stop seeking the truth.”</p></blockquote> <p>What an appropriate motto for anyone in public health! Thank you Dr. Needleman.</p> <p> </p> <p> </p> <p> </p> </div> <span><a title="View user profile." href="/author/cmonforton">cmonforton</a></span> <span>Wed, 07/26/2017 - 05:00</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Wed, 26 Jul 2017 09:00:50 +0000 cmonforton 62897 at https://scienceblogs.com A physicist clueless about cancer lectures cancer biologists on...cancer! https://scienceblogs.com/insolence/2017/07/18/a-physicist-clueless-about-cancer-lectures-cancer-biologists-on-cancer <span>A physicist clueless about cancer lectures cancer biologists on...cancer!</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>There's a good rule of thumb about headlines (other than <a href="https://en.wikipedia.org/wiki/Betteridge%27s_law_of_headlines">Betteridge's Law of Headlines</a>) that I use when perusing articles. It's particularly useful for evaluating headlines about medical and science stories. Basically, if a headline says something like, "everything you know about X is/might be/could be wrong" or "everything scientists know about X is/might be/could be wrong," it's a highly reliable indication that much of what is in the article that follows is very likely to be unmitigated, grade-A bullshit. I realize that it might be confirmation bias on my part (I am, after all, a skeptic), but it's a rule of thumb that has rarely let me down. It is, after all, a very lazy trope on the part of editors and journalists designed to pique the reader's interest and imply that there's been some sort of radical new finding that's overturned much of what scientists thought about a topic before. Science, of course, doesn't usually work that way. Findings that totally overturn a scientific paradigm are rare; most new findings are evolutionary, not revolutionary. This is good for science. It's not so good for news stories and headline writers.</p> <!--more--><p>My rule definitely didn't let me down yesterday, too, as I started seeing on my social medial an article in Newsweek by Jessica Wapner that definitely follows it. Oh, sure, there's a paragraph or two out of a very long article presenting one scientist criticizing the crank idea presented, but for the most part the article is all credulous praise. Entitled, <a href="http://www.newsweek.com/2016/07/29/cancer-evolution-cells-637632.html">A New Theory on Cancer: What We Know About How It Starts Could All Be Wrong</a>, the title fits the pattern, as does the article that follows. It is unmitigated, grade-A bullshit. Not only that, to the lazy trope of lionizing a "scientific maverick" (whose ideas are, of course, what show us that "what we know about how cancer starts could all be wrong") who is most unworthy of lionization. Unsurprisingly, it is a theoretical physicist. It could be confirmation bias on my part again, but it sure does seem that physicists seem particularly prone to entering a new field, coming up with a new "insight" in it, and then wondering why all the scientists there hadn't thought of the insight he's had and indeed reject it. In any case, it's a physicist we have met before, Paul Davies, who three years ago with his partner in crime <a href="http://www.mso.anu.edu.au/~charley/">Charles Lineweaver</a> (another physicist, in this case an astrophysicist) made a splash with his idea that cancer is a throwback to an ancient genetic “sub-routine” where the mechanisms that usually instruct cells when to multiply and die malfunctions, thus forcing the cells to revert back to a default option that was programmed into their ancestors long ago, or, as it's called, an atavism, a "reawakening" of ancient genetic subroutines. <a href="http://scienceblogs.com/insolence/2014/08/08/atavistic-chemotherapy-a-new-form-of-cancer-quackery-based-on-misunderstanding-evolution/">I wrote about it then</a>. I described why his ideas are wrong and how they've inspired a quack. So did <a href="http://scienceblogs.com/pharyngula/2011/04/26/aaargh-physicists/">biologist P.Z. Myers</a> (<a href="http://scienceblogs.com/pharyngula/2015/12/06/the-haeckelization-of-paul-davies/">multiple times</a>) Nothing's changed since then, except that Wapner cranked up the worship of the Brave Maverick Scientist to a cringe-inducing 11.</p> <p><a href="http://www.newsweek.com/2016/07/29/cancer-evolution-cells-637632.html">Behold</a>:</p> <blockquote><p> Paul Davies knows what’s wrong with cancer research: too much cash and too little forethought. Despite billions of dollars invested in fighting this disease, it has remained an inscrutable foe. “There is this assumption that you can solve the problem by throwing money at it,” he says, “that you can spend your way to a solution.” Davies, a theoretical physicist at Arizona State University (ASU)—and therefore somewhat of an interloper in the field of cancer—claims he has a better idea. “I believe you have to think your way to a solution.” </p></blockquote> <p>Bloody hell. As a cancer surgeon and biologist, I couldn't help but be monumentally pissed off when I read this paragraph. The hubris just oozes from every word of Davies' quoted. So does the condescension and contempt for us poor, poor, oncologists, surgeons, and cancer biologists, who (or so Davies apparently thinks) are so deeply embedded into the existing paradigm that they can't appreciate the brilliance of his insights. ""I believe you have to think your way to a solution"? What does he think cancer biologists have been doing for well over a century now, dating back to the 1800s? Sitting around in their labs waiting for that sweet, sweet grand money to flow in, so that they can do whatever experiment that pops into their heads on any given day?</p> <p>He also betrays the bias of his background as a theoretical physicist. Let me give him an education. To make progress against cancer takes a lot more than "thinking." Yes, thinking is important, but it's worthless without actual experimental evidence from the laboratory, which is then translated into the clinic and validated through clinical trials. This is a process that can take decades, of which "thinking" is only the first step. The hard work of cancer biology, like any science, is not necessarily coming up with ideas and insights. The real thinking that has to be done is to design strategies to assess which ideas lead to testable hypotheses that can result in a better understanding of cancer and, at least as importantly, identify mechanisms that can be targeted for therapy. The hubris that Davies demonstrates is breathtaking, and Wapner doesn't call him out on it in the least.</p> <p>If you don't believe me that Davies is peddling grade-A bullshit, then check out this next passage:</p> <blockquote><p> Over the course of several years spent pondering cancer, Davies has come up with a radical approach for understanding it. He theorizes that cancer is a return to an earlier time in evolution, before complex organisms emerged. When a person develops cancer, he posits, their cells regress from their current sophisticated and complex state to become more like the single-celled life prevalent a billion years ago.</p> <p>But while some researchers are intrigued by the theory that cancer is an evolutionary throwback, or atavism, plenty more think it’s silly. That theory suggests that our cells physically revert from their current form—a complex piece in the even more complex puzzle that makes a lung or a kidney or a brain—to a primitive state akin to algae or bacteria, a notion that seems preposterous to many scientists. Yet gradually, evidence is emerging that Davies could be right. If he is—if cancer really is a disease in which our cells act like their single-celled ancestors of eons ago—then the current approach to treatment could be all wrong. </p></blockquote> <p>"Gradually evidence is emerging that Davies could be right"? No. It's not. Really, it's not. Nothing Davies has thought of is remotely new. As I discussed a long time ago, it is not surprising that the hallmarks of cancer <a href="http://www.ncbi.nlm.nih.gov/pubmed/10647931">described by Douglas Hanahan and Robert Weinberg in 2000</a> and <a href="http://www.cell.com/cell/fulltext/S0092-8674(11)00127-9">updated in 2011</a>. The original six hallmarks were:</p> <ol><li>sustaining proliferative signaling</li> <li>evading growth suppressors</li> <li>resisting cell death</li> <li>enabling replicative immortality</li> <li>inducing angiogenesis</li> <li>activating invasion and metastasis</li> </ol><p>Cancer biologists have known for a long time that the genes involved in developing cancer control cellular processes like these, and these processes are very ancient ones. Just because these processeas are ancient, however, does not mean that Davies is correct. His first line of argument is that cancer is found in virtually all multicellular organisms have cancer, which is true but basically irrelevant. Then he argues:</p> <blockquote><p> The evidence that cancer is an evolutionary regression goes beyond the ubiquity of the disease. Tumors, says Davies, act like single-celled organisms. Unlike mammalian cells, for example, cancer cells are not programmed to die, rendering them effectively immortal. Also, tumors can survive with very little oxygen. To Davies and his team, which includes Australian astrobiologist Charles Lineweaver and Kimberly Bussey, a bioinformatics specialist at ASU, that fact supports the idea that cancer emerged somewhere between 1 billion and 1 and a half billion years ago, when the amount of oxygen in the atmosphere was extremely low.</p> <p>Tumors also metabolize differently from normal cells. They convert sugar into energy incredibly fast and produce lactic acid, a chemical normally resulting from metabolism that takes place in the absence of oxygen. In other words, cancer cells ferment, and scientists don’t know why. This phenomenon is known as the Warburg effect, named for Otto Warburg, a German biochemist who won a Nobel Prize in 1931 for his discoveries about oxygen and metabolism. Up to 80 percent of cancers display the Warburg effect. Researchers know that many cancers depend on the Warburg effect for their survival, but they don’t know why. To Davies, the strange way in which tumors metabolize also speaks of cancer’s ancient past: They are behaving as if there were no oxygen available. </p></blockquote> <p>Yes, tumor cells are not programmed to die (a process called apoptosis, or programmed cell death), an essential process in building multicellular organisms, particularly of keeping cells under control and from proliferating outside of control of the organism. However, as <a href="https://freethoughtblogs.com/pharyngula/2017/07/17/paul-davies-is-not-a-medical-doctor/">P.Z. Myers notes</a>, there are normal cells that have the same ability, such as germ line cells. As a cancer biologist myself, I can't help but note that another relevant cell type is the stem cell. Stem cells are cells that can <a href="https://stemcells.nih.gov/info/basics/1.htm">differentiate into any cell type and have in essence unlimited replicative potential</a>. It would make more sense to say that cancer cells in some ways resemble stem cells, and, yes, cancer stem cells are a hot (if controversial) area of research. Just ask Max Wicha, a pioneer in the field. Unlimited replicative ability is not an atavistic property.</p> <p>As for surviving in very little oxygen, mammalian cells do the same thing. It is not an atavistic property. When oxygen tension is low, they revert to glycolysis, which doesn't require oxygen. The disadvantage is that glycolysis produces much less energy per molecule of glucose than oxidative metabolism does. It is true that many tumor cell types do "prefer" glycolysis over aerobic metabolism. It's something that Otto Warburg observed back in the late 1920s, and it's the reason that PET scans work. PET scans use radiolabeled glucose Tumor cells, because of their dependence on glycolysis, use a lot of glucose, which means that areas with tumor cells "light up" on PET, allowing the detection of tiny tumor deposits. I've <a href="http://scienceblogs.com/insolence/2010/05/17/dichloroacetate-dca-and-cancer-deja-vu-a/">discussed the Warburg effect</a> on <a href="http://scienceblogs.com/insolence/2016/08/22/did-the-experimental-cancer-drug-3-bromopyruvate-3-bp-cause-the-deaths-of-cancer-patients-at-a-german-alternative-medicine-clinic/">multiple occasions</a>. Again, there's nothing "atavistic" here.</p> <p>It's also not as though we don't understand some of these things as well. The Warburg effect is associated with the <a href="https://en.wikipedia.org/wiki/PKM2">PKM2 isoform</a> of a key enzyme in glycolysis, pyruvate dehydrogenase. Attempts to use inhibitors of aerobic glycolysis in the clinic or other drugs that target the Warburg effect have not been dramatically successful.</p> <p>Although PZ did a fine job deconstructing this nonsense, but, being a cancer physician, I found one part that really stood out to me:</p> <blockquote><p> Davies thinks the moneyed and narrow focus on targeted therapeutics is misguided. These new drugs tend to focus on attacking cancer’s strengths rather than its weaknesses; its muscle rather than its Achilles’ heel. For example, a medication might be designed to stop the abnormal protein that is allowing a cell to divide without stopping. </p></blockquote> <p>I laughed out loud when I read this. How stupid we are, we cancer biologists. We never would have thought of this without a genius like Davies to lead the way. Oh, wait. We did think of it. Long ago. Targeting mechanisms of that allow cancer cells to evade apoptosis is a major focus of cancer research. It's even listed as one of Hanahan and Weinberg's hallmarks of cancer! Bloody hell! The contempt Davies must have for the long history of cancer research is <em>palpable</em>. Small armies of scientists, postdocs, and graduate students have been working on just this problem for decades! Let's put it this way. I started graduate school in 1990, and apoptosis was a major focus of research. I could show Prof. Davies my Cancer Biology class notes from then if he likes. (I'm pretty sure I still have them somewhere.) Davies makes it sound so easy, doesn't he? Oh, and it's not "the abnormal protein" that allows cells to divide without stopping. It's proteins, as in many, and there are <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2117903/">other forms of programmed cell death besides apoptosis</a>.</p> <p>It gets worse:</p> <blockquote><p> But, says Davies, for as long as cell division has existed, so have threats to it. “Life has had 4 billion years to evolve responses to those threats,” he says. Tumors are incredibly adept at circumventing the stress of a new drug by developing genetic abnormalities that preserve their ability to divide. Cancer patients know this strength all too well: Many once-potent therapies stop working because tumor cells become resistant, eventually exhausting all treatment options.</p> <p>The atavistic theory portends new approaches. Drugging tumors with the lowest possible dose could prevent the evolution of therapy-resistant pathways that would otherwise enable the cancer to spread around the body. “You don’t have to get rid of it,” says Davies, “you just need to understand it and control it.” </p></blockquote> <p>Bloody hell times a thousand! Yes, tumor cells become resistant. It's what they do. They're <a href="http://scienceblogs.com/insolence/2011/08/23/the-complexity-of-cancer/">genetically unstable</a> and have a high rate of mutation, which leads to a <a href="http://scienceblogs.com/insolence/2012/04/09/medicine-and-evolution-part-13/">lot of tumor heterogeneity</a>, with the cells different parts of tumors often being quite different from each other, upon which selective pressures can work. Chemotherapy and other drugs are a powerful selective pressure that forces them to evolve resistance.</p> <p>As for using low dose chemotherapy, Davies is behind the times, too. Has he never heard of metronomic chemotherapy? I have. Robert Kerbel <a href="http://www.nature.com/nrc/journal/v4/n6/abs/nrc1369.html">first proposed it at least 15 years ago</a>, and it is exactly what Davies describes, using the lowest possible dose of chemotherapy administered continuously or frequently. Of course, the goal here is not to keep resistance from developing. It's actually based on Judah Folkman's pioneering work on tumor angiogenesis (the ability of tumor cells to induce the ingrowth of blood vessels to supply its nutrient and oxygen needs. The idea is that low dose chemotherapy is antiangiogenic and targets the endothelial cells lining the blood vessels. There is a form of chemotherapy based on evolutionary considerations, though, <a href="http://scienceblogs.com/insolence/2009/06/02/medicine-and-evolution-part-12-using-evo/">known as adaptive chemotherapy</a>. These ideas all long predate Davies' leaping into the field of cancer research as the Great Physics Hope here to save us dumb physicians and biologists from our own stupidity.</p> <p>Speaking of angiogenesis, if there's a characteristic of tumor cells that is not the least bit atavistic, it's the cancer cell's ability to induce angiogenesis to feed itself. Single cell organisms have no need for angiogenesis. Nor do they have the need for the ability to evade an immune system. These are characteristics of multicellular organisms that cancer cells retain. Moreover, if you get into the weeds, you find that cancer cells interact with normal host cells and each other, and that that interaction is necessary for its spread and survival. There was just an interesting paper earlier this month that shows how cancer cells interact with host blood vessels and immune cells in order to invade the vasculature and spread via the bloodstream. When tumor cells arrive at other organs, it's their ability to adhere to the surrounding collagen and cells and begin to grow that determines whether they turn into metastases. There's a whole field known as tumor microenvironment that studies the interaction of cancer cells with the surrounding cells, structural proteins, and circulating signaling molecules of the host.</p> <p>To shamelessly paraphrase <a href="https://en.wikiquote.org/wiki/Space">Douglas Adams</a>, <a href="http://scienceblogs.com/insolence/2011/08/23/the-complexity-of-cancer/">cancer is complicated</a>. Really complicated. You just won't believe how vastly, hugely, mind-bogglingly complicated it is. I mean, you may think it's a complicated to figure out your computer, but that's just peanuts to cancer. Basically Davies cherry picks aspects of cancer that are shared with ancient single-celled organisms and ignores all the characteristics that are not. He dismisses the "existing paradigm" that cancer is primarily a genetic disease and ignores very old observations that certain tumor suppressors and oncogenes are directly associated with cancer. In some cancers, targeting these genes is an effective treatment. Gleevec, for instance, <a href="https://www.nature.com/scitable/topicpage/gleevec-the-breakthrough-in-cancer-treatment-565">targets a single abnormal protein</a>.</p> <p>Then he has the audacity to complain:</p> <blockquote><p> Many oncologists are skeptical that it ever will. Evolutionary biologist Chung-I Wu, at the University of Chicago, calls the atavistic theory “an extreme position.” Scientists have also criticized Davies’s reference to the discredited “recapitulation theory” that human embryos develop temporary vestigial organs—gills, a tail, a yolk sac—as support for the atavistic model. “I’ve been ridiculed by the biology community,” says Davies. </p></blockquote> <p>Yes, Davies has been ridiculed. I'm ridiculing him now. He richly deserves it. Like all good cranks, though, Davies views the ridicule as evidence that he's right:</p> <blockquote><p> Davies is unfazed by the objections. “My feeling is, Who cares? The idea was to come in from the outside and lend a fresh perspective,” he says. Davies sees the criticism as largely rooted in territoriality and financial concerns. “Cancer is a multibillion-dollar industry that’s been running for decades. There’s a lot of vested interests out there.” After five years with the NCI program, Davies is now funded by NantWorks, a sprawling private health care company owned by scientist and billionaire investor Patrick Soon-Shiong (who made his fortune reworking the breast cancer drug paclitaxel to be more effective) to continue his work developing the atavistic model. </p></blockquote> <p>Ah, yes. The last refuge of the crank. When scientists ridicule your ideas, attack big pharma and the "territoriality" of cancer researchers. Now, don't get me wrong. Scientists are human. They can be territorial. They sometimes protect their turf. They can have financial interests. But notice something. Davies had a National Cancer Institute grant to pursue his vision. The clear implication in the paragraph above is that he doesn't have it anymore, which means that he likely failed to renew it, which means that the NCI found his reapplication wanting. Why might that be? In fairness, NIH grants are hard to get, but the implication is that Davies failed to produce enough promising data with his approach to convince the NCI to renew his grant. So now he's in bed with big pharma himself! I wish he'd tell me: Why is it so horrible for scientists he dismisses as in the thrall of the existing paradigm and protecting their turf to be—dare I say—colluding with big pharma, but it's perfectly fine for him to be funded by a billionaire's health care company?</p> <p>Of course, it's not just Davies. There's an oncologist, Mark Vincent, who should really know better but unfortunately seems to be trying to out-Davies Davies:</p> <blockquote><p> Vincent, who had his first atavism insight at around the same time as Davies, is also pursuing the theory. Vincent takes the single-celled phenomenon one step further, believing that cancer could be its own species. The stark difference between our healthy cells and cancerous ones looks more like a jump across the evolutionary tree rather than a hop to another branch. “It seems to me to be a different form of life,” he says. Vincent acknowledges that DNA mutations often cause cancer, but he sees the genetic paradigm as “very incomplete.” </p></blockquote> <p>Um, no. Cancerous cells are not their own "species." For one thing, they can't live on their own outside of the body. Yes, their genomes are <a href="http://scienceblogs.com/insolence/2011/02/21/why-cant-we-cure-cancer/">screwed up</a>. Real screwed up. And scientists would be the first to admit that the genetic "paradigm" is incomplete (although probably not "very incomplete"), because there are contributions to cancer from metabolism and the tumor microenvironment that we don't yet understand. It is, however, interesting how many of the genes mutated in cancer are intimately involved with DNA repair.</p> <p>Basically, what Davies proposes is nothing more than <a href="https://freethoughtblogs.com/pharyngula/2015/12/06/the-haeckelization-of-paul-davies/">a 100 year old idea</a> that he resurrected and tarted up for the 21st century. Because he doesn't have a background in cancer, after finding this shiny new (to him) toy he became utterly fascinated with it and couldn't understand why cancer biologists don't find it as fascinating as he did. The reason, of course, is because it's a 100 year old idea that was found long ago not to be consistent with the data. Pesky that!</p> <p>Look, I don't mind people from other disciplines becoming interested in cancer. Insights from physics, chemistry, and other sciences can be valuable and can shake things up. However, what makes cancer researchers grind their teeth when reading an article like this lionizing someone like Davies is being lectured by someone who didn't have the humility to actually learn the history of the field he's claiming to transform. If he had bothered to do that, maybe he wouldn't have made such a fool of himself. Or maybe he would have. He was widely castigated by evolutionary biologists and cancer researchers in 2014 when he first published his ideas, and in the interim he apparently hasn't developed any humility.</p> <p>I might have to look into his tow or three most recent publications to see if his arguments have gotten any better, but <a href="https://freethoughtblogs.com/pharyngula/2017/05/13/davies-and-lineweaver-are-back-on-the-atavisms-bandwagon/">PZ took care of one of those already</a>. They haven't.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Mon, 07/17/2017 - 21:24</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Tue, 18 Jul 2017 01:24:28 +0000 oracknows 22588 at https://scienceblogs.com Study: Cuts to Texas’ family planning budget led to more abortion, unintended teen pregnancy https://scienceblogs.com/thepumphandle/2017/07/15/study-cuts-to-texas-family-planning-budget-led-to-more-abortion-unintended-teen-pregnancy <span>Study: Cuts to Texas’ family planning budget led to more abortion, unintended teen pregnancy</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>In 2011, Texas legislators slashed the state’s family planning budget by 67 percent. The justification? To reduce abortions by defunding clinics associated with an abortion provider (read: Planned Parenthood). Now, it turns out Texas legislators actually accomplished the opposite: narrowing access to family planning services only led to more unplanned pregnancies and more abortions.</p> <p>In a <a href="https://www.academia.edu/19435560/Family_Planning_Funding_Cuts_and_Teen_Childbearing">study that will soon be published</a> in the <em>Journal of Health Economics</em>, researcher Analisa Packham found that in the years following the 2011 funding cuts, Texas’ teen birth rate went up by 3.4 percent, which suggests that nearly 2,200 teens would not have given birth if funding hadn’t been cut. Also in the three years after the cut, Texas’ teen abortion rate went up by about 3 percent. Those numbers mean that because teen childbearing often comes at significant cost to taxpayers, the budget cut likely ended up costing Texas taxpayers more than the millions that legislators claimed they “saved” by slashing family planning.</p> <p>“Just seeing the increase in raw data is striking because you don’t see this mirrored in other states,” Packham, an assistant professor of economics at Miami University Farmer School of Business, told me. “The increase in teen pregnancy is a costly unintended consequence of attempting to close down these clinic sites, which don’t even provide abortion.”</p> <p>Back in 2011, Texas lawmakers decided to remake the state’s family planning landscape. They cut the state’s family planning budget from $111 per biennium to $37.9 million and put in a three-tiered system that favored clinics with comprehensive health services over clinics that primarily provided family planning services (read: Planned Parenthood). That meant family planning clinics would absorb the brunt of the budget cut. The result: By 2012, 25 percent of family planning clinics had shuttered, 18 percent reduced service hours, and about half had to fire staff. By the end of 2013, according to the study, more than 160 clinics had lost all funding, included 82 clinics that were forced to shut their doors. The number of publically funded family planning clinics went from 287 to 126 in two years. (Also important to note: At the time of the budget cut, it was already illegal for clinics to provide an abortion if they accepted public money.)</p> <p>In analyzing state health data, Packham found that the funding cuts resulted in higher teen birth rates among those ages 16, 17, 18 and 19, but she did not find an impact on 15-year-olds. The birth rate in Texas counties with a Planned Parenthood clinic increased by 3.2 percent in the four years following the funding cut, though Packham said a 2013 measure to bar Planned Parenthood from the Texas Women’s Health Program could have contributed as well. Overall, 11 Planned Parenthood clinics closed after the 2011 cuts. Teens in richer Texas counties seemed to be less affected by the budget cuts than their peers in lower-income counties.</p> <p>So, how is Packham able to confidently attribute increases in teen births to the state’s funding cut? After all, teen pregnancy is a complex issue with many contributing factors. To help isolate the effects of the funding cut, Packham used something called the synthetic control design, which is a technical way of saying she compared birth rates in Texas to rates in other states that have a similar teen birth pattern. Then, if Texas experienced a sharp break from its peers after 2011, Packham could more confidently attribute the birth increase to the funding cut. (And as we know now, the state did experience a spike after 2011.)</p> <p>Packham said as far as she knows, her study is the first to examine the impact of family planning funding cuts on childbearing. It’s a critical policy issue, she told me, because research shows that teen pregnancy is often associated with a host of adverse outcomes, such as living in poverty, fewer educational opportunities, lower wages and greater dependence on public assistance. The kids of teen parents are also more likely to live in poverty.</p> <p>“If we care about reducing teen pregnancy, one way to do that is to increase access to contraception,” she said. “It’s essentially an investment in women and children. No matter what side of the aisle you’re on, (family planning) should be something that everyone supports.”</p> <p>In recent years, Texas lawmakers did restore a portion of the eliminated family planning funds. But rebuilding lost infrastructure isn’t that easy. Packham writes:</p> <blockquote><p>In the past two years, the Texas state legislature has simultaneously restored funding for family planning services by 19 percent and implemented new restrictions on abortion providers and clinics affiliated with abortion providers. Given the high fixed costs of establishing a network of health care facilities, few publicly funded clinics have been able to rebuild and achieve funding comparable to previous levels. Moreover, several Texas abortion clinics and other affiliated clinics have closed since the 2013 regulations. It is unclear how these policies will affect childbearing and reproductive health in the years to come, and future work should consider the impacts of the fluctuation of funding on teen health outcomes.</p></blockquote> <p>Packham noted that many of the Texas clinics forced to shutter served a particularly important role for low-income women, with many clinics being the only source in the community where women could access contraception at low or no cost.</p> <p>“One of the big issues here is that the stated policy goal (of the Texas funding cut) was to reduce abortion,” she told me. “But by cutting funding for publically funded family planning clinics that don’t provide abortion, it’s unlikely that we’d see that policy goal met.”</p> <p>Right now in Congress, the GOP is considering a health care bill that would kick Planned Parenthood out of the Medicaid program and scrap mandates to cover contraception as an essential health benefit. And <a href="https://www.revealnews.org/article/trump-administration-suddenly-pulls-plug-on-teen-pregnancy-programs/">news just broke</a> this past week that the Trump administration has cut more than $213 million in teen pregnancy prevention programs and research, even though family planning efforts have been <a href="http://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12080/full">shown to yield</a> a significant return on investment. Packham said if Republicans succeed in defunding Planned Parenthood, she wouldn’t be surprised to see higher rates of unintended pregnancy across the nation.</p> <p>“Funding for family planning is a smart long-term investment,” she told me. “At the end of the day, this funding pays back benefits in kind.”</p> <p>To download a full copy of the Texas study, go <a href="https://www.academia.edu/19435560/Family_Planning_Funding_Cuts_and_Teen_Childbearing">here</a>.</p> <p><em>Kim Krisberg is a freelance public health writer living in Austin, Texas, and has been writing about public health for 15 years. Follow me on Twitter — </em><a href="http://www.twitter.com/kkrisberg"><em>@kkrisberg</em></a><em>.</em></p> <p> </p> </div> <span><a title="View user profile." href="/author/kkrisberg">kkrisberg</a></span> <span>Sat, 07/15/2017 - 10:08</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Sat, 15 Jul 2017 14:08:21 +0000 kkrisberg 62891 at https://scienceblogs.com Massive measles outbreaks in Europe: A harbinger of things to come in the US? https://scienceblogs.com/insolence/2017/07/12/massive-measles-outbreaks-in-europe-a-harbinger-of-things-to-come-in-the-us <span>Massive measles outbreaks in Europe: A harbinger of things to come in the US?</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>If any of you are bloggers out there who like to write about studies, have you ever decided that you wanted to write about a study and discovered as you started writing that your university doesn't have access to the journal? Yeah, that happened to me last night. I had wanted to move on from writing about antivaccine nonsense, as it seems that that's all I've been writing about for the last several days (probably because it almost is), but I couldn't because I couldn't count on someone getting me a copy soon enough to be able to write about it last night. So until I get a hold of the paper vaccines it is again, because I saw an article that reminded me very much of just the sort of thing antivaxers could bring upon us if we let them.</p> <p>Remember yesterday when I wrote about Kent Heckenlively's unbelievably brain dead <a href="http://scienceblogs.com/insolence/2017/07/11/an-antivaxer-starts-a-whitehouse-gov-petition-for-a-five-year-moratorium-on-childhood-vaccines-hilarity-ensues/">proposal for a five year moratorium on childhood vaccines</a>. Yes, it is exactly as ignorant and idiotic as it sounds. As I thought about it more, I was reminded of another <a href="http://scienceblogs.com/insolence/2017/03/21/massive-measles-outbreak-in-romania-a-warning-to-the-us/">post that I had written back in March</a>, about a massive measles outbreak in Romania that at the time had infected 3,400 and resulted in the deaths of at least 17. Then it occurred to me. Wht's happening in Romania now would be a mild harbinger of things to come if antivaxers ever managed to see their vision of stopping or even significantly decreasing the use of childhood vaccines.</p> <!--more--><p>That's why it's worth an update, and unfortunately I saw one yesterday that tells me the measles outbreak in Romania is as bad as ever. But it goes beyond just Romania. <a href="http://www.bbc.com/news/health-40568017">Behold the horror</a>:</p> <blockquote><p> Thirty-five people have died in the past year from measles outbreaks across Europe, the World Health Organization has warned.</p> <p>It described the deaths - which can be prevented with vaccination - as an "unacceptable tragedy".</p> <p>A six-year-old boy in Italy was the latest to die from the infection. More than 3,300 measles cases have been recorded in the country.</p> <p>The most fatalities - 31 - have been in Romania.</p> <p>But there have also been deaths in Germany and Portugal since June 2016.</p> <p>Dr Zsuzsanna Jakab, the WHO regional director for Europe, said: "Every death or disability caused by this vaccine-preventable disease is an unacceptable tragedy.</p> <p>"We are very concerned that although a safe, effective and affordable vaccine is available, measles remains a leading cause of death among children worldwide, and unfortunately Europe is not spared. </p></blockquote> <p>It is criminal that a vaccine-preventable disease like the measles is a major cause of death in children in developed nations. We have Andrew Wakefield to "thank" for this. Death and disease in Europe and all over the world are his legacies and will remain his legacies. He is to blame for this.</p> <p>The Italian child who died was a six year old boy suffering from leukemia who reportedly <a href="http://www.euronews.com/2017/06/23/childs-death-from-measles-caught-from-unvaccinated-brother-reignites-debate-in">caught the measles from an older sibling</a> whom the parents had decided not to vaccinate even though their son with leukemia had a compromised immune system and couldn't be vaccinated himself. If that's not a case of child neglect, I have a hard time envisioning what is. In essence, the parents' negligence resulted in the death of their child with leukemia.</p> <p>As I noted when I wrote about the Romanian measles outbreak, the antivaccine movement is very active there, complete with the usual conspiracy theories, such as the belief that the US purposefully infected people with HIV using polio vaccines and a direct link between vaccines and widespread HIV in Romanian orphanages. As in the US, in Europe a lot of this is <a href="http://web.archive.org/web/20160424115340/http://www.unicef.org/ceecis/Tracking_anti-vaccine_sentiment_in_Eastern_European_social_media_networks.pdf">driven by social media</a>, where conspiracy theories about big pharma, national governments, the European Union, and Western governments combine with the usual fear mongering using dubious testimonials and bogus scientific studies.</p> <p>In the face of this, many countries in Europe still do not have mandatory vaccinations, as a <a href="http://www.eurosurveillance.org/images/dynamic/EE/V17N22/art20183.pdf">survey from 2010 reported</a>:</p> <blockquote><p> In total 15 countries do not have any mandatory vaccinations; the remaining 14 have at least one mandatory vaccination included in their programme. Vaccination against polio is mandatory for both children and adults in 12 countries; diphtheria and tetanus vaccination in 11 countries and hepatitis B vaccination in 10 countries. For eight of the 15 vaccines considered, some coun- tries have a mixed strategy of recommended and mandatory vaccinations. </p></blockquote> <p>Until recently, these strategies worked reasonably well, and vaccine compliance was high. However, in the wake of this outbreak, EU public health officials have been playing catchup with vaccination campaigns. Progress has been hard-won:</p> <blockquote><p> The Region has been progressing towards measles elimination. A total of 37 countries have interrupted endemic transmission, according to the assessment of the Regional Verification Commission for Measles and Rubella Elimination based on 2015 reporting. However, remaining pockets of low immunization coverage allow the highly contagious virus to spread among those who choose not to vaccinate, do not have equitable access to vaccines or cannot be protected through vaccination due to underlying health conditions. </p></blockquote> <p>In addition, multiple countries are taking action to increase vaccine uptake beside education programs. For example, Germany has <a href="http://www.bbc.com/news/world-europe-40056680">made moves to tighten its vaccine requirements</a>:</p> <blockquote><p> Parents in Germany who fail to seek medical advice on vaccinating their children could face fines of up to €2,500 (£2,175; $2,800).</p> <p>Health Minister Hermann Gröhe said it was necessary to tighten the law because of a measles epidemic.</p> <p>A mother of three died of measles in the city of Essen this week.</p> <p>The government wants kindergartens to report any parents who cannot prove they have had a medical consultation.</p> <p>However, Germany is not yet making it an offence to refuse vaccinations - unlike Italy. </p></blockquote> <p>What's Italy doing? In Italy, there have been three times more measles cases this year already than there were in all of 2016. So in response, in May Italy made 12 vaccinations compulsory for children, <a href="http://www.bbc.com/news/world-europe-39983799">including</a>:</p> <ul><li>polio</li> <li>diphtheria</li> <li>tetanus</li> <li>hepatitis B</li> <li>haemophilus influenzae B</li> <li>meningitis B</li> <li>meningitis C</li> <li>measles</li> <li>mumps</li> <li>rubella</li> <li>whooping cough</li> <li>chickenpox</li> </ul><p>Parents of children who aren't fully vaccinated according to schedule by age 6 could face a fine. It's not clear what they will do beyond that, but it's a strong statement.</p> <p>Meanwhile, in France, distrust of vaccines is very high. <a href="http://www.lemonde.fr/sante/article/2016/10/24/les-francais-font-de-moins-en-moins-confiance-aux-vaccins-selon-une-etude_5018964_1651302.html">A recent survey</a> indicated that only 69% of respondents trust vaccines, with only 52% believing that vaccines have more benefits than risks. Worse, the distrust is higher among the young.</p> <p>In response to low vaccination uptake, the French government has mandated that, as early as next year early childhood vaccines that are unanimously recommended by French health authorities <a href="http://www.lefigaro.fr/conjoncture/2017/07/04/20002-20170704ARTFIG00236-vaccins-tabagisme-deserts-medicaux-toutes-les-annonces-sante-d-edouard-philippe.php">will become mandatory</a>. Currently, only three childhood vaccines are mandatory (diphtheria, tetanus and poliomyelitis), while eight others are only recommended. All will become mandatory now, although it's not yet clear what the penalty will be for noncompliance. In Slovenia, mandatory vaccination policy, complete with fines, has worked to bring compliance up to 95%.</p> <p>I've always been ambivalent about punitive measures like fines to enforce mandatory vaccination, but I suspect that's because school vaccine mandates, in which children must be up-to-date on the CDC-recommended schedule before they can enter school and the only penalty is that unvaccinated and undervaccinated can't attend school, have generally worked very well and, thus far, nonmedical exemptions based on personal belief has have not (yet) reached the levels that could produce a catastrophe such as what Europe is currently experiencing—you know, the sort of thing people like Kent Heckenlively are working to produce.</p> <p>Truth be told, I'm still ambivalent about methods more stringent than laws like SB 277, which eliminate personal belief exemptions to school mandates. I hope things don't get so bad that that begins to change.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Tue, 07/11/2017 - 22:37</span> <div class="field field--name-field-blog-categories field--type-entity-reference field--label-inline"> <div class="field--label">Categories</div> <div class="field--items"> <div class="field--item"><a href="/channel/education" hreflang="en">Education</a></div> </div> </div> Wed, 12 Jul 2017 02:37:31 +0000 oracknows 22584 at https://scienceblogs.com