Medicine https://scienceblogs.com/channel/medicine/feed en “A gift to the construction industry”: catchy quotes from Court of Appeals argument on OSHA’s silica standard https://scienceblogs.com/thepumphandle/2017/10/14/a-gift-to-the-construction-industry-catchy-quotes-from-court-of-appeals-argument-on-oshas-silica-standard <span>“A gift to the construction industry”: catchy quotes from Court of Appeals argument on OSHA’s silica standard</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>OSHA <a href="http://scienceblogs.com/thepumphandle/2016/03/24/sorry-it-took-so-long-osha-issues-rule-to-protect-workers-exposed-to-silica-dust/">took the long road</a> to adopt a standard to address respirable crystalline silica. Although the final rule was issued in March 2016, it is being challenged by both industry and labor groups. The first says OSHA went too far, the other says OSHA didn’t go far enough.</p> <p>The long road, however may be coming close to end. The U.S. Court of Appeals for the District of Columbia Circuit heard oral arguments last week from parties that are challenging the rule. Judges Merrick Garland, David Tatel and Karen LeCraft Henderson spent more than two hours listening to arguments from the National Stone, Sand and Gravel Association (NSSGA), the Brick Industry Association (BIA), the U.S Chamber of Commerce, the North America Building Trades, the United Steelworkers and others.  Attorneys with the Department of Labor’s Office of the Solicitor were there, too, to defend the OSHA rule.</p> <p>I enjoyed listening (and relistening) to the <a href="https://www.cadc.uscourts.gov/recordings/recordings2018.nsf/FBB1D597702702BE852581A70057DDFE/$file/16-1105.mp3">court’s audio</a> of the oral argument. What made it particularly enjoyable was listening to the judges---they did their homework!</p> <p>Judges Garland and Tatel, in particular, probed, cajoled, and challenged the attorneys to clarify their arguments. The judges pressed the attorneys on issues concerning economic feasibility, health risks, and the legal standard for substantial evidence. There were plenty of references to prior litigation on OSHA health standards. They mentioned significant previous court decision on OSHA standards, such as for asbestos, lead and formaldehyde.  I felt a bit like an outsider, listening to the attorneys speak about those rulings. They described them as if they were old friends who remain relevant today. And like relationships with old friends, we don't always agree about what she said or remember events in the same way.</p> <p>There were times during the oral arguments that the presenting attorney rose to a judge’s challenge for a cogent response. But I cringe a few times when I heard nervous laughter from an industry attorney who knew he was stumped by the judge’s question.</p> <p>Below are just some of my favorite quotes and exchanges. The text doesn't capture the animation I heard in the audio from the courtroom or the commitment of the attorneys to their arguments. I've included a time stamp at each quote so you can listen for yourself. (I had difficulty distinguishing Judge Garland’s from Judge Tatel’s voice. If I incorrectly attribute the quotes, please leave a comment and I’ll correct it.)</p> <p>NSSGA and BIA argue that OSHA overstates the risk of health harm caused by exposure to respirable crystalline silica. Their attorney, William L. Wehrum, said:</p> <blockquote><p>“We assert that OSHA had a thumb on the scale. We believe the record makes clear that OSHA came to this rulemaking with a determined goal of reducing the level of the standard. We believe it clouded OSHA’s judgement and caused it to lose objectivity, which we believe permeates the entire proceeding." [00:02:36]</p></blockquote> <p>Judge Tatel chimed in:</p> <blockquote><p>"You say that OSHA had its thumb on the scale, which is a curious statement given our standard of review. The question is: is there significant evidence in the record to support OSHA’s position for what it did? <em>You</em> can certainly point to contrary evidence, but OSHA has explained <em>all</em> that. ...You have to make your argument in terms of our specific standard of review, which is the substantial evidence question. Our case law is very specific about that."</p></blockquote> <p>Sounding like a law professor Tatel added:</p> <blockquote><p>"What’s your <em>best</em> argument regarding the substantial evidence test?" [00:04:19]</p></blockquote> <p>Wehrum had difficulty providing a short and sweet and precise answer.</p> <p>Judge Garland addressed the problem for the court of dueling scientists. William Wehrum tried to describe the evidence from his side's experts, but Garland interrupted:</p> <blockquote><p>"We have scientists on both sides and the law here is quite clear. When there are scientists on both sides, OSHA is permitted to take the ones that are most likely to protect worker safety. There is <em>supposed</em> to be a thumb on the scale in terms of safety. ...That's what our own case says. It is perfectly appropriate for OSHA to weight in favor of worker safety. That's right, isn't it. [00:09:56]</p></blockquote> <p>William Wehrum: "Correct your honor to a point, but that dosen't insulate OSHA from review.</p> <p>Soundly a bit frustrated, Garland said:</p> <blockquote><p>"That's what we doing here, but it is not enough to say there is a plausible mechanism. You have to be able to show that OSHA's studies are not <em>themselves</em> substantial evidence."</p></blockquote> <p>The attorney representing the U.S. Chamber of Commerce was also schooled by Judge Garland. This time it was a math problem.</p> <p>Attorney Michael Connolly argued that there are so few deaths today is the U.S. from silicosis that OSHA has not met its burden of demonstrating that exposure to respirable silica poses a significant risk of harm to workers. Connolly pointed to the low number of silicosis deaths reported on death certificates and compared to the millions of workers in silica-related industries.</p> <p>Judge Garland asked [00:18:50]:</p> <blockquote><p>"Is that the right <em>division</em>? Dividing the total number of deaths that are reported on the death certificates by the total number of workers in <em>industry</em>? Or is the right number the total number of deaths at a certain level of exposure? That is, in terms of the 1 in 1,000 test.</p></blockquote> <p>(The "1 in 1,000" comes from a <a href="https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=preambles&amp;p_id=748">1980 Supreme Court ruling</a> about OSHA's benzene standard. The Supreme Court justices did not offer a specific ratio but indicated that the threshold likely fell somewhere between 1 death per 1 billion (which would not be considered significant) to 1 death per 1,000 (which would be significant.))</p> <p>Judge Garland continued:</p> <blockquote><p>"It's not supposed to be just 1 over the entire population of the United States, or 1 over everybody who works. It’s supposed to be 1 over 1,000 people who work at a certain exposure level, isn’t that right?"</p></blockquote> <p>Michael Connolly: "Sure. That’s correct."</p> <p>Judge Garland:</p> <blockquote><p>"Isn't it exposed to silica <em>at a certain exposure levels</em> that matters? Not all people who may have been exposed to silica? [20:03]</p></blockquote> <p>Score one for the judge.</p> <p>I wish I'd been in the courtroom for that exchange. I would have turned my head to see if Judge Garland's remark brought a smile to the attorneys who were defending OSHA's rule.</p> <p>Labor Department attorney Kristen Lindberg was charged with responding to some of the arguments raised by the industry petitioners. Among her excellent synopsis was this:</p> <blockquote><p>[00:35:00] "It's worthwhile to step back a little bit and review the support OSHA had in the record for its findings. Their risk assessment findings were supported by nearly all of the occupational health and medical organizations that commented on the rule, including NIOSH, the American Cancer Society, the American College of Occupational and Environmental Medicine, the American Thoracic Society, the Association of Occupational and Environmental Clinics, and the American Public Health Association."</p> <p>"... Industry petitioners want you to reject conclusions that have overwhelming support among scientists and that were supported by the independent peer reviewers who scrutinized OSHA’s risk assessment. They want you to reject this extensive body of scientific evidence on the flimsy basis that there are flaws in some of the studies that OSHA relied upon and that there is uncertainty in epidemiology. They want you to impose a legal burden on OSHA that the agency could never meet."</p> <p>[00:36:53] "The broad support for OSHA’s conclusions within the scientific community should increase the court’s confidence that OSHA’s analysis is sound. The courts understand that OSHA, in marshalling scientific evidence to support a risk assessment, cannot ever reach perfection because the science those risk assessments are based on is not perfect. There <em>will be</em> flaws in studies, there <em>will be</em> stronger and weaker studies, there may be some uncertainty, but what OSHA has done here, its extensive analysis based on a huge body of evidence conforms fully with the OSH Act and with the requirements of courts that have interpreted the OSH Act."</p></blockquote> <p>Bradford Hammock argued the case on behalf of the National Association of Home Builders and other industry groups. He tried to convince the judges that OSHA's requirements for the construction industry are not technological feasible.</p> <p>Victoria Bor, the counsel for North America’s Building Trades Unions dismissed Mr. Hammock's assertions. Her argument began with the following [00:67:40]</p> <blockquote><p>"By way of context, Table 1, which is the centerpiece of the construction standard, is a <em>gift to the construction industry</em>. Most OSHA standards set a permissible exposure limit and require employers to monitor their workplaces and devise their own strategies following the hierarchy of controls to bring exposures below the permissible exposure limit (PEL). The silica standard gives employers options. They can follow the traditional approach or they can follow Table 1, which is in effect is a manual that lists 19 of the 23 construction tasks that most commonly generate significant silica exposure, and specifies control strategies for each. Employers who fully and properly implement the controls listed on Table 1 are freed from monitoring their workplace and have a safe harbor for complying with the PEL.</p> <p>"...OSHA assumes that most employers will follow table, which is a completely reason assumption because it tells employers exactly what they have to do, frees them from monitoring, and gives them a safe harbor for complying with the PEL."</p> <p>"Now rather than accepting this gift, as Mr. Hammock already explained to you, the industry petitioners point to Table 1 and argue that to the extent it requires the use of respirators....OSHA is conceding that the standard isn't feasible. ...The petitioners’ argument completely ignores that Table 1 does not require employers to comply with the PEL. What it requires is for employers to implement the listed controls. So whether the PEL can be reached without the use of respirators---the question that the industry petitioners focus on--- is actually completely irrelevant."</p></blockquote> <p>Victoria Bor continued:</p> <blockquote><p>"What is relevant, as Ms. Goodman [of the Labor Department] said, is that the typical employer can comply with Table 1 most of the time. On this question, the petitioners argument on feasibility rests on vague assertions that in <em>certain</em> circumstances,<em> certain</em> employers may not be able to use <em>certain</em> of the wet methods listed in Table 1 at <em>some</em> time. …Petitioners point to <em>no</em> evidence that undermines OSHA’s conclusions that most employers will be able to comply with Table 1 by utilizing those controls most of the time."</p></blockquote> <p>There was dead silence after her rebuttal. None of the judges asked Victoria Bor to clarify or further defend her arguments. They seemed convinced.</p> <p>The excerpts above are just some of memorable moments from the oral argument. Another was a lengthy argument by the unions and rebuttal by the Labor Department about OSHA's provisions for medical surveillance and medical removal protections. It was the one time that the Labor Department's case seemed on shaky ground.</p> <p>If you  <a href="https://www.cadc.uscourts.gov/recordings/recordings2018.nsf/FBB1D597702702BE852581A70057DDFE/$file/16-1105.mp3">listen to the audio</a> for yourself you'll hear the word "grapple" used numerous times by attorneys for the unions. You'll hear the Labor Department attorneys repeat the phrase"de minimis benefit." You'll hear one judge say to an industry attorney "it's not your principle argument, it's your <em>only</em> argument" and another judge mention "a shopping list." You'll hear all the parties claim that OSHA's decisions are, or are not, "supported by the record." Finally you'll hear many references to previous Supreme Court and Appeals Court decisions on other OSHA standards.</p> <p>It's been many years since OSHA started down the road toward a comprehensive silica standard. People will disagree on when the agency actually hit the road, but they know that last week's stop at the U.S. Court of Appeals means the road may soon be coming to an end.</p> <p>Judges Garland, Henderson, and Tatel are now at the wheel. They will decide whether OSHA's rule will stand as is, or whether the agency needs to make a U-turn.</p> <p>I relished listening to the oral arguments. I'll be eager to read the judge's opinion when it's issued.</p> <p> </p> <p> </p> <p> </p> </div> <span><a title="View user profile." href="/author/cmonforton">cmonforton</a></span> <span>Sat, 10/14/2017 - 11:19</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Sat, 14 Oct 2017 15:19:29 +0000 cmonforton 62941 at https://scienceblogs.com Gun control laws can impact death rates. But we need more research to find what works. https://scienceblogs.com/thepumphandle/2017/10/05/gun-control-laws-can-impact-deaths-rates-but-we-need-more-research-to-find-what-works <span>Gun control laws can impact death rates. But we need more research to find what works.</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Guns are the third leading cause of injury-related death in the country. Every year, nearly 12,000 gun homicides happen in the U.S., and for every person killed, two more are injured. Whether Congress will do anything about this violence is a whole other (depressing) article. But there is evidence that change is possible.</p> <p>Last year, a <a href="https://academic.oup.com/epirev/article/38/1/140/2754868/What-Do-We-Know-About-the-Association-Between" target="_blank" rel="noopener noreferrer">study</a> published in <em>Epidemiologic Reviews</em> “systematically” reviewed studies examining the links between gun laws and gun-related homicides, suicides and unintentional injuries and deaths. Researchers eventually gathered evidence from 130 studies in 10 countries, finding that in certain places, gun restrictions are associated with declines in gun deaths. For instance, laws that restrict gun purchasing, such as background checks, are associated with lower rates of intimate partner homicide; while laws addressing access to guns, such as safe storage policies, are associated with lower rates of unintentional gun deaths among children. Study co-authors Julian Santaella-Tenorio, Magdalena Cerdá, Andrés Villaveces and Sandro Galea write:</p> <blockquote><p>This heterogeneity in approaches and implementation methods makes it critical to identify approaches that are less likely to be effective and to identify which strategies, looking forward, may be more likely to work. In addition, examining the associations between specific policies and firearm-related deaths across countries can improve our understanding about which types of laws are more likely to be successful in reducing firearm mortality rates in similar contexts or within diverse legal frameworks.</p></blockquote> <p>The study’s findings are a mixed bag — some of the gun laws studied seemed to reduce gun deaths, while others seemed to make no difference or increase deaths. For example, a number of studies examined found no association between concealed carry laws and gun homicides in the U.S. However, one study using injury data from southern Arizona found higher proportions of firearm injuries and deaths associated with concealed carry. Yet another study in Colombia examined the effects of laws banning the carrying of guns during weekends after paydays, holidays and elections days in two Colombian cities, Cali and Bogota. That study found a 14 percent reduction in homicide rates in Cali during no-carry days and a 13 percent reduction in Bogota.</p> <p>Studies on background checks and waiting periods came in mixed as well. For example, one study cited found no association between waiting periods and homicides and suicides. On the other hand, researchers have found that gun purchase bans for people with certain mental health conditions were associated with fewer homicides. One study found more stringent background checks were linked with fewer gun homicides. States with laws banning people with domestic violence restraining orders from owning and purchasing a gun also experienced reductions in intimate partner homicide. But one study found no homicide effect for laws that restricted gun access among those convicted of domestic violence.</p> <p>Two cross-sectional studies analyzed found that gun permits and licenses were associated with lower rates of gun suicide. In Missouri, researchers studied the effect of repealing requirements that people need a valid license to buy a gun, finding the repeal was associated with a 25 percent increase in homicide rates. On laws regulating gun storage, one study found that such child access prevention laws were associated with fewer unintentional gun deaths among children younger than 15, but not among older teens. Another found child access laws were linked to a reduction in all suicides among people ages 14 to 17. A study using hospital discharge data found that such storage laws were associated with lower nonfatal gun injuries among those younger than 18.</p> <p>The <em>Epidemiologic Reviews</em> study included research on particular laws as well. For example, a study on the U.S. Gun Control Act of 1968 — which restricted the sale of so-called <a href="https://en.wikipedia.org/wiki/Saturday_night_special" target="_blank" rel="noopener noreferrer">Saturday night specials</a>, among many other measures — did not find associated changes in homicide rates. But a study on Washington, D.C.’s 1976 law banning ownership of automatic and semiautomatic firearms and handguns found an “abrupt” reduction in homicide and suicide rates. Globally, Australia’s 1996 National Firearms Agreement, which banned certain kinds of firearms, was linked with a significant reduction in gun death rates. In addition, Australia has not experienced a mass shooting since the law was enacted. Control gun laws in Brazil, Austria and South Africa were also associated with fewer gun deaths.</p> <p>Overall, researchers were able to identify some “general observations” in combing through the 130 studies — most notably finding that the simultaneous enactment of laws targeting multiple gun regulations were associated with fewer gun deaths in certain countries. Another big finding: we simply need more research to understand what works and what doesn’t to prevent gun deaths. The researchers also noted that few studies have delved into the impact of gun safety laws on particular populations or whether such laws affect social attitudes, norms and behaviors. The authors write:</p> <blockquote><p>To conclude, we have provided an overview of national and international studies on the association between firearm-related laws and firearm injuries/deaths. High-quality research overcoming limitations of existing studies in this field would lead to a better understanding of what interventions are more likely to work given local contexts. This information is key for policy development aiming at reducing the burden posed to populations worldwide by violent and unintentional firearm injuries.</p></blockquote> <p>In more recent gun research, a <a href="http://content.healthaffairs.org/content/36/10/1729.abstract" target="_blank" rel="noopener noreferrer">study</a> published this month in <em>Health Affairs</em> set out to quantify the clinical and economic burden associated with emergency room visits for gun-related injuries in the U.S. Researchers examined data from the Nationwide Emergency Department Sample, identifying 150,930 people between 2006 and 2014 who showed up to an ER alive, but with a gun-related injury. That number represents a weighted estimate (that’s a fancy term for adjusting data to represent the greater population) of 704,916 patients.</p> <p>ER visits for gun injuries was lowest among those younger than 10 and highest among ages 15 to 29. Incidence of gun injury was about nine-fold higher for male patients — among men ages 20 to 24, more than 152 patients per 100,000 visited the ER for a gun injury. Most of the patients had been injured in an assault or unintentionally. The proportion injured in an attempted suicide was more than two-fold higher among Medicare beneficiaries. Handguns were the most common cause of the injury, followed by shotguns and hunting rifles.</p> <p>Among the more than 150,000 cases of gun injury at the ER, 48 percent were discharged home, 7.7 percent were discharged to other care facilities, about 37 percent were admitted to the hospital and just more than 5 percent died during their ER visits. Overall, 8.3 percent of the gun injury patients either died in the ER or as an inpatient. The average charge for gun injury in the ER was about $5,250; the average charge for those admitted was more than $95,000. Over the entire study period, gun-related injuries cost $2.9 billion in ER charges and $22 billion in inpatient care.</p> <p>Authors of the <em>Health Affairs</em> study also pointed out the need for more research, citing a 1996 federal measure known as the Dickey Amendment that said injury research funds at the Centers for Disease Control and Prevention could not be used to advocate or promote gun control. Co-authors Faiz Gani, Joseph Sakran and Joseph Canner write:</p> <blockquote><p>Researchers, politicians and government officials must work together to ensure that research funds are allocated to promote the understanding of the complex interplay between social, economic and medical factors associated with firearm-related injuries. Only through the adoption of an evidence-based public health approach can the resulting substantial medical and financial burden be reduced.</p></blockquote> <p>To request a full copy of the ER study, visit <a href="http://content.healthaffairs.org/content/36/10/1729.abstract" target="_blank" rel="noopener noreferrer"><em>Health Affairs</em></a>. For a copy of the gun policy study, visit <a href="https://academic.oup.com/epirev/article/38/1/140/2754868/What-Do-We-Know-About-the-Association-Between" target="_blank" rel="noopener noreferrer"><em>Epidemiologic Reviews</em></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 — <a href="http://www.twitter.com/kkrisberg" target="_blank" rel="noopener noreferrer">@kkrisberg</a>.</em></p> </div> <span><a title="View user profile." href="/author/kkrisberg">kkrisberg</a></span> <span>Thu, 10/05/2017 - 12:30</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Thu, 05 Oct 2017 16:30:31 +0000 kkrisberg 62938 at https://scienceblogs.com If Rigvir is effective "virotherapy" for cancer, why are quack clinics selling it and quackery promoters like Ty Bollinger promoting it? https://scienceblogs.com/insolence/2017/10/02/if-rigvir-is-effective-virotherapy-for-cancer-why-are-quack-clinics-selling-it-and-quackery-promoters-like-ty-bollinger-promoting-it <span>If Rigvir is effective &quot;virotherapy&quot; for cancer, why are quack clinics selling it and quackery promoters like Ty Bollinger promoting it?</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p><em>Last week, I <a href="http://respectfulinsolence.com/2017/09/25/rigvir-a-cancer-cure-imported-from-latvia-that-cancer-patients-should-avoid/">wrote about Rigvir</a>, a highly dubious cancer therapy developed in Latvia. Rigvir is an oncolytic virus, and its proponents claim that it targets only cancer cells for destruction, leaving normal tissue alone. Its history and how it came to be approved in Latvia in 2004 and added to the Latvian Health Ministry's list of reimbursable medications in 2011 remain rather mysterious, but how it is being marketed does not. For example, Rigvir has become a new favorite treatment at a number of quack clinics, such as the Hope4Cancer Institute in Mexico, where Rigvir is offered along with <a href="https://sciencebasedmedicine.org/ask-the-science-based-pharmacist-what-are-the-benefits-of-coffee-enemas/">coffee enemas</a> and a wide variety of quackery. Moreover, as I described last week, there is a striking paucity of evidence supporting the efficacy of Rigvir against any cancer, even melanoma, the cancer for which Rigvir is approved in Latvia and for which there appears to be almost no published evidence at all. Certainly there is nothing resembling well-designed randomized clinical trials supporting the efficacy of Rigvir. Basically, few outside of Latvia and Eastern Europe had heard of Rigvir, as it had flown under the radar, most likely because Latvia is a small country. Then Ty Bollinger featured Rigvir in <a href="https://www.cancertutor.com/ttac-global-quest-cancer-killing-viruses-cancer-stem-cells-gmos-juicing/" rel="nofollow">Episode 3</a> of his alternative medicine propaganda video series <a href="https://www.cancertutor.com/global-cancer-documentary/" rel="nofollow"><cite>The Truth About Cancer</cite></a> (<cite>TTAC</cite>), complete with "miracle cure" testimonials, and suddenly Rigvir wasn't so obscure any more.</em></p> <!--more--><h2><cite>The Truth About Cancer</cite> promotes Rigvir</h2> <p>As I've discovered since last week, the people who run the International Virotherapy Center, where Rigvir is manufactured and sold, are not particularly happy about the increased level of attention directed at them. Indeed, within 15 hours of last week's post going live, I had received an e-mail from someone named Lelde Lapa, whose title was listed as Assistant of Business Development Department at the International Virotherapy Center (IVC). She was quite…unhappy with my post. Personally, I was amazed at how fast I received such a long e-mail after publishing my post. Clearly the IVC has many Google Alerts set for Rigvir and its name and is fast to act.</p> <p>As of this writing, the exchange is up to four e-mails, two from Ms. Lapa and two responses from me. One thing stood out, and that was how my charge that IVC irresponsibly markets Rigvir using patient testimonials seemed to produce the most defensive response. Based on that, I thought I would look a bit more at how Rigvir is actually marketed, starting with how Ty Bollinger featured it in Episode 3 of <cite>TTAC</cite>. (After all, Ty Bollinger's video series is where most cancer patients interested in alternative medicine learn about Rigvir.) Although I couldn't force myself to watch more than about the first half hour of the first episode of <cite>TTAC</cite> when it was first released, fortunately <a href="https://sciencebasedmedicine.org/the-truth-about-cancer-series-is-untruthful-about-cancer/">Harriet Hall could</a> and I did download all the episodes off of YouTube when they were briefly available for free. This allowed me to watch the segment on Rigvir, which starts at around the one hour mark and takes up most of the last half hour of the episode.</p> <p>The segment begins with an interview with Kaspars Losans, MD, IVC's medical director. Dr. Losans claims that Rigvir is a "very good" virus that specifically targets cancer cells and leaves normal cells alone. Next up, we meet Ivars Kalvins, PhD, who is the Director of the <a href="http://www.osi.lv" rel="nofollow">Latvian Institute of Organic Synthesis</a>, which is a "state research institute specializing in pharmaceutical research, organic chemistry, molecular biology and bioorganic chemistry." (The appearance of a scientist from a Latvian state research institute made me wonder a bit about collusion between the government and the IVC, for obvious reasons.) In his narration, Bolinger notes that Dr. Kalvins is a member of the European Academy of Sciences and <a href="http://www.independent.co.uk/news/science/european-inventor-award-can-a-british-inventor-win-in-the-oscars-of-innovation-10306192.html">one of three finalists for the European Medicine Award in 2015</a> and has many publications and patents. In contrast, he does not mention that Dr. Kalvins <a href="http://www.delfi.lv/bizness/uznemumi/vairakas-arstu-organizacijas-prasa-izvertet-rigvir-kompensesanu.d?id=48494303">owns a 3% stake in Rigvir</a>. Googling him, I found that he is best known for developing a heart medication, <a href="https://en.wikipedia.org/wiki/Meldonium">Mildronate</a> (generic name: meldonium). Interestingly, although Bollinger claims Kalvins has over 650 publications, I could only find ten in PubMed.</p> <p>In any case, my first thought was: If such a seemingly good "conventional" scientist is behind Rigvir, then why is it that the IVC has not published anything resembling good science supporting its claims for Rigvir? This is not a person who doesn't know how to publish. Oddly enough, he is not co-author of any of the few publications I could find in PubMed about Rigvir. Less oddly, given his support of Rigvir, he is not well-regarded outside of Latvia, basically because he makes claims for meldonium that are <a href="http://www.cnn.com/2016/03/08/health/sharapova-doping-meldonium-mildronate/">equally unsupported</a>. Indeed, meldonium was the alleged performance-enhancing drug that Russian tennis player Maria Sharapova was <a href="http://www.cnn.com/2016/03/08/health/sharapova-doping-meldonium-mildronate/">caught using last year</a>, leading to her suspension. Although it is approved in Latvia and several former Soviet Republics, it is not approved in the U.S. or European Union. Maybe Dr. Losans isn't quite the good conventional science that the first impression gave me.</p> <p>Be that as it may, Dr. Kalvins goes through the standard "history" of Rigvir, specifically about how Prof. Aina Muceniece discovered it. Interesting to me is Dr. Kalvins's claim that Rigvir is used "very, very successfully" to treat melanoma and "not only melanoma." I also wondered about his claim that Rigvir is a native, non-modified virus. That, of course, is likely true, as Rigvir is an Echovirus, specifically ECHO-7. As I mentioned last time, Echoviruses are RNA viruses that were thought to be orphan viruses (viruses with no known disease associated with them) but in fact do cause mostly (but not always) mild febrile diseases. In any case, Dr. Kalvins claims that Rigvir is a "non-mutating" virus, which, of course, also set my skeptical antennae a'twitching given that there is no such thing as a totally non-mutating virus. I suppose it's possible that he means the ECHO-7 strain used in Rigvir doesn't cause mutations in human cells, but who can tell for sure?</p> <p>We also meet another physician, Peteris Alberts, MD, PhD, who is IVC's Head of Research &amp; Development. After Bollinger says that Rigvir's activity was first demonstrated in mice, Dr. Alberts says:</p> <blockquote><p> <strong>Dr. Peteris Alberts:</strong> They found that if you take a tumor from a patient, put it into a hamster, then it will start growing, or something like that. If you put [it] on the virus, it will just fade away. Do you know who did that observation first? Ms. Garklava, the lady you saw this morning.</p> <p><strong>Ty:</strong> Really? </p> <p><strong>Dr. Peteris Alberts:</strong> Yeah. She did that. </p></blockquote> <p>There is a very brief shot of Bollinger interviewing an old woman, but none of the interview is heard, which I found odd.</p> <p>Indeed, there are a lot of claims made for Rigvir, none of which seem to be supported by any publications that I've been able to find indexed in PubMed. For example, Dr. Kalvins is shown saying:</p> <blockquote><p> There are at least ten different cancers, locations of cancer like renal cancer, like breast cancer, like stomach, lung, many others, also prostate cancer, which is very, very common for men. But, approved officially, it is only for melanoma now, but this is a very, very big success because we see that the people who use this virus for other indications of other types of cancers also can be healed. </p></blockquote> <p>If this is true, then the IVC should publish these results. One of the excuses that IVC makes for not having published clinical trials to support Rigvir's efficacy and safety against cancer is lack of finances. However, if the IVC has already done preclinical work that shows all this, there is absolutely nothing preventing it from publishing those results. It hasn't. Why is that? (I think I know the answer.)</p> <p>Another claim is made by Elita Shapovalova, MD, an oncologist at Riga East Clinical University Hospital:</p> <blockquote><p> In melanoma cases, in earlier stages when patients receive Rigvir, the percentage survived is 92 percent. And later stages, for example, if they receive Rigvir it's 60 percent. If they don't receive it, it's only 9 percent. There's no chemotherapy medicine that can treat melanoma, at least not found. In the beginning, we were using radiotherapy. But then, it got rejected. So we could not use it because it kills the immune system and it's very hard to fight. We come back to chemotherapy — the medicine in the chemotherapy field is not found to cure melanoma. And the second negative is that it has side effects, which simply destroys the immune system, which lowers the quality of life of the patient, and simply changes the whole life of the patient by these side effects. </p></blockquote> <p>Again, if this is true, then the IVC should publish these results. As I <a href="hhttp://respectfulinsolence.com/2017/09/25/rigvir-a-cancer-cure-imported-from-latvia-that-cancer-patients-should-avoid/">discussed last week</a>, the existing publications indexed in PubMed supporting the efficacy of Rigvir against melanoma are <em>very</em> unconvincing, and there are no randomized clinical trials to speak of, at least none to which I have access. (In actuality, in our e-mail exchanges, Ms. Lapa basically admitted that the IVC has no clinical trial results that meet modern standards.) For other cancers, the paucity of evidence is even more obvious.</p> <p>None of that stops Dr. Kaspars Losans from claiming:</p> <blockquote><p> Then comes the second mechanism of RIGVIR. Whenever those RIGVIRs are attracted to cancer cells, those cancer cells become visible for the human immune system. Until that time, they are invisible, they have the natural ability to be hiding from the immune system. And due to the RIGVIR guidance, because RIGVIR is attached, and attach to cancer, and RIGVIR is inside the cancer cell. So the immune system, due to RIGVIR, recognizes cancer and starts to react against this cancer. </p></blockquote> <p>One more time, if this is true, than IVC should publish these results. This is the sort of immunological mechanism that would take a lot of cell culture, animal, and clinical work to demonstrate properly. That's a detailed mechanism that Dr. Losans is claiming. If IVC has the experimental and clinical results to demonstrate such a mechanism, it should publish them. If it doesn't, it has no business making claims like this on a documentary by a well-known proponent of cancer quackery, or anywhere else, for that matter.</p> <p>Also, Dr. Alberts should stop making the ridiculous claim that prefaced Dr. Losan's description of Rigvir's mechanism of action that Rigvir is "the first real cancer therapy where you have an oncolytic virus which also has immunomodulating activity." There are lots of oncolytic viruses under study with immunomodulatory activity. <em><strong>That's the point!</strong></em> <a href="http://www.nature.com/nrd/journal/v14/n9/full/nrd4663.html?foxtrotcallback=true">That's the whole idea behind oncolytic viruses</a>, that they "promote anti-tumour responses through a dual mechanism of action that is dependent on selective tumour cell killing and the induction of systemic anti-tumour immunity." Seriously, even if everything the IVC and its minions say about Rigvir is true regarding its mechanism of action, Rigvir is not the only oncolytic virus with a dual mechanism of action!</p> <p>Finally, having Antonio Jimenez, the director of the Hope4Cancer Institute opining about how Rigvir boosts the immune system doesn't help the credibility of Rigvir:</p> <blockquote><p> Often times, in clinical practice, we focus on optimizing the immune system – getting the best immune system possible. And that's great. But still, cancer cells have now developed a way to bypass immune recognition. And the International Virotherapy Center here in Latvia, with the studies on RIGVIR, they have concluded that the RIGVIR is binding to the receptor site on the cancer cell surface, called the CD55. When it binds to this receptor, now the T-cells, the B-cells, the natural killer cells, will recognize the cancer cells and mount a specific immune response. </p></blockquote> <p>Again, that's a very specific mechanism that Jimenez is proposing. Where's the evidence to support it?</p> <p>Again, seriously, any truly scientific institute that had developed a drug would not want a quack like Ty Bollinger or Dr. Jimenez endorsing its discovery. That's the kiss of death as far as scientific credibility goes. Yet IVC embraces these quacks, sells to the Hope4Cancer Institute, and gladly lets its product be featured on a video documentary series designed to attack conventional oncology and promote alternative cancer quackery.</p> <p>I also can't help but scoff at the claims, made by several IVC boosters, that Rigvir has "no side effects." For one thing, there is no such thing as an effective medicine that has absolutely no side effects. It's clearly just not true. After all, even in the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560272/"><cite>Melanoma Research</cite> paper from 2015</a> that I trashed last week as being so badly done, the authors noted that in previous clinical studies Rigvir had caused subfebrile temperature (37.5°C for a couple of days), pain in the tumour area, sleepiness, and diarrhea. Again, whenever anyone claims that an anti-cancer medication (or any medication, for that matter) is completely without side effects, I start becoming very suspicious.</p> <h2>But what about the testimonials?</h2> <p>A key part of <cite>TTAC</cite>'s segment on Rigvir consists of three testimonials. The first was from a woman named Khrystyna Yakovenko, who in 2012 was diagnosed with melanoma that had metastasized to the liver:</p> <blockquote><p> It all started in the end of 2012. When I contacted my doctor, he diagnosed melanoma of the fourth stage, with a metastasize of the liver. They prescribed the plan of chemotherapy and at that time, I even didn't understand what is what. I completely trusted our Ukrainian doctors and I trusted the methods they are using. I trusted this plan of chemotherapy. So I simply didn't realize — I didn't realize the effect of this diagnosis completely, entirely at that moment. </p></blockquote> <p>I can't help but note that here Bollinger invokes a typical trope used by quacks, that you have to "believe" in the therapy, saying, "one of the very important parts about a successful cancer treatment is that you believe in it and you're ready to fight to save your life." After that, Yakovenko relates:</p> <blockquote><p> I was not feeling afraid. I was not falling into panic. Simply, I understood that I had no right to leave it. I had to fight. When I first came to my therapy center, doctors didn't say, "Yes, we will do it." They said, "We will try." Because the stage was late. I think that sometimes on the earlier stages — on the initial stages people who have this very scary diagnosis, they sometimes are by themselves. They lose hope. They stop the fight. And they simply leave it. But, sometimes there are people who, even at late stages, they continue to fight, and continue to find the out of the situation. In this case, as the disease simply just is overwhelming. </p></blockquote> <p>So, basically, Ms. Yakovenko is a woman who was given a "maximum" of a couple of years to live, but was alive in late 2015 or early 2016, when this film was being made. That's about three years, which is very good but not evidence that Rigvir prolonged Ms. Yakovenko's life. Melanoma can have a highly variable course, and there are patients who survive with stage 4 melanoma for years. They are the outliers, of course, but there are too many of them to take someone who survived less than twice as long as predicted as slam dunk evidence that whatever cancer treatment she chose worked. I also can't help but notice that no scans are shown, and no mention is made of whether her cancer shrank, was stable, or progressed. Yes, this is yet another unconvincing <a href="http://oracknows.blogspot.com/2004/12/understanding-alternative-medicine.html">cancer cure testimonial</a>.</p> <p>A more recent interview, dated December 2016, is published on the <a href="https://virotherapy.blog/2016/12/05/i-have-personally-met-this-brave-lady-just-a-few-days-ago/">blog of the Virotherapy Foundation</a> (mentioned last week). Thus, Ms. Yakovenko's story is continuing to be used to promote Rigvir, with her saying, "I have already been alive for 2 years and 7 months thanks to Rigvir," which suggests that this interview occurred in the latter half of 2015, given that she started Rigvir in February 2013.</p> <p>The next testimonial is a man named Ruslan Isayev, who reports that he was only given seven months to live. In the interview, we are not even informed what kind of cancer Mr. Isayev had, other than that he had surgery for it. I presumed that he had melanoma, which turned out to be correct, as you will see, but it's very sloppy not to have specified the cancer. In any event, Mr. Isayev states that he tried chemotherapy after his surgery but couldn't take it and stopped, living "for one year more without chemotherapy," after which he decided to start Rigvir. Naturally, he credits the Rigvir with saving his life and even holds up a picture of his son, noting that he had been told that it would be very difficult for him to have any more children and that when he learned that his wife had become pregnant he vowed that "if were to be a girl, a daughter, I would name her after Aina Muceniece — after Professor Aina Muceniece, who was the discoverer, the great person, so Aina. And if it were to be a boy, then I would name him after the chairman of virotherapy, Jurgis, who is the grandson of Professor Aina Muceniece." It was a boy, and he named him Jurgis.</p> <p><a href="https://sites.google.com/a/njit.edu/yzs3portfolio/hum-102/research-paper">A little Googling revealed</a>, though:</p> <blockquote><p> In an interview on May 28, 2014, Ruslan Isayev gave a personal account of his experience with stage III skin melanoma. When he was diagnosed in 2010, the Chechen Republic doctors refused to operate on Ruslan. He went to Dagestan for surgery and after two weeks of lying in bed, the doctors gave Ruslan just seven months to live. He went to Grozny for chemotherapy, but after four doses he began to feel worse and worse. A local doctor then prescribed Interferon Alfa, a pharmaceutical drug meant to slow down tumor growth. Ruslan took this drug for one and a half years until a friend mentioned RigVir, an oncolytic virus created by the Latvian Academy of Sciences. After his third injection of RigVir, the doctors said his lymphonodus had shrunk and metastases disappeared. After a year of taking RigVir, Ruslan is alive and healthy. </p></blockquote> <p>Stage III melanoma is curable, I note. True, its survival rate is not great, but if the surgery is adequate long term survival is possible. I also note that Isayev received what sounds like considerable conventional therapy, including chemotherapy and a year and a half of interferon-alpha. As is the case with most such testimonials, it's very difficult to ascertain whether the treatment had anywhere near the effect claimed because too little information is given. <a href="http://es.allreadable.com/3160GnON">An account in Spanish</a> reveals a rather convoluted story in which Mr. Isayev had surgery, had a number of complications, briefly underwent chemotherapy, and then underwent treatment with interferon-alpha, during which time he claims that his disease did not progress but that it "didn't help me, either." (Stable disease is actually a desirable outcome.) He then claims that after he switched to Rigvir his lymph nodes shrank, his metastases disappearing. Overall, it's a convoluted story that does not really show that Rigvir is the reason why he's still alive. Again, most likely, it's the variable course of melanoma progression, the surgery, and interferon-alpha that have resulted in his continued survival.</p> <p>Finally, there is a Russian woman named Zoya Sokolova, who states that she was diagnosed with "third stage cancer." Again, the cancer isn't identified, and I assumed that it was melanoma as well. This time, I was incorrect. It was sarcoma, as you will see. (Google is my friend.) In any case, in <cite>TTAC</cite>, Ms. Sokolova reports:</p> <blockquote><p> It was— the diagnosis was very sudden for me. It was after a very strong stress, and then after a month and a half, I was diagnosed with a third stage cancer. Already after the surgery I had my chemotherapy, then they assigned another six chemotherapy and a full course of radiotherapy. My condition allowed only for chemotherapy to be handles, and after the fourth, I wasn’t able to stand up from the bed. I became a bed patient. Before these courses of chemotherapy I was told about a center, about a treatment, but I believed in our doctors and their treatment methods. So I decided to follow that path. </p></blockquote> <p>Then:</p> <blockquote><p> It seemed that they wanted it to be so for me, but they couldn’t give a warranty, they couldn’t say for sure that I would [beat] this disease. That moment when I couldn’t stand up from the bed on my own. I was so weak, and my relatives decided to take a van, to make a bed for me, and simply drive me to Riga, to the center. Before coming to Riga I made a blood test and a complete observation for the doctors here to have the full picture of my condition. When the doctor saw my blood test she was really astonished because all the blood tests was lower than for a live person. She was astonished how I managed to get here, staying alive. </p></blockquote> <p>Here's what it sounds like to me as a surgeon, based on the account above and the <a href="https://books.google.com/books?id=ktdKDQAAQBAJ&amp;pg=PT226"><cite>TTAC</cite> book</a> that told me she was being treated for sarcoma. <a href="https://www.cancer.org/cancer/soft-tissue-sarcoma/detection-diagnosis-staging/staging.html">Stage III sarcoma</a> means that either the cancer is larger than 5 cm in diameter and grade 3 histology or that it has spread to nearby lymph nodes. I note that stage III sarcomas are still potentially curable. Actually, even some cases of stage IV sarcoma are potentially curable if the distant metastases can be completely resected by surgery. Indeed, surgeons frequently resect lung and liver metastases from sarcoma, when they are few enough and small enough to be completely resected.</p> <p>My reconstruction of the testimonial is that Ms. Sokolova underwent radical surgery for her cancer, followed by chemotherapy and radiation, both of which are frequently used to treat sarcoma. She obviously had a very bad time of it, suffering multiple complications to the point where she was bedridden. After she began the Rigvir, she slowly recovered from the complications that she had suffered and, of course, attributed her recovery to Rigvir. At no point in this testimonial is any evidence provided that the Rigvir had any effect on her tumor. As far as I could tell from every description of her case, she was tumor-free at the time she chose to use Rigvir, just very ill from complications of surgery, radiation, and chemotherapy. Rigvir almost certainly did not save her, as much as Ms. Sokolava believes that it did, <a href="https://virotherapy.blog/2017/03/02/some-earlier-videos-from-zoya-sokolova/" rel="nofollow">tells the Virotherapy Foundation that it did</a>, and now uses virotherapy to "<a href="https://youtu.be/5InWy4_fVBo">strengthen her well-being</a>" and prevent recurrence. Again, there is no evidence that Rigvir prevents the recurrence of sarcoma.</p> <p>Not surprisingly, Bollinger laps up this story as evidence of how great Rigvir is as a cancer treatment.</p> <h2>A previously discussed testimonial revisited</h2> <p><a href="http://respectfulinsolence.com/2017/09/25/rigvir-a-cancer-cure-imported-from-latvia-that-cancer-patients-should-avoid/">In my post last week</a>, I briefly mentioned a testimonial that is featured on the <a href="https://www.virotherapy.eu/testimonials.php" rel="nofollow">International Virotherapy Center website</a>:</p> <iframe width="560" height="315" src="https://www.youtube.com/embed/yUdhf4rFqDY" frameborder="0" allowfullscreen=""></iframe><p> In brief, Nadine is a British woman who had melanoma in 1999 that recurred in 2009. We know that she's undergone surgery, radiation therapy, and chemotherapy, but that she still has cancer. She is portrayed in the video as doing well after having started Rigvir, even though she is not cancer-free. What I didn't know (but perhaps should have discovered through Googling) last week is that Nadine has a <a href="https://www.gofundme.com/nadineking">GoFundMe page</a> that paints a much more dire picture of her situation. It was last updated six months ago, which makes me worry about whether she is still alive:</p> <blockquote><p> Recently, she has seen huge success from a treatment she had at the Global Virotherapy Cancer Clinic in Latvia. The centre there offers holistic care and a course of virotherapy. Incredibly, just one week after returning from Latvia, Nadine's scan showed that the 2cm tumour on her lung had completely disappeared and all-but-two of her other tumours had shrunk significantly. This is a huge breakthrough and so now Nadine needs to obliterate all the other ones too and go back to Latvia every three months for further treatment at a cost of around £7,000 a time.</p> <p>Although this treatment isn't available in the UK, it is something that is now being trialled in the USA in combination with immunotherapy, which Nadine is receiving through our amazing NHS.</p> <p>This treatment is working amazingly well at keeping surface lumps and bumps at bay - a few injections at sites near them sees them shrinking and vanishing - so this must be kept going.</p> <p>Unfortunately though, the cancer has managed to take up residence in her lower intestine, making it impossible to eat or drink. Nadine, as resilient and incredible as ever, hasn't taken this lying down and has insisted the surgeons try to clear enough of her stomach to allow fluids to pass. As soon as this happens, she will be heading to Hungary for Gerson Therapy. This holistic therapy has been responsible for some fantastic results in other melanoma patients, and Nadine is determined to get out there and get this thing back under control. This therapy will cost around £7,000 too. So, Nadine really needs YOUR help! </p></blockquote> <p>Malignant small bowel obstruction due to melanoma is definitely not good. Fortunately, update #2 shows that she did undergo surgery for her bowel obstruction:</p> <blockquote><p> Just a little note to say Thank you to everyone who's checked in with me after my operation on Tuesday. </p> <p>I've been using the cannabis oil instead of morphine and codeine for pain relief, with the added bonus that I can't be bothered to speak or move.... My kids and sister are delighted!!!! Lol</p> <p>I am soooooo happy too, that with your help I'm almost at my target to help towards my next batch of treatment...I can't thank you enough.xxx<br /> I promise to send each of you a thank you message , bear with me... Xxxxx</p> <p>So next week once the shoulder starts to heal I have a full on week of getting back on track.</p> <p>Monday I'm meeting a lady to discuss Biomagnetism therapy, Tuesday follow up at the nutritionists, weds back to hospital for checks, Thursday we get back on the virotherapy injections.....and Saturday I start the spring mindfulness course, this is key in keeping my mind focused and living in the moment.xxxxxxxx</p> <p>Some times people ask me what I'm doing for work, as you can see, my full time job is trying to stay as well as possible and keep plugging away at trying to find why I've got this disease in the first place. </p></blockquote> <p>That was six months ago. It is unclear when the video featured on the IVC website was shot, but it's dated August 11, 2017. However, in it Nadine doesn't mention any surgery for a bowel obstruction; so either that was intentionally not mentioned, with the bowel surgery falling under the rubric of "many operations," or this video was recorded before her bowel obstruction, which, I note, happened while she was undergoing virotherapy, as was made clear to me reading her GoFundMe page. Obviously, the Rigvir didn't stop her tumor from progressing. Yet, the IVC is still using Nadine's testimonial in a deceptive—dare I say irresponsible—manner to sell Rigvir. Yes, I stand by my original assessment, and unfortunately that irresponsible and unethical use of patient testimonials to promote Rigvir is having an effect, particularly now that more and more alternative cancer clinics appear to be offering it.</p> <p>Meanwhile, Rigvir marketers appear to be using <a href="http://www.delfi.lv/news/national/politics/rigvir-versas-pret-rsu-asocieto-profesori-purvinu.d?id=49269519">using legal thuggery to try to silence Latvian critics</a>. For example, Riga Stradiņš University recently received a letter from Sorainen, a law firm representing Rigvir Holding, regarding Dr. Santa Purvina, who is faculty there. The letter asked whether Dr. Purviņa's <a href="http://www.delfi.lv/bizness/uznemumi/vairakas-arstu-organizacijas-prasa-izvertet-rigvir-kompensesanu.d?id=48494303">statement</a> that the studies upon which the approval of Rigvir were based were inadequate represented the view of the University. If that isn't an attempt at intimidation, I don't know what is.</p> <p>The more I learn about Rigvir and the International Virotherapy Center, the more I think the whole operation stinks to high heaven. It should be interesting to see what lands in my e-mail in box this week. Be assured that I do plan on publishing the entire e-mail exchange eventually. I merely held off because I was particularly interested in how the IVC will respond to the e-mail that I sent on Friday. In the meantime, the whole Rigvir operation is starting to remind me of the Burzynski Clinic, only worse given the marketing to alternative cancer clinics and the even more transparent than usual excuses for not doing clinical trials. What I do see is the marketing of Rigvir using the same methods that <a href="http://respectfulinsolence.com/2011/11/29/burzynski-the-movie-subtle-its-not/">Stanislaw</a> <a href="http://respectfulinsolence.com/2011/12/12/what-dr-stanislaw-burzynski-doesnt-want/">Burzynski</a> uses to market antineoplastons, patient testimonials and through alternative medicine-promoting hucksters like Ty Bollinger, whose documentary has <a href="http://respectfulinsolence.com/2017/06/05/cassandra-callenders-cancer-is-progressing-and-the-quackery-isnt-stopping-it/">persuaded cancer patients</a> to <a href="http://respectfulinsolence.com/2016/04/19/another-young-woman-with-cancer-lured-into-quackery-by-ty-bollinger/">eschew effective treatments</a> in <a href="http://respectfulinsolence.com/2016/05/27/yet-another-woman-with-breast-cancer-lured-into-quackery-by-ty-bollinger-and-holistic-medicine-advocates/">favor of quackery</a>.</p> <p>That's not a good strategy for a company marketing a science-based treatment. It is, however, a good strategy if you're marketing quackery. Which is it, Rigvir?</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Sun, 10/01/2017 - 21:40</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Mon, 02 Oct 2017 01:40:29 +0000 oracknows 22634 at https://scienceblogs.com Gwyneth Paltrow's goop: Psychic Vampire Repellent as female "empowerment" https://scienceblogs.com/insolence/2017/09/22/gwyneth-paltrows-goop-psychic-vampire-repellent-as-female-empowerment <span>Gwyneth Paltrow&#039;s goop: Psychic Vampire Repellent as female &quot;empowerment&quot;</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Back in the day I used to do a weekly feature every Friday that I used to call <a href="http://respectfulinsolence.com/category/friday_woo/">Your Friday Dose of Woo</a>. For purposes of the bit, woo consisted of particularly ridiculous or silly bits of pseudoscience, quackery, or mysticism, such as the <a href="http://respectfulinsolence.com/2007/01/19/your-friday-dose-of-woo-miraculous-quest-1/">Quantum Xrroid Consciousness Interface</a>. Amazingly, I managed to keep that up for a couple of years, but over time I started sensing that I was getting a bit too repetitive. The same bits of pseudoscience kept recurring. Over time I had to dig more and more to find suitable bits of woo that amused me enough to inspire me to ever more over-the-top heights of sarcasm.</p> <p>Earlier this week, it occurred to me that, should I ever want to resurrect YFDoW, I could easily just do a weekly column about some bit or other of utter nonsense from <a href="http://respectfulinsolence.com/2017/06/23/gwyneth-paltrow-shows-that-the-quantum-xrroid-consciousness-interface-was-ahead-of-its-time/">goop</a>, the website and now lifestyle magazine developed by actress turned into this generation's Oprah Winfrey (at least with respect to promoting self-indulgent, New Agey nonsense like <a href="https://drjengunter.wordpress.com/2017/01/17/dear-gwyneth-paltrow-im-a-gyn-and-your-vaginal-jade-eggs-are-a-bad-idea/">jade eggs</a>). I don't plan on doing that, mainly because it's been a long time since I've been able to tie myself to an artificial schedule of having to do a specific kind of post on every Friday. That doesn't mean that I can't take today to thank Gwyneth Paltrow for providing me with what is likely to be a long-term go-to source of pseudoscience and quackery, a well that I can draw from whenever the mood hits me.</p> <!--more--><div style="width: 460px;display:block;margin:0 auto;"><a href="/files/insolence/files/2017/09/open-uri20170711-9401-p7dtp6.jpeg"><img src="http://scienceblogs.com/insolence/files/2017/09/open-uri20170711-9401-p7dtp6-450x450.jpeg" alt="" width="450" height="450" class="size-medium wp-image-11067" /></a> Only $30? What a bargain! </div> <p>After all, where else could I purchase <a href="https://shop.goop.com/shop/products/psychic-vampire-repellent">Psychic Vampire Repellant</a>? That's right. You read that right. goop is selling <em>actual psychic vampire repellent</em>! But what is this product, actually? Glad you asked:</p> <blockquote><p> A spray-able elixir we can all get behind, this protective mist uses a combination of gem healing and deeply aromatic therapeutic oils, reported to banish bad vibes (and shield you from the people who may be causing them). Fans spray generously around their heads to safeguard their auras. </p></blockquote> <p>This is how you use it:</p> <blockquote><p> Shake gently before each use. Spray around the aura to protect from psychic attack and emotional harm. Avoid contact with eyes. Do not ingest or inhale. </p></blockquote> <p>And such a bargain, at a mere $30 for a 3.4 oz bottle!</p> <p>But, I ask (that is, after asking where I can get me some of this), what the heck is in this stuff? Only the highest quality ingredients:</p> <blockquote><p> Sonically tuned water, rosewater, grain alcohol, sea salt, therapeutic grade oils of: rosemary, juniper, and lavender; a unique and complex blend of gem elixirs, including but not limited to: black tournaline, lapis lazuli, ruby, labradorite, bloodstone, aqua aura, black onyx, garnet, pyrite and mummite, reiki, sound waves, moonlight, love, reiki charged crystals. </p></blockquote> <p>Skeptics that goop's customers are, I'm sure they want to know who the reiki master is who's charging those crystals up. Inquiring minds want to know. (Too bad Paltrow's customers aren't exactly what you would refer to as "inquiring minds.") Fortunately, I am, although I have to question whether wasting my inquiries on the sort of mystical, "empowering," New Age bullshit that Paltrow sells is a good use of my brain cells. Probably not, but it amuses me, at least to a point, and if it helps explain why what she's selling is bullshit it's worth it. It's also worth it because I can point out that Paltrow's minions over at goop are learning a bit about how to protect themselves from charges of selling quackery and unproven medical treatments:</p> <blockquote><p> Disclaimer: This product has not been evaluated by the FDA. Gem Elixirs are not intended to diangose, treat, cure, or prevent any medical condition. Gem Elixirs are not intended to replace the advice or care of a medical professional. </p></blockquote> <p>This is what we refer to a <a href="http://scienceblogs.com/whitecoatunderground/2008/01/14/quack-miranda-warning/">Quack Miranda warning</a>.</p> <p>Of course, psychic vampire repellent is so silly that there's really not much to do with it but to point at it and mock. However, it's also of a piece with everything that Paltrow is trying to do, as was revealed by an <a href="http://goop.com/goop-magazine-cover-story-full-qa-gwyneth/">interview with her published</a> by her new goop Magazine that appeared earlier this week. It's almost as though she's trolling her detractors in a way. The photo of her portrays here in a bikini covered in mud. Then she describes the origin of her interest in quackery (I know, I know, to her it's "health and wellness"). It began when her father became ill and required a feeding tube after surgery:</p> <blockquote><p> But yes, getting back to wellness: Long story short—when my dad got sick, I was twenty-six-years-old, and it was the first time that I contemplated that somebody could have autonomy over their health. So while he was having radiation and the surgery and everything, and eating through a feeding tube, I thought, “Well, I’m pushing this can of processed protein directly into his stomach,” and I remember thinking, “Is this really healing? This seems weird. There’s a bunch of chemicals in this shit.”</p> <p>It was where I started to make the connection, or to wonder if there was a connection, and started doing a bunch of research on sugar and cancer and environmental toxins and pesticides and everything else. And I think what happens is, as soon as you test something and it works and you feel better, you really catch that “wellness” bug. </p></blockquote> <p>"There's a bunch of chemicals in this shit"? I have news for Paltrow: There's a bunch of chemicals in <em>everything</em>, including each and every thing goop sells. Heck, her psychic vampire repellent is full of chemicals. She named some of them. Of course, whether the chemicals that are advertised as being in there actually are in there, who knows?</p> <p>It turns out that Paltrow has become so credulous that she'll try almost anything, no matter how ridiculous. She views this as being brave, inquisitive, and adventurous. I view it as being so "open minded" that her brains fell out long ago. I could tell from her interview that she had tried <a href="http://respectfulinsolence.com/2016/06/30/a-clinical-trial-of-foot-bath-detoxification/">detox foot baths</a>, one of the most outrageous health scams out there. She didn't feel any better after that (surprise! surprise!); so she moved on. She also tried some sort of "color therapy," but apparently it wasn't fo her.</p> <p>She's also very, very much into "cleanses," like the Master Cleanse and the Alejandro Junger cleanse:</p> <blockquote><p> It’s only a three-day cleanse, and also I’m very “all or nothing.” So I was very amped up on the idea of seeing it through to completion. My best friend did it with me and she ate a banana on the second day, and I was like, “You f%$ked it up. All results are off.” I felt very toxic and sluggish and nauseous on the second day, and by the third day I started to feel really good. And in the book, some people do it for seven days, ten days, thirty days. I was like, “I’m good with the three-day introductory cleanse.” And I remember the next day, I was like, “Oh wow, I just did this cleanse and I feel so much better, so I can have a beer and a cigarette now, right?” It was the nineties.</p> <p>But I do remember feeling that that’s where I caught the bug. And then the Alejandro Junger cleanse was really instrumental in terms of explaining to me that, especially as detox goes, our bodies are designed to detoxify us, but they were built and designed before fire retardants and PCBs and plastic, so we have a much, much more difficult time, and the body needs some support, which is why cleanses can help. I just anecdotally felt great and so I started doing more and more. And by the time goop came around and we started writing about wellness content, then it started to get really fun. And the girls make me try everything. I’m always the one. </p></blockquote> <p>As I like to say, "detoxification" is <a href="http://respectfulinsolence.com/2011/06/06/detoxifying-fashionably/">fashionable nonsense</a>. There are a couple of "flavors" (if you'll excuse the term) of rationales for "detoxification." One is that we're "poisoning ourselves from within," also known as autointoxication. The idea here is that the poop accumulating in our colons is leeching "toxins" into the bloodstream through our colons and slowly poisoning us, causing all manner of chronic disease. Never mind that we don't have 20 lbs of built up fecal matter in our colons, as those claiming that "death begins in the colon" often opine. The colon is very good getting rid of the body's solid waste; it doesn't accumulate except in the case of significant disease. When it does, it usually results in acute, not chronic illness. (Toxic megacolon, anyone?) The second rationale is more like the one that Paltrow makes, that "chemicals" are assaulting out body in such quantity and new forms that our livers are no longer able to "detoxify" our body without help. The problem, with this claim is that it's just not true, either. There is no need to "detoxify.</p> <p>Not surprisingly, Paltrow is now starting to think that medical marijuana will be an important "natural" health aid and treatment for various things that we evil, reductionistic "Western" doctors don't accept. Never mind that the <a href="http://respectfulinsolence.com/?s=marijuana+cannabis">evidence for the utility of medical marijuana</a> for most of the conditions for which it is advocated is, at best, thin and, at worst, nonexistent.</p> <p>Paltrow also has a—shall we say?—rather loose interpretation of what constitutes good medical evidence:</p> <blockquote><p> And then we are as a culture, very resistant to more natural options.</p> <p>I think there’s a general reticence to this idea that we can be autonomous over our own health, that there are other options. So, that if you have arthritis or IBS, you can maybe, possibly, make a diet change that’s really impactful. There might not be board-certified physicians doing double-blind studies that can lay out the results in the same way; the empirical evidence is anecdotal. But, you’ll have people really resistant to the idea, like it’s better to be on five prescription drugs than to maybe cut gluten out of your diet.</p> <p>And at goop, our job isn’t to recommend, or to have an opinion: We’re just like, this is fascinating. Let’s ask this doctor this, let’s ask this doctor that. I think we know that, for example, we’ve tried certain things that are more holistic, and they’ve had incredible effects. But it doesn’t behoove a pharmaceutical company or chemical company to spend lots of money on trials about whatever it is. </p></blockquote> <p>Hmmm. If only there were a way to determine whether going "gluten-free" helps irritable bowel syndrome or arthritis... If only... Oh, wait, there is! It's called science. It's called randomized clinical trials, which Paltrow just dismissed in favor of a much weaker form of evidence prone to all sorts of biases, including the human tendency to confuse correlation with causation and the regression to the mean of symptoms, in which people tend to take remedies when their symptoms are at their worst and then attribute the regression to the mean of their symptoms to whatever they took or did, regardless of whether it actually affected the course of their symptoms or not.</p> <p>How convenient, though. Paltrow washes her hands of responsibility for selling quackery by, in essence, invoking a variant of <a href="https://rationalwiki.org/wiki/Just_asking_questions">JAQing off</a>. <em>We're not recommending anything</em>, Paltrow is saying, <em>we're just asking questions that you can ask your doctors! Oh, and big pharma isn't interested in our questions or remedies because it can't profit off of them. Profiting off of them is our business model, after all! <a href="https://gizmodo.com/is-this-the-beginning-of-the-end-for-goop-1802113804">We make false health claims for profit!</a></em></p> <p>Now here's what's irritating. There's no denying that it's an unfortunately effective tactic, but it's irritating nonetheless. But what do I know? I'm just a middle-aged white male. Obviously my criticism of the pseudoscience and quackery peddled by goop is a product of my wanting to oppress women—or at least my being afraid of women "empowered" by goop to—gasp!—ask questions. So spake The Paltrow:</p> <blockquote><p> I really do think that the most dangerous piece of the pushback is that somewhere the inherent message is, women shouldn’t be asking questions. So that really bothers me. I feel it’s part of my mission to say, “We are allowed to ask any question we want to ask. You might not like the answer, or the answer might be triggering for you. But we are allowed to ask the question and we are allowed to decide for ourselves what works and what doesn’t work. We’re allowed to decide for ourselves what we want to try or not try.” </p></blockquote> <p>Oh, bullshit. Paltrow and her minions are more than allowed to "ask questions." Paltrow just doesn't like the answers she gets because her questions are premised on belief in pseudoscientific quackery. None of that stops her from bravely marching deeper and deeper into the swamp of pseudoscience for profit disguised as female "empowerment":</p> <blockquote><p> Yeah, I mean, I think it’s our mission to empower women. Our mission is to support women with content, product, ideas, where they can get closest to their real identity and have the courage to speak and operate from that place. Whatever it is that they want to do in the world, whether they want to stay home with children, whether they work, whether they want to start a second career, whether they want to understand, like, you know, how an alternative health modality might benefit them.</p> <p>Our mission is to have a space where curious women can come. We are creating an opportunity for curiosity and conversation to live. That the knock-on effect of that conversation is that somebody might think to themselves, “Oh, wow. This is how I can manage a difficult relationship at work.” Or, “Wow, like, maybe I can improve my relationship with my mother or my understanding that this is her personality.” Or, “Wow, maybe if I up my vitamin C intake, let me try it, let me speak to my doctor or see if it’s something I should do.” You know, whatever it is. So, we know that the world follows the consciousness of women. So we’re just trying to create this environment where, really, women again, can just feel okay about getting close to themselves and working from that place. </p></blockquote> <p>That space? Well, one example was Paltrow's ridiculous "wellness summit" earlier this summer. Oh, and haters gonna hate, not because they support science and recognize Paltrow for the snake oil saleswoman that she is. Oh, no. It must be because they're afraid of "empowered" women:</p> <blockquote><p> Yeah, when we had our wellness summit a few weeks ago, it was so incredible to see all of these curious like-minded women congregating in a space, making friends, having conversations, exploring all these different avenues together. It was really powerful. You know, it’s like, how do you control that? If there is an inherent cultural fear of women getting together and talking, pushing boundaries, you control it by ridiculing them for talking to each other. </p></blockquote> <p>No, women weren't being ridiculed for "talking to each other." <strong><em>Gwyneth Paltrow</em></strong> was being ridiculed for being a con artist, selling bogus "wellness" to women in the name of "empowerment." And she didn't like it. Not one bit. <a href="http://respectfulinsolence.com/2017/07/21/are-gwyneth-paltrow-and-goop-winning-against-skeptics/">She did richly deserve it, too</a>. </p> <p>Basically, goop is a scam. It is nothing more than an online vessel to sell old-fashioned snake oil. Paltrow no more "empowers" women by selling her snake oil than, for example, <a href="https://www.csicop.org/si/show/stanislaw_burzynski_four_decades_of_an_unproven_cancer_cure">Stanislaw Burzynski</a> "empowers" cancer patients by selling them his ineffective cancer "cure."</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Fri, 09/22/2017 - 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/medicine" hreflang="en">Medicine</a></div> </div> </div> Fri, 22 Sep 2017 05:00:39 +0000 oracknows 22628 at https://scienceblogs.com Does the flu vaccine cause miscarriages? https://scienceblogs.com/insolence/2017/09/14/does-the-flu-vaccine-cause-miscarriages <span>Does the flu vaccine cause miscarriages?</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>The reason there wasn't a post yesterday is simple. The night before, I was feeling a bit under the weather. As a result, I went to bed early, neglecting my blogly responsibilities. As I result, I missed the release of a whopper of a study that normally would have been all over like...well...choose your metaphor. On the other hand, the one day delay isn't necessarily all bad because it lets me see the reaction of cranks to this study, the better to apply some not-so-Respectful Insolence to it. The crankiest of these cranks, of course, is Mike Adams, a grifter deep in the thrall of any form of pseudoscience that he can sell to burnish his brand and keep the rubes buying and who knows how to whip his minions into a fine frothy head of anti-pharma conspiracy mongering. In actuality, though, I was a little bit disappointed, as Adams was <a href="https://web.archive.org/web/20170914014113/http://www.naturalnews.com/2017-09-13-cdc-funded-study-confirms-flu-shots-linked-to-spontaneous-abortions-vaccine-experts-rush-to-explain-away-the-findings.html" rel="nofollow">almost restrained</a>, at least by his usual crazed standards:</p> <!--more--><blockquote> A CDC-funded medical study being published by the medical journal <em>Vaccine</em> has confirmed a shocking link between flu shots and spontaneous abortions in pregnant women. The study was rejected by two previous medical journals before <em>Vaccine</em> agreed to publish it, further underscoring the tendency for medical journals to censor any science that doesn’t agree with their pro-vaccine narratives. <p>“A study published today in <em>Vaccine</em> suggests a strong association between receiving repeated doses of the seasonal influenza vaccine and miscarriage,” <a href="http://www.cidrap.umn.edu/news-perspective/2017/09/study-signals-association-between-flu-vaccine-miscarriage">writes CIDRAP</a>, the Center for Infectious Disease Research and Policy.</p> <p>“A puzzling study of U.S. pregnancies found that women who had miscarriages between 2010 and 2012 were more likely to have had back-to-back annual flu shots that included protection against swine flu,” reports <a href="https://medicalxpress.com/news/2017-09-prompts-flu-vaccine-miscarriage.html">Medical Xpress</a>, a pro-vaccine news site that promotes vaccine industry interests. Notice that the opening paragraph of their study assumed the study couldn’t possibly be true. It’s “puzzling” that mercury in flu shots could cause spontaneous abortions, you see, because these people have no understanding of biochemistry and the laws of cause and effect.</p></blockquote> <p>Actually, as has been documented so many times before, it is Mike Adams who has no understanding of biochemistry—or any other science—other than what it takes for him to portray himself to his gullible followers as a "real scientist." As for the "laws of cause and effect," whenever someone says something like that in reference to an epidemiological study, I know he's really, really clueless, because if there's anything that's very difficult to do in an epidemiological study with reliability it's determining cause-and-effect. That's why the cardinal rule of epidemiology is that correlation does not equal causation. It might, but usually it doesn't, and it usually takes a whole lot more than just one study with a correlation to start to suggest causation. This is particularly true when a study like the one Adams is gloating about is such an outlier, which this study most definitely is, as you will see. It's also an exercise in data dredging that illustrates the danger of small numbers in studies like this.</p> <p>Let's go to the <a href="http://www.sciencedirect.com/science/article/pii/S0264410X17308666">study</a> itself. I can't help but note that Frank DeStefano of the CDC is a co-author. DeStefano, as you might recall, is one of those CDC investigators that antivax conspiracy theorists like those who made the propaganda film <a href="http://respectfulinsolence.com/2016/07/18/in-which-andrew-wakefield-and-del-bigtrees-antivaccine-documentary-vaxxed-is-reviewed-with-insolence/">VAXXED</a> portray as one of the main villains in the <a href="http://respectfulinsolence.com/2015/08/25/kevin-barry-you-magnificent-bastard-i-read-your-antivaccine-book/">"CDC whistleblower" conspiracy theory</a>. Also, several of the authors receive pharma money for research support. Nicola Klein, for instance, receives research support from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, MedImmune, Novartis, and Protein Science, while Allison Naleway receives funding from GlaxoSmithKline, MedImmune, and Pfizer. Others receive support from MedImmune and Novavax. So basically, this was a study funded by the CDC and carried out by CDC scientists and scientists receiving significant pharma funding. I just couldn't resist pointing that out. I know, I know, antivaxers will claim that the findings were so compelling that not even the CDC and pharma shills could hide them, but it would amuse me to point these things out to antivaxers.</p> <p>Yet, here we see Del Bigtree, producer of VAXXED, gleefully citing J.B. Handley gloating over this study:</p> <blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr" xml:lang="en">Tough breaking news for <a href="https://twitter.com/ChelseaClinton">@ChelseaClinton</a> <a href="https://twitter.com/DrPanMD">@DrPanMD</a> <a href="https://twitter.com/doritmi">@doritmi</a> FLU SHOT linked to MISCARRIAGE! <a href="https://twitter.com/hashtag/endvaxinjury?src=hash">#endvaxinjury</a> <a href="https://t.co/6JwjnsAviY">https://t.co/6JwjnsAviY</a></p> <p>— Del Bigtree (@delbigtree) <a href="https://twitter.com/delbigtree/status/908085483799928833">September 13, 2017</a></p></blockquote> <script async="" src="//platform.twitter.com/widgets.js" charset="utf-8"></script><p> I wonder if he knows that DeStefano is a co-author. He probably doesn't care, because DeStefano, like any scientist, can be a hero or a villain depending solely upon whether he produces information or studies that agrees with the antivaccine narrative that the flu vaccine is not just useless but dangerous. Be that as it may, the article above is a typical bit of Handley's Dunning-Krugger arrogance of ignorance, even more full of hyperbole and nonsense than the usual Mike Adams' endeavors in that area. Indeed, Handley even uses the <a href="https://www.skepticalraptor.com/skepticalraptorblog.php/vaccine-package-inserts-debunking-myths/">argumentum ad package insert</a> gambit. (Whenever I see that gambit used by an antivaxer, my estimation of his cluelessness goes up several notches, which for Handley is really saying something.) In any case, you can get a feel for how much the authors of this study are stretching to find a correlation—any correlation—between influenza vaccines and miscarriages that they're looking at combinations of vaccines by their brief justification for the <a href="http://www.sciencedirect.com/science/article/pii/S0264410X17308666">study</a>:</p> <blockquote><p> Since 2004, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and other organizations have recommended routine influenza vaccination for pregnant women regardless of gestational age [1,2]. Influenza in pregnancy can cause serious, life-threatening illness in both the mother and fetus, as demonstrated during the 2009 pandemic [3,4]. Numerous studies of influenza vaccine during pregnancy have not identified serious safety concerns [5–12], but relatively few investigations have evaluated vaccination in the first trimester, a period when the embryo is highly vulnerable to teratogens and other factors [5,13]. A case-control study conducted by the Vaccine Safety Datalink (VSD) demonstrated that influenza vaccination during early pregnancy in the 2005–06 and 2006–07 influenza seasons was not associated with spontaneous abortion (SAB) [14].</p> <p>The emergence of a pandemic influenza virus, A/California/ 7/2009 (H1N1)pdm09 (pH1N1), led to rapid development and widespread use of vaccines containing pH1N1 antigens. Several studies have evaluated the safety of vaccines containing pH1N1 in pregnancy, but few have focused on outcomes in early pregnancy [15–19]. Using a design and protocol similar to the previous study [14], we conducted a case-control study to determine if receipt of influenza vaccine containing pH1N1 was associated with SAB.</p></blockquote> <p>Notice the eight studies cited (references 5-12) that failed to find significant safety issues with the vaccine in pregnancy, and a study (<a href="https://www.ncbi.nlm.nih.gov/pubmed/23262941">reference 14</a>) using VSD data failed to find an association between flu vaccination with spontaneous abortion. That's actually a lot of data for the safety of the flu vaccine during pregnancy, which makes me wonder what the justification for yet another study looking for an association between influenza vaccination and miscarriages. If I were a funding agency and received a grant application to do a study like this with text above in the "Background and Significance" or the "Impact" section, my first reaction would be: Why on earth would we fund this? It's all been done before, many, many times. Yet the CDC funded this study. So much for antivax claims about the CDC not being concerned about vaccine safety and not being willing to look for adverse reactions due to vaccines.</p> <p>I also find it rather odd that the authors would say that few studies have been done looking for a correlation between vaccination against influenza, when in fact there have been a lot, many well-designed, and they've pretty much all been negative. Whenever you see a study that finds something a lot different from the bulk of the studies that have been done before, the first question to be asked is: Are the results of the current study so robust that they indicate a hole in the existing data addressing the question asked that we should begin to question the cumulative results of all the studies that have gone before? Keep that question in mind as I continue.</p> <p>Also consider the bias that exists in journals to publish novel findings. As this <a href="https://www.washingtonpost.com/news/to-your-health/wp/2017/09/13/researchers-find-hint-of-a-link-between-flu-vaccine-and-miscarriage">news report</a> points out, this is the "first study to identify a potential link between miscarriage and the flu vaccine." That's almost certainly the reason that it was published. Adams, in his haste to portray as a conspiracy to silence, inadvertently tells me something. That this paper was rejected by two previous journals is not surprising to me. What is surprising is that <em>Vaccine</em> ultimately accepted it. Of course, how Adams would know that this paper was submitted elsewhere and rejected, I don't know, which is why I have my doubts about Adams' claims.</p> <p>So what about the study itself? First, it's a case-control study. Basically, that means that the authors found a cohort of women who had miscarriages (the cases) and compared them to a cohort of women who didn't have miscarriages but instead delivered full term infants or had stillbirths during the study period (the controls). The authors chose two flu seasons (2010 to 2012) and asked if women who had miscarriages were more likely to have been vaccinated for influenza within 28 days prior to miscarriage, as well as for different time periods before miscarriage.</p> <p>The most critical aspect of any case control study if, of course, the matching of cases to controls. The idea is to match them as closely as possible on all relevant factors other than the condition under investigation (in this case, miscarriage). Not uncommonly, investigators will do a 2:1 match, controls to cases, in order to make the comparison more robust. It's not mandatory, and Donohue et al chose not to do this. In this study, cases had SAB and controls had live births or stillbirths and were matched on site, date of last menstrual period, and age. I also note that the database they used was the Vaccine Safety Datalink (VSD). As I like to say, the VSD is an excellent rebuke to antivaxers who claim that doctors don't care about vaccine safety. It's a database designed to document adverse events associated with vaccination, and it's a huge database. I've discussed it before on <a href="http://respectfulinsolence.com/?s=%22vaccine+safety+datalink%22">more than one occasion</a>.</p> <p>So what did the study find? Here's a summary of the cases analyzed:</p> <p><a href="/files/insolence/files/2017/09/StudySchema2.png"><img src="http://scienceblogs.com/insolence/files/2017/09/StudySchema2-450x282.png" alt="" width="450" height="282" class="aligncenter size-medium wp-image-11052" /></a></p> <p>if you look at the tables in the paper, the first thing you will notice is that the adjusted odds ratios (aORs) for miscarriage as a function of having received the flu vaccine are nearly all around 1.0 or not statistically different from 1.0. Obviously, there are exceptions. Basically, the study found that, if a woman had consecutively received a flu vaccine containing the 2009 H1N1 virus the season before and had the flu vaccine in one of the two seasons studied, the aOR in the 1–28 days was 7.7 (95% CI 2.2–27.3). Otherwise, the aOR was 1.3 (95% CI 0.7–2.7) among women not vaccinated in the previous season; i.e., not statistically significant from 1.0, meaning no detectable difference in miscarriage rates compared to women who had not been vaccinated. This effect was noted in both seasons.</p> <p>Now here's where you should be skeptical.</p> <blockquote><p> This study has several important limitations. First, the most striking findings relate to the association between SAB and IIV [inactivated influenza vaccine] in women who previously received pH1N1-containing vaccine. This interaction effect was not an a priori hypothesis; the results were generated in a post hoc analysis with small numbers of women in the various subgroups. Although the interaction was observed in each of the two seasons studied, the point estimates were substantially larger (though not statistically different) in the first season for reasons that are unclear. Second, although most cases had an ultrasound, assignment of a precise date of SAB was challenging. With guidance from an obstetrician we integrated different types of information from the medical record (e.g., ultrasound results, clinical and laboratory findings, provider notes) to estimate the timing of the SAB. Estimation of SAB dates was independent of vaccination status so any error should bias the results toward the null (i.e., non-differential misclassification). Third, we studied only women who had clinically confirmed SAB; the proportion of women with clinically unrecognized pregnancy loss is uncertain but may be substantial [50,51]. Our results could be biased if women who sought care for SAB were more likely to be vaccinated in the 28-day exposure window.</p></blockquote> <p>So what we're looking at is an association, nothing more. It's an association with a lot of caveats, too. Basically, having found nothing more than one association with an aOR of 2.0 for the 1-28 day window of exposure to the influenza vaccine before miscarriage that was barely statistically significant (95% confidence interval: 1.1-3.6), the authors did a post hoc analysis looking for other associations. (Never mind that the "association" they found was eminently unimpressive given the size of the confidence intervals.) "Post hoc" means that they did additional analyses not originally specified. Basically investigators don't usually do post hoc analyses if there is a robust association in their data. They do it when they fail to find an association or only find an unimpressive association that is not robust. Also, post hoc analyses are <a href="http://journals.lww.com/epidem/pages/articleviewer.aspx?year=2010&amp;issue=05000&amp;article=00017&amp;type=abstract">prone to type 1 errors</a>, which means finding a statistically significant "association" where there is none; i.e., finding a false positive. When the numbers in the subgroup are so small and the study is observational (i.e., retrospective), that tendency is even stronger. Then there was the issue that the cases and controls were not as comparable as one would like in a case control study. For example, cases were significantly older than controls and more likely to be African-American, to have a history of 2 spontaneous abortions, and to have smoked during pregnancy. The authors did some correcting for age and history of spontaneous abortions, but it's questionable to me whether it was adequate.</p> <p>Basically, the authors did what we refer to as a subgroup analysis, in this case the subgroup being women who had received H1N1 vaccination the season before they received the flu vaccination in the seasons examined? That clearly wasn't a primary hypothesis being tested. Rather, it was a hypothesis the authors clearly came up with while doing the study. One wonders if this analysis was prespecified or whether the protocol was changed midway through. I only ask that because antivaxers went wild over claims by the "CDC whistleblower" that the Atlanta MMR study changed its protocol part way through the study, but, here, where the analysis seems to suggest such an "adjustment" during the study (although it is certainly possible that the H1N1 analysis was prespecified in the original protocol, given the choice of the 2010-11 and 2011-12 flu seasons), we hear...silence. Whatever the case, there clearly was post hoc analysis strongly resembling p-hacking going on here, in which the investigators, having failed to find much, started looking at other potential associations. Certainly, it smells that way.</p> <p>Speculations about the protocol aside, the investigators found what they found, namely an aOR of 7.7 for cases versus controls for exposure to the H1N1 vaccine the year before plus the flu vaccine within 1-28 days before their miscarriages. This was based on some very small numbers, though, namely 14 miscarriages and 4 controls. In other words, this is almost certainly a statistical fluke, given that it was only found for women who had received H1N1 the season before and had received the flu vaccine within 28 days of their miscarriage, and that the association was not observed for pretty much any other time window or combination. When considering such a result, one also has to consider biological mechanism and plausibility, and it is just not very plausible from a biological or immunological standpoint that this combination of flu vaccines—and only this combination—given only during a specific time window will cause miscarriages. Like Dr. Gregory Poland, the editor of <em>Vaccine</em>, I don't believe these findings, either.</p> <p>I particularly don't believe them in light of what we already know, based on studies Tara Haelle <a href="http://www.redwineandapplesauce.com/2014/01/08/the-real-story-on-the-flu-vaccine-during-pregnancy/">summarized the data</a> with respect to flu vaccines and miscarriages, stillbirths, and birth defects in 2014, using mainly studies published during the prior two years, and the results were very consistent and overwhelming: There was no association between vaccination for influenza and adverse fetal outcomes. Just for yucks, I did some PubMed searches myself for more recent studies, and found basically the same thing, but instead of listing those studies, I'll just refer you to a <a href="https://www.ncbi.nlm.nih.gov/pubmed/25409473">recent large meta-analysis</a> that found that the risk of stillbirth was actually lower in women vaccinated against influenza and no difference in the risk of spontaneous abortion. In other words, this new study is an outlier. It's such an outlier, that scientists are correct to be very skeptical of its results. Heck, even the authors are skeptical of its results. Unfortunately, they're not so skeptical that they don't resist making the call for "more research." They'll probably get the funding for that "more research," and then when the inevitable negative study is finally published, no one will remember it. They'll all remember this study, and, of course, the antivaccine movement will be flogging it for years to come.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Thu, 09/14/2017 - 02:50</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Thu, 14 Sep 2017 06:50:50 +0000 oracknows 22623 at https://scienceblogs.com Naturopaths and quack stem cell clinics revisited https://scienceblogs.com/insolence/2017/09/11/naturopaths-and-quack-stem-cell-clinics-revisited <span>Naturopaths and quack stem cell clinics revisited</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>A week ago, I wrote about a <a href="http://respectfulinsolence.com/2017/09/01/whats-scarier-than-dubious-stem-cell-clinics-naturopathic-stem-cell-clinics/">naturopath in Utah named Harry Adelson</a>, who was advertising his use stem cells to treat lumbar and cervical disk problems, including degenerated and dehydrated disks. That alone was bad enough, but what elevated "Not-a-Dr." (my preferred translation of the "ND" that naturopaths like to use after their names to confuse patients because it's so close to "MD") Adelson above and beyond the usual naturopathic quackery is his cosplay of an interventional radiologist, in which he purchased a C-arm to use fluoroscopy to inject his "stem cells" right into the intervertebral disks of patients. In the meantime, I also reiterated just how much damage naturopaths do when they try to <a href="http://respectfulinsolence.com/2017/09/05/patients-lose-when-they-chose-naturopaths-over-real-doctors/">treat real diseases like cancer</a> and how <a href="http://respectfulinsolence.com/2017/09/07/a-naturopathic-cancer-quack-tries-to-silence-criticism-with-legal-thuggery/">sensitive they are to having their quackery called out</a>.</p> <!--more--><p>Getting back to naturopaths using what they claim to be "stem cell therapy," Not-a-Dr. Adelson is not alone among naturopaths in opening clinics devoted to isolating who knows what kind of cells from patients' bone marrow and/or adipose tissue and injecting them who knows were without any good evidence that they actually do anything. Sadly, they are like a lot of MDs in "regenerative medicine," only even less concerned about science. Indeed, I soon discovered that there are quite a few naturopaths out there offering prolotherapy and a variety of stem cell therapies, just like unethical MDs do. All I had to do was to Google "stem cells" and "naturopathy" to find a number of examples. For instance, the Stem Cell Rejuvenation Center in Phoenix is run by Not-a-Drs. <a href="https://www.the-stem-cell-center.com/staff" rel="nofollow">Timothy Pierce, Jaime Ewald, and Julie Keiffer</a>, who <a href="https://www.the-stem-cell-center.com" rel="nofollow">claim to be able</a> to use stem cells derived from adipose tissue or isolated from bone marrow to treat autism, amyotrophic lateral sclerosis (Lou Gehrig's disease), cerebral palsy, degenerative disc disease, heart disease, muscular dystrophy, Parkinson's disease, stroke, spinal cord injuries, and, of course, erectile dysfunction, <a href="https://www.the-stem-cell-center.com/fees" rel="nofollow">all for the low, low price</a> of $7,100 for either adipose or bone marrow-derived stem cell treatments or the deal of $9,600 for both. What a bargain for something that hasn't been shown to work in clinical trials! And how on earth are naturopaths allowed to do bone marrow biopsies and liposuction to gather the marrow and adipose tissue, respectively upon which to work their woo? Well, in Arizona, minor surgery is <a href="http://respectfulinsolence.com/2007/07/25/more-on-legalized-quackery-in-arizona/">within the scope of practice of naturopaths</a>.</p> <p>Elsewhere in Arizona, <a href="http://www.eastvalleynd.com/promote-healing-with-stem-cell-therapy/" rel="nofollow">East Valley Naturopathic Doctors</a> also offer "stem cell therapy":</p> <blockquote><p>This incredible advancement in natural healing means that stem cells can be harvested from a patient’s fatty tissue and reintroduced into that patient’s body. These stem cells have the ability to travel to areas of the body that have damaged tissues. The stem cells can then either instigate healing or actually transform into the type of cells needed to repair an injured area. The possible benefits of this kind of treatment are staggering!</p> <p>Because the FDA has yet to approve this therapy, it cannot be said that stem cells are used specifically for the treatment of any disease. However, empirical evidence shows that this therapy is beneficial to people who suffer from many different illnesses, such as:</p> <ul><li>Neurological diseases</li> <li>Chronic joint pain</li> <li>Autoimmune conditions</li> <li>Heart disease</li> <li>Pulmonary issues</li> </ul></blockquote> <p>How nice. It's basically a quack Miranda warning for their stem cell facility, <a href="http://globalhealthstemcelltherapy.com" rel="nofollow">Global Health Stem Cell &amp; IV Therapy</a>, run by two of the naturopaths there, Not-a-Dr. Jason Porter and Not-a-Dr. Julie Keiffer. Wait, didn't I just say that Keiffer works at the Stem Cell Rejuvenation Center, too? Wow. More cosplaying of real doctors, she must work at two different practices and out of two different stem cell centers. The ones listed on her website include East Valley Naturopathic Doctors, Valley Medical Weight Loss, and Peace Wellness Center, which appear to be where she sees patients. On her website, she <a href="http://www.drjuliekeiffer.com/stem-cell-and-prp-treatments.html" rel="nofollow">advertises using platelet-rich plasma</a> for the following purposes:</p> <blockquote><p>For Hair loss and hair thinning, PRP is injected into the scalp to stimulate the hair follicle strength. In addition to injections, Micropen™ with PRP topically assists with the stimulation of the hair follicle.</p> <p>For sexual enhancement, the O-Shot® procedure for women and the Priapus Shot ® procedure for men, delivers PRP into the genitalia which may enhance sensitivity, strength and possibly size for men. For more detailed information refer to Patient Resources for links to desired sites.</p></blockquote> <p>Oh goody.</p> <p>I could go on, but you get the idea. I've found naturopaths offering dubious stem cell therapies in <a href="http://www.h3clinic.com/stem-cell-therapy" rel="nofollow">Canada</a>, <a href="http://www.infusio.org/about-us/" rel="nofollow">Germany</a>, <a href="http://www.getprolo.com/jonathan-birch-nd/" rel="nofollow">California</a>, <a href="http://centerforintegratedmed.com/integrative-medicine/practitioners/payson-flattery-nd-dc-daapm/" rel="nofollow">Oregon</a>, and all over. It's apparently becoming such a thing that actual MDs running dubious stem cell clinics are feeling threatened. For instance, here is Dr. Chris Centeno asking, "<a href="https://www.regenexx.com/naturopaths-stem-cells/" rel="nofollow">Should you let a naturopath stick a needle in your spine?</a>" His answer is no, for many reasons that are correct:</p> <blockquote><p>Much has been made by naturopaths that their training is now equivalent to that of an MD or DO physician. However, some of the issues that came up in the recent board discussion were reports of naturopaths missing common medical side effects of spinal injections, like a dural leak. In fact, naturopaths were not even able to understand that this was a possible complication of the spinal injection procedure they performed. So how is it possible with all of the hours that naturopaths claim they train that they’re not able to conceptualize or catch a simple and common complication of spinal injection? The reason is contained in a simple statement made by one of our fellows.</p> <p>A few weeks ago, we had a patient who needed to be checked for a postprocedure infection. I couldn’t see the patient, so I had one of our two fellows check him out. While all of the data looked like the patient didn’t have an infection, what the fellow told me verbally was important. He said that the patient “didn’t look toxic.” What the fellow meant was that after training in a large university medical center where he saw many patients who were infected and toxic, or “sick,” and many who were not, he was using that experience filtered through the large neural network in his head to rule out a pattern of patient characteristics that he had associated with patients who were sick, or toxic. These may be the paleness of the skin, a glassy look in their eyes, how they interact, and so on. Every MD or DO who trained in a large university medical center knows what that fellow meant. The issue with naturopaths, chiropractors, and acupuncturists is that they don’t train in these settings. So when they learn how to perform procedures that may injure patients and make them “toxic,” they have no way of knowing, despite many weekend courses, how a sick patient presents. Why? Most of their training is on well patients with chronic problems, like pain or irritable bowel disease or allergies, not on ill patients undergoing surgery in the hospital.</p></blockquote> <p>It's true. One of the most important skills we as physicians learn is how to recognize when a patient "looks sick," and by "looks sick" I mean sick enough that he's about to take a significant turn for the worse if something isn't done very soon. It's very much a skill that involves pattern recognition. It's hard to explain in words how to do it. I can list some of the characteristics we physicians look for, as Dr. Centeno did above, but in practice it's more of a gestalt, the recognition of several observations together that tell you the patient is doing poorly. As I point out, medicine should be based in science, but there are still skills in pattern recognition that are part of the art of medicine. Perhaps one day AI will be able to replicate the ability of an experienced clinician to recognize this constellation of observations that tell us that a patient, even one who might not appear that sick at the moment to an untrained observer, is about to get a lot sicker soon. This skill can't be learned quickly. It takes seeing a lot of patients, ranging from not-so-sick, to teetering on the brink, to having fallen over the cliff into life-threatening decompensation, and naturopaths simply do not see enough sick enough patients to develop that skill. (In fairness, some physician specialties never do, either, and I sometimes worry that it's been so long since I did general surgery that my skills in that area might have become rusty.)</p> <p>Of course, Dr. Centeno is doing the very same thing naturopaths are doing; so, even as I agreed with everything he said about naturopaths and more, it was hard for me not to get the impression as I read his article that that he was far more about protecting his turf than he was about actually protecting patients. (If that weren't the case, Dr. Centeno wouldn't be selling expensive and unproven stem cell therapies for indications for which they remain largely untested and unproven, would he? He'd be doing real clinical trials to determine if they work, instead of what he is doing now.) Reading his op-ed, I have little doubt that he views these naturopaths offering stem cell therapies more as a threat to his business model, as competitors muscling in on his action, endangering his profits. Even as I agreed with what he wrote about naturopaths, I couldn't help but think that he's no better and in fact might be worse than the naturopaths doing stem cell therapy. After all, he has the training to know better, but apparently does not (or chooses not to). He's decided to forego all that pesky rigorous science and, instead of doing proper clinical trials, to forge right ahead selling his treatments using <a href="https://www.regenexx.com/outcomes/" rel="nofollow">patient registry data</a> and <a href="https://www.regenexx.com/recent-results/back-case-results/" rel="nofollow">anecdotes</a>. In this, he has a lot in common with the naturopaths he denigrates.</p> <p>Indeed, when it comes to stem cells, I fear that we as MDs are teaching naturopaths our worst habits. For instance, look at the excuses made by this stem cell quack named Dr. Mark Berman, complete with a <a href="http://scienceblogs.com/whitecoatunderground/2008/01/14/quack-miranda-warning/">quack Miranda warning</a> about his treatments, for charging big bucks to patients for what he <a href="https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/">openly admits are unproven therapies</a>:</p> <blockquote><p> But a website for his <a href="http://stemcellrevolution.com">Cell Surgical Network</a>, an umbrella for dozens of stem cell clinics nationwide, lists more than two dozen other conditions the physicians are “currently studying,” including Parkinson’s, amyotrophic lateral sclerosis — more commonly called Lou Gehrig’s disease — congestive heart failure, lung disease, glaucoma, and muscular dystrophy.</p> <p>The website is careful not to promise that the stem cell injections can cure or treat those diseases, and Berman said he makes it clear to all patients that the work is investigative and not FDA-approved.</p> <p>Berman acknowledges that he has no published studies to back up his treatment. But he says he’s certain it works and is safe. As proof of his confidence, he notes that he used the therapy to successfully treat his wife for hip pain.</p> <p>He says critics, including pharmaceutical companies and academics, want to profit by patenting stem cells and fear “disruptive technologies” that come from entrepreneurs rather than from their own incremental research. </p></blockquote> <p>I'd say that it's more like Dr. Berman not wanting to wait for that "incremental research" to determine whether the treatments he is providing patients actually work and are safe. He basically admits that he has no evidence other than his certainty that "it works and is safe." That's just not good enough, particularly if you're charging patients close to $9,000 a pop. I consider that to be unbelievably unethical, whether it's a naturopath doing it or an MD like Dr. Berman. They both claim to do tests to demonstrate that stem cells are present, but, absent their publishing their protocols, there's no way of knowing if they actually know what they're doing. I highly doubt they do.</p> <p>In the end, naturopaths go where the ducks are, but, even more than that, they go where the quacking is the loudest. It doesn't matter if it's really "natural" or not. After all, in functional medicine what is "natural" about doing batteries of blood tests for dozens of hormones, nutrients, and other factors and then providing supplements and intravenous therapies to "correct" them all? What is "natural" about extracting fat and doing all sorts of manipulations to isolate individual cell types or doing bone marrow biopsies and isolating the stem cells, then reinjecting them? Of course, then there's the issue of whether what is being injected are really "stem cells" at all, which in many cases is highly doubtful given the lack of rigorous descriptions of the protocols used to isolate the stem cells. Stem cell clinics have become a profit train for unethical real doctors. Given that naturopaths are quacks who cosplay real doctors, it's not surprising that they'd cosplay the unethical ones too and jump on the gravy train.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Sun, 09/10/2017 - 21:26</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Mon, 11 Sep 2017 01:26:58 +0000 oracknows 22621 at https://scienceblogs.com A pharma shill working on behalf of an industry-funded group shows how easy it is to publish propaganda as a legitimate op-ed https://scienceblogs.com/insolence/2017/09/08/a-pharma-shill-working-on-behalf-of-an-industry-astroturf-group-shows-how-easy-it-is-to-publish-propaganda-as-a-legitimate-op-ed <span>A pharma shill working on behalf of an industry-funded group shows how easy it is to publish propaganda as a legitimate op-ed</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>As a medical blogger with a skeptical bent and a rather aggressive proclivity towards defending science-based medicine, I generally like STAT News. Sure, it's occasionally screwed up royally (e.g., its <a href="http://respectfulinsolence.com/2016/06/02/unintentional-propaganda-for-stanislaw-burzynskis-cancer-quackery-from-journalists-who-should-know-better/">credulous false balance reporting</a> on a patient of cancer quack Stanislaw Burzynski named Neil Fachon), but in general it's usually a good source of medical news and analysis. No publication is perfect, of course, but STATNews is generally better than average, and I appreciate that.</p> <p>That's why I was disappointed to see how thoroughly a pharma-backed astroturf group whose mission is to loosen restrictions on physicians interacting with drug companies played STATNews last week and how long it took STATNews to do something about it. The screwup began last Friday, when STATNews published an op-ed by a physician named Dr. Robert Yapundich entitled <a href="https://www.statnews.com/2017/09/01/doctor-pharma-sales-reps/">How pharma sales reps help me be a more up-to-date doctor</a>. No, that's not a joke. That's actually what the title of the op-ed was. If you click on the link now, you'll find a note from the editor of STATNews explaining that the article has been retracted and providing reasons (although not a particularly in-depth explanation) for why the op-ed had been retracted. However, the <a href="https://web.archive.org/web/20170901111434/https://www.statnews.com/2017/09/01/doctor-pharma-sales-reps/">almighty Wayback Machine will show us why</a>, when I saw the article over the weekend, my first reaction, was "WTF?" but why the whole op-ed stunk to high heaven and set my skeptical antennae twitching furiously. (<a href="https://www.healthnewsreview.org/2017/09/tone-deaf-pharma-conflict-interest-stat-piece-praising-drug-reps-fails-disclose-industry-payments/">I note that I was not alone</a>.) However, I didn't write about it until things blew up yesterday with revelations that were very embarrassing to STATNews, particularly about the undisclosed conflicts of interest on Dr. Yapundich's part and—surprise! surprise!—<a href="https://www.healthnewsreview.org/2017/09/a-blow-to-stats-credibility-public-relations-firm-may-have-ghostwritten-op-ed-praising-drug-reps/">ghostwriting</a>.</p> <!--more--><p>First, let's take a look at the offending article, with the help of the Wayback Machine. <a href="https://web.archive.org/web/20170901111434/https://www.statnews.com/2017/09/01/doctor-pharma-sales-reps">Dr. Yapundich notes</a>:</p> <blockquote><p> As a neurologist in practice for more than 20 years, I have experienced many changes that regulate and limit the drug industry’s interaction with physicians and other health care providers. These changes are aimed at preventing companies from having undue influence on physicians. </p></blockquote> <p>Correct. Dr. Yapundich even seems to concede that it's a good idea to prevent pharma reps from having undue influence over doctors. But in the op-ed he soon expressed "worry" that "lawmakers could eventually implement further restrictions on these interactions that could de facto ban communications between pharmaceutical companies and doctors." Personally, I'm not sure that that would be such a bad thing, but clearly Dr. Yapundich thinks that it would be, were such a ban ever to occur. Personally, I also highly doubt that such a complete ban would ever be instated, much less enforced. Be that as it may, Dr. Yapundich seems to fear such an eventuality. Why? He seems to think that drug reps are necessary for doctors to keep pace with the fast-changing world of health care and new drug treatment recommendations:</p> <blockquote><p> Many doctors find it difficult to keep pace with the breakneck speed of research and development. With more than 7,000 new medicines in the pipeline, treatment options are constantly expanding. In 2016, U.S. authorities approved 46 new medicines for sale.</p> <p>Unaware of the latest treatments, many doctors stick to their old prescription patterns. That can lead to people not getting the best medications for their illnesses. By one calculation, the average American patient fails to receive the recommended drug in nearly one 1 of every 3 doctor visits.</p> <p>Drug company representatives can provide doctors with vital nuggets of information on the latest treatments while preserving their freedom to treat patients as they see fit. </p></blockquote> <p>He even used an anecdote about how a drug rep told him about a new drug to treat Parkinson's disease psychosis. (More on that later.)</p> <p>I can't speak for my fellow physicians, but my response to this sort of twaddle is that if you can't find other ways to keep up with the medical literature other than meeting with drug company reps whose job it is to persuade you to prescribe more of their product and to choose their products over those of competing drug companies, you really should reassess your continuing medical education strategy, particularly in the age of the Internet. I'm not one of those who argue that doctors should never have contact with pharma reps, but, come on! These are not physicians. They might not even have a science background. There are better sources for information.</p> <p>Also, doctors seem to have a rather arrogant belief that their judgment is not affected by gifts that drug companies love to lavish on physicians. It is a truly arrogant view that ignores huge amounts of social science and psychology research that shows that even relatively small gifts can <a href="http://www.nytimes.com/2009/05/19/health/research/19beha.html">influence behavior</a> subconsciously. Yes, we are social apes, and we feel a <a href="https://epub.ub.uni-muenchen.de/14241/1/Malmendier_Schmidt_2012_You_Owe_Me.pdf">powerful urge to reciprocate</a>. It's the reason why charities, for instance, will frequently include little gifts in their mailings soliciting donations. People feel very guilty accepting even tiny gifts without some form of reciprocation. It's our nature. I get really tired of hearing my colleagues opine about how they are not at all influenced by drug company gifts. I really have to bite my tongue sometimes, rather than doing what I really want to do and responding, "Bullshit!" They really believe that, but I know they're basically deluding themselves, which is why it irritates me so much to hear them self-righteously proclaim that they could never, ever be influenced by such trinkets.</p> <p>Of course, the real point Dr. Yapundich is getting at is something that his pharma paymasters (oops, did I spill the beans?) want so, so badly:</p> <blockquote><p> Doctors benefit from hearing about such off-label uses, as they inform doctors about alternative uses of medications. However, existing law essentially bans industry reps from discussing off-label uses — even those that are widely popular in the medical community and proven to be effective and safe. Preventing sales reps from mentioning these uses can be detrimental to patients, especially considering that some conditions have no FDA-approved treatments. In these situations, off-label uses can be doctors’ only option for prescribing. Patients would benefit from having physicians be as informed as possible about effective off-label uses. </p></blockquote> <p>Off-label prescribing, of course, is a major part of medicine. Drugs are frequently used for indications for which they are not FDA-approved, because once a drug is FDA-approved for one indication it can be used for any indication. Not infrequently, there is evidence for the use of a given drug for an indication other than the indications for which it was approved by the FDA. Physicians thus have the freedom to prescribe drugs off-label when they see fit, based on their evaluation of their patients and interpretation of clinical trials. It's part of our professional judgment and obligation. However, drug companies have a vested interest in promoting off-label use because it improves their bottom line. Also, why bother going through the tedious and difficult process of applying to the FDA for approval for a new clinical indication when the same thing could be accomplished by persuading a critical mass of doctors in the relevant specialty to use their drug for a non-FDA-approved indication? There's a reason why it's illegal for drug companies to advertise off-label uses for their drug. If they could do that, then all they would have to do is to get their drug approved for one indication and, instead of relying on physicians interpreting the evidence to start using their product off-label, they could promote such uses themselves, even if the drug hasn't yet been approved for that indication or if the evidence for the off-label use is not that strong.</p> <p>Even in the original iteration of this article, there was a major red flag in the bio of Dr. Yapundich:</p> <blockquote><p> Robert Yapundich, M.D., is a neurologist practicing in Hickory, N.C., and a member of the Alliance for Patient Access. The alliance supports regulations that expand manufacturers’ ability to discuss off-label uses, particularly those that are accepted in compendia and practice guidelines or reimbursed by the government and insurers. </p></blockquote> <p>So Dr. Yapundich is a member of a group that supports expanding manufacturers' abilities to discuss off-label uses. That's bad enough. However, not long after STATNews published his op-ed, Twitter erupted:</p> <blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr" xml:lang="en">might want to disclose that author has been paid $200k+ in last 2 years <a href="https://t.co/QnmU27SPZ7">https://t.co/QnmU27SPZ7</a> <a href="https://t.co/DMJgJ69yrl">https://t.co/DMJgJ69yrl</a></p> <p>— Zach Brennan (@ZacharyBrennan) <a href="https://twitter.com/ZacharyBrennan/status/903650457612156929">September 1, 2017</a></p></blockquote> <script async="" src="//platform.twitter.com/widgets.js" charset="utf-8"></script><p> And:</p> <blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr" xml:lang="en">This pro drug rep article fails to mention the author received 134K in pharma payments in 2015. Disgusting!<a href="https://t.co/lFHjBaFNu7">https://t.co/lFHjBaFNu7</a></p> <p>— Stephen Popovich (@sjpopo) <a href="https://twitter.com/sjpopo/status/903946326219554817">September 2, 2017</a></p></blockquote> <script async="" src="//platform.twitter.com/widgets.js" charset="utf-8"></script><p> It's actually worse than that. It turns out that Dr. Yapundich received $332,294 between 2013-2016 from pharmaceutical companies, which was not disclosed in the original article. That's a pretty impressive lapse, don't you think? Funny how he somehow forgot to disclose that or <a href="https://www.statnews.com/2017/09/01/doctor-pharma-sales-reps/">didn't think it important</a>:</p> <blockquote><p> As a matter of policy, we ask all our contributors to disclose payments from industry and other possible conflicts of interest. In this case, the author disclosed no conflicts other than his affiliation with an organization that supports expanding manufacturers’ ability to discuss off-label uses of drugs. In response to reader questions, we contacted Yapundich and he told us he had received more than $300,000 in recent years from pharmaceutical companies, including one he mentioned in the article. He also acknowledged that his organization was funded in part by pharmaceutical companies. We disclosed that information at the bottom of the article on Tuesday. </p></blockquote> <p>I'm not the sort who argues that physicians should never meet with pharmaceutical company representatives and salespeople, although personally I do try to keep my contact with them to a minimum. Occasionally, I've even gotten useful information from them, but I can't recall a time when it was anything I wouldn't have soon learned for myself another way. STATNews' misstep was on another plane entirely. Here we have a physician who belongs to a what looks all the world to me like an astroturf group funded by pharma whose purpose is to lobby and do PR for loosening restrictions on pharmaceutical companies discussing off-label uses of their products. </p> <p>That new addendum/disclaimer was the only change made; that is, until sometime yesterday afternoon, after the other shoe dropped in the form of an article by Kevin Lomangino at HealthNewsReview, <a href="https://www.healthnewsreview.org/2017/09/a-blow-to-stats-credibility-public-relations-firm-may-have-ghostwritten-op-ed-praising-drug-reps/">‘A blow to [STAT’s] credibility’: MD listed as author of op-ed praising drug reps didn’t write it. Ghostwriting/PR influence</a>. Lomangino interviewed Dr. Yapundich and discovered that he didn't write it. He contributed to it after a draft had been presented to him, but:</p> <blockquote><p> Here is Yapundich’s account of how the events surrounding the op-ed unfolded:</p> <ul><li>The concept for the STAT article, as far as Yapundich knows (although this hasn’t been verified), came from the <a href="http://allianceforpatientaccess.org/">Alliance for Patient Access</a> (AfPA), a physician group whose stated mission is “ensuring patient access to approved therapies and appropriate clinical care.” The group is supported financially by <a href="http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2017/07/AfPAAssociateMembersJune2017.pdf">nearly 30 pharmaceutical companies</a>.</li> <li>Yapundich is on the board of AfPA, and his membership is disclosed in the STAT piece. He says a staff member from the organization initially approached him about getting involved with the op-ed. The premise — “How pharma sales reps help me be a more up-to-date doctor” — is something Yapundich says he agrees with passionately. It didn’t take much convincing for him to decide to participate.</li> <li>Yapundich stated clearly that he did not write the initial draft of the article and doesn’t know who did. He said he “agrees with the spirit of the article” and “wouldn’t have put his name to it” otherwise. “AfPA sent me an initial draft that they composed, I made some changes and edits to it, and the process went back and forth for about a month until it was published,” he said.</li> </ul><p>That’s when the problems began in earnest.</p> <p>As we <a href="https://www.healthnewsreview.org/2017/09/tone-deaf-pharma-conflict-interest-stat-piece-praising-drug-reps-fails-disclose-industry-payments/">reported</a> earlier this week, Yapundich received more than $300,000 from the drug industry between 2013 and 2016, according to the federal Open Payments database. And yet disclosure of that conflict of interest was initially missing from Yapundich’s op-ed; it was added only after an outcry in the comments section of the STAT piece and on <a href="https://twitter.com/ZacharyBrennan/status/903650457612156929">Twitter</a>. </p></blockquote> <p>So, not only was the op-ed published without a complete accounting of Dr. Yapundich's conflicts of interest, but it was ghostwritten, and the anecdote he told about finding out about a new treatment for Parkinson's disease psychosis was, to put it kindly, embellished:</p> <blockquote><p> “It didn’t come out the way I intended it to,” he said, speaking of the op-ed that carried his name. “The article made it seem like I’d never seen the drug before and that was not what I intended.”</p> <p>He told me he was well aware of the drug at the time of the encounter with the sales rep, and that the rep had said something interesting about the drug — “new medication data,” Yapundich called it — that “set off a light bulb” in his mind and subsequently led to the positive patient encounter.</p> <p>“I hope there aren’t other parts of the article that escaped my editorial oversight or review,” Yapundich said. “The next time I do one of these op-eds, I should be the one doing the drafting and they should be the ones doing the editing and reviewing.” </p></blockquote> <p>Ya think? That is so obvious that it's amazing that Dr. Yapundich needed to be publicly embarrassed by being called out for his failure to disclose how much he benefits from pharma payments. Indeed, his contortions on the issue are epic:</p> <blockquote><p> Yapundich says he understands the importance of such financial disclosures and that the omission was unintentional. It resulted from miscommunication with AfPA and uncertainty regarding the disclosure requirements.</p> <p>“In regards to COI, I’m not sure what is needed,” he recalled writing to his AfPA liaison. “Do you need the company names? Which years? What type of COI?”</p> <p>His contact reportedly wrote back: “Hold on financial info. Hopefully only needed for AfPA and not for you individually.”</p> <p>That’s the last Yapundich heard about the disclosure issue until STAT called him to clarify, he says. </p></blockquote> <p>Bloody hell, this is disingenuous. If you receive over $300,000 from pharmaceutical companies over the last 3 or 4 years, you should disclose it. You don't have to name the companies. It's clear that AfPA thought it could hide just how beholden to pharmaceutical companies Dr. Yapundich is by rolling it all into itself and having him disclose only that he belongs to the AfPA. Of course, most people are not going to look into the AfPA more, and the vague explanation that it promotes more discussion by pharma reps of off-label uses doesn't tell the whole story in a way that communicates the magnitude of the COI.</p> <p>Then, of course, there is the involvement of Keybridge Communications, who's just as vague about its explanation for the lapse in full disclosure of COIs:</p> <blockquote><p> His explanation of the financial disclosure confusion appears to cast blame on STAT for not being thorough enough. But it may also reflect failure to respect accepted standards for acknowledging conflict of interest.</p> <p>“As you know,” Snyder wrote, “Dr. Yapundich has many relationships with the pharmaceutical industry. This is no secret; the relationships are publicly detailed here. We didn’t send this along as we were under the impression that the editor was asking about the Alliance for Patient Access, and Dr. Yapundich wrote the piece in his capacity as a member of AfPA.” </p></blockquote> <p>Yes, there is blame to be placed on STAT, but Mr. Snyder is being quite disingenuous here. Keybridge Communications is a PR firm that touts its goal as "to get your message in front of your target audience, whether it’s influencers and consumers or lawmakers and voters, noting that opinion media "drives the public debate – and enables our clients to expand their footprint, sway attitudes, and achieve their strategic goals." In other words, it tries to get op-eds published in high profile outlets like STAT in order to promote its clients' message. I don't believe for a minute that Keybridge doesn't know what was being asked when STAT asked for relevant COIs or that it didn't know damned well that its response would hopefully placate STAT without revealing the hundreds of thousands of dollars that Dr. Yapundich had received to be a pharma shill. (Yes, he is a <em>real</em> pharma shill, unlike the pharma shill accusations quacks and antivaxers frequently level at skeptics.)</p> <p>Unfortunately, STAT fell for it. Even more unfortunately, STAT appears to be circling the wagons more than it should. Lomangino notes that when he raised his detailed concerns with the editors of STAT they declined to offer a detailed response or even to "make an attempt to investigate further and get back to me." According to Lomangio, STAT told him, basically, he was "welcome to do that" himself.</p> <p>I agree with Lomangino that op-ed contributions are not news pieces and therefore that op-ed writers should have more latitude. They are, after all, writing opinion pieces. Unfortunately, at the time this op-ed was published, STAT's vetting procedures were so lax that they allowed a ghostwritten puff piece (as Lomangino put it) by a pharma-funded astroturf group and distributed through its PR company. Yes, I know that a lot of legitimate op-ed writers have PR companies getting their offerings published in newspapers, magazines, and online outlets, but it should be possible to make it more difficult for companies to get ghostwritten articles published. In this case, a few simple searches on Google and a couple of relevant websites (e.g., the Open Payments database) would have revealed that Dr. Yapundich wasn't disclosing everything.</p> <p>As I said, I generally like STAT (although one of its reporters doesn't much like me any more—I won't say who). It was a welcome addition to health reporting. It's not perfect, and I don't expect perfection. I do, however, expect better than this when it comes to a very basic function of journalism, disclosing relevant conflicts of interest.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Fri, 09/08/2017 - 02:50</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Fri, 08 Sep 2017 06:50:32 +0000 oracknows 22620 at https://scienceblogs.com Patients lose when they chose naturopaths over real doctors https://scienceblogs.com/insolence/2017/09/05/patients-lose-when-they-chose-naturopaths-over-real-doctors <span>Patients lose when they chose naturopaths over real doctors</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>I write frequently about naturopathy here because, of all the dubious pseudoscientific medical "disciplines" out there, naturopathy (along with chiropractic) has achieved the most "respectability." Indeed, as I like to point out in my own specialty (breast cancer), the Society for Integrative Oncology (SIO) even <a href="https://integrativeonc.org/join-sio">admits naturopaths</a> as members. Indeed, the immediate past president of SIO is a naturopath (and, depressingly, <a href="https://medicine.umich.edu/dept/family-medicine/suzanna-m-zick-nd-mph">faculty at my medical alma mater</a>, the University of Michigan), as was the SIO president in 2014. So entrenched are naturopaths in SIO that they have been prominent co-authors on SIO clinical guidelines papers, <a href="https://academic.oup.com/jncimono/article/2014/50/346/913277/Clinical-Practice-Guidelines-on-the-Use-of">like this set of breast cancer guidelines</a>, with <a href="http://respectfulinsolence.com/2014/12/01/old-wine-in-a-new-skin-the-society-for-integrative-oncology-issues-guidelines-for-breast-cancer/">two naturopaths as co-authors</a>, one as first author. Basically, in academia at least, naturopaths have certainly surpassed chiropractors in terms of seeming respectability, even though they promote alternative medical treatments that, <a href="http://respectfulinsolence.com/">as I pointed out recently</a>, kill cancer patients dead through lack of effective treatment.</p> <!--more--><p>I was reminded of this unfortunate infiltration of naturopaths when I saw a story a week ago from, of all places, New Zealand, "<a href="https://www.stuff.co.nz/national/health/96110398/naturopathy-under-microscope-after-two-cancer-sufferers-speak-out-under-shadow-of-death">Naturopathy under microscope after cancer sufferers speak from under shadow of death</a>." It tells the story of two cancer patients who relied on naturopaths for treatment and didn't live to regret it, at least not long.</p> <h2>An almost certainly preventable death</h2> <p>Naturopaths sell themselves to cancer patients as offering treatments that are "natural," although I've always been puzzled how many treatments offered by naturopaths (like high dose intravenous vitamin C, "functional medicine, or various diagnostic tests like thermography) are any more "natural" than what "conventional medicine offers. What is really most attractive to patients is the claim that they can treat cancer without the toxicity associated with known effective treatments for cancer, such as radiation, surgery, and, most feared of all, chemotherapy. Unfortunately, when patients with highly treatable cancers believe these claims, the <a href="https://www.stuff.co.nz/national/health/96110398/naturopathy-under-microscope-after-two-cancer-sufferers-speak-out-under-shadow-of-death">result can be fatal</a>:</p> <blockquote><p> It is late July. An Auckland woman sits at her dining room table, frail, cosseted in a wool-knit beanie, brittle wisps of hair poking out.</p> <p>She knows her time is running out. She doesn't know it, but she will be dead in two weeks.</p> <p>First, though, she wants to speak out to call for regulation of naturopaths after her bitter experience with alternative therapies.</p> <p>"From my point of view the naturopath has used people like me as guinea pigs," the Auckland woman told Stuff. "I don't think naturopaths should try to heal cancer. I trusted in naturopathy, I don't trust in it any more." </p></blockquote> <p>This is the price patients with treatable cancers can end up paying for trusting naturopaths. This patient, who is not named in the story, didn't even have cancer, but rather a premalignant condition known as <em>ductal carcinoma in situ</em> (DCIS). I've <a href="http://respectfulinsolence.com/2015/08/21/how-should-we-treat-stage-0-breast-cancer/">written about DCIS on multiple occasions </a>, because it is a condition whose management is becoming less straightforward as we understand more about the biology of the disease. The reason is that not all DCIS progresses to life-threatening breast cancer in a woman's lifetime; indeed, most probably do not, to the point where watchful waiting is being <a href="http://www.nejm.org/doi/full/10.1056/NEJMclde1512213">discussed as a viable treatment option</a> for women with low grade, low risk DCIS. There is a clinical trial, the Low Risk DCIS (LORIS) trial, comparing outcomes between immediate surgery and active monitoring for low-risk DCIS. Close to 100% of women with DCIS women should survive their disease with treatment.</p> <p>Here is this patient's story. It began in 2013:</p> <blockquote><p> In July 2013 she had been diagnosed with ductal carcinoma in situ (DCIS), a pre-cancerous breast condition. Her oncologist told her she had a "50/50" likelihood of contracting breast cancer, and recommended an immediate double-mastectomy.</p> <p>"I was shocked and scared of surgery, I'd never had surgery. Then you face one breast, both breasts, no breasts, you start looking for alternatives."</p> <p>Unaware some DCIS strains are more aggressive than others, she believed time was on her side and she could try alternative medicine. </p></blockquote> <p>We don't have any information on the features of this woman's DCIS that would allow me to estimate her risk. For instance, we don't know from this story whether it was high or low grade, low grade being much lower risk. We don't know if it had high risk features, like comedo necrosis, which portends a high risk of progression to invasive cancer. I was also puzzled by the recommendation for immediate bilateral mastectomy. Mastectomy is usually not indicated for DCIS. Most DCIS lesions can be treated with breast conserving surgery (lumpectomy) followed by radiation. Mastectomy is reserved for cases of diffuse or extensive DCIS in which all the disease can't be removed by lumpectomy. Bilateral mastectomy is rarely indicated for DCIS, the main exception being when both breasts are involved with extensive DCIS, a very uncommon situation. In fairness, some women with extensive DCIS in one breast and DCIS in the other breast amenable to mastectomy will opt, not necessarily unreasonably, for bilateral mastectomy, but this is usually the woman's choice, and this article states that the oncologist recommended bilateral mastectomy. Again, no reason for this recommendation is provided in this news story; so I don't know whether this patient had any of the indications for a bilateral mastectomy in DCIS. I'd be willing to bet that she probably didn't and that this recommendation was probably a recommendation for massive overtreatment.</p> <p>I mention this because the aggressiveness of the recommended surgery almost certainly played a role in this Auckland woman's disastrous decision to forego effective treatment. Whatever her reasons, though, this is how her story played out. The woman and her husband found a naturopath, whose name is never mentioned (much to my irritation), having heard stories about her alleged success rate and discovered that she was affiliated with Cape Town University. (<em>Did they mean the University of Cape Town?</em> I wondered.) The naturopath also advertised that she had an MDipNat.Herb from the South African College of Natural Medicines, which is apparently a degree in herbal medicine of some sort. This particular naturopath saw her and then followed up her treatments with Internet consultations:</p> <blockquote><p> The naturopath continued treating the Auckland woman over the internet using words such as "tumours" and "cancer". "At this stage there is nothing to worry about," she emailed.</p> <p>Apart from a grueling regime of daily natural supplements, for a time the naturopath told her to simply apply ointment to her breasts.</p> <p>The woman emailed the naturopath photos of her bruised breasts: "Hi, those green spots definitely little tumours," the naturopath replied. "It looks like there is just the start of cancer, would most probably have developed into major pictures!!! ... fantastic those come out".</p> <p>A week later the Auckland woman sent more pictures.</p> <p>"Wow, girl this looks great," the naturopath replied. "The top one looks at this stage there is nothing to worry about ... you can just apply zambuck ointment to that to draw out the last anger and puss ... do you have that, can I courier you some?" </p></blockquote> <p>Now here's something I never figured out. Naturopaths contend that theirs is "natural medicine" that is much less toxic and causes many fewer side effects; sometimes it's claimed that there will be no side effects. Yet their treatment regimens are often quite onerous. For example, read the description of this woman's regimen, which got to the point where she had to get up earlier every morning just to "go through all my stuff." She spent thousands on "myriad pills, drops, powders and ointments the naturopath advised her to take." Then consider other alternative cancer treatments favored by naturopaths, like the Gerson protocol, which requires drinking thirteen organic juices (which have to be prepared fresh hourly) and well over a hundred supplement pills per day, as well as a basic organic whole food plant-based diet plus five coffee enemas per day. <a href="https://sciencebasedmedicine.org/the-gerson-protocol-and-the-death-of-jess-ainscough/">I kid you not</a>.</p> <p>In any case, none of her treatments worked, and in fact the woman became progressively fatigued to the point where she gave up less than a year later and gave the supplements back because she "didn't believe in them any more." Even so, instead of going back to real medicine, she went to another naturopath and didn't finally undergo surgery until January 2016. One thing that bothers me about this story is that the timeline isn't really very clear. As a cancer doctor, I really want to know when this patient was diagnosed with invasive cancer, as that would clarify my discussion a lot. However, I do know how the story ends, and it ends tragically:</p> <blockquote><p> Before dying, the woman confronted the naturopath by email about her treatment methods and unavailability.</p> <p>And with days left to live, the Auckland woman asks one last time, "I don't understand why there are no regulations?"</p> <p>It's late July. Pale, hunched, shuffling, months after her cancer had spread to her lymph nodes, the woman holds on.</p> <p>"If we could make a difference there with regulation, that would help everyone – that would help the naturopath," she says.</p> <p>"I'm starting my chemotherapy, it's quite exciting, the hope is it will shrink the existing cancer but it has spread, I don't know how much hope there is.</p> <p>"I don't want to lose hope."</p> <p>It was not to be. This month, she passed away. </p></blockquote> <p>When the reporter, Simon Maude, contacts her one last time, instead of expressing regret, the naturopath makes it all about her:</p> <blockquote><p> And the naturopath? We give her a final phone call.</p> <p>She's closing her holistic health practice in September, she says.</p> <p>"I've just had it. At the end of the day it's a thankless job, I've given my life to people to try and help them, I've had enough". </p></blockquote> <p>Selling ineffective supplements that fail to prevent what was almost certainly an eminently preventable death is a "thankless job." I suppose so because this naturopath definitely doesn't deserve anything resembling thanks. I did, of course, try to figure out who this naturopath is, and I think I did. Since I can't be sure, I will not publish my speculation, however. Instead, I will move on to the second case.</p> <h2>Another way naturopaths harm cancer patients</h2> <p>The second patient, a 55-year-old woman named Jane Norcross-Wilkins, had breast cancer and treated by the same naturopath, but her case is quite different otherwise. She had breast cancer in 2001, but it recurred in 2011. By 2015 it was stage IV and incurable. As her husband, Mike Malcolm put it, she just wanted more time, with the rationale, "OK, if I can't beat it, I can work with it and see how far I can go," which is certainly not unreasonable and is the way many patients with terminal cancer think. It's also the approach taken by real oncologists: To slow the progression of the cancer for as long as possible while also balancing the toxicities of therapy with the limited anticipated benefits and taking into account the patient's values (e.g., to fight for as long as possible vs. to be as comfortable as possible for as long as possible). However, such decisions require a dispassionate assessment and communication of the actual prognosis versus the risks and toxicities of therapy. Naturopaths frequently short circuit that necessary discussion with false hope, as in the case of Norcross-Wilkins, who went to see this same naturopath in December 2015:</p> <blockquote><p> Upfront with the naturopath about Jane's terminal cancer diagnosis, they listened as the naturopath held court. "She's good at talking herself up, she highlighted how certain parts of the cancer process can be interrupted or changed with processes she used, stopped and reversed.</p> <p>"You could listen to her all day, she's very knowledgeable, she explains things in layman's terms."</p> <p>Jane was put on a gruelling regime of expensive natural remedies. She discovered homeopathic melatonin sold to her for $50, retailed elsewhere for $12; vitamin C caplets sold for $140 retailed for $87 over the counter. </p></blockquote> <p>As with the first patient – not only was Norcross-Wilkins' regimen expensive, it was brutal:</p> <blockquote><p> Mike explains: "It was like a detox, a purge, I've never seen anything like it, the amount of things she had to take. But the naturopath said 'no, no Jane's got to keep on doing it, it's a little bit hard at the start but you're killing the cancer, you're giving the cancer an environment it can't live in'.</p> <p>"But Jane couldn't live like that." </p></blockquote> <p>As it became apparent that the woo wasn't working, the naturopath became progressively more difficult to get a hold of, even after having promised at the beginning that Norcross-Wilkins could call her "any time." Phone calls went unreturned, and e-mails were not answered for days. When Norcross-Wilkins was hospitalized for three weeks in January 2016 the naturopath didn't inquire about her. The end result:</p> <blockquote><p> Angry emails sent to the naturopath ended with Jane and Mike dumping her late the following month. </p> <p>A final March 2016 letter from Jane to the naturopath ended: "I strongly suggest you set up supervision for yourself and a highly experienced practitioner to ensure that you are working ethically ... I also suggest you look into registering with a body such as the NZ Natural Health Council or the NZ Society of Naturopaths Inc.</p> <p>"I do not wish to continue as your client," Jane concluded.</p> <p>The naturopath apologised profusely, and promised not to treat cancer sufferers any more. She refunded the cost of some of Jane's medicine's [<em>sic</em>]. </p></blockquote> <p>Let's just put it this way. Real oncologists don't have the option, ethically, of avoiding their patients who aren't doing well. In any event, Norcross-Wilkins married Malcolm in December 2016 and died on February 8, 2017.</p> <p>Defenders of naturopaths and other quacks will frequently point to patients like Jane Norcross-Wilkins and ask, "What do they have to lose? Conventional medicine can't save them." The response is simple, if not easy. Patients like Norcross-Wilkins are going to die, but what naturopaths like this one rob them of are effective palliative care, so that they suffer more than they need to, both from their cancer progression and from the quack therapies they undergo; money that could go to their estate that instead is spent on ineffective nostrums; quality time with their families before their condition deteriorates too much; and a chance to put their affairs in order properly before the end.</p> <h2>The naturopath responds</h2> <p>There are usually at least two sides to every story, and this one is no exception. Unfortunately, the naturopath's side of the story comes across as self-serving and very much covering her posterior:</p> <blockquote><p> "Cancer IS an exhausting disease," the naturopath tells Stuff. "There's no nice way to treat cancer, you show me a patient who is doing anything that is making them feel better.</p> <p>"People think because [my treatment is natural] it should feel good. It's not, there's no easy way to treat cancer."</p> <p>Tumours, cancer – at this point shouldn't the naturopath have stopped and suggested the woman go back to her oncologist?</p> <p>"It's not my place to refer them to a specialist," she tells us. "I can't do that because I'm a naturopath." </p></blockquote> <p>That last bit strikes me a very intentionally legalistic justification. Let's just put it this way. I don't know the law in New Zealand, but whatever it says regarding the regulation of medical practice I'd be willing to bet that there's nothing in it that forbids a naturopath from saying to a patient who is clearly not getting better, "I really think you should see an oncologist."</p> <p>Be that as it may, it turns out that naturopaths are not regulated in New Zealand. New Zealand Society of Naturopaths vice-president Sharon Erdrich is quoted as saying that New Zealand naturopaths want "tighter regulations." This claim would seem to be belied by the fact reported that a non-regulated health profession can submit an application to the Ministry of Health to be regulated and the observation that the "ministry has not received an application from naturopaths to become regulated under the Health Practitioners Competence Assurance Act 2003."</p> <h2>Beyond cancer and New Zealand</h2> <p>Of course, naturopaths are not just dangerous to cancer patients, as a <a href="https://www.stuff.co.nz/world/australia/96193975/australian-naturopath-admits-raw-food-diet-advice-endangered-babys-life">recent story</a> that I had thought about blogging about but somehow never got to shows. In this incident, which <a href="http://respectfulinsolence.com/2015/07/10/this-is-what-happens-when-you-trust-a-naturopath-to-treat-a-real-disease/">occurred two years ago</a>, an Australian naturopath, using the rationale that a breastfeeding mother needed to "alkaline" her milk and "eliminate the toxins" from the baby's body, recommended a 100% raw vegan diet:</p> <blockquote><p> An Australian naturopath who instructed a breastfeeding mother to stick to a "raw food" diet to cure her son's eczema has admitted that her advice endangered the baby's life.</p> <p>Marilyn Bodnar, 61, was accused of directing the mother, a midwife who cannot be named for legal reasons, to abandon other medical advice and adhere to a strict diet of raw vegetables, fruit and seeds.</p> <p>By the time the mother took the baby to hospital, he was limp, had sunken eyes and police believe he was just days from death.</p> <p>According to court documents, Bodnar, from Sydney's south-west, made the mother feel guilty for eating "rubbish" during her pregnancy and using steroid creams for the boy's eczema. </p></blockquote> <p>When the baby developed a fever, this naturopath's irresponsible advice went even beyond this. She advised the mother to drink nothing but water, saying, "You're not allowed to drink anything if you want to see him better." When the infant started vomiting, the naturopath went beyond even that and told the mother to continue, saying, "increased temperature meant increased vitality." By the time the baby was taken to the hospital, he was <a href="http://www.news.com.au/national/nsw-act/courts-law/marilyn-bodnar-pleads-guilty-over-starving-baby-case/news-story/c3b025005c6a871899ecb9dd7a0da246">badly emaciated</a> and, at eight months, weighed only 6.39 kg, which placed him in the zero percentile for babies his age.</p> <p>Nor is this the first time Bodnar <a href="http://www.news.com.au/national/nsw-act/courts-law/marilyn-bodnar-pleads-guilty-over-starving-baby-case/news-story/c3b025005c6a871899ecb9dd7a0da246">endangered a life</a>:</p> <blockquote><p> It can now be revealed that Bodnar — who boasts online of being able to help “parents and children’s health and infertility” — faced a manslaughter trial in 1988 over the death of a woman who was on a water only diet for 63 days.<br /> Bodnar was acquitted of the manslaughter of 42-year-old Narelle Niemann, who lost 35 per cent of her body weight while she was under Bodnar’s care.<br /> Prosecutors argued Bodnar failed to get professional help when her condition deteriorated, but the jury found her not guilty. She argued at trial she was helping Ms Niemann as a friend and not as a patient. </p></blockquote> <p>So Bodnar's been at this sort of thing for nearly 30 years at least? One wonders why Australian authorities couldn't stop her until now. Not that we in the US have anything to brag about on the score of stopping naturopathic quacks from endangering lives. For instance, four months ago, I wrote about the case of Jade Erick, a young woman with eczema who <a href="https://sciencebasedmedicine.org/naturopathic-death-from-iv-turmeric/">died of a hypersensitivity reaction</a> when a naturopath named Kim Kelly <a href="https://sciencebasedmedicine.org/naturopathy-and-dubious-compounding-pharmacies-a-deadly-combination/">treated her in his office with intravenous curcumin</a>.</p> <p>Another case that <a href="hhttp://respectfulinsolence.com/2017/03/22/naturopaths-use-the-murder-of-a-quack-to-promote-naturopathic-licensure/">I've discussed here</a> before involved a woman in Bowling Green named Fikreta Ibrisevic who sought the services of a local naturopath named Juan Sanchez Gonzalez to treat her rhabdomyosarcoma and was quoted in news reports as having told her and her husband Omer Ahmetovic that "chemotherapy is for losers" and that he could "guarantee" that Ibrisevic would be cancer-free with his treatments within three months. Predictably and tragically, Gonzalez's quackery didn't work. Ibrisevic also sought out the care of other naturopaths. Unfortunately, by the time Ibrisevic realized this and sought out conventional medical care it was too late for her. Although she accepted chemotherapy, the cancer was too advanced. She died of it on February 27, 2017. This case is compounded by further tragedy, as well. On a Friday evening after office hours four days after his wife's death, the grieving husband allegedly walked into Gonzalez's office and shot him dead.</p> <h2>There are no "good naturopaths"</h2> <p>I started this article by complaining about the SIO, which will no doubt consider my mentioning of the organization unfair in relationship to discussing these cases of naturopaths leading to the deaths of cancer patients. The reason is that most of the naturopaths I just discussed were not licensed and didn't come from "approved" schools. To some extent, there might be a reasonable point there, but only in that naturopaths who join SIO are usually associated with academia, which (usually, but certainly not always) keeps their worst impulses under control. Usually. Unfortunately, though, organizations like the SIO, as well as most integrative medicine physicians, turn a blind eye to the quackery inherent in naturopathy. To illustrate this, I like to relate an anecdote. (You can skip the next paragraph if you've heard it before, as I do repeat it from time to time.)</p> <p>Back when I published my Perspective article, "<a href="http://www.nature.com/nrc/journal/v14/n10/abs/nrc3822.html">Integrative oncology: Really the best of both worlds?</a>" in <cite>Nature Reviews Medicine</cite> three years ago, the SIO immediately criticized me for spending so much of it discussing homeopathy, which its leadership properly rejected as being pseudoscience. There were two aspects of this complaint that amused me. First, homeopathy was a far smaller part of the first draft of the article, but reviewers forced me to add more. Second, even more amusing (or disappointing—or both) was that it was clear that the SIO had no clue how integral homeopathy is to naturopathy. I responded by pointing out that naturopathy schools include many hours of homeopathy in their curricula and that naturopaths are tested on homeopathy in the NPLEX, the licensing examination used by states that license naturopaths. I also couldn’t resist twisting the knife a little bit by pointing out that one of the authors of the SIO clinical guidelines for breast cancer was a naturopath who at the time had an open clinical trial of homeopathy listed on ClinicalTrials.gov. Basically, <a href="http://respectfulinsolence.com/2011/01/28/you-cant-have-naturopathy-without-homeop/">you can't have naturopathy without homeopathy</a>. To reject homeopathy as pseudoscience but still accept naturopaths as co-equal medical colleagues is inherently contradictory, because all naturopaths are trained in homeopathy and most of them use it.</p> <p>Consider, for example, Kim Kelly, the "naturopathic physician" whose irresponsible use of an unproven treatment like IV curcumin for eczema <a href="http://respectfulinsolence.com/2017/04/11/death-by-intravenous-turmeric-why-licensed-naturopaths-are-no-safer-than-any-other-naturopath/">killed Jade Erick</a>. He graduated from Bastyr University, basically the Harvard or Yale of naturopathy schools, the <em>crème de la crème</em> of naturopathy schools. (Never mind that being the <em>crème de la crème</em> of quack schools is <em>not</em> a good thing.) Any naturopath who looked at his credentials would tell you that he is everything that a good, well-trained naturopath should be, and he is fully licensed by the State of California to practice naturopathy. Yet, as I <a href="http://respectfulinsolence.com/2017/08/14/the-death-of-jade-erick-from-intravenous-curcumin-mystery-solved/">discussed before</a>, this upstanding naturopath offered a veritable cornucopia of quackery: biopuncture (an unholy union of homeopathy and acupuncture), naturopathic detoxing, hormonal balance treatment, intravenous nutrition, intravenous vitamin C, a dangerous modality like intravenous peroxide, and various “wellness programs.”</p> <p>Let's just put it this way. I've examined the practices of many naturopaths in my time. Outside the very privileged, cloistered, and protected ivory towers of medical academia, I've been unable to find any detectable difference between the level of quackery offered by the great unwashed unlicensed mass of naturopaths who didn't graduate from schools like Bastyr and the elite group of naturopaths (elite only among naturopaths, that is) who did go to "accredited" naturopathy schools and are licensed. Yes, I acknowledge that I haven't done a systematic study and my views might be affected by confirmation bias, but even if that's true I've found a whole lot of what naturopaths would consider their <em>crème de la crème</em> offering a whole lot of quackery and <a href="http://respectfulinsolence.com/?s=Sh*t+naturopaths+say">discussing it in private forums</a>, including some faculty of naturopathy schools and leaders of organized naturopathy, again the <em>crème de la crème</em>.</p> <p>I tend to focus on cancer when I discuss the quackery in naturopathy because I'm a cancer surgeon. As a cancer doctor, I recognize that naturopaths are dangerous and harmful to cancer patients. No, strike that. They are dangerous and harmful to <em>all</em> patients.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Mon, 09/04/2017 - 21:00</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Tue, 05 Sep 2017 01:00:08 +0000 oracknows 22617 at https://scienceblogs.com Surveys of safety net providers find worsening rates of burnout, professional satisfaction https://scienceblogs.com/thepumphandle/2017/09/01/surveys-of-safety-net-providers-find-worsening-rates-of-burnout-professional-satisfaction <span>Surveys of safety net providers find worsening rates of burnout, professional satisfaction</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>Across the country, federally qualified health centers provide a critical safety net, delivering needed medical care regardless of a person’s ability to pay. And so it’s worrisome when researchers document a sharp increase in dissatisfaction among the clinicians and staff who make those centers run.</p> <p>“We’re not sure why we saw things getting worse in the centers,” said Mark Friedberg, a senior natural scientist at Rand Corporation and director of their Boston office. “The best takeaway from this study is we need to track this. We need to get to the bottom of it because it is alarming.”</p> <p>Friedberg and his colleagues surveyed FQHC staff in 2013 and 2014 as part of a larger evaluation of the FQHC <a href="https://innovation.cms.gov/initiatives/fqhcs/" target="_blank" rel="noopener noreferrer">Advanced Primary Care Practice Demonstration</a> at the Centers for Medicare &amp; Medicaid Services (CMS), which focused on patient-centered medical homes. To conduct the study, researchers sampled all 503 FQHC sites participating in the demonstration project, ultimately receiving survey responses from more than 1,200 clinicians and staff in 2013, representing 440 FQHC sites. A follow-up survey in 2014 gained responses from more than 500 clinicians and staff who had also participated in the baseline survey and represented nearly 300 FQHC sites. The results were <a href="http://content.healthaffairs.org/content/36/8/1469.abstract" target="_blank" rel="noopener noreferrer">published</a> in the August issue of <em>Health Affairs</em>.</p> <p>Researchers found that even though the survey took place only about 15 months apart, responses “worsened significantly over time.” Between surveys, overall satisfaction rates declined from 84.2 percent to 74.4 percent, while rates of burnout increased from 23 percent to 31.5 percent. The proportion of survey respondents who said they were likely to leave their practices within two years rose from about 29 percent to more than 38 percent.</p> <p>Also, 12 of 13 practice culture measures worsened over the two-survey period, with the greatest declines related to teamwork and facilitative leadership. Other workplace environment measures that worsened over time included work control as well as working in a hectic or chaotic practice atmosphere.</p> <p>While the surveys didn’t tease out the specific reasons for increasing dissatisfaction, the researchers did offer some guesses. Friedberg and co-authors Rachel Reid, Justin Timbie, Claude Setodji, Aaron Kofner, Beverly Weidmer and Katherine Kahn write:</p> <blockquote><p>For example, rapid adoption of new electronic health records (which can disrupt practice workflow and distract from face-to-face care), expansion of coverage under the Affordable Care Act (which may have caused a demand surge for many clinics), and medical home transformation (whether spurred by the CMS FQHC Advanced Primary Care Practice Demonstration or other initiatives) all could have stressed FQHC clinicians and staff members.</p></blockquote> <p>“I was surprised to see that big of a change in such a short period of time,” Friedberg told me. “If you look at measures of physician satisfaction over time, by and large across the country, it’s remarkably stable. So with that as a prior finding, this was a surprise.”</p> <p>On the other hand, Friedberg said FQHCs, which typically care for patients with complicated health, behavioral and social needs, often do experience staff turnovers every few years. With that in mind, he said the survey results could also simply be reflecting the challenging environments inside FQHCs — or as Friedberg said, “it could be all we’re seeing is two points in time in their natural histories.” Still, he said neither explanation is very reassuring, especially considering the critical importance of FQHCs in caring for the nation’s most vulnerable populations.</p> <p>“I hope that more work is done to confirm, update and better understand the causes of what we reported,” Friedberg said. “The best possible thing would be that someone fails to confirm what we found. I’d love to be not correct on this because I do worry that this is a leading indicator of the sustainability of our safety net. …How long can you run a system in which things are getting worse for the workforce?”</p> <p>To request a copy of the study, visit <a href="http://content.healthaffairs.org/content/36/8/1469.abstract" target="_blank" rel="noopener noreferrer"><em>Health Affairs</em></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" target="_blank" rel="noopener noreferrer"><em>@kkrisberg</em></a><em>.</em></p> </div> <span><a title="View user profile." href="/author/kkrisberg">kkrisberg</a></span> <span>Fri, 09/01/2017 - 12:50</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/medicine" hreflang="en">Medicine</a></div> </div> </div> Fri, 01 Sep 2017 16:50:53 +0000 kkrisberg 62917 at https://scienceblogs.com What's scarier than dubious stem cell clinics? A naturopathic stem cell clinic! https://scienceblogs.com/insolence/2017/09/01/whats-scarier-than-dubious-stem-cell-clinics-naturopathic-stem-cell-clinics <span>What&#039;s scarier than dubious stem cell clinics? A naturopathic stem cell clinic!</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>I've frequently written about bogus stem cell clinics that use hard sell techniques to sell unproven and expensive "stem cell treatments" to desperate patients. For instance, I <a href="http://respectfulinsolence.com/2015/01/02/about-gordie-howes-miraculous-recovery-after-stem-cell-treatment-in-mexico/">deconstructed the story</a> claiming that hockey great Gordie Howe <a href="http://respectfulinsolence.com/2015/02/04/gordie-howe-how-not-to-report-about-dubious-stem-cell-therapies/">improved</a> so markedly after a severe stroke, thanks to stem cells offered to him for free (because of his celebrity) by a dubious stem cell company (Stemedica) through its Mexican partner (Clínica Santa Clarita). The whole incident basically opened my eyes to just how unethical the for-profit stem cell clinic industry is, as clinics use hard sell techniques <a href="http://respectfulinsolence.com/2016/08/29/what-do-used-car-salesmen-and-stem-cell-clinic-entrepreneurs-have-in-common/">more akin to used car salesmen</a> to peddle potentially <a href="http://respectfulinsolence.com/2016/07/05/the-dangers-of-stem-cell-tourism/">dangerous therapies</a> even <a href="http://respectfulinsolence.com/2016/07/11/stem-cell-tourism-a-problem-right-here-in-the-good-ol-usa/">right here in the good ol' USA</a>. The level of corruption and lack of ethics are <a href="http://respectfulinsolence.com/2016/10/03/stemedica-cell-technologies-run-by-the-same-people-who-brought-you-penta-water-woo/">truly astounding</a>. Indeed, some stem cell clinics have <a href="http://respectfulinsolence.com/2017/07/20/quack-stem-cell-clinics-are-following-the-trail-blazed-by-stanislaw-burzynski-and-charging-patients-to-be-in-dubious-clinical-trials/">followed the Stanislaw Burzynski model</a> in getting patients to pay to be on dubious clinical trials that are designed primarily to sell product rather than to answer any sort of scientifically important question.</p> <p>The problem, of course, is that very few stem cell therapies have compelling evidence for efficacy and safety. Yet that doesn't stop dubious stem cell clinics all over the country from selling treatments claiming to improve or cure everything from heart disease to lung disease to cancer to even autism, all with minimal evidence that what these clinics are doing can do anything of the sort. That's why I view it as very much a good thing that the FDA has recently <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm">made noises</a> about <a href="https://www.statnews.com/2017/08/29/stem-cell-fda-knoepfler/">cracking down on stem cell clinics</a>, a move that's long overdue. I hope it continues.</p> <p>Regardless of whether the FDA's new loving attention to stem cell clinics is sustained or not, yesterday I learned of something very, very disturbing. Let's just put it this way: What's scarier than an unregulated, dubious stem cell clinic selling "stem cell"-related "cures" for lots of money? I'll tell you. It's an unregulated, dubious stem cell clinic selling "stem cell"-related "cures" for lots of money run by naturopaths. I kid you not. there's a clinic in Park City, Utah, the <a href="https://www.docereclinics.com">Docere Clinics</a>, in which a naturopath is advertising <a href="https://www.docereclinics.com/adult-stem-cell-therapy-utah/">stem cell therapies</a> that it offers. The naturopath, <a href="https://www.docereclinics.com/our-staff/">Harry Adelson</a>, ND (Not-a-Doctor) is d<a href="https://www.docereclinics.com/adult-stem-cell-therapy-utah/">escribed thusly</a>:</p> <blockquote><p> Stem cells, specifically mesenchymal stem cells (MSCs), have been called “patient-specific drug stores for injured tissues” because of their broad range of healing abilities. MSCs are directly responsible for healing damaged tissues after injury. Upon encountering damaged tissue, they release proteins that decrease inflammation, kill invading microbes, and trigger the growth of new connective tissues and blood vessels. In the case of severe damage and cell death, MSCs have the ability to turn into healthy versions of damaged or destroyed cells that they encounter.</p> <p>When we take MSCs from your own bone marrow, from your own fat, or from both, concentrate and/or isolate them, and then inject them directly into your problem area, we ‘trick’ your body into thinking that there has been a new injury without actually causing any tissue insult, and you get a second chance at healing. In the case of advanced osteoarthritis where the population of stem cells has been depleted, we are repopulating the area with stem cells, and thereby restoring the body’s natural ability to heal itself. </p></blockquote> <p>The only good thing I can say about this is that Docere Clinics don't claim to be able to treat spinal cord injury, autism, or cancer. Believe me, that isn't saying much. Because, quite strategically, Docere Clinics does treat all manner of musculoskeletal pain syndromes, some of which stretch the imagination as conditions that would need something like stem cell therapies. For instance, like many "regenerative medicine" stem cell clinics, Docere claims it can treat osteoarthritis and avascular necrosis. It also claims that it can treat back pain of various etiologies and bone spurs. (One wonders why on earth one would need a treatment as expensive and radical as stem cell therapy in order to treat bone spurs.) Ditto carpal tunnel syndrome, whose pathophysiology is pretty well understood and which is treated quite effectively by carpal tunnel release surgery. (I know. I've that surgery 15 years ago and it basically cured my carpal tunnel syndrome, other than a minor twinge every now and then.)</p> <p>Looking at the list, I see no condition for which stem cell therapies have been shown to be efficacious or safe, but I do see conditions that are primarily ones of chronic pain, which means that they are likely to be particularly susceptible to placebo effects. Without rigorously designed randomized, placebo-controlled, double blind clinical trials, it would be very difficult to determine whether any therapy has a significant impact on these conditions. Is there any RCT data supporting what Not-a-Dr. Adelson does? Nope. None of that stops him from doing what naturopaths love to do and <a href="https://www.docereclinics.com/our-staff/">cosplaying a real doctor</a> by wearing scrubs in all his videos and pictures on the clinic website:</p> <blockquote><p> Dr. Adelson began his training in regenerative injection therapy (prolotherapy) in 1998 while in his final year at The National College of Naturopathic Medicine, in Portland, Oregon after having been cured of a rock-climbing injury with prolotherapy. During his residency program in Integrative Medicine at the Yale/Griffin Hospital in Derby, Connecticut, he volunteered after hours in a large homeless shelter in Bridgeport, Connecticut, providing regenerative injection therapies to the medically underserved while gaining valuable experience. He opened Docere Clinics in Salt Lake City in 2002 and from day one, his practice has been 100% regenerative injection therapies for the treatment of musculoskeletal pain conditions. In 2006 he incorporated platelet rich plasma and ultrasound-guided injection into his armamentarium, in 2010, bone marrow aspirate concentrate and adipose-derived stem cellls, and in 2013, fluoroscopic-guided injection (motion X-ray). </p></blockquote> <p>Prolotherapy, of course, has been around a long time but <a href="https://sciencebasedmedicine.org/prolotherapy/">lacks convincing evidence for clinical efficacy</a>. <a href="https://www.painscience.com/articles/platelet-rich-plasma-does-it-work.php">The same can be said of platelet-rich plasma</a> (PRP). Neither have particularly compelling evidence for utility in the conditions for which they are commonly used. It's possible that PRP might have an effect in some conditions, but there really isn't much in the way of decent evidence to show that it does.</p> <p>But wait! Did you do a double take when you saw that last sentence, wherein a naturopath is using fluoroscopy to guide his injection of stem cells. Just let that sink in a moment. How on earth could he ever be qualified as a naturopathic quack to use fluoroscopy for anything? Get a load of <a href="https://www.docereclinics.com/c-arm-fluoroscopy-utah/">where he injects the cells</a>, too:</p> <blockquote><p> Of the fluoroscopically-guided injections that we perform, one that stands out is the injection stem cells into the intervertebral disc. Discs are structures that are rich with nerves, but are the least vascularized tissue in the body. The way discs maintain hydration is through movement; as the disc moves, hydration comes from the vertebral bodies (bones) above and below. When we lead sedentary lifestyles or suffer traumatic injuries, the discs can become ‘desiccated’, meaning dehydrated. A dry disc is an extremely painful disc. Being able to inject a dry disc with stem cells is the primary reason we became interested in fluoroscopically-guided injection. </p></blockquote> <p>That's right, Not-a-Dr. Adelson is injecting "stem cells" of unclear provenance into cervical discs because he thinks the stem cells will somehow un-desiccate them and turn the old, atrophied cervical disks to shiny new ones. Here he is cosplaying a real interventional radiologist:</p> <iframe width="560" height="315" src="https://www.youtube.com/embed/txGfEiR6oF0" frameborder="0" allowfullscreen=""></iframe><p> Yes, he's injecting into cervical and lumbar disks. What could go wrong? Well, there are nerve roots nearby that could be damaged. One can damage the disks themselves. There's a reason why becoming a board-certified interventional radiologist takes as many years as becoming a surgeon does. Perhaps what's most disturbing about this is that Not-a-Dr. Adelson trained at Yale's integrative medicine program. I wonder if Steve Novella knows his school's quackademic medicine program admits naturopaths. It led me to find that the Director of the Yale Adult and Pediatric Integrative Medicine Program is a <a href="http://medicine.yale.edu/integrativemedicine/about/ather_ali.profile">naturopath</a>. Although the Yale/Griffith Hospital integrative medicine program appears to <a href="http://www.griffinfacultyphysicians.org/Specialty-Care/Integrative-Medicine">exist no more</a>, in its day it did have naturopaths as residents, as evidenced by this advertisement for a <a href="http://www.griffinhealth.org/About/News-Releases/Post/7335/The-Integrative-Medicine-Center-at-Griffin-Hospital-presents-Naturopathic-Approaches-to-Pain-Management">talk on naturopathic approaches to pain management</a>, given by one of the naturopath residents.</p> <p>So does Not-a-Dr. Adelson have any evidence to back up his treatment? Well, he has a TEDX talk:</p> <iframe width="560" height="315" src="https://www.youtube.com/embed/050DSXIScz0" frameborder="0" allowfullscreen=""></iframe><p> It's basically an anecdote about a veteran of the Iraq/Afghanistan wars named Chris who had severe chronic low back pain due to a degenerated L4/L5 disk, suffered as a result of injuries due to his bad luck of being too close to two two different IED explosions. Apparently this veteran came to him asking him to inject stem cells into his disc. At about the 1:20 mark, you see how Adelson justifies his unethical actions. He basically portrays the options, but paints the ethical option (not using stem cells) in the worst possible light, as abandoning the patient. He portrays the other best option, enrolling the patient on a clinical trial, in an equally bad light, dismissing it saying that, well, you know, you have to be aware that you might bet a placebo. The next option he jokes about, namely taking the patient to "my offshore stem cell clinic" to treat him. Then, he portrays what he did, using an unproven technique that hasn't been validated scientifically or in clinical trials on a single patient, as the best option, the heroic option, the "can do" option. He even brags about how doing an autologous stem cell transplant is no different than doing a hair transplant. He also justifies his action by his own "conversion experience" using prolotherapy to treat his shoulder injury from rock climbing. I also learned the name of the surgeon who taught him how to do injections. Not surprisingly, it was a doctor, an orthopedic surgeon, who runs a dubious stem cell clinic in Florida.</p> <p>Not-a-Dr. Adelson makes the claim that the outcomes were "so much better" than PRP that stem cell treatments "instantly became 100% of my practice," bragging about how he traveled to various Central and South American stem cell clinics. One man he mentioned was Carlos Cecilio Bratt, MD, who, it turns out, runs a stem cell clinic in Venezuela, and runs what sounds like an assembly line doing stem cell treatments. (One wonders why he hasn't published his results.) He also went to the infamous Stem Cell Institute in Panama City. He also went to Ecuador. Finally, he found MDs and DOs willing to teach him how to use a C-arm and do fluoroscopy. Naturally, Adelson finished his story by bragging about how much Chris claims his pain has improved and how good his results are. Did he mention any clinical trials? No, of course not. He does have <a href="https://static1.squarespace.com/static/5943f86b03596eaae6506cfa/t/594aa3c01e5b6cc5d6dc0164/1498063824445/adelson-naturopathic-stem-cells+%281%29.pdf">an unrandomized, highly dubious clinical "trial</a>," though. Unfortunately, what he doesn't have is any mention of whether he had institutional review board (IRB) approval to do that retrospective chart review and to publish it. Worse, he doesn't have anything resembling real informed consent:</p> <blockquote><p> Patients presenting to Docere Clinics in Park City, Utah, between July 15, 2014, and November 15, 2014, who were deemed candidates for autologous stem cell therapy, were asked to choose between being treated with BMAC [bone marrow aspirate concentrate] or SVF/ PRP [stromal vascular fraction suspended in platelet rich plasm]. e conversation can be summarized as follows: “I can do a bone marrow aspiration and treat you with BMAC, with which I have ve years of experience and am aware of data supporting its use, or I can do a lipoaspiration and a blood draw and treat you with SVF suspended in PRP, which has the potential to provide us with a far greater yield of stem cells and, theoretically, a superior outcome. However I have little experience with it and there are very few data supporting its use.” Patients then self-selected into the BMAC or the SVF/PRP group. </p></blockquote> <p>Then, he changed the protocol:</p> <blockquote><p> During this period and during preliminary follow-up with patients, I began to notice a trend that many SVF/ PRP patients reported higher satisfaction than those in the BMAC group, but the remainder were experiencing no improvement at all. Beginning November 16, 2014, I be- gan o ering patients SVF prepared as described above but suspended in BMAC rather than PRP, hypothesizing that the combination could o er the consistency of BMAC with the augmented outcomes of SVF. </p></blockquote> <p>This is half-assed, "make it up as you go along" clinical research at its most dubious. Adelson then looked at his outcomes using a retrospective survey. Basically, everyone appears to have done roughly the same. Given that there wasn't a hint of a whiff of a statistical analysis or power calculation, that's basically that can be said. As for the lack of IRB involvement, Adelson appears to be taking advantage of the fact that the IRB requirement, strictly speaking, only applies to human subjects research funded by the federal government, carried out at an institution (e.g., a university) that receives federal funding, or when a clinical trial is being done as the basis to seek FDA approval. True, some states have their own laws requiring that any research inside their borders have IRB approval according to the Common Rule, but I don't know if Utah is one of them.</p> <p>Not surprisingly, Adelson seems utterly oblivious to what we already know about invasive surgical procedures: There can be a significant placebo effect any time you inject anything into the spine or discs. I like to use the example of vertebroplasty for lumbar spine fractures due to osteoporosis. It's been shown convincingly in at least a couple of good randomized, placebo-controlled trials to be no better than placebo. The usage of vertebroplasty has even declined as a result, albeit not nearly as much as it should have. (Yes, doctors sometimes share something in common with not-a-doctors; the unwillingness to give up treatments that science has shown to be ineffective.) Without a good RCT, it's impossible to tell if Not-a-Dr. Adelson is getting the results he gets due to placebo effects or not. Yet he just cruises along, using an unproven therapy. Worse, who knows what Adelson is actually injecting? He's described his technique for isolating stem cells, but one thing I see lacking is any characterization of the cells to demonstrate that they are what he claims they are. I also see a lack of followup images to demonstrate that the concoctions injected into the discs have had any effect at all biologically in rehydrating and renewing them. Basically, Adelson's clinical "evidence" is a joke, and a bad one at that. Yet, Docere Clinics continue to offer the treatment, and even <a href="https://www.docereclinics.com/referral-incentive">offer a 10% discount per patient</a> to current patients who refer new patients. Capitalism!</p> <p>But how can this be legal? Apparently, in Utah, it is. Britt Hermes contacted the Utah Division of Occupational and Professional Licensing and received this reply:</p> <blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr" xml:lang="en">Naturopath Harry Adelson who harvests and injects stem cells (using fluoroscopy!) got the approval of Utah authorities.</p> <p>This is bullshit. <a href="https://t.co/c6DaYVZHJe">pic.twitter.com/c6DaYVZHJe</a></p> <p>— Britt Marie Hermes (@NaturoDiaries) <a href="https://twitter.com/NaturoDiaries/status/903324133408337921">August 31, 2017</a></p></blockquote> <script async="" src="//platform.twitter.com/widgets.js" charset="utf-8"></script><p> Yes, in Utah, naturopathic quacks can basically do anything, science be damned. Or so it would seem. Worse, Not-a-Dr. Adelson is not alone. There are quite a few naturopaths out there offering prolotherapy and "<a href="http://www.eastvalleynd.com/promote-healing-with-stem-cell-therapy/">stem cell</a>" <a href="http://www.getprolo.com/jonathan-birch-nd/">therapies</a>. Be afraid. Be very, very afraid.</p> </div> <span><a title="View user profile." href="/author/oracknows">oracknows</a></span> <span>Fri, 09/01/2017 - 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/medicine" hreflang="en">Medicine</a></div> </div> </div> Fri, 01 Sep 2017 05:00:07 +0000 oracknows 22616 at https://scienceblogs.com