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	<title>Your Doctor&#039;s Orders &#187; Skeptical medicine</title>
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	<link>http://yourdoctorsorders.com</link>
	<description>A blog by Terry Simpson, MD, FACS</description>
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		<title>Caldwell Esselstyn: Proponent of Plant Based Diet</title>
		<link>http://yourdoctorsorders.com/2012/01/esselstyn/</link>
		<comments>http://yourdoctorsorders.com/2012/01/esselstyn/#comments</comments>
		<pubDate>Wed, 11 Jan 2012 17:20:48 +0000</pubDate>
		<dc:creator>thedoc</dc:creator>
				<category><![CDATA[Skeptical medicine]]></category>
		<category><![CDATA[China project]]></category>
		<category><![CDATA[crestor]]></category>
		<category><![CDATA[diets]]></category>
		<category><![CDATA[eating healthy]]></category>
		<category><![CDATA[Esselsytn]]></category>
		<category><![CDATA[fat]]></category>
		<category><![CDATA[fats]]></category>
		<category><![CDATA[good food habits]]></category>
		<category><![CDATA[medical studies]]></category>
		<category><![CDATA[Myths]]></category>
		<category><![CDATA[nutrition]]></category>
		<category><![CDATA[plant based diet]]></category>

		<guid isPermaLink="false">http://yourdoctorsorders.com/?p=1604</guid>
		<description><![CDATA[Caldwell Esselstyn started out life as a surgeon and went into preventive medicine- sadly his population based studies and conclusions have flaws in them, and his plant based diet thoughts will not prevent coronary artery disease. ]]></description>
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Caldwell Esselstyn started his professional career as a surgeon at Cleveland Clinic and quickly became interested in prevention instead of surgery.  Sadly, he fell into the traps of a person looking at population data to find the cure for a disease.  If you have watched the movie “Forks over Knives “ you can hear him  n detail – but if you don’t want to poke your eyes out we will give you a capsule summary of a surgeon who went from the operating room to the pseudoscience table. </p>
<p>Dr. Esselstyn noted the risk of heart disease in rural China was low in the 1970’s – and presumed that they didn’t have a “western diet.”  Now there are two flaws in his population statistics: First in the 1970’s in rural China most individuals were starving to death – it was the end of the cultural revolution and any source of food that could be found and eaten was.  The second issue is if you examine data from The China Study you will see that heart disease mortality was lowest in the rural communities that were able to eat more meat.  In The China Study (again, I promise this will be a topic later) – they used mortality statistics from the time during the end of the Cultural Revolution.  Rural China was starving then, all trees had been used for fuel, there were virtually no birds left (combination of deforestation and hungry humans) and rice was used for the army.  </p>
<p>Dr. Esselstyn then talks about Norway during World War 2, when they were occupied by the Nazi Germany, and how that heart disease diminished as the Norske were forced to eat a plant based diet.  That was a great assumption to make, but when examining the data from Norway there are a few interesting factoids – Meat consumption dropped 60% but fish increased 200 per cent. Vegetables and potatoes increased but sugar decreased by half.  And when the data is put to a microscope in 1942 and 1943 when mortality declined, animal proteins were still higher than before the war.  It appears that Norway suffered from increasing fish (great source of Omega 3 fatty acids) and foraged for foods such as wild greens, grew and ate a lot of potatoes, but had a low amount of sugars and almost no margarine (I don’t know a respectable Norwegian today who cooks with margarine).  The sad part of the war was the increase of mortality from infectious diseases – especially pneumonia (my mother’s cousin who fought for the resistance died of this, as did many of his comrades).<br />
<div id="attachment_1609" class="wp-caption aligncenter" style="width: 243px"><img src="http://yourdoctorsorders.com/wp-content/uploads/2012/01/codrow-233x300.jpg" alt="" title="OLYMPUS DIGITAL CAMERA" width="233" height="300" class="size-medium wp-image-1609" /><p class="wp-caption-text">Norway in WW2 ate a lot of fish- and this roe was popular</p></div><br />
Esselstyn then did a study of patients with coronary artery disease patients who did not have diabetes, high blood pressure, or currently smoke. His goal was a plant based diet with less than 10 per cent of calories derived from fat. This severe diet eliminated oils, fish, fowl, and meat. They were allowed to eat a plant based diet including grains, vegetables, lentils, and fruits.  </p>
<p>He followed these patients for up to 12 years – his numbers are confusing as he started with 24 patients and six dropped out (leaving 18). One of the 18 died from his heart disease (leaving 17).  At ten years there were 11 patients. They did angiography and reported a regression of 11 lesions with 14 remaining stable.<br />
<div id="attachment_1606" class="wp-caption alignleft" style="width: 310px"><img src="http://yourdoctorsorders.com/wp-content/uploads/2012/01/angiogramlesion.jpg" alt="" title="angiogramlesion" width="300" height="300" class="size-full wp-image-1606" /><p class="wp-caption-text">Angiogram- xray - of a plaque. Not enough to do surgery on though</p></div><br />
Analysis of this study is this: coronary angiography is unreliable, and subject to wide interpretation as to the percent narrowing of a vessel from plaque. Taken from a slightly different angle a lesion that is critical can look normal.  Also, it is the platelets on these plaques that do the damage – and a small change in the amount of platelets sitting on a plaque will change it.  None of the angiograms of these individuals rose to the level of requiring intervention (none needed bypass, or a stent, or balloon angioplasty).  </p>
<p>When any study talks about a “cardiac event” it means to most of us a heart attack. If you have a small lesion in a coronary artery and then that lesion accumulates a blood clot that is what a heart attack is.  The blood clot (from platelets – a sticky component of blood that helps you clot ) blocks the flow of blood to the heart muscle. If the clot blocks blood flow for a long time then the heart muscle dies and you have a myocardial infarction, if it opens up then all you have is a heart attack.  This has little to do with the size of the lesion, and more to do with the complex chemistry of the coagulation system. Hence, taking aspirin a day or Plavix is more beneficial.  </p>
<p>The other major problem with the study is that these individuals were on lipid lowering medications.  Dietary reduction of lipid level (Cholesterol and lipoproteins such as VLDL, HDL) is about ten per cent on average, but never more than twenty per cent.  However, lipid-lowering medications – such as Crestor – can remarkably lower levels of the lipids.  In addition, lipid-lowering medications are best for reducing inflammation.  They are anti-inflammatory to blood vessels, meaning in addition to lowering the lipids and cholesterol, their main effect is to reduce the chance of having a “coronary event.”<br />
<div id="attachment_1607" class="wp-caption aligncenter" style="width: 310px"><img src="http://yourdoctorsorders.com/wp-content/uploads/2012/01/crestor1-300x258.jpg" alt="" title="crestor1" width="300" height="258" class="size-medium wp-image-1607" /><p class="wp-caption-text">Crestor shown to be effective at decreasing the plaque in arteries</p></div><br />
The final issue are my ancestors – Native Americans and Norwegians – who, when eating a diet high in fatty fish, have lower rates of heart disease.  That is a population statistic, however, the science behind it is clear.  Fish are high in omega-3 fatty acids, which Dr. Esselstyn wouldn’t like – but the omega 3 fatty acids are protective against heart attacks as well as raising the “good cholesterol” HDL, and have the same anti-inflammatory features that medications do.<br />
<div id="attachment_1608" class="wp-caption aligncenter" style="width: 310px"><img src="http://yourdoctorsorders.com/wp-content/uploads/2012/01/eskimofish-300x202.jpg" alt="" title="eskimofish" width="300" height="202" class="size-medium wp-image-1608" /><p class="wp-caption-text">One of my cousins, preventing heart disease and eating fat</p></div></p>
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		<title>Pseudoscience and HCG</title>
		<link>http://yourdoctorsorders.com/2012/01/pseudoscience-and-hcg/</link>
		<comments>http://yourdoctorsorders.com/2012/01/pseudoscience-and-hcg/#comments</comments>
		<pubDate>Fri, 06 Jan 2012 19:43:48 +0000</pubDate>
		<dc:creator>The Doc</dc:creator>
				<category><![CDATA[Skeptical medicine]]></category>
		<category><![CDATA[diets]]></category>
		<category><![CDATA[HCG]]></category>
		<category><![CDATA[HCG diet]]></category>
		<category><![CDATA[Myths]]></category>
		<category><![CDATA[pseudoscience]]></category>
		<category><![CDATA[skeptical medicine]]></category>

		<guid isPermaLink="false">http://yourdoctorsorders.com/?p=1570</guid>
		<description><![CDATA[Pseudoscience cures for medicine abound, and the HCG diet presents an example of how and why these scams continue to be flourish.  A combination of confirmation bias with a lack of training in scientific method and perhaps self-interest provides fertile ground for quack cures.]]></description>
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<p>There is a lot of pseudoscience in medicine, and the reason that we have medical treatments that are quackery is because of the industries built around them.  This was made evident by the recent issues with the HCG diet. Contrary to what reasonable people would think, the new FDA ban on over-the-counter HCG did not shut down the industry built around HCG. The FDA states “HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or &#8220;normal&#8221; distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets”</p>
<p>There is an entire HCG diet industry kept alive by those who make their living promoting this weight loss method.  What has gone away is the ability of non-physicians to sell the drops, tablets, troches – all HCG must be prescribed by a physician. Within two miles of my home there are five places that advertise HCG diet. None of these places is a physician’s office. Whether the FTC or FDA cracks down on these is another matter.</p>
<p>These weight loss clinics sell the HCG –either by breaking the law and prescribing without a license, or they are finding a physician who will write the script without seeing the patient.   For a physician to write a prescription without seeing a patient is not only bad medicine it is unethical- and, at least in Arizona, would probably result in the physician being sanctioned by the medical board.</p>
<p>Because the FDA has, without equivocation, stated that HCG is not useful for weight loss, proponents of HCG are now circulating “articles” of “studies” showing that HCG works. But the HCG controversy provides a microcosm of how proponents of woo-woo medicine (medicine that is based on pseudoscience) use “studies” to promote their treatments.</p>
<p>The article that should have put the nail in the coffin of HCG was written in 1976 in the Journal of the American Medical Association. The paper was a study of 202 patients treated with either HCG or saline placebo.  The physicians administering the medicine did not know if they gave the patient HCG or if they gave the patient the saline (salt water). The patients did also not know.  All patients were placed on the 500 calorie diet.  At the end of the study, there was no difference between those who were given HCG and those who were given placebo in terms of weight loss. There was also no difference in fat loss. There was no evidence that those who had received HCT were more or less satisfied, and the dropout rate was the same. Thus, they could not prove what the advocates of HCG said- that people who use HCG along with the diet will feel better and adhere more to the diet, and that there was no more or less fat loss among those patients. This was the article that, temporarily, put the nail in the coffin for HCG.</p>
<p>The reasons physician-scientists consider this article a good article are: (a) The study was randomized so the patients did not know what they were getting.  This eliminates bias of the patient. (b) The physicians did not know what the patients were getting – eliminating the bias of the physician (c) The results were reviewed by non-bias staff (d) the study was prospective- meaning the subjects were followed ahead of time so the authors could not manipulate the data either way. (e) the article appeared in a journal that is peer reviewed, meaning editors read the article for its content, have the ability to ask the authors to submit raw data, and can spot bias.</p>
<p>That article, along with others, put away the HCG diet industry for a while, until 2007. In 2007 a book was written about HCG – by Kevin Trudeau, called “The Weight Loss Cure ‘they’ don’t want you to know about.”  The Federal Trade Commission fined Trudeau 37 million dollars for making false statements in this book. Oddly enough book is still sold, and many of the “HCG weight loss coaches” make money selling it.  The book is bunk, by the way – total, complete and utter nonsense promoting HCG.</p>
<div id="attachment_1516" class="wp-caption aligncenter" style="width: 170px"><img class="size-full wp-image-1516" title="Trudeaubook" src="http://yourdoctorsorders.com/wp-content/uploads/2011/12/Trudeaubook.jpg" alt="" width="160" height="220" /><p class="wp-caption-text">This silly book resurected a bad diet</p></div>
<p>Contrast the great article in JAMA with an article that the HCG coaches are currently recommending, by Dr. David Bryman, an osteopath from Scottsdale, who published a non-randomized study with a higher protein low calorie diet- showing the HCG had more weight loss (The Bariatrician &#8211; 2010 Vol 25, page 11). The problems with this study are several: first there is no randomization, second there is no control, third there is no blinding, and fourth there is a clear bias, fifth the article is retrospective  &#8211; so it can come to the conclusion it likes. The article is worthless.</p>
<p>Having “journals” gives people who practice pseudoscience (be it chiropractic, acupuncture, homeopathy) a sense of legitimacy. Sadly, those journals do not follow scientific principles of research, evidence or science-based medicine.</p>
<p>Confirmation bias is a bias hard to overcome. This is seen in the HCG diet industry. If you attribute weight loss to HCG, then everyone who loses will confirm your bias that it was the HCG.  It is clear that it is the diet – whether it is a high protein 800 calorie, or the original 500 calorie diet, that will provide the weight loss.  However, the people who sell it, or the books and meal plans, are convinced that the HCG is doing the work- in spite of the lack of science supporting their claim.  Much like acupuncture, or homeopathy &#8211; if someone believes it, and then is confirmed by placebo effect, it is difficult to overcome that bias.  Add in that a part or all of one&#8217;s living is made by some pseudo-scientific endeavor and the pseudoscience becomes a religion.</p>
<p>It is difficult to convince someone their “experience” is not accurate or even that their “experience” isn’t what they think it is.</p>
<p><img class="aligncenter size-medium wp-image-1571" title="snake-oil-scam" src="http://yourdoctorsorders.com/wp-content/uploads/2012/01/snake-oil-scam-300x254.jpg" alt="" width="300" height="254" /></p>
<p>HCG shows the ultimate “placebo” effect.  A placebo is a pill or injection that has no active substance in it – commonly a sugar pill or a saline injection.  Placebo comes from Latin, meaning “I shall please.”  To test whether a chemical, hormone, or some agent works, you have to test it against a placebo. Some people, 35-55% of them, with some diseases, will have an equal effect with a placebo as with the hormone tested (in this case HCG). Placebo works best with nebulous things that cannot be measured- like appetite. As was shown in the JAMA study when HCG was compared with saline injections, there was no difference.  HCG works by placebo effect.</p>
<p>The problem is that HCG is not a placebo.  HCG is a hormone, one that has effects that can be long lasting and harmful. We don’t know if the hormone has a tumor promoting effect as other hormones do (estrogen with breast and uterine cancer and testosterone with prostate cancer, HCG may have tumor promoting effects – it certainly can increase venous thrombosis). The other problem is physicians who prescribe this are giving legitimacy to a treatment that does not work, and can cause harm. They are also placing themselves at risk by stating they have evaluated a patient</p>
<p>As with all pseudoscience- there are people who firmly “believe” in this without a shred of legitimate evidence. Proving that having a degree (MD, DO, RN) does not make one a skeptic, and clearly degrees do not teach people how to think and apply the scientific method. Many in pseudoscience use the logical fallacy of an appeal to authority – e.g.- a doctor prescribed the HCG, and a nurse is my coach so it must be good.</p>
<p>In terms of the other scams in medicine- Homeopathy is one that actually has a board sanctioned by the State of Arizona. It isn&#8217;t odd that Arizona is so backward, after all, it is the wild west. But I like the quote from Dr. Zina Pitcher, when the State of Michigan tried to force the University of Michigan to have a homeopathic school:</p>
<p><strong><em>&#8230;shall the accumulated results of three thousand years of experience  be laid aside, because there has arisen in the world a sect which, by  engrafting a medical dogma upon a spurious theology, have built up a  system (so-called) and baptized it Homœopathy? Shall the High Priests of  this spiritual school be specially commissioned by the Regents of the  University of Michigan, to teach the grown up men of this age that the  decillionth of a grain of sulphur will, if administered homœopathically,  cure seven-tenths of their diseases, whilst in every mouthful of  albuminous food they swallow, every hair upon their heads, and every  drop of urine distilled from the kidneys, carries into or out of their  system as much of that article as would make a body, if incorporated  with the required amount of sugar, as large as the planet Saturn?</em></strong></p>
<p>The power of the purse did cause the school to come to the University of Michigan, although eventually the Supreme Court did state that the Regents of The University of Michigan were not answerable to the legislature.  The homeopathic school was merged into the medical school in 1920&#8242;s &#8211; and homeopathy was gone for a while. Sadly- it is back.</p>
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		<title>The Ornish Myth</title>
		<link>http://yourdoctorsorders.com/2011/12/the-ornish-myth/</link>
		<comments>http://yourdoctorsorders.com/2011/12/the-ornish-myth/#comments</comments>
		<pubDate>Sat, 10 Dec 2011 19:23:25 +0000</pubDate>
		<dc:creator>The Doc</dc:creator>
				<category><![CDATA[Skeptical medicine]]></category>
		<category><![CDATA[Dean Ornish]]></category>
		<category><![CDATA[diets]]></category>
		<category><![CDATA[eating healthy]]></category>
		<category><![CDATA[Healthy Eating]]></category>
		<category><![CDATA[healthy eating habits]]></category>

		<guid isPermaLink="false">http://yourdoctorsorders.com/?p=1528</guid>
		<description><![CDATA[Dean Ornish published a paper claiming a reduction in coronary atherosclerosis from a low fat diet. Ornish dispells any low carb diet, but his diet data is flawed. Ornish is the lead health-blogger for Huffington Post, and is favorably mentioned by Dr. Oz.
]]></description>
			<content:encoded><![CDATA[<p><object classid="clsid:d27cdb6e-ae6d-11cf-96b8-444553540000" width="560" height="315" codebase="http://download.macromedia.com/pub/shockwave/cabs/flash/swflash.cab#version=6,0,40,0"><param name="allowFullScreen" value="true" /><param name="allowscriptaccess" value="always" /><param name="src" value="http://www.youtube.com/v/9XwqYjrSfhY?version=3&amp;hl=en_US&amp;rel=0" /><param name="allowfullscreen" value="true" /><embed type="application/x-shockwave-flash" width="560" height="315" src="http://www.youtube.com/v/9XwqYjrSfhY?version=3&amp;hl=en_US&amp;rel=0" allowscriptaccess="always" allowfullscreen="true"></embed></object></p>
<div id="attachment_977" class="wp-caption aligncenter" style="width: 310px"><img class="size-medium wp-image-977" title="coronary-artery-disease-cross-section" src="http://yourdoctorsorders.com/wp-content/uploads/2011/08/coronary-artery-disease-cross-section-300x289.jpg" alt="" width="300" height="289" /><p class="wp-caption-text">Heart artery plaque-  low fat diet doesn&#39;t prevent this</p></div>
<p>Never has it been more clear that publishing a paper in a respected journal can lead to a career. Even if the science has changed it. It has been 15 years since Dean Ornish published his data showing a 3 percent reduction in the plaques seen by coronary angiograms on a select group of patients who followed his diet and “lifestyle” plan.  To be exact: they found 1.75% improvement after one year and 3.1% improvement after five years.  Where the control group increased by 2.3% in one year and 11.8% at five years. This was a group of 28 patients who followed his diet to the letter.</p>
<p>In 15 years no one has reproduced that data. No one. In medicine we see a lot of data come through, when it is not reproduced, or unable to be reproduced by others we look at it with a very jaundiced eye. Or to be blunt &#8211; we don&#8217;t believe it. Yet, his data, with all the issues it has- is still touted by a few in the popular press as &#8220;proof&#8221; that the &#8220;low fat&#8221; works. We have levels of evidence in medicine, and while Ornish attempted to get to the highest level of evidence, by having a control group &#8211; he fell short with several major statistical issues: (a) his study does not contain enough people to be anywhere nearly significant (b) one cannot rely on angiographic photographs which are interpreted in many different manners (c) one cannot control outside factors, exercise, BMI, smoking cessation.</p>
<p>In contrast, we now have an entire group of lipid medications. A recent study in New England Journal of Medicine showed how that Crestor had produced a regression of plaque in 63% of the individuals.</p>
<p>Lets be clear- the medication data is using far more sensitive instruments to measure plaque. Intra-vascular ultrasound where they thread a tiny ultrasound probe into the artery and  measure the plaque precisely.   In the Ornish data, he used photos of angiograms ( show two cardiologist the same angiograms and you will get two different interpretations of it &#8211; angiograms are not precise). The medications show specific reductions in plaque- not everyones &#8211; unlike Ornish. It is rare that anything does 100 per cent to everyone.</p>
<p>When looking at angiograms- like Ornish did- the interpretation of them is so variable, that no scientific publication today would accept that data, or its interpretation. The small amount of plaque reduction is too small to be anything but observer bias.</p>
<div id="attachment_1546" class="wp-caption aligncenter" style="width: 310px"><img class="size-full wp-image-1546" title="Before-and-After-Pictures-Reversing-Coronary-Heart-Disease-Naturally" src="http://yourdoctorsorders.com/wp-content/uploads/2011/12/Before-and-After-Pictures-Reversing-Coronary-Heart-Disease-Naturally.jpg" alt="" width="300" height="186" /><p class="wp-caption-text">Two views of the same image- angiogram interpretation is flawed</p></div>
<p>Still, from one old paper- Dean Ornish has made a career, being the anti-Atkins, and riding the anti-cholesterol, low-fat band wagon with the same religious fervor as Keyes did thirty years ago (see my earlier post about that).</p>
<p>The difficulty is this: science has caught up with us, and we know a lot more about how plaque forms and doesn’t form. We know that dietary cholesterol is far less important that what the liver makes. We know that the dietary component may be far more related to the triglycerides – and they are raised far more by the grains and pastas that Ornish loves.</p>
<p>Still, Ornish is the lead health-blogger for Huffington Post, has influenced Bill Clinton (see the previous post) and is favorably mentioned by Dr. Oz. He still argues against those who advocate any &#8220;low carbohydrate&#8221; solution, based on his &#8220;empiric&#8221; data.</p>
<p>Personality, the willingness to believe in  your hypothesis no matter what science says, and the desire by the public to see “natural” leads to a great career in politics, and entertainment. For most scientists, Ornish&#8217;s paper isn&#8217;t a breakthrough, but borders on confabulation.</p>
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		<title>Physician Ethics and Dr. Burzynski</title>
		<link>http://yourdoctorsorders.com/2011/12/physician-ethics-and-dr-burzynski/</link>
		<comments>http://yourdoctorsorders.com/2011/12/physician-ethics-and-dr-burzynski/#comments</comments>
		<pubDate>Sat, 03 Dec 2011 03:24:01 +0000</pubDate>
		<dc:creator>The Doc</dc:creator>
				<category><![CDATA[Skeptical medicine]]></category>
		<category><![CDATA[cancer treatment]]></category>
		<category><![CDATA[physician ethics]]></category>

		<guid isPermaLink="false">http://yourdoctorsorders.com/?p=1506</guid>
		<description><![CDATA[Dr. Burzynski has been in the news lately. He runs a cancer treatment facility based on his own ideas about cancer. We look at Dr. Burzynski from the perspective of physician ethics, and whether he passes the test of being ethical. We do not attempt to make judgement about the efficacy of the therapy he promotes. ]]></description>
			<content:encoded><![CDATA[<p><object width="560" height="315"><param name="movie" value="http://www.youtube.com/v/UTOZdd4Yje4?version=3&amp;hl=en_US"></param><param name="allowFullScreen" value="true"></param><param name="allowscriptaccess" value="always"></param><embed src="http://www.youtube.com/v/UTOZdd4Yje4?version=3&amp;hl=en_US" type="application/x-shockwave-flash" width="560" height="315" allowscriptaccess="always" allowfullscreen="true"></embed></object></p>
<div id="attachment_1507" class="wp-caption aligncenter" style="width: 310px"><img class="size-medium wp-image-1507" title="hippocraticoath" src="http://yourdoctorsorders.com/wp-content/uploads/2011/12/hippocraticoath-300x264.jpg" alt="" width="300" height="264" /><p class="wp-caption-text">The first written code for physicians</p></div>
<p>There are four pillars of Physician Ethics &#8211; and it is from these that modern physicians make decisions. It is from these we judge ourselves, and &#8211; if called upon, our colleagues. Those Four Pillars are autonomy, nonmaleficence, beneficence, and justice.</p>
<p>Dr. Burzynski is a physician who runs a cancer clinic in Houston that specializes his own invention of cancer therapy called antineoplastons. He has been in the news lately because one of his supports has threatened a 17 year old blogger in Great Brittan with legal action. There is plenty of discussion in the blog world about Dr. Burzynski&#8217;s therapy- and I wrote a short piece about this in another blog- but was asked to discuss this from the ethical perspective of a physician.</p>
<p>Autonomy<br />
As a physician we have ethical obligations, and expectations to our patients. One of them being autonomy – people are truly free to choose their treatment, but must have the information that is required to make a choice. More about innovation and research in a bit, but there are plenty of cancer patients who willingly submit themselves to treatment that has no proven benefit beyond a lab.</p>
<p>Nonmaleficence<br />
Another key tenet for physicians is nonmaleficence – to not use our skill and knowledge to harm a patient. Deliberate harm would be to put a patient at risk for a treatment we know doesn’t exist. Risk associated with procedure does not count as “doing harm” unless the procedure has no hope of benefit. We know conventional chemotherapy has the potential to cause illness, and even death &#8211; I know this personally because my brother died four years ago after his first dose of chemotherapy put his frail body into septic shock, from which he did not recover. Some suggested that because my brother had metastatic lung cancer that the chemotherapy robbed him of the few months he had- and therefore the physician went against nonmaleficence by administering a therapy that would not do benefit. But that chemotherapy was not to prolong Jimmy&#8217;s life- certainly there were no illusions that it would cure him &#8211; but he was suffering horribly, and it was hoped a reduction of the tumor burden would give him some relief. In surgery- we know there are risks involved, but if a patient suffers a known complication from surgery- it is not that the physician did harm &#8211; the surgeon did not violate the Hippocratic oath (most of us never took that oath, but we adhere to many of its principles, including nonmaleficience). In Dr. Burzynski&#8217;s case &#8211; if he knows the treatment won&#8217;t work, then he is doing harm &#8211; but if he believes it works he is not guilty of nonmaleficience.</p>
<p>Beneficence<br />
This is the tenet that as a physician it is our duty to act in the best interest of the patient. This means to directly intervene, if possible, for the comfort and well-being of our patient. The key is that we are not the ones who judge this- it is the patient, and not the physician, that determines this &#8211; and involves other aspects besides health and survival. As a physician we must be trusted, we must be truthful, and we must respect confidentiality of our patients above all else. It is our goal to ease pain and suffering- and not cause it. And while not all providers and patients weigh this the same- this is not judged by the physician, only by the patient.</p>
<p>Justice<br />
This is not judgement- this is the concept of fairness to all. While there are limited resources- we must find a way to make these resources to our patients in a fair manner. The transplant world deals with this in how organs are distributed among those in need.</p>
<p>Innovation and Research<br />
Dr. Burzynski claims that he has a cure, or better treatment for cancer than anyone else. There have been phase 1 and phase 2 trials of these treatments, but no published phase 3 trials comparing them to standard treatments. But let us step back, because innovation is not the same, in medicine, as research.<br />
Innovation is different than research. In surgery we innovate every day- no two operations are the same, and sometimes we do operations that we have never done before. That requires an informed consent with a patient- and an open and honest discussion. Some feel it involves an Institutional Review Board (IRB) &#8211; but it doesn&#8217;t This is where the patient has autonomy, this is where the surgeon has nonmaleficence, this is where he uses his Beneficience and justice to bring something to the patient.</p>
<p>That is different than research. In research, which is the systematic acquisition of data for the purpose of generalizable inference – this requires equipoise. Equipoise requires that even though we believe our treatment might be best, we provide different treatment arms so that it can be tested. Clinical equipoise is satisfied if there is an uncertainty in the medical community regarding the therapy (antineoplastons) and this allows the clinical investigator to do a trial until there is statistical evidence to convince the medical community about this treatment.</p>
<p>Because Burzynski has not satisfied the medical community with equipoise, we question the treatment- and can only be convinced by a phase 3 trial. Until he does- the medical community, and others- will remain skeptical of his treatment. Some have demanded he release his data to peer reviewed journals. That, of course, cannot be done. We cannot compel Burzynski to release his data. But that his data has not been reproduced by the accepted academic world in the United States will be an ongoing issue.<br />
This means patients have to pay the high cost of his research, the high cost of getting treatment from him and that is because insurance companies won’t pay for treatment until that treatment passes through our standard method of evaluating therapies.</p>
<p>Given those pillars- what is Dr. Burzynski, as a physician ethically obligated to do? While he may not be required to do anything, medical ethics would require that he enter patients into phase 3 trials, comparing large groups of patients to random treatment arms, to determine if his treatment has more merit than others. If he does this than the medical community is required to respond, and open up those treatments to patients who wish to participate. Doing that in his own clinic, without having other non-vested physicians also treat him &#8211; is not satisfactory.</p>
<p>We believe strongly in ethics for physicians &#8211; and from an ethical point of view, Dr. Burzynski meets some of the pillars &#8211; but without a full and open process that can be evaluated by physicians that are not involved (and there are plenty of physicians who have stated his treatments are not as efficacious as standard treatments) &#8211; Dr. Burzynski fails at justice. If he has a cancer treatment better than others- and the only way it can be obtained is by paying thousands of dollars- then this represents a failure of one of the pillars of medical ethics.</p>
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		<title>Beware of Outrageous Claims</title>
		<link>http://yourdoctorsorders.com/2011/10/beware-of-outrageous-claims/</link>
		<comments>http://yourdoctorsorders.com/2011/10/beware-of-outrageous-claims/#comments</comments>
		<pubDate>Fri, 21 Oct 2011 01:25:57 +0000</pubDate>
		<dc:creator>The Doc</dc:creator>
				<category><![CDATA[Skeptical medicine]]></category>
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		<description><![CDATA[Imagine if you took every product out there that was said to promote health- purify it, concentrate it and then sell it in a multi-level marketing firm. That is what Sisel does. Do I recommend these products- absolutely not.]]></description>
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Recently someone asked me about Sisel International -  a multi-level marketing company that says they have a product that if you take it will extend your lifespan.</p>
<p>In their introductory video there was more about how selling their products, and developing others to sell the products, you could make more money than in other multi-level marketing firms.</p>
<div id="attachment_1452" class="wp-caption aligncenter" style="width: 226px"><img class="size-full wp-image-1452" title="tom_mower_sr" src="http://yourdoctorsorders.com/wp-content/uploads/2011/10/tom_mower_sr.png" alt="" width="216" height="267" /><p class="wp-caption-text">Founder Tom Mower, founded the company while in prison</p></div>
<p>Then come the non-supported claims:<br />
They cite “Harvard studies” that humans can live 200 years, and that they think 90 per cent of aging is environmental and 10 per cent is genetic. To start – there is no real science behind this. There are plenty of scientists who will say the upper limit of aging is around 120 years. Although the oldest person on record died when she was 122 years old.  The Sisel video then says the ingredients in their product will reverse aging – and by intervening with this- you can live longer. The claim if you start at 20 years you can live 200 years. If you start at age 50 you can live to be 140 years old &#8212; no biologic studies done on their products, just claims. In fact, recently the original scientists who claimed that one of the products could reverse aging, have said that they were wrong.</p>
<p>One Sisel product  they claim “<strong>turns on the genes of youth</strong>” and will “<strong>regenerate the brain</strong>.”  Evidence of this?  None. Can the brain regenerate- not really very well.  I can imagine many stroke patients would love to have a product that could regenerate their brain. <em> Don&#8217;t you think if this product worked as stated,  people like Michael J. Fox would be taking it, and promoting it&#8217;s amazing power of brain re-generation?</em> C&#8217;mon. So I asked my fellow physicians &#8211; two neurologists and a two neurosurgeons if this was a credible claim- &#8211; they said it <strong>was not</strong>.</p>
<p>They have taken  Resveratrol- equal to 174 glasses of red wine – and cite how you can double the lifespan of yeast and bacteria .   They claim these products turn on youth genes – all 52 of them &#8211; of course if a product can turn on those genes, it is likely a cell might run wild and become a cancer.  Dr. Richard A. Miller, professor of pathology at the University of  Michigan, among those who question longevity benefits from resveratrol  and stated, &#8220;People who bought the story for the last 10 years have been fooled.&#8221; The original research into this has was flawed, and stated so by the authors.</p>
<p>They also claim that they have great anti-oxidants. What they don’t know is that the human body’s biochemistry depends on oxidation for the life of the cell and energy itself. That if we even get anti-oxidants in the blood stream that we would die quickly from overwhelming bacteria- because the white cells kill bacteria through oxidation. See my previous post about oxidation.</p>
<p>They also state that with this if you have a heart attack on this you will not have cardiac damage if you take this. This is simply false. If you have a heart attack- where the coronary artery is occluded- and the artery is not re-opened by bypass, angioplasty, stent, or certain chemicals- the heart muscle fed by that artery will die. That means heart damage- there is no product that can prevent that from happening.</p>
<p>Other products they claim show amazing benefits to regenerate “your entire system” – containing sulfated limu moi  which they  claim it will regenerate the immune system that will get it to that of a baby &#8211; most babies, by the way, have poor immune systems.</p>
<p>They quote Linus Pauling “every disease to a mineral deficiency.” Linus Pauling won the Nobel prize in chemistry- he was not a biologist, nor was he a physician. I knew Linus Pauling, met him when I was at Stanford- nice fellow, but he knew better than to make that claim. Getting a pathogenic virus is not from a mineral deficiency- it is from a germ.</p>
<div id="attachment_1453" class="wp-caption aligncenter" style="width: 228px"><img class="size-medium wp-image-1453" title="linus_pauling4" src="http://yourdoctorsorders.com/wp-content/uploads/2011/10/linus_pauling4-218x300.jpg" alt="" width="218" height="300" /><p class="wp-caption-text">Linus Pauling, Nobel winner, believed in germs, not just mineral deficiency</p></div>
<p>They claim that outside of smoking- the most toxic place is your bathroom. Of course Sisel has an entire line of  personal and skin care products that are toxin free.  Have they tested these “toxic free personal care products” &#8212; nope. While people should be careful about the products they use- there is no assurance that these products have been tested even in laboratory animals.</p>
<p>Outrageous claims- and some people will believe them, because they are good at marketing. This is not a company about health- this is a company about sales, and they will purify any fad product and take the most outrageous position. I don&#8217;t doubt the purity of those products- but I certainly doubt that the claims they make will stand the scrutiny of biologic testing.</p>
<p>So why has not the FDA stopped this company? Because the FDA does not have jurisdiction over supplements. Almost any supplement can be sold with any claim. However, if the FDA considers aging a disease, they may go after this company for stating that they can treat “aging.”</p>
<p>There are many supplements on the markets with outrageous claims-  but until the company is able to prove their claims with their own studies, their own biology- they remain an unregulated group of multi-level marketers.</p>
<p>As a physician- <strong>I do not recommend the purchase or use of any of these products.</strong> Now before the head honchos over at Sisel International start screaming and getting up in arms, I am a well educated physician with a medical degree.  <em>Based on my own knowledge, education, and experience, I have no other logical conclusion, and therefore opinion, that I can come to other than what I stated above.  Therefore, after thorough personal research of this company&#8217;s claims, I advise anyone reading this blog, to consider the above statements before purchasing these products.</em></p>
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		<title>Gluten- a Short Course: When and How to Choose It</title>
		<link>http://yourdoctorsorders.com/2011/09/gluten-a-short-course/</link>
		<comments>http://yourdoctorsorders.com/2011/09/gluten-a-short-course/#comments</comments>
		<pubDate>Tue, 20 Sep 2011 18:01:16 +0000</pubDate>
		<dc:creator>The Doc</dc:creator>
				<category><![CDATA[Skeptical medicine]]></category>
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		<description><![CDATA[Many people today are talking about diets that are “gluten-free.” Restaurants are offering “gluten-free” menus. There are websites, chiropractors, and others proclaiming that going on a gluten-free diet will provide improved health. But lets be clear- unless you have an allergy to gluten, removing gluten from your diet will not provide better health.]]></description>
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<p>Many people today are talking about diets that are “gluten-free.” Restaurants are offering “gluten-free”  menus.  There are websites, chiropractors, and others proclaiming that going on a gluten-free diet will provide improved health.  But lets be clear- unless you have an allergy to gluten, removing gluten from your diet will not provide better health, weight loss, but eliminating gluten will dramatically limit what you can eat.</p>
<p>But there are some people who are “allergic” to gluten- and for them having a gluten free diet is the difference between health and illness – between a risk of some rare cancers for which we don’t have great treatment for. We call that condition celiac disease – for those who have celiac disease, being gluten free is critical. Other names for this disease include celiac sprue, gluten sensitive enteropathy, non-tropical sprue, and a few other names.</p>
<p>Gluten is a protein that is found in wheat, barley, rye, and oats. Gluten is a protein that allows wheat to have “elasticity” – meaning you can roll out the dough- or toss it in the air and make a great pizza crust.  You can’t do that with non-gluten grains—no one can make a pizza or great bread from corn alone. Gluten is also used to thicken soups, ketchup, soy sauce, and is found in almost every processed food out there.  Take gluten out of the American diet and you will be challenged to find good alternatives.</p>
<p>When a person is allergic to gluten their symptoms include malnutrition, anemia, osteoporosis, infertility, short stature, and inability to thrive. However, the “classic” symptoms are not necessarily common.  There are a number of patients who have silent celiac disease, where they will be discovered to have atrophy of their absorptive surface of the small bowel without any symptoms, or just mild symptoms such as an iron deficiency anemia.  There are a number of forms of celiac disease that respond well to a gluten free diet – and remain normal after introduction of gluten into the diet.</p>
<p>Celiac disease is best diagnosed with a biopsy of the small intestine. Most often the biopsy is performed endoscopically from the first part of the small bowel, the duodenum. However, those biopsies can be negative, and more distal small bowel may show the classic pathologic appearance.  Those biopsies most often have to be done surgically, or with advanced endoscopic equipment.</p>
<p>The small bowel, under a microscope, has many small finger-like projections called villi. These serve to increase the surface area of the small bowel to allow for maximum absorption of nutrients.  In celiac disease, there is atrophy of these villi – seen microscopically- and this improves when gluten is removed from the diet.</p>
<div id="attachment_1269" class="wp-caption aligncenter" style="width: 304px"><img class="size-full wp-image-1269" title="celiac-sprue" src="http://yourdoctorsorders.com/wp-content/uploads/2011/09/celiac-sprue.jpg" alt="" width="294" height="368" /><p class="wp-caption-text">Above normal villi, below- atrophied</p></div>
<p>While celiac disease is classically called an “allergy” to gluten – it does promote some antibodies against the connective tissue elements – leading some to call this an auto-immune disease. However, when the foreign protein is withdrawn, there is no residual auto-immune function.  The “auto-antibodies” may simply reflect the gluten protein unfolded – and having a similar structure to the bodies own endomysium protein.</p>
<p>There have been various reports about the prevalence of celiac disease – ranging from 1:300 among Northern Europeans (Celtic) to 1:122.  There is a large genetic distribution of the disease – with a high concordance among identical twins of up to 70 per cent.  There are some genetic markers that have a high association with celiac disease, but the expression of the disease is variable &#8211; meaning that the genetic marker is a tendency but not a certainty of celiac disease. If everyone who had the genetic markers were to develop the disease, it would be estimated that 1 in 22 people would have this. However, this is not the case.</p>
<p>Diagnosis of celiac disease is made based on clinical suspicion of the classical presentation (iron deficiency, osteoporosis, with abdominal complaints) followed by some tests. A biopsy is the most reliable test, however there are blood tests ( IgA anti-gliadin and IgA anti-endomysial and anti-tissue transglutaminase) that are over 90 per cent accurate. Even with a negative blood test but a high enough suspicion, duodenal biopsy or even surgical biopsy is warranted.</p>
<p>There are plenty of questions about celiac disease- we don’t know the actual prevalence in the population, we don’t know if being gluten free as demonstrated by follow up biopsy has a lower incidence of lymphoma.</p>
<p>What we do know is that gluten is not a health issue in people who do not have celiac disease. Gluten-free will not cure autism. Gluten free will not facilitate weight  loss. There are, however,  groups who will claim that gluten is a health issue- there is no basis for this claim. If someone has told you to remove gluten from your diet, and you do not have a test showing celiac disease (one of the tests listed above)- please see a physician to resolve this.</p>
<p>For people who have celiac disease- there is a bit of culinary hope. Thomas Keller, one of the world&#8217;s greatest chefs and owner of Ad Hoc, French Laundry, Per Se, and Bouchon- has developed a flour that works well.   You can purchase it from Williams-Sonoma.</p>
<div id="attachment_1276" class="wp-caption aligncenter" style="width: 426px"><img class="size-full wp-image-1276" title="Kellerflour" src="http://yourdoctorsorders.com/wp-content/uploads/2011/09/Kellerflour.jpg" alt="" width="416" height="500" /><p class="wp-caption-text">Thomas Keller has come up with a great flour, gluten Free. </p></div>
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