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Bausell points out that
"...just because someone with a PhD or an MD performs a clinical trial doesn't mean that the trial possesses any credibility whatsoever. In fact, the vast majority of these efforts are worse than worthless because they produce misleading results."
The book includes valuable lessons on how to tell credible research from the other kind. Even the most experienced researchers will find food for thought here, and for the layman it will be a revelation.
Research is full of pitfalls. Negative studies tend not to get published (the file drawer effect). Research done by believers and pharmaceutical companies tends to be more positive than research done by others. Studies from non-English speaking countries are notoriously unreliable for various reasons – 98% of the acupuncture studies from Asia are positive, compared to 30% from Canada, Australia, and New Zealand. The researcher may delegate the actual research to others, who may make undetected mistakes or deliberately skew results to please their boss. Double blind studies may not be truly blind: subjects may have been able to guess which group they were in. Subjects who are not responding may drop out. People who believe in homeopathy are more likely to volunteer for homeopathy studies. Researchers may put a positive spin on their findings or reach conclusions that are not justified by the data. Even if the research is impeccable, we arbitrarily use p=.05 as the measure of statistical significance, and this means there is a 5% probability that the results will appear falsely positive just by chance. There are more pitfalls, and Bausell covers them all.
When you come right down to it, no experiment is beyond criticism, and most published research is wrong. So how can we decide which studies are credible? We now have published guidelines such as the 22 item Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of randomized controlled trials, but Bausell offers some simpler criteria that can rule out the worst offenders:
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too often the nature of science itself is misunderstood or misrepresented to the public. Science is not an arcane and privileged discipline. By its very nature it is meant to be transparent and public. Science is nothing more than a systematic and careful use of evidence and logic to evaluate factual claims. And good science possesses certain virtues that are not unique to science but generic to all intellectual endeavors: fairly accounting for all available evidence, using valid and internally consistent logic, using unambiguous concepts and language, proper use of statistics, being quantitatively precise and accurate, and above all being honest.
And yet there are numerous and powerful influences in society that strongly appose the scientific basis of medicine. Driven by some combination of ideology or the desire for profit they wish to eliminate standards of science in health care, or (often under the guise of "health care freedom") create a double standard in which unscientific methods and products can thrive unchecked. Others simply lack the training or knowledge to achieve minimal standards of quality for scientific medicine. And even the best traditions of scientific medicine can benefit from more critical analysis.
Within the practice of medicine there is already a recognition of the need to raise the standards of evidence and the availability of the best evidence to the practitioner and the consumer – formalized in the movement known as evidence-based medicine (EBM). EBM is a vital and positive influence on the practice of medicine, but it has its limitations. Most relevant to this blog is the focus on clinical trial results to the exclusion of scientific plausibility. The focus on trial results (which, in the EBM lexicon, is what is meant by "evidence") has its utility, but fails to properly deal with medical modalities that lie outside the scientific paradigm, or for which the scientific plausibility ranges from very little to nonexistent.
All of science describes the same reality, and therefore it must (if it is functioning properly) all be mutually compatible. Collectively, science builds one cumulative model of the natural world. This means we can make rational judgments about what is likely to be true based upon what is already well established. This does not necessarily equate to rejecting new ideas out-of-hand, but rather to adjusting the threshold of evidence required to establish a new claim based upon the prior scientific plausibility of the new claim. Failure to do so leads to conclusions and recommendations that are not reliable, and therefore medical practices that are not reliably safe and effective.
QuoteThe Council, comprised of doctors, food allergy authorities, school and professional foodservice leaders and others with expertise in the issue, will serve as a resource to schools, restaurants, and manufacturers who are trying to help consumers who might have a peanut allergy. The Council will provide its expert guidance as NPB works to build better understanding and correct misinformation about effective allergy management practices.
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a published false statement that is damaging to a person's reputation; a written defamation.
Quote from: LinksEtc on July 01, 2014, 02:12:44 PM
sesame seeds labeling: US specific (laws, loopholes)Quote from: LinksEtc on June 02, 2013, 02:08:58 PM
www.regulations.gov
Request of Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds
FDA-2012-N-0711-0053Quote
FARRP would assert that the FDA does not have compelling scientific data on the prevalence, severity and potency of other foods to consider any additions to the existing FALCPA list. In fact, if the three factors of prevalence, severity and potency are examined together, several of the existing foods may not belong on the list. Soybean allergy appears to be less prevalent than any of the others on the FALCPA list, soybean is not an especially potent allergenic food, and soybean has caused very few severe reactions. Much the same could be said for wheat allergy (not for celiac disease which does have higher prevalence). Crustacean shellfish allergy is very prevalent but the potency and severity of crustacean shellfish appear to be rather low. FARRP would encourage FDA to develop an algorithm based upon prevalence, severity and potency to determine which foods belong on the priority allergens list. The decisions should be based upon science. FARRP would note that ILSI-Europe is working on the development of an algorithm for possible use in the EU and FDA should monitor this ongoing activity. FARRP would further note that the U.S. does not really have good data on prevalence. This is also true on a worldwide basis (Rona et al., 2007), although the EU has funded the EuroPrevall project that should, when published, fill that gap for the EU. U.S. estimates are based mostly on telephone surveys (Sicherer et al., 1999; Sicherer et al., 2004; Sicherer et al., 2010). Telephone surveys are not supported by clinical confirmations. Thus, FARRP would encourage FDA to work with other federal agencies to obtain better estimates of the prevalence of various specific food allergies in the U.S. based upon unselected populations and clinical confirmations.
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http://www.foodallergy.org/about/leadership/advisorsQuote
Steve Taylor, PhD
Professor, Department of Food Science and Technology
Director, Food Allergy Research and Resource Program
University of Nebraska-Lincoln
Lincoln, NEQuote from: LinksEtc on January 27, 2014, 08:13:49 AM
FDA-2012-N-0711-0062 (GM)QuoteIn addition to our direct comments, we fully endorse comments submitted by the Food Allergy Research and Resource Program.
How nice it would be if, for once, companies didn't fight some additional regulations. It would be so nice if they said - you know, we support mandatory sesame labeling because we care about our customers and we are committed to their safety. No company likes complicated or excessive regulations, but requiring the labeling of sesame makes sense. Instead of fighting us, why not be true partners with us FA consumers?
I would like to know more about (FARE - FARRP - Food Industry - FDA) relationships & how they influence sesame allergy labeling (that is, if those relationships influence sesame labeling). Again, I'm not accusing ... just expressing my wish to better understand the interactions of these groups.
Are experts ever discouraged from examining the current accuracy of statements like "the USA 8 most common allergens cause 90% of reactions"?
Prevalence Of Food Allergy To Uncommon Foods Based On Oral Food ChallengesQuote from: LinksEtc on March 12, 2014, 05:30:20 PM
I've said it before ... "The Top 8" is sounding more & more like "the Earth is flat".
QuoteQuote from: LinksEtc on June 26, 2014, 07:29:14 AM
"How Manufacturer-Funded Research Compromises Patient Care"
http://www.forbes.com/sites/robertpearl/2014/07/24/how-manufacturer-funded-research-compromises-patient-care/?utm_source=followingimmediate&utm_medium=email&utm_campaign=20140724Quote
Regardless of the etiology, research bias and skewed results are real when medical companies fund studies on their products.
Quote from: LinksEtc on July 02, 2014, 04:30:55 PM
Tweeted by @CSPI
"Coca-Cola's Assault on Tap Water"
http://civileats.com/2013/11/13/coca-colas-assault-on-tap-water/QuoteHerein lies the inherent problem that accompanies "working with" Big Food; most health advocates' suggested changes and policies pose a threat to its profits.
Quote from: LinksEtc on July 01, 2014, 02:12:25 PM
"Scientists Say F.D.A. Ignored Radiation Warnings"
http://www.nytimes.com/2010/03/29/health/policy/29fda.html?pagewanted=1&_r=0QuoteFor patients, navigating the debate can be difficult because doctors, patient advocacy groups and manufacturers often endorse positions that are in their economic self-interest. Radiologists, who often own and use CT machines, for instance, often endorse their use; while gastroenterologists, who often own and use camera scopes, often favor their own methods. Patient groups often get financing from drug and device makers, or physician-specialty groups.QuoteI was first ignored, then pressured to change my scientific opinion, and when I refused to do that, I was intimidated and ultimately terminated
So often, quality of info and/or advocacy seems tied to $ and/or politics.
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"Misquoted And Misunderstood: Peanut Bans In Schools And A False Sense Of Security"
http://blog.onespotallergy.com/2014/01/misquoted-and-misunderstood-peanut-bans-in-schools-and-a-false-sense-of-security/QuoteI was very interested to learn that in 1999, Ms. Munoz Furlong received a $14,000.00 grant from The Peanut Foundation, which is the research arm of the American Peanut Council.Quote
Here are the grant particulars:QuoteThe decision makers and parents should also be educated that bans do not work.