Letters to the Editor Issue 233
Release of UK QMUL PACE Data “A Gamechanging Win for People with ME / CFS”
Last week, Queen Mary University of London (QMUL) released data from its controversial PACE study on myalgic encephalomyelitis / chronic fatigue syndrome. The data release came after five years of pressure from patients and scientists who questioned the study’s claim that graded exercises and cognitive behavioural therapy were effective treatments for patients with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS).
The PACE trial has attracted mounting criticism in recent months from scientists, including a group of over 40 who said in an open letter to The Lancet, the journal that published the original paper that PACE’s flaws “have no place in published research.” In August, a UK tribunal ordered the release. The following experts and advocates in the US and the UK responded to the release of the data:
Professor Jonathan Edwards of University College London, one of the letter’s signatories said:
“The new analysis of the PACE trial appears to confirm the consensus view that CBT and graded exercise therapy were associated with a mild placebo effect.”
Dr David Tuller journalist and public-health expert at the University of California-Berkeley who had been publicly critical of the trial added:
“Let’s be clear. These findings are really much worse than those presented in published, ‘peer-reviewed’ papers “If these were the best findings for $8 million, then PACE really will not survive legitimate scrutiny.”
Jennifer Brea, co-founder of #MEAction explained:
“The release of data from Queen Mary University of London’s PACE study into Myalgic Encephalomyelitis proves that graded exercise and cognitive behavioral therapy were never effective treatments for those suffering from ME. The more than 1 million people that suffer from ME in the United States need real research into the causes and potential treatment of this horrific disease and we hope that the release of this data proves once and for all that this research is long overdue.”
LA Cooper, of #MEAction Network in the United Kingdom added:
“We are thrilled with the long-awaited outcome. The only way forward to ensure we better understand this disease and discover adequate treatments is through strong, trustworthy science. We believe that the release of the data is a huge step in the right direction.”
An analysis published Wednesday by the trial’s own authors states that just 21% of patients found improvement with graded exercise, as compared to the 61% they originally reported in The Lancet. Critics think that when the data is independently analyzed, it will show that exercise has no positive benefit at all. Graded exercise is a commonly prescribed treatment for ME/CFS but many patients and researchers believe it can make symptoms worse, sometimes permanently.
A petition led by #MEAction with over 12,000 signatures was presented at the tribunal as evidence of the level of public interest in data release. Over two dozen patients’ charities in 14 countries called on PACE’s authors to release their data for independent reanalysis. But Queen Mary University spent over £200,000 on legal fees on a tribunal appeal to try to prevent the data’s release.
For more information about Myalgic Encephalomyelitis:
For more information about the PACE trial:
Harvard Professor Says Prescription Drugs Are Killing Population
A Harvard Professor has claimed that prescription drugs are not only ineffective at treating most illnesses, but are actually killing the population.
Arnold Seymour Relman, professor of Medicine at Harvard University and former Editor-in-Chief of the New England Medical Journal says:
“The medical profession is being bought by the pharmaceutical industry, not only in terms of practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”
The pharmaceutical industry is the most prevalent medicine industry worldwide, as it is hypothesized that the medicines provided by it quickly gives respite from ailments and treats a person, despite of the fact that thousands of people die every year from prescription drug use.
According to a new study, almost 80 percent of meta-analyses had some sort of industry tie-up, either through sponsorship or speaking fees, research grants and things like that, which again leads to the fact that drugs may help someone by giving some sort of relief or lowering pain, but they can also cause a large amount of harm.
These drugs can instantly relieve acute pain and distress. But the treatment of chronic diseases poses a grave problem. Thus, in relieving a diseased condition, other abnormal physiological and pathological problems may develop. The side effects from these drugs can range from mild side effects like fatigue and constipation, to strong side effects like suicidal thoughts, insomnia, coma, severe infection and so on.
“Any drug causing more side effects than benefits will not be called a medicine. It would rather be called a poison.”
Here, we are talking about antidepressants. Dr Peter Gotzsche, co-founder of Cochrane Collaboration (the world’s foremost body in assessing medical evidence), is currently working to make the world aware of the fact that the side effects associated with the several pharmaceutical grade drugs are actually killing people all over the world. According to his research, 100,000 people in the United States alone die each year from the side effects of correctly-used prescription drugs. He published many papers reasoning the fact that antidepressants are making people suffer with its harmful effects to a large extent.
In context of antidepressants, recent example is a study published in the British Medical Journal by researchers at the Nordic Cochrane Centre in Copenhagen. It states that the pharmaceutical companies are not disclosing all information regarding the results of their drug trials.
Tamang Sharma, a PhD student at Cochrane and lead author of the study, said:
“We found that a lot of appendices were often only available upon request to the authorities, and the authorities had never requested them. I’m actually kind of scared about how bad the actual situation would be if we had the complete data.”
This is not the first time that the pharmaceutical companies are portraying only the half-truth of their drug trials to get the antidepressants on to the shelves. There are many other examples where we can see that the drug companies are selling their drugs on the basis of a bunch of lies and half-told truths.
Source: Naomi Calligaro <firstname.lastname@example.org>
Supplements Are Safe: Who Is Lying to You Now?
by Helen Saul Case
Once again, the media threatens the public with the false notion that supplements of essential nutrients and minerals are dangerous and should be treated "like a medication." (And doesn't "treat it like a medication" just reinforce the point that prescription drugs are dangerous? But I digress.)
Bad Reporting of a Bad Report
For a morning news program that claims to deliver "all that matters," it would seem CBS has fallen quite short of that promise.
On July 27, CBS News led their segment "New Study Sounds the Alarm on Dietary Supplements" with the declaration that "a new investigation may have you rethinking some of your vitamins." Well that gets our attention, doesn't it? Except their "news" has nothing to do with vitamins.
"A new study by Consumer Reports outlined health risks associated with dietary supplements - including vitamins, probiotics and weight-loss aids," says CBS. But not one of the 15 supposedly harmful supplement ingredients listed in the Consumer Reports article was a vitamin. Or a probiotic. Why does CBS even mention them?
CBS quotes the deputy content editor at Consumer Reports: "Unlike drug products that must be proven safe and effective, dietary supplements do not have to go through FDA approval." But that's not a true statement either. If prescription drugs "must be proven safe and effective," why are so many people dying? CBS forgets to mention that more than 100,000 deaths occur every year due to prescription medications taken as directed. They also forget to mention the most recent report from the American Association of Poison Control Centers: supplements caused zero deaths in 2014. And no, it wasn't just a "good year." Decades of data confirm the remarkable safety of supplements. Vitamins and probiotics, in particular, are extremely safe.
In order to drive home the alleged danger of dietary supplements, CBS takes the time to highlight the death of one young man who used caffeine powder. Caffeine is a stimulant, not a nutrient. "Caffeine and nutrients have very little in common," says Gert Schuitemaker PhD, and Bo Jonsson MD. "Nutrients are part of the human metabolism and are necessary for maintaining proper health." CBS doesn't mention that. They just cast a shadow over all supplements.
As for dietary supplements not being FDA approved, lack of FDA approval does not mean supplements are unregulated. They are regulated.
ALL Dietary Supplements Are Regulated
We should not confuse FDA approval with FDA regulation. Just because a dietary supplement is not FDA approved does not make it "bad." And pharmaceutical drugs that are FDA approved are not automatically "good." Supplement companies are responsible for ensuring the safety of their products and for providing accurate labelling. If they don't, the FDA has always had the power to take dangerous or falsely labelled products of any kind off the market.
To reiterate, the U.S. Food and Drug Administration can, at any time, pull any supplement off the shelves. Make no mistake, they use this power. Health and Human Services (HHS) Secretary Tommy G Thompson stated, "[T]he FDA will not tolerate the marketing of dietary supplements that are more likely to harm health than help it."
"FDA regulates both finished dietary supplement products and dietary ingredients." [U.S. Food and Drug Administration, http://www.fda.gov/Food/DietarySupplements/ ]
Bias in "Consumer Reporting"
Conflict of interest may have much to do with that negative Consumer Reports article on supplements. All one needs to do is look over the panel of "experts" Consumer Reports picked to help them "develop the criteria" for the list of 15 supplement ingredients to avoid. To learn more you will want read: http://articles.mercola.com/sites/articles/archive/2016/08/09/consumer-reports-attacks-supplements.aspx
Supplements Are Overwhelmingly Safe
The CBS news report did one thing right: it quotes the Council for Responsible Nutrition who gave a very responsible response: "More than 150 million Americans take dietary supplements each year... Overwhelmingly, dietary supplements are safe and play a valuable role in helping Americans live healthy lifestyles."
Supplements are safe, CBS. Report that, please.
(OMNS Assistant Editor Helen Saul Case is the author of The Vitamin Cure for Women's Health Problems and coauthor of Vegetable Juicing for Everyone. Her latest book is Vitamins & Pregnancy: The Real Story.)
3. Starfield, B. "Is US Health Really the Best in the World?" JAMA 284(4) (Jul 26, 2000): 483-485. http://extension.oregonstate.edu/coos/sites/default/files/FFE/documents/us_health_care.pdf
See also: Lazarou, J., B. H Pomeranz, P. N. Corey. "Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies." JAMA 279(15) (Apr 15, 1998): 1200-1205.
Nutritional Medicine is Orthomolecular Medicine
Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information: http://www.orthomolecular.org
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Editorial Review Board
Ian Brighthope, M.D. (Australia)
Ralph K. Campbell, M.D. (USA)
Carolyn Dean, M.D., N.D. (USA)
Damien Downing, M.D. (United Kingdom)
Michael Ellis, M.D. (Australia)
Martin P. Gallagher, M.D., D.C. (USA)
Michael J. Gonzalez, N.M.D., D.Sc., Ph.D. (Puerto Rico)
William B. Grant, Ph.D. (USA)
Ron Hunninghake, M.D. (USA)
Michael Janson, M.D. (USA)
Robert E. Jenkins, D.C. (USA)
Bo H. Jonsson, M.D., Ph.D. (Sweden)
Peter H. Lauda, M.D. (Austria)
Thomas Levy, M.D., J.D. (USA)
Stuart Lindsey, Pharm.D. (USA)
Joseph Mercola, D.O. (USA)
Jorge R. Miranda-Massari, Pharm.D. (Puerto Rico)
Karin Munsterhjelm-Ahumada, M.D. (Finland)
W. Todd Penberthy, Ph.D. (USA)
Jeffrey A. Ruterbusch, D.O. (USA)
Gert E. Schuitemaker, Ph.D. (Netherlands)
Jagan Nathan Vamanan, M.D. (India)
Ken Walker, M.D. (Canada)
Atsuo Yanagisawa, M.D., Ph.D. (Japan)
Robert G. Smith, Ph.D. (USA), Assistant Editor
Helen Saul Case, M.S. (USA), Assistant Editor
Michael S. Stewart, B.Sc.C.S. (USA), Technology Editor
Andrew W. Saul, Ph.D. (USA), Editor and contact person. <email@example.com>
This is a comments-only address; OMNS is unable to respond to individual reader emails. However, readers are encouraged to write in with their viewpoints. Reader comments become the property of OMNS and may or may not be used for publication.
Tel Aviv University Research Reveals How Melanoma Spreads to Other Organs in the Body - Findings may lead to a cure for the deadly disease
In a landmark discovery, researchers at Tel Aviv University have unravelled the metastatic mechanism of melanoma, the most aggressive of all skin cancers.
According to a paper published today [22 August 2016] in the journal Nature Cell Biology, the scientists discovered that before spreading to other organs, a melanoma tumour sends out tiny vesicles containing molecules of microRNA. These induce morphological changes in the dermis in preparation for receiving and transporting the cancer cells. The researchers also found chemical substances that can stop the process and are therefore promising drug candidates.
"The threat of melanoma is not in the initial tumour that appears on the skin, but rather in its metastasis - in the tumor cells sent off to colonize in vital organs like the brain, lungs, liver and bones," said research leader Dr Carmit Levy of the Department of Human Molecular Genetics and Biochemistry at TAU's Sackler School of Medicine. "We have discovered how the cancer spreads to distant organs and found ways to stop the process before the metastatic stage."
The TAU group worked in close collaboration with Prof Jörg D Hoheisel and Laureen Sander at the German Cancer Research Center (DKFZ) in Heidelberg, Dr Shoshi Greenberger at the Sheba Medical Center at Tel HaShomer, Israel and Dr Ronen Brenner at the Wolfson Medical Center in Holon, Israel. Lab research was led by Dr Shani Dror of Dr Levy's research group.
Morphological Changes in the Dermis
Melanoma, the most aggressive and lethal type of skin cancer, causes the death of one person every 52 minutes according to data from the Skin Cancer Foundation; the number of diagnosed cases has been on the rise for the past three decades. Despite a range of therapies developed over the years, there is still no full remedy for this life-threatening disease. The new study proposes novel and effective methods for diagnosing and preventing this most deadly of skin cancers.
The researchers began by examining pathology samples taken from melanoma patients. "We looked at samples of early melanoma, before the invasive stage," Dr Levy said. "To our surprise we found changes in the morphology of the dermis - the inner layer of the skin - that had never before been reported. Our next task was to find out what these changes were, and how they related to melanoma."
In the ensuing study, the group was able to discover and block a central mechanism in the metastasis of melanoma.
According to Dr Levy, scientists have known for years that melanoma forms in the outer layer of the skin, the epidermis. At this early stage, the cancer is unable to send off colonizing cancer cells because it has no access to blood vessels - the highways that carry the cells to other parts of the body. With no blood vessels present in the epidermis, the tumour first needs to contact the abundant blood vessels running through the dermis. But how was the connection made?
"We found that even before the cancer itself invades the dermis, it sends out tiny vesicles containing molecules of microRNA," Dr Levy said. "These induce the morphological changes in the dermis in preparation for receiving and transporting the cancer cells. It then became clear to us that by blocking the vesicles, we might be able to stop the disease altogether."
Transforming Melanoma into a Nonthreatening Illness
Having discovered the mechanism, the researchers proceeded to look for substances that could intervene and block the process in its earliest stages. They found two such chemicals: one (SB202190) inhibits the delivery of the vesicles from the melanoma tumour to the dermis; and the other (U0126) prevents the morphological changes in the dermis even after the arrival of the vesicles. Both substances were tested successfully in the lab, and may serve as promising candidates for future drugs. In addition, the changes in the dermis, as well as the vesicles themselves, can be used as powerful indicators for early diagnosis of melanoma.
"Our study is an important step on the road to a full remedy for the deadliest skin cancer," said Dr Levy. "We hope that our findings will help turn melanoma into a nonthreatening, easily curable disease."
FDA Alert - Supplements Under Attack, Again!
by Dr Denis Wilson
New FDA guidelines for dietary supplements were released, and the news is BAD!
The industry has been long waiting for clarification from the FDA about how to introduce ‘new’ dietary supplement ingredients. The current regulations are so restrictive and make it so expensive for a manufacturer to comply, that new dietary supplement innovation has essentially halted for the past decade.
To bring in a new dietary ingredient, the manufacturer must complete a “NDI” application (New Dietary Ingredient), which requires pharmaceutical level research and testing. Yet, these natural ingredients are not protectable by patents nor covered by insurance, making the investment a losing proposition. The industry has been waiting for clarification from the FDA on the NDI guidelines in hope of making them more reasonable, especially since these natural supplements are generally safe to begin with.
The FDA finally released the news. The outcome is earth-shatteringly disappointing.
We are asking you to contact your legislators to protest, by using this easy form provided by the Alliance for Natural Health (ANH): www.anh-usa.org/action-alert-stop-the-massive-attack-on-supplements/
We don’t want you to get lost in all the details of this ongoing FDA saga, so here are some key points that we excerpted from the lengthy ANH article. (You can read the full article here: www.anh-usa.org/fda-massive-attack-on-supplements/ )
The new NDI guidelines set standards for natural products higher than pharmaceutical standards
The new guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI notification. Note that safety studies in the past have been required of drugs, but never for natural supplements.
In addition the agency states that additional safety studies may be needed if the target population changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification. The FDA admits they do not impose this standard on pharmaceutical medications!
The rules seem to be set up for the pharmaceutical industry to take over the dietary supplement industry
Under current law, if an “IND” application is filed for an ingredient bya pharmaceutical company that wants to use a dietary supplement in a formula—that is, an ingredient is being studied for use as part of a new drug—that ingredient can no longer be produced or included in a supplement.
Think that sounds crazy? This has already happened to pyridoxamine, a form of vitamin B6, even though in the end it resulted in this valuable form of natural B6 being no longer available either as supplement or drug. Essentially, if a pharmaceutical company wanted to take all supplements off the market, they could effectively do so by submitting applications for every nutrient, whether or not they really intend to use them in a drug formula.
The FDA can manipulate the definition of “chemically altered” to destroy the supplement industry
The FDA is also broadening the group of substances that must submit NDIs by adopting a loose definition of what it means for a supplement to be “chemically altered”. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient.
This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed. It appears that this is quite intentional. The aim is to destroy supplement innovation in the hope that this will eventually destroy the supplement industry.
Our cost for natural supplements would escalate if pharmaceutical companies take over
Probiotics - the “good” bacteria which our bodies, and in particular, our immune systems, absolutely depend on - could also be on the chopping block. The agency cites risks for these supplements which are purely theoretical and have never posed a problem. Is it a coincidence that Big Pharma is now very interested in producing its own versions of this product? Having probiotics subject to prescription - or costing $100 a bottle - will be a disaster for the health of Americans.
It’s the same old story. The agency, under the guise of protecting us, is really just protecting its funder, the drug industry, and is throttling any chance of innovation and improvement in supplements. This is so corrupt that it is hard to understand how Congress can continue to turn a blind eye to it, but of course Big Pharma funds political campaigns as well.
We are asking you to contact your legislators using this easy form provided by the Alliance for Natural Health: www.anh-usa.org/action-alert-stop-the-massive-attack-on-supplements/
Thank you for your help and please share this email with everyone you know!
Yours in Health,
Dr Denis Wilson
Original Sources: Dr. Wilson <firstname.lastname@example.org>
via: Peter Fischer <email@example.com>
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