Dawson Church
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 In four of the trials that Kristol studied, the placebo exhibited better results than the drug. The mean difference between the placebos and the drugs was a 'clinically insignificant' difference..."18
These results are not atypical; Prozac had to go through ten clinical trials in order to accomplish four trials with a marginally better cure rate than a placebo.19 Two trials is what the Food and Drug Administration requires for proof of efficacy; currently drug companies can conduct many trials before they can produce two that show that their drug is marginally more effective than a placebo. |
Mike Adams, the Health Ranger
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 CU also urges them to establish a system to ensure honest descriptive results of the trials that laypersons can use, and to create that system in a timely manner.
A provision in the Senate bill that could make it more difficult for patients who are harmed by an unsafe drug to sue the pharmaceutical company also should be removed, CU said. |
Mike Adams, the Health Ranger
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 AIDS drug trials, but says that the last trial took place in 2001 and thus the trials are not continuing, as BBC reporter Jamie Doran claims. The ACS gives the extent and statistics of the experimental drug trials, based on its own records, and contracts the Vera Institute of Justice to conduct "an independent review of ACS policy and practice regarding the enrollment of HIV-positive children in foster care in clinical drug trials during the late 1980s and 1990s" (New York City ACS). |
Dr. Abram Hoffer, MD, FRCP (C) and Dr. Harold D. Foster, PhD
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 Blind, Controlled Studies
As Director of Psychiatric Research in Saskatchewan for the Department of Public Health, Dr Hoffer supervised six blind therapeutic trials with schizophrenic patients during the period 1952 to i960. This was the first time that blind, controlled trials were used in psychiatric research history, a design adopted on the advice of Dr Bud Fisher, a member of the Canadian Department of Health. The first two trials studied the benefits of a yeast nucleotide preparation in the treatment of schizophrenia. Results were negative. |
Mike Adams, the Health Ranger
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 The truth about clinical trials for prescription drugs is that most trials are a sham. The numbers and conclusions are almost universally fraudulent. They're designed to get the drug approved by the FDA for marketing, not to actually determine any level of safety of efficacy for the public.
You see, virtually no drugs are tested in combination with other drugs. Nor are drugs tested for sufficient time to determine their long-term risks. And even the trials that are completed are cherry-picked by their sponsors to drum up the most favorable results possible. |
Ann N. Martin
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 In my opinion, AAFCO's feeding trials are inadequate and limited in scope, oversimplifying the acceptable test results and limiting the feeding trials to only eight dogs. In addition, the feeding trials only last a matter of months and give no indication of how these foods might affect animal companions who eat commercial foods for years.
The Pet Food Institute
The Pet Food Institute (PFI) is the official mouthpiece for pet food manufacturers in the United States and Canada. In order to belong to PFI, you must be a commercial pet food manufacturer. |
David Winston, RH(AHG), and Steven Maimes
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 Factors such as dosage in trials can create varying results. Using Asian ginseng as an example, clinical trials in China get dramatically higher responses than Western trials. Much of the discrepancy may lie in the dosage. Most Western studies are based on daily doses of two hundred milligrams of ginseng, but Chinese studies use much higher amounts—up to ten times more.
5. Rarely are herbalists consulted when studies on herbal products are designed. This is very unfortunate, because they are the authorities on the effective clinical use of these substances. |
Ann N. Martin
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| In my opinion, AAFCO's feeding trials are inadequate and limited in scope, oversimplifying the acceptable test results and limiting the feeding trials to only eight dogs. In addition, the feeding trials only last a matter of months and give no indication of how these foods might affect animal companions who eat commercial foods for years.
The Pet Food Institute
The Pet Food Institute (PFI) is the official mouthpiece for pet food manufacturers in the United States and Canada. In order to belong to PFI, you must be a commercial pet food manufacturer. |
Dr. Abram Hoffer, MD, FRCP (C) and Dr. Harold D. Foster, PhD
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| This was the first time that blind, controlled trials were used in psychiatric research history, a design adopted on the advice of Dr Bud Fisher, a member of the Canadian Department of Health. The first two trials studied the benefits of a yeast nucleotide preparation in the treatment of schizophrenia. Results were negative. The remaining six focused on vitamin B-3, both niacin and niacinamide. These trials were followed by one double-blind confirmatory report by J.R. Wittenborn3 and many other reports in the clinical literature. |
Mike Adams, the Health Ranger
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 Moeller: I actually have full sets of human trials. We finished three sets of human trials where they took our 10 pm product, and the data we can give you on our product is different. We can go in and say, "Look, in the human trials on eye infections, they used this much for this amount of time, they saw improvement in this amount of time, full recovery in this amount of time. Upper respiratory tract infections, urinary tract infections, abdominal pain and diarrhea, you name it." We have data on about 26 different problems that they've used, and all the data's independent. |
Mike Adams, the Health Ranger
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 They could conduct trials on a particular drug in which five trials reveal that the drug kills people and five other trials reveal that it helps people, and guess which five you will hear about? Guess which five the mainstream press will cover in the news? Guess which five will show up in a published peer-reviewed article in the medical journals? They also don't tell you about the influence of medical journals themselves. |
Mike Adams, the Health Ranger
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| And even the trials that are completed are cherry-picked by their sponsors to drum up the most favorable results possible. This, the FDA claims, is the "gold standard" of drug safety. Which is why, of course, over 100,000 Americans were killed by prescription drugs last year alone.
To help solve this little problem, I say we make all clinical trials open source. Free the data. Let the public and the medical community read for themselves what the results are... for the "good" studies and the bad ones, too. |
Paula Begoun and Bryan Barron
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 In some trials, the silicones slowed the penetration of the actives (thus reducing the potential for a sensitizing reaction), but other trials noted accelerated penetration of the actives, indicating that the specific type of silicone emulsion included must be carefully coordinated with the specific active ingredients (Source: Journal of Cosmetic Science, November-December 2004, pages 509-518).
Whether or not Clinique has succeeded in their efforts to create a gentler sunscreen remains to be seen. |
Donna Jackson Nakazawa
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 Within five years he hopes to move on to human trials. One thing he will be looking to answer in his pig study is the question of distance: it's one thing to grow new axons the short fourteen centimeters it takes to travel from a rat's spine to his feet. But what about the greater length nerves must run from a pig's spine to its toes? And what about the distance motor neurons have to travel in, say, a six-foot-tall man, whose longest nerve spans a full three feet?
Kerr is hoping to start clinical trials in paralyzed adults within five years—before 2012—if all goes well in his study on pigs. |
Paula Begoun and Bryan Barron
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| In some trials, the silicones slowed the penetration of the actives (thus reducing the potential for a sensitizing reaction), but other trials noted accelerated penetration of the actives, indicating that the specific type of silicone emulsion included must be carefully coordinated with the specific active ingredients (Source: Journal of Cosmetic Science, November-December 2004, pages 509-518).
Whether or not Clinique has succeeded in their efforts to create a gentler sunscreen remains to be seen. |
David Winston, RH(AHG), and Steven Maimes
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| Using Asian ginseng as an example, clinical trials in China get dramatically higher responses than Western trials. Much of the discrepancy may lie in the dosage. Most Western studies are based on daily doses of two hundred milligrams of ginseng, but Chinese studies use much higher amounts—up to ten times more.
5. Rarely are herbalists consulted when studies on herbal products are designed. This is very unfortunate, because they are the authorities on the effective clinical use of these substances. Examples of research flawed by a basic lack of understanding of herbal practice abound. |
Mike Adams, the Health Ranger
See article keywords and concepts |
| They could conduct trials on a particular drug in which five trials reveal that the drug kills people and five other trials reveal that it helps people, and guess which five you will hear about? Guess which five the mainstream press will cover in the news? Guess which five will show up in a published peer-reviewed article in the medical journals? They also don't tell you about the influence of medical journals themselves. |
Dawson Church
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| Two trials is what the Food and Drug Administration requires for proof of efficacy; currently drug companies can conduct many trials before they can produce two that show that their drug is marginally more effective than a placebo.
Modern surgery is amazing—yet sometimes unnecessary
The many studies that fail to show that the drug is helpful are called "file drawer studies," because they're quietly filed in dusty corners and never submitted to the FDA or medical journals—though Kristol was able to obtain them to include in his meta-analysis. |
Ann N. Martin
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| AAFCO and Feeding Trials
Another aspect of pet food that AAFCO oversees is the feeding trials. A typical feeding trial uses eight dogs over one year of age. All the dogs must be of normal weight and health. Prior to the start of the trial all dogs must pass a physical examination. Their general health, body, and coat are evaluated. At the end of the trial four blood values are measured and recorded. They include hemoglobin, packed cell volume, serum alkaline phosphates, and serum albumin.
For six months the dogs are only fed the food being tested. |
Craig Pepin-Donat
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 How Supplements Are Made
Compared to prescription drugs, the number of clinical randomized control trials for supplements, considered the gold standard for evidence-based support, is minuscule at best. Even with all the clinical studies performed on prescription drugs, we still see the significant dangerous side effects for consumers. According to Neal Spruce, "The supplement industry will never have the financing to do clinical trials that would give the consumer the absolute proof that supplements work. |
Anne Harrington
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 Analyzing the combined results of fifteen clinical trials that used inert tablets as placebo controls, Beecher determined that the effect of these placebos was profound: on average, placebos affected about a third of patients in the placebo group (though there was great variability across the trials), and in certain instances produced "gross physical change[s]" that could "exceed those attributable to potent pharmacological action."68
Recognizing that placebo effects were powerful, however, was not the same thing as saying they were therapeutically useful. |
David Winston, RH(AHG), and Steven Maimes
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| Using Asian ginseng as an example, clinical trials in China get dramatically higher responses than Western trials. Much of the discrepancy may lie in the dosage. Most Western studies are based on daily doses of two hundred milligrams of ginseng, but Chinese studies use much higher amounts—up to ten times more.
5. Rarely are herbalists consulted when studies on herbal products are designed. This is very unfortunate, because they are the authorities on the effective clinical use of these substances. Examples of research flawed by a basic lack of understanding of herbal practice abound. |
Donna Jackson Nakazawa
See book keywords and concepts |
| In lupus trials, the Rituxan story is less rosy: in 2006 the FDA issued a warning following two deaths from viral infections of lupus patients who were using Rituxan "off label"—meaning that they had been prescribed the drug even though it has not yet been approved for lupus. Doctors and analysts are unsure about cause and effect and may never know the truth; lupus patients have compromised immune systems, and it's impossible to say whether Rituxan alone was responsible for these infections. Two clinical trials using Rituxan to treat lupus patients are now under way. |
David W. Grotto, RD, LDN
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 CARDIOVASCULAR DISEASE: Over fifty trials, including human intervention trials, have shown that consumption of soy products improves cholesterol ratios, and reduces total cholesterol and LDL cholesterol, especially in individuals with elevated cholesterol.
Tips on Using Soy
SELECTION AND STORAGE:
• Dried soybeans can be purchased in prepackaged containers and bulk bins.
• Edamame can be purchased frozen or precooked. Edamame should be deep green and firm with no bruised pods. Fresh edamame may be available seasonally in natural food and specialty markets. |
Dr. Abram Hoffer, MD, FRCP (C) and Dr. Harold D. Foster, PhD
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| The first two trials studied the benefits of a yeast nucleotide preparation in the treatment of schizophrenia. Results were negative. The remaining six focused on vitamin B-3, both niacin and niacinamide. These trials were followed by one double-blind confirmatory report by J.R. Wittenborn3 and many other reports in the clinical literature.4
NAD given in l-gram doses (though not NADH, which was not available at the time) was usually and very quickly effective in the treatment of schizophrenia when prepared so that it would not be destroyed by stomach acid. |
Ray D. Strand
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 Investigators in the early 1980s began trials in which patients took CoQlO supplements. Over the past twenty years, interest has continued to mount and numerous clinical studies have tested the results of CoQlO in cardiomyopathy and congestive heart failure patients. No fewer than nine placebo-controlled clinical trials have taken place around the world. Eight international symposia have been held on the biomedical and clinical aspects of CoQlO, at which physicians and scientists from eighteen different countries presented more than three hundred papers. |
Dr. Jonathan Prousky, BPHE, BSc, ND, FRSH
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 Table 11: Grades of Evidence
A
Systematic reviews of randomized controlled trials and/or randomized controlled trials with or without double-blind placebo control.
B
Systematic reviews of observational studies and/or high-quality observational studies including cohort and case-control studies, and/or nonrandomized controlled trials.
C
Case-series, case-reports, and/or poor quality cohort and case-control studies.
D
Expert opinion without explicit critical appraisal or based on physiology, bench research or "first principles. |
David W. Grotto, RD, LDN
See book keywords and concepts |
| CARDIOVASCULAR DISEASE: Over fifty trials, including human intervention trials, have shown that consumption of soy products improves cholesterol ratios, and reduces total cholesterol and LDL cholesterol, especially in individuals with elevated cholesterol.
Tips on Using Soy
SELECTION AND STORAGE:
• Dried soybeans can be purchased in prepackaged containers and bulk bins.
• Edamame can be purchased frozen or precooked. Edamame should be deep green and firm with no bruised pods. Fresh edamame may be available seasonally in natural food and specialty markets. |
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