XTEND-15sec-NEWSt
6th August 2004
Please click on the summary link of interest:
Secret US report surfaces on antidepressants in children...n1
An article by Jeanne Lenzer in the British Medical Journal makes interesting reading! An official within the US, FDA Dr Andrew Mosholder reached a conclusion based on evidence available to the FDA that antidepressants were causing suicidal tendencies in some children.
However, he was prevented from presenting his report to an FDA advisory committee in February. To read the complete article pleas click here.
Warren Matthews comments: Not much for me to comment about here. Long time readers know my views on giving anti-depressants to children. They are prescribed far too readily and sometimes with very negative consequences. If you have a problem with children they may well be helped by our new neurological formula which is designed to alleviate depression, anxiety and improve brain function and learning ability. It is all natural and targets multiple areas of the brain. It is suitable for children 12 years and over. For details click here.
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Good news for red wine drinkers...n2
It's well known that drinking red wine in moderation can have some health benefits, mainly attributed to a compound called resveratrol. Now, scientists at the University of Virginia Health System have discovered how.
They found how resveratrol helps to starve cancer cells by inhibiting the action of a key protein that feeds them. The protein, called nuclear factor- kappa B (NF-kB), is found in the nucleus of all cells and activates genes responsible for cell survival. "We used physiologically-relevant doses of resveratrol and found dramatic effects on human cancer cells," said Marty Mayo, assistant professor of biochemistry and molecular genetics at U.Va.
Mayo said that the resveratrol in one glass of wine three or four times a week is the right amount to block the protein from feeding cancer cells. Drinking much more than that, however, could stop this affect and, in fact, lead to a greater risk of cancer, he said. To read the balance of this article click here.
Warren Matthews comments: Resveratrol is a very effective substance. It has uses which far exceed that of just an anti-cancer agent. It also has anti-aging properties. Although the resveratrol in wine is great for red wine drinkers you don't have to drink wine to get the benefits of this nutrient.
It can be extracted from the grape skin in a high potency form. This extract can vary from 5 - 50% of active Resveratrol. The extract can be put into a tablet and the benefits can exceed those received from a moderate intake of red wine... provided that the high potency version is used (50%) and the resveratrol is not diluted by stomach acid.
This nutrient is not very common because of its high cost. We use an optimum amount of the 50% potency in our Total Balance and protect it against stomach acid by releasing it in the duodenum along with the other 84 active ingredients. If you would like to learn more about resveratrol and read some clinical studies, please click here.
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Consumer Group urges ban on Cholesterol Drug...n3
In a letter published Thursday in the medical journal The Lancet, a consumer advocacy group warns that the danger of such life-threatening side effects is unacceptably high with Crestor, a statin that was approved by the Food and Drug Administration last August.
To read the rest of the article please click here.
Warren Matthews comments: Since this article was published there have been others all with a similar theme. All indications are that this is the most questionable of all the statin drugs. If your physician insists that you use a statin drug, suggest that you first try our new generation cholesterol formula which we have just released and will provide details on next week. For preliminary info click here.
If you do opt for a statin drug suggest one of the others rather than Crestor which has to many questions hanging over it. Remember the statin drug Baycol which was withdrawn after unacceptable levels of deaths.
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Secret US report surfaces on antidepressants in children (Full Article)f1
Jeanne Lenzer
New YorkInternal memos and a secret government report about the negative effects of antidepressants in children-suppressed by the US Food and Drug Administration-have surfaced publicly.
The Alliance for Human Research Protection, a national network dedicated to ensuring ethical standards in medical research, published the documents on 26 July.
The published documents confirm earlier news accounts that a government expert with the FDA's Office of Drug Safety, Dr Andrew Mosholder, found that children taking antidepressants were twice as likely to become suicidal as children taking placebo. He reportedly urged the agency to follow the lead of British health authorities by warning doctors that the risks of the newer antidepressants, except fluoxetine, might outweigh the benefits when used in children.
The leaked documents show his data and conclusions. The FDA has subsequently acknowledged to the BMJ that Dr Mosholder was prevented from presenting his report at an advisory committee meeting on 2 February and was told that if he was asked any questions during the meeting he could respond to queries only by using a prepared script approved by his supervisors.
Dr Mosholder had evaluated data from 22 studies using nine drugs in 4250 children and found that 74 of the 2298 children taking antidepressants had a "suicide related event" compared with 34 of the 1952 children taking placebos.
When questioned about the decision to suppress Dr Mosholder's report, Dr Robert Temple, associate director for medical policy in the FDA's drug evaluation centre, defended the agency's actions. "We thought the analysis was premature," he told the BMJ.
Both the raw data and Dr Mosholder's interpretation were "imperfect" said Dr Temple, adding that some of the behaviours labelled "suicidal" were highly suspect and could have been accidents, such as a child "who hit her head with her hand." FDA officials acknowledged, however, that some cases classified as "accidental injury" could be suicide related. Because of this, the FDA has contracted with Columbia University to further study and classify events that might be considered to be suicide related.
Some of these events, he added, such as superficial cutting, "might be due to anxiety" and not represent true suicidal intent.
Dr Thomas Laughren, the FDA's team leader for psychiatric drug products, told the BMJ that he had reported the relative risk ratios of all the drugs evaluated at the advisory meeting and that it was Dr Mosholder's conclusions, and not the data, that were withheld.
Responding to critics who say studies of antidepressants other than fluoxetine show little or no efficacy in children, Dr Temple said absence of proof should not be interpreted to mean the drugs are ineffective.
Dr Jerome Hoffman, an epidemiologist and professor of medicine at the University of California at Los Angeles, told the BMJ that the flip side of Dr Temple's claim that antidepressants in children could be life-saving is that they could be life threatening-as suggested by Dr Mosholder's report.
"Most Americans undoubtedly believe that the FDA demands reasonable evidence that a drug is safe before it is allowed to be used," said Professor Hoffman. "But this episode suggests that they reject this precautionary principle' in favour of the idea that no drug is dangerous unless it is proven' to be so."
"The FDA... attempted to silence Dr Mosholder [but] repeatedly claimed to support his concern' for the safety of children," added Professor Hoffman, "but this apparently didn't extend to supporting his desire to express that concern publicly. That may be the most dangerous aspect of this entire affair."
The FDA has launched a criminal investigation to find out which employees leaked Dr Mosholder's report. Meanwhile the suppression of the report has triggered Congressional investigations by Senator Charles Grassley, who has interviewed employees in the agency's Office of Drug Safety, where Dr Mosholder worked.
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GOOD NEWS FOR RED WINE DRINKERS: RESEARCHERS DISCOVER THAT A PROTEIN IN GRAPE SKINS CAN KILL CANCER CELLS (Full Article) It's well known that drinking red wine in moderation can have some health benefits, mainly attributed to a compound called resveratrol. Now, scientists at the University of Virginia Health System have discovered how.
They found how resveratrol helps to starve cancer cells by inhibiting the action of a key protein that feeds them. The protein, called nuclear factor- kappa B (NF-kB), is found in the nucleus of all cells and activates genes responsible for cell survival. "We used physiologically-relevant doses of resveratrol and found dramatic effects on human cancer cells," said Marty Mayo, assistant professor of biochemistry and molecular genetics at U.Va.
Mayo said that the resveratrol in one glass of wine three or four times a week is the right amount to block the protein from feeding cancer cells. Drinking much more than that, however, could stop this affect and, in fact, lead to a greater risk of cancer, he said.
The findings, discovered by Fan Yeung, a postdoctoral fellow at U.Va., are published in the May 20 online edition of the Journal of the European Molecular Biology Organization (EMBO) found at:
http://embojournal.npgjournals.com.
Resveratrol is an antioxidant found in a number of plants, including grape skins, raspberries, mulberries and peanuts. Its job in nature is to fight fungus during the rainy season, and it is especially prevalent in grapes used in making red wine. Resveratrol is also sold over-the-counter in the U.S. as a nutritional supplement.
For a number of years, scientists have known that resveratrol acts as an anti-cancer agent, but its role has not been well understood. Mayo and his team demonstrated that cancer cells treated with resveratrol died because they became sensitive to a compound called Tumor Necrosis Factor alpha (TNFa). The U.Va. Health System researchers found that resveratrol initiated a reaction in the NF-kB molecule that caused the cancer cells essentially to self-destruct in a process called apoptosis.
The use of NF-kB inhibitors like resveratrol also has important implications for increasing the effectiveness of cancer therapy. "Researchers are always looking for ways to improve cancer therapy," Mayo said. "Current studies are using compounds similar to TNFa in conjunction with resveratrol to kill cancer cells." Clinical trials using this approach in patients are showing encouraging results, Mayo said, and this researchmay explain why this combined therapy is effective.
Previous studies have also shown that resveratrol can help control atherosclerosis, heart disease, arthritis, and autoimmune disorders. Mayo believes the inhibition of NF-kB may be responsible in those disorders, as well, since NF-kB can control inflammatory responses.
Mayo's research on resveratrol was funded by grants from the National Cancer Institute and the Paul Mellon Prostate Cancer Institute.
May 25, 2004.
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Consumer group urges ban of cholesterol drug
Concern over side effects of Crestor grows (Full Article) By Robert Bazell
Correspondent
NBC News
Updated: 9:31 p.m. ET June 24, 2004
Otis Elliott started taking the cholesterol-lowering drug Crestor and developed severe muscle pains within days.
"(I) just couldn't stand it anymore, the pain was too severe," says Elliott. But by then it was nearly too late; Elliott went into kidney failure, which doctors say almost killed him.
In a letter published Thursday in the medical journal The Lancet, a consumer advocacy group warns that the danger of such life-threatening side effects is unacceptably high with Crestor, a statin that was approved by the Food and Drug Administration last August.
"So everywhere you turn there are ads for Crestor and there is no question that those ads help to sell drugs, but what patients have not known and what I think a lot of doctors have not known is that the drug has unique risks," says Dr. Sidney Wolfe of the nonprofit group Public Citizen. All statins carry a slight risk of muscle damage, but the consumer group says the danger is higher with Crestor, and only Crestor threatens the kidneys.
Ever since Crestor was approved by the FDA, the manufacturer, AstraZeneca, has been heavily advertising the drug.
AstraZeneca says the concern about side effects is just flat-out wrong. "We believe the safety profile for Crestor has been very, very extensively studied and we're confident that it is comparable to the other statins," says David Brennan, the company's CEO.
What is at stake is a potential portion of an enormous market - and human lives. Sales of statin drugs in the United States now total $14 billion a year, with 13 million people taking them. And experts say the number of people who should be taking the drugs is triple the number who are currently taking them.
FDA officials say they agree with the manufacturer that Crestor is safe and effective, but add that they will continue to study reports of harmful side effects, such as Elliott's case, to see if they reveal an unusual pattern.
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