XTEND-15sec-NEWSt
8th April 2005
Please click on the summary link of interest:
Another arthritis drug withdrawn from the market...n1
Pfizer has agreed to suspend sales of its arthritis drug Bextra after US and European regulators said the risk of serious side effects, including a potentially fatal skin allergy, outweigh the benefits.
The US Food and Drug Administration also asked Pfizer to add a "black box" warning - the strongest possible - to the label of its painkiller Celebrex. Bextra and Celebrex belong to a class of drugs known as COX-2 inhibitors that also includes Merck & Co's Vioxx, which was withdrawn last year because of an increased risk of stroke and heart attack.
To read the Reuters article please click here.
Warren Matthews comments: It is really quite a pity that so many people have had to suffer potential fatal side effects from these drugs when there are natural safe alternatives! If you suffer from any form of arthritis or joint pain I would strongly suggest that you have a look at a technical report that we have prepared on this subject. If you don't want to go that 'deep' you will still find a lot of interesting information on the natural options where we have details of our new Arthrit-Eze product. Please click here.
P.S. Just as we getting ready to send out this newsletter we received an unsolicited email from David a customer who was one of the first to receive our new Arthrit-Eze product. This is what he says: "I've only been using the Arthritis supplement for a few days now, but it seems to work. I've almost cut out the pain meds I was taking. GREAT!!!!!!!"
NOTE: As we say on our website we don't expect it to work this quick, but in some cases it will!
back to top
Proposed EU ban on some supplements could be overturned...n2
An 11th hour decision by the senior advisor to the European Court of Justice, Advocate General Geelhoed has deemed the proposed EU directive on Supplements to be illegal. His decision has still yet to be ratified by other judges in June, but this is expected to happen.
If accepted, the Food Supplements Directive, which was set to ban around 75 per cent of supplements and health products currently on the market, will be shelved. In a statement read out on Tuesday morning, Advocate General Geelhoed, pronounced that the directive infringes the principle of proportionality because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration have not properly been taken into account.
If the Advocate General's recommendations are adopted, in effect, the ban on vitamin and mineral forms not included on the EU's 'Positive list,' due to come into effect on 1 August 2005, will be declared illegal. In essence, the positive list of allowable nutrient forms will be deemed to be too narrow, too restrictive, and based on flawed science.
This would avoid the totally irrational situations that the Food Supplements Directive would otherwise create. For example, synthetically produced selenium would have been allowed on the positive list, while the natural source found in Brazil nuts would not; synthetic forms of Vitamin E (often used in 'adverse' vitamin studies reported in the media) would be allowed, but the natural, most beneficial food forms would not.
"It is commendable that the EU Advocate General has seen through the flawed science and law of the Food Supplements Directive and reached his recommendations today," said Dr. Robert Verkerk, Executive Director of the ANH. "All that ANH is campaigning and working cooperatively for is the right for consumers to have access to safe natural healthcare and for legislation to be based on good science and good law. This is a great day for the tens of millions of people who believe passionately in the benefits of natural, preventative healthcare."
Warren Matthews comments: This is positive news, but not entirely unexpected. Consumer's worldwide are becoming increasingly aware of the 'drive' behind the scenes of 'interested parties' to try and limit the public access to effective natural treatments. Politicians or other people of influence are now however, beginning to take note so hopefully we will see a trend towards more sensible regulation.
I think that most responsible manufacturers have no problems with most of the proposed regulations which are being introduced in many countries throughout the world... providing the regulations are directed towards ensuring quality and accuracy of labels. The concern has been, and still is that innovation may be stifled due to unreasonable restriction of ingredients. This current decision in Europe is a step in the right direction and will if ratified have beneficial flow-on effects world wide.
back to top
DHA May Improve Cholesterol Particle Size in At-Risk Children?n3
COLUMBIA, Md., April 5, 2005 /PRNewswire-FirstCall via COMTEX/ -- Docosahexaenoic Acid (DHA) causes beneficial changes in blood cholesterol measurements in children with high cholesterol and a family history of heart disease, according to the results of a recent study published in The American Journal of Cardiology this month. The study used Martek DHA(TM), which is produced from microalgae.
"Children with high cholesterol and a family history of heart disease are at increased risk for heart disease as adults. The exciting news is that DHA, an omega-3 fatty acid, may improve the quality of cholesterol in these children.
To read the rest of this article published in Nutraingredients.com please click here.
Warren Matthews comments: This is an interesting 'twist' on the benefits of DHA for children. We are very much aware of the benefits of DHA in our Omega 3 DHA/Esters but this may be a further benefit. Irrespective of whether cholesterol is an issue or not in children they should be taking at least one dose of a quality Omega 3 supplement daily. In that regard we know of no purer Omega 3 with such a high DHA content than our own Xtend-Life Omega 3 which you can find by clicking here.
back to top
Important notice: All material provided within XTEND-15sec-NEWS is for informational and educational purposes only, and is not to be construed as medical advice or instruction. No action should be taken solely on the contents of this publication. Consult your physician or a qualified health professional on any matters regarding your health and wellbeing or on any opinions expressed within this newsletter. The information provided in this newsletter is believed to be accurate based on the best judgment of the editor but the reader is responsible for consulting with their own health professional on any matters raised within.
Pfizer Suspends Another Painkiller (Full Article)f1
Toni Clarke - Reuters
Pfizer has agreed to suspend sales of its arthritis drug Bextra after US and European regulators said the risk of serious side effects, including a potentially fatal skin allergy, outweigh the benefits.
The US Food and Drug Administration also asked Pfizer to add a "black box" warning - the strongest possible - to the label of its painkiller Celebrex.
Bextra and Celebrex belong to a class of drugs known as COX-2 inhibitors that also includes Merck & Co's Vioxx, which was withdrawn last year because of an increased risk of stroke and heart attack.
The suspension, which threatens Pfizer's top-flight credit rating, is the latest setback for the class of drugs that began last September when Merck withdrew Vioxx after it showed increased risk of heart attack and stroke in patients who took it for more than 18 months.
The FDA also asked the makers of dozens of other prescription and nonprescription painkillers, including Motrin, Advil and Aleve, to strengthen warnings about possible heart risks and potentially life-threatening gastrointestinal bleeding. The new warnings do not apply to aspirin.
Motrin and Advil, which are versions of ibuprofen, are members of a class of drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs. Bextra, Celebrex and Vioxx are selective NSAIDs designed to reduce the risk of gastrointestinal bleeding.
The FDA said it singled out Bextra for suspension because it gives no added advantage as a painkiller and can cause a potentially life-threatening skin condition called Stevens-Johnson syndrome, an allergic reaction that usually begins as a blistering of the mouth and lips and can spread to to the rest of the body.
The Bextra decision surprised analysts because an FDA advisory panel in February voted to keep Bextra on the market, and the FDA usually follows the advice of its advisory panels. But investors bet that Celebrex, which had sales of US$3.3 billion in 2004, would be shored up by the request for warnings on other drugs, and Pfizer's stock closed little changed at US$26.90. It hit a four-year low in December.
"Bextra being suspended is certainly a negative, but this is largely balanced out by the leveling of the playing field," said Albert Rauch, an analyst at AG Edwards & Sons. "Now they're all being painted with the same brush."
Pfizer said it disagrees with the regulatory decisions on Bextra, which include a request from Canada to suspend the drug. The company said it would explore options with regulators under which it might be allowed to resume sales of the drug, which amounted to US$1.3 billion in 2004.
Still, Moody's Investors Service said it may cut Pfizer's "triple-A" senior debt rating. Only seven US companies have this rating from Moody's and Standard & Poor's, including Johnson & Johnson, General Electric Co and Exxon Mobil. Merck lost its triple-A rating last year after its problems with Vioxx.
Sales of Pfizer's COX-2 inhibitors have slowed since December, when the FDA called on doctors to limit prescribing Celebrex and Bextra in light of evidence that they also may increase the risk of heart attack and stroke.
The FDA said it was willing to "carefully review" any proposal by Merck to reintroduce Vioxx, reflecting the assessment of the advisory panel which concluded that Vioxx, Bextra and Celebrex all posed some level of heart risk but that Vioxx was safe enough to return to the US market. All three drugs should have a black box warning, the panel said.
Analysts think Vioxx would have an uphill battle competing with Celebrex if it did manage to return to the market, but such a move could help limit Merck's litigation liability. The company has been sued by thousands of patients who claim they were hurt by the drug. Now Pfizer is expected to be faced with similar suits.
"There will be a stampede of lawsuits," said Matt Zapf, head of product liability at the Chicago law firm of Goldberg Kohn.
Merck's shares rose 60 cents, or 1.8 percent, to US$33.49 on the New York Stock Exchange.
"We continue to believe that Celebrex is a good drug for Pfizer and will help drive numbers, just not at the levels we would have hoped for 18 months ago," said Jason Fox, an analyst at H&R Block Financial Advisors.
(Additional reporting by Debra Sherman in Chicago, Susan Heavey in Washington and Ed Tobin and Bill Berkrot in New York)
08/04/05
back to top
f2
Study Suggests DHA May Improve Cholesterol Particle Size in At-Risk Children
(Full Article)
2005-04-05 - Martek Biosciences Corporation COLUMBIA, Md., April 5, 2005 /PRNewswire-FirstCall via COMTEX/ -- Docosahexaenoic Acid (DHA) causes beneficial changes in blood cholesterol measurements in children with high cholesterol and a family history of heart disease, according to the results of a recent study published in The American Journal of Cardiology this month. The study used Martek DHA(TM), which is produced from microalgae.
"Children with high cholesterol and a family history of heart disease are at increased risk for heart disease as adults. The exciting news is that DHA, an omega-3 fatty acid, may improve the quality of cholesterol in these children. The small size of the 'bad LDL cholesterol' shifted to the large, fluffier type which floats easier in the blood stream without being taken up by the artery wall. This may prevent plaque build-up in the artery and heart disease in these high risk children. These results add to our other recent research which showed that DHA increases the ability of blood vessels to dilate or increase blood flow," said Dr. Marguerite Engler, the study's lead investigator and professor at the University of California, San Francisco.
The study funded by the National Institutes of Health, involved twenty children (between the ages of 9-19) with inherited high cholesterol. The children were stabilized on a low-fat diet for 6 weeks and then randomized to receive 1.2 grams per day of Martek DHA(TM) or a placebo for 6 weeks. Supplementation with DHA significantly increased the amount of the large, buoyant LDL (low-density lipoprotein) and large HDL (high-density lipoprotein) particles and decreased the amount of small dense LDL particles associated with increased risk of cardiovascular events.
back to top
