Last week in Xtend-Your-Life we wrote about the withdrawal from the market of the arthritis drug VIOXX manufactured by Merck & Co. To review that article please go to our Xtend Your Life archives and click on issue 1st October 2004. The Wall St Journal has now run an article referring to a government study that suggests that this drug in its short history has been responsible for more than 27,000 due to heart attacks and other related cardiac problems.
We are on track to complete the first batch late December and release it to customers shortly after. In the meantime don't overlook the benefits of Total Balance and Omega 3. Here is a comment from a customer that you may find interesting:
"It wasn't until I began the Enbrel, Celebrex combo that I began to feel real pain relief. I know both of these drugs are extremely toxic and I would love to find another way but scared of having the excruciating pain return. My symptoms of pain have gotten even more improved since I have been on your supplements and Omega three combo. Is there any hope in the future for a natural replacement that will equal this toxic drug combo for pain relief??"
The Council for Responsible Nutrition (CRN) has reacted angrily to the article published in last week's Lancet - which suggested that dietary supplements may be doing more harm than good, and accused the journal of "creating publicity over practicing journalistic integrity".
Scientists from the University of Niss, Serbia and Montenegro, and the Cochrane Hepato-Biliary Group carried out a review of previously published trials, where antioxidant supplements had been used for the prevention of gastrointestinal cancers. To read the rest of this article by NutraIngredients.com please clicking here.
There is much more to the issue of this study than is indicated as it tends to throw all supplements into the same 'pot' but that is like comparing apples with oranges. For example, reference is made to Vitamin A and indeed there is a case for not using Vitamin A which is a synthetic substance and should only taken in the form of a precursor such as beta carotene.
This is why we don't use Vitamin A in any of our products. But, then there is a big difference in types of beta carotene... some are synthetic and some are natural and the molecular structure is quite different as is the action of them in the body. Same thing applies to the different types of Selenium.
Then there is the question of dose rates. Many people overdose on the common vitamins and minerals on the understanding that more is better... this is not so, and in fact many common vitamin/mineral supplements have excessive doses of some of the common vitamins. They are very cheap, but more is not necessarily good. A prime example is Vitamin C. Doses taken orally in excess of about 400mgs per day (unless you have an ailment) will undergo changes in the stomach that will activate rather than suppress free radicals. This is why our levels of vitamins in Total Balance are quite low as there are better, more potent, and natural ingredients that are safer!
Supplementation by US consumers could save the state $15 billion in health costs according to a study published last week. Philippa Nuttall spoke to Elliott Balbert, president of the Dietary Supplement Education Alliance (DSEA), about what this research really means and why he remains wary about fortified foods.
The study, commissioned by the DSEA and carried out by the Lewin Group, discovered that daily use of calcium by people over the age of 65 would save $13.9 billion over five years. To read the rest of the article please click here.
Report: Vioxx linked to thousands of deathsf1
Newspaper cites government study on recalled pain drug (Full Article)
Updated: 6:15 p.m. ET Oct. 6, 2004
Merck & Co.'s arthritis drug Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before it was pulled from the market last week, the Wall Street Last week, Merck abruptly recalled Vioxx, an arthritis treatment and one of the company's top-selling drugs, after an internal study showed that patients taking the drug were more likely to suffer a cardiac event than those taking a placebo.
The Journal's report, citing a study by the Food and Drug Administration, said that from Vioxx's approval in 1999 through 2003, an estimated 27,785 heart attacks and sudden cardiac deaths would have been avoided if Celebrex, a competing drug made by Pfizer Inc., had been used instead of Vioxx.
The article said the figures were projections based on findings from an analysis of a database of patients of Kaiser Permanente, a large health-maintenance organization.
No comment was immediately available from the FDA or Merck.
Analysts said Merck is now confronting the possibility of multiple lawsuits in connection with the recall.
The FDA study has not been released to the public, but a copy has been requested by Senate Finance Committee Chairman Charles Grassley, R-Iowa, who is investigating how the FDA handles safety concerns, the Journal said.
The study drew on data from about 1.4 million Kaiser patients, who had taken one of the painkillers called nonsteroidal anti-inflammatory drugs, or NSAIDs. That included 40,405 patients who had taken Celebrex and 26,748 who had taken Vioxx, the Journal said.
A Merck spokesman told the Journal that the company could not comment on the full study, "as we have not yet had the opportunity to review it."
Other pain relievers may cause problems
At the same time, scientists and European regulators are now questioning the safety of other pain relievers like Vioxx, saying these medications also might raise the risk of heart attack and stroke.
On Wednesday, the European Medicines Agency in London announced it would review drugs similar to Vioxx. And researchers writing in the New England Journal of Medicine voiced their concerns as well with such drugs as Pfizer's popular Celebrex.
The medical journal published two reports on the issue Wednesday on the Internet, ahead of their planned publication, because of their public health importance.
Studies done five years ago when Celebrex and Vioxx were approved suggest that the same mechanism that inhibits inflammation and makes the drugs easier on the stomach than traditional painkillers also blocks a substance that prevents heart problems, according to Dr. Garret FitzGerald, a University of Pennsylvania cardiologist who led the studies, which were designed by him but funded by the drug companies.
"I believe this is a class effect," meaning that the problem also applies to Celebrex and Pfizer's newer, similar drug, Bextra, which remain on the market.
He called on the FDA to change its advice to patients and doctors to reflect the new safety concerns. In a separate report also released by the medical journal, Dr. Eric Topol of the Cleveland Clinic chastises the FDA for not requiring Merck to do studies investigating heart problems with Vioxx when hints of them first appeared years ago.
Pfizer's medical director, Dr. Gail Cawkwell, insisted that its drugs are safe.
"The data for Celebrex is robust and exceeds, in the length of patients in studies and in the size of studies, the data Vioxx has," she said.
Spare the stomach, risk the heart?
She called FitzGerald's contention "an interesting theory," but said, "there is no evidence" of increased risk of heart problems among the 75 million Americans who have taken Celebrex. Long-term studies are not yet available on Bextra, which was approved in 2001.
FDA officials did not immediately return phone calls seeking comment.
When Merck voluntarily withdrew Vioxx, FDA officials said heart problems were unique to that drug and that the mechanism underlying them wasn't known.
But FitzGerald and colleagues published two studies in 1999 and another in 2001 suggesting that by selectively blocking one of the two substances called prostaglandins that lead to inflammation, these so-called COX-2 inhibitors were sparing the stomach at the expense of the heart.
"There's a good prostaglandin and a bad prostaglandin as far as the heart is concerned," he explained.
Suppressing both, as older painkillers like aspirin and other non-steroidal anti-inflammatory drugs, or NSAIDS do, helps the heart. But shutting down just the "good" one raises the risk of high blood pressure, hardening of the arteries and clotting, he reports.
The studies will be published in the Oct. 21 print edition of the medical journal.
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CRN castigates Lancet for incendiary reporting (Full Article)f2
10/4/2004 - The Council for Responsible Nutrition (CRN) has reacted angrily to the article published in last week's Lancet - which suggested that dietary supplements may be doing more harm than good, and accused the journal of "creating publicity over practicing journalistic integrity".
Scientists from the University of Niss, Serbia and Montenegro, and the Cochrane Hepato-Biliary Group carried out a review of previously published trials, where antioxidant supplements had been used for the prevention of gastrointestinal cancers.
The researchers looked at 14 randomised trials - totalling over 170,000 participants - before concluding that supplementation with b-carotene, vitamins A, C, E, and selenium (alone or in combination) compared with placebo on oesophageal, gastric, colorectal, pancreatic and liver cancer incidences provided "no protective effect".
They then went a step further and concluded there was "a small but statistically significant increase of 6 per cent relative risk in mortality among people taking antioxidants compared with placebo". And added that two combinations of supplements, namely b-carotene and vitamin A and E, were associated with an even higher relative mortality risk of 30 per cent for b-carotene and vitamin A and 10 per cent for b-carotene and vitamin E.
"We could not find evidence that antioxidant supplements can prevent gastrointestinal cancers; on the contrary, they seem to increase overall mortality," said lead researcher Dr Goran Bjelakovic.
The CRN expressed its unhappiness with many aspects of the research, but saved its real annoyance for the way in which the Lancet had reported the findings.
"It's not news to say that we don't know for sure what might prevent cancer," said Annette Dickinson, president of the CRN, questioning the rationale of using "only three studies that focused on healthy people".
"While studies can successfully draw upon unhealthy populations to find solutions for healthy populations, antioxidant supplements alone should not be expected to reverse the negative effects created by a lifetime of smoking or poor dietary habits," she said.
Her colleague - the CRN's vice president, scientific and international affairs, John Hathcock - added that he saw little value in comparing different supplements in the same meta-analysis.
"Comparing different supplements in the same meta-analysis results in violating a primary rule of meta-analysis - combining only similar studies - and discounts the valuable information one would otherwise learn about the individual supplements," said Hathcock.
"Averaging out the effect of beta-carotene and selenium in the same meta-analysis is like saying if you have a husband who is morbidly fat with a wife who is morbidly thin, you've got a couple with an ideal weight," he said.
However, the trade body was most aggravated by the way in which the Lancet had decided to present the research by highlighting the following quote by David Forman from the University of Leeds, UK and Douglas Altman from Cancer Research UK: "If their findings are correct, 9000 in every million users of such supplements will die prematurely as a result. The prospect that vitamin pills may not only do no good but also kill their consumers is a scary speculation given the vast quantities that are used in certain communities". The CRN believed instead the journal should have focused on the fact this research is still in its preliminary phase.
"Lancet's handling of this article makes it frighteningly clear that we have moved into an age where getting headlines takes precedence over a scientific journal's responsibility to report without bias," said Dickinson.
Indeed, Forman had told NutraIngredients.com last week that although he felt comfortable with the conclusion there was no proof that vitamin supplements had protective effects against gastrointestinal cancer, he felt the authors of the study had more confidence in the findings that supplementation could be responsible for premature deaths than he did.
"This is somewhat preliminary and there are a number of statistical problems with the way the researchers looked at the data," he said. He noted that a particular problem was the inclusion of one study, which had used an "abnormal" group of patients, including people that were unhealthy and smoked.
"Part of the problem is also that the researchers looked at all available studies dealing with gastro-intestinal cancer and supplementation, but they now need to do another study taking into consideration all papers on mortality and supplementation," he added.
The group is now carrying out such research, but - depending on the results - it could have been beneficial to the supplement industry if this study had been concluded before such potentially damaging research was published.
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Supplementation means gains for tax payer's pocket and health (Full Article)f3
9/27/2004 - Supplementation by US consumers could save the state $15 billion in health costs according to a study published last week. Philippa Nuttall spoke to Elliott Balbert, president of the Dietary Supplement Education Alliance (DSEA), about what this research really means and why he remains wary about fortified foods.
The study, commissioned by the DSEA and carried out by the Lewin Group, discovered that daily use of calcium by people over the age of 65 would save $13.9 billion over five years - by reducing hip fractures - and daily use of folic acid among women would save $1.3 billion over five years from prevented birth defects.
Omega-3 fatty acids, glucosamine and saw palmetto supplements, which have been around for less time and involved in less research, also showed substantial promise for improving health and quality of life and potentially reducing health care costs.
As far as Elliott Balbert was aware, this was the first time that supplements had been quantified in terms of healthcare, as "savings for the tax payer".
More importantly, he noted that if certain health problems could be avoided by using supplements then the quality of people's lives would be improved. As Balbert stressed this is particularly important in the case of folic acid and its ability to reduce birth defects.
Among other things, he wanted this research to be used to urge congress to support certain bills, which would encourage the use of supplements.
"For example, there is a bill that would allow food stamps to be used to buy dietary supplements," he said, adding that they can be used to buy candy, so why not nutritional supplements.
However, Balbert does not believe that legislation is enough to get the supplementation messages out to the American people. He also thinks that doctors need to have preventative training so that they understand supplements and are thinking as much about preventing diseases as they are about curing them.
The consumer media has been full recently of articles about the problems that can ensue when herbals interact with prescription drugs; greater emphasis on the use of supplements seems to imply greater risk for the consumer. But, Balbert says that it is the responsibility of the individual to check what they are taking and why, as they would with OTC drugs.
"Where there is known information it should be displayed on the bottle, but it is not realistic to think that every supplement can be tested against every drug," he said. Likewise, just because there have been a few problems, he is frustrated that some people may try to tar all supplements with the same brush.
As far as fortified foods and the role they have to play in the nation's health are concerned, Balbert thought there should be more dose specific functional foods, but expressed concern that consumers are not sure to receive the required dose if it is not clearly explained.
While this research is specific to the US and there are no immediate plans to carry out similar research in Europe or Asia, it would obviously be interesting to see how much money and lives could be saved globally through supplementation.
Speaking at this year's World Economic Forum, current chair of GAIN Jay Naidoo, also chairman of the board of the Development Bank of Southern Africa, said that if wheat flour was fortified in the 75 most needy countries with iron and folic acid, iron deficiency could be reduced by 10 per cent, and birth defects could be lowered by a third.
Such fortification would cost a total of about $85 million, or about 4 cents per person, he said.
"As a result, we estimate these countries would gain $275 million in increased productivity and $200 million from the enhanced earning potential," Naidoo claimed. "There are many other examples to emphasize that public-private partnerships to invest in food fortification are investments not only in health, but also in national economies."
Also, recent report from the Copenhagen Consensus, a panel of eight of the world's most distinguished economists, included fortification programmes as one of its top priorities for facing global challenges.
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