Sunday, February 27, 2005

Vitamins: Will they be regulated as drugs?

Some warn of draconian measure by world body, others roll eyes...

Posted: February 25, 2005
By Ron Strom
© 2000

While e-mails circulating about the imminent banning of over-the-counter vitamins and minerals in the U.S. are overly hysterical and in some cases downright false, food-supplement activists still are skeptical about new guidelines likely to be put into effect later this year by a U.N.-linked global commission.
As with many e-mail warnings passed through the ether, the current letters include some accurate information but with overblown conclusions and misleading predictions.
One such warning talks of new global regulations overriding U.S. law. Though they theoretically could be used as a tool by the World Trade Organization, the guidelines under consideration would not supersede regulations that govern what supplements will be available at local health-food stores in the U.S.
Those who distribute the warnings, however, are convinced that Americans could be seeking a doctor's prescription to get their usual vitamin E dosage in the not-too-distant future.
All the anxiety centers around the Codex Guidelines for Vitamin and Mineral Food Supplements, which likely will be finalized in July at a meeting of the Codex Alimentarius (food code) Commission in Rome. The commission, established in 1963 by the Food and Agriculture Organization of the United Nations and the World Health Organization, develops the international food code that intends to ensure the safety of food, and provides regulations for global trade of food products.
The supplement guidelines were finalized in a meeting of the Committee on Nutrition and Foods for Special Dietary Uses in Bonn, Germany, in November. The meeting has been described as a struggle between those nations that see supplements as "food," such as the U.S., and those that see them as "drugs," such as most of the European countries. Observers say the final product saw the Europeans' viewpoints win out on most issues.
"Under Codex authority, these guidelines are optional suggestions, not a mandatory trade standard that must be followed in trade between countries," explains Suzan Walter of the American Holistic Health Association on the group's website.
However, Walter points to powers of the World Trade Organization to use the non-mandatory guidelines in trade disputes, which could compel losing parties to adopt certain global regulations, such as the Codex guidelines.
"Therefore, the regulations in the guidelines must be taken seriously," she writes.
Walter says the biggest concern in the guidelines is that they will limit the dosage amounts of common vitamin and mineral supplements to "safe" levels. It has yet to be determined what those levels are.
Meanwhile, in the European Union, the EU Food Supplements Directive is set to take effect on Aug 1. Though there is a list of 28 "safe" vitamins and minerals that will continue to be sold in EU countries, there are 200 substances that will be restricted. Activists in the U.S. feel such restrictive policies are precursors to what could occur on this side of the Atlantic.
Stateside activists also are concerned about legislation that was introduced two years ago to regulate certain supplements in the U.S. Though the bills died when the 108th Congress ended in December, new versions are thought to be ready for introduction in March or April.
One of the bills from last Congress would have granted the Food and Drug Administration authority to regulate supplements in the same way that it regulates over-the-counter drugs.
These bills would weaken the Dietary Supplement Health and Education Act of 1994, which gave consumers who use supplements certain protections against government regulations.
Many of the warning e-mails mention bill numbers from last Congress that no longer apply. The new bills, assuming they are introduced, likely will have different numbers.
Walter points out her concern about a line included in the Federal Register having to do with U.S. regulations.
She writes: "The United States Federal Register, Oct. 11, 1995, FDA Policy on Standards, states that 'where a relevant international standard exists, or completion is imminent, it will generally be used in preference to a domestic standard. ...' If this is still the FDA policy, once the Codex guidelines are finalized this summer, will we find the FDA working to use this against the Dietary Supplement Health and Education Act?"
Some in the U.S. welcome stricter regulations on supplements., a website that exposes myths and hoaxes, said in an analysis of the Codex scare that Americans should be subject to more safeguards.
"Despite their presence on store shelves, not all dietary supplements are safe for consumers to use, let alone are beneficial to their health," the analysis said. "Products can be 100 percent natural yet deliver a deadly payload, as have some in the past. Lacking regulation of such ingestibles, there is no protection afforded consumers, and authoritative-looking labels are no guarantee that what is being vended in those bottles they envelop is not harmful. Under current law, dangerous supplements get onto the market and stay there, with serious physical harm resulting among those who use them, as was the case with ephedra, which caused strokes, heart attacks, and upwards of 150 deaths before the Food and Drug Administration was finally able to get it out of the stores."
The piece goes on to sing the praises of the legislation introduced in 2003, saying it "looked to regulate dietary nostrums by imposing quality and safety standards on them, and by giving the FDA the ability to take them off the market before a great number of folks have been harmed by them."
The site doesn't see a threat to impose the regulations based on the United States' membership in the WTO, saying the standards would only come into play when American manufacturers of dietary supplements "look to vend them on the international market."
Snopes notes: "What [the Codex Alimentarius Commission] seeks and what it can do are very different things. It has no power to force its will on any nation. Codex standards are voluntary, which means if the U.S. doesn't adopt them, they will not govern the regulation of vitamins, minerals or dietary supplements in the USA."
Some analysts see the new guidelines as another step toward world government and believe the large pharmaceutical companies are behind the effort. If those companies, by working through the World Trade Organization, the argument goes, can get supplements to be regulated as prescriptions, they can cash in on a new and lucrative market.
Consumer advocate Tim Bolen recently pointed the finger of blame at pharmaceutical giant Merck.
The company "controls the manufacturing and distribution of the base ingredients of the only supplements that will be available in Europe – and possibly North America" once international regulations take effect, he wrote.
"This is battle for world domination – period. Either 'we the people' run our governments, and decide world policy, or big multinational corporations will – through the WTO."

Comment: I don't have enough information yet on this to be sure where it's going to end up. I really doubt that U.S. consumers will let this get to the point that supplements will have to be ordered through your doctor by prescription, but if that were to happen, it would be a travesty. I will keep investigating this and let you all know if we begin to go in this direction.


Tuesday, February 22, 2005

Bird Flu Could Become Epidemic

By PAUL RECER, AP Science Writer

WASHINGTON - A bird flu virus may mutate to a human form that becomes as deadly as the ones that killed millions during three influenza pandemics of the 20th century.

Dr. Julie L. Gerberding, head of the Centers for Disease Control and Prevention, said Monday that scientists believe it is highly likely that the virus that has swept through bird populations in Asia will evolve into a pathogen deadly for humans.
"We are expecting more human cases over the next few weeks because this is high season for avian influenza in that part of the world," Gerberding said in remarks at the national meeting of the American Association for the Advancement of Science.
Although cases of human-to-human transmission have been rare, "our assessment is that this is a very high threat" based on the known history of the flu virus, she said.
In Asia, there have already been a number of deaths among people who caught the flu from chickens or ducks. The mortality rate is very high about 72 percent of identified patients, said Gerberding. There also have been documented cases of this strain of flu being transferred from person-to-person, but the outbreak was not sustained, she said.
The avian flu now spreading in Asia is part of what is called the H1 family of flu viruses. It is a pathogen that is notorious in human history.
"Each time we see a new H1 antigen emerge, we experience a pandemic of influenza," said Gerberding. In 1918, H1 appeared and millions died worldwide. In 1957, the Asian flu was an H2, and the Hong Kong flu in 1968 was a H3.
There had been small appearances of the H1-type of avian viruses in other years, but nothing like the H5 now rampaging through the birds of Asia.
"We are seeing a highly pathogenic strain of influenza virus emerge to an extraordinary proportion across the entire western component of Asia," she said. "The reason this is so ominous is because of the evolution of flu. ... You may see the emergence of a new strain to which the human population has no immunity."
Study already has shown that the virus can infect cats who can then infect other cats, which Gerberding said was "another harbinger" of the possibility of a human pandemic.
"The science here is all alerting us that we have a great deal to be concerned about," she said.
The CDC chief said her agency is getting ready for a possible pandemic next year.
A special flu team, organized last year, continues to monitor the spread of the avian flu and to analyze the strains as they appear.
The government has ordered 2 million doses of vaccine that would protect against the known strains of avian flu. Gerberding said this would give manufacturers a head start on making the shots that would be needed to combat a full-blown epidemic of an H1-type of flu in this country.
CDC is also plugged into an international communication and monitoring system that, it is hoped, will give an early warning of the emergence of a deadly new flu.

COMMENT: I have been watching this very carefully and I feel everyone should make sure they have the best immune function possible. A & zinc, Vit C, Echinacea, thymus support as well as many Chinese mushrooms have a powerful effect on improving the immune system. If you have concern that your immune system might be suppressed, this would be the time to start a program to make improvements, before this becomes a potential epidemic or even worse pandemic.


Friday, February 18, 2005

Vitamin D May Ward Off Prostate Cancer


ORLANDO, Fla. - Getting a little sunshine may be one way for men to cut their risk of prostate cancer. A large study presented at a cancer conference Thursday found that men with higher levels vitamin D in their blood were half as likely to develop aggressive forms of the disease than those with lower amounts.

Doctors are not ready to recommend the "sunshine vitamin" without more study, but many see little harm in getting the 15 minutes a day that the body needs to make enough of this nutrient.
"When you were little and your mother said, `Go outside and play,' it wasn't just to get you out of her hair," but may have been instinctive advice about something good for health, said Dr. Eric Klein, a prostate cancer specialist from the Cleveland Clinic.
He had no role in the research, which involved nearly 15,000 men in the Physicians' Health Study at Brigham and Women's Hospital and Harvard Medical School (news - web sites) in Boston. Five years ago, this study found that men who consumed a lot of calcium had modestly higher rates of prostate cancer.
The new findings fit with that notion, because too much calcium lowers vitamin D, and are especially believable because researchers got them by measuring blood samples rather than relying on what men said they ate — an imprecision that has hurt past studies of food and cancer risk.
Blood samples were taken in 1982, when the study began. Eighteen years later, 1,082 of the men had developed prostate cancer. Their levels of two common forms of vitamin D in the stored blood samples were compared with those of 1,701 men in the study who did not get cancer.
Levels of one or the other vitamin D derivative did not make much difference in prostate cancer risk. However, men with higher levels of both had roughly half the risk of developing aggressive tumors — the kind most likely to kill — than men with lower levels, said Dr. Haojie Li, who led the study.
That is in keeping with what previous studies have shown about prostate cancer, Klein noted.
Men in northern latitudes have higher cancer death rates, and vitamin D levels are lower in older men, who are most prone to prostate cancer.
Melanin, which gives skin its color, blocks ultraviolet light that spurs vitamin D production. Blacks, who have a lot of melanin, also have the highest rates of prostate cancer.
Experiments also suggest vitamin D inhibits cell growth. "So there is some lab evidence that vitamin D may be anti-cancer," Klein said.
It could be that the risk comes from too little vitamin D, and that consuming lots of vitamin D is not helpful, doctors say.
How much should people get? The recommended daily amount is 400 international units, but most scientists think that is probably low, Li said.
Most milk is fortified with vitamin D, but drinking a lot of it might raise the risk of prostate cancer because of its calcium content. Getting enough vitamin D from food is difficult, but doctors do not recommend supplements because they can cause unsafe levels of calcium to build up.
"If you start overloading on vitamin D you're going to cause other problems," said Dr. Durado Brooks, chief of prostate cancer research at the American Cancer Society (news - web sites).
Hence the advice to get a little sunlight — but not too much, because that can raise the risk of skin cancer.
Researchers presented two other studies from the same group of 15,000 doctors. One found that men who were overweight were 30 percent more likely to die of prostate cancer than normal-weight men. Those who were obese were nearly twice as likely to die.
The second study examined a protein in the blood, acid-labile subunit or ALS, that blocks the effects of a hormone that spurs cells to grow and has been linked to many types of cancer.
Compared with men with low levels of ALS, men with higher amounts of it were 40 percent to 60 percent more likely to develop prostate cancer, and their chances of having advanced cancer more than doubled, said Lorelei Mucci, a Harvard epidemiologist who led the study.
ALS needs more study, but may be a new marker for predicting cancer risk and may be a target for developing new treatments, Klein said.

COMMENT: Gee, how unusual that Medical Doctors don't want to recommend something that could reduce Prostate Cancer by 50%, I am so shocked. I have been recommending for the last year, based on a lot of research, that everyone increase there Vit D3 intake to at least 1600 IU's daily (4 times the RDA) and if you have a chronic disease, much more. Getting more sun makes sense too, but many don't get enough and use sun screens that prevent vit D from being absorbed. A person working outdoors all day gets around 30 to 40 thousand units a day, without toxicity. You be the judge.


Wednesday, February 16, 2005

Green Tea: Holding Back the "Obesity Tsunami"

Between 1900 and 1950, with the help of modern scientific medicine, the life expectancy of Americans leaped more than 200% from 47 to 68 years. The second half of the 20th century saw life expectancy continue to rise, albeit at a somewhat slower pace. By the year 2000, people could expect to live, on average, for 77 years, a growth rate of about 75%. One would think that, with continued improvements in medicine, nutrition, health awareness, and life style, by 2050 we might expect to be breaking 100.1
One would think that…but we may actually be facing something quite different — the first decline in human life expectancy in hundreds of years! The reason: our ever-expanding waistlines. It's well documented: As body mass goes up, life expectancy goes down.
"My colleagues and I believe that within the next 50 years, life expectancy at birth will decline as a result of the obesity epidemic that will creep through all ages like a human tsunami," said Professor Jay Olshansky, an expert on the epidemiology of aging and the biodemography of survival at the University of Illinois, Chicago. "There has been a dramatic increase in obesity among the younger generation; it is a storm that is approaching," he added.
Dr. Olshansky's conclusions are supported by recent research from the Rand Corporation, which found that one in five US adults classified themselves as obese, which is bad enough, but when their weight was measured objectively, one in three was actually considered obese.
Obesity triples the risk of heart disease and raises the risk of developing diabetes by a factor of 10. It not only shortens lifespan, it is linked to higher health care costs than smoking or drinking and plays a principal role in disability at all ages.2
Of course, the first level of protection against the "obesity tsunami" must be sensible diet and lifestyle measures. Unless we have extraordinarily good genetic luck, we can't expect much from a fast-food diet and a couch-potato existence. On top of these, there are important nutritional steps we can take to reduce body fat while adding years to our lives. Key among these is a food that is widespread across Asia, but much less well known in the West: green tea.

Controlling Body Fat

Green tea is probably best known for its potent antioxidant activity, which offers significant protection against cancer and heart disease. However, new evidence confirms that ingesting green tea can also help reduce body fat and promote beneficial levels of lipids (e.g., cholesterol), blood sugar, and insulin.3
The most recent scientific confirmation comes from Japan, where (along with China) green tea is the second only to water as a popular drink. In a double-blind, controlled study, 38 healthy Japanese men (aged 24—46 years) were randomly assigned to one of two groups: Group 1 ingested oolong tea containing 690 mg of a green tea extract known as catechins; Group 2 received ordinary oolong tea, containing just 22 mg of catechins.

Green Tea Lowers Body Fat Levels: Results After 12 Weeks

After 12 weeks, during which both groups ate the same diet, the green tea group wound up with significantly lower body weight, body mass index (BMI), waist size, and visceral, subcutaneous, and total fat levels (see figure). These changes were associated with a more beneficial blood lipid profile.4 While dietary measures and ordinary tea reduced the body fat measures by only about 2% to 3% across the board, ingesting green tea trimmed fat levels by as much as 10% to 12%.
The key ingredients in green tea are chemicals known as catechins, of which scientists have identified several varieties (isomers). These include catechin, catechin gallate (Cg), gallocatechin, gallocatechin gallate (GCg), epicatechin, epicatechin gallate (ECg), epigallocatechin, and epigallcatechin gallate (EGCg).
Of these, EGCg seems to be the most important. Many studies have shown that, once ingested, EGCg is quickly absorbed and widely distributed all over the body, where it performs its antioxidant, antiviral, antiplaque-forming, and anticancer feats. Also well documented is its ability to lower blood pressure and blood sugar, two important elements of the metabolic syndrome," also known as "syndrome X." This silent killer starts as a general derangement of the body's metabolic functions, including obesity, high blood pressure, elevated cholesterol and triglycerides, insulin resistance, and high blood glucose levels. Over many years, these metabolic disruptions can develop into heart disease, diabetes, and kidney failure.5-10 Now we know that the EGCg and the other catechins in green tea significantly reduce the accumulation of body fat and help normalize blood lipid levels and other aspects of this syndrome.4
There are really only two ways to reduce body fat: either we make less fat or burn more. It's as simple as that. But as we all know, getting it done is not so simple. There is one simple strategy that offers substantial benefits, not only for losing fat but also for a wide range of other important health benefits. We're talking, of course, about ingesting green tea.

Green Tea Fights Fat

Green tea appears to fight body fat at both ends: First, it reduces the accumulation of fat by regulating fat-producing mechanisms in the liver and other locations in the body. In-vitro studies show that green tea catechins markedly inhibit digestive enzymes (lipases) that break down triglycerides, which could translate into reduced fat digestion in humans.11, 12
Second, it turns up the body's metabolic engines, which literally burn fat for energy.11, 13, 14 This latter process is known as thermogenesis. Burning fat faster means there is less fat left to inflate that spare tire.
A recent randomized, double-blind Swiss study demonstrated that green tea generates a significant thermogenic effect.13 The subjects were 10 healthy young men, aged 24 to 26 years, who ranged from lean to mildly obese (8% - 30% body fat). Their typical daily energy intake included 35% to 40% fat, in other words, the typical Western diet. The treatments consisted of: 1) a powdered green tea extract (roughly equivalent to 4 cups of tea); 2) caffeine (which is known to be thermogenic) in an amount equal to that found naturally in the green tea extract, and 3) a placebo. Each subject experienced each of the treatments on a rotating basis. During the 56-weeks of the study, the men were restricted to a standard weight-maintenance diet consisting of about 13% of energy intake as protein, 40% as fat, and 47% as carbohydrate.
Compared with placebo and caffeine, the green tea extract produced a significant increase in total energy expenditure of about 4%. That may not sound like much, but, like interest compounded in a bank account, a small effect continued day after day for an extended period adds up. Also, this 4% increase corresponds to a large increase in the thermogenic component of total energy expenditure: about 35% to 43%. The men taking the green tea extract burned 266 more calories per day than those taking the placebo. The authors concluded that "…oral administration of the green tea extract stimulated thermogenesis and fat oxidation and thus has the potential to influence body weight and body composition…"
Fat doesn't shorten our life spans by itself. It usually contributes to the breakdown of other systems in the body. For example, excessive body fat accumulation is closely linked to heart disease and diabetes, two of the most common potentially fatal chronic diseases. Fortunately, green tea can come to the rescue in both these conditions, and helping control body fat is only part of the story.

Reducing Heart Disease

Heart disease is much less prevalent in Japan, where people drink lots of green tea, than it is in the US. In one recent study, Japanese green tea drinkers had a 30% risk of suffering a heart attack compared with 45% for non-drinkers.15
Green tea catechins contribute to cardiovascular health at least partly through their antioxidant activity. They combine with other powerful antioxidants, such as vitamins C and E and the enzymes superoxide dismutase (SOD) and catalase, to prevent free-radical-induced damage to the vascular endothelium, the delicate lining of blood vessels where atherosclerotic plaque can form. By preventing the oxidation of other antioxidants, catechins may increase the concentration of vitamin E in low-density lipoprotein (LDL — "bad") cholesterol, thus helping protect LDL from peroxidation, an early stage in plaque formation.
Green tea catechins may also help prevent the formation of atherosclerotic plaque by decreasing the absorption of triglycerides and cholesterol. Studies show that at high doses, green tea ingestion decreases LDL cholesterol and increases high-density lipoprotein (HDL — "good") cholesterol.16

Controlling Blood Sugar

The anti-diabetic properties of tea catechins have a long history in number of ancient folk medicine traditions, especially the Chinese. United States Department of Agriculture research has confirmed the health benefits of green tea, demonstrating that, like its two-pronged attack against fat, tea also takes on blood sugar from two different directions. First, it helps control blood sugar indirectly by enhancing insulin activity (in vitro) by more than 15 fold.17
Second, green tea catechins can also directly suppress blood sugar levels. When humans in a clinical trial ingested tea catechins (200 mg — 500 mg) before consuming 50 g of starch (which is converted to glucose by digestive enzymes), glucose production was suppressed, apparently because the catechins inhibited the enzyme action. It has also been found that green tea catechins markedly suppress the uptake of glucose via the intestines for transfer to the bloodstream.17
Some physicians recommend 4 to 6 cups of green tea a day; others recommend 8 to 10 cups (the average in Far Eastern societies is about 5 to 10 cups a day). That's a challenging amount for even tea lovers to imbibe on a daily basis. Fortunately, researchers have concluded that it's just as effective to take green tea extract supplements, which contain the equivalent amount of catechins in a couple of easy-to-swallow capsules.

Protocol: Losing Weight, Reducing Body Fat

It goes without saying that keeping our weight body fat content within desirable limits is a goal we all need to reach if we want to achieve our maximum life span. Yet, Americans are losing the battle of the waistline. Professor Jay Olshansky, an expert on the epidemiology of aging and the biodemography of survival at the University of Illinois, Chicago, predicts that we are on the verge of the first decline in American life expectancy since the advent of modern medical science and nutrition…

Comment: For more on how to lose weight for the long term, see my website:

Life Long Organic Green Tea

GreenTea Capsules

Long Term Weight-Loss


Tuesday, February 15, 2005

Coffee May Help Prevent Liver Cancer

WASHINGTON - That hot cup of coffee may do more than just provide a tasty energy boost. It also may help prevent the most common type of liver cancer. A study of more than 90,000 Japanese found that people who drank coffee daily or nearly every day had half the liver cancer risk of those who never drank coffee.

The American Cancer Society (news - web sites) estimates that 18,920 new cases of liver cancer were diagnosed in the United States last year and some 14,270 people died of the illness. Causes include hepatitis, cirrhosis, excess alcohol consumption and diseases causing chronic inflammation of the liver.
Animal studies have suggested a protective association of coffee with liver cancer, so the research team led by Monami Inoue of the National Cancer Center in Tokyo analyzed a 10-year public health study to determine coffee use by people diagnosed with liver cancer and people who did not have cancer.
They found the likely occurrence of liver cancer in people who never or almost never drank coffee was 547.2 cases per 100,000 people over 10 years.
But for people who drank coffee daily the risk was 214.6 cases per 100,000, the researchers report in this week's issue of the Journal of the National Cancer Institute (news - web sites).
They found that the protective effect occurred in people who drank one to two cups of coffee a day and increased at three to four cups. They were unable to compare the effect of regular and decaffeinated coffee, however, because decaf is rarely consumed in Japan.
It's the caffeine in coffee that makes some people nervous and it has been shown in other studies to prompt mental alertness in many people. Some studies have suggested caffeine aggravates symptoms of menopause or intensifies the side effects of some antibiotics. Heavy caffeine use has been linked to miscarriage. But studies have also shown that a skin cream spiked with caffeine lowers the risk of skin cancer in mice.
"It's an excellent, interesting and provocative study and their conclusions seem justified," commented Dr. R. Palmer Beasley of the University of Texas M.D. Anderson Cancer Center in Houston.
"It will provoke a lot of new work here," said Beasley, who was not part of the research group.
While the study found a statistically significant relationship between drinking coffee and having less liver cancer, the authors note that it needs to be repeated in other groups.
And the reason for the reduction remains unclear.
However, Inoue's team noted that coffee contains large amounts of antioxidants and several animal studies have indicated those compounds have the potential to inhibit cancer in the liver.
In their study, the team also looked at green tea, which contains different antioxidants, and they found no association between drinking the tea and liver cancer rates.
"Other unidentified substances may also be responsible" for the reduction in cancers, they said.
A separate study reported in the same issue of the journal reported no relationship between drinking caffeinated coffee or tea and the rates of colon or rectal cancer.
However, that analysis did find a 52 percent decline in rectal cancer among people who regularly drank two or more cups of decaffeinated coffee.
In that study a team led by Karin B. Michels of Brigham and Women's Hospital in Boston analyzed data from two large studies — the Nurses' Health Study of women and the Health Professionals' Follow-up Study involving men. The analysis of nearly 2 million person years found 1,438 cases of colorectal cancer.

While they did not find any association between cancer rates and consumption of caffeinated coffee or tea, people who regularly drank two or more cups per day of decaffeinated coffee had about half the incidence of rectal cancer as those who never drank decaf.
The rate of rectal cancer was 12 cases per 100,000 person-years among those who consumed two or more cups of decaffeinated coffee per day. For those who never drank decaffeinated coffee, the rate was 19 cases per 100,000 person-years.
That difference may, however, be due to differences in lifestyle, the researchers commented, suggesting that drinkers of decaffeinated coffee might be more health conscious overall.
The Japanese study was funded by the Ministry of Health, Labor and Welfare of Japan. The U.S. study was funded by the National Institutes of Health (news - web sites).

Comment: Coffee enema's have been used for years to help with liver cancer. Looks like just drinking it seems to help as well, as a preventative measure.


Vitamin C Project

Take 8 important minutes and watch this flash website by Bill Sardi. Share this with everyone you know who values there health, especially heart patients.


Monday, February 14, 2005

Study Links Pain Killers to Heart Risk

Study Links Pain Killers to Heart Risk


NEW YORK - A new study has linked pain killers Vioxx, Celebrex and Bextra to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs.
Vioxx and Celebrex increased patients' risk of heart attack and stroke by about 20 percent while Bextra increased the risk by 50 percent, according to a study by WellPoint Inc., the nation's largest provider of health benefits which is based in Indianapolis.
Dr. Sam Nussbaum, WellPoint's executive vice president and chief medical officer, said Monday the study is further evidence of an "increasingly compelling trend" of data that show the drugs elevate patients' risk of heart attack and stroke.
Later this week the U.S. Food and Drug Administration (news - web sites) is holding hearings on the safety of the class of drugs known as Cox-2 inhibitors. Merck & Co. removed Vioxx from the market last year after a study showed it doubled patients' risk of heart attack and strokes.
Pfizer Inc. makes Bextra and Celebrex, which remain on the market.
WellPoint studied the records of 7,232 patients over the age of 40 taking one of the three drugs and compared them with records of 629,245 people older than the age of 40 who were not taking any of the drugs. WellPoint shared the data with researchers at the University of Indiana's medical school, who adjusted the information for heart attack and stroke risk factors, such as age.
WellPoint began the study after Vioxx was removed from the market. It examined patient records from January 2001 through June 30, 2004. All the patients were on the drugs for at least 18 months. Merck officials have insisted the problems with Vioxx didn't become apparent until patients were taking the drug for at least that long.
Drug companies have criticized studies that retrospectively examine patient records, saying the gold standard of drug trials is a blind, placebo-controlled study.
But Nussbaum defended the practice.
"This is how drugs are used in the real world," said Nussbaum. "It is an important and sound analysis."
Nussbaum said WellPoint had shared the data with the FDA (news - web sites) as well as Merck and Pfizer.
Pfizer spokeswoman Mariann Caprino said the company had been given the study results, but had not seen all the data or the methodology. She added the WellPoint report did not change the preponderance of peer-reviewed, scientific studies that support Celebrex's safety.
Pfizer has previously said that a review of its internal studies did not show that either Celebrex or Bextra increased patients' risk for cardiovascular problems.
A Merck spokeswoman couldn't find anyone aware of the study. The FDA didn't return calls.
Nussbaum said WellPoint's study had not caused it to alter its policy of requiring doctors to receive prior authorization before prescribing Bextra or Celebrex. He said that was because the FDA had approved the drugs.
WellPoint's policy could change depending on the outcome of the FDA hearing. Recently, health maintenance organization Kaiser Permanente told its doctors to stop prescribing Bextra.
Dr. Eric Matteson. a professor of medicine in the division of rheumatology at the Mayo Clinic in Rochester, Minn. said the study was significant because of the amount of patients it included and because it backs up other studies.
"All the signals are pointing in the same direction," Matteson said.
There have been two studies linking Bextra to increased risk of heart attack and strokes while two separate trials indicated Celebrex elevates the likelihood of cardiovascular problems.
Matteson doesn't expect the FDA to remove Bextra and Celebrex from the market. Cox-2 inhibitors were developed to be reduce the risk of gastrointestinal problems associated with older pain relievers such as naproxen. However, unlike Vioxx, neither Celebrex or Bextra can say on their labels that they reduce gastrointestinal problems.
Matteson said there is anecdotal evidence of their benefit.
He said he would not be surprised if the FDA demands that Pfizer put a "black box" warning on Celebrex's label to highlight the cardiovascular risk. That is the agency's most severe warning.
Bextra already has a black box warning.
"Clearly there is a degree of risk in these drugs and doctors need to be more careful about prescribing them," said Matteson.

First Blog Post

Hi Everyone,

I have created a BLOG to share news and comments on Health, Wellness and Anti-Aging. Come here often to see what's new in the science of wellness.