Thread: The Vitamin Myth: Why We Think We Need Supplements

The Vitamin Myth: Why We Think We Need Supplements

Nutrition experts contend that all we need is what's typically found in a routine diet. Industry representatives, backed by a fascinating history, argue that foods don't contain enough, and we need supplements. Fortunately, many excellent studies have now resolved the issue.

Paul Offit Jul 19 2013, 9:12 AM ET

slipah/Flickr

On October 10, 2011, researchers from the University of Minnesota found that women who took supplemental multivitamins died at rates higher than those who didn't. Two days later, researchers from the Cleveland Clinic found that men who took vitamin E had an increased risk of prostate cancer. "It's been a tough week for vitamins," said Carrie Gann of ABC News.

These findings weren't new. Seven previous studies had already shown that vitamins increased the risk of cancer and heart disease and shortened lives. Still, in 2012, more than half of all Americans took some form of vitamin supplements.

What few people realize, however, is that their fascination with vitamins can be traced back to one man. A man who was so spectacularly right that he won two Nobel Prizes and so spectacularly wrong that he was arguably the world's greatest quack.

When Albert Einstein was asked what he thought of Pauling's work, he shrugged his shoulders. "It was too complicated for me."

In 1931, Linus Pauling published a paper in the Journal of the American Chemical Society titled "The Nature of the Chemical Bond."Before publication, chemists knew of two types of chemicalbonds: ionic, where one atom gives up an electron to another; and covalent, where atoms share electrons. Pauling argued thatit wasn't that simple -- electron sharing was somewhere between ionic and covalent.

Pauling's idea revolutionized the field, marrying quantum physics with chemistry.

His concept was so revolutionary in fact that when the journal editor received the manuscript, he couldn't find anyone qualified to review it. When Albert Einstein was asked what he thought of Pauling's work, he shrugged his shoulders. "It was too complicated for me," he said. For this single paper, Pauling received the Langmuir Prize as the most outstanding young chemist in the United States, became the youngest person elected to the National Academy of Sciences, was made a full professor at Caltech, and won the Nobel Prize in Chemistry. He was 30 years old.

In 1949, Pauling published a paper in Science titled "Sickle Cell Anemia, a Molecular Disease." At the time, scientists knew that hemoglobin (the protein in blood that transports oxygen) crystallized in the veins of people with sickle-cell anemia, causing joint pain, blood clots, and death. But they didn't know why.

Pauling was the first to show that sickle hemoglobin had a slightly different electrical charge--a quality that dramatically affected how the hemoglobin reacted with oxygen. His finding gave birth to the field of molecular biology.

In 1951, Pauling published a paper in the Proceedings of the National Academy of Sciences titled "The Structure of Proteins." Scientists knew that proteins were composed of a series of amino acids. Pauling proposed that proteins also had a secondary structure determined by how they folded upon themselves. He called one configuration the alpha helix--later used by James Watson and Francis Crick to explain the structure of DNA.

At least 15 studies have now shown that vitamin C doesn't treat the common cold.

In 1961, Pauling collected blood from gorillas, chimpanzees, and monkeys at the San Diego Zoo. He wanted to see whether mutations in hemoglobin could be used as a kind of evolutionary clock. Pauling showed that humans had diverged from gorillas about 11 million years ago, much earlier than scientists had suspected. A colleague later remarked, "At one stroke he united the fields of paleontology, evolutionary biology, and molecular biology."

Pauling's accomplishments weren't limited to science. Beginning in the 1950s--and for the next forty years -- he was the world's most recognized peace activist.

Pauling opposed the internment of Japanese Americans during World War II, declined Robert Oppenheimer's offer to work on the Manhattan Project, stood up to Senator Joseph McCarthy by refusing a loyalty oath, opposed nuclear proliferation, publicly debated nuclear-arms hawks like Edward Teller, forced the government to admit that nuclear explosions could damage human genes, convinced other Nobel Prize winners to oppose the Vietnam War, and wrote the best-selling book No More War! Pauling's efforts led to the Nuclear Test Ban Treaty. In 1962, he won the Nobel Peace Prize--the first person ever to win two unshared Nobel Prizes.

In addition to his election to the National Academy of Sciences, two Nobel Prizes, the National Medal of Science, and the Medal for Merit (which was awarded by the president of the United States), Pauling received honorary degrees from Cambridge University, the University of London, and the University of Paris. In 1961, he appeared on the cover of Time magazine's Men of the Year issue, hailed as one of the greatest scientists who had ever lived.

Then all the rigor, hard work, and hard thinking that had made Linus Pauling a legend disappeared. In the words of a colleague, his "fall was as great as any classic tragedy."

"He wrote that if I followed his recommendation of taking 3,000 milligrams of vitamin C, I would live not only 25 years longer, but probably more."

The turning point came in March 1966, when Pauling was 65 years old. He had just received the Carl Neuberg Medal. "During a talk in New York City," recalled Pauling, "I mentioned how much pleasure I took in reading about the discoveries made by scientists in their various investigations of the nature of the world, and stated that I hoped I could live another twenty-five years in order to continue to have this pleasure. On my return to California I received a letter from a biochemist, Irwin Stone, who had been at the talk. He wrote that if I followed his recommendation of taking 3,000 milligrams of vitamin C, I would live not only 25 years longer, but probably more." Stone, who referred to himself as Dr. Stone, had spent two years studying chemistry in college. Later, he received an honorary degree from the Los Angeles College of Chiropractic and a "PhD" from Donsbach University, a non-accredited correspondence school in Southern California.

Pauling followed Stone's advice. "I began to feel livelier and healthier," he said. "In particular, the severe colds I had suffered several times a year all my life no longer occurred. After a few years, I increased my intake of vitamin C to ten times, then twenty times, and then three hundred times the RDA: now 18,000 milligrams per day."

From that day forward, people would remember Linus Pauling for one thing: vitamin C.

In 1970, Pauling published Vitamin C and the Common Cold, urging the public to take 3,000 milligrams of vitamin C every day (about 50 times the recommended daily allowance). Pauling believed that the common cold would soon be a historical footnote. "It will take decades to eradicate the common cold completely," he wrote, "but it can, I believe, be controlled entirely in the United States and some other countries within a few years. I look forward to witnessing this step toward a better world." Pauling's book became an instant best seller. Paperback versions were printed in 1971 and 1973, and an expanded edition titled Vitamin C, the Common Cold and the Flu, published three years later, promised to ward off a predicted swine flu pandemic. Sales of vitamin C doubled, tripled, and quadrupled. Drugstores couldn't keep up with demand. By the mid-1970s, 50 million Americans were following Pauling's advice. Vitamin manufacturers called it "the Linus Pauling effect."

Scientists weren't as enthusiastic. On December 14, 1942, about thirty years before Pauling published his first book, Donald Cowan, Harold Diehl, and Abe Baker, from the University of Minnesota, published a paper in the Journal of the American Medical Association titled "Vitamins for the Prevention of Colds." The authors concluded, "Under the conditions of this controlled study, in which 980 colds were treated . . . there is no indication that vitamin C alone, an antihistamine alone, or vitamin C plus an antihistamine have any important effect on the duration or severity of infections of the upper respiratory tract."

When he occasionally appeared before the media with obvious cold symptoms, he said he was suffering from allergies.

Other studies followed. After Pauling's pronouncement, researchers at the University of Maryland gave 3,000 milligrams of vitamin C every day for three weeks to eleven volunteers and a sugar pill (placebo) to ten others. Then they infected volunteers with a common cold virus. All developed cold symptoms of similar duration. At the University of Toronto, researchers administered vitamin C or placebo to 3,500 volunteers. Again, vitamin C didn't prevent colds, even in those receiving as much as 2,000 milligrams a day. In 2002, researchers in the Netherlands administered multivitamins or placebo to more than 600 volunteers.

Again, no difference. At least 15 studies have now shown that vitamin C doesn't treat the common cold. As a consequence, neither the FDA, the American Academy of Pediatrics, the American Medical Association, the American Dietetic Association, the Center for Human Nutrition at the Johns Hopkins Bloomberg School of Public Health, nor the Department of Health and Human Services recommend supplemental vitamin C for the prevention or treatment of colds.

Although study after study showed that he was wrong, Pauling refused to believe it, continuing to promote vitamin C in speeches, popular articles, and books. When he occasionally appeared before the media with obvious cold symptoms, he said he was suffering from allergies.

Then Linus Pauling upped the ante. He claimed that vitamin C not only prevented colds; it cured cancer.

In 1971, Pauling received a letter from Ewan Cameron, a Scottish surgeon from a tiny hospital outside Glasgow. Cameron wrote that cancer patients who were treated with ten grams of vitamin C every day had fared better than those who weren't. Pauling was ecstatic. He decided to publish Cameron's findings in the Proceedings of the National Academy of Sciences (PNAS). Pauling assumed that as a member of the academy he could publish a paper in PNAS whenever he wanted; only three papers submitted by academy members had been rejected in more than half a century. Pauling's paper was rejected anyway, further tarnishing his reputation among scientists. Later, the paper was published in Oncology, a journal for cancer specialists. When researchers evaluated the data, the flaw became obvious: the cancer victims Cameron had treated with vitamin C were healthier at the start of therapy, so their outcomes were better. After that, scientists no longer took Pauling's claims about vitamins seriously.

In 1971, he declared that vitamin C would cause a 10 percent decrease in deaths from cancer.

But Linus Pauling still had clout with the media. In 1971, he declared that vitamin C would cause a 10 percent decrease in deaths from cancer. In 1977, he went even further. "My present estimate is that a decrease of 75 percent can be achieved with vitamin C alone," he wrote, "and a further decrease by use of other nutritional supplements."

With cancer in their rearview mirror, Pauling predicted, Americans would live longer, healthier lives. "Life expectancy will be 100 to 110 years," he said, "and in the course of time, the maximum age might be 150 years."

Cancer victims now had reason for hope. Wanting to participate in the Pauling miracle, they urged their doctors to give them massive doses of vitamin C. "For about seven or eight years, we were getting a lot of requests from our families to use high-dose vitamin C," recalls John Maris, chief of oncology and director of the Center for Childhood Cancer Research at the Children's Hospital of Philadelphia.

"We struggled with that. They would say, 'Doctor, do you have a Nobel Prize?' "

Blindsided, cancer researchers decided to test Pauling's theory. Charles Moertel, of the Mayo Clinic, evaluated 150 cancer victims: half received ten grams of vitamin C a day and half didn't. The vitamin C-treated group showed no difference in symptoms or mortality. Moertel concluded, "We were unable to show a therapeutic benefit of high-dose vitamin C." Pauling was outraged. He wrote an angry letter to the New England Journal of Medicine, which had published the study, claiming that Moertel had missed the point. Of course vitamin C hadn't worked: Moertel had treated patients who had already received chemotherapy. Pauling claimed that vitamin C worked only if cancer victims had received no prior chemotherapy.

Bullied, Moertel performed a second study; the results were the same. Moertel concluded, "Among patients with measurable disease, none had objective improvement. It can be concluded that high-dose vitamin C therapy is not effective against advanced malignant disease regardless of whether the patient had received any prior chemotherapy." For most doctors, this was the end of it. But not for Linus Pauling. He was simply not to be contradicted. Cameron observed, "I have never seen him so upset. He regards the whole affair as a personal attack on his integrity." Pauling thought Moertel's study was a case of "fraud and deliberate misrepresentation." He consulted lawyers about suing Moertel, but they talked him out of it.

Subsequent studies have consistently shown that vitamin C doesn't treat cancer.

"The thing to do with [these reports] is just ride them out ... We see no impact on our business."

Pauling wasn't finished. Next, he claimed that vitamin C, when taken with massive doses of vitamin A (25,000 international units) and vitamin E (400 to 1,600 IU), as well as selenium (a basic element) and beta-carotene (a precursor to vitamin A), could do more than just prevent colds and treat cancer; they could treat virtually every disease known to man.

Pauling claimed that vitamins and supplements could cure heart disease, mental illness, pneumonia, hepatitis, polio, tuberculosis, measles, mumps, chickenpox, meningitis, shingles, fever blisters, cold sores, canker sores, warts, aging, allergies, asthma, arthritis, diabetes, retinal detachment, strokes, ulcers, shock, typhoid fever, tetanus, dysentery, whooping cough, leprosy, hay fever, burns, fractures, wounds, heat prostration, altitude sickness, radiation poisoning, glaucoma, kidney failure, influenza, bladder ailments, stress, rabies, and snakebites. When the AIDS virus entered the United States in the 1970s, Pauling claimed vitamins could treat that, too.

On April 6, 1992, the cover of Time--rimmed with colorful pills and capsules--declared,

"The Real Power of Vitamins: New research shows they may help fight cancer, heart disease, and the ravages of aging." The article, written by Anastasia Toufexis, echoed Pauling's ill-founded, disproved notions about the wonders of megavitamins. "More and more scientists are starting to suspect that traditional medical views of vitamins and minerals have been too limited," wrote Toufexis.

"Vitamins--often in doses much higher than those usually recommended--may protect against a host of ills ranging from birth defects and cataracts to heart disease and cancer. Even more provocative are glimmerings that vitamins can stave off the normal ravages of aging." Toufexis enthused that the "pharmaceutical giant Hoffman-La Roche is so enamored with beta-carotene that it plans to open a Freeport, Texas, plant next year that will churn out 350 tons of the nutrient annually, or enough to supply a daily 6 milligram capsule to virtually every American adult."

Pauling believed that vitamins and supplements had one property that made them cure-alls, a property that continues to be hawked on everything from ketchup to pomegranate juice and that rivals words like natural and organic for sales impact: antioxidant. The National Nutritional Foods Association (NNFA), a lobbying group for vitamin manufacturers, couldn't believe its good luck, calling the Time article "a watershed event for the industry." As part of an effort to get the FDA off their backs, the NNFA distributed multiple copies of the magazine to every member of Congress.

Speaking at an NNFA trade show later in 1992, Toufexis said, "In fifteen years at Time I have written many health covers. But I have never seen anything like the response to the vitamin cover. It whipped off the sales racks, and we were inundated with requests for copies. There are no more copies. 'Vitamins' is the number-one-selling issue so far this year."

Although studies had failed to support him, Pauling believed that vitamins and supplements had one property that made them cure-alls, a property that continues to be hawked on everything from ketchup to pomegranate juice and that rivals words like natural and organic for sales impact: antioxidant.

Antioxidation vs. oxidation has been billed as a contest between good and evil. The battle takes place in cellular organelles called mitochondria, where the body converts food to energy, a process that requires oxygen and so is called oxidation.

One consequence of oxidation is the generation of electron scavengers called free radicals (evil). Free radicals can damage DNA, cell membranes, and the lining of arteries; not surprisingly, they've been linked to aging, cancer, and heart disease. To neutralize free radicals, the body makes its own antioxidants (good).

Antioxidants can also be found in fruits and vegetables--specifically, selenium, beta-carotene, and vitamins A, C, and E. Studies have shown that people who eat more fruits and vegetables have a lower incidence of cancer and heart disease and live longer. The logic is obvious: if fruits and vegetables contain antioxidants--and people who eat lots of fruits and vegetables are healthier--then people who take supplemental antioxidants should also be healthier.

In fact, they're less healthy.

In 1994, the National Cancer Institute, in collaboration with Finland's National Public Health Institute, studied 29,000 Finnish men, all long-term smokers more than fifty years old. This group was chosen because they were at high risk for cancer and heart disease. Subjects were given vitamin E, beta-carotene, both, or neither. The results were clear: those taking vitamins and supplements were more likely to die from lung cancer or heart disease than those who didn't take them--the opposite of what researchers had anticipated.

In 1996, investigators from the Fred Hutchinson Cancer Research Center, in Seattle, studied 18,000 people who, because they had been exposed to asbestos, were at increased risk of lung cancer. Again, subjects received vitamin A, beta-carotene, both, or neither. Investigators ended the study abruptly when they realized that those who took vitamins and supplements were dying from cancer and heart disease at rates 28 and 17 percent higher, respectively, than those who didn't.

In 2004, researchers from the University of Copenhagen reviewed fourteen randomized trials involving more than 170,000 people who took vitamins A, C, E, and beta-carotene to see whether antioxidants could prevent intestinal cancers. Again, antioxidants didn't live up to the hype. The authors concluded, "We could not find evidence that antioxidant supplements can prevent gastrointestinal cancers; on the contrary, they seem to increase overall mortality." When these same researchers evaluated the seven best studies, they found that death rates were 6 percent higher in those taking vitamins.

In 2005, researchers from Johns Hopkins School of Medicine evaluated nineteen studies involving more than 136,000people and found an increased risk of death associated with supplemental vitamin E. Dr. Benjamin Caballero, director of the Center for Human Nutrition at the Johns Hopkins Bloomberg School of Public Health, said, "This reaffirms what others have said. The evidence for supplementing with any vitamin, particularly vitamin E, is just not there. This idea that people have that [vitamins] will not hurt them may not be that simple." That same year, a study published in the Journal of theAmerican Medical Association evaluated more than 9,000 people who took high-dose vitamin E to prevent cancer; those who took vitamin E were more likely to develop heart failure than those who didn't.

In 2007, researchers from the National Cancer Institute examined 11,000 men who did or didn't take multivitamins. Those who took multivitamins were twice as likely to die from advanced prostate cancer.

In 2008, a review of all existing studies involving more than 230,000 people who did or did not receive supplemental antioxidants found that vitamins increased the risk of cancer and heart disease.

On October 10, 2011, researchers from the University of Minnesota evaluated 39,000 older women and found that those who took supplemental multivitamins, magnesium, zinc, copper, and iron died at rates higher than those who didn't.

They concluded, "Based on existing evidence, we see little justification for the general and widespread use of dietary supplements."

Two days later, on October 12, researchers from the Cleveland Clinic published the results of a study of 36,000 men who took vitamin E, selenium, both, or neither.

They found that those receiving vitamin E had a 17 percent greater risk of prostate cancer. In response to the study, Steven Nissen, chairman of cardiology at the Cleveland Clinic, said, "The concept of multivitamins was sold to Americans by an eager nutraceutical industry to generate profits. There was never any scientific data supporting their usage." On October 25, a headline in the Wall Street Journal asked, "Is This the End of Popping Vitamins?"Studies haven't hurt sales. In 2010, the vitamin industrygrossed $28 billion, up 4.4 percent from the year before. "The thing to do with [these reports] is just ride them out," said Joseph Fortunato, chief executive of General Nutrition Centers."We see no impact on our business."

How could this be? Given that free radicals clearly damage cells--and given that people who eat diets rich in substances that neutralize free radicals are healthier--why did studies of supplemental antioxidants show they were harmful? The most likely explanation is that free radicals aren't as evil as advertised. Although it's clear that free radicals can damage DNA and disrupt cell membranes, that's not always a bad thing. People need free radicals to kill bacteria and eliminate new cancer cells. But when people take large doses of antioxidants, the balance between free radical production and destruction might tip too much in one direction, causing an unnatural state in which the immune system is less able to kill harmful invaders. Researchers have called this "the antioxidant paradox."

Whatever the reason, the data are clear: high doses of vitamins and supplements increase the risk of heart disease and cancer; for this reason, not a single national or international organization responsible for the public's health recommends them.

In May 1980, during an interview at Oregon State University, Linus Pauling was asked, "Does vitamin C have any side effects on long-term use of, let's say, gram quantities?" Pauling's answer was quick and decisive. "No," he replied.
Seven months later, his wife was dead of stomach cancer. In 1994, Linus Pauling died of prostate cancer.

---

This is an excerpt from Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine
.
http://www.theatlantic.com/health/archive/2013/07/the-vitamin-myth-why-we-think-we-need-supplements/277947/?google_editors_picks=true

Study finds link between fish oil and higher prostate cancer risk

CTV National News: Dangers of fish oils

Medical Specialist Avis Favaro looks into a study that suggests Omega-3 supplements may be linked to an increase in prostate cancer risk.

CTVNews.ca Staff
Published Thursday, July 11, 2013 3:37PM EDT
Last Updated Thursday, July 11, 2013 10:29PM EDT

A new study is raising questions about omega-3 fatty acids, which are found in oily fish and fish supplements, suggesting that men with high levels of the oils in their bloods might also have a higher risk of prostate cancer.

Omega-3 fatty acids have long been hailed for their apparent ability to lower blood pressure and cholesterol and perhaps protect against heart disease. They’ve also thought to have anti-inflammatory properties that might help prevent a number of forms of cancer.

But a new study has found that men with prostate cancer were more likely to have higher levels of omega-3 fatty acids in their blood than similar men without prostate cancer.

Related Links

• Fred Hutchinson Cancer Research Center study

Photos


A new study has found a link between fish oil and higher prostate cancer risk.



Prostate cancer patient Derek Lawrence, 82, believes fish oil has been beneficial to his health.



Canadian urologist Dr. Arthur Grabowski says the results of other studies on fish oil and prostate cancer conflict with the findings of this study.

Of the 834 men studied, those with high levels of EPA, DPA and DHA omega-3 fatty acids were at 43 per cent greater risk of prostate cancer than those with low concentrations.

Those with the very highest levels of omega-3s also were 71 per cent more likely to have aggressive, "high-grade" prostate tumours than those with lower levels.

High levels of omega-3s equal a little more than two servings of salmon per week.

It is unclear why high levels of omega-3 fatty acids might be linked to a higher risk of prostate cancer risk. But the authors note that this study replicates similar findings they made in 2011, in a study that found a link between high blood levels of DHA and high-grade prostate cancer.

The authors say the reasons why omega-3s might be linked to prostate cancer aren’t clear. It's possible, they say, that fatty acids convert into compounds that can damage cells and DNA, or could suppress the immune system.

But it’s important to note that the study did not show a cause-and-effect relationship between omega-3s and cancer; it only drew a link between the two.

It’s thus possible that there are other factors at play that could be affecting the risk of prostate cancer, such as genetics.

Prostate cancer patient Derek Lawrence, 82, says he takes a teaspoon of fish oil every morning and feels it is beneficial to his health.

“Sometimes you don’t get the whole story and people jump to conclusions,” Lawrence said, adding that he despite hearing about the study, he was not going to stop taking fish oil.

As well, the study looked only at blood levels of fatty acids and did not assess the participants’ diet or supplement use.

Canadian urologist Dr. Arthur Grabowski notes that the results of other studies on fish oil and prostate cancer conflict with the findings of this study.

Fish oil has been found to cut the risk of dying of prostate cancer by 40 per cent, and prevent heart disease and strokes.

"This is not the final word on whether omega 3 fatty acids put patients at higher risk for prostate cancer," he told CTV News.

"What I tell my patients is I recommend against taking any supplement to reduce the risk for any disease because there can often be unintended consequences to these supplements that we have not yet studied."

While Grabowski does not recommend his patients take omega-3 supplements, he does recommend they eat a healthy and balanced diet.

"Because a diet that has been shown to be healthy for your heart, in most cases, have been shown to be healthy for your prostate," he said.

VP research Prostate Cancer Canada Stewart Edmonds said people should be cautious about taking supplements.

“While they may be beneficial for other disease, they may risk other health problems,” Edmonds said.

The study used data from men who participated in the Selenium and Vitamin E Cancer Prevention Trial (SELECT), a large trial that looked at test whether selenium and vitamin E, might reduce prostate cancer risk. In fact, that study showed no benefit from selenium and an increase in prostate cancers in men taking vitamin E.

The researchers narrowed in on 834 men with prostate cancers, including 156 with high-grade cancer, and compared them to 1,393 men selected randomly from the 35,500 participants in SELECT.

http://www.ctvnews.ca/health/study-f...#ixzz2Zctdkjo6

Vitamin E May Cause Prostate Cancer | Men's Health News

news.menshealth.com/breaking-cancer-preventing-pills-backfire/.../11/‎

• Cached

Oct 11, 2011 - Early studies showed vitamin E may prevent prostate cancer, but a new trial shows an increased cancer risk among men who popped this ...


Vitamins and Supplements Could Cause Cancer, According to ...
www.thedailybeast.com/.../vitamins-and-supplements-could-cause-cancer...‎

• Cached

Oct 11, 2011 - When a huge study examining whether vitamin E supplements can reduce the risk of prostate cancer had to be halted prematurely in 2008, ...

Vitamins and supplements may or may not work, or cause other problems, But vaccines do work:

http://www.alipac.us/f19/hpv-vaccine...throat-283926/

FDA cracks down on illegal diabetes remedies

Matthew Perrone, AP Health Writer 1 hour ago
WASHINGTON (AP) -- The Food and Drug Administration is cracking down on more than a dozen companies that market illegal treatments for diabetes, ranging from bogus dietary supplements to prescription drugs sold online without a prescription.

All of the products aim to cash in on the country's diabetes epidemic, which affects nearly 26 million Americans. Regulators worry that consumers who buy such unapproved products could put off getting legitimate medical care, which could exacerbate heart disease, kidney failure and other deadly complications.

The FDA sent warning letters to 15 companies, both in the U.S. and abroad, ordering them to stop selling diabetes treatments which violate U.S. drug laws.

Three of the products targeted are marketed as "natural" supplements, but actually contain unlisted pharmaceutical ingredients. For example, Diexi, which is sold as a traditional Indian "herbal formula," actually contains metformin, the most common prescription drug used to treat diabetes. The product is sold by Amrutam Life Care, of Surat, India.

"Consumers should exercise caution before using products claiming to be herbal or all-natural alternatives to FDA-approved prescription drugs," the agency said in a statement Tuesday. "These products should be considered unsafe and should not be used."

Other products include genuine dietary supplements that make unproven claims to treat or prevent diabetes. For example, Diabetes Daily Care is a capsule-based supplement containing cinnamon extract and other herbs. Its manufacturer, Nature's Health Supply Inc., claims it "safely and effectively improves sugar metabolism."

Under U.S. law, only FDA-approved medicines are permitted to make claims for treating or preventing disease.

Other companies targeted by the FDA run online pharmacies that sell prescription drugs for diabetes without a prescription. The FDA issued a warning letter to www.bestcheapmedsonline.com for marketing unapproved versions of diabetes drugs like Januvia, from Merck & Co. Inc.

The FDA warns patients against buying prescription medications on the Internet. Only 3 percent of online pharmacies actually comply with all U.S. pharmacy laws, according to a review by the National Association of Boards of Pharmacy.

People with diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because they've become resistant to the hormone, which controls blood sugar levels. These patients face higher risks of heart attacks, kidney problems, blindness and other serious complications.

Many diabetics require multiple drugs to control their blood sugar levels.

The U.S. market for prescription diabetes drugs is the largest in the world, with sales of $22 billion last year. Sales have ballooned more than 60 percent in the last four years from $13.6 billion in 2008, according to health data firm, IMS Health.

The FDA said it has not received any reports of injury or illness connected with the products, but is taking action as a precautionary measure. The FDA sent the warning letters to the companies last week, but posted them online Tuesday morning. The letters gives each company 15 business days to reply and explain how they will come into compliance with U.S. law. FDA warning letters are not legally binding, but the agency can take companies to court if they are ignored.

http://news.yahoo.com/fda-cracks-down-illegal-diabetes-140142593.html

RELATED

http://www.alipac.us/f19/government-...states-284287/

Are Supplements Killing You? The Problem With Vitamins, Minerals

Neil WagnerNov 16 2011, 10:02 AM ET




In two recently published studies, researchers suggest that supplements can do more harm than good if taken in addition to a healthy diet


Most people understand that taking nutritional supplements that have unproven health effects is taking a gamble. Yet few realize that this may also be true for vitamin and mineral supplements.

Two recently published studies suggest that vitamin and mineral supplements can do more harm than good. One study uncovered a definite link between taking Vitamin E and an increased risk of prostate cancer. The other suggests the possibility that elderly women taking vitamin and mineral supplements were at a higher risk of early death, though the study's results are open to interpretation.

MORE FROM THE DOCTOR:
New Research on Alzheimer's
Heavy Drinking Affects Diet
Fall Back and Change Batteries

---

Taken together, both studies call into question the wisdom of taking vitamin and mineral supplements on top of a normal diet. It just might be too much of a good thing.

THE BACKGROUND
Vitamins, minerals, and other micronutrients are needed in small amounts for good health. Without them, diseases such as scurvy will develop (Vitamin C). Some of the effects of vitamin and mineral deficiency have been known for hundreds of years and the amounts needed to prevent deficiency are given as the recommended daily allowance (RDA), formerly the minimum daily requirement.

The current consensus is that a proper diet provides all the micronutrients that most people need.

In recent times, supplementing the diet with vitamins and minerals has shifted from trying to prevent deficiencies to taking higher amounts of them in an effort to enhance health. Studies indicate that about half of all people in the U.S. in the year 2000 were taking at least one supplement. And while the effects of too little of a vitamin or mineral are well known, there's been little opportunity to study the effects of higher levels of these substances on health.

Overdoses of vitamin A and D can occur and lead to health problems. Both are fat-soluble vitamins (as is vitamin E) and can build up in the body over time. But such overdoses are rare. And since excess water-soluble vitamins are excreted and don't build up in the body, overdoses of them are even rarer. But as with everything else, it's almost certain that the effects of vitamins and minerals on health follow an upside down U curve: too little is bad for health and so is too much. The two recent studies are fairly preliminary investigations into what constitutes too much.

VITAMIN E RAISES PROSTATE CANCER RISK: THE SELECT TRIAL
The SELECT trial (the Selenium and Vitamin E Cancer Prevention Trial) was designed to determine the long range effect of selenium and vitamin E supplements on prostate cancer. Previous studies had hinted that both of these substances might offer protection against prostate cancer. But the trial found a 17 percent increase in the risk of developing prostate cancer in men who took 400 units of vitamin E daily, and no protection against developing prostate cancer from selenium.

Over 35,000 men from the U.S., Canada, and Puerto Rico were split into four groups in a randomized controlled study. One group took 400 International Units of Vitamin E per day, the second took 200 micrograms of selenium a day, the third took both vitamin E and selenium, and the fourth took only inactive placebo.

All men were 50 years or older and showed no initial signs of prostate cancer, as judged by a digital rectal examination and PSA level. Enrollment began in August 2001 and ended in June 2004.

Preliminary results from the study in 2008 showed an increased rate of prostate cancer among both the group taking vitamin E and the group taking selenium.

While these increases were not statistically significant, the increase in the vitamin E group was nearly so. The trial had been designed to seek a protective effect from either vitamin E or selenium. It wasn't finding one and instead was finding evidence of possible harm. Because of this, subjects stopped taking the supplements in October 2008. They continued to be tracked for new cases of prostate cancer.

The recently published article included results as of July 2011. It found an increase in new prostate cancers among all three groups taking supplements, with the increase only significant in the vitamin E group. That group showed a 17 percent increase in the rate of prostate cancer compared to the placebo group.

The selenium group showed a nine percent increase and the group taking both selenium and vitamin E showed a five percent increase, increases that were not statistically significant and could have been caused by chance alone. The results of the group taking both vitamin E and selenium suggest that selenium somehow blunts the ability of vitamin E to increase prostate cancers.

The researchers don't offer a biological explanation for why vitamin E appears to increase the risk of prostate cancer. They do express concern that the rate of prostate cancer continued to rise even after subjects stopped taking vitamin E supplements, suggesting that harm continues for years afterwards. They also note a 2005 study that found that 50 percent of U.S. individuals over the age of 60 take vitamin E containing supplements and 23 percent of them are taking at least 400 IU of vitamin E per day. The SELECT study may give them a reason to reconsider this. The adult RDA for vitamin E is 22.5 IU a day.

WOMEN AND SUPPLEMENTS: A CONFUSING PICTURE
The Iowa Women's Health Study looked at the effect of taking vitamin and mineral supplements on mortality on nearly 39,000 U.S. women aged 55 to 69 and used information collected from 1986 through 2008.

At the start of the study, 66 percent of the study subjects reported using at least one supplement. This increased to 85 percent in 2004, with 27 percent reporting use of four or more supplements.

The study examined the effect of taking 14 individual supplements and also a multivitamin. The researchers concluded that women who took any of six supplements or a multivitamin had a slightly higher risk of death over the study period:

• Multivitamins were associated with a 2.4 percent higher risk of earlier death
• Vitamin B6 gave a 4.1 percent higher risk
• Folic acid gave a 5.9 percent higher risk
• Iron gave a 3.9 percent higher risk
• Magnesium gave a 3.6 percent higher risk
• Zinc gave a 3 percent higher risk
• Copper gave an 18 percent higher risk
• Calcium gave a 3.8 percent lower risk of death

However, different types of statistical analyses markedly changed these results.

This was an observational study, which allowed the researchers to look at the possible effects of taking supplements in a large group of people over a long period of time. The researchers simply observed the subjects; they did not alter or affect the type or amount of supplements the subjects were taking. This type of study can only suggest a possible link between taking supplements and a change in risk of death; it cannot show that they caused death.

All supplement use was self-reported by the subjects.

The women in the study completed a 16-page questionnaire on their dietary and lifestyle habits in 1986, including supplement use. They were also asked about other factors such as their age, height, education, physical activity, diet, and certain medical conditions, such as high blood pressure. Follow-up questionnaires were completed in 1997 and 2004.

During the course of the study, 15,994 of the women died. Those who died from injury, accident, or suicide were not included in the study results, since it's unlikely that supplement use could have played a part in those deaths.

The researchers analyzed the data for any association between supplement use and mortality, using validated statistical methods and adjusting the results for other possible factors known to affect mortality including age, lifestyle, smoking, alcohol, and certain medical factors. And different statistical treatments gave different results.

Different Statistical Methods, Different Meanings
The statistical model used by the researchers adjusted the results for participants' age and energy intake, nutritional factors (alcohol use; fruit and vegetable consumption; saturated fatty acid consumption; and consumption of fruits, vegetables, and whole grain products) and non-nutritional factors (educational level, place of residence, diabetes, high blood pressure, body mass index, waist to hip ratio, hormone replacement therapy, physical activity, and smoking status).

But the different adjustments gave different results:

• When the results were only adjusted for age and energy intake, taking vitamin B complex, vitamins C, D, E, and calcium all gave a significantly lower risk of mortality, while only copper gave significantly higher mortality.
• Adding in adjustments for the non-nutritional factors listed above, only calcium gave a significantly lower risk of death. Copper, multivitamins, vitamin B6, and iron gave a significantly higher risk.
• Adding adjustments for both nutritional and non-nutritional factors gave the results the researchers' conclusions were drawn from, with six supplements raising the death risk and calcium lowering it.

These different results are why some people have drawn different conclusions from the study than the authors did.

In general, when an effect is present in some statistical models and absent in others, it means that if the effect actually exists, it's a small one.

THE TAKEAWAY
The results suggest the possibility that vitamin and mineral supplements may be doing people who eat a standard diet more harm than good, an idea that simply doesn't enter into the minds of most people. They also suggest that taking additional calcium is beneficial, though calcium's effect on the heart is controversial. It will take studies that are more controlled to confirm or disprove both of these ideas.

The researchers are particularly concerned about the effect of iron because they observed a dose-response relationship between the amount taken and the death rate: the higher the dose taken, the greater the risk of mortality.

The results should not be interpreted to mean that vitamin and mineral supplements can cause early death. One possible scenario is that women were taking supplements in response to illness, which may have been the reason for their earlier deaths. But since most people can get all the nutrients they require from eating a balanced diet, the study does raise the question of whether routinely taking a vitamin or mineral supplement is a good idea.

The study results have already proved controversial. Commentary has ranged from lauding the study as groundbreaking to criticizing it as an example of poor science.

Perhaps the best way to look at the results is to acknowledge that they raise the question of whether vitamin and mineral supplements may generally do more harm than good, but unfortunately, they don't give a clear answer to the question.
Robert M. Russell, M.D., special expert to the Office of Dietary Supplements (ODS) at NIH and former senior scientist and director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University told TheDoctor that, "Trying to make sense of observational epidemiology study results can at times be difficult. Different populations, study designs, lengths of follow up often can account for confusing and seemingly contradictory results."

"In general, what we have learned from an accumulating database from both observational epidemiology and interventional studies is that the vitamin and minerals are safe to take in RDA amounts (as are contained in most over the counter multivitamin-multimineral preparations). Further, we have learned that taking large amounts of single nutrients or nutrient combinations often lead to chronic undesirable toxic effects with implications for chronic disease such as cancer. We have seen this with beta-carotene with a stimulation of lung cancer at high doses, and now we are seeing a similar picture with high dose vitamin E vis-a-vis prostate cancer."

"So what is the best advice for the public? Stick to a varied diet, if you want to take supplements, take a multivitamin-multimineral that has RDA amounts. Don't jump on the silver bullet of the day single nutrient band-wagon until there is enough evidence for both efficacy as well as long term safety. That said, in order to get RDA amounts of calcium and vitamin D, a single nutrient supplement may be necessary for some people. Following the nutrient guidance of our National Academies of Science is my best advice."
Image: tazik13/Shutterstock.

---

This article originally appeared on TheDoctorWillSeeYouNow.com, an Atlantic
partner site.

http://www.theatlantic.com/health/archive/2011/11/are-supplements-killing-you-the-problem-with-vitamins-minerals/248450/

RELATED

http://www.alipac.us/f19/fda-warns-o...eroids-284537/

List of recalled items @

http://www.alipac.us/f19/safety-cert...estion-284539/