FDA clears safety test to screen Tysabri patients

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WASHINGTON (AP) — The Food and Drug Administration on Friday approved a new diagnostic test to help identify patients who have an increased risk of developing a rare brain infection while taking Biogen Idec's multiple sclerosis drug Tysabri.

Tysabri is one of a handful of drugs used to control multiple sclerosis, a debilitating disease in which the body attacks its own nervous system. Prescribing of the drug has been tightly controlled by the FDA because of a rare infection that causes inflammation of the brain, known as multifocal leukoencephalopathy, or PML. Currently there is no treatment or cure for PML, which usually causes death or severe disability.

The newly approved Stratify JCV test is designed to detect a common virus that increases the likelihood of developing the brain infection. The John Cunningham virus is harmless in most people, but can become dangerous in patients taking immune system-suppressing drugs like Tysabri.

Doctors can use the results of the blood-based test, combined with facts about the patient's medical history, to determine whether they are at risk of developing the brain infection. Other factors that influence a patient's risk include how long they've been taking Tysabri and whether they've previously taken other medications that weaken the immune system.

The test was developed by Quest Diagnostics.

The FDA also updated Tysabri's label to specify that patients who test positive for the virus have a higher risk of developing PML.

"This label change marks an important advance in assisting people with MS and their physicians to make better-informed decisions concerning the challenges of balancing effectiveness with safety," said Dr. Nicholas LaRocca, vice president of the National MS Society.

Tysabri was temporarily pulled from the market shortly after its launch in 2005 after three patients taking the drug developed PML. FDA allowed the drug back on the market the following year but under a restricted distribution program. Only doctors and pharmacies registered with the company's distribution program are permitted to prescribe and dispense the drug.

Biogen, based in Weston, Mass., sells Tysabri through a partnership with Elan Corp., an Irish drugmaker.

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Report: Industry decides US food ingredient safety

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SAN FRANCISCO (AP) — Thousands of ingredients that go into food have been classified as safe by private industry alone, without any U.S. government oversight, according to a new report published Wednesday.

Since the early 1960's, private companies and industry trade associations have determined at least 3,000 ingredients are safe, with no federal scrutiny, the study found. The ingredients include everything from artificially synthesized chemicals used in chewing gum to grape seed extract used in cheese and instant coffee.

The peer-reviewed report published in the Comprehensive Reviews in Food Science and Food Safety journal draws on research funded by the Pew Health Group, the health and consumer safety arm of the nonprofit Pew Charitable Trusts.

"We don't know the names of a lot of these chemicals because the companies have never told FDA or the public about them," said Erik Olson, Pew Health Group's director of food and consumer safety programs and one of the study's authors. "Often there is not publicly available data on the potential health impacts because FDA has never evaluated them."

The Grocery Manufacturers Association says the industry only classifies ingredients as safe after a battery of rigorous biological tests but agrees that more transparency would help build consumer confidence.

"The system is less transparent than it should be so we're looking to open that dialogue," said Leon Bruner, the association's chief science officer, who agreed the study's estimates were reasonable. "We are completely comfortable with increasing the transparency or the visibility of ingredients that go through the process."

The Federal Food, Drug, and Cosmetic Act makes food manufacturers responsible for ensuring food ingredients are safe. Companies can classify an ingredient as "generally recognized as safe" for use in a specific product but aren't required to tell the Food and Drug Administration about what they find.

Some do, through a voluntary notification program that gives the FDA a chance to review the findings.

Officials have said that if a company markets a food or beverage the agency believes is unsafe, the government can always issue warning letters or seize the product.

FDA Deputy Commissioner Michael Taylor said Wednesday the study raised important issues.

"Transparency in decision-making is a high priority for FDA, and FDA considers it timely to explore whether the statutory and regulatory framework for food additives adequately addresses today's need for transparency," Taylor said.

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Worried about vitamin safety? Experts offer advice

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In this Thursday, Oct. 13, 2011 photo illustration, multivitamins are poured from a bottle in Philadelphia. Two studies released in Oct. 2011 raised gnawing worries about the safety of vitamin supplements and a host of questions. Vitamins have long had a "health halo" - many people think they won't hurt and at worst might be unnecessary. The industry calls them an insurance policy against bad eating. But our foods increasingly are pumped full of them - even junk foods and drinks often are fortified with nutrients to give them a healthier profile - so the risk is rising that we're getting too much. Add a supplement and you may exceed the upper limit. (AP Photo/Matt Rourke) In this Thursday, Oct. 13, 2011 photo illustration, multivitamins are poured from a bottle in Philadelphia. Two studies released in Oct. 2011 raised gnawing worries about the safety of vitamin supplements and a host of questions. Vitamins have long had a "health halo" - many people think they won't hurt and at worst might be unnecessary. The industry calls them an insurance policy against bad eating. But our foods increasingly are pumped full of them - even junk foods and drinks often are fortified with nutrients to give them a healthier profile - so the risk is rising that we're getting too much. Add a supplement and you may exceed the upper limit. (AP Photo/Matt Rourke) The nutritional label of a box of multivitamins is photographed in Philadelphia on Thursday, Oct. 13, 2011. Two studies released in Oct. 2011 raised gnawing worries about the safety of vitamin supplements and a host of questions. Vitamins have long had a "health halo" - many people think they won't hurt and at worst might be unnecessary. The industry calls them an insurance policy against bad eating. But our foods increasingly are pumped full of them - even junk foods and drinks often are fortified with nutrients to give them a healthier profile - so the risk is rising that we're getting too much. Add a supplement and you may exceed the upper limit. (AP Photo/Matt Rourke) The nutritional label of a box of multivitamins is photographed in Philadelphia on Thursday, Oct. 13, 2011. Two studies released in Oct. 2011 raised gnawing worries about the safety of vitamin supplements and a host of questions. Vitamins have long had a "health halo" - many people think they won't hurt and at worst might be unnecessary. The industry calls them an insurance policy against bad eating. But our foods increasingly are pumped full of them - even junk foods and drinks often are fortified with nutrients to give them a healthier profile - so the risk is rising that we're getting too much. Add a supplement and you may exceed the upper limit. (AP Photo/Matt Rourke)eval("var currentItemd57851005a80479aaeeb90a12c70b9ff = 1;");eval("var nextd57851005a80479aaeeb90a12c70b9ff = 0;");eval("var previousd57851005a80479aaeeb90a12c70b9ff = 0;"); Two studies this week raised gnawing worries about the safety of vitamin supplements and a host of questions. Should anyone be taking them? Which ones are most risky? And if you do take them, how can you pick the safest ones?

Vitamins have long had a "health halo." Many people think they're good for you and at worst might simply be unnecessary. The industry calls them an insurance policy against bad eating.

But our foods are increasingly pumped full of them already. Even junk foods and drinks often are fortified with nutrients to give them a healthier profile, so the risk is rising that we're getting too much. Add a supplement and you may exceed the upper limit.

"We're finding out they're not as harmless as the industry might have us believe," said David Schardt, a nutritionist at the consumer group Center for Science in the Public Interest.

This week, a study of nearly 40,000 older women found a slightly higher risk of death among those taking dietary supplements, including multivitamins, folic acid, iron and copper. It was just an observational study, though, not a rigorous test.

Another study found that men taking high doses of vitamin E — 400 units a day — for five years had a slightly increased risk of prostate cancer.

As many as one-third of Americans take vitamins and nearly half of people 50 and older take multivitamins, surveys suggest. Americans spent $9.6 billion on vitamins last year, up from $7.2 billion in 2005, according to the Nutrition Business Journal. Multivitamins top the list, at nearly $5 billion in sales.

Yet there is no clear evidence that multivitamins lower the risk of cancer, heart disease or any other chronic health problems. No government agency recommends them "regardless of the quality of a person's diet," says a fact sheet from the federal Office of Dietary Supplements. And vitamins aren't required to undergo the strict testing required of U.S.-approved prescription medicines.

Some fads, such as the antioxidant craze over vitamins A and E and beta-carotene, backfired when studies found more health risk, not less. And studies that find more disease in people with too little of a certain vitamin can be misleading: Correcting a deficiency so you have the right daily amount is different from supplementing beyond recommended levels.

The best way to get vitamins is to eat foods that naturally contain them, said Jody Engel, a nutritionist with Office of Dietary Supplements. "Foods provide more than just vitamins and minerals, such as fiber and other ingredients that may have positive health effects."

Schardt adds: "It's virtually impossible to overdose on the nutrients in food."

Some folks may need more of certain nutrients and should talk with their doctors about supplements:

— Postmenopausal women regarding calcium and vitamin D to protect bones.

— Women planning on pregnancy regarding folate, or folic acid, to prevent birth defects.

— People over age 50 and vegans who may need vitamin B12. "As we get older, a number of us no longer produce enough acid in the stomach to extract the B12 in food," Schardt explained.

— Pregnant women, who may need extra iron.

— Breastfed infants and possibly other infants concerning vitamin D.

Vitamin D is a nutrient many of us may need to supplement. Last fall, the Institute of Medicine, a panel of scientists who advise the government, raised the recommended amount but also warned against overdoing it. People ages 1 to 70 should get 600 international units a day, older folks 800 units.

If you do need a supplement, beware: Quality varies. Consumerlab.com, a company that tests supplements and publishes ratings for subscribers, has found a high rate of problems in the 3,000 products it has tested since 1999.

"One out of 4 either doesn't contain what it claims or has some other problems such as contamination or the pills won't break apart properly," said company president Dr. Tod Cooperman.

For example, one gummy bear calcium product had 250 percent of the amount of vitamin D claimed on the label. Another liquid product made with rose hips had just over half the amount of vitamin C listed.

"You don't have to pay a lot. Price is not necessarily linked to quality," he said. "The quality doesn't really relate to where you're buying it. I know many people are surprised by that or don't want to believe it, but that is the case. We find good and bad products in every venue."

Mark Blumenthal, executive director of the American Botanical Council, suggests looking for "seals of approval" or certifications of quality from groups that spot-test supplements such as the USP, or United States Pharmacopeia; NSF International and NPA, the Natural Products Association.

Experts offered this advice:

— Keep it simple. The more ingredients there are in a supplement combo, the more chance that one of them will not be the right amount, Cooperman said.

— Consider a supplement combo tailored to your gender and age, the Office of Dietary Supplements suggests. Multivitamins often contain little iron, and ones for seniors give more calcium and vitamin D than products aimed at younger adults.

— Take vitamin D with dinner. A study found significantly more absorption of that nutrient when it was consumed at the largest meal, which tends to have more fat, than at breakfast, Cooperman said.

— Watch out for vitamin K — it promotes clotting and can interfere with common heart medicines and blood thinners such as warfarin, sold as Coumadin and other brands.

— Current and former smokers are advised to avoid multivitamins with lots of beta-carotene or vitamin A; two studies have tied them to increased risk of lung cancer.

— For cancer patients, "vitamins C and E might reduce the effectiveness of certain types of chemotherapy," Engel said.

— People having surgery should know that some vitamins can affect bleeding and response to anesthesia.

With any supplement — ask your doctor.

__

Online:

Vitamin facts: http://ods.od.nih.gov/factsheets/list-VitaminsMinerals

and http://ods.od.nih.gov/factsheets/MVMS-HealthProfessional

FAQs: http://ods.od.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx

Dietary advice: www.dietaryguidelines.gov

Vitamin E and prostate study: http://jama.ama-assn.org/content/306/14/1549

Video interview with author: http://jama.ama-assn.org/content/306/14/1549/suppl/DC1

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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