Take note, parents of children with autism: FDA says supplement is a drug

The "dietary supplement" sold as OSR#1 is actually a toxic drug, with potentially serious side effects, the Food and Drug Administration has warned.

The product was the subject of a story published in the Times Health section a few months ago: Industrial chemical OSR#1 used as autism treatment

Here's the latest article, on the warning letter from the agency: FDA warns maker of product used as alternative autism treatment

The story quotes Ellen Silbergeld, an environmental health expert at Johns Hopkins University, as saying: "An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children."

-- Tami Dennis

Photo credit: Chicago Tribune

Supplements guru sues over his own product

The world of dietary supplements is unpredictable and sometimes, well, zany. But here's a story that should give pause to anyone lured by the extravagant claims of many supplements makers.

Gary Null, a nutrition and fitness guru, critic of conventional medicine and hawker of dietary supplements on his website, filed a suit Monday with the Supreme Court of New York County against one of his own herbal supplements -- or more specifically, a company that provided some of its nutrient ingredients. The suit alleges that after taking two daily doses of the product, Ultimate Power Meal, for a month, Null fell ill with "excruciating fatigue along with bodily pain" and bleeding "from within his feet."

A visit to his physician revealed extremely elevated levels of Vitamin D in Null's body, which led Null to investigate the contents of the Ultimate Power Meal. Null's complaint charges that the defendant in the civil case, Triarco Industries Inc., had erred in preparing the Vitamin D source for the product, making it 1,000 times more potent than the product's content label claimed. The suit seeks damages of $10 million.

As The New York Post, which broke the story, observes, "not exactly a ringing endorsement" of his own product.

Null consumed his power meals after his symptoms appeared, believing the product "would help him and relieve his condition."

"Fortunately, only one lot of Power Meal was defective and none of the product reached the retail market," says Null on his website's "store." But the New York Post, citing papers filed in the suit, reports that "six consumers were hospitalized with severe kidney damage" and that Null, while ill, "had dozens of his customers calling him, as well as threatening and condemning him."

It's not at all uncommon for the content of dietary supplements to contain doses wildly different than those indicated on their labels--and that's when nutritional contents are listed on labels, which is not always. (At least one commercial lab regularly issues reports documenting the mislabeled and unlabeled contents of dietary supplements.) 

New federal rules make the manufacturers of dietary supplements subject to inspections to ensure "good manufacturing procedures." Those rules aim to improve quality problems that have long plagued the supplements industry. But for the smallest manufacturers, those regulations are just now coming into force. Otherwise, the Food and Drug Administration's role in regulating dietary supplements is very limited: Dietary supplements are allowed onto the market without prior approval from the FDA. So, unless the agency has reports that indicate a product may be harmful, it can stay in broad circulation indefinitely.

So, buyer beware -- and apparently that goes for Gary Null, whose "Ultimate Power Meal," fortunately for him, didn't quite live up to its name.

As for Vitamin D toxicity -- this is controversial. Most of us do not get enough of this vitamin, which our bodies produce in response to sunlight as well as take in from dietary sources, and evidence is mounting that adequate Vitamin D levels are important for staying healthy. But the National Institutes of Health have said that 50 micrograms, or 2,000 international units, is the safe daily limit for anyone over a year old. The Vitamin D Council, headed by Dr. John J. Cannell, counters that adults can tolerate more than 10,000 IU daily safely.

--Melissa Healy

Depression symptoms may lift with Transcendental Meditation

Medication isn't the only way people successfully battle depression -- exercise and acupuncture are two alternative methods. A new study suggests that Transcendental Meditation may also be an effective way to lessen depression symptoms.

Two studies compared months of Transcendental Meditation practice with health education (which served as a control) on depression. The TM technique uses a mantra to help people achieve a relaxed state, and the practice is typically done for about 15 to 20 minutes twice a day. The methodology of both studies was the same: Participants were asked to do TM or follow a health education program twice a day for 20 minutes.

Researchers measured depression symptoms at the beginning of the studies and three, nine and 12 months later. Since there is a link between depression and a risk for cardiac events in people who have coronary heart disease, participants in both studies also had cardiovascular risk factors such as carotid artery wall thickness.

In one study, participants included 59 African American men and women ages 55 and older, and in the other, participants included 53 native Hawaiian men and women ages 55 and older. In both studies, the meditation groups had a far greater reduction in depression symptoms than the control groups. There were no substantial differences between genders.

Researchers speculate that meditation may trigger changes in the body's chemistry, affecting serotonin (a neurotransmitter that may be linked to depression) and fostering better reactions to environmental stress.

"These results are encouraging and provide support for testing the efficacy of Transcendental Meditation as a therapeutic adjunct in the treatment of clinical depression," said Hector Myers, a co-author of one of the studies, in a news release. Myers is director of clinical training in the Department of Psychology at UCLA.

The studies will be presented April 9 at the annual meeting of the Society of Behavioral Medicine in Seattle.

-- Jeannine Stein

For breast cancer treatment that causes joint pain, acupuncture may help

Joint pain is a common side effect for women being treated with aromatase inhibitors for breast cancer. The treatment halts estrogen production in post-menopausal women, which means less of the hormone can fuel certain breast cancer cell growth.

While women often remedy the discomfort with painkillers, researchers wondered if acupuncture might also help. In a paper published in the March 1 issue of the Journal of Clinical Oncology, researchers enrolled 43 women in a randomized, blind study. The women were being treated with aromatase inhibitors for breast cancer and were also experiencing musculoskeletal pain.

Some were assigned to a true acupuncture group, in which joints were specifically targeted, and others were assigned to a sham acupuncture group, in which needles were inserted superficially into the skin in locations that were not real acupuncture points (this group served as a control for a potential placebo effect). Treatment went on for 12 sessions over six weeks.

Women were asked to rate the severity of their pain and its effect on daily functions, on a scale of 0 to 10. At the beginning of the study, the true acupuncture group's average pain rating was 6.7, and the sham group's was 5.6. After six weeks, the true acupuncture group rated their pain on average 3.0, and the sham group rated theirs 5.5.

In addition to seeing a significant decrease in the severity of their pain, the true acupuncture group also noticed improvement in their overall physical well-being.

"Since aromatase inhibitors have become an increasingly popular treatment option for some breast cancer patients, we aimed to find a non-drug option to manage the joint issues they often create, thereby improving quality of life and reducing the likelihood that patients would discontinue this potentially lifesaving treatment," said Dr. Dawn Hershman, senior author of the study, in a news release. Hershman is the co-director of the breast cancer program at the Herbert Irving Comprehensive Cancer Center at New York-Presbyterian Hospital/Columbia University Medical Center, and an assistant professor of medicine and epidemiology at Columbia University Medical Center.

— Jeannine Stein

Photo credit: Rick Loomis / Los Angeles Times