Low cholesterol linked to Parkinson's in men (Full Article)full1
Reuters
Updated: 4:06 p.m. ET Sept. 29, 2005

NEW YORK - Is it possible to have too low a level of cholesterol? A cholesterol profile that reduces the risk of heart disease may increase the risk for Parkinson's disease -- at least for men -- researchers report.

Going back several years, studies have uncovered associations between low cholesterol and suicide, stroke, depression, even violence. While the findings in most cases did not stand up to scrutiny, the suspicion remains that very low cholesterol might influence mental function.

Now, at the annual meeting the American Neurological Association held this week in San Diego, California, Dr. Xuemei Huang described a possible link to Parkinson's disease.

Huang and colleagues, from the University of North Carolina at Chapel Hill, measured the lipid levels of 124 Parkinson's patients and a group of 112 similar people free of Parkinson's disease.

Huang reported that, after adjusting for age, smoking, and use of lipid-lowering agents, men with low total and LDL ("bad") cholesterol levels had an increased risk of Parkinson's.

For example, compared to men with LDL cholesterol levels higher than 135, those with levels between 91 and 135 were 6 times more likely to have Parkinson's, and those LDL levels below 91 were 4 time more likely.

Huang proposed several possible mechanisms to explain the link between low cholesterol and risk of Parkinson's disease. One is that cholesterol helps rid the body of environmental toxins that might trigger Parkinson's.

"Another possible mechanism underlying our finding is the role of cholesterol as a precursor for hormones/chemical modulators that are involved in central nervous system function in a variety of ways," he said.

The association did not hold true for women. "Our findings of the gender differences are intriguing...the lifetime risk of Parkinson's disease is about two-fold higher in males than females," Huang noted.

"The fact that LDL cholesterol levels increase with age in men until 65 years of age, and until 75 years in women, may be relevant to our findings of gender-specific association between cholesterol and Parkinson's disease," he commented.

Expanding on this point, Huang concluded: "The fact that cholesterol levels tend to increase with age in young or middle age adults, yet decrease in later life when the risk of Parkinson's disease increases, suggests caution in balancing the benefits and risks of medication use in achieving 'optimal' cholesterol levels."

NCCAM Revises Report of Echinacea Study, Notes Criticism of Low Dosef2   
(Full Article)

2005-10-12 - American Herbal Products Association (AHPA) (Silver Spring, MD, October 12, 2005) -- The National Center for Complementary and Alternative Medicine (NCCAM) has revised its website to correct erroneous statements it had made previously about a study on low-dose preparations of Echinacea angustifolia root published in the New England Journal of Medicine on July 28, 2005. The revisions were made only one week after the American Herbal Products Association (AHPA) requested such corrections in a letter dated October 4, 2005, to Stephen Straus, MD, NCCAM's director.

"It is satisfying to think that someone at NCCAM actually listened to our well-reasoned arguments," commented AHPA President Michael McGuffin. "We have also requested that NCCAM now make some effort to broadcast this corrected message widely, so that the misinformation that was so broadly distributed in July might be clarified."

A particular grievance voiced in AHPA's letter to Straus identified as "a gratuitous criticism" NCCAM's statement about herbal products, specifically, "… what's on the label may not always be what's in the bottle." That statement has now been removed.

AHPA's letter also discussed comments that had been attributed to Dr. Straus in numerous media reports, some of which appeared to defend the researchers selection of the low dose (900 mg per day) of Echinacea angustifolia root used in the study, and others which dismissed all echinacea products as ineffective, regardless of dose or species. The revised page on the NCCAM site addresses both of these complaints. For example, a new sentence has been added to acknowledge that "critics of this study believe the dose of E. angustifolia used was too low," and a concluding sentence on the lack of efficacy found in this research is now careful to identify these findings in the context of "preparations of E. angustifolia at the 900 mg per day dose." In addition, the revised NCCAM review has completely removed an extensive commentary by Dr. Straus, in which he described the recent study as "well-designed" and the low-dose used as "internationally recognized."

"AHPA will continue to monitor communications about herbs and supplements made by NCCAM and other federal offices," added McGuffin. "It is essential that all such communications are factual and do not mislead the public."

AHPA's October 4 letter to Dr. Straus is available online at the AHPA website, at http://www.ahpa.org/05_1004_LetterToStraus.pdf. The current revision of NCCAM's review of the recent low-dose Echinacea angustifolia root study can be accessed at http://nccam.nih.gov/clinicaltrials/echinacea_rr.htm.

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NBTY, Inc. to Pay $2 Million Penalty For Alleged Violations of FTC Order f3
(Full Article)
2005-10-12 - Federal Trade Commission (FTC)

Company Distributes Dietary Supplements in the U.S. and Abroad

Under the terms of a consent decree approved by the Federal Trade Commission for submission by the U.S. Department of Justice (DOJ) to the federal court for approval, NBTY, Inc. (NBTY, formerly Nature's Bounty, Inc.), a leading manufacturer and distributor of dietary supplements in the United States and abroad, will pay a $2 million civil penalty to settle charges that it violated the terms of a 1995 Commission order by making false and misleading health claims about two of its products. The FTC charged that the defendant made unsubstantiated promises that its products would cause consumers to lose weight or cure a variety of health problems.

"Misleading health claims prevent consumers from getting useful information and can delay treatment for serious medical conditions," said Lydia B. Parnes, Director of the FTC's Bureau of Consumer Protection. "Companies already under order for making deceptive health claims should know better than to try it again."

Case Background

In 1995, NBTY and its two wholly owned subsidiaries, Puritan's Pride, Inc., and Vitamin World, Inc., settled FTC charges that they made deceptive claims for 26 products. The FTC alleged that, among other things, the company claimed falsely or without substantiation that its products promoted weight loss, increased muscle mass, decreased body fat, promoted hair growth, prevented premature hair loss, lowered cholesterol, and prevented arthritis. Under the terms of the order settling the matter, NBTY agreed not to make unsubstantiated claims about any dietary supplement and not to misrepresent the results or conclusions of any test, study, research article, or any other scientific opinion or data. NBTY further agreed to pay $250,000 in consumer redress.

The Alleged Violations

If approved by the court, the consent decree will resolve allegations that NBTY violated the 1995 order through its subsidiaries. The FTC charges that from 2001 through 2003, Dynamic Essentials, Inc., an NBTY subsidiary, marketed a Tongan seaweed extract, "Royal Tongan Limu," advertising in English and Spanish that it was clinically proven to cure, prevent, or treat a range of diseases and disorders such as allergies, diabetes, cancer, and Alzheimer's disease.

The FTC alleges that during this same period, NBTY, through its subsidiaries, also claimed that "Body Success PM Diet Program" reduces body fat, increases metabolism, and causes weight loss, even during sleep. According to the FTC, the company lacked reliable scientific evidence to prove that its claims for either product were true, and misrepresented that tests, studies, research, articles, scientific opinion, and data supported its claims for Royal Tongan Limu.

The Consent Decree

Under the terms of the consent decree, NBTY and its subsidiaries are barred from violating the 1995 order, and NBTY must pay $2 million in civil penalties. The consent order also contains terms requiring NBTY to distribute the order to certain company personnel, as well as to keep relevant records and provide them to the Commission to ensure compliance with the order's terms.

The Commission vote approving the consent decree and authorizing transmission to DOJ for filing was 4-0. DOJ submitted the proposed consent decree to the U.S. District Court for the Eastern District of New York on October 12, 2005.

Copies of the consent decree and complaint are available from the FTC's Web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint in English or Spanish (bilingual counselors are available to take complaints), or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.

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