FDA Warns Consumers on Sexual Enhancement Products

The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal.

Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as “dietary ingredients.” The FDA has issued multiple alerts about these contaminated dietary supplements.

Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death.

In the case of Stiff Nights, following a consumer complaint, the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

"Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications.”

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

The FDA remains committed to stopping the illegal marketing of unapproved drugs and will continue to protect the public with vigorous law enforcement and criminal prosecution of violators.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Public Weighs in With Nearly 100,000 Comments for Grand Canyon Protection

/PRNewswire/ -- After nearly 100,000 members of the public called for protecting the Grand Canyon from mining, a Pew Environment Group ad (http://www.pewminingreform.org/pdf/WishAd.pdf) today urged Congress to support legislation that would permanently ban new mining claims on public lands surrounding the park. Under the antiquated mining law of 1872, more than one thousand uranium mining claims have been staked just outside park boundaries.

H.R. 644, authored by Rep. Raul Grijalva (D-AZ), chair of the House National Parks, Forests and Public Lands Subcommittee, would protect approximately one million acres of U.S. Forest Service and Bureau of Land Management lands surrounding Grand Canyon National Park from new mining claims. The bill would make permanent a moratorium on claim staking called for in July by U.S. Interior Secretary Ken Salazar.

As the initial public comment period for the Department of Interior's environmental review of the withdrawal proposal ended October 30, 98,355 messages had been received in support. Called for by Grijalva and Representative Nick Rahall (D-WVA), chairman of the House Natural Resources Committee, along with Pew and other conservation groups, the withdrawal is a response to federal data that show thousands of mining claims within five miles of Grand Canyon, Death Valley, Arches and other national parks.

"Presidents since Theodore Roosevelt have recognized that the Grand Canyon, America's national icon, must be preserved for future generations to enjoy," said Jane Danowitz, director of Pew Environment Group's public lands program. "Now it's time for Congress to safeguard the Grand Canyon from threats posed by the 1872 mining law and permanently protect this natural wonder."

Roughly five million people from around the world visit the Grand Canyon each year. The Colorado River, which has shaped the canyon's dramatic twists and turns, is an important source of water for more than 25 million people downstream. The Metropolitan Water District of Southern California and the Southern Nevada Water Authority have both raised concerns about uranium mining near the Grand Canyon.

Hardrock mining is responsible for the largest toxic releases in the United States, according to the Environmental Protection Agency. The 1872 law allows corporations and individuals "free and open access" to more than 350 million acres of public lands across the West, resulting in $1 billion annually of gold, uranium and other metals mined from public lands without payment of a royalty, according to the Congressional Budget Office.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Toxic BPA Contamination - Groups Support Consumers Union Call for FDA Protection From BPA in Canned Food

/PRNewswire/ -- In response to Consumer Reports' new report on contamination of canned food products with the synthetic sex hormone bisphenol A (BPA), the Breast Cancer Fund, Clean Water Action, Clean New York, Center for Health, Environment & Justice, Physicians for Social Responsibility, Oregon Toxics Alliance and other environmental health advocates support Consumers Union's call for FDA to immediately act to protect consumers from BPA.

BPA is linked to neurological, endocrine and reproductive health effects, breast cancer and other serious health problems.

"Consumer Reports' results are sobering, and confirm what we already know: Americans are exposed to toxic BPA every day through canned food," said Janet Nudelman at the Breast Cancer Fund. "A synthetic estrogen linked to breast cancer should not be in our food, period. It's well past time to ban BPA from food and beverage containers."

Bobbi Chase Wilding of Clean New York says, "Consumers should not have to read scientific journals to determine what is safe when shopping for their families. FDA needs to step up and step in."

Mike Schade from the Center for Health, Environment & Justice adds, "We know there are companies that want to do the right thing. Wal-Mart, Target, Babies R Us, Nalgene, CamelBak and others have been working provide their customers with safer, BPA-free products -- the products consumers want. The time has come for the food industry to follow suit."

The product testing found that almost all of the 19 name-brand foods tested contain measurable levels of bisphenol A (BPA). Results are in the December 2009 issue and are available free online at www.ConsumerReports.org

Consumers Union sent a letter to FDA Commissioner Margaret Hamburg requesting that it move this year to ban the use of BPA in food- and beverage-contact materials.

Congress is currently considering legislation that would ban the use of BPA in all food and beverage containers.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Community Pharmacists Report Supply Shortages, Insurance Red Tape in Growing Fight against H1N1 Flu

(BUSINESS WIRE)--Community pharmacists have stepped up to meet the shortage of Tamiflu by compounding doses for children suffering from the H1N1 flu virus, but they are struggling with supply problems and insurance plans, according to the National Community Pharmacists Association.

Tamiflu’s manufacturer, Roche, asked pharmacists to compound the medicine until supplies improve. The time-intensive process involves extracting powder from capsules, calculating the quantity of medicine, and mixing the right amount with liquid, such as cherry syrup, to produce a suspension with the appropriate prescribed strength for young children.

Over a recent 48-hour period, 80 community pharmacists from around the country told NCPA about their experiences compounding Tamiflu. Nearly half (48%) reported preparing 25 or more suspension compounds since Sept. 1. Virtually all (97%) experienced difficulty in obtaining commercial Tamiflu suspension and many (48%) said the same about Tamiflu capsules, consistent with a front-page story in The Washington Post.

Most prescription coverage is administered by pharmacy benefit managers (PBMs) and 61% of pharmacists surveyed had difficulty adjudicating claims with them for compounded Tamiflu. Most commonly mentioned were the big three – CVS Caremark, Express Scripts, Inc. and Medco Health Solutions, Inc. – but nearly every PBM was identified as a source of difficulty.

Experts advise starting antiviral treatment as quickly as possible. But one pharmacist said, “We had several children that are ‘covered’ by the federal employee [health benefits] program [administered by CVS Caremark] and were told that this compound requires prior authorization which can take from 24 to 72 hours to obtain.”

“Compounding has long been a specialty of independent community pharmacists, and they’re working overtime against H1N1,” said NCPA Executive Vice President and CEO Bruce T. Roberts, RPh. “They’ve helped countless children and won the gratitude of just as many parents.”

“Unfortunately, this is harder than it should be,” Roberts added. “We hope insurance plans and PBMs will reexamine their claims processes to ensure kids get relief as quickly as possible.”

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

Study Examines Mercury in Vaccines

/PRNewswire/ -- The injectable, multi-dose H1N1 vaccine contains the mercury-based preservative thimerosol to reduce risks of bacterial contamination. The presence of thimerosol has once again raised concerns whether there are risks posed to children when the tiny amount of mercury contained in thimerosol is included in a vaccine. In a recent issue of the Journal of Pediatrics, however, a team of scientists supported by the National Institutes of Health reported findings that should alleviate those concerns. The researchers, led by author Michael E. Pichichero, MD, Director of the Rochester General Research Institute, Rochester General Hospital, Rochester, NY evaluated levels of mercury in the blood of the smallest children -- prematurely born and low birth weight infants after they received a dose of a childhood vaccine containing thimerosol. They found the levels of mercury were exceedingly low.

The issue of administering vaccines containing mercury has been controversial because at very high levels mercury is known to cause organ damage (brain/kidneys). Consequently in 2001, as a precaution, at the prompting of the American Academy of Pediatrics, the Centers for Disease Control, and the Food and Drug Administration, the use of thimerosol in childhood vaccines was reduced or eliminated. However, after examining the evidence the Institute of Medicine issued an opinion that an association between thimerosol exposure and autism was not supported by the evidence. Nevertheless the contention that mercury in vaccines causes autism continues to be debated. The newly released multi-dose, injectable H1N1 Influenza vaccines contain the preservative thimerosol and thimerosol is 50% ethyl mercury, which has sparked a renewed debate on the safety of administering this new influenza vaccine.

The purpose of the study was to find out how much mercury from a vaccine containing thimerosol stays in a child's body," said Dr. Pichichero. "What we found was that blood mercury levels before vaccination were often detectable, even at a level similar to many children after the vaccination. By just breathing the air, mothers were passing to their unborn infants some slight amounts of mercury. The mothers did not eat fish that contains mercury, so in the United States and other countries where fish is consumed by pregnant women the levels of mercury would be presumably even higher. After the babies were given vaccines containing thimerosol, their blood levels of mercury did rise to very low levels and then fell rapidly to baseline levels by day ten after the vaccination."

Since thimerosol has been largely removed from vaccines in the US since 2001, this study of 72 newborn infants was conducted at the Hospital Durand in Buenos Aires, Argentina. In Argentina, like many countries of the world, vaccines are purchased through sources supported by the World Health Organization and the WHO has rejected the notion that thimerosol in vaccines is unsafe. This is the third and final study by Dr. Pichichero and his colleagues that tested mercury levels following the injection of vaccines containing thimerosol. Previous studies were conducted on term newborns, and on 2-and 6-month old infants. In those studies, the researchers also found the mercury levels in the vaccinated children were very low and quickly returned to pre-vaccine levels, usually within three to seven days. In 1999, when the first concerns about thimerosol in vaccines was raised, it was presumed that the ethyl mercury in thimerosol would behave in the same manner as methyl mercury in fish after ingested. The three NIH-supported studies clearly refuted that idea.

Dr. Pichichero and colleagues concluded that with this latest data, it is time to recognize that the risk of exposure to thimerosol in vaccines is minimal to non-existent. "The H1N1 vaccine is safe and should be given to those at risk as recommended by the US Centers for Disease Control," Dr. Pichichero said.

Rochester General Research Institute is part of the Rochester General Health System (RGHS) in Rochester, NY. The Research Institute is focused on clinical and translational research in the areas of infectious diseases and immunology, cardiovascular diseases, cancer, and innovations in
biotechnology. The Rochester General Research Institute has alliances with the Rochester Institute of Technology, the Cleveland Clinic and Roswell Park Cancer Institute.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

California Office of Environmental Health Hazard Assessment Review Verifies Safety of Synthetic Turf

/PRNewswire/ -- Representing the latest convincing data on the safety of synthetic turf, the California Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, released a report last week dated July 2009 which indicated there is a negligible human health risk from inhaling the air above synthetic turf. The OEHHA summary also stated "it is unlikely that the new generation of artificial turf is itself a source of MRSA."

OEHHA searched the available literature related to the safety of new generation artificial turf fields, those which contained crumb rubber infill. They analyzed whether these fields emitted levels of chemicals or particulates into the air that are a health risk when inhaled, and also any potential risk factors for MRSA infection. Based on the data from two 2009 New York studies and a 2006 report of indoor fields, they found that "Both reports concluded that these fields did not constitute a serious public health concern, since cancer or non-cancer health effects were unlikely to result from these low-level exposures." Other key findings included:

-- Analyzing the chemicals detected above the fields in New York, OEHHA
noted that "many of these occurred at similar concentrations in the
air sampled upwind of the fields" - which suggests that the source of
these chemicals was not from the turf fields.


-- Cancer risks are negligible, lower than many common human activities.
OEHHA created a test scenario to determine the exposure and health
risks of an athlete playing on an artificial turf field from age five
until age 55 for nearly 100 chemicals. The results showed an exposure
to five chemicals with a lifetime cancer risk above one in one
million, which is considered a negligible risk. As OEHHA explains
"these estimated risks are low compared to many common human
activities." To give context, their website states that the cancer
risk of breathing California air (in 2000) due to diesel particles was
540 in one million.


-- Synthetic turf is not a source of MRSA. OEHHA stated that "It seems
unlikely that the new generation of artificial turf is itself a source
of MRSA, since MRSA has not been detected in any artificial turf
field." That conclusion is consistent with the findings of the Penn
State January 2009 study conducted on the lifespan of staph on grass
and synthetic turf, which was sponsored by the STC and the
Pennsylvania Turfgrass Council.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

Toys to Toxic Waste: New Report Details Corporations that Skirt Responsibility and Shun Consumer Safety to Save Money

/PRNewswire/ -- As the U.S. Chamber Institute for Legal Reform holds their annual summit - an event dedicated to championing corporate misconduct and evading accountability - a new report released today details true stories of corporations that knew their products were dangerous, yet failed to act and protect consumers.

"They Knew and Failed To" details numerous examples of medical devices, prescription drugs, and other consumer products that remained on the market after critical safety concerns had been raised within the company, while using all means necessary to avoid being held accountable for their misconduct.

In one example, police officer Tony Zeppetella of Oceanside, Calif. had paid $313 to "upgrade" his standard bullet proof vest. The Ultima body armor Zeppetella had purchased was widely used by law enforcement, military personnel, and even worn by the President and Mrs. Bush. Unfortunately, Zeppetella was shot and killed on a routine traffic stop in June 2003, when a bullet penetrated his vest.

Second Chance, the manufacturer, had known as early as 1998 that heat and sunlight caused the material to degrade, making the vests penetrable. Internal corporate memos from 2001 revealed an executive at the company had recommended notifying customers about the products' defect, saying, "Lives and our credibility are at stake." It was not until September 2003 that the company eventually recalled 130,000 vests, three months after Zeppetella was shot. The company had known for five years there were problems with their vests, but failed to notify consumers, putting law enforcement and service members' lives at risk. Several years later, Second Chance recalled another 98,000 vests.

"While most businesses act in good faith to serve their customers and communities, unfortunately some corporations recklessly put lives at risk for the sake of profit," said American Association for Justice President Anthony Tarricone. "While front groups like the Chamber stage events practically celebrating corporate misconduct, this new report convincingly illustrates the importance of holding wrongdoers accountable."

The full report, "They Knew and Failed To," is available at: www.justice.org/clips/TheyKnewAndFailedTo.pdf.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page