New Yorkers Get a Sneak Peek at alli®

(HealthDay News) -- Pharmaceutical giant GlaxoSmithKline isn't wasting any time.

On Monday, about a month before its over-the-counter (OTC) weight-loss drug alli® will actually be on store shelves throughout America, the company opened a multimedia exhibit in the much-shopped and often congested Union Square area of Manhattan.

This "look, learn, but don't buy" preview of the only weight-loss medication currently approved by the U.S. Food and Drug Administration and available without a prescription is getting the same sort of advance media play that kicked off campaigns for prescription drugs such as Viagra and the sleeping aid Lunesta.

But is alli being over-hyped? GlaxoSmithKline doesn't think so.

"We're positioning alli as an honest voice in a category known for hype," said Joe Cadle, marketing director of GlaxoSmithKline Consumer Healthcare. "The alli experience will teach people the difference between alli and the rest of the weight-loss category." The OTC dosage of alli (orlistat) is 60 milligrams (mg), a dilution of the prescription amount. Orlistat is not a new weight-loss drug; the FDA approved it in 1999.

Cadle said that people currently spend $1 billion a year on ineffective weight-loss products that make unrealistic claims. "alli is much more than just pills in a bottle," he said, adding that GlaxoSmithKline was offering a companion book called Are You Losing It? Losing Weight Without Losing Your Mind and other weight-loss material.

But the magic question seeking the magic answer for millions of overweight Americans is, "Does it work?"

Not surprisingly, Cadle said it does, but not by itself. "alli is not a magic pill," he said. "You have to eat a reduced-calorie, low-fat diet and be willing to do the work. If you do, you can lose 50 percent more weight. If you lose 10 pounds without taking alli, you could lose 15 when taking it."
Marketed to overweight adults over age 18, alli is expected to cost between $1 and $2 a day. It works by blocking the body's absorption of fat.

It's designed not to have an adverse effect on the cardiovascular system as did other weight-loss products such as ephedra, Cadle said. The FDA banned ephedra after medical evidence indicated it increased heart attack risk.

Alli is not without its critics, however, chief among them Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group in Washington, D.C., who has spoken against orlistat's side effects before.

When another pharmaceutical company, Roche, marketed orlistat in prescription strength as Xenical, Wolfe spoke out. "Animal studies done by Roche show that rats developed aberrant crypti foci, ACF, precancerous lesions in the colon from Orlistat, which put them at higher risk of colon cancer," Wolfe said in a recent interview. "An independent study by researchers in 2006 found the same thing."

But another expert said Wolfe's concerns are unfounded.

"There are more than 100 clinical studies, including 30,000 clinical trial patients, and nine years of post-marketing surveillance with more than 29 million patient treatments, all showing no such risk with orlistat use," said Dr. Vidhu Bansal, director of medical affairs for GlaxoSmithKline Consumer Healthcare. "The FDA concluded the same in their recent review," she added.

Wolfe maintained that the FDA relied heavily on testimony by a panel comprised of pharmaceutical company representatives. But that is only part of the difficulty, he said. The side effects were embarrassing, dramatic and distasteful enough to cause orlistat to lose popularity.

"The RX (prescription) drug's popularity went down, because it caused all sorts of acute problems, mainly gastrointestinal," Wolfe said. "Twenty-five percent of people got oily spotting (from the rectum), because the fat is going in one end and coming out the other. You definitely wouldn't want to take it while on a first date."

Wolfe said some people also experienced gas, loose or more frequent stools, and inhibition of fat-soluble vitamins. "We wanted the FDA to ban the RX version," he said. "It should never have been approved for over-the-counter sales."

But the FDA denied Public Citizens' petition.

This is precisely why GlaxoSmithKline is strongly recommending that a person adopt a low-fat diet when using alli. "These unwelcome side effects will only occur if people eat too much fat while taking the weight-loss drug, Cadle said. "And if they eat too much fat, then they're not following the program."

Cadle said alli will be sold in drugstores, mass market retailers such as Wal-Mart and Target, club warehouse stores, and some grocery stores.

More information
The FDA has a location on its Web site outlining the approval process for alli®.

Low-Dose CoQ10 Supplements Won't Ease Parkinson's

(HealthDay News) -- Low doses of an antioxidant called coenzyme Q10 (CoQ10), sold as a dietary supplement, do not appear to improve Parkinson's disease symptoms, a German study finds.

It's believed that a malfunction of the mitochondria (the part of a cell that converts food to energy) may play a role in Parkinson's disease. CoQ10 also affects mitochondrial processes, according to background information in the study.

"Because of these functions, CoQ10 has attracted attention concerning neuroprotective actions in neurodegenerative disorders linked to mitochondrial defects or oxidative (oxygen-related) stress, such as Huntington's disease and Parkinson's disease," the study authors wrote.
They noted that previous studies had suggested that high doses (1,200 milligrams) of CoQ10 may slow the physical deterioration (such as tremors and movement problems) in people with Parkinson's disease.

In this new study, researchers at the Technical University of Dresden studied the effects of CoQ10 in Parkinson's patients who did not have changes in their motor function and were on stable treatment for the condition.

The patients were divided into two groups. The treatment group of 55 patients took 100 milligrams of CoQ10 three times a day for three months, followed by a two-month "washout" where they did not take the antioxidant. The other 51 patients took a placebo.

Both groups were assessed for Parkinson's symptoms before the start of the study, each month during treatment, and again after the washout period. After three months, blood levels of CoQ10 in the treatment group increased from an average of 0.99 milligrams per liter to 4.46 milligrams per liter.

But the study found that CoQ10 did not improve Parkinson's disease symptoms.
The findings were published online Monday in the Archives of Neurology and are expected to appear in the July print issue of the journal.

More information
The American Academy of Family Physicians has more about Parkinson's disease.

(HealthDay News) -- A pill might one day achieve the same calorie-burning effects of vigorous exercise.

(HealthDay News) -- U.S. Food and Drug Administration officials on Friday searched the facilities of a pet food manufacturer and one of its suppliers in the continuing probe of contaminated dog and cat food products, the Associated Press reported.

The officials searched an Emporia, Kan., pet food plant operated by Menu Foods and the Las Vegas offices of ChemNutra Inc., the news service said, citing information supplied by the companies.

Menu Foods made many of the more than 100 brands of pet food recalled since March 16 because of contamination by the chemical melamine. ChemNutra supplied Menu Foods with wheat gluten, one of two ingredients imported from China and tainted by melamine used in the recalled pet products. Both companies said they were cooperating with the investigation, the AP said.

On Thursday, the FDA said some 6,000 hogs have been quarantined across eight U.S. states because they may have eaten contaminated salvage pet food.

At the same time, U.S. Department of Agriculture (USDA) officials said that meat from 345 hogs that ate tainted feed has already entered the U.S. food supply, the AP reported.

The quarantined hogs are on farms in California, New York, South Carolina, North Carolina, Utah, Kansas, Oklahoma and Ohio, the AP said. And the USDA reported that swine from slaughterhouses in Kansas and Utah may have entered the food supply. Government officials, however, consider the threat to human health to be very low.

The swine are thought to have been exposed to food contaminated by two chemicals, melamine and cyanuric acid, that was sent as salvage by companies who have had to recall massive quantities of dog and cat food as the pet food recall rolls on.

"Today we notified eight states that adulterated swine products will not be approved to enter the food supply," Capt. David Elder, director of the FDA's Office of Enforcement Office of Regulatory Affairs, said during a Thursday afternoon teleconference.

He stressed, however, that "based on information currently available, the FDA and the USDA believe the likelihood of illness after eating such pork is extremely low. However, the agencies also believe it is prudent to take this measure."

According to the AP, potentially contaminated pet food scraps may also have found their way to a poultry feed mill in Missouri. That case remains under investigation.

Melamine was first found in pet foods manufactured by the Canadian company Menu Foods, which began its widely publicized recall March 16. That recall included moist dog and cat foods made with melamine-contaminated wheat gluten imported from China.

The recall has since expanded to other pet food manufacturers and other pet food ingredients, including imported rice protein concentrate and corn gluten.

In a new recall added on Thursday, Chenango Valley Pet Foods, of Shelburne, N.Y., announced it was recalling a variety of shipments of dry pet foods, including selected packets of: Doctors Foster & Smith Chicken & Brown Rice Formula Adult Lite Dog Food; Doctors Foster & Smith Chicken & Brown Rice Formula Adult Lite Cat Food; Lick Your Chops Lamb Meal, Rice & Egg Cat Food, and Bulk Chicken & Brown Rice Formula Adult Lite Dog Food.

In addition to melamine, the FDA has now found cyanuric acid in the rice protein concentrate and wheat gluten used in much of the pet food recalled over the past few weeks.

Like melamine, cyanuric acid is a chemical that can be used to boost the apparent protein content of foods. It is most often used as a stabilizer in outdoor swimming pools and hot tubs.
"The combination of melamine and cyanuric acid is of concern to human and animal health," Elder said. "Melamine, at detected levels, is not a human health concern."

The USDA will compensate hog farmers affected by the tainted pet food, Kenneth Peterson, an assistant administrator for field operations at the USDA Food Safety and Inspection Service, said during the teleconference.

"The pork and pork products from these animals will be destroyed," Peterson said. Each year, more than 105 million hogs are slaughtered in the United States, the AP noted.

Elder also announced that the FDA has been granted visas to go to China to look for the sources of the contamination.

On Thursday, China banned melamine from its food products, but rejected the charge that the substance caused the pet deaths, the AP reported.

China's Foreign Ministry said in a statement that there was no evidence to support the FDA's claim but that it would cooperate with the United States to find out what actually killed the animals.
"At present, there is no clear evidence showing that melamine is the direct cause of the poisoning or death of the pets," the statement said. "China is willing to strengthen cooperation with the U.S. side ... to find out the real cause leading to the pet deaths in order to protect the health of the pets of the two countries."

An unknown number of dogs and cats have been sickened or died after eating chemical-laced pet food.

More information
For more information on pet food, visit the U.S. Food and Drug Administration.