Pet drugs are subject of safety fears

Sun, 11 Mar 2007 11:11:58 GMT
By JEFF DONN, Associated Press Writer
Authorities and pet owners are beginning to raise serious questions about the safety and effectiveness of animal medicines, mirroring worries over human drugs like the painkiller Vioxx.
Tested on just a couple hundred animals, a drug meant for pets is less apt than a human one to show all its failings until it reaches market, veterinarians say. More than 700 drugs have been approved for pets, but many others are used legally without explicit approval for animals. Most pet drugs were first developed for people.

But there is deepening awareness that what works in people may not work in animals. Indeed, each species of animal — even varying breeds — may react differently to the same drug.

Further, animals can't say if a drug makes them feel bad. "I can't tell until you see something physical," says Laurryn Simpson of Commerce Township, Mich., who founded the Web site dogsadversereactions.com.

The worries arise at a time when intensifying demand has pressured the FDA to hire more reviewers and sort through research more quickly to decide whether to approve new pet drugs. Given the smaller pet market, many companies save development costs by relying on cheaper experiments with typically a tenth as many subjects as in human tests.

Dr. Stephen Sundlof, the vet who directs the FDA's Center for Veterinary Medicine, says if the agency insisted on the same size studies as for people, "we would have very few drugs" with formal approval for pets. But he adds, "The rigor is every bit as great as with human drugs."

Since the year 2000, reports of side effects in animal drugs have gone up about 90 percent, to 34,603 last year, FDA records show. The agency ties the growth to new types of drugs and greater understanding of potential dangers — not worsening safety. However, vets say that the vast majority of side effects are never reported, so it's hard to gauge overall safety.

And many vets barely speak of possible side effects when they recommend a drug, some clients complain.

Jean Townsend, of Johns Island, S.C., says her vet breathed "not one word" of side effects when he prescribed the painkiller Rimadyl for her arthritic, limping Labrador retriever.

Encouraged by an advertisement showing dogs romping playfully, Townsend says she was glad to soothe her pet's aches. Within a month, though, he collapsed and began to vomit blood. A week later, he had to be put to sleep, his kidneys and liver ravaged beyond repair, his medical records show.

"The medicine blew him apart," says Townsend. Her vet and FDA reviewers all blamed the drug, which was originally targeted for humans.

Without admitting wrongdoing, drug maker Pfizer paid out roughly $1,000 to each of 300 pet owners, including Townsend, to settle a lawsuit in 2004.

Rimadyl, taken by more than 10 million dogs since 1997, is now tied to more than 3,000 pet deaths, FDA data show. Many of these pets, predominantly dogs, had damaged livers or kidneys.

Rimadyl is in the same broad NSAID family of drugs as Vioxx. However, unlike Vioxx, it stayed on the market.

The FDA stresses the need for medicines like Rimadyl, partly because pets cannot tolerate the range of pain-killing alternatives that humans can. Dogs are more sensitive to aspirin than humans. And a single Tylenol can kill a cat.

But sometimes a drug's risk is too great to accept. A heartworm medicine, Proheart 6, was pulled from the market in 2004 after FDA researchers found evidence of fatal side effects.

U.S. struggles with bioterror defenses

Sun, 11 Mar 2007 10:27:00 GMT
By KEVIN FREKING, Associated Press Writer
WASHINGTON - More than five years after the Sept. 11 attacks, the government cannot show how the $5 billion given to public health departments has better prepared the country for a bioterrorism attack or flu pandemic.
Congress responded to the 2001 strikes and anthrax-tainted letters sent to lawmakers by putting much more money toward emergency preparedness. State health departments typically get tens of millions of dollars per year to prepare for bioterrorism; it was in the hundreds of thousands before Sept. 11.

The money came with a catch: Washington had to set criteria to evaluate how well the dollars were spent. That assignment fell to the Centers for Disease Control and Prevention, which has struggled with the task.

"We're not able to demonstrate accountability," said Craig Thomas , chief of the http://www.cdc.gov
Association of State and Territorial Health Officials: http://www.astho.org

New wealth buys makeovers in China

Sun, 11 Mar 2007 10:56:17 GMT
By ALEXA OLESEN, Associated Press Writer
CHANGSHA, China - The beautician from Chairman Mao's hometown looks at herself in the mirror and bursts into tears of joy. Forty pounds lighter, jaw slimmer, eyes and nose refined, breasts lifted, 30-year-old Chen Jing has just been through an extreme makeover for a Chinese reality show called "Lovely Cinderella."
It's a sharp insight into China's own makeover, as a consumer generation moves ever further from communist founding father Mao Zedong's era of drab-is-beautiful austerity.

Modeled after "The Swan," Fox TV's reality television show, "Lovely Cinderella" was created in south China's Hunan province and has tapped into a surging Chinese interest in cosmetics and cosmetic surgery — luxuries beyond the means of most a generation ago, but gaining in popularity as incomes grow.

Consumers have quickly developed their own tastes, no longer chasing Hollywood's notion of perfection but opting for their own traditional aesthetic.

Zhang Xiaomei, a publisher of fashion magazines in Beijing, says that early blunders taught doctors and patients that cosmetic surgery needed to be customized for the Chinese face.

"It was popular to do a surgery 10 years ago, a so-called European-style double eyelid that really made eyes sort of pop and appear more Caucasian but it didn't look good and Chinese women have learned from that," said Zhang.

High noses and super-plump pouts have also fallen out of favor, she said, giving way to techniques that play up, instead of distort, Asian beauty.

Asked whom they wanted to look like, "Cinderella" contestants rattled off only Asian names: Li Jiaxin, a former Miss Hong Kong; actress Maggie Cheung; and Kim Hee-sun, a South Korean soap opera star.

This full embrace of beauty is a contrast to 30 years ago when even primping could be seen as counterrevolutionary.

"Your whole life was dedicated to revolution, to the Communist Party, to struggling for the communist cause," said Zhang.

Watching the taping of "Cinderella" with approval, Lu Zaining, mother of beautician Chen, agreed things had changed.

"People then would have criticized you for putting on lipstick," she said. "Back then, we couldn't imagine having a television."

In the southern city of Changsha, where "Cinderella" is taped, spas offer seaweed wraps and slimming massages, and in plastic surgeon Li Fannian's Yahan Cosmetic Surgery Clinic, posters for implants called Magic Peach and Dream Xcell show ivory-skinned women with bursting cleavage.

The clinic's most commonly performed surgeries are minimizing eye bags, sculpting noses and shaving the jawbone to soften the face.

Chinese ideas of physical perfection today jibe with ideals espoused for centuries in Chinese literature and art, Li said, describing wide, bright eyes and a face "shaped like a goose egg or a sunflower seed."

Double eyelid techniques today are much more subtle and give the appearance of larger eyes, he said, but do not try to make Asian women look Caucasian.

"Cinderella" contestant Yang Shaqin, a Beijing undergraduate, said she always wanted to look more like her mother. After eight procedures, she no longer felt like an ugly duckling but insisted she would never date a man shallow enough to have cosmetic surgery.

"We have a Chinese saying, 'A man should possess talents and a woman grace,'" Yang said. "Men shouldn't be worried about these trivial sorts of things."
These trivial things are driving a booming industry. And Chinese men are also not shy about using products and sometimes surgery to look better.
About 10 percent of the clients at the Yahan clinic are men, said Li, and the concept of the metrosexual has arrived, known in Mandarin as "dushi yunan" or "urban pretty man." They spend an average of $10 a month on grooming products, according to a report in the official Xinhua News Agency in December.
Xinhua cited a survey of 2,239 men aged 18 to 60 in seven Chinese cities that found men in Shanghai to be the country's most vain because they spent just over 17 minutes a day gazing in the mirror.
Men and women together spent $12 billion on beauty products in 2005, up 13 percent from the previous year, according to the China Association of Perfume, Essence and Cosmetics Industry.
The United States Cosmetic, Fragrance, and Toiletry Association last year called China its "largest future growth market," and companies like Avon Products Inc., Mary Kay Inc., L'Oreal SA, and Procter & Gamble Co. are all fighting for a share.
Zhang, the publisher, estimates there are about 1 million plastic surgeries a year in China. In the United States, with less than a quarter of China's population of 1.3 billion, twice as many operations were performed in 2005.
Hao Lulu, a Beijing fashion writer and aspiring actress, became a sensation in the Chinese media — which dubbed her the "Artificial Beauty" — after she had 16 surgeries to redo her eyes, lips, nose, cheeks, neck, breasts, upper arms, buttocks, thighs and calves.
China, which had virtually no cosmetic surgery a few decades ago, now claims to be an innovator. Last year, a military-run hospital announced it had become the second facility in the world after France to attempt a complex partial face transplant — grafting a donated nose, upper lip, cheek and eyebrow onto a farmer who had been mauled by a black bear.
The risks some take for beauty can be harrowing, especially in an industry that lacks regulation.
Wang Junhong, a 37-year-old fashion retailer from Guangzhou in south China's Guangdong province, collected elegant European trousers that she adored but couldn't wear because she was only 5 feet 2 inches tall.
So she spent $9,700 to gain two inches in a procedure that involved breaking her legs, driving pins into the bone and gradually cranking the pins apart to lengthen the bones as they heal.
"The more I thought about doing it, the more I was convinced I had to do it," said Wang, as she lay in a hospital bed in 2005, her legs encased in brutal-looking frames with spokes that jabbed through her legs.
Her treatment went smoothly, but Chinese media frequently report on bungles that result in deformity and infection. In November, the Health Ministry banned the procedure except for medical reasons.
But height increases job prospects and help-wanted ads sometimes stipulate the requirements for white-collar posts.
"Taller people will have more opportunity for promotion," said Sun Honggang, an editor for Human Capital and Career Post, a Beijing newspaper dedicated to employee recruitment.
"Lovely Cinderella" producer Wang Zhiyi said that while his show is meant as entertainment, it's also cautionary. The footage is graphic, showing grotesquely swollen postoperative faces and surgeons vigorously sucking fat from a contestant's waist.
A video clip shows Chen, the beautician, crying out on the operating table for her husband and for more anesthetic. Later, she is shown throwing up and weeping in her hospital room because she misses her 5-year-old son.
But as she gazes at herself in front of the studio audience, the memories seem to evaporate like the theatrical fog blasted out of fire extinguishers before she stepped to the mirror.
What would Mao, leader of China from the 1949 revolution until his death in 1976, make of "Lovely Cinderella"?
Chen, born in Mao's hometown of Xiangtan in Hunan, laughs.
"How can I answer that?" she says. "I think that people today, with their more liberal ways of thinking, are at a place where if someone has an opportunity to change their life and become more confident, then everyone would want to support that."

Medical marijuana clinics face crackdown

Sun, 11 Mar 2007 11:14:07 GMT
By ANDREW GLAZER, Associated Press Writer
LOS ANGELES - Federal agents trailed Sparky Rose as he drove a Porsche Carrera convertible to his medical marijuana clinic. Under California law, clinics are supposed to dispense marijuana just to seriously ill people and clinic owners are to get only "reasonable compensation." But to the U.S. Drug Enforcement Administration, the sports car suggested that Rose might be pocketing big money from his purportedly nonprofit clinic, New Remedies Cooperative.
Rose was arrested in October and accused of illegal drug trafficking — charges he denies. According to court papers, an investigation turned up records showing $2.3 million was deposited in a New Remedies bank account over eight months starting in December 2005, and Rose wrote himself weekly checks of $9,600.

California was the first of 12 states to allow the sale of marijuana for medicinal purposes, mainly pain control, and is regarded as having the loosest regulations.

Oversight is lax and there are few specific guidelines for buyers and sellers of a drug still illegal under federal law.

Who can open a clinic, what constitutes reasonable compensation and who can grow and supply marijuana are all open to broad interpretation — factors that have helped fuel a surge in new clinics, to about 400 statewide. Los Angeles alone has about 100.

Oakland, Santa Rosa and even famously permissive West Hollywood are among cities that have imposed moratoriums on new clinics amid concerns owners and buyers are abusing the law. Los Angeles Police Chief William Bratton has called for a similar moratorium in his city.

The DEA also has taken notice, embarking on a stepped-up effort targeting clinics run by people who appear to flout the reasonable compensation provision.

Federal officials raided 11 Los Angeles-area dispensaries in one day in January, the largest such crackdown. They returned to one of the clinics in West Hollywood this past Wednesday, breaking down a door and seizing additional records.

DEA spokeswoman Sarah Pullen said authorities chose clinics that were making big money, had become hot spots for crime or were part of large franchises. The raided clinics on average raked in $20,000 in profits each day, she said.

Many clinics were buying pot wholesale from street dealers and reselling it for twice the roughly $100-an-ounce black-market rate, Pullen said. "It's become something we can't ignore," she said.

That investigation is continuing and has yet to produce any arrests or charges. Some clinics have remained closed while others reopened.

West Hollywood City Councilman Jeff Prang said the federal government should leave it to local governments to monitor and regulate marijuana dispensaries that provide relief for those suffering from cancer, Parkinson's, http://www.freesparky.org — "My dispensary was a nonprofit and to paint me or my employees as profiteers is simply appalling."
He also wrote that the silver Porsche was leased and valued at less than $50,000.
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News Researcher Judy Ausuebel contributed from New York.