(US/CN) Animal Tester

[Guest guest]

Animal Tester

Jehangir Pocha

Forbes.com

10.30.06

 

An American venture helps pharmaceutical companies outsource touchy lab work to

China.

 

With pressure groups and rising costs making it difficult for Western

pharmaceutical firms to expand their animal testing laboratories at home, Glenn

Rice has pioneered outsourcing of this work to China.

 

Rice, 50, is the decorous chief executive of Bridge Pharmaceuticals, a contract

research organization in the San Francisco Bay area. He splits his time between

there and the labs in Beijing, where scientists are cheap and plentiful and

pesky protesters held at bay.

 

" This is a country with a large number of canines and primates, and if we

establish preclinical testing facilities here, we can change the dynamics of the

industry, " says Rice, who spun Bridge out of sri International in Menlo Park,

California in 2004. " Animal testing also does not have the political issues it

has in the U.S. or Europe or even India, where there are religious issues as

well. So now big pharma is looking to move to China in a big way. "

 

It's being welcomed with open arms. The Chinese government, which has already

turned the country into the world's factory, is now eager to move its economy up

the value chain and turn China into the world's biology lab. Beijing is fast

becoming China's leading biotech center, and Bridge, situated in the lush sprawl

of the city's Zhongguancun Life Science Park, has been given " big benefits and a

five-year tax holiday " for being here, says Rice.

 

" But beyond that, it's the whole menu of advantages that attracted us, " he says.

" In terms of animal supply China is a good place to be, as it is the world's

largest supplier of lab monkeys and canines [mostly beagles]. The physical

infrastructure is great, people of the kind we hire speak some English, and

costs are about one-fourth of those in the U.S. "

 

All of this will allow Bridge, which has raised about $26 million from private

equity investors, to be profitable in just a year on $6 million in revenues,

says Rice. With pharma majors Roche, Pfizer (nyse: PFE - news - people ) and Eli

Lilly (nyse: LLY - news - people ) all having announced plans to set up research

units in China recently, midsize pharmaceuticals that can't afford similar

setups are increasingly looking to outsource their animal testing (or

" preclinical trials " ) to companies such as Bridge. Rice declines to name any of

his clients. But he says outfits like his can offer prices less than half those

charged by U.S. competitors. That's why the global preclinical outsourcing

industry, which was worth $2 billion last year, could double by 2008.

 

But in this business, the bottom line alone can't swing many arguments, at least

not publicly. Rice says outsourcing research to China will also benefit hundreds

of thousands of people suffering from uncommon and " orphan " diseases, deadly

illnesses that afflict small numbers of people but remain incurable as the

market for drugs to treat them is too small to merit research. Given the steep

cost of drug development and the steeper rates of failure, " unless there is a

market of about $500 million a year for a drug, big pharma companies will not

invest in it, " says Rice. " In China we can reduce the cost of research, so

suddenly it becomes feasible to develop drugs for orphan diseases, like

Huntington's disease, which we are working on for a client. "

 

Yet it's hard to shake the aura of tension that surrounds animal testing. U.S.

regulations generally require that all drugs must be tested on at least two

species before being submitted for approval by the Food & Drug Administration,

and Bridge's Beijing facilities are designed to experiment on rats, mice,

rabbits, dogs and monkeys. The animals are bred for laboratory use and must be

kept germ-free; in their stark white rooms, numerous dials and meters monitor

air quality, temperature and humidity.

 

Great attention is also paid to how often the animals' cages are cleaned and how

often they are exercised. But the moral questions about inflicting pain and

suffering on animals to comfort and cure humans can't be so neatly addressed.

Technicians in Bridge's lab hold white mice in the palms of their hands, pinch

their ears back and inject them with test chemicals as they squeal. On other

floors rabbits and beagles will also be infected with diseases, have surgery

performed on them, be fed substances that will have an unknown effect on their

health and have their organs removed, examined and weighed. Yet the dogs, for

example, innocently leap up and paw playfully at the very scientists who

experiment on them.

 

Keeping the animals in such carefully controlled and monitored environments is

expensive (even in China), tedious and--because Bridge adheres to U.S.

standards--heavily regulated to try to minimize pain. For example, testing is

conducted on animals only after a committee decides there is no other way to

acquire the required data. If the test involves surgery, steps requiring

adequate anesthesia, recovery time and postoperative care must be followed.

 

" Unfortunately there is no substitute to testing on live animals, " says Rice.

" Predictions from the test tube are just not there yet as the test tube is just

not as dynamic as the physiology in the body. If we stopped animal testing, new

drug development would stop short. "

 

Yet campaigners in the West, such as the People for the Ethical Treatment of

Animals (PETA), want industry to invest more in developing and validating

replacements for animal testing such as human tissue cultures, donated blood or

silicon chips lined with human cells.

 

Some radical groups have broken into animal testing laboratories to free their

furry inmates and even bombed research centers. Rice says this is " just not an

issue " in China. Living under an authoritarian state has made most Chinese

congenitally wary of public protest and challenging friends of the state, as

most international drug companies undoubtedly are.

 

" We believe in engagement rather than protest, " says Lu Di, 75, of the Chinese

Association for the Protection of Small Animals in Beijing. Her tiny office is

overrun with wounded and discarded animals, including a fluffy feline who likes

to sip from water glasses. " Animal testing is inevitable, and we want to focus

on advocating companies and universities to use the best standards and processes

they can to minimize any pain caused to the animals, " Lu says.

 

With Chinese NGOs effectively muzzled, Jason Baker, PETA's Asia-Pacific director

in Hong Kong, says his group is lobbying shareholders of Western pharmas to ban

animal testing being outsourced to countries and contractors that do not follow

U.S. standards of animal care. " PETA submitted shareholder resolutions to more

major pharmaceutical and chemical companies last year, requesting that

contractors be held to the same standards as in-house company laboratories, "

says Baker. " We are very concerned about this recent and disturbing trend of

companies to contract with laboratories in countries in which animal welfare

oversight is poor and public awareness is low. There is no doubt this is

intended to circumvent American animal welfare laws, as minimal and unenforced

as those may be. "

 

Rice says such actions don't worry him because Bridge isn't in China to take

" shortcuts on animal welfare. " Its Beijing vivariums will soon be approved by

the U.S.-based Association for Assessment & Accreditation of Laboratory Animal

Care, he adds. (PETA and Lu's group, however, are troubled by operations in

China generally.)

 

China's own standards for animal testing are poorly designed, Lu says, and it's

unclear how the industry will be regulated across the country if contract

research does indeed boom.

 

Rice is also wary. " When we first looked at China, we tried to use local

companies, but they just didn't have the quality control and standards, " he

says. " We've built our own organization so we can control every aspect of it,

and we spend a lot on hiring the best people and training them. "

 

Bridge's Beijing operations are headed by Ada Kung, a Taiwanese national who has

studied and worked in the U.S. Without Kung and a core team of five other

expatriates, Bridge would not be able to maintain international standards, Rice

admits. But he says he has no doubt contract research firms such as Bridge will

soon help China morph into a major player in the pharmaceutical industry . " I'm

amazed by their determination to learn from us, " he says. " Today it may seem

like it's too early to do much more than we are doing in China. But tomorrow, or

the day after, it'll be a different story. "

 

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