BROOKLIN, Ontario,
Canada - China's booming medical biotechnology
industry is producing controversial drugs and gene
therapy treatment programs that are being sought
out by critically ill foreigners seeking potential
cures unavailable elsewhere.
China's Beike
Biotechnologies harvests stem cells from the
umbilical cord or amniotic membrane and injects
them into patient's spinal region. More than 1,000
patients, including 60 foreigners, have been
treated for a variety of conditions including
Alzheimer's disease, autism, brain trauma,
cerebral palsy and
spinal cord injury, according
to a study published Monday in the journal Nature
Biotechnology.
"We met foreigners there
who were happy with Beike's treatments," said
Peter Singer of the McLaughlin-Rotman Center for
Global Health at the University of Toronto and
co-author of the study.
However, China's
regulatory agency, the State Food and Drug
Administration (SFDA), did not require clinical
trials, making it difficult to evaluate the
efficacy of these therapies, Singer said. It is a
controversial approach and Beike and others in
China would be considered "rogue companies" in
North America or Europe, he said.
Although
less than 10 years old, China's medical biotech
industry has become both an innovator and a place
where the world's biggest pharmaceutical companies
contract out their very expensive clinical
research and trials. One of China's largest firms,
WuXi PharmaTech, is listed on the New York Stock
Exchange and recently acquired a US biologics
firm.
"The Chinese biotechnology industry
is like a baby dragon, which will grow quickly and
soon become hard to ignore," Singer said.
In 2007, China had sales of US$3 billion
in biopharmaceuticals, dwarfed by the $59 billion
in sales by US biotechnology companies in 2006,
according to the accounting firm Ernst & Young
LLP.
Singer and colleagues interviewed 22
Chinese companies to obtain the first detailed
analysis of developments in the rapidly growing
but largely unknown health biotech sector.
Spurred by government investment, China
developed the world's first commercialized gene
therapy product called Gendicine. It is used in
the treatment of head and neck cancers and more
than 5,000 patients have been treated so far,
about 400 of them from overseas. The drug is
currently undergoing further clinical trials in
China for several new indications, including
liver, abdominal and pancreatic cancer.
Chinese firms are also developing vaccines
to address both local and global needs. They
include Shanghai United Cell Biotech, which is
manufacturing and marketing one of only two oral
cholera vaccines available worldwide (and the only
one available in tablet form). Other firms are
working on an oral HIV vaccine and novel vaccines
against Japanese Encephalitis, SARS and pandemic
avian influenza (H5N1 strain).
However,
China's primary focus is on meeting the health
needs of its 1.3 billion inhabitants.
"China is not just a low-cost
manufacturer. It is investing in drug research and
development," said co-author Sarah Frew, a
research associate at the McLaughlin Rotman Center
for Global Health. "There are many innovative
products either on the market or close to being
marketed."
Shanghai's Sunway Biotech
Company has developed a gene therapy treatment for
cancer called H101, which is licensed by Onyx
Pharmaceuticals Inc of California. Sunway did all
of the clinical development and trials and brought
the product to market far faster and less
expensively than Onyx could have, she said.
Experts note that China is the world
leader in gene therapy simply because US and
European companies have much tougher safety and
efficacy requirements.
Gene therapies use
genetically engineered viruses to transport
genetic material into the nucleus of cells that
are malfunctioning. No such therapy has been
approved by US regulators as safe and effective.
Human testing has been temporarily stopped several
times in the US and Europe because of patient
deaths.
"Regulations to protect patients
in China are considerably weaker than in the US,"
said Peter Laurie, deputy director of Public
Citizen's health research group, a
Washington-based non-profit watchdog group.
A few years ago, US researchers working in
China deliberately infected Chinese AIDS patients
with malaria in hopes the resulting malarial fever
would destroy the AIDS virus. Such experiments are
illegal in the US, and widely considered dangerous
and unethical, Laurie said.
"Any foreign
company doing clinical trials or clinical research
in China is ethically suspect unless it's doing so
to improve the health of people there," he said.
International standards for drug testing
are rigorous, time-consuming and expensive, but
they are crucial to protect patients, he added.
Frew says China's drug safety regulator,
the SFDA, is modeled on the US Food and Drug
Administration. "The standards are quite high but
enforcement has been tainted by corruption," she
said.
Last July, Zheng Xiaoyu, the head of
the SFDA, was executed for taking bribes from
companies to approve their products, including an
antibiotic that killed several people. Since that
scandal, the SFDA has been much stricter and more
serious about rebuilding its credibility, said
Frew.
However, China's researchers do not
always follow international standards and are
unlikely to be able to export their products or
therapies to the developed world in the near
future. That's one reason why China's medical
biotech hasn't grown faster.
The study
notes that international investors see enormous
potential in the sector to become the world's
pharmacy for generic drugs and the next generation
of drug and treatment blockbusters. But there has
been little outside investment thanks to poorly
enforced regulations and China's uncertain
financial system, rigid restrictions on the export
of capital and continuing doubts about the Chinese
government's protection of intellectual property
rights.
"China still has one foot in the
closed society of the past," said Singer. "For the
sake of both national and global health, we hope
China will embrace the financial and regulatory
reforms needed to attract the venture capital
required for sustained innovation in the health
biotech sector."
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