Experimental Drugs. Your Moral Compass?

[PaPaPeng]

Here's a good one for you to think about. Its this a good thing, a
benign thing or something evil and so like China to put people's lives
at stake?

Experimental drugs flourish in China
January 9, 2008
http://www.atimes.com/atimes/China_Business/JA09Cb02.html

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."

(Inter Press Service)