- Hello Jeff - The boom in China's experimental drugs may
sound promising to those of us with terminal illness however, one worries
about safety issues.
- Are these drugs being rushed to market without proper
preliminary safety protocols? As with the case of stem cell
harvesting from umbilical cord and amniotic fluid, have the donors been
screened for HIV/AIDS, HBV/HCV? Even worries of prion disease make
me wonder about the safety risks.
- I think we all need to slow down and look very closely
at the biotech boom in China. We know that many bogus drugs
have entered the world pharmaceutical market from China.
- China is also expanding its vaccine research. Again,
countries around the globe rely on vaccine to protect against disease.
As we know, vaccine is NOT a silver bullet and hope of a Bird Flu vaccine
for H5N1, in my opinion, is definitely NOT going to be a miracle preventative
measure against bird flu.
- As with most things in life, if it looks to good to be
true, it probably isn't.
- China Business
- Experimental drugs flourish in China
- 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
- 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
- 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
- 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,
- 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
- 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)
- Patricia A. Doyle DVM, PhD
- Bus Admin, Tropical Agricultural Economics
- Univ of West Indies
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