Re: Need advice on clinical trials


mainframetech wrote:
J,
Thank you for the information. Peter may also appreciate it, since
he had asked me for that type of info. He might want the link to it.

Actually I had previously seen this case. Read my comments to J.


Peter,
Please stop taking personal issue with what I say. I promise I'm
not out to insult you, only defend my point of view from your
viewpoint.


Artemisinin is not simply an alternative herb. Not if the Gates
Foundation is applying it to many patients for malaria. Interestingly
enough, if you have a medical background you'll appreciate that the
scientists and doctors that have commented on the Artemisinin studies
say that it kills cancer in the same way it kills the malaria parasite.
It apparently is drawn to the iron-rich cancer (or malaria host) cells
and kills the cells (apoptosis?) when in the presence of an
overabundant amount of iron. It seems to leave the normal cells alone.
You can see where this method would be more able to kill cancer in the
fine interstices of the body that surgery or maybe directed radiation
might miss. Happily, because of the Gates Foundation, we know the
compound is safe for humans, and painless.

Again, I suggest to all seekers here to research 'Artemisinin' and
the 2 doctors that have been studying it; Drs. Henry Lai and Narendra
Singh at the University of Washington. This compound can be taken at
the same time as many other treatments and not get in the way. I think
there is only a problem with radiation therapy where you have to wait a
while. Have a look at the compound and make your decisions.

But understand that these are test tube studies and that just about
anything will kill cancer in the test tube. There is still no
evidence that Artemesinin is effective against cancer in humans, or
superior ot other chemotherapeutic agents when used in optimal dosages,
or even that the effective dose against cancer is known. And it may
interfere with other treatments, if it is effective. It is one of
those things to try when there are no other options of known usefulness
in treatment or palliation..

I have also just received information that there is a lot of fake
Artemesinin about. See the following ---

Fakes, bottlenecks hobble herb's fight vs malaria

By Tan Ee Lyn

HONG KONG (Reuters) - Li Guoqiao was a village doctor in
China's southwestern Yunnan province in 1974 when the
government asked him to try using an herbal drug,
artemisinin, to treat malaria patients.

What followed was one of China's first clinical trials
using the herb, and the results were startling. All 18
patients felt better within hours and recovered a few days later.

"Within 2 hours, their fever came under control. One of
them was a woman who had just suffered a miscarriage and
was unconscious when she was brought in. She recovered,"
said Li, now a professor at the Tropical Medicine Institute
in Guangzhou University of Traditional Chinese Medicine in
southern China.

Chinese herbalists used leaves from the Artemisia annua, or
sweet wormwood shrub, to treat mosquito-borne malaria for
more than 1,500 years. But it was not until the late 1960s,
that scientists identified the anti-malarial ingredient in the plant.

Today, artemisinin is widely regarded by medical experts as
the best drug against malaria -- which kills a person every
30 seconds. According to the World Health Organization
(WHO), 90 percent of these deaths occur in sub-Saharan
Africa.

In 2001, the WHO said artemisinin should be used in
combination with other drugs to slow down any development
of resistance.

But artemisinin is in short supply and this fact, plus the
high pries charged for it, have led to the production of
fake drugs, in some cases causing death.

"Fake drugs are all over the place and they are really
creating problems in Asia. We are afraid they might get
into Africa too as demand increases," said Kevin Palmer,
WHO's regional adviser for malaria in the Western Pacific.

Fakes seized in recent years in Vietnam, Cambodia and
Thailand contained no artemisinin.

"They are easy to fake, 97 percent of fakes seized are just
chalk. It's very worrying ... someone is making millions,"
Palmer said, adding that Interpol was investigating the cases.

Professor Li said: "These people are very sick and after
eating these pills, they are ineffective and the victims
become unconscious and die. This is very unethical."

In Thailand, government workers conduct spot tests at least
twice a year in districts where fake anti-malarial drugs are
known to have surfaced. These districts are typically along
the Thai-Cambodia and Thai-Myanmar border.

"We use our equipment, called mini-lab, to check the drugs
in the field to see if they are genuine," said Wichai
Satimai of Thailand's Public Health Ministry.

While there are no official figures of deaths from fake
anti-malarial drugs in Thailand, Wichai said results were grave.

"Fake drugs cause complications and higher mortality. If
the drug is sub-standard -- say it has only 50 percent of
the active ingredient -- it can't kill the whole protozoa
(parasite). It will produce drug resistance," Wichai told Reuters.

FAKES AND BOTTLENECKS

Malaria is one of the world's oldest diseases and infects
between 300 million and 500 million people each year, killing
over a million of them, according to WHO. It is also an
economy killer, with the drain on African output estimated by
WHO at $12 billion yearly.

It is caused by protozoan parasites, which thrive in humans
and are passed person-to-person by female Anopheles
mosquitoes.

There is no vaccine against the parasite, which has grown
resistant to well-known anti-malarial drugs, like chloroquine
and pyrimethamine.

In early December, the World Health Organization launched a
new global effort to find a vaccine by 2015. In the
meantime, artemisinin-based combination therapies (ACTs)
remain the most effective cure for the disease.

But supplies are tight.

"Supplies of the raw material (artemisinin) from China and
Vietnam are limited. It's a natural product and they aren't
growing enough to supply the world's demand," said Palmer.

Developing countries must buy ACTs from WHO-accredited
suppliers if they want to use funds from the U.N.-backed
Global Fund to Fight AIDS, Tuberculosis and Malaria. So far,
only two suppliers -- Swiss drug maker Novartis AG and Guilin
Pharmaceuticals Company in China's southwestern city of
Guilin -- are WHO-accredited.

Launched in 2002, the Global Fund makes up about two-thirds
of financing to prevent and treat malaria and it is the
main financier of developing countries' scale-up of ACT
drugs.

The Chinese drug maker will soon be switching production
from artemisinin to ACTs. And that has increased fears of fakes.

"The people in Guilin are now worried that they (makers of
fakes) will start copying their artesunate combination
tablet, which they are producing for Africa. They are
really scared," Palmer said.

One way to beat ACT fakes is to get more genuine suppliers
accredited with WHO.

"The main producers of combination therapies are in China
and Vietnam, but most of them don't meet international
standards. They are not available for purchase by the Global
Fund although they can be marketed as they are," said Palmer.

WHO is working with producers to improve their production
facilities and quality control, he said.

"In many cases, these drugs are not getting to the people
who need them, they are using less effective drugs because
that's all they can afford," he said. "It's a real crisis at
the moment."


Peter Moran

.

Relevant Pages

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  • Re: Need advice on clinical trials
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