Take your meds

[Guest guest]

The New York Times Sunday magazine has a longish article about Chinese

Western Medicine industry and the FDA. You may have to register with

NYT (which is no big deal) to read it. Basically it says that much of

our medications now come from China and they aren't being inspected.

Below is an excerpt....

 

 

http://www.nytimes.com/2008/11/02/magazine/02fda-t.html?ref=magazine

 

 

 

China's leap to one of the biggest suppliers of pharmaceutical

ingredients in the world happened over the last decade, as the Chinese

government subsidized the construction of manufacturing plants that

have undercut prices everywhere. Generic drug makers in the United

States, where price competition is fierce, were the first to seek

cheaper drug ingredients in China. Last year, generic drug

applications to the F.D.A. listed 1,154 plants providing active

pharmaceutical ingredients: 43 percent of them were in China, and

another 39 percent were in India. Only 13 percent were in the United

States. Branded drug makers, with their fatter profit margins,

resisted buying ingredients from China for years, but with their

businesses now suffering, even major pharmaceutical companies like

AstraZeneca, Bayer, Baxter and Pfizer have announced deals to

outsource manufacturing to China.

 

The F.D.A.'s apparent inability to keep names straight is no trivial

matter. One reason the agency failed to inspect the Changzhou plant

that produced deadly heparin, for instance, was that someone mixed up

the facility's name and concluded that the plant had already been

inspected. Chinese plant names, a vestige of its once strictly

controlled economy, are often very similar, and translations can vary.

For instance, there are 57 separate drug master files — the basic

F.D.A. record of a plant's name, location and approved product — with

" Shanghai " in the name. Some are obvious repeats, like the ones for

" Shanghai No. 6 Pharmaceutical Factory " and " Shanghai Number 6

Pharmaceutical Factory. " But others could be separate plants. Or maybe

not. It's just too hard to tell.

The record is particularly bad in China. Over the past six years, the

F.D.A. has managed to inspect annually an average of just 15 of the

714 Chinese drug plants that export to the United States. At its

present pace, the F.D.A. would need more than 50 years to visit all of

these Chinese plants. By contrast, the F.D.A. inspects domestic drug

plants every 2.7 years.

 

Inspectors volunteer for the grueling overseas assignments, and, it

turns out, they don't much like traveling to parts of Asia. " I went to

Taiwan once, and after initially spending a night in a very nice

hotel, I was transferred several hours by car to a hotel closer to the

plant, " recalls DeVaughn Edwards, who worked as an F.D.A. inspector

for 14 years until he left in 2006. " The bed consisted of two

mattresses on the floor. There was no lock on the door. You had to

hope that no one came in. It was dark; there were no amenities, no TV

that worked. There was a shared restroom down the hall. It was only

one night there, but it was enough to make you not want to revisit the

plant or spend too much time there. "

 

When inspectors do go to China, their reports sometimes read like a

bureaucratic rendering of Mark Twain's " Innocents Abroad. " During a

2001 trip, for example, two F.D.A. inspectors visited a plant that was

exporting acetaminophen to the United States. The plant had never been

inspected. " The F.D.A. inspection team was met at the hotel in Wenzhou

by representatives from Wenzhou No. 3 Pharmaceutical Factory and . . .

transported by public ferry and then company vehicle to the

manufacturing facility on Dong Tou Island off the coast of Wenzhou, "

their report states. " There is no street address or plot number, and

the address of the facility is given only by the county and province. "

 

Once the team arrived in what seemed like the middle of nowhere, the

inspectors learned the drug was being manufactured at another plant —

one that once had a similar name but had recently changed it. " In

fact, " the report continues, " inspection found that there were

initially three separate and independent firms operating under the

names Wenzhou No. 1 Pharmaceutical Factory, Wenzhou No. 2

Pharmaceutical Factory and Wenzhou No. 3 Pharmaceutical Factory. The

location of Wenzhou No. 1 Pharmaceutical Factory was also determined

by the F.D.A. inspection team during the visit to Wenzhou, and it was

learned that the firm is operating under a new Chinese name; however,

the English translation of that name was not available. " So the two

inspectors flew back to the United States — at taxpayers' expense —

never having inspected a thing.

[Guest guest]

Douglas

Really makes you feel comfortable about the products we use

 

 

 

400 29th St. Suite 419

Oakland Ca 94609

 

 

 

alonmarcus

 

 

 

 

 

 

 

 

[Guest guest]

How does the Chinese herb manufacturing industry compare to Taiwan's? My

perception is that it is superior, more legitimately regulated in Taiwan

than in PRC. Would anybody closer to that industry care to comment on that?

 

On Sun, Nov 2, 2008 at 11:24 AM, alon marcus <alonmarcus wrote:

 

> Douglas

> Really makes you feel comfortable about the products we use

>

>

>

 

 

--

, DAOM

Pain is inevitable, suffering is optional.

 

 

 

[Guest guest]

Having worked one of the big 5 Pharma Giants, I can say that not only

is China involved in the manufacturing, but also India.

 

Al, to answer your question, I have also been told that the in TAWAIN,

GMP methods are employed to ensure a high quality product void of

contamination.

 

Just recently, it was announced that virutally every single milk-based

product had been contaminated from China. China supplies staples such

as milk, which companies that make everything from twinkies to

ding-dongs to half & half use. Therefore, it was implied that a huge

amount of these American sold products were contaminated with a

chemical that can cause neurological disorders, as well as birth-defects.

 

We need to be very aware that the sourcing from China is being used in

everything from Meds to food...food that we all eat even if we shop at

Whole Foods...

 

In our society, purity is being harder and harder to maintain.

 

That's why I am attempting to grow all my own food. The only thing I

cannot control is my neighbor, and he or she not using chemicals that

would eventually end up in my soil, since we are adjacent to each other...

 

, " Al Stone " <al wrote:

>

> How does the Chinese herb manufacturing industry compare to Taiwan's? My

> perception is that it is superior, more legitimately regulated in Taiwan

> than in PRC. Would anybody closer to that industry care to comment

on that?

>

> On Sun, Nov 2, 2008 at 11:24 AM, alon marcus <alonmarcus wrote:

>

> > Douglas

> > Really makes you feel comfortable about the products we use

> >

> >

> >

>

>

> --

> , DAOM

> Pain is inevitable, suffering is optional.

>

>

>

[Guest guest]

On Sun, Nov 2, 2008 at 12:16 PM, d.siena <sienasmiles wrote:

 

> Al, to answer your question, I have also been told that the in TAWAIN,

> GMP methods are employed to ensure a high quality product void of

> contamination.

>

 

 

 

 

 

My PRC provider also promotes their products as passing (Australian?) GMP.

The problem is that everyone touts " GMP " but that is meaningless in a

marketplace where adulterated products are so widespread.

 

Then there's the question of who's GMP is one following, and how rigorous is

the accreditation process?

 

 

--

, DAOM

Pain is inevitable, suffering is optional.