Friday, February 15, 2008

We really need to panic more - FDA inspection of Chinese drug suppliers

I remember the good old days. Back then, the public panicked about apple's sprayed with relatively harmless insecticides. In those days we panicked about everything.

Ok, so we still see insane full page ads in the NYT accusing immunization of inducing a plague of autism. On the other hand, where's the panic about our drug supplies?

The FDA would take 40-50 years at its current rate to inspect today's Chinese drug manufacturers?! Plants like the one producing defective Heparin?! ...
F.D.A. Broke Its Rules by Not Inspecting Chinese Plant With Problem Drug - New York Times

... Baxter International announced on Monday that it was suspending sales of its multidose vials of heparin after four patients died and 350 suffered complications, many of them serious. Baxter bought the active ingredient for this product from Scientific Protein Laboratories, which has plants in Waunakee, Wis., and Changzhou City, China...

... Ms. Gardiner said that recent tests by Baxter had found subtle chemical differences among the lots that Scientific Protein shipped to Baxter “but it is unclear what impact the differences would have” on Baxter’s heparin product.

Dr. Ajay Singh, director of dialysis at the Brigham and Women’s Hospital in Boston, said he was astonished by what he called the many failures to ensure a safe supply of heparin. There are 450,000 people in the United States on dialysis, and nearly all of them need copious doses of heparin, he said. Heparin is also used in cardiac surgery and among chronic care patients.

“We need to ensure that this country has access to the crucial medicines it needs,” Dr. Singh said. “This is a national security issue.”

The heparin scare comes at a particularly delicate time for the F.D.A. Over the past year, a wave of tainted goods from China, including deadly pet food ingredients and tainted fish, has prompted concern about whether regulators are adequately monitoring imports’ safety.

The Government Accountability Office released three reports in recent months that found that the drug agency provided little oversight of the increasing number of foreign plants that export food, drugs and devices to the United States.

Although the agency must inspect domestic drug plants once every two years, the investigators found that it inspected foreign drug plants at best once every 13 years. The agency’s record in China, now one of the biggest drug suppliers in the world, is even worse. Of the 700 approved Chinese drug plants, the agency has been able to inspect only 10 to 20 each year and would need 40 to 50 years to inspect them all.
Really, this would be a great time for panic.

Instead the American public behaves like a pithed frog -- a study in learned helplessness.

We really, really, need to get the GOP completely out of power.

Update 2/15/2008: If our medication supply is having quality issues, they would not all be as obvious as fatalities. They might only show up in large scale studies ...


Anonymous said...

“The American public behaves like a pithed frog,” ah yes and how very right you are Gordon!

The consensus trance that has fixed the American public in a state that can be described as you have done, lots of images come to mind but they are all overshadowed by the seriousness of the situation, is very troubling.

I really have doubts about any awakening taking place. The GOP and a spineless Democratic party that has proven unable to exert any will upon the travesties that are unfolding. The most basic underpinnings of the culture we live in proceed to be eradicated with not a whimper from those who should, or could, put a stop to it.

We are in dire straits and would be blessed if it where about the "Sultans of Swing." But alas the American Dream once achieved, continues to need to be fed, and therein lies the bitter pill of materialism, the pill that not only takes our all but also puts one to sleep.


Anonymous said...

I majorly agree that we need to get the GOP completely out of power. How this can be done needs some creative courage and probably cannot be accomplished via parliamentary means at this point (that's how I see the situation). I would love to be wrong about that.

And, Alan, you put it very well--"the most basic underpinnings of the culture we live in proceed to be eradicated with not a whimper from those who should, or could, put a stop to it". We are losing our basic rights ...or, more correctly, those rights are being taken away from us, by our government. At the same time, a system to provide essential health care, that every American should be entitled to, is not only missing from GOP agenda, but runs contrary to it. This is one, but certainly not the only, travesty.

Regarding the horrendous problems and potential disasters with imported Chinese products, some very serious improvements in inspection are needed. And how nice it would be to put reasonable limits on these imports.

Thanks for listening...

Clara Landau