Yesterday in the NYT:
Federal drug regulators said Wednesday that a critical blood thinner that had been linked to at least 19 deaths and whose raw components were produced in China contained a possibly counterfeit ingredient that mimicked the real drug.
Routine tests failed to distinguish the contaminant from the drug, heparin. Only sophisticated magnetic resonance imaging tests uncovered that as much as 20 percent of the product’s active ingredient was a heparin mimic blended in with the real thing. Federal officials said they did not know what the contaminant was.
Beginning in November, public health officials received reports of patients experiencing severe allergic reactions after being given Baxter’s product. Baxter initiated a series of recalls that culminated last week in a withdrawal of nearly all of Baxter’s heparin production.
The F.D.A. has now received 785 reports of serious injuries associated with the drug’s use. Forty-six deaths have also been reported to the agency, but Dr. Woodcock said that just 19 of these appeared related to the suspect heparin. Baxter executives said that the total death toll was actually four.
Why am I bringing this up? It is another example of the canary in coal mine when it comes to products made in whole or in part from China.
Why is it that we must keep the pressure on FDA to be more vigilant in examining drugs made from Chinese components?
China has become by far the largest supplier of pharmaceutical ingredients in the world, but there is growing concern about the quality of the products made there. Last year, the F.D.A. discovered that a pet food ingredient shipped from China contained toxic levels of melamine, which was added to make it appear higher in protein. Many pets became ill, and some died.
In addition, Panamanian investigators have concluded that at least 174 people were poisoned, 115 of them fatally, by counterfeit cold medicine linked to an unlicensed Chinese chemical plant.
A series of independent assessments, including one by the agency’s own Science Board, have found that the F.D.A. is increasingly overwhelmed by its many responsibilities and is incapable of protecting the public from unsafe drugs, medical devices and food — particularly from China.
Overwhelmed? Oh yeah...it's yet another agency that the Bush administration has made cuts in their budget and in their workforce in the past several years.
Where is Congress? Why aren't they working to expand FDA testing labs so that FDA won't be so overwhelmed? Isn't the safety and health of Americans important enough to warrant immediate action?
There is a growing bipartisan consensus on Capitol Hill that the agency needs a rapid infusion of money. The Bush administration has proposed an increase in the agency’s budget next year of just 3 percent — not enough to keep up with increased expenses. But the F.D.A. commissioner, Dr. Andrew C. von Eschenbach, said in a recent interview that the agency needed more money.
Dr. von Eschenbach said Wednesday that, even if the agency had adequately inspected the China plant, it might not have caught a problem resulting when "someone either intentionally or unintentionally manipulates a product." He said that the agency needed to approach its inspections program "in a more strategic way" and that it needed "good surveillance" of adverse events associated with unsafe drugs "so that we can respond and mitigate that outcome."
But the F.D.A. has for years had a drug safety surveillance system that relies on voluntary reports by patients and doctors to report problems. The agency itself estimates that these reports represent as little as 1 percent of the actual number of drug problems.
True...how many times do people question their physicians about side effects of the drugs they are taking. Haven't commercials for drugs instilled in people's heads that side effects are normal?
The question remains, how many prescription drugs are Americans taking daily that have in some way had adulterated components added, with no one the wiser?
How many people will die as a result of the adulterated component itself, or from them not receiving the full dose of the real drug component?