The tainted heparin scandal widens.

An article posted on Medscape reveals:

The heparin-contamination saga is continuing, with the latest countries to recall products being France, Italy, and Denmark… the heparin medicinal products from Rotexmedica and the heparin API from Opocrin had all been manufactured using products sourced originally from China by four Chinese companies…

Meanwhile, another US heparin manufacturer has recalled some heparin products because of concern about the contaminant… implicated in the adverse reactions.

As I pointed out in an earlier article,  the contaminent wasn’t placed there by accident. It was a cheap chemical, chondroiten, which had sulfate groups added so that it would test as heparin in routine quality control testing.

The problem is that too many American newspapers are writing editorials as if this was merely a quality control problem that FDA inspections would eliminate.

For example, the LATimes writes:

It took a long line of regulatory failures and legal loopholes for a contaminated drug to reach U.S. hospitals. Last year, the FDA weakened its policies for inspecting pharmaceutical plants, so the drug had never been checked before entering this country.

Actually no. The drug was deliberately diluted with a drug that would pass routine drug testing.

Plants in this country are subject to unannounced inspections, but China eschews them.

Ah, but that assumes that no one will be on the watch for inspectors. Heck, when I was a doc in rural Idaho, our potato plant knew when the Immigration would be coming to check papers, because no one would turn up for work that day. Do you think American visitors wouldn’t be easy to pick out at the airport or hotel, making “unannounced” inspections impossible?

Chinese inspections are lax, and inspections by the understaffed FDA are far too infrequent.

Inspections won’t work. You need a full time watchdog…one who won’t accept a bribe…

…HR 3610 would require more FDA inspection of overseas plants, paying for increased staff through fees on the manufacturer. It also would require pharmaceutical labels to show where the drugs were made.

Again, you assume honesty. But would an honest man go out of their way to find a drug that is cheap and would pass routine tests? Obviously not. And if they cheat in big things, what makes you think that the labels and paper work would be honest?
Inspectors would have missed the contamination, since the hypersulfated chondroiten could only be detected using nuclear magnetic resonance spectroscopy and capillary electrophoresis…not something one could carry in one’s luggage.
Finally, the FDA notes that some of the heparin did not come from drug manufacturing companies, but from factories labled as chemical plants which are not inspected by the FDA. So where do you inspect?
Again, the real story is not in the MSM but in the newsletter Chemical and Engineering News:

Rep. Bart Stupak (D-Mich.)… says contaminated heparin is the second instance in the past year of “what appears to be intentional adulteration of food and drugs coming into this country from China.” Melamine was detected in imported Chinese pet food last year.

Yes, Stupak and Dingle are proposing more inspections as the way to prevent future problems.

To think that simple inspections will find the hidden corruption that allows such deliberate contamination is naive.  The criminals will merely find another way to outwit the inspectors to make money.

If there is to be inspections, could I suggest that the ones to do such inspections should include FBI agents familiar with organized crime?

Because if the chemical was substituted at a number of different plants, this suggests local kickbacks and bribery at many levels so that the scheme would work.

And therein lies the a story ignore by Congress and the MSM: The depth of corruption in China that allows such incidents to take place.

——————

Nancy Reyes is a retired physician living in the rural Philippines

Be Sociable, Share!