People have died, and the case, which started out as an accident inquiry, and then morphed into a industrial error, has now become a homicide investigation.
And the culprit is corporate corruption, and a culture of corruption that extends into the highest level of government.
But I”m getting ahead of my story.
The story started last November, when a cluster of patients in a dialysis unit started getting some horrific allergic reactions.
Now, allergies in dialysis patients aren’t rare: most are due to plastic allergy, or to other drugs they are taking (especially ACE inhibitors for blood pressure). Once in awhile, it is even due to a heparin allergy.
Heparin is a “natural” substance, made from cow or pig intestines. Sometime you get allergies to any natural substance, so an occasional allergic reaction is not unknown. But a series of allergic reactions caused a “headsup” report to be sent to the FDA.
After an investigation, in early February, the FDA sent a drug warning to doctors and pharmacists about the problem, which had been traced to heparin…all the heparin involved came from one company, Baxter, which supplies most of the heparin to the USA. But more investigation showed that the batch involved in the hundreds of allergic reactions all came from one manufacturing plant in China.
Unfortunately, the FDA had never checked the plant (it inspected one plant in that area of China, but were not aware there were two plants with similar names in the area), even though it had been supplying heparin to Baxter since 2004. So in February, the FDA inspected the plant, and found “several deficiencies” in the drug manufacturing process, including problems with the material supplied by one vendor, but still couldn’t identify the source of the problem.
So what was going on? And what was the cause of the allergic reactions?
The culprit turned out to be a chemical that mimics heparin in routine drug tests, so would not be picked up by the usual quality control testing. But it wasn’t a coincidental or accidental contamination: Chemical and Engineering News points out that chondroitin, which is derived from cartilage, is cheap and abundant. But in order to use it as a cheap substitute in heparin, it would have to be treated to add extra sulfate groups so that it would test similarly to heparin in drug testing.
In other words, there is no way this could have “accidentally” been added to the heparin. A lot of deliberate decisions were required:
Someone who deliberately searched for a way a way to use a cheaper chemical to add to the manufactured product so they could make a larger profit.
Someone with knowledge of chemistry and pharmacological testing who would know the substitution would not be detected by routine tests.
Someone to actually make the substitution product
Someone to figure out how to add it during manufacture without leaving a paper trail or other evidence that could be found by outside inspectors.
Someone to bribe local authorities and others not to spill the beans on the scam.
Chemical and Engineering news points out the extent of the contamination, which may have gone to other countries, and that European companies are finding similar problems in heparin supplied from other Chinese suppliers:
The oversulfated CS was found in heparin active pharmaceutical ingredient (API) lots from Scientific Protein Laboratories’ (SPL) Changzhou plant in China, as well as the crude heparin used to make the API. In some samples as much as 50% of the API was oversulfated CS. SPL supplied Baxter Healthcare with heparin API. Baxter has recalled its heparin products, as have three Japanese companiesâ€”Terumo, Otsuka Pharmaceutical, and Fuso Pharmaceutical Industriesâ€”that used heparin API supplied by SPL. German company Rotexmedica GmbH, a unit of the French company Groupe Panpharma, has also recalled heparin sourced from China, although from different suppliers.
Like previous scams where a cheaper ingredient that mimicked protein killed cats and dogs, or the cough medicine scam that killed over a hundred in Panama because the sweet chemical usually used in anti freeze was substituted for corn syrup, the heparin case brings up the question of outright fraud to make money rather than a simple quality control issue.
And that is frightening, because China supplied much of the generic medicine for third world countries, who don’t have the sophisticated tests to figure out the problem.
The World Health Organization estimates that up to 200 thousand people die a years due to counterfeit drugs, many of them from fake antimalarials or fake antibiotics.
The NYTimes reported that most of the fake medicines are manufactured in China, and a 2004 investigation of a fake anti malarial medicine pointed out the depth of the corruption that allowed the fake drugs to be made and sold: those involved included the Chinese FDA, Thai distributors and Hong Kong money launderers. Most of the drugs are exported, since when Chinese die, local authorities tend to be more strict in punishing the culprit.
But the sophistication of the fake drugs, that often are made to mimic the real drugs, and even to pass routine quality control testing, suggests a depth of corruption that is unfathomable to the more naive Americans and Europeans, who see this depth of corruption only in organized crime.
So expect a few Chinese to be punished for the fake Heparin, but the deeply ingrained culture of corruption remains. And that is not good news.
Nancy Reyes is a retired physician living in the rural Philippines. Her website is Finest Kind Clinic and Fishmarket.