- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.
- Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."
Although this case has been extensively covered by some major newspapers, with kudos going to the Chicago Tribune, New York Times, and Wall Street Journal (in alphabetical order), the story has inspired, in my humble opinion, very little commentary, and that commentary has been remarkably reticent. This week, though, some interesting points were raised in the blogsphere.
On the PharmaLot blog, Ed Silverman interviewed personal injury attorney Eric Turkewitz, who undoubtedly had some of his own axes to grind. Nonetheless, he made some points that others have not.
- Baxter International could be in serious legal trouble - "Assuming the reports are true. Baxter sold a counterfeit drug, which is in violation of federal law. We lawyers like to call it ‘negligence per se.’ They had an obligation to verify the goods they sold are bona fide. But it appears that Baxter sold something different." Furthermore, "They have an obligation to make sure the stuff they’re selling is what they say it is. They’re the ones selling the product."
- Baxter International executives ought to have known that deliberate counterfeiting was a potential source of contamination - "I think it’s impossible for anybody to say, with a straight face, that they’re taken by surprise by what’s happened. The dangers of counterfeiting, because of the vast sums of money at stake, are well known in the pharmaceutical industry. And one aspect of that problem is counterfeit ingredients in the production process as opposed to a counterfeit finished product that enters the supply chain in the US and is mixed in with a legitimate shipment or sold as a substitute. This is the issue with the production in China. It’s called foreseeable risk. For Baxter, I don’t know if (the sourcing) was a decision to save money or they had to look for another supplier. But whatever the reason they used this supplier, they can’t excuse it. I can’t think of any excuse (Baxter) can come up with that will hold water."
Also, Nancy Reyes, described as a retired physician living in the rural Philippines, made some points on the Blogger News Network about what commentary there has been about the case.
- The commentary seemed to assume that the problem was due to accidental contamination, not deliberate counterfeiting - "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." However, "The drug was deliberately diluted with a drug that would pass routine drug testing.
- The suggested solution, more inspections, could be evaded by people who deliberately seek to sell counterfeit drugs - "Inspections won’t work. You need a full time watchdog…one who won’t accept a bribe…" Furthermore, inspections "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?" In summary, "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?"
It seems to me that the public discourse about this case has been strangely reticent. After all, after getting intravenous heparin, patients died, and many patients got very sick. So where is the outrage? Instead, the problem seems to be discussed as if it were a natural disaster or an innocent accident, which could not have been prevented, and for which no one was to blame.
What criticism there has been was of the US Food and Drug Administration for its inadequate inspections of outsourced drug suppliers. With the exception of the interview above, there has been little criticism of the US companies who sold drugs without paying much attention to how they were produced.
Finally, almost nothing has been heard from physicians (with the recent exception of Dr Reyes). In my extensive file on this case, I have found no other commentaries written by physicians, in newspapers, and certainly not in medical journals. Maybe it just takes a long time for such things to get published.
Yet, physicians' prime obligation is to put their patients' interests first. Presumably many well-meaning physicians gave heparin to their patients assuming it was safe, pure, and more likely to do more good than harm, only to see some of them sicken, and a few die. One would think physicians would be hopping mad to find out the drug they trusted was not really made by the venerable drug company whose label adorned it, that it was really made in unknown Chinese "workshops," and was apparently deliberately contaminated long before it got to the US.
Maybe physicians are so deep into a state of learned helplessness, or so fearful of company lawyers waving SLAPPs that they can't or won't express outrage. But if we don't get mad when bad things happen, more and more bad things will happen. It is our role as physicians to stand up for our patients. So the least we can do is express our outrage when the drugs we prescribe for them turn out to be contaminated and counterfeit.
So let me say it: This case is outrageous. It demands not only a scientific, but a criminal investigation. Any people identified as responsible for contaminating the heparin, and responsible for selling the contaminated heparin without making adequate attempts to assure its purity, should be prosecuted. The negative incentives for counterfeiting drugs, and for selling drugs likely to be contaminated without adequately assessing their purity should be so strong that no one in their right mind would dare to do this again.
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