An Example of the Pharmaceutical Supply Chain Harming and Killing People
Blood thinning agent heparin was adulterated in 2006/7
Do people understand the potential for the pharmaceutical supply chain to harm patients?
If I’m honest, I’ve been shocked by how little people have understood the role of the drug supply chain during the COVID plandemic. If you bought a piece of electrical equipment and you were shocked or even electrocuted, the finger would be pointed at something going wrong in the manufacturing supply chain. Why not for the manufacturing supply chain for the COVID jabs? We were told “follow the science”, which was bound to lead nowhere.
If people had known about what happened during 2007/8, it would have been very different. It can be explained by the extract from COVID Supply Chains: Fact not Fiction
CHAPTER 7 THE POTENTIAL FOR PATIENT HARM
It is not just obstacles and issues locked into the commercial supply chain at launch. There is potential for a far more serious outcome. In 2007/8, pharmaceutical supply chains became the subject of global debate among key stakeholders, but for the wrong reasons.
A tragic event occurred that shocked the world into realizing that pharmaceutical supply chains had the potential to kill and maim unsuspecting patients. A blood thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance [100X cheaper] that had been illegally substituted for the genuine registered material. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).
The full account of this has been documented in the report: After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, authored by PEW Health Group
This is the PEW HEALTH GROUP summary:
“In late 2007, US health officials began receiving reports of unexpected allergic-type reactions in patients undergoing dialysis. The reactions were linked to a widely used blood thinner—heparin—and specifically to an adulterant that had been introduced during manufacture of the drug in China.
The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. “Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and distribution have become increasingly complex in recent years.
Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers, and distributors.”
“The number of drug products made outside of the United States doubled from 2001 to 2008, according to FDA estimates. The FDA estimates that up to 40 percent of finished drugs used by US patients are manufactured abroad, and 80 percent of active ingredients and bulk chemicals used in US drugs come from foreign countries.
Increasingly, the United States relies on drug manufacturing in developing countries—mainly China and India. Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution, and the existence of criminal actors willing to capitalize on supply chain weaknesses has created the potential for counterfeit or substandard medicines to enter the system and reach patients. As evidenced by the adulteration of heparin and other case studies outlined in this report, these rare but potentially serious events can have grave consequences.”
This is not just the US, it’s a global threat
Although this was reported in the US, EU countries were affected, and it led to legislation being passed in the EU and US.
In the EU, it was the Falsified Medicines Directive, 2011.
In the US, it was FDASIA Title VII Drug Supply Chain Provisions, 2012.
Both sets of legislation were ignored before and during COVID.
Keep banging the SUPPLY CHAIN drum
As a subscriber, you may be wondering why I keep on banging the supply chain drum. If you have worked out why, then maybe begin some banging yourself? Drop it into conversations with those less convinced than you.
If you are not convinced, or if you believe US DOD, BARDA, and other non-pharmaceutical supply chain bodies did the whole thing themselves, please do think again. I’m happy to exchange honest views if it helps.
Best,
Hedley
Thank you for bringing us this important history.
I just updated the footnotes on the fourth excerpt of your interview with Debi Evans https://transcriberb.dreamwidth.org/151426.html to include a link to this important blog post.
Thanks to your substack, and your book, I get it, that as you say, one must "Keep banging the SUPPLY CHAIN drum." These products don't arrive on a magic carpet.