Outsourcing Our Health: Prescription Drugs Made in China
Posted on October 1, 2010Is it an overbroad generalization to declare that there is nothing some US companies won’t try to outsource in order to increase profit? I think not. Gone are the days of “Made in the USA”; instead, we could run around our houses, reading the labels on things bought at Walmart and Target and playing a modified version of the license plate game.
Aside from the obvious argument against outsourcing American jobs, I really don’t care where my t-shirt is made. Or my shoes. Or even my computer. Bad design, shoddy workmanship, and inferior materials, while not ideal, are probably an acceptable risk given the potential consequences of each. But I have to draw the line at allowing US manufacturers to outsource the production of items that could, in fact, kill me. Well, no US company would put your life at risk in such a way, you say? Ha! Think again.
Over the past decade, the safety and efficacy of prescription drugs available for purchase in the US has suffered due to drug companies’ increasing the frequency by which they shift drug manufacturing processes overseas. This practice allows companies to avoid the costly and burdensome regulation it would face by the FDA if operations remained in the US; very few overseas plants are subject to effective safety inspections by US government regulators.
Once manufactured, the companies then import the finished products back into the country for distribution and sale, often subjecting US consumers to unsafe or inferior prescription drugs. Skeptical? In have one word for you – Heparin.
In 2008, almost a hundred Americans died after taking Heparin that was made from ingredients imported from China. After the tragedy, it became clear that the FDA lacked both the funding and manpower to regulate all foreign prescription imports.
Baxter Healthcare Corporation, producer of roughly 50% of US heparin sales, ceased production of multiple-dose vials of the drug after reports of allergic reactions and hypotension in patients who received high doses of the drug. Common complaints included nausea, vomiting, trouble breathing, excessive sweating and rapidly falling blood pressure, a potentially fatal complication. Four deaths were initially reported and a too-limited recall was initiated.
Heparin is made from pig intestines and has been around for about 80 years. Baxter sells 100,000 vials of Heparin a day. The drug, when given by IV or injection, is effective at treating or preventing blood clotting. Although normal clotting is welcome after cuts and bruising, Heparin is a must-have during cardiac surgery and other procedures where blood is removed from the body, such as dialysis.
Upon investigation, it was determined that a manufacturing plant in China was a primary source for the active ingredient in the drug. Officials allege that the regular heparin ingredient was replaced with an over-sulphated derivative of chondroitin sulfate, which is derived from shellfish and most commonly used to treat arthritis. Plant operators substituted the real heparin with the synthetic chondroitin, which mimicked heparin’s properties (but not functions) at a fraction of the cost. Up to 60% of any given batch was found to be replaced with the counterfeit substance. The theory of intentional wrongdoing, rather than carelessness or negligence, was bolstered by evidence that the plant had been under pressure from superiors to be more cost-effective. There was also a shortage of pigs in China at the time – the raw materials necessary to make the real Heparin.
It turned out that the FDA failed to perform a scheduled inspection of the plant prior to the incident. Further study revealed that the FDA is able to inspect less than 10% of overseas drug manufacturing plants. Since China is the largest producer of pharmaceutical ingredients on the planet, and enjoys 15% of the market, that’s a terrifying statistic. Once the FDA finally got around to visiting the suspect plant, it found serious deficiencies.
Although Baxter was ultimately held responsible for the mishap, the company had relied on a US supplier for the tainted ingredient; the supplier, Scientific Protein Laboratories, had been supplying the Heparin market for over 30 years. Because of the stranglehold on the Heparin market that Baxter enjoys, it was impossible for a total recall to be carried out. FDA officials determined that removing the drug from the market posed more of a risk to US patients than an occasional adverse reaction. All told, over 80 people died from the tainted Heparin; an additional 800 suffered injury.
Democrats in the US House of Representatives recently introduced a legislative bill that would give the US Food & Drug Administration (FDA) the ability to better regulate the world prescription drug market, thereby increasing the safety of drugs that are imported into the US. Under the new legislation, foreign inspections would need to be carried out in parity with domestic inspections no matter where the plant is located. The bill would also require drug makers to ensure the safety of their products and would allow the FDA to institute recalls of unsafe drugs.
