It’s the same old song—contaminated drugs from China. The news was reported by Laurie Burkitt in the Wall Street Journal on April 17, 2012. Chinese authorities halted the sale of 13 drugs, because the gelatin capsules used in manufacturing were found to have high levels of the heavy metal chromium. The affected products included two antibiotics and 11 herbal products. And as we hear over and over, cost pressures apparently provoked the producer to use industrial grade gelatin instead of food grade gelatin in the manufacture of these capsules.
There have been repeated episodes of food and drug disasters stemming from imports from China. Authorities state that the majority of drug capsules made in China are produced in plants monitored closely by multinational companies with “…tight sourcing restrictions…” and heavy monitoring. In this case, much of tainted material was used to produce drugs for in country use. Apparently, with a new national health insurance in place in China, the government is pressured to lower health care and drug costs and in turn is putting pressure on producers. The new capitalist low bid system may incite poor production quality by squeezing manufacturers and diminishing profits.
In this instance, it is the “Chinese people … cheating themselves,” but in an age of global markets, poor quality products, like a deadly flu virus, cross borders and kill. In 2008, the health care supplier Baxter recalled its heparin after dozens of deaths occurred.
According to the FDA, between 2007 and 2008, 81 U.S. deaths were attributed to contaminated batches of heparin. The contaminated heparin was found in 10 other countries. The team, led by Professor Ram Sasisekharan of MIT, identified the contaminant as over-sulfated chondroitin sulfate (OSCS), which has a structure similar to heparin: a long, complex chain of repeating sugar molecules. The contaminant, derived from animal cartilage, therefore was not readily identified by traditional testing for heparin purity. Clinical investigations linked the deaths to activation of two inflammatory pathways: one initiating clotting and dilation of the blood vessels, and the other stimulating anaphylactic reactants.
Bad products come out of places other than China, and patients suffer all over the globe. Adulteration, contamination, counterfeiting, and product tampering create serious threats to the public health around the world. In widespread catastrophe, the glycerin used in antipyretics, cough syrup, and teething products was adulterated with the highly toxic solvent, diethylene glycol (DEG). Adults and children in Panama, and children in Haiti and Nigeria died. According to the FDA, in the past 20 years, DEG contamination has led to 570 deaths worldwide. In 1937, the USA witnessed more than 100 deaths due to diethylene glycol used as a sweetener in cough syrup. The FDA and other scientists reported that DEG was linked to renal toxicity, but the agency had no enforcement power at that time.
Outrage about the inability and ineffectuality of the FDA ultimately led to the enactment of the Federal Food, Drug, and Cosmetic (FDC) Act of 1938. The act gave the FDA teeth and bite. It extended the Agency’s control to cover cosmetics and therapeutic devices, required safety testing before a drug could be marketed and set safe tolerances for components known to be toxic. For a fascinating overview of the events of 1937, please read the post by Deborah Blum on March 12, 2012, entitled “Cough Syrup, Dead Children and the Case for Regulation.”
[She is also the author of my newest “favorite” book, “The Poisoner’s Handbook: Murder and the Birth of Forensic Medicine in Jazz Age New York” available at Amazon. (http://www.amazon.com/The-Poisoners-Handbook-Forensic-Medicine/dp/1594202435)]
Those of us working the health care field were appalled by reports about melamine in infant formula in China, which sickened 300,000 children and killed 6 babies. Melamine …the same contaminant in pet food that sickened thousands of pets in the USA.
The globalization of pharma has moved manufacturing off shore:
• 80 percent of the raw material used in manufacturing drugs, including those made in the US, come from overseas.
• Almost the entire supply of antibiotics, allergy medicines, diabetes medications, and antihypertensives, comes from China or India.
• Virtually 100% of aspirin is now made in China
• FDA inspects less than 11 percent of all foreign drug manufacturing facilities.
[sources: http://www.nytimes.com/2009/01/20/health/policy/20drug.html and the USGAO)
One approach to solving these problems involves improving systems. China, India, Brazil and Turkey all now require serialization, to enable track and trace of product. The US and EU are designing a standardized process for serialization, track and trace and authentication to improve supply, quality, and logistics.
Another approach is “onshoring” or “reshoring” — bringing business back to the USA. Pressed by the rise in wages in China, and fuel costs provoking rapid price increases for shipping, manufacturers are looking to come home. And a stagnant wage structure in the USA has prompted many companies to consider a return of production facilities to the USA.
Manufacturing overseas is fraught with problems like poor product quality, contamination and adulteration, patent infringement and unpredictable or slow supply. A report by the Boston Consulting Group predicts that a tipping point, based on costs of doing business in China, will be reached by 2015, when it will be financially sound to bring production back, or set up a new plants here. Last month, Whirlpool opened a new plant in Cleveland after off shoring most of their operations for years. And Baxter opened a new pharmaceutical manufacturing facility in Georgia. As manufacturing returns, there will be an increased demand for a wide range of life scientist ranging from fermentation chemists, biomedical engineers, analytical scientists, to regulatory affairs personnel and governance and risk compliance specialists. Check the job listings and check with recruiters.