Chinese medicine is in trouble, again. This time, however, it is not Traditional Chinese Medicine (TCM) but all forms of medicine in China. I’ve written a number of times about Aristolochia species in TCM (visit the plant page for links to those blog entries) and, most recently, 15th april about other substances found in TCM preparations that either weren’t declared on the packaging or are banned from use.
The latest story, however, is not about what is in TCM but what is on both TCM and conventional medications and supplements. There is concern that many manufacturers of gel capsules for medical use are supplying products with high levels of chromium.
Soluble capsules as a delivery mechanism for medication are not new. I haven’t researched the full history but the earliest use I’m interested in comes in 1881 when Dr. George Henry Lamson used what is generally described as a new invention from America to deliver a fatal dose of aconitine from Aconitum napellus, monkshood, to his brother-in-law without the boy being aware of the distinctive taste.
The focus of attention with capsules has been, until now, what was in them rather than what the capsule itself is capable of doing. Unsurprisingly, people would take for granted that the material used to make the capsules would not do them any harm.
As you would expect, chromium is not all villain. It is one of the many metals that is, in tiny amounts, essential to the proper functioning of the human body. It is the larger concentrations that cause concern, though in the case of chromium ‘larger’ still means pretty small. Understanding the complete chemistry of the different forms of chromium is beyond my intention but there is a way to get a quick overview.
In the west, chromium poisoning has been in the news as the result of wear to artificial hip joints with chromium, and cobalt, in the wearing surface. As a result, a number of summaries for patients have been produced aiming to give a simpler interpretation of the science. Whether they succeed is another matter since there is a sevenfold difference between what people say is an acceptable level.1 There is also the complication, with hip joints, about whether the chromium in the blood is a worry for toxicity or just as an indicator of joint wear that could lead to mechanical problems.
That complication does not exist in China where the concern is simply about whether there is enough chromium in the capsules to cause poisoning.
The story was broken by China Central TV on April 15th when its consumer programme described an investigation in Xinchang, Zhejiang Province that found industrial gelatin being used to make capsules for medicinal use2.
By Sunday evening, The State Food and Drug Administration (SFDA) suspended the sale of capsules identified by CCTV as having high levels of chromium.3 The report suggested that the chromium levels were, in some cases, 90 times the permitted level.
On Wednesday, China Radio International suggested that chromium-plated moulds were being used by some manufacturers because they were very much cheaper that all stainless steel moulds4. It quoted a Chinese language report as saying that chromium-plated moulds needed to be re-plated twice a year, suggesting that the chromium was being lost to the capsules though offering no evidence comparing capsules from different mould types. Reading between the lines of the story, it seems that there is a difference between ‘medicines’ and ‘healthcare products’ because, it says, government supervision of the latter is ‘even more lax’.
By this Sunday, the People’s Daily English was reporting that inspection teams were now working in three provinces to investigate manufacturers5 and early this morning the story broke in the Western media when Reuters (reported by Yahoo News) detailed a number of detentions, arrests and product seizures in connection with the use of industrial gelatin.6
The same report noted that 80 illegal production lines had been shut down in the previous week. Though there have been no reports of any illness arising from chromium in capsules long-term cumulative effects are possible. And, for me, the story is more about the lack of control and the willingness of manufacturers through greed or ignorance to use potential unsafe materials and methods than any effects of this one metal.
The damage to China’s reputation resulting from another manufacturing safety scare may explain why the SFDA is acting so swiftly but, you have to think, it’s all about horses and stable doors.
People’s Daily has set up a home page for the scandal.7 It has a wholly unscientific survey of responses to the situation that shows only 65% of people saying they will not take capsules at the present time. As the story spreads, I’m sure there will be those who claim it is all a plot by western pharmaceutical companies to protect their profits.
1.Cobalt and Chromium Poisoning in DePuy
ASR Metal on Metal Hip Implants
2.Industrial gelatin used to make pills: TV report CCTV English website 16th April 2012
3.China issues alert on "chromium-contaminated" capsules CCTV English website 16th April 2012
4.Chrome-plated Capsule Moulds A Graver Threat CRIEnglish.com 18th April 2012
5.China steps up probe into contaminated drug capsules People’s Daily Online 22nd April 2012
6.China detains dozens in poison drug capsule scandal. Yahoo News 23rd April 2012
7.Capsule Scandal: When patients meet toxic drugs People’s Daily Online