[Excerpted from this month’s From the Editor column at my magazine.]
In last June’s From the Editor page, I wrote about a scandal involving Chinese “innovation,” namely a rip-off that literally involved scraping a western company’s name off of cell-phone chips and painting a Chinese company’s name on them. I received some guff for that editorial, and have been told at numerous conferences in the past year that China will dominate the 21st century, because the world is bowl-shaped or flat or somesuch.
I maintain that the country’s poverty-level population (800 million), out-of-balance birthrates (in the 1990s, some provinces peaked at 32 male births to one female, thanks to advances in portable sonograms), and catastrophic environmental record are going to yield so much unrest as to counter its “economic miracle.” Those of you who’ve had the misfortune of listening to me expound on this subject know that I believe China’s one-party dictatorship makes it impossible for the nation to truly accommodate itself to the western world; instead, it does a passable impression of capitalism. But when it breaks down, it breaks down critically.
Let’s take China’s role in exporting chemicals, a major economic driver. Those exports have made plenty of news lately, after
- an ingredient (or two) used by Chinese livestock-food suppliers to falsify protein tests led to the deaths of a number of pets in the U.S., and
- a counterfeit ingredient in cough syrup supplied by a Chinese company poisoned at least 100 people n Panama.
These problems don’t only plague China’s exports; the same ingredients have led to deaths within China, too. Perhaps we should envision these as growing pains, a result of China’s crash course in modernizing the SFDA and bringing its drug supply under regulation. If anything, that would mark these events as symptoms of the country’s attempt to join the international community.
That reading might be a valid one, given that the toxic ingredient in the cough syrup happened to be diethylene glycol. After all, the Food, Drug and Cosmetic Act was passed in the U.S. in 1938 after the use of diethylene glycol in “Elixir Sulfanilimide” led to the deaths of more than 100 Americans.
Seventy years ago, there was no requirement for tox-tests for drug formulations. The manufacturer’s lab tested for flavor, appearance and smell, but not toxicity. So this elixir shipped, and the death followed. At the time, the agency was simply fortunate that the product was called an “elixir.” According to an FDA article, if it had been called a “solution” instead, “FDA would have had no legal authority to ensure the recovery of the drug and many more people probably would have died.” As it was, agents had to fan out across the country to help in the recall of the elixir. All told, 234 out of 240 gallons of the toxic product were recovered.
Following the diethylene glycol disaster, the FDA was given greater authority to regulate drugs, and evolved into the agency we know today, for better and worse.
Nowadays, we hold congressional hearings about tougher standards for Advisory Committees. Concerned about conflicts of interest, our representatives debate regulations stipulating that no one who is an expert enough about a subject to get paid for it should be responsible for evaluating it. (Hey, it’s my reductio and I’ll ad absurdam if I want to.)
As it turns out, China — and that one-party system of theirs — has also developed new regulations to deter conflicts of interest. In their case, a court recently ordered the execution of the former head of the SFDA.
In May, Zheng Xiaoyu was convicted of taking more than $832,000 in bribes in cash and gifts during his tenure. According to a state newspaper, “Under his watch, six types of medicine approved were fake and pharmaceutical companies got away with using false documents to apply for approvals.” Oh, and an antibiotic produced under not-so-aseptic conditions looks to have killed at least 10 Chinese patients.
The government has already taken the occasion of the sentencing to announce a new food-recall system; we’ll see how it overhauls the drug process. I’m all for creative destruction, but I’m hoping it won’t take too many more of these episodes before we see China adopt some semblance of global standards. I’m not optimistic about this, of course.
Fortunately for Mr. Xiaoyu, if the method of execution is lethal injection, then there’s always a chance he’ll come out of this experience just fine.