Two dozen people hospitalized after reacting badly to a toxic chemical found in toothpaste. Three people die and many others are sickened by contaminated antibiotics. Thirteen infants die of malnutrition after receiving powdered milk with no nutritive value. These statements could easily have been ripped from the headlines of major newspapers around the world, recounting horrific tales of criminal negligence—or outright criminal practices—on the part of Chinese pharmaceutical and food companies, as well as officials at the China's State Food & Drug Administration (SFDA).
But what makes this even more interesting is that these statements could just as easily have been pulled from U.S. newspapers at the turn of the last century. In fact, a century ago, headlines like these were published about criminal behavior on the part of American companies.
About 18 months ago, I wrote about the burgeoning drug industry in China: "The dragon is awake, and just as Chinese industry is impacting everything from fuel prices to textiles, so too will the economic ripples begin to impact the pharmaceutical industry. Just what that impact will be and how the world will respond remains to be seen."
I must admit that this is not the impact that I had envisioned. And to some extent, it puts the boots to my contention that advances by Chinese companies and the government had diminished the impression of the "Made in China" stamp as cheap and low-quality.
As I indicated above, however, we may need to cut China a little slack as it goes through its industrial growing pains, for in the grand scheme of things, it wasn't that long ago that we in the West were having similar problems. In the pre-FDA days in the United States, any quack with the will and a gullible audience could sell tinctures, potions, and elixirs and call them cures. The fact that these concoctions often did more harm than good was beside the point, as the traveling medicine show moved on to the next town. And it wasn't just rogue individuals…corporate America was a willing partner in the charade.
To a large extent, this behavior and the deaths they caused were the impetus behind the formation of the U.S. FDA, as wonderfully chronicled in Philip Hilt's book Protecting America's Health, published in 2003.
To be metaphorical about it, China seems to still be very much in the "Wild West" phase of its industrial development, at least with respect to pharmaceuticals. If it were only trying to live up to its own standards, then there probably wouldn't be much of a problem in the West. But because it needs (and wants) to compete on the world stage, the Chinese industry is being forced to mature faster than it would perhaps like or can handle without assistance.
The country is making an effort, however, as witnessed by the recent decision to sentence Zheng Xiaoyu, the former head of the SFDA, to the death penalty for corruption and negligence that led to food and drug recalls following numerous deaths and hospitalizations. How's that for a growing pain?
A couple of weeks ago, the SFDA released a statement discussing its current Five-Year Plan to improve the safety of its food and drug review and inspection systems, suggesting that "efforts will be made to strengthen infrastructure construction, improve technical equipment, and remarkably promote food and drug safety standard and inspection technology, so that to improve food and drug manufacturing order, effectively keep within limits the illegal and criminal activities on manufacturing and marketing counterfeit or substandard food and drug, and reduce the food and drug safety accidents greatly."
Bureaucratic double-talk and backside coverage? Possibly, but I am confident we could find the same language on the U.S. FDA and EMEA's web sites.
Besides, given the questions raised in recent years about deaths and sickness related to approved drugs (or combinations) like Phen-Fen, Vioxx, and Avandia or the whole process of gene therapy, perhaps we are not in the best position to be throwing stones. (Open note to former and current U.S. FDA officials: I may not always agree with your decisions, but I would never advocate the death penalty—it seems a tad harsh.)
Are there flaws in the Chinese system? Undoubtedly. But rather than view them with derision, perhaps we should lend them a hand, because I firmly believe my original premise still holds. The pharma-breathing dragon is awake and it's coming to a global market near you.
Note: This commentary was prompted in part by reader Tom Paine, who was interested in a follow-up to my December 2005 Out of Order "Pharma-breathing dragons".