What if Barbie Took Some Bad Heparin?
For those of you wondering whether I've contracted a bad case of baby brains, I am here to tell you that while work on Parenting Inc. continues, I have been keeping up with the news.
But today, I thought I'd talk about the FDA. A couple of stories over the past week have brought attention, yet again, to gaps in the food and product safety nets that fall under the FDA's purview.
Last week, FDA officials announced they had put their finger on the contaminant in the blood thinning drug Heparin. It was a cheap and widely used dietary supplement sold to relieve joint pain. They can't say for sure that the contaminant was responsible for the more than 700 allergic reactions and possibly 19 or more fatalities among American patients, but they strongly suspect it.
That news came on the heels of a House report that criticized the FDA for its lack of "meaningful" oversight of the fresh spinach industry following the E. coli outbreaks in 2006.
To quote from the fine story by Christopher Lee:
The most common problems uncovered by FDA inspections of 67 facilities included inadequate restroom sanitation, litter piles and indoor condensation posing a risk of food contamination by microorganisms. Inspectors also found buildings vulnerable to rodent infestation and workers with uncovered hair and poor hygiene.
So there is more to the problem than wild pigs running loose in the fields of central California.
In fact, on both fronts, FDA's critics have said the problem is a shortage of manpower and resources.
I guess I find it curious that in the case of the CPSC, the steady drum beat of recalls secured support for a sweeping reform bill, while the succession of bad news stories about contaminated food and drugs has not had the same effect for the FDA.
Some say the reason is the FDA is not in as dire straits as the CPSC. And Congress has been giving the agency more money. Last fall, it granted the FDA more funding for post market surveillance of drugs and the agency was able recently to move forward with an effort to step up its presence in China. But a coalition of business and consumer groups that support increased FDA funding said the agency still doesn't have what it needs to cover its myriad responsibilities.
As William Hubbard, a former top FDA official who is part of that industry-consumer lobbying group, told Marc Kaufman, "The history of some of these developing countries in terms of substituting or counterfeiting concerns is a long and well-documented one...And at this point, the FDA doesn't have the resources or system in place to make sure some of these bad drugs don't get through to the public."
So help me understand what is going on here. Are potentially fatal contaminants in drugs somehow less scary than lead paint on your kid's toy? Would people be more upset if a wild pig ran through a Barbie Dream House? Or Elmo had to go to the ER after taking some bad heparin?
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