Monday, December 1, 2008 at 8:09 am
Fix the FDA
There is no agency that has more effect on our day-to-day safety than the Food and Drug Administration. It is also responsible for maintaining consumer confidence in products that account for one-quarter of our economy. And yet, the Bush Administration has set it adrift. For more than half of the past eight years, it hasn't even had a permanent commissioner.
Its performance over the past few days underscores why the incoming Obama Administration should make fixing the FDA--quickly--a top priority. At the Environmental Working Group's Enviroblog, our former TIME colleague Elaine Shannon lays it out:
It's been a long time since the FDA front office could make a statement about a food or drug problem without sending our doubletalk detectors (that's the polite term) into red alert.
The latest episode to kick the meter into the red zone started with an Associated Press report last Tuesday that that the FDA had discovered traces of the industrial chemical melamine and a related compound, cyanuric acid, in a few U.S- made infant formula samples. It's hardly surprising that the story, sketchy as it was, made headlines around the globe: everybody who hasn't been living on Mars for the last couple of years knows about the massive melamine tragedy unfolding in China, caused by unscrupulous manufacturers who deliberately spiked baby formula supplies with the chemical to boost their apparent protein levels.
Melamine, a plastics component, is toxic in its own right and when combined with cyanuric acid can cause kidney stones and kidney failure. To date, according to Time Magazine, more than 60,000 Chinese babies have been sickened and at least four have died from drinking tainted formula. The scandal is still spreading as reports surface almost daily of melamine turning up in exported food or animal feed from China.
Flooded with alarmed calls, FDA officials quickly tried to reassure worried parents that there was no comparison with the Chinese situation. On Wednesday, the Associated Press reported, Dr. Stephen Sundlof, director of FDA's Center for Food Safety and Applied Nutrition, characterized the levels of melamine found in Nestle's Good Start Supreme Infant Formula with Iron and the cyanuric acid level in Mead Johnson's Enfamil Lipil with Iron as “extremely low” – about l0,000 times less than the levels reported in Chinese infant formula. (Two Nestle's samples tested positive for melamine at 0.137 and 0.14 parts per million, and three Mead Johnson samples tested positive for cyanuric acid at 0.247, 0.245 and 0.249 parts per million. Chinese formula had shown levels of 2500 parts per million.)
But there was nothing reassuring about the agency's bungled handling of the matter.
For one thing, FDA officials didn't make public their own test results in an orderly fashion, with ample information on their website. They ran tests in October, sat on the results for several weeks, then released incomplete and inaccurate data to the AP in response to a Freedom of Information Act request. Corrections issued Wednesday only stoked confusion and doubt.
Even more suspicious, headlines about U.S. formula supplies prompted FDA to move the goal posts. On Oct. 3, in the midst of the Chinese scandal, agency officials posted an advisory on their website asserting that “FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns.” That seemed to be a bureaucratic way of saying that anything more than zero wasn't safe.
The zero-tolerance position lasted only as long as Chinese products were the issue. When U.S. manufacturers' products came under scrutiny, agency officials scrambled to set out a new position. On Friday, they issued an update on FDA's investigation that declared that formula adulterated with 1 part per million of either melamine or cyanuric acid (but not both) was safe.
That mark just happens to be well above the adulterant levels found so far in U.S. formula. The FDA advisory declares flatly, “FDA's ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas."
We hope so. But as has been said so many times about so many aspects of the Bush administration's governing style – hope is not a policy. If you don't have anything to hide, why hide? If you know what you're doing, why bungle?
Once the new team takes over FDA, maybe we'll find out why the agency handled the melamine issue this way. And maybe we'll learn a lot more about why FDA has been so determined to resist calls for reducing other contaminants that we know are in food and drink. There will undoubtedly be investigations led by members of Congress like Rep. Rosa DeLauro, D-CT, who told the Washington Post's Lyndsey Layton, “This FDA, this Bush administration instead of protecting the public health, is protecting industry.”
But the first priority has to be the health of our children. They can't wait months or years for Congress and the new administration to turn FDA's file cabinets inside out.
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Senior Writer Karen Tumulty has been TIME's National Political Correspondent since 2001, and has also covered the White House and Congress for the magazine. A native of San Antonio, she is a graduate of the University of Texas at Austin and Harvard Business School, where her career choice has significantly lowered the average salary of her graduating class. But she gets lots of free magazines. Read More »
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Joe Klein is TIME's political columnist and author of six books, most recently Politics Lost. His weekly TIME column, "In the Arena," covers national and international affairs. In 2004 he won the National Headliner Award for best magazine column. Read More »
Michael Scherer is the White House correspondent for TIME. He previously worked for Salon.com, Mother Jones, and the Daily Hampshire Gazette. A native of San Francisco, he graduated from U.C. Santa Cruz and Columbia University's Graduate School of Journalism. Read More » Follow Michael Scherer on Twitter
Jay Newton-Small is the congressional correspondent for TIME. Born in New York, she spent time growing up in Asia, Australia and Europe following her vagabond United Nations parents. A graduate of Tufts University and Columbia’s Graduate School of Journalism, Jay previously covered politics for Bloomberg News. And, yes, despite the misleading name SHE is a she. Read More » Follow Jay Newton-Small on Twitter
Amy Sullivan is a senior editor at TIME magazine, and author of the book The Party Faithful: How and Why Democrats are Closing the God Gap (Scribner, 2008). A Michigan native, she holds degrees from the University of Michigan and Harvard Divinity School. She writes about religion and politics for TIME, but no longer answers to the name "Bible Girl." Read More »
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Monday, December 1, 2008 at 8:19 am
Delauro sums it up well: all the Bush Administration ever did was disregard the public in favour of industry and corporations.
Monday, December 1, 2008 at 8:20 am
Hi KT -- Hope you enjoyed the weekend. It looks like the Obama adminstration is going to have play "Whack-a-Mole" with virtually every regulatory agency. I agree that there has been so much neglect in this area, particularly with imports from China. Also the FDA could regulate tobacco in an effort to reduce smoking.
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There is the financial crisis, there is health care, there is stimulus, etc., etc. How does he prioritize? What Executive Order minefields has the Bush adminstration left behind to thawrt his efforts?
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As Oliver Hardy commented more tha once to Stan Laurel, here's "another fine mess' that has to be cleaned up.
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Monday, December 1, 2008 at 8:36 am
You know what else the FDA is a joke on? Nutritional Supplements. There are people every day taking all manner of "vitamins" and other supplements who don't have a CLUE what they are really taking. Look at the pro athletes that get positive tests from over the counter supplements that don't list the ingredients that are actually in the pills. Besides that a lot of supplement companies have different products coming off the same lines and they have a lot of cross contamination. But the FDA? They want no part in regulating these supplements. Mind you ephedra was on the market for YEARS as an OTC supplement. I myself took it plenty of times. But it was only after several athletes, most notably an offensive lineman from the Minnesota Vikings, died after taking supplements with ephedra in them that the FDA pulled those products off the market. Yet if you take any EAS product you still run the risk of taking some ephedra because they still make ephedra based products but they just don't sell them in the U.S. and again there is the cross contamination. Right now there are several NFL players facing suspension because they all took the same supplement, something called star caps I believe, that had something in it that wasn't on the label. And the funny thing is the NFL knew that the company that makes star caps was lying about what was in their product but the FDA didn't. Some how ill bet that the supplement makers were pretty big donors to GWB.
Monday, December 1, 2008 at 8:36 am
"Set it adrift" is an understatement.
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The agency and its mission has been actively undermined.
Monday, December 1, 2008 at 8:39 am
It's the same story over at the FTC. I attended an open workshop on green claims in the textiles and building industry this past summer, and the FTC reps there admitted they weren't enforcing existing regulations. In their words "It's not a rollover issue" if consumers are confused or put off by confusing or fraudulent claims about "green" products. But it IS an issue of consumer confidence and the future of the promised wonderfulness of the Green Economy if people view environmental claims as just so much snake oil. (Example: the sudden appearance of "bamboo" clothing and household textiles, which are actually just mislabeled rayon.)
(I realize I post on some pretty odd subjects; it all sorta makes sense once you know I am an American Studies professor with three degrees in textiles. I blog elsewhere on ethical consumption with an emphasis on clothing, and am on sabbatical writing a book on pink and blue. If you see me posting here, you can assume I am procrastinating.)
Monday, December 1, 2008 at 8:52 am
The Washington Post reported the other day that the incoming Obama administration has been scrutinizing the beleaguered Federal Emergency Management Agency (FEMA) and plans to give it a "facelift."
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First off, the likely plan is to break off the agency from the Department of Homeland Security, a move that by itself would help restore the pride that folks at FEMA felt when it was an independent agency.
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http://www.washingtonpost.com/wp-dyn/content/article/2008/11/24/AR2008112402461.html
Monday, December 1, 2008 at 8:56 am
Oddly enough, the origins of the FDA are very convenient to cite if you want a quick example of why unregulated markets are not the panacea that true-believer Conservatives imagine. As in most things, the ideal is a proper balance between public stewardship and private self-interest. It's not coincidental that the balance hasn't been this askew since the last groundbreaking economic meltdown.
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http://www.fda.gov/oc/history/historyoffda/default.htm
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Adulteration and misbranding of foods and drugs had long been a fixture in the American cultural landscape, though the egregiousness of the problems seemed to have increased by the late 19th century (or at least they became more identifiable). By this time science had advanced significantly in its ability to detect this sort of fraud. Also, legitimate manufacturers were becoming more concerned that their trade would be undermined by purveyors of deceitful goods. Quinine-containing cinchona bark powder could be made less therapeutically effective--and much more profitable--by cutting it with just about anything, alum and clay masked poor wheat flour and thus netted a heftier return for the unethical company, and sufferers of any number of serious or self-limited diseases were relieved only of their finances by vendors of worthless nostrums. Even the so-called ethical drug firms were guilty of this practice.
Monday, December 1, 2008 at 9:02 am
Dirks--
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A primary source of market failure is asymmetrical information between seller and buyer of a good. Regulation of sellers goes back to medieval bazaars, where fair weights were certified.
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These policies, of course benefit honest traders. Otherwise they are driven out of business by people selling adulterated products.
Monday, December 1, 2008 at 9:05 am
I know its early and this is way off topic but I hope we will be discussing Barry McCaffery at some point today and how he sold out the American people, and the Military and even at times oddly enough Don Rumsfield, to line his own pockets all the while being allowed to do so by major television networks who of course are not even reporting the story. I wonder if TIME will be reporting on it or looking the other way like everybody else.
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P.S.
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I am listening to Sarah Failin Palin and she is totally recycling her stump speech and trying to make it apply to Saxby Chambliss. This is such an EPIC FAIL.
Monday, December 1, 2008 at 9:05 am
FTC
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And the EPA. I know people there. One would deliver a memo to a supervisor, saying the proposed policy change was illegal. The word from above was "Let them sue us. Implement it."
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And now the traditional blogospheric lament. Why didn't the media report on this while it was happening?
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More to the point, as George Lakoff has pointed out, this looks to the media and the Congress like three issues--the FDA, FTC, EPA--when it is in fact one issue.
Monday, December 1, 2008 at 9:07 am
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jayack: The agency and its mission has been actively undermined.
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Oh goodness gracious, no...actively? The principle is that the bad actors will weed themselves out of business because they are producing an inferior product. Whether an industry is regulated or not is irrelevant to the Market. As it concerns this baby formula-melamine issue, it should only take thousands of infant sicknesses and deaths in order for this principle to assert itself. They're only sacrifices on the altar of That Greater Glory, the Free Market.
Monday, December 1, 2008 at 9:19 am
Karen
Happy Birthday!!
Monday, December 1, 2008 at 9:43 am
KT here--
Annie: thanks!
Monday, December 1, 2008 at 9:46 am
KT here--
Also, Jayack, I think the media has reported on it pretty actively, though it has gotten the attention it deserves from the public. Though the FDA is not really part of my portfolio as a political writer, I can point to this:
http://www.time.com/time/magazine/article/0,9171,1003443,00.html?promoid=googlep
and this:
http://www.time.com/time/magazine/article/0,9171,1109345,00.html
Monday, December 1, 2008 at 9:56 am
Happy Birthday KT.
Monday, December 1, 2008 at 10:02 am
Altho' not the only ineffective department during the Bush 2 years I am amazed at how little fuss we have made when it comes to our food and medicines. So a timely review should be on the list of priorities. As sg noted above, I look in vain for a post on the Expert-Talking Head/Business/Military Connection set out by the NYT in much detail over Gen McCaffrey, a regular NBC type. I hope this will be up for discussion.
And, KT, Happy Birthday.
Monday, December 1, 2008 at 10:11 am
HBD, KT!
Thanks for your efforts.
Monday, December 1, 2008 at 10:24 am
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It's Karen's birthday? Hey - Happy Birthday; you share your bith date with:
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Bette Midler
Richard Pryor
Lee Trevino
Woody Allen
Lou Rawls
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and many others...
Monday, December 1, 2008 at 10:36 am
KT-
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Not planning to beat this to death; I thought the sarcasm was evident.
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Yes, when toxic toys came in from China, it was noted in the story that the inspection facility was laughingly small and ineffective. But we didn't see any 12 part Chanda Levin series on the illegal dismantling of the regulatory apparatus.
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Also didn't see two years of hearings on the same thing.
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As digby says, there are a lot of land mines laid.
Monday, December 1, 2008 at 10:38 am
OT and probably a little bit in bad taste
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But where is the poster who promised that the Hillary Clinton as SOS was baloney all because "Al Giordano said so"? It seems Al's batting average is tanking right about now.
Monday, December 1, 2008 at 10:48 am
Jay--
I think that the WSJ in particular has done great work, not just on the food part of the agency, but also on the drug part.
Monday, December 1, 2008 at 11:04 am
KT -- Happy birthday! How does a new adminstration queue up its new staff to address these issues?
Monday, December 1, 2008 at 11:19 am
I have a serious question. When was the last time a new president was asked if the people in his cabinet would do what he told them to do? If anybody can remember another time it has happened I would love to know.
Monday, December 1, 2008 at 11:32 am
Elaine Shannon at Environmental Working Group here. I loved being at Time with Karen (Happy 26th Birthday!!!) and the rest of the Swampland crew, but I couldn't pass up the chance to hammer away at the environmental health issues that matter to every one of us. Especially our kids. Most especially now, when there's a real chance for change. Yep, we expect the new admin to give FDA a top-down bottom house-cleaning. But as you'll see on our website (ewg.org), we're not waiting for the new team to get rolling. Ken Cook, my boss, has written to all the major North American formula makers, asking them to tell the public what they're doing to keep the formula supply free of deadly melamine and other industrial chemicals. Ken's letter went out Wednesday. We're still waiting. If any of you want to lend your voices to the effort, you can write Karen here, write me on our site (enviroblog.org) and write the formula makers yourselves. The names and addresses are on Ken's letters at: http://www.ewg.org/node/27390
Elaine
Monday, December 1, 2008 at 11:43 am
Chris Matthews on the angry left being Obama's real problem Yeah that guy is REALLY trying to get elected to the Senate. lol
Monday, December 1, 2008 at 1:09 pm
Happy birthday to KT, but…
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… if the FDA starts doing its job, how will I ever learn to do without the yummy taste of melamine in everything?
Monday, December 1, 2008 at 1:33 pm
Happy birthday KT and let's give Joyomama the post of the day prize.
Monday, December 1, 2008 at 5:02 pm
Happy Birthday!
Obama has got a lot on his plate. I hope he appoints some good folks to take over these agencies.
Monday, December 1, 2008 at 6:07 pm
Oh, my Jose, thanks, I guess. (blush)
This thread shows the extent to which George W. Bush was "not a regulating type of guy', which kind of begs the question of what the FTC, EPA, FDA and other "regulatory" agencies have been up to for the last 8 years. (Might it involve hookers, cocaine and file cabinets?)
And I am allowed to post now. I just spent the day in the library.
Monday, December 1, 2008 at 9:54 pm
Happy b-day KT.
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On-topic, FDA is nowadays one of the most corrupt of govt. institutions, almost to the point of laughter. For your chuckles and viewing pleasure, 62 drugs on the market that will literally ravage your eyeballs (including the aging boomer's favorite: Botox):
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http://www.worstpills.org/public/page.cfm?op_id=84
Saturday, December 27, 2008 at 6:56 am
[...] Vote Fix the FDA [...]
Tuesday, January 13, 2009 at 9:50 am
[...] Posted by Karen Tumulty | Comments (0) | Permalink | Trackbacks (0) | Email This We have argued here before that fixing the FDA should be at the top of Barack Obama's priority list. This story--easy to miss [...]