Bathtub-Government Fun: Toying With Safety While A Lame Duck Leadership Circles the Drain

By Deborah Newell Tornello
aka litbrit

Six holiday shopping seasons ago, the question on many toy-buyers' minds was whether to go with the God Bless America Barbie or the United We Stand Lego Set.

Given the state of the Consumer Product Safety Commission at this point in time, however, parents will be grateful if they're able to choose (not to mention distinguish) between Regular and Unleaded.

And attempting to get straight answers from its Chairman is proving to be a risibly fruitless exercise.  Witness Senator Claire McCaskill (D-Missouri) as she grills Consumer Product Safety Committee Chairman Nancy Nord this week:

Senator McCaskill repeatedly asks Ms. Nord why she has not, to date, requested more money for her agency, the underfunded, dilapidated and ineffectual state of which was exposed in a similar senate hearing last month; highlights included the introduction to the culture of a new and unfortunately-named martyr of sorts--Bob, the Small Parts Guy--as well as this picture of the CPSC Toy Testing lab on display:

Ms. Nord repeats her non-answer with robotic consistency and an oddly fixed gaze to match:

"If you gave us more money, we would spend more money."

The bizarre yet telling episode concludes with Senator Bill Nelson (D-Florida) going all Socratic on Ms. Nord, explaining that she was a political appointee of the White House who answered to the White House budget office and was only allowed to ask for the amount said office approved.

Senator Nelson, pointing to Ms. Nord: "You can't ask for more, even though you say you'll spend more, because you're under orders from the White House not to ask for more.  Is that correct?"

Ms. Nord:  "I have never had a conversation like that with the White House."

Weboy has more on appointee Nancy Nord.

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The lead-befouled toy troubles have recently spread to Hong Kong, Shanghai, Singapore, Malaysia and Thailand as stores there follow the lead of US companies and remove various items from their shelves. Meanwhile, the total numbers of toys recalled Stateside continue to soar:

Oct. 5 (Bloomberg) -- Toys ``R'' Us Asia Ltd., a unit of Hong Kong-based Li & Fung Group, said it removed from its stores Chinese-made toys that contained lead, a day after eight U.S. companies recalled products tainted with the dangerous metal. [...]

At least 15 million items made in China were recalled in the U.S. over the past two months, according to data compiled from the U.S. Consumer Product Safety Commission Web site. The U.S. Congress held hearings in September on lead in children's toys, which may cause brain damage if ingested, and the safety of Chinese imports. China last week said it has made progress in rooting out dangerous goods through better production oversight.

Toys ``R'' Us Inc., Walt Disney Co. products maker Kids II Inc. and six other companies yesterday recalled Chinese-made items ranging from Baby Einstein blocks and Winnie the Pooh bookmarks to aluminum water bottles and toy flashlights.

Kids II recalled 35,000 of Disney's Baby Einstein Discover & Play Color Blocks, and Toys ``R'' Us, the largest U.S. toy chain, called back 15,000 units of Children's Toy Decorating Sets, the Safety Commission said in statements yesterday. No injuries have been linked to any of the recalled items, the agency said.

Other items withdrawn from the market yesterday were books, ``Pirates of the Caribbean'' toy flashlights and wooden pull- along wagons. Dollar General Corp. recalled 192,000 key chains and 63,000 Frankenstein Tumblers.

(H/T the priceless petulant)

Testing Agency Head Under Fire; Senate Committee Asks: Is it Safe?

By Deborah Newell Tornello
aka litbrit

Lawmakers, including the tenacious Senator Dick Durbin (D-Ill), grill Nancy Nord (of the Consumer Product Safety Commission), demanding to know why lead-laden children's toys and jewelry are still arriving in the United States.

Sen. Dick. Durbin (D-Ill.) charged that the CPSC was not aggressive enough in stopping unsafe toys and children's jewelry manufactured in China from entering the U.S.

He said the agency never obtained information on shipments of the Chinese products so that it could inspect to see whether many of the products had lead paint in them.

Weboy was none too impressed; the background information he provides about Nancy Nord neatly replicates what has become an all-too-common story arc (hell, for many Bush appointees, it's a career template):

Well, Nancy Nord is the Acting Head of the CPSC because the head of the CPSC resigned rather abruptly (last) summer, and Bush has done nothing to replace him (the CPSC has a three person directorate; with the party of the President essentially controlling the majority) since March, when he tried to appoint the former head of The National Association of Manufacturers (you know, people who might not like the CPSC) in his place. And why did the last guy resign, you ask?  Oh, you know... to go work for a law firm that advises clients on how to... you know, avoid having to deal with the CPSC.

 

Yes, it would seem that Consumer Product Safety is yet another area like... oh, I don't know, let's say FEMA... where the Bush Administration has allowed benign neglect to substitute for policy.  Bush has appointed, er, cronies, to this commission (see #9 of the last link), good Republican doo-bees, and now here's Nancy Nord to tell us, Gosh, the CPSC is underfunded. Now there's a surprise.

During testimony Nord admits, disturbingly, that despite harsh criticisms of Chinese toy manufacturers and calls for crackdowns in 2004, a "significant amount" of children's jewelry the agency tested still contains lead, amending that, shortly thereafter, to "almost all of it". She also describes the testing facility as a 1950's-era missile testing site in Gaithersburg, Maryland, some of the buildings of which do not even meet code. Nord goes on to report how their lone product tester, a man named Bob, is overwhelmed (imagine that!) and can't reasonably be expected to test the countless thousands of toys and other products coming into the country every day.

This is a still shot of the toy testing facility, the place where Bob ("Our small parts guy") decides if toys--the ones he gets to that day, anyway--are safe enough for Americas consumers and children. Yes, this is really the toy lab, as presented to the Senate Wednesday:

The United States of America's Consumer Product Safety Commission,
Toy Testing Division
(as shown behind the senators' chairs)

Honestly, I don't know whether to laugh or cry. Certainly, this is nothing new, this underfunding and undermining of a United States government agency tasked with protecting the public.  As I wrote about extensively this year, the FDA has been similarly hamstrung by the Bush administration, and despite the shocking revelation that less than 1% of food imports arriving Stateside are even being inspected at all, the agency is quietly closing labs around the country and cutting staff. Furthermore, in a classic Bushian hand-off of henhouse keys to Big Pharma fox, the FDA has shifted much of its drug-testing function (in exchange for drug-testing funding) to the drug companies themselves.

Perhaps Grover Norquist wouldn't have been so quick to fill his bathtub if he'd known it was coated with lead.

Published in part Thursday at my place.

(H/T the priceless petulant)

Frank Zappa: On Freedom and the First Amendment; on Crossfire and in Prague, Czechoslovakia

By Deborah Newell Tornello a.k.a. litbrit

As promised  in the thread about Frank Zappa and the issue of PMRC labels yesterday, here is the video of Frank Zappa's prescient and pro-First Amendment brilliance as seen on Crossfire in 1986. Also in this post, I've uploaded a film short of FZ's Czechoslovakian adventures. And later today, I'll type out a portion of the transcript from the 1975 British lawsuit in which Frank Zappa sued the Crown and post that, too. You readers deserve the best, right?!

Okay, then, let's get started. What you're about to see is a video clip--in three parts--of Maestro Zappa appearing on the CNN program Crossfire. Also appearing are On the left! Tom Braden, On the right! Robert Novak, and along with Mr. Zappa--In the crossfire!--is Washington Times columnist John Lofton.

Also offered in three parts, here is a film short of Frank Zappa during his historic visit to Prague, where he met and socialized with mutual fan and friend Vaclav Havel. In comments at the FZ thread yesterday, Captain Goto wrote:

Vaclav Havel was an enormous fan, who invited Zappa to visit Czechoslovakia as a sort of cultural ambassador. Zappa was quoted as saying to Havel how sorry he was that Havel would have to meet with Reagan, mincing no words about his opinion of Ronnie's intelligence.

In Zappa's retelling, in less time than it takes to blink, US officials roared into Prague to inform the Czechs, in no uncertain terms, that Frank would be have *no* part of *any* kind of meeting with Havel for *any* reason, under *any* circumstances...

Some of the soundtrack is in English while other parts are in Czech, which I don't speak; even so, I thoroughly enjoyed--and therefore highly recommend--this rare and unusual film.

More, More, More on Leave!

Speaking of paid leave, last week, LizardBreath suggested that "if workers, on average, think that two weeks of leisure increases their utility by more than employers think it costs them, but transaction costs (cultural factors, whatever) keep them from bargaining for that outcome, then mandating that a part of every worker's compensation consist of paid vacation is going to make everyone better off -- it will literally increase compensation to workers in terms of utility, without injuring employers."

On that subject, commenter Kathy G. sent me a paper on "Compensation Inequality" from the Quarterly Journal of Economics which suggests something along those lines may be happening. It appears that compensation benefits rise much faster for professionals than does income. The chart's a bit long, so I'm putting it below the fold. The takeaway, basically, is that in most professions, professionals appear to have bargained for significantly more leave relative to other workers than income. There are a variety of ways to explain this, but it's a provocative finding, and one that suggests leave may be quite a bit more valuable than we realize, given how insistent those workers with actual bargaining power are on obtaining it.

What A Worker Wants

Another quick note on vacation time: It's telling, I think, that as you travel up the skills ladder, where workers have significantly more bargaining power, vacation time increases rapidly. Full time workers obviously get more than part time workers, but everything I've seen suggests white collar workers get significantly more time off than blue collar workers, and highly skilled knowledge workers -- arguably the most privileged class at the moment -- often get European-levels of time (if anyone knows of data breaking vacation days up by profession, I'd love to see it). So as workers are better able to craft job contracts in accordance with their preferences, paid leave rockets up. My hypothesis isn't that this happens because the less advantaged workers don't want the time, but because they don't have the leverage to make employers give it to them.

And also, yes, putting relatively more resources towards leisure will almost certainly reduce total productivity and thus pay. And I don't think liberals should have to reach for tenuous arguments about a well-rested workforce being a more productive workforce, and thus this policy paying for itself. Not everything has to enhance growth. It's actually quite crucial that we can argue for policies because they'd make for a better society rather than merely a more robust economy. Trading some income for some leisure is a perfectly appropriate choice -- but one you'll lose if you're always trying to justify the trade in terms of income.

Anyway, this is one of my perennial hobbyhorses, but I really think it's a big deal. The economy's absolute control over our political discourse really limits the room we have to argue for and enact possibly worthwhile policies.

Diminished Capacity: FDA Downsized and Privatized; America is at Risk

The Bush Administration's Dangerous Contempt For Science and Scientists Alike

by Deborah Newell Tornello
a.k.a. litbrit

Poison by Andy Warhol and Jean-Michel Basquiat, 1984

"We would have been spared the ignominy and disgrace of great scientific men bending their efforts to defeat the purpose of one of the greatest laws ever enacted for the protection of the public welfare. Eminent officials of our Government would have escaped the indignation of outraged public opinion because they permitted and encouraged these frauds on the public." -- Father of the Pure Food and Drugs Act and USDA Chief Chemist Dr. Harvey W. Wiley, MD, in 1929, on what America might have had if the Act were enforced as intended.

"I don't want to abolish government. I simply want to reduce it to the size where I can drag it into the bathroom and drown it in the bathtub." -- Disgraced conservative activist and likely subpoena recipient Grover Norquist, on NPR's Morning Edition, May 25, 2001.

"Government is the entertainment division of the military industrial complex." --The late Frank Zappa

Adulterated grain products from China slip through Humvee-sized holes in America's regulatory safety net and proceed to sicken and kill thousands of pets.  Counterfeit and toxic ingredients poison thousands of people worldwide and continue to threaten America's food supply.  And tubes of toothpaste laced with the antifreeze diethylene glycol actually wind up on store shelves around the country before someone with authority can order them pulled, but not before the public learns that the scientists and analysts at our Food and Drug Administration are so underfunded, and stretched so thinly, they can inspect only 1% of imports, if that. All of which make recent revelations--to civilians like me, at least--that much more shocking, that much more illogical.  For not only have the powers that be who control the FDA been shrinking its staff--today, the agency has over a 1,000 fewer scientists and analysts than in 1997 (despite the number of imported goods having skyrocketed during that time) and management wants to let go even more of these specialized personnel--they have also been furtively closing laboratories and setting forth plans to close yet more.

"In the middle of all these outbreaks and contamination issues, the timing of the proposal is extraordinarily bad," said Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America.

                        

Over the next several years, the FDA wants to close labs in Philadelphia; Denver; Detroit; Alameda, Calif.; Lenexa, Kan.; San Juan, Puerto Rico; and Winchester, Mass. Those operations and an estimated 250 employees would then be moved to five multi-purpose "mega-labs" that could handle all types of FDA testing.

The multi-purpose labs are in Atlanta; Jamaica, N.Y.; Jefferson, Ark.; Irvine, Calif.; and Bothell, Wash. A forensic chemistry lab in Cincinnati wouldn't be affected.

That's right.  Even as the nation's food supply is threatened as never before, industry forces--and the lobbyists and politicians who love them--are systematically enfeebling the very agency entrusted with protecting it, meaning that if things continue in this manner, the agency's current and oft-derided less-than-1% inspection rate is going to start looking pretty good.

But I'm getting ahead of myself.

A Tale Of Two Doggies

It was a warm afternoon in January of this year, and I was on hold with the FDA, having searched for the regional office's number and been transferred--twice--after telling my story.  Twenty minutes went by, but finally there was a person speaking to me; she asked how she could help me.  She couldn't truly help me, of course, because earlier that day I'd held this big bear-dog head in my arms and cried right into the fur of his ear, Vito, Vito, wake up...Please!  I had to know he wasn't there any more.  Before I could say goodbye, I had to know, with certainty, that he'd already gone.

So I told the FDA agent about our dog, Vito, and I also told her about his brother Dax who died nearly instantly, shockingly, after violent convulsions the day before.  Both had eaten dog food that our vet confirmed was contaminated with aflatoxin, the deadly mycotoxin produced by Aspergillus flavus, a mold to which corn is notoriously susceptible.  Grains meant for humans must, by law, be virtually free of the mold (minute amounts are seemingly allowed in peanut butter), though low levels are permissible in pet food and animal feed.  I related everything to the agent: where and when we bought the food and how to reach our vet, who wanted to send her all the lab results directly.

The next day, the vet's office called--they wanted me to authorize release of our dogs' records--but there was no word from the agent.  Weeks passed, then months.  I left messages on the FDA answering machine but no-one called back.  I wanted answers, explanations, something; I wanted someone to tell me how, in a country as wealthy and advanced and admirably, obsessively safety conscious as this, enough lethal toxin to kill two 110-lb. dogs before their second birthdays found its way into dog food that we bought in a store we trusted (past tense).

Grief and anger turned to bewilderment: I knew most federal agencies were understaffed and underfunded these days, under this administration, but the seeming lack of concern about an incident involving a deadly poison really troubled me.  What's more, I didn't even have the satisfaction of knowing that my report had helped anyone--that something had been done to save other dogs from the horrible fate that Dax and Vito met.

Then, in early April, stories of poisoned cats and dogs were everywhere; well, they were everywhere that I'd been reading since January, as well as on a few network news programs.  This must be the same thing, I thought, reading through the articles and blogs and swearing off corn for the rest of my natural life.

But the poison wasn't aflatoxin--it was something else.  Initially, news reports said the pet food was laced with aminopterin, a chemical widely reported to be rat poison, but which is, in actuality, a fairly expensive and volatile chemotherapy drug.  Then that was mysteriously ruled out.  Finally, the toxic substance was identified: melamine.  In China, I learned, it is common practice to adulterate grain proteins with ground melamine--the polymer boosts the nitrogen ratings (these assess a grain's protein content) and brings the seller a higher per-pound price.   And other grains were affected, possibly grains meant for humans.  Certainly, grains meant for animals that some humans eat.  New York Times reporter David Barboza reported from China that various farmers admitted they'd been spiking animal feed and grains with melamine for several years.  At that point, the FDA had found it in rice protein, wheat gluten, and corn protein.

It's in the human food supply, I thought.

Poison With An Unexpected Side Effect: Illuminating Government's Shadier  Side 

The tragic deaths of thousands of cats and dogs, and the unprecedented pet food recalls that followed, would of course leave Americans with many unanswered questions.  Even so, the tragedy led to several unexpected discoveries.

The FDA itself did not, initially, carry out the testing that resulted in mistakenly identifying aminopterin  as the substance that was killing the animals.  Instead, the agency contracted out the lab testing to the New York State Food Laboratory, the efforts of which were proudly trumpeted in the April 1 (!) Washington Post even as scientists at the FDA as well as Cornell University were already finding melamine, not aminopterin, in the pet food they analyzed:

Using sophisticated drug screening panels, the lab determined a banned rodent poison called aminopterin might be killing the household pets.

The lab is part of Food Emergency Response Network, a federally supported group of state and federal facilities with expertise in testing food for chemical, biological, and radiological hazards. With a staff of about 40 chemists, microbiologists and technicians, the lab is one of a few dozen state-level facilities capable of doing such tests and regularly screens foods for pesticides.  [...]

"We brought about 100 years of combined expertise to bear on this," said lab Director Daniel Rice. "Trouble shooting with each other was a real asset in this case."  [...] The lab has been around for decades, but became part of FERN after the Sept. 11, 2001, terrorist attacks as part of the government's effort to protect the nation's animals and food supply.

Yet two days prior,  the New York Times reported that FDA scientists held a press conference during which they said the affected animals' kidneys were full of melamine crystals, and that the pet food itself had been found to contain melamine.  If labs in the Food Emergency Response Network are this good at correctly identifying toxins in pet food, Heaven help us when we're under a national threat and human food is affected.

And what of this Food Emergency Response Network?  It's a recently-established group of state and federal labs, the allegiance and cooperation of which are called for in the Presidential Directive 9 of The Bioterrorism Act of 2002--in other words, it's flush with Homeland Security funding.  The network makes use of eLEXNET, which is the Electronic Laboratory Exchange Network, a relatively open Web-based network (not behind FDA or USDA firewalls) that enables multiple government agencies responsible for food safety to compare, communicate, and coordinate findings of laboratory analyses.  It was created by SAIC (Science Applications International Corporations) who were awarded the contract in 2006--SAIC is by far the largest government contractor (you can read more about them here) and enjoys an extremely close relationship with defense contractor giant Lockheed Martin, the largest defense contractor and recipient of American tax dollars among the many similarly-blessed corporations currently working "in partnership" with the federal government.

Another massive software system implemented at the FDA in recent years is known as CARVER + Shock.  Whereas eLEXNET connects the various agencies, laboratories, and individuals working in  the field food safety across the nation, CARVER + Shock is a threat assessment software tool, originally developed for the military, that is based on a series of computer-generated questions:

"In warfare, the military must attack the jugular of its opponent," said principal investigator Phil Pohl. "Here, we ask the same tough questions, but to identify the food supply jugular and protect it."

Specifically, the CARVER questions follow its acronym to ask how Critical, Accessible, Recognizable, and Vulnerable each part of any food process is, as well as the physical Effect of an unwanted intervention and how long it would take to Recover from it.

"Shock" rates the degree to which a specific attack on the food chain would raise public apprehension.

"An attack on a baby food plant would produce more emotional shock than one on a frozen pizza plant," says Sandia researcher Susan Carson, who worked on software that helped develop the questions needed for a one-size-fits-all program. "We factor that in." The move from limited to widespread possible use The conversion from questions-asked-in-person to questions-asked-by-computer began with Carson and Pohl shadowing FDA staff at meetings with industry personnel and writing down the questions asked. .

Sandia, by the way, works in partnership with--yes,  again--Lockheed Martin, as much a training ground for politicians, particularly those with budget-appropriations powers, as it is a repository for departing politicians seeking private-sector lobbying and legal work.  The unholy alliance of  lobbyists, defense contractors and the Pentagon has a name in Washington: The Iron Triangle.  And from all accounts, what the Iron Triangle wants, the Iron Triangle gets.

I wrote about this revolving door--and specifically how it benefited deputy national security advisor Stephen Hadley, who with the  help and expertise of high-ranking Lockheed Martin official Bruce Jackson, in 2002 fabricated a rationale for the invasion of Iraq--back in January.  Therein, I quoted a comprehensive article by reporter  Richard Cummins:

Hadley, looking out of the windows from his West Wing office, was on the inside. Sure, Hadley had the requisite government experience for a deputy national security advisor. He had been an assistant secretary of defense under Bush's dad. But he had been through the revolving door, too: Stephen Hadley, the point man for justifying the invasion of Iraq, had also lawyered at Shea & Gardner, whose clients included Lockheed.

We know that the FDA, like many federal agencies, is cutting costs by replacing human analysis with computer-generated versions.  Was the CARVER + Shock software used to arrive at the woefully off-base conclusion that a few dog and cat deaths simply weren't all that threatening, which in turn led to critical delays--delays during which adulterated food kept making its way into consumer's homes and ultimately into the bodies of American pets, as well as livestock--and thus the human food supply?  It's certainly a question I'm asking.

Don't Circle The Wagons--Eliminate Them!

The proposed closure of numerous FDA laboratories over the next few years is not widely mentioned in the national media, but newspapers in the affected cities--Denver, Detroit, Kansas City, Philadelphia, San Francisco, San Juan, and Winchester Mass.--have reported on the shutdowns and consolidations.  As one would imagine, the scientists are not happy: the downsizing of any organization inevitably means job losses, relocations, and an overall lowering of esprit de corps; in this case, the downsizing also means FDA scientists and the work they do will be compromised, undermined, and delayed at a time when the nation can least afford it, too.

Some lawmakers are outraged:

Two senior House Democrats are ripping what they say are Food and Drug Administration plans to cut more than a third of its regulatory analysts.

                              

“This drastic cut comes at a time when the volume of food imports doubles every five years and at a time when the American public appears to be exposed to an increasing amount of unsafe, contaminated food,” Reps. John Dingell, D-Mich., and Bart Stupak, D-Mich., wrote in a June 15 letter to FDA Commissioner Andrew von Eschenbach. “Thus, we are shocked to learn that FDA has plans to cut 196 microbiologists, chemists and engineers from the agency.”

For its part, the FDA says it won't eliminate any jobs; instead, the agency plans to "redeploy” positions--hire a field investigator instead of replacing a scientist, say--should employees leave, which many assuredly will do if their options are to relocate themselves, their spouses, and their families or find work in the private sector.  Of course, the talent and experience of these often highly-specialized scientists will go elsewhere, too.

When the closure/consolidation plan was first set forth over a decade ago, a 1996 GAO (General Accounting Office)  audit proved the closures and analyst cutbacks were a terrible idea, declaring that the projected cost savings were overstated, the operational efficiency gains from consolidation, questionable.  A forthcoming GAO audit is expected to set forth even more arguments against the lab closures.

From the Detroit Free Press:

But some congressional Democrats say labs such as Detroit's -- located along the river just miles from the Ambassador Bridge, one of the busiest border crossings in the nation -- should be built up, not shut down.

"It's just not a priority with the FDA," Stupak said Wednesday of imported food inspections. "They're trying to reduce the size of government."

In a letter last month to Appropriations Chairman Rep. David Obey, D-Wis., Dingell and Stupak said there is evidence the FDA plan would drastically undercut the agency's ability to inspect food at a time when reports of outbreaks have been in the news, including salmonella contamination in peanut butter and tainted pet food linked to ingredients from China.

In an interview published in the June 24 Boston Globe, FDA Assistant Commissioner Dr. David W.K. Acheson discussed the enormous challenges the FDA faces today:

Q Critics make the case for a single food safety agency with recall authority and a mandate to standardize inspections.

A Simply creating a single food safety agency, moving groups of federal employees around under a different organizational structure, frankly, I think is more likely to create a bigger hole in food safety, certainly for sure in the short term. I worry about that.

Q The agency inspects roughly 1 percent of the $60 billion in imported food. How much more does the FDA need for inspectors?

A I do not believe that simply doubling, tripling, increasing by a factor of 10 the number of inspectors is going to solve the problem. One has to build this into a comprehensive preventative strategy, working with industry to help them understand what preventative controls work the best. You then need to potentially verify that they're doing that.

(Ah yes, working with industry.  Lots more on that shortly.)

Here's a graph from the New York Times (April 30, 2007) that shows how inspection rates have plummeted even as the number of food imports coming to America has soared: At this point, any reasonable person will be asking how the closure of important (and in most cases, highly specialized) labs could possibly be a good idea for the country.  For one thing, consolidating them into mega-labs--a move that will still result in net losses of vital scientists and analysts during a time when the nation's food supply is at greater risk than any other time in our history--means locating vital analytical resources in a handful of highly-populated, highly target-rich areas: Atlanta, Jamaica, N.Y. (near Manhattan), and Irvine, CA (near Los Angeles), for example.  It makes absolutely no sense to concentrate the nation's best scientific minds and resources in the cities most likely to be affected, as history has borne out, not when America may well need to rely on fast, accurate, and specialized lab work in order to save lives.

A Hundred Years Of...Servitude?

Cheerful It's Our Centennial! press releases notwithstanding, America's Food and Drug Administration in 2007 is a battered and beleaguered vessel under assault from all sides; virtually since its inception, the agency has been underfunded, undermined, and overruled to near-death.  That it chugs along anyway can be attributed to the dedication of scientists and analysts on board, Americans whose talent, training, and ethics qualified them for the job of protecting American consumers in the first place.  Make no mistake, though:  the Bush Administration have already cannibalized the Good Ship FDA--"reassigning" analysts, closing labs and pushing to shutter even more--and as recent food-contamination and toxic import scandal have demonstrated, it's been taking on water for some time now.   And the likelihood of being afloat come the next dawn almost completely depends on the kindness of sponsors.  Sponsors with agendas.

"The FDA has essentially become the government affairs office of the pharmaceutical industry," (Congressman Maurice Hinchey, D-NY) said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate." Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor of an FDA reform bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury.

According to the Appropriations Committee, two officials of the Biotechnology Industry Organization and two officials of the Pharmaceutical Research and Manufacturers Association attended at least half of the 112 meetings.

In a statement, the FDA's Susan Cruzan said the agency faced a number of technical problems to be resolved before submitting the proposal. The FDA had "extensive discussions" with the industry about financing, marketing and infrastructure. She added that the agency also met with consumer groups and that each meeting followed the law's requirements.

The congressmen--Maurice Hinchey (D-NY) and Bart Stupak (D-MI)--have a somewhat different take on the numbers as well as the legal and ethical issues these meetings raise.  From Rep. Stupak's June 11 press release:

"The data surrounding the FDA's meetings on PDUFA IV make it more clear than ever that the agency and drug industry continue to have a relationship that is far too cozy and inappropriate.  By treating the drug industry like a privileged client that deserves preferential treatment rather than a regulated industry, the FDA is jeopardizing the health and safety of the American public.  There is no reason for the FDA to meet nearly two dozen times as often with the drug industry than it does with consumer and patient groups.  It's time for Congress to step in and fix a broken system so that the American people are the only clients the FDA serves."                                       

Stupak said, "The FDA's 112 meetings with drug industry groups offer stark evidence of the coziness between the FDA and the drug industry.  Congress must work to provide sunshine and transparency to the new drug approval process.  At a minimum, Congress must ensure consumer advocates are present as we move forward with re-authorization of the Prescription Drug User Fee Act.  The health and safety of the American people are at risk when drug industry representatives are the only individuals in the room advocating new drugs and keeping harmful drugs on the market."

                                 

Seventy-two FDA staff members participated in the 112 meetings with industry, combining for a total of 1,852.5 hours of meeting time, or 231.5 business days.  Forty-nine representatives of the regulated industry met with the FDA, combining for 2,116 hours, or 264.5 business days.  [...]

Despite consulting with industry representatives 112 times on PDUFA  IV, the FDA apparently only had discussions with consumer and patient groups five times.

                                 

If the country had not spent the last seven years watching an imperial president and his water-carriers engage in one outrageous and anti-American act after another, this sort of ridiculous bag-man consortium masquerading as democracy might have raised a number of eyebrows, or perhaps even caused a stir.  An actual stir!  But sadly, Americans are almost at the point of no return, shock-wise; that we have in fact come to expect such constitutionally-questionable behavior from our so-called leaders reflects a disturbing level of resignation on the part of voters.  And as far as Big Pharma--or for that matter, any giant commercial interest--is concerned,  a resigned electorate is a docile, easily-convinced one.

Exalting The Patron; Shooting The Messenger

What happens to individuals within the FDA when they speak out about the potential dangers of drugs?  They're smeared, discredited, ignored, and pressured to resign. Just ask analyst and FDA whistleblower Dr. David Graham, a devoutly religious man and a dedicated scientist:

In August 2004, Graham told his supervisors that, in light of his research, high-dose prescriptions of the painkiller Vioxx, which appeared to triple heart attack rates, should be banned. They told him to be quiet. Their reasoning was circular: That's not the FDA's position; you work here; it can't be yours.

Alternatively, have a word with Dr. Andrew Mosholder:

Dr. Andrew Mosholder, another FDA reviewer, faced similar pressures last year when he completed a study showing that antidepressants increased suicidal behavior in children. Further studies proved that Mosholder's science was spot on. But his bosses told him not to report the findings. When someone with access to the study passed his results to the press, the FDA launched an investigation into the leak. According to Tom Devine at the Government Accountability Project, who later became Graham's lawyer, several scientists were interrogated and threatened with possible jail time.

Such intimidation has worked. In 2002, about one in five FDA scientists told federal investigators that they felt pressure to approve drugs despite reservations about safety and efficacy. Two-thirds said they lacked confidence that the agency adequately monitors drug safety after approval.

And you can also talk to  ex-deputy director of the Division of Drug Risk Evaluation, Rosemary Johann-Liang, who resigned just a few weeks ago:

She took her staff's advice and recommended in February 2006 that Avandia get a "black box" warning about congestive heart failure. For doing so, FDA staffers told Senate Finance Committee investigators, Johann-Liang was verbally reprimanded and told to talk to her director before making any major recommendations related to drug safety.  [...] Johann-Liang speaks of a convoluted system in which the FDA requires a higher level of proof of risk than of effectiveness.

The FDA approves diabetes drugs such as Avandia if clinical trials show they meet the "surrogate endpoint," or goal, of lowering blood sugar, she says, but then doesn't require makers to do follow-up studies of whether patients actually feel better and live longer.

And of course, be sure to read about the clouds of controversy surrounding  Sanofi-Aventis' antibiotic Ketek; it is a sordid tale in which the eventually-imprisoned doctor conducting the drug's safety testing (Study 3014) for the pharmaceutical company was found to have fabricated results, which fact Sanofi-Aventis kept from the FDA, which finally became aware of the drug's dangerous effects on liver function when, and because, their own scientists (including the tenacious Dr. Graham) discovered them:

E-mails from David Graham, an FDA safety official, (argued) that telithromycin (Ketek) had not been proven safe, safer drugs were available for the same indications, the approval was a mistake and it should be immediately withdrawn. There were 14 cases of liver failure, including at least 4 deaths, vision problems, blackouts, syncope, and potentially fatal myasthenia gravis. Graham wrote, “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned.”

Salus Populi Suprema Est Lex

Said Cicero, The welfare of the people is the ultimate law.

In the late 1880's, when USDA chemist Harvey Wiley embarked on a mission to clean up the nation's food supply and promote the growing and preparation of healthful, unadulterated, real food to American farmers and consumers, the average American pantry contained numerous threats. In the years following the Civil War, America and her economy were transformed by the onset of the Industrial Age; factories opened and communities became cities, making it necessary to bring in grains, milk, eggs, and meats from outlying rural areas in order to feed everyone. And at that point, unscrupulous manufacturers were everywhere--then, as now, they did anything and everything imaginable to increase their profit margins: diluting milk with water, for example, or cutting sugar with cheap saccharine. And they spiked their products, particularly medicinal and cosmetic ones, with dangerous preservatives, metals, salts, and even drugs like opium. In his book Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (Knopf, 2003), author Philip J. Hilts writes:

Wealth in America was rapidly leaving the hands of a large number of landowners and flying into the hands of a few industrialists, reaching the point before the end of the century when about 60 percent of the wealth was in the hands of one percent of the population. Along with the boom in business, the nation found it would have to undergo what began to be called, euphemistically, "cycles"-crashes at regular intervals. There were full depressions in 1873, 1884, and 1893. Perhaps just as important, business and politics had merged into one entity. The era of the common man envisioned not long before had never arrived. The control of politics, once in the hands of kings and hereditary gentry, rapidly passed to a moneyed class. [...] The United States Senate was referred to as the "millionaire's club," and it resembled a convention of industry representatives. Because of strong party control over state legislatures and election rules, it had become common for wealthy men to pay a fee to the party to get themselves nominated and elected to office. "The Senate, instead of representing geographical areas, came to represent economic units," writes historian Sean Cashman. In Congress, it was lumber rather than Michigan, oil rather than Ohio, silver rather than Nevada. There were no public services to speak of, and protests were crushed by private squads or government troops, or both.

Dr. Wiley's formidable efforts, along with superhuman perseverance fueled in no small part by the courage of his convictions, finally led to President Roosevelt's signing of the historic legislation known as The Pure Food and Drugs Act of 1906. From an archived article at the FDA's site:

All through the 1880s and 1890s, pure-food bills were introduced into Congress--largely through his work--and all were killed. Powerful lobbies had established themselves. To bring his cause to the public, and with a budget of $5,000, Wiley organized in 1902 a volunteer group of healthy young men, called the Poison Squad, who tested the effects of chemicals and adulterated foods on themselves. Women banded together, notably in the Federated Women's Clubs, for political clout. Major canners became supporters of the legislation and voluntarily abandoned the use of questionable chemicals. Finally, the battle was won on June 30, 1906, when President Theodore Roosevelt signed the Pure Food and Drugs Act, largely written by Wiley, who was then appointed to oversee its administration.

   

The battle had been won--but not the war. Wiley had many adversaries in Congress and in the food and patent-medicine industries, and in 1912 he left his government post. A headline of the day read: WOMEN WEEP AS WATCHDOG OF THE KITCHEN QUITS AFTER 29 YEARS.

It is true that women activists were Dr. Wiley's allies, just as it's true that the nation's favorite chemist enjoyed widespread popularity among women in general. The trouble was, women couldn't yet vote--how quickly we forget! Note that the FDA's article describes Dr. Wiley's adversaries as having been "in Congress and in the food and patent-medicine industries". However, in the interests of paying attention to history and thus generally avoiding the doomed repetition thereof, the agency might have elaborated on the disturbingly familiar tactics of the lobbyists who ultimately forced Dr. Wiley--the accomplished and respected chemist who dared to investigate and criticize food additives; the official who dared suggest that whiskey makers who diluted their product with sugar water should be required to disclose this on labels--from his position. (While still in office, however, he established the Bureau of Foods, Sanitation, and Health for Good Housekeeping, an independent organization devoted to the cause of pure, unadulterated foods. After leaving government service, Wiley took on the role of full-time director.)

Missing from the site, too, are any excerpts from (or mention of) the book Dr. Wiley would write twenty years later (shown here), laying out in exquisitely-written and oftentimes dryly witty prose exactly what happened. His first manuscript was mysteriously lost at the printers, so Wiley self-published a complete re-write, which reportedly took another decade. Once they hit the stores, though, copies of Dr. Wiley's exposé flew off the shelves and then disappeared mysteriously, too; today, few even exist outside college archives and the Library of Congress. One might wonder about the forces behind such blatant censorship and malfeasance if one had somehow missed the straightforward, all-but-underlined clues strung together in its title: History of a Crime Against the Food Law: The Amazing Story of the National Food and Drugs Law Intended to Protect the Health of the People Perverted to Protect Adulteration of Food And Drugs (the entire manuscript is online here). Dr. Wiley wrote about the coordinated attacks on his efforts to enforce the new law (attacks that ultimately led him to resign from government work just six years after the law's enactment):

At the time this investigation took place the total expenditures made by the Referee Board of the money appropriated by Congress to enforce the Food and Drugs Act amounted to over $175,000. Every dollar of this money was expended in protecting and promoting violations of the law. It seems strange in view of these findings which were approved by the House of Representatives that no effort was made to impeach the Secretary of Agriculture and the President of the United States who had thus perverted money appropriated for a particular use to activities totally repugnant to the purpose of the appropriation. [...] It is a striking comment also on the attitude of Congress and the people at large that no steps have ever been taken from 1911 to 1928 to correct these outrages on the American people and to attempt to restore the law to its power and purpose as enacted. Administration after administration has come and gone and these abuses still persist.

In  an effort to demonstrate how different the system is in 2007, how much progress has been made, FDA vanity articles and press releases point out how Dr. Wiley, working and writing all those years ago, could never have imagined how things would be now.  But the conscientious chemist's own words--laboriously written, re-written, and self-published in 1929--tell us otherwise:

Thus we see, through all the branches of food enforcement activities, this laissez faire principle. There is no longer any virtue in applying the penalties prescribed by law. There is no longer any adulteration that threatens health. Business must be preserved. Penalties were intended as aids to reformation. They are not now to be inflicted except as a last resort. Such is the regrettable condition into which law enforcement has fallen.

Plus ça change, plus c’est la même chose.  The more things change, the more they remain the same.

Senator Dick Durbin (D-IL) On The Pet Food Recall, The FDA And Food Safety

[Posted by litbrit.]

"If you want to do business with the United States, you'll do it on our terms when it comes to health and safety."

At hearings today, Senator Durbin speaks out on behalf of all who eat.  He goes through the timeline of this massive recall, pointing out many of the systemic vulnerabilities, including those of the FDA, that led to our food supply being tainted, and calls for reform.  Great stuff.

(H/T Petulant)

Crossposted at litbrit; also Shakesville.

FDA Widens Import Alert (To Put It Mildly), Concedes That Animal Fatalities Number In The Thousands

[By litbrit, who seems to have misplaced her appetite.]

A number of journalists and bloggers have been following the food-adulteration issue very closely, including Goldy at HorsesAss, who to his credit manages to find some dark humor in all this--really--and sends up the FDA's recent update.  (You remember, the one they issued on Friday, with food-supply protectors assuring us that humans aren't at risk because even if melamine had got into pork, it would only be a small percentage of the pork, and pork itself is only part of the American diet anyway.)  Goldy also points to a new, quietly-expanded Import Alert buried in the FDA website:

IA #99-29, 4/27/07,  IMPORT ALERT #99-29,

"DETENTION WITHOUT PHYSICAL EXAMINATION OF ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL OR HUMAN FOOD USE DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"

TYPE OF ALERT: Detention Without Physical Examination (Countrywide)[...]

PRODUCTS: Wheat Gluten   Rice Gluten   Rice Protein   Rice Protein Concentrate   Corn Gluten   Corn Gluten Meal   Corn By-Products   Soy Protein   Soy Gluten   Proteins (includes amino acids and protein hydrosylates)   Mung Bean Protein

PROBLEM: Poisonous or Deleterious Substance   Unfit For Food   Unsafe Food Additive

PAF:          PES     COUNTRY:      China (CN)     MANUFACTURER/SHIPPER:     All

CHARGES:   "The article is subject to refusal of admission pursuant to     section 801(a)(3) in that it appears to bear or contain a     poisonous or deleterious substance, which may render it     injurious to health [Adulteration, section 402(a)(1)]"

Look at that list now--it includes just about every form of grain protein there is.  Soy, rice and mung bean proteins that go into cookies and pizza dough and baby food, as well as countless "healthy" smoothies served at juice bars across the country.  Would you like a sprinkle of melamine  splash of cyanuric acid shot of protein powder in your mango shake for just a dollar more?

At a presser on April 26, FDA official Dr. Dan McChesney said the number of animal fatalities associated with the tainted food was "in the  high teens":

REPORTER: ...Jim Kirshner with WDIV-TV in Detroit. Do you have a total number of pets either killed or sustaining some sort of injury from the pet food contamination? What figures do you have confirmed at this point?

         

DR. MCCHESNEY: This is Dan McChesney from FDA. What I previously said I believe in response to the Washington Post question was that it's in the high teens, maybe 17 or 18 that we have confirmed. But again that's not our focus. Our focus is to remove product that was contaminated, contained either wheat gluten or rice concentrate from commerce so we don't involve other animals or get it into other parts of the supply system.

         

REPORTER:  At some point will you make a count, take a count, of the number of dogs, cats involved?

         

DR. MCCHESNEY: I don't know. We've had multiple, many thousand calls from consumers, and we are looking at that, but I'm not sure we will ever come up with a final number here. It's just, I just don't think we can ever get there.

 

But in the above-mentioned Import Alert issued the very next day (April 28) the FDA finally reports a death toll that approaches the truth, which is to say, a number in the thousands as opposed to the high teens.  The Feds also mention the enormity of this recall:

This has been one of the largest pet food recalls in history, a recall that continues to expand.  Thus far, 18 firms have recalled product, 17 Class I and 1 class II,  covering over 5,300 product  lines.  As of April 26, 2007, FDA had received over 17,000 consumer complaints relating to this outbreak, and those complaints included reports of approximately 1950 deaths of cats and 2200 deaths of dogs.

Gina Spadafori at Pet Connection blog (which took the lead early on, putting together a database of dog and cat deaths and keeping abreast of all the food-tainting developments) has this to say:

Look … you would not believe the crap we have had to take for our Pet Connection database. We have been accused of promoting everything from hysteria to our own careers, and through it all the FDA has said nothing that substantiated what we and the independent Veterinary Information Network knew was the scope of the tragedy. [...]

Perhaps now every time a media outlet says “16″ or even “17 or 18″ or “high teens” or some other such nonsense, the reporter will get this FDA document in their e-mail inbox from, like, every one of us who cares about making these pets count.

I take absolutely no joy in being “right,” and I would gladly be wrong to have all those pets still alive. But I truly do believe if it weren’t for the pressure from those of us working to get this information out and force the FDA to step up, there’d be a lot more people grieving for their pets tonight.

And tainted products would still be flowing into this country.

Expect even those high numbers to continue to rise.  What's more, we'll soon be seeing the recall of an undetermined number of food products meant for humans; when that happens, the uproar will be deafening.  I would add that there have been numerous anecdotal reports of livestock and horses suffering kidney failure, too, but these illnesses and deaths have not been officially recognized or counted yet; it is also unclear if the FDA or USDA plan to intervene in the common and ongoing practice of adding salvage pet food and scraps to hog feed, responsible for last week's pork recall and the euthanization of thousands of pigs. Stay tuned.

From Cicero's Mouth To Congress' Ear

[litbrit is inspired to look back]

Over at Harp and Sword, Minstrel Boy reminds us of Cicero's bold tactics in court all those centuries ago and posits that our own Senate and House should turn their attentions to the lessons of our forbears:

This comes from his first great legal victory. Cicero prosecuted Gaius Verres for crimes he committed while governor of Sicily. Theft of artworks, unlawful detention and execution of Roman citizens. The crimes were numerous and heinous. The biggest hurdle facing Cicero in his prosecution of Verres was that the ill gotten gains had been used quite liberally as bribes in the case. The jury was composed of Senators and the defense counsels were Hortensius and Metellus Pius who, at the time, were both consul-elect.

Knowing that there was a very limited time for the trial (if it progressed into the new administration there would be no chance at all of a conviction) Cicero rose on the first day of court and said this:

"Gentlemen of the court, at this great political crisis there has been offered to you, not through man's wisdom but almost as the direct gift of heaven, the very thing you most need---a thing that will help more than anything else to mitigate the unpopularity of your Order and the suspicion surrounding these courts. A belief has become established---as harmful to the republic as it is to yourselves---that these courts, with your senators as the jury, will never convict any man, however guilty, if he has sufficient money.

But the character of the many I am prosecuting, is such that you may use him to restore your own good name. Gaius Verres has robbed the Treasury and behaved like a pirate and a destroying pestilence in his province of Sicily. You have only to find this man guilty, and respect in you will be rightly restored. But it you do not---if his immense wealth is sufficient to shatter your honesty---well then, I shall achieve one thing at least. The nation will not believe Verres to be right and me wrong---but they will certainly know all they need to know about a jury of Roman Senators!"

Such fascinating reading!  I highly recommend the entire post, which may well inspire you to pull a few history books of the shelf for a little reacquainting session.

(H/T oddjob)