Friday, June 29, 2007

Friday Frank: I'm the Slime; SNL, 1973

I'm not sure what to make of the fact that a video of Mr. Zappa performing this particular song appeared on the 'Tube as I was writing that post (below).

Eerie coincidence, life imitating art, or a little of both? Only the enlightened know for sure, and they're not telling.

Bon Weekend, Everyone.

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

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.

Adulterated grain products from China slip through Humvee-sized holes in America's regulatory safety net and then sicken and kill thousands of pets. Counterfeit and toxic ingredients poison tens of 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 makes recent downsizing revelations that much more shocking: not only has the Bush administration pushed for further shrinking of FDA staff--today, the agency has 1,000 fewer scientists and analysts than in 1997 (despite the number of imported goods having skyrocketed during that time) and management wants to fire or retire even more of these specialized personnel--the president has actually closed numerous laboratories already and 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.

This enfeebling of the FDA, a key agency entrusted with protecting the nation's food supply--the safety of which is regularly threatened--has already produced grim consequences.  If the lab-closings continue apace, the agency's current and less-than-1% inspection rate is going to start looking good.

Poison that also illuminates

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.

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.

Another recently implemented software system at FDA is known as CARVER + Shock, which is a threat assessment software tool originally developed for the military; its algorithm draws on data generated by a series of 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."

Sandia works in partnership with Lockheed Martin, a multi-faceted defense contracting conglomerate and consistently one of the largest recipients of American tax dollars.  The corporation is 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. It is also part of an unofficial alliance of lobbyists, defense contractors, and the Pentagon which, in Washington, is known as The Iron Triangle.

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. We also know that an algorithm does not follow the same processes as a human brain.  A trained analyst employs (among other skills) constructivist logic: he or she would make the obvious leaps from a pet-food threat to an animal-feed threat to a human-food-supply threat.

Was the CARVER + Shock software used to arrive at the more mathematically-based (and incorrect) conclusion that a few dog and cat deaths simply weren't all that threatening? And did this in turn lead to critical delays--delays during which adulterated food kept making its way into consumers' homes and ultimately into the bodies of American pets, as well as livestock--and thus the human food supply?

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.

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 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 no sense to concentrate the nation's best scientific minds and resources in the cities most likely to be affected by a terrorism incident, as history has borne out.  Certainly 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 the 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.

Sadly, Americans are almost at the point of no return, shock-wise; that we have in fact come to expect this behavior from our leadership in Washington 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 dangers of potential 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. The agency 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.

After 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.  As the distance between field and table grew--with numerous types of goods now traveling miles and changing hands repeatedly before a customer ever bought them at the store--the average American pantry would come to contain a variety of threats to human health (and even life).

It was during this time that 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 food to American farmers and consumers.

Unscrupulous food and liquor 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 and superhuman perseverance 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 the agency might have elaborated on the lobbyists' tactics that 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--to leave 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 FDA's site, too, are any excerpts from (or mention of) the book Wiley would write twenty years later (shown left), laying out in exquisitely-written and oftentimes dryly witty prose exactly what happened.

Wiley's first manuscript was mysteriously lost at the printers, so he self-published a complete re-write, which reportedly took him another decade. Once copies of Dr. Wiley's exposé appeared in stores, they seemed to sell extremely quickly; then they, too, disappeared altogether.  Today, few even exist outside college archives and the Library of Congress.

To understand the nature of Wiley's opposition, consider that these individuals and their companies sought nothing less than censorship of a United States government chemist--one who headed up a then-novel regulatory agency and who was also a consumer advocate at a time when the protection of consumers was itself  a nascent concept.  With almost limitless malfeasance propping up their business model, silencing Wiley and preventing his truths from gaining traction in the larger public were acts of self-preservation.

Wiley knew, of course.  He lays it out neatly in the book's 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).

Here, Wiley remarks on 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 and show 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.

Also at Ezra Klein.

Once Again, An Imported Seafood Scare

I've written about China shipping deadly puffer fish labeled as monkfish and that country's adulteration of fish feed with melamine. I've described the kinds of things analysts are finding in other imported Chinese seafood--antibiotics in catfish, for example. And while researching and writing a story about the USDA's plans to allow chicken imports from China, I came across a nauseating description of fish farms: Chinese farmers actually suspend the chickens over ponds, allowing the birds' feces to serve as feed. All the while, Chinese seafood shipments kept arriving at our ports and making their way to grocery stores and restaurants nationwide--at least until yesterday:

The U.S. Food and Drug Administration yesterday banned the import of five types of farm-raised fish and shrimp from China because they have been found to contain unsafe drugs, some of which can cause cancer.

The species include catfish, shrimp, eels, basa -- a kind of catfish -- and the carp-like dace. The FDA is not ordering that the products be pulled out of restaurants or from supermarket shelves but said that all incoming shipments would be stopped immediately. The chemicals found in the food "could cause health problems if consumed over a long period of time," said David Acheson, the FDA's assistant commissioner for food protection.

Those unsafe drugs and "chemicals" they're referring to? Some, like fluoroquinolone, are powerful, broad-spectrum antibiotics with various negative side effects (neuropathy, heart problems, and hypoglycemia, to name a few). Their use in edible goods is prohibited here, largely because certain bacteria have already developed quinolone-resistant strains (gonorrhea, for example) and mycobacterium (i.e. certain strains of tuberculosis) have, alarmingly, begun developing resistance, too.

Dear Government: Since the US doesn't have the capability to inspect all these containers and you keep cutting back the FDA's budget, reducing its staff, and closing its labs, when are you going to put a full stop to all ingestible imports from China until such time as that nation can prove it has cleaned up its foul act? I look forward to hearing your answer.

Friday, June 22, 2007

Friday Frank: Amazing Mr. Bickford "Dupree's Paradise"; 1984

A claymation treat for your ears and eyes and daydreams. It's neoclassicalicious!

Bon Weekend, everyone.

(H/T Mechaniktom)

Tuesday, June 19, 2007

Food Safety Issues, Toxic Toys, And A Regulatory System In Disarray

It's time for our government to face facts: we have a serious problem with imported food and other goods coming to the United States from China. And it's time for our government to bring some real muscle (read: money) into the regulatory agencies--specifically, the FDA and the USDA--who are tasked with protecting American consumers from dangerous products. That we are currently inspecting only 1% of imports is nothing short of pathetic. That our most vulnerable citizens are also the most likely to be affected by dangerous products should put the fear of God into some of those pious, vote-seeking suits, many of whom who can undoubtedly recite the Beatitudes by heart without a trace of irony in their voices when they get to the Blessed are the poor; blessed are the hungry; blessed are the meek bits. Because the most vulnerable (and least politically valuable) among us are also those who are hit the hardest: lower-income families who buy non-brand toothpaste at discount stores, for example, and children of all backgrounds innocently playing with lead-tainted toys because they have no reason to think that adults in a foreign land somewhere would deliberately put their health in jeopardy. And, of course, animals.

This afternoon, I received a letter from my congressman, Bill Young , responding to my request that he support strengthening the FDA and even completely reforming the entire regulatory system, if need be. Referring to H.R. 2108, the Human and Pet Food Safety Act, Congressman Young writes:

With regard to your support for H.R. 2108, as you are aware, this bill would directly target the FDA's authority to prevent or react to human and pet food recalls in the future. Many constituents like you have expressed great displeasure with the FDA's response to the most recent pet food contamination as well as the agency's responsibility to fully protect the nation's food supply. Specifically, H.R. 2108 would provide the FDA with mandatory recall authority; require the FDA to establish adverse event reporting standards and penalties; and provide standing FDA authority to inspect overseas. The bill also will address surveillance and early detection issues that were so apparent earlier this year.

H.R. 2108 has been referred to the House Energy and Commerce Committee where it awaits further consideration. Because of your interest in this matter, and in an effort to be of all possible assistance to you, I have taken the liberty of sharing your support for the Human and Pet Food Safety act with my colleagues on the committee. As they continue to review H.R. 2108, please know that they will keep your thoughts in mind.

Well, things appear to be moving in the right direction. I'd like to urge all U.S.-based readers to drop a line to their Congresspersons (you can find e-mail links and other contact information for all members at the House site). Squeaky wheels, critical mass, and all that.

Today, the New York Times brings us this unsettling story (my emphasis):

Over all, the number of products made in China that are being recalled in the United States by the federal Consumer Product Safety Commission has doubled in the last five years, driving the total number of recalls in the country to 467 last year, an annual record.

It also means that China today is responsible for about 60 percent of all product recalls, compared with 36 percent in 2000.

Much of the rise in China’s ranking on the recall list has to do with its corresponding surge as the world’s toy chest: toys made in China make up 70 to 80 percent of the toys sold in the country, according to the Toy Industry Association.

Combined with the recent scares in the United States of Chinese-made pet food, and globally of Chinese-made pharmaceuticals and toothpaste, the string of toy recalls is inspiring new demands for stepped-up enforcement of safety by United States regulators and importers, as well as by the government and industry in China.

It's not an exaggeration to say that we're in deep trouble with this whole imports-from-China mess. Very deep trouble. Numerous readers have suggested that since China holds so much of America's debt, our government is deliberately turning a blind eye to the dangerous food and other products they ship to our nation, container load after container load. Don't like our melamine-tainted wheat gluten? You'll come around to our way of thinking when we start calling in those notes, remarked one dry-witted reader. Others have noted that large multinational corporations--even American-based ones (perhaps especially American-based ones)--have such huge investments in China, they will frown on, if not fight outright, any attempts to regulate Chinese imports on the American end because such efforts would ultimately--and negatively--affect their own profit margins.

Then there are the counterfeiters. Everything can be faked! But an imitation Louis Vuitton purse sold on Canal Street in New York--legally and morally questionable a purchase as it may be (another argument for another post)--is one thing; fake glycerin in the form of diethylene glycol (also known as antifreeze) in cough syrup is another matter altogether. That stuff will kill you and your kids, as it has already, in tragic numbers, in Bangladesh, Haiti, Nigeria, Argentina, India and Panama.

So. We have to start somewhere, and it seems to me that fortifying our regulatory agencies with serious budget appropriations (so they can improve on that dismal 1% inspection rate, for one thing), giving them the authority to act quickly when the nation's food supply is threatened, and sending them abroad, if necessary, to conduct inspections are excellent ways to begin tackling a problem that will definitely grow larger and more unwieldy every year unless it is addressed. Unlike some countries, America has not lost thousands of children to poisoned medicine--yet. But as thousands of bereaved American dog and cat owners will sadly attest, we've most certainly had our own canary-in-the-coal-mine episode, and we can't sit around hoping that things work out on their own. Contact your Congresspersons and urge support for H.R. 2108, the Human and Pet Food Safety Act.

Also at Shakesville.

Monday, June 18, 2007

No Responsible Sex, Please--We're American TeeVee

The hypocrisy--it burns. American network television has the ability to enlighten and educate countless millions through PSA's (public service announcements) and commercial advertising promoting condoms. Yet sanctimonious, look-the-other-way attitudes prevail over here, and condom advertising remains one of those experiences you're more likely to have in foreign lands. I wish this was a function of our country's blissful freedom from serious problems like HIV and other STD's. Hardly. I wish this meant that America was not, in fact, a country besieged with so many unwanted pregnancies that it held the dubious honor of having one of the highest abortion rates in the developed world.

What it is, however, is yet more evidence of a different serious problem--one that ironically seems more prevalent in America than elsewhere these days, which is to say, powerful right-wing religious groups controlling what the masses can and cannot see. To wit: another condom commercial--one that sounds rather funny in an eye-rolling kind of way--has been rejected by two of America's largest TV networks (my emphasis).

In a commercial for Trojan condoms that has its premiere tonight, women in a bar are surrounded by anthropomorphized, cellphone-toting pigs. One shuffles to the men’s room, where, after procuring a condom from a vending machine, he is transformed into a head-turner in his 20s. When he returns to the bar, a fetching blond who had been indifferent now smiles at him invitingly.

Directed by Phil Joanou (“State of Grace”), with special effects by the Stan Winston Studio (“Jurassic Park”), the commercial is entertaining. But it also has a message, spelled out at the end: “Evolve. Use a condom every time.”

“We have to change the perception that carrying a condom for women or men is a sign they’re on the prowl and just want to have sex,” said Linda Kaplan Thaler, chief executive of the Kaplan Thaler Group, the New York advertising agency that created the “Evolve” campaign. “It’s a sign of somebody being prepared — if the opportunity arises — to think about their own health and the health and safety of their partner.”

But the pigs did not fly at two of the four networks where Trojan tried to place the ad.


Representatives for both Fox and CBS confirmed that they had refused the ads, but declined to comment further.

In a written response to Trojan, though, Fox said that it had rejected the spot because, “Contraceptive advertising must stress health-related uses rather than the prevention of pregnancy.”

In its rejection, CBS wrote, “while we understand and appreciate the humor of this creative, we do not find it appropriate for our network even with late-night-only restrictions.”

“It’s so hypocritical for any network in this culture to go all puritanical on the subject of condom use when their programming is so salacious,” said Mark Crispin Miller, a media critic who teaches at New York University. “I mean, let’s get real here. Fox and CBS and all of them are in the business of nonstop soft porn, but God forbid we should use a condom in the pursuit of sexual pleasure.” ads depicting middle-aged white guys dragging their wives into lingerie stores because they've suddenly grown a pair of big V-for-Viagra horns are appropriate for network television.

Ads showing pharmaceutically-enhanced middle-aged white guys abandoning their car-washing activities mid-stream, fiddling with the hose so it can spray on its own, and nipping indoors with their female partners for a hand-rubbed finish are also appropriate for network television.

But ads that promote the use of condoms during the very act such medicines purport to support? Banned!

I'm especially irritated that these think-tank people (and the networks who love them) seemingly frown upon using condoms to prevent unwanted pregnancy and allow enjoyable, non-procreative sex--and reject that sort of ad--while giving the odd pass to efforts that stress disease-prevention, which is clearly the more noble purpose of condoms in their opinion. Both purposes are important, of course, but admitting this is tantamount to accepting that people might actually be engaging in the whole messy act with something other than family-makin' on the mind. For purposes that have to do with, oh, enjoyment and escape and pleasure, for starters. And they can't have that, you know.

Not until they can figure out a way to tax it.

Contraceptive advertising is meant for grownups, yes, and any group of network suits possessed of a collective brain-cell count in the double-digits would want to aim such commercials at adults and air them at the appropriate times (as in, not on Saturday morning). Other countries--even Latin American ones with large Catholic populations--have been able to get this, and the results are entertaining and memorable (two very good things to be if you're a commercial that wants to be, ah, effective). A few of litbrit's picks:

This funny French one hits uncomfortably close to home:

And from Argentina, bless them, comes this awesome ad:

Another French ad (and another too-close-to-home scenario for me!):

Finally, for pure belly laughs (or else howls and shrieks of the better-you-than-me variety) nothing beats this one (the actor is American or Canadian, but I've never seen this aired in the States--have any readers?):

(H/T Lisa in Baltimore)

Also at Shakesville.

Saturday, June 16, 2007

Friday Saturday Frank: Suicide Chump

Apologies! After a very long Friday, I was too tired to sit upright at my desk, much less open my computer. The last thing I remember is threading myself between cat and child and husband. Then blackness. (There was no Journey ballad playing beforehand, thankfully.)

This is wonderful old black-and-white footage of Frank in action. I'm going to ask Maestro what year this is; I'd guess early seventies.

Bon Weekend, everyone.

Sunday, June 10, 2007

Sunday Grace

The face of woman in Western art, in her many incarnations. An offering of beauty, the transient and eternal alike--at once, in fact--unwrapped and presented with a videographer's gentle flourish and Yo-Yo Ma's poignant cello.

Via the brilliant Lord Whimsy, who notes:

An absolute joy to watch. The sequence sometimes gives the impression that the eternal face behind it all is actually flirting with you.

If you're interested, here is the approximate progression:

Leonardo Da Vinci, Raphael - Raffaello, Titian - Tiziano Vecellio , Sandro Botticelli , Giovanni Antonio Boltraffio, Albrecht Dürer, Lucas Cranach the Elder, Antonello da Messina, Pietro Perugino, Hans Memling, El Greco, Hans Holbein, Fyodor Stepanovich Rokotov , Peter Paul Rubens, Gobert, Caspar Netscher, Pierre Mignard, Jean-Marc Nattier, Élisabeth-Louise Vigée-Le Brun, Sir Joshua Reynolds, Franz Xaver Winterhalter, Alexei Vasilievich Tyranov, Vladimir Lukich Borovikovsky, Alexey Gavrilovich Venetsianov, Antoine-Jean Gros, Orest Adamovich Kiprensky, Amalie, Jean-Baptiste Camille Corot, Édouard Manet, Flatour, Jean Auguste Dominique Ingres, Wontner, William-Adolphe Bouguereau, Comerre, Leighton, Blaas, Renoir, Millias, Duveneck, Cassat, Weir, Zorn, Alphonse Mucha, Paul Gaugin, Henri Matisse, Picabia, Gustav Klimt, Hawkins, Magritte, Salvador Dali, Malevich, Merrild, Modigliani, Pablo Picasso.

[Video by eggman913]

[H/T Lisa in Baltimore]

Saturday, June 09, 2007

The Sopranos' Metaphysical Tenor

Like everyone else who's been watching HBO's crime drama The Sopranos since its first irresistible season, I have a few thoughts (very well, unsolicited predictions, so consider yourself warned) regarding tomorrow night's much-anticipated grand finale. In a note to Ezra, I wrote:

My own take on what's going on at Casa Soprano? I think the whole final season--beginning with the first half that aired last year, with Tony in the hospital--has been Tony's coma dream as he approaches death (in much the same style as the movie Jacob's Ladder, during which Tim Robbins' character's psychotropically-induced death dream was played out over the course of the movie). I believe Tony actually ratted out the New York family at the end of the previous season, turning state's evidence and going into the witness protection program. You'll remember how in that coma dream, he was a salesman named Kevin Finnerty (going with the reasoning that Feds customarily give protected witnesses new identities with WASP-y names, as opposed to obviously Italian ones), and he was staying in some Marriot-like hotel, with a different ID in his wallet and different kids' voices on his home answering machine? And how at one point he looked out the window and saw the sun do that odd flashing thing, which it did again when he went to the desert with the Vegas stripper girl after winning at the roulette table (at which point Tony raised his arms and yelled "I get it! I get it!")?

Also, remember in the first half of this last season, while T was in the coma, how the bright hospital light shining into his face tied in with the light (inside a house) toward which his dead cousin was urging him--come in, come on in? That same light--and awareness--burned and buzzed at him from above when he first began his peyote trip with the stripper and found himself on her bathroom floor.

Anyway, I think the entire final season has been Tony's conscience (and/or subconscious self) imagining how it all might have played out if he hadn't flipped. And the flipping actually took place after the Feds nabbed him and Johnny on the porch that snowy winter day (the final episode of the previous season). He imagines/dreams himself running and getting away, running through the snow and tossing away his weapon (which even turns up a couple of years later and gets him in trouble), setting the stage for the final season's alternate reality. He has classic parental-worry dreams about his daughter--whom she will date and marry, what career she will choose--as well as his son (will AJ's long-demonstrated patterns of disaffectedness and disinterest persist, and are they symptoms of depression or rather, of the payback cycle--recriminations, guilt, etc.--of a violent and heritable pathology?). Tony is a sociopath, which fact the onscreen shrinks have gone to great lengths to explain. But so is his son, as the writers have shown in an admittedly uneven way. And so were his parents--both of them.

If the series is about Tony Soprano's soul, the final season (both halves) are about the way a sociopath's soul might interpret messages from the universe within and without--for example, memories about family and projections about the future of various loved ones; the relentlessly random outcome of the roulette table; deus ex machina events like Christopher wrecking his SUV and being so conveniently "killable"--as he approaches death. While most moral beings would experience the final "life-flashing-before-one's-eyes" slideshow as just that--a slideshow--the sociopath might turn such an event into one colossal justification for his life choices, one big, final sunflash of insight that everything is random and uncontrolled anyway, that no-one can be counted on, that everyone is out to get you--and indeed, that everyone has already gotten all your crew (last week), and you're next.

Which brings us to the final episode. If I'm close to right in my take on this, you'll see no small amount of visual metaphors dotted throughout the finale. What happened--how and when Tony flipped--may be explored enough to tie up some loose ends, but Chase, more than most screenwriters, seems to appreciate the messy and unexplained element of Being Alive, so perhaps not. I do believe Tony dies.

He's already dead, in fact.

Okay, so perhaps I do have a tendency to overthink things a tiny bit. Still, if my predictions prove close to correct--or even dead-on, so to speak--do remember that you read it here first.

Sopranos fans are invited to share their own thoughts and predictions in comments, and of course, to raise a glass of Brunello in honor of David Chase, a gifted and darkly witty writer.

Salute e millegrazie, Signor Chase. Al futuro!

Friday, June 08, 2007

Friday Frank: Zoot Allures & Trouble Every Day; New York, 1984

Classic Frank. Listening to this makes me want to start Happy Hour a half-day early!

Bon Weekend, everyone.

Wednesday, June 06, 2007

Food Safety This Wednesday: Chinese Leaders Vow To Toughen Regulations And Improve Inspection System

It remains to be seen whether the Chinese government is responding as gravely concerned leaders, forward-looking and justifiably worried businessmen, or public relations pros throwing down the expected comfort words, muffling fires (or attempting to) before they rage out of control. Perhaps they're acting in all three capacities--judge for yourself:

SHANGHAI, June 6 — Responding to growing international concerns about tainted food and counterfeit drugs, China said late Tuesday that it was overhauling its food and drug safety regulations and would introduce nationwide inspections.

The announcement, from the State Council, the nation’s highest administrative body, is the strongest signal yet that Beijing is moving to crack down on the sale of dangerous food and medicine and also trying to calm fears that some of its exports pose health problems.

The move follows a series of embarrassing episodes this year involving China’s export of contaminated pet food ingredients and toothpaste. The shipments of tainted pet food ingredients set off one of the largest pet food recalls in United States history.

Last month, an article in The New York Times revealed that at least 100 people had died in Panama after taking medicine containing a toxic chemical called diethylene glycol that had been produced in China and exported as the harmless syrup glycerine.

And in recent weeks, several countries, including the United States, Panama and Nicaragua, recalled or issued warnings about toothpaste made in China because it contained diethylene glycol.

While Beijing has strongly defended the quality and safety of its food and drug exports, and even denied that toothpaste it exported was unsafe, government regulators at the same time have stepped up safety inspections and shut down companies accused of producing unsafe food or counterfeit drugs.

But with pressure growing from regulators in the United States, Europe and other parts of the world, and international food companies expressing concern about the risks of importing Chinese-made food and feed ingredients, Beijing is pushing for a more forceful response to the crisis.

In its announcement on Tuesday, which was posted on a government Web site, China said that the state council had approved a new food and drug safety guarantee system on April 17 and that an outline of the new program was being distributed to government agencies nationwide.

While the new program sets laudable goals, the outline offers little in the way of a plan by which to achieve them. For example, officials state that by 2010, they will have implemented new controls on food and drug imports and exports; however, it is not clear what these controls will be, nor how the consistency of an exporter's compliance therewith might be monitored--and acted upon, if necessary--in the interest of ongoing commerce if not public health. Absent too is any meaningful plan for carrying out and enforcing the program fairly and uniformly across a nation as massive as China, especially since much of it is rural and remote. The program does call for more random testings of medicines (oddly, food is not specifically mentioned as needing more random inspections) and will require that inspection information (presumably a written label or bill of lading) be supplied with 90 percent of all food products. But why not randomly inspect food as well as medicine slated for foreign shipment, since many of the Dangerous Export Incidents precipitating this rather-too-late announcement actually were about food products? Adulterated, rotten, mislabeled, and otherwise toxic food products that were destined for--that landed in--America's human and animal food supply? And why not require that inspection information be supplied for all food products, not just 90% of them?

As for promises to check up on food makers and crack down on counterfeiters in general, I would ask, How? Will this be yet another strong-arm movement that winds up hurting the least powerful while pretending not to notice the transgressions of those who were in a position to do whatever they had to do to not have their transgressions noticed?

But the challenges facing China are enormous because its regulatory system is weak and enforcement is particularly difficult, partly because the economy is growing so fast and also because local officials accept bribes and sometimes allow small companies to flout regulations.

Also, regulators here say many exporters of food and medicines are mislabeling goods and shipping them illegally.

Two weeks ago, food and drug safety issues were even on the table in Washington during the strategic economic dialogue hosted by Treasury Secretary Henry M. Paulson Jr.

“These are issues China has to deal with over time,” says Rio D. Praaning, secretary general of the Public Advice International Foundation in Belgium, an advisory group that is working on food and drug safety issues around the world. “But we can’t wait. We have interim developments. We have patience, but frankly patience is out the window when people start dying.”

We have patience, but frankly patience is out the window when people start dying.

Hear, hear, Mr. Praaning. One quibble, though: people haven't just started dying. The issue of tragic deaths and illnesses caused by dangerous food and medicine imports has been an underreported but nonetheless horrifying--and continually developing--story for some time, now.

Also at Shakesville.

Saturday, June 02, 2007

Import Alert: Put Down That ToothAntifreeze Paste!

Taking a hiatus from my hiatus, I'm popping into the blogosphere for a moment to urge everyone to look closely at his toothpaste tube this morning: if there is any mention of it having been imported from China--or if it's one of the brands specifically mentioned by the FDA in their latest warning--you're strongly advised to avoid using it, as it may contain diethylene glycol (also known as antifreeze):

Consumers were advised yesterday to discard all toothpaste made in China after federal health officials said they found Chinese-made toothpaste containing a poison used in some antifreeze in three locations: Miami, the Port of Los Angeles and Puerto Rico.

Although there are no reports of anyone being harmed by the toothpaste, the Food and Drug Administration warned that the Chinese products had a “low but meaningful risk of toxicity and injury” to children and people with kidney or liver disease.

The United States is the seventh country to find tainted Chinese toothpaste within its borders in recent weeks.

Agency officials said they found toothpaste containing a small amount of diethylene glycol, a sweet, syrupy poison, at a Dollar Plus retail store in Miami, sold under the brand name ShiR Fresh Mint Fluoride Paste. The F.D.A. also identified nine other brands of Chinese toothpaste that contain diethylene glycol, some with concentrations of 3 percent to 4 percent.
You can see the entire list of adulterated (and potentially-adulterated) brands here.

Adding insult to injury (let us not forget the countless number of human beings around the world, many of them children, who died after ingesting diethylene glycol-adulterated cough syryp) is the cavalier attitude of Chinese officials. Here, as they say, is the money quote:

Over the years, counterfeiters have found it profitable to substitute diethylene glycol for its chemical cousin, glycerin, which is usually more expensive. Glycerin is a safe additive commonly found in food, drugs and household products. In toothpaste, glycerin is used as a thickening agent.

Chinese regulators said Thursday that their investigation of toothpaste manufacturers there had found they had done nothing wrong. Chinese officials also said that while small amounts of diethylene glycol could be safely used in toothpaste, new controls would be imposed on its use in toothpaste.

The F.D.A. said diethylene glycol in any amount was not suitable for use in toothpaste.

Question: why does the United States afford Most Favored Nation trading status to a country that not only places a lower value on safety--indeed, on human life--than we do, but is quite bald-faced in its admission of same? Chinese officials also said that while small amounts of diethylene glycol could be safely used in toothpaste...(!) I mean, I'd much rather see our government get tough on all imports from all countries, requiring that, at a minimum, U.S. health and safety standards be met--and instituting severe penalties, up to and including full-on embargoes, if necessary--than have to witness the kind of slavish genuflection we've been seeing America perform at the altar of free trade lo these recent months.

Antifreeze in toothpaste? For the love of all that is sane, FDA, put a stop to all Chinese food and drug imports until such time as that nation's officials can demonstrate, provably, that they take health and safety standards seriously--at least as seriously as American families, if not American regulatory agencies, are taking all this.

Also at Shakesville.

Friday, June 01, 2007

Friday Frank (Because Really, Hiatus Or Not, It's Mandatory): Stairway To Heaven (Led Zepplin), Cleveland 1988

Frank and the crew take this overplayed classic rock piece to new levels of guitar-y wonder. Given the fixed and faraway camera position, I think this footage was shot by an audience member with a sneaked-in camera. So, no closeups.

It's finally Friday and exams are over--all good. But it's the first day of summer, thus the lads are now underfoot, and I am very much under siege. So I'll take my escapes however I find them (and five minutes of Frank go a long way).

Bon Weekend, Everyone.