Chaos, control; chaos, control. You like? You like?
"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."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.
-- 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.
"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.
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.
"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."
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.
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.”
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.
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.
"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 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.
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.
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.
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.
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.”
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.
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.
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.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.
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.
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.
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.
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.
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.”
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.
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.
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.
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.”
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.You can see the entire list of adulterated (and potentially-adulterated) brands here.
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.
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.
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.The F.D.A. said diethylene glycol in any amount was not suitable for use in toothpaste.
