The Ranbaxy story: why we still can't trust our medications

It isn't just China that struggles with counterfeit and defective medications.

India's Ranbaxy makes much of the generic Lipitor consumed in the US -- and today a Pulitzer prize quality Fortune investigation makes it clear that Ranbaxy is a criminal enterprise.

Ranbaxy has been fined $500 million (no criminal prosecutions) in the US, but most of its crimes took place in weaker nations and during a time when America's regulatory agencies were reeling under GOP attack (emphases mine) ...

Dirty medicine - Fortune Features

.... On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements...

...  the sixth-largest generic-drug maker in the country, with more than $1 billion in U.S. sales last year ...

... we simply don't know what we're dealing with," says Dr. Roger Bate, an international pharmaceutical expert. "No one has actually gone into these sites to expose what's going on."...

... Drug applications work on the honor system: The FDA relies on data provided by the companies themselves....

... Ranbaxy took its greatest liberties in markets where regulation was weakest and the risk of discovery was lowest...

... The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line...

.... directed to substitute cheaper, lower-quality ingredients in place of better ingredients, to manipulate test parameters to accommodate higher impurities, and even to substitute brand-name drugs in lieu of their own generics in bioequivalence tests to produce better results...

.... the majority of products filed in Brazil, Mexico, Middle East, Russia, Romania, Myanmar, Thailand, Vietnam, Malaysia, African Nations, have data submitted which did not exist or data from different products and from different countries...

... drugs for Brazil were particularly troubling. The report showed that of the 163 drug products approved and sold there since 2000, only eight had been fully and accurately tested...

... deceptions greatly accelerated the pace of the company's FDA applications. They were also a grave public-health breach...

... the drugs Ranbaxy was actually selling on the U.S. market were an unknown quantity...

... Thakur knew the [HIV] drugs weren't good. They had high impurities, degraded easily, and would be useless at best in hot, humid conditions. They would be taken by the world's poorest patients in sub-Saharan Africa, who had almost no medical infrastructure and no recourse for complaints. The injustice made him livid...

 ... The inspectors also took and tested samples of Sotret, Ranbaxy's version of the acne drug Accutane, and found that it degraded far in advance of its expiration date....

[In 2006] ... the FDA ... did nothing to stop all the drugs that were already on the market,... .... Ranbaxy got six new approvals....

... September 2008, [the FDA] announced it was restricting the import of 30 drug products made by Ranbaxy (11 of which had been approved after Thakur's first contact with the FDA three years earlier). The agency still did nothing to recall the very same drugs on pharmacy shelves all over America, despite finding that Ranbaxy had committed fraud on a massive scale....

... many of Ranbaxy's senior executives were expected to ... carry suitcases full of brand-name drugs ... former employees suspect that the company used the brand-name drugs as a substitute for its own in testing...

The company is still in business, Tempest and Sigh aren't in prison, and the recent $500 million fine will soon be forgotten. In the meantime, does anyone imagine Ranbaxy is the only fraudulent manufacturer of generic drugs? And will Americans ever wake up?

We're wasting our time GOP scandal-theater, and ignoring the real scandal in front of us.

See also

• Ranbaxy: Looking Under the Rock. In the Pipeline 5/13 
• FDA Fails to Catch Generic Drug Disasters - The People's Pharmacy 5/2013
• FDA Let Drugs Approved on Fraudulent Research Stay on the Market - ProPublica (Cetero Research - 4/2013)
• We really need to panic more - FDA inspection of Chinese drug suppliers 2/2008
• Pet food poison and pithed America 3/2008 -- melamine poisoning
• The case of the curious silence: Counterfeit Heparin killed 62+ 4/2008
• Fraud and global supply chains - unanticipated consequence 5/2007
• Poisoned medicine: Even I am stunned. 5/2007

Update: The People's Pharmacy has five responses I liked, I omitted the one I disliked

1) Country of origin labeling. You should know where your medicine comes from!
2) The name of the manufacturer of your medicine should be on the label.
3) The FDA should release its bioequivalence curves for all generic drugs. These data should not be kept secret, as they currently are.
4) We must demand unannounced inspections in all countries that wish to export pharmaceuticals to the U.S. market.
5) Every foreign drug manufacturing company must be inspected every two years, just as U.S. manufacturers are inspected.

Fraud on Cyber: An annotated sample of Gordon's Notes

For the past fifteen years I've been fascinated by how the information technologies of the late 20th century supercharged old frauds. I suspect that our current depression, and the Depression of the 1930s, have enabling technologies as one common cause.

It takes time for law and custom to adapt to new technologies and complexities, and until they do frauds as old as the human mind take on new forms and power.

For almost ten of those fifteen years I've been publishing notes here. In honor of a post I'm working on now I've assembled an annotated biography. There's a sort of grouping order to the list, it's not chronological ...

• Causes of the crash of '08 - how much fraud? (Feb 2009).
• Causes of the Great Recession: China, GPSII and RCIIIT. Now for Act III (April 2008) - The rising wealth of China and India is the best news of the past century. Information technologies, like agriculture, writing, and the printing press, enable both the good and the bad in humanity - including new innovations in fraud. Together they have turned our world upside down.
• Lewis and Einhorn - repairing the financial world (Jan 2009). We didn't do the repairs.
• Michael Lewis on the End of Wall Street. My God (Dec 2008). When we could still be shocked.
• Global finance and parasites (Sept 2009)
• The subprime mortgage story: a problem of the weak (Nov 2007) We are all marks, but some suffer more than others.
• Memphis mortgages, complexity attacks and long term consequences (May 2010) - Information asymmetry is at the heart of IT enabled complexity attacks.
• Emergence: how entropy and incentives create scams (Nov 2009) IT enables complexity, complexity, entropy and emergence yield happy accidents.
• Malice, incompetence, and happy accidents (May 2011) I love this Dilbert cartoon on emergent fraud through IT enabled complexity attacks
• Complexity attack – the illustrated version (Dec 2009) Dilbert again. Scott Adams at his best.
• Emergent fraud: Anthem and automatic payment denials (Oct 2010) - a handy example of a complexity attack
• The Health Savings Account preventive visit scam (Nov 2010) - Complexity attacks are ubiquitous
• When the market is your deity, there is no such thing as corruption (July 2009) Marketarianism defined
• Brad DeLong: Principles for enlightenment 2.0 (March 2008) - One of my earliest Marketarian posts, before I started using that term.
• Scylla and Charybdis: Corruption, health care reform and climate change. (Dec 2009) - Alas, we lost.
• Campaign Finance Reform - The Publicly Owned Politician (Oct 2008) - Treat politicians as publicly traded corporations
• The Empire Strikes Back: complexity, mobile phone plans, and Apple defeated (June 2008) - few remember that Apple lost its war on the phone companies. I think if Jobs health had been better he'd have made another go at this.
• Mobile phone fraud - The accidental data charge and other scams (Nov 2009) - The list of mobile phone related scams is amazing. Perhaps everything we need to know about the past twenty years could be understood from this list.
• InfoUSA and Wachovia Bank sell out the vulnerable elderly (May 2007)
• Marked! Where did all our investments go? (Nov 2008) - we'd already had a lost decade
• Melamine sickened infants: 53,000 and counting (Sept 2008) - Not just an American problem, but the GOP removed much of our ability to respond
• Toxic heparin: fraud is looking likely (Mar 2008). I'm still amazed so little came of this.
• Pet food poison and pithed America (Mar 2008). When I realized Americans were overwhelmed.
• Fraud and Globalization: Toy Story III (June 2007) Do you think this has stopped?
• Poisoned Toothpaste from China: this would be a good time to start freaking out (May 2007). We never did.
• 21st century deception and the evolution of the emergent mind (June 2007). Deception and response made the human mind. So what will our time make?
• Credit card scammers: the story continues (Jan 2007). Yawn.
• Stop net fraud - make the banks pay for the externalities (Oct 2005). Easy to fix.
• Security costs money, it's cheaper for banks to pay the crooks. (May 2005)
• We've come a long way -- fraud 2008 (May 2008) - Yep, we knew.
• The Land of Rand (April 2005) Before the crash.
• Mob scams 200 million in small charges, shades of Netfill (Feb 2004) Yawn.
• Credit Card Fraud explodes -- Yawn. (Sept 2003). We had lots of warning of what was coming.

Is your drywall emitting toxic radioactive gases? No, really …

This Consumer Report blog article is the first I’ve heard of this one. Apparently the reports started in 2007, with customers learning of corrosive gases emitted from drywall manufactured in China. Consumer Reports wrote of this in March 2009, and again today (emphases mine) ….

Homeowners seek remedy as probe of Chinese drywall continues: Consumer Reports on Safety

As if the problems with Chinese drywall weren't bad enough, two fires are being investigated by the Consumer Product Safety Commission and the Florida State Fire Marshal's Office to see if toxic drywall contributed to the blazes. It's not too far-fetched given the reports of corroded electrical wiring, air conditioner coils, and other appliances and electronics degraded by the drywall.

The Los Angeles Times reported this week that some experts believe the problematic drywall was made using a radioactive phosphorus substance—phosphogypsum—that is banned for construction use in the U.S. but has been used by Chinese manufacturers for almost a decade.

Copies of Chinese customs reports obtained by The Times indicate that drywall made with phosphogypsum was shipped to the U.S. in 2006 by at least four Chinese-based manufacturers and trading firms….

… Also this week, the CPSC responded to four senators who last month asked the agency to "expedite its investigation and testing" of the drywall. In its status report, the CPSC said it was working with the Environmental Protection Agency, the Centers for Disease Control and Prevention, and other agencies to "coordinate a federal action plan." This involves collecting samples of drywall and degraded electrical components, taking air samples in affected homes, and formulating health advice for residents.

… The CPSC says it has received more than 608 incident reports from 21 states and the District of Columbia with most coming from Florida, Louisiana, and Virginia.

In an earlier analysis comparing some samples of imported drywall with its American-made counterpart, the EPA discovered:

• Sulfur was detected in all of the Chinese drywall samples, but in none of the four U.S.-manufactured drywall samples.
• Significant levels of strontium were detected in the Chinese drywall samples. Strontium was also detected in the U.S.-made samples, but at much lower levels.
• Two organic compounds associated with acrylic paints were found in the Chinese drywall samples, but not in the U.S.-made samples.

… Unfortunately, it seems the only sure way to rid a home of problems is to tear out the Chinese drywall and replace it—a very expensive and involved process.

Our Take: While the finger pointing as well as the CPSC, CDC and EPA investigations continue, affected consumers should be extra vigilant in monitoring potential health effects as well as electrical safety hazards that might occur from yet another tainted product from China.

Thus far the problems seem localized to 3 states, but we’ll all need to keep an eye on this one.

We plan to cut our own trees and hew the wood for our future home remodeling projects.

On the bright side, Obama is resurrecting the government Bush wrecked. In a couple of years we might be almost back where we were in the year 2000.

See also:

• pufferfish and drugged eels
• poisoned toothpaste
• Christmas light lead
• counterfeit medications and glycol poisoning
• surgical supply fraud
• “fake” fur that’s genuine dog
• toxic heparin
• melamine infant formula, melamine and cyanuric acid in pet food, more melamine, more in Africa
• Salmonella snacks

Update 7/11/09: It's gone national. The US Consumer Protection agency has a drywall page. This is one of the agencies Obama has been raising from the dead. The CPSC PDF report from July 2009 has a lot of details. They're focusing on a particular mine in China, the problems go back to pre-2006. A lot of American construction may be affected.

Homebrew life forms - oh joy

Those playful primates are at it again ...

Amateurs are trying genetic engineering at home - Yahoo! News

Using homemade lab equipment and the wealth of scientific knowledge available online ... hobbyists are trying to create new life forms through genetic engineering...

In her San Francisco dining room lab, for example, 31-year-old computer programmer Meredith L. Patterson is trying to develop genetically altered yogurt bacteria that will glow green to signal the presence of melamine, the chemical that turned Chinese-made baby formula and pet food deadly...

Truly, a heartwarming tale of the creative impulse at work. It brings back fond memories of those days of "Homebrew computing", or, in my case, the Delta DOS User Group [1]. It's the sort of science experiment my daughter would particularly enjoy.

If history repeats itself, which it's somewhat prone to do, we'll see all manner of creativity. We may expect some "worms and viruses" of course -- girls will be girls after all.

That's no big problem. We'll just plug in the biological equivalent of, say, Norton antivirus. Hmm, come to think of it, Norton didn't work too well. Much better to switch operating systems; really, OS X has many advantages.

Oh, wait. We really don't know how to change our genetic operating systems.

This could be a problem ...

[1] Or was it the Delta DOS Users Group? Memory fails alas. Those were the BBS days, when we used Telnet at night to visit distant modems. Hmm. it appears I have just created just created what will be forever more be the preeminent "hit" on searches for the DDUG. RIP DDUG.

Melamine in Minnesota cookies - but where were they made?

So where these cookies made in China -- or Vietnam?

Warning expanded on tainted cookies

... State officials are expanding their warning about contaminated cookies being sold in Minnesota.

The Minnesota Department of Agriculture is warning consumers to avoid eating any Wonderfarm brand cookie-type biscuits due to melamine contamination....

... State officials are urging consumers to immediately dispose of any Wonderfarm brand cookie products, which are made by Interfood Shareholding Co. in Vietnam.

There's no particular reason that Melamine, used to counterfeit protein, should be limited to Chinese products.

It's impressive how little interest there is among consumers in this topic, and how feeble the reporting is. This report doesn't tell us how these products came to be sold in Minnesota.

Salvaging world’s food and medication supply chains and resurrecting the FDA - thank you team Obama

Yesterday was an end to the 14 monster years, the 8 years of dread, the years of environmental decimation, to Rumsfeld and torture and Cheney and …

Damn, it’s a long list.

Good thing Obama has a huge amount of talent to call on ... Gore. Biden. Kerry. Buffet. The Clinton. Obama doesn't come alone, he comes with a superb team and a deep bench.

Somewhere on their to do list is the integrity of the world’s medication and food chain. Fake Heparin, poisonous infant food, poisonous animal feed, counterfeit surgical supplies, toxic toys, -- we've seen 'em all.

Meanwhile the GOP Bush cronies continued to destroy the FDA, the agency that was supposed to protect us from all this.

Fraud in the food and med supply chain has been only one of a non-stop list of disasters falling on pithed America. Ninety percent of Americans still have no idea what's going on; this was one of the many issues that didn't merit campaign attention.

That's over now. No, it's not that Americans have fully woken up. It's that we've dumped the incompetents, and we've engaged the O team.

This TIME story is a reminder of why we need the O team, and why the GOP needs to reform itself. Emphases mine ...

China's Melamine Woes Likely to Get orse – TIME

By Austin Ramzy / Beijing Tuesday, Nov. 04, 2008

First, a tainted product emerges, killing some and sickening many more. Its origin is traced to China, where a combination of greed and negligence allow the danger to slip into the food chain...

...As early as January, infants in China raised on Sanlu brand baby formula began developing kidney problems, and parents raised complaints that were ignored by company and local government officials. When the news finally broke in September, tests found four infants had died and more than 60,000 were sickened from formula tainted with melamine.. Expanded inspections found traces of melamine in milk powder from 22 of the country's 109 producers. The substance also showed up in whole milk and dairy products ranging from White Rabbit candies to chocolate used in sex toys in the U.K.

In late October, the scope of the scandal broadened when Hong Kong authorities announced that eggs imported from the mainland also contained melamine, the result of tainted feed given to chickens. Beijing ordered widespread testing of animal feed, and discovered 3,600 tons of contaminated product. The country's agriculture minister, Sun Zhengcai, called the tainted eggs an isolated problem. And the state press trumpeted news that sauces tainted with toxic chemicals were imported from three Japanese factories.

Change some of the details above and you could have the Chinese Product Safety Scandal of 2007. That round was touched off when the death of more than 100 Panamanians was traced back to cough medicine tainted with dietheylene glycol from China. Then hundreds of pets in North America were killed by eating food made from Chinese raw ingredients, also tainted with melamine. As last year's scandal spread, problems were found with Chinese-produced toys, tires, seafood and toothpaste... ...The Chinese embassy in Washington declared that it was "unacceptable for some to launch groundless smear attacks on China" over food and drug safety problems...

There's even more frightening details in a recent NYT Magazine expose on drug manufacturing in China....

The Safety Gap - Can the F.D.A. Ever Hope to Police Chinese Meds? - NYTimes.com
By GARDINER HARRIS

... China now produces about two-thirds of all aspirin and is poised to become the world’s sole global supplier in the not-too-distant future. But are the Chinese factories safe? Who knows? The U.S. Food and Drug Administration, the European Medicines Agency and other competent government regulators rarely, if ever, inspect them...

In China, where thousands of drug manufacturers sell products in the local markets, profit margins are razor thin, and counterfeiting and contamination are common. In 2002, the Pharmaceutical Association, a Chinese trade group, estimated that as much as 8 percent of over-the-counter drugs sold in China are counterfeit.

... China has in recent years exported poisonous toothpaste, deadly dog food, toys made with lead paint and tainted fish. In one infamous example this spring, Chinese manufacturers substituted a cheap fake for the dried pig intestines used to make the drug heparin, which is given to dialysis and surgery patients to prevent blood clotting. As deaths among those taking the drug mounted, the F.D.A. discovered the taint and banned the contaminated drug. In the end, 81 people may have died from allergic reactions, and tens of thousands around the world were exposed to danger. F.D.A. officials admitted that the agency should never have approved the Chinese-made heparin for sale in the United States; the agency, it turned out, had never inspected the Chinese plant making it.

Concerns about Chinese drugs have become so intense that just three weeks ago, the Health and Human Services secretary, Michael O. Leavitt, announced that the F.D.A. would open an office in Beijing by the end of the year and offices in Shanghai and Guangzhou next year. The agency still plans to send inspectors to China from the U.S., but the offices will provide “an infrastructure that will make those people more effective,” Leavitt said at the time of the announcement.

China’s leap to one of the biggest suppliers of pharmaceutical ingredients in the world happened over the last decade, as the Chinese government subsidized the construction of manufacturing plants that have undercut prices everywhere. Generic drug makers in the United States, where price competition is fierce, were the first to seek cheaper drug ingredients in China. Last year, generic drug applications to the F.D.A. listed 1,154 plants providing active pharmaceutical ingredients: 43 percent of them were in China, and another 39 percent were in India. Only 13 percent were in the United States. Branded drug makers, with their fatter profit margins, resisted buying ingredients from China for years, but with their businesses now suffering, even major pharmaceutical companies like AstraZeneca, Bayer, Baxter and Pfizer have announced deals to outsource manufacturing to China.

I have been writing about the drug industry for more than a decade, but I have rarely written about a subject that both branded and generic drug makers wanted to discuss less...

The F.D.A. regulates more than $1 trillion worth of consumer goods, which amounts to about 25 cents of every consumer dollar spent in this country. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. The agency is responsible for monitoring a third of all imported goods, from eggplant to eyeliner, microwave ovens to monoclonal antibodies, slaughterhouses to cellphones. But with fewer than 500 import inspectors and computer systems so old that repairmen must be called out of retirement to fix them, the agency is increasingly beset by a sense of futility.

Even the F.D.A.’s staunchest defenders now acknowledge that something is terribly wrong. Among them is Peter Barton Hutt, who served as the agency’s general counsel during the Nixon administration and is widely considered the dean of the F.D.A. bar in Washington. I’ve interviewed Hutt dozens of times over the years, and he has always defended the F.D.A. No more. “This is a fundamentally broken agency,” Hutt told me earlier this year, “and it needs to be repaired.”...

... To ensure the safety of imported drugs, the F.D.A. relies almost entirely on its own inspections of foreign plants. This was not much of a problem 30 years ago, when most medical products consumed in the United States were made here and F.D.A. inspectors could drive around to plants in their district. Most of those plants have since moved abroad, and now decades can pass between inspections. Testifying before Congress in April, Dr. Janet Woodcock, director of the F.D.A.’s drug center, spoke with rare frankness about the ability of the agency to do its job abroad. “The F.D.A. of the last century is not configured to regulate this century’s globalized pharmaceutical industry,” she testified.

Other current and former F.D.A. officials I talked to echoed Woodcock’s warning. Tim Wells, who was a field investigator and then a compliance officer for 24 years at the F.D.A., now does private audits of drug plants and sees the holes in the agency’s safety net. “A company I recently visited abroad hasn’t been inspected for 10 years,” he told me.

Besides being more frequent, domestic inspections are unannounced and more intense. And when inspectors find dangerous conditions at domestic plants, they generally return promptly to ensure that those conditions get fixed. Not so in foreign plants. In a report released Oct. 22, government auditors reported that between 2002 and 2007, F.D.A. inspectors found dangerous conditions in 15 foreign plants. Only one of those plants was reinspected within two years, the auditors found. In every other case, the agency took foreign managers at their word that promised changes were made.

The record is particularly bad in China. Over the past six years, the F.D.A. has managed to inspect annually an average of just 15 of the 714 Chinese drug plants that export to the United States. At its present pace, the F.D.A. would need more than 50 years to visit all of these Chinese plants. By contrast, the F.D.A. inspects domestic drug plants every 2.7 years...

... When inspectors do go to China, their reports sometimes read like a bureaucratic rendering of Mark Twain’s “Innocents Abroad.” During a 2001 trip, for example, two F.D.A. inspectors visited a plant that was exporting acetaminophen to the United States. The plant had never been inspected. “The F.D.A. inspection team was met at the hotel in Wenzhou by representatives from Wenzhou No. 3 Pharmaceutical Factory and . . . transported by public ferry and then company vehicle to the manufacturing facility on Dong Tou Island off the coast of Wenzhou,” their report states. “There is no street address or plot number, and the address of the facility is given only by the county and province.”

Once the team arrived in what seemed like the middle of nowhere, the inspectors learned the drug was being manufactured at another plant — one that once had a similar name but had recently changed it. “In fact,” the report continues, “inspection found that there were initially three separate and independent firms operating under the names Wenzhou No. 1 Pharmaceutical Factory, Wenzhou No. 2 Pharmaceutical Factory and Wenzhou No. 3 Pharmaceutical Factory. The location of Wenzhou No. 1 Pharmaceutical Factory was also determined by the F.D.A. inspection team during the visit to Wenzhou, and it was learned that the firm is operating under a new Chinese name; however, the English translation of that name was not available.” So the two inspectors flew back to the United States — at taxpayers’ expense — never having inspected a thing.

The F.D.A.’s apparent inability to keep names straight is no trivial matter. One reason the agency failed to inspect the Changzhou plant that produced deadly heparin, for instance, was that someone mixed up the facility’s name and concluded that the plant had already been inspected. Chinese plant names, a vestige of its once strictly controlled economy, are often very similar, and translations can vary. For instance, there are 57 separate drug master files — the basic F.D.A. record of a plant’s name, location and approved product — with “Shanghai” in the name. Some are obvious repeats, like the ones for “Shanghai No. 6 Pharmaceutical Factory” and “Shanghai Number 6 Pharmaceutical Factory.” But others could be separate plants. Or maybe not. It’s just too hard to tell.

Compounding the problem is the F.D.A.’s antiquated technology. Its computer systems are so awful that officials have no way of knowing which names, or which plants, are real. To determine which factories need to be inspected, agency investigators must consult two incompatible databases, one of which lists 3,000 foreign drug plants exporting to the United States and the other 6,800. Which number is right? Nobody really knows. Officials have told House investigators that their best guess for the number of foreign drug plants exporting to the United States is 2,967, while the Government Accountability Office recently guessed 3,249. Neither can the agency tell in many cases when the plants were last inspected (or, more important, which have never been inspected), where they are located or what products they make.

The combined ports of Los Angeles and Long Beach receive about 45 percent of all ship-borne trade that comes to the United States, or some 5.2 million containers a year. When I visited one day in May, giant cranes were unloading and loading more than 30 ships, each bearing about 2,500 containers. Some 40 to 50 of those containers — a tiny fraction of the total — were trucked to a gigantic warehouse about a half-mile from the ports. There the F.D.A. and Customs and Border Protection cracked open shipping containers that they considered suspicious and then emptied the containers into a large examination area in front of the bays, arranging the boxes and crates as if they were pathologists lining up organs from an autopsy.

Just about every crate I saw contained some kind of food product. One crate came from Indonesia, and its manifest said it contained products with chicken inside. Indonesia plus chicken suggests avian flu to F.D.A. officials. So they decided to take a look. The crate turned out to contain chicken seasoning, but no actual chicken. Still, the cans were sent off for testing. Deeper into the guts of the container were glass jars of sambal terasi, a hot sauce. They would probably be sent back because the F.D.A. requires makers of low-acid foods in jars or cans to register with the agency.

The labels on high-end olives from Italy were lacking the required nutritional information, so back to Italy they went. Jars of jam made of figs and tangerines indicated they were produced close to Ukraine, so an F.D.A. inspector said that he wanted to sample the product for radioactive fallout from the 1986 Chernobyl disaster...

... This year, 18.2 million shipments of food, devices, cosmetics and drugs are expected to enter more than 300 U.S. ports; the F.D.A. had 454 investigators in 2007 — one and a half per port — to scrutinize them. ...

... the U.S. Justice Department announced that it had opened a criminal investigation of Ranbaxy, the largest Indian drug maker, with $390 million in annual sales in the United States. In a motion filed in federal court in Maryland, the Justice Department accused Ranbaxy of “a pattern of systemic fraudulent conduct,” including filing fabricated drug data to the F.D.A. and using drug ingredients from unapproved and uninspected plants. AIDS drugs purchased by the President’s Emergency Plan for AIDS Relief were among the medicines implicated, the Justice Department charged. ..

... Officer James Ng of Customs and Border Protection started the tour by putting a package from China through an X-ray machine. The pictures showed row upon row of vials. “When it looks like this, it’s usually anabolic steroids inside,” Ng said. He opened the box, put on a pair of half-glasses and took out one of the vials, which was filled with a white crystalline powder. “It says it’s testosterone,” Ng said and then handed the vial to von Eschenbach.

“It’s an incredible example,” von Eschenbach said, his eyes bright. “It’s a steroid from China, but the label is written in Spanish.”

Customs seizes any steroids and narcotics they find, but they give other drugs to F.D.A. inspectors, who laboriously fill out handwritten forms and send letters to intended recipients. If the recipient swears that the drugs are for his or her own personal use, the F.D.A. often releases the detained package. It takes an hour or two to process each package, “an obstacle that makes their job functionally impossible,” according to a 2003 Congressional investigation. Thousands of packages can pile up waiting for F.D.A. review, and the agency often releases packages without any investigation for lack of staff.

Even when there are inspectors on the job, they cannot be sure every ingredient in a medicine is safe. The F.D.A. confines nearly all of its regulations and much of its inspection oversight to the active part of most pills, which generally constitutes between 1 percent and 10 percent of a pill’s volume. Much of a pill is fillers, binders, coatings, colorants and lubricants that are almost entirely unregulated.

The syrup in which cough and fever medicines are delivered has figured in at least eight mass poisonings around the world in the past two decades, with three of the four most recent cases originating in China. Hundreds died in Panama in 2006, at least 88 children in Haiti died in 1995 and 1996 and some 30 infants died in India in 1998 — all from toxic syrup. In 1937, 107 people in the United States died because of similar toxic syrup. In fact, it was this incident that led to the creation of the modern F.D.A. But plants making fillers and other nondrug ingredients of pills and syrups are rarely, if ever, inspected by the F.D.A. or any other regulatory agency...

... Unlike reforming Social Security or health insurance generally, fixing the F.D.A. won’t mean allocating enormous sums or necessitate reconceiving the system. It just requires some money and will. There are already legislative changes in the works. Bills now circulating on Capitol Hill would require food, medical- device and drug makers to pay annual registration fees to the F.D.A. Those fees would be used to allow as many inspections of foreign firms as domestic ones.

There also seems to be agreement that our regulatory agencies can’t rely on China to police its own factories.

More inspectors will certainly help, but even regular inspections of Chinese plants cannot ensure safety. Inspectors can be hoodwinked; tests can be fooled. “No matter how many F.D.A. inspections they do,” says Senator Sherrod Brown, Democrat of Ohio, “our safety is still at risk if the pressure continues to cut costs.” Brown has introduced a bill to require labels disclosing the source country of key drug ingredients. Some lawmakers have gone as far as to suggest a ban on all drugs made with Chinese ingredients, but China has become such a crucial supplier that a ban would lead to the collapse of the U.S. health care system. And our dependence is only growing: when PricewaterhouseCoopers cited the best place for pharmaceutical outsourcing in the world in an October report to drug companies, its pick was China...

If you're not scared, you're not paying attention.

Bush and the GOP descendants of the Gingrich invasion destroyed the FDA.

Destroyed it, because, of course, the libertarian market deity is supposed to solve these problems.

It's been a damned long 14 years.

Now we have Team O. Their mission is to ...

1. Find someone with deep pockets and resources along the supply chain who can be assigned legal responsibility. Let them be reimbursed appropriately.
2. We need a to be able to enter the NDC code for any drug in an FDA web site and get a full report on where the ingredients come from. Few consumers will ever do this, but the lawyers will love it and it will introduce supply chain transparency.
3. We need China to be strong, happy, and prosperous. We also need safe medications. If that means our inspectors live in Chinese plants (and get rich for their hardships), then we put tariffs on the production of those plants to pay for the inspectors.

There are good people at the FDA. A sane leader will find much support.

Melamine is deeply embedded in China's food chain

Dogs in China are most often raised for fur or food.

The death of these 1500 dogs from melamine poisoning reminds us how compromised China's food chain is.

The Associated Press: 1,500 Chinese raccoon dogs die from tainted feed: "Some 1,500 dogs bred for their raccoon-like fur have died after eating feed tainted with melamine, a veterinarian said Monday, raising questions about how widespread the industrial chemical is in China's food chain.

The revelation comes amid a crisis over dairy products tainted with melamine that has caused kidney stones in tens of thousands of Chinese children and has been linked to the deaths of four infants.

The raccoon dogs — a breed native to east Asia whose fur is used to trim coats and other clothing — died of kidney failure after eating the tainted feed, said Zhang Wenkui, a veterinary professor at Shenyang Agriculture University.

'First, we found melamine in the dogs' feed, and second, I found that 25 percent of the stones in the dogs' kidneys were made up of melamine,' said Zhang, who performed a necropsy — an animal autopsy — on about a dozen dogs.

Zhang declined to say when the animals died, but a report Monday in the Southern Metropolis Daily said the deaths occurred over the past two months.

There are lessons for the pharmaceutical chain as well.

Also a few lessons for libertarians everywhere.

Nostalgia for the Soviets: they made us look good

DI reviews the history of a Soviet atomic weapon production facility: Damn Interesting: In Soviet Russia, Lake Contaminates You.

Millions poisoned. Everything secret. Mopping up plutonium.

The amazing part is that life expectancy fell by "only" 30% in the poisoned region. Humans are fairly radiation resistant.

Sigh. The Soviets made us look so good by comparison. China tries with its melamine poisoned infants, but, really, they don't have their heart in it.

Now, instead of feeling so much better than the Soviets, we contemplate the rule of President Palin.

One can almost feel a perverse nostalgia for the Soviets.

Melamine sickened infants: 53,000 and counting

This weekend's NYT Magazine reports 53,000 infants have been poisoned by fraudulent milk products.

The number, of course, will rise.

Not surprisingly the story was suppressed by the Chinese federal government lest the bad news tarnish the Olympic glow.

In the old days we'd feel a bit of pride about our superior government, but those days are gone. The Bush administration does the same sort of thing. Back to The Jungle reviews a book written after the pet food poisoning last year. The Bush-devastated FDA earns plenty of scorn.

I suspect, because it's only human, that many Chinese citizens thought Americans were making an unseemly fuss about dog food problems. I know several American right wingnuts expressed similar feelings early in the story.

53,000 children. This could have been avoided.

It will happen here if we don't get the GOP out of power.

In the meantime, I think we'll reduce the powdered milk that goes into my son's "peanut butter snack".

Update 9/30/08: Great NYT Editorial on the 1858 New York "swill milk" fraud by Bee Wilson, author of “Swindled: The Dark History of Food Fraud From Poisoned Candy to Counterfeit Coffee." Same framework, same horrors. I don't even want to bother thinking about how libertarians answer these things.

Chinese recall of melamine contaminated infant formula

The formula is not approved for distribution in the US, but the FDA suspects ethnic markets may sell it here. Infant formula contaminated with melamine has been recalled in China:

FDA: Melamine found in baby formula made in China - USATODAY.com

... The Food and Drug Administration is alerting Asian and ethnic markets across the USA that infant formula made in China may be contaminated.

The FDA is working with state health agencies across the country to make members of Chinese-American communities aware of the danger.

Chinese newspapers report that some infant formula has been linked to kidney problems and kidney stones in babies in China because the formula contains melamine — the same industrial contaminant from China that poisoned and killed thousands of U.S. dogs and cats last year.

Sanlu Group, the major Chinese dairy that produced the formula, has recalled 700 tons of the product, state Xinhua News Agency reported today.

No baby formula approved for use in the USA is manufactured in China, the FDA says. 'We want to reassure the public that there's no contamination in the domestic supply of infant formula,' says Janice Oliver, deputy of operations at the FDA's Center for Food Safety and Applied Nutrition."

It's very likely that Chinese infants get quite a bit of melamine in their formula. It's used to make formula appear more nutritious than it is, allowing use of cheap ingredients. Melamine has no nutritional value, so the infants are being both poisoned and starved of nutrients.

Humans are supposed to be fairly resistant to its effect, and the toxicity in cats and dogs was supposed to require simultaneous contamination with cyanuric acid -- still these are baby kidneys. Many must have been harmed.

I wonder if the recall is a sign that China is getting more serious about caring for its people?

A good reminder that the food fraud saga continues.

Update 9/14/08: Turns out a New Zealand company forced the recall, it wasn't a sign of increased attention by Chinese authorities. Infants died, we may never know how many. It sounds like the nutritional content of the "formula" may have been very low, probably lower than the dog food shipments.

Private farming now, private manufacturing when?

Emily and Christina have joined a farm coop. We get a weekly produce share, and we're invited to visit and put the kids to work (as if).

It's good stuff. No melamine. No salmonella.

So what's next?

Why not private manufacturing?

Can't find a decent toaster? What if we could buy shares in a local manufacturing facility, and get goods built to our specs?

Well, we have been expecting computer controlled on demand manufacturing for a while ...

Gordon's Notes: A quick preview on the next thing to blow your world apart (Nov. 2005)

Do it yourself. Almost. ... Dan's Data provides a quick update on the state of the art in 3 dimensional "printing". As in download the specs, run the illegal hacking software, and print yourself an anonymous encrypted cell phone...

Probably going to happen, even without the nano stuff.

Maybe I'll get a good toaster before I die ...

The melamine is still coming from China ...

The report of this successful intercept was published on Dec 26, 2007:

FDA Says It Halted Melamine-Tainted Pet Treats

...Sampling by the FDA’s Los Angeles District showed that pet treats imported from China, including treat seed sticks for cockatiels and honey cakes for hamsters tested positive for melamine, according to a government report...

You gotta love those Google alerts -- a small release in a bird focused pet site shows up on my news page as though it were on the front page of the NYT.

This is not good news. Yes, it's nice to know the FDA is catching some melamine contaminated imports, but that's a bit like reading about the DEA making a big cocaine haul.

It just tells us that the supply lines are still running.

The one bright spot is that if the Dems hold the Senate and Obama takes the Presidency, then there's hope for a resurrected FDA and policies that hold importers liable for product defects. The FDA only has to hold on until then ...

Of course if McCain wins ...

Toxic heparin: fraud is looking likely

Two weeks ago I wrote: Gordon's Notes: Toxic heparin was fraud, not accident. A comment rightly corrected me -- I'd jumped the gun.

Today, however, it's looking like fraud. Chondroitin sulfate was manufactured in place of heparin, contaminating up to 10% of the nation's supply of a heavily used medication. The Chinese government is denying investigators access to the suspected source of the counterfeited medications...

Heparin Discovery May Point to Chinese Counterfeiting

Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting...

...The contaminant, the regulators said, is a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain...

Federal officials stopped short of saying that the contaminant — constituting as much as 50 percent of the active ingredient in heparin — was counterfeit...

... the authorities left little doubt that they believed that the contaminant was not an unintended byproduct of some manufacturing process.

In its natural state, chondroitin sulfate does not have anticlotting properties. But it mimics heparin when altered to form what is called oversulfated chondroitin sulfate. That is what made it difficult for Baxter International, the manufacturer of the heparin associated with the allergic reactions, to detect the impurity...

...“The base compound, chondroitin sulfate, is very abundant and an inexpensive compound,” said Moheb Nasr, director of the agency’s office of new drug quality and assessment. Chemically modifying it, Mr. Nasr added, “will not be that expensive either.”

The F.D.A. said it had found the contaminated heparin at Changzhou SPL, the Chinese plant that supplies the active ingredient to Baxter...

... Erin Gardiner, a spokeswoman for Baxter, said Wednesday that tests found the supplies were contaminated before they arrived at the Changzhou plant. “The consolidators and workshops handle the crude material, so that is where our focus is turning,” Ms. Gardiner said.

So far, Ms. Gardiner said Baxter’s investigators had been denied access to the consolidators and workshops. “We will continue to seek access.”

Last week, the F.D.A. said it had not yet visited the workshops.

Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. Traders and producers say it is far cheaper than heparin, as little as one-twentieth the cost. That could be an enticement for counterfeiters, especially in the wake of a virulent pig virus that swept across China last year, substantially reducing the availability of the starting materials needed to make the active ingredient in heparin.

Contaminated heparin sourced from China has also turned up recently in Germany, where about 80 allergic reactions have been reported. But investigators there have yet to identify the contaminant. F.D.A. officials said their discovery of chemically modified chondroitin sulfate came exactly one year after the discovery that a pet food ingredient shipped from China contained toxic levels of melamine, which was added to make it appear higher in protein. Many pets became ill, and some died.

Around the same time, The Times reported that an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine in Panama, killing nearly 120 people and disabling hundreds more.

Diethylene glycol mimics its more expensive chemical cousin, glycerine, a safe ingredient used in medicine, food and toothpaste.

The F.D.A. said its search for answers in the heparin case had been made easier because of the cooperation it had received from China’s State Food and Drug Administration. That was not the case when United States officials inquired last year about the melamine and diethylene glycol.

The agency cited an accord signed in December by the governments of China and the United States as one reason for the cooperation they had received recently, which they said allowed American investigators to quickly begin their investigation of the additive...

So, does anyone really think that we happened to catch the very first instance of massive counterfeit in the American medication supply chain? If so, please contact me about a new financial instrument I've created just for you ...

People I love very much take medications every day. I suspect many of them are sourced from nations that have very weak regulatory and enforcement agencies, and a feeble justice system.*

Reading this article closely, I feel the journalists are quietly building a good case for panic. They are probably wondering what they need to do -- wander the streets banging drums?

Pithed.

PS. Bill Gates gets his medications from the same places we do. So does Warren Buffett. Maybe some people who own Senators will decide the turn up the heat a bit?

* The US now has weak regulation and enforcement, so we should all be very, very nice to our lawyers.

Pet food poison and pithed America

We all know frogs will jump out of a beaker of slowly warming water -- long before it boils.

If they've been "pithed" however, they'll just lie there. Pithed frogs don't hop.

Americans have been pithed. Fifteen years ago any of the melamine/cyanuric acid pet food poisoning, Heparin contamination, surveillance society or a dozen similar stories would have resulted in general excitement and even regulatory action.

Now, we just give 'em a stunned look and move on. Maybe it's all we can do. After 12 years of GOP rule (8 of Bush, 4 where the GOP held the House and Senate) we're kind of crushed.

So I really shouldn't be quoting this SF Chronicle article telling us nothing has changed in the pet food world (emphases mine):

The Pet Food Recall: One Year Later, Has Anything Changed?

A year ago, Canada's Menu Foods announced it was recalling more than 60 million containers of dog and cat food sold in the United States. Although the name Menu Foods wasn't familiar to pet owners, the recalled cans and pouches bore the labels of dozens of the most familiar and trusted brands in the marketplace.

In the end, more than 1,000 brands of pet food were recalled over a period of about four months, and two chemicals, melamine and cyanuric acid, were blamed for kidney failure that killed thousands and sickened tens of thousands of pets from what came to be called melamine-associated renal failure....

...I didn't guess when I began covering this story with Gina Spadafori at Pet Connection that it would turn into the largest consumer recall in history, trigger an international trade scandal, launch congressional hearings, spur proposed legislation on food safety and get both American and Chinese businesses owners indicted. I couldn't have foreseen that the incident would put a spotlight on Chinese imports which would eventually reveal lead in children's toys and toxins in toothpaste, and prompt the recent recall of the drug heparin.

But it's equally hard to believe that after all that, the answer to the question "Could it happen again?" is probably "Yes."

The reason for that is simple: None of the changes that might prevent a repeat of last year's pet food recall have been implemented. There have been no improved inspections of pet food plants, no comprehensive overhaul of the patchwork of state, federal and industry manufacturing standards and regulations, no increased transparency and accountability — not even something as simple as printing the name and contact information of the actual manufacturer on pet food labels — and no revisions to pet food labeling laws. The Food and Drug Administration still does not have the authority to issue mandatory recalls.

Most of us closely involved in this story find all that hard to understand. "In this age of potential bio-terror and random cross-species crossover horrors like the avian flu, this is incomprehensible," said Pet Connection editor Gina Spadafori. "Our animals are the canaries in the coal mine, and as bad as the death toll was in our pets, it could have been much, much worse, in both animal and human populations. So why is there still not a national veterinary reporting system for a nationwide emergence of disease that is not only killing animals but could also potentially already be in or emerging in the human population? And why are we still unable to inspect all but the tiniest percentage of imported foods?"...

...The adulteration of protein concentrates with melamine and cyanuric acid was found to be both longstanding and widespread in China, so it seemed unlikely something like this hadn't happened before.

And in fact, it had. The Journal of Veterinary Investigative Diagnosis recently reported that melamine and cyanuric acid contamination was responsible for the deaths of thousands of pets in 2004.

Researchers working with tissue samples from animals who died in the U.S. recall compared them to samples from pets who died in a number of Asian regions including the Philippines, Japan, South Korea and Hong Kong. Those deaths led to a recall of Pedigree dog foods and Whiskas cat foods, and were blamed on mycotoxin contamination. But the study found that both groups of pets had the unmistakable crystals and damage in the kidneys caused by melamine and cyanuric acid.

While there's no evidence any other mycotoxin-attributed food recalls, pet or human, were misidentified, it does put the pet food recall squarely in the big picture of this country's broken food safety system.

A fix for that broken system may be coming, even if it's a bit slow. The FDA recently announced a meeting where it will discuss changes in the regulation of pet food ingredients, processing and labeling with representatives from the pet food industry, government agencies, veterinary medical associations, animal health organizations and pet food manufacturers at that meeting. One group not on that list is pet owners, but they have asked to hear from us. Comments should be made on docket number 2007n-0487 at www.regulations.gov/. [jf: I tried this. I don't think the site is accepting comments yet on this item. I'd recommend an email to your Senator or Representative instead.]

"The recalls exposed deep problems with food safety regulation in China as well as in the United States, and I see many signs of efforts to do something about them," said Nestle. "Lasting improvements won't happen overnight, and they won't happen at all unless people who care about these issues keep pressuring the industry and the FDA to do what they say they will do."

Did you catch the implication that we ought to be reexamining other "mycotoxin" or "fungal" related food poisoning episodes to see which were the result of fraud?

I'm sympathetic to the stunned -- I'm about half-pithed myself. It takes a lot of energy to put pressure on the FDA in the best of times, but this is Bush's FDA -- neutered, broken, led by people opposed to their own mission.

If we put McCain into the White House we deserve to eat Melamine and lead for breakfast.

Toxic heparin was fraud, not accident

I realize I'm repeating myself, but this really would be a good time to panic.

A major medication, Heparin, was manufactured in very substandard conditions. The final product contained counterfeit chemicals designed to fool quality tests. It was then distributed widely in the US healthcare systems.

Up to 10% of the entire US supply of Heparin may consist of a counterfeit drug:

FDA says recalled heparin contained contaminant - USATODAY.com

In a finding eerily similar to the contamination of pet food last year, the Food and Drug Administration said Wednesday that a counterfeit chemical has been detected in recalled supplies of the blood thinner heparin.

From 5% to 20% of the active pharmaceutical ingredients in some heparin supplied by Chinese companies to Baxter (BAX) Healthcare is a similar, but different, chemical that mimics the blood thinner in commonly used tests.

Nineteen people have died since Jan. 1, 2007, from allergic reactions that appear to be associated with contaminated heparin, says Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research. The death toll had been four.

Last year, thousands of pets fell ill after eating food made with adulterated wheat flour from China. The flour contained two industrial chemicals, melamine and cyanuric acid, added to make it appear to be the more expensive wheat gluten.

Baxter, which supplied half of the heparin used in U.S. clinical settings, first recalled some of its heparin products on Jan. 17. The company expanded the recall on Feb. 27 to include all of its multidose, single-dose and Hep-Lock products, used to flush intravenous lines to ensure that they aren't blocked by blood clots.

The USA's main other supplier of heparin, APP Pharmaceuticals, (APPX) has not had any reported allergic reactions associated with its products. It increased production after the Baxter recall.

Heparin is commonly used in many medical and surgical procedures. Initial analyses could find nothing wrong with the recalled product, says Woodcock.

"It reacts like heparin in some of the conventional tests used for heparin, which is why conventional acceptance tests of this ingredient might not detect this contaminant," she said.

But sophisticated tests by Baxter and the FDA, including nuclear magnetic resonance spectroscopy and capillary electrophoresis, showed slight differences. The counterfeit chemical is very like heparin in its molecular makeup and is also from an organic source, says Baxter's Peter Arduini. The raw ingredient in heparin comes from the lining of pig intestines.

Baxter Healthcare is based in Deerfield, Ill. Wisconsin-based Scientific Protein Laboratories (SPL) supplies Baxter's heparin from sources in China.

SPL has been a successful supplier of the active pharmaceutical ingredient in Baxter's heparin for almost 30 years with no problems, says Arduini.

Both the FDA and Baxter said they can't yet confirm that the heparin-like compound was the cause of the allergic reactions, but they are centering their investigation on them. They also don't know if it was introduced intentionally.

The news is good for Baxter as a company, says Aaron Vaughn at investment firm Edward Jones.

"Originally, it was a Baxter story. Now, it's become China supplying the U.S. market with goods that are not up to international standards," he says,

Good for Baxter? Maybe under current law.

We need to change the law.

Let me say that again.

We need to change the law.

Distributors must be held responsible -- only then will they be incented to move their supply chain away from unreliable sources. Congress should be considering vary large tariffs on medications coming from countries with known production and quality issues. The tariffs can help pay for the compensation claims that should be paid to injured persons.

This is why we need trial lawyers like John Edwards. It's also why we need to get the GOP out of the executive office, and resurrect America's regulatory infrastructure.

Update 3/20/2008: Yep, it sure looks like fraud.

Dog food blogging: CBC news story

Gee, before Google News I never read the Winnipeg StarPhoenix. Another story on the f/u to the melamine / cyanuric acid contaminated Chinese gluten episode:

Pets deserve better food standards: expert

To make a point about pet food, veterinarian Meg Smart brewed up a pot of leather boots, wood chips and motor oil.

"It would pass (Canadian) standards," she said about her concoction.

Smart, a nutrition expert from the Western College of Veterinary Medicine at the University of Saskatchewan, will be featured on a CBC documentary about the pet food industry on Thursday night.

"It's a complex system," said Smart about the industry. "Most diets aren't out there to harm animals. Most are adequate."

But many pet foods aren't adequate. In the spring of 2007, pet owners across North America watched as nearly 50,000 of their cats and dogs fell ill because of tainted food [1]. Menu Foods, a Toronto-based manufacturer, recalled all of their products containing contaminated wheat gluten, an ingredient the company imported from China.

Smart said these companies made a mistake and would never knowingly produce a dangerous product, but the ingredients used in the food may not be carefully monitored.

"I'd like to see a set of requirements, like for humans . . ." said Smart. "Or else, people have no way of knowing what they're feeding their pets."

Today, very few regulations exist for pet food. Leather boots contain enough nitrogen to pass Canadian standards. Wood chips contain enough fibre and carbohydrates. Motor oil contains enough fat.

Pet food ingredients are controlled and monitored by the Canadian Veterinary Medical Association, but they only monitor food manufactured in Canada. Most of the pet food Canadians purchase, around 85 per cent, is manufactured in the U.S.

So, what are you feeding your pet? Smart recommends people read food labels carefully because some pet food is well made.

Jason Skotheim has operated Horizon Pet Nutrition in Rosthern since the company started in 2004. He said his company is making sure the ingredients in their product are top quality and locally grown.

"We're trying to make this food like a Hundred Mile Diet for your dog," said Skotheim, referring to the popular diet book for humans.

His company sources all its ingredients and stays completely away from wheat gluten in favour of whole grains.

"Pets are part of the family unit," he said. "We want to make a premium pet food that people can trust."

Skotheim refers to small pet-food companies like Horizon as a cottage industry in Canada. Despite their competition from pet-food giants like Del Monte, Mars and Procter & Gamble, Horizon's business continues to grow.

Smart uses Horizon dry pet food for her dogs, but she says commercials are misleading when they say the food is recommended by veterinarians.

Small privately held companies can manage their services, and their reputations, in ways that large publicly held companies cannot. There's a lesson here that goes beyond my personal interest in Kateva's diet.

[1] I think that 50,000 number is suspect, though we'll never really know. The Wikipedia summary reports a US-only fatality rate in the hundreds, and I believe that was largely cats. Their urinary pH seemed to cause a greater formation of the melamine/cyanuric acid crystals and renal failure. Really though, there's no money to study this sort of thing.

Pet poison follow-up: melamine and cyanuric acid

I've had a standing Google search on melamine for the past few months; I wanted to track developments beyond the lifespan of the original story. Today it served up an article on the mechanisms of the pet poisoning.

Last May there was still some questions about the nature of the toxin. That appears to have been settled - at least for cats:

UC Davis researchers identify toxic chemicals in pet food - Campus News

... Veterinary Toxicologists at UC Davis have discovered the toxicity of the chemicals behind the deaths of approximately 16 pets in the United States this year. The pilot study conducted in April and May of 2007 found that a combination of melamine and cyanuric acid caused cats in their study to experience acute kidney failure.

The two chemicals, found in nearly 60 million packages of recalled pet food in March of 2007, have been added as a source of protein in some brands of pet food, but until recently had not been tested for their toxicity.

"There were no published reports of toxicity studies examining the combined effects of melamine and cyanuric acid in any animal species," said director of the study and associate professor of Veterinary Toxicology Birgit Puschner. "We needed to determine with certainty whether or not melamine or cyanuric acid alone or in combination, could cause renal disease."

Although the University of Iowa conducted a similar study with pigs, UC Davis is the only research institution to find and publish the cause of toxicity in the recalled pet food. Their findings were published in the November issue of the Journal of Veterinary Diagnostic Investigation...

The Wikipedia article on the pet food recall already includes the citation. That's fast!

My personal sense is that Americans have mostly forgotten about the problem and have not changed their buying habits.

For example, Eukanuba, who used to make our dog's food, once boasted of their US based supply chain. They are now owned by Iams, who's name is now on our food. They make no such claims.

Clearly consumers have not been demanding any real changes.

It's hard to be a "market of one".

The feeding of dog and primate: NYT Magazine's peek into the maze

NYT Magazine 9/2/07: They Eat What We Are reads like an excerpt from a much longer book. It's a small window into a large and complex enterprise - the business of industrial dog food. Mr Kaufman is studiously neutral, and he makes an interesting observation on how diet is diverging. Highly educated middle class diets are becoming "organic" and "natural" -- for both humans and their canine comrades. The other 80% of America is moving to an increasingly processed and industrial diet for both humans and canines, with technologies migrating from one species to another.

Kaufman only touches briefly on the melamine story, though it's obviously in the background.

There's too much here to fit into a NYT Magazine article, but the unacknowledged book should be quite interesting ...

Flatline - escaping the hideous smiley face of junk

I remember the hideous smiley faces of the 1970s. For years they haunted boomer dreams, but now we're trapped in the pit of the smile, deluged in cheap junk that's worth less than nothing ...

Gordon's Notes: Riding the dragon - Fallows on China

James Fallows .... The curve is named for the U-shaped arc of the 1970s-era smiley-face icon, and it runs from the beginning to the end of a product’s creation and sale. At the beginning is the company’s brand: HP, Siemens, Dell, Nokia, Apple. Next comes the idea for the product: an iPod, a new computer, a camera phone. After that is high-level industrial design—the conceiving of how the product will look and work. Then the detailed engineering design for how it will be made. Then the necessary components. Then the actual manufacture and assembly. Then the shipping and distribution. Then retail sales. And, finally, service contracts and sales of parts and accessories.

The significance is that China’s activity is in the middle stages—manufacturing, plus some component supply and engineering design—but America’s is at the two ends, and those are where the money is. The smiley curve, which shows the profitability or value added at each stage, starts high for branding and product concept, swoops down for manufacturing, and rises again in the retail and servicing stages. The simple way to put this—that the real money is in brand name, plus retail—may sound obvious, but its implications are illuminating....

So how can one escape the smile and restore "balance to the force"? One approach is fundamentally Darwinian. Strong brands invest in defect analysis and early detection, eliminating suppliers who deliver flawed product. Consumers forget about commodity products and invest in brands. Consumers miraculously develop a memory for what brands fail...

Oops. The memory part is the problem. Do you remember what companies had melamine in their dog food? Do you think you'll remember a year from now? Diethylene glycol in the dime store toothpaste? The DVD player that broke after one month? The wireless home phone that always crackled? The noisy fan, the sloppy wrench, the flimsy toaster ....

What other strategies are there? How else can the curve be balanced between design, brand, manufacturing and retail? How can costs be shifted from retail and brand to invest in better manufacturing and design -- anywhere?

I think we need to look for new options. What if an insurance company were to provide insurance policies guaranteeing devices performed to spec on delivery and for two years post sale? The policy would include a large rider to cover recalls, including a prize to anyone who found a recall qualifying defect. Anything that qualified for coverage would be able to display an appropriate and meaningful "seal of approval". Consumers could choose to get the insurance or not, some might decide the "insurable" measure was enough by itself. Vendors would, of course, have to pay for the "seal".

Perhaps this would produce a kind of "meta-brand", allowing manufacturers to outsource branding and shift investments to design and manufacturing - flattening the hideous smiley.

Bring in the lawyers: the sharks circle Menu Foods

Once upon a time, I was a champion of tort reform. I am, after all, a physician. I was a country doc for years, and I lived in fear of the trauma of medical liability litigation. It is a corrosive and nasty fear. The axe falls where it will, and the destruction is great.

Alas, I have followed the entropic path of all wounded romantics into a regretful accommodation with the limits of human nature. We may yet develop an alternative to the erratic and often unjust vagaries of medical malpractice litigation, but it will take a long, long time for reasons too complex to fully describe here. (In brief, health care is not a market operation, but even if it were we'd run into the same problems as described below.)

In the world of corporate behavior, however, the choice is easy. Americans have chosen, for six years now, to dismantle the protection of government. Libertarian theory tells us the "market" should replace that protection, but that theory depends on the rational choice of consumers who are completely overwhelmed and increasingly sheep-like. That leaves us with the lawyers.

This is from a lawyer sponsored web site, a site devoted to Melamine litigation that's essential to protecting not only the health of our pets, but also the health of our children:

More Court Dates on the Menu, in the Wake of Menu Foods Recall

Trenton, NJ: In the aftermath of the huge Menu Foods pet food recall this past spring, the New Jersey state legislature is considering joining two other states - Illinois and Tennessee - in granting pet owners the right to sue for loss of companionship and reasons other than economic loss - and to claim damages up to a specific cap.

The legislation differs from current civil law statutes, which limit pet owners to the right to litigate for economic damages only.

Neil Cohen, the Assembly Deputy Speaker, introduced the Bill in the New Jersey State assembly after finding several brands of the recalled pet food still on store shelves in New Jersey.
About 100 brands of pet food manufactured by Menu Foods of Canada were ordered recalled back in March after the food was found to be contaminated with melamine, an industrial binding agent that's toxic to animals and can result in kidney failure. Scores of treasured pets were sickened, and many died after eating contaminated pet food.

Under U.S. law, pets are classified as property, and while there are provisions for criminal charges if a pet is abused, current civil law only allows pet owners the right to sue for economic damages if a pet is harmed, or dies.

The new legislation, if enacted in New Jersey as it has in Tennessee and Illinois, would grant plaintiffs the right to sue pet food manufacturers, producers or distributors of adulterated pet foods, or any other person or persons who might have contributed to the contamination that may have caused, or led to a pet's illness or death.

The proposed Bill would also clear the way for compensation over loss of companionship, costs of veterinary care, training, and any other unique value the pet may have had. A show dog, for example.

A cap of $15,000 would be placed on total damages payable.

According to an article published this month in the Journal of the American Veterinary Medical Association, pet owners have been in for a rude awakening when they discover just how low animals - including pets - are positioned in the eyes of the law. Pets have been shown to contribute high value to their owners overall, and a unique value in certain circumstances. There has been a push to reflect that value in legislation.

Therapy dogs, for example, are known to represent a source of real comfort to sick, frail or elderly patients. Guide dogs are yet another example of animals which perform a valued service.

Currently, there are at least 50 class-action lawsuits filed against Menu Foods, and there may be more given the scope of the recall, and the number of pet owners affected. In the beginning of June the U.S. Food and Drug Administration (FDA) revealed more than 4,000 reports of pet deaths in the wake of the Menu Foods recall, and the FDA is currently in the process of wading through a backlog of 21,000 calls...

...Veterinary associations oppose the idea of non-economic rewards for pet injury or death; the American Veterinary Medical Association, for one, fears that the proposed New Jersey legislation will drive up the costs of veterinary care, and could lead to frivolous lawsuits.

While Cohen's bill was motivated by the tainted pet food recall and targets that specific circumstance, some like the New Jersey Veterinary Medical Association feel that the legislation could open the door for other loss-of-companionship lawsuits, such as vaccine reaction or an unsuccessful surgery. Time will tell.

However, as pet owners continue to challenge existing laws which place their pets no higher up the importance scale than a coffee table, and as more States bring in legislation clearing the way for the right to seek non-economic damages, the pets will finally have their day in court...

Menu Foods Legal Help

If your pet has suffered or died as a result of eating any of these pet foods, please contact a lawyer involved in a possible [Menu Foods Lawsuit] who will review your case at no cost or obligation.

It will drive up the cost of veterinary care, but more significantly it will inflict a lot of the anxiety upon vets that physicians no. It will also, I suspect, significantly improve the quality of veterinary care -- which is not always what it could be. Alas, in our imperfect world, we need the lawyers. We need Menu Foods to go down in flames, and we need the lawyers to attack across a wide range of American industry.

I wish it were not so.