I wish I could say I was surprised, but pharmaceutical companies and medical device manufacturing is very big business in New Jersey and when those companies say jump, elected officials say "How high?" Wouldn't it be nice if they put as much thought into the health and safety of their constituents?

The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly.

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters.

Sometimes I'm just rendered speechless, and this is one of those times. Natasha Chart via Sustainable Food at Change.org:

Obama's considering appointing a former Monsanto vice president, Mike Taylor, to head the Food Safety Working Group at the FDA.

As Jill Richardson writes at LaVidaLocavore at the link above, Taylor thinks the FDA wastes too much time on food safety inspections at meat packing plants. Further, he believes that one of their main problems is that they have to slow down their line speed too much.

Everyone who's read anything about the horrendous working conditions at US meatpacking plants knows that incomplete kills before slaughter and worker injuries increase dramatically when line speeds increase.

As also noted at the Ethicurean, Taylor is the reason milk from rBGH/rBST cows doesn't have to be labeled. Bovine growth hormone is perfectly safe, after all. Except for cows, or humans who drink its breakdown products in milk.

So yes, Mike Taylor is the person we have to thank for putting pus from mastitis-infected cows into the milk supply, and exposing milk-drinking Americans by the millions to greater cancer risks.

This guy is heading up a food safety working group.

I'm just swimming in the changeiness.

Kids, if you care about your food, you know what to do:

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(Thalidomide - when wonder drugs went awful)

One of the bigger scandals to hit the pharmaceutical industry came in the form of Thalidomide, a drug marketed throughout Europe in the late 1950's as sedative, pain killer and a morning sickness preventative for pregnant women.

Only it wasn't. By 1960 the drug was widely available throughout the world (even as an over-the-counter item in Germany) and the horrible side effects came to light. Children born with an alarming number of birth defects, most in the area of gross deformities.

By 1961, the FDA instituted a recall of Thalidomide and banned its use. But the question was, why did the FDA take so long to make these horrific discoveries and why did they wait almost a year to get them off the market?

As a result, the FDA utilized more stringent testing - although judging from the amount of drug recalls and related scandals the past several years, it would give pause to the idea that the system is foolproof.

Oddly enough, Thalidomide has made something of a comeback in recent years, not as a antidote for morning sickness but as a treatment for skin lesions and multiple Myeloma and other cancer forms.

This interview, from the ABC Sunday series "From The Capitol" from August 12, 1962 features George P. Larrick, Commissioner of the FDA talking about the Thalidomide scandal and the FDA's role in public safety.

It would be nice if we were out of the woods over future Thalidomide scandals. But that's not likely.

I guess we have to start getting prescriptions for this stuff, huh?

WASHINGTON (AFP) – Popular US breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the US Food and Drug Administration (FDA) has said.

"Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug," the FDA said in a letter to General Mills which was posted on the federal agency's website Tuesday.

Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four percent in six weeks.

Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.

Those claims indicate that Cheerios -- said by General Mills to be the best-selling cereal in the United States -- is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholesterolemia, and to treat and prevent coronary heart disease.

"Because of these intended uses, the product is a drug," the FDA concluded in its letter.

Not only that, but Cheerios is a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease," the FDA said.

That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol four percent in six weeks" message has been featured on the box for more than two years.

This is what happens after eight years of starving government, I guess:

While much of the current debate about improving food safety has focused on federal agencies -- the Food and Drug Administration, the Department of Agriculture and the Centers for Disease Control and Prevention -- the bulk of food safety work is performed by about 3,000 local and state agencies, which handle everything from inspections of restaurants, food processing plants and grocery stores to detecting outbreaks and removing unsafe products from stores.

But those agencies are struggling, and Congress must reengineer the national system, according to an analysis by the George Washington University School of Public Health and Health Services, based on consultations with health experts, consumer groups and food executives nationwide.

"Congress needs to take responsibility for telling the government what its job is," said Michael R. Taylor, an author of the study who teaches at George Washington and is a former top official at the FDA and USDA. The study urges Congress to invest at least $350 million over five years to bolster underfunded state and local agencies and ensure a basic level of food safety in each state.

The analysis describes a fractured collection of food safety professionals all trying to do the same thing -- prevent illness from contaminated food -- but their efforts are hampered by weak coordination, poor communication, varying abilities, inconsistent methods and a lack of federal leadership. The report urges Congress to create a single cohesive food safety network composed of local, state and federal agencies and accountable to the secretary of health and human services.

"We need one food safety system, not 50," said Joseph Corby, executive director of the Association of Food and Drug Officials. "State and local agencies do 2.5 million inspections a year, analyze hundreds of thousands of food samples, and most of this work is not done in a coordinated fashion and not used by the federal agencies."

Communication between state and local officials and federal agencies is often disjointed, the study found. During a recall of a tainted product, for example, the FDA will often obtain from a food processor a distribution list that identifies retailers who received the product, but the agency does not routinely share that information with local or state officials, even though they are responsible for checking store shelves to make sure tainted products have been removed.

Meanwhile, states that interview people who have become sick from food to figure out which products may be suspect often do not share victims' identities with the CDC, citing privacy laws, even if that data would help federal officials better track an outbreak.

It's going to take a while to rebuild the inspection structure for food safety:

After decades of steady progress, the safety of the nation’s food supply has not improved over the past three years, the government reported Thursday. And, it said, in the case of salmonella, the dangerous bacteria recently found in peanuts and pistachios, infections may be creeping upward.

The report, from the Centers for Disease Control and Prevention, demonstrates that the nation’s food safety system, created when most foods were grown, prepared and consumed locally, needs a thorough overhaul to regulate an increasingly global food industry, top government health officials said Thursday.

“The system needs to be modernized to address the challenges and changes of the globalization of the food supply and rapid distribution chains,” said Dr. David Acheson, associate commissioner for foods at the Food and Drug Administration. “F.D.A. needs to do more inspections.” Dr. Stephen F. Sundlof, director of the agency’s food center, agreed. “As supply chains get longer and longer,” Dr. Sundlof said, “there’s more opportunity to introduce contaminants that have a public health effect.”

The report is likely to deepen tensions between the F.D.A. and the Department of Agriculture, which have long been rivals in overseeing food safety. An Agriculture Department campaign begun in 2006 to reduce salmonella contamination of meat and poultry has been successful, the report noted. But Dr. Robert Tauxe, deputy director of the C.D.C.’s division of foodborne diseases, suggested that whatever progress the department had made in improving overall food safety might have been lost by the F.D.A.

Could I interest you in your local sustainability movement, where food is either grown in your own backyard - or purchased directly from the farmer who grew it? It's probably a lot safer.

Urban sustainability is one of the quickest-growing grassroots movements in the nation. In my Philadelphia neighborhood, I can eat in dozens of local restaurants who only buy from local food producers and suppliers. (Buy Fresh, Buy Local is a popular local bumper sticker.) I buy produce from an urban farm that was constructed on a reclaimed brownfield site (the stuff is grown hydroponically, so no nasty toxins from the soil - and no GMO seed! I get my garden seedlings from the same place. Homegrown is best!) And let's not forget: the sooner you get the produce once it's removed from the soil, the more nutrients it has.

Plus, local food just tastes better. Try chopping up a juicy, fresh tomato and sauteing it in olive oil with salt, pepper, cinnamon and a pinch of sugar. Serve over pasta and you'll have something with which no jar sauce can compare. Yum!

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See that nice fellow up there refusing to answer any questions about why his company kept selling salmonella-tainted products even after it knew it was making them?

Doesn't it somehow figure that he was a Bush administration appointee to the USDA panel charged with overseeing the quality and safety of peanut products?

The president of the peanut company linked to a nationwide salmonella outbreak serves on an industry advisory board that helps the U.S. Department of Agriculture set quality standards for peanuts.

Stewart Parnell, president of Peanut Corp. of America, based in Lynchburg, Va., was first appointed to the USDA’s Peanut Standards Board in July 2005 and was reappointed in October for a second term that runs until June 2011, according to the USDA.

Conservative governance in action, folks.

Parnell was removed from the board last week.

More about the Peanut Standards Board here.

I just can't get over how well that self-policing policy has worked for our national food supply!

Federal officials have released a tidal wave of fresh recalls in the past 24 hours as they connect the dots in the supply chain of tainted peanut-related products.

The latest recalls by 25 companies listing dozens of items include Walgreen's chocolate candy with peanuts, Best Brands peanut butter cookie dough and Hain Celestial's frozen pad Thai dinners, including one made for Trader Joe's.

On Saturday, Harry and David of Medford joined the recall, pulling Olympia Delight Trail Mix products, and Berkeley, Ca.-based Clif Bar and Co. pulled eight more of its protein bars.

The recall has reached a fever pitch since it was expanded to include all products - from roasted peanuts to peanut butter -- from Peanut Corporation of America's plant at Blakely, Ga., where Food and Drug Administration investigators found two strains of salmonella and evidence that on 12 occasions in 2007 and 2008 the company sold food even after it had tested positive for salmonella.

In a startling revelation on Saturday, the Atlanta Journal Constitution said the president of Peanut Corp., Stewart Parnell, serves on an industry advisory board that helps the U.S. Department of Agriculture set quality standards for peanuts.

From the same administration that claimed they kept us safe, more good news:

WASHINGTON -- The government said schools and agencies in at least three states were shipped possibly tainted peanut products that have been recalled in a nationwide salmonella outbreak. The products were shipped as part of the federal school meal program.

A spokesman for the Agriculture Department's Food and Nutrition Service said schools, daycare centers and group homes in California, Idaho and Minnesota received roasted peanuts and peanut butter from Georgia-based Peanut Corp. of America. The USDA had said previously that school meal programs were not affected by the large-scale recall.

Stores have already pulled more than 430 kinds of cakes, cookies and other peanut-containing foods from shelves in what the Food and Drug Administration is calling one of the largest product recalls in memory. The outbreak has sickened more than 500 people in the United States. As many as eight deaths may be linked to the outbreak.

The government has opened a criminal investigation into the outbreak.

Stephen Sundlof, head of the FDA's food safety center, said Friday the Justice Department will investigate possible criminal violations by the Blakely, Ga., peanut processing plant that shipped tainted products to dozens of other food companies.

You see what the Republican non-enforcement policy did to the FDA? Their reliance on inspiring ideals like voluntary self-reporting of problems with the food and drug industries? Things like this:

The Georgia food plant that federal investigators say knowingly shipped contaminated peanut butter also had mold growing on its ceiling and walls, and it has foot-long gaps in its roof, according to results of a federal inspection.

More than 500 people in 43 states have been sickened, and eight have died, after eating crackers and other products made with peanut butter from the plant, which is owned by the Peanut Corporation of America. More than 100 children under the age of 5 are among those who have been sickened.

The plant sells its peanut paste to some of the nation’s largest food manufacturers, including Kellogg and McKee Foods. As a result of the contamination, more than 100 products have been recalled, mostly cookies and crackers.

Officials from the Food and Drug Administration and the Centers for Disease Control and Prevention traced the outbreak to the Peanut Corporation of America plant in Blakely, Ga. On Jan. 9, investigators descended on the plant for a thorough inspection, which was completed Tuesday.

The report from the inspection, first posted on the Internet by Bill Marler, a lawyer, cites 12 instances in 2007 and 2008 in which the company’s own tests of its product found contamination by salmonella.

In each case, the report states, “after the firm retested the product and received a negative status, the product was shipped in interstate commerce.”

It is illegal for a company to continue testing a product until it gets a clean test, said Michael Taylor, a food safety expert at George Washington University.

The Washington Post reports that it's serious enough to expand the recall to all products the company produced in the past two years:

In one of the largest food recalls in history, the Food and Drug Administration asked retailers, manufacturers and consumers yesterday to throw out every product made in the past two years from peanuts processed by a Georgia plant at the heart of a deadly nationwide outbreak of salmonella illness.

I've been reading a lot lately about this latest Salmonella scare, turning the somewhat sublime peanut into a thing of fear. It occurred to me that these scares, this tainted food seems to be something of a new plague in recent years.

And then I started thinking about Upton Sinclair, the eminent Muckraker of the early 20th Century, whose book "The Jungle" exposed the entire meat packing industry as a cesspool of filth, disease and corruption.

The fact that this iconoclast, this thorn in the side of Business, this pain in the ass of corrupt government was able to get the likes of President Roosevelt to establish The Food and Drug Administration as a legitimate watchdog for consumers as early as 1906 speaks volumes over the power of the press and progressive ideals and giving useful information to a receptive public.

Then as now, the power of the uncensored voice can still bring about change. Back in the early 20th century it was the unbiased and free press (a minority even then). Today it's the blogosphere. The forum has changed but the message is still the same.

So here is a clip of Upton Sinclair, talking about his early days and his run for Governor of California as a reminder of where we all came from.

I've been predicting major food poisoning for the past eight years, and how ironic is it that the most prominent example happens only after Bush is on the way out the door?

I used to work for an FDA-compliance consulting firm, and shortly after Bush took over, the FDA called all its agents back from the field "to rewrite the field manual" (even though it was updated on a regular basis) and announced they would no longer do random inspections of facilities. In fact, the only manufacturing facilities they would inspect were the ones that were already operating under a consent order!

There was even an FDA FAQ directed at employees: Q. "Isn't this defacto deregulation?" A.: "Of course not! We are simply trying to make the agency more efficient." (Hint: Whenever they spell out an objection in order to deny it, it's usually a dead giveaway.)

I was appalled. I gathered up all the supporting documentation and started making phone calls to science and business reporters: The New York Times, the Washington Post, the L.A. Times, the Boston Globe, even the trade industry publications.

No one was interested. Everyone I spoke to said they found it hard to believe that the U.S. government would risk the food and drug supply like that and treated me like a crank.

Not so far-fetched now, huh?

The Food and Drug Administration is not staffed to handle the growing complexity of food inspection, especially now that a significant amount comes from abroad and is never inspected, a leading candidate to head the embattled agency said yesterday.

Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic - and reported to be on President Barack Obama's short list to become FDA chief - said food inspection is swamped by the FDA's other responsibilities: the approval of medications and medical devices.

The result is an overworked and understaffed agency continually hit by sweeping food scares that sicken scores of people and sometimes result in death.

"The truth be told, the FDA is a failed agency ... the main problem is that it is terribly underfunded," Nissen said. "It needs to do more inspections, especially of foods brought in internationally. We are all very vulnerable. This has to be fixed and fixed quickly."

I used to work for an consulting firm that specialized in FDA compliance for pharma and medical device companies, and I can tell you the consultants had no faith whatsoever in the FDA approval process during this administration. Looks like their concerns were warranted:

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.

[...] The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.

  For all the things to raise the specter of impeachment over, Lou Dobbs chooses poison tomatoes. Go figure.

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"You know, I have heard a lot of reasons over the years as to why George W. Bush should be impeached. For them to leave the Food and Drug Administration (FDA) in this state, its leadership in this sorry condition and to have no capacity apparently or will to protect the American consumer - that is alone, to me, sufficient reason to impeach a President who has made this agency possible, and has ripped its guts out in its ability to protect the American consumer. It's insane what is going on here."