Tags: Food and Drug Administration

Fraud Alert: FDA Allowed Drugs with Fraudulent Testing to Remain on the Market

I’ve said it before and I’ll say it again. Essentially the entire U.S. economy is one gigantic fraud.  No one has honor anymore in this society, it is a totally forgotten and discarded virtue.  The ethos of the land is to take whatever you can however you can.  It doesn’t matter who you hurt or what sorts of immoral acts you need to do to get it.  One of the key dynamics that allows for such blatant theft is that the regulatory agencies that are supposed to protect us are in fact gatekeepers from the criminals in their respective industries.  In the financial area, this manifests with the SEC and CFTC revolving door to Wall Street.  In healthcare, it manifests with the FDA.  I’ve highlighted the FDA’s shadiness previously, most notably in my piece:  The FDA is Caught Spying on its Employees and Creating an “Enemies List.”  Now in this latest story, we find how little the FDA concerns itself with public health.  From Pro Publica:

On the morning of May 3, 2010, three agents of the Food and Drug Administration descended upon the Houston office of Cetero Research, a firm that conducted research for drug companies worldwide.

Lead agent Patrick Stone, now retired from the FDA, had visited the Houston lab many times over the previous decade for routine inspections. This time was different. His team was there to investigate a former employee’s allegation that the company had tampered with records and manipulated test data.

When Stone explained the gravity of the inquiry to Chinna Pamidi, the testing facility’s president, the Cetero executive made a brief phone call. Moments later, employees rolled in eight flatbed carts, each double-stacked with file boxes. The documents represented five years of data from some 1,400 drug trials.

Pamidi bluntly acknowledged that much of the lab’s work was fraudulent, Stone said. “You got us,” Stone recalled him saying.

Based partly on records in the file boxes, the FDA eventually concluded that the lab’s violations were so “egregious” and pervasive that studies conducted there between April 2005 and August 2009 might be worthless.

The health threat was potentially serious: About 100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston’s tainted tests. The vast majority, 81, were generic versions of brand-name drugs on which Cetero scientists had often run critical tests to determine whether the copies did, in fact, act the same in the body as the originals. For example, one of these generic drugs was ibuprofen, sold as gelatin capsules by one of the nation’s largest grocery-store chains for months before the FDA received assurance they were safe.

Stone said he expected the FDA to move swiftly to compel new testing and to publicly warn patients and doctors.

Instead, the agency decided to handle the matter quietly, evaluating the medicines with virtually no public disclosure of what it had discovered. It pulled none of the drugs from the market, even temporarily, letting consumers take the ibuprofen and other medicines it no longer knew for sure were safe and effective. To this day, some drugs remain on the market despite the FDA having no additional scientific evidence to back up the safety and efficacy of these drugs.

By contrast, the FDA’s transatlantic counterpart, the European Medicines Agency, has pulled seven Cetero-tested medicines from the market.

For its part, the FDA has finished its review of just 21 of the 53 submissions it has received, raising the possibility that patients are taking medications today that the agency might pull off the market tomorrow.

To this day, the agency refuses to disclose the names of the drugs it is reassessing, on the grounds that doing so would expose “confidential commercial information.” ProPublica managed to identify five drugs that used Cetero tests to help win FDA approval.

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Aspartame: Coming to a Milk Carton Near You (Without a Label)

Rightly or wrongly, aspartame is a highly controversial artificial sweetener.  I’m no scientist and I haven’t researched it throughly enough to come to my own conclusion, but generally I try to eat minimally tampered with foods.  This is where this story begins to present serious issues for me.  The debate here is not whether aspartame will be allowed in milk; it already is.  The issue is whether or not dairy producers will have to let consumers know that it is there.  In a world where tuna isn’t tuna and beef is increasingly horse meat, we should demand more information than ever before as far as the substances we put in our bodies.  As usual, I would expect the FDA to side with the lobbyists and corporate America rather than consumers’ best interests.  From the Huffington Post:

Got diet milk? The dairy industry for the past three years has been hoping to sell you some under the guise of just plain “milk,” so that chocolate and strawberry varieties that contain artificial sweeteners would no longer need to carry a special label.

Last week, the Food and Drug Administration (FDA) acknowledged a 2009 petition from the International Dairy Foods Association (IDFA) and the National Milk Producers Federation that seeks to drop the FDA requirement to label milk and other dairy products as “artificially sweetened” when they contain sweeteners such as aspartame.

Aspartame is used in a range of products, including diet soda and yogurt, and is sold to consumers under the brand-name Equal (which also includes some other ingredients). Some researchers have found that artificial sweeteners alter people’s brain chemistry, making them crave higher-calorie foods, which in turn makes them more prone to obesity and diabetes.

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The Meat Industry Now Consumes 80% of All Antibiotics

Care for a side of horse meat with that dose of tetracycline in your chicken wings?  Recovery never tasted so good!  Basically since 2003, antibiotic use for sick people is flat, but up 50% for use in the meat industry.  These stats are shocking.  From Mother Jones:

Last year, the Food and Drug Administration proposed a set of voluntary “guidelines” designed to nudge the meat industry to curb its antibiotics habit. Ever since, the agency has been mulling whether and how to implement the new program. Meanwhile, the meat industry has been merrily gorging away on antibiotics—and churning out meat rife with antibiotic-resistant pathogens—if the latest data from the FDA itself is any indication.

Note that that while human antibiotic use has leveled off at below 8 billion pounds annually, livestock farms have been sucking in more and more of the drugs each year—and consumption reached a record nearly 29.9 billion pounds in 2011. To put it another way, the livestock industry is now consuming nearly four-fifths of the antibiotics used in the US, and its appetite for them is growing.

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In an email, a Pew spokesperson added that while  the American Meat Institute reported a 0.2 percent increase in total meat and poultry production in 2011 compared to the previous year, the FDA data show that antibiotic consumption jumped 2 percent over the same time period. That suggests that meat production might be getting more antibiotic-intensive.  

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Coming to America…Biotech Salmon!

The FDA always has your back.  This government agency, which is well known for corruption (watch the movie Burzynski), seems to be inching closer toward approving a biotech salmon product called AquAdvantage Atlantic salmon egg.  Sounds tasty!  From Reuters:

(Reuters) – A controversial genetically engineered salmon has moved a step closer to the consumer’s dining table after the U.S. Food and Drug Administration said Friday the fish didn’t appear likely to pose a threat to the environment or to humans who eat it.

AquaBounty officials said they were caught by surprise by the news that its product was a step closer to approval as years of controversy had followed the company’s application for a go-ahead from the regulator.

Hahaha.  Even the company itself was surprised its product could get approved so easily!

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