FDA

Major drug research company faked thousands of documents to get drugs approved, FDA says no big deal

Tuesday, August 16, 2011 by: Ethan A. Huff, staff writer
Tags: drug research, fraud, health news

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(NaturalNews) It is truly astounding to witness the utter corruption that takes place -- and practically in plain sight -- within the pharmaceutical drug industry. The US Food and Drug Administration (FDA) has announced that drug firm Cetero Research, for many years knowingly forged thousands of clinical trial documents for drug companies in order for them to gain drug approval. The FDA's response to this, though is that this massive corruption is basically no big deal.

It is no secret, of course, that the FDA routinely works in illicit tandem with drug companies to get dangerous drugs on the market in exchange for cash. One example of this includes the Lexapro scandal in which the FDA approved this dangerous antidepressant drug for children at the same time as federal and state governments were suing Forest Laboratories, maker of the drug, for pushing it on children (http://www.naturalnews.com/026444_children_F...).

The FDA's own scientists have even publicly indicted the agency for censoring truthful scientific data, intimidating and unfairly targeting supplement companies, and using the drug approval system to extort cash from drug companies in exchange for its rubber stamp of approval (http://www.naturalnews.com/025298_FDA_scient...).

The entire racket between the FDA and Big Pharma is mind-bogglingly extensive, and it is even seen in the FDA's recent announcement "against" Cetero. While it initially appears that the FDA is upset at Cetero for lying via its clinical trial documents, the agency's solution is to tell the drug companies to go back and redo them themselves.

FDA not interested in truly regulating drug industry, tells it to go regulate itself

In the FDA's recent announcement concerning Cetero, the agency declared that both an internal company investigation and a third-party audit revealed "significant instances of misconduct and violations" in conducting clinical trials. Between April 2005 and June 2009, there were at least 1,900 instances of fraud and falsified studies, and each one of these instances was falsely used to prove that a drug was safe before it went on the market.

"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," said the FDA, noting that drug companies may have to go back and perform new safety studies.

But the real kicker is that the FDA also stated that this is not really that big of a deal. Millions of people's lives are on the line as potentially fatal drugs were approved with false data -- but according to the FDA, nobody should be concerned. In fact, the FDA has known for years that Cetero has been falsifying data, and the agency has done absolutely nothing about it.

FDA does not even know which companies used Cetero's corrupt services

One would assume that the nation's food and drug regulatory agency would at least have saved records of which drug companies used Cetero for their early clinical trials. Such information is standard on any drug application, right? Apparently not. The FDA actually has no idea which drug companies used Cetero's services, and it is now asking drug companies to search their records and determine whether or not they contracted with Cetero.

Even a cursory analysis of this whole approach shows how utterly foolish it actually is. Does the FDA really think the drug companies that used Cetero, are going to willingly participate in this? Of course not. It would mean the companies would have to go back and redo their clinical trials if they fess up.

These are important questions that should be asked:

- Why does the FDA itself not have records of the research companies used for the drugs that it approves?

- Why is the FDA apparently unconcerned about the safety of these drugs, considering they were approved using falsified data?

- Why is the FDA not attempting to hold Cetero accountable for its actions, other than to make an announcement about them?

Despite the nonchalant way in which the mainstream media is reporting on this issue, what Cetero has done is nothing short of high-profile crime. By falsifying drug trial data, Cetero has willingly put millions of people's lives at risk. The only right thing to do is immediately shut down the company and order a full investigation. All parties involved must be held accountable, including those at the FDA that may have been complicit as well.

However, in the real world, the FDA's solution is to tell the fox to go back and guard the hen house a little bit better, while simultaneously reassuring the world that the fox itself is safe and would never hurt anybody. In fact, the agency is actually alleging that all approved drugs -- even those that were approved with falsified Cetero data -- are perfectly safe and "unlikely to be affected" by this massive criminal cover up.

So there you have it. While it is absolutely insane to make such a claim, the FDA has done just that, and it expects the world to take it seriously. The FDA's logic is essentially no different than, say, an amusement park claiming that all of its roller coasters are safe, even after it was determined by multiple investigations that the manufacturer of the coasters had lied about the quality of the materials used, and that the pieces may not actually hold together.

The question remains, would you ride those roller coasters, or have the nerve to tell other people to ride those roller coasters? The FDA did.

Sources for this story include:

http://www.reuters.com/article/2011/07/26/us...

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