FDA ALLOWS DRUGS THAT WERE APPROVED AFTER FRAUDULENT RESEARCH TO BE SOLD ON THE MARKET.

 

In another signal that the watchdog agency, FDA, is not successfully hampering the pharmaceutical sector's brazeness in marketing drugs whose clinical trials have either been tampered with or have been downright fraudulent, the government agency has now allowed a medicine to remain for sale, even though its approval was based on clearly worthless information.

The drug Temodar, used and marketed as a chemotherapy agent for cancer, was discovered to have received approval on information that was patently worthless.  The drug was manufactured by a pharmaceutical company and the research done independently by a firm called Cetero Research.  

Cetero was the subject of a federal investigation by the FDA that was initiated by a whistleblower working at the research lab, who told of practices that included tampering and manipulation of test results in the trials of the chemotherapy drug.  

The owner of Cetero collaborated, promptly offering the federal investigators boxes of files relating to the research on the drug.  As he did this, he also boldly admitted that most of the work done on the drug by Cetero was completely fraudulent.  

The issue become much more worrisome when it was discovered that not only Temodar, but another 100 drugs were tested similarly by the research firm.  Most of the them, about 81, were generic versions of existing drugs on which Cetero had performed critical tests to verify if the generic copies were in substance and effect comparable to the originals.  

This investigation should have raised a firestorm and swift action to remove all drugs from the market that were under the same cloud of suspicion by the watchdog US agency.  Instead the FDA quietly investigated the case, and left all the drugs on the market, without any interruption of sale or distribution.  

To this day Temodar, and other drugs, are still used and sold, even though none of the evidence used to prove its efficacy has been certified or new information added to warrant continuing sale of the compound.

In Europe, watchdog agencies have pulled almost all of Cetero's tested compounds.  

Although the FDA requested twice that drug makers supply new trials and evidence for the medications, both requests were unmet and deadlines expired. 

To date the FDA refuses to tell what information on research it has received, and it also refuses to tell which drugs have received some form of compliance by the manufacturers in the form of new research, and which ones have not, leaving potentially dangerous drugs on the market.

Pro Publica was able to identify at least five drugs that were tested by Cetero. They are Temodar, Torisel, Lazanda, Generic Ibuprofen, generic Tramadol.  

The drugs discovered by Pro Publica, were never disclosed by the FDA, because the agency maintained that to do so would expose "confidential commercial information".  It seems that a government agency, paid to protect the public at large is more interested in protecting the rights of commercial interests instead. 

Partial source: Scientific American/ Pro Publica 4.21.13