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(NaturalNews) Research into internal company documents has revealed that Pfizer Inc., the world's largest research-based pharmaceutical company, tampered with the results of at least 16 study reports about its epilepsy drug, Neurontin. In order to expand the market for the drug, Pfizer unlawfully removed, altered, and changed published study findings that revealed unfavorable results.
Of the 20 study reports that were produced, eight of them were not published in medical journals at all and another eight had their original study designs altered in some way in order to arrive at alternate outcomes. Some of the primary outcomes were changed to new ones while others were replaced by secondary outcomes. Still others were simply removed altogether.
The scheme of off-label prescribingPfizer practices a strategy that most, if not all, drug companies employ. Following the approval of one of their drugs for a specific use, drug companies will continue sponsoring clinical trials on other possible uses in order to expand their drug market. Though not technically allowed to market their drugs for unapproved uses, drug companies will distribute information to medical professionals about the results of these additional studies that favor expanded drug uses.
In order to arrive at favorable results, industry-funded research trials are often altered, forged, and manipulated to suit the cause, as was the case with Pfizer.
When Pfizer was sued back in 2004 for illegally promoting Neurontin, it settled the case for $430 million. Expert witness Kay Dickersin of Johns Hopkins University was able to obtain the documents revealed in her study while serving for the case. Just last year, Pfizer was sued again using the original case as well as being accused of manipulating study data.
If a drug company wishes to change the goal of a particular study once it has begun, it must be done formally through an official amendment. The fact that most of the time this does not happen indicates that deceitful activity is taking place.
Dickersin suggests mandatory submission of study protocols and primary endpoints when companies register clinical trials in the public database. This will help to hold the drug companies accountable for their undertakings and eliminate the tendency to alter data through dishonest means.
Drug companies should also continue to be prosecuted to the full extent of the law for their violations. Harsher penalties for blatant violations should be implemented in order to reign in the violators and restore the integrity of the clinical trial process.
Sources for this story include
http://abcnews.go.com/Health/wireSt...
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