Anonymous
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Anonymous
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Feeling good about selling or working for a company that develops and sells Oncology drugs? That is what many in pharma say that they feel when confronted by the fact that the FDA publicly publishes the fact that licensed generics are equivalent to the branded drugs that they compete with and numerous peer reviewed scientific studies by the largest and most influential clinical professional organizations in the world have shown that over 80% of the branded drugs docs write scripts for can be replaced by those same generics.
So what happens when the basis for the efficacy of the research for the justification of those drugs is undermined by a peer reviewed study published in one of the world's most influential scientific journals?
"Nature
Drug development: Raise standards for preclinical cancer research
The scientific community assumes that the claims in a preclinical study can be taken at face value — that although there might be some errors in detail, the main message of the paper can be relied on and the data will, for the most part, stand the test of time. Unfortunately, this is not always the case. Although the issue of irreproducible data has been discussed between scientists for decades, it has recently received greater attention (see go.nature.com/q7i2up) as the costs of drug development have increased along with the number of late-stage clinical-trial failures and the demand for more effective therapies.
Over the past decade, before pursuing a particular line of research, scientists (including C.G.B.) in the haematology and oncology department at the biotechnology firm Amgen in Thousand Oaks, California, tried to confirm published findings related to that work. Fifty-three papers were deemed 'landmark' studies (see 'Reproducibility of research findings'). It was acknowledged from the outset that some of the data might not hold up, because papers were deliberately selected that described something completely new, such as fresh approaches to targeting cancers or alternative clinical uses for existing therapeutics. Nevertheless, scientific findings were confirmed in only 6 (11%) cases. Even knowing the limitations of preclinical research, this was a shocking result."
http://www.nature.com/nature/journal/v483/n7391/full/483531a.html
So what happens when the basis for the efficacy of the research for the justification of those drugs is undermined by a peer reviewed study published in one of the world's most influential scientific journals?
"Nature
Drug development: Raise standards for preclinical cancer research
The scientific community assumes that the claims in a preclinical study can be taken at face value — that although there might be some errors in detail, the main message of the paper can be relied on and the data will, for the most part, stand the test of time. Unfortunately, this is not always the case. Although the issue of irreproducible data has been discussed between scientists for decades, it has recently received greater attention (see go.nature.com/q7i2up) as the costs of drug development have increased along with the number of late-stage clinical-trial failures and the demand for more effective therapies.
Over the past decade, before pursuing a particular line of research, scientists (including C.G.B.) in the haematology and oncology department at the biotechnology firm Amgen in Thousand Oaks, California, tried to confirm published findings related to that work. Fifty-three papers were deemed 'landmark' studies (see 'Reproducibility of research findings'). It was acknowledged from the outset that some of the data might not hold up, because papers were deliberately selected that described something completely new, such as fresh approaches to targeting cancers or alternative clinical uses for existing therapeutics. Nevertheless, scientific findings were confirmed in only 6 (11%) cases. Even knowing the limitations of preclinical research, this was a shocking result."
http://www.nature.com/nature/journal/v483/n7391/full/483531a.html