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Generic drugs: a dangerous public misunderstanding?

Generic drugs: a dangerous public misunderstanding?

Dr. Elizabeth Cohen, senior medical correspondent for CNN's Health, Medical and Wellness unit made a dangerously incorrect statement in her report on generic drugs in the US (Seen at approximately 1:37 of the following video).



On the July 26th broadcast of American Morning, she indicated that generic drugs are identical in every way to name brand drugs they are replacing. With the exception of truly identical drugs known as ultragenerics (a very small minority of generic drugs), her statement is simply untrue.

For drugs to be considered generic, they are first deemed 'bioequivalent' to their originator molecules, a status that is acknowledged to a contain difference of between 80-125% in terms of amount of active drug contained in a given pill (http://en.wikipedia.org/wiki/Generic_drug#Approval_and_regulation).

What do these acknowledged differences mean to patients? Physicians, including Dr. Cohen, simply don't know. But to state to laypersons watching CNN that generic drugs are identical to their innovator products is dangerous, especially coming from a physician. The medical literature contains many examples where generic drugs (especially anticonvulsants and anticolagulants) have produced markedly different responses in patients compared to their originator molecules.

In closing, I would ask Dr. Cohen this: if generic drugs are so identical to their originator compounds, then why are virtually no generic birth control pills available to the millions of women who would buy them? The answer is that one could do a very simple 9 month study to demonstrate that the drugs don't prevent pregnancy equally well as originator molecules do. The generic companies know this. But this sort of difference in say, mortality, or seizure frequency would take a much longer and costly study to prove. Such a study would not be in the interest of generic drug companies to do. And so generic drugs are deemed by the public, and obviously some physicians like Dr. Cohen, to be identical.

For the sake clarity and perhaps safety, at least some clarification or qualification of Dr. Cohen's comments is warranted.

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