Pharmaceutical companies should come clean on data

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  • Updated: July 5, 2013 - 6:11 PM


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pumiceJul. 5, 13 6:34 PM

From the article: "[R]eleasing detailed clinical data ... is an important move that should become standard for an industry whose credibility is at stake." Amen!

mandansmomJul. 5, 13 9:59 PM

As a culture, we reap what we sow. Americans must accept that things go wrong with humans, and there are no silver bullets. Just this week, articles about the unfortunate first-place showing of the US in women addicted to opiates. Countless drugs fast-tracked to market because there is a market for pills to make us thinner, happier, less prone to age-associated ailments (without any lifestyle modifications). Kid has a fever? Throw an antibiotic at it or you'll have to skip work. We demand a pill or a procedure for everything, and get mad when it's too costly or not perfect. Grow up, Americans.

jimjimjimjimJul. 6, 13 7:51 AM

If you knew what it takes to get a drug approved in this country you would know be surprised any drugs ever make it to market. 10-12 years and a couple billion dollars is not uncommon and many of these drugs never see approval.

jimjimjimjimJul. 6, 13 7:58 AM

: "[R]eleasing detailed clinical data ... is an important move that should become standard for an industry whose credibility is at stake." Amen!"

It is released. The FDA reviews all clinical data before approval. A NDA (New Drug Application) can take over 6 months to process (PDUFA) and cost a million dollars in fees. The actual drug may have taken 10 years and 2 billion to get to the NDA. Very few drugs make it to NDA and more receive a CRL (Clear Response Letter) rejecting the application. This could end the manufacturers attempt to go forward or result in more studies. People need to educate themselves on the process.

hrearden57Jul. 6, 13 8:41 AM

Prescription drugs have dramatically extended the life and improved the health of Americans.

checkfactsJul. 6, 1310:10 AM

The First Commandment of the pharmaceutical industry: "A treatment is more profitable than a cure". -

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