When you consider the coverage of drug importation, drug safety "issues" such as Ketek or SSRIs, Part D, PDUFA or the release of big government run comparative trials like ALLHAT and CATIE as well as the release of the IOM drug safety report, we at drugwonks are reminded of what Shmuel Goldfish -- Sam Goldwyn -- the head of MGM once said about a particular bad movie his studio produced:
Go see it and see for yourself why you shouldn't go see it.
In general the coverage was objective in the sense that journalists reported what was being fed to them. Given tight deadlines and less space, reporters don't have the luxury of offering perspective or opinion...or do they?
In several instances, articles -- in our opinion -- were clearly written in a way to garner front page placement. That meant objectivity, balance, scientific rigor were sacrificed. That was the case with most coverage regarding Ketek, SSRIs and most recently Zyprexa and the cost of cancer drugs. For the most part, the best coverage on these issues -- the reporting that was comprehensive and balanced -- came from trade publications such as Biocentury, Genome Web, Drug Discovery and Development. Fellow bloggers and newsletters offered more in-depth analysis that was not tainted or spun by the usual suspects, namely Sid "Vicious" Wolfe.
Our point of view is clear: let science shape policy and guide decisions in a transparent fashion. Give patients and regulators the tools to make medicine predictive, personalized and prospective. We are tired of the either-or debate about formularies, DTC, pricing. Science and informatics is allowing us to move away from such obtuse choices. As Janet Woodcock, the Mother Courage of personalized medicine, has put it: medicine is no longer a matter of running studies to determine whether everyone should get drug A or drug B. It's a matter of developing tools to help people decide who gets drug A and who gets drug B.
Indeed, I am awaiting the results of a new genetic test to determine which statin will work best for me. No more trial and error, no more running to the doctor's office after one side effect after another. And imagine what it means for drug advertising when mass marketing of medicines doesn't matter or when one size fits all guidelines become even less relevant?
But I digress. In general the inability to place discussion of these contentious issues in context of where medical science is heading has contributed to public misunderstanding and poor policy.
Which is why I beat up on the IOM drug safety report so consistently. The report fails to look at post market surveillance as part of a complete feedback system for information that includes drug researchers and patients. It fails to integrate the scientific tools of the critical path and the emergence of personalized medicine into it;'s discussion and offers America more data dredging of little value. The IOM drug safety committe is a group of false prophets peddling 19th century solutions to 21st century challenges.
Drugwonks will provide alternatives that, unlike the IOM recommendations, will promote patient safety in real time, won't strangle drug development and discourage the best and brightest from advising the FDA.
And we will seek to provide the scientific foundation -- and personalized medicine viewpoint -- of any healthcare policy issue.
As we move ahead we will be guided by what Eric Hoffer noted about adapting in a era of turmoil and transition:
"In times of change, learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists."