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Wednesday, October 15, 2014 1:24:10 PM
We are probably spending way too much time explaining science, and not getting to the reason a news program or newspaper would want to cover this story: it's about corruption in the pharma world, not about pharma in a corrupt world. Let's think about not trying to kill their enthusiasm with a lot of scientific background, but instead, do more or a "press release" that can be shared with not just "60 Minutes" or "Frontline" but also the NY Times, LA Times, Washington Post, etc...
Here's my rough draft...please comment!
Dear “60 Minutes” Editor:
Picture this…
You’re a small pharma company that has developed a new, best-in-class therapy for preventing cardiovascular disease – the number one killer in the US. This new therapy – clearly gaining acceptance in the medical community at large – is a potentially revolutionary new chemical derived from fish oil, and protected by dozens of long-term patents. (If fact it could be the “aspirin” of the 21st century, with all sorts of uses.)
Initial test results prove successful – and the FDA approves limited sales of the new drug to an extremely small population (those with extremely high triglycerides). To expand the use of the drug to a larger population, however, the FDA gets you to agree to commit to spending hundreds of millions of dollars to conduct long-term tests that will take several years to complete. In exchange, the FDA agrees to allow expanded sales once the tests are well underway.
Then, just as you have spent hundreds of millions of dollars to meet your part of the agreement, the FDA suddenly – and mysteriously - reverses direction and, in an unprecedented action cancels the agreement without just cause or due scientific process. With no recourse, except more appeals to…the FDA.
Again, this is an unprecedented action by the FDA, and was never communicated beforehand to your company.
Moreover, information regarding various FDA personnel involved in this unexpected maneuver indicates major conflicts of interest with big pharma rivals working on similar therapies - and a large hedge fund.
Going forward, the FDA continues to stall decisions, appeals, and even lawsuits to keep from having to allow your small company from being cleared to sell its drug to a larger population. Your stock price drops from $17 a share to under $1 a share within months. While still committed to spending hundreds of millions more to keep this drug alive, your company is suddenly on the ropes and fighting for survival.
A Senate Committee has recently asked the FDA about its behavior about the cancellation of this agreement (called an “SPA”), but due to the endless bureaucracy, it’s highly likely the FDA will get away with their actions and the real truths will never come to light.
That is, unless a news program like “60 Minutes” steps in to bring these matters to a larger audience.
If this can happen to small pharma companies – including those working on important new drugs to combat cardiovascular and infectious diseases – is the FDA really acting in our best interests? Or are they acting on behalf of big pharma, and Wall Street?
Is “60 Minutes” interested in this kind of story, then please contact me. I am a physician from ___________, and can point your editorial staff to several important website and other sources of information to help you make a decision about whether or not this is a newsworthy topic.
My number is _____________. I hope to hear from you soon!
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