[No external article links on title this time...all links are below.]
Should you choose to accept the mission, your choices are:
1. Avandia - GSK, A Physician and the Senate
2. Lipitor - The Senate, Pfizer and a Doctor who doesn't actually practice
3. Vytorin - Two large Pharmas, The Senate, and ... well some more baggage,
or, here is the bonus
4. The FDA, and the number of centuries it will actually take them to complete inspections, should they choose to follow their own rules for once!!!!
Here are some links to guide you through the sorrow:
Lipitor and Jarvik (this one's from yours truly!)
And the FDA
Whatever the heck happened to this industry? Why is there no permanent learning and adoption from old debacles?
It is proudly announced that the very presence of the FDA in the '60s saved many children from cancer and death through suspicious drugs that were sold like aspirin in Europe.
However, the very FDA now seems to be this megalolith that can barely move due its own weight. Among other things, people are now questioning the FDA's role in each of the individual debacles surrounding the pharmaceutical industry. Plus, the FDA's very functioning is now in question....
In the midst of all this the White House and the Solicitor-General actually dared defend FDA's status via federal preemption to be the most effective "overseer" of all things food, drug or device related.
How they can achieve this, suddenly or gradually, I cannot sense! And so cannot most people. Plus, the Congress seems to be the weakest link in the chain...
Without worrying about the completely useless patent "reforms", they should seize the opportunity to find out, among other things,
1. Why, despite Congress and the press raising enough doubts about the Lipitor ads, does Pfizer seem to play them fearlessly anyway..?
2. Do the investigations made by various Senators, Committees and other Capitol Hill-related odds and ends, actually have any meaning, purpose and consequence, given how company after company seems to be steeped in scandal...?
And, we the people, have to sit and wonder, given FDA's stringent regulations in the US, if we see so many failures, what of the "emerging" markets and all the development work that goes on there?
As if this was not enough, here is what UCSF is suggesting for medical devices. "Regulate them seeking more information like you would do for pharmas". Given the FDA's success with pharma, the irony almost makes the article humorous:
Ironies aside, the article and what UCSF suggests, is accurate by the letter...!!! But is the FDA the right organization to do it?
So what you say? Everybody recognizes problems - what is your contribution? Here is my simple solution:
Make the different divisions in the FDA more entrepreneurial, punish them for their "slips" and provide them with more money and power...oh, before that, throw the existing structure and the dinosaurs in the FDA's office files out....
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