Showing posts with label Peter Pitts. Show all posts
Showing posts with label Peter Pitts. Show all posts

Tuesday, May 07, 2013

Let Us Fear the Price of "Cutting-Edge" Drugs!

I must respond to the opinion piece by Peter Pitts, president of the Center for Medicine in the Public Interest, regarding the high cost of new drugs. The piece. titled "Another Voice: Cutting-edge drugs are worth the cost in the long run," was published in The Buffalo News of all places (here).
"We shouldn’t fear the price tag of these new medicines," says Pitts. "Expensive medicine may be a bitter pill, but these advanced therapies offer hope to millions of patients, keeping them healthier for longer."
Unfortunately, the numbers Pitts cites in defense of that statement suggests the opposite.

Pitts says that the cost to bring a new drug to market – "from the time it is a twinkle in a scientist’s eye, through a decade or more of lab research, to clinical trials and finally FDA approval" – is $1.2 billion. This, according to Pitts, justifies the prices of the most expensive medications, including four biopharmaceuticals approved in 2012 that cost more than $200,000 per year, per patient.

At $200,000 per patient-year, a drug company can recoup the development cost by treating 6,000 patients in just one year! A far cry from offering "hope to millions of patients!"

Even with insurance paying for the bulk of such treatments, only the rich can afford the co-pays for these drugs that "our children and grandchildren will grow up to marvel," according to Pitts. Marvel, indeed.

Tuesday, April 07, 2009

The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!

"My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters," says Peter Pitts, author of Drug Wonks, which is widely read by the pharmaceutical industry (see "Sponsored Links: Implications & Applications").

"What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee."

MY sources tell me that FDA Intern is tracking down who discussed these letters at higher levels in the FDA.
Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even former FDA commish Andy von Eschenbach!

FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!

(Click for an enlarged view. Print it and show your friends!)

"In fact," says Pitts, "[the issue] should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion."

Better be careful Mr. Pitts! You might just get what you wish for and MORE -- ie, Sydney Wolfe sitting on that advisory committee!



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