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Accentuate the Positive



Wishful thinking? Sue me!



Published January 24, 2006
Related Searches: pharma companies Development Phase I Manufacturing

It's a new year, so I'm trying to be a little less, well, irate. Don't get me wrong; it's fun to get outraged, but it can be pretty draining for both writer and reader. Wouldn't it be great if you got to this page and weren't bombarded with angry, snarky ripostes about the media, governments (local and foreign), and Pfizer & the Yankees?

How often do you want to read me ranting about how the government is complicating the healthcare system in a way that combines maximum consumer confusion with minimum consumer benefit? Sure, the first week-plus of the year was replete with stories of how elderly Americans are completely befuddled by the workings of the new Medicare prescription drug "benefit," and how several states are covering their citizens' pill-shortfall until the federal program is actually functioning, but do you really want to read about that?

And how often do you want to read about how the mainstream media is utterly clueless (if not hostile) about the workings of the drug industry? It's a new year, so we hold out hope for change. And then an article in the New York Times begins, "Even as pharmaceutical companies poured a record amount of money into drug development in 2005, the industry's research drought grew worse. According to newly released statistics from the Food and Drug Administration, it approved only 20 new drugs, down from 36 in 2004. Only once in last 10 years has the number of newly approved drugs been lower than last year's figure." That's right: the writer manages to imply that R&D expenditures in 2005 should have yielded FDA approvals in 2005! Fortunately, in paragraphs sixteen and seventeen of the article, he mentions that drug development is a decade(s)-long process (but doesn't get around to mentioning how the threat of price controls in 1994 chilled R&D for a span back then, leading to a Phase III/approval drought nowadays).

Or I could go on about Reuters' recent article on the FDA's new microdosing guidelines, which includes a comment from Dr. Sidney Wolfe at Public Citizen, complaining that "[b]y inviting the companies to do fewer safety studies, spend less money, they are almost by definition increasing the potential risks." But who wants to read my facetious take that the Pharma industry is just itching to release risky, dangerous products on an unsuspecting marketplace?

Nope, I'm going to accentuate the positive in 2006! That's my resolution (for as long as it lasts)! Here's some positivity for you: I believe that Merck's "lean manufacturing" initiative is more than lip service, and can begin to transform the relationship between major Pharma companies and contract service providers! I believe that a revised FDA stance on cGMPs for Phase I materials will boost demand for CTM manufacturers! I also believe that Acomplia will get approved and Sanofi-Aventis will rapidly get to work on an SR (strawberry release) version! I'm hoping (but I don't quite believe) that 2006 is the year that we start to see structural changes in the way drugs are developed, manufactured and distributed (go, RFID!).

And I believe that Pfizer will get back on track, from the inside-out, just like the Yankees started to with Robinson Cano and Chien-Ming Wang.

Gil Roth
Editor
gil@rodpub.com



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