And today, from the delusional thinking report …

ITEM … If you are both a director of Pfizer AND the physician-in-chief at Massachusetts General Hospital, is it really sensible for you to go on record as a defender of the pharmaceutical industry in the midst of a media storm about some of its excesses?

Licensed pharma reps: an opportunity waiting to happen

Naturally there is wailing and gnashing of teeth at the recent legislation passed by the Washington, DC council that will require all pharmaceutical and related field representatives to be licensed. However, I see this as an immense strategic opportunity that is just waiting to happen. After all, let’s be honest, we all know that the [...]

Recognition of a “truth deficit.” Is the rubber hitting the road?

The following quote is lifted from today’s FiercePharma, with full acknowledgement, under the heading ‘Pharma CEOs mull industry “truth deficit”.’
“We love it when pharma CEOs depart from their usual talking points about financial results and restructurings and pipelines, to wax philosophical on their place in the [world].”
Is it actually possible that some of the major [...]

Failure all around in conduct of post-approval drug trials

We can probably be equal-handed in raising questions about “who’s to blame” for the continuing poor record for conduct of post-approval studies of approved drugs requested by the US Food & Drug Administration at the time of approval.
According to the most recent report from the FDA, as of September 30, 2006, there were a total [...]

GINA appears close to approval, but …

GINA — the Genetic Information Nondiscrimination Act — appears to be close to passage after Sen. Tom Coburn finally withdrew his “hold” on the bill late yesterday. Although one can parse the details to death, this appears to be a further victory for “common sense” in health care over the financial interests of payers and [...]

Reagan-Udall: an update

According to former FDA Commissioner Mark McClellan (now the chairman of the Reagan-Udall Foundation, among other roles), there has been significant, if slower than hoped, progress in the establishment and initial development of the Regan-Udall Foundation.
The Foundation’s fundamental remit is to support the FDA’s scientific mission. For an introductory overview of Dr. McClellan’s current assessment [...]

Prescription prices: going up … or going down?

According to data released yesterday by pharmacy-benefit manager Express Scripts, 2007 was the first time in at least five years that consumers paid less on average for prescription drug co-payments. Which may or may not be surprising, depending on your point of view, but it may also be in direct contrast to recent data suggesting a major [...]

“Let’s appoint a chief strategy officer!”

There’s was an interesting article in today’s Wall Street Journal about “strategy masters” and their evolving roles in big pharma companies. I love it!
“We’ve got clients asking fundamental questions about what businesses they should be in,” the article quotes Ian Wilcox of the Hay Group as saying.
Now that’s scarey. Some of the world’s largest pharmaceutical companies don’t [...]

Lordy … I have competition out there!

I gather Andy von Eschenbach is now a blogger too! He’s going for once a week and you can’t comment or send him questions … but at least it’s a regular communication to the public. Let’s hope he pulls very few punches. As I have said before, the FDA needs to lead so that others [...]

Vytorin, Zetia, and expectation management

What we seem to be seeing in reactions to the Vytorin clinical trial “scandal” is a case of serious mismanagement of people’s expectations, which is going to cost Merck and Schering millions if not billions of dollars. Hopefully there is a key learning here that we can all take home. This is absolutely not about [...]