QDIS Blog

As long time readers know, I’ve posted quite a bit about flu pandemics and now the Center for Disease Control (CDC) today issued a guide for communities on preparing for a flu pandemic. The Washington Post had a story on it.

CDC Issues Guide on How to Fight Flu Pandemic - washingtonpost.com

The emphasis is on dealing with situations before a vaccine or drug is available. They call it “non-pharmaceutical interventions”. The Post article does point out that one of the areas that is not addressed is the use of face masks. These were extremely popular in Asian countries during the SARS outbreak a year or so ago. It seems the CDC is still evaluating that doing their own research as well as looking at historic data. I’m sure that as soon as they complete their evaluation they will release their recommendations.

Here is the actual pdf (106 pages).

Community Strategy for Pandemic Influenza Mitigation (PDF - 2.51 MB)

Other Resources
PandemicFlu.gov

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More job cuts for pharmaceutical companies came across my desk this morning.

PharmaLive: Ligand Announces Corporate Restructuring

Ligand is laying off 276 people or 76% of its work force and closing down its UK subsidiary. Many high level executives are stepping down including the Chief Financial Officer, Chief Scientific Officer, General Counsel and the heads of human resources, operations, regulatory affairs and project management!! The VPs of Research and Development will stay on.

AstraZeneca axes 3,000 jobs worldwide - Yahoo! News

AstraZeneca to Slash Jobs Despite Growth: Financial News - Yahoo! Finance

AstraZeneca has announced the elimination of 3,000 jobs or 5% of it workforce over the next three years. No more details but this year will indeed be a year of upheaval for large pharmaceutical companies.

I think this was to be expected, given the number of mergers in past years. There seems to be a pendulum that swings back and forth between merging and downsizing. The interesting thing now though is that both are occurring at the same time! So maybe a pendulum isn’t the best analogy and it is really more like The Whip carnival ride where things are rotating upon multiple axis’s at once.

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You may remember that I posted about the FDA closing some regional labs back in mid December. Now Some Senator including Ted Kennedy and Arlen Specter s are asking that the FDA not doing anything until it is reviewed by Congress.

Senators Ask FDA to Keep Regional Labs - washingtonpost.com:

They have written to Dr. von Eschenbach and asked that this be reviewed.

“We recognize that FDA faces serious budget constraints that force difficult choices, but it is far from clear that consolidating ORA labs is a reasonable response to these difficult constraints,” they wrote.

It will be interesting to follow up on this since the FDA had said these labs would be closed by April. That is a very short timeframe given how slow Congress usually is.

I am wondering, given the timing with the e.coli problems, if this wasn’t a gamble to increase their budget? I personally doubt it and think it is much more likely to have been a typical bureaucratic response to dealing with an insufficient budget.

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Just wanted to alert readers to a segment of PBS Newshour with an interview with Dr. Andrew von Eschenbach. It has both audio and streaming video of the interview as well as a transcript of the interview.

Online NewsHour: Newsmaker Interview | FDA Overhauls Drug Oversight | January 31, 2007 | PBS:

Several interesting thing I picked out were as follows:

• All the initiatives announced earlier this week will be done within their current budget.
• The pilot program for “report cards” will start in March 2007.
• Reiterated this is a first step in an ongoing processes.

I found this exchange interesting. Margret Warner was trying to get at how the FDA will handle situations where there is disagrement between scientists such as the recent Vioxx case.

MARGARET WARNER: Well, let me ask about a specific examine, because when Congress looked into the Vioxx situation, there was testimony on the Hill that there had been scientists who had expressed misgivings about Vioxx’s safety, and they had been basically overruled or were not listened to by FDA managers. Is that going to be corrected?

DR. ANDREW VON ESCHENBACH: Yes. Well, in the sense that we have to have processes in place where differences of opinion can come forward when there are needs for that to come through, an ombudsman function or be brought for resolution, those processes have to be in place.

The interesting thing is, although he did answer the question (but it was a simple yes or no question) he didn’t have any specfics. In other cases, he had specifics but in this case it was just, we need to have a process.

Overall, I thought it was a good interview and hopefully these initiatives will indeed be the first steps in improving the FDA and drug safety.

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