QDIS Blog

Seems the external panel of experts has recommended approval of Sanofi’s H5N1 bird flu vaccine. While the FDA doesn’t have to follow the panels advice, they typically do. This despite the fact that the vaccine only showed antibodies in approximately 50% of the people vaccinated.

Sanofi Gets Nod From FDA Panel:
Sanofi Bird-Flu Shot’s Benefit Isn’t Clear, FDA Says

I would comment that vaccination are not 100% effective in all cases. I know from painful experience that this is the case. When I was young I was given a attenuated live vaccine for measles along with gamma globulin. Then as an adolescent, I developed full blown measles.

However to help prevent a pandemic, 100% effectiveness is not necessary. It is only necessary to vaccine a critical number of folks that will help prevent the spread of the disease. Right now, I think that this particular vaccine is not worth the risk unless you happen to be a chicken farmer. No one in the US has ever developed bird flu and right now it is difficult to spread from human to human. There have only been 270 cases in 10 countries world-wide. An interesting comment in the article is that this vaccine will NOT be commercially available and that governments will likely stockpile it to protect first responders and healthcare workers if needed.

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Several additional lay-offs have come across my desk recently for the pharmaceutical industry and I thought I would list them.

Pfizer to cut 10,000 jobs in Japan
Dated 1st March it reallt deals with the issues Pfizer announced these back on Jan. 23.
Abbott cuts 200 scientists, hundreds of drug reps | Chicago Tribune
From a Feb 26th article that Abbott will be getting rid of 200 scientists mainly in drug discovery and an unspecified number of sales reps. Tje drug discovery units effected are early discovery, and metabolic research in areas such as obesity and diabetes.
delawareonline ¦ The News Journal ¦ 50 jobs to be cut at plant in Bear (near Newark, Delaware): AstraZeneca to shed 3,000 jobs by 2010.

Let’s hope that these trends don’t translate into much higher employment in the coming year.

Technorati Tags: Abbott Labs, AstraZeneca, down-sizing, layoffs, Pfizer

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The AP had a nice report this week related to food safety and the FDA.

FDA cuts food inspections by half

They report that over the last three years, food safety inspections have dropped in half! Here are some other startling facts from their investigation:

- There are 12 percent fewer FDA employees in field offices who concentrate on food issues.
- Safety tests for U.S.-produced food have dropped nearly 75 percent, from 9,748 in 2003 to 2,455 last year, according to the agency’s own statistics.

After Sept 11, 2001 the FDA urged increasing food inspection and that did indeed happen and peaked in 2003 but have fallen back and erased those gains.

I have stated before that given the number of high profile cases in the last year, there will be increased scrutiny in this area, especially from Congress. I would not at all be surprised by a hearing on this sometime before the summer. The problem is, there are many other areas of higher priority now such as the war in Iraq.

The budget for next year does include modest gains for food safety of $10.6 million, but most critics agree this is only a very small portion of what is really needed to do their job properly. Some claim that as much as ten times that amount would be necessary.

The FDA Commissioner had his to say.

“We’re applying resources to targeted areas. So in a way, it’s not a matter of ‘Are you inspecting one out of 100 or 10 out of 100?’ The real issue is if you can define risk. Are you applying the 10 inspectors to the 10 areas of concern? Then it’s essentially you’re covering 100 percent of your problem, which is not covering 100 percent of the universe,” FDA commissioner Dr. Andrew von Eschenbach said.

While this is a good goal and I am a advocate of risk based assessment, it ignores the fact that some risks exist that we do not know about. In the case of the lettuce e.coli problems it may be that a feral pig defecated in the field and that was the source of the contamination. I doubt anyone would have had that on their list of criteria for risk assessment.

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CNN Money reported yesterday that the sentencing of Dr. Lester Crawford, the former FDA commissioner was completed yesterday. He ended up being fined $89,377 and three years of probation as well a 50 hours of community service.

Former FDA chief fined $89,377 - Feb. 27, 2007

Boy did I get this wrong. You may remember I made a prediction back in October that said he would be fined $10,000 and given 2-3 months probation. This was based upon my pessimistic view of high level officials ever being truly held accountable. I am glad to see that the judge thought this was worthy of more punishment than that. It is interesting that the fine is much larger than the agreed amount of $50,000 between Crawford and the prosecutor, but still lower than what could have been handed down.

I personally would like to have seen more hours of community service given out. Fifty hours is just slightly more than one work week.

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