FDA - lack of oversight

The New York Times reports that the FDA does very little to ensure the safety of clinical trials participants - auditing fewer than 1% of testing sites. We can all only hope the recently signed FDA Reforms will improve these appalling statistics - for all of us.

Mercury in vaccines

There is no "causal association between early exposure to mercury" (from vaccines) and "deficits in neuropsychological functioning" in 7 - 10 year old children according to an article in the New England Journal published today. Over 1000 children were examined in the tests, while the tests did not specifically look for a link to autism, the results seem to indicate that parents (and children) can breath easy. Though reassuring this is undoubtedly not the last we shall hear on this subject.

FDA Reforms

According to an article in Forbes magazine the recent passing of the FDA Amendments Act of 2007 is the biggest overhaul of the FDA in decades. The Consumers Union called it 'the most significant prescription drug safety reforms in 45 years'. Central to the new legislation is new funding and oversight of drug safety and risk minimization. The legislation also codifies the post phase 1 clincal trials database, conflict of interest for advisory committee members, and $25 million for the FDA to perform routine active surveillance.

All-in-all we may be headed towards a safer (though never totally safe) world.

From toxins to drugs

Wikipedia of a few days ago focused in upon Amanita phalloides a rather poisonous fungus. Which brought me back to the post on ticks and bugs - and the discussion of toxins.

Prof Alan Harvey is Editor-in-Chief of the journal Toxicon. A few weeks ago Alan was in the Elsevier offices in New York. In this video he talks briefly about toxins that have been transformed into drugs!

Travels

For the past three weeks or so I have been roaming around Europe. After time in Amsterdam and too much time in Schiphol airport I went to Bratislava for the European Teratology Society meeting.

After Bratislava I moved onto Basel in Switzerland via a couple of stops in Germany to visit editors. I was in Basel for the European Environmental Mutagen Society meeting.

Both meetings contained sessions that focused upon the growing interest in epigenetics in their fields. Positioned slightly differently but interesting from the outside observer to see these two fields crossing over slightly.

For more on epigentics there is a good intro via Science (though old), a European network and an article in EHP in March 06.

Travels Woes

I'm currently stuck at Schiphol airport - my flight delay by 5 hours. So some time to write. I was in Ermelo this week for an Elsevier meeting, one afternoon / early evening we went for a walk in the forest. We left with the warning ringing in our ears about ticks and Lyme Disease also a nice post in Wikipedia.

Safe to say that I did not find any ticks, and we did have a good time. But I thought I would use the potential tick attack to present a few posts of the field of Toxinology. There is an International Society on Toxinology and I would be disingenious if I did not admit that Elsevier publishes their official journal Toxicon.

More to follow . . .