Thursday, March 26, 2009

Sparky, Phaky and Trooper, the medical device manufacturer!!!

[Click on Post Title for Link to External Article]

Conducting sting operations can be boring sometimes, apparently! So, some of the following names were used (I made up Sparky, but how would you know?)

1. Device Med-Systems (okay, that's for warm up)
2. Adhesiablog (apparently, titled to be a surgical adhesive. So, the blog did not raise any eyebrows?)
3. April Phuls
4. Timothy Witless
5. Alan Ruse, and to top it off,
6. Chetesville, Ariz

It is not like Grassley was suffering from want of material, you know. Or we. No one was going to miss this, but now that we have it, it is time to frolic on the floor..unless of course, you forget the fact that these people are supposed to examine and approve trials on humans...

The IRB and its function

Amidst the laughter that April Fool's Day was subsumed with March Madness, we may have forgotten what IRBs are supposed to do. IRBs can be part of large institutions, such as teaching hospitals, University hospitals, etc. or they can be independent.

They ensure that studies performed on humans meet the medical and ethical standards and are within reason - simply put, Frankenstein doesn't get to build his/her monster in the name of research.

Want to dig deeper than the primary school level mention here?

Knock yourself out on this link!

One bad apples = IRB dead?

No, not really. There are several IRBs across this country. Many of them would have caught this, maybe..Many actually function just to satisfy the local needs of the communities they serve.

Remember, most countries don't have the faintest notion of an ethics review board that goes beyond what can be termed as "eye wash". (This, based on the personal experience of yours truly!)

Then, do we just stand by and defend this?

No! Obviously, the FDA, the HHS and Congress have failed again. And so has our friendly, neighborhood administration (by failing to split the FDA in a timely manner). The FDA itself has existed for too many years in a very brazen, devil may care environment. The organization, and its guidances have become toothless (and now we are on a pistachio scare, for nuts' sakes...).

Whither Grassley?

Yes, he loves to hit the roof. However, where was he all these years? And why is Grassley the only contestant in a letter-writing contest to the FDA, IRBs and the biotech companies in Congress? Is everyone else already bought out, or do they not care enough?

What we really need:

What we really need is a thorough washing, rinsing and drying (saw that with a nice regional drawl..).

A thorough examination of "trust" based systems that also includes a plan on how to manifest and maintain this trust, while ensuring that they system has checks, balances and inspections that allow people to scrutinize and perform their functions well. Systems need to be modernized as well - with electronic record keeping and sleuthing tools, IRBs may just be able to catch Chetesville, Az. off the map.

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