Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (4376)	7/30/2001 1:02:46 PM
From: Biomaven	Read Replies (2) \| Respond to of 52153

(somewhat OT) I grumble about the FDA a lot. However, the following BMJ abstract shows what can happen if medical techniques get adopted without any regulatory oversight at all. Very few patients intubated without drugs survive Intubating patients without the use of muscle relaxants or anaesthetics drugs, as is the practice of UK paramedics, results in very poor survival rates according to a retrospective database study by Lockey and colleagues (p 141). They found that out of 486 patients with trauma who were intubated without drugs (55.8% by physicians and 43.9% by paramedics), only one survived. Laryngoscopy and attemped intubation without drugs have potential risks such as increasing intracranial pressure, vomiting, and unrecognised oesophageal intubation. The authors suggest that since there have been no controlled trials of different methods of airway management, the use of non-drug assisted intubation deserves further scrutiny. Interestingly, surgical procedures (not involving new medical devices) pretty much aren't regulated in the US at all. Instead it's pretty much a peer-review system. I don't think the same would work for drugs though - too many dollars at stake to trust anyone. I've often thought what I'd do if I was FDA dictator. It's not an easy call, but I think I'd introduce some sort of provisional approval subject to studies tougher than the existing Phase IV system. I might also allow some drugs to be approved as safe but with efficacy not yet nailed down. I'd then place restrictions on who could prescribe drugs which only had limited approval. Finally, I definitely would spend more on monitoring newly-approved drugs. Peter