LEGAL ISSUES AND FDA INHIBIT USE OF HIGHLY BENEFICIAL ANAESTHETIC DRUGS

Below is a report from one of my regular correspondents, an American anesthesiologist

An anesthesiologist from a prestigious institution gave a talk on "conscious sedation" today. Conscious sedation has become a "hot" issue because more and more non-qualified people are performing sedation in remote locations (worst are doctor's and dentist's offices, but also emergency rooms, GI lab (colonoscipy), clinics, x ray etc.), sometimes with deadly results. Most deadly results occur when drugs cause airway obstruction and respiratory depression; many of those administering conscious sedation have limited experience with airway management..

Some believe that only anesthesia providers (MD, trained nurse anesthetists) should do this sedation - these providers have extensive experience with airway management, administering general anesthesia daily. This is the ideal, done in a few places (U Pittsburg hospitals do this because liability is thought to be greater than cost). But in the real world, there simply are not enough anesthesia providers to do all this sedation. So most institutions have instituted policies for conscious sedation, with anesthesiologists writing policies on training, and writing guidelines.

For many children or retarded adults, general anesthesia is used, at great expense. Equipment is expensive, and postoperative recovery time is required. For other patients, providers use old drugs like pentobarbital - gives sedation, preserves respiration, but lasts a long time - hangover may last 24 hours, and recovery time in hospital may be hours. Combination with opiates (narcotics) given for pain relief may lead to airway obstruction and/or respiratory depression. Less experienced providers may have difficulty handling these complications.

Dexmedetomidine is an alpha 2 agonist, a lot like clonidine.
But Dexmedetomidine is expensive. Not used much.

FDA rules require separate application, at great expense to manufacturer, for "pediatric use", so drug companies write disclaimer ("not approved for pediatric use") in instructions. Most providers are reluctant to use it "off label" (against recommendations of drug company) in children, mostly for medicolegal reasons. If a complication occurs, drug company will not back up provider.

Because dexmedetomidine provides some advantage for conscious sedation in children, it has been increasingly used "off label". Recent rules introduced under the Bush administration have increased pressure and have tightened the requirements to seek approval for drugs with more common use in pediatrics. Now, the company is funding FDA-required studies of dexmedetomidine, which has been done in the institution the lecturer was working.. .

Almost magical results - dental cleaning of a retarded 18 year old in the dentist's office, and the patient was awake and walking minutes after the procedure; in the past, general anesthesia was needed in an operating room for such patients ($ 25/minute) and recovery room (> $200/hr). The health insurance company happily paid the $1000 anesthesiologist's fee for enabling the procedure in the dentist's office because they saved thousands compared to doing the same in a hospital.

But here you have an older drug that has obvious advantages - but it has simply not been used because many are reluctant to try any new drug in children because there is so much liability. Likewise, if someone wanted to do similar procedures in pregnant women, they would be reluctant to use new drugs as well.

In addition, companies are reluctant to introduce new drugs for pediatric use because of the expense of seeking approval; competition by small players simply doesn't occur.

And Sens Schumer and Kennedy are smiling all the way to the cash register - they are introducing legislation to require drug companies to pay an additional 25% (above the present nearly 1 Billion (yes, with a B) cost for approval) for approval, to "guarantee safety". [Classic Leftist thinking - if something is simply not attainable (like equal outcome education), throwing money at it will solve the problem].

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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