Voice of Frustration

This is the text of an email from Anthony F. Kirkpatrick MD PhD (via Tony Tobin):

FDA approval of ketamine coma therapy
From: Anthony Kirkpatrick MD, PhD
Sent: 13 October 2009 14:37:54
To:

Today, a physician in Australia wrote the following:

"I hope the FDA sees the light and approves the Ketamine coma therapy in the U.S before too long...good luck and keep up the great work."

My reply:

"In my opinion, the FDA will never approve a disease specific indication for ketamine such as CRPS because there is no patent protection and, therefore, no money to be made by a drug company in going through the FDA approval process for a specific disease state / diagnosis.

There is little financial incentive for the FDA to approve ketamine for a specific pain diagnosis without a drug company supporting the New Drug Application (NDA). More than 60% of FDA's budget comes from drug companies. Check this site out:

http://www.rsdfoundation.org/en/research.html

Thirty years ago, the FDA approved ketamine for a specific route of administration (IV) and dosage range up to and including general anesthesia to treat breakthrough pain regardless of the underlying disease state / diagnosis.

Forget about the FDA ----- it is not the solution. Third party payers (e.g., Australian, US Governments) are likely to reimburse patients for ketamine treatments with the publication control studies like those found here:

http://rsdhealthcare.org/PatientInfo/outpatient_ketamine.htm

It is unlikely that a study with an active placebo control (e.g. midazolam, fentanyl) conducted in the ICU will ever take place from an ethical standpoint given that ketamine has already been proven effective at a low dose for treating CRPS on an outpatient basis. Under this circumstance, how many patients with CRPS would volunteer to be intubated and mechanically ventilated for 5 days in the ICU with an active placebo instead of ketamine?"

A. Kirkpatrick, MD, PhD

www.rsdfoundation.org
www.rsdhealthcare.org