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Re: KI



Dear Carol,

I think I've read enough material from you to believe that I do you no injustice by following your suggestion. I have circulated your reply to Susan's question to most of my relatives and many folks in my address book including Pres. Bush and the three Texas congresspersons that supposedly represent me. I doubt if any in the Congress or the President will even reply, but it hardly hurts to try.

I did send you a copy of what I distributed which included some mild opinions of my own.

Sincerely,
Maury          maury@webtexas.com
=========================================
"Carol S. Marcus" wrote:

 At 11:20 AM 8/10/02 -0400, Susan McElrath wrote:
It is time to rethink the KI issue from the ground up to reflect changes in our society since the nuclear age began. Why do I not see recommendations to restrict milk intake following an incident, and forget the worries about mass distribution of KI?

Susan McElrath
voice: (770) 222-0829
fax: (801) 838-5284
cell: (770) 633-8591
smhp@bellsouth.net

----------------------------------------

August 10, 2002

Dear Susan:

I think that the people who are knowledgeable are not in charge, the people in charge are not knowledgeable, and so many federal bureaucracies are claiming a role that no one is really in charge or is doing what needs to be done.

Let me give you an example of supreme bureaucratic dysfunctionality, courtesy of the U.S. Food and Drug Administration (FDA) Division of Counterterrorism, no less.  It will not grant a waiver to make two "investigational" drugs available to U.S. Public Health Service emergency medical response teams under the National Disaster Medical System.  These emergency teams are the four National Medical Response Teams (NMRTs), which are volunteer teams that assemble and are ready to fly out 2-4 hours after being called up, and 35 Disaster Medical Assistance Teams (DMATs), that arrive within about 24 hours.  As a member of the Western NMRT and the Los Angeles-based DMAT, I was asked to advise the Commander on equipment and supplies needed for effective response to a Radiologic Dispersion Device (RDD), or "dirty bomb".  Among the special drugs I recommended we carry in limited supplies, for persons significantly internally contaminated, and for first responders who may become inadvertently internally contaminated, were KI (which we can buy), Prussian Blue (an oral drug that binds Cs-137 and promotes fecal excretion), and Ca/Zn-DTPA, (intravenous drugs used to chelate transuranic elements and promote renal excretion).  All four drugs are most effective when used as closely as possible to the time of the event.

Prussian Blue and Ca/Zn-DTPA have been used for decades, but they obviously have very little actual use.  Fortunately, we do not have many contamination events in the world.  It is not possible to get these drugs approved by FDA without doing clinical trials, which of course are unethical and virtually impossible to do.  For this reason, these drugs have landed in a perpetual limbo, in which they exist as Investigational New Drugs (INDs).  Using them requires IRB approval, with written consent forms reviewed yearly, and the whole nine yards of miserable paperwork.  The holder of the INDs is the DOE; the REAC/TS people at Oak Ridge own these INDs, and only permit "co-investigators" to join the IND.  For eight years, I was the "co-investigator" for Southern California, so that I could stockpile Ca/Zn-DTPA for an accidental contamination event.  REAC/TS has held this IND for 25 years!  When I requested that these drugs be stockpiled for our NMRT and DMAT teams, REAC/TS said no---we could not get them and could not even qualify as "co-investigators".

As of July 1, 2002, FDA has a new regulation that permits approval of drugs without standard clinical trials because the trials would be unethical or impossible.  This was done post 9/11.  Wonderful, yes?  No.  The problem is that the REAC/TS material comes from a supplier in Germany (where these drugs are approved), but the manufacturer is not interested in approval in the United States, which would require legal responsibility for adverse events.  There is not much of a market for this, and it would not ordinarily pay for a manufacturer to go through all of FDA's  hoops and paperwork to maintain approval as an FDA-approved drug facility.

So until we find a manufacturer who is willing to make this drug at a probable loss, FDA says that our teams cannot use these drugs.  The lead Medical Officer of the Division of Counter-Terrorism says that FDA has no statutory authority to grant any waivers to its usual system, and he hopes that some manufacturer will show up one of these days anxious to lose money making these drugs.  When asked if the FDA had sought Congressional help in obtaining the necessary statutory authority, he said that he had no idea, and that he was "20 levels down" from the people who make those decisions.

Instead of supporting lots of bureaucrats who claim that they are helpless to do anything, let's unbudget them, take the money saved, and subsidize a drug manufacturer to make these drugs, or at least pass a law that permits FDA to grant a waiver so that our emergency Federal response teams can get the drugs we need from REAC/TS.

If any of you Radsafers out there know Tom Ridge's e-mail address, or have contacts with a Congressperson that might be interested in this, or are friends with the Editor of the Washington Post, be my guest and forward this e-mail on to them.

Disgustedly yours,
Carol

<csmarcus@ucla.edu>

Carol S. Marcus, Ph.D., M.D.
 
 
 

--
It is the soldier, not the lawyer, who has given us the right to
a fair trial.                                Charles M. Province
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