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.
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.
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