I cannot give out names or details but here is my email confirming my interest in doing the radio show. It contains the main points and problems in getting access to new medications and drugs.
Dear Dr. TTTT:
Yes, I would be quite willing to be on your program. The lack of access to
clinical trials is a problem that should be highlighted for the American public.
I talked to both my son and wife. They agree it is a good idea. My son gave me
permission to talk about his disability on air.
How long a segment would you be planning? I could go two hours or more on
various aspects of this issue.* Here are the five parts to the problem of Lack
of Patient Access to Breakthrough Clinical Trial Medications and/or procedures
that may be of interest to your audience:
(1) The politics of the problem
(2) Personal horror stories re my son condition and limitations highlighting the
desperate horror of the situation quality of life issues with ghastly risk of
death always lurking in background as result of the disease or current
inadequate full of side effects medication.
(3) Horror stories of others I know (relatives and close friends) with deadly
conditions bacterial infections, multiple Myeloma, Alzheimer’s, Multiple
(4) The difficulty in accessing clinical trials medication—either for
compassionate use or qualifying for a trial (Two Paul stories one regarding CNTO
1275 Ustekinumab—compassionate use and the other Rituxan—clinical trial where
his lesions were too small.
(5) The terrible frustration that cures are available but just out of reach and
the almost fiendish institutional cruelty that allows informed patients and
their loved ones to know of amazing breakthroughs without being able to avail
themselves of them.
Frank Burroughs of Abigail Alliance is very well connected. He will
definitely want to help. He might even be a good guest on your show. Certainly
he will want to give me impute as to his progress in Washington trying to change
the law regarding rights of patients to clinical trials. His Right to Life
Supreme Court challenge failed last January. The court refused to hear it.
Boston Legal, the TV program with William Shatner starring as a senior partner
(Denny Crane) in the law firm with early stage Alzheimer’s is currently doing a
two part show based in part on the Supreme Court’s refusal to hear Frank
Burroughs challenge to the FDA rules for clinical trials and lack of patient’s
In the Boston Legal version the Denny Crane character is trying to get access to
an experimental Alzheimer’s drug. He has gotten the Supreme Court to hear his
case and he will argue it in this week’s episode. I mention the show as it might
be useful as the set up to use to introduce me and my son’s problem.
Right now Frank Burroughs is pushing another piece of legislation in Congress to
give the sickest and most desperate patients access to phase II and III
medications. These are the patients who under current practices have the LEAST
access to the meds. The really sick patients fail at making it past the
exclusion criteria of the clinical trials protocol.
Frank would be an interesting guest as well although he and I have very
different political views (He’s conservative. I am more liberal) and moral views
regarding embryonic stem cell research. Any research that helps my son I am for.
He is a staunch Roman Catholic and has a different perspective. Still we are in
agreement on the need to change the law and FDA proctocols and procedures
regarding clinical trials.
A third person who would have contacts with the FDA is XXXX MD FACC
Senior Director, SSSS GGGG at (Big Pharma company name withheld). I have corresponded with him by email after Frank Burroughs set up the contact. I am not sure that he would
want (Big pharma company) name mentioned, but he is a good man. He might give us an FDA
contact person as well.
He might also want some input as to what I say. I do not want to embarrass him
or (Big Pharma company). His company is playing by the rules as they exist now. They have no
Dr.XXXX might also have some ideas about how he would like the clinical
trials rules changed so drugs can get to market sooner. (Big Pharma company) could save a
billion dollars for each clinical trial, it does not have to do with some FDA rule
The CNTO 1275, Ustekinumab, could have very wide applications for many, many
other of the eighty autoimmune diseases in addition to psoriasis that it has
been tested on is under FDA review for approval to treat.
Eighty billion on eighty clinical trials for eighty autoimmune conditions over
thirty years is lot of money and time to spend on unnecessary duplicative
clinical trials. If (Big Pharma company) could test all autoimmune diseases at once in one
trial instead of eighty, a lot of (big pharma company) capital could be conserved. I would
think Big Pharma like (this particular big pharma company) would be eager for changes and someone like Dr. XXXX might want to add to your program at least indirectly.
Let me know when you might want me on and the direction you would like to take
Thank you so much for your response and interest in this problem.