Government Reform and Oversight Committee
February 12, 1998
Dr. Lyle Cheadle and his daughter Janet
Mr. Chairman, and Members of the Committee, my name is Dr.
Lyle E. Cheadle, Ph.D. This is my daughter Janet Isabella
Cheadle. She is seven years old and she has been to Hell and
back. She has been diagnosed as a Stage IV Neuroblastoma cancer
patient. Over a period of 17 months beginning on February
28, 1996 she has suffered through 10 months of very aggressive
chemotherapy, 6 days of ablation chemotherapy, 3 days of total
body radiation therapy. Twice each day. And then a very gruesome
bone marrow transplant resulting in the doctors telling us
on February 17 and 18, 1997 that our daughter had only hours
to live. With God's will, many prayers and tears the good
lord brought her back from the brink of death.
She was discharged, in remission only to incur 3 life threatening
secondary infections. She has been in relatively good health
since August 1997. That may sound like good news, but this
disease has 93% rate of recurrence which results in death.
Most medical journals do not give survival rates after 2 years.
They know what happens.
After seeing what the damage standard protocols have wreaked
on our daughter Janet we began research for alternative treatment.
We came across the Burznynski Clinic in Houston, Texas. WE
contacted the clinic and we were told the Oncology Division
of the Food and Drug Administration had to approve the treatment.
On September 15, 1997, I wrote a letter to Mr. Paul Zimmerman,
the Consumer Safety officer requesting that my daughter be
allowed treatment at the Burzynski Clinic. While awaiting
an answer we gathered all the medical records on Janet and
sent them to the Burzynski clinic for evaluation.
After waiting approximately three weeks for an answer from
Mr. Zimmerman, I called his number and via voice mail asked
if he had any intentions of responding to my letter as a result
of my phone call. JoAnn Minor called me and said we have to
wait for Dr. Burzynski's treatment protocol before we can
do anything. The protocol package was sent to the FDA via
fax. It was returned to the Doctor's office, disapproved in
less than five hours. The Doctor's office called and said
the FDA had disapproved the protocol and would not allow the
Doctor to treat Janet prophylactically. I was shocked by this
response from the FDA.
The same evening I tracked down Mr. Zimmerman at his home
phone and called him. He could not recall reading the letter
It amazes me that I wrote the letter and sent it express mail
directly to him. He could not recall reading the letter. He
seemed confused several days before my call. I had Dr. Reginald
Moore, MD call MR.. Zimmerman. He also seemed to be confused
when Dr. Moore called.
The morning after I called Mr. Zimmerman at this home I received
a call from Mr. David Banks, also from the FDA. I cried and
begged both of these men to at least give my daughter a fighting
chance at life. My pleas fell on deaf ears. Mr. Banks sent
me a write-up apparently from the Journal of the American
Medical Association by a Dr. Green. It was dated 1992 I recall.
It was a smear of the treatment I was seeking and the Doctor
who invented it.
I called Mr. Banks back He told me to cal a Dr. Blaney at
the Texas Children's Cancer Center. I was referred to a Dr.
Stacey Berg. WE discussed janet's cancer. Dr. Berg stated
that a patient in remission was not eligible to participate
in the clinical trial for obvious reasons -- nothing to measure.
I spoke of the Burzynski clinic. Dr. Berg stated she was familiar
with the clinic. She agreed Janet had nothing to lose and
everything to gain. She could not understand the logic behind
the FDA's decision to refuse Janet treatment in view of the
very, very poor prognosis of janet by 3 highly qualified oncologists.
I wrote 4 letters to the President, a letter to the First
Lady, every member of the Texas Delegation to Congress. Unfortunately,
only Senators Phil Gramm, Kay Bailey Hutchison, and Representative
Chet Edwards responded. The FDA responded to Phil Gramm. They
have not responded to Senator Hutchison because she has sent
3 letters to me apologizing for the delay. I have received
nothing back from Representative Chet Edwards except a letter
telling me that he can not change a policy, procedure or regulation
of a government agency. The FDA tells me their hands are tied
by the laws the Congress has passed. I just wonder who is
in charge?
The FDA's reasons for not approving the treatment I seek
for Janet are that it is inherently dangerous or there is
no evidence the treatment would work. How in God's name do
they know whether it works or not if we don't try? When I
asked the FDA why they say the treatment is dangerous, they
tell me that to reveal that information would violate the
Doctor's proprietary rights. I wrote a letter to the doctor
asking him to refute the FDA's statement which he did in a
letter dated December 12, 1997 which is attached to my testimony.
Mr. Chairman, it appears to me that the only patients allowed
to be treated by this Doctor are the terminally ill. What
chance does any treatment process have which has only basket
cases to work with? This gives the FDA amply opportunity to
say "see, we told you it wouldn't work."
Mr. Chairman, my family feels like trapped rats. We do not
know from day to day if this cancer is going to return with
a vengeance and kill our child, but we know that there is
a 93% chance it will do so. We feel like screaming and lashing
out at those who would sit and pass a death sentence on our
daughter. Mr. Chairman, what the FDA is doing is tantamount
to murder - that is the only word that I can come up with
to describe their actions.
The FDA is the most arrogant agency of government I have
ever encountered. They are drunk with power over the life
or death of cancer patients. They are vindictive and spiteful
of anyone that does not adhere to their perceived norms. Mr.
Chairman, we have had a long war with cancer. The FDA needs
to get on board to help conquer this terrible disease that
kills 600,000 Americans every year. They apparently despise
individual researchers when they should be acting in concert
with them. They are a thorn in the side of finding a cure
for cancer why should I have to fight the FDA to save my child?
They should be helping me not hindering me.
We wonder why our government is locking themselves behind
secure doors, metal detectors, armed guards, etc. We have
forgotten that our government is of the people, for the people.
We do not need bureaucrats setting up their little kingdoms
in our government agencies.
I also strongly feel that the GAO needs to conduct an exhaustive
audit of the FDA to find out if they are working for the American
taxpayers and not the big pharmaceutical companies.
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