Government Reform and Oversight Committee
February 12, 1998 Dr. Lyle Cheadle and his daughter JanetMr. 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.