- Brain
cancer
- National
media ignores story of boy as he fights feds for
his life
- By
Joie Munda and Ken Hulme, May 4,
2000
HOUSTON (Thursday
5-4-00)--A young boy is fighting for his life from
an aggressive form of brain cancer. The federal Food
& Drug Administration may well have become his
worst enemy in the battle.
Thomas, 4, the son of Arizona
parents Jim and Donna Navarro, has
medulloblastoma, an aggressive form of brain cancer.
Recently doctors operated on the young boy to remove a
golf-ball-size tumor. Without additional treatment,
Thomas will die.
What would you do if you were
Thomas' parents? Worse still, what would you do if
your child were suddenly struck with this fatal form
of brain cancer?
As his young life hangs in
the balance, vital questions have emerged for Thomas'
parents, and by implication for the nation:
1. Which cancer treatments
are best?
The prescribed Food and Drug
Administration (FDA) treatment of radiation and
chemotherapy, with their dramatic and debilitating
side effects? Or an experimental treatments (approved
in FDA trials) with an high success rates and no known
side effects?
2. Who has the right to
decide which treatment is best for this 4 year old--or
any child with medical options: the parents and their
doctor, or the government?
3. Is the FDA always right
in its policies and practices?
The "Recommended
Treatment"
When Thomas was diagnosed
with brain cancer in September of 1999, not
surprisingly, his parents were devastated. But within
days, surgeons had successfully removed the cancerous
growth. As a follow-up, they recommended an aggressive
cocktail of radiation and chemotherapy, a course
typical for this type of cancer.
Medulloblastoma takes just 45
weeks to grow a second tumor. If the first one has
been removed, the second one is fatal unless the
patient undergoes this type of "salvage therapy," as
one study calls radiation treatment in children
Thomas' age.
Initially, Jim was willing to
trust doctors with the next step in his child's care.
But, he soon became skeptical when no one would talk
to him about what Thomas' condition would be like
after chemotherapy and radiation. And doctors were not
willing to show the Navarros any survival reports of
medulloblastoma.
That's when the Navarros
learned some shocking news!
"Every patient doctors have
treated with radiation and chemo at her son's age was
'either crippled or dead,' " says Donna Navarro.
When Jim wanted to know
the ingredients of the chemotherapy, the doctor said,
"You don't need to know." That's when, "Our first red
flag went up," says Jim.
Later, Jim was assured by the
radiologist that the side effects would be manageable.
"He had listed skin redness, fatigue, nausea,
vomiting, and loose stools and had me sign it," says
Jim. The doctor leaves the room. About 10 minutes
later he comes back and says, "Oh, Dad, by the way, I
forgot. He'll also have fluid on the middle ear,
hearing loss, memory loss, hyperthyroidism, low level
hormones, spinal growth deficit, hyper-pituitarianism,
secondary tumors, cerebral necrosis, and he went on
down the list." Thomas' doctors were unavailable for
comment.
The Journal of Clinical
Oncology confirms the Navarros' fears. In a December
1999 study by St. Jude Children's Research Hospital,
"all patients lost cognitive function during and after
[radiation] therapy."
In fact, the summary went on
to state that "all patients treated in this
fashion--with salvage radiation therapy--have
significant neuropsychologic deficits (including a
significant loss in IQ). Our experience demonstrates
that medulloblastoma in infancy is a curable disease,
albeit at significant cost."
Suddenly, Jim and Donna
realized their son could become an invalid, requiring
a lifetime of care.
Searching for an
Answer
As they began to turn a deaf
ear to the radiologists, Jim and Donna worked
feverishly to find a solution.
Using the Internet, they
spent thousands of hours becoming experts on their
son's condition. They also made friends through online
chat rooms with other families in similar straits.
There they also learned of a clinic in Houston, Texas,
that had been approved by the FDA to do clinical
studies for certain types of cancer. Would this clinic
provide the answer?
Then, the unthinkable
happened. Because the Navarros were unwilling to
submit their son to traditional FDA approved
treatments, doctors finally turned the family over to
child protective services.
The Navarros decided to flee
the state. They've been living in a hotel in Houston
for the past six months.
There they located Dr.
Stanislaw Burzynski, a medical doctor and cancer
researcher. The Navarros found Burzynski to be candid
about his successes, introducing them to a thriving
young man in college, a cancer survivor who has been
healthy for 12 years, and an 8-year-old who has been
cancer-free for three years.
Burzynski was equally candid
about his failures. Overall, Dr. Burzynski?s
non-toxic, antineoplaston therapy, has had stunningly
positive results among medulloblastoma patients,
including patients of Thomas' age.
Dr. Burzynski told Jim to
pitch to the FDA on a new protocol, or study. Jim
contacted an FDA official who agreed to the plan,
which would require submission of a book-length
document prepared by Dr. Burzynski. Working well into
the night for a week, Dr. Burzynski wrote the protocol
only to have the FDA official change his mind.
"I have been dealing with the
FDA for 17 years," Burzynski says, "and I have gone
from one disappointment to another."
It was a painful setback for
the Navarros. And the FDA has told the family that
Burzynski?s treatments are off-limits to Thomas until
they exhaust the "approved methods", radiation and
chemotherapy."
A Parent's Right to
Choose
Their plight has caught the
attention of some impressive supporters, including
Arizona Senator John McCain, and Ambassador
Alan Keyes. A bill ? The Thomas Navarro FDA
Patient Rights Act (H.R. 3677) ? has been introduced
in Congress by Rep. Dan Burton, (R-IN),
chairman of the Government Reform Committee, who also
threatened FDA commissioner Dr. Jane Henney
with hearings over the handling of the Navarro
case.
In a December letter to her
(http://cancerbusters.com/congress.html), the
congressman wrote: "His [Thomas'] parents,
after extensive review of treatment options, have
determined that this treatment is what is best for
their child."
It's the idea of "parent's
rights" to choose what is the best medical treatment
for their child that's at the heart of the
matter.
"If this intelligent,
educated couple can not take their son to the doctor
of their choice," says Dr. Julian Whitaker,
advocate of alternative medicines and frequent guest
of the 700 Club, "how can we say we live in this
wonderful, free country?"
The FDA and "Big
Money"
Whitaker blames the problem
not only on "benevolent caution" on the part of the
FDA, but on jealousy of Dr. Burzynski, who may have
found a cure for certain types of cancer.
"It's the only significant
breakthrough in cancer research this century," says
Dr. Whitaker.
It's a discovery that
Burzynski made at the age of 24 in his homeland of
Poland. As an M.D. with a doctorate in biochemistry,
Dr. Burzynski noticed that cancer patients are
deficient in specific peptides--clusters of amino
acids. In fact, he found that these peptides assist
cells in learning when to die. But cancer cells never
get the message and become "immortal." Then, as new
cancer cells reproduce, they join together forming
tumors.
Dr. Burzynski invented what
he termed "antineoplastons," (literally, "no new
formations"), a mixture of synthetic peptides and
organic acids. Antineoplastons not only "persuade" the
cancer cells to die, but also act on the genes
controlling the cancer. The cancer suppressor gene is
turned on, and the gene that causes cancer is
suppressed.
So why won?t the FDA permit
Thomas Navarro to be treated by Burzynski? Both
Burzynski and Whitaker say it has to do "big money"
and how the FDA "interacts" with pharmaceutical
companies.
"The past commissioner of the
FDA, now he is an official of one of the large
pharmaceutical companies, with a salary of $2 million
a year," says Burzynski.
"They [the FDA] would
like to protect the old order, they would like to
protect the interests of large pharmaceutical
companies, they would like to use chemotherapy and
radiation therapy for many years to come, even though
there may be treatments which can be much better and
which can be free from adverse reactions of
chemotherapy and radiation therapy."
Dr. Burzynski says that the
FDA has recently restricted his clinical trials, to
only the most hopeless cancer cases, and only after
the patients have first undergone chemotherapy and
radiation. (FDA Commissioner Jane Henney made
the same case to Jim Navarro during an April 10 C-Span
broadcast). But under a previous, FDA-monitored,
Burzynski clinical trial three years ago involving
eight children who had medulloblastoma --and no prior
treatment-- seven have survived and are doing well!
A Long Wait
So the Navarros
wait--unwilling to treat theirchild with radiation and
chemotherapy because of devastating side
effects--unable to get the treatment they desire at
Dr. Burzynski's clinic.
"If our son dies," says
Jim...but Donna finished his thought: "They will
convict us of manslaughter."
"If our son dies," says
Donna, "he will not be buried in the United States.
And I will not call this country my home."
"Time is running out," says
Dr. Whitaker. "Thomas is about to have another MRI.
But his father says he is beginning to fall, and that
his speech is slurring. There is no doubt that this
tumor is coming back. And those people siting at the
desk of the FDA are open and willing to letting him
die. And they will blame it on the family, and say
that the family is too emotional, and ? Burzynski
doesn?t do studies.? They will blame it on everyone
except themselves. And they have the power. All they
have to do is say, "Give him the therapy."
What can you
do?
Jim and Donna hope that you
will pray for their son, and that you will take time
to write a letter or email to your congressman
supporting The Thomas
Navarro FDA Patient Rights Act (H.R.
3677). Click here to
find your Senator or Representative:
http://congress.nw.dc.us/cgi-bin/alertpr.pl?dir=citizens&alert=18,then
type in your zip code and send an email.
The family would also welcome
donations at
(http://www.fundrover.com/display_fund.asp?id=70).
"We're almost completely out of money," Jim says.
Send an email of
encouragement or a donation to the Navarros:
cancerbusters@aol.com, or visit their website
(www.cancerbusters.com)
For more information on Dr.
Burzynski?s antineoplaston cancer therapy, visit his
website: http://www.cancermed.com. Give us your
feedback
As we update the Navarro
story, we may publish some of your comments.
Support the Thomas Navarro
FDA Patient Rights Act, HR 3677, which will
provide expanded access to new treatments for all
Americans, especially patients with cancer. Contact
your Congressmen and see Thomas's story:
http://www.cancerbusters.com.
