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By John Hammell
Political Coordinator for The Life Extension
Foundation
On July 25th, 1995 the Oversight and Investigations
Subcommittee of the House Commerce Committee held an
important oversight hearing on the FDA's abuse of
power.
New Email Address
They announced a new email address
<fdaabuse@hr.house.gov> so that allegations of FDA
Abuse can be reported directly to the subcommittee in an
expeditious fashion, enabling them to establish a
comprehensive and responsible means of addressing each
allegation. Where it is justified, the Subcommittee will
investigate and refer matters to the appropriate
authorities. Through this effort they hope to calculate the
extent of FDA employee misconduct, but they acknowledge
that the harm already done to millions of patients who have
been denied access to needed treatments because of the
impact of FDA abuses of authority cannot be measured.
Please do not indiscriminately send email to their email
address. Please only send cases that you have personal
familiarity with and can supply sufficient details on to
clearly illustrate a pattern of abuse. Please only send
them things they can use and don't waste their time with
anything else. They see the problem very clearly. They just
need strong cases through which to document it.
Kessler is a NO SHOW
Although FDA Commissioner Kessler was extensively
briefed in advance on the cases discussed at the hearing,
and his appearance was requested, he failed to appear,
claiming that he had not been given sufficient time to
prepare. Allegedly, he will be ready to testify "in two
weeks." Congressman Joe Barton (R-TX), Chairman of the
Subcommittee stated his displeasure at Kessler's non
appearance as did several of the witnesses who traveled
long distances with horrific detailed stories of abuse to
relate. Barton stated that if necessary, he would subpoena
the information sought by his subcommittee from the
FDA.
These hearings are a prelude to drafting FDA Reform
legislation. I should mention that Waxman (as might be
expected) opposes the whole effort, and is the only member
of the subcommittee who does. He will strongly recommend
that Clinton veto any FDA reform legislation that reaches
his desk. For this reason we will have to make it veto
proof. Kessler's attacks on tobacco are a direct effort to
align himself with the Whitehouse in an effort to shoot
down FDA reform. The one thing Kessler does well is spew
out propaganda. He operates a media machine. The only way
we will succeed in veto proofing our FDA reform legislation
will be to begin now to build a bigger grass roots army in
support of FDA Reform.
Witness Testimony
The star witness was Paul Michaels, a 14 year old boy
who had been diagnosed in 1985 with an inoperable brain
tumor that was 3 inch diameter (optic hypothalamic glioma
astrocytoma). The diagnosis as verified by biopsy. There
was no treatment available for Paul, although some doctors
suggested radiation. The majority of the doctors felt
radiation offered no hope of a cure and that it would cause
severe deficits, not the least of which was blindness. So
at the age of 4, Paul was sent home to die.
To shorten the story, Paul is under antineoplastin
treatment from Dr. Burzynski. After long statements by
Burzynski's attorney, Rick Jaffe, which outlined the FDA's
relentless campaign against the Dr., and by Paul's mom,
outlining his medical history, Paul stole the hearing with
a brief statement that I am sure will remain foremost in
the minds of all who attended the hearing. He stated that
the FDA was trying to take away the only weapon he had
against cancer. He did not think it was right that he
should have to fight his own government in order to
survive.
After 8 years on antineoplastins, Paul has been able to
lead a normal life. He does well in school. He plays in the
orchestra and mows lawns. He is recovering. Dr. Bruce Cohen
at the Cleveland Clinic was delighted with Paul's progress
when they met with him in 1991. He requested a frozen slide
of Paul's biopsy to test himself to see that Paul actually
had the kind of tumor the reports indicated. Dr. Cohen's
findings concurred with the original biopsy report. Cohen
recommended in writing that Paul stay on Burzynski's
treatment.
If the FDA cuts off Paul's access to antineoplastins, he
will die.
Several other witnesses also presented testimony
including Earl Wright, inventor of the Sensor Pad. Mary
Gormon testified that she had used the Sensor Pad to detect
a tiny cancerous tumor that a mammogram had missed. Wright
outlined an Orwellian story of FDA abuse that almost
destroyed his company, and still prevents American women
from benefiting from his simple device which enables breast
lumps to be easily detected through breast self
examination.
Support Senator Barton's Subcommittee
Additional hearings on FDA Abuse will be held. It's
about time Congress is providing us with Oversight of the
FDA. Barton's subcommittee acknowledges that it is long
overdue. I was impressed by the sincerity of the effort
being made, and by the interest in the hearing. I got to
the Rayburn building 2 hours ahead of time, and there were
people already in line ahead of me. By the time they began
letting people into the hearing room, the line went 40
yards down the corridor and around the corner. A lot of
people did not get in. It's important that we all show
Barton's subcommittee our support.
To get a transcript of the hearing testimony, call The
House Commerce Committee at 202-225-2927.
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