The case of Dr. Stanislaw Burzynski is a prominent example
why we need FDA reform. During Dr. Burzynski's trial,
his critically ill patients were faced with the loss of
access to his experimental drug, antineoplastons. Many
of us in Congress found the government's conduct and handling
of this case to be heavy-handed and costly. In fact, it
is the subject of an ongoing congressional investigation.
Americans should not have to fear that the government
will take away their access to alternative therapies.
They should not be forced to leave their country to get
medical treatment. The current avenues available to Americans
to get experimental therapies such as compassionate investigational
new drug-use exemptions or treatment exemptions are grossly
inadequate and a bureaucratic nightmare. One Burzynski
patient endured the pain and suffering of this disease
for six weeks while the FDA tried to decide whether or
not this individual should have the treatment. I believe,
as do millions of Americans, that the ultimate decision
whether to pursue a medical treatment, even experimental
or unapproved treatments, should be left to the individual
and his or her physician.
Most Americans don't realize that they don't have a
legal right to the medical treatment of their choice.
A bipartisan coalition of members of Congress and I introduced
the Access to Medical Treatment Act, so that this right
may be restored to the American people while maintaining
a role for the FDA to prevent fraud and abuse.
Rep. Peter DeFazio (D., Ore.)
Washington
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Our 12-year-old son has a brain tumor that has shrunk
by 70% in volume over the past two years while on Dr.
Burzynski's treatment. Dr. Burzynski's story is an extreme
case that highlights everything that is wrong with our
government and our medical system. Children with brain
tumors die needlessly while the FDA has spent 14 years
wasting tax dollars on a legal vendetta. During this process,
the FDA was issued a cease-and-desist order from a federal
judge to stop distributing false information about Dr.
Burzynski, a shameful statement about our government.
To those of us who have children leading healthy lives
on Dr. Burzynski's antineoplastons while their cancers
disappear over time, the FDA's efforts against Dr. Burzynski
and us are ugly representations of a system gone sour.
Now we are demanding that the FDA approve antineoplastons
once and for all. The FDA has acknowledged that the treatment
is safe and that it is effective against brain tumors.
This treatment must be fast-tracked for approval and made
available as a treatment choice to cancer patients, and
especially to parents whose children have brain tumors.
Ted Wadman
Corvallis, Ore.
* * * * *
Ms. Blevins's assumption that patients who choose alternativist
cancer treatments like antineoplastons are choosing freely
is erroneous. Patients don't choose an unapproved treatment
unless marketing efforts lead them to believe that it
can make them well. But for patients who swallow the unsubstantiated
claims of proponents and sellers, free choice has limited
utility. The utility of freedom of choice depends on reliable
information. It is freedom of informed choice that counts.
There is no evidence from properly controlled clinical
trials that antineoplastons have improved anyone's health.
Without clinical trials, there is no way to distinguish
a patient's response to a treatment from the effects of
chance and bias. This poses no problem for antineoplaston
promoters. They cite poignant testimonials by patients
who claim remissions. While many are offered sincerely,
they are subjective and unreliable.
What some patients interpret as an extraordinary recovery
may be just a better-than-average outcome, within the
normal variation of the disease. Some cancer patients
offer testimonials because they are moved by the prestige
or personal traits of their doctors.
Ms. Blevins misleads readers by stating, "Cancer patients
shouldn't have to break the law in order to use the medical
treatment of their choice." Except for laws directed at
"controlled substances" like marijuana, there are no laws
against patients using unapproved medical treatments.
Consumer protection laws are directed at marketing practices
that are deceptive, exploitative, and threats to public
health.
William M. London
Director of Public Health
American Council on Science and Health
New York
* * * * *
The FDA's case against Dr. Burzynski is irrational.
While the agency offers little hope to cancer victims,
it is waging an all-out battle against physicians whose
treatments offer hope and a promise of recovery. They
are prosecuting Dr. Burzynski and suppressing antineoplaston
therapy even though top physicians at the National Cancer
Institute and the FDA agree that it works.
The FDA has presided over a failed war on cancer at
a cost of $35 billion in government-sponsored research,
$200 billion in private research and $1 trillion in treatment
more than 25 years. Worse yet, there has been no substantial
improvement in cancer cure rates over the last several
decades. Cancer rates continue to escalate.
According to court testimony from Paul Zimmerman, an
FDA project manager in oncology, the FDA had stonewalled
approval for Dr. Burzynski's IND (Investigational New
Drug) trials for more than six years, far in excess of
the usual 30-day hold. In addition, Mr. Zimmerman revealed
that the FDA has, incredibly, never approved a drug submitted
by an individual.
Henry Kriegel
President
Kriegel & Associates
Bozeman, Mont.
(Kriegel & Associates is a national marketing and public
relations firm that represented the Dr. Burzynski Patient
Organization.)
