The following article appeared in The Wall Street
Journal, June 2, 1997:
Fighting Cancerand the FDA
by Sue A. Blevins
June 2, 1997
Paul Michaels is only 16, but he's endured
enough battles to last a lifetime. When he was four,
Paul was diagnosed with an inoperable brain tumor; doctors
said he wouldn't live beyond 10. Rather than accept
that verdict, his parents consulted a number of physicians
across the country and eventually chose to treat him
with an experimental drug called antineoplastons. The
treatment appears to have worked. Paul's mother, Mary
Michaels, says that MRI scans show Paul's tumor, once
three inches in diameter, has shrunk to the size of
a pea, and he leads a normal life. Paul remains on antineoplastons.
Pursuing that treatment, however, meant joining
another battle, one that in some ways has been more
frustrating than the fight against cancer: a battle
against the Food and Drug Administration. Antineoplastons
have not gone through the FDA's rigorous evaluation
process, and therefore do not have the agency's approval.
Paul's parents knew this when they decided on his
therapy, but that's not enough to satisfy the regulators,
who are dead set against allowing even terminally
ill patients the freedom to choose therapies that
lack the FDA's imprimatur. Paul and his mother have
made several trips to Washington over the years, pleading
with Congress to get the FDA off their backs. "It's
like I'm at war against cancer, and the federal government
keeps trying to take away the only weapon I have,"
Paul told one congressional subcommittee.
FDA Loses a Round
The FDA has lost one round in that battle. Last
week a federal jury acquitted Stanislaw Burzynski,
the doctor who manufactures antineoplastons. Dr. Burzynski,
a Polish-born physician and biochemist, faced contempt-of-court
charges for violating a 14-year-old injunction against
shipping antineoplastons across state lines. In the
1983 case, the FDA had sought an injunction to stop
Dr. Burzynski from using antineoplastons at all. Federal
Judge Gabrielle McDonald turned the FDA down, holding
that Dr. Burzynski could continue to treat patients
with antineoplastons--but only in his home state of
Texas. Once the drug crossed state lines, Judge McDonald
declared, the FDA's federal jurisdiction kicked in.
Most of Dr. Burzynski's out-of-state patients couldn't
afford to move to the Lone Star State. They traveled
to Houston for initial treatment, and then moved the
drug across state lines for their own personal long-term
use, according to Steve Siegel, who heads an organization
of Dr. Burzynski's patients. The patients also established
a legal defense fund for Dr. Burzynski, knowing that
unless he prevailed against the FDA, they would lose
their cancer treatment.
The FDA continued its attempts to prosecute Dr.
Burzynski. It took four grand jury investigations
before an indictment was finally handed up. Dr. Burzynski
was charged with 40 counts of distributing an unapproved
drug in interstate commerce, 34 counts of mail fraud
and one count of contempt of court for violating the
1983 court order. Dr. Burzynski was tried on those
charges in February. A mistrial was declared in March,
and the 34 counts of mail fraud were dropped. Federal
prosecutors later dropped the 40 counts of interstate
distribution of an unapproved drug. But on May 19
a second trial commenced on the contempt charge. Prosecutors
claimed Dr. Burzynski violated the previous court
order because he continued to treat patients who lived
out of state, knowing they might ship the drug across
state lines. The defense argued that Dr. Burzynski
treated patients who lived outside Texas, but that
he didn't ship the drug to other states. The jury
deliberated for three hours before acquitting Dr.
The FDA, meanwhile, has approved antineoplastons
for clinical trials. So Dr. Burzynski's patients are
free to continue their treatment. But how many more
cancer patients are going to face similar problems
with the FDA? "I think it's safe to assume that most
Americans don't even realize that they don't have
the right to decide how they will cure their own disease,"
says Candace Campbell, executive director of the American
Preventive Medical Association. "For instance, in
California, it is illegal for a doctor to treat cancer
with anything except [FDA-approved] chemotherapy,
radiation and surgery."
That is why doctors and patients across the nation
are pushing for federal legislation that would give
Americans the right to use medical treatments not
currently approved by the FDA. The Access to Medical
Treatment Act, sponsored by Reps. Peter DeFazio (D.,
Ore.) and Joe Barton (R., Texas), would allow patients
to be treated by a licensed health-care practitioner
with any medical treatment, so long as they are informed
about the risks and benefits of the treatment. "I
want to get the thousand-pound gorilla known as the
FDA off of the backs of people who want access to
beneficial alternative health treatments, without
compromising the public's safety," Rep. DeFazio says.
Supporters of the bill are not trying to eliminate
the FDA's role entirely. Practitioners would be required
to inform patients whether the agency has approved
a drug. "There is a role for the FDA," says Ed Gochenour,
a Georgia state senator who was recently treated with
antineoplastons. "Ideally, I'd like the FDA to tell
me whether or not a drug is toxic, but beyond that
I'd like to make my own decisions on whether or not
I want to use it."
Three Different Answers
Last November, the 44-year-old Mr. Gochenour was
diagnosed with a brain tumor, and sought the advice
of numerous neurosurgeons in the Atlanta area. "I
got three different answers from three top doctors,"
says Mr. Gochenour. "One doctor suggested chemotherapy,
then radiation and then gamma-knife treatment. The
second recommended surgery, then radiation and then
finally chemotherapy. The third recommended starting
with chemotherapy, followed by radiation, and then
told me that the gamma-knife treatment and surgery
would destroy good cells and should be used as last
resorts." After Mr. Gochenour's cancer made headlines
in Georgia, he received some 40 letters and phone
calls suggesting alternative treatments. Roughly half
mentioned Dr. Burzynski's antineoplaston therapy.
As a result, Mr. Gochenour decided to meet Dr. Burzynski
and undergo antineoplaston treatment. "Now my tumor
is gone and I didn't even experience any toxic side
effects from Dr. Burzynski's treatment," Mr. Gochenour
says. Six months later, he remains comfortably on
his antineoplaston regimen.
Cancer patients shouldn't have to break the law
in order to use the medical treatment of their choice.
And even though Dr. Burzynski's patients won one round
with the FDA, how many future cancer patients must
fight battles to gain access to the medical treatment
of their choice? The only way to ensure that Americans
are free to choose their own medical treatments is
to recognize that health freedom is a basic right.
Ms. Blevins is president of the Washington-based
Institute for Health Freedom.
Reprinted with permission of The
Wall Street Journal. Copyright © 1997, Dow Jones
& Company, Inc. All rights reserved.