FDA: Keeping Medication from Cancer Patients

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FDA: Keeping Medication from Cancer Patients

JoAnn Guest

May 03, 2006 22:19 PDT

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FDA: Keeping Medication from Cancer Patients

http://www.cato.org/pubs/regulation/reg20n1-per.html#PERSPECTIVE_4

 

One of the most egregious infringements on individual liberty is the

Food and Drug Administration's war on cancer patients. For more than

fourteen years, the FDA has tried to prevent Americans from using an

experimental anticancer drug because it has not met its approval.

 

Here is how the war began. Stanislaw Burzynski, a Polish-born

physician

with a doctorate in biochemistry, discovered a nontoxic cancer

therapy

in 1967. In 1970 he escaped communist oppression and came to America

to

work on his new discovery. Since 1977 more than twenty-five hundred

Americans have sought out Burzynski's experimental therapy, which he

named antineoplastons (meaning anticancer). Most of his patients had

been diagnosed as terminal after chemotherapy and radiation had

failed

or made their illnesses worse. Although Burzynski makes no claim to

cure

all types of cancer, his treatment has benefited many patients—

clinical

x-rays show that many tumors were reduced following antineoplaston

therapy; some patients have gone into complete remission; and none

of

Burzynski's patients have experienced toxic side effects.

 

Even so, the American Cancer Society placed Burzynski's therapy on

its

" unproven methods " blacklist in 1983. Several months later the FDA

sought an injunction to stop him from treating patients with

antineoplastons because it had not approved the treatment. Federal

Judge

Gabrielle McDonald denied the FDA's request to shut Burzynski's

clinic.

Instead, the judge ruled that Burzynski could continue to treat

patients

in Texas, but she prohibited him from shipping antineoplastons

across

state lines.

 

For the next eleven years, Burzynski fought numerous battles with

the

federal government—his research clinic was raided by FDA officials;

his

medical records were confiscated; and he was subjected to three

federal

grand jury investigations between 1986 and 1994, but no indictments

were

handed down. Burzynski continued to treat hundreds of terminally ill

cancer patients with remarkable outcomes for many. In 1994 the FDA

even

approved Burzynski's manufacturing facility and granted him

permission

to conduct clinical research trials.

 

Then on 24 March 1995 Burzynski appeared on the CBS television show

" This Morning, " accompanied by three patients. The patients had been

diagnosed with terminal cancer, but after receiving antineoplastons

it

appeared that they were free of cancer. That very afternoon the FDA

raided Burzynski's clinic. A fourth grand jury investigation got

underway.

 

In the meantime, Congress held hearings to determine whether the FDA

was

acting improperly. In July 1995, one of Burzynski's patients gave a

dramatic testimony before a congressional subcommittee. Paul

Michaels

was four years old when he was diagnosed with an inoperable brain

tumor,

and he later underwent antineoplaston therapy. Paul, then fourteen

years

old, told the subcommittee, " It's like I'm at war against cancer,

and

the government keeps trying to take away the only weapon I have. "

 

On 20 November 1995, the fourth grand jury returned an indictment

against Burzynski. He was charged with one count of contempt of

court

for violating the order against interstate delivery of

antineoplastons,

thirty-four counts of mail fraud for submitting false or misleading

insurance claims, and forty counts of distributing a non-FDA

approved

drug in interstate commerce. A mistrial was declared on 3 March 1997

with mail fraud charges dropped, but prosecutors plan to retry the

case.

 

According to Dean Mouscher, spokesman for the Burzynski Research

Institute, " Mail fraud charges were brought about because Dr.

Burzynski

mailed healthcare bills that the federal government alleges are

false

and misleading. " Why were Burzynski's bills allegedly false? " He

used a

chemotherapy code on his bills rather than a code for

antineoplastons,

because no such code exists, " said Mouscher.

 

According to federal law (Title 18, U.S.C. Section 1341), any person

who

mails a false or misleading healthcare bill can be charged a

$250,000

fine and sentenced to five years in jail for each piece of mail. The

law

applies to mail sent by government and private carriers. Burzynski

says,

" My main `crime' is that I did not prevent the patients who came to

receive the treatment with antineoplastons in my clinic in Houston

from

leaving Texas and continuing self-administration of antineoplastons

outside the state of Texas. "

 

Representative Joe Barton (R-Tex.) wonders if the FDA has misused

its

power in order to punish Burzynski. According to the Washington

Times,

Barton said, " It is extraordinarily rare for a grand jury to fail to

indict at the request of a U.S. Attorney. " Its failure to do so

after

three attempts, he said, is " virtually unprecedented. "

 

Burzynski's case highlights the crux of the problem with most

regulations today: they restrict the freedom of individuals to

engage in

voluntary transactions. Representatives Barton and Peter DeFazio

(D-Ore.) recently reintroduced the Access to Medical Treatment Act,

H.R.

746, which addresses this issue. The act specifies that patients may

be

treated by a licensed healthcare practitioner with any medical

treatment

desired, even if the treatment has not been approved by the FDA. The

bill stipulates that practitioners must inform patients about the

risks

and benefits of the proposed treatment and whether a drug is FDA

approved.

 

FDA reform is desperately needed to help Americans access medical

treatments of their choosing. Many regulations take freedoms away

from

individuals, but FDA regulations are taking lives. Should we allow

the

FDA to maintain that role?

 

 

JoAnn Guest

mrsjo-

www.geocities.com/mrsjoguest/Diets