Life Extension Foundation:
Update September 1995
The FDA's Vendetta Against Dr. Burzynski
By Dean Mouscher, Director, Clinical
Trials Burzynski Institute
Stanislaw R. Burzynski is an MD with a Ph.D. in
biochemistry. In 1967, while studying blood as a graduate
student, he found certain peptides that had never been
described before.
Comparing the blood of patients with different diseases,
Dr. Burzynski found that over 98% of cancer patients were
deficient in the peptides he had found-often with blood levels
of only 2% of those of healthy individuals. This led him to
suspect that these compounds-or a lack thereof-were implicated
in the development of neoplastic (cancerous) disease.
Most cancer experts believe we all develop cancer cells
hundreds if not millions of times in our lifetimes. Given the
trillions of developing cells, the millions of errors that can
occur in the differentiation (maturing) process of each cell,
and our constant exposure to carcinogenic substances (smoke,
car fumes, radiation, etc.), the laws of probability dictate
that mis-developing cells must occur frequently in the life of
each individual. It stands to reason that a healthy body has a
corrective system to "reprogram" newly-developed cancer cells
into normal differentiation pathways before the cancer can
take hold.
Dr. Burzynski postulated that healthy organisms have just
such a corrective mechanism, which he termed the "Biochemical
Defense System." He called the substances produced by this
system "antineoplastons." Their purpose is to "reprogram"
cancer cells to die like normal cells. Healthy cells are not
affected.
Dr. Burzynski continued his research at Baylor University
until 1977, when he felt he was ready to begin treating
advanced cancer patients with the peptides he had discovered.
After getting a written opinion from his lawyer that doing so
would not violate any state or federal laws as long as he
treated patients only in Texas, Dr. Burzynski began to give
antineoplastons to patients with hopeless cancers-often with
dramatic results.
The FDA Seeks An Injunction
In 1983 however, the FDA went to court for an injunction to
stop Dr. Burzynski from manufacturing or using antineoplastons
in his practice. U.S. District Court Judge Gabrielle McDonald
turned them down. In an 18-page decision, Judge McDonald made
it clear that Dr. Burzynski could continue to "manufacture,
package, sell, and distribute antineoplastons, so long as it
occurs wholly intrastate."
Ignoring Judge McDonald's decision, the FDA tried to stop
Dr. Burzynski by writing dozens of letters to Senators,
Congressmen, insurance companies and pharmaceutical firms.
These letters contained lies and distortions so outrageous
that on October 23, 1985 Judge McDonald issued a Cease and
Desist order, commanding the FDA to stop issuing false and
misleading information about Dr. Burzynski.
A Series Of Raids And Grand Jury Investigations
In 1985, FDA agents and armed Federal Marshalls raided Dr.
Burzynski's clinic and seized all his patient records-200,000
documents in all. In order to continue treating patients with
advanced cancer, Dr. Burzynski had to install a copier-at his
expense-at FDA headquarters and hire someone to shuttle back
and forth, making copies of his records and bringing them back
to the clinic. Dr. Burzynski had to make appointments with the
FDA to make copies of his own documents.
Later in 1985, Federal prosecutors representing the FDA
presented everything they seized in the raid-plus another
100,000 documents subpoenaed shortly after the raid-to a
Federal Grand Jury. Their investigation of Dr. Burzynski
lasted nine months, but prosecutors couldn't convince the
Grand Jury that there was probable cause to believe a crime
had been committed. No indictment was returned.
In 1990, the U.S. Attorney's office in Houston,
representing the FDA, convened another grand jury to
investigate Dr. Burzynski, again for alleged violations of
Judge McDonald's order. To the FDA's dismay, this Grand Jury
also refused to indict Dr. Burzynski.
More Raids And Grand Juries
In 1993, the FDA again raided the Burzynski Research
Institute because of alleged bacterial contamination of
antineoplastons, but tests proved conclusively that there was
no contamination.
In 1994, U.S. Attorneys-again representing the FDA-convened
a third Grand Jury to investigate Dr. Burzynski. And for the
third time, a skeptical Grand Jury refused to return an
indictment. The main casualty this time was the Assistant U.S.
Attorney on the case, who was removed for prosecutorial
misconduct involving abusive and improper use of
subpoenas.
The latest chapter in the FDA's twelve-year campaign to
stop Dr. Burzynski from treating patients with antineoplastons
kicked off on March 24, 1995 with another raid on the clinic.
Seven federal agents herded employees into a room and kept
them there until they filled out forms with personal
information. They then spent seven hours rifling through file
cabinets and drawers, leaving with boxes of patient records
and other documents.
Shortly thereafter the FDA began serving clinic employees
with subpoenas commanding them to testify before a Federal
Grand Jury investigating Dr. Burzynski. To date, federal
prosecutors representing the FDA have subpoenaed nine
employees including Dr. Burzynski. In addition, they have
ordered him to turn over tens of thousands of pages of
documents, including more patient records and diagnostic
films.
An Arbitrary Fishing Expedition
The law prohibits Grand Juries from "arbitrary fishing
expeditions". Yet that is exactly what federal prosecutors are
engaged in. Besides patient records-many of which have already
been presented four times to various government
investigators-prosecutors have subpoenaed "any and all
agreements, draft agreements, proposals, correspondence,
notes, memos, tape recordings, notes of conversations,
telephone messages, reports, raw data, studies or other items
to, from, or with any foreign or domestic pharmaceutical
company or university, including contact person's name, title
and phone number."
While this information is of no use in investigating
criminal activity, it gives the FDA the opportunity to write
letters to everyone they uncover, letting them know that Dr.
Burzynski is the target of a federal investigation and to
issue subpoenas to some of these people. This is more than
just speculation. It is the exact behavior that sparked a 1985
"Cease and Desist" order against the FDA by US District Court
Judge Gabrielle McDonald.
And so, on June 15 1995, prosecutor Amy LeCocq subpoenaed a
huge Dutch pharmaceutical conglomerate-which has conducted
negotiations with Dr. Burzynski-for all correspondence, memos,
documents or other records it had regarding Dr. Burzynski or
anyone associated with him. The obvious purpose of this
subpoena was to frighten the company-which does a large
business in the U.S.-into having no further contact with Dr.
Burzynski.
Prosecutors have also subpoenaed all patient billing
records, again with no time limitation whatever. Dr. Burzynski
has been treating patients since 1977. They have subpoenaed
his accountants for every conceivable document an accountant
can possess (again with no limitation on time), a classic
fishing expedition. Prosecutors have even subpoenaed the names
and addresses of every person who has ever received a brochure
from Dr. Burzynski! As if that weren't enough, the subpoena
went on to demand "Any other lists of persons", an absurdly
general and burdensome request.
FDA Harassment, Illegal Actions And Terrorism
Besides throwing the entire clinic into chaos, wasting
thousands of hours of employee time, and terrifying advanced
cancer patients who don't know whether they will be able to
continue getting the only medicine that has been able to help
them, the grand jury's actions have severely threatened Dr.
Burzynski's ability to practice medicine. Without patients'
previous MRIs and CAT scans, Dr. Burzynski has nothing to
which he can compare new scans, and no way of knowing if
patients' tumors are growing or shrinking.
Moreover, the FDA has been careful to seize films and
medical records of Dr. Burzynski's most successful cases,
crippling his ability to defend himself by confiscating his
single most valuable asset-proof of the anti-cancer activity
of antineoplastons.
In the current case there has been illegal use of subpoenas
as well. Dr. Ralph Moss, an award-winning journalist and
author of books about cancer, was subpoenaed and ordered to
produce every document in his possession-electronic, magnetic,
printed or otherwise-relating to Dr. Burzynski. Dr. Moss has
written favorably about Dr. Burzynski in the past.
Unfortunately for Amy Lecocq, the prosecutor in charge of
this case, her subpoena of Dr. Moss violated at least six
federal laws governing subpoenas of journalists. Such
violations carry a penalty of administrative reprimand or
other disciplinary action. When Dr. Moss pointed this out to
Lecocq and gave her the opportunity to withdraw the subpoena,
she did so with alacrity.
It's been said that a prosecutor can get a Grand Jury to
indict virtually anyone. But despite the avalanche of
documents supplied by the government to four Grand Juries, it
has yet to convince any of them of probable cause to believe
Dr. Burzynski has committed a crime. And so, unable to stop
him legally, the FDA seems determined to harass him to
death.
The NCI Report on Dr. Burzynski
The FDA's actions are all the more outrageous because their
own oncology division has granted Dr. Burzynski permission to
conduct Phase II clinical trials! In addition the National
Cancer Institute (NCI)-following a visit by seven NCI experts
to Dr. Burzynski's Houston clinic for a review of patient
records-confirmed several remissions in patients with
"hopeless" brain tumors after treatment with antineoplastons.
Their report states that "The site visit team documented
anti-cancer activity in this best-case series and determined
that Phase II trials are warranted to determine the response
rate."
In other words, the question is no longer "Do
antineoplastons work?"; it is: "How consistently do they
work?"
And yet, despite the NCI report, despite the fact that the
FDA's own scientists wish to see antineoplastons tested, the
FDA's "enforcers" remain obsessed with shutting Dr. Burzynski
down.
How long will this continue? Until your outrage puts a stop
to it.
You can start by writing letters, phoning, and faxing your
Senators and representatives in the House. To obtain, the
phone numbers of your representatives, call the U.S.
Congressional switchboard number:
1-202-224-3121
Washington in Review
Life Extension News From Our Nation's Capitol
New Health Freedom Bill Introduced In Congress
On June 29, 1995, representatives Frank Pallone
(D-NJ) and Dennis Hastert (R-IL) jointly introduced
the Food and Dietary Supplement Consumer Information
Act of 1995 (H.R.1951) in the US House of
Representatives.
The purpose of this bill is: "To amend the Federal
Food, Drug, and Cosmetic Act to allow food and dietary
supplement manufacturers to communicate truthful,
nonmisleading information to consumers concerning the
nutritional content and disease prevention benefits of their
products, (and) to repeal or clarify rules enacted by the
Dietary Supplement Health and Education Act of 1994."
Rep. Pallone was an original cosponsor of the
Dietary Supplement Health and Education Act of 1994
(DSHEA). Rep. Hastert was a cosponsor of DSHEA in the
last Congress and serves as Chief Deputy Majority Whip and
Vice Chairman of the Health Sub committee of the House
Commerce Committee, both of which have primary
jurisdiction over the U.S. Food And Drug
Administration (FDA).
Both House members want to include the issue of the FDA's
regulation of foods and supplements in the FDA reform debate
and it is likely we will see Congressional hearings on the
subject before the end of the year.
The new bill is cosponsored by Rep. Bill Richardson
(D-NM), the House author of DSHEA; Rep. Peter
DeFazio (D-OR), an early supporter of DSHEA and House
author of The Access To Medical Treatments
Act; and Rep. Dan Frisa (R-NY), who
defeated Phil Schiliro, Administrative
Assistant to Rep. Henry Waxman in last
November's election for a Long Island, New York seat. Rep.
Waxman is a longtime supporter of the FDA, whose power was
reduced sharply when the Republicans gained control of the
House.
Repairing Last Year's Bill
One of the purposes of H.R.1951 is to
repair the flaws in the DSHEA, which, in its original version,
would have allowed companies to make all truthful health
claims about their products. This basic principle was watered
down significantly in the legislative process that led to
passage of the DSHLEA.
In addition to its clear-cut position on the right to make
truthful health claims, the new bill prevents the FDA from
classifying foods and dietary supplements as "drugs", and
abolishes the recently created Presidential Commission
on Dietary Supplement Labels, which was called for by
the DSHLEA.
According to Rep. Pallone, the reason the
bill calls for the abolition of the Presidential Commission is
a recent U.S. Supreme Court decision that
eliminates the need for the Commission. In his speech before
the House (when introducing the bill), Rep. Pallone
said: "I think the philosophy and public policy
objective concerning claims should be guided by the sage words
of Justice Stevens who recently wrote in a landmark commercial
speech case, Rubin vs Coors Brewing
Co.
"'Any `interest` in restricting the flow of accurate
information because of the perceived danger of that knowledge
is anathema to the First Amendment; more speech and a
better-informed citizenry are among the central goals of the
Free Speech Clause. Accordingly, the Constitution is most
skeptical of supposed state interests that seek to keep people
in the dark for what the government believes to be their own
good.'"
n Rep. Pallone's speech before the House,
he went to great lengths to explain the damage to the American
people caused by FDA censorship of truthful health claims. As
he put it:
"When we passed the Nutrition Labeling and Education
Act in 1990 (NLEA), we authorized the FDA to pre-clear all
health claims that a food or dietary ingredient could prevent
a disease or health related condition. Congress wanted the FDA
to allow such claims because of the overwhelming scientific
evidence between disease and nutritional status. It also was
allowed so that industry could better educate its customers
regarding the benefits of their products. The FDA was given
the discretion to use a standard that they called 'significant
scientific agreement' to decide whether to approve a health
claim. The record of the agency in this area has been a
failure and should be reformed.
"When the NLEA was passed, the FDA was asked to
evaluate nine health claims for foods and supplements. It
approved only two for supplements; first was that calcium
prevents osteoporosis and second, after initially rejecting
the claim, that folic acid prevents neural tube birth defects
for women of child bearing age. It also approved claims that
antioxidant and fiber rich foods like fruits and vegetables
could help prevent heart disease and cancer. It refused to
approve the same claims for supplements of those dietary
ingredients.
"The case of the Folic Acid health claim is most
illustrative of the problem with the FDA being the censor of
truthful, nonmisleading information and the terrible price our
country pays for being kept in the dark. When NLEA was passed,
the FDA was asked to evaluate a health claim for folic acid
preventing certain birth defects. In November of 1991, the FDA
denied the health claim, stating that there was no
'significant scientific agreement' to approve the claim.
Subsequently in July of 1992, the US Public Health Service
published an advisory asking all women of child bearing age to
get adequate folic acid in their diets by foods or supplements
to prevent these tragic birth defects.
"Public and scientific outrage finally forced the FDA
to reverse itself in the fall of 1993 and the claim was
approved. But what was most outrageous...was that the FDA
testified in a Senate Labor and Human Resource Committee
hearing in October 1993 that it had been aware of scientific
data that folic acid could prevent these birth defects for ten
years! They argued that, in their opinion, there was no
'significant scientific agreement' when the Nutrition Labeling
and Education Act was first enacted in 1990 until the FDA
reversed itself in the fall of 1993. In the interim, the
American public was kept in the dark, and an estimated
additional 2,000 children were born with birth defects that
could have been prevented had the information been allowed to
reach women in a responsible manner.
"For ten years when the first scientific data started
coming in, women were not allowed to be told that Folic Acid
might prevent neural tube birth defects. In this period of
time, these tragic and irreversible birth defects struck
approximately 20,000 babies. If any of my colleagues have ever
seen a child born with anencephalopathy or spina bifida, then
they know the pain and suffering these children and their
parents face.
"These are children who are disabled, disfigured, and
have short life spans. The costs to take care of these
children run in the millions. Yet the information was out
there that an adequate amount of folic acid had the potential
to avert these birth defects. The risk to women of child
bearing age who could have received this information was zero.
The benefit potential was thousands of birth defects
prevented. But American women were kept in the dark and we
will never know precisely how many babies born with these
defects could have been averted. We do know that this number
reaches into the thousands.
"Now the same thing is happening with a class of
nutrients called antioxidants which scientific research is
showing huge potential in reducing or eliminating known risk
factors for cancer and cardiovascular disease. As I introduce
this legislation, I point out that in the June 21st edition of
the Journal of the American Medical Association there was
another study on Vitamin E and compelling evidence that it can
reduce the risk of heart disease has been published.
"This is another study that adds to the overwhelming
number of scientific studies that antioxidants have important
contributions to make in the fight against degenerative
diseases that are driving our health care costs into oblivion.
And just a month ago, scientists confirmed that a mineral
antioxidant, selenium, has the ability to protect the human
immune system and minimize damage from viral infections. These
studies promise innovation and cost effective treatments for
people with viral illnesses. But such information will never
reach the consumer in time under current FDA policies."
Why We Must Support This Bill
Because of the change in leadership in Congress, the
chances of passing a fully intact health freedom bill, which
guarantees your our rights to learn about and use the
supplements of our choice, is very good this year, but only if
we register our support for the bill with members of
Congress.
Therefore, we urge you to contact your
representatives in Congress immediately in order to urge them
to become cosponsors of The Food and Dietary Supplement
Consumer Act of 1995 (H.R.1951) and to help persuade their
colleagues to support the bill.
Please call, write, and fax your support for this
bill to your elected representatives now! If you do not have
the phone number, fax number, and address or your
representatives, just call the Capitol Switchboard
at:
1-202-224-3121
Alternative Treatment Bill Introduced In Congress
On July 13, 1995, Rep. Peter DeFazio (D-OR)
introduced The Access To Medical Treatment
Act (H.R.2019) in the U.S. House of Representatives. A
companion bill will soon be introduced in The Senate
by Sen. Tom Daschle (D-SD).
This bill would allow an individual to be treated
by any health care practitioner who is legally authorized to
provide health professional services in the State in which the
services are provided, using any method of treatment the
individual desires, as long as:
1. The treatment causes no serious harm other than
reactions normally experienced with routinely used medical
treatments for the same medical condition; and
2. The patient is fully informed about the treatment and
its possible side effects.
Why This Bill Is Needed
he outrageous actions of the FDA against Dr. Burzynski and
his patients, which is described in the lead article in this
issue of the FDA Raid Report, make
it very clear why we need legislation to protect our rights to
have access to the medical treatments of our choice.
The FDA is doing everything it can to put Dr. Burzynski out
of business, and perhaps behind bars, simply because he has
dared to offer cancer patients an alternative to surgery,
chemotherapy, and radiation-the three standard modes of
treatment in the United States. The FDA is trying to destroy
Dr. Burzynski, even though his antineoplaston treatment has
been highly effective in treating some patients, and despite
the fact that more Americans are afflicted with and dying of
cancer today than ever before!
The Access To Medical Treatments Act does
not alter the FDA's responsibility to approve treatments as
safe and effective. It attempts to open up what is now a
system that is closed to alternative treatments. The bill
forbids claims by those offering alternative treatments to
guard against "major marketing efforts" for non-FDA
approved treatments.
Why We Should Support This Bill
e urge support for H.R.2019 because it
gives Americans considerably more freedom than they have today
regarding access to alternative treatments. It will be
especially useful for patients who suffer from diseases
considered "incurable" by mainstream medicine, who have no
options other than to explore alternative treatments for their
condition.
It will also be beneficial for alternative physicians such
as Dr. Burzynski, who don't actively promote their services,
and who would love to be left alone by the FDA's enforcement
agents. The problem with the bill is that it is too
restrictive on medical claims by alternative practitioners.
Such restrictions could easily be used by the FDA-in direct
contradiction to the wishes of Congress-to continue their
illegal and immoral actions against alternative medicine.
We strongly recommend that you support this bill.
Again, we urge you to phone, fax, and write your
representatives in Congress in order to urge them to support
The Access To Medical Treatment Act (H.R.2019). To find out
how to contact members of Congress, just call the Capitol
Switch board at:
1-202-224-3121
New First Amendment Lawsuit Against The FDA
On June 30, 1995, the Nutritional Health Alliance
(NHA) filed a lawsuit in Federal District Court for
the Southern District of New York seeking a declaratory
judgment that provisions of the Nutrition Labeling And
Education Act (NLEA) and the U.S. Food And
Drug Administration's (FDA) implementing regulations
of that act are invalid under the first amendment to the U.S.
Constitution to the extent that they constitute "prior
restraint" of constitutionally protected speech.
The lawsuit, which was filed by the New York law firm of
Bass & Ullman, attacks that portion of
the NLEA which prohibits manufacturers and marketers of
dietary supplements from using truthful, nonmisleading
information to inform the public about the value of dietary
supplements for the prevention of diseases and other
health-related conditions.
According to NHA President Gerald Kessler,
"the NHA has filed this case as part of its continuing
campaign for health freedom and freedom of speech." Mr.
Kessler further stated that: "We must continue the fight for
the right of the dietary supplement industry to make truthful
and non-misleading health claims and for the right of the
American public to receive information which is crucial to
their health and well-being."
This is the fourth first amendment lawsuit filed against
the FDA that is now in the U.S. courts. A crucial hearing is
scheduled before the U.S. Court of Appeals in San
Francisco at 9 AM on August 15, 1995 with regard to
the first amendment lawsuit filed against the FDA by
Durk Pearson and Sandy Shaw. An in-depth
report on these first amendment lawsuits will be carried in
the next issue of LIFE EXTENSION
MAGAZINE.
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