When Richard Nixon announced the War on Cancer on
December 23, 1971, cancer accounted for 17% of all deaths. At
the time the main weapons against it were primitive -- surgery,
radiation and chemotherapy. Today -- 24 years and tens of
billions of research dollars later -- cancer accounts for 24% of all
deaths and the main weapons against it are still surgery, radiation
and chemotherapy.
By systematically targeting independent medical innovators who
reject the conventional wisdom -- the richest source of new ideas
in any field of endeavor -- the FDA is directly responsible for
a significant share of this failure.
Perhaps the most compelling example is Stanislaw R. Burzynski,
a Houston-based medical doctor with a PhD in biochemistry. For
the past eigh{*filter*} years he has treated advanced cancer patients
with antineoplastons -- non-toxic substances he discovered that
stimulate the activity of "good" genes such as tumor suppressor
genes, while suppressing cancer-causing genes such as
oncogenes. The result is that cancer cells are "reprogrammed" to
die like normal cells.
In 1991 seven National Cancer Institute specialists performed a
site visit at Dr. Burzynski's clinic and studied the records of
seven terminal brain cancer patients he had treated. The team
concluded that in every case antineoplastons caused anticancer
effect, and verified five cases as complete remissions
(disappearance of tumor).
By 1994 antineoplastons had been aproved by the FDA for Phase
II clinical trials.
Despite his success and good relations with the FDA's oncology
division (which has given him permission to conduct several
Phase II clinical trials), Dr. Burzynski has been stuck in a twelve-
year nightmare of legal harassment by its enforcement division.
Like the character in Kafka's The Trial, he cannot face his
accuser or know who he is, is not told what crime he is accused
of, and does not know when, if ever, the nightmare will end.
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 a raid on his 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 file cabinets and drawers, leaving with boxes
full of patient records and other documents.
Two federal agents also paid an unexpected (and unwelcome) visit to
the home of a Long Island patient, demanded to come inside (although
they didn't have a search warrant), and threatened the patient
(seriously ill with an aggressive brain tumor) with a subpoena if he
didn't cooperate. "We've been trying to get this guy (Dr. Burzynski)
for ten years," said one of the agents, "and you're going to help us."
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 suppoenaed 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.
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 Dr.
Burzynski has presented four times already 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
supposed criminal activity (is it illegal to sign agreements?), it
does give the FDA the opportunity to write letters to the above
letting them know Dr. Burzynski is the target of a federal
investigation. This is more than mere speculation -- it is exactly
the behavior that sparked a 1985 "Cease and Desist" order
against the FDA by US District Court Judge Gabrielle
McDonald.
Prosecutors have also subpoenaed all patient billing records with
no time limitation whatsoever. 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.
Besides throwing the entire clinic into chaos, wasting thousands
of hours of employee time, making it impossible to get work
done and costing the clinic hundreds of thousands of dollars, the
grand jury's actions have severely threatened Dr. Burzynski's
ability to treat patients. 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.
Such behavior by the agency charged with protecting the nation's
health is nothing new. In 1983, the FDA went to court for an
injunction that would close Dr. Burzynski's clinic and stop him
from using antineoplastons. US District Court Judge Gabrielle
McDonald refused. 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.
In 1985 FDA agents and armed Federal Marshalls raided Dr.
Burzynski's clinic and seized all 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 and bringing them to the clinic. To
further the indignity, Dr. Burzynski had to make an appointment
each time.
Federal prosecutors representing the FDA presented everything
they seized in the 1985 raid -- plus another 100,000 documents
subpoenaed shortly after the raid -- to a 1985 Federal Grand Jury.
Their investigation of Dr. Burzynski lasted nine months, but
prosecutors couldn't even convince the Grand Jury there was
probable cause to believe a crime had been committed. No
indictment was returned.
In 1990 the Houston US Attorney's office, 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 refused to indict Dr. Burzynski as well.
In 1993 the FDA raided Burzynski Research Institute for
supposed bacterial contamination of antineoplastons, but tests
proved conclusively that there was no contamination. If the FDA
had suspected that a drug produced by, say, Bristol Myers was
contaminated, would it have mounted such a raid?
In 1994 US 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
only casualty this time was the Assistant US Attorney on the
case, who was removed for prosecutorial misconduct involving
abusive and improper use of subpoenas.
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.
It's been said that a prosecutor can get a Grand Jury to indict a
ham sandwich. 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.
How long will this continue? Until your outrage puts a stop to it.
You can make a big difference by writing letters to your Senators and
Congressman. To find out their names and addresses, phone numbers or
fax
numbers, call (202) 225-3121.
Janet Reno is head of the Department of Justice, and is the ultimate
boss of the Assistant US Attorneys in Houston, Amy Lecocq and George
Tallichet, who are conducting the Grand Jury investigation and writing
the subpoenas mentioned above. Her address is:
Janet F. Reno, Attorney General
Department of Justice
Constitution Ave. and 10th St. NW
Washington DC 20530 Tel. (202) 514-2001
You can also write Jamie Gorelick, Assistant Attorney General, at the
same address
Tel. (202) 514-2101