FDA vendetta against cancer doc 
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 FDA vendetta against cancer doc

 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

 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
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

Mon, 15 Dec 1997 03:00:00 GMT
 [ 1 post ] 

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