FDA

**History Between Dr. Burzynski and FDA**
Dr. Burzynski's Efforts to Comply with FDA	FDA Actions Blocking Dr. Burzynski	Stated FDA Policy


		1976 - FDA Bureau of Drugs Director Richard Crout states in The Cancer Letter of March 12, 1976, that when anyone other than large institutions ask permission to conduct clinical trials, "You want harsh regulations... sometimes we say it is proper to hinder research."
1977 - Dr. Burzynski obtains legal opinion letter from law firm of Caldwell & Baggott that treating patients in Texas with his experimental drug, antineoplastons, will not violate any State of Texas or Federal laws.
		1978 - FDA investigator Alicia Abbott reports that John Lewis MD, Chairman of the Harris County Medical Society's Board of Ethics, told her that while Dr. Burzynski could not ship drugs out of Texas, "Physicians often provide a supply of drugs for out-of-state patients to take home with them, and he would not consider this unusual." Jan. 18, 1982 - Dr. Crout is quoted as saying "I never have and never will approve a drug to an individual, but only to a large pharmaceutical firm with unlimited resources." Sept. 8, 1982 - FDA official William Nychis writes Herbert Koch MD of Harris County Medical Society that "A physician who manufactures and uses a drug within his own practice of medicine...is not subject to [FDA regulations] since the practice of medicine is properly regulated by state or local authorities."
May 6 1983 - Dr. Burzynski applies to FDA for an IND (Investigational New Drug) permit, to conduct clinical trials on antineoplastons. Most INDs are approved within 30 days. June 13, 1983 - Dr. B. re-applies to FDA for IND, responding to 5/31 refusal letter. Fall, 1983 - Dr. Burzynski hires Carl Bruch, PhD, former Chief Scientist of FDA's Bureau of Medical Devices, to bring manufacturing of antineoplastons into compliance with FDA standards.	March 1983 - FDA takes Dr. Burzynski to court in a civil action to stop him from manufacturing and using antineoplastons. US District Court Judge Gabrielle McDonald issues injunction forbidding Dr. Burzynski from shipping antineoplastons across state lines, but adds that "Nothing contained herein shall be construed as restraining, enjoining or in any way prohibiting the manufacture, processing, packing, holding, promotion, labeling, sale or distribution of antineoplastons ... when it is undertaken strictly and wholly intrastate." May 9, 1983 - FDA writes in a motion for summary judgment that if Judge McDonald does not rule as it wishes, "...the government would then be obliged to pursue other less efficient remedies, such as actions for seizure and condemnation of the drugs or criminal prosecution of individuals..." May 31, 1983 FDA denies Dr. Burzynski's request for an IND stating that he does not have sufficient "training or experience." Dr. Burzynski is an MD PhD in biochemistry who conducted NCI-funded cancer research at Baylor College of Medicine for 7 years, and has at this point run his own cancer clinic for 6 years. Sept. 21, 1983 - Unscheduled visit by FDA agents who demand several hours from Dr. Burzynski, despite being told his schedule is full with gravely ill cancer patients. Dr. B. has to reschedule several patients to later in the week. The agents insist on coming back a second day during which the schedule is again full of patients, and refuse Dr. Burzynski's offer to meet with them on a day in which no patients had been booked. Dec. 15, 1983 - FDA again denies IND application.	July 7, 1983 - FDA Associate Commissioner Robert Wetherell Jr. writes to US Representative Robert W. Davis that Judge McDonald's injunction "does not prohibit the distribution of antineoplastons within the State of Texas."
August 3, 1984 - Dr. Bruch reports that Dr. Burzynski's manufacturing procedures meet FDA GMP (Good Manufacturing Practices).	Feb. 1984 - FDA again denies IND application.
Dec. 18, 1985 - Mitchell Yokuyama MD, of the Antineoplaston Study Group at Kurume University in Japan, writes FDA requesting permission for Dr. Burzynski to export a small quantity of antineoplastons to Japan for experimental use.	July 17, 1985 - FDA agents raid clinic and seize 200,000 pages of documents, including all patient medical records. In order to continue treating patients, Dr. B installs copier at his expense at FDA office and must make appt. in advance to copy them as needed. Oct. 24, 1985 - Judge McDonald tells FDA to stop releasing misleading and inappropriate information about Dr. Burzynski. As a result of FDA's letters to insurance companies, income has fallen off sharply, the production of medicine is interrupted, and patients suffer severely.
	April 17, 1986 - FDA writes Dr. B, denying his and Kurume University's request to allow Dr. Burzynski to send antineoplastons to Japan for experimental use. 1986 - Federal Grand Jury investigation of Dr. Burzynski dissolves with no indictment. Apparently FDA is unable to find any evidence Dr. B has shipped drugs out of state. Nevertheless, FDA refuses to release the seized documents, which have not been returned as of this writing.
Feb. 12, 1987 - Dr. Burzynski and two professors from the Medical College of Georgia meet with FDA officials in Washington and, in support of the IND application, present: Two sound theoretical models explaining anti-cancer activity of antineoplastons in humans Three studies showing anti-cancer activity of antineoplastons in animals. Nov. 17, 1987 - Dr. B responds to 10/28 denial with more data and explanations.	Oct. 28, 1987- In spite of Feb. meeting, FDA again denies IND request.
	Jan. 13, 1988 - FDA states in a letter that it now believes antineoplastons have shown anti-cancer activity, but again deny IND request, demanding further testing.
	1989 - Following a trip to Japan to verify the Japanese studies showing anti-cancer activity of antineoplastons, FDA finally allows Dr. Burzynski to begin testing one oral preparation of antineoplastons.	Jan. 4, 1989 - FDA Commissioner Frank Young issues a public statement to demonstrate how quickly FDA approves cancer drugs. He says that it is a "misperception" that FDA insists on "particular designs of trials, or that large numbers of patients are needed. In fact, cancer drugs have been approved on extremely small databases (well under 100 patients), with responses in less than 10, and on the basis of studies whose design was anything but classic." He adds that in at least one case, a cancer drug was approved on the basis of only 6 responses.
	1990 - FDA initiates a second long Grand Jury investigation. Again, thousands of documents are subpoenaed and many employees are subpoenaed to testify, including Dr. Burzynski. Again, no indictment is returned.
1991 - Dr. Burzynski hosts a team of 6 National Cancer Institute scientists who spend a day exhaustively reviewing the records of 7 "terminal" brain cancer patients treated with antineoplastons. The team concludes that 5 of the 7 have had complete response (disappearance of tumor) and 2 partial response. Its report states unequivocally that "anti-tumor activity was demonstrated in this best-case series..." NCI official Michael Friedman MD writes in an internal memo dated 10/31/96 that "It turns out that antineoplastons are well-defined, pure chemical moieties...The human brain tumor responses are real."
May 24, 1993 - Nicholas Patronas MD, NCI's Chief of Neuroradiology and the leader of the 1991 team that audited Dr. Burzynski's brain tumor results, testifies in an Austin courtroom that antineoplastons are the most effective treatment for brain tumors he has ever seen. When asked what will happen to patients if they are deprived of access to the drug, Dr. Patronas replies, "I think these patients will die." When Dr. Patronas returns to Washington he is severely reprimanded for having supported Dr. Burzynski. On May 28, under pressure, he withdraws a paper on antineoplastons he was scheduled to present at an international cancer conference in Sweden. 1993 - Dr. Burzynski receives permission from FDA to test intravenous antineoplastons to treat brain cancer, and begins clinical trials.
Feb. 1994 - Dr. B. sends letters to approx. 12 large pharmaceutical companies asking them to participate in joint development of antineoplastons. All decline - possibly due to fear of retaliation by FDA. Mar. 1994 - Dr. B. hosts Shlomo Flechter MD, a neurologist at Israel's famed Weizmann Institute, who is interested in conducting clinical trials of antineoplastons. June 1994 - Burzynski Clinic sends letters to 2,000 neurosurgeons asking for patient referrals in order to speed up the clinical trials. Nov. 1994 - Dr. B. reaches an agreement of Lori Kunkel MD of UCLA to conduct clinical trials of antineoplastons in the treatment of lymphoma.	1994 - FDA initiates 3^rd Grand Jury investigation of Dr. Burzynski. Again, no indictment is returned. The Houston press reports that Assistant US Attorney Jim Powers is reassigned due to prosecutorial misconduct during the investigation.
	1994-1995 - FDA delays more than 9 months before finally responding to Dr. B's request for permission to have Dr. Kunkel of UCLA conduct clinical trials. By the time FDA finally responds, Dr. Kunkel has left UCLA, and those studies are never conducted. Mar 23, 1995 - FDA agents Hansen and Biegelman pay unscheduled visit to the Long Island home of Burzynski brain tumor patient Domenick Pugliese. They have no search warrant, but aggressively insist on searching the home, telling the family they have been trying to "get" Dr. Burzynski for ten years. The agents insist the treatment is ineffective and suggest the family seek other treatment. When the family refuses to cooperate, the agents threaten several times to return with a subpoena. Mar 24, 1995 - FDA raids Burzynski Clinic and confiscates boxloads of records, including patient medical records. April - November 1995 - Fourth Federal Grand Jury investigation. Every month more documents and employees are subpoenaed. Government uses subpoenas to intimidate and harass those who have worked with Dr. Burzynski, including journalist and author Ralph W. Moss and executives of Akzo Nobel, a huge Dutch pharmaceutical conglomerate. Govt. also subpoenas the medical files and patient records of Dr. Nozorodan, an independent surgeon who implants catheters for many Burzynski patients November 15, 1995 - FDA Commissioner David Kessler faces harsh questioning by Congressman Joe Barton's Investigations Subcommittee about FDA's abuse of Grand Juries, and about how he can justify four Grand Juries with no indictment. November 20, 1995 - Dr. Burzynski is indicted for having released his out-of-state patients to return home with a supply of antineoplastons. The charges are based upon "interstate commerce of a new drug."	May 1995 - Former FDA Chief Counsel Peter Barton Hutt states in an article in Reason Magazine, "If you beat the FDA in court, you have an angry FDA that is willing to slit your throat. When the FDA loses a case, it has a mind like an elephant. It's just something you've got to understand about the FDA. Once the agency makes a collective decision, trying to make it let go is almost impossible. These are FDA crusades -- in a real sense they are vendettas."
March 1996 - Taking advantage of the window of opportunity provided by Congressman Barton, Dr. Burzynski files some 60 new clinical trial protocols, greatly expanding his effort to receive FDA approval. September 1996 - Dr. B submits the brain scans of 29 of his clinical trial patients to review by a neuroradiologist at the famed Barrows Neurological Institute in Phoenix. The report finds 13 complete responses, 8 partial or initial responses, and 8 patients who did not respond. All patients were considered terminal when they began treatment with antineoplastons. Sept. 10, 1996 - Burzynski Clinical Trials Director Dean Mouscher requests a meeting with FDA to discuss the data generated by clinical trials, demonstrating that antineoplastons are safe and effective in the treatment of cancer.	Jan. 1996 - Government attorneys seek a court order to stop Dr. Burzynski from treating his patients who do not qualify for clinical trials, and calls any resulting harm to patients "irrelevant." Appalled, Congressman Barton calls another hearing on FDA Abuses of Authority. Under pressure from Mr. Barton, Commissioner Kessler agrees to permit Dr. Burzynski to continue treating his current patients, and to expand his current, limited clinical trials. April 1996 - FDA inspects Dr. B's mfg. facility, and finds that testing procedures it had recently approved are now "inadequate." Once again, FDA apparently tries to cut off the flow of new patients to strangle the clinic financially. In violation of its own rules (21 CFR 312.42 (c), which requires FDA to "attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing a clinical hold order"), FDA orders Dr. Burzynski to stop accepting new patients. Strangely, FDA rules that the treatment is safe for current patients, but unsafe for those who have not yet begun. When FDA had tried to cut off current patients in the past, the result was a massive public outcry and Congressional hearings. Many terminally-ill patients who had come to Houston for treatment are left stranded, and deteriorate rapidly. After Dr. Burzynski responds to all FDA's comments, and under pressure from Congress, FDA lifts the clinical hold on May 1, 1996. April 1996 - Present - FDA constantly issues new and arbitrary conditions which create difficulties for the clinic and patients. Sept. 15, 1996 - FDA answers Dean Mouscher's 9/15 letter and refuses to meet with Dr. Burzynski to discuss his proof that antineoplastons are safe and effective cancer drugs. FDA claims that it has never accepted data from a single investigator, although it knows there are many co-investigators in these trials. FDA also states that the cancer initiatives announced in March by Pres. Clinton, VP Gore and FDA Commissioner Kessler have changed nothing. Oct. 11, 1996 - Govt. lawyers file motions to keep all evidence of efficacy out of the upcoming trial (scheduled for Jan. 6, 1997). According to the govt., allowing jurors to see such evidence "is a thinly-veiled effort to expose the jury to the specter of Dr. Burzynski in the act of saving lives. Permitting it will certainly infect the jury's consideration of the real issues with irrelevant, emotional, prejudicial and misleading concerns regarding whether antineoplaston works and the unfortunate fate of Dr. Burzynski's patients."	March 1996 - FDA Commissioner Kessler appears at a White House press conference with Pres. Clinton and VP Gore to announce new, expedited approval procedures for promising cancer drugs.