13. A VISIT TO HOUSTON:
BURZYNSKI CONTINUES FIGHT
UNDER THE FDA GUN

From The Cancer Chronicles #32-#33
© June 1996 by Ralph W. Moss, Ph.D.


In mid-April, [1996] I travelled to Houston to interview Dr. Stanislaw R. Burzynski, MD, PhD, his attorney Richard Jaffe, and others involving in defending the innovative cancer doctor. On the day before I arrived, Dr. Burzynski —for the first time in his entire career—was forced to turn away cancer patients who arrived at his clinic for treatment.

This was my fourth visit to his clinic. This time I wanted to show solidarity with the patients and with the beleaguered researcher as much as to assess how the recent barrage of attacks has affected the Burzynski Research Institute. What I found was an amazing picture of fortitude in the face of unimaginable adversity. On a personal level, Dr. and Mrs. Burzynski seem to be holding up remarkably well, and going about their business, which happens to be treating people with cancer.

If the leaders of FDA and the US Attorney's office in Houston who dreamed up this latest attack thought their actions would cripple BRI, they were greatly mistaken. Public inquiries about antineoplaston treatment have never been higher (sometimes totalling an incredible 1,000 calls per day). People are beating down the doors to get in. BRI is advertising on the Internet for physicians and is adding a new production line at their giant Texas plant.

Think about this for a minute: the government announces that it has indicted a doctor on 75 counts of fraud. Does the public run in the opposite direction? Absolutely not. There is instead a tremendous increase in patient, public and media interest and sympathy for the beleaguered physician. This one fact speaks volumes about what the average American thinks of the cancer-related information emanating from agencies of the US government.Common sense tells us that Burzynski is a legitimate and innovative scientist, not a fraud.

First, it is now well known that in 1991 NCI sent hand-picked scientists to investigate Burzynski's work. They only had time to look at six cases, but they concluded that antineoplastons actually caused regressions in these six.

Second, Burzynski himself pleads for his methods to be evaluated by independent scientists. He came before the Office of Alternative Medicine's advisory board and offered to have OAM independently review every case coming into his office for a full year. He found no takers.

Third, nearly a dozen top US medical centers are now investigating through clinical trials a substance called phenylacetate. Phenylacetate is the main ingredient in Burzynski's compound, antineoplaston AS2-1. And the erstwhile NCI scientist who developed this treatment learned about it in Texas at Dr. Burzynski's feet.

My visit to BRI left me tremendously concerned for the future of this embattled institution, and for this country as well. Dr. Burzynski's cause is our cause. We simply cannot allow him to be destroyed. If cancer patients, well-meaning doctors and supporters let the federal government annihilate Dr. Burzynski and his treatment, it will be a loss for all future generations.

UPDATE ON CASE (1996): Confused about developments in Houston? Join the crowd. The last few months have witnessed a bizarre tangle of actions, attacks, motions and countermotions; and the trial hasn't even begun! Here is a quick chronological summary of developments in the case through the first half of 1996. (More details can be found at BRIs Internet site http://catalog.com/bri/bri.htm.).

Feb. 9: US District Court Judge Sim Lake rules that Dr. Burzynski cannot treat patients outside of clinical trials. Then, probably because he recognizes the harm this would cause patients, he stays his own order, so that it does not immediately go into effect. Burzynski files four new "treatment use INDs" (Investigational New Drug applications) with the FDA. This is to enable him to treat most patients.

Feb. 23: The FDA informs Burzynski that his request for "treatment use INDs" has been refused. But after pressure from Congress ( especially Rep. Joe Barton, R-TX), FDA agrees to allow Burzynski to enroll most of his current patients in a catch-all clinical trial, "CAN-1." This covers patients who began treatment before Feb. 23.

Feb. 27: Lake extends his stay until noon, March 27, 1996 on condition that Burzynski appeals his ruling to the 5th Circuit Court of Appeals. Burzynski files his appeal.

February 29 to March 25: Burzynski, working frantically, files 60 new clinical trial protocols with the FDA. If approved, these would create 60 new clinical trials into which most of Dr. Burzynski's patients could be enrolled. Dr. Burzynski would be able to continue treating most current and future patients.

March 12: FDA responds to Burzynski's request for permission to charge clinical trial patients to at least recover the cost of manufacturing antineoplastons. Such permission is necessary because Burzynski receives no outside funding. Janet Woodcock, MD, of FDA says that before they will consider such a request, Burzynski must submit detailed records of every payment ever made by his patients—more than 2,500 over the past 18 years.

March 26: More than 20 of Burzynski's patients hold a press conference in Washington, DC the day before Judge Lake's order is to go into effect, cutting off 120 patients from antineoplaston treatment. (The FDA still has not responded to the 60 new protocols.)

March 27: At the 11th hour, Judge Lake extends his own stay until the Fifth Circuit rules on Burzynski's appeal. As a result of this "stay of execution," Burzynski may continue to treat his patients as before.

March 28: FDA inspectors arrive at Burzynski's manufacturing facility for a "routine" inspection. Previously, the huge and modern facility had exceeded Current Good Manufacturing Practices standards. This time, inspectors claim to find several deficiencies. These include a failure to sample and test incoming plastic IV bags for microbiological contamination, and to maintain Certificates of Analysis from the supplier, Abbot Labs, certifying sterility of each batch received. Burzynski asks Abbot for this and Abbot replies that this documentation was already on file with the FDA; they do not provide such a certificate for any of their other customers.

FDA also attacks the pyrogen-testing procedure (pyrogens are impurities that can cause fever). But the procedure Burzynski uses was approved by the FDA during several inspections, most recently August, 1993. FDA also demands testing of certain reference media. But again when Burzynski tells the supply company (Associates of Cape Cod, Inc.) of FDA's comment, it writes back: "We do the standardization in-house and provide our customers with a Certificate of Analysis which is recognized and accepted by FDA." Clearly, whole new standards are being created for Burzynski.

March 29: The White House and FDA Commissioner David Kessler announce sweeping changes designed to hasten the approval of new anticancer drugs, and promise expanded access to same for cancer patients.

April 10: FDA puts all clinical trials of antineoplastons on "partial hold," citing the inspection report. It is "partial" since Dr. Burzynski may continue to treat current patients, but for the second time, they say he may not accept new patients. FDA agrees that Burzynski has responded to all its comments in the inspection report, but insists that the hold is necessary until a re-inspection can be performed. In so doing, FDA seems to violate its own rules: Code of Federal Regulations 21 CFR 312.42 subsection (c) states that FDA will attempt to "discuss and satisfactorily resolve" the matter with the sponsor before issuing the clinical hold order.

BRI spokespersons point that out there has never been an incident of contamination of antineoplastons, and in fact FDA found no trace of contamination during its inspections. Yet in effect FDA is telling Dr. Burzynski's patients that antineoplastons present a more "immediate and serious risk" than their own fast-growing tumors — but only if they began treatment after April 10. Besieged by desperate patients and their families, Burzynski continues to accept some new patients, but cannot put them in clinical trials — slowing the approval and widespread availability of antineoplastons.

April 15: The Fifth Circuit Court of Appeals affirms Judge Lake's order forbidding Burzynski from treating patients outside of clinical trials. The stay is vacated. Dr. Burzynski now faces prison if he treats patients outside of the clinical trials. He must cut off treatment to patients who began after April 10 (the cut-off date of FDA's "partial hold") and to those who do not qualify for any clinical trial and began treatment after February 23 — in all, about 20 patients. He will also have to turn away more than 100 very advanced cancer patients scheduled to begin treatment over the next month. The Burzynski clinic asks FDA's Chief of Oncology, Dr. Robert DeLap, if he would at least extend the cut-off date to April 15 so that existing patients would not be cut off. DeLap refuses.

April 16: For the first time since opening his practice in 1977, Dr. Burzynski is forced to turn away cancer patients who have arrived at his clinic for treatment. Many have fast-growing tumors including glioblastoma multiforme — a brain cancer so aggressive it can double in size every ten days. "These patients do not agree with FDA that the minuscule, theoretical risk of undetected pyrogens is a greater threat than their untreated cancers," says BRI's Dean Mouscher. "But they are powerless. It is difficult to describe their anguish, and that of their families."

April 25: Patient P.G., battling breast cancer that has metastasized to her brain, is admitted to the hospital. She arrives after the FDA hold is imposed, and has been waiting for treatment. In a separate action, Anthony DeCicco of the FDA's Division of Antiviral Drugs telephones Dr. Burzynski to tell him that he must stop treating his HIV patients. Dr. Burzynski reminds him in writing that this action directly violates promises by high FDA officials, including Commissioner Kessler, that FDA would not interrupt the treatment of any patient who began before February 23.

April 29: FDA inspectors arrive at the manufacturing facility for re-inspection. They remain till May 1.

May 1: The inspection finishes at 11:00 AM. Late that afternoon, word comes from Washington that Burzynski may once again accept new patients. For the patient in the hospital who is now close to death, it comes too late.

May 9: FDA sends a letter with "comments" on 12 more of the clinical trials Dr. Burzynski is conducting. Many of the comments concern a clinical trial of rare brain tumors in children such as rhabdoid tumor of the brain, the most aggressive of all childhood cancers. Conventional therapy is useless against it. Burzynski is currently treating two children suffering from rhabdoid brain tumors. Dr. Burzynski has evidence of success against this type of tumor. But FDA informs Burzynski that he must stop accepting new rhabdoid tumor patients for treatment because this tumor is so rare that "it is unlikely that this trial will generate any useful scientific data."

And so it goes...More documentation is available from BRI detailing the struggle. A nationally-renowned cameraman, has put together a videotape chronicling patients' struggle with FDA for the right to treatment of their choice. For information, call (214) 707-4907.


Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.



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