10. TEXAS RAIDERS STRIKE AGAIN:
FDA AND POSTAL AGENTS
RAID BURZYNSKI CLINIC

From The Cancer Chronicles #27
© May 1995 by Ralph W. Moss, Ph.D.

On Friday, 3/24/95, the Burzynski Research Institute (BRI) in Houston, TX was raided by seven agents of the Food and Drug Administration (FDA) and the US Postal Service. The government agents herded BRI employees into a back room and then attempted to seize the medical records of 17 patients. Only 9 names corresponded to active Burzynski patients. The FDA also took the names and phone numbers of all current clinic patients.

Off the record, FDA employees have told us that such a raid had to have been planned far in advance. But, even so, it may have been triggered by two media events. In mid-March, Stanislaw R. Burzynski, MD, PhD, director of the clinic, had appeared on the "Eye on America" segment of the CBS Evening News. The response to this report was so overwhelming that Burzynski and three of his patients were asked to appear on the CBS This Morning show on March 24.

Dr. Burzynski spoke about his antineoplaston treatment for cancer, small peptides of natural origin that he says are part of a Biochemical Defense System in the body. The patients presented their compelling stories. Two had had non-Hodgkin's lymphoma and one had had brain cancer. All claimed to be in complete, long-term remission on the treatment and spoke forcefully and eloquently about their experiences. Ironically, in light of what was about to happen, Burzynski mentioned several times that he would treat free of charge patients who enrolled in his FDA-approved trials.

Millions of people saw this show, and the response was immediate, positive, and intense. There were over 2,000 phone calls to the Burzynski Research Institute (BRI) that day and on subsequent days. For a moment, it seemed as if the long, dark night of neglect of this remarkable work was over.

PREMATURE CELEBRATION: At post-broadcast celebrations, everyone agreed that the CBS shows had raised public awareness of Dr. B.'s concept of cancer therapy to a new level. At around 2 p.m., Dr. and Mrs. Burzynski got on a plane from New York to Houston.

Fifteen minutes after they were in the air, the FDA obtained a Search and Seizure Warrant from U.S. Magistrate Frances H. Stacy. Then, just past 5 p.m., after Dr. B.'s lawyer, Rick Jaffe, had left his office, the federal agents entered BRI's modern premises. Office manager Barbara Tomaszewski asked them to wait until she could contact Mr. Jaffe. But they told her that if she didn't allow them to search for the documents they wanted then they would do it by force.

In many ways, of course, the memory of the Jonathan Wright clinic raid on 5/6/92 hung over this action (CC #12). A surreptitiously taken videotape of the Wright raid has been shown all over the world. This time FDA refused to allow staff to take pictures of the action.

Also, they arrived after 5 p.m.: a midday raid of Burzynski in 1985 had led to patient outrage and the formation of a patient rights legal action fund to defend Dr. B. But this time they still took a nurse away from the cancer patient she was treating. They then systematically began their search and seizure operation, which continued until around 11:30 p.m.

What did they want? There is a 1983 consent decree that allows Burzynski to treat patients in Texas, but not to routinely ship medicines out of state. The main issue seemed to be the purported shipment of medicine across the Texas state line. We say "seems" since the charges have been sealed, and FDA representatives refuse to comment or meet with members of the Alternative Medicine Program Advisory Council (AMPAC).

Burzynski is adamant that he does not ship the medicines out-of-state without the explicit permission of FDA. There is a longstanding policy at BRI that any employee will be immediately terminated if he or she does so. Nevertheless, it is impossible to monitor the activities of every employee and every patient. ARRIVING HOME: Arriving home, Dr. B. was alerted to the raid in progress at his clinic.

Rushing there, he found it swarming with agents going through his papers and pecking away at his computers. They reluctantly allowed him to make copies of the files they were taking, because otherwise he could not treat his active patients. BRI's Custodian of Records was subpoenaed to testify on 4/17/95 before a Grand Jury investigating the case. Burzynski chose to boldly face his accusers, a decision which threw the federal attorneys' case off balance.

In addition, surgeons who have been doing emergency surgery for Burzynski's patients have also been subpoenaed before the grand jury and ordered to bring an enormous number of documents, including medical records and details of their medical practice. To us, this is clearly harassment—an attempt to isolate Burzynski, so that when his patients need emergency services, such as catheter placements, they won't be able to get them.

To add to the tension, after the raid BRI was under steady surveillance, with agents in unmarked cars recording the license plate numbers of people entering and leaving the Institute. Put mildly, this did not foster an atmosphere conducive to the healing of cancer! This is FDA mind-body medicine in reverse, with a devastating message of fear to any hapless patients who thought they heard a message of hope emanating from Houston.

CBS RESPONSE: Over that weekend, The Cancer Chronicles sent out the first of several memos to inform members of the Alternative Medicine Program Advisory Council (AMPAC), NIH officials, Congressmen, and other interested parties of the raid. On Tuesday, March 28, This Morning featured the Burzynski raid as its lead item, right after the regular morning news. Dr. B. and Rick Jaffe were interviewed by satellite, and they gave a mature and balanced presentation of the matter.This Morning's host said on the air that his staff would be keeping a very close watch on developments at the Burzynski clinic. Burzynski has also been interviewed by and may soon appear on ABC News Nightline.

The irony is that for several years Burzynski has enjoyed decent relations with the FDA in Washington. FDA has approved trials of antineoplastons not just at BRI but at Memorial Sloan-Kettering and the Mayo Clinic. Just days before the raid, the OAM's advisory council, AMPAC, held a meeting and heard a favorable presentation on Burzynski's work. A representative of FDA was at that meeting but there was absolutely no indication from her that FDA looked askance at BRI's conduct, or that there were violations that could not have been corrected by amicable means. The raid raises the disturbing possibility that someone on high wanted to wreck this relationship and make these scientific trials fail.

THREE THEORIES: The raid has been a public relations fiasco for the FDA. So why would it shoot itself in the foot like this? There are three theories we have heard for this turn of events:

The good ol' boy network. According to this theory, the FDA in Washington (including Commissioner David Kessler) knew nothing about the raid. It was engineered by a "good ol' boy" network of agents in Houston's FDA enforcement branch. These people are ignorant and/or contemptuous of the improved relations between the national FDA and alternative medicine, and vent their anger at what they stupidly think is the leading "quack" doctor in their midst.

In favor of this theory: mid-level government employees did seem to be taken by surprise by the raid; we have heard that The Cancer Chronicles fax was for many their first word of the event. On the other hand, it seems equally incredible that anyone would dare to take such an action without at least Dr. Kessler's tacit support.

Postal theory. According to this theory, the raid originated not with the FDA at all but with US Postal Inspectors, because of an alleged use of the mails to illegally ship antineoplastons out of state. A postal inspector did accompany the FDA agents on the raid. And one postal inspector allegedly told a Burzynski brain cancer patient that "we have better treatments for cancer" than antineoplastons!

"Given the difficulty of delivering a letter on time," Dean Mouscher, a BRI employee commented on Compuserve on 3/27/95, "one can understand why the post office prefers to tackle something easy like brain cancer."

Establishment theory. According to this view, the action had to come from the top, and is part of a long-time effort on the part of the cancer establishment, including Kessler, to "get" the innovative Texas physician. According to this theory, the raid was the response of quackbusters, in and out of government, who became panicked and outraged over the growing acceptance of Burzynski, and especially his CBS appearances.

This theory is supported by the precision timing of the action, as well as by the fact that another FDA action in 1993 also took place while Burzynski was away, in that case at an OAM meeting attended by FDA officials. Whatever the final explanation, the raid on Burzynski was a shot across the bow of the entire alternative health movement.

Burzynski patients have been contacted and harassed by FDA agents, apparently for nothing more than receiving and taking antineoplastons for their own use . One cancer patient has allegedly been threatened with a Grand Jury subpoena of his own. In New York, FDA agents came to a patient's house and demanded that his wife turn over medicines, which she refused to do. But with a complete list of Dr. B.'s patients, the FDA can now contact some very sick people and their family members and attempt to generate "evidence" to be used to put their physician out of business—or worse—in prison. As if having cancer weren't hard enough—patients now have to deal with vigilantes masquerading as health protectors!

Finally, in the midst of all this legal trouble, the NCI, FDA, and Memorial Sloan-Kettering Cancer Center (MSKCC) have taken an action almost certain to scuttle clinical trials of antineoplastons at MSKCC.

Together, they arbitrarily decided to change the terms under which Burzynski's medicines would be tested. Under a prior agreement with Burzynski, MSKCC was supposed to test antineoplastons in adults with brain tumors 5 centimeters (two inches) or smaller, and who did not have multiple tumors. Yet in two years, MSKCC has enrolled very few patients in this trial.

Then, without consulting Dr. Burzynski, Sloan-Kettering asked for and got permission from the FDA and NCI to test antineoplastons in patients with tumors of any size, with multiple tumors, with distant metastases, and with lower "Karnofsky" (performance) scores. A patient who has already failed to respond to surgery, radiation, and/or chemotherapy, who has numerous huge tumors, metastases in the liver and lungs, and a declining performance score can now be enrolled to "test" this gentle non-toxic treatment, whose protocol was designed to treat patients in earlier stages.

It is known to all that these antineoplastons, at the dosages given, almost certainly will not work in this situation. Patients will die. Nevertheless, its "failure" will be loudly announced to the public, most probably on national television, and will deal a heavy blow to this treatment and to alternative medicine in general. Some people apparently think this trick will dispose of Dr. Burzynski, leaving the field clear for any "genius" who wants to "discover" antineoplaston-like drugs.

Burzynski's case reminds us of the words of Bishop Martin Niemoeller, who failed to respond when others were persecuted by the fascists: "Then they came for me, but by that time no one was left to speak up."

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Ralph W. Moss, Ph.D. is the author of many books and three documentaries on cancer-related topics. Hehas been an advisor on alternative cancer treatments to the National Institutes of Health, Columbia University, and the University of Texas. He researches and writes reports on many different kinds of e with cancer. For information on Healing Choices, you can email your order to contact coordinator Anne Beattie @ 144 St. John's Place, Brooklyn, NY 11217; Phone 718-636-4433; Fax 718-636-0186.

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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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