1. Early Victory (1989)
2. Dr. B. Faces U.S. Probe (1990)
3. Trials and Tribulations (1992)
4. A Letter to Morales (1992)
5. A Patient's Son Speaks Out (1993)
6. Interview with an Orthodox Nurse (1993)
   Rep. Porter Speaks Out (1993)
7. Grand Jury on the Move (1994)
8. NCI Director Fails to Credit Dr. B. (1994)
9. Texas Raiders (1995)
10. Judge Restores Licens (1995)
11. Lesson from the Past (1995)
12. A Visit to Houston (1996)

Stanislaw R. Burzynski, M.D., Ph.D. of Houston has won an important round in his battle against the Aetna Life Insurance Company. An Illinois judge has ruled that Aetna's attorneys overstepped their bounds by seeking confidential records of patients from other insurers. He ordered them to pay over $11,000 in legal fees to Abady and Jaffe, the New York law firm that represents the Houston doctor.

Aetna had originally sought such records as part of its $600,000 RICO (Racketeering Influenced and Corruption Organizations Act) suit against Burzynski, the discoverer of antineoplastons. The Wall Street Journal recently called the RICO act "a horror" and a "Frankenstein's monster," adding, "Only Congress has the power to kill the creature" (November 15, 1989).

If Aetna wins, it can collect three times this amount, plus legal costs, effectively putting the clinic out of business. Grace Monaco is Aetna's consultant on the case.

The present suit arose when the court twice refused to allow Aetna's attorneys to see complete medical records of patients covered by other companies. It did allow them to see some such records, provided that all private information was deleted.

Frustrated by these restrictions, Aetna's attorneys "decided that it was perfectly okay to go to these insurance companies directly...and seek information from them," in the words of U.S. District Judge Michael Mihm. Aetna's attorneys, Hinshaw and Culbertson, had a Springfield, Illinois clerk send subpoenas to fellow insurance companies.

"It's a little hard for me to understand why legal issues would be assigned to secretaries and clerks," the judge stated in his decision, October 13, 1989.

The other insurance companies thought they were facing "an official mandate of the Court," said the judge. The result was that the attorneys received private records of Dr. Burzynski's patients in disregard not just of the judge's orders but of confidentiality. "I'm very troubled" by this situation, the judge told the lawyers in a phone conference, calling their indifference to his order "almost unconscionable."

Judge Mihm did not disqualify Aetna's attorneys from the case. But he ordered them to pay Abady and Jaffe's fees in connection with this complaint. He also barred Aetna from any use of this information and ordered the data segregated. Judge Mihm's decision is the latest slap at the attorneys of the billion dollar company.

[INTERESTING IN THE LIGHT OF WHAT WAS TO COME--ED]

On July 2, [1990] Stanislaw Burzynski, MD, PhD, developer of antineoplastons, was called before the federal Grand Jury to answer questions about alleged "mail fraud." "The investigation is centered not on the treatment's efficacy but on how insurance is billed by Dr. Burzynski's staff," according to Le Trombetta, director of public information for the Burzynski Research Institute. It now appears the Grand Jury will actually indict "Dr. B." The Polish-born scientist is already fighting a "racketeering" (RICO) suit brought by the gigantic Aetna insurance company.

Antineoplastons are naturally occurring peptides (small proteins) found in human blood and urine. Burzynski has used them to treat cancer since 1977. In March, 1983 the FDA filed a lawsuit against him, alleging interstate shipment of medicine. But U.S. District Court Judge McDonald ruled that Federal law did not prohibit Burzynski from treating patients with antineoplastons within Texas altough he could not ship them across state lines.

This was a setback for the FDA; soon another government agency, the US Attorneys office, began a Grand Jury investigation. After some early activity this investigation died down.

"In the meantime," says Trombetta, "in 1986, one of Dr. Burzynski's patients sued their insurance company, Aetna, for payment of treatment. Dr. Burzynski joined the suit and was then countersued by Aetna and charged with racketeering."

On April 6 of this year Dr. B's lawyer moved to have Aetna's RICO case dismissed. It was at this point that the Grand Jury investigation suddenly became active again. "We have reason to suspect that Aetna has conspired with the government in the current action against Dr. Burzynski," Trombetta said.

In June, Burzynski's attorneys, Abady & Jaffe, fought back with a racketeering charge against Aetna, and "quackbuster" Grace Powers Monaco, who has served as Aetna's consultant on their suit. They are hoping that others who have been denied payments by the giant company will join the suit.

The same US Attorney, Henry Oncken, who brought the case against Dr. B. was himself recently forced to resign because of his role in the growing savings and loan (S & L) scandal. Eleven Houston attorneys sent a letter to Sen. Phil Gramm complaining that Oncken was soft on big-time criminals. "There seems so little being done to punish these mega-buck bandits," they wrote. But his office made sure to subpoena Dr. B. the day before Oncken was forced out.

This trouble comes as Burzynski's scientific star is rising. The International Journal of Tissue Reactions published a special supplement on "Antineoplastons: Tissue Culture and Chemoprevention Studies". This peer-reviewed journal has an editorial board with respected scientists from over a dozen countries. The editor, A. Bertelli of Milan, has himself studied antineoplaston A10. He observed "significant growth inhibition" on a human colon adenocarcinoma cell line with no major side effects at all but the highest concentrations.

There is now intense interest in antineoplastons in Japan, China, Italy, Poland, and other countries. Dr. B. was recently featured in a highly favorable article in Oncology News, sponsored by Adria Laboratories.

In May a Houston federal judge ordered Trans–america Occidental Life Insurance Co. to pay medical bills for a patient who received antineoplastons. The patient benefited from the treatment, according to her attorney, but died when she "stopped the treatment after she and her husband sold their house to pay medical bills." The judge ruled that her bills were covered because "they involved medical services made by a licensed physician."

The establishment is not trying to put Dr. B. out of business for being a charlatan, but precisely because he is one of the most respected doctors in the alternative field. He is the one who publishes most regularly in the peer-reviewed literature and doggedly fights for FDA approval. This shows that the quackbusters demand for peer-reviewed studies is a "red herring": when you do publish, they go after you with double force....

In October, the National Cancer Institute (NCI) is scheduled to conduct clinical trials with Dr. S. R. Burzynski's antineoplastons. Antineoplastons are peptides which Burzynski claims constitute a biochemical defense system in the body. NCI has announced that several medical institutions will take part in the trial. Impetus came from an NCI trip last fall, in which site visitors concluded that Burzynski's treatment had indeed successfully shrunk 7 cases of brain tumor.

"We are trying to ascertain in a scientific way," NCI said, "the real value of antineoplastons. Are they of benefit to cancer patients?" There will be 4 independent trials, each involving 25–30 people with different types of brain tumors.

AETNA FIZZLES: In late March, Aetna's five year suit against Burzynski was thrown out of court. This fierce struggle with the insurance giant began in 1986 when the husband of a Burzynski patient sued Aetna for payment of treatment. When Burzynski joined the suit, he was promptly countersued by Aetna for...racketeering!

The fight was bitter and very expensive. When "Dr. B." as he is called got permission in 1989 to test his compounds in people, Aetna asked FDA to revoke this hard-won IND. Aetna also allegedly sent a mass mailing to fellow insurance companies, asking them to no longer reimburse Burzynski's patients.

On March 31, US District Court Judge Kenneth Hoyt threw out Aetna's suit, and simultaneously the patient's original claim.

EMPRISE SURPRISE: When this newsletter began publishing, the most ominous cloud on the horizon was Emprise, Inc., an organization headed by Grace Powers Monaco, Esq., a Washington attorney, who not only aided Aetna in its Burzynski suit but won an NCI grant to compile a data base on `questionable' therapies. After running into a wall of opposition from health activists, and the imminent failure of the Aetna suit, Emprise folded. This spring Monaco announced that Emprise had dissolved last December. Monaco says she has "semi-retired from the practice of law" and is merely consulting on cancer prevention. She remains affiliated with the Candlelighters Childhood Cancer Foundation.

THE JAMA GAME: On June 3, 1992, the Journal of the American Medical Association launched a full-scale attack with an article on Burzynski by Saul Green, PhD, entitled "Antineoplastons—An Unproved Cancer Therapy." JAMA didn't mention that Green was scientific director of Emprise, involved in the Aetna suit. Burzynski has submitted a rebuttal to JAMA with 137 references. [THEY NEVER PUBLISHED IT, ED.]

On Wednesday, September 16, 1992, the following resolution was introduced by Ralph W. Moss, PhD, editor of this newsletter, at a special forum immediately after the NIH meeting [the "Chantilly meeting that effectively launched the Office of Alternative Medicine, ed.].

The resolution was seconded by Dr. Carlton Hazelwood, a professor at the Baylor College of Medicine, and approved unanimously by over 100 attendees at the NIH meeting:

"We, the individual members of the assembled Advisory Committee of the office of alternative medicine within the National Institutes of Health (NIH), call on you, the Attorney General of the state of Texas, to suspend all legal actions now underway by the state of Texas and the Texas

Medical Licensure Board while the NIH is conducting the scientific evaluation of the antineoplaston therapy of Stanislaw Burzynski, MD, PhD."

Dean Mouscher (Compuserve's Cancer Forum, CIS #70401,1236) spent many months searching for a treatment for his father's brain cancer. He finally settled on Dr. Stanislaw Burzynski's peptide treatment, antineoplastons. In November, Dean sent this letter to Texas Attorney General Dan Morales, who in engaged in efforts threatening to take away Dr. Burzynski's medical license. In early January, the elder Mouscher's exam again showed that his tumors had stopped growing and had shrunk a little, and his neurological functioning was better.

I understand that you are currently engaged in efforts to prevent Dr. Burzynski in Houston from practicing medicine. I understand and appreciate your desire to protect the public from fraud and I am certain you would be interested in hearing any valid information about him.

I investigated Dr. Burzynski for my father, who is suffering from glioblastoma multiforme, a viciously aggressive brain tumor that rarely responds to radiation or chemotherapy, and then only briefly. It is basically a death sentence....[I spoke to] Dr. Patronas, an NCI neuroradiologist with 20 years experience, whose knowledge of Dr. Burzynski came not from rumors but from a site visit during which he audited a number of cases. He told me that he believes in Burzynski's results, that he found the evidence "extremely impressive," and that "in 20 years in this business I haven't seen anything that looks so promising."

But the most impressive evidence...is my father himself. A scan taken on 11/9/92 shows that the tumors have stopped growing and that there is some necrosis [tissue death] within two of the three tumors. That is the opinion not only of Dr. Burzynski, but also of Dr. Michael Gorey, the radiologist at Evanston Hospital here. And in fact, my father's neurological condition—which had been declining rapidly—seems little changed since he began taking Dr. Burzynski's antineoplastons.

I would be happy to send the radiology reports at your request. I know that many in the medical establishment are hostile to Dr. Burzynski. We should keep in mind how often the medical establishment has been proven wrong....Mr. Morales, I am sure that you have only the public's interest at heart. I urge you to consider the possibility that Dr. Burzynski's treatment is in fact saving lives.

I urge you to keep in mind the very real possibility that had your efforts to prevent him from treating patients succeeded, my father might be dead...."

Dean Mouscher also posted the following conversation he had with a "protocol nurse" about another treatment, called TRA, coincidentally developed in Houston.

Dean: What have your results been with TRA?

Nurse: We don't know yet, we've been doing it for too short a time and the results haven't been tabulated.

Dean: How long have you been doing it?

Nurse: A year.

Dean: Is that too short a time to get a feel for whether it's working or not? These tumors progress pretty quickly. I would think a year would be enough to see if you had any results or not.

Nurse: Well, like I told you, the results haven't been tabulated yet, so we don't know if it represents an improvement or not.

Dean: There haven't been any spectacular results?

Nurse (defensively): No, no spectacular results, but it hasn't worked any worse than anything else.

[Dean adds: That's easy to believe, since everything else is essentially useless. ]

Dean: Have you heard of a guy by the name of Burzynski who apparently practices in Houston?

Nurse: Hah! He's a quack.

Dean: Why do you say that?

Nurse (slightly stunned and offended that he questioned her blanket statement): Well, I told you he's from Houston, and everybody around here pretty much accepts that he's a quack. He derives his treatment from urine.

Dean adds: I couldn't help shaking my head again at this very interesting mentality. Even if Burzynski never cured anyone, why is he any more of a quack than they are? After all, they themselves have never been able to help anyone with a glioblastoma multiforme. And yet they're so self-important with their little projects, spending years and who knows how much money seeing if new drug XYZ prolongs survival from 4.3 to 4.7 months."

Last April [1992], Rep. John E. Porter (R-IL) sent the following letter to Texas Governor Ann Richards, concerning the case of Dr. S.R. Burzynski...

"I am writing to convey my concern over the Texas Department of Health's attempt to prevent the Burzynski Research Institute (BRI) from using antineoplastons on its patients. The Texas Medical Practices Act recognized an appropriate role of experimental drugs and drug combinations in the treatment of terminal diseases.

"Section 5.09 of this Act states: `a physician licensed to practice medicine under this Act may supply patients with any drugs, remedies, or clinical supplies as are necessary to meet the patients' immediate needs.' Seeking a permanent injunction against BRI's antineoplaston therapy is in direct conflict with this provision.

"Prominent oncologists at leading cancer centers across the country have examined the records of BRI's patients and acknowledge that the antineoplaston therapy is having beneficial effects. If successful in its lawsuit against BRI, the state of Texas will deny these patients the only treatment which as having any positive effect. In my opinion, this would be a tragedy."

"While still experimental, antineoplastons are poised to enter the FDA approval process. I urge you to delay any further action against BRI..."

On March 10, Stanislaw R. Burzynski, MD, PhD, won a major victory in his battle to keep practicing medicine in the state of Texas. An administrative law judge ruled that the former Baylor College of Medicine researcher can continue to treat cancer and AIDS patients in his Houston clinic with his new class of non-toxic medicines called antineoplastons. This ruling came despite another Texas law that supposedly prohibits people from distributing or prescribing drugs that have not yet been approved by the FDA. The judge's ruling had been requested by the State Board of Medical Examiners.

But Judge Earl A. Corbitt upset their plans. He ruled that the Texas Medical Practices Act allows physicians to prescribe "any drug" to minister to the immediate needs of their patients. This right, he said, takes precedence over the general provisions of the Texas Food, Drug and Cosmetics Act, which allegedly make it a crime to manufacture, distribute, or prescribe drugs not approved by the FDA. "The decision," says Dr. B.'s victorious attorney, Richard Jaffe, "strikes a significant blow for freedom of choice." Corbitt's decision will stand unless the board changes it for matters of policy.

"The decision is life-saving for many of Dr. Burzynski's advanced cancer and AIDS patients," said Jaffe. "But it is also an important precedent for all complementary health practitioners who use treatments and supplements that have not yet received FDA approval."

BURZYNSKI TO BE INDICTED? The ink was hardly dry on this historic ruling, however, when the U.S. Attorney's office in Houston stepped up its harassment. There is a real possibility that Burzynski will be indicted by the U.S. government in the near future.

For almost 10 years, Burzynski has been investigated by various U.S. Attorneys and Grand Juries in Houston.  Their presumption has been that he defrauds insurance companies by inducing their clients to take a useless cancer remedy. In addition, they allege that he ships his medicines across state lines, in contravention of FDA regulations.

Over the years, at least five different Grand Juries, three consecutive U.S. attorneys, and five assistant U.S. attorneys have been involved in this vendetta. Burzynski employees and family members have repeatedly been called to testify. Dr. B. himself has been called twice. Yet these investigators have never been successful, except in wasting time and energy. In fact, after Burzynski testified three years ago, the result was not an indictment, but a pink slip for U.S. Assistant Attorney, Philip Hilder.

During Easter/Passover week this year, however, there was stepped-up activity. "What is going on now seems to be a desperate last ditch effort to produce an indictment," says the Houston attorney. Numerous current and former employees are again being subpoenaed to testify.

A USELESS REMEDY? Are antineoplastons really a "useless cancer remedy"? Not according to NCI, which conducted a site visit in 9/91 that validated the effectiveness of these drugs in some cases. In fact, the OAM/NIH has now arranged for clinical trials at Sloan-Kettering, the Mayo Clinic, and NCI itself. And not according to hundreds of Dr. B's devoted patients.

It is also well known that Burzynski has a strict company policy that prohibits the shipment of antineoplastons across state lines. However, cancer and AIDS patients are legally allowed to take home a three months' supply of medicine for their own use, and frequently do so. Word about antineoplastons is spreading in this way.

In late April, the U.S. Attorney's office launched an attack on one of Dr. B's most prominent local supporters, the Harris County Attorney, Mike Driscoll, who is also a board member of the Burzynski Research Institute. Burzynski had treated Driscoll's wife, Betty Rose, who had cancer. The Grand Jury subpoenaed copies of the last 10 years of Driscoll's campaign records, which showed that Dr. B. made donations of about $1,000 per year to Driscoll's campaign. There was no crime or impropriety in this, however.

"Many folks on the local political scene are well aware of Driscoll's devotion to his late wife during her illness," wrote the Houston Business Journal, "and his appreciation for Dr. Burzynski's efforts to save her." It called the attempt to insinuate corruption "ham-handed" (4/2). In fact, these reports are part of the public records and can be readily obtained by anyone, according to the Houston Post (4/20). So why all the grandstanding? Driscoll believes it is "to discredit him in connection with grand jury testimony about Dr. Burzynski."

According to attorney Jaffe "Several grand jurors asked him what he thought of Burzynski, and why. He told them that he basically believes Dr. Burzynski is helping people, saving lives, and was a good man" (Houston Insider, 4/20/94).

In the 1980s, the Aetna Insurance Co. sued Burzynski for fraud. This case was eventually thrown out of court, but not before Burzynski countersued for over $100 million. That suit is still alive. Some observers believe that Aetna is behind the investigation. At the very least, Aetna would be the main beneficiary of the indictment. In fact, the government's case against Burzynski is virtually identical to the old Aetna suit.

SETTING THE RECORD STRAIGHT:
NCI DIRECTOR FAILS TO CREDIT BURZYNSKI'S DISCOVERY

But the whole story is not told in Dr. Broder's article. For he fails to mention the fact that in part this new treatment is based on the life work of an unconventional Houston physician, Stanislaw R. Burzynski, MD, PhD.

The article in question appeared June 3 in the Journal of the American Medical Association (1994; 271:1693-1695). It was co-authored by the NCI director and his colleague, Judith E. Karp, MD. They reviewed some recent progress in controlling the expression of so-called ras-oncogenes (growth-regulating genes) and "ras-encoded proteins" in influencing the outcome of various human cancer. Ras genes, similar to animal viruses, were first discovered in human cancers in 1982 (Der CJ et al. PNAS 1982;79:3637). This is widely considered a major breakthrough in understanding the genetics of cancer.

Ras oncogenes make some of the proteins that are responsible for regulating the health and appearance of the proteins that are found on the surfaces of cells. When these genes mutate, and their protein products become abnormal (become "overexpressed or deranged" is the technical terminology), they can "serve as critical driving forces in the evolution of many...cancers," wrote Drs. Karp and Broder.

By blocking such cell-surface changes, scientists hope to "provide a powerful molecular target for therapy and prevention of a broad spectrum of malignant neoplasms." including those of the colon, pancreas, prostate, bladder, lung, brain, and possibly also breast cancer. A TALE OF THREE AGENTS: The NCI scientists then cite three new investigational agents that seem able to help preserve normal cell membrane structures and functions. These thre eare the common anti-cholesterol drug, lovastatin; limonene (or common citrus oil, found in lemons, dill, etc.); and something called phenylacetate. We needn't discuss the first two here. The third, phenylacetate, targets a particular site on the cell surface, the scientists write, and thereby inhibits ras-driven cancerous cell growth. In addition, it "could theoretically exert an antitumor effect, even in the absence of ras abnormality." It should be noted that of the three agents, only phenylacetate naturally occurs in the human body; the other two are foreign substances.

"Some of these approaches," Drs. Broder and Karp say, "could yield new cancer prevention strategies.... These agents are presently in clinical development for prostate cancer and glioblastoma multiforme" and "several important clinical studies are under way."

A quick check of the footnotes reveals that some of the work in question is being done by Dvorit Samid, PhD, herself presently at NCI (J Clin Invest 1993; 91:2288-2295). Dr. Samid is currently involved in the NCI clinical trial of phenylacetate as a new treatment for brain cancer.

SEPARATING THE MEDICINE FROM THE MAN: This article immediately set off bells in the alternative community. With the oblique reference to Dr. Samid, Drs. Karp and Broder reveal the hidden sources of their ideas. For this work on phenylacetate is derived from the work of the beleaguered Dr. Burzynski. Yet there is no mention of Burzynski in Broder's account.

The real story is this: In 1988, at the urging of a prominent cancer activist named Bob DeBragga, Dr. Samid began investigating the work of Dr. Burzynski, who was one of DeBragga's doctors. Samid was then of the Uniformed Services University of Health in Bethesda, MD. She began to experiment with synthetic analogs of the urine-derived antineoplastons, and particularly with the one called AS2-1.

In Oncology News (7-8/90), she is quoted as saying, "AS2-1 profoundly inhibits oncogene expression and the proliferation of malignant cells without exhibiting any toxicity toward normal cells...The Antineoplaston[s] can actually induce terminal differentiation [i.e., reversing malignancy]....Such a dramatic phenomenon is seldom seen." Phenylacetate, as she learned from Dr. Burzynski, is the main ingredient of AS2-1. While her earlier articles bore no mention of this intellectual debt, in her most recent paper, she says, she is able to credit Burzynski as a source of her work.

"Basically," Burzynski says, "through the elucidation of the mechanism of action of ras-oncogenes, my theory of the Biochemical Defense System has been proven, as far as the first ingredient, phenylacetate, is concerned. The human body can defend itself against cancerous growth by using this body substance, phenylacetate, which interferes with the information processing in ras-oncogene pathways."

Ironically, Burzynski remains under fierce attack by state regulators, especially the Texas Board of Medical Examiners. Broder could greatly help the situation by properly acknowledging the parentage of his own ideas. Cancer history is replete with examples of ideas taken, unacknowledged, from unconventional scientists. The cases of Beard, Gerson, and Ivy come to mind. We would hate to think that this article by Drs. Broder and Karp is yet another `rip off' of an alternative pioneer by the cancer establishment. At NCI, this process is sometimes euphemistically called "separating the medicine from the man." Rest assured: the alternative health movement will never stand for this, and is in a position today to fight so that simple justice is done.

---

TEXAS RAIDERS STRIKE AGAIN
FDA AND POSTAL AGENTS
RAID BURZYNSKI CLINIC

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 memosto 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."

Dr. Stanislaw R. Burzynski, the controversial Houston, TX cancer doctor, has won a major political struggle against the Texas State Board of Medical Examiners (TSBME). On Friday, February 3, 1995, an Austin judge ruled that Burzynski, one of the country's leading alternative doctors, could continue to practice medicine in the state. This came as welcome news to the staff of the Institute, as well as to more than 200 people with cancer and AIDS who believe their lives depend on their continued access to antineoplastons.

Burzynski discovered these natural, non-toxic peptides in Poland more than two decades ago. They are currently under examination worldwide, including at the NCI, MSKCC, and the Mayo Clinic.The TSBME initiated this action several years ago, when it charged Dr. B with violating Texas law by treating patients with drugs that are not approved by the U.S. Food and Drug Administration (FDA).

Burzynski replied that Section 5.09 of the Texas Medical Practices act authorized him to treat patients with any necessary drugs. The law reads that "a physician licensed to practice medicine under this Act may supply patients with any drugs, remedies or clinical supplies as are necessary to meet the patients' immediate needs." Back in May 1993, a two-day hearing was held before an administrative law judge, Earl Corbitt. His ruling was to serve as a recommendation to the TSBME. Corbitt eventually ruled that antineoplastons were indeed necessary to meet the patients' immediate needs for survival. He received testimony from Dr. Nicholas Patronas, the chief of Neuroradiology at NCI, who led a site visit for the government in which it was concluded that Burzynski's treatment was in fact effective in the treatment of some cases of brain cancer. He also heard from several patients who claimed to have greatly benefitted from the nontoxic peptide treatment. Corbitt concluded that the State had not offered any evidence to the contrary.

In August, 1994, however, the TSBME met again and emphatically rejected Judge Corbitt's decision. Astonishingly, they ruled that the mere survival of patients did not qualify as an "immediate need" under the law. Therefore, according to the Board, Dr. B. had been breaking the law by giving this treatment to his patients outside the context of FDA trials. In a decision that outraged defenders around the world, the Texas Board put this innovative researcher on probation for 10 years. This was a sword of Damocles over his head and that of hundreds of anxious patients.

Dr. Burzynski, through his veteran lawyer, Richard Jaffe, appealed the Board's decision to Texas District Court Judge Paul Davis. They expected a long and drawn out struggle. Thus, even his most ardent supporters were surprised when Judge Davis ruled from the bench (i.e., immediately) to reverse the Board's decision. He called their decision:

"In excess of the agency's statutory authority, not reasonably supported by substantial evidence, capricious or arbitary, and characterized by abuse of discretion."

It is now up to the Texas medical board to decide whether or not it will appeal this stinging rebuke. If they do, as now seems likely, Burzynski supporters say they are likely to be dealt an even more definitive rejection of the notion that Texas patients are too stupid to make their own choices in cancer care.

In September, 1991, NCI sent a team of site visit team to Dr. Burzynski's clinic in Houston. After reviewing six cases, they concluded that his results in brain cancer were as good as any they had seen in 20 years.I remember thinking at the time, "Now it's gonna hit the fan." I knew that such validation would result in a furious counterattack. And within months there was was an intensification of attacks in the Journal of the American Medical Association, and elsewhere.

Real cancer quacks are self-defeating. Their unethical behavior refutes whatever good results they may obtain by their sheer temerity. By contrast, it has been Dr. Burzynski's insistence on an objective test of his compounds and concepts (while he continues to treat patients) that has gotten him into all this trouble. Sensing this, I called the chapter on him in The Cancer Industry (1989) "the fiercest battle."

It is his insistence of doing things the scientific way that has made him the flashpoint for the whole cancer war. That is why the enemies of alternative medicine are fighting so fiercely to destroy him, regardless of the deadly effects on 300 cancer patients today, and the immeasurable harm to the patients of tomorrow.

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.

EDITORIAL: AGAIN, DEFEND BURZYNSKI!

I recently flew to Houston to have a first-hand look at what this persecution is doing to the Burzynski Research Institute. I met with Dr. and Mrs. Burzynski, with patients, and with his attorney, Rick Jaffe. What I saw left me frightened.

You cannot help but be inspired by Dr. B. He is like that indomitable bird, the storm petrel. It soars above the waves, deriving an inexhaustible source of energy from the turbulence it finds beneath its wings.So Burzynski goes on, day by day, treating his patients, trying to do some good in the face of his implacable enemies—cancer and some agencies of the federal government.

I have always enjoyed talking science with Dr. Burzynski. Now it is a bittersweet experience. We discuss the relationship of ras oncogenes and methylation. Yet there is a sadness: all these potential breakthroughs will be moot if Dr. B. winds up in an orange jumpsuit. Not much biomedical science gets done in prison.

I came away from Houston in a state of muted alarm. I believe the situation is much worse than most of us imagined. We have naively assumed that someone (A reporter? A Congressman? The President?) would expose, and thereby put an end to, this outrage. But there are people in the FDA and the Houston US Attorney's office who are dead set on putting Burzynski away for a good long time. The judge seems hostile and eagerly subscribes to the government's flimsy arguments.So forget the Hippocratic oath, the Helsinki Declaration or freedom of choice. And never mind whether Dr. B. has really helped people! This is what the war on cancer really comes down to—a war by our government on the most promising non-toxic treatments.

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.

home | ralph's bio | moss reports list | order a report | phone consultations
special reports | subscribe to our newsletter | newsletter archives | ralph's books | contact us

---

CancerDecisions® PO Box 1076, Lemont, PA 16851 Phone Toll Free: 800-980-1234 | From Outside USA: 814-238-3367 | Fax: 814-238-5865 Copyright © 2008 All Rights Reserved.