The Fiercest Battle: Stanislaw Burzynski and the Fourteen-Year Campaign to Bury a Cancer Treatment

An Essay

Preface

This essay draws primarily on Daniel Haley’s Politics in Healing: The Suppression and Manipulation of American Medicine (2000), which documents the Burzynski case through court records, internal government memos, Congressional testimony, and interviews with patients, physicians, and participants. Additional sources include Ralph Moss’s The Cancer Industry and Tom Elias’s The Burzynski Breakthrough.

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On October 11, 1996, FDA lawyers filed a motion to keep all evidence of efficacy out of Dr. Stanislaw Burzynski’s upcoming criminal trial. Allowing jurors to see such evidence, the government argued, would be “a thinly veiled effort to expose the jury to the specter of Dr. Burzynski in the act of saving lives.” Proof that his treatment worked would “certainly infect the jury’s consideration of the real issue with irrelevant emotional, prejudicial, and misleading concerns regarding whether antineoplastons work and the unfortunate fate of Dr. Burzynski’s patients.”

The FDA was not being careless with language. It was stating its position clearly: whether a cancer treatment saves lives is irrelevant to whether its developer should be imprisoned. This was the culmination of a fourteen-year campaign involving raids, four grand juries, the seizure of confidential patient records, and finally a 75-count indictment carrying 229 years in prison. The campaign failed. Burzynski was acquitted. But the treatment that prompted such extraordinary prosecution remains unapproved decades later, while cancer patients who might benefit from it continue to die.

The Discovery

Stanislaw Burzynski earned both his MD and PhD by age 24, the youngest person in Poland to hold both degrees in the twentieth century. His doctoral research at the University of Lublin focused on blood analysis. Most patterns in his data were readily explained, but certain fractions puzzled him. His professor advised him not to worry—no one had ever figured out what those meant. Burzynski, unwilling to face his public thesis defense without an answer, investigated further. The unknown fractions turned out to be peptides, clusters of amino acids that form the building blocks of protein.

This discovery would define his life’s work.

Under pressure to join the Communist Party in Poland—and facing an uncertain future when he refused—Burzynski emigrated to the United States in 1970. He arrived with twenty dollars and his peptide research. He secured a position at Baylor College of Medicine in Houston, working under Dr. George Ungar in the Anesthesiology Department. The placement proved fortunate. In the cancer section, his research would have been directed by others. Under Ungar, he was free to follow his own questions.

In 1974, Burzynski won a grant from the National Cancer Institute. The funding allowed him to acquire equipment unavailable in Poland and to push his peptide research further. Where he had identified 39 peptides in Poland, he now isolated 119 distinct compounds of 10-15 amino acids each. Scientists had largely dismissed peptides as waste products or artifacts—”chemical UFOs,” as Burzynski put it, “which some people were seeing and some people were not seeing.”

Burzynski suspected otherwise. In Poland, he had noticed that one peptide was almost completely absent from the blood of a prostate cancer patient. In Houston, he tested this observation systematically. In 1974, he and Ungar published findings showing that the peptides caused up to 97% inhibition of DNA synthesis and cell division in cancer cells in tissue cultures. If DNA was inactivated and cells could not divide, cancer could not spread.

He named the compounds antineoplastons—literally, anti-cancer agents.

The mechanism he proposed was elegant. Cancer patients consistently showed deficiencies of these peptides compared to healthy individuals. The peptides appeared to function as a biochemical defense system, distinct from the immune system. Rather than destroying defective cells, they reprogrammed them. “Cancer is really a disease of cells that are not programmed correctly,” Burzynski explained. “Antineoplastons simply reprogram them so that they behave normally again.”

This was not immune therapy. It was not chemotherapy. It was something new: naturally occurring compounds that corrected cellular malfunction without destroying healthy tissue.

Early Validation, Early Attacks

In 1976, Burzynski presented his findings at a convention of the Federation of American Societies for Experimental Biology. Out of 3,700 papers, his became the lead Associated Press story. The Houston Chronicle reported that “a chemical with the power to change cancer cells back to normal cells has been extracted from human urine... It apparently detects cells that are getting out of line and feeds them new information that returns them to normal.”

The Baylor Cancer Research Center invited him to join—on condition that he abandon his private practice. Burzynski had seen how institutions stifled initiative in Communist Poland. He declined.

His private practice was also producing results. Working with Dr. William Mask at Jack County Hospital in Jacksboro, Texas, Burzynski conducted clinical trials. Mask would later testify: “There’s no doubt in my mind. I’m convinced that in my 40 years of experience in seeing cancer, this treatment is the best.” He cited a Wichita Falls patient cured of bladder cancer and stated that he would recommend antineoplaston treatment over traditional chemotherapy and radiation, which “kill the good cells as well as the bad cells.”

In 1977, Burzynski published a paper reporting that antineoplastons showed “profound anti-tumor activity without any significant toxicity in 21 patients.” Of these 21 far-advanced cancer patients, 86% showed some degree of clinical improvement. Four patients—19%—achieved complete remission. Four more achieved partial remission. Side effects were minimal or nonexistent.

The response from the cancer establishment was immediate. Houston’s Twelve Oaks Hospital, which had allowed Burzynski to conduct trials, cancelled his permission as soon as the paper appeared. The Harris County Medical Society’s Board of Ethics investigated him for making his own non-FDA-approved medicine, though preparing one’s own medicines was traditionally within a physician’s prerogatives.

In January 1983, the American Cancer Society attacked Burzynski in its magazine. The ACS declared it “does not have evidence that treatment with antineoplastons results in objective benefit.” The same article, however, reported the data from Burzynski’s 1977 study: 86% improvement, 19% complete remission, minimal side effects. The ACS published evidence undercutting its own conclusions.

A comparison illuminates the double standard. Dr. Steven Rosenberg’s study on Interleukin-2 at the NCI produced one complete remission out of 25 patients with advanced cancer—a 4% rate. The treatment received an avalanche of attention and moved toward FDA approval. Antineoplastons, with a complete remission rate nearly five times higher, received “no evidence of benefit.”

Rosenberg was President Reagan’s surgeon and a powerhouse at NCI.

Burzynski was a Polish immigrant operating a clinic in Houston.

The Siege Begins

During Easter Week 1983, the FDA sued Dr. Burzynski in civil court without warning. The agency asked the court to “force permanent cessation of all scientific and medical work on the development, manufacture, and administration of antineoplastons.” By chance, Burzynski’s lawyer was in the courtroom on another matter. He heard what the FDA was requesting and told the judge that such an order would cause people’s deaths.

The next month, Judge Gabrielle McDonald refused the FDA’s request. She did grant an injunction against interstate shipments until Burzynski obtained FDA approval of an Investigational New Drug application. But she specifically allowed his work to continue within Texas.

Robert Spiller, the lead FDA attorney, did not accept the ruling gracefully. He told the judge that if she would not shut down Burzynski, the FDA would be forced to use other methods—seizures and criminal prosecution. He was outlining a game plan that would unfold over the next fourteen years.

Burzynski applied for an IND the same month. Before May ended, the FDA rejected it. The agency knew that antineoplastons would not be effective in the standard P388 mouse leukemia test—Burzynski had warned them his compounds were species-specific and would not work in mice. The FDA used this as grounds for refusal anyway and demanded more data. When Burzynski provided it, they demanded more. The cycle continued for six years.

On July 17, 1985, the FDA raided Burzynski’s office. Agents waving search and seizure warrants, accompanied by a U.S. marshal, loaded eleven four-drawer file cabinets and carted them off. Some files were urgently needed for treating current patients. Under court order, Burzynski was allowed to install a xerox machine in the FDA office and send staff to make copies when needed.

Patients sued for return of the confidential medical records. They lost. A three-judge appeals panel sided with the FDA, in effect establishing the agency’s right to seize doctor-patient files. The Supreme Court refused to hear the case. As of 2000, the FDA still had not returned the files.

Shortly after the raid, the FDA obtained addresses from the seized records and began sending misleading information to Burzynski’s patients. Letters also went to insurance companies that had been paying for antineoplaston therapy. On October 24, 1985, Judge McDonald directed the FDA to stop releasing false information about Burzynski.

The FDA convened its first grand jury. For months, agents searched for evidence that Burzynski had shipped antineoplastons across state lines—a violation of the interstate commerce laws the agency administered. They found nothing. He had been scrupulously careful. The grand jury disbanded without returning an indictment.

In 1986, the U.S. Postal Service joined the campaign. It sent letters to Burzynski patients informing them of an investigation into “alleged improper insurance billing practices.”

The same year, Kurume University in Japan requested permission to obtain antineoplastons from Burzynski for testing. The FDA denied the request.

The IND application continued to grow. By the time the FDA unexpectedly approved it on March 16, 1989—for breast cancer study only—the documents made a stack six feet tall. IND applications from pharmaceutical companies are generally approved in 30 days. Burzynski’s took six years. In that time, between 2.5 and 3 million Americans died of cancer.

“We are at the end of the war,” Burzynski told Dr. Ralph Moss after the approval. “But at the end of the war comes the fiercest battle.”

He was premature by eight years.

Vindication from Within

In 1990, the FDA convened a second grand jury. Again, thousands of documents were subpoenaed. Again, most of Burzynski’s employees were called. Again, the grand jurors could find no reason to indict.

That same year brought validation from an unexpected quarter. The 9th International Symposium on Future Trends in Chemotherapy, held in Geneva, devoted a special session to antineoplastons. Seven papers were presented by researchers from Japan, Poland, China, and the United States. The July-August issue of Oncology News put the story on its front page: a “completely new type of anti-tumor agent that is non-toxic and seems to make malignant cells revert to normal.”

Dr. Dvorit Samid of the Uniformed Services University of Health Sciences reported that “Antineoplaston AS2-1 profoundly inhibits oncogene expression and the proliferation of malignant cells without exhibiting any toxicity toward normal cells.” The compound did not kill cancer cells. It reprogrammed them to behave normally.

On October 4, 1991, six NCI scientists visited Burzynski’s clinic. They spent a day reviewing records of seven terminal brain tumor patients treated with antineoplastons. After returning to Washington, they began making favorable noises. An internal memo from Dr. Michael Friedman, associate director of NCI’s Cancer Therapy Evaluation Program, stated: “Antineoplastons deserve a closer look. It turns out that the agents are well-defined, pure chemical entities... The human brain tumor responses are real.”

In December, Burzynski presented at NCI by invitation. On January 6, 1992, the agency announced it had confirmed anti-tumor responses during the October site visit. NCI stated it would sponsor antineoplastons through the FDA approval process, with clinical trials to start as early as March.

Three weeks later, the Texas Department of Health filed suit seeking a permanent injunction against antineoplastons in Texas and asking the court to order all supplies destroyed.

Dr. Nicholas Patronas, NCI’s Chief of Neuroradiology, had been part of the team that verified Burzynski’s brain tumor results. On May 24, 1993, he testified at a Texas hearing: “Antineoplastons are the most effective treatment for brain tumors I have ever seen.” Asked what would happen to patients deprived of the drug, Patronas answered: “I believe these patients will die.”

When Patronas returned to Washington, he was severely reprimanded for having supported Burzynski. Under pressure, he withdrew a paper on antineoplastons scheduled for a cancer conference in Sweden.

The NCI had just announced it would help develop antineoplastons. Its own chief of neuroradiology had just testified that the treatment was the most effective he had ever seen for brain tumors. And that testimony earned official rebuke.

The Appropriation

The sequence of events between 1990 and 1995 reveals a systematic effort to separate Burzynski from his discoveries.

After synthesizing antineoplastons in 1980, Burzynski patented the more effective compounds. One compound, his “AS5,” turned out to be the chemical phenylacetate. He stopped using it in 1981 because it left the body too quickly to be effective. His more complex formulations worked better. He did not patent phenylacetate.

In June 1990, Elan Pharmaceutical signed a letter of intent giving them rights to license and distribute antineoplastons. The agreement provided for a 90-day period during which Elan would have nearly unlimited access to Burzynski’s research and methodology. Burzynski introduced Elan to Dr. Dvorit Samid, whose research supported his work.

At the end of the 90-day period, Elan announced it would not sign a contract with Burzynski, citing his lack of patent protection for phenylacetate—the one compound he hadn’t patented because it was less effective.

Shortly after cancelling its agreement with Burzynski, Elan gave a grant to Dvorit Samid to research phenylacetate. Samid then moved to NCI’s Clinical Pharmacology Branch.

In the fall of 1992, the NCI journal announced that the agency had contracted Elan Pharmaceutical to conduct clinical trials with phenylacetate. Burzynski learned this from the announcement, not from NCI. The agency had told him it would help develop antineoplastons. Instead, it was developing the one compound he hadn’t patented—his least effective formulation.

NCI obtained patents on phenylacetate. These were assigned to its parent organization, the Department of Health and Human Services.

An internal NCI memo dated April 29, 1993, acknowledged the problem in writing: “Political issues are a real concern. Former Congressman Berkley Bedell is concerned that we are taking the antineoplastons away from Burzynski.”

While NCI proceeded with phenylacetate trials, it sabotaged the antineoplaston trials it had promised to conduct. The agency admitted only a handful of patients. In one case, a patient named Ingrid Schultz—whose tumor had responded at Burzynski’s clinic—was enrolled in the NCI trial. Investigator Dean Mouscher was told by a Mayo Clinic doctor that they were diluting the antineoplastons four to one. When Mouscher expressed astonishment, the doctor claimed he didn’t really know much about it.

Ingrid Schultz died.

In 1994, Dr. Mario Sznol of NCI proposed major protocol changes: treating larger tumors and patients with metastases, but with no increase in dosage. Burzynski recognized that treating more advanced cancer without increasing the dose would guarantee failure. He proposed a separate trial with adjusted dosages for advanced cases. NCI ignored the request and approved the changes over his objection.

An NCI investigator later wrote a letter to his hospital’s Institutional Review Board stating that “amendments have been made at the request of the NCI.” This directly contradicted NCI officials who had claimed the amendments came from the investigators.

In May 1995, an internal memo revealed that NCI’s clinical trials monitoring service had been instructed not to send any clinical trial data to Burzynski—the treatment’s developer.

That summer, NCI announced it was cancelling its antineoplaston trials because “a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol.” The agency had modified the protocol over his objections, blocked him from receiving data, diluted dosages to levels he had warned would be ineffective, and then blamed him for the failure to reach consensus.

NCI’s phenylacetate trials continued.

The Final Assault

In 1994, FDA prosecutor Robert Spiller convened a third grand jury. Again, thousands of documents were subpoenaed. Again, no indictment was returned.

In April 1995, Spiller convened a fourth grand jury. This one was not told about the previous three.

On the same day that FDA agents appeared on CBS morning news with Burzynski and three patients in remission, the agency raided his clinic again, confiscating more records and confidential patient files.

Former FDA Chief Counsel Peter Barton Hutt explained the dynamic 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... 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.”

In November 1995, Congressman Joe Barton held hearings on FDA conduct. Commissioner David Kessler was questioned about convening four grand juries over a nontoxic therapy without finding anything criminal. Under pressure, Kessler committed to allowing current Burzynski patients to continue receiving antineoplastons.

One week after the hearings, the FDA secured an indictment against Burzynski on 75 criminal charges. Conviction would mean 229 years in prison.

The legal theory was novel. Burzynski had never shipped antineoplastons across state lines—he knew better. The FDA’s previous attempts to prove otherwise had failed. But for the fourth grand jury, the agency argued that when out-of-state patients came to Houston, received treatment, and took their medicine home, Burzynski was engaging in interstate commerce. This arrangement had been going on for years with FDA knowledge. It had not been considered a crime during the first three grand juries.

The theory extended further. Since Burzynski was now, under this definition, violating interstate commerce law, his insurance claims sent through the U.S. mail constituted mail fraud—because he had not informed insurance companies that he was breaking the law.

In January 1996, FDA lawyers sought to bar Burzynski from treating any patients who did not qualify for FDA clinical trials. When Burzynski pointed out that patients would die, the FDA attorney called any resulting harm to patients “irrelevant.”

Under Congressional pressure, Commissioner Kessler agreed to let current patients continue treatment and to expand clinical trials. In April, the FDA again tried to cut off new patients, arguing that while treatment was safe for current patients, it would not be safe for new ones. The restriction was lifted on May 1, 1996, after further Congressional intervention.

During one of the periods when FDA shut off patient access, Mary Collins—a longtime Burzynski supporter—developed breast cancer. She wasn’t worried. She would go to Houston and take antineoplastons. When she called to make arrangements, she learned the FDA had momentarily shut him down. Antineoplastons weren’t available when she needed them. She died.

What the Jury Saw

The trial opened in January 1997. The FDA’s motion to exclude evidence of efficacy was granted. Jurors would not be allowed to consider whether antineoplastons worked.

Numerous government witnesses appeared under coercion. The FDA had threatened to prosecute them for aiding and abetting Burzynski’s supposed infractions unless they testified. Not one spoke against him. Most noted that FDA regulations permitted patients returning from Mexico to bring back medical supplies. They wondered why medicine from Mexico was legal but medicine from Texas was not.

Outside the courthouse, patients demonstrated, chanting “Save the doctor who saves lives!” Inside, the defense brought a parade of patients. Barred from discussing their recoveries, their appearance spoke for itself.

Mary Jo Siegel led the Burzynski patients’ defense group. When diagnosed with low-grade non-Hodgkins lymphoma, her doctor had told her chemotherapy would not help and that spontaneous remissions in her cancer type had never occurred. She would surely die. After treatment with antineoplastons, she returned with no tumor. Her doctor proclaimed it a spontaneous remission.

The prosecution asked each defense witness the same question: “Did Dr. Burzynski victimize you?” All said no. Several, before being cut off, stated that the government was victimizing them by prosecuting their doctor.

The defense attempted to introduce a report from Dr. Robert Burdick, a Seattle oncologist and professor at the University of Washington Medical School. Burdick had evaluated seventeen brain tumor patients on antineoplaston treatment. His findings provided context for Burzynski’s results:

Neurosurgeons, as a rough estimate, cure one in every 1,000 brain cancer patients they operate on. Radiation therapy slows tumor growth, gaining perhaps one month of life, and may cure one in 500-1,000 patients. Chemotherapy, despite thirty years of clinical trials, has not produced a single drug or combination that elicits more than an occasional transient response in primary brain tumors.

Against this background, Burdick reviewed Burzynski’s cases: seven complete remissions out of seventeen patients. Nine additional partial remissions of 50% or more. One case of stable disease.

“The response rate here is an astounding 81%, with an equally astounding 35% complete remission,” Burdick wrote. “It is very clear the responses here are due to antineoplaston therapy and are not due to surgery, radiation, or standard chemotherapy.”

Judge Lake took the report under advisement for one day and ruled it irrelevant.

On March 3, 1997, Judge Lake declared a mistrial. The jury was deadlocked 6-6 on all counts. The judge then threw out the 34 counts of insurance and mail fraud, stating: “There is no evidence of insurance or mail fraud in this case.”

The FDA immediately scheduled another trial for May on the remaining interstate commerce charges.

Juror Darlene Phillips published a letter in the Townsend Letter for Doctors and Patients. The case should never have been tried in criminal court, she wrote. It should have been returned to Judge McDonald’s civil court, where the FDA had lost in 1983. Moreover, the FDA had already approved 71 clinical trials in which Burzynski was given full liberty to ship antineoplastons out of Texas. The jurors had not known this during the trial. When Phillips learned it afterward, she felt she had been “involved in a ridiculous waste of two months of my life. After all, wasn’t this a moot point at this time? Surely our government has real ‘criminals’ to prosecute.”

Before the second trial, prosecutor Michael Clark offered to drop all criminal charges if Burzynski would plead guilty to one count of civil contempt and pay a $250,000 fine. Burzynski refused. “I don’t want to admit to anything that makes it look like I did anything wrong at all. I did nothing wrong. I was always very careful to obey every court order.”

During jury selection, one potential juror said, “The FDA is like the Gestapo.” Another asked, “Why isn’t the FDA on trial instead of Dr. Burzynski?” The prosecution struck both.

The second trial lasted three days. The jury deliberated for two hours and acquitted Burzynski on all counts.

After the verdict, prosecutor Clark expressed concern about “a trend toward government bashing.”

The government had bashed first.

The Cost

Fourteen years. Four grand juries. Raids and seizures. Coerced witnesses. A 75-count indictment. Motions to suppress evidence of saving lives as “prejudicial.” Patients who died during shutdowns. An acquittal.

And the treatment remains unapproved.

Dr. Michael Friedman, who had written that “human brain tumor responses are real,” transferred to the FDA, where he became Deputy Commissioner—colleague to Mary Pendergast, who oversaw Robert Spiller’s prosecution. In January 1998, Elan Pharmaceutical announced that Pendergast had become its Executive Vice President for Governmental Affairs.

NCI obtained patents on phenylacetate while sabotaging trials of antineoplastons. The agency’s internal memo acknowledged the political concern that they were “taking the antineoplastons away from Burzynski.” They proceeded anyway.

The FDA approved Interleukin-2, which patients may have no more than a 15% chance of surviving. The agency approved Gemcitabine, which allows pancreatic cancer patients to live a few weeks longer. Against a background where neurosurgeons cure perhaps one in a thousand brain cancer patients, Burzynski demonstrated an 81% response rate and 35% complete remission in Dr. Burdick’s evaluation of seventeen cases.

Antineoplastons do not work every time. Nothing does. But the documented record shows results that exceed any comparable treatment for certain cancers, achieved without the devastating side effects of chemotherapy and radiation. Patients do not lose their hair. Their immune systems are not destroyed. They are not at risk of dying from the treatment itself.

Former FDA Commissioner Frank Young had proclaimed in 1989 that the agency would approve a new drug if it proved effective in as few as ten patients. Antineoplastons passed that threshold years before. In 1996, Commissioner David Kessler and Vice President Al Gore announced the FDA would move rapidly to approve promising new cancer drugs.

The one drug the FDA spent fourteen years trying to destroy was not what they had in mind.

Congressman Dan Burton introduced a bill that would restrict FDA authority to bar any patient from any investigational new drug, provided the patient or guardian gives informed consent acknowledging the risks. The principle is simple: patients facing death should have the right to try treatments that might save them, even if those treatments lack full FDA approval.

Dr. Burzynski has developed a new formulation that appears to be one thousand times more potent than current antineoplastons—and still nontoxic. In laboratory tests, it causes cancer cells to revert to normal and then die at the next normal cell division. To offer this breakthrough anytime soon would mean starting over with the FDA. Would they again take six years to approve an IND? Burzynski does not have the resources to push two products through the agency simultaneously.

One American dies of cancer every minute.

The FDA’s position at trial was that evidence of saving lives is irrelevant—”prejudicial,” even. They meant it in a legal sense, arguing such evidence would unfairly bias jurors. But they revealed a deeper truth about institutional priorities. Procedure matters more than outcomes. Regulatory authority matters more than patients. The FDA would rather imprison a doctor for a novel interpretation of interstate commerce law than explain why a treatment that achieves 35% complete remission in brain tumors remains unavailable to the dying.

In 1979, Burzynski told writer Gary Null: “I’m going to fight no matter what they do because I believe I’m doing the right thing. I believe this is our obligation to people. If you find something that’s valuable, you must continue; I believe that we’ve found something that may be able to save lives.”

He fought. He won. The treatment he developed still awaits the approval it was promised in 1992.

The question is not whether Stanislaw Burzynski is a maverick or a genius or a saint. The question is simpler: If a treatment shows extraordinary results in terminal patients, results confirmed by government scientists, results that far exceed standard therapies—why does the government spend fourteen years and millions of dollars trying to imprison its developer?

And what happens to the patients while that prosecution unfolds?

We know the answer to the second question. Some of them died.

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References

Haley, Daniel. Politics in Healing: The Suppression and Manipulation of American Medicine. Washington, DC: Potomac Valley Press, 2000.

Elias, Tom. The Burzynski Breakthrough. Nevada City, CA: Lexikos, 1997.

Moss, Ralph W. The Cancer Industry. Brooklyn, NY: Equinox Press, 1996.

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