by Dean Mouscher
The latest chapter in the Food and Drug Administrationís 14-year-old war against cancer pioneer Stanislaw Burzynski ended abruptly on May 27, when a jury acquitted him on the lone remaining charge. Burzynski had originally stood trial on 75 federal felony counts, with most charges dismissed in March.
With the May acquittal of cancer researcher Stanislaw Burzynski in his federal retrial of earlier charges, onlookers are arriving at a powerful consensus: That it is intolerable in a democratic country that the government prevents fully-informed citizens from healing themselves in the manner they choose.
Interviews and press conferences with Burzynski's highly articulate patients terrified that their own government would take away their last hope for life brought that message home. Burzynski himself rejoiced that his 14-year persecution may have reached an end.
On this day after Memorial Day, I'm happy to be able to say the FDA's war against us is over,î said Burzynski, after the verdict. And hopefully it may mark the beginning of the end of the war against cancer. The case ended as a major embarrassment for the FDA. After devoting 14 years and untold millions of dollars of public funds, prosecutors were unable to convince jurors that Burzynski was guilty of even one of the 75 counts.
Congress is looking into the case as well...to examine the behavior of the government. In a letter to Department of Health and Human Services Secretary Donna Shalala, dated June 5, Rep. Joe Barton (R-Texas), chairman of the Investigations and Oversight subcommittee of the House Commerce Committee, asked for all documents from the FDAís associate chief counsel for enforcement Robert Spiller and the FDA Office of Chief Counsel related to Burzynski, and a detailed accounting of the resources expended by the FDA related to investigating and prosecuting him. Barton also asked Shalala to locate and preserve for safekeeping ìall material that may be reasonably related to this investigation.
Burzynski is the Polish-born medical doctor with a Ph.D. in biochemistry who has been treating cancer patients with antineoplastonsónon-toxic, naturally occurring peptides and amino-acid derivatives since 1977. He has had particular success with brain cancers and lymphoma.
As a Ph.D. candidate in Poland, Burzynski noticed differences in the blood of healthy patients and cancer patients. That led him to the discovery of peptides that were abundant in healthy blood, but almost absent in cancer patients. The antineoplastons Burzynski now uses are derived from those peptides.
However, in the U.S. Burzynski has been the target of federal regulators for years, with his clinic raided continuously. The trial that ended in March was a partial vindication for the doctor, with most of the charges dismissed, and a deadlocked jury disposing of the rest for the time being.
A Moot Point
Not lost on the jury in that trial was the fact that most of the indictment was moot. The FDA already had approved 73 phase II clinical trials of antineoplastons, under which Burzynskiís patients were being treated. Thus, Burzynski was treating out-of-state patients, and even shipping the drug out of Texas (violations of interstate commerce were among the original charges) with full FDA knowledge and approval.
Clearly, this made both trials a puzzlement to many, including jurors. But prosecutors apparently felt they had left themselves no way out. Negotiations broke down over the unresolved charges, leading to the retrial in May. This time, however, there was a marked difference in the jury pool. Everyone in Houston now knew about the FDAís long harassment of Burzynski and his patients. The judge said he didnít care if possible jurors knew about the case, so long as they could put their opinions aside and listen to the evidence.
The voir dire, where lawyers speak to prospective jurors in a group, seemed at times as if it would deteriorate into an angry mob scene. One prospective juror told prosecutors the FDA was like the Gestapo. A 24-year career marine said the case made him ashamed of his country, and that he found it ìvery disturbing. When asked if they had any questions, one woman stood up and asked, Why isn't the FDA being prosecuted for violating our constitutional rights? In Roe versus Wade, the Supreme Court determined that interfering in the doctor-patient relationship is an unconstitutional invasion of the patientís right to privacy.
Prosecutors in the second trial dropped all counts (with prejudice, meaning they could not be retried) against Burzynski Research Institute and all 40 interstate commerce counts against Burzynski himself. Thus, all that remained of the original 75-count indictment was a single count of contempt of court. Still, a conviction could have destroyed Burzynskiís career, ended patientsí access to antineoplastons, and stopped research on the drug.
Testimony in the retrial lasted just three days, two for the prosecution and one for the defense. As with the first trial, the prosecution called witnesses who seemed to hurt its case. Even the chief FDA witness admitted that Burzynski had been trying to cooperate with the FDA for 14 years, that the data he had sent occupied fully 25 feet of shelf space at FDA headquarters, and that the FDA had never approved a drug for an individual, but only for large pharmaceutical companies with unlimited resources.
This time jurors took just two-and-a-half hours to find Burzynski not guilty on the remaining charge.
It was a Big Brother issueî said juror Stephanie Shapiro afterward. The order was ambiguous, and the jurors felt Burzynski had made every good-faith effort to follow it. Moreover, we were disturbed that the government had not exhausted civil remedies before resorting to this very serious criminal trial.
The Tables Turned
And the tables seemed to turn quickly. An investigative arm of the Justice Department, the Office of Professional Responsibility, is investigating possible prosecutorial misconduct in the Burzynski case. After the not-guilty verdict, prosecutor Michael Clark was seen on local news shows, sweating profusely as he told reporters that he will be exonerated of any wrongdoing.
What next for Burzynski? He continues to accrue patients to the clinical trials being conducted under Investigational New Drug exemptions filed with the FDA. Those trials are showing particularly promising results for patients with primary malignant brain tumors and non-Hodgkinís lymphoma.
In the clinical trial of mixed gliomaóa deadly form of incurable brain cancer half of the patients responded to antineoplastons. Patients had to have at least 50-percent reduction in the size of their tumors to count as responses. Fully 25 percent saw their tumors disappear completely. Conventional chemotherapy is essentially useless against this type of tumor. Trials for anaplastic astrocytoma and brainstem glioma, two more deadly tumors with terminal prognoses, are nearing completion as well.
Will the FDA now accept the scientific data on antineoplastons and approve the drug invented by a man they have been trying to jail for a decade and a half?