The FDA's Vendetta Against Dr. Burzynski
By Dean Mouscher,
Director, Clinical Trials
Burzynski InstituteStanislaw R. Burzynski is an MD with a Ph.D. in biochemistry. In 1967, while studying blood as a graduate student, he found certain peptides that had never been described before.
Comparing the blood of patients with different diseases, Dr. Burzynski found that over 98% of cancer patients were deficient in the peptides he had found-often with blood levels of only 2% of those of healthy individuals. This led him to suspect that these compounds-or a lack thereof-were implicated in the development of neoplastic (cancerous) disease.
Most cancer experts believe we all develop cancer cells hundreds if not millions of times in our lifetimes. Given the trillions of developing cells, the millions of errors that can occur in the differentiation (maturing) process of each cell, and our constant exposure to carcinogenic substances (smoke, car fumes, radiation, etc.), the laws of probability dictate that mis-developing cells must occur frequently in the life of each individual. It stands to reason that a healthy body has a corrective system to "reprogram" newly-developed cancer cells into normal differentiation pathways before the cancer can take hold.
Dr. Burzynski postulated that healthy organisms have just such a corrective mechanism, which he termed the "Biochemical Defense System." He called the substances produced by this system "antineoplastons." Their purpose is to "reprogram" cancer cells to die like normal cells. Healthy cells are not affected.
Dr. Burzynski continued his research at Baylor University until 1977, when he felt he was ready to begin treating advanced cancer patients with the peptides he had discovered. After getting a written opinion from his lawyer that doing so would not violate any state or federal laws as long as he treated patients only in Texas, Dr. Burzynski began to give antineoplastons to patients with hopeless cancers-often with dramatic results.
The FDA Seeks An Injunction
In 1983 however, the FDA went to court for an injunction to stop Dr. Burzynski from manufacturing or using antineoplastons in his practice. U.S. District Court Judge Gabrielle McDonald turned them down. In an 18-page decision, Judge McDonald made it clear that Dr. Burzynski could continue to "manufacture, package, sell, and distribute antineoplastons, so long as it occurs wholly intrastate."
Ignoring Judge McDonald's decision, the FDA tried to stop Dr. Burzynski by writing dozens of letters to Senators, Congressmen, insurance companies and pharmaceutical firms. These letters contained lies and distortions so outrageous that on October 23, 1985 Judge McDonald issued a Cease and Desist order, commanding the FDA to stop issuing false and misleading information about Dr. Burzynski.
A Series Of Raids And Grand Jury Investigations
In 1985, FDA agents and armed Federal Marshalls raided Dr. Burzynski's clinic and seized all his patient records-200,000 documents in all. In order to continue treating patients with advanced cancer, Dr. Burzynski had to install a copier-at his expense-at FDA headquarters and hire someone to shuttle back and forth, making copies of his records and bringing them back to the clinic. Dr. Burzynski had to make appointments with the FDA to make copies of his own documents.
Later in 1985, Federal prosecutors representing the FDA presented everything they seized in the raid-plus another 100,000 documents subpoenaed shortly after the raid-to a Federal Grand Jury. Their investigation of Dr. Burzynski lasted nine months, but prosecutors couldn't convince the Grand Jury that there was probable cause to believe a crime had been committed. No indictment was returned.
In 1990, the U.S. Attorney's office in Houston, representing the FDA, convened another grand jury to investigate Dr. Burzynski, again for alleged violations of Judge McDonald's order. To the FDA's dismay, this Grand Jury also refused to indict Dr. Burzynski.
More Raids And Grand Juries
In 1993, the FDA again raided the Burzynski Research Institute because of alleged bacterial contamination of antineoplastons, but tests proved conclusively that there was no contamination.
In 1994, U.S. Attorneys-again representing the FDA-convened a third Grand Jury to investigate Dr. Burzynski. And for the third time, a skeptical Grand Jury refused to return an indictment. The main casualty this time was the Assistant U.S. Attorney on the case, who was removed for prosecutorial misconduct involving abusive and improper use of subpoenas.
The latest chapter in the FDA's twelve-year campaign to stop Dr. Burzynski from treating patients with antineoplastons kicked off on March 24, 1995 with another raid on the clinic. Seven federal agents herded employees into a room and kept them there until they filled out forms with personal information. They then spent seven hours rifling through file cabinets and drawers, leaving with Boxes of patient records and other documents.
Shortly thereafter the FDA began serving clinic employees with subpoenas commanding them to testify before a Federal Grand Jury investigating Dr. Burzynski. To date, federal prosecutors representing the FDA have subpoenaed nine employees including Dr. Burzynski. In addition, they have ordered him to turn over tens of thousands of pages of documents, including more patient records and diagnostic films.
An Arbitrary Fishing Expedition
The law prohibits Grand Juries from "arbitrary fishing expeditions". Yet that is exactly what federal prosecutors are engaged in. Besides patient records-many of which have already been presented four times to various government investigators-prosecutors have subpoenaed "any and all agreements, draft agreements, proposals, correspondence, notes, memos, tape recordings, notes of conversations, telephone messages, reports, raw data, studies or other items to, from, or with any foreign or domestic pharmaceutical company or university, including contact person's name, title and phone number."
While this information is of no use in investigating criminal activity, it gives the FDA the opportunity to write letters to everyone they uncover, letting them know that Dr. Burzynski is the target of a federal investigation and to issue subpoenas to some of these people. This is more than just speculation. It is the exact behavior that sparked a 1985 "Cease and Desist" order against the FDA by US District Court Judge Gabrielle McDonald.
And so, on June 15 1995, prosecutor Amy LeCocq subpoenaed a huge Dutch pharmaceutical conglomerate-which has conducted negotiations with Dr. Burzynski-for all correspondence, memos, documents or other records it had regarding Dr. Burzynski or anyone associated with him. The obvious purpose of this subpoena was to frighten the company-which does a large business in the U.S.-into having no further contact with Dr. Burzynski.
Prosecutors have also subpoenaed all patient billing records, again with no time limitation whatever. Dr. Burzynski has been treating patients since 1977. They have subpoenaed his accountants for every conceivable document an accountant can possess (again with no limitation on time), a classic fishing expedition. Prosecutors have even subpoenaed the names and addresses of every person who has ever received a brochure from Dr. Burzynski! As if that weren't enough, the subpoena went on to demand "Any other lists of persons", an absurdly general and burdensome request.
FDA Harassment, Illegal Actions And Terrorism
Besides throwing the entire clinic into chaos, wasting thousands of hours of employee time, and terrifying advanced cancer patients who don't know whether they will be able to continue getting the only medicine that has been able to help them, the grand jury's actions have severely threatened Dr. Burzynski's ability to practice medicine. Without patients' previous MRIs and CAT scans, Dr. Burzynski has nothing to which he can compare new scans, and no way of knowing if patients' tumors are growing or shrinking.
Moreover, the FDA has been careful to seize films and medical records of Dr. Burzynski's most successful cases, crippling his ability to defend himself by confiscating his single most valuable asset-proof of the anti-cancer activity of antineoplastons.
In the current case there has been illegal use of subpoenas as well. Dr. Ralph Moss, an award-winning journalist and author of books about cancer, was subpoenaed and ordered to produce every document in his possession-electronic, magnetic, printed or otherwise-relating to Dr. Burzynski. Dr. Moss has written favorably about Dr. Burzynski in the past.
Unfortunately for Amy Lecocq, the prosecutor in charge of this case, her subpoena of Dr. Moss violated at least six federal laws governing subpoenas of journalists. Such violations carry a penalty of administrative reprimand or other disciplinary action. When Dr. Moss pointed this out to Lecocq and gave her the opportunity to withdraw the subpoena, she did so with alacrity.
It's been said that a prosecutor can get a Grand Jury to indict virtually anyone. But despite the avalanche of documents supplied by the government to four Grand Juries, it has yet to convince any of them of probable cause to believe Dr. Burzynski has committed a crime. And so, unable to stop him legally, the FDA seems determined to harass him to death.
The NCI Report on Dr. Burzynski
The FDA's actions are all the more outrageous because their own oncology division has granted Dr. Burzynski permission to conduct Phase II clinical trials! In addition the National Cancer Institute (NCI)-following a visit by seven NCI experts to Dr. Burzynski's Houston clinic for a review of patient records-confirmed several remissions in patients with "hopeless" brain tumors after treatment with antineoplastons. Their report states that "The site visit team documented anti-cancer activity in this best-case series and determined that Phase II trials are warranted to determine the response rate."
In other words, the question is no longer "Do antineoplastons work?"; it is: "How consistently do they work?"
And yet, despite the NCI report, despite the fact that the FDA's own scientists wish to see antineoplastons tested, the FDA's "enforcers" remain obsessed with shutting Dr. Burzynski down.
How long will this continue? Until your outrage puts a stop to it.
Burzynski Acquitted Of Fraud
Judge Declares Mistrial on Other ChargesWhile the famed cancer researcher has emerged unscathed from this most-recent government harrassment, there is still no consensus on how to handle the man or his treatments.
On March 3 [1997], a U.S. District Court judge in Houston acquitted famed cancer researcher Dr. Stanislaw Burzynski on all 34 fraud charges brought against him by the U.S. Food and Drug Administration for lack of evidence.
Then Judge Sim Lake declared a mistrial on the remaining 41 charges because the jury was deadlocked after six days of deliberation, with six jurors favoring acquittal on all counts, five favoring conviction on all counts, and one undecided.
Afterwards, the government said it would retry the doctor on the other counts, but patients and supporters of Burzynski vowed to fight that decision. At press time, prosecutors had not announced any new attempt to try Burzynski.
"The government has been harassing Dr. Burzynski and his patients for more than 15 years," said Steve Siegel, head of the Burzynski Patient Group. "They put forth their best case and their best lawyers and still could not win because they had no evidence. I hope they will realize it's time to leave Dr. Burzynski alone and fight cancer, not cancer patients."
Burzynski has been under investigation by the U.S. Attorney's office in Houston and the FDA for more than 15 years. Authorities have alleged that he illegally dispenses a class of experimental cancer drugs, called antineoplastons, that he develops and manufactures, and distributes at his clinic in Houston. Antineoplastons are synthesized versions of peptides found in human blood and urine. In the current case, Burzynski was on trial for violations of interstate commerce by treating non-Texans in Texas, selling drugs unapproved by the FDA, and filing fraudulent insurance claims via the U.S. mail.
The trial involved 20 days of testimony from more than 50 government witnesses. After the insurance fraud charges were thrown out and the jurors deadlocked on the remaining issues, Burzynski emerged unscathed from all charges.
"This is quite a reaffirmation for us that we never did anything wrong," said Dean Mouscher, clinical trials director at the Burzynski Research Institute, in Stafford, TX. "The issue for the FDA was one of control." Burzynski's antineoplaston therapy is a nontoxic alternative to chemotherapy, which-ironically, given the fact that Burzynski was on trial for violations surrounding its use-is now approved by the FDA for 71 Phase 2 clinical trials. Antineoplastons have been recognized by the National Cancer Institute and the FDA as safe and potentially effective against various types of cancer.
Rita Star of the Burzynski Patient Association reported that the three prosecutors attempted to paint Burzynski as a greedy man, who put very little money into research, and who violated the rules of science by "not being a team player."
Chief prosecutor Mike Clark said repeatedly that Burzynski "just didn't follow the rules" by defiantly introducing an unapproved cancer drug into interstate commerce. Prosecutor George Tallichet said that Burzynski had not conformed to the standards of the Food, Drug and Cosmetic Act, and urged jurors to enforce the law. He tried to depict Burzynski as a con man who preys on, profits from, and hides behind his patients.
The prosecution called as witnesses 19 relatives of Burzynski patients who have died, but none of them had anything bad to say about him. Instead, they insisted that the defendant had given them complete and honest information, and that he operates a high-quality, health care facility. Some of Burzynski's patients and their relatives have launched a crusade to raise money for his defense and to push the FDA and Congress into changing the law. Many of them rallied at the courthouse in his support.
A Lack of Victims
If the government does decide to retry this landmark case, Dr. Burzynski could still get life imprisonment on the interstate shipment charges. The mail fraud charges Lake threw out cannot be appealed.
Jury foreman John Coan, one of the six jurors who voted for acquittal from the start of the deliberations, said, "I think this was a government witch hunt. I couldn't find any victims."
Burzynski's patients collected 150,000 signatures on petitions protesting the trial. Four Congressional hearings have been held about FDA misconduct in the Burzynski case.
Despite years of unrelenting attack by the FDA, the efficacy of Burzynski's therapy has yet to be determined. The FDA has repeatedly raided Burzynski's clinic, seizing documents that are never returned and preventing any type of scientific evaluation of efficacy. In fact, while the FDA enforcement division has worked to stop Burzynski, the FDA drug evaluation division has expanded his authority to conduct clinical trials on terminally ill cancer patients.
Controversy Brings Fame
If the FDA enforcement division's objective is to stop cancer patients from going to Burzynski, their actions have had the opposite effect. The many FDA attacks against Burzynski have made him a national celebrity. His once obscure clinic is constantly receiving calls from prospective patients, and he has appeared on numerous TV shows, including "CBS Evening News," "CBS Morning News," "48 Hours," "20/20" and on CNN. "Hard Copy" and other tabloid shows have covered the trial, and there has been intense coverage in The New York Times.
The news reports have resulted in increasing numbers of cancer patients traveling to Houston to see him. The FDA does not dispute the National Cancer Institute Review showing cures of several brain tumor patients.
Even taxpayers who favor FDA regulation are now questioning why the government would spend millions of dollars trying to stop a cancer therapy from being sold and, in the process, create a public relations campaign that's turned it into a multimillion-dollar enterprise.
The ability of companies to benefit from being attacked by the FDA is not new. The Life Extension Foundation is ten times larger than it was when the FDA first attacked it in 1987, which is largely the result largely of free publicity generated as a result of the FDA's continuous attacks.
Future FDA Activities: A Modest Proposal
Based upon the three grand juries that were impaneled in the ongoing prosecution of Dr. Stanislaw Burzynski, plus the use of the FBI, the Attorney General's office, the U.S. Attorneys Office, the National Cancer Institute and the FDA over the past 15 years, it can be estimated that at least $8 million have been spent in the attempt to destroy Burzynski.
The government could pay for the costs of 50 astrocytoma (grade 4) patients who volunteer to use Burzynski's experimental antineoplaston treatment in lieu of conventional therapy. These patients will ordinarily not live more than 12 months, and conventional therapy has been proven useless in treating this form of brain cancer. Burzynski has reported particularly good success with this type of cancer.
The government could pay for the treatment as long as these 50 test subjects lived. If most of the patients were alive after a year, a breakthrough cancer treatment could be announced. If most of the patients are dead within 12 months, then this report would appear in Life Extension magazine and every other reputable alternative medicine publication.
What we have now is a media circus. Patients who were successfully treated by Burzynski are appearing on TV, and convincing other cancer patients to stampede to Houston. The FDA demands that Burzynski take patients for clinical trials who have already failed conventional therapies, and Burzynski insists that his therapy will not work on these types of patients. So after 15 years and about $8 million in tax dollars, we still don't have definitive evidence on the value of Burzynski's antineoplaston therapy. For terminally ill cancer patients and their families, the Burzynski fiasco could be considered a government-induced disaster.
These letters contained lies and distortions so outrageous that on October 23, 1985 Judge McDonald issued a Cease and Desist order, commanding the FDA to stop issuing false and misleading information about Dr. Burzynski.
Fire the FDA agents that defrauded Dr. Burzynski. Slapping them on the wrist and scolding them sends the message throughout government that, while such behavior is wrong, other politicians and bureaucrats --m parasitical elites -- can get way with doing similar and often worse. In short, that is how politicians and bureaucrats earned the label, "parasitical elite".
And it surely would have put a quick-stop to the abuse that followed.
Theater of the absurd.
Even taxpayers who favor FDA regulation are now questioning why the government would spend millions of dollars trying to stop a cancer therapy from being sold and, in the process, create a public relations campaign that's turned it into a multimillion-dollar enterprise.
The ability of companies to benefit from being attacked by the FDA is not new. The Life Extension Foundation is ten times larger than it was when the FDA first attacked it in 1987, which is largely the result largely of free publicity generated as a result of the FDA's continuous attacks.