Surely this can’t go on for much longer.
Clinical trials on Burzynski’s signature treatment, antineoplastons, were stopped following the death of a child and horrifying findings by the US FDA. But Burzynski is still in business selling chemotherapy in untested and unapproved combinations, describing critics as hooligans and suggesting that former patients are prostitutes and crooks trying to make money from him.
For further background on Burzynski and on recent developments, I strongly recommend you read the recent USA Today investigation by Liz Szabo. It is an impressive piece of work – thorough, fair, accurate and utterly shocking. Watch the accompanying videos, view the embedded source documents and then ask how on earth Burzynski is still going.
Despite being in use for decades, antineoplastons have never been shown to be safe or effective. Since 1996, they had only been available as part of FDA approved clinical trials but none of these trials has ever been published.
This is how Burzynski’s lawyer, Richard Jaffe, described the trials (in his book, Galileo’s Lawyer):
It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment
Despite a lack of trial data, there has still been growing concern over the side effects of the treatment. In 1998, the FDA concluded that the therapy had contributed to the deaths of at least seven people through hypernatraemia (high sodium levels). One of Burzynski’s own informed consent documents put the risk of hypernatraemia at 21%.
In June 2012, a six-year-old boy, Josia Cotto, had been undergoing treatment for an inoperable brain tumour and died with an astoundingly high blood sodium level of 205 mEq/L. Burzynski’s staff blamed that reading on a “false laboratory report based on a contaminated sample”.
According to FDA inspections performed after Josia’s death, Burzynski has failed to report at least 18 hypernatraemia cases.
Six weeks after Josia’s death, on July 30th 2012, the FDA prevented Burzynski from giving antineoplastons to any new children. Six months later, this clinical hold was extended to include new adult patients.
According to a letter sent to the Burzynski Institutional Review Board announcing the restrictions, the FDA had no assurance that the Board was adequately protecting the rights and welfare of the human subjects.
The FDA based its decision on objectionable conditions and a continuing pattern of deficiencies found during the last three inspections.
The most recent inspection was between January and March this year.
Addressing Burzynski, the inspectors wrote:
you failed to protect the rights, safety and welfare of subjects under your care.
Burzynski was charged with serious offences, some dating back to 2001. These included:
- Inflating success rates in 67% of cases, by inaccurately reporting how tumors responded to treatment
- Destroying patients’ original records
- Failing to report “unanticipated problems” to the Institutional Review Board — sometimes for six or seven years
During the inspection, the FDA found:
- Four cases from 1998 or 1999 in which patients were hospitalised for serious issues (such as pneumonia, lack of consciousness or bleeding in the skull) that Burzynski researchers failed to report until 2005. Similar problems had been found in a 2001 inspection.
- Forty-eight patients suffered a total of 102 drug overdoses from 2005 to 2013. One of these patients had a seizure and another was hospitalised in intensive care with a breathing tube. This represents a continuing problem, dating to reports of overdoses in inspections as early as 2001.
Burzynski’s Review Board was also found to have repeatedly granted requests for patients to have antineoplastons outside of clinical trials. In some cases, those decisions were made without consulting patients’ medical records.
According to USA Today, Burzynski said in an interview that his staff work hard to train patients and their families to administer antineoplastons correctly and pointed out that none of the overdoses had been fatal.
The amount of medication that these patients receive is not dangerous. At worst, they would sleep for a few hours.
Burzynski has dismissed criticism of his work, calling his detractors “hooligans” and “hired assassins”.
In reference to former patients who had spoken out against the clinic, Burzynski said:
We see patients from various walks of life. We see great people. We see crooks. We have prostitutes. We have thieves. We have mafia bosses. We have Secret Service agents. Many people are coming to us, OK? Not all of them are the greatest people in the world. And many of them would like to get money from us. They pretend they got sick and they would like to extort money from us.
He suggested that history will vindicate him, just as it has vindicated other persecuted medical pioneers, such as Louis Pasteur and that in the future, everyone will use his therapies.
One former patient now speaking out against Burzynski is Abra Hall, who together with her mother Stacey Huntington, gave a moving interview which can be viewed on the USA Today website (video 5).
In January next year, Burzynski is due to go before the Texas Medical Board as a result of a complaint by Huntington. A board panel will hear the case and may recommend that disciplinary action is appropriate.
She is concerned about both billing irregularities and the quality of treatment her daughter received. Abra Hall developed sepsis after leaving the clinic to continue treatment at home. One month after this, she was hospitalised again with a lung infection. She also developed serious complications from high doses of steroids.
Huntington says she decided to speak out to prevent other families from being taken advantage of.
When you get a diagnosis of cancer, you are pretty vulnerable. I think they take advantage of that.
As far as I am aware, the Burzynski Clinic have not commented on the USA Today investigation.
Wow, the medical establishment and the status quo cheerleaders have pulled out all the stops in their latest propaganda hit piece published in USA TODAY on November 15, 2013.
It’s enough to make one want to give up hope for any goodness in the human condition.
Trying to “debunk” USA TODAY’s diatribe on Nov. 15, 2013 would be like someone living in Nazi Germany trying to debunk the writings of Joseph Goebbels, or an African American trying to explain to his slave master that he too is also a human being with rights and emotions, or the parents of an American soldier trying to explain to members of the Westboro Church how disrespectful it is to hold up signs that read “God Hates Fags” during their child’s funeral.
This type of unbridled hate and bigotry goes far too deep for any rational human discourse.
He did not respond to any of the very serious and worrying findings, nor did he even seem to recognise them, blindly maintaining that antineoplastons are safer and more effective than other types of chemotherapy.
If you remember anything from this essay, it should be this: What frightens the establishment about Antineoplastons has nothing to do with a Polish man in Texas who invented them. It’s about their loss of control and authority—over a highly profitable and highly sustainable share of a totalitarian market. Anyone who feels the need to come up with “Conspiracy Theories” to explain the lack of acceptance of ANP by the establishment in any other way, simply doesn’t understand how the system works.
Implausible conspiracy theories of this nature can be very damaging to cancer patients, misinforming them and leading them to lose faith in their doctors and sometimes even deny themselves effective treatment in favour of unproven or disproven alternatives.
I have yet to see any reasonable argument for why Burzysnki should be allowed to continue.
Doctor accused of selling false hope to families Liz Szabo, USA Today, 15/11/13
Experts dismiss doctor’s cancer claims Liz Szabo, USA Today, 15/11/13
Families run out of hope, money after cancer treatments Liz Szabo, USA Today, 15/11/13
Why we fight for patients Orac, Respectful Insolence, 10/11/13
Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic David Gorski, Science Based Medicine, 11/11/13
Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board Orac, Respectful Insolence, 15/11/13
The Burzynski Empire strikes back David Gorski, Science Based Medicine, 18/11/13
Burzynski blogs: My Master List Josephine Jones
If this has left you feeling moved to take action, please take note of Bob Blaskiewicz’s plea at the end of his TAM talk on Burzynski and patients. You can contact Bob at The OTHER Burzynski Patient Group site.
The Houston Cancer Quack site contains useful information on writing about the Burzynski Clinic.