As regular readers of this blog know, I have cancer, and I believe the law should show no mercy to people who exploit cancer patients and their loved ones. While it's hard to imagine that someone could be so heartless, there are people in the world who profit from our fear, and the lack of education around science and evidence-based medicine. The result of this cruelty: our suffering and death.
One doctor who has been long the target of such "false hope" concern is Stanislaw Burzynski, of "antineoplaston" fame. The Houston-based provider was recently featured in a major investigative takedown in USA Today reported by health journalist Liz Szabo.
Today, Skeptic and pro-science crusader Robert Blaskiewicz shares news of thehoustoncancerquack.com, a new online campaign calling for a congressional investigation into the Burzynski Clinic, and an examination of why the FDA's reviews of their operations have led to little more than hand-slaps. Why is this guy still in business?
Robert Blaskiewicz writes:
The FDA recently released observation notes from a site inspection of the Burzynski Clinic in Houston, Texas. Stanislaw Burzynski is known for discovering, developing, manufacturing, prescribing, and dispensing (at an in-house pharmacy) a substance he calls "antineoplastons" (ANP), which he says can cure some cancers, including some difficult and devastating brain stem tumors.
Burzynski has also prescribed antineoplastons as an AIDS and lupus treatment.
In the mid '90s, during a trial that included 76 federal indictments, Burzynski's legal team struck a deal with the FDA that stipulated that he could only dispense antineoplastons as part of clinical trials. He promptly opened a huge number of clinical trials.
According to his lawyer: "Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future."
Burzynski charges an enormous amount for the treatment, by recent accounts $30,000 to start and $7,500 per month thereafter. While patients may technically receive antineoplastons for free, the fees involved with being on this clinical trial are highly irregular.
Initial estimates for the cost of treatment run into the hundreds of thousands of dollars, and as most insurance companies don't cover the costs of this unproven, unpromising treatment patients and families raise that money in any way they can, often reaching out to their communities for donations.
Most worrying is that of his more than 60 trials registered on the clinicaltrials.gov website, only one is listed as completed and it remains unpublished. From the point of view of cancer researchers, the status of research into antineoplastons as a cancer treatment is for all intents and purposes exactly where it was when the first trials were approved in the mid-1990s.
This year, the FDA's inspectors found a host of unthinkable research violations in Houston:
1) The FDA told Burzynski (as investigator, the subject of the inspection) "You failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection." This means that several patients who were reported as "complete responses" did not meet the criteria for that outcome defined in the investigational plan, as were patients who were reported as having a "partial response" and "stable disease." No failure to comply with protocols for "progressive disease" are noted in the FDA's observation report, only the outcomes that would suggest that ANP have had a therapeutic effect.
2) The FDA told Burzynski: "You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [….] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects." [emphasis added]
3) The FDA observed that patient records showed that many overdoses were not included in the Hospitalization/SAE/Overdose list. Patients who had Grade 3 or 4 (serious or life-threatening) toxic effects were supposed to be removed from treatment, according to Burzynski's protocols. One patient had 3 Grade 3 events followed by 3 Grade 4 events. Another patient had 7 disqualifying toxic events before he was removed from the study. The FDA noted that Burzynski did not report all adverse events as required by his own study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported.
4) The FDA observed: "Your […] tumor measurements initially recorded on worksheets at baseline and on-study treatment […] studies for all study subjects were destroyed and are not available for FDA inspectional review." [emphasis added] This is one of the most damning statements, as without the baseline measurements how can anyone evaluate the outcomes? What respectable journal could possibly publish them?
What is more astounding is that this is not the first time FDA inspectors have noticed irregularities with Burzynski's research practices; this is only the most recent example an uninterrupted, decade-long string of abysmal inspections (available here). Yet no action was ever taken to shut the research down. Indeed, while his clinic producing far more unimpressive inspection reports than completed trials, Burzynski somehow managed to gain approval for a Phase III clinical trial in children with brain tumors! (The trial is listed as withdrawn prior to enrollment.)
On November 15th, these findings, and others, were reported in a fine investigative series by Liz Szabo on the front page of USA Today, who interviewed Burzynski and asked him about criticism. His reply was frightening. According to Szabo:
"Burzynski dismisses criticism of his work, referring to his detractors as 'hooligans' and 'hired assassins.' As for criticism from former patients, Burzynski says, '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.'"
When asked about how Burzynski managed to pursue his research despite the repeated violations of his own protocols, the FDA has refused to disclose any information about how things were allowed to get so bad.
This is unacceptable.
Last week, after nine months, the FDA finally released two warning letters, one addressed to the Burzynski's Institutional Review Board (staffed mostly by Burzynski's pals) and Burzynski himself.
His entire organization seems to have roundly failed to satisfy the FDA that his results are reliable and that his patients are protected. Further, and this is highly irregular, the FDA notes:
The records BRI submitted to FDA on [DATE REDACTED], were not in the files that you provided regarding Patient 022387 during the inspection. However, during the inspection, you provided other Case Report Forms for this patient, with the same titles and for the same visit date as noted above, but containing information that differed from that which BRI submitted to FDA. […] Please explain why the Case Report Forms at your site for Patient 022387 differed from the Case Report Forms that Burzynski Research Institute submitted to FDA's Division of Oncology Products 2.
This is staggering, honestly, and I'm certain that the FDA was not impressed by such imaginative record keeping.
Despite all this, Burzynski will still show up for work tomorrow morning and continue seeing patients, just as he has done for decades.
The Skeptics for the Protection of Cancer Patients, who have collected dozens of appalling stories from Burzynski's patients, are currently pressing for a congressional investigation into the approval process for research done by Burzynski. We want to find out what went wrong and fix it to protect the most vulnerable and desperate cancer patients.
To give you a sense of how desperate these patients are and how badly we need your help to end this, consider the fact that even after the devastating USA Today cover story, patients are still gathering thousands of signatures from well-meaning but uninformed strangers demanding access to the treatment.
What happened in Houston can not be allowed to happen again. We are asking cancer patients, their families, and their loved ones to write to their representatives in Washington, to put the inspection notes into legislators' hands, and to ask them to call for an investigation into the clinic. We've set up a website, thehoustoncancerquack.com, where we have draft letters for your representatives and all the supporting documents that your representatives will need to come to a decision. We also have feedback forms so that we can monitor the responses and run as efficient and targeted campaign as possible.
Besides contacting your representatives, you may also want to contact a certain key committees and caucuses on Capitol Hill. These include the House Cancer Caucus (co-chaired by Steve Israel of New York and Lois Capps of New York), the Senate Cancer Coalition (chaired by Dianne Feinstein), and especially the Childhood Cancer Caucus (co-chaired by Michael McCaul of Texas and Chris Van Hollen of Maryland). It is important to ask members to support more urgent research into rare childhood brain tumors. As it stands, there are not a lot of good treatments for these tumors, and we want desperate parents to feel like they have better options than the hocus pocus in Houston.
If medical professionals decide, after reviewing the evidence, that the Burzynski Clinic represents a danger to public health, they should write to the Texas Medical Board. There are procedures in place that can be invoked in extreme circumstances that could protect prospective patients, but they need to be initiated by either doctors or patients.
As Liz Szabo's USA Today piece made clear, when patients who end up destitute and stranded in Houston with dying children, they often end up at Texas Children's Hospital. The hospital has a charity, the Kangaroo Crew, that flies home children who need continual medical attention free of charge. If you would like to directly mitigate some of the suffering caused by Burzynski's "everything but the squeal" business model of patient exploitation, please donate to the Kangaroo Crew. It would be wonderful to take the misery engendered by the Burzynski Clinic and turn it into something positive for children with cancer this Christmas.
We are also looking to ally ourselves with established cancer patient advocacy and consumer protection groups. Concerned members of the international community can help too by promoting reliable information about antineoplastons and Burzynski online. We have developed SEO-savvy strategies for making good content visible online. Two of our more urgent needs are volunteers to translate Burzynski's Wikipedia page into Chinese, Polish, and other languages. If you can help with this please contact the Guerilla Skeptics on Wikipedia.
Email: You can contact the Skeptics for the Protection of Cancer Patients at firstname.lastname@example.org.
Video: For more detailed background on this issue, please see the "Why We Fight" lectures by me and oncologist David Gorski:
Part I (Gorski)
Part II (Blaskiewicz)