The Houston Cancer Quack

After more than 2 years of legal proceedings, the Texas Medical Board publicly reprimanded Houston cancer quack Stanislaw Burzynski. Though the sanctions handed down were less severe than those recommended by the Medical Board’s lawyers, they may yet go a long way to protect patients from some of the worst abuses of the Burzynski Clinic.

The Board Staff, following findings from the Administrative Law Judge who oversaw the lengthy proceedings, had recommended that Burzynski’s license be revoked, but to stay the revocation pending four years of monitoring, in addition to $360,000 in fines and compensation to former patients. At the hearing, the Board voted to reduce the fine to $40,000 and to suspend Burzynski’s medical license; they then stayed the suspension as a way to guarantee him due process when he messes up. $20,000 dollars will go to a single patient. (All but one of the patients identified in the Board’s main complaint are dead and are unavailable for comment.)

According to a press release from the Medical Board, reported in the American-Statesman:

“Among the violations are numerous instances of misrepresenting services billed; failing to supervise and allowing those working in his clinic to misrepresent themselves to patients; and a continued failure of not informing patients of potential risks before and during treatment.”

In November 2013, in the days after devastating FDA Form 483s (investigation notes) that illustrated decades of incompetence at the Burzynski Clinic were released on the web, and just days before the damning USA Today investigation into the Clinic was due to be released, the reporter investigating the Clinic told me about an allegation that I had threatened the Clinic and that it was being reported to the FBI. Apparently, the Clinic was anticipating my appearance in the upcoming article and was trying to get ahead of the coverage. If you can’t fight the message, I imagine, attack the messenger. And, if you are about to be ripped apart on the front page of the paper with the highest circulation in the country, make sure that the FBI has launched a criminal investigation into your critics to make it seem like you are being threatened by dangerous people, and not merely by curious writers with time to muckrake and a colossal amount of damning evidence.

The only problem with the little scheme is that I was not in the USA Today article. I did not know what was going to be in the article. Skeptics had no means (other than the quality of our own research) to anticipate what the journalist would report. When the article came out, I didn’t recognize the names of any of the experts cited in it.  Every point in that investigation was made and verified by people who were not associated with the skeptic movement.

Bob:

1. DON’T PANIC.

2. DON’T PANIC.  Again.

3.  DON’T TALK TO ANYONE.

4.  Let’s talk.

Can you talk by phone this afternoon?

1.  Don’t panic.

2.  Realize it’s not as bad as you fear.

3.  Stop doing any bad things you are doing. [For the record, I wasn’t doing anything bad.]

4.  Do any good things you can do, as approved by your legal adviser.

5.  Don’t panic.

6.  Don’t talk to people about it.

7.  Don’t panic.

Cool.

Should I continue to write about the Clinic and its various shenanigans? Do I do a report on the [USA Today article, which was out by this time] for Virtual Skeptics tomorrow night, which I’m sure people are expecting? Does that count as good?

Yes.  Absolutely. […]

I got a call from a number in Atlanta that I did not recognize, picked it up, and a recorded voice said, “The FBI reports [my heart stops] that a house is broken into every 6 minutes. We will be happy to put a free sign in your yard indicating that you have a home security system. Just provide your address… [heart starts up again]. *click*”  Not cool, telemarketers, not cool. […]

Sorry, but I lol’ed. That’s why you can’t panic.

OK.  Talked to him.  He was friendly. He was asked by another office – he didn’t specify which one – to contact you.  Probably Texas.  I explained I represent you and would coordinate any response, and invited him to give the other office my name and phone number.  He didn’t seem familiar with why he was asked to reach out to you.  Though one cannot be certain, that strongly suggests they aren’t gunning for you.  So:  for now I will wait for a call.  If anyone contacts you, politely say, “I’m represented by an attorney, Ken White at [phone number] and I’d like to talk to him, or you are free to call him.  I’m not going to speak without him.”

Update.  Got a call from an FBI agent in Texas.  He was very casual.  The phrase “looks like a First Amendment issue, but we just have to check things out” was used.  That’s encouraging.

It turned out that the Burzynski Clinic had complained to the FBI about my web show, The Virtual Skeptics. As I described the relevant clip to Ken:

I was reporting on the FDA’s 483s […], which revealed a host of violations including overdoses, destroying tumor measurements, all sorts of horrible stuff. I was conveying the idea that the revelations were devastating to the clinic and that Eric Merola had to re-cut the ending of his new movie, and I used an iPad special effects app to show a missile strike on the clinic.

To Whom It May Concern:

Please allow Mrs. Carolyn Powers to file the complaint with the FBI while I am away in San Francisco at a conference. It was extremely disturbing to find out the latest of what Mr. Robert Blaskiewicz would like to do to us. He seems like a psychopath that will not stop until we are dead and the Burzynski Clinic is destroyed. He has harassed me and my clinic for years.

Thank you for your help,

Stanislaw R. Burzynski, M.D., Ph.D.

If you want to see why we are so appalled by the Burzynski Clinic in the first place, read the story of Burzynski patient Amelia S.

On November 19th, the Texas Medical Board made its opening statement in the matter of the Board vs. Stanislaw R. Burzynski, to begin the long-delayed disciplining of a notorious cancer quack. It should be noted that this is not a matter of Big Pharma vs. Burzynski or the FDA or other moneyed interests vs. Burzynski, as many who hold Dr. Burzynski to a lower standard of evidence than other researchers claim. The current action came about because patients complained to the Board about what they experienced at the Clinic. It’s not Burzynski vs. Big Pharma. It’s Burzynski against his own patients. Those who are calling for the proceedings to end are actually opposing the right of cancer patients to demand the minimal standard of care.

The following text is a transcript made from a recording by a member of the Skeptics for the Protection of Cancer Patients who attended the proceedings. The Board’s case was made by Mr. Lee Buckstein.

Ladies and gentlemen:

Dr. Sidney Farber, after World War II, worked in a basement of Boston’s Children’s Hospital trying to come up with a medicine for children who had leukemia, which was a really horrific death sentence for children. He’s acknowledged and it’s widely undisputed that he is one of the world’s pioneers of cancer chemotherapy. His successes made him one of the most respected members of the medical community and took him from the basement to an office with a grand view of Boston Harbor across the river into Cambridge. Today there are buildings named after Dr. Farber on both sides of the river. The list of Nobel Laureates that came out of Dr. Farber’s cancer research program is long. Despite all the accolades, Dr. Farber was more concerned with his frustration with the apparent resistance of cancer cells to each new medication he found. His proteges Dr. Emil Frei and Dr. Emil Freireich proposed the idea of combination chemotherapy. It was was a combination of medical punches to floor the cancer long enough for the immune system to finish it off. Dr. Farber’s overriding concern was protection of the patients from the side effects the toxicity of the ingredients in the cocktail of drugs. This cocktail they came up with was called (BAM), almost insidious, but the two young physicians under Dr. Farber’s supervision insisted that they would do everything possible to protect the patients. Still Dr. Farber initially showed Dr. Frei and Dr. Freireich the door.

But ultimately they worked out this fundamental tenet of cancer research. Protect the patient from the disease AND the cure. The principles that were developed in their combination treatment research became the cornerstone, the standard for cancer research all over the world. These principles for physicians involved in clinical investigations evolved into the study designs, the requirement that biostatistically significant data and appropriate objective analysis to backup conclusions. These principles for physicians involved in clinical investigations evolved into the standards for Phase 1, Phase 2, and Phase 3 trials for innovative treatments. We’ll be talking a lot about Phase 1, Phase 2, and Phase 3 in this trial. Phase 1 a small number of patients to determine the parameters of safety. Phase 2, a larger number of patients to determine whether safety and efficacy support a decision to move on to Phase 3. And finally Phase 3, studies of several hundred, at a minimum, several hundred patients in randomized trials with control groups of patients receiving a standard treatment. The bargain that Dr. Frei and Dr. Freireich struck with Dr. Faber was to engage the discipline of science to objectively pursue data for an objective evaluation while protecting the patients as much as possible.

And this was as a time when all 3 doctors knew that most their patient subjects would suffer from the disease and the treatment and then die. The fundamental principle in their bargain was that the patient with their family would have a choice if they entered into the frontier of cancer research. There was no deception that the choice was between life and death. the choice was between a more comfortable demise or being part of the journey forward toward a cure for tomorrow’s patients, tomorrow’s children.

The only thing that made this choice acceptable to Dr. Farber, Dr. Frei, and Dr. Freireich and the medical professional community was the discipline of science, the promise that doctors involved in research would honestly follow the the guidelines involved and this is where Dr. Burzynski departed from the promise of the medical professional community a long time ago. Consistently as will be shown through testimony and documents in this case, Dr. Burzynski has supervised, directed and controlled activities that are clinical research, human experimentation, clinical investigation in such a way as to masquerade as the discipline of science. The care of the patients in this case the conduct of Dr Burzynski and his clinical studies as both doctor and investigator, the manipulation and influence on the institutional review board that is supposed to be policing him, the publications and reports on his treatment of patients and his misleading promotional marketing statements about his treatment of patients with cancer all represents a breaking of the promise made between Dr Farber, Dr. Frei and Dr Freireich. I have lost count of the times that Dr Burzynski has insisted that he should be awarded the Nobel Prize for his treatment of cancer patients. Scientists do not with the Nobel Prize by cheating their way into it, and it is cheating. The frontier of science is where the medical professional community insists that the real discipline of science be applied at patients. Dr Burzynski and his witnesses will describe the frontier of science as the Gold Rush, where anything goes, especially unloading entire arsenals of medications on naieve and desperate cancer patients and families almost all in uses of these medications unapproved by the FDA and unproved by the accepted process of Phase 3 study and peer review in the general medical professional community. The frontiers of science are not a wilderness or a wasteland. The discipline of science is not the guile of a gunslinger. No matter how many cancer tumors Dr. Burzynski seems to shrink, or even kill with his magic bullets, Dr. Burzynski and his witnesses will explain how they can observe test tubes and petri dishes full of dead cancer cells and cell cultures and know exactly what happens on a genetic and molecular level inside the body of a living human being, a living cancer patient. They might as well just tell you that he uses magic bullets. Dr Burzynski and his witnesses will describe the frontier of science as a place where the end justifies the means. The frontiers may be the range of true pioneers such as Dr. Farber, Dr. Frei, and Dr. Freireich, but it is not the Wild West. So Board staff will not be focused on Dr. Burzynski’s magic bullets. Board Staff will be focused on the allegations in the second amended complaint. Those are the facts, along with the supporting facts the board staff is required to prove by a preponderance of the evidence, and I’m going to summarize what we are going to talk about.

First of all, misleading patients to form expectations about the outcomes for treatments of cancer, and this is a violation of section 164.05285 of the Texas Medical Practice Act forbidding unprofessional dishonorable conduct that is likely to deceive or defraud on injure the public. And subsequent to board rule 19.8i Using false misleading and deceptive advertising.

Secondly, Dr. Burzynski’s failure to meet the standard of care in evaluation and treatment of patients A through G this is a violation of section 164.05186 of the Texas Medical Practice Act failure to practice medicine in an acceptable professional manner consistent with public health and welfare further defined by Board rule 190.81a failure to meet the standard of care and 190.81c which is the failure to use professional diligence. It’s also a violation of section 164.05385 prescribing or administering a drug or treatment that is nontherapeutic in nature or nontherapeutic in the manner in which it is administered.

Thirdly, Dr. Burzynski’s failure to adequately document medical rationale for the coding and billing of medical services of his patients, the patients in this case, and actually this is only applying to the patients for whom we have coding and billing, which is patients A through G. This is a violation 164.05285 committing unprofessional or dishonorable conduct and it’s further defined by Board rule 190.82j providing medically unnecessary services to a patient, or submitting a billing statement to a patient or a third party payer that the licensee knew or should have known was improper. It’s a violation of 164.05381 [?] a rule that violates and state or federal law if the act is connected with a physician’s practice of medicine. I realize that there has been a prior ruling as far a federal law but there’s a violation of this section by violating this section by violating section 311.0025 of the Texas Health and Safety Code. And actually part of the statute, section 164.05387 it’s a violation of the Act if you violate section 311.0025 of the Texas Health and Safety Code, including specifically improper billing practices.

Fourthly, Dr. Burzynski’s failure to adequately document who was really making the evaluation and treatment decisions for patients A through G. This is a violation of section 164.05183 and a violation of a Board rule, particularly Board Rule 165.1 by failing to maintain adequate medical records and section 200.3 by failure to follow guidelines for the practice of complementary and alternative medicine.

And then fifthly, Dr. Burzynski’s failure under chapter 200 to meet the ethical and professional responsibilities of a physician involved in clinical investigation. This is for patients A through F, but it’s also for patients G through CC. We, the Board Staff, will be focused on four particular areas. First, the evaluation of tumor response. Secondly, reporting side effects and adverse events. Thirdly, manipulating the process of institutional review board review and approval. and then other unethical and unprofessional conduct related to clinical investigation activities involved in the treatment of patients. This is also a violation of 164.05183 by violation of the Board Rule 200.3, it’s a violation 164.05186 failure to practice medicine in an acceptable and professional manner consistent with public health and welfare, as further defined in board rule 190.a1k, which says if he prescribed drugs and medications in violation of rule 200, it’s a violation.

Sixthly, Dr. Burzynski’s failure to obtain adequate informed consent. This is a violation of 164.05186 failure to practice medicine in an acceptable manner and particularly a violation of Board Rule 190.81h, failure to disclose reasonable alternative treatments to a proposed procedure or treatment and Board Rule 190.81i failure to obtain informed consent from patients prior to performing tests treatments or procedures.

Seventh, Dr. Burzynski’s failure to disclose ownership interests to patients. That’s a violation of 164.05285 unprofessional or dishonorable conduct and that is further defined by Board Rule 190.82h referring a patient to a facility, laboratory or pharmacy without disclosing the existence of the licensee’s ownership of the entity to the patient.

Eighth, Dr. Burzynski practice of medicine by unlicensed subordinates the appearance of the practice of medicine by unlicensed subordinates and inadequate supervision and inadequate delegation. This is a violation of 157.001 of the Act where a delegating physician is responsible for an unlicensed subordinate representing to the public that they are authorized to practice medicine and also the delegating physician is responsible for medical acts delegated to subordinates. It’s a violation of 164.05388 for failure to supervise adequately the activities of those acting under the supervision of the physician. It’s a violation of 164.05389 delegation of professional medical responsibility or acts to a person who is not qualified by training, experience, or licensure to perform the responsibility or actions.

Ninthly, and this is the ninth and last enumeration, Dr. Burzynski’s misleading promotional statements to the public, including articles describing the results of Dr. Burzynski’s clinical investigations, this is a violation of 164.05285 unprofessional or dishonorable conduct and particularly a violation of board rule 190.82i, using false misleading or deceptive advertising.

Today Dr. Fost will explain why Dr. Burzynski’s conduct, practice model, clinical investigation model and public marketing statements are cheating the discipline of science. Tomorrow Elaine Kloos the coding and billing expert will explain how Dr. Burzynski and the employees under his supervision, direction, and control cheated in coding and billing for patients A through G. Monday, Dr. Wetmore will explain the details of how Dr. Burzynski and the employees under his supervision, direction, and control cheated on the standard of care, and how Dr. Burzynski’s conduct, practice model and clinical investigations model, and public marketing statements are cheating. Tuesday Patient F and his wife, and Wednesday Patient A’s wife, will testify how they got cheated by Dr. Burzynski and employees under his supervision, direction, and control.

Remember Dr. Farber who I introduced at the very beginning of the opening. By the way the cancer hospital at the Boston Children’s Hospital was renamed the Sidney Farber Cancer Center in 1974. Dr. Farber, in his office, high above the Boston Children’s Hospital parking lot, Dr. Farber showed Dr. Frei and Dr. Freireich the door when they first faced his skepticism about protecting patients adequately in the rush to advance cancer treatment. If Dr Farber had reviewed this contested case, I am confident that he would show Dr. Burzynski’s cheating the window.

I thank you.

AUSTIN, TX

On November 19th, the Texas Medical Board takes its case against Stanislaw Burzynski to the State Office of Administrative Hearings. The Board alleges that Stanislaw Burzynski, who operates a cancer clinic in Houston, in treating 7 cancer patients (6 of whom are now dead): 1) violated the standard of care, 2) failed to demonstrate an adequate medical rationale for evaluation, diagnosis and treatment, and 3) violated standards of adequate documentation. The TMB also alleges that Burzynski’s practices of medicine: 1) constituted inadequate discussion of treatment alternatives; 2) constituted improper charges for care, drugs, medical supplies and other services 3) constituted inadequate informed consent; 4) aided and abetted the unlicensed practice of medicine; 5) constituted inadequate direction, supervision and control of medical care personnel; 6) constituted improper delegation of medical tasks; 7) constituted inadequate disclosure of ownership interest in a facility to which a patient is referred; and 8) violated the ethical and professional responsibilities of clinical investigators.

In the past, patients loyal to Dr. Burzynski have rallied the press to their cause, and they often believe that they will die if Burzynski loses his license. They often genuinely believe that Burzynski has cured them of their cancer using either his proprietary and experimentally unproven “antineoplastons” or his “personalized gene-targeted therapy,” an untested chemotherapy cocktail + sodium phenylbutyrate (a prodrug for antineoplastons), which Burzynski also manufactures. While these patients’ desperation is real and make compelling interviews, one must always approach personal anecdotes with skepticism, as 1) no anecdote is adequate to prove a medical claim and 2) no amount of bad evidence is equal to a single piece of good evidence–in the case of experimental treatments, large, controlled, and replicated clinical trials.

The fact remains that there are instances of spontaneous remissions in the medical literature for all of the “untreatable” cancers Burzynski’s patients claim he can treat. Burzynski has never shown that his patient response rates are higher than the spontaneous remission rate, or even better than current best practices, in controlled clinical trials. Burzynski has opened over 60 trials since the late 1990s and has published no reputable results (http://bit.ly/60Trials). When the media focuses solely on the few dozen patients who have gone to Burzynski and happen to have survived, they miss the rest of the 8,000 patients Burzynski claims to have treated who are not at the hearing supporting him. Those patients deserve to be remembered too, and their silence is deafening.

For authoritative background on the Burzynski case and the controversy surrounding it, the Skeptics for the Protection of Cancer Patients recommend USA Today reporter Liz Szabo’s thorough investigation (http://bit.ly/USATodaySzabo). For expert commentary on clinical trial design, breast cancer surgeon, translational medicine researcher, and editor of the Science Based Medicine blog David Gorski, M.D., Ph.D., may be reached for comment at SBMEditor@icloud.com.

The Skeptics for the Protection of Cancer Patients is a group of cancer survivors, families, and community members devoted to advancing ethical, promising, and transparent cancer research.

When we last left cancer quack Stanislaw Burzynski, he was facing the Texas Medical Board on some 200 pages worth of charges, which stem in part from patient complaints and in part from documents originally FOIAed by skeptics and publicized by USA Today. As far as I can tell, all of the original charges are still there, but the judge ordered the TMB to slim the charges down to a manageable size. In March, Burzynski lost a large number of motions to suppress evidence, including testimony by FDA inspectors, FDA inspection documents, and the testimony of a former employee that seemed especially damaging to him. These motions generated an enormous amount of paperwork, a huge chunk of the sum total of the legal documentation produced during the proceedings so far. I thought that it must have been expensive. Turns out it was.

In late July, a very surprising document appeared in the public case file at the SOAH website. It was titled, “RESPONDENT’S COUNSEL MOTION TO WITHDRAW”. Rick Jaffe, Burzynski’s attorney for the last couple of decades, was in large part responsible for Burzynski not going to prison in the 1990s. He also helped open the loophole that has allowed Burzynski to profit mightily off the misery of patients by putting patients into FDA-approved clinical trials of Burzynski’s almost certainly worthless patent medicine, which he calls antineoplastons. Burzynski has sat comfortably in this loophole for better part of the last 20 years, not producing convincing results for any of the 60+ trials he opened and charging huge fees for his services. Honestly, I thought Jaffe would be buried in the Burzynski family crypt.

Soon, a new lawyer, Dan Cogdell, started filing motions on Burzynski’s behalf. Cogdell is a criminal defense lawyer who was also part of the original team that kept Burzynski out of prison. He has since successfully defended an Enron executive, and appears to be counsel for the Texas Attorney General, who has been indicted on charges of violating state securities laws.

Anyway, the judge in Burzynski’s case was concerned that it was very late in a very complicated case to be changing lawyers. At all points, as is only correct, the court protected Burzynski’s due process rights. Another administrative law judge heard Jaffe’s explanation in private and decided that Jaffe needed to withdraw from the case. We still did not know why though.

The answer came soon, however, when Jaffe withdrew from another case, that of Greg Burzynski, the apple that did not fall far enough from the tree. Greg is facing very similar charges to his old man’s but that case is fairly early on in the litigation process. Jaffe explained in his motion to withdraw:

Respondent is a vice president and an employed physician at the Burzynski cancer clinic in Houston. The clinic is owned by Respondent’s father, Stanislaw R. Burzynski. Undersigned counsel had represented Stanislaw Burzynski in a related SOAH board case.

Undersigned counsel is taking legal action against Respondent’s employer which might have a material adverse effect on Respondent’s interests as an officer and employed physician at the clinic. As a result of such action, undersigned counsel will likely have a conflict of interest with Respondent, at least until the anticipated legal action is resolved.

And there it was. Rick Jaffe was suing Burzynski. I squeed. So, I went to PACER, a national database of legal filings and periodically checked up to see if there was any more action, and when you look up Burzynski, you see that he is in bankruptcy court for proceedings instigated by Jaffe. Before you get too excited, this is one way a lawyer tells you, “Give me my damned money.” According to the filings at PACER, Jaffe has charged Burzynski almost a quarter of a million dollars and Burzynski is not paying.

Once the judge signed off on the new counsel, the new team started asking for continuances, delays so that they can get up to speed. The Texas Medical Board staff vigorously resisted the notion that a continuance was in order because one of the conditions for Burzynski changing counsel was that that it would not alter the trial schedule. Also, as the TMB noted in their objection:

There is no hardship involved in this scheduling, because Respondent has already had years, not months of notice; years, not months of opportunity for discovery; years, not months of delays in being held accountable.

The TMB also mentioned that one of the witnesses, Patient E, had died during previous delays.

In the motion for the continuance, the Burzynski team went so far as to suggest that perhaps Jaffe had hurt Burzynski’s case deliberately:

Additionally, Mr. Jaffe has now led suit against Respondent in the Bankruptcy Court in an attempt to force an involuntary bankruptcy for the Respondent. It is Respondent’s belief that Mr. Jaffe has taken actions to undermine Respondent’s position in this case, all of which prejudices Respondent and his ability to properly prepare his defense.

The TMB challenged this characterization:

When Respondent claims that Mr. Jaffe cast a shadow and concem regarding his actions in his representation of Respondent in this matter, that’s just another way of saying that somebody thinks that Mr. Jaffe did a really bad job as Respondent’s attorney.

Perhaps one of the most interesting and surprising items in the motion for a continuance, was the Burzynski team’s request for mediation:

Finally, Respondent desires to have this case mediated prior to a hearing on the merits in the hope that the pending issues can be resolved amicably with the Medical Board’s Staff, as opposed to proceeding to a full trial on the merits.

This could be another stall for time or it could be an indication of how weak Burzynski thinks his case is. But the TMB was not having any of it:

Board Staff’s Complaint in this case sets out Respondent’s egregious, unethical, unprofessional conduct that includes serious violations of the standard of care and a systematic practice set up for Respondent to avoid responsibility for his clinical decision making, the adverse effects of his treatment decisions, his direction of his unlicensed employees to mislead patients into believing that they are being treated by licensed physicians and his failure to appropriately and adequately supervise the employees under his direction and control. Respondent made no previous attempts to even inquire about mediation, but under these allegations, it is difficult to see any prospect that has not already been repeatedly communicated to Respondent’s counsel, former and current. If there was ever a time for the mediation process at SOAH, it has long passed. If Respondent wishes to make an offer of settlement, Board Staff will appropriately handle it, but that is no reason for delay in this proceeding.

The judges stood by the original schedule that they had set for the rest of the proceedings. According to the scheduling order, the hearing on the merits will begin at:

9:00 a.m. on November 19, 2015, at the State Office of Administrative Hearings (SOAH), 300 West 15th Street, Fourth Floor, Austin, Texas, and will continue through November 25, 2015, before recessing until January 19, 2016, when it will reconvene at 9:00 a.m. and continue through January 29, 2016, if necessary.

Why do we mention the time/dates? In the past, Burzynski’s supporters have shown up to all of his legal proceedings in the past, truly believing that if their doctor loses his license or goes to jail, they will die. They’ve been very effective at persuading media to cover them favorably, and there has never been a skeptical voice present to answer questions for the media. Honestly before now there have never been enough people aware of what’s happening at the clinic to mount an effective skeptical showing. I’m asking for volunteers in the Austin area to go to the State Office of Administrative Hearings on the morning of Nov. 19th and exercise their right to protest the ongoing travesty that is the Burzynski Clinic. If you are interested, please contact The Skeptics for the Protection of Cancer Patients via email at SkepticsProtect@gmail.com or through their Facebook page, and we’ll make arrangements from there.

If you are in the Austin area, please come out to speak for those patients who are silent. It’s probably the most important thing that skeptics can do.

For a quick background on Burzynski and his dubious treatment you can do no better than David Gorski’s 2013 TAM presentation:

https://www.youtube.com/watch?v=kxLJhZ1MTBQ

And my follow up, where we put some faces to the misery and discover some additional horrors about the Burzynski Clinic:

https://www.youtube.com/watch?v=NqA5eWjr4pk

The Skeptics for the Protection of Cancer Patients is a group of cancer survivors, family, and community members devoted to advancing ethical, promising, and transparent cancer research. For more information, visit thehoustoncancerquack.com or the SPCP Facebook page.

Exciting news. The Center for Inquiry has picked up the Burzynski issue and is devoting resources to our fight against Burzynski’s inane and exploitative medical adventurism. Today, they sent a letter to the officials at the FDA who were apparently responsible for the recent decision to allow Burzynski to reopen his endless, unrevealing, but highly lucrative clinical trials. They also sent the letter to USA Today.

Please write to your congressional representative about Burzynski, and feel free to read through and adapt the CFI letter for the text of your communication with your rep. Report any replies you receive to skepticsprotect@gmail.com.

Also, we are STRONGLY encouraging skeptics to contact Sen. Claire McCaskill’s office. Sen McCaskill was the one who brought Dr. Oz in front of her committee last week. You can use her consumer protection alert page to encourage the office to take this issue seriously. St. Louis skeptics had a meeting with her staffers last week, so they know what our complaint is. We would like you to just let them know that you are excited about their involvement and that it really is a worthy use of the Senator and her staff’s time.

Sign our Change.org petition!

OVER 100 OVERDOSES AND ALL BASELINE SCANS “DESTROYED”

In November, the FDA released inspection notes from a visit to the Burzynski Clinic that took place at the beginning of last year. The owner, Stanislaw Burzynski, has claimed for over 35 years to have a proprietary treatment that treats the most deadly brain cancers (as well as AIDS and a whole host of other unrelated diseases). He has been distributing these drugs under the auspices of “clinical trials” for over 15 years. Of the over 60 trials that Burzynski opened he has completed and published exactly zero.

The latest FDA observations are damning in the extreme. For instance:

• Burzynski (as investigator, the subject of the inspection) “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 defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.
• Additionally, some patients admitted failed to meet the inclusion criteria for the study.
• Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found.
• Patients who had Grade 3 or 4 toxic effects were supposed to be removed from treatment. 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.
• Burzynski did not report all adverse events as required by his study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported. There are several similar patients.
• 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] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
• “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.” This is one of the most damning statements, as without any…not a single baseline measurement…there is no way to determine any actual effect of the antineoplaston treatment. This means that Burzynski’s studies–which by last account cost $30,000 to begin and $7000 a month to maintain–are unpublishable.
• Some adverse events were not reported to the Burzynski Clinic IRB for years. (One patient had an adverse event in 1998 and the oversight board did not hear about it until 2005.)

Since the release of this information, the Burzynski Clinic has been the subject of a USA Today feature which chronicled his abysmal research track record and failure to produce meaningful results. Now that Burzynski is facing sanctions with the FDA and the Texas Medical Board, it is time that skeptics acted to make sure that this Teflon quack does not get off again. Please sign our new petition. The Skeptics for the Protection of Cancer Patients will see to it that your signature makes gets in the hands of lawmakers.

Sign our Change.org petition!

*Congressional feedback submission form is at the bottom of this page* 

Now that Burzynski’s failure to help patients has been thoroughly documented by USA Today, it is important that skeptics and patient advocates seize the opportunity to press Capitol Hill to take action and investigate how it was that a quack like Burzynski was able to charge patients, their families, and their communities for an unproven and supremely unpromising therapy for decades.

To do this, you must write your representatives in the House and Senate and ask them to launch an investigation. We don’t mean “send them an email.” We need you to send in an actual physical letter to their office and follow it up with a phone call or a visit to their local office. Usually their contact info is on their office website. You may want to send your letters to your reps’ DISTRICT offices, as there may be delays of several weeks sending letters to Capitol Hill due to security screenings. Alternately you may fax them.

We are providing a couple of documents for your convenience, and we hope you use them. First, we have a draft letter to your congressperson you can use, but you should tailor it to your representative. Go to their website and find out which committees that they are on. If they are on a science, research, or oversight committee, you want to make the case that their committee has a stake in the outcome. Also, check their Wikipedia biography to see if they are a cancer survivor. This is crucial, as we will follow up on promising leads. Also, when you report in, note which staffer in the representative’s office you’ve been referred to and any details about them that you think might help us craft persuasive communications (for instance, a family member with cancer, if they mention it). You can send all that info to skepticsprotect [at] gmail [dot] com.

Besides your modified, personalized letter, we ask you to send along a physical copy the 483s, the FDA’s documentation of all the Clinic’s research protocol and ethics violations for the last decade. Lastly we ask you to include the most recent warning letters that were sent to Burzynski and to his Institutional Research Board. We want those documents and the horrors they contain in the hands of our representatives. And we want them to act.

In your letter, ask for an investigation and remember to set aside time on your calendar in two weeks to call your representative and follow up. Ask specifically if they will support an investigation of how the FDA allowed Burzynski’s research to go unimpeded for decades despite ample warnings and horrific site reviews.

Please check the Childhood Cancer Caucus to see if your representative is a member. Burzynski has claimed that his antineoplastons can cure even the most devastating and difficult childhood brain tumors, including brain stem tumors. His track record of experimentation on children–and his lack of results to show for it–should be investigated, and these congresspersons will be crucial.

The key committee regarding this matter in the House is the Committee on Oversight and Government Reform, and we certainly recommend that you look and see if your representative is on that committee. But you can also approach the committee itself (or the Subcommittee on Energy, Health Care and Entitlements) for an investigation into the FDA’s continued approval of Burzynski’s catastrophically flawed trials. Send your documents here:

Committee on Oversight and Government Reform
2157 Rayburn House Office Building,
Washington, DC 20515
Phone: (202) 225-5074 Fax: (202) 225-3974

In the Senate, your best bet is the Committee on Health, Education, Labor and Pensions. If your senator (listed below) is on one of these committees, please take special action and write to them.

Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

Democrats by Rank

Tom Harkin (IA)
Barbara A. Mikulski (MD)
Patty Murray (WA)
Bernard Sanders (I) (VT)
Robert P. Casey, Jr. (PA)
Kay R. Hagan (NC)
Al Franken (MN)
Michael F. Bennet (CO)
Sheldon Whitehouse (RI)
Tammy Baldwin (WI)
Christopher S. Murphy (CT)
Elizabeth Warren (MA)

Republicans by Rank

Lamar Alexander (TN)
Michael B. Enzi (WY)
Richard Burr (NC)
Johnny Isakson (GA)
Rand Paul (KY)
Orrin G. Hatch (UT)
Pat Roberts (KS)
Lisa Murkowski (AK)
Mark Kirk (IL)
Tim Scott (SC)

During the upcoming winter recess, you might want to stop by your representatives’ district offices. From experience, I know that these offices are congenial places and the staff is genuinely interested in hearing from constituents. It would be positively outstanding of you to sit down with a staff member and walk them through the FDA documents.

When you have contacted your reps, fill out this form to report on your interaction with your representative so we can follow up in the best way possible. One submission per congressional office contacted, please. Send questions and supporting documents to rjblaskiewicz [@T] gmail [d0t] com.

(*UPDATE* We are getting reports that people who are submitting their letters via the web are generally not able to attach the documents and are being shrugged aside. This is why we are asking you to send the documents via snail mail.)  

• If you are not too familiar with the Burzynski case, for the layman’s introduction, please read: http://disinfo.com/2012/11/stanislaw-burzynski-and-the-antineoplaston-scam/ 
• For an introduction to what was released last week, read David Gorski’s: http://scienceblogs.com/insolence/2013/11/11/the-fda-reports-on-its-investigation-of-the-burzynski-clinic-and-burzynski-research-institute/
• For a semi-technical intro to Burzynski’s cash cow, antineoplastons, read: http://scienceblogs.com/insolence/2011/12/12/what-dr-stanislaw-burzynski-doesnt-want/
• Gorski’s review of the original Burzynski Movie is also extremely useful for understanding how the Clinic operates: http://scienceblogs.com/insolence/2011/11/29/burzynski-the-movie-subtle-its-not/
• The best summary of what we’ve found as we’ve researched the stories of patients who did not make it is this TAM talk: http://www.youtube.com/watch?v=NqA5eWjr4pk
• Lastly, we have collected all of the patient stories that we have been able to find at The OTHER Burzynski Patient Group. For a representative case that summarizes some truly, truly disturbing behavior, please see the case of Levi G.

To skeptics outside of the US who want to help, you can write about Burzynski. We have a page that shows how to boost good information into the searches that Burzynski ranks well in. Please use those same strategies to link to the USA Today article. Another possibility is for skeptics with expertise in languages other than English to contact Susan Gerbic’s Guerrilla Skepticism on Wikipedia to see if they need anyone to translate the Burzynski page into those languages–Burzynski appeals to desperate people all over the world. If you know someone who could translate his page into Chinese, for instance, that would be wonderful.

Any questions can be can be directed to skepticsprotect [at] gmail [dot] com. You can leave tips in the comments of this page.

Thank you in advance for all you are going to do.

On March 7th, PBS station CBT12 in Colorado is going to air the hagiographic Burzynski: Cancer is Big Business. CBT12 is notorious for using conspiracy theories to raise money at pledge time. It’s a cheap tactic. Last year, they aired the AE911 Truth movie during pledge week. It’s lucrative. Most conspiracy theorists, while they openly distrust mainstream media outlets, seem to yearn for the respectability that comes from being broadcast on them. And when their stories appear on CPT12, and I say this because the station continues to push this garbage, it seems that the conspiracy theorists reward the station.

I have come to expect the exploitation of ignorance on the part of CPT12. When it’s a truther movie, well, it makes PBS look bad, but that’s about it. But this movie has led so many people into Burzynski’s clutches, gotten so many patients entangled in his unpublishable trials and quack “gene therapy”, that I can say with a high degree of confidence that CPT12 is BANKING ON ITS VIEWERS’ LIVES.

Worse, at the breaks in the film, Eric Merola, the guy who contacted my employer in December, will be appearing alongside a spokesperson for the clinic to talk to the station’s fundraising director. This is unacceptable. Nonetheless, CPT12 has taken down misleading alt med propaganda before, so it is worth taking a strong stand and lobbying that they follow precedent and take this down.

Most importantly, one should contact Colorado state legislators who are also cancer survivors and alert them to this upcoming travesty, including state senator and esophageal cancer survivor Rollie Heath (rollie.heath.senate@state.co.us, (303) 866-4872, fax: (303) 866-4543) and state representative and breast cancer survivor Dianne Primavera (dianne.primavera.house@state.co.us, (303)-866-4667).

You might also contact the station, and demand that they either change their schedule or have an independent physician appear with Burzynski’s toadies. You know, because it’s a medical issue and a movie director and PR guy can’t add anything meaningful to the discussion.

Shari Bernson (she’s the host between breaks)
Director of Development
sbernson@cpt12.org

Willard “Wick” D. Rowland, Jr
President & CEO
wrowland@cpt12.org

Station:  (303) 296-1212
Toll-Free:  1-800-727-8812
Fax:  (303) 296-6650

Also, please register a complaint with the PBS ombudsman about the movie being aired at all and this weird little station’s repeated tarnishing of the name of public broadcasting:

http://www.pbs.org/ombudsman/feedback.html

We are making only reasonable, responsible requests. PLEASE follow through and contact the station and the PBS ombudsman.