Texas Medical Board’s Opening Statement

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.

 

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