False Claim of Urine Cancer Cure

Dr. Stanislaw Burzynski of Houston, Texas has been treating terminally ill cancer patients with "unconventional" treatments for over thirty years. He has publicly claimed that he can treat inoperable pediatric brainstem tumors. However, Burzynski does not have board certification or formal training in oncology.

One family was told that the treatments would cost around $100,000 out of pocket because most insurance companies refused to cover treatments from Burzynski's clinic.

Burzynski refers to his cure as "antineoplastons" which were originally made from a mixture of blood and urine he obtained from public parks, bars, and penitentiaries, but have been synthesized in a lab since 1980. His treatment has not be cleared by the FDA. One reason it hasn't been approved is that he simply won't file to have it reviewed. Instead, Burzynski refers to it as more of a natural cancer therapy that can be used to treat other medical problems such as AIDS and lupus.

Some of his former patients say that Burzynski did in fact cure them or a relative, but the National Cancer Institute said that there is no evidence that he has cured a single patient. 

In 1995, Burzynski was charged with 75 felony charges for various violations against the Food, Drug, and Cosmetic Act. One of the conditions of his bail was that he could no longer prescribe his antineoplastons. Former patients went all the way to Washington to defend Burzynski's practices. In 1996, the FDA allowed Burzynski to continue to treat patients, but only through an official trial. His indictments ended in two trials that resulted in a hung jury and an acquittal.

In 2012, one of his patients passed away because he had too much sodium in his blood, which is one of the side effects of antineoplastons. Then the FDA told Burzynski that he couldn't give any new children his treatment. Investigators also found that he was inflating his success rate, destroying his patients' original medical records, and wasn't reporting unanticipated problems to the FDA trial board.

Burzynski is going in front of the medical board in January because of a patient who acquired a life threatening blood infection after leaving the clinic to continue her treatment at home. 

Comments from Allen: A lot of people don't like this doctor, including the members of the Texas 3rd Court of Appeals, which affirmed suspension of Dr. Burzynski's license in 1996 for dispensing unapproved drugs, as it stated:

Dr. Burzynski's patients are extremely vulnerable. They will pursue any treatment which provides them with even a glimmer of hope because they feel it better to pursue every possibility rather than resign themselves to the fate that almost certainly awaits. This pursuit of life can at times lead to irrational thoughts, and certain opportunists would not hesitate to prey on their vulnerability. The State of Texas in conjunction with the FDA protects these patients from such exploitation. Although we do not mean to imply that Dr. Burzynski is such an opportunist, neither can we find him to be above the laws written to protect his patients. We will not allow our sympathy for the terminally ill to hinder our duty to uphold the law

Texas State Bd. of Medical Examiners v. Burzynski, 917 S.W.2d 365 (1996).

Having beaten the rap in 1995 in criminal court, and then getting the permission of the FDA to conduct clinical trials, Dr. Burzynski has been able to continue selling hope to the terminally ill for lots of money. Can he be stopped?

I understand the State of Texas is gunshy here, having been beaten twice by Dr. Burzynski's legal team.  Texas tried proving him liable for criminal fraud twenty years ago and failed.  In fact, Dr. Burzynski's fellow physicians in Texas appear to be gunshy about going on the record and stating what they believe about Dr. Burzynski.  My guess is that they are worried about having to defend a slander suit filed by a guy who beat the State of Texas twice in court on this, as there are many reports on the internet that people who have spoken out against this doctor receiving threats of lawsuits from the Burzynski Clinic.

The FDA dropped the ball by allowing Dr. Burzynski to conduct clinical trials of his antineoplastons, but apparently did not spell out how those clinical trials were to be conducted.  One would expect the trials to continue for a fixed period of time with a control group of patients under specific conditions. Instead, the "clinical trials" appear to go on perpetually with no published results of the results of the trials.  The FDA found, recently, some people in these "clinical studies" had just finished chemo therapy; some were stated to be "in remission" after treatment when they were not; some continued to treat (and pay) after they displayed dangerous side effects;etc.

Without following proper controls, the results of any clinical trials are worthless.

I think the doctor is very vulnerable to a civil suit or class action suit by patients who have paid lots of money to participate in this "clinical trial," based on the representation that antineoplastins are a safe and effective means of treating cancer.  The FDA recently sent Dr. Burzynski a letter informing him he is violating FDA regulations by claiming his drugs are "safe and effective" for treating cancer on his website.  Since he has never completed his clinical trial, and has not had the FDA review the results of such a completed trial, and the FDA has not approved antineoplastins for cancer treatment, Dr. Burzynski cannot make that claim.

This making of a false claim in violation of FDA regulations may expose Dr. Burzynski to liability for misrepresentation, something he has avoided forever by making his patients sign an informed consent release.  An informed consent release, when it is effective, is only effective when the information given to the patient is accurate.

Dr. Burzynski would be wise to stop making unfounded claims about his product.

Years ago, Warner-Lambert Co., maker of the mouthwash Lysterine, claimed its mouthwash cured the common cold and sore throats.  In 1978 the Federal Trade Commission forced Warner-Lambert to stop making those false claims.  Lysterine did so.  Despite that, the advertising of curing colds had become so widespread that, even decades after stopping the false advertising, plenty of Lysterine customers continued to buy Lysterine as a cold remedy.

Who knows?  Dr. Burzynski has a lot of fans out there.  Just like Warner-Lambert, if he stops making the claims that his antineoplastins cure cancer, people may still believe it anyway.

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Allen Browning is an attorney in Idaho Falls, Idaho who handles personal injury and criminal defense. He has over 30 years of experience and handled thousands of cases. Allen handles cases from all over Idaho. Call (208) 542-2700 to set up a free consultation if you are facing legal trouble or you have been involved in an accident.

Also, check out browninglaw.net for more information about Allen and Browning Law.

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Sources for more information:
http://www.bbc.com/news/health-22717245

http://www.forbes.com/sites/peterlipson/2013/11/11/fda-documents-paint-disturbing-picture-of-burzynski-cancer-clinic/

http://www.usatoday.com/story/news/nation/2013/11/15/stanislaw-burzynski-cancer-controversy/2994561/