Since there is a formal letter writing campaign to the FDA to have Burzynski’s “clinical trials” investigated, I thought that I would post the letter I just snail mailed. (F*ing stamps, how do they work?) You will see some of my earlier post in this letter, but the FDA needs to recognize that Burzynski is openly and flagrantly making a mockery of US drug development regulations and scientific standards in front of the entire world.
Constance Lewin, M.D., M.P.H.
Branch Chief, Good Clinical Practice Branch I
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5354
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA
Dear Dr. Lewin:
I am writing because I am deeply concerned that the FDA has not fulfilled its mandate to regulate clinical research trials in the matter of the Burzynski Research Institute (9432 Katy Freeway, Houston, Texas 77055). Stanislaw Burzynski has been injecting cancer patients for years with “antineoplastons,” a derivative of urine, for well over 20 years and exacting exorbitant sums of money up-front (tens to hundreds of thousands of dollars per patient), yet he has never produced a single study that has stood up to peer-review. How can the FDA allow this unpromising line of research to continue?
It is my understanding that a warning letter was sent to the Clinic’s IRB in 2009 for breaching good clinical practice standards on multiple accounts, but that no further investigation has been undertaken. Why has this happened? Furthermore, all the while he has been claiming to his patients that he has a 30-50% cure rate (see below). But where are the studies? Why isn’t the FDA demanding the studies before authorizing further research?
If you take a look at the public record, Dr. Burzynski has assembled quite a record of getting people to raise enormous amounts of money for desperate causes that usually end in failure. In fact, every single patient that I have found in media coverage of Burzynski for the past 10 years, with a sole exception, is dead.
- On Nov. 1, the Irish Times reported that one patient had to raise EUR 50,000. Keith Gibbons’ friends are still trying to raise money, but I’ve seen no update of his progress. [UPDATE: I am sad to report that Keith died in Dec 2011]
- On 26 June, 2011, The News of the World reported that the parents of Zoe Lehane Levarde were trying to raise 1 million for treatment at the Burzynski Clinic (1 million to get into a drug trial?). Zoe is now dead.
- On 5 June, The Sunday Express reported that Luna Petagine needed to raise $20,000 to just find out if she was eligible for Burzynski’s unproved treatment.
- In January of last year, an 8-year old girl from Australia, who had raised $135,000 for treatment, died, according to the West Australian.
- The Evening Standard reported on 23 July that Wayne and Zorzia intended to take their son to the Burzynski Clinic. According to the article: “The clinic says its antineoplaston therapy, which targets cancer cells without destroying normal cells, could give Fabian a 30 to 50 per cent chance of survival. But the treatment will cost £100,000 for the first year and is not eligble for NHS funding. A spokesman for Great Ormond Street Hospital said there was no medical evidence to suggest it would be more effective than chemotherapy.” The poor kid died that September, having only raised $50,000.
- In March 2005, the Montreal Gazette reported that a five-year old girl, Raphaelle Lanterne, died after her parents went against medical advice and saw Burzynski.
- In October 2003, The Gazette reported that the parents of Antonio Luk were looking for $200,000. I found that his foundation raised $30,000. Treatment was $10,000/month. Antonio died in 2004. Featured in the same article was teenager, Wesley Stefanik, another patient of Burzynski, who it seems also succumbed to his cancer.
- On 29 September 2002, the Dallas Morning News reported that Burzynski patient Christian Titera’s costs were $13,000/month. The family raised $61,000. He died in April 2003.
- On 21 April 2002, the New York Daily News reported that Taylor Mouzakes’ family was paying $10,000/month. Taylor died in 2006.
- Mirjam Binnendyk, 24, went to Burzynski’s clinic, reports the Montreal Gazette in 2001, and she was happy with the treatment at the time, though the $200,000 price tag was an out-of-pocket expense. She appears to have died in 2008, but I have not been able to pin down the year.
- Brandon Hamm, reports the Dallas Morning News on Feb 17 2002, was delivered into the care of Burzynski. It cost his family $13,425 to begin treatment. “‘I just hope this treatment at the Burzynski Clinic has him up and running in a year like the other children I read about,’ said Ms. LeJeune [Brandon’s mother], referring to testimonials on the Burzynski Clinic’s website.” He died the next day, and the death was reported in the paper on the 20th.
- From the Globe and Mail, 9 March 2000:
“Jean and Tom Walsh also found Dr. Burzynski on the Internet. Their 26-year-old daughter, Andrea, had also been diagnosed with a fast-growing brain tumour. They borrowed $16,000 to start her treatment, then borrowed more. Andrea suffered severe side-effects, including high fevers, disorientation and constant thirst. When Jean complained, the nurses told her these were signs the tumour was breaking up. A few weeks later, she was told that Andrea would soon be back to work. “I can’t tell you how happy we were,” Jean recalled. Her daughter died two days later, on the plane on her way home. That was 2½ years ago. Jean and Tom are still paying off their debts.”
- In the same article, the Globe and Mail reports that Rosmari Brezak, whose treatment was projected to cost $300,000, after five weeks in treatment at the clinic, had a massive seizure and lapsed into a coma. She died on March 9.
- The St. Petersburg Times of 3 Feb 2000 said that the husband of 29-year old Tracy Bolton was attempting to raise $10,000 to take his wife to Burzynski. When she died on the 9th, her husband was reported by the Times as saying: ”If only we had gotten the money a week sooner, we would have been out there.”
- Norma Chaimberlain of Cardiff, reported The People on 26 July 1998, was receiving £4000/month supplies of intravenous antineoplastin, and her family was tasked with raising the projected £90,000. She did not live through the year.
Need I go on? If the FDA is to play an important role in the development and maintenance of public safety, it must vigorously pursue practitioners whose methods are no more scientific than those of the goat-gland doctors of old.
I appreciate your urgent attention to this matter and look forward to hearing from your department.
Thanks to Rhys for retweeting this post. If you would like to give to a REAL kids’ cancer charity, one that turns nobody away, even if they can’t pay (unlike Burzynski), please consider giving to St. Jude’s. Let’s turn this cancer quack into an asset!