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.
Sincerely,
Robert Blaskiewicz
Atlanta, GA
RJB
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!
Skeptical Humanities 
Heartbreaking stories. This man and his clinic are vampires.
You don’t know both sides of the argument. The only reason very few clinical trials exist (and they do exist) to support the use of antineoplastons is because the FDA wouldn’t allow him to originally by deeming his treatment illegal. Eventually after 14 years in court he won the right to conduct his trials, at which point the FDA took away all his federal funding. I’ve seen numerous people give testimonials as to the fact that his treatment worked for them and their loves ones. So to answer the question of “why does he continue to administer his treatment?” it’s because he believes in saving lives rather than adhering to the money hungry cancer treatment industry.
Funnily enough, I’ve gone into the case in some detail, as have many of those who read this, my and similar blogs. We all reached the same conclusion. There are indeed two sides to this. Either:
– Burzynski has an ineffective therapy which he’s selling at high prices to the desperate via a legal loophole, or
– Burzynski has an effective therapy (although this doesn’t seem to be borne out by survival rates) and, since he has published nothing of value in 35 years, is denying thousands of dying people its benefits in order to earn as much money as possible via a legal loophole.
Sometimes both sides of the argument are equally damning.
Cody, he’s a con man. He’s taking you into his confidence, and he is taking you for all you are worth. Get away from him and get your family members away from him.
THIS DOCTOR IS NOT BEING SUPPORTED BY THE FDA HIS TREATMENT WORKS WITH NO SIDE EFFECTS THE MAN HAS TO CHARGE MONEY FOR IT…THE PHARMACEUTICAL COMPANIES NEVER WANT THIS DOCTOR TREATMENT TO WORK AS IT DOES THEM OUT OF BILLIONS OF DOLLARS AND THEIR CHEMO AND RADIO ACTIVE TREATMENTS WILL BE LOST FOREVER!!!!! WAKE TO F**k UP PEOPLE!!!!! AND RESEARCH A LITTLE…..THE CANCER TREATMENTS WE HAVE APPROVED ARE ONLY GIVING A 5 YR SURVIVAL RATE!!! THE SECRET IS PREVENTION FOLKS NOT CURE!!! LOOK AT POUR DRINKING WATER LACED WITH FLUORIDE ALSO VACCINES LACED WITH A COCKTAIL OF MERCURY AND OTHER CANCER CAUSING TOXINS PLEASE FOR GOD SAKE THINK ABOUT A NEW BORN BABY NOW RECIEVED 72 VACCINES COMBINES BEFORE THE AGE OF 2?????? THIS HELPS THE CANCER BUSINESS…DR BURZYNSKI HAS FOUND THE ANSWER BUT THEY WILL KILL HIM BEFORE THEY ALLOW HIM TO USE IT AND BEFORE THEY WOULD APPROVE OR PATENT IT!!!!!!
[…] Skeptical Humanities: Letter to the FDA about Dr. Burzynski […]
I know that this guy has his supporters, and like Wakefield’s supporters they probably would use FDA intervention as a sign that this guy is being suppressed. His ideas are bunk and obviously harmful. I say screw the FDA shutting him down, this guy needs to go to jail for a very long time. Maybe, while he rots in a cell he can try and grasp the foolishness of injecting people with piss.
Simply ignorant. Maybe you can grasp the foolishness of the derivation of chemo therapy medications- insecticide or the of the fact that chemo and radiation have such horrible side-effects and don’t cure cancer.
If I can show you that his claims are unwarranted, I wonder if you would see him in a different light? Are you open to that possibility?
I agree it is time the FDA got the results of all those supposed “clinical trials”. Its been over 20 years! And then there is of course the ethical question of charging an arm and a leg for “clinical trials”.
Its time “Dr” Burzynski did something or got off the can.
If you have to totally fund the research and all costs of treatment from the patients’ cost of treatment, sure it’s going to cost an arm and a leg. There is no government or major pharmaceutical firm funding of the trial. Decades of patient data give them nothing to get him out of the way of their profit from illness so the keep his program in perpetual “clinical study” wherein they can do their best to thwart him. In their attempts to prosecute him personally, send him to jail, the government did everything it could to keep any facts about his efficacy rate or treatment safety (the substances are formulated, not derived from urine) out of the court proceedings.The FDA even acknowledged it safe and effective (they took all of his patient records on more than one occasion) It took 6 Grand juries for them to get 1 indictment. The $trillions cancer treatment industry, make no mistake about this, is all about treating, not curing cancer. A cure would stop the gravy train they have for treatment! If this works, they have all of that to lose! This treatment profits vs cure dichotomy extends to every other realm of major illness in our medical system making any progress to actual cure of anything much less likely. There’s no real work on any cure for any of them, only towards more chronic, very profitable, treatment.
I agree. Antineoplastons have been given more than their fair shot at this point. Publish and/or perish! 🙂
[…] is the sales pitch of the clinic, not evidence of effectiveness. One blogger looked at all the media coverage of fund-raising for Burzynski and said, “In fact, every single patient that I have found in media coverage of […]
[…] sadly, it is not. And available anecdotal evidence (from news articles of high profile cases) suggest that most of the patients who entered into the […]
I also have a petition to the FDA here: http://www.change.org/petitions/us-food-and-drug-administration-attn-constance-lewin-md-mph-inspect-burzynski-research-institute
Big thanks to Rhys for signing & tweeting it!
I POSTED THIS ON SCIENCE BLOG. THOUGHT YOU MIGHT LIKE TO SEE IT TOO. THANKS FOR YOU LETTER TO THE FDA I AM GOING TO CONTACT THEM TOO.
I HAVE FILED WITH TEXAS MEDICAL, PHARMACY BOARD. FILED POLICE REPORT HERE IN FLORIDA AND IN PROCESS OF DOING ONE IN HOUSTON.
FEEL FREE TO CONTACT ME.
HI
I JUST CAME FROM THE BURZYNSKI CLINICAL TREATMENT. I FEEL I WAS DEFRAUDED. I WAS THERE THREE MONTHS (SUPPOSED TO BE 3 WEEKS)
I WAS GIVEN CHEMO. ONE DESTROYED SO MUCH TISSUE THEY COULD NOT OFFER ME MUCH EXCEPT MORE CHEMO AND FOLLOW UP.
I WAS GIVEN ALL KINDS OF DRUGS, PAIN KILLERS,MORPHENE, VALIUMS ETC.
WHEN I FIRST CALLED THEM THEY SAID NO CHEMO.
EVERYONE I SAW THERE HAD CHEMO. THEY TRAINED PEOPLE IN THE INFUSION ROOM TO USE THE ANTINEOPLASTONS VIA PORTS THEY HAD IN THEIR BODY AND THEN SENT THEM HOME. MOST WERE EUROPEANS.VERY FEW AMERICANS THAT I SAW.
I AGREE WITH MOST ALL ASSESSMENTS HERE AND THEN SOME.
I WOULD LIKE TO DISCUSS FURTHER WHAT CAN BE DONE I WANT TO SHUT THIS GUY DOWN.I BEFRIENDED SEVERAL PEOPLE AT THE CLINIC WHO HAVE TOLD ME THINGS THAT ARE MAKING MY HAIR CURL.
UNBELIEVABLE STUFF. THIS NEEDS TO GET OUT TO THE PUBLIC.
SORRY FOR THE CAPS THE CHEMO MAKES IT HARD TO TYPE, READ ETCH ALONG WITH PILLS I AM CURRENT TAKING.
HE CHARGED MY CREDIT CARD OVER $85,000 AND IN ADDITION BILLED MY INSURANCE COMPANY. TO ME THIS IS GETTING PAID TWICE.
I AM IN DISPUTE WITH CC COMPANY OF COURSE BUT MY INSURANCE IS STILL PAYING CLAIMS HE FILED, SEVERAL DUPLICATES, WRONG DATES ETC. LOTS OF MISINFORATION I NEED TO SORT THRU.
I SAW THE GUY TWICE, SAW MY SUPPOSED DOCTOR FOR A TOTAL OF 18 MINUTES WAS GIVEN A DR WHO I FOUND OUT WAS NOT EVEN LICENSED IN TEXAS TO PRACTICE MEDICINE.
I WAS GIVEN A PRESCRIPTION FOR $30000 THAT I WAS TOLD I HAD TO BUY AT THE CLINICS PHARMACY, THEN FIND OUT THE CLINIC OWNS IT. THE DRUG WAS NEVER APROVED BY FDA FOR MY SITUATION YET THEY GAVE IT ANYWAY. I WAS TOLD THEY GIVE IT TO EVERYONE NO MATTER WHAT THEY HAVE BY THE CFO.
THERE IS SO MUCH TO TELL. I NEED HELP PUTTING THIS ALL TOGETHER. I FILED POLICE REPORTS, COMPLAINTS W/MED AND PHARMACY BOARDS IN TEXAS.
I WOULD LOVE TO PUT ALL THE BILLS ONLINE FOR EVERYONE TO SEE
THEY REFUSED ME FURTHER TREATMENT WHEN THEY FOUND ABOUT MY DISPUTE WITH CREDIT CARD COMPANY.
I THEN WENT TO MD ANMDERSON AND YOU WONT BELIEVE WHAT THEY TOLD ME ABOUT BURZYNSKI. I AM NOW BACK HOME DOING REGULAR CHEMO AND MONITORED BY ANDERSON IN HOUSTON.
PLEASE IF ANYONE CAN OFFER SOME HELP.
ALL THE EVIDENCE I HEARD AND SAW SUGGESTS THE % OF HELP IS ONLY WITH BRAIN TUMORS IN CHILDREN.
BUT YOU HAVE TO REMEMBER HE USES CONVENTIONAL THERAPY SO YOU WILL NEVER KNOW WHAT WORKED. THE BAD PART IN MY MIND IS THAT HE ALSO USED ON ME ANYWAY DRUGS THAT HAD NOTHING TO DO WITH MY SITUATION BUT HAVE HORRIBLE POTENTIAL EFFECTS AND ONE THERAPY HE PRESCRIPED COST $30,000 FOR 60 PILLS ALONE
I AM MORE THAN WILLING TO HIRE AN ATTORNEY TO GET THIS GUY OUT OF MEDICINE.
[…] to me that Dr. Burzynski’s cured a single cancer. In fact, Skeptical Humanities has been tallying publicly available cases of patients who went to Burzynski and did not survive. It’s a depressing read, and these are […]
[…] to me that Dr. Burzynski’s cured a single cancer. In fact, Skeptical Humanities has been tallying publicly available cases of patients who went to Burzynski and did not survive. It’s a depressing read, and these are […]
[…] to me that Dr. Burzynski’s cured a single cancer. In fact, Skeptical Humanities has been tallying publicly available cases of patients who went to Burzynski and did not survive. It’s a depressing read, and these are […]
You need to get your facts right
THE little girl from Mourneabbey battling an aggressive form of brain cancer, Zoe Lehane-lavarde, for whom the ‘ My Sister Zoe’ appeal was launched, tragically succumbed to her illness last Friday.
Eighteen-month-old Zoe ( pictured ), daughter of Alex Lavarde and Orlaith Lehane, died last Friday evening in a hospital in Brussels with her family by her side.
It is understood that Zoe’s condition had deteriorated over the last fortnight. No funeral arrangements have at the time of print been made but it will be a private ceremony.
The family wish to convey their appreciation for the support the My Sister Zoe appeal has received and all those involved with the various fund-raisers.
The family have also asked for privacy at this time.
Zoe, who along with her twin brother Leo celebrated their first birthday last April, was diagnosed with the cancer last March. The condition, A typical teratoid/Rhabdoid Tumour (AT/RT), is an extremely rare and highly aggressive form of brain cancer that often spreads through the central nervous system.
In March Zoe underwent surgery to remove the tumour. Due to the rare nature of her condition, and as her age meant the required chemotherapy was high risk, Zoe’s parents investigated less invasive treatment in America.
This brought them to the pioneering Burzynski Clinic in Texas, where Zoe responded well to treatment.
The ‘My Sister Zoe’ appeal was launched by relatives and friends of the family in order to help pay for the expensive treatment.
Fund-raising events held in aid of Zoe included the Face of Mallow contest, a motorcycle run, a fashion show and a music concert.
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.
You need to get your facts right, that she responded well to the treatment at Burzynski Clinic in Texas
THE little girl from Mourneabbey battling an aggressive form of brain cancer, Zoe Lehane-lavarde, for whom the ‘ My Sister Zoe’ appeal was launched, tragically succumbed to her illness last Friday.
Eighteen-month-old Zoe ( pictured ), daughter of Alex Lavarde and Orlaith Lehane, died last Friday evening in a hospital in Brussels with her family by her side.
It is understood that Zoe’s condition had deteriorated over the last fortnight. No funeral arrangements have at the time of print been made but it will be a private ceremony.
The family wish to convey their appreciation for the support the My Sister Zoe appeal has received and all those involved with the various fund-raisers.
The family have also asked for privacy at this time.
Zoe, who along with her twin brother Leo celebrated their first birthday last April, was diagnosed with the cancer last March. The condition, A typical teratoid/Rhabdoid Tumour (AT/RT), is an extremely rare and highly aggressive form of brain cancer that often spreads through the central nervous system.
In March Zoe underwent surgery to remove the tumour. Due to the rare nature of her condition, and as her age meant the required chemotherapy was high risk, Zoe’s parents investigated less invasive treatment in America.
This brought them to the pioneering Burzynski Clinic in Texas, where Zoe responded well to treatment.
The ‘My Sister Zoe’ appeal was launched by relatives and friends of the family in order to help pay for the expensive treatment.
Fund-raising events held in aid of Zoe included the Face of Mallow contest, a motorcycle run, a fashion show and a music concert.
I’m talking about an older, unnamed child. You are talking about Zoe, who I blogged about here: https://skepticalhumanities.com/2011/11/26/stanislaw-burzynskis-public-record/
How can you look at her outcome and tell me that she responded well to Burzynski’s treatment? You need to understand that initial responses to cancer treatment correlates poorly with outcomes (and her treatment, presumably, was of the mixed type that Burzynski can give, not just straight antineoplastons). This is not an opinion.
I’m of course upset that Zoe succumbed to her disease. But I’ve done my homework.
RJB
So you are against injecting people with proteins in urine, but you are ok with injecting people with poison?
Why hasn’t there been innovation in cancer treatments over the last 25 years?
I guess if the guy who suggested doctors should wash their hands was banished for being to progressive, innovation in cancer treatments have no chance at all.
“So you are against injecting people with proteins in urine, but you are ok with injecting people with poison?”
In the correct doses, those horrid drugs, despite the freaking awful side effects, do seem to kill a lot of the cancers, and there is evidence to back it up. If Burzynski publishes his findings and they are supported by other researchers, hell yes, pump me full of piss when I get cancer. It’s not the piss part I’m worried about, it’s the piss-poor science. (I’m secretly proud of that line, but I’ll never tell.)
“Why hasn’t there been innovation in cancer treatments over the last 25 years?”
But there have been, and if Burzynski is saying otherwise, then he’s not up on the research. Survivability rates for cancer have never been better! See: http://seer.cancer.gov/csr/1975_2008/results_merged/topic_survival_by_year_dx.pdf
We haven’t seen ANY advances in Burzynski’s work in 20 years. NONE. Perhaps his perspective is skewed.
“I guess if the guy who suggested doctors should wash their hands was banished for being to progressive, innovation in cancer treatments have no chance at all.”
Actually, you have this backwards. The guy who suggested washing hands before and after childbirth was actually the first person to practice clinical, evidence-based medicine. None of his peers would. That man’s work sets the stage for the current medical research and clinical paradigms! (He was also a complete asshole, I understand, which didn’t help convince people, I should mention.) If Burzynski is right, then every. single. oncologist–everyone of them a possible future cancer patient–will weep with joy and crown him freaking King Stanislaw the Really Great.
RJB
“Proteins in urine” vs “poison”?
You *are* aware that proteins can be poisons too? I’m not saying the ones Burzynski uses are necessarily poisons (although as always, it’s in the dosage, and Dr B does seem to use doses high enough to cause serious side effects).
Depannage Informatique PC Urgence…
[…]Letter to the FDA about Dr. Burzynski « Skeptical Humanities[…]…
It’s interesting that you are so willing to point out the deaths of patients treated by Dr. S yet you seem to have no desire to consider the 25% success rate that he’s had with his cases and especially as it compares to the less than 5% success rate that many FDA “approved/funded” treatments have shown. It’s no surprise that research run by our government would choose to oppress the research of someone who is making strides towards successfully treating cancer patients without the “good ol boy” network run by our controlling government. My wife’s father went through all of the “usual” treatments and went from having 2-4 years to only having 6 months in a matter of weeks. And guess what…even with insurance there were still thousands in bills to be paid! The truth is that there is a larger percentage of Dr. B’s patients who have survived post treatment and are remaining cancer free than those who have been treated with traditional methods. But I guess that makes sense considering that the FDA hasn’t approved a drug to fight cancer since 1987. Seriously….we’re gonna stick with drugs that hold a 25 yr lag on development? Bottom line our government is all about the money and so are the companies that are taking millions in tax dollars hand over fist to provide drugs that kill the patients faster. I’m not sayin that patients aren’t cured through traditional methods but I am saying that traditional methods are far less affective. Just one more reason why we can’t trust our government to help preserve the health and integrity of our health system. But I’m sure Oboma care has answer…somewhere in the double talk and my tax dollars paying for abortions I’m sure there’s an answer. Thank you for posting such a one sided view of one man’s life’s work, it just drips with medical and scientific integrity.
I am very sorry about your father-in-law, Danny, but could you show me the published, properly controlled study in a respectable peer-reviewed journal that shows a 25% cure rate. If what you are saying is true, this should be very easy.
I didn’t go into the post to “pick out the bad from among the good,” like you suggest. I tried to be as comprehensive and representative as I could, including everyone I could find who turned up in a LexisNexis search. What I found does not jibe with the 25% cure rate. But I would love to be proved wrong.
Every single one of the people you think is suppressing these treatments is a future cancer patient. And doctors and cancer researchers know this. So, what’s their motivation to keep themselves at higher risk? Would you take money in exchange for your life? Why would you assume that they would when you wouldn’t?
I typed “cancer drug approved” into Google and discovered that a new cancer treatment was reported approved 46 minutes ago in the WSJ: http://online.wsj.com/article/SB10001424052970204652904577193072555662052.html
What are the chances? Either that you happen to post on my website after 25 years of no progress on cancer and an hour later, whammo!, new treatment, or that someone is not being honest with you? If Burzynski does not know that these treatments are available, well, then I don’t see how he could provide a high standard of care.
As to the claim that no new drugs have been approved for cancer treatment in the last 25 years, here are the new cancer drugs and treatments that were approved in 1996 alone:
Anexsia; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996
Aredia (pamidronate disodium for injection); Chiron; Treatment for osteolytic bone metastases of breast cancer, Approved August 1996
Arimidex (anastrozole); AstraZeneca; Treatment for advanced breast cancer in postmenopausal women, Approved January 1996
Campostar; Pharmacia & Upjohn; Treatment for metastatic colorectal cancer, Approved June 1996
CEA-Scan; Immunomedics; Diagnostic imaging product for colorectal cancer, Approved April 1996
Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection); Orphan Medical; Treatment of meningeal leukemia or lymphocytic lymphoma, Approved October 1996
Eulexin (flutamide); Schering-Plough; Treatment for prostate cancer, Approved June 1996
Feridex I.V.; Advanced Magnetics; Contrast agent for magnetic resonance imaging of liver lesions, Approved February 1996
GastroMARK; Advanced Magnetics; Contrast agent for magnetic resonance imaging of the gastrointestinal tract, Approved May 1996
Gemzar (gemcitabine HCL); Eli Lilly; Treatment for pancreatic cancer, Approved May 1996
Hycamtin (topotecan hydrochloride); SmithKline Beecham; Treatment for metastatic ovarian cancer, Approved May 1996
Kadian; Purepac Pharmaceutical; Treatment for chronic moderate to severe pain, Approved July 1996
Leukine (sargramostim); Immunex; Treatment for the replenishment of white blood cells, Approved November 1996
Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories; Treatment for advanced prostate cancer, Approved January 1996
Photodynamic Therapy; Sanofi-aventis; Photodynamic therapy device for the treatment of esophageal cancer, Approved January, 1996
Taxotere (Docetaxel); Rhone Poulenc Rorer; Treatment for locally advanced or metastatic breast cancer, Approved May 1996
UltraJect; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996
Visipaque (iodixanol); Nycomed; Diagnostic contrast agent, Approved April 1996
Zoladex (10.8 mg goserelin acetate implant); AstraZeneca; Treatment for advanced prostate cancer, Approved January 1996
The full list going back to 1995 is here: http://www.centerwatch.com/drug-information/fda-approvals/drug-areas.aspx?AreaID=12
If he told you that these drugs/treatments did not exist, then he is either utterly ignorant of modern treatment methods or deceitful. At the rate he is charging, he should at least be able to afford a google search.
You don’t seem to understand how badly I want to be wrong about this, how desperately all his critics want to be mistaken. We want this to be true–I have friend who learned last week that he is out of treatment options for cancer–but Burzynski hasn’t given us any reason to believe him.
RJB
Burzynski has purposely stalled completing trials so that he can stay in business. He makes millions of dollars a year in profits now, he never needs to get approval for what he does. He uses the idea that he’s not accepted by science as a psychological tool. His sell is that he has a miracle drug that is being prevented from reaching the market by big pharmaceutical companies as it would put them out of business. But he’s the one who’s stopping his work from reaching approval.
It’s a very appealing story if you have someone you love who is dying of cancer. The last chance for them, what are you going to do? Even if it’s not real, why not?
And sadly, Burzynski has made a very good living out of selling ‘why not?’ to desperate parents. Millions from giving them damn all for their money.
The claim that he’s a rogue genius who’s work is being suppressed by the FDA and ‘Big Pharma’ is nonsense. He uses Chemo’ primarily at his clinic, and buys the required drugs for it wholesale FROM Big Pharma and even some of the antineoplastones themselves. One in particular he buys at below $5 a kilo and doles it out at hundreds of dollars a shot. If anything he does works it’s the chemo, not antineoplastones
Spelk
Wow! A lot of big Pharm ghost writers on this blog! Check out the documentary “Burzynski” …then discern and decide for yourself just what the truth is. It’s not here.
Another paranoid fantasy about Big Pharma or is it the masons and illuminati?
What did I get wrong?
How much more money do we have to donate to St.Judes before they provide with a cure to cancer? I can’t believe I once jumped on the band wagon of helping these parasitic cancer organizations. This is a ridiculously biased attempt to defame Dr.Burzynski and his cancer research. He doesn’t guarantee survival… I am appalled that you would even mention this considering the prognosis my cousin received of “max 8 months” at st.Judes, like chemo offers any better?! Atleast, Dr. Burzynski offers a higher probability of survival, many more of his patients do survive than those who undergo chemo. Personally, if I am told I am going to live for, maybe, 8 months, I’m going to try something other than chemo, its clearly not a cure. Chemo is so hopeless, cancer patients have nothing to lose by exploring other options.
What research am I defaming? Please, point me to the published study in a peer-reviewed journal that warrants my respect. If I can show you that his claims are unwarranted, I wonder if you would see him in a different light? Are you open to that possibility?
RJB
after prolonged and unfsucessucl chemotherapy, his parents got FDA approval to send him toa0Dr Stanislaw Burzynskia0but, although during the seven months of his treatment at the Burzynski clinic, Thomas’
When the FDA keeps asking for a “peer review” are clearly still in the tank for more cash on symptom treatment (especialy when they where the ones who stole the proof to begin with) rather then curing the cause witch the FDA and Pharma only want to do, Everyone knows even a four year old would tell you that radiation is toxic and will kill off more of your good cells along with the cancer then it would return with a vengeance in a short time. You forgot to metion the reason Burzynski couldn’t produce a study on peer review for his research is because the FDA and some federal agents raided his office or home for the paitent files during his 90s legal debacle. So it’s clear Dr S.B was on to something and “they” wanted to suppress his work to turn him into a fraud. And on a side note, antineoplastons are no longer extracted from urine, that was a method that burzynski used during his early findings for treatmet in the 70s. They now are plentifuly found in peoples own blood and likely other sources aswell. But the good thing is that nearly all of the paitens who where treated by him made replacment coppies up for him to show the FDA of his proof of work their treatments. It’s clear Pharma and FDA are quickly loosing their grasp on convincing people to use deadly drugs pact full of DDT and other chemicals along with the glowing stuff is sure to get more and more attention over the next few years and we believers and survivors are commited to convince america along with the rest of the world that traditional doctors today only want your money and purposely deny safe and proven drugs and deny funding for real potential permanent cures while cutting the amount of time to aprove dangerous drugs while still using radiation to keep you alive as a temporary cure long enough just to pay them off without even getting fully rid of the cause is just sad, just beyond plain messed up. THE MORE WE EXPOSE THE CRONYIST AND CRONYISM THAT PURPOSELY INFECTED CAPITALISM THROUGH THE BACK DOOR “WE THE PEOPLE” LEFT UNLOCKED, THE MORE FASTER THESE REAL CRIMINAL, YACHT SAILING MONEY MAKERS WILL FALL. DEAMND CURES NOW!! NOT HALF BAKED TREATMENTS, HELP PUT AN END TO GREED AND CORRUPTION IN AMERICA.
The Woo is strong in that one.
If I remember right, his treatments only had high success rates when started early. Nothing was going to save these people who died within days of seeing him, so I don’t see how that is the fault of the doctor. Intact, I’m certain that advanced stage cancer patients were not even in the criteria of patients he would accept in his trials.
Luke, if that were the case, he’d be able to publish those results in a real journal. And if advanced case patients aren’t in the trial criteria, why is he treating advanced cases under the auspices of an ANP “trial”?
Bob, the scepticism is strong in you.
Please comment when the failure of FDA shutting him down, if he is a dangerous quack, the loopholes on texas law don’t count.
Also, why does the FDA require such amounts of cash to start phase 3 trials?
How did he pass phases 1 and 2?
[…] Skeptical Humanities: Letter to the FDA about Dr. Burzynski […]
Hmm. Weird comments in here. So, he’s a fraud? FDA spent thousands trying to put him out of business. Sent him to court for 5 times, only getting the results they wanted on the fifth try. So, four times the judges found nothing wrong in what he was doing and several witnesses testified in favor to Dr. Burzynski’s treatment.
Not happy with that, the FDA forced a fifth trial – somewhat (Dollars probably) they judge claimed that Dr. was unable to proceed with the dissemination of it’s treatment.
It is not a popular way of fighting cancer because FDA won’t do the Trials under Dr.’s supervision and methods. During the FDA’s trials little were known of how they applied the methods on Antineoplaston treatments.
The BigPharma and the FDA are very skeptical of this type of treatment because they have a lot invested on the common way we deal with cancer today – and frankly, Burzynski’s treatment isn’t as profitable as those we got today.
For a butcher it isn’t a very good idea that people start becoming vegans, as well as for a pharmaceutical company it’s not good for business to have a healthy disease free population. It’s logic.
I have watched the documentary and it doesn’t seems to be any fraud at all. Although, it is common to see big industries and corporations to invest on misinformation, lobbying and propaganda. Not saying that this is the case here, but you cannot put that hypothesis aside.
There are three concepts in latin that we all should have in mind all the time when dealing with people or institutions:
– “argumentum ad ignorantiam”;
– “argumentum ad populum”;
– “argumentum ad hominem”.
Google it up.
We should be more intelligent of our approach to information. We should just listening to whatever someone says without being able to do the proper research ourselves and if we don’t have the resources to do so, we should demand our government to implement a legislation that forces scientific institutions to translate the results and put it up to the public’s access and to legislate medic institutions to force them to only charge the patient if clear positive results are obtained.
Don’t take FDA’s word for granted as well as any Dr.’s opinion also. Be an opinion leader yourself and demand transparency always!
Don’t be an idiot that is.
Well said.
I have just been reading non factual highly opinionated crap everywhere.
I just want facts.
Rafael, I appreciate your note. However, I need to point out some glaring problems with what you have said. The question of whether or not the therapy worked was not the question in the legal trials, as best I can tell. His billing and marketing practices were found to be illegal, and for that he was convicted of fraud. This is unrelated to whether or not the treatment works.
There is an irony in your telling me about the logical fallacies, as I teach entire classes about them at the college level. In fact, I’m presenting at the world’s premier conference on critical thinking in a few weeks. (http://www.randi.org/site/index.php/component/content/article/3-newsflash/1735-you-know-whats-amazng.html) Furthermore, you make make logical fallacies even as you admonish me (without giving any examples of my using them). For instance, you say that “several witnesses testified in B’s favor” and then tell me to be careful about the appeal to popularity. But your thinking (several people testify on B’s behalf, therefore ANP works) is exactly that fallacy. It’s not true because a bunch of people say it’s true–it’s the ad populum and the problem with anecdotal evidence.
You also make bald assertions, unqualified statements without evidence: for instance, that a big pharma conspiracy exists (–show me, don’t tell me). You say that curing cancer would not be in the interest of drug companies, but you forget that cancer is something that everyone will eventually get–your body is constantly producing cancerous cells that are being destroyed by your immune system. It is only a matter of time before one of those little bastards slips through and you have cancer. THIS APPLIES TO EVERYONE. You are in effect saying there is no money in treating a disease that absolutely everyone on the planet will get eventually (and, given enough time, repeatedly). Put that way, doesn’t the assertion sound absurd? (And let’s not forget that big pharma execs and their family members still die from cancer.)
You seem to labor under the delusion that Burzynski does not charge astronomical prices for his piss cure. (Of course, any charge is unreasonable for an unproved or failed treatment, which ANP certainly is by any reasonable definition.)
Lastly, the most absurd statement is that you watched his commercial and didn’t see any fraud. Do you expect him to say, “I’m defrauding you?” This seems to be absolute gullibility on your part. I strongly suspect that you are latching onto ideas that please you rather than the bare fact that Burzynski has never had a trial that showed any repeatable promise in 30 years. Not. A. Damned. One. Once you come to grips with that fact, a lot of other things will make sense.
RJB
Bob
Why do we get cancer mostly? Poor diets? Stress? Environmental pollution? a mixture of the above?
Do you know anything about the food industry in the united states? Do you know how the sugar industry lobbies over and over? Do you know anything about the corn syrup sweetener? Fat introduced in hour diets? Habits of super sizing?
Do you know how many cancers we get from this?
This is not just big pharma. Grow up, we got big banks as well running the show, and I am a capitalist, I like money, for me capitalism is just nature applied to modern society, eat or be eaten.
I can see you are a critical thinker, and a critical speaker, probably one of the ones who loves the sound of your own voice(maybe a bit too much).
However if you have nothing productive to say, opening that mouth will only shake the air. That is the problem with hardened critics.
Unless you have any medical background and a Ph.D in scepticism does not count, you are just another random opinion introducing nothing factual.
Well, you insult me and then invoke the argument to authority fallacy. Why would I take you seriously?
[…] Skeptical Humanities: Letter to the FDA about Dr. Burzynski […]
[…] to me that Dr. Burzynski’s cured a single cancer. In fact, Skeptical Humanities has been tallying publicly available cases of patients who went to Burzynski and did not survive. It’s a depressing read, and these are […]