Letter to the FDA about Dr. Burzynski

November 30, 2011

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!

48 Comments | #Burzynksi, #burzynski cures, antineoplastons, Burzynski, Burzynski Clinic, Burzynski cure rate | Permalink
Posted by Bob

Gallows Humor in the Service….

November 30, 2011

What would you do if a grenade landed in your Humvee? These guys found out. Don’t worry, nobody gets hurt, I mean, other than emotionally scarred for life:

RJB

1 Comment | derp | Permalink
Posted by Bob

This Week in Conspiracy (30 November 2011)

November 29, 2011

Already time for another roundup? So be it.

Conspiracy Theory of the Week:

I loved this one. Lots:

I think that we should parachute Joe Nickell in to investigate!
Anyway, as we plow into the last weeks of the semester, I’m working on a fun (for me) little series about my favorite rock album. Those should start coming out soon.
RJB

9 Comments | 9/11 conspiracy theories, conspiracy theory, history, mass media, politics, Uncategorized | Permalink
Posted by Bob

Stanislaw Burzynski’s public record

November 26, 2011

I’m going to put aside the conspiracy theories for a minute to talk about an issue that has suddenly gotten quite big quite on the Internet, though my interest in this topic goes back about 15 years.

Many years ago, the son of a friend was diagnosed with brain cancer.  He held on for about a year and had the best treatment possible at St. Jude’s. His mom had done everything possible, but in the last stages, he was too sick to participate in an experimental trial. My friend began looking for another option. From her perspective, anything that even looked like an option was preferable to what surely awaited her.

One day, near the end, I got a call. It was my friend, and she wanted to bounce an idea off of me. She had heard about a doctor somewhere in the south who had an experimental treatment. The main ingredient? An extract of urine. I listened to her, and then I crushed her. If this guy had a cure for cancer, then he’d have multiple Nobel Prizes right now. Of course, I did not mean or even want to extinguish that last bit of hope, but the doctor forced me to. I don’t know who this doctor was, but I have never forgiven him for putting me in that position, for preying on my friend’s misery, or for trying to take away the last days she had with her son.

Her son died shortly thereafter, at home, which is something, I guess.

Stanislaw Burzynski, M.D. [for now] runs a clinic in Houston, TX. He’s been running “clinical trials” on people with extracts from urine for decades. Is this the same guy? I don’t know. I don’t care.

If you take a look at the public record, Dr. [for now] Burzynski has assembled quite a record of getting people to raise enormous amounts of money for desperate causes which usually end in failure.

  • 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 8/10/12: It’s with a heavy heart that I report that Keith Gibbons succumbed to his tumor. My condolences go out to his loved ones.]
  • 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 the unproved treatment. [UPDATE 8/10/12: I am distressed to report that Luna has passed away. The $100,000 raised to take her to Burzynski did not help, as the treatment was suspended after a month.]
  • 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 2o00:

“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? And this is the public record, people. Of the records I searched, I found one girl who seems to have beaten cancer into a 3rd remission. Almost everyone else I saw who had been touched by this guy is dead.

Now we hear that this guy’s representatives are threatening bloggers who question the unproven treatment? They started with Quackometer, who caught wind of yet another international fundraising event (I think that is how most of these cases ended up in the newspapers I researched–so many fundraisers). Andy came up with some reasonable concerns about Burzynski’s practices, and I quote at length:

  • Burzynski is a ‘lone genius’. Great scientific medical cures rarely stem from single individuals. They are the result of collaboration and teams. Such breakthroughs need to be assessed by peers to ensure that the researcher is not mistaken or overstating their case.
  • Burzynski is claiming he has found the ‘cause of cancer’ and his antineoplaston therapy is its cure. Cancer is a name given to many different diseases. There is not a single cause and treatments need to be targeted as specific forms. It is a common quack claim that they have found the ‘single cause’ and they have a ‘unique cure’.
  • The ‘cure’ – Antineoplastons – which were extracted from urine (yes – its the piss treatment) – has no good independent peer-reviewed RCT evidence suggesting it is effective.
  • Consequently, the treatment is not approved by US regulators. However, it is approved if treatment is part of a trial.
  • The Burzynski clinic charges hundreds of thousands of dollars for people to enroll themselves in a trial.
  • These trials of this ‘new and pioneering treatment’ have been going on for decades – since 1977. No end appears to be in sight.
  • The website Quackwatch has raised concerns about the origin of Burzynski’s claimed PhD.

Someone who apparently represents this unproven piss peddler then released a barrage of positively unhinged rants and threats against not only Andy, but also his family. This bloke doesn’t seem to understand that not only do we have the right to question Burzynski’s “miraculous” treatments, but an obligation to question them.

The threats, then, are unforgivable. And skeptics have noticed, including Orac, before whose mighty word processor the very mountains tremble. (Update: Numerous lists are going up of bloggers writing about this. Here’s LizDitz’s running tally of articles.)

It’s time for Burzynski, after decades of trials, to submit his data to peer-review or to stop treating and charging patients.

RJB

Please donate to St. Jude’s, who don’t turn people away, even if they can’t pay. Unlike Burzynski, who was once found guilty of fraud.

121 Comments | #Burzynksi, #burzynski cures, antineoplastons, Burzynski, Burzynski Clinic, Burzynski cure rate, science, Uncategorized | Permalink
Posted by Bob

This Week in Conspiracy (20 Nov 2011)

November 22, 2011

It was a crazily jam-packed weekend for those of us at Skeptical Humanities, so this is a little late and a little short. On Saturday, Eve and I put on our thinking helmets (sometimes you just need the extra protection) and attended an event by paranormal enthusiasts. One of us will be writing about it soon, I’m sure. We were so tired at the end of the day, I think we missed our first skeptics in the pub event since…ever.

This morning, we were out again. I had been invited by the Alabama Freethought Association to talk about conspiracy theories. About 20 people showed up, and Lake Hypatia seems to be a sort of Mecca for southern atheists.

Speaking of Mecca, when we got there, an hour early (stupid time change), in one of the sitting areas on the lovely campus, we found a Koran under the bench. We pointed it out when our hosts arrived, and they brought it inside because someone might think that leaving it outside would be a desecration. That’s class, people. Learn from them.

Onto the week that was weak!

Conspiracy Theory of the Week:

That’s all for now, m’laddies. I’ve got lots more, but not a lot of time at the moment. So, keep your eyes open for more from this week in next week’s edition.

RJB

8 Comments | 9/11 conspiracy theories, Anonymous the movie, conspiracy theory, critical thinking, history, John Orloff, mass media, politics, psychology, Roland Emmerich, Uncategorized, who was shakespeare | Permalink
Posted by Bob

Masala Skeptic Reviews Twilight, Readers Make Funnies

November 22, 2011

Yeah, I’m just going to let you read this one by Maria Walters, who specializes in searing critiques of Twilight. This one is “Twilight: Breaking Wind.” And please be sure to pay attention to the comments and the guy who really pierces the heart of literature. Repeatedly. With a machete.

Also, enjoy Buffy vs. Sparkle Tits:

RJB

1 Comment | fun, humanities, literature, mass media, paranormal | Permalink
Posted by Bob

Medieval Homeopathy: Holy Blood, Wholly Water

November 22, 2011

Ronald C. Finucane was a professor of medieval history and chairman of the Department of History at Oakland University in Rochester, Minnesota. A couple of his works may hold interest for skeptics, particularly his book Ghosts: Appearances of the Dead and Cultural Transformation (originally published as Appearances of the Dead: A Cultural History of Ghosts), which traces the way accounts of ghosts changed as society and religious beliefs changed.

In another book, Miracles and Pilgrims: Popular Beliefs in Medieval England, Finucane discusses several twelfth-century pilgrimage shrines known for their healing miracles. While his primary purpose is “to find out how medieval people interacted with their spiritual heroes, the saints” and to “look at the conditions of medieval life which reinforced this faith in wonder-working saints, and made them so important to the people who lived and died so many centuries ago” (p. 14), Finucane also notes that

perhaps the information provided by medieval curative cults may appeal to those interested in modern “faith-healing” and other alternative therapies in both the West and the East. Some findings may elucidate the behaviour of pilgrims at shrines which still play an important part in the lives of many people…. (p. 14)

Indeed, a number of Fincucane’s observations would be of interest to skeptics and those convinced of the efficacy of “alternative healing.” He notes, for instance, that some of the ailments “cured” by saints’ relics may have resolved on their own or were likely of a waxing and waning nature. Even “blindness” (which was not necessarily total) can be affected by diet and therefore by growing cycles. Some cures were partial; some were temporary. Many, if not most, were non-spontaneous. That is to say, the sufferers often weren’t instantaneously cured at the shrine. Instead, sometime after they returned home, they started feeling better. He also notes that psychological factors had a great effect on the apparent cures.

Finucane also discusses something that sounds suspiciously like the medieval equivalent of homeopathy:

A widely-used healing substance was water which had absorbed the virtues of a relic, for example by washing a saint’s corpse. (p. 89)

“Take two sips of corpse-wash and call me in the morning.” Canterbury Cathedral had something even better than Essence of Dirty Cadaver: they had the blood of Thomas à Becket, England’s most famous martyr.

One of the most common agents of cure among Becket’s followers was water containing–in theory–a tincture of the blood shed at his martyrdom (constantly diluted ever since to make up supplies to sell to pilgrims). (pp. 89-90)

Note the word “sell.”

Of course, it’s not really homeopathy: there is no question of “like curing like,” but there is a sense of “water memory.” Water that had come into contact with water that had come into contact with water that had come into contact (etc.) with Becket’s blood retained the healing properties of Becket’s blood, even if no blood remained. The explanation for why the water would remain efficacious was different in the Middle Ages. Proponents of homeopathy use pseudo-science to explain why their magic water is magic. Medieval proponents of cure-by-saint didn’t have a problem with the idea that the water was miraculous: that was pretty much the point, after all. Finucane explains how it worked:

Relics…emitted a kind of holy radioactivity which bombarded everything in the area, and as early as the sixth century it was believed that objects placed next to them would absorb some of their power and become heavier. They affected oil in lamps which burned above them, cloths placed nearby, water or wine which washed them, dust which settled on them, fragments of the tomb which enclosed them, gems or rings which touched them, the entire church which surrounded them, and of course the hopeful suppliants who approached to kiss, touch, pray before and gaze upon them. (p. 26)

And, yes, grave dust mixed with water also had curative properties. Sometimes the miracle substance got diluted even further:

Metal phials or ampullae of “Becket water” or “Canterbury water” became the symbol of the archbishop…. These ampoules, often worn round the neck, could be re-used…. (p. 90)

In some cases, pilgrims brought the phials back to their parish church, where they were hung from the ceiling,

to be taken down and rushed to the dying or ill as needed. One twelfth-century rural pastor [followed this practice]. Some of them he thought less full than they ought to have been, no doubt because of evaporation, so he poured out what was left of all of them into a basin, added “ordinary” holy water from the church supply, refilled them, and then hung them up out of reach. No one would know the difference anyway. (pp. 157-158)

True enough. From the point of view of medieval believers, it probably wouldn’t matter that the priest had tampered with the water in the phials. The nature of the relic’s “holy radioactivity” was such that it didn’t matter if the blood was diluted beyond Avogadro’s number. The miraculous powers of the saint (or God working through the saint) could transcend mere physics. Not so with homeopathy. For most people, “well, it’s magic” is no longer a good enough explanation, so homeopaths have to try to come up with sciencey-sounding explanations for why scientific laws don’t apply to their magic potions. These explanations often appeal to quantum physics. “Quantum:” it’s the new “abracadabra.”

By the way, you will be pleased to know that skeptics interfered with the workings of magic even in the Middle Ages:

While Hugh of Lincoln’s corpse was being embalmed…, his biographer Adam inspected the holy intestines and claimed that they were exceptionally clean–a miracle. He querulously added that certain bystanders, who “made light of the miracle,” replied that the physical condition of the body was due as much to Hugh’s dysentery and his pious abstinence as to any miracle. (pp. 50-51)

ES

3 Comments | history | Tagged: , , , , | Permalink
Posted by Eve

Today, South Dakota. Tomorrow….the WORLD!!!

November 15, 2011

I was recently interviewed on David Leonard’s Alive at Five radio show out of Yankton, SD. It’s a fun show that covers a  lot of topics that I find interesting. The interview was a hoot, and thanks to David for inviting me to talk about 9/11 Truthers.

RJB

 

 

1 Comment | 9/11 conspiracy theories, conspiracy theory, critical thinking, mass media, politics, psychology | Permalink
Posted by Bob

This Week in Conspiracy (13 Nov 2011)

November 13, 2011

Well, I’ve done it again. I spent another week in the trenches, occasionally poking my head over the parapet, and taunting the forces of conspiracy theory.

Bob

On with the pain!

Twit of the Week:

It was that crazy-haired spray-on tan nutjobby from Ancient Aliens, after the whole premise of the modern History Channel was lampooned on South Park:

Tsoukalos: Good. Let them. Deep down they know (!) we’re on the right track… No worries. RT @kuhnlevel u inspire me but my history profs hate u! lol

Original Tweet: http://twitter.com/Tsoukalos/status/134686039854948352

Conspiracy Theory of the Week

That’s it folks. Keep it crazy. I’m off next week to do some field work on Saturday, and then I’ll be going to Alabama to give a talk about conspiracy theories to a group of freethinkers there. Yay!

(Did you notice that Anonymous completely dropped off the map this week? It’s now known as Ignominious!)

RJB

5 Comments | 9/11 conspiracy theories, conspiracy theory, history, mass media, politics, Uncategorized | Permalink
Posted by Bob

Happy Nigel Tufnel Day!

November 11, 2011

Today goes to eleven!!!

This is for Eve:

(With thanks to Brian Gregory, whose list, I trust, is getting shorter.)

RJB

Leave a Comment » | derp, fun | Permalink
Posted by Bob

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