Refael Elisha Cohen: A Family’s Misery Exploited

December 25, 2013

I would rather be doing anything other than writing this right now, but as Susan Gerbic has put it, advocates of science and evidence-based medicine have “drawn a line in the sand” and I don’t feel that we can yield an inch.

For the last few weeks, skeptics have been following the heartbreaking plight of the family of Refael Elisha Cohen, a 6-year old with medulloblastoma, a devastating brain tumor. According to the family, every single medical option has been tried–chemotherapy, surgery and radiation–but the monster has come back. At this late stage, there are compassionate options, palliative care and the relief of pain.

The family, understandably, is still looking for something, ANYTHING that might conceivably help their son. This desperation has sadly driven them into the hands of Stanislaw Burzynski at just the time that he needs a little good PR. The family has embarked on a campaign, appealing to the White House for a compassionate use exemption so that Refael Elisha can receive antineoplastons, Burzynski’s “signature” drug, which have been pumped into generations of cancer patients but have never met the most basic requirements of the scientific community. (In fact, we have seen 3 high profile campaigns simultaneously, unprecedented in the two years I’ve been following the clinic.)

While there are no demonstrable benefits of antineoplaston therapy, there are known side effects, about 3 pages worth, according to the Clinic’s own patient consent form. Because nobody wants to see a child die, a hundred thousand people have signed the petition to allow a compassionate exemption for Rafael Elisha. I share the generous sentiment of these signers, that a child deserves a regular life. Yet, knowing what that Clinic is after two years of continual searching for evidence that the treatment might work, having read the stories of literally hundreds of former patients, I can say without fear of contradiction that to support this family’s quest for antineoplaston therapy puts cancer patients in harm’s way.

I’ve largely remained silent about this campaign, which has featured prominently in the global Jewish press. It seems clear in the numerous reports that have appeared in the press that the family has not received accurate information about Burzynski, the treatment, or the prospects for that drug’s approval. An article came to my attention this morning that I felt I needed to answer, “Houston Boy Battles Brain Tumor; Needs Community Support.” written by the Campaign to Save Refael Elisha Cohen and which appeared in the online Jewish Voice. I hope that the two sentences I submitted in the comments will appear, but just in case they don’t, I figured that I would use my own venue as an opportunity to critique some of the points that were made.

According to the press release published at the Jewish Voice (which is all I can call this appeal, even if it is touching and sincere), a group of volunteers are collecting and sorting leads from around the world for potential treatments. I would like to offer them an additional source, if they have not seen it, clinicaltrials.gov, which lists all active registered clinical trials. Currently, there are 57 trials currently open for treatments into the type of tumor Rafael Elisha has. Any one of these trials is a better option than any illusory trial that the clinic might dangle in front of this family, and I hope they look into these options. I’m certain that Rabbi and Mrs. Cohen will understand that all anyone wants is for their child to heal, and if there was any evidence that the Burzynski Clinic had anything promising, that I would go down to Houston and hold the front door open for them.

In fact, there is one medical option which several prominent cancer researchers continually taught as the most promising for brain tumors.

The latter is called antineoplaston therapy, developed by Doctor Stanislaw Burzynski. The therapy uses peptides and amino acids’ and is manufactured in a block long pharmaceutical laboratory which operates directly under FDA Supervision. The FDA recognizes that the trials show efficiency, but has pulled its approval in 2012 pending reapproval possibly within the year. Current negotiation process is over interpretation of argumentative technicalities.

I would suggest that the statement that antineoplastons are “taught as the most promising for brain tumors” could not possibly be less true, as evidenced by this USA Today article, “Experts Dismiss Doctor’s Cancer Claims.” There is no evidence that any cancer, much less the intractable ones that Burzynski has claimed success for, are caused by “antineoplaston deficit,” which is the entire premise of the therapies. Lack of antineoplastons are simply not recognized as a cause of cancer. Secondly, as far as I can tell, Burzynski has never identified a therapeutic target for these drugs. Instead, we get vague words that sound nice like, “it turns off the cancer cells,” but we are not given an explanation of how that is supposed to happen. I’m willing to bet that if you were to ask the Cohen family how this drug is supposed to work, they won’t be able to tell you either. And if they have the mechanism, I’d honestly be eager to hear it.

The statement that “the FDA recognizes that the trials show efficacy” is purest bunk. There are no clinical trials that would demonstrate this. None. Burzynski has never completed and published a single clinical trial. The tumors he treats, especially the brain tumors, have a pretty high turnover rate. You would think that in over 15 years he might have managed to publish a single clinical trial, but he hasn’t. As part of a deal with the FDA 16 years ago, Burzynski agreed to only treat patients with ANP under the auspices of a clinical trial. So he opened dozens and never published a single finished one. We should not be surprised, of course, when his lawyer says of the Clinic’s trials:

[W]e decided to hit the FDA with everything at the same time. All of his current patients would be covered in a single clinical trial which Burzynski called “CAN-1.” As far as clinical trials go, it was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease.

The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

….and that…

Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future. […]

Make no mistake. Burzynski’s publication history, which is open for ANYONE to see at clinicaltrials.gov, is perhaps the most abysmal ever put forward as a marketing tool with a straight face. What he offers instead is his cherry-picked best cases and case series. While we delight that these people have survived, and while we understand why these patients support Burzynski so fervently, they tell us nothing about whether or not the treatment works. If you are only looking at the people who happened to survive, say, there are a dozen, just by looking at them you don’t know how many died. 20? 40? 1,000? 10,000? You don’t know because you are only looking at the survivors. This is why his claimed results are meaningless without published clinical trials. The family and friends of the Cohens should be demanding that Burzynski publish his damned trials so that the FDA will have no choice BUT to allow antineoplastons. Instead, the well-wishing allies of the Cohens are demanding an end-run around the scientific approval process, which is designed to bring effective drugs to market safely. Early this year, Burzynski told the BBC on camera that “Phase II clinical trials were completed just only a few months ago.” Don’t take my word for it. Start at 23:35 or follow the link above:

This was in the spring, which means that it’s been about a year since Burzynski “completed” his clinical trials. Now it is his obligation to publish. If they work, any delay can be attributed directly to his not publishing his results.

Because the clinical trials are supposedly already “completed.” He just told you that himself. As of last month, at least, Liz Szabo at USA Today could report:

Even his staunchest supporters wonder why Burzynski’s drugs are nowhere close to receiving FDA approval. […]

In fact, the FDA hasn’t had a chance to approve Burzynski’s drugs. He has never officially asked.

Although Burzynski said he has completed 14 intermediate-phase studies, he has yet to file a new drug application, the final step toward getting a drug approved.

So, why the end run around regulation if his drugs work? Again, his treatment is “nowhere close to receiving FDA approval.” Why does this family believe otherwise? If nothing else, I would be keenly interested in knowing that.

The statement that the process of restarting trials is due to “current negotiation process […] over interpretation of argumentative technicalities,” is also tragically inaccurate. According to a warning letter issued 2 days after the Cohen family launched their petition to the White House, the issues are not mere technicalities. I quote Liz Szabo of USA Today again:

In letters to Burzynski and his research institute posted online Wednesday, the FDA says that Burzynski inflated success rates for experimental drugs that he calls antineoplastons. The FDA also says Burzynski failed to report side effects and to prevent patients from repeatedly overdosing.

The FDA placed Burzynski’s clinical trial on hold last year after the death of a 6-year-old boy, Josia Cotto, of Linden, N.J. The FDA also conducted several months of inspections of Burzynski’s research.

But when the FDA asked to see the child’s medical files, Burzynski sent the agency records that were different than those stored in his office, giving the appearance that the records had been altered, according to the warning.

Burzynski’s failure to keep accurate patient records “raises concerns about subject safety and data integrity, as well as concerns about the adequacy of safeguards in place at your site to protect patients.”

We’re talking about over a hundred overdoses and no evidence to suggest that the Burzynski took steps to prevent them from continuing.  These are basic regulatory issues. Would you willingly send someone to a restaurant that had an unbroken, decade-long string of failed health and safety inspections? Then why would you ever send a child with cancer to a clinic with the exact same record? Even if they were selling conventional treatment, you wouldn’t send a child there. None of this is the regulators’ fault, mind you. Again, Burzynski is responsible and his supporters should hold him to account. Nobody can say the FDA hasn’t given him a chance!
According to today’s letter in the Jewish Times:
Ironically, the Cohens reside 10 minutes away from the Burzinsky clinic. They can see the meds that can potentially save their son even touch the medicine but cannot administer the antineoplaston due to the FDA clinical hold.
If the family was allowed to handle a bag of the antineoplastons, given the true state of Burzynski’s business and trials, it was unfathomably cruel and cynical. I truly hope that did not happen.

According to the press release:

Firstly let us state in crystal clear turn the Cohens are rational, intelligent people. They have researched the Burzynski option on many levels and encourage people to watch the eponymous film “The Burzynski movie part 1 & 2”. In doing so one can readily comprehend why the Cohens are doing their utmost to obtain this treatment. Who within reason could blame them?

Nobody doubts this, but these poor people are also under duress and running out of time. The two Burzynski two movies are veridically worthless.  Again, you have a handful of anecdotes from a few people who happen to have survived and no opposing views. This has been an effective recruiting tool for the desperate, but as this oncologist’s analysis reveals, the director clearly did not understand the patient files that were given to him. The second movie is simply dishonest by omission. Furthermore, the director is clearly a true believer and given to irresponsibly demonizing critics instead of taking into account contradictory evidence. Take for instance his comments about a prominent Burzynski critic who started his online skeptical career debunking Holocaust deniers:

Screen shot 2013-04-05 at 11.15.52 AM

 Nobody blames the Cohen family for their petition or their desire that their son survive. However, the whole reason that decade-long record of overdoses, inaccurate outcomes, and make no mistake, untold millions of dollars raised and clearly wasted on apparently unpublishable clinical trials, were allowed to happen is because Burzynski’s desperate patients campaigned for him the last time he faced regulatory sanctions. So when those lobbying for Burzynski charge that skeptics:

actively speaking against the petition while strong arming others to follow suit are trying to directly hurt the compassionate work of over 80 strong volunteers who are working around the clock to aid the Cohen family

…they are correct, because it has happened before and untold hundreds of cancer patients bore the consequences of that kindness. Uninformed compassion can and has done immense damage in the past. It is my sincere hope that Refael Elisha Meir ben Devorah is healed entirely and he that does not suffer.

For people who want to understand why I and dozens of other skeptics are fighting, this video puts our campaign in context. Please watch it before accusing skeptics of being heartless:

If, after reviewing the evidence, you believe that the Burzynski Clinic needs to be held responsible for its clearly deficient clinical trials, visit thehoustoncancerquack.com for information about how you can help stop this.

RJB

2 Comments | antineoplastons, Burzynski, Burzynski Clinic, politics, Uncategorized | Permalink
Posted by Bob

Happy Birthday, Dr. Burzynski!

January 4, 2013

Happy Birthday, Dr. Burzynski!.

Skeptics for the Protection of Cancer Patients are kicking off a project to celebrate the life’s work of Stanislaw Burzynski by giving immense amounts of money to…anyone else. Well, not just anyone, but St. Jude Children’s Hospital. Follow the link and find out how you can help get money and GOOD INFORMATION into the hands of potential Burzynski patients.

RJB

1 Comment | #Burzynksi, #burzynski cures, antineoplastons, Burzynski, Burzynski Clinic, Burzynski cure rate | Permalink
Posted by Bob

Another patient who trusted Stanislaw Burzynski has died

October 31, 2012

I have started a storify page that is devoted solely to the people who have gone to Burzynski’s clinic. Earlier this week, Rachael Mackey, a truly vibrant person died at the age of 28 of a brain tumor. In her last month, she banked on Burzynski. I am heartbroken. Here is Rachael’s story.

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

Mehmet Oz interviews Dr. Burzynski

December 19, 2011

Here’s an interview by Dr. Oz with Dr. Burzynski.

I’ll go out on a limb. Dr. Oz, you are a whore. A slutty, shameless medical whore. You’ll get into bed with anyone.

RJB

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

More patients whose deaths Burzynski has presided over…

December 5, 2011

It’s not over, people. A few days ago, I started posting the stories of patients who had been to see Stanislaw Burzynski and appeared in the news. In the previous post, almost all of them, with a single exception, a girl whose cancer had already been in remission twice (odd, I’m given to understand), died. Orac has recently looked at three cases that have been presented as evidence of Burzynski’s treatment, and he raises some profound, disturbing questions. I omit these cases.

As I suspected, there have been many more. They seem to appear in the news when some family makes a desperate appeal for money to go to  Burzynski’s clinic for his unproven treatments:

  • On December 1, 2011, the UK’s Watford Observer reports that a 4-year old girl from Oxley Hall is fighting an “ependymoma brain tumour”:

“But at The Burzynski Clinic in Houston, Texas, a pioneering treatment could prove the answer to [the family’s] prayers. The family had to raise £20,000 for preliminary tests, which established that [the girl] is suitable for treatment, and further cash for ongoing medication.” [emphasis added].

The same paper reported on 18 July that the family successfully raised £100,000 for the treatment.

  • In Australia, the Ballarat Courier reported on 29 Nov of this year that a group is raising money for Braydon Stefan’s trip to the Burzynski clinic by auctioning off tradesmen’s services. They have already raised $60,000, for a Dr. Charles Teo (could an Aussie look into this guy?) who thought that Burzynski might be a good match for Braydon, at least according to the Courier on the 23rd. [Update: I’m distressed to report that Braydon died in June of 2012]
  • On 23 November 2011, the Cambridge Evening News reported that the family of Supatra Adler, a 6-year old diagnosed with a “Diffuse Intrinsic Pontine Glioma brain stem tumour.” They spent 3 weeks at the Houston clinic, and they had doubts:

“We started doubting ourselves with this course of action as it required using up all our savings and travelling to Houston, Texas, for an extended period of time. You see the money is not really the issue other than we were worried it was a scam like so many other alternative treatments out there and if we expended all our savings on this treatment and it was a scam then we would have nothing left should a legitimate treatment come available. During this period it was a constant high and low moment for us as we flip-flopped on whether or not we should go. In the end we both agreed that since the mainstream medical community was offering us no hope for Supatra that we should try everything and anything.” But in the end the cost was immense: “She added the treatment had almost exhausted their savings, costing more than £89,000 so far with yearly costs of up to £63,000.” [Update: 8/10/12: I am very sorry to report that Supatra died in June of this year.]

  • On 29 June 2011 of this year, the Las Vegas Journal-Review reported that teenager Kassidy Merritt was going to see Burzynski for treatment of a brain stem ganglioglioma. Her father said that it was costing them $30,000 to start treatment, that the Ronald McDonald House would not put them up in Houston because of Burzynski, and that their doctors called Burzynski a quack. I’m happy to report that she’s still fighting, though I don’t know what her status is as far as the Burzynski clinic is concerned. We’re certainly pulling for her!
  • On 17 February 2011, the Contra Costa Times reported that a fundraiser was being held for 4-year old Noah Stout, who had an inoperable brain tumor. Burzynski’s treatment was at the time projected to cost $135,000, toward which mensch Carlos Santanta donated a guitar for auction. He is still fighting too, and that’s a damn cute kid!
  •  On 27 January 2011, the Grand Haven Tribune reported that Christine Tooker was raising money for treatment. I have only seen her appear in one other article, in October about end-of-life care, and she sounds extremely practical about what is happening to her. I wish her the best.
  • Randy Goss, whose story I encountered while looking through the “cancer cures” section of Yahoo’s message boards, according to the person who posted: “[Goss’] treatment was with Dr. Burzynski’s antineoplastons for kidney cancer […] After being cancer free the malignancy returned in 2000 and he was successfully treated again by Dr. Burzynski” At the time of the post, Mr. Goss was seeking additional media coverage of his cure. By his own account, he was feeling better and gaining weight after his return from Burzynski’s clinic in 2000, and he gave his contact information in Dunkirk, New York information in a post, seeking to spread the message of his cure. He died in 2001 of cancer.
  • On 14 December 2009, the Patriot-Ledger reported on Natalie Hull who was diagnosed with a diffuse intrinsic pontine glioma. It’s not certain that she ever saw Burzynski, however. The family was praying at the time that she would be accepted at his clinic, and they had reached financial ruin (had they applied with the standard gigantic fee that Burzynski apparently require?), but the paper reported that Natialie had died a few days later.
  • On July 30, 2009, the Salt Lake Tribune reported that the parents of Maryn Cella were optimistic about raising $100,000 to get their daughter treatment. There was a $20,000 down payment. Maryn succumbed to her cancer. The blog that her mother set up recording the experiences is an instructive, genuinely affecting read about the roller-coaster that treatment can be. I will leave it to others to examine the family’s experience with Burzynski.
  • On 11 May 2008, the East Valley Tribune reported that 2-1/2 year old Briannah Olsen had undergone treatment at the Burzynski clinic. Again we see a story of a shrinking tumor, but which ends with tragedy.
  • On 3 April 2008, The Spokesman Review reported that Greg Hiatt was seeing Burzynski for treatment. “

“Greg is doing really well,” his wife said with conviction. “He hasn’t needed to have his chest drained since he began treatment and hasn’t had any side effects.” She credits the positive attitude of those at the Burzynski Clinic and their faith in God for the fact her husband is still functioning when he was given such a negative prognosis. “Our faith has kept us strong,” she said. In the meantime, Hiatt’s medical costs are adding up – his medications alone total more than $35,000 each month. The family believes in the course they have chosen, but know their medical insurance won’t stretch to cover many of the expenses they are facing.”

I can find no outcome, and hope that Greg is well.
  • On 18 August 2006, the Lowell Sun reported that 6-year old Justin Bissett had been enrolled with the Burzynski Institute, but it was not without significant expenses, for which his community kicked in:
“The Bissett family has found some hope in a clinical trial for an experimental molecular treatment that Justin has been enrolled in at the Houston-based Burzynski Research Institute.

Bissett said there has been a marked improvement in Justin since. But the treatment, as well as Justin’s medications and specialized nutritionist, constitute a significant financial burden on the family, Bissett said. The latest in a series of fundraisers to help offset the medical costs will be held tomorrow in Tewksbury, courtesy of a group of Bissett family members and friends.”

Justin has since died.
  • Lisa Johnson of Plymoth told the Star-Tribune on 15 May 2006 that: “[W]hen a doctor at the Mayo Clinic says there is no cure, why would I question that? But I take all of these recent occurrences as sign that God is saying, `Lisa, you’re going to be OK. Hold on to hope.’ And I feel this treatment with Dr. Burzynski is my only hope.” She died in 2008.
  • The Chicago Daily Herald reported on 6 July 2005 that Mateo Casimiro Rotger was undergoing the Burzynski treatment through the clinic: “Today, Mateo is part of a Federal Drug Administration study at the Burzynski Clinic in Houston, Tex., which specializes in cancer treatment. Though it is costly – Rotger estimates $8,000 per month for medical costs and equipment – members of St. Isidore Church in Bloomingdale are offering their grown-up piggy banks. The church has set up a fund to help offset Mateo’s medical costs, many of which are not covered by insurance.” Mateo passed away in September. The memorial website says of Burzynski’s treatments: “We hope that this is the treatment that will answer our prayers. However, as with all things worthwhile, there comes a price and a rather expensive one. The cost of the doctors’ fees, treatments and medicine comes to about $150,000 for only one year’s worth of treatment. “
  • On September 22, 2004, the State Journal-Register (Springfield, IL) reported that a benefit dinner for Kathy Robertson was being held to “help defray the cost of experimental cancer treatment for Robertson at the Burzynski Clinic in Houston.” I am unable to find her outcome online, and hope it turned out well.
  • An announcement in the 14 Aug 2004 Arkon Beacon Journal announced the following golf benefit:

Organizers of the “J.E.M. Golf Outing” — scheduled for Aug. 29 at Raccoon Hills Golf Club in Kent — are offering up lots of prayers for a rain-free day, but, more importantly, for remission for the three people designated as beneficiaries of the outing:

+ Eunice Huffman-Nichols, a 41-year-old Streetsboro mother of two who was diagnosed with a brain tumor seven years ago. (Eunice died in July of 2005.) [Update 9/29/13: I received a message from Eunice’s brother, who asked I relay the following information: “My sister Eunice, did raise funds for the treatment. She had a 64% reduction of her tumor after 6 months on the ANP treatment, continued for a few more months on the treatment until there was not growth or reduction for a number of months. She was able to walk again, regain her vision and even started driving again! Ended the treatment and stayed stable until her death. She was off the treatment completely for 4+ months with no changes in the tumor at all and then had an emergency situation unrelated to the tumor and passed away while in the ER.”]

+ Mary Vukich, an 11-year-old from Orwell in Ashtabula County with strong ties to the Akron-area community. She was diagnosed at the Cleveland Clinic in October 1999 with six inoperable brain tumors. (I believe that Mary is alive and a member of the Burzynski Patient Group.)

Like the other two, Mary received alternative medical treatment (not covered by insurance) at the Burzynski Clinic in Houston. Cost to golf is $100 per player or $400 per foursome.

  • On 10 January 2004, Deseret Morning News reported a fundraiser for Megan Thompson. The projected goal was $180,000. I found no outcome on the web.
  • Evan Shaw reported a cure in the 22 July 2003 Calgary Herald. It cost $190,000. I can find no follow up and hope for the best. Searching for corroboration of this story, I came across the story of Albert Loranger who was looking to raise $11,000 a month. I can find no outcome.
  • On 27 April 2003 the Sunday News reported that Linda Biemiller was raising money to visit the Burzynski Clinic:
“In January of this year the couple traveled to Burzynski Clinic in Houston, Texas, to meet with Dr. Stanislaw Burzynski, a physician who treats patients with brain tumors using antineoplaston therapy.

“We spent two weeks at the clinic receiving training on how to administer the treatment,” said John. He explained that a portable pump administers two different medicines every four hours for almost two hours, 24 hours a day. The initial treatment and trip to Houston cost more than $25,000, with ongoing costs of $7,200 a month for an average of six to eight months. If the outcome is good, Linda would be put on a pill form of the treatment at a cost of $2,000 a month.”

Linda died in June 2005.

It’s hard to say what happened in many of these cases. The recent ones are still unfolding, of course. The older ones, well, they stop asking for money. You can’t read much into that. A few of the people reported that they were getting better or that the tumor had stopped growing, only to die shortly thereafter.  (I am starting to feel that when Burzynski reports that the tumor is shrinking, one should get a second opinion.)
Cures are few and far between, and you can’t use them to establish causality, especially as Burzynski has treated patients with mixed modalities. If more of these patients had lived, however, I suspect that Burzynski would use their testimony at every possible opportunity, since he does not have the clinical trials that, after 30 years of “tests”, would show that his therapy works. His public record is a body count, and the FDA needs to step in and stop this horrible, ongoing pillaging of grief.
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.

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

The Observer still doesn’t understand Burzynski

December 3, 2011

The Observer, the epicenter of l’affaire Burzynski, has responded to the deluge of criticism from the medical, scientific and skeptical communities about its coverage of the cancer quack, Stanislaw Burzynski, who continues to pump unproven urine-derived treatments into terminal cancer patients and charges them insane fees up front for the privilege. Entire communities throw untold sums of money at the slimmest (nonexistent, really) hope that these patients will recover at the Burzynski Clinic, and the Observer finds this uplifting.

Horse shit. And shame on The Observer.

The reader’s editor column today, which I believe is essentially an ombudsman’s column, does nothing to serve the readers who might damn well end up in the clutches of the monster from Texas. The title of the article is simply beyond the pale:

The readers’ editor on… kind hearts and a cruel illness: Is it so surprising where desperate parents will turn in the search for a cure for their terminally ill child?

No. Not at all. They are vulnerable and desperate, which is why it is our collective responsibility to protect them. What is surprising is that your editor is unwilling to say, “Boy, we really messed up by giving someone a platform to promote what will inevitably be massive fraud of the most callous and depraved kind.” But look how the Observer continues to frame the issue:

Yet what was intended as a gripping, human-interest story quickly drew a sustained attack on the paper for apparently offering unquestioning support for a highly controversial cancer treatment, known at antineoplaston therapy.

First off, it’s not controversial therapy at all. It’s a failed therapy. 30+ years and no credible science to back it up? FAILED.

The Observer, unbelievably, is trying to twist this story into some sort of attack on the family of Billie Bainbridge, the little girl whose sickness prompted the original article. They actually close the article with the line: “But some participants in the debate have combined aggression, sanctimony and a disregard for the facts in a way which has predictably caused much distress to the Bainbridge family.”

They point out that the Rhys Morgan, a 17-year old who was actually threatened by the Burzynski’s hired toughs (they actually sent him a google map image of the kid’s house, which translates into, “We know where you live”), did not talk to the Bainbridges before he asserted that they “looked on the Internet.” (The Observer fails to demonstrate that this was factually incorrect. Just saying.)

So what? That is the least important part of Rhys’s original post. The fact remains that a 30-year fraud is claiming another little victim. Who gives a tiny nutty crap about how the parents heard about the scam artist?

Hey, do you want to see some bad writing? Notice how the paper goes from indignation that the Internet somehow failed to…recognize that Billie’s family was looking at anecdotal evidence(?), to a defense of the paper:

“Billie’s parents know it is unproven, but there are other families in this country who were told by their hospital that their condition was terminal and nothing could be done for them, but were then treated at the clinic and survived. Knowing this, Billie’s parents felt they couldn’t sit back and do nothing if there was a small chance this treatment would save her life.”

And this is the point that is being lost in the vitriol that is flying around the internet. Undoubtedly, the Observer was wrong not to have included criticism of the treatment. A simple check with Cancer Research UK would have revealed the depth of concern about it and, no question, that concern should have been in the article, but because it was absent doesn’t mean that the paper was promoting the treatment, as some have suggested (“pimping” it, as one science writer so crudely tweeted).

Uncritically giving a cancer quack uncritical press? How could we possibly have mistaken that for promotion? We should have just called it as it was: a shoddy, pathetic, and irresponsible attempt at journalism.

The Internet apologizes for not making this clearer.

Now do you f*cking job and protect Billie, her family, and your readers from this immense fraud.

RJB

Please consider donating to St. Jude’s Children’s Hospital. They turn nobody away, even if they can’t pay. Unlike Burzynski.

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

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

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