Although I don’t write about him as much as I used to, there was a time a couple of years ago when Houston cancer quack Stanislaw Burzynski was a frequent topic of this blog. His story, detailed in many posts on this blog and in an article I wrote for Skeptical Inquirer, is one that involves many facets, including an abysmal failure of the normal government agencies designed to protect patients from abuses like his to actually do their jobs and—oh, you know—protect patients. If you want an idea of how utterly impotent our regulatory agencies are, the Burzynski case is as good an example as you’ll see.
I’m talking to you, Texas Medical Board. You allowed him to charge patients huges sums of money over the course of nearly forty years to be treated with his unproven chemicals isolated from urine and blood that he dubbed antineoplastons, even though he has failed utterly during those four decades to publish convincing evidence of efficacy and safety. I’m also talking to you, FDA. In 1997 you let Stanislaw Burzynski’s lawyer pull a fast one on you and get you to agree to stop going after Burzynski if he only gave antineoplastons to patients under the auspices of valid, FDA-approved clinical trials. Burzynski promptly did this, submitting over 70 clinical trials to the FDA, and then using them to continue business as usual: charging patients big bucks for his ineffective therapy. Yes, Burzynski’s clinical trials were (and are) a sham. The only difference is that for the last 18 years Burzynski has the cover of FDA-approved clinical trials. In that time, for some reason you’ve been utterly ineffective in shutting him down. Oh, sure, you managed to put his clinical trials on partial clinical hold after Burzynski killed a six year old boy named Josia Cotto with his treatment, so that he couldn’t enroll any new patients but could keep treating existing patients, but even that didn’t last. Even a lean kill of an innocent child wasn’t enough. You let him start up his clinical trials again after only a year or so off. No one knows why. No one can find out, given how impenetrable your bureaucracy and, above all, your exception to Freedom of Information Act (FOIA) requests that allows you to refuse to produce documents that might reveal trade secrets.
OK, I might have been a little too hard on the TMB (although, if anything, I’m taking it easy on the FDA for its role in this). The TMB is, after all, trying once again to prosecute Burzynski and take his medical license away. The hearing started three weeks ago and will resume again in January, leading me to ask if this is the time, after nearly four decades, when Stanislaw Burzynski finally faces justice. I hope so.
Unfortunately, as gratifying as it is to see Burzynski’s latest legal troubles, complete with a major schism between him and his former consigliere and lawyer Richard Jaffe over unpaid legal bills, the down side of seeing Burzynski being dragged in front of the TMB again is watching him use patients as shields again and seeing his followers crawl out of the woodwork to regurgitate the same old misinformation that I spent so much time refuting over the course of three years or so. Perhaps the most depressing Burzynski “blast from the past” to show up again is Hannah Bradley and her (now) husband Peter Cohen. Hannah, as you might remember, is one of Burzynski’s so-called “success stories.” In the months leading up to Burzynski’s hearing before the TMB, she showed up in a video in support of Burzynski, along with Stanislaw Burzynski’s personal propagandist Eric Merola:
Of course, I’m very happy that Hannah Bradley-Cohen is doing well and getting on with her life with her husband. I really am. She seems to be a wonderful young woman, at least as far as I can tell from reading about her and viewing her videos. It’s good to see her enjoying life with Peter. What I do not like is to see Hannah being used yet again as propaganda for Stanislaw Burzynski, no matter how willingly she participates in that propaganda. Why, I will explain in a minute. Unfortunately, just yesterday I saw another example of pure propaganda for Burzynski published in—where else?—the Daily Mail. It comes in the form of an article entitled British woman given just 18 months to live after being diagnosed with cancer defies doctors to marry after raising £200,000 to have controversial treatment in the US.
Yes, the story is exactly as you would predict just based on the title alone. It’s a paean to the “Brave Maverick Doctors” who buck the status quo, all in order—of course!—to cure cancer. It doesn’t matter whether or not these Brave Maverick Doctors can actually cure cancer or not, and, as I’ve discussed many times before, Burzynski cannot. He can’t even come close. Yet he’s still lionized in the “alternative cancer cure” community as the Brave Maverick Doctor who can cure brain cancers that regular neurosurgeons and oncologists can’t. Even now, four years after I took a serious interest in Burzynski, even as my view evolved from not being sure that he was a quack to being quite sure now that he is, I still can’t believe this. After all, antineoplastons, if they worked, would be chemotherapy. Certainly they have toxicities potentially as bad as chemotherapy. Then, as I’ve described time and time again, Burzynski has hijacked the concept of “precision medicine” (or “personalized medicine” or whatever you want to call it) by incompetently doing what can only be described as a parody of real precision medicine using very expensive, sometimes very toxic, cocktails of targeted pharmaceuticals. AS I like to put it, he’s making it up as he goes along.
In any case, it was because of his reputation among alternative cancer cure believers, including Suzanne Somers, who included a chapter about Burzynski in her book Knockout, that Pete and Hannah discovered Burzynski a few years ago, as yesterday’s Daily Fail story describes:
Burzynski, who charges thousands of dollars for his treatment, has been accused of selling hope.
But Pete watched a documentary about the doctor called Burzynski, The Movie, which convinced him that Hannah should seek treatment in Texas.
At first, Hannah didn’t want to know.‘The radiotherapy was causing my hair to fall out and I felt exhausted all the time,’ she said..
‘It took Pete three to four months to persuade me to watch the documentary, and when I finally did I saw it twice and kind of just knew I had to do it.’
But the treatment didn’t come cheap. The couple had to raise the $300,000 (£200,210) needed to pay for it.
They launched Team Hannah and friends and family quickly rallied around to bring the cash rolling in.
‘I’m originally from Surrey and one friend reached out to a local radio station there,’ Hannah says.
‘They ran a campaign for people to donate £1 to our cause. Another friend threw a charity ball.’
It wasn’t long before the couple had reached their target and they flew out to Texas at the end of 2011.
The couple spent seven weeks in the US, with the treatment being administered using a catheter for medicine called a Hickman line four times a day.
This is a story Pete, being a bit of a filmmaker himself, documented in a video he called Hannah’s Anecdote:
Hannah’s story featured prominently in the sequel to Burzynski The Movie: Cancer Is a Serious Business, which was entitled Burzynski: Cancer Is A Serious Business, Part 2. (Clearly, Eric Merola, the “auteur” responsible for both Burzynski movies, really needs to go back to film school to relearn how to come up with better titles for his Burzynski advertisements disguised as documentaries.) Part of that segment of the movie featured Pete and Hannah practically crying over how “mean” skeptics have been to Burzynski and them. Of course, I’ve never yet found an example of a skeptic saying mean things about the couple; personally, I’ve said from the beginning that I always hoped that Hannah would do well, whether from the antineoplastons or from the other treatments that she had undergone.
In fact, if you look at Hannah’s anecdote carefully, it becomes clear that the antineoplastons, if they had any effect at all, were almost certainly not responsible for Hannah’s good fortune. I discussed Hannah’s case in detail nearly three years ago, but it’s worth reiterating the CliffsNotes version. Basically, in February 2011, out of the blue Hannah suffered a seizure. She had never had a seizure before; so an immediate evaluation was performed, which revealed a brain tumor. She underwent surgery April 1, 2011 to remove a grade III anaplastic astrocytoma. Surgery was followed by a six week course of radiation therapy. It was at this point that Hannah apparently still had residual tumor, or at least her doctors thought she did, which led to her and Pete’s search for an answer, which then led her to Burzynski.
Contrary to Burzynski’s claims and how his therapy is marketed, even the story of a patient who sincerely believes Burzynski saved her life demonstrated a situation very much to the contrary. At least a third of Hannah’s anecdote deals with all the difficulties that Hannah experienced with her treatment, including high fevers, a trip to the emergency room, and multiple times when the antineoplaston treatment was stopped. She routinely developed fevers to 102° F, and in one scene her fever reached 103.9° F. She felt miserable, nauseated and weak. I’ve seen some chemotherapy patients suffer less from their treatment. I also noted that the reaction of the clinic staff was rather blasé, even though at one point Hannah clearly demonstrated a change in mental status, appearing “drunk” and complaining of double-vision, which made me think such issues were a common complication of antineoplastons. At another point, Pete and Hannah come to believe that the fevers might have been due to the tumor breaking down, which strikes me as implausible. Hannah even developed an extensive rash, which looked to me a lot like erythema multiforme, which is generally an allergic rash, often due to drug reactions.
Near the end of the video, Pete displayed an MRI dated July 29, 2012 that looked quite good, with little or no enhancement left. The question, of course, is: Does this mean that Burzynski’s antineoplaston treatment worked for Hannah? Sadly, the answer is: Not necessarily. It might have. It might not have. Why do I say this? First, the median survival for anaplastic astrocytoma (which is a form of glioma) is around 2 to 3 years, and with different types of radiation therapy five year survival is around 15% or even higher. Even now, we are only approaching the five year mark, which will be in February. Be that as it may, long term survival for patients with astrocytomas is not so rare that Hannah’s survival is so unlikely that the most reasonable assumption has to be that it was Burzynski’s treatment that saved her. Second, there is a phenomenon in brain cancer known as pseudoprogression. Basically, what happens after surgery and radiation therapy is that there is an area of healing, where dead brain tissue (and, after radiation, tumor) provokes an inflammatory reaction. Because MRI images are based on blood flow, that area shows up as enhancement, sometimes increased enhancement that can take a long time to disappear. Thus, pseudoprogression can sometimes be mistaken for a tumor recurrence or residual disease. Indeed, up to 28% of cases of seeming tumor progression can be due to pseudoprogression, as this review describes. I’ve long speculated that Burzynski is too incompetent to understand this, leading him to mistake the resolution of pseudoprogression for tumor response to antineoplaston therapy, or, worse, that he understands pseudoprogression and is cynically taking advantage of it, such that now Hannah states:
Hannah has set up a business distributing healthy coffee and is looking forward to starting a family with Pete.
‘My scans show just a space where the tumour was,’ she says. ‘I’m incredibly fortunate.
‘I wouldn’t tell people not to go to Dr. Burzynski. But it’s very difficult to be treated by him because he’s not recognised so you have to apply to take part in one of his trials.
‘My advice to anyone diagnosed with a life threatening condition would always be to never give up.’
No, Burzynski’s clinical trials are a scam, as I’ve described many times.
When I initially wrote about Hannah, I was very worried about her. I’m very happy to see that my concern was overblown at the time. Hannah is doing quite well now. This is in marked contrast to Laura Hymas, a young woman with a similar sad tale, except that her cancer was of a less aggressive variety. She, too, became a media sensation in the UK after raising money to go to Houston to be treated by Burzynski. She, too, appeared to be doing well, so much so that when I wrote about Hannah and Laura, I mentioned Laura as the one Burzynski case that might actually have benefited from her treatment. It turns out that I was wrong about that, too, as Laura Hymas died a year and a half ago, only a year after I wrote about them.
Meanwhile, while it might have been understandable that the press fell for Burzynski’s scam back in the 1990s—or even up until a few years ago—it is no longer understandable or acceptable. Burzynski is no Brave Maverick Doctor curing cancer where no one else can. He is a quack. Whether he believes he is curing cancer or not, who knows? The end result is the same: Lots of patients given false hope and emptying their bank accounts to enrich Burzynski. Aiding and abetting him are rags like The Daily Mail and propagandists like Eric Merola. Here’s hoping that the TMB finally shuts him down after all these years.
from ScienceBlogs http://ift.tt/1IZTddZ
Although I don’t write about him as much as I used to, there was a time a couple of years ago when Houston cancer quack Stanislaw Burzynski was a frequent topic of this blog. His story, detailed in many posts on this blog and in an article I wrote for Skeptical Inquirer, is one that involves many facets, including an abysmal failure of the normal government agencies designed to protect patients from abuses like his to actually do their jobs and—oh, you know—protect patients. If you want an idea of how utterly impotent our regulatory agencies are, the Burzynski case is as good an example as you’ll see.
I’m talking to you, Texas Medical Board. You allowed him to charge patients huges sums of money over the course of nearly forty years to be treated with his unproven chemicals isolated from urine and blood that he dubbed antineoplastons, even though he has failed utterly during those four decades to publish convincing evidence of efficacy and safety. I’m also talking to you, FDA. In 1997 you let Stanislaw Burzynski’s lawyer pull a fast one on you and get you to agree to stop going after Burzynski if he only gave antineoplastons to patients under the auspices of valid, FDA-approved clinical trials. Burzynski promptly did this, submitting over 70 clinical trials to the FDA, and then using them to continue business as usual: charging patients big bucks for his ineffective therapy. Yes, Burzynski’s clinical trials were (and are) a sham. The only difference is that for the last 18 years Burzynski has the cover of FDA-approved clinical trials. In that time, for some reason you’ve been utterly ineffective in shutting him down. Oh, sure, you managed to put his clinical trials on partial clinical hold after Burzynski killed a six year old boy named Josia Cotto with his treatment, so that he couldn’t enroll any new patients but could keep treating existing patients, but even that didn’t last. Even a lean kill of an innocent child wasn’t enough. You let him start up his clinical trials again after only a year or so off. No one knows why. No one can find out, given how impenetrable your bureaucracy and, above all, your exception to Freedom of Information Act (FOIA) requests that allows you to refuse to produce documents that might reveal trade secrets.
OK, I might have been a little too hard on the TMB (although, if anything, I’m taking it easy on the FDA for its role in this). The TMB is, after all, trying once again to prosecute Burzynski and take his medical license away. The hearing started three weeks ago and will resume again in January, leading me to ask if this is the time, after nearly four decades, when Stanislaw Burzynski finally faces justice. I hope so.
Unfortunately, as gratifying as it is to see Burzynski’s latest legal troubles, complete with a major schism between him and his former consigliere and lawyer Richard Jaffe over unpaid legal bills, the down side of seeing Burzynski being dragged in front of the TMB again is watching him use patients as shields again and seeing his followers crawl out of the woodwork to regurgitate the same old misinformation that I spent so much time refuting over the course of three years or so. Perhaps the most depressing Burzynski “blast from the past” to show up again is Hannah Bradley and her (now) husband Peter Cohen. Hannah, as you might remember, is one of Burzynski’s so-called “success stories.” In the months leading up to Burzynski’s hearing before the TMB, she showed up in a video in support of Burzynski, along with Stanislaw Burzynski’s personal propagandist Eric Merola:
Of course, I’m very happy that Hannah Bradley-Cohen is doing well and getting on with her life with her husband. I really am. She seems to be a wonderful young woman, at least as far as I can tell from reading about her and viewing her videos. It’s good to see her enjoying life with Peter. What I do not like is to see Hannah being used yet again as propaganda for Stanislaw Burzynski, no matter how willingly she participates in that propaganda. Why, I will explain in a minute. Unfortunately, just yesterday I saw another example of pure propaganda for Burzynski published in—where else?—the Daily Mail. It comes in the form of an article entitled British woman given just 18 months to live after being diagnosed with cancer defies doctors to marry after raising £200,000 to have controversial treatment in the US.
Yes, the story is exactly as you would predict just based on the title alone. It’s a paean to the “Brave Maverick Doctors” who buck the status quo, all in order—of course!—to cure cancer. It doesn’t matter whether or not these Brave Maverick Doctors can actually cure cancer or not, and, as I’ve discussed many times before, Burzynski cannot. He can’t even come close. Yet he’s still lionized in the “alternative cancer cure” community as the Brave Maverick Doctor who can cure brain cancers that regular neurosurgeons and oncologists can’t. Even now, four years after I took a serious interest in Burzynski, even as my view evolved from not being sure that he was a quack to being quite sure now that he is, I still can’t believe this. After all, antineoplastons, if they worked, would be chemotherapy. Certainly they have toxicities potentially as bad as chemotherapy. Then, as I’ve described time and time again, Burzynski has hijacked the concept of “precision medicine” (or “personalized medicine” or whatever you want to call it) by incompetently doing what can only be described as a parody of real precision medicine using very expensive, sometimes very toxic, cocktails of targeted pharmaceuticals. AS I like to put it, he’s making it up as he goes along.
In any case, it was because of his reputation among alternative cancer cure believers, including Suzanne Somers, who included a chapter about Burzynski in her book Knockout, that Pete and Hannah discovered Burzynski a few years ago, as yesterday’s Daily Fail story describes:
Burzynski, who charges thousands of dollars for his treatment, has been accused of selling hope.
But Pete watched a documentary about the doctor called Burzynski, The Movie, which convinced him that Hannah should seek treatment in Texas.
At first, Hannah didn’t want to know.‘The radiotherapy was causing my hair to fall out and I felt exhausted all the time,’ she said..
‘It took Pete three to four months to persuade me to watch the documentary, and when I finally did I saw it twice and kind of just knew I had to do it.’
But the treatment didn’t come cheap. The couple had to raise the $300,000 (£200,210) needed to pay for it.
They launched Team Hannah and friends and family quickly rallied around to bring the cash rolling in.
‘I’m originally from Surrey and one friend reached out to a local radio station there,’ Hannah says.
‘They ran a campaign for people to donate £1 to our cause. Another friend threw a charity ball.’
It wasn’t long before the couple had reached their target and they flew out to Texas at the end of 2011.
The couple spent seven weeks in the US, with the treatment being administered using a catheter for medicine called a Hickman line four times a day.
This is a story Pete, being a bit of a filmmaker himself, documented in a video he called Hannah’s Anecdote:
Hannah’s story featured prominently in the sequel to Burzynski The Movie: Cancer Is a Serious Business, which was entitled Burzynski: Cancer Is A Serious Business, Part 2. (Clearly, Eric Merola, the “auteur” responsible for both Burzynski movies, really needs to go back to film school to relearn how to come up with better titles for his Burzynski advertisements disguised as documentaries.) Part of that segment of the movie featured Pete and Hannah practically crying over how “mean” skeptics have been to Burzynski and them. Of course, I’ve never yet found an example of a skeptic saying mean things about the couple; personally, I’ve said from the beginning that I always hoped that Hannah would do well, whether from the antineoplastons or from the other treatments that she had undergone.
In fact, if you look at Hannah’s anecdote carefully, it becomes clear that the antineoplastons, if they had any effect at all, were almost certainly not responsible for Hannah’s good fortune. I discussed Hannah’s case in detail nearly three years ago, but it’s worth reiterating the CliffsNotes version. Basically, in February 2011, out of the blue Hannah suffered a seizure. She had never had a seizure before; so an immediate evaluation was performed, which revealed a brain tumor. She underwent surgery April 1, 2011 to remove a grade III anaplastic astrocytoma. Surgery was followed by a six week course of radiation therapy. It was at this point that Hannah apparently still had residual tumor, or at least her doctors thought she did, which led to her and Pete’s search for an answer, which then led her to Burzynski.
Contrary to Burzynski’s claims and how his therapy is marketed, even the story of a patient who sincerely believes Burzynski saved her life demonstrated a situation very much to the contrary. At least a third of Hannah’s anecdote deals with all the difficulties that Hannah experienced with her treatment, including high fevers, a trip to the emergency room, and multiple times when the antineoplaston treatment was stopped. She routinely developed fevers to 102° F, and in one scene her fever reached 103.9° F. She felt miserable, nauseated and weak. I’ve seen some chemotherapy patients suffer less from their treatment. I also noted that the reaction of the clinic staff was rather blasé, even though at one point Hannah clearly demonstrated a change in mental status, appearing “drunk” and complaining of double-vision, which made me think such issues were a common complication of antineoplastons. At another point, Pete and Hannah come to believe that the fevers might have been due to the tumor breaking down, which strikes me as implausible. Hannah even developed an extensive rash, which looked to me a lot like erythema multiforme, which is generally an allergic rash, often due to drug reactions.
Near the end of the video, Pete displayed an MRI dated July 29, 2012 that looked quite good, with little or no enhancement left. The question, of course, is: Does this mean that Burzynski’s antineoplaston treatment worked for Hannah? Sadly, the answer is: Not necessarily. It might have. It might not have. Why do I say this? First, the median survival for anaplastic astrocytoma (which is a form of glioma) is around 2 to 3 years, and with different types of radiation therapy five year survival is around 15% or even higher. Even now, we are only approaching the five year mark, which will be in February. Be that as it may, long term survival for patients with astrocytomas is not so rare that Hannah’s survival is so unlikely that the most reasonable assumption has to be that it was Burzynski’s treatment that saved her. Second, there is a phenomenon in brain cancer known as pseudoprogression. Basically, what happens after surgery and radiation therapy is that there is an area of healing, where dead brain tissue (and, after radiation, tumor) provokes an inflammatory reaction. Because MRI images are based on blood flow, that area shows up as enhancement, sometimes increased enhancement that can take a long time to disappear. Thus, pseudoprogression can sometimes be mistaken for a tumor recurrence or residual disease. Indeed, up to 28% of cases of seeming tumor progression can be due to pseudoprogression, as this review describes. I’ve long speculated that Burzynski is too incompetent to understand this, leading him to mistake the resolution of pseudoprogression for tumor response to antineoplaston therapy, or, worse, that he understands pseudoprogression and is cynically taking advantage of it, such that now Hannah states:
Hannah has set up a business distributing healthy coffee and is looking forward to starting a family with Pete.
‘My scans show just a space where the tumour was,’ she says. ‘I’m incredibly fortunate.
‘I wouldn’t tell people not to go to Dr. Burzynski. But it’s very difficult to be treated by him because he’s not recognised so you have to apply to take part in one of his trials.
‘My advice to anyone diagnosed with a life threatening condition would always be to never give up.’
No, Burzynski’s clinical trials are a scam, as I’ve described many times.
When I initially wrote about Hannah, I was very worried about her. I’m very happy to see that my concern was overblown at the time. Hannah is doing quite well now. This is in marked contrast to Laura Hymas, a young woman with a similar sad tale, except that her cancer was of a less aggressive variety. She, too, became a media sensation in the UK after raising money to go to Houston to be treated by Burzynski. She, too, appeared to be doing well, so much so that when I wrote about Hannah and Laura, I mentioned Laura as the one Burzynski case that might actually have benefited from her treatment. It turns out that I was wrong about that, too, as Laura Hymas died a year and a half ago, only a year after I wrote about them.
Meanwhile, while it might have been understandable that the press fell for Burzynski’s scam back in the 1990s—or even up until a few years ago—it is no longer understandable or acceptable. Burzynski is no Brave Maverick Doctor curing cancer where no one else can. He is a quack. Whether he believes he is curing cancer or not, who knows? The end result is the same: Lots of patients given false hope and emptying their bank accounts to enrich Burzynski. Aiding and abetting him are rags like The Daily Mail and propagandists like Eric Merola. Here’s hoping that the TMB finally shuts him down after all these years.
from ScienceBlogs http://ift.tt/1IZTddZ
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