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Dublin: 11 °C Monday 20 May, 2013

Campaign launched to save teen cancer sufferer’s life

Sean Lyne is suffering from stage four cancer and has discovered a clinic in the US that could offer him a life-saving treatment.

Sean Lyne is hoping to travel to the US for potentially life-saving treatment
Sean Lyne is hoping to travel to the US for potentially life-saving treatment

THE FAMILY AND friends of a Dublin teenager suffering from cancer have started a campaign to raise funds so he can travel to America for life-saving treatment.

Sean Lyne, a 19-year-old from Crumlin was diagnosed with a glioma brain tumour in March of this year. Doctors in Dublin have told him the cancer has reached Stage 4 so chemotherapy and radiation, although he is still undergoing them, will only shrink and control the tumour – not get rid of it. They have told him it is inoperable.

Through his own research, the young Dubliner discovered a clinic in Texas which offers treatments that could save his life. However, this treatment will cost at least €120,000.

Described as an “eternal optimist” by his friends, Sean is determined to make it to the Burzynski Clinic and his family have rallied around him.

Friends and fellow students at Ballyfermot College have organised a campaign to raise the necessary funds.

Experimental

Lyne, a trainee nurse has talked to his doctors about the experimental treatment he would receive in America. It would involve antineoplaston therapy that uses a group of synthetic chemicals to protect the body.

Although he realises the treatment is experimental and holds no guarantee, Lyne hopes to be in Texas by November.

Just a day after the campaign was set up, there are already numerous events organised, including a four-day cycle in Templebar, bucket collections outside Croke Park, bag packing and head shaving.

Health deteriorating

Speaking to TheJournal.ie, close friend Cassie Delaney explains that Sean has just undergone six weeks of chemotherapy and radiation and is “in a pretty bad way at the moment”.

“He has a break until next week,” she says, “But he will be back on 450mg of chemotherapy tablets every day next week.”

Last week, he had to return to hospital because he had a bleed in his brain.

Describing her friend, Delaney uses words such as “compassionate” and “giving” and says he is a keen GAA player. She tells me of his wish to become a nurse and how he got a distinction in all his pre-course exams. After completing his first year at Ballyfermot, he had just applied for a degree programme through the CAO system but will not be going to college for the moment.

The pair met though an African volunteer programme. However, two weeks before they were due to fly out to Malawi, Sean was given the awful diagnosis.

Sean’s mother, Mary Lyne, is the driving force behind the campaign but Delaney, a journalism student in Ballyfermot College, has been charged with gathering press attention for the cause. Her fellow student, Daragh Power has been appointed as the chair of fundraising. As a trained musician, he reckons he can make money appear – and quickly!

For more information about Sean and all the fundraising initiatives, check out the blog and the Facebook page.

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Comments (73 Comments)

  • Buffy 28/08/11 #

    This is one of those articles that makes me so sad, because I know what it’s like to have a family member diagnosed with cancer, and I know what it’s like to watch a family member or friend pass away from an illness that can’t be cured. It’s scary, and upsetting, and difficult, and if someone tells you there is a cure, you want to leap at the chance and grab it with both hands. When you find someone that purports to have a cure, of course, you don’t want to look for things that will disagree with or debunk that cure. Unfortunately, when those things exist, it’s not always the best course to ignore them – hope is valuable, but false hope is cruel and devastating.

    I first encountered Burzynski when a women called Laura Hymas began fundraising to receive treatment at his clinic. I wrote a post about the value of hope, and Burzynski himself at the time. As time has passed, more people appear to be finding Burzynski, perhaps inspired by others they have seen in articles like this, and the post (http://www.zenbuffy.com/2011/05/how-much-does-hope-cost/) seems more relevant than ever.

    To the people who have linked the Burzynski documentary as proof that the cure works, or that it is being suppressed by “big pharma”, I would point out that the movie was produced, directed, written, and edited by one man, Eric Merola, who is a friend of Burzynski. This is not an independent documentary, it’s a long advertisement. I would also ask you to consider whether the fact that someone is famous or has a movie about them automatically makes them more credible – many popular celebrities have, for example, continued to tell people not to vaccinate their children, cleaving to evidence that has been comprehensively refuted. This dangerous misrepresentation of information has resulted in a large increase in the number of children suffering from measles, a disease we once thought we were close to eradicating completely.

    How much would you pay for hope? £75,000? How about $140,000? Maybe €120,000? Given a life-threatening illness, or a chance to completely change your circumstances, I’d guess that most people would say that hope is priceless, and that they would pay anything, and indeed, everything, for that chance at hope. The fact that hope is priceless often comes up when discussing medical treatments, particularly those for terminally ill people. Skeptics are often decried as horrible people who aim to steal hope from people when they debunk various quack treatments, dangerous cults, or weird beliefs; in many cases, these quack treatments have successfully preyed on very vulnerable people who are trying to fight something that we probably all fear – an early, or untimely, death. And who are we, the nameless, soulless skeptic, to come and tear this last hope from the hands of the dying?

    Well, in answer, I’d first like to turn my initial question around – we all probably have a good idea of exactly how much we’d pay for that last dash of hope, but how much do you suppose you’d charge for it? An assertion oft put forward by proponents of alternative medicine, for example, is that there are cheap and effective treatments available for many life-threatening conditions, such as cancer and AIDS, but that because the molecule can’t be patented, “big pharma” can’t make a profit, and therefore isn’t interested. It is lucky for us, therefore, that these renegade magicians are available to offer this cure, at this extremely cheap price, to everyone, profit-free. Oh, wait. That’s not quite right. Actually, each “cheap and effective” cure that “big pharma” ignores because it can’t turn a profit is usually bundled up with some appropriate pseudo-science sounding nonsense, perhaps tacked to someone with a dubious qualification, and usually offered to the public at the phenomenal price of approximately €yourLifeSavings.

    Burzynski’s antineoplastons have been in clinical trials since he first conceived them as a cancer treatment. These trials have yet to prove that they are in any way effective. Independent studies failed to replicate Burzynski’s results. Dr Howard Ozer of the Allegheny Cancer Center in Philadelphia, called the research “scientific nonsense”. The FDA haven’t approved the treatment for any diseases. Burzynski has been convicted of fraud for claiming money from insurance companies for false cancer treatments. The evidence does not do much to raise hopes for hopeless people, but to ignore it does no one any good.

    Pedalling false hope is a charlatans game, practised by the lowest of the low. They prey on people who have found themselves in desperate situations, and who have found themselves low on hope. They take advantage of vulnerable people, and leave them financially destitute, and once again, hopeless. Sometimes, the nonsense they sell (whether it is a physical product, or the promise of the metaphysical divine) is so laughable that it’s easy to forget that it’s not a victimless crime.

    I can only suggest that anyone who truly wishes to help cure the diseases which rob us of friends, relatives, and loved ones, should donate to a respected and established charity or trust, or even donate time to help care for those who are dealing with these illnesses. Medical science is making huge advances, and diseases once thought deadly are now treatable, and in some cases, curable. As for the rest, we’ll get there. I hope that Sean manages to find a cure, because for anyone to be robbed of life so young is a truly sad thing.

    Whenever I think of Burzynski or read another article about him, I am reminded of a poem by Emily Dickinson, which I studied in school. It is called “Hope is the thing with feathers”, and for me, it has always spoken right to the heart of hope itself – it never stops, it is not abashed, and it asks for nothing.

    Hope is the thing with feathers
    That perches in the soul,
    And sings the tune–without the words,
    And never stops at all,

    And sweetest in the gale is heard;
    And sore must be the storm
    That could abash the little bird
    That kept so many warm.

    I’ve heard it in the chillest land,
    And on the strangest sea;
    Yet, never, in extremity,
    It asked a crumb of me

    Reply
  • My heart goes out to Sean and his family, I can’t imagine how tough it must be to go through something like this, and I really hope he manages to recover, whatever treatment he undertakes.

    For people asking for specifics on why Burzynski is seen as a con artist, here is an article on which outlines the problems with Burzynski’s treatment: http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html

    In the 90s Burzynski was convicted by the state of Texas of advertising a cancer treatment with no proven results and was ordered to stop advertising his treatment as a cure for cancer until it could be proven that it worked.(Source: http://www.quackwatch.org/04ConsumerEducation/News/burzynski.html) In 1995, a grand jury charged Burzynski with 75 counts of criminal contempt, mail fraud, and violations of the Food, Drug and Cosmetics Act and in 1998 the courts ruled against him, with the jury saying “Dr. Burzynski’s own testimony demonstrates that the FDA notified him in February 1984 that it found deficiencies in his [drug approval] application and required additional data. He candidly admits that he has neither provided the data requested nor explained to the FDA his reasons for considering that data unnecessary.” (Details: http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski2.html http://openjurist.org/819/f2d/1301/united-states-v-burzynski-cancer-research-institute-r http://www.quackwatch.org/04ConsumerEducation/News/burzynski.html )

    He’s been running his treatment as “clinical trials” for at least a couple of decades now, and the vast majority of them are still in phase II testing to prove if they have any beneficial effect at all (with the accusation that they might even have skipped over phase I to prove that they’re safe. See http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski2.html). Three different experts in clinical trial setup found that “Clinical trials conducted by [Dr.] Burzynski are poorly designed and unlikely to produce interpretable results”. Another review found that because of how the trials were set up “[Dr. Burzynski's] data can never be useful to show true merit or lack of merit of his drug”.

    Reply
  • I dont know anything about this guy or his "cure"
    I just hope this young man gets what ever he needs to help him

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  • My wide passed away from the same tumour in 2009.if this guy has hope then please don’t take it away from him. from all the research i’ve done this is a real shot in the dark,but it’s still a shot so hopefully he gets there.from my first hand experience with this type of tumour though ,November is too far away

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  • Joanna 30/08/11 #

    I have been following this debate for a while. It breaks my heart to read of a case like this, and I do have personal experience of how horrible it is. My mother died of cancer last year.

    I have just been reading Cancer Research UK’s website, for their comments on the treatment at question here.

    http://cancerhelp.cancerresearchuk.org/about-cancer/cancer-questions/what-is-antineoplaston-therapy

    As well as false hope, this treatment offers some extremely distressing side-effects, up to and including seizures. So in addition to going through a treatment which in 35 years of trials has yet to produce any solid evidence in its favour, as well as time, money, and having to deal with the actual disease that you will in all probability not be helped with, you run the risk of suffering further.

    I don’t think anyone should give up hope. But hope in the right things.

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  • Aidan M 28/08/11 #

    I don’t know if this lad is right or wrong but I do know there is no such thing as a cure for cancer. They could possibly get his cancer to go into remission and eventually he’d be disease free and here’s hoping it works for him and it’s not a scam.

    Reply
  • Buffy 30/08/11 #

    I’ve asked myself previously about the information in the film, as this is not the first time I’ve seen it referenced as proof, and I believe that the information in the film is untrue. I believe this based on the available evidence provided by sources outside of this film, such as my own reading of the papers published about his treatment, the trials, etc. In addition to the many articles you may have found, you have quite probably overlooked other documentation, such as the published papers on his treatments, details of his fraud conviction, his lack of medical qualifications and possible falsification of academic qualifications, etc. It’s easy to cherry-pick information when you’re only looking to prove one side of the argument. I watched the movie, and read the website, and visited the patient group sites *as well as* reading the scientific papers, the FDA information, the fraud conviction. With all of the information in front of me, I made an informed decision about what I believed to be the truth of the matter. I would encourage you to at least pay lip-service to avoiding confirmation bias by reading some of the links that have been posted here. Otherwise, you’re not really arguing, you’re just advertising.

    All of the papers about the treatment are published by Burzynski himself and no independent research facility has been able to replicate the results. The papers are case studies, not trials, and case studies are considered among the weakest forms of evidence. A paper written about a single patient, or a handful of cherry-picked patients is not proof of anything, and the existence of many such papers proves only that Burzynski can type, and nothing more. Case studies are not the same as randomised controlled trials, which are considered the gold-standard for proving the efficacy of a treatment. Burzynski’s treatment has yet to be proven in such a trial – in fact, such a trial has yet to even be completed. Case studies are not proof that you can rely on, and are far too open to exploitation and fudging of data. It was a poor case-study paper that sparked the MMR controversy too.

    Anecdotal evidence, news articles, and youtube videos are not proof of something being effective. For something to be effective, it has to be repeatedly proven to be effective in a robust, clinical manner – this is standard for all potential treatments for any illnesses. Claiming that you have a cure for serious illness is, in many countries (including america) not actually legal, and many of Burzynski’s problems (and, indeed, his fraud conviction) relate to the fact that he has advertised this treatment as a cure – something which he is not legally allowed to do until it has been proven.

    I’m not saying that the FDA and/or pharmaceutical companies are above reproach – I value skeptical and rational thought, and am very well aware of cases where the they have behaved badly. This, however, does not negate the fact that Burzynski’s treatment is, as of yet, completely unproven and being falsely advertised.

    The simple fact of the matter is that I do not know of a single, legitimate treatment that had to advertise itself as “something big pharma don’t want you to know about”. Typically, treatments advertised in this way, and accompanied by hyperbole-filled persecution stories, are either not proven to be effective, or proven to be ineffective. It’s rare that a legitimate product has to set itself up as the persecuted and much maligned underdog in order to gain market share, and rarer still that products advertised as something “big pharma/the man/the govt” don’t want you to know about are actually things that “big pharma/the man/the govt” don’t want you to know about.

    In return to your opening question, I’ll ask you one – have you seen aspirin advertised recently as a development that “big pharma” wanted to keep quiet? How about at any point in it’s history or development? How about a more recently developed drug which has proven its effectiveness – have you seen any material claiming that Herceptin is something that “big pharma” don’t want you to know about or can’t make money from and therefore won’t produce?

    In short – I make my decisions based on the best evidence available to date, not advertisements or propaganda. If evidence arises which conclusively proves my previous assertions to be incorrect, I will, absolutely, change them. I adjust my beliefs and expectations based on the evidence that I see, even if that evidence contradicts a belief which I perhaps once held dear. To paraphrase Tim Minchin – if you can show me that it works, and how it works, I will spin on a dime and run through the streets proclaiming that we have, at last, a miracle cure.

    Reply
    • There is at least one independent group who claim to have validated Burzynski’s ideas, but the study they put out wasn’t terribly good and only found publication in a poor quality journal. Still, I think it’s important to note this when claiming that no independent researchers have been able to validate his claims. The vast majority of independent groups have, it is true, been unable to replicate his results, but there’s at least one group making claims to the contrary.

      Reply
    • Buffy 30/08/11 #

      Thanks for clarifying that. I haven’t seen that study myself, so perhaps it’s time for another literature search. Don’t suppose you have an author(s) names? The only papers I have seen, even in my most recent searches, have all had Burzynski as an author.

      Reply
    • It’s a Japanese group, don’t have the names to hand right now. The study is mol-bol, not clinical, and purports to throw light on the biochemical mechanism of antineoplaston action. But, as I said, it’s not very good and published in a crap journal.

      Reply
    • Here’s a link to one of the Japanese group’s papers that were mentioned: http://www.ncbi.nlm.nih.gov/pubmed/16012735

      Reply
  • I’ve read the article and accompanying comments with deep understanding for the different positions shown here.
    I lost a dear friend to breast cancer After she rejected ‘conventional’ treatment and put her faith and money in a hands-on healer.
    Metastisis to the lungs and brain and a painful death were the results.
    Not to mention a bankrupted family.

    Dr Burzynski charges a mighty high price for a treament with no proven track record.
    How is it independant research has not been able to duplicate his claims?
    A cure for any type of cancer would be a God send and I for one would be leery of confiding my money to a treatment with no clinical proof it works.
    Having said that, my deepest sympathy goes to this young man and his family in their search for remission from this cancer.

    Reply
  • "To SAVE teen SUFFERES life"

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  • The film seemed quite honest to me. But as others have said on here, it is VERY biased. I would be very skeptical of this Dr.

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  • I.B 28/08/11 #

    please god he gets enough money to go for this operation anything or whatever gives him hope to get through each day is a help. Don’t give up hope an keep positive.

    Reply
  • Thank you to everyone for kind words I know friends and family are thankful for them and for the ones being negative we really don’t need to hear it a saying goes don’t have something nice to say don’t say anything at all use it

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    • I have something nice to say: Spend the money on treatment that actually works, not on a quack who bullies schoolkids. Evidence-based medicine. It works!

      I have Ben Goldacre’s excellent book Bad Science, and while he doesn’t mention Burzynski specifically in that book, he does tell you enough to let you recognise a disgusting quack (and convicted fraud) when you see one.

      I’ll quote the excellent (and brave) Rhys Morgan: A 2004 analysis of evidence for a number of alternative treatments for cancer, including Burzynski’s own antineoplaston therapy, said that “The label “unproven” is inappropriate for such therapies; it is time to assert that many alternative cancer therapies have been “disproven.”” In short, it’s quackery – ineffective treatment promoted as effective and sold for a very high price.

      TRiG.

      Reply
  • It takes a lot of time to debunk sCAM. Nothing I have read or seen inclines me to even suspect this quack might have a cure for cancer. Below is from 30 years ago. So in 30 years this con artist has failed to provide any evidence whatsoever he has, on his own, discovered a cure for cancer.

    “In 1982, consultants to the Ontario (Canada) Ministry of Health visited Burzynski’s clinic and reviewed records of twelve patients selected by Burzynski from among the thousands he had treated. According to the OTA report, the Canadian doctors “found no examples of objective response to Antineoplastons.” In 1985, the Canadian Bureau of Prescription Drugs examined the records of Canadian doctors who had treated patients at Dr. Burzynski’s clinic in Houston. Of 36 patients, 32 had died without showing signs of improvement. Of the remaining 4, one patient died after slight improvement, while one patient died after stabilizing for a year. The 2 remaining patients had widespread cancer.”

    The video “documentary” is full of the usual nonsense you always get when investigating con artists.

    Here’s a link to Quackwatch http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html

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  • Most of the posts here are written by very very silly people. This guy was convicted of medical fraud. There is no scientific basis to his bogus "cure". Read any material NOT written by this quack or his stupid sCAM followers and you will see that.

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  • I don’t know if I actually want to continue in this debate to be honest. The family and patient’s decisions are deeply understandable and, though I stand by my opinions on the matter, I feel increasingly conflicted about my involvement.

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    • Buffy 30/08/11 #

      I understand your discomfort lesmondine – I had the same difficulties when I first posted about Burzynski alluding to another similar article about him. I spent a very long time writing my blog, and my first comment on this article, because of those conflicts. My father has, just recently, finished cancer treatment, so I know all too well how horrible it is to be told a family member has cancer. It is undeniably terrifying. That said, I know equally that, even when faced with this reality, I couldn’t bring myself to suggest any of the alternative treatments that I have seen listed for cancer, Burznyski’s among them.

      We were lucky – treatment has, for now, removed the cancer and made my dad well again. I can’t imagine the pain of being told that there is no treatment, or that the treatment won’t work. Still, though, what I find upsetting is people who take advantage of those in these vulnerable situations. Families are so often left in a very poor financial situation because they have spent every dime on a miracle cure, or on a healer, or on someone who claims they can talk to the dead. I have watched members of my extended family spend money on psychics, trying to talk to dead relatives, and it breaks my heart to see them being taken advantage of when they are grieving.

      Although it is a thorny issue, and although people will always berate you for stealing hope, I still think it’s important that people learn to recognise quack cures that will rob people of life and life savings. I don’t blog or comment so that I can destroy hope, I do it so that I can shed light on people pedalling false hope, which is something I believe to be utterly despicable. If someone has been diagnosed with a life-threatening illness, they deserve better than to be lied to, cheated, and ultimately, disappointed.

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    • Les, does being in proximity of tragedy mean we should abandon people to quacks (well meaning or dishonest)? Should we let them raise thousands of pounds to travel to America to undertake a treatment that will not work? Exhausting their families and friends life savings on the chance that spontaneous remission takes place?
      Should we allow them to facilitate the continuation of this quackery so it can hook more people on the false hope it peddles?
      Should we allow them to divert charity funds from those seeking a cure who might have an actual chance of discovering one and helping thousands?

      The answer to most of those is “no” for me.

      I felt slightly uncomfortable addressing this the last time it arose. But it was the right thing to do and remains the right thing to do.

      The people pointing out this doesn’t work and that it is nothing more than false hope may look like the bad guys superficially but they aren’t charging thousands of pounds selling nothing more than one doctors pet theory and a cure that doesn’t work.

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  • Your severe ignorance in this matter is revolting William Grogan. Shame on you for dismissing what might be this boy’s only chance at survival based on your microscopic level of “research” and your obvious suggestibility by a media with an insatiable appetite for controversy.

    Do yourself justice and attempt to redeem yourself through some education by those not motivated by $250,000 USD per round of chemo. Watch this documentary on Dr. Stanislaw Burzynski:

    http://www.youtube.com/watch?v=H0ibsoqjPac

    Reply
    • So spending €120,000 on a treament with no documented scienfic proof of effectiveness and NOT approved by the global governing body for medical treaments is fine but the $250,000 USD per round of chemo that is accepted by the medical community and has proven effectiveness is wrong? Your ‘educational video’ appears to be obviously biased from the get go.

      I feel for this man. I really do. Cancer is a horrible disease and brain cancer even moreso. But there’s hope and there is false hope. And even worse there are those that use peoples false hope to make money.

      Reply
  • In 2008, the US FDA (the body with oversight of the medical establishment) issued a “warning letter” to this “clinic”. The following are some extracts. See how often the clinic referred to as the “IRB” failed to do their research properly. This is an extract. The entire letter is on the FDA website. To quickly read this, just read the sentence iimmediately after the paragraph number which I have placed ********* .

    Between December 3 and 10, 2008, Mr. Patrick D. Stone, representing the Food and Drug Administration (FDA), inspected the Burzynski Research Institute (BRI) Institutional Review Board (IRB). The purpose of this inspection was to determine whether the IRB procedures for the protection of human subjects complied with Title 21 of the Code of Federal Regulations (CFR), Parts 50 and 56. ….
    From our review of the establishment inspection report, the documents submitted with that report, and your April 2, 2009 written response to Form FDA 483, ********* we conclude that the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects. ********* We wish to emphasize the following:
    It is unclear why the IRB allowed the study to go forward in humans when additional toxicity studies in animals were requested. In addition, it is unclear why the IRB allowed Dr. (b)(4) to continue (b)(4) the study when it appears that he initiated this research study, i.e., began dosing subjects, prior to obtaining IRB approval.
    During the inspection in December 2008, you told the FDA investigator that you were unaware that this IND was on clinical hold. However, (b)(4) responded to the IRB in a letter dated September 4, 2008, and referenced the clinical hold placed on the IND by FDA. Minutes of the October 24, 2008 IRB meeting indicate that the IRB decided to “draft a letter to (b)(4) stating that their application for this IRB to act as an IRB for their study be placed on hold until such time as we receive information regarding the FDA’s position on the Toxicity Studies. At that time we will also review their Toxicity Studies and consider continuing their application.” The IRB conveyed this information in a letter dated November 3, 2008; however, the letter was only sent to Dr. (b)(6) and not to (b)(4).
    In your written response, you state that “[t]he IRB was informed that the sponsors were in discussion with FDA regarding their IND status. Based on this, the IRB considered its relationship to both sponsors and protocols in abeyance.” As discussed above, the final piece of correspondence issued by the IRB in regard to the (b)(4) study was sent only to Dr. (b)(6) therefore, there is no documentation to demonstrate that (b)(4) was aware of the lRB’s abeyance status of this study.
    In an April 4, 2005 letter, the IRB informed the sponsor-investigator that the revised documents had been approved. During the inspection, no Investigator’s Brochure was found in the lRB’s file. Therefore, it appears that the IRB approved the research without ever receiving one, which could impact an lRB’s ability to determine whether risks to subjects were minimized and whether risks were reasonable in relation to anticipated benefits.
    In your written response, you state that the clinical protocol for (b)(4) was never approved for patient enrollment. Your response does not comport with the correspondence sent by the IRB to the sponsor-investigator. During the inspection, you told the FDA investigator that this study was placed on clinical hold by the FDA. It is unclear when the IRB became aware of the clinical hold status and why the IRB informed the sponsor-investigator on April 4, 2005 that the study had been approved.
    2. ********The IRB failed to prepare, maintain, and follow written procedures for conducting its initial and continuing review of research ************ [21 CFR 56.108(a) and 56.115(a)(6)]. Specifically, the IRB has no written procedures for conducting reviews of device studies to determine whether they involve a significant risk device and had no evidence that it had in fact conducted such reviews [21 CFR 812.66].
    3. ********** The IRB failed to ensure that informed consent would be sought from each prospective subject *********** or the subject’s legally authorized representative in accordance with and to the extent required by 21 CFR Part 50 [21 CFR 56.111(a)(4)] and that informed consent would be appropriately documented in accordance with and to the extent required by 21 CFR 50.27 [21 CFR 56.111(a)(5)].
    4. ************ The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest, **************** except to provide information requested by the IRB [21 CFR 56.107(e)].5. The IRB failed to conduct continuing reviews for the following IRB approved studies [21 CFR 56.109(1)]:
    6. *********** The IRB failed to maintain copies of all research proposals reviewed, scientific evaluations,************ if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators and reports of injuries to subjects, and correspondence with investigators [21 CFR 56.115(a)(1) and 56.115(a)(4)].
    7. ********** The IRB failed to prepare and maintain the minutes of IRB meetings in sufficient detail to show attendance at the meetings *************** ; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution [21 CFR 56.115(a)(2)].a. It appears that the IRB tape records its meetings, which are then transcribed into a hard copy format. It is difficult to discern what studies are being discussed because the minutes do not reference the exact study titles or study numbers. In addition, it appears that when the transcriptionist does not understand certain words, they are transcribed as either blanks or question marks. Due to the numerous blanks, it is difficult to determine whether controverted issues were discussed.
    8. Each IRB is required to have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution [21 CFR 56.107(a)].
    Our inspection revealed that, in some instances, when an IRB member had a conflict of interest for a particular study, another person, who was not an IRB member, was allowed to take the place of the conflicted member and participate in the IRB’s action. There is no provision in FDA regulations for this type of action.

    Reply
  • I say give it a shot. What the hell is money compared to a life? From reading about this clinic, I reckon they know a thing or two about cancer. If 50,000 people donate a measly 3 euro it’s a GO!

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  • Can I thank the people above who put a lot of their time into clearly pointing out that this treatment is nonsense. To those of you who still cannot understand, very little can be done, you probably do not have a scientific education, are probably not good at basic logic and are poorly read. That’s why these sCAM con artists continue to thrive. Without the gullible they would have no income. Until we have politicians who are better scientificially educated little will change. We need tough laws to protect the gullible. As for God blessing us, I’m sorry but there’s no gods either. My suggestion to the family is acccept the reality of the situation. Spend as much time as is left with the boy and don’t waste what little you have travelling needlessly. While he is alive there is always hope. Soon Science will find cures for all cancers.

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    • I want to thank you William for your comments. This has made me more motivated to go on and raise as much money as I can. I would rather for Seán to try any treatment even if it might be “nonsence” it would be best for him to try something. If you know Seán like I do hes the kind of guy that would never loose hope or give up on anything! Its his decision to go forward with this treatment his family never decided this. Now can you please F**k off and annoy somebody else? Cheers.

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    • Sean,lets get this straight. You are a friend and you want to waste the last months of your friend’s life trying a bogus treatment which has NO chance of working and in the process make a complete fool of himself and yourself? You also want to aid in defrauding your other friends and the community at large out of €120,000? Now that I have told you this quack has already been convicted of fraud will you pass on this information when you are asking people for their money? If you don’t what does that make you? I have a great deal of sympathy for you. You literally haven’t a clue. It is people like you desparate to help their dying friends that these scum target. Did you not read the other well thought out posts that clearly showed that this vile human only wants your money and CANNOT cure your friend. Your statement of giving him hope is total bullshit. All you you seem to want to do is fool him. Would like to be fooled when you are dying?

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    • Ahh William how about this I will get in contact with you again in 6 months and let you know how Seán is doing how about that?? And please when I tell you that Seán is improving and nearly cancer free. Please give me the respect and admit that you were wrong about all this ok? It is amazing how so many people out there in the world would say you cannot do this, you cannot be cured, you cannot achieve what you wanted to achieve. That is bullshit!!! Maybe it hasnt worked for a lot of people but whats not to say that it wont work for Seán? Dont ever say Seán cannot be cured you are not a psychic!!! Seán will be cured and when that happens I would like a written apology to Seáns family! I will be on to you again when that time comes!.

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    • You haven’t addressed a single point put to you by me or other people on this forum. You have no desire to learn.

      Will you tell those who give you their money that he has been convicted of fraud? Will you mention that his PhD is fraudulent? Will you mention that he had no background or training in Cancer research when he made his miraculous cancer cure 40 years ago? Will you mention that no other scientist or doctor can duplicate his work? Will you mention my post below showing that out of 36 of his BEST patients put to a Canadian group of scientists that 34 died and two still had widespread cancer?

      Look at yourself. Have you any knowledge of Science or medicine? Have you ever before now examined the huge fraud that exists in the “miracle cure” business? Can you admit that you do not know what you are talking about?

      Sean may recover but if he does it will have nothing to do with the con artist who wants your money. Do you think that treatment using an extract of urine could legitimately cost €120,000?

      It’s very hard to address your last post in such a forum. It is so full of illogical disconnected remarks. What will YOU do if the treatment doesn’t work? Will you just say we tried and condemn yourself to being included as another mark of this “clinic”. There are no Psychics. I cannot predict the future but the chances of this treatment working are far less than the chances of winning the lottery.

      Why hasn’t this fake PhD won the Nobel Prize? He has apparently “treated” 8,000 sick people. Why can’t he simple publish the number treated and the number cured? Why, because he hasn’t cured anyone. Sean won’t be the first.

      Don’t fool yourself into thinking that you are helping your friend. You are not. You are harming him. Instead of spending his last days with his family in peace because he has accepted his condition, you want him to travel 10,000 miles and be conned by a scum bag that you can’t recognise because you can’t even be bothered putting your brain in gear. I now offer to address any specific point you make from what you have read or seen in that silly video and try and get you to understand where you are wrong. Will you take up that simple challenge? The challenge to learn.

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    • Mr Grogan I will be in touch in 6 months. You better start making out that hand writen apoligy! :-D

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    • could not have said it better myself, there are mixed views on the clinic, if the clinic is a scam and what it is claimed to be we the friends and family of Sean will do anything we can and try anything he has the support of many people so don’t worry if it doesn’t work let me assure you we will keep trying. Thank you for your concern enjoy reading your letter in a few months :D

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  • Why because it not backed or funded by a big pharma brand? If it was would you believe it? This and the gerson theory have worked for many people.

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  • Unfortunately this "clinic" is run by a con artist. There is no chance whatsoever that attending this bogus "clinic" will cure the man. His "cure" is total nonsense.

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    • Do you have details to back this up?

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    • Can you be more specific please?

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    • Aaron 28/08/11 #

      ‘His "cure" is total nonsense’

      So is your response. Why come out with a statement like that? Have you dealt personally with this clinic or is your life that sad you need to shoot down other people’s dreams to make yourself feel good?

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    • You might do some research before discounting a therapy which has proven to be successful for similar cancers previously. Fantastic documentary on this treatment and the scam that is the ‘Cancer Business’ as created by the Pharmacutical companies (hint: it’s in their financial interests NOT to find a cure for cancer).

      You can watch it here: http://vimeo.com/24821365

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    • This guy’s cure involves using materials isolated from URINE to turn cancer cells back to normal. He has NO training in cancer medicine and the medical credentials he has from his home in Poland are questionable. He has performed human experiements without accreditation and permission from the global medical governing bodies.

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    • The bloody neck of you I am a close friend of the family and for you to even say this bullshit how dare you, who are you to say all this stuff the family have researched a lot into this place their not a stupid family and to even say this, family and friends are working hard to get this for Sean what we don’t need is somebody crushing the hopes of many people that remain hopeful to get Sean there and would kindly like you to keep your comments to yourself were asking for support not negativity

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    • Edwina. No-one is saying they’re stupid. We’re saying they’re vulnerable and likely to be less skeptical than they might normally be in the hope that this disproven, bogus treatment might help.
      Burzynski’s treatment has been in clinical trials since it’s existence. The few trials that have finished have been somewhat positive. However, independent trials run by people not in connection to Burzynski have all come back negative.
      This is an disproven treatment.

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  • @William Grogan,
    Firstly, you seem to place a lot of faith in the FDA and it’s ‘benevolence’ in all areas relating to promoting the health of US citizens. If I were you, I would google ‘FDA and big pharma’ in order to educate yourself as to how the FDA has become a vessel to promote the economic ‘health’ of the pharmaceutical industry and not the physical health of the public. If you believe that the FDA is here to protect your health, then you will probably also believe that the Wall Street banks were there to protect the financial interests of homeowners during the housing market bubble that burst in 2008. To find out how things really work in the world, just follow the money.

    Secondly, if you are going to quote the dubious opinions of a man whose sole aim in life is to debunk any and all alternative forms of medicine that pose a threat to the profits of big pharma, then you should at least educate yourself on who this guy really is. I’m talking of course about Stephen Barrett, M.D, the creator of the quackwatch.org website that you so enthusiastically quote throughout your postings on this page. The man is there to spread disinformation and to promote the interests of big pharma. It’s quite obvious when you see the vehemence with which he will attack anything that is remotely considered alternative by the medical establishment. This page should give some context to this man’s medical ‘opinions’: http://www.quackpotwatch.org/quackpots/quackpots/barrett.htm

    Thirdly, if Burzynski really is such a quack, then I doubt that so many of his patients would have grouped together to create this website: http://www.burzynskipatientgroup.org/
    You would do well to browse through the website a little and get a feel for what some of his patients have to say about his treatment with antineoplastons. Or are all these patients deluded quacks too?

    @Buffy: your statement that the Burzynski documentary cannot be trusted because it was made by a friend of his is completely disingenuous and distracts from the issue at hand. Whether the documentary maker is a friend of his is completely beside the point. The one question you should ask yourself is whether the information provided in the film is true or not. There are many local and national news articles dating back 20 years that I have found on the internet that support the evidence brought forward in this documentary. Not least of which, the evidence about the 5 failed Grand Juries that the FDA brought against Burzynski, as well as the Congressional Hearings(!) that were set up in order to investigate the FDA’s constant harassment of the Burzynski clinic.

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    • The FDA is actually neither here nor there. The fact is that the data Burzynski has published (and he has left lots and lots of his data unpublished – why?) is not compelling. It is methodologically flawed – he has never used control groups, lumps patients with different conditions together and doesn’t distinguish them in his results and he uses unreliable definitions of “successful treatment” – and, even then, his results are not significantly different from what we might expect without his treatment.

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    • Another problem with the FDA-centric focus on the subject is that it assumes fundamental incompetence on the part of other nations. Do you not think that, if Burzynski’s data was compelling, his methods would be in demand in “conventional” healthcare across the developed world? The interest in antineoplaston treatment from healthcare professionals across the world is negligible.
      Furthermore, the idea that there is some conspiracy to suppress cancer cures is ridiculous to anyone who has ever worked in “conventional” (whatever that means) cancer research. Consider for instance that there are cancers that can now be cured even at late stages – notably testicular cancer and lymphomas – if there’s a conspiracy, the conspirators have taken their eyes of the ball, no? But the idea of a “universal” cancer cure is difficult to contemplate for those that understand the subject – cancer, after all, is not a single disease, it is a diverse family of diseases, each biochemically and genetically unique.

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    • Can you point out a SINGLE statement on quackwatch that is inaccurate? Is someone charging €120,000 for extract of Knat’s piss part of Big Pharma?

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  • That is the wonderful thing about advancements in medicine,they are advancements that were made through trial & error. If you do not try methods outside the norm,we would still be killing people for being witches,when in fact it is mental illness. We are all allowed to have our own beliefs. It is sad that an individual will take the time to write a comment which in fact,hat you are really doing is trying to take away a young man & his family’s chance of survival & hope or to take it away from anyone. Your mother must be really proud of you!! I am not GOD.You will deal with him when you die!

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  • Mr.Rooney ,Since you have so much free time to do research,why don’t you research the positives success stories the clinic has had? A suggestion I hope you do take me up on is , start to Pray,PRAY HARD,that a loved one and or family member never gets what my nephew has been diagnosed with. If it does happen to you,then you will understand why we are using this clinic,because standard medicine is not giving a positive result.I wish you well ,GOD BLESS!

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  • I wonder how many lives 120,000 could save in a less developed country and in the right hands.

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    • Why not sell your pc/ laptop you are using and donate the money? Since millions don’t have one. Heck, sell anything you have, that others don’t. Donate it all to the ‘right hands’. Oh yeah, you might get some money for your ‘high horse’ too.

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  • Some real cranky people posting. Give the lad hope, he’s not got anything else. If it was my child, I’d do anything no matter how out there the treatment was, and I think many would do the same, despite their comments.

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    • Buffy 29/08/11 #

      I don’t think that anyone is encouraging the family or Sean himself to give up hope. Maintaining hope and positivity throughout treatment is extremely important. We have dealt with the demon of cancer in my own family, so I know exactly how difficult it can be to deal with chemo, the side effects, and the fact that it seems to suck happiness out of the house sometimes.

      What people are saying is that accepting false hope as truth may be even more damaging than accepting the reality, and in this case, it’s likely to be financially damaging too. The people who are questioning Burzynski’s treatment simply don’t want to see the family pin all of their hopes on Burzynski, and invest a significant amount of money, only to be cheated of both their money and their son. Some of the comments have been much more harsh than I particularly like, considering that the family are likely reading this, and so this message has been somewhat lost, but I’d encourage you to look at some of the longer comments here which explain more about Burzynski and attempt to provide counterpoint evidence which many people, including myself, believe that others should be aware of.

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  • screenshot taken from movie posted by Piotr above:
    [URL=http://imgur.com/V67KO][IMG]http://i.imgur.com/V67KO.jpg[/IMG][/URL]

    Looks promising. BTW this is a very aggressive form of brain cancer, occurring in children.

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  • Please enough with the “educational “ post’s! I know Sean, and the Lyne family most of my life, and they are far from being naive, or stupid people. Rest assured much research has already been done, and the family are are fully aware of the risks they’re undertaking. You need ask yourself if this was you, or your loved one what you would do? Sean desperately needs supporters-not critics. So if all you have to offer is a positive comment please do so. Thank you*

    We forget how delicate life is, without hope what is left!

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  • I also want to point out that the IRB is an Independent Review Board, not paid by the Burzynski Clinic or affiliated with the Burzynski Clinic, it is INDEPENDENT. All clinical trials have an IRB.

    I would also like to point out that Ignaz Semmelweis, M.D. (Google It) was also called a quack back in the 1800s for believing that doctors should wash there hands after working with each patient so as not to kill them. And what do you know, he was right.

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    • Ignaz Semmelweis findings were eventually confirmed by science (A certain Florence Nightingale and her creative use of statistics and infographics had much to do with this) at present none of Dr. Burzynski’s theories on how to cure cancer are and neither have his supposed results been replicated.

      We can perhaps forgive the medical establishment in the 1800’s for rejecting Semmelweis ideas as they did not proceed in a scientific fashion to reach conclusions and design treatments. We do now and Dr. Burzynski’s work is sadly lacking in any scientific verification via independent replication of the RCT’s he claims to have conducted (but strangely has never published the results of them in a peer reviewed paper or indeed made public in any way).

      As regards the FDA approved badge people often want to wave around. Well that was the result of a legal appeal by Dr. Burzynski to try and continue practising after legal action was taken by the FDA and the Texas Medical board in an attempt to remove his license to practice. As a result of this a judge, those excellent arbiters of scientific knowledge, decided that the treatment should be tested.

      Can you provide more details of the IRB? What institution they are based at? What organisations they are affiliated with?

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    • “They laughed at Semmelweis, yes, but they also laughed at Bozo the Clown”, to paraphrase Carl Sagan.

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  • To all those who maintain that antineoplaston therapy has absolutely no future, here’s an intersting article from 2003:
    http://peoplebeatingcancer.org/about-david

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    • Buffy 05/09/11 #

      We could continue to go back and forth posting links at each other, but it’s clear that it would achieve nothing. You are convinced that individual patient stories are as good as clinical evidence, overlooking the fact that, in addition to the phenomenon of spontaneous remission or regression in cancers potentially playing a part in his success stories, there is no fact checking or verification applied to such stories. That being the case, no amount of evidence linked will convince you otherwise, because you would rather believe compelling patient anecdotes than the available scientific data on the efficacy of the treatment.

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  • Buffy,
    Of course, we must not turn our backs on established, well-researched clinical trials, tests and results in order to establish whether particular treatments are of benefit to the human race. Our medical world would be a dangerous and chaotic place without such rigorous adherence to scientific theory. Thank god we have that.
    However, we should also not ignore the mountain of evidence that CAN be provided by ‘compelling patient anecdotes’ when the number of such anecdotes reaches a critical mass. i.e. when there are enough of them to make their existence more than a simple statistical aberration. I realize that, for some people, the jury is still out regarding the veracity of all the personal stories from patients who have benefited from being treated with Burzynski’s antineoplastons, so I’m not going to try to convince you of the relevance of these stories.

    But at the end of the day we are all dealing with probabilities. None of us can know anything with 100% certainty. All we can do is take in the information that we are exposed to and form an opinion based on that information. What each of us believes in this world is that which we believe to be the most probable explanation of a phenomenon, whether we are an expert on a particular subject, or simply an interested layman. All that we have are simply the probabilities that we attribute to a particular explanation of something that we see in the world.
    I try to base my opinions not just on a simple aspect of a single story or article, but on a whole range of data and sources of information that I have become aware of in the last 10 or so years that I have been connected to the internet. I’ve read a lot of rubbish that seemed plausible at first but didn’t stand up to further scrutiny, and I’ve read a lot of shocking facts and statistics that I couldn’t and wouldn’t believe at first, but turned out to be true in the end. We live and learn every day so that we can form a view of the world around us that gives us structure and the ability to be at peace with ourselves. That’s all. Thank god we all have different opinions. It’s how we learn from each other, at least! Even if we are stubborn about letting go of old ideas. All I can do here is try to explain to you WHY I believe a certain theory, and hope you respect that in the same way that I respect your views on the more scientific and clinical evidence-based information that you use to support your view of the medical world. I applaud the passion that you have in trying to expose the real quacks in the world, whose activities are a danger to the public, and I sincerely wish you further success in this endeavour.

    For the record, the reasons that I attribute value to many of the Burzynski patient stories that I have read are the following:

    1.
    I don’t trust corporations to do the right thing anymore. When I first learned about how the housing bubble was created and then how it burst, I couldn’t believe that elements of the banking industry could be so evil. Then I watched the documentary Inside Job (winner of the 2011 best documentary Oscar) and realised that there are people at the top of the business (banking) hierarchy who really are that greedy and evil. It was a real eye-opener. And I don’t believe that the pharmaceutical industry is any different to the banking industry when it comes to putting patients’ health before profits. If that were the case, the Vioxx scandal would never have happened.

    2.
    I don’t trust the FDA to do the right thing anymore. Again, if you look at the Vioxx scandal, you’ll see that the FDA was also complicit in making sure that the dangers of this drug were never reported. It was Dr Richard Horton, editor of the Lancet who said:

    “In the case of Vioxx, the FDA was urged to mandate further clinical safety testing after a 2001 analysis suggested a ‘clear-cut excess number of myocardial infarctions’. It did not do so. This refusal to engage with an issue of grave clinical concern illustrates the agency’s in-built paralysis, a predicament that has to be addressed through fundamental organizational reform.”

    To my knowledge, such organizational reform at the FDA has not occurred. In fact, the only organizational reform I believe it has gone through is a steadily increasing level of influence on FDA operations by big pharma consultants who have access to the highest levels of decision making in that organization.

    3.
    I don’t trust the medical establishment anymore since it has become nothing more than a vessel with which huge pharmaceutical corporations can further their quest for profit maximization at the expense of a genuine desire to promote long term health in the human population. If this were not the case, then nutrition would be a fundamental part of all medical training. But we all know that the effects of poor nutrition are a major source of profit for big pharma, so why change a winning formula, heh?

    Knowing these things about corporations, big pharma and the FDA, I end up looking at the Burzynski documentary in a new light. It is the integrity of the FDA and the interests it represents that I start to question, not the integrity of the patients themselves who appear in the footage of the grand juries and congressional hearings (and the countless web pages that many of them have set up to write about their experiences). And if the results of Burzynski’s own trials and experiments are brought into question by an industry that clearly has a lot to lose if the current reliance on chemotherapy and radation were to collapse as a result of a new way of treating cancer, then I naturally start to question the questioning.

    I may be wrong, of course, and all the information that I have seen has simply led me to the wrong conclusions. We are all human, after all. You can never be 100% sure. But until then, my money is still on Burzynski.

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    • Eric> This post is very typical of those who cannot sort facts from nonsense. You talk of probability but clearly do not understand it. The apparent patient anecdotes are not valid at all in this case because they are clearly fabricated. I’ve already posted details of the total failure to cure patients who’s names were given to the Canadian investigators as successes. Therefore this shows Burzynski cheats. He claimed these people were cured when they were obviously not because most of them were dead. Furthermore why doesn’t he give details that he has to show his success rate? He doesn’t because he can’t cure anyone. If he kept simple figures; patient name, address, date of entry, diagnosis, treatment, outcome he would have the Nobel Prize by now if he actually cured people. Nothing man creates is 100% perfect, so neither are the FDA or large pharmaceutical companies. However to pull out one example that may show a failure of the FDA or companies who are very tightly regulated and compare that exception to the wholesale fraud of Burzynski is farcical. Burzynski is a convicted con artist. Reading about his background, history and reading it in the light of the wider scientific community it is obvious he has no cure for cancer of any description AND that would be a fact even if the FDA were a bunch of incompetent crooks. The fact is the Burzynski is very close to zero probability of having a cure and the FDA are probably 95+% correct in what they do.

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  • “Burzynski’s treatment has been in clinical trials since it’s existence. The few trials that have finished have been somewhat positive. However, independent trials run by people not in connection to Burzynski have all come back negative.”

    Rhys, you don’t know what you’re talking about. If you want people to donate to your cause, that’s fine, but don’t try to discredit something that you don’t know about. Japan has done trials on Antineoplastons that Dr. Burzynski uses and has published them in peer reviewed journals and they have positive results. PubMed Dr. H Tsuda at Kurume University Hospital.

    Regarding the “urine” statement made by Grr, there are other approved medications taken from urine; premarin.

    Also, “He has performed human experiements without accreditation and permission from the global medical governing bodies,” this statement is also totally false. Dr. Burzynski’s medications are in FDA APPROVED clinical trials. That means that the medical governing body for the United States of America approves of Dr. Burzynski using these medications in clinical trials to see what their effectiveness are.

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    • Grr Diff 01/09/11 #

      I take your point, Ms Powers but 2 wrongs don’t make a right. The drug you mentioned has been subject to great controversy. Premarin is a horse equivolent form of oestrogen – a well researched and understood hormone. These anitneoplastons are random protein molecules taken from urine that have questionable purpose.

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  • watch the film and make your own mind up. Looks to me like the FDA, big phaarma and the US govt have a lot of awkward questions to answer.

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    • The film, as pointed out above, is essentially a lengthy advert produced by a friend of Burzynski’s. It is also full of misunderstandings. I wouldn’t be so cynical, however, to describe it as wilfully misleading; I think the film-maker really does think the treatment is a valid one, he just doesn’t have the training or knowledge to understand the complex issues of cancer and medical trials.
      To give one example of where the film-maker betrays his naïveté: the film makes a fuss about how the government have apparently attempted to patent the antineoplaston treatment. The evidence presented for this is a patent filed in the 90s by a scientist which declares “government interest”. Looks suspicious? Not if you understand the issues. First of all, the scientist who filed the patent was indeed researching so-called antineoplastons, however, their research never went anywhere and fizzled out nearly 20 years ago. Secondly, and more to the point, while the declaration of “government interest” may pique the interest of a layman, it is actually very trivial. Any scientist funded, even partially, by a government grant (which is A LOT of scientists) may well have to declare “government interest” as a matter of routine. It’s not an uncommon clause to find in patents for this very reason.
      That’s just one example of the misplaced suspicion and misunderstanding of the issues in the documentary.
      I sincerely wish the best for this young man and his family. Their position is unimaginable.

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  • John 04/01/12 #

    It’s working for http://www.hopeforlaura.co.uk give this person some hope too.

    Reply

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