FDA Allows Final Phase Review of Dr. Burzynski’s Lifesaving Brain Cancer Treatment to Proceed

This also means that additional patients will receive the treatment while it is being studied.
It will be a Phase III study, in which the treatment is given to large groups of people to confirm its effectiveness. The patients will be split into two random groups. One group will receive just radiation therapy, and the other group will receive antineoplastins with radiation therapy. Our heart goes out to members of the first group, because Phase II and earlier treatments make it very clear that the treatment works.
Readers will recall our article about how dying patients have until recently been denied access to the treatment under the FDA’s compassionate use program. Even when the agency finally relented under the pressure of stories about dying children, it still put roadblocks in the way, such as not allowing Dr. Burzynski himself to administer the treatment, so that the dying children had to find other doctors willing to offend the FDA and agree to do it.
Keep in mind also that the treatment had been freely available in Dr. Burzynski’s clinic until the FDA tried to shut him down and insisted on formal trials in exchange for relenting. It is possible that the FDA had assumed that formal trials would end the treatment because the necessary funds would not be raised.
All of this was just another chapter in the saga of the FDA’s antagonism toward antineoplaston therapy, and the longtime persecution of Dr. Burzinski by the medical establishment, even though he was saving lives and there were no other good treatments to offer his patients.


  1. They should also have a third group that was totally without chemotherapy or radiation.

  2. It has been a little over a year since we lost my beautiful, talented, intelligent 22 year old granddaughter to an inoperable glioblastoma multiforme tumor (brain cancer). She was treated at UCSF with radiation and chemotherapy for the 1 1/2 years that she lived with this monsterous disease. Her treatment was the only option she had, and her doctors were great. We were certainly grateful to all of them for the wonderful and compassionate care they gave her. We also tried every conceivable alternative treatment holistically. We were willing to try anything that would give her a fighting chance. She and her parents (my daughter), and in fact all of her family, were very proactive and supportive in her care. We would have given anything to have the option outlined in Dr. Burzinski’s treatments. To think that the FDA would deny dying patients an experimental treatment based on policy, when they have exhausted all other options, seems unnecessarily cruel and pointless.

  3. As a 30 yr healthcare professional, I wish to add my voice to those asking that Dr. Burzynski be allowed to continue his treatment protocols and research. He is a brilliant doctor and needs to be allowed to do what he does best..care for the patient and do what he can to help them. Thank you.

  4. Hi
    I thought I read elsewhere that Dr. Burzynski had been using a natural therapy that did NOT also use chemo or radiation. This article says his treatment includes both his therapy with chemo, so what is the point? Chemo is toxic and would no doubt undo any good the other therapy offers.
    Please enlighten me. Thanks
    Caroline Olson
    Founder – Children Against Cancer

  5. This is nothing new. They have been persecuting doctors and lay people alike who find safe, EFFECTIVE cancer treatments. This history of persecution goes back at least 80 years to Nurse Cassiie (essiac), Dr Max Gerson (Gerson Therapy). Mr. Halsey (the Halsey formula) the doctor who had to go to CUBA to do studies on the use of shark cartilage (it works), and then the beautiful and wonderful DOCTOR Simoncini who has saved lives all over the world with his cancer treatment, safe, nontoxic, cancer treatment. the establishment rewarded Dr. Simoncini with 3 years in prison.
    We need to fight back, people.

  6. This is so long over due. The FDA has acted as an enemy to cancer patients and persecuted Dr. Burzynski long enough How long does the Phase 3 study last and is there a period after a successful Phase 3 study before this therapy may be widely administered? This therapy has been proven effective time and time again.

  7. Why in concert with chemo? Is that merely a concession to big pharma? In fact as legislation would have it with vitamin C IV that a pharmaceutical must be part of the IV. Or does Burzynski feel the chemo adds value?

  8. Saving lives is more important & allowing the doctor who discover this treatment to administer this valuable therapy should be the best way to receive feedbacks. No one should hinder progress-this is a matter of life & death. If it was someone you love or a family member or even you who is dying, wouldn’t you want to be saved?

  9. Congratulation to Dr Burzynski for his therapy with antineoplaston, our family lost a family member to brain cancer in 2013.
    Thank you for your good work.

  10. If there is anything to be done for people with braincancer, it should be done. This doctor had good results. It’s time to get egotism out of the way and let this man do his job, which is to help people with this condition. He has has many good results, and that should have been enough in the first place. It’s a shame he had to go through so much, just to do his job. Shame on those opposing his methods. Valuable time was wasted, that could have been used to help people in need.

  11. The FDA is a broken system with deep pockets long removed from protecting the people of this country. They rarely do anything good unless external pressure is applied and I guess this is one of those times. Keep the pressure on until all cancer patients have access to early stage alternative treatments instead of traditional chemo and radiation.

  12. There are obviously 2 sets of laws in this country. One for the poor and lower income levels and another, completely different, for the wealthy and powerful. If the Bush’s, Cheney’s, Clintons or Obama’s needed this procedure it would be passed today. Example: Donald Rumsfeld promised his cronies that aspartame would become legal and it has, despite being a poison that can lead to blindness, mental disorders and premature death in women….and has never been proven to help weight reduction in anyone!
    The long arm of the AMA is yet another Fascist organization that seeks to control American health and well being by enforcing Draconian laws against anything ‘they’ can’t control and/or make money from. Legal genocide is alive and well in America today.

    1. The socalled “rich” get too much medical care and it is killing them. Those who avoid medical care or cannot afford it, but eat well, avoid poisons and doctors, exercise and avoid legal drugs are more apt to be healthy and live longer and healthier. My parents died as the result of their medical care from Tricare and Medicare. I avoid doctors and drugs and have for the last 20 yrs and refuse to see medicare doctors and refuse drug perscriptions (the last ones I took left me with chronic problems) and I may well survive healthier and longer than did my parents. I look at what has happened to my acquaintances who have put their faith in chemo, drugs and allopathic medicine-they are to a person, older than their years, unhealthy, misdiagnosed, overtreated and overdrugged. So far, the odds are in favor of my course. At least I am healthier, look and feel younger than those 20 yrs my junior.

  13. I highly support Dr. Burznyski’s work and have known people in Houston, Texas who have received his life saving treatments.

  14. I am so glad that the trial can continue! Sometimes I get the idea that the FDA is not really interested in helping people get well, but mainly helping the pharma companies prosper! I think there could be some conflict of interest issues within the FDA. Can someone enlighten me on that?

    1. And I am not glad that these ‘fair trials’ were set. How can anyone believe that comparing chemotherapy with chemotherapy is going to yield any miraculous results? It;s like comparing people who play russian roulette on daily basis with people whoplay the same russian roulette, but are also given bulletproof vest. That gun will kill them at some point, right?
      And as far as conflict of interest – please check the bio of each and every person working at the high levels of FDA. Not one person there has been free of financial ties to the pharmaceutical companies – directly or indirectly. So why would they cut the branch they sit on?

    2. The original legislation that created the FDA assigns their duties as “promoting the industry” and “protecting patients”. This might have seemed a logical combination back in the 1940’s but obviously is a conflict of interest now.
      What US citizens really need is a Consumer Protection Bureau with strong regulatory powers – powers which would apply to the medical industry as well as others. Tough to achieve since businesses have more funds with which to purchase congresional votes.

  15. Follow the MONEY, it will lead right back to Big Pharma, behind all of this HARASSMENT!!!

  16. The FDA doesn’t care about anything, even vaccines, yet they’re going to check on a Dr. That’s saving lives!!! What a riot! They are all nuts & corrupt! Everyone knows how really awful they are! Why don’t they go after the Pharm. instead of a good Doctor. This USA stinks! Stop FDA. Let these cancer victims get there help they need!!! Maybe we’ll give them vaccines with mercury in them!!!! Are you people trying to kill people? How do you all sleep at nite?

  17. The FDA doesn’t care about anything, even vaccines, yet they’re going to check on a Dr. That’s saving lives!!! What a riot! They are all nuts & corrupt! Everyone knows how really awful they are! Why don’t they go after the Pharm. instead of a good Doctor.

  18. Everything, when it comes to health and healing a person must do everything they can. If something works, there should be no question or opposition especially when someone’s life is at steak. As an example, Dr Lederman’s technique of radio static surgery (non evasive) for brain tumors was revollutionary in the late 50’s and now widely accepted and practiced in other medical institutions.

  19. I would welcome some substantiated data from Dr. Burzynski using accepted study protocols showing that his therapies work and are not harmful. At this point, there is little to support his claims except for vague conjectural reports that his therapies work and his subjects have had reduction in their tumors. By what criteria? Compared to what other therapies? Compared to controls? If his therapies work, through what mechanism? And why aren’t there other labs and clinics able to reproduce his data, which is lacking to start with? I think Dr. Burzynski reeks of snake oil and smoke and mirrors, and a lot of desperate, hopeful patients are the victims of his pseudoscience.
    Just one review of Dr. Burzynski’s work: 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, 1 patient died after slight improvement, while 1 patient died after stabilizing for a year. The 2 remaining patients had widespread cancer.
    Miraculous cures being surpressed by the medical mainstream? I don’t think so. It’s easy to blame corporate America for the shortcomings of modern medicine; it’s even worse to take advantage of this trend to cash in at the expense of the most vulnerable, severely ill individuals. At $5-10,000 a month cost for treatment, paid out-of-pocket, for something that is highly suspect, Dr. Burzynski should be more open to having his treatment evaluated objectively in peer-reviewed medical journals. Otherwise, it appears that the only beneficiary of antineoplastin therapy is Dr. Burzynski’s bank account.

    1. chemotherapy costs far more…..and the results are not beneficial. Most cancer patient deaths (after chemotherapy) are listed as respiratory failure so as not to negatively impact the oncology department stats (I know this from personal experience as a medical professional, as well as extensive research). The stats on chemotherapy are fraudulent and misrepresented, to protect the income stream for those touting it. Chemo destroys the immune system and if someone survives chemo, the body has no defenses remaining.

    2. I can bet that in 50 years (after Dr. B is dead and huge pharmaceutical company patents the exact treatment Dr. B discovered) Dr. Burzynski’s protocol (under a new name no doubt) will be widely available to anyone with $750,000 AND well proven in random trials orchestrated for that purpose by FDA. All of us writing in this comment section will be dead by then (cancer no doubt) and unable to say a word, but the new generation of bloggers will be wondering why Dr. Burzynski did not publish it earlier… Such a bad doctor, charging for his services and not wanting to sell his data to SCREWTHEM Pharma, Inc.

  20. How is letting him have phase 3 trials antagonism? And Burzynski has no published Phase II studies in reputable journals (2 months ago he published part of a study that the editor said nobody reviewed and his “full phase II” was published in a journal listed on Beale’s list of dodgy journals). In the absence of that data, how would you ever know what the results of the phase II trials are? Honestly.

  21. I firmly believe the Dr. Should be able to administer his miracle cures. The FDA is not our friend

  22. People should have the right to not resort to chemotherapy and the above treatment. Kevin Trudeau mentions many recommendations of non-surgical natural methods to overcome cancer.
    Also people should have the right to not have their blood drawn as shown in the above picture.
    People’s Health Rights should be allowed to decide what is best for their health including declining government mental, physical Health DICTATIONS! ! ! ! ! ! ! ! ! I have been tremendously victimized by government mental health and did not have your support to stop that terrorization ! ! ! ! ! ! ! ! ! !

  23. I support Dr. Burzinski in his efforts to treat his patients with antineoplastins. I strongly object to the longstanding witch hunt to destroy this man and his practice. My hope is that an independent investigation can be conducted to determine who is behind the effort to discredit him and to hold the guilty parties accountable with fines and jail terms. I saw the documentary film on “Burzinski” and was appalled at the government collusion with Big Pharma to discredit and destroy this great doctor.

  24. How can our policy makers point finger at others.
    Are they ignorant to what is going on in free America.
    We must take responsibility and use our votes to change this.
    Some how we have become lazy sheep.
    Spread the word and don’t use anger or fear to do this…it just makes us and them alike.
    Its really not hard to change the peoples views…just show them how much of a sheep we’ve become.
    They have used fear and use our ignorance to their advantage, and no one wants to be a dumb sheep.

  25. We need to ban any former chemical and/or pharmaceutical company employee or board members from being a FDA employee or board member as it would be a conflict of interest in any decision making action for that person.

  26. Dr. Burzynski worked very long and hard to get to this last phase of his trials. He had to fight many legal battles with his own funds to reach phase 3. Congratulations Dr. B for your achievement to go forward. However, we need to ban any former chemical and/or pharmaceutical company employee or board members from being a FDA employee or board member as it would be a conflict of interest in any decision making action for that person. Maybe the FDA would be quicker to respond to good treatments that work and stop challenging those who accomplish responsible medicine.

  27. We have all seen the self-styled fortune tellers in the tabloids who’s guesses are worse than chance but who still claim special knowledge and are believed by a gullible public.
    Some years ago “Skeptical Inquirer” looked at Burzinski’s actual record, showing that anti-neoplastons were less effective than conventional medicine and had in fact killed patients with excessive sodium levels.
    Brezinski’s successes were shown as statistically false due to elimination of patients that died for reasons other than cancer that could have been entirely due to the treatment itself. He also shared with Cancer Centers of America the policy of not including patients who had tried and failed at some other treatment. Anyone can get better statistics by eliminating the hard cases.
    Brezinski was able to follow each questionable “study” with another “phase” that would “prove” curative some simple chemicals that others had already tested and rejected. He was also shown to have been censored for not providing an accepted standard of care and merely started again somewhere else.
    LEF has uncritically republished Brezenski’s self-serving publicity releases and apparently they are not the only one.

    1. Please identify the sources of these accusations. I’d like to read them myself; or are they the publications coming from the FDA study that diluted down the treatment protocols that Dr. B. used relegating them to purposed failure. The FDA is biased–supported and influenced by the companies from which pay it the most.

    2. Actually, those accusations you level clearly apply to the actions of various FDA trials, poorly designed, fraudulently undertaken and run by the researchers /companies/doctors benefitting financially from the status quo (chemotherapy).

    3. Robert, if you want anyone to take your comment seriously, you really need to get into a habit of paying attention to details; in your five short paragraphs “comment” regarding doctor Burzynski, you managed to misspell his name FOUR times. Your cred is therefore shot to hell.

  28. I understand that Liza Cozad Lauser was granted use of neoplastons within the last month. Let’s hope more patients are also allowed access.

  29. All I can say is , “that is good news”. How many people had to die because of the bull headedness of the FDA?

  30. Glad Dr Burzynski’s formula is getting a fair trial, and hope it passes.
    However, the other side of the story is his treatment is so expensive!
    My friend went to him about 1.5 years ago to start treatments, only
    to find out that her insurance (good insurance) wouldn’t pay the
    $3,000 per shot. And can’t remember exactly, but think she had
    to have shots at least weekly if not more often. She and her
    husband couldn’t afford and so had to go home after only
    one shot. And she died about a year later.
    So besides proving this formula works, what also needs to be
    addressed is getting insurance companies to pay for it. Else
    children and adults will continue to die.

    1. This is why it’s so important that the FDA is allowing these trials. In time, when it’s approved by the FDA, then insurance WILL pay. It’s a start in the right direction. Insurances only pay if something is approved by the FDA. That’s why any natural treatments aren’t covered by insurance even though they are cheaper and usually work better in the long run. They won’t cover a 3000.00 shot, however they will cover a 35,000.00 chemo infusion! This is personal info from a friend, not heresay.

      1. I have heard good things about Dr. Burzynski’s cancer cure and am very suspicious of “fair” trial sponsored by FDA. Something similar had taken place in the past and (see for yourself!) FDA had no qualms about saying that “Dr. B’s protocol does not work” even though the trial was not at all what Dr B invented!!! (the doc involved in it stole Dr Burzynski’s method AND changed his protocol, yet kept saying it was the same method Dr B used), so hearing that they want to COMBINE his original method with chemo is just laughable. What are they going to compare???? Does anyone know that AMA considers patient cured if they live with cancer for 5 years??? Never mind 75% of these ‘cured’ folks die in 5 more years and 100% in 15 years! How many patients of Dr Burzynski were kids 20 years ago and still can testify to (and test negative) for having cancer? Zero zip nada. If anyone thinks that FDA can give a fair chance to any method that would put big pharma out of profit – you are delusional. Look at what Obamacare is doing to this nation… Wake up, people!

  31. What REALLY irks me is that according to the article, ” One group will receive just chemotherapy, and the other group will receive antineoplastins with chemotherapy.” WHY isn’t the “other group” getting ONLY antineioplastins??? Chemotherapy is POISON.

  32. Where is all this anti-Burzynski comment coming from? This man has been persecuted, jailed, fined, and tricked into believing he would have an opportunity to a genuine FDA clinical trial, This was done by a doctor he trusted who spearheaded a bogus trial in collusion with the FDA, not using the recommended protocols Dr. Burzynski set up and causing failure of the process.
    He was hauled to a hearing before Congress, with his successfully treated patients in attendance, and found by Congress to be innocent of all charges. He is not the only one to have been subjected to this treatment. Big Pharma and the FDA are not likely to give up until they subdue this good man permanently and bankrupt him. Their own failures of treatment are not dragged onto the front pages, but Dr. Burzynski is fair game for their abuse, reviled and treated shabbily.
    Follow the money, folks: the establishment, including the AMA is reluctant to give up the perks of treating cancer by burning, poisoning and slashing patients, as long as insurance companies pay for it. Dr. B is entitled to charge for his treatments, as he has underwritten the entire costs for his R &D, his equipment and personal care for all these years, without being able to collect from the insurance companies. I would venture to state he is not happy to have to use chemo along with his antineoplaston therapy, however, and wonder if that wouldn’t skew the results.
    In my view, this doctor is a saint and the AMA et al, it the devil!

  33. I’m not familiar with him besides having seen his name several times connected to unorthodox cancer treatment. I’m not qualified to say anything against him. But, would it not be prudent to start with boswellia supplementation and dosing daily with lemon water? The D-limonene content of lemons, used as a natural pesticide, is widely mentioned as having anti-tumor properties, possibly similar in ways to the softgel capsules containing orange peel oil, but with other constituents. If I could give only one item of health advice it has to be “avoid sugar.”

  34. Notice the trial involves chemo to be added in both cases. It’s not chemo vs antineoplastons. The corrupt FDA is insisting on helping the chemo industry as if that’s some eternal standard of efficacy. This is Bullsh*t.
    Also the paid shills claiming Dr B needs more proof of efficacy – we’re onto you. Dr B has a long history of antineoplaston efficacy and this is all just more harrassment for Big Pharma’s chemo racket. All brought to you by the organized crime Jesuit banker cartel that owns nearly half the corporations, the corrupt Federal Reserve and uses toxic injury to subjugate America since their takeover in 1913. Just more of the same folks from these hidden Jesuit criminal poisoners.

    1. You are absolutely, 100% spot on correct. I am thoroughly acquainted with the lengthy history of Dr. Burzynski’s work from the beginning. I am also very aware of the history of Big Pharma’s all out attack, with the aid of the FDA and they’re shills world-wide, to put a stop to this man’s cure for cancer. Every human being on Earth needs to watch the documentary about Dr. Burzynski, his work and progress, and his success with cancer patients, and how he has been repeatedly attacked by the powers that be, spanning over 20 years. This documentary PROVES that the powers that be, the evil elite, do NOT want to see a cure for cancer and many other diseases. And anyone who watches this documentary, will never look at the world we live in the same. NO ONE can dispute the success of this great man’s work, yet the FDA and big Pharma, along with they’re paid shills, will stop at nothing to protect their industry. An industry designed to MAKE US ALL SICK, and profit from it, without EVER offering up a cure, a cure that Dr. Burzynski has proven time & time again, SAVES LIVES. I strongly urge everyone to see this documentary. The evidence can NOT be denied.

    2. Dan, I was with you until your unfounded religious attack “organized Jesuit banker cartel”. The “cartel” that was associated with the earliest known “secret” banker cartel was unlikely to be the Catholic jesuit order. I think you are ignorant and careless if you think Jesuit was Jewish but neither were associated with the group to which you refer. However, Rockefeller comes to mind ……
      Perhaps you are unaware that one of the largest pharma companies is German and was allied closely with Nazis and the Holocaust and survived to foist various drugs (poisons) on the world, including thalidomide which is STILL in use today and approved by the FDA…….
      You need to educate yourself and learn some logic, rationality and science and philosophy before spewing your ignorant hate….you are not credible …..

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