"This is the story of a medical doctor and Ph.D. biochemist who has discovered gene-targeted cancer medicines that are known to cure most types of human cancers." "The opening 30 minutes of this film is designed to thoroughly establish this fact - so the viewer can fully appreciate the events that follow it." "My name is Sergeant Ric Schiff." "I am an eleven-year veteran of the San Francisco police department." "I hold the department's highest medal of honor for bravery that used to mean a lot more to me than it does now." "What I'd like to talk to you about today is my now 7 year old daughter." "This is an identical twin, her sister is now dead." "Her sister, when she was 4 years old, Crystin developed a highly malignant brain tumor that had spread throughout her spine and her brain." "The doctors told us that we had really no options- take her home and let her die, or bring her in for massive dosages of chemo and radiation simultaneously." "In either event she was going to die, they were quite certain of that - and very quickly." "Believing her only chance to be the standard route, we gave her the chemo and radiation." "It burnt her skull so bad she had second degree burns and her hair never came back." "To change her diapers we had to wear rubber gloves because her urine was so toxic and it burned her." "At the end of 6 months, miraculously she survived the standard treatment, although there was a high expectation that she wouldn't." "She still had cancer." "We were told "sorry we've done everything we can, now she's going to die, probably within a couple of months."" "My wife and I choosing not to accept that, started reading the first book I picked up, the third chapter, discussed Dr. Burzynski." "As you may guess, I have some expertise in fraud, in fact I'm quite certain there are enough attorneys in the room that I could be voir-dired as an expert in fraud" "and, I conducted my own investigation." "I have no doubt the man is not a fraud." "I have no doubt that he does what he does out of earnest belief that his medicine works." "Now, you are in a position to judge for yourselves whether it works or not" "but it's well established by the FDA, that it's non-toxic." "Eighteen months later, we took my daughter off the Antineoplastons she had not died." "She had no signs of tumor, she remained free for eighteen months of cancer." "Within a month, the cancer was wide-spread in her brain." "We put her back on Burzynski's by the way at the objections of our doctors who for some reason felt that it had failed her." "We put her back on [Antineoplastons] - within nine weeks the tumor was completely gone." "She died last July, of neurological necrosis - her brain fell apart from the radiation." "The autopsy showed that she was completely cancer-free." "Out of fifty-two cases of that disease ever, no one died cancer-free, just Cryssie." "So she didn't die of a terminal illness she died of my inability to care for her properly and she died from bad advice." "She died because there is a government institution, that disseminates false information and is not looking out for the welfare of the people." "You know, ladies and gentlemen I swore an oath eleven years ago and I think most of us in this room swore it at one time or another to uphold the constitution?" "It says "life" right in the beginning." "I first heard of Dr. Burzynski back in the late 1980's... when he was in a battle with the Texas Medical Board and the FDA regarding his innovative approach to cancer." "I wasn't surprised by that-anyone who is innovative in medicine creates waves in the medical system." "However, in his case, I was continually surprised that they didn't put him out of business." "I kept hearing about him." "So in the mid 1990's I said:" ""Dr. Burzynski, I want to come down and visit your clinic and find out what you're doing, it's very new to me."" "When I arrived, he had seven charts ready for me to review- that had been reviewed by the National Cancer Institute who also made a site visit the year before." "The National Cancer Institute reported that these seven patients were either in complete remission, or there was substantial improvement." "I was astounded." "Dr. Burzynski had MRIs of brain tumors," "known to be almost universally fatal, that had simply disappeared." "It was obvious to me, that Dr. Burzynski had made the most important discovery in cancer treatment - ever." "It's what we have been looking for." "A Polish native, named Stanislaw Burzynski, attended Lublin Medical University where he graduated first in his class at age 24" "and then received his PhD in biochemistry the following year." "While undergoing his research to acquire his PhD, Dr. Burzynski made a profound discovery." "He found a strain of peptides in human blood and urine, that had never before been recorded in biomedical research." "As his curiosity in these peptides evolved, he made another profound observation" "people who were inflicted with cancer, seemed to lack these newly discovered peptides in both their blood and urine" "while those who were healthy and free of cancer appeared to have an abundance of these peptides." "Dr. Burzynski theorized that if he could somehow provide a way to chemically extract these peptides from the blood and urine of healthy donors, and administer these peptides to those with cancer- perhaps it would be useful in treating the disease." "Now discovering something in the urine at that time, that had not been discovered before is like finding a whole bunch of islands ten miles off the coast of Miami, it came as a big surprise." "All of the sudden he was besmirched as the urine doctor." "We forget that extracting things from the urine is an established medical modality." "Tens of millions of women have been swallowing extracts of horse urine, Premarin, for decades" "but all of the sudden it was abhorrent to our sensitivities." "Well, Dr. Burzynski now synthesizes all of the Antineoplastons." "Dr. Burzynski's manufacturing facility in Stafford, Texas, where his Antineoplastons are now synthesized, is a multi-million dollar, 46,000 square-foot facility, which staffs five engineers, four chemists, three pharmacists, four medical doctors, and four researchers." "From where we started in the 1970's, is now forming a completely new approach to cancer treatment which is called "gene-targeted therapy"." "Antineoplastons are medicines which work on the genes that are causing cancer, and now, there is 25 medications which belong to the family of gene-targeted therapy which are approved by the FDA in the United States." "The problem with these medicines is that they don't cover as many genes as Antineoplastons, many of them simply work on single genes, and this is not enough to have long-term responses." "A single medicine is not going to do it, it's not enough." "Antineoplastons work on close to one hundred different genes." "Our bodies contain two categories of genes that allow cancer to flourish:" "oncogenes, and tumor suppressor genes." "When someone has cancer, they have a higher level of oncogenes switched on, with a higher level tumor suppressor genes switched off." "The goal is to tell the body to both switch back on the tumor suppressor genes, and turn off as many oncogenes as possible." "Statistically, every day, one out of 10,000 cells in our body may develop in the wrong way, and some of these cells may become cancerous cells." "But why we don't develop cancer all of us, is because we have a protective system" "we have Antineoplastons who will immediately force these malignant cells to die, by working on the genes:" "by turning on the genes which fight cancer, and turning off the genes which promote cancer, as long as we have proper amount of Antineoplastons in our system we should not develop cancer, if we are deficient then we can develop cancer." "This means I put together the theory of the second quote/unquote immune system in our body." "Today, Dr. Burzynski is permitted by the FDA to treat cancer patients using Antineoplastons in FDA-approved clinical trials." "Since brain cancer is one of the most difficult types of cancer to treat, he places a heavy focus on brain cancer in his clinical trials." "On May 15th of 2000," "I was diagnosed with an inoperable, stage three, anaplastic astrocytoma brain tumor." "Following my diagnosis I was told that I had six to eighteen months to live." "So I met with an oncologist there in Los Angeles and in San Francisco, and they were telling me at that time-the oncologist told me that the protocol for me would be to do Temodar, which is a chemotherapy, followed by a course of radiation." "I asked them what that treatment would get me and they said maybe five years." "Maybe five years of life?" "So of course I asked what would happen after five years, if I get to that five years and they said "well, we'll see what's available at that time"" "meaning I would perpetually be on a course of treatment." "Didn't sound good enough for me." "Also at that time I had heard about Dr. Burzynski in Houston, and I found out about Dr. Burzynski through a friend of mine." "But I met with a prominent neurosurgeon here, who wrote off Dr. Burzynski." "He told me point blank that "antineoplastons don't work"." "But Dr. Burzynski's treatment really sounded right to me." "So I started on his treatment on June 6, of 2000." "In December of 2000, all that was left of the tumor was scar tissue" "and again, this was confirmed through an MRI." "On October of 2001 I stopped Antineoplaston therapy altogether." "I've had annual MRIs since that time, so over the course of the last eight years, annual MRIs have confirmed, all that's left of the tumor is scar tissue" "and I've been off the treatment for that entire time." "So, Dr. Burzynski cured me of a brain tumor." "If we review Jodi Fenton's medical records, who was known at this time as Jodi Gold, before she was married in 2005" "it shows she underwent an MRI at St. John's medical center in Los Angeles on May 11th of 2000, where they found a two centimeter mass, which they suspected was cancer." "The pathology department at St. John's performed a biopsy four days later, and confirmed that she did indeed have a malignant brain tumor." "Ordinarily the FDA requires that anyone who wishes to be a part of Dr. Burzynski's trials, must first have already undergone chemotherapy and radiation-and failed." "However, since Jodi's tumor was so aggressive and her prognosis severely grim, she managed to get special exception status to be placed into this trial without undergoing any other prior treatment whatsoever." "An MRI on June 1st of 2000, revealed the size of the enhancing portion of Jodi's tumor, which was the part of her tumor that was the most aggressively growing." "On June 6th, she started Antineoplaston treatment, and by July 3rd, only a month after starting treatment the enhancing portion of her tumor was gone." "Her tumor remained non-existent up until September of the following year, when she stopped her antineoplaston therapy altogether." "It's one thing to be shown a single anecdotal case with this type of brain tumor, and it's another to simply compare clinical trial data of inoperable anaplastic astrocytoma patients treated with toxic radiation and chemotherapy, versus, clinical trial data using only Dr. Burzynski's non-toxic Antineoplaston therapy." "A 2005 clinical trial report using only radiation and chemotherapy, found that 5 of 54 patients, or 9%, were cancer-free at the end of treatment." "While a 2008 clinical trial report using only Antineoplastons, found that 5 of 20 patients, or 25%, were cancer-free at the end of treatment-with no toxic side-effects." "Jodi Fenton is one of them." "If Jodi Fenton had undergone the therapies originally prescribed to her, her life would have been very different." "Now she is alive, well, and prospering." "It's as if she had a bacterial infection, and Dr. Burzynski treated it with antibiotics." "Four years after my diagnosis, I had run into one of the neuro-oncologists I had met with," "And told him that I had gone to Dr. Burzynski and I was cured, and he kind of wrote it off." "I was very excited to tell him that I was cured, and he really burst my bubble about it." "So it was somewhat depressing for me." "Another doctor that I have, when I told him that I had anaplastic astrocytoma, he was very excited, he was like "bleep!" "bleep!" "bleep!" "I can't believe this is you, because do you know what the prognosis for this is?", and I said yes." "He said "l can't believe you survived this", and he was very excited for me." "Now, if you are ever going to go into cancer treatment, you do not want to go into childhood brain tumors." "Because childhood brain tumors by-in-large are 100% fatal." "This would be the worst class of cancers to treat, but he began getting enormous success." "Arguably, the worst type of cancer is inoperable brainstem glioma." "It usually occurs in the brain of a child." "And, unfortunately, there is very little that can be done." "Radiation is the only "treatment" available which can be used to slow down the progress." "So that's the type of tumor for which there is no curative treatment, no chemotherapy which has been approved, and numerous clinical trials were performed but failed in the past." "So we selected this type of tumor because we would like to prove the point beyond any doubt that this type of cancer can be cured by the use of Antineoplastons, and we already have proof that it can be cured." "She was diagnosed in March of 1996, she was eleven, and pretty much just started having really bad double vision is how we discovered it and went to the eye doctor and that's when they did the MRI and discovered it was a brainstem glioma." "And they explained that hers was diffused, where it was like the Healthy tissue and the cancerous tissue were swirled together" "so of course surgery wasn't an option." "And with the radiation they suggested, her prognosis was probably going to be about eight to eighteen months." "The thing is, with the radiation, what it would do to you from what I understood is," "They would shoot the beam through your ears, and the beam would burn your healthy and your cancerous cells outside-in." "So all your hair around your ears would be gone, never grow back, your ears would become deformed and burnt, you would be come deaf, it would also destroy your pituitary gland which is the gland that helps you grow as you hit puberty..." "Yeah, she was eleven at the time and that was a real concern I had." "And it would make you stay in an eleven year-old body, and basically you'd go into a vegetative state, where you couldn't take care of yourself, which wasn't a very good quality of life." "My big concern was with the oncologist that we were originally dealing with was how it was going to affect her development, and when she started to enter the teenage years, starting her period, and growing and developing" "and he just looked at me and said" ""well, frankly Mrs. Ressel, she's not going to live that long."" "What she would have to go through in those extra months- that would be horrible." "I wouldn't want to go through it." "Why do it?" "You're handed a death sentence anyway, so what was the point of the radiation?" "You know, then, you have to say okay, "modern medicine doesn't have an answer, let's find our own."" "Jessica Ressel's brainstem glioma was confirmed by an MRI in Springfield, Missouri; and the children's hospital of St. Louis Missouri." "Jessie Ressel is riding on the best news she's had since March." "She and her parents now believe they are on their way to a cure, for what doctors had said was an incurable brain tumor." "Here at the Burzynski Clinic in Houston, Texas, the Ressels have found an experimental drug they could only dream of eight months ago." "That's when Jessie was still a fifth-grader, at a catholic elementary school in Springfield." "It's when one of her eyes started crossing in, she started seeing double, it's when Jessie went to the doctor and learned that she had one of the most aggressive kinds of brain cancer- a malignant tumor doctors said would kill her within months, and that radiation would only give her a little more time." "And I would only live for like three months, and live in pain and that's it." "Nota fun life." "I'd still die." "Today the medical pictures tell a different story, you can see the improvement immediately just looking at Jessie's eyes now, compared to last May." "An MRI on May 7th of 1996 revealed the size Of the enhancing portion of Jessica's tumor." "One month into starting Antineoplaston treatment, her tumor disappeared." "However, given the aggressive nature of this type of tumor, it quickly returned in August, and remained until November." "In which time, Dr. Burzynski doubled her Antineoplaston dosage until her tumor went away in December." "Only to return again in January of 1997, stayed around until April, and finally disappeared in May of 1997- one year after starting Antineoplaston treatment." "Jessica's tumor remained non-existent, up until October 2001, when her brainstem glioma was considered resolved." "There were very few doctors that you would tell them that you were seeing Dr. Burzynski that would be kind of encouraging and positive with you." "Most of them, they would hear the name Burzynski and they wouldn't want to deal with you-because they were afraid." "I am so relieved that we found Dr. Burzynski because literally it did save her life." "Here she is now twenty-four, and she's got a little boy who is almost five, and her second baby will be born in October- we just found out she's having a little girl." "Again, it's one thing to observe a single anecdotal childhood brainstem glioma survivor, and it's another see the results from FDA-supervised clinical trials treating Jessica's type of cancer." "Here is a table illustrating studies published in 2006, comparing the results of different childhood brainstem glioma treatments." "There were three groups treated with radiation and chemotherapy, and two groups treated with Dr. Burzynski's Antineoplastons." "Out of all three groups treated with radiation and chemotherapy: only 1 of 107 patients, or O.9% were cancer free after treatment." "However, this patient did not live beyond five years-presumably being devastated by the amount of radiation and chemotherapy." "Out of both groups treated with Antineoplastons, 11 of the 40 patients, or 27.5% were cancer-free after treatment." "And 11 of the 40 patients, or 27.5%, lived more than five years." "Most of these brainstem glioma survivors who were not previously subjected to toxic chemotherapy and radiation before starting Antineoplaston treatment have gone on to enjoy full healthy lives." "So the good news is that cancer can be cured." "The worst type of cancer can be cured." "For good." "The people who are surviving, they live normal lives." "No side-effects from the treatment, no symptoms, no sign of tumors-back to life." "We started some of them as children and now they have their own children." "There is no impairment of fertility." "They just live normal lives." "The bad thing however is that we know that we cannot help everybody, but some of these patients." "Well, if about 30% of patients can survive over five years, and a number of them live over ten years without any sign of cancer, that's a good thing." "But obviously this is just the beginning, we need to perfect this." "We need to introduce the newer generation of Antineoplastons which we call the "second" and "third" generation of Antineoplastons to make the treatment more effective, to cover a broader spectrum, and to be easier to administer." "They came back, they said she has this large baseball-sized tumor in her abdomen and not only that, but it's in her kidney-it was every where, it was in her kidney and her liver and her lungs." "So here we are thinking, basically, this child has literally a few months to live, is basically what they told us." "At that point we said, "well, we think we can get the original tumor out."" "So they had this surgeon, he was able to go in, he got the whole tumor" "she did lose her left kidney and her left adrenal gland." "And it was four drugs, and it was like eight pages of side-effects and very little hope that it would even work." "The drugs were:" "Mitotane  Doxorubicin   Etoposide   and Cisplatin." "... and they told us admittedly "this is the most toxic regimen that we have."" "We have a six-month old with one kidney, and the side effects were kidney failure, hearing failure, leukemia- other kinds of cancers coming from this... and I was just like "even if she's going to pass away, I can't do this to her I can't, why would I want her last few months of life to be miserable?"" "I didn't know what to do." "I just knew that I didn't want to put her through all that intense high-dose chemo and miss out on what might be the last bit of time that we have with her, because I had talked to my uncle" "he's in his 60's now, but in 1969- my cousin-his daughter was three years old and she got cancer of some kind." "He told me about what that was like in that time." "They just kept giving her more chemo, and more chemo, and more chemo, and then finally we had this long several-hour conversation one day and he told me," "I asked him because I was trying to prepare myself, I said," ""what was it like when a doctor tells you, that's it." "We can't do any more."" "My uncle Ray told me that for the last few weeks of my cousin's life, they celebrated Christmas once a week." "They had a Christmas and a birthday once a week until that was it." "I was putting myself in his shoes, and I was just thinking, I couldn't watch my daughter whither away, and at least I wanted whatever time I had to be happy." "As happy as could be anyway." "And not just watch her whither away from chemo that's not doing any good any more." "We had actually asked the endocrinologist at M.D. Anderson about Dr. Burzynski, he told us "he was a quack, and that there was no evidence that it worked"" "but at that point I was like "well, yours doesn't really work either."" "The other thing that I did, on the FDA's website you can look up the day that which any drug was granted FDA approval and I realized that the oldest drug they wanted to give Kelsey had come out in the early 1970's... the newest drug they wanted to give Kelsey came out around 1988... and I realized, this isn't the cutting edge of technology, they're giving us the same old stuff ..." "I just thought, well, this is ridiculous." "It felt to me like they were grasping at straws." "I was doing all that research and Sarah and Susan found the Burzynski Clinic." "Sarah said "l want to take her there."" "I looked at it like, well, if she's only got approximately 9 months to live, and we come over here and we don't have all the side-effects... well, in 9 month's time, which am I going to be better off doing?" "If the ending result is the same?" "Upon the removal of Kelsey's left kidney and left adrenal gland, her diagnosis was confirmed at the University of Texas Medical Branch, and again at M.D. Anderson cancer center." "Where, a month later, M.D. Anderson also confirmed that Kelsey's cancer had spread to her lungs." "After desperately researching Kelsey's situation, her family decided to decline all chemotherapy treatments offered by M.D. Anderson, and instead, enroll Kelsey into one of Dr. Burzynski's clinical trials." "By this time, Kelsey's cancer had also spread into her liver." "After starting her Antineoplaston treatment, the tumor in Kelsey's liver was gone by August of 2007." "CT scans of her chest revealed six tumors in her lungs at the start of treatment." "One-by-one, the tumors in Kelsey's lungs began to go away leaving one small spot four years later which was deemed to be inactive and most likely scar tissue." "Today, Kelsey Hill is considered to have had a complete response to her Antineoplaston treatment." "Since Dr. Burzynski began treating cancer patients with Antineoplastons, he has successfully treated virtually every type of cancer relieving thousands of families from across the world of this dread disease." "Yet, unlike other clinical trials which are supported by billion-dollar pharmaceutical companies, and are often assisted by large tax-funded research grants from the National Cancer Institute, the United States government currently prohibits any tax-payer money to be granted to Dr. Burzynski's FDA-approved clinical trials." "A single Phase 3 trial will cost about twenty-five million dollars." "So how many can you run?" "You can run few at best." "Nobody is giving me any money for that, we have to make money for that" "and it's twenty-five million dollars." "Some other pharmaceutical companies, who come with an idea, they go to the National Cancer Institute and they receive a handsome grant" "fifteen million dollars, whatever, and they do clinical trials." "No one is giving me any money, okay?" "I am working like in a war-time condition," "when the bombs are falling, we still have to treat patients, and we still have to do Phase 2 clinical trials." "Given the existence of a treatment that is curing cancer at a rate that traditional medicine could only dream of, and doing so without any damaging side-effects, most would assume that every penny of our tax dollars allocated for cancer research would be thrown in Dr. Burzynski's direction." "The problem that we face however, is that a huge financial house has been built on the paradigm of purging the body of cancer cells." "Burzynski's discovery, means that the foundation, the walls, and the roof of that house, need to be replaced." "Think about it, we've got thousands of doctors in oncology, and in oncology residency programs, we've got the pharmaceutical industry pumping out chemotherapeutic agents every month." "There are all kinds of machines that deliver radiation we've got all this stuff in the war on cancer, and it's trillions of dollars." "I find it very interesting that we have all these walks for the cure of cancer." "We've got all the wristbands, we've got all the donations" ""we're going to find a cure in this decade."" "All this money keeps pouring in- and it all goes to the same guys." "The pharmaceutical industry is arguably the most profitable industry on our planet, with it's profits being triple that of all of the Fortune 500 companies." "Rising profits result in rising stock prices, the only way this industry can sustain this profitable momentum is by continuing to introduce new patented drugs." "And since the pharmaceutical industry relies on the FDA as it's gatekeeper to introduce these new drugs, it's in their best interest to insure the FDA remains as compliant as possible." "And since the FDA is also an office of the United States government, it's in the government's best interest to preserve one of its most powerful industries." "The former editor-in-chief of the New England Journal of Medicine, Dr. Marcia Angell, has been very outspoken with the idea that:" ""it's time to take the Food and Drug Administration back from the drug companies."" "In 1992, Congress put the fox in the chicken coop." "It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval." "The user fee act put the FDA on the payroll of the industry it regulates... and it has drastically changed the way it operates." "The part of the agency that reviews new drugs now gets more than half of its money from the pharmaceutical industry." "The FDA's coziness with industry is underscored by the composition of it's 18 advisory committees- outside experts who help evaluate drugs." "Incredibly, many of these advisers work as consultants for drug companies." "The FDA behaves as though the pharmaceutical industry is its user, not the public." "In 2010, the fee revenue paid by the pharmaceutical industry to the FDA has risen to over a half a billion dollars-annually." "PhRMA now pays over $14 million per application for most cancer drugs submitted to the FDA-to ensure a timely approval." "It's important to understand that neither Congress or the FDA had requested this new fee structure to occur." "Instead, PhRMA itself went to Congress and imposed these new fees onto the FDA, in essence purchasing the FDA's drug evaluation department from both the government and the public." "In a 2007 health policy report, sponsored by Pfizer, supporting the renewal of these user fees, they revealed  that the median review time for priority drugs- those for serious life-threatening diseases such as cancer," "was sped up from 21 months in 1993 to 6 months in 2004." "Dozens of cancer therapies have been reviewed and approved within 3 or 4 months." "Meanwhile, Dr. Burzynski, his patients, and other supporting scientists have made every conceivable effort to get the FDA, and thus the government, to cooperate in the research, review and approval of Antineoplastons since 1977." "Before I started, I asked my lawyers for their advice:" "Can I use an experimental treatment-which was the treatment of Antineoplastons-can I use this in my private practice, and can I be involved in cancer research, as simple as any private company" "Dr. Burzynski's attorneys investigated both state and federal law to find out if it was legal for him to start his own biomedical research company, making Antineoplastons, and administering them to his patients within his private practice." "They found that according to both the Taxes state and federal law, the use of any drug, or new drug, can be used to meet the immediate needs of the patients of a licensed doctor." "particularly when there was no other available option for them." "The law stated that such activity was not governed at the time by the Texas Food, Drug and Cosmetic Act and is not otherwise unlawful under the laws of the state of Texas." "However, Dr. Burzynski would not be legally allowed to introduce or deliver Antineoplastons into interstate commerce." "Which means, he had to keep his activities only within the state of Texas to avoid breaking any federal laws" "As long as he did this, his actions were not within the regulatory authority of the FDA." "However, once word began to spread that Dr. Burzynski was successfully treating what was once considered terminal incurable cancer patients people began traveling from all over the county to receive Antineoplaston treatment." "For a long time, I didn't have any contact with the Texas Board of Medical Examiners, until around 1984, some of my patients told me that they were approached by the agents sent to them by the Texas Board of Medical Examiners" "who were trying to convince them to file complaints against me." "This was shocking to me." "What is surprising is that they were using the state money, they were using taxpayers money to travel a long distance, like from Houston to California to convince our patients who were in California to file complaints against me." "This was completely irrational." "But nothing else happened at the time until I met by coincidence the Vice President of M.D. Anderson Cancer Center, Dr. Hickey, who informed me that I will have problems with the Texas Board of Medical Examiners." "And obviously the problems began." "I was called to the Texas Board of Medical Examiners, they began investigating me." "However, there were no complaints from the patients, the patients were happy, we were treating patients who were very advanced, for whom there was no treatment available, and they were getting good results." "So, apparently, there was no justification for such action." "This was a very unpleasant investigation, they were trying to convince me again to stop my research and to stop treating patients." "After about two years of going back-and-forth and being called to the board" "finally they proposed to me that I should present to them a number of cases of patients who benefitted from my practice." "They informed me that such medical records would be reviewed by expert oncologists and if they are satisfied that I am not harming patients and the patients are benefitting from my activity then they would leave me in peace." "I was very happy with this," "I believed that the Texas Board would do an objective review of our results and finally they would leave me alone" "because we had amazing results in the treatment of very difficult cancer cases." "I supplied to them twice as many medical records which showed without any doubt great results in the cancer treatment." "Incurable forms of cancer completely disappearing, with patients going into complete remission and patients who were cured and living a normal life after that." "In 1986, Dr. Burzynski agreed to present to the Texas State Board of Medical Examiners forty cases of various types of cancer he had successfully treated using Antineoplastons." "In patients ranging from breast, bladder, lung, liver, brain, head and neck, and lymphoma." "After submitting these cases to the medical board, he didn't hear back from them, leaving him to assume that the board was satisfied and would leave him in peace." "However, two years later, the board came back again, pretended that the cases he submitted were not successful, and claimed he was violating a law that didn't exist, which was grounds for the board to cancel, revoke, or suspend his license." "It was a shock to me." "I believed in justice, I believed in the high ethics of the board but this was just a lie." "The medical board had no case against Burzynski." "Which prompted the board to file their first amended complaint in 199O" "still the board had no case-which prompted them to file a second amended complaint in 1992." "The medical board kept coming back each time with the same argument, practically making Xerox copies of their prior claims, changing the titles and simply resubmitting them." "After about five years of this, sixty of Dr. Burzynski's patients petitioned the board to stop harassing their doctor." "The board then tried to ignore these petitions by attempting to strike them from the record." "Finally in May of 1993, this case went to trial." "During this trial one of the NCI's leading experts Dr. Nicholas J. Patronas, a board certified radiologist since 1973, professor of radiology at Georgetown University and founder of neuroradiology section at the NCI recognized the absurdity of the Texas medical board's case against Burzynski" "put his own career on the line and flew himself to Texas to testify on Dr. Bruzinski's behalf." "Dr. Patronas testified under oath his role at the National Cancer Institute." "Q:" "Basically, just in layman's terms, you do all the imaging work and interpretation for the National Cancer Institute testing of drugs?" "A:" "Exactly." "That's my job to asses the effectiveness of drugs that are given there" "Q:" "Dr. Patronas, did there come a time when you became aware of Dr. Burzynski?" "A:" "Yes, NCI asked me to join a group of other physicians and scientists to come to Houston on a site visit to Dr. Burzynski's Institute." "And I was called as an expert in assessing the images to evaluate the effectiveness of his treatment." "The basic conclusion was that in five of the patients with brain tumors that were fairly large, the tumor resolved, disappeared." "Q:" "And that's part of what you do at the hospital, is to evaluate treatments on brain cancer patients?" "A:" "Well, since I am the neuroradiologist I see all brain tumors." "And I see a large volume of them." "Q:" "You testified that five of the patients had their tumors resolved, they all " "A:" "Disappeared." "Q: --disappeared." "Can you give some kind of context of that?" "How often does that happen, just by spontaneous remission?" "A:" "I'm not aware that spontaneous remissions occurs." "The available treatments only rarely produce results like that." "The only medication -- the only treatment, which I think is the last resort, is radiation therapy." "Conventional chemotherapy is-- provides very little, nothing, basically." "So when this happens it is very rare." "In these cases, all the patients had already failed radiation." "Q:" "What happens with these patients who failed radiation with brain cancer?" "A:" "That's it; they die in 12 months." "Q:" "So you are saying basically that for someone already failed radiation there's not too much else" "A:" "Nothing to offer, exactly." "Q:" "And there is nothing that you could do at NCI?" "A:" "Nothing we can do, no; not at the present time." "Q:" "What about these five patients, how come they lived?" "A:" "Well, it's amazing, the fact that they are not handicapped from the side effects of any treatment, and the side effects of most aggressive previous treatment are worse than the tumor itself." "So these particular individuals not only survived, but they didn't have major side effects." "So I think it is impressive and unbelievable." "Q:" "How many times have you seen this, in your experience?" "How often does that happen?" "A:" "I don't" " I have not seen it at any time." "Q:" "Now let me ask your opinion or advice." "Based on what you have seen from these patients" "What would happen, let's say for some reason Dr. Burzynski's brain tumor patients can't get the medicine any more and have to go off the treatment." "What's going to happen to them, in your opinion?" "Mr. Helmcamp:" "Objection, Your Honor, not relevant." "Mr. Jaffe:" "I think it's relevant." "That's really the issue we are advocating in this case." "Judge Corbitt:" "I'll overrule the objection." "The witness:" "I think these patients will die." "Not surprisingly the judge ruled in Dr. Burzynski's favor." "Finding that the medical board did not introduce any evidence at the hearing that Antineoplastons are not safe and effective, nor did they introduce any competent or substantial evidence at the hearing that" "Antineoplastons are not generally recognized by experts qualified by scientific training and experience to evaluate their safety and effectiveness." "And, as far as the law goes, it does not apply to a licensed physician who manufactures his own medications and solely uses it on his own patients in the state of Texas." "Now, most would think that at this point the Texas Medical Board would stop wasting their time," "Burzynski's time, terminal cancer patients' time, and the taxpayers money, pursuing a case they knew they couldn't win." "Well, think again." "The state of Texas wants Houston doctor Stanislaw Burzynski to stop treating his patients with drugs that he produces at his own pharmaceutical plant." "The drugs called Antineoplastons are non-toxic compounds of proteins and amino acids, often lacking in cancer patients." "Even though the state of Texas acknowledges that the drugs may be helping some who are terminally ill, the state says the drugs shouldn't be used." "This is the state board of medical examiners, which licenses doctors in Texas this is the agency challenging Dr. Burzynski in court." "One judge has already told the board members that they don't have a case." "All of this nonsense which is going on now should disappear." "Because they should realize that I am right, okay?" "They are fighting a losing battle." "I am saving human lives, and if they put me out of business, the people will die." "This is the brain of an eight-year-old boy with a huge tumor most thought would kill him." "He used Dr. Burzynski's drug." "Images of his skull taken six years later show the tumor has almost disappeared." "Dr. Bruce Cohen is the director of neurologic oncology at the prestigious Cleveland Clinic." "The only explanation is that it shrunk because of the therapy Paul has received." "He confirmed Dr. Burzynski's results on Paul." "Seven years that we've had Paul and he's been healthy," "I owe it to this man, and there is no way I'd ever be Able to thank him enough for what he's done for us." "Today that boy Paul Michaels and his anxious family sit in the courtroom with other patients." "Undeterred by the 1993 ruling, the Texas Medical Board took Dr. Burzynski to a higher, district court." "Of course this time they knew they couldn't raise any issues about whether or not his treatment was effective:" "The Texas State Board of Medical Examiners, which has fought to suspend Dr. Burzynski's license because his treatments have never been approved, says quote:" ""The efficacy of Antineoplastons in the treatment of human cancers is not of issue in these proceedings."" "It takes a bureaucrat to come up with that idea, because, to a layman, that would really be the question." "Well, Dr. Burzynski has won his latest round in court, the Medical Examiners order was reversed, but that is not expected to be the end of his trouble with the state of Texas." "The Texas Medical Board took this imaginary case all the way to the Texas State supreme court, where the judge issued an erroneous probation order against Burzynski, which Burzynski successfully served." "But, again, leaving the Texas Medical Board completely unsuccessful in their efforts to remove his medical license." "So if efficacy was not an issue, and Dr. Burzynski wasn't breaking any laws, then why would the Texas Medical Board continue on with this empty pursuit?" "Well, it was eventually realized - even by the mainstream press" " that the Food and Drug Administration had been pressuring the Texas Medical Board to continue trying to take away Dr. Burzynski's medical license." "For this story we wanted to talk to the FDA about its policies and procedures." "The FDA did agree to talk to us on background where it wouldn't be quoted, but it repeatedly refused our requests for on-camera interviews." "While they were busy pressuring the Texas State Medical Board to try to revoke Dr. Burzynski's medical license, they were even busier trying to revoke Dr. Burzynski completely from society - by trying to place him in prison." "The FDA and PhRMA quickly realized that if Dr. Burzynski's discovery would be given a fair review process, not only would chemotherapy and radiation dwindle into obscurity, financially crippling the industry, but it would also mean that for the first time in history, all of that income would funnel away from PhRMA and into the lap of one single scientist who holds the exclusive patent rights." "Apparently, the FDA had not ruled out the possibility of this happening one day." "On March 12th, 1976, FDA Bureau of Drugs Director Richard Crout states in "The Cancer Letter":" ""when anyone other than large institutions ask permission to conduct clinical trials, you want harsh regulations"" ""sometimes we say it is proper to hinder research"" ""and once these guidelines were adopted, the FDA would consider itself 'bound' by them."" "In 1982, Crout states again:" ""I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances."" "And so, the fiercest fight in FDA history began." "Dr. Burzynski's dealings with the FDA commenced in 1983." "At that point the FDA commenced a civil action to try to close the clinic and stop all patients from receiving the medicine." "Before the judge in this case had announced her ruling, the FDA sent her a letter, warning her in advance," ""if this court declines to grant the injunction sought be the government"" ""thus permitting continued manufacture and distribution of antineoplastons"" ""the government would then be obliged to pursue other less efficient remedies"" ""such as actions for seizure" (also known as raiding his clinic and home)" ""and condemnation of the drugs" (also known as a propaganda campaign)" ""or criminal prosecution of individuals" (also known as throwing Dr. Burzynski in prison)" "Regardless of these threats from the FDA:" "... the judge in the case basically said he can treat anybody he wants in Texas, but he can't ship his medicine in interstate commerce." "The FDA viewed that as a failure and told Dr. Burzynski's attorneys at the time that they "have other ways to get him"." "Let's talk about the other ways." "In 1985, the FDA convened a grand jury to hear evidence to try to indict Dr. Burzynski." "In connection with that they had a raid of his clinic where they seized 200,000 pieces of paper including all of his medical records of all patients." "It's a little difficult to practice medicine when you don't have medical records." "Obviously they came armed, and they confiscated all of our medical records." "It took us about 12 to 14 years to recover these medical records." "In the meantime we were permitted to make copies of these medical records in their office." "But it was also a neglect of human well-being, we were treating very sick people and they took their medical records, we needed these medical records to fight for the lives of these patients." "But they took this away, they didn't care for these patients, the patients could die." "They were not important." "They presented the evidence to the grand jury, no indictment." "In 1986 they come back and seize another 100,000 documents, no indictment." "In 1990, another grand jury, either the second or the third, they present more documents," "Dr. Burzynski testifies extensively before the grand jury, no indictment." "In 1991 to 1993, the FDA investigates Dr. Burzynski, we don't know if evidence was presented to another grand jury." "In 1994, another grand jury, no indictment." "1995, another grand jury, this grand jury started in March of this year, on March 25th it was Dr. Burzynski along with a few of his patients appeared on CBS Show This Morning..." "Let me play devil's advocate, you all were very desperate folk, you had undergone some cancer treatment correct?" "None at all for you?" "No, I had no treatment you had undergone some treatment, could it not have been that the treatment that you received prior to Dr. Burzynski's treatment was what in fact really cured you?" "I'll jump on that, no way, because the recurrence I had was in a brand new spot that had not been involved before so if all the punishment that I went through for the year went out of my system, and after it went out of my system all of the sudden a new tumor comes in" "how could that first treatment have helped the subsequent tumor?" "Later that day the FDA came-another raid." "More patients documents, more subpoenas..." "We were flooded with calls last Friday with people wanting to know how to get a hold of you, they are going to see this story this morning, see that you've been raided by the FDA, and they are going to want to know if you are for real," "or if the concerns of the FDA may have something to do with your treatments and the viability of your treatments." "Let me jump in here, I don't think there's really an issue as I mentioned regarding the safety of the drug, and the FDA isn't contending at this point that the drug doesn't work," "the only issue is that according to the FDA it has not been proven by controlled clinical trials, so at least in terms of safety the FDA isn't saying that it's not safe and the FDA isn't even saying that it doesn't work, alright," "right now they're just contesting, or apparently they're contesting whether Dr. Burzynski himself has been shipping the medicine out of state, which in some respects is quite ridiculous since he has approval to ship the medicine out of state to various cancer institutions around the county, he ships it out of the county to various countries," "because it's being used in other places and he ships it to individuals who have been granted permission by the FDA to receive the medicine under what is called "compassionate use INDs (investigational new drug)"." "May, June, and July more witnesses testify before the grand jury, more documents." "So we've had now-four, five, or six grand juries." "Let me talk about the subpoena practices:" "most recently, the FDA has now subpoenaed the medical records of every patient who has gone on TV and told their story about Dr. Burzynski." "We'll let the committee judge what they think of that." "Let's talk about dissemination of false information by the FDA:" "in 1985 the FDA tells anyone who calls inquiring about Dr. Burzynski that he's being criminally investigated." "When the judge in the case found out about that, he issued a cease and desist and a strong reprimand against that." "The FDA now has refined this tactic, instead of waiting for people to call up the FDA, what they'd done is subpoena all the records from Dr. Burzynski about his business associates and all the researchers around the world," "and there are many of them who are researching antineoplastons- his therapy." "Now what they are doing is systematically contacting everyone, who does business with him, or who may do business with him, and telling about the grand jury investigations and subpoenaing documents" "I believe that they are doing this in order to make it more difficult for him to do business." "I'd like the following questions to be asked to the FDA:" "how much money have they spent in the last ten years to try to put Dr. Burzynski out of business?" "How many documents can they subpoena?" "And how many more grand juries does he have to go to?" "And why can't patients, who have advanced cancer, seek the medical treatment of their choice?" "Upon the commencement of the FDA's 1995 grand jury against Dr. Burzynski, an oversight and investigations subcommittee was organized by Congressman Joe Barton in an attempt to intervene in the FDA's relentless harassment of Dr. Burzynski and his patients." "In my opinion, you have every right to use the investigative authority and the judicial resources of the federal government to the justice department to convene a grand jury, that's very appropriate, the first time, perhaps even the second time," "it becomes questionable the third time, the fourth time, and the fifth time, it is not I think an illogical conclusion to think that the FDA has a vendetta against Dr. Burzynski, or wants to retaliate for some reason-now, that's my opinion." "How many grand jury investigations have to occur, that result in no finding of fault before you as commissioner of the FDA would encourage those within your organization to cease and desist?" "Mr. Chairman, how do you know that there were no findings of fault that were returned from that grand jury?" "There have been no indictments returned." "Mr. Chairman, I'll ask counsel to comment, but I don't think those are the same as a matter of law those are the same things." "I'm baffled by the splitting of hairs here but" "I am just trying to understand the exchange between the witness and the chairman." "What I understood the chairman to say is that there have been four grand juries convened?" "At least four." "I am left then with rather strong inference that if you convene four separate grand juries and there is no indictment returned, notwithstanding that prosecutors tell us always that it's possible to indict a ham sandwich that probably there's not much there." "Dozens of Dr. Burzynski's patients who had traveled to Washington D.C. from all corners of the United States stood up and expressed their outrage with the FDA and Commissioner David Kessler." "The FDA has made a list, and decided who can live and who will die, I guess I didn't make that list." "I've had no chemotherapy, I've had no radiation," "I choose Dr. Burzynski instead after a lot of research and a lot of searching." "I've been in remission since 1989." "Dr. Kessler:" "I'm not a statistic." "We're frustrated, there are rights, our constitutional rights have been violated, this has got to end, my children are asking me "daddy what does the future hold", my one daughter wrote a letter to the president of this county and said "please don't pull the plug on my daddy"." "And that just broke my heart and broke my wife's heart." "My husband is a walking miracle, sixteen months ago our doctors told us there is nothing else they can do, and they told us to enjoy what little life he has left." "Look at him, he biked 32 miles after being on Dr. Burzynski's treatment for two months and they're saying we can't have it?" "I have a report from my family physician which tells how well I am doing, my tumors are leaving my body, and my condition is improving every day" "Now the FDA is saying to me:" ""no, your doctor is a criminal, he should be put in jail, and he needs to be shut down"" "... this is criminal!" "I want the FDA to get out of our lives and stay out of our doctor-patient relationship." "What the classical conventional medicine had to do for me was there-nothing." "For me, the next thing was the minister." "I did not want to undergo chemotherapy, which I had a new name for, "kill 'em therapy"." "Or any type of radiation," "I was extremely lucky that I found Dr. Burzynski." "And I don't want the FDA to take this right from me." "I came eighteen years ago from Communist Romania, and the tyrant dictator Ceausescu, never stopped a doctor from treating anybody." "How can we have something like this in the United States?" "Barely a week after these hearings, on November 20th, 1995, Dr. Stanislaw Burzynski was indicted." "Burzynski was charged with 75 counts of violating federal law, and fraud." "If convicted, Burzynski would face a maximum of 290 years in federal prison, and $18,500,000 in fines." "Not to mention what would happen to his patients." "He is their last chance for life but now the federal government is issuing a death sentence for the patients of this cancer doctor." "On February 9th, Houston federal court judge Sim Lake ruled" "Dr. Burzynski's treatments have been quote: "illegal under Texas and Federal Law since 1984"" "and he ordered them stopped on all but a handful of patients." "Then, he put a stay on his own order, a stay of execution." "I believe that most of these 300 people will die within a short period of time if the treatment is stopped." "In 1996, not only did scores of Dr. Burzynski's patients return to Washington DC to protest his indictment, but many of them testified again before another congressional hearing headed by congressman Joe Barton." "Our first witness is Mariann Kunnari, is that correct?" "Yes, that's correct." "From Aurora, Minnesota." "This is Dustin Kunnari and he is on Dr. Burzynski's antineoplaston treatment." "And this is my husband, Jack Kunnari." "Now, in February of 1994 our lives were drastically changed." "My son Dustin was only two and a half years old at the time." "He was diagnosed with a brain tumor the size of a golf ball." "The surgeon removed 75% of his tumor, and the remaining 25% was diagnosed from a biopsy as a malignant, very aggressive medulloblastoma brain tumor- one of the most deadly forms of brain cancer." "The doctors told us Dustin had only a few months to live." "The first treatment offered us was radiation." "But the radiation doctor told us that at his young age, Dustin would become a vegetable, and it would only extend his life for maybe a few months." "The next doctor wanted us to enroll Dustin into an experimental chemotherapy, which was highly toxic." "The side effects would include hearing loss, kidney and liver damage, bladder, stunted growth and a possible leukemia." "One question I'd like to ask is: would you do that to your child?" "We weighed the harm these experimental drugs would cause against the fact that they would not cure Dustin, and decided not to subject him to these drastic measures." "But our oncologists told us that their opinion took precedence over us as parents." "This put added stress to the already stressful situation we were in." "In April of 1994, we visited Dr. Stanislaw Burzynski in Houston." "Dr. Burzynski made us no promises, but said, that he "often had good results with brain tumors, at worst it would not hurt Dustin"" "and it offered the best hope in a longer quality of life." "An MRI six weeks after we started Dr. Burzynski's treatment revealed no tumor." "We were very overjoyed." "Dustin continued Antineoplaston therapy, and one year later a tumor one-inch by one-inch in size was found on the MRI, that would be in April of 1995." "Dr. Burzynski immediately raised Dustin's dose of Antineoplastons." "There were still no harsh side-effects at all." "The next MRI in September of 1995 revealed that the tumor had almost disappeared again." "To this day, it has not reappeared." "If you look at Dustin right now," "he's a happy, healthy four-year-old, who has out-lived his prognosis." "There is not traditional treatment that would have kept him alive, with such good quality of life." "FDA Commissioner David Kessler loves to grab headlines as a man who loves children so much he wants to protect them from the ravages of smoking." "If Dr. Kessler loves children so much, why have he and his agency been trying so hard to cut off my son's last hope for life?" "Without this treatment, my son will die." "This is a photo of Dustin Kunnari at four years old in 1996." "This is a photo of Dustin Kunnari at eighteen years old in 2009." "His brain cancer never returned." "In 1996, because of pressure from the politicians and American opinion, the FDA agreed to accept all of the patients for whom we had at the time into a program of Phase 2 clinical trials." "Basically we filed and received permission from the FDA to proceed with 72 different Phase 2 clinical trials which covered practically any type of cancer." "This was such tremendous work, that basically it was necessary for me to work almost around-the-clock, with six secretaries who were typing different protocols, and later I learned that the FDA had to create a special task force to be able to review these protocols." "For soft tissue sarcoma, there is a special protocol for that." "For breast cancer-a special protocol." "For lung cancer, a few different protocols." "For brain tumors, about over twenty different protocols for different types of brain tumors." "So, just a year before his trial facing life in prison, the Food and Drug Administration had finally authorized the very thing that Dr. Burzynski and his patients had ever wanted." "Even still, the FDA would not back down in making sure Burzynski's trial moved forward." ""Federal prosecutors concede that a cancer doctor they will put on trial here in January for using an innovative but unapproved drug has been "saving lives."" ""The prosecution marks the first time the FDA has tried to jail a scientist for using a drug on which he is conducting FDA-authorized clinical trials."" ""In a pre-trial motion, Assistant U.S. Attorney Mike Clark objected to a defense request for the jury to visit the chemical plant where Dr. Burzynski manufactures antineoplaston."" ""The jury visit request "is a thinly veiled effort to expose the jury to the specter of Dr. Burzynski in his act of saving lives."" ""Whether antineoplaston does or does not work is not an issue, and the jury should not be asked to decide the question."" ""He added that is the issue comes up at trial, it would be an irrelevant, emotional, prejudicial and misleading concern."" "The issue of whether Antineoplastons work may not even come up during the trial." "The judge says "that's not relevant."" "But the defense contends that's exactly the point." "And what was done in developing the drug and administering it, was done to save lives." "This trial cost the American taxpayer 60 million dollars while costing Dr. Burzynski over 2.2 million." "700,000 dollars of Burzynski's legal defense was raised primarily by Dr. Julian Whitaker through his newsletter "Health and Healing"." "After Dr. Whitaker wrote of the plight and injustice being done to Dr. Burzynski, his readers sent in close to 18,000 checks in small donations for Burzynski's legal defense." "The trial is expected to last about two months, the jury will then decide whether Burzynski is a fraud, or a medical pioneer." "On March 4th, 1997, due to a deadlocked jury, the judge declared a mistrial." "And, after saying the government had not presented sufficient evidence, he ordered that Dr. Burzynski be acquitted of nearly half of the 75 counts." "You voted to acquit?" "To acquit, absolutely." "Not guilty." "Not guilty" "I voted for acquittal." "I voted my mind, and my heart..." "I do not believe that Dr. Burzynski is a criminal." "...and I had voted to acquit..." "But the FDA was still not backing down." "They took Dr. Burzynski to trial, again" "Though, after apparently accepting the absurdity of their case, on May 19th the FDA suddenly dropped 40 of the 41 remaining charges." "The FDA's facade in trying to convince the world that Burzynski was a criminal was completely unraveling." "Even the jurors who voted not guilty in the first case, took time off of work to join the patients' protest in front of the court house during the second case." "I am appalled at the Food and Drug Administration and their actions." "We're here today, basically, to protest the witch hunt that's going on by the FDA." "We have to stick together and really support these patients that are suffering not only health-wise but having to come down here to make a stand against the FDA." "Please don't waste my money abusing the system to make sure that you maintain your power." "The jury spent about three hours deliberating this house of cards, leaving Burzynski acquitted of the final charge." "Every one of Dr. Burzynski's patients now, every future Burzynski patient is and will be on a clinical trial." "There were many patients who would have liked to testify on our behalf and convince the jury and the judge that without the treatment they would die." "But the judge did not admit any statements which could show that the treatment is effective." "The judge did not allow the jury to visit our facility where we produce the medicine." "They were trying to keep it away from the jury." "If this information would have been presented to the jurors, then this trial would have been finished very quickly." "And that's what the jurors told us because after the trial we talked to the jurors, and they were shocked that such information about the treatment which was saving the lives of patients was not presented to them." "And I was sick listening to the lies of prosecutors from the U.S. Attorneys." "It was not necessary for them to do it, they could tell the truth, they represented the biggest power, but they still were doing this all the time." "So they were trying to do it in a sneaky way, and that's what is horrible, that's what should be exposed because I think the United States deserves better." "While all of this was taking place, Burzynski knew that the easiest way to keep the government from putting him out of business or in prison, was to partner with an established pharmaceutical company." "An interest was shown from Japanese pharmaceutical company "Chugai", and the Italian pharmaceutical company "Sigma-Tau", but both deals eventually evaporated likely due to the "rapport" developed so far between Antineoplastons and the FDA." "Being an "issue, indeed", and were unable to verify the likelihood that they could openly and effectively work with the FDA." "Then, by 1990, it seemed that Burzynski's luck had finally changed." "Burzynski has apparently treated the sister-in-law of the Chairman and CEO of Elan Pharmaceuticals." "Elan enthusiastically drafted a letter of intent, stating they would aggressively pursue the filing of the necessary protocols with the Food and Drug Administration for approval and marketing of Antineoplastons as quickly as possible." "They soon negotiated financing, licensing agreements, and royalties." "In the midst of closing this deal with Elan, more good news emerged." "Dr. Dvorit Samid: a scientist and medical professor from Maryland who Burzynski had hired to further study Antineoplastons, managed to present her work at an oncology symposium in Switzerland, which landed her and Antineoplastons a cover story in a 1990 issue of "Oncology News"." "In 1989, we retained Dr. Dvorit Samid as our consultant." "Dr. Samid at that time worked at the Uniformed Services Medical School in Baltimore, and later she moved to the National Cancer Institute." "She did a lot of work with Antineoplaston's ingredients." "Unfortunately when the pharmaceutical company entered the picture" "Elan Pharmaceutical, our consultant Dr. Samid became too close." "She really became a consultant for Elan Pharmaceutical and she was working with Elan from this time." "And suddenly, Elan Pharmaceuticals terminated their licensing agreement, stating..." "Elan has significant doubt as to whether the active substances comprising of Antineoplastons have patent protection, thereby rendering an agreement meaningless." "Antineoplastons are not just one chemical." "We have different ingredients in Antineoplastons." "One of these ingredients was known before." "We discovered that this was the metabolite of Antineoplastons, and it was known and it was available before." "So when we patented our invention, our lawyers told us" ""look, you can't patent this particular ingredient because it was known before let's list it in your patents, but don't patent this because you will never get a patent for that."" "But this is the least important ingredient of Antineoplastons." "While this was an odd turn of events more good news continued to pour in!" "." "It was in October 1991 when Dr. Nicholas Patronas led the National Cancer Institute on their site visit, the very same site visit Dr. Patronas would later base his testimony when defending Burzynski against the Texas Medical Board." "This site visit not only confirmed that Antineoplastons were curing what was previously considered incurable brain cancer, but, it garnered their interest in conducting a confirmatory trial under Division of Cancer Treatment sponsorship at the National Cancer Institute." "These trials involved most of their top experts, including, Dr. Michael Friedman:" "the Associate Director of the Cancer Therapy Evaluation Program." "In a memo addressed to his director, Dr. Friedman wrote:" ""l thought you would be interested in this."" ""Antineoplastons deserve a closer look."" ""It turns out that the agents are well-defined, pure chemical entities." "The human brain tumor responses are real."" "The National Cancer Institute's "Decision Network" then convened, and gave the green light to conduct government-sponsored clinical trials of Antineoplastons." "Initially everybody was very excited about it, everybody wanted to proceed, the people who reviewed our results" "the experts from the NCI, they did a very good job." "They were critical of course, but they were also highly complimentary for the way we treated patients and the results we got." "It looked like everything should open and move forward." "Suddenly everything came to a stop." "And then we found that a few months later Elan received permission to do clinical trials with this particular ingredient." "Ours was pushed back for about four years, and Elan was allowed to proceed with theirs suddenly." "When Elan terminated their business deal with Burzynski, they went behind his back, recruited Dr. Dvorit Samid, and partnered with the National Cancer Institute, where Dr. Samid soon became a section chief." "Elan then co-sponsored laboratory research and clinical trials testing only this single ingredient, called: "Phenylacetate"" "the same chemical that Burzynski was advised he couldn't patent, and had already proven to be quite limited against cancer as a single substance as far back as 1980." "After the treatment in a small number of patients we found that the activity was quite limited." "That's why I decided to abandon phenylacetate, and we use the other Antineoplastons." "One of them contains phenylacetate as the second ingredient." "Phenylacetate alone has very small activity, it's not very effective." "While Burzynski was facing continuous harassment from state and federal agencies, the earliest phenylacetate studies were published in April of 1992, authored by Dvorit Samid, hosted by the National Cancer Institute." "Burzynski sat in awe as he witnessed the National Cancer Institute recruit one of his researchers, push his research aside, and begin to test phenylacetate without him, reporting:" "...phenylacetate is both effective in inducing tumor cell maturation and free of cytotoxic and carcinogenic effects, a combination that warrants attention to its potential use in cancer intervention." "The National Cancer Institute apparently pretended that they have discovered this all on their own." "Burzynski's name failed to appear in the acknowledgments, or any of the references listed in this report." "Burzynski knew these tests would fail since he had already proven this in his own laboratory twelve years before." "Abandoned by the National Cancer Institute, he sat powerless on the sidelines as the attempted high-jacking of his discovery unfolded before his eyes, ending in the hideous train wreck he warned them it would." "The National Cancer Institute, Elan, and Dr. Samid spent over four years and tens of millions of dollars testing phenylacetate." "The use of phenylacetate alone was not successful and the NCI or Elan could not use the other ingredients of Antineoplastons because they were covered by the patents owned by me." "They were trying to commercialize this, but without the other ingredients they couldn't do much with this." "This needed to be given in conjunction with the others." "While coming to terms with this reality, the National Cancer Institute decided to honor the government sponsored clinical trials of Antineoplastons they had initially promised Burzynski in 1991." "From the moment this dialogue was re-opened, the National Cancer Institute proposed altering the treatment protocols that Burzynski had spent 20 years perfecting." "Burzynski told them, that until they agree to a protocol that he has confidence in, he was not going to provide the National Cancer Institute with any Antineoplastons." "Dr. Michael Friedman told Burzynski:" ""in response to your correspondence, one last time, we will revise the protocol with regard to dose and schedule in compliance,"" ""however, if you are unable or unwilling to provide the Antineoplastons in the near future, we will pursue alternative sources to procure the drug, or its active components, and will proceed." "Burzynski responded:" ""l appreciate very much that you have finally decided to follow my recommendation regarding dosage."" ""But your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise."" ""It is hard to imagine that a federal employee would consider patent infringement."" "Placing these ominous threats from Michael Friedman aside, they finally managed to agree on a protocol." "The protocol was simple." "Patients with tumors larger than 5 centimeters, more than one tumor, or with metastasis are excluded." "After everything was approved and Burzynski released his medicine, a full year passes, in which time over 15,000 Americans had been diagnosed with the types of brain cancer this trial was focusing on." "Yet, America's National Cancer Institute was somehow having difficulties in accruing patients." "So they used this as an excuse to go behind Burzynski's back, again, and take it upon themselves to drastically alter the protocols." ""Dr. Friedman, it has been brought to my attention that the protocol has been amended to accept patients with tumors measuring over 5 centimeters, multiple tumors, or with metastasis."" ""I am outraged that without my knowledge Memorial Sloan-Kettering Cancer Center with NCI's permission changed the protocol."" ""Treatment of patients with these conditions will require a different protocol, with a different schedule and different dosages."" ""I hereby request that the amendments be cancelled immediately and the original protocol be used as promised."" "The National Cancer Institute responds:" ""sorry, but the amendments have been approved."" "Burzynski fires back:" ""Let me make perfectly clear that as the discoverer and developer of Antineoplastons, and the individual with nearly 20 years clinical experience using them,"" ""it is my professional opinion that the drugs will not produce substantial benefit in such advanced patients."" ""As I have repeatedly informed you, the protocol that we are currently using for such advanced tumors, requires doses three times greater than that currently being used."" "These trials have been conducted at the Mayo Clinic in Minnesota, and the Sloan-Kettering Hospital in New York." "Currently there are only eight patients enrolled." "I'm very dissatisfied with that because our desire is achieve the proper enrollment in as quickly a manner as we can in order to really test this hypothesis." "Friedman blamed Burzynski for this slow motion, saying Burzynski restricted admissions to the trials too stringently" "To speed things up admission standards for the trials have been lowered, to bring in patients in worse physical condition, this over Dr. Burzynski's strenuous objections." "We get the idea that the main interest is to let these patients die rapidly, and make sure that the treatment will never work." "Dr. Burzynski has threatened legal action to halt these new admissions, and the NCI has suspended recruiting, leaving the trials with just those scientifically unsatisfactory eight patients." "Meanwhile both the FDA and the Texas Medical Board are still trying to stop Burzynski." "On May 8th of 1995, less than two weeks before this broadcast, the National Cancer Institute issued an internal memo to all of those involved in the Antineoplaston trials." ""For the record." "The clinical trials monitoring service has been instructed not to send any Antineoplastons..."" "..."clinical trial data to Dr. Burzynski, the Burzynski Research Institute, or anyone inquiring about the Antineoplastons clinical trials."" ""Any inquiries that may be related to the trials or Dr. Burzynski are to be referred to the associate director:" "Dr. Michael Friedman."" "Friedman then taunts Burzynski:" ""l must convey my deep pessimism." "We are in no way obligated to obtain your consent."" ""Your insistence on dictating the manner in which we conduct or review these clinical trials is both presumptuous and inappropriate."" ""The future of these trials rests entirely with the NCI,"" ""since our primary obligation is to the American public."" "Burzynski responds:" ""Your letter of June 6th conveys pessimism." "My letter conveys outrage."" ""Patients were admitted against admission criteria, their treatment was discontinued, and their lives were jeopardized for frivolous reasons."" ""In spite of your promise we never received any detailed data on these patients."" ""There must be a reason why you are afraid to provide us with complete copies of medical records."" "Well, there was a very good reason why Dr. Michael Friedman was afraid to provide Burzynski with complete copies of these patients' medical records." "It took us at least half-a-year before we forced the NCI to release some of this information to us." "And then we found that they severely violated the protocol." "They did not comply at all with the protocol." "On top of that, patients were forced to stop the treatment of Antineoplastons because of massive fluid retention." "This is something in which we don't see with Antineoplastons, the typical side-effect of Antineoplastons is dehydration, which means elimination of the fluids, the patients are losing a lot of fluid to the point where they have to drink a lot of extra fluid." "We don't see increased fluid retention." "I was curious how this could happen." "I knew that the patients were receiving a lot of intravenous fluid, but then we learned that perhaps the fluids which they were receiving were not Antineoplastons." "In October of 1995, the National Cancer Institute's "Cancer Information Service" issued a public statement for anyone inquiring about their clinical trials of Antineoplastons." "In it they stated," ""because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of Antineoplastons."" "To their credit, and according to the scientific standards set by the National Cancer Institute, this was indeed the truth." "However, four years after these trials were closed, and two years after Burzynski defeated the FDA and won his freedom, the National Cancer Institute just couldn't leave well enough alone, and decided to vindictively publish these scientifically invalid Antineoplastons trials in the peer-reviewed medical literature." "In it, they described how nine patients were treated, and no patient demonstrated tumor regression." "However, whoever was responsible for publishing this report was apparently careless enough to also include the Antineoplaston concentrations detected in the blood of the nine patients during treatment." "We compared this to the data which we have in our studies." "We found that they were severely diluting the medicine, and this is why the patients had fluid overload." "Antineoplaston AS2-1 consists of two ingredients:" "called Phenylacetate, and Phenylacehlglutamine." "And about 2.7 times lower level of Phenylacetate was found in the patient's blood compared to what we see in our patients' who receive successful treatment." "Phenylacehlglutamine, there was about a 36 times lower level in patient's blood compared to what we see in our patients who receive the right dosage of Antineoplastons." "And the concentrations of Phenylacehlisoglutamine, one of the main ingredients of Antineoplaston A10, were close to one hundred and seventy times lower than what we see in the treatment of patients with Antineoplastons." "And that's what we found out from the patients' husbands or the patients themselves." "That's what they were doing." "So this was horrible." "This was a criminal act." "They should be prosecuted for that." "Because obviously, they knew what they were doing, and they knew that these patients had really no chance to respond to any treatment, they were going to die." "And that's what happened." "After we realized what they were doing, we decided to force them to stop the clinical trials." "And since then obviously, The National Cancer Institute hates us they do whatever they can but they do not cooperate with us anymore." "Most of us would assume, that with any story such as this, surely there's another side to it." "Our story is no exception." "After the National Cancer Institute intentionally violated all protocols of their own Antineoplaston trials, and after all state and federal agencies had failed in their 14-year campaign to remove Burzynski from society, after all of the dust settled," "a profound truth began to emerge." "It was October 4th, 1991, that America's National Cancer Institute hosted their site visit to Burzynski's clinic, and verified for themselves that "anti-tumor activity was documented by the use of Antineoplastons."" "Seventeen days later, on October 21st, 1991," "The United States of America as represented by the Department of Health and Human Services, and Dr. Dvorit Samid filed a patent for Antineoplastons AS2-1 ." "They even had the audacity to include Burzynski as a reference." ""The invention described herein may be manufactured, used and licensed by or for the government, for purposes..."" "At the time, Burzynski had no idea this had happened, but did have his suspicions when they began to openly test Phenylacetate without him, and the National Cancer Institute knew it." "In an April 1993 NCI memo, distributed to those involved with Burzynski, they state their concerns:" ""Political issues are a real concern." "Congressman Bedell is concerned we are taking the Antineoplastons away from Burzynski." "Burzynski has patents on Antineoplastons."" ""Since phenylacetic acid, or Phenylacetate, may be the active component of Antineoplastons, our involvement has become an issue."" "Five months later, the United States of America and Dr. Dvorit Samid file their second extended patent on Antineoplastons." "And, guess who else was in it?" "In March of the following year, America files it's most extensive updated Antineoplaston patent to date, spanning one hundred and eleven pages." "Seven months later, they file a fourth one." "June 6, 1995, the United States government has a field day filing their fifth, sixth, seventh, and eighth extended patent on Antineoplastons." "The following day, America files it's ninth, tenth, and eleventh extended Antineoplaston patent." "And, a couple of months after the eleventh patent was filed," "Dr. Michael Friedman leaves hid position at the National Cancer Institute, and becomes Deputy Commissioner of Operations for the Food and Drug Administration, working directly under Dr. David Kessler." "And by November of that year, after a decade of failed grand juries, the United States of America's Food and Drug Administration finally manages to indict Dr. Burzynski." "One month into America's criminal trial against Burzynski, America's first patent on Antineoplaston AS2-1 is approved." "A month after America fails in their second trial against Burzynski, their second and third Antineoplaston patents are approved." "Over the course of the next three years, the United States patent office approves all eleven copy-cat patents on Antineoplastons AS2-1 ." "And as we know, all of this was being done based on the fact that the United States, which is the National Institutes of Health, together with a pharmaceutical company, which is Elan Pharmaceuticals was tying simply to steal my invention." "That's what they wanted." "It's not that we had successful visit from the National Cancer Institute in which they determined that "this treatment works great"" "and they decided that we should go into Phase 2 clinical trials which would be sponsored by them." "No." "This gave the idea of some high-ups at the FDA to conspire with the pharmaceutical company so that they could steal the invention from me and get it, because it was good." "That's the whole story." "They knew that If I'd be still free, they won't be able to do it." "Because they knew that if I would sue them they wouldn't have a chance in court because we have had our patents before them." "So that's why they attempted to wipe me out financially, to put me in prison, to attack me from every possible angle:" "FDA, which is the federal government, state government... to be able to steal my invention." "That's the real thing from the National Cancer Institute and Elan Pharmaceuticals." "They failed." "We survived, and we continue to move forward." "These patents are full of useful information." "Aside from noticing their blatant infringement, "Compositions and Methods for Treating and Preventing Cancer", using the distribution of Antineoplastons AS2-1's ingredients." "They enthusiastically state:" ""The neoplastic conditions treatable by this method include:" "neuroblastoma, leukemia, myelodisplasia, acute glioma, prostate cancer, breast cancer, melanoma, lung cancer, medulloblastoma, and lymphoma" to name a few." "They also point out how Antineoplastons can also be used as a cancer preventative." "However, the most revealing piece of information found in these patents is where they state:" ""Current approaches to combat cancer rely primarily on the use of chemicals and radiation which are themselves carcinogenic and may promote recurrences and the development of metastatic disease."" "Let's read that one again, shall we?" ""Current approaches to combat cancer rely primarily on the use of chemicals and radiation, which are themselves carcinogenic and may promote recurrences and the development of metastatic disease."" "Now how could the U.S. Patent Office be corrupted to the point that they issue patents on medical therapies that have already been patented, and issue them to someone who had nothing to do with their discovery or use?" "How could that happen?" "And how could the patent office then assign these fraudulent patents to some of the most powerful institutions in American government?" "And imagine, all of this was being done while these same government agencies were spending millions of taxpayers' dollars trying to put Dr. Burzynski in jail so he could not fight the criminal theft of his discovery." "Well, what about ten million patients who have died of cancer over the last twenty years?" "The majority of them could have been saved if the government had not blocked the therapy that they know could save them." "The entire approach is totally wrong." "It's based on the microscopic diagnosis of cancer which is about one hundred and sixty years old." "Without really looking at what is causing cancer, without looking for the genetic signature of the cancer— the technology in this area is developing, it's available today if somebody would like to use it he can have at least some idea" "of what is "the best to use for this patient"." "But the doctors are uniformly resistant against it, they don't want to hear about it, they just use the combination of medicines in which they have learned by heart, and they know that that's what they should use for everybody." "Terrible waste, waste of resources, a terrible waste of human lives because in the meantime these patients obviously will not respond and they could respond if they would be given good medicine." "Terrible waste of resources from the large insurance companies, as they will obviously pay for very expensive regimens which are going to fail, but at the same time when you try to select what is the best medicine for a patient based on their genetic signature they may not pay you," "because they say "no, this medicine is not yet FDA approved, and it shouldn't be used."" "It's a totalitarian approach: everybody's the same, everybody should receive the same medical regimen, and don't you dare look at somebody as an individual— treat everybody the same way." "It's good for the pharmaceutical companies because they will make billions of dollars, good for doctors who don't want to learn much because they need to learn medicine by heart, and they can use the same thing all over again for a number of years." "But of course bad news for patients who are going to have adverse reactions and very few of them will have real good results." "That's a problem." "True progress in medicine has always, without exception, been violently resisted by medical authorities who cling to the beliefs of their time." "In 1840, Ignaz Semmelweis, an Austrian obstetrician noted that over 20%, that's one out of five, women giving birth in the hospital died four to six days later of puerperal fever." "These women were then autopsied in the basement of the hospital." "And the doctors who performed these autopsies wore no gloves, can you imagine that?" "Believe it or not, they then would leave the autopsy room and go straight to the delivery room to assist other births without even washing their hands." "Then Dr. Semmelweis' good friend and fellow physician accidentally cut his finger while he was doing an autopsy." "In six days, this doctor died with the same signs and symptoms of puerperal fever." "All of the sudden Semmelweis knew, he realized that the doctors were transferring the disease from the autopsy room to the delivery room, and he urged his colleagues to simply wash their hands." "For this unforgivable sacrilege, he was drummed out of the medical profession and he died in an insane asylum." "Now today we have the same kind of arrogant commitment to belief, but with cancer treatment we have a trillion-dollar business built on those beliefs." "So if you think Semmelweis had a problem, just imagine the problem Dr. Burzynski faces." "There was no money involved in "hand washing" vs. "non-hand washing"." "The smear campaign against us continues, from good doctors, from the American Medical Association, from the American Cancer Society." "Despite of the fact that it should have stopped a long time ago." "The fact that we are permitted to enter Phase 3 trials means that the treatment already shows safety and efficacy in Phase 2 trials." "This means that at this moment we should receive overwhelming support, instead of being harassed as we are so far." "In 2009, Phase II FDA-supervised clinical trials of Antineoplastons successfully came to a close." "Phase III trials are the third and final phase before reaching FDA approval." "These trials could begin worldwide in 2010, barring the ability to raise money to fund them." "The FDA has officailly mandated that some patients participating in these Phase III trials also be subjected to radiation treatment while simultaneously receiving Antineoplaston treatment — claiming it would be "unethitical" not to do so." "It is simply a matter of time before Antineoplatons and other forms of gene-targeted therapy will begin to replace chemotherapy and radiation for the treatment of most cancers." "This film is dedicated to everyone who has been affected by cancer."