Controversial cancer doctor gets green light by the FDA to resume clinical treatments

The FDA's decision "marks an important step in the development of antineoplastons for the treatment of various forms of brain tumors," the institute said in its statement.

by Liz Szabo, USA Today

The Food and Drug Administration has given a controversial Houston doctor the green light to resume administering experimental cancer treatments.

The FDA has lifted restrictions on a clinical trial run by Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. Burzynski, 70, has wrangled with state and federal medical authorities for nearly 40 years over his claims that he has discovered natural substances that can fight certain cancers.

Burzynski — hailed as a maverick by his fans but derided as a snake oil salesman by mainstream doctors — has long claimed to have achieved dramatic success in hard-to-treat cancers, especially brainstem tumors that are usually considered fatal. According to the National Cancer Institute, however, Burzynski has not produced proof that his drugs save lives by publishing a randomized, controlled trial in a peer-reviewed journal.

The FDA placed Burzynski's clinical trial on a partial hold — barring him from enrolling new patients — after the 2012 death of a 6-year-old New Jersey boy in his study.

Last year, the FDA issued a sternly worded warning letter to Burzynski, expressing concern about patient safety and the accuracy of his records. The FDA can lift those restrictions once Burzynski meets its requirements.

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Reference:
Burzynski Clinic

Cancer is Serious Business, The Movie, Part I:

ABOUT BURZYNSKI, THE MOVIE (PART I):

Burzynski, the Movie is an internationally award-winning documentary originally released in 2010 (with an Extended Edition released in 2011) that tells the true story of a medical doctor and Ph.D biochemist named Dr. Stanislaw Burzynski who won the largest, and possibly the most convoluted and intriguing legal battle against the Food & Drug Administration in American history.

His victorious battles with the United States government were centered around Dr. Burzynski's gene-targeted cancer medicines he discovered in the 1970's called Antineoplastons, which have currently completed Phase II FDA-supervised clinical trials in 2009 and has been given permission by the FDA to begin the final phase of FDA testing–randomized controlled clinical trials.

When Antineoplastons are approved, it will mark the first time in history a single scientist, not a pharmaceutical company, will hold the exclusive patent and distribution rights on a paradigm-shifting medical breakthrough.

Antineoplastons are responsible for curing some of the most incurable forms of terminal cancer. Various cancer survivors are presented in the film who chose these medicines instead of surgery, chemotherapy or radiation - with full disclosure of medical records to support their diagnosis and recovery - as well as systematic (non-anecdotal) FDA-supervised clinical trial data comparing Antineoplastons to other available treatments—which is published within the peer-reviewed medical literature.

One form of cancer - diffuse, intrinsic, childhood brainstem glioma has never before been cured in any scientifically controlled clinical trial in the history of medicine. Antineoplastons hold the first cures in history - dozens of them. [ANP-Childs Nerv Syst. - 2014] [ANP -Pediatric Drugs - 2006] [ANP - PubMed 2003] [ANP - PubMed 2006] [ANP - Cancer Therapy 2007] [Rad & other - PubMed 2008] [Chemo/Rad - PubMed 2005]

This documentary takes the audience through the treacherous, yet victorious, 14-year journey both Dr. Burzynski and his patients have had to endure in order to obtain FDA-approved clinical trials of Antineoplastons.

Dr. Burzynski resides and practices medicine in Houston, Texas. He was able to initially produce and administer his discovery without FDA-approval from 1977-1995 because the state of Texas at this time did not require that Texas physicians be required to adhere to Federal law in this situation. This law has since been changed.

As with anything that changes current-day paradigms, Burzynski's ability to successfully treat incurable cancer with such consistency has baffled the industry. Ironically, this fact had prompted numerous investigations by the Texas Medical Board, who relentlessly took Dr. Burzynski as high as the state supreme court in their failed attempt to halt his practices.

Likewise, the Food and Drug Administration engaged in four Federal Grand Juries spanning over a decade attempting to indict Dr. Burzynski, all of which ended in no finding of fault on his behalf. Finally, Dr. Burzynski was indicted in their 5th Grand Jury in 1995, resulting in two federal trials and two sets of jurors finding him not guilty of any wrongdoing.  If convicted, Dr. Burzynski would have faced a maximum of 290 years in a federal prison and $18.5 million in fines.

However, what was revealed a few years after Dr. Burzynski won his freedom, helps to paint a more coherent picture regarding the true motivation of the United States government's relentless persecution of Stanislaw Burzynski, M.D., Ph.D.

Note: When Antineoplastons are approved for public use, it will allow a single scientist to hold an exclusive right to manufacture and sell these medicines on the open market—potentially leaving the pharmaceutical industry absent in profiting from the most effective gene-targeted cancer treatment the world has ever seen.

The Burzynski Documentary Series is directed and produced by Eric Merola - Read VARIETY's review - Read The Los Angeles Times review



Cancer is Serious Business, The Movie, Part II:

ABOUT BURZYNSKI, THE MOVIE, PART II :

In the compelling follow-up to the internationally award-winning documentary, Burzynski, the Movie; Burzynski: Cancer is Serious Business, Part II explores the current status of Antineoplastons' clinical testing sanctioned by the United States Food & Drug Administration—and features a modern story of the struggling journeys of cancer patients being treated today at the Burzynski Clinic in Houston, Texas.

For most patients undergoing Burzynski's treatment, their advanced cancer itself runs secondary to the constant barrage of skepticism coming not only from their local oncologists, but also from friends and family who feel their loved ones are making suspect treatment decisions—even though mainstream oncology has already left many for dead.

As the story unfolds, you will observe a real-time change of hearts and minds from many of these doctors and families. Unlike the first documentary, Part II showcases interviews with board-certified oncologists, surgeons and neurosurgeons, who witnessed patients leave their care, soon to return in great health after opting for the Burzynski Clinic.

Since the mapping of the Cancer Genome, Burzynski has pioneered an expansion of his therapy which he calls, "Personalized Gene-Targeted Cancer Therapy", where each patient's Genomic Cancer Atlas is mapped and a treatment regimen is personally tailored for each individual patient—vs. the conveyor belt, "one-size-fits-all" approach that current oncology adheres to.

Due to the slow-moving, bureaucratic obstacles enforced on Antineoplastons by America's FDA, this new expanded "personalized gene-targeted" direction has allowed more patients (who are denied access to Antineoplastons) to benefit from Burzynski's practice in ways never before thought possible. And yet, still with similar resistance and controversy endured by Burzynski's Antineoplaston therapy.

The film also takes you to Kurume University in Fukuoka, Japan—where independently designed studies of Antineoplastons have been underway for 27 years—without Dr. Burzynski's (the inventor's) involvement or supervision. Learn how this team of Japanese pathologists, oncologists and surgeons have studied these anti-cancer co mpounds using their own methodologies—resulting in the first ever independently-run randomized controlled clinical trials.

"After twenty-seven years of independently testing Antineoplastons—including randomized clinical trials, we found that Dr. Burzynski was right. It's obviously not anecdotal anymore."

- Hideaki Tsuda, MD - 2013, Kurume Medical University, Fukuoka Prefecture, Japan

You will be placed into the turbulent journey of how the industry utilizes its now usurped regulatory agency to both block Antineoplastons' Phase 3 clinical trial process—and orchestrate a group of "information hit men" (also known as an "Astroturf Campaign") to pollute all channels of public information in an effort to confuse the public over the truth behind Antineoplastons. This international Astroturf group also engages in the intimidation and harassment of prospective and current terminal cancer patients under Dr. Burzynski's care.

However, most notable of all—are the earth-shattering events that occurred upon the final days of production of this film—you'll be left speechless, yet with so much to say, when you witness the story and shocking conclusion to Burzynski: Cancer Is Serious Business, Part II.

"I can't imagine a world where other people will not have the privilege that I have had—the privilege to have their life saved by a new technology that can cure cancer—it's terrifying." 

- Laura Hymas - 2013, Glioblastoma Grade IV brain cancer patient, after experiencing a complete remission under Antineoplaston therapy.

Disclaimer: This documentary film series  is not affiliated with Dr. Stanislaw Burzynski MD, PhD, The Burzynski Clinic, or the Burzynski Research Institute, Inc. It is an independent film series produced by Eric Merola, and should not be misunderstood as an advertisement for the Burzynski Clinic. This film series and this web site is not intended to replace professional medical advice.