The Innovative Cancer Treatment the FDA Doesn’t Want You to Know about – and the Frankfort woman whose life it might have saved

FRANKFORT – What happens when a trained MD with a PhD in biochemistry discovers the genetic mechanism that can cure many human cancers? For Dr. Stanislaw Burzynski it has meant a battle of time, wits and money.

Burzynski stands to be the first person in history to own the intellectual property rights for a cancer treatment that was not created by a pharmaceutical company.

Since the 1970s when the Houston-based doctor first discovered a specific gene targeted therapy option for cancer treatment called Antioneoplastons, non-toxic compounds of proteins and amino acids, often lacking in cancer patients, he has been embroiled in lawsuits from the Federal Drug Administration (FDA) while at the same time going through FDA clinical trials testing his innovative approach to cancer. He went before four grand juries and the Texas Supreme Court, none of whom found any fault with his work or practice. But this did not stop the FDA from continuing harassment of Burzynski for years to come, until the case against him was eventually thrown out, paving the way for the reluctant approval of his formula in clinical trials.

Why? Cancer treatment is a billion-dollar industry and the pharmaceutical companies stand to lose if a safe alternative treatment becomes the standard. The FDA was chastised by Congressional members during a hearing for persecuting Burzynski, and it finally allowed him to conduct clinically-controlled trials on his own medicine. He has successfully treated many types of cancer in patients worldwide, with no harmful side effects.

One of his success stories: Kendra Gilbert of Frankfort, who was 22 when she was diagnosed with a grade-three anaplastic astrocytoma, an inoperable brain tumor, in 2006. After Gilbert's biopsy at Mayo Clinic, and radiation and chemotherapy treatment at the University of Michigan, the prognosis was sobering: one to three years with continued treatment; 15 months at best. "I cried and prayed, a lot," said Gilbert's mom, Melissa. Together with Gilbert's Dad, Randall, the family learned of Burzynski and contacted him. "We knew we had to try something."

Over the next 18 months, the Gilbert family spent six weeks at the Burzynski Clinic while Kendra received treatment and Randall learned to be her care giver. Kendra returned home and continued treatment for the next 16 months. The family also used everything they had as collateral to pay for the costly treatments. "We were fortunate we had the means to do so, and we had health insurance, but we had to go through a grievance process three times before they agreed to pay," Melissa explains.

Gilbert is now 27, engaged and cancer-free for the past three years. She is monitored with MRIs every four months, less if everything is okay. "I'm alive!" Kendra says with a huge grin, "and I know more now about how people in a hospital want to be treated." She is back in nursing school, which she had to put on hold when she got sick. "It's very frustrating to be behind, but I think it will make me a better nurse,"she says.

The Gilberts want people to know about the work being done at the Burzynski clinic, and were instrumental in bringing "Burzynski, The Movie – Cancer is a Serious Business" to the Garden Theatre in Frankfort this past summer. "The event drew over 250 people, the largest group to attend a filming since the theatre re-opened," Melissa Gilbert says. "This is something we went through, but it is not about us. We want to raise the level of awareness for gene therapy as a cancer cure."

Burzynski is currently preparing for Phase III of clinical trials, 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 U.S. government currently prohibits any taxpayer money to be granted to Burzynski's FDA-approved clinical trials.

"A single Phase III trial will cost about $25 million. So how many can you run? You may run a few at best," says Burzynski in the film.

"Some other pharmaceutical companies who come with an idea, they go to the National Cancer Institute and receive a handsome grant – $15 million, whatever – and they do clinical trials. No one is giving me any money, OK?"

If Burzynski's discovery were given a fair review process, it would impact chemotherapy and radiation industry, but it would also mean that for the first time in history, all of that income would funnel away from the pharmaceutical companies and into the lap of a single scientist, who holds the exclusive patent rights.

In 2010, the fee revenue paid by the pharmaceutical industry to the FDA rose to more than a half billion dollars annually. The Pharmaceutical Manufacturers Association now pays more than $1.4 million per application for most cancer drugs submitted to the FDA to ensure a timely approval. According to the Washington Post, a 2007 health policy report sponsored by Pfizer supported the renewal of these user fees; the report revealed that the median review time for priority drugs – those for serious life-threatening diseases such as cancer, decreased from 21 months in 1993 to six months in 2004. Dozens of cancer therapies have been reviewed and approved within three or four months. Meanwhile, Dr. Burzynski, his patients, and other supportive scientists have made every conceivable effort to get the FDA to cooperate in the research, review and approval of antineoplastons since 1977. BN