Transcript - Chapter 5 of 10 - NCI & FDA Intro
28:48 - 34:57 - Interactive sourced transcript
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 dreaded 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.
Dr. STANISLAW BURZYNSKI - on camera interview:
A single Phase 3 trial will cost about twenty-five million dollars. So how many can you run? You may 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, like working somewhere in the Gaza Strip or the West Bank—when the bombs are falling, we still have to treat patients, and we still have to do Phase 2 clinical trials.
ON-SCREEN TITLE CARD:
National Cancer Institute annual budget: $5,200,000,000. [SOURCE: NCI]
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.
Dr. JULIAN WHITAKER - on camera interview:
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. [SOURCE: ACS]
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.
ON-SCREEN TITLE CARD:
PhRMA: New Medicines. New Hope.
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. [SOURCE: Fortune 4/30/07 Company Annual Reports] [Time Mag 2004]
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 it’s 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...
NARRATOR (reading along with highlighted portions of a Boston Globe article):
... 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. [SOURCE: Boston Globe 2007]
NARRATOR (reading along with highlighted portions of the FDA’s Prescription Drug User Fee Rates for Fiscal Year 2010):
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 $1.4 million, per application, for most cancer drugs submitted to the FDA—to ensure a timely approval. [SOURCE: FDA PDF pg 1]
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. [SOURCE: LA Times 2000] In a 2007 health policy report, sponsored by Pfizer, supporting the renewal of these user fees, they revealed...
NARRATOR (reading along with highlighted portions of a George Washington University’s Health Policy Response Project, co-authored by Pfizer):
... 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. [SOURCE: G Washington/Pfizer Report PDF pg 3]
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.
"Burzynski" Director releases 3rd film (2014)
Chapter 4 & 5 - (22:10-34:57)