The following documentary is a MUST-SEE for everyone! I have yet to see anything so fully documented that exposes the extraordinary measures that the FDA will resort to in order to ensure that cancer remains the killer that it is, and that Chemotherapy remains the torture-chamberous non-curing treatment that it is. Not to mention, this film, in addition to detailing the FDA's 14 year campaign to remove Dr. Stanislaus Burzynski, who found a cure for cancer, from society, also reveals the battle Dr. Burzynski had with the National Cancer Institute, who is just as bad.
"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."
It comes to no surprise to most of us that the median annual American pharmaceutical company profits triples the median annual profits of all of the Fortune 500 companies. But, how does Big Pharma maintain these astounding profits? Well, through its gatekeeper: the FDA, and the National Cancer Institute.
"Big Phama" didn't manifest overnight. It was an ongoing process that started in the 1970s and 1980s. At the time, profitability of the pharmaceutical industry was two times greater than the median of all industries in the Fortune 500. In the 1990s, when the
Prescription Drug User Fee Act (PDUFA)-
which authorizes drug companies to pay "user-fees" to the FDA for each brand-name drug considered for approval, greatly speeding up the approval process - kicked in, the drug industry's profitability grew to almost four times greater than the median for all industries in the Fortune 500.
After the PDUFA was enacted, the part of the FDA that reviews new drugs received more than half its money from user fees and it grew by leaps and bounds. Meanwhile, the part of the FDA that monitors safety, ensures manufacturing standards, and checks ads for accuracy deteriorated. Not only that, the approval process for brand-name drugs shortened to 3 months, from its previous 21 months. Yet, here it is 2011, and Antineoplaston Therapy has been waiting approval since 1977.
On June 21, 1977, Dr. Burzynski's attorney's investigated both state and federal law to find out if it was legal for him to start his own biomedical research company to make the Antineoplastons (non toxic cancer treatment) and administer them to patients within his private practice. He found out it was legal as long as he avoided interstate commerce.
However, it was not soon after that Burzynski's patients found themselves harassed by the
Texas State Board of Medical Examiners(TMB) to file charges against their doctor, and the FDA started its witch hunt.
In 1983, the FDA obtained an injunction from a federal district court prohibiting Dr. Burzynski and the Burzynski Research Institute from shipping antineoplastons in interstate commerce without first obtaining the approval of the FDA. The injunction, however, did not preclude intrastate distribution of the antineoplastons.
On July 28, 1986, the TMB began investigating Dr. Burzynski, even though no formal complaint had been filed, and on November 18, 1986, a notarized agreement between Burzynski and the TMB was created requiring the doctor resent a list of 40 successful cases. He submitted double that number. He never heard back.
On September 6, 1988, the TMB convened a hearing to decide whether or not to revoke Burzynski's medical license.
Texas State Board of Medical Examiners vs. S. Burzynski
Dr. Burzynski faced numerous battles with the federal government over the years. Between 1986 and 1994, he was subjected to three federal grand jury investigations. No indictments were ever handed down. However, during that time federal officials raided his research clinic and confiscated his patients' medical records.
Then in March 1995, Dr. Burzynski appeared on the CBS TV show "This Morning," accompanied by three of his patients. That very afternoon, the FDA raided his clinic again. A fourth federal grand jury investigation got underway, and by November 1995, charged Dr. Burzynski with 40 counts of distributing a non-FDA approved drug in interstate commerce, 34 counts of mail fraud, and one count of contempt of court for violating the order against interstate delivery of Antineoplastons. Rep. Joe Barton (R-TX) noted that a grand jury's failure to indict someone after three attempts is "virtually unprecedented."
On February 9, 1996, US District Court Judge Sim Lake ruled that Dr. Burzynski cannot treat patients outside of clinical trials. In other words, he issued a death sentence for hundreds of Dr. Burzynski's patients.
This prosecution marked the first time the FDA had tried to jail a scientist for using a drug on which he was conducting FDA authorized clinical trials. This trial alone, which was not even based on whether or not antineoplastons work or not cost the American taxpayer $60 million, while costing Dr. Burzynski over $2.2 million!
On March 4, 1997, due to a dead-locked jury, a mistrial was declared.
The FDA still did not back down. A second federal trial got underway May 19, 1997 to try Dr. Burzynski on the contempt of court charge. A federal jury acquitted Dr. Burzynski on May 27, 1997.
At the same time, Dr. Burzynski was fighting the Texas Medical Examiner's Board and the FDA, the National Cancer Institute, under Dr. Michael Friedman, tried to co-opt his discovery and render it ineffective.
A former employee of Dr. Burzynski, Dvorit Samid, betrayed him when she partnered with Elan Pharmaceutical through her employment with the National Cancer Institute and tried to hijack Burzynski's discovery. The problem was that she used only one component of the antineoplaston, phenylacetate, which when isolated, has very little clinical effect.
When that didn't work, the National Cancer Institute said they would accept Dr. Burzynski's antineoplastons; however, only if they could revise the protocol that Dr. Burzynski had perfected. Burzynski refused. The NIC threatened with patent infringement. Finally, they came to an agreement. Yet, within a very short time, in March 1995, the NIC tried to drastically alter Burzynski's protocol to make his treatment less effective!!
Four years after the NCI trials were closed and two years after Burzynski defeated the FDA, winning his freedom, the NCI, in February of 1999, decided to vindictively publish the scientifically invalid Antineoplaston trials in peer-reviewed medical literature. However, whoever published the invalid trials forgot to leave out the dosage, which in some patients was 2.7 times lower than the protocol demanded, and in other patients, 36 times lower, and, in even other patients, 170 times lower!
Li-Chuan Chen, PhD, who worked as a scientist for the National Cancer Institute from 1991-1997, said that when the NCI or assigned entities conducted trials on alternative cancer therapies they always altered the protocol and let it fail in order to discredit the therapy. He went on to say, "Scientists never look at it carefully, because as he says,
Popeye is telling you something and you don't question him...under the capitalist sun, there is nothing sacred."
Here's the kicker. On October 21. 1991, the United States of America as represented by the Department of Health and Human Services, along with "Inventor": Dvorit Samid filed a patent for Antineoplastons. On October 12. 1993, the US and Dvorit Samid file for a second patent on Antineoplastons. And on March 7, 1994, the US and Dvorit Samid file its most comprehensive patent spanning 111 pages. Seven months later they file a fourth one. On 6/6/1995, the US files its 5th, 6th, 7th, and 8th extended patent. The next day, the US files its 9th, 10th, and 11th patent. A few months later, Dr. Michael Friedman leaves his position at the NCI and becomes Deputy Commissioner of Operations for the FDA, working directly under Dr. David Kessler.
In the three years (1997-2000) after Dr. Burzynski was indicted, all of the US patents for Antineoplastons were approved. However, one paragraph within these patents, in particular, is quite revealing:
Since 2009, the only obstacle in the way of Antineoplasmons is the $300 million pricetag on the final phase of FDA clinical testing...and the FDA's requirement that children with inoperable brainstem glioma to also under go radiation treatment in these Phase 3 trials, claiming it would be unethical to do otherwise.
Links:
Big Pharma Deals to Preserve High Drug Prices Skyrockedted in FYI 2010
The Truth About Drug Companies by Marcia Angell
Pay-For-Delay: How Drug Company Pay-Offs Cost Consumers Billions
Families USA
Bush Administration Back Pharmaceutical Industies Over the Needs of Millions of Senior Citizens
Read more...
