FDA agrees to let patients get controversial drug

 

March 22, 2014

 

Dear Burzynski Movie subscribers,

 

It's been a while since I felt compelled to take the time to fact-check and correct the incorrect and incomplete work of a so-called investigative journalist, but Liz Szabo's latest article in USA Today had to be addressed.

The good news is, all the petitions and all the constant outreach to the FDA has broken new ground, for now.

 

March 21, 2014: FDA agrees to let patients get controversial drug

 

Below is a critique.
USA Today's March 21, 2014 "article" is in italic orange -- with the verifiable corrections using some basic fact-checking in black/bold:

The Food and Drug Administration has agreed to allow a handful of cancer patients to receive unapproved drugs from a controversial Texas doctor, but only if they can find another physician to administer them.


This above statement seems accurate.

***

The drugs are made by Houston doctor Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year.


USA Today conducted no investigation into Burzynski. They simply contacted all of Burzynski's opponents and gave them a platform, while ignoring everyone and everything else that would show her "investigation" to be inaccurate and incomplete. An investigation has to "investigate", there was neither in this case.

***

While his supporters consider him a medical maverick, mainstream doctors describe him as a snake-oil salesman.


What is a "mainstream doctor"? Does this mean a doctor that exclusively supports mainstream medicine? Does this mean these doctors actually looked into ANP therapy? Or does this mean all doctors Liz Szabo cherry-picked and asked while ignoring any other mainstream doctors input? You also have to ask: If you were a mainstream doctor, would you stick your neck out in support of this scientific innovation knowing that you would be met with a barrage of harassing emails, phone calls, and potentially be ostracized from your profession?

***

Burzynski has claimed for more than 36 years to be able to cure certain hard-to-treat brain tumors with drugs he calls antineoplastons.


Wrong. Dr. Burzynski doesn't "claim" anything. The peer-reviewed data found in the medical literature clearly explains the so-called "claim". We don't "claim" gravity exists, it just does. What about the countless patients cured by Burzynski? Do they get a say in this? Do they also "claim" their cancers were cured? Or, do their medical records clearly show that they were cured? Why is it so hard for a journalist to investigate a claim, vs. just saying "he claims, she claims"?


Based on this logic, apparently, the FDA also "claims" that Antineoplastons (ANP) are the first and only cures in medical history for a DIPG (which many of these kids seeking ANP are diagnosed with) by granting the first and only Phase 3 trials using ANP on a DIPG in its history.


* Source: FDA grants permission for Phase 3 ANP for DIPG: http://www.burzynskimovie.com/images/stories/Understanding/EmailFromFDA_Phase3_ANP.pdf


Why would the FDA grant Phase 3 trials for this? Did they just pull a name out of a hat and grant these trials? No, the FDA granted this permission because ANP had successfully completed Phase 1 & Phase 2 trials (Phase 1 verifies its safety, Phase 2 verifies its efficacy), and since these trials demonstrated cures of DIPG using ANP, that is why they granted permission for Phase 3 randomized trials.

This is called: "using the scientific method".

A DIPG in a child has never been cured in medical history -- why would the FDA make such a claim in this case? It's quite simple, the science proved it works and cures in many cases, and therefore the science was allowed to progress. There are no "claims" other than what can be proven. Maybe it's because the cancer industry doesn't like anyone else "claiming" anything as they own the luxury of claiming what cancer medications work or not work -- and we know how well that has worked out for us.


Sources : DIPG failures:


1. All patients died using chemo and radiation & toxic side effects were devastating:
http://www.ncbi.nlm.nih.gov/pubmed/17278121


2. All patients died using Temodar (chemo) and radiation & bone marrow was devastated:  http://www.ncbi.nlm.nih.gov/pubmed/15565574


3. The Lancet published an extensive exposé on how no progress has been made in DIPG therapy, despite numerous attempts. It also states how adding radiation to any therapy in a randomized trial for a DIPG would be unethical since radiation has never once cured a DIPG. If a hospital would agree to allow a Phase 3 trial (all of this is covered to great extent in "Burzynski: Part 2") they would be forced to add radiation to ANP therapy, doing nothing but complicate the trial itself.

*Source, read the Lancet's article
http://burzynskimovie.com/images/burzynsk/lancetreviewbrainstem.pdf


There is no reason why ANP shouldn't be placed on the market immediately for a DIPG since ANP is the first to cure it. The problem is, if it's approved for one condition like a DIPG, that means any patient can get it "off label" opening up the flood gates for cancer patients seeking ANP. This obviously cannot be allowed by the industry (the FDA is a part of this industry), and will do whatever it can to stop it. The FDA still has to give the illusion that it serves the public, which is why they are buckling in this instance.


Sources: DIPG successes:

1. 27.5% DIPG cure rate using ANP vs chemo & radiation:
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf


2. 17% DIPG cure rate using ANP:
http://www.ncbi.nlm.nih.gov/pubmed/12718563?dopt=Abstract


3. 11%:
http://www.ncbi.nlm.nih.gov/pubmed/16484713?dopt=Abstract


4. Even more:
http://www.cancer-therapy.org/CT/v5/B/PDF/42._Burzynski,_379-390.pdf

***

The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer.


The above links are examples definitive published evidence. Notice how this writer links to a PDF highlighting her point, vs. the National Cancer Institute (NCI) website itself. Is it perhaps because on the NCI website it clearly says:

"A phase II study also conducted by the developer [Burzynski] and his associates at his clinic reported on 12 patients with recurrent and diffuse intrinsic brain stem glioma. Of the ten patients who were evaluable, two achieved complete tumor response, three had partial tumor response, three had stable disease, and two had progressive disease. Patients ranged in age from 4 to 29 years."

The NCI felt its own source to be "definitive enough", why not Liz?

*Source:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5#Reference5.12

 

*One thing that they always fail to acknowledge, is the overwhelming prejudice against Burzynski and ANP among the highest peers of the cancer profession. It's one thing to say "he hasn't published his data", which he has extensively... and it's another to say "not one of the big journals will allow him to publish his data."

Take the most recent Lancet submission, from Phase 2 trials treating Glioblastoma (GBM) Brain Cancer with survivals up to 16 years. The prestigious Lancet did not even bother to read the submission, and rejected it outright due to sheer prejudice, only 2 hours after it was submitted.

READ THE REJECTION FOR YOURSELF HERE.

So ask yourself, is that a demonstration of objective science, or is this discrimination against competing science that has the potential to reduce their paychecks, and force them to later say "we were wrong"?


If The Lancet accepted this paper, all the establishment's cancer websites would be forced to change, and The Lancet would be roundly ridiculed and attacked for simply adhering to the scientific method.

(If the facts are mutable based upon the needs of the moment, then science is dead. We might as well pack up and give it up because there is never going to be any honest reporting about what experimentation shows.)


As for no randomized trials being published, the Japanese have finished a 27-year study, ending with randomized studies showing double survival rate in the ANP group, and the Japanese didn't even give the patients the traditional ANP infusion, they only gave injections and oral forms of ANP. These trials are up for publication, and were covered extensively in "Burzynski: Part 2". Liz Szabo of USA Today wouldn't dare mention that.

***

Burzynski has been unable to give these drugs since 2013, when the FDA placed his experiments on hold after the death of a 6-year-old New Jersey boy taking antineoplastons.


This is accurate. Though since no child has ever lived through a DIPG diagnosis outside of ANP, why is this a surprise that anyone has died from this diagnosis?

***

In December, the FDA sent Burzynski a warning letter, noting that he inflated his success rates and failed to report side effects and to prevent patients from repeatedly overdosing. The Texas Medical Board also charged Burzynski last year with false advertising.


This is nothing new. The FDA and the Texas Medical Board work tirelessly to try to destroy Burzynski, and have been doing so since the 1980s. Yet, all legal actions and otherwise have failed, because none of the legal actions against Burzynski have been based on fact or verifiable evidence. Judges and juries can usually smell this "B.S.", and so far have done so in Burzynski's case.

***

None of that has deterred a group of eight families whose loved ones are suffering from incurable brain tumors and who would like to try Burzynski's patented therapy. Those families include the parents of 12-year-old McKenzie Lowe of New Hampshire; the parents of 6-year-old Refael Elisha Cohen of Texas; and 47-year-old Liza Cozad-Lauser of California.

All contacted the FDA to ask for "compassionate use" of antineoplastons.

The FDA acknowledged Friday that it has agreed to allow them to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an "investigational new drug," as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials.


This is going to be a challenge. The FDA has simply passed the buck on this one. If a patient wants ANP now for a DIPG, they have to find an oncologist to first file for the "IND", which can takes weeks or months to complete, the patient could die waiting for this paperwork to be completed. Second, the patient is no longer allowed to even consult with the Burzynski Clinic, instead, an oncologist with no experience administering the drug has to set up each patient for the whole duration. Then, you add to that the constant barrage of lies and propaganda (much like this USA Today article and the previous articles published by them on this subject) placing further unease on the part of the oncologist who is going to be intimidated by his/her peers and pressured not to take part in helping these patients. It will take a very courageous set of oncologists to step into the line of fire they will receive for following the Hippocratic Oath.

I will say now for the record, if one of these patients manages to get all the permissions and overcome all the obstacles needed to gain access to ANP, and they are cured as a result -- you will not see a single mention of this cure by this USA Today writer or anyone else in the mainstream press. But if one of them dies, USA Today and others will exploit that to no end.

***

The FDA grants an average of more than 1,000 requests a year for expanded access.


Burzynski will supply antineoplastons for free, says his attorney, Richard Jaffe.


This certainly debunks any claim of Burzynski being a greedy snake oil salesman. Why would a greedy con man allow his medications to be given away for free, under the hands of an oncologist he has no relationship with?

***

While Cozad-Lauser has found a doctor willing to administer the antineoplastons, McKenzie's family members say they have contacted dozens of doctors, but have been unable to find a qualified oncologist to agree to participate.


"I'm an adult. I should be able to make this decision," says Cozad-Lauser, who was diagnosed with an inoperable brain stem tumor, diffuse intrinsic pontine glioma, or DIPG, 18 months ago. Although the tumor is diagnosed in 200 to 300 people a year, there are few long-term survivors. "My own government is telling me I can't choose a medicine. I should have the right, when there is no standard of care available to me and every doctor had told me I have no chance of survival."


Rocker Sammy Hagar has come out in support of Liza Cozad-Lauser recently [link].

***

Refael's family posted an update on their Facebook page, asking friends to help them find a doctor in the New York area, where the child is in the hospital. Because Refael is in a coma, however, he's unlikely to benefit from antineoplastons, says attorney Antonio Martinez, a lobbyist working with the ANP Coalition, a group advocating for antineoplaston access.

 

Rafael's family had 102K signatures on a White House petition, originally denying this child to gain access to ANP [link].

***

"It's the FDA's job to protect the public, but when does the FDA's authority go too far?" asked Martinez. Addressing Refael's case, he asks, "Why couldn't they (the FDA) have allowed him to try ANP six months ago? Now, he has almost no chance."


McKenzie's grandfather, Frank LaFontain, says he hopes to get treatment for his granddaughter, who has had chemotherapy and radiation, while she's still healthy. Today, he says, "she runs, she plays basketball for her school, there's no stopping her. She just keeps going."


McKenzie's online petition has garnered almost 70K signatures [link].

***

Burzynski has attracted a large following over the years from supporters of alternative medicine and critics of the FDA, with whom he has often done battle. A new study in JAMA Internal Medicine finds that about half of Americans believe in medical conspiracies, such as the notion that government and industry are hiding cures from the public.


Nothing has become a more misused term than "conspiracy theory". What exactly is a conspiracy theory? Well, in order for a "conspiracy" to occur, it would entail more than one person "conspiring" to commit an unethical or illegal act. A "theory" is something that is theoretical and can't be proven." So is it a "conspiracy theory" that the medical establishment has made every attempt at blocking the scientific progress of ANP? Can this be proven as fact or is it just a wild theory? I'll let you figure than one out on your own :)

I love how writers like Liz Szabo think they live in a world where conspiracies have never existed. That whole ENRON or Vioxx thing -- those were just "conspiracy theories" too, right Liz?

***

Others have been critical of the FDA's tolerance for Burzynski.


This is a matter of perspective. I don't see how the FDA has been remotely tolerant of Burzynski. If they were, ANP would have been approved for a DIPG years ago by the FDA, instead of the FDA proudly sentencing kids to die at the FDA's hands, and having to deal with these new near unobtainable hurdles by the FDA. I can't for the life of me see how anyone could say the FDA has been tolerant of Burzynski in the least. Particularly since the FDA tried to throw him in prison for the rest of his life while simultaneously trying to steal one of his patents!

*Sources: http://burzynskimovie.com/index.php/transcript/chapter-9

Perhaps those whose egos and bottom lines that are threatened, or those who have zero education on the ANP subject are the most critical, which brings us to our next debacle:

***

"I have no idea why the FDA would do this after finally showing signs of doing its job with respect to Burzynski," says oncologist David Gorski, whose blog, Respectful Insolence, has long been critical of Burzynski. "It's a major propaganda victory for Burzynski."


A guy who is paid to write blogs attacking this innovation and other innovations that compete with the status quo, a guy who has never once met a Burzynski patient, never once visited the Burzynski clinic, a guy who supposedly finished his residency and now writes "thought police" blogs for a living -- yeah, let's hear more about what this guy has to say, that's productive. He does fit the angle for Liz's one-sided propaganda, so I understand why she included his irrelevant opinion.


* Source (and this is only what has been made public):
http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/

***

In a statement, the FDA says the agency has a duty to protect patients from unproven products that could do more harm than good.


I'll let you judge that one for yourself.

***

"Patients, including those who are terminally ill, deserve this protection when taking a product that has not been found to be safe and effective," the FDA said in its statement. "We recognize that there is a range of opinion about the extent to which individuals should be able to decide for themselves how much risk they are willing to tolerate from an experimental therapy."


So, in the end, the idea of having "freedom" to choose your cancer therapy once your are diagnosed, that's still open for debate according to the FDA.

However, if you want ANP... that is a freedom you do not have the right to choose. Not to mention that the only two drugs on the market for brain cancer, Temodar and Avastin, have also not been found to be safe and effective to fight brain cancer. Where are all these "safe and effective" options the FDA is going on about, if there hasn't yet been a "safe & effective" option for brain cancer to date in the first place? Not to mention that neither Temodar or Avastin had to complete a multi-arm randomized study before reaching the market for brain cancer - nor did either of these drugs cure a single patient before being placed on the market.

Source (time code starts at 1:08:25): https://vimeo.com/69209285

***

Richard Saunders, whose daughter Amelia was treated by Burzynski, says he welcomes the FDA's decision. Amelia, from the United Kingdom, died of cancer at age 4, in 2013.


I remain close friends with Richard Saunders and his lovely wife since the making of "Burzynski: Part 2". Contrary to the lies and distortion put forth by the paid blogger mentioned above, they had no issues with how I handled their case while making the film. The Saunders family went into this with open eyes, and tried the only possible option on planet earth that could have helped their daughter Amelia. Very tragic and sad for everyone, Amelia wasn't one of the lucky ones to respond to ANP therapy.

***

"If there is any way for patients to get access to antineoplastons, and have the choice to do so — but under controlled, professionally guided circumstances — then that has to be a good thing," says her father, Richard, who wrote a book about his experience, called Saving Amelia


That seems to make logical sense. After all, it is quoted from a person who actually had first-hand experience with this.

***

Some doctors and patient advocates say they're disappointed by the FDA's decision.


Tina Cowles, whose husband died of lung cancer after being seen by Burzynski in 2012, says antineoplastons may deserve further study. But she's glad that it won't be done by Burzynski.


I am unfamiliar with this case, but since it was a lung cancer diagnosis, and ANP is not allowed to be given to any patients except brain cancer patients since the late 1990s by the FDA, it's hardly relevant to the ANP question.

***

"I would agree with not letting Burzynski anywhere near any cancer patient," says Cowles, who said she felt "duped and disappointed" after going to Burzynski's clinic. "He strikes me now as egotistical and paranoid. And oh, what a financial empire he as built on the backs of the desperate and dying."


Hardly a financial empire can be built when you have to give the medications (ANP) away for free.

***

Jan Buckner, chair of oncology at the Mayo Clinic in Minnesota, says he wouldn't advise patients to take antineoplastons.


"There have not been well-conducted studies that demonstrate efficacy of antineoplastons for patients with any malignancy," says Buckner, who tried to conduct a rigorous clinical trial of antineoplastons in the 1990s, until Burzynski withdrew support for it. "There are known toxicities. Since there is not clear benefit, I would not advocate treatment with antineoplastons outside the setting of a well-designed clinical trial."


Ah, Dr. Buckner and the non-existent NCI trials. What is most astonishing about these "trials" were, they weren't trials at all. Yet they were published in the literature as ANP failing to work. Their own paper admits they didn't administer Antineoplaston A-10 at all, as well as extremely low levels of Antineoplaston AS2-1.

These trials were pseudoscience in the name of orthodoxy, to oppose pseudoscience while protecting orthodoxy.

This has been covered in great extent in "Burzynski Part 1", and how they didn't even administer proper doses, or any doses of ANP, and how when Burzynski realized it, he pulled out of the trial. Then, Buckner and the rest published these nonexistent trials as "proof" that ANP doesn't work.


*Source: http://burzynskimovie.com/index.php/transcript/chapter-8

*Source (starts at time code 1:18:25): https://vimeo.com/24821365

***


Oncologist Howard Ozer says he's disappointed that the FDA is allowing patients to take antineoplastons outside of a rigorous clinical trial.


"This is a cop-out," says Ozer, director of the University of Illinois Cancer Center, who studied Burzynski's research results in the 1990s.


Who is this guy? Where is his alleged "research"? Why not ask someone else who also studying Burzynski's research in the 1990s who was working at the National Cancer Institute (Dr. Chen), in the same lab as Dr. Dvorit Samid who tried to steal one of the patents - sanctioned by the NIH & FDA itself?


*Source (starts at timecode 1:20:00, Dr. Chen): https://vimeo.com/24821365

***


"Because it can be toxic and cause life-threatening sodium problems, patients (who take antineoplastons) are at risk and could die," Ozer says.


This statement continues to rise to the surface with zero evidence to back its claims. All evidence points toward it being safe, gentle and nontoxic. Yet, forgetting about how chemotherapy and radiation cause side effects spanning pages and pages long. The administration of ANP hasn't changed since the 1980s, why not see what a brain cancer expert has to say about its toxicity in a court of law under oath?


*Source (pg 13 of PDF, pg 122 of document): http://www.burzynskimovie.com/images/stories/Understanding/93_5_24_Patronas_Burzynski.pdf

***

 

The scientific community will learn nothing by giving these patients antineoplastons, because there will be no comparison group, Ozer says. Any doctor who agrees to give antineoplastons could be biased in favor of them, which could skew the results.


(Go back and read that statement one more time).
So what Ozer is suggesting is, a doctor in favor of ANP might be able to magically create a cancer cure for a DIPG when it's never been cured before in history? Does this mean science is irrelevant and since doctors can skew cures and magically make cures happen by just "supporting ANP" -- these patients might be cured? Well, if that's the case, I guess we need to learn whatever magic it is these doctors are doing -- if just "thinking about and supporting ANP" is enough to cure a person… who needs ANP, chemo, or anything else at all? Maybe we've been doing this all wrong! Please share more of this wisdom with us Ozer!

***

Oncologist Henry Friedman says the FDA made a savvy political decision in granting compassionate use of the drugs.


"It will deflect criticism from anybody who says the FDA is unilaterally denying dying patients something that could help them," says Friedman, deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University in North Carolina, who also reviewed Burzynski's studies in the 1990s. "It will get FDA off the hook."


I've spoken at great length to Henry Friedman, he is just as scared as any other high profile oncologist of ANP getting out into the world, as he and all of his peers will be forced to admit they were wrong all these years. Dr. Friedman was also Senator Kennedy's oncologist, who had a Glioblastoma (GBM) just like James Treadwell, Laura Hymas, and countless other ANP patients who once had a GBM. What happened to Senator Kennedy's GBM under Dr. Friedman's hands?

***

 

Burzynski declined to comment.


Good for Burzynski, why bother.

***


Sandy Smith, who took her son Andrew to see Burzynski, says she approves of the FDA's decision, because it could allow scientists to learn if antineoplastons have any value.


"With true science, if something is working, then someone else should be able to come up with the same results," says Smith, a breast cancer survivor from Michigan, whose son died of a DIPG at age 8 in 2009.


Smith says she felt misled by Burzynski, who seemed to wash his hands of their case when her son developed complications. Their family spent $24,000 in two weeks at Burzynski's clinic — more than her husband, the minister at a small church, makes in a year. They paid Burzynski's fees with donations from other churches.
Smith says the FDA plays an important role in protecting vulnerable families from opportunists who prey on people suffering from life-threatening diseases.


"We can't just have a free-for-all where everyone feels entitled to do anything and there is no consideration of safety," she says.


Yet Smith says she can understand the desperation of families.


"I wish it were easy to say, 'This doesn't work. Don't waste your time on this,'" she says. "You don't want to take away someone's hope."


Well, no one can please everyone, and every patient's case is different. If we documented every patient's "bad experience" within conventional cancer centers, the stacks of paper would be enough to wrap around the earth several times and perhaps to the moon and back.

(End of the critique and fact-checking of USA Today's "FDA agrees to let patients get controversial drug", by Liz Szabo -- feel free to copy/paste this page into the comments section of this March 21, 2014 article)

 

***

-------------------------------

 

BURZYNSKI: CANCER IS SERIOUS BUSINESS, PARTS I & II


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