Does Burzynski movie buzz come at the worst time for the FDA?

5 comments
Eddi Monzon
Eddi Monzon

Lets be clear. Dr. Burzynski has been given permission to start Phase III trials. However, it is not the ideal testing he originally requested. FDA is still requiring that the patients get treated with chemotherapy while under going the Phase III trial. This will have obvious effects to Dr. Burzynski's treatment method. Honestly, the facts line up, his patients have given permission, and FDA still plays loose with their own rules.

anarchic teapot
anarchic teapot

Burzynski may have permission to start Phase III trials, but I doubt he ever will - or if he does, nothing will get piublished, just like the 61+ Phase II trials over the last 34 years. He makes his money - millions of dollars a year - from posing as a brave maverick doctor and selling dubious therapies that only he holds patents for. It's not in his financial interest to pu_blish. Meanwhile, as patients approach the end, they're quietly sent home to die. Frequently penniless. Those who realise they've been scammed get shouted down, but Burzynski must reckon: what the hell, they'll die anyway so it's not going to make much of a difference. That the Discovery Channel should repeatedly broadcast such dangerous nonsense as a documentary and even give it an award does them no credit whatsoever.

h jones
h jones

Well said Steve Walker. Watch the movie before you decide.

laurie pederson
laurie pederson

This movie and others like it will help shine the light on this situation, share this important message, and find a way to make change. The newest compelling documentary film to feature Dr. Burzynski is CUT POISON BURN, which is a heart-wrenching look at why we are losing the war on cancer and how the FDA is in cahoots with big pharmaceutical. This story centers around the Navarro's - a family who's son Thomas was an unwilling victim in their sick war, as the one treatment that might have helped was withheld from him until it was too late. Finfd out more at www.cutpoisonburn.com - where you can order a dvd or download a copy at any price - even free.

Steve Walker
Steve Walker

Good article, with one problem. The Avastin decision was not scientific. It was judgmental and heavy-handed. Looking at exactly the same data and outcomes, the European Union retained approval, and the leading coalition of cancer doctors in the US recommended its continued use, which lead to a decision by Medicare/Medicaid to continue covering its use for metastatic breast cancer. All the trials reviewed by FDA showed that Avastin delayd progression of the disease. None of the trials, by prior agreement with FDA, were designed to measure overall survival, but that is the criterion FDA decided to use to withdraw its approval. The appeals process was controlled entirely by the FDA, with a number of serious irregularities. Avastin remains approved by FDA for several other cancers, where it has precisely the same side effects and risks, and was recently approved by FDA again for use in ovarian cancer. The FDA's decision was a rigid policy enforcement move made by the chief of the agency's cancer drug office, and it was actually very poorly supported by the science. Hamburg erred by backing him up on it. It is important to fully research and understand FDA's resgulatory decisions instead of just taking their word that what they did was based on "science." They never admit mistakes, and they never correct them. They make a lot of mistakes, and their action on Avastin was one of them. In fact, the person behind it, Dr. Richard Pazdur, Director of FDA's cancer drug office, was also involved in the suppression of Burzynski's research, and is in the movie, coming off as what he is, a prickly, difficult to deal with regulator with too much power and no respect for anyone who disagrees with his views and decisions. On the cost of Burzynski's treatment, the FDA and others did such an extreme hatchet job on his research, it has been difficult for him to fund the clinical trials needed to gain approval, so patients are left with the bill. Had the FDA and others not tried so hard to kill it, his treatments would have been tested in clinical trials by now, and if they worked, they would be approved, covered by insurance, and in additional well-funded clinical trials to test for expanded uses. It is a good thing that the real FDA is being exposed in the Burzynski movie. And don't be too quick to blame the phrama and bio industries for this. The FDA and the clinical research community (the latter being an enormous, and enormously powerful, financial special interest) are quite capable of crushing promising research on their own, and were aggressively involved in trying to crush Burzynski. Perhaps the worst result of all this is that the campaign against Burzynski prevented the research that was needed to move it forward, by many years. We can't afford that kind of nonsense with so many lives at stake. A better question would have been to ask why the FDA hasn't been investigated and dragged in front of Congress to explain itself.

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