I don't know if it's a sign that I've arrived as being a bit more influential than just a blogger or just dumb luck when reporters start sending me things, but I'll take it. It's like blog fodder being served to me on the proverbial silver platter. Unfortunately, as a result of receiving a press release, FDA Denies Treatment to Two Terminally Ill Young Women, from two different sources, after yesterday's hilarious (if I do say so myself) bit of fun with a certain woman who fancies herself a "Thinker" when everything she writes shows that she is anything but, I find myself tackling a much more serious topic that elicits in me a complicated mix of outrage and sadness because it involves corrupting the most noble impulses of the human spirit by yoking them to the service of a man who deserves none of it at the expense of dying cancer patients. Did I say "dying cancer patients"? Given that I did, you know of whom I speak. Yes, it's Stanislaw Burzynski yet again. Truly, Count Stash is very much like what his heavy Polish accent reminds me of: A vampire who, no matter how many times you shoot or stab him (unless it's with a wooden stake through the heart), always rises again. I had hoped that Liz Szabo's excellent USA TODAY cover story about Burzynski in November might have been that stake, but unfortunately it appears not to have been.
As I've been documenting since before the Christmas holidays, patients with deadly brain tumors, both children and adult, have been putting themselves into the news in the service of trying to get the Food and Drug Administration (FDA) to lift its partial clinical hold on trials of Burzynski's "wonder drug," antineoplastons (ANPs). Those of you who've followed this story will recall that, as the result of a death of a child named Josia Cotto in June 2012 due to hypernatremia (too much sodium in the blood, a known complication of ANP therapy), the FDA put a partial clinical hold on Stanislaw Burzynski's clinical trials. Later, in January 2013, the FDA showed up at the Burzynski Clinic for an inspection and expanded the partial clinical hold to include adults. Now, to review briefly, a partial clinical hold means that Burzynski can keep treating the subjects already enrolled in his ANP clinical trials but cannot enroll any new subjects to those trials. The trials are, in essence, closed to accrual. That's why, beginning around Thanksgiving and continuing until now, there has been a concerted effort to try to reverse that situation. The Burzynski Clinic was very much built on the idea that he had a "natural" and "nontoxic" therapy (ANPs) that could cure incurable brain cancers. Without that concept, he was in trouble.
Burzynski's cynically jumping on the bandwagon of "personalized medicine," arrogant to the point of proclaiming himself a "pioneer" in the field of genomic medicine, by offering what he has referred to as "personalized gene-targeted cancer therapy" but what I refer to as "making it up as you go along." Unfortunately for Stash, this involves nothing more than using a commercially available gene test and then using its results to pick a cocktail of very expensive targeted chemotherapy agents from big pharma, which doesn't really sit too well with the "natural" crowd. Besides, the only difference between what Burzynski is doing and what, say, M. D. Anderson is doing is that Burzynski clearly doesn't know what he is doing and M. D. Anderson does. Moreover, poor Burzynski doesn't offer anything that any "brave maverick" oncologist couldn't offer. There's nothing unique in his "personalized, gene-targeted therapy." Given the choice of going to M.D. Anderson, Memorial Sloan-Kettering, or any number of cancer centers doing cutting edge genomic research in cancer or Burzynski's Houston office building, where are you going to go? It's no wonder Burzynski is floundering without ANPs. ANPs distinguished him from the pack, let him claim to have something "natural" that no one else had (never mind that he chemically synthesized ANPs in his manufacturing facility). Also unfortunately for Stash, selling an existing drug as a "prodrug" for ANPs apparently wasn't selling much better, either.
All of this is likely why a group known as the ANP Coalition was founded by a man, Ric Schiff, who is on the board of directors of the Burzynski Research Institute. It's why groups like the Alliance for Natural Health USA (ANH-USA) have tried to smear Liz Szabo and use patient stories to try to tug on the heartstrings of its members to the point where they will write their legislators to put pressure on the FDA to lift some of the restrictions on ANP use by allowing compassionate use exemptions for ANPs for patients with horrible tumors, people like a young Jewish boy in Houston with a medulloblastoma (an aggressive tumor of the brain) named Raphael Elisha Cohen, a twelve year old girl named McKenzie Lowe, who has a diffuse intrinsic brainstem glioma (DIPG), and Liza Cozad, the wife of the drummer in rock star Sammy Hagar's band, Liza Cozad, who also has a DIPG. It is Liza Cozad and McKenzie Lowe who were the subject of the press release from ANH-USA sent to me, which I will reproduce in full in case it goes down the memory hole:
McKenzie Lowe, age 12, and Liza Cozad Lauser, age 46, are both battling diffuse intrinsic pontine glioma (DIPG), a type of cancer that attacks the brain stem. There are currently no effective, FDA-approved treatments for this disease. The one option that has shown promise, antineoplastons therapy, is being denied them by the US Food and Drug Administration.
“Antineoplastons, which are peptides and amino acid derivates that activate tumor-suppressing genes, have shown tremendous potential in battling DIPG,” explained Gretchen DuBeau, executive and legal director of the Alliance for Natural Health USA (ANH-USA). “It is quite literally the only effective tool available to fight the disease, but in both these cases the FDA is preventing their use of the therapy. These young women have applied for Compassionate Use Exemptions, but neither has been granted permission to begin treatment,” DuBeau said.
The “Compassionate Use” or “Single Patient Protocol” exemption via the FDA’s expanded access rule allows for the case-by-case use of an experimental or unapproved drug outside of a clinical trial. To qualify, applicants must prove that they have a life-threatening condition; that no other treatment exists; and that the treatment offers no more risk than the disease. “Both candidates meet all these criteria,” DuBeau noted, “yet the exemptions are being withheld.”
The FDA’s denial has evoked a media uproar and a groundswell of support for the women. Senator Kelly Ayotte (R-NH) sent the agency a personal letter requesting that the FDA grant Ms. Lowe’s exemption. Two online petitions have garnered over 80,000 signatures asking the White House to intercede and pressure the agency to grant the exemptions.
“In addition,” DuBeau said, “ANH-USA forwarded over 26,000 letters to Congress from its members, asking that action be taken. And Sammy Hagar, former front man for Van Halen, is hosting a rock legends concert on February 12 to raise money and awareness for Ms. Lauser, who is the wife of his drummer, David Lauser.”
Lauser told reporters, “Why would you withhold something that would give her a chance?”
“Given the aggressive nature of this disease,” DuBeau explained, “the FDA’s failure to act swiftly to grant exemptions to these young women is seriously jeopardizing their ability to fight the cancer that has invaded their bodies. But since the FDA is not required to respond in any particular time frame,” DuBeau said, “there are no guarantees that an answer will come in time.”
The same misconceptions behind Burzynski's ANPs that were in the last set of press releases by the ANH-USA are there again, the most important of which is the flawed central premise, that ANPs are the only things that could give Lowe and Cozad a chance at survival. Sadly, because, despite the roughly six dozen phase II clinical trials Burzynski registered, only one of them has been completed, and that trial's final results remain unpublished. Indeed, there is no significant difference between the press release above and the press release issued January 6 about—you guessed it—Liza Cozad and McKenzie Lowe. The only difference is that press release was more detailed about Cozad's and Lowe's condition, and this one updates the efforts going into trying to pressure legislators to petition the FDA to do something that the FDA should never do: Compromise science and patient safety for political considerations.
I realize that these two people, one woman, one girl, are in a horrible situation. They have unrelenting, currently incurable disease. The problem is this. There is no evidence that Burzynski can do any more for them with his ANPs than conventional medicine can with science- and evidence-based palliative care, and there is plenty of evidence that ANPs are not benign drugs. Arguably, they are even more so than some commonly used varieties of chemotherapy. Burzynski likes to claim that no one has ever survived DIPG, but that claim is simply not true. Survival is rare, but certainly not unprecedented. So, absent the results of properly designed and conducted clinical trials, properly reported, there is simply no evidence to support Burzynski's claims other than the odd case report and small case series from the larger phase II trials, none of which are particularly convincing. Indeed, even his latest attempt at scientific relevance, poster presentations at the Society of Neuro-Oncology meeting last December showed some pretty abysmal results.
Perhaps the most infuriating aspect of this effort by ANH-USA and the ANP Coalition is one that I almost have to laugh at. Do you remember how the ANH-USA tried to claim that USA TODAY was running a "smear campaign" against Burzynski, based on Liz Szabo's expose? It was a ridiculously over-the-top lie, of course, but it comes across as even sillier given the article I saw in USA TODAY just last night, Sammy Hagar: Drug lobbyist (Really), which really should shatter any notion that there is some vast pharma-controlled conspiracy at USA TODAY to crush the upstart Burzynski because he's too close to the cure for cancer:
In the “Not Something You See Every Day” category, former Van Halen frontman Sammy Hagar is leading a group of other hard rock musicians in a campaign to get the Food and Drug Administration to approve an experimental treatment for a friend’s brain cancer.
In a letter sent at the end of January to FDA’s Center for Drug Evaluation and Research, Hagar and pals ask the agency to allow Liza Cozad-Lauser to have access to “an experimental treatment involving the use of antineoplastons.”
Cozad-Lauser is the wife of Hagar’s drummer, David Lauser, and the other signatories on the letter share the heavy metal connection: Van Halen drummer Michael Anthony; bassist Jack Blades of Night Ranger and guitarist Joe Satriani, who has played with a range of bands including Deep Purple.
I'm not a huge fan of Sammy Hagar's music, although I did like some of the stuff he did with Van Halen and some of his solo work, but I do have to say: He sounds like a straight up guy trying to do what he thinks is the right thing. Unfortunately, unbeknownst to Hagar, his altruistic impulse has been partially placed in the service of a cause that will harm cancer patients, his friend's wife included. Raising money for his friend's wife is good. Raising money and "awareness" among his fans to petition Congress in favor of Burzynski is not. The problem is that, while raising money for his friend's wife is a good thing, that good thing becomes very tainted if the purpose of the money raised from his concert tonight is to lobby Congress to pressure the FDA or even change the law. It's very easy to understand wanting to help a bandmate's wife, but unfortunately Hagar's desire to do good has been yoked to a cause that will, if he succeeds, harm cancer patients who are drawn into Burzynski's orbit. Worse, it's clear that Hagar and his friends have been fed the party line by someone associated with Burzynski. Just look at this statement issued by Hagar and friends:
“We are aware there are differences of opinion within the medical community regarding the efficacy and potential of antineoplastons in treating patients afflicted with this illness,” they write. “We are not asking the FDA to take a side in this debate. We are writing to simply urge that Liza be allowed to receive the treatment she seeks while research on the potential of antineoplastons for potential widespread use continues.”
No, there really aren't "differences of opinion within the medical community regarding the efficacy and potential of antineoplastons" against cancer, unless you define "difference of opinion" as Burzynski and his acolytes versus every other oncologist and oncology professional organization. Hagar has, sadly, fallen for the manufactroversy. ANPs have already been researched and judged almost universally by anyone who's looked at them besides Burzynski and a Japanese researcher not to have significant potential against cancer. Worse, if the FDA were to allow a compassionate use exemption for Liza Cozad Lauser and McKenzie Lowe, then there would be no valid reason for it to refuse a compassionate use exemption for anyone that Burzynski could produce with a terminal cancer. He'd be back in business again, no pesky need to publish those clinical trials he's already claimed to have done, no need to enroll more patients on clinical trials. That alone would be reason enough, but, as much as Burzynski drones will try to paint me as cold and heartless, I'm thinking of Liza Cozad and McKenzie Lowe. As hard as it is for their families to accept, they would be better off not going anywhere near the Burzynski Clinic. Burzynski will treat them, and they will spend a lot of time with portable infusion pumps, ports, IV medications, and the like. In the end, they will likely suffer a significant decrease in the quality of their remaining life, with no evidence that choosing ANPs will prolong it significantly.
What's clear to me is that Burzynski is trying to do what worked for him the last time his back was against the wall, in the 1990s: (1) rally the base by appearing on quackery-friendly radio shows (now usually podcasts) claiming oppression and firing Godwins at his enemies (oh, look, he just did it a couple of days ago); (2) tug at the heart strings with cancer patient anecdotes like this entirely credulous one recently published, Dartmouth dad appeals to FDA to renew son's tumor treatment (even Hannah Bradley and Pete Cohen recorded a video in support of the effort); (3) recruit celebrities like Sammy Hagar and Joe Satriani; and (4) try to pressure individual Congressional representatives. It's even worked with Sen. Kelly Ayotte (R-NH), and, although I haven't been able to locate the letter to the FDA from her, I'm told that it's worked with Sen. Jeanne Shaheen (D-NH).
There's little doubt at the moment that Burzynski is in trouble. I've heard rumors that, when put together with other sources to which I have access, paint a picture of a clinic in big trouble due to a large drop in patient volume. The Texas Medical Board is on his case again. The FDA, for now at least, shows no signs of loosening up its partial clinical hold on ANP clinical trials. As bad as his situation is, though, Burzynski could still potentially turn it around if he succeeds in his strategy, as I've outlined above. That's why now is not the time to be complacent. Now is the time to turn up the heat. Write your Congressmen and Senators. Don't let credulous articles like this one or the USA TODAY article pass without letters to the editor. Be ready for all the entertainment blogs and magazines that will likely report on Sammy Hagar's concert as an uplifting human interest story and ignore or downplay the issues with ANPs. Now is not the time to let the pressure off.
These tactics disgust me. They make a mockery of cancer patients like myself who participate in real clinical trials.
With only a small chance of benefit, we risk sacrificing much of the remaining quality time in our lives so that research can be advanced, not so that celebrities can bump their friends to the front of the line.
Just to be clear, this kind of media campaign wouldn't be any more palatable if these patients were seeking uncontrolled access to trials that really did have some potential for benefit. The breast cancer bone marrow transplant story from the 90's illustrates how end-plays around the process delay research. If every cancer patient who is willing to risk taking experimental drugs gets them through politics not protocols, who is left to actually be in a controlled trial?
We are not asking the FDA to take a side in this debate
Instead, they are asking the FDA not to take a side in the scam-or-experiment debate, which is unfortunate, that being the FDA's job.
I'm not surprised that Ayotte has fallen for this scam. She has been reliable in the sense that whatever her opinion on a given issue, you can safely assume that the opposite is closer to the truth.
Shaheen is up for re-election this year. I know the Republicans have dreams of taking that seat, although I'm not aware of a plausible candidate to take her on (and I'm one of her constituents).
Ignorance is a bipartisan issue.
Merck (Glaxo, Sanolfi, you pick) has been experimenting on cancer patients for 35 years. They refuse to publish their results, but they claim that their special, non-toxic medicine works. The FDA has finally stopped this activity after a child died from receiving the therapy and numerous lapses were found in Merck's medical recordkeeping (including falsification of data), financial management, and care for the welfare of experimental subjects.
Do you think anyone would be lobbying the FDA to allow Merck to continue after they'd done that? Doubtful. Burzynski is a multimillionaire living in a $6M mansion in Houston.
$6M buys a lot of mansion.
MedTek - Unfortunately, that's not a very effective argument, given that a couple of big pharma companies have recently received ten-figure fines precisely for promoting drugs for unproven uses while hiding evidence of life-threatening side effects, and their business is still in full swing while their CEOs and major investors lounge freely about their own multi-million-dollar mansions.
Jane, the pharmaceutical companies were punished (likely not harshly enough) and can now no longer promote those drugs for the unproven uses. Shouldn't Burzynski be held to the same standards? Fined a large amount and stopped from promoting his quack cure for unproven uses?
The FDA has fined drug manufacturers for promoting certain drugs for "off label" use.
Burzynski has never completed clinical trials for his ANPs or gotten approval from the FDA, during the 30 plus years he has been "treating" cancer patients. And, as Orac stated above, he now prescribes (and sells, through his pharmacy), cancer treatment drugs which have no proven therapeutic value for his patients' particular types of cancers. (The kitchen sink approach)
The thing is, if a good friend said to you, "My wife has found a wonderful new treatment for her cancer, will you help raise money to pay for it?" would you say "Great, sign me up!" or would you say "What exactly is this treatment? Is it proven? I want to research it before I join in the fundraising." Most people would go straight to the first and consider the second tactless or worse. I myself think that caution would be the part of a good friend, but I'm in a minority there.
I would ask for time to investigate before deciding, and then I'd say something like, "I've checked out this doctor of your wife's, and I don't like what I've learned, I don't think he can help her. In good conscience I can't promote him or raise money for him. I think you ought to hear what I've found out, but it's okay if you don't want to, and whatever you and your wife decide to do, I won't criticize you. I'll still be your friend, and be with you through everything, I just won't help you raise money."
Lifestyle, experimental injected substance and medical advice from rock musicians.
What could possibly be wrong?
@Vasha #10- I too would be in the same minority there. I'm afraid occasions like that are really not a good time to be your usual tactful self & not ask questions as there's simply too much at stake.
Of course, living in Australia (where it is generally known that proven cancer treatments, for now, anyway) are covered by the State makes it a lot easier to identify situations in which a friend may be the target of a scam. I have found myself in the situation where I was concerned that a friend was being hoodwinked by "alternative" medicine. Although I wasn't directly asked for money my forthrightness regarding the issue did not bode well for the friendship, which I suppose can only be expected.
Surely Burzynski & his long used method of by-passing federal law regarding clinical trials is no secret by now? I understand the desperation of families of the desperately ill, though I'm frequently shocked by the willingness of some people to believe in a "conspiracy to suppress cancer cures". One only has to read a few of the replies to Hannah Bradley's latest vlog to see how virulent an idea it is.
It is despicable when anyone uses terminally ill children to further their own cause. Imagine the (justified) outcry if larger drug companies tried it as a marketing ploy.
their business is still in full swing while their CEOs and major investors lounge freely about their own multi-million-dollar mansions
Dispatch from the Why In G-d's Name Am I Bothering to Fact-Check This Dep't:
Merck's CEO is Bucks County, PA, parcel 47-009-031-019, a four-bedroom house on a 1.56 acre lot, valued at $1.12 million. Not that 5210 square feet is anything to sneeze at, mind you.
Count Scamula, whom one might idly observe has substantially fewer responsibilities, is Harris County, TX, account 1298230010001. Regrettably, their search engine is down. It value at just over $5 million, and from memory, the house alone has a footprint of a third of an acre, about 6 times that of Merck's CEO's, with something like 10 bedrooms. The lot, again from memory, is around 20 acres.
I'd say that the complaint that the comparison is "not a very effective argument" is rather sorely dependent upon the fact that Scamley basically has no job other than "promoting drugs for unproven uses while hiding evidence of life-threatening side effects."
^ ("it is valued at"; time to plug the Firefox memory leak with signal 9 again)
It's good that this "pioneer in gene targeted therapy" was able to use a commercial service for genotyping tumor (for gene targeted therapy) that was already providing services to a couple hundred medical centers.
I suppose he's like the pioneers who settled the American West in the 1960's by buying a home there. Bold pioneers who crossed the Continental Divide in driving snow, using nothing but a Greyhound bus and an Interstate.
a couple of big pharma companies have recently received ten-figure fines precisely for promoting drugs for unproven uses while hiding evidence of life-threatening side effects
Which drugs are you referring to? If it's Avandia, you should also add that those alleged "life-threatening side effects" turned out to be unfounded.
I have developed some sympathy for drug companies recently. Many of the high-profile cases that appear to prove that drug companies are interested only in money, and not in patients welfare don't hold up to closer scrutiny. I think this is part of a current trend towards demonizing large corporations, which I don't think is very helpful.
For example GSK spent billions developing Avandia, a hypoglycemic drug prescribed for diabetes. The drug is very effective, and works by increasing insulin sensitivity, which is reduced in type 2 diabetics. However, between 2007 and 2010 some studies found an association between use of the drug and increased risk of cardiovascular disease. GSK were censured and fined for not making this information available at the time it launched the drug. The drug was withdrawn and law suits were brought, all of which must have cost GSK huge amounts of money.
However, more recent studies suggest that all drugs of this class have some adverse CV effects, though this is hard to tease out from the adverse CV effects of diabetes itself. Avandia now appears to be one of the safer hypoglycemic drugs, and the FDA have removed the restrictions on its marketing. This means that many patients were put on more dangerous and less well-tested drugs while Avandia was under suspicion. It seems to me that more patients were put at risk and were very probably hurt by the knee-jerk reactions of regulators than by the behavior of GSK.
It does seem odd to me that GSK were censured and fined for developing and marketing a very effective drug that is no recognized to be very safe, while Burzynski has been apparently free to peddle his dangerous and unproven treatments for decades relatively unmolested.
Bold pioneers who crossed the Continental Divide in driving snow, using nothing but a Greyhound bus and an Interstate.
Forced by hunger to resort to eating a Doner on the way, no doubt...
In these parts we spell it donair. Which leads me to wonder if the problems of the Donner Party were all due to bad spelling.
The whole find a cure for cancer is a total scam.
Lots of fat cats making money and people are dying, like my mom did and grandmother before that.
It's a big money maker. Why find a cure.
The blood suckers (drug companies) are making a killing and the FDA is in bed with them. Yeah, they fine. Got to look like they are doing something. But they are the government.
And do you people here REALLY trust your government?
Are you kidding me. This government would bankrupt a lemonade stand.
@Mike - so, what about the groups of Cancer that can be cured? How about the longer survival rates?
Anything other than rant?
Okay. They are all saints.
What was I thinking?
And what's up with drugs causing serious problems with some patients. Drugs approved by the almighty FDA?
Any repercussions for them?
Not really, they are the government! They are not responsible for anything.
Mike, please try to make sense.
I think you will find that when drugs go bad it also goes bad for the drug companies. Vioxx ring any bells?
You are being incoherent because most of the things you claim don't happen have happened.
So, got any actual proof for your rant?
Mike, your shot pattern is all over the place. Try adjusting your choke bore.
The blood suckers (drug companies) are making a killing and the FDA is in bed with them. Yeah, they fine. Got to look like they are doing something. But they are the government.
If only the drug companies, FDA and US Government were made up of human beings like you and me, with parents and wives and children who got cancer, and who got cancer themselves. Then maybe they would care about finding cures for diseases instead of wanting everyone to be sick forever. But no, those inhuman bastards, "they fine" while the rest of us suffer the increasing longevity and healthy old age they are inflicting on us.
If only drug companies operated like normal companies, with shareholders who want them to make a profit by producing safe and effective drugs, instead deliberately making poisons to kill their customers for no apparent reason.
One more thing:
Are you kidding me. This government would bankrupt a lemonade stand.
The most successful economy on the planet is run by idiots who would "bankrupt a lemonade stand"? What chance do the rest of us have?
@Kreb - good point....and I will point out that it was government intervention and regulations that prevented the fairly regular series of "Depressions" that the US has experienced since its founding, right up until the Great Depression.....not exactly a great track record for "Big Business."
The 2008 Crash can be directly linked to the Federal Reserve keeping any and all regulation away from so-called Derivative Swaps & encouraging the fanciful accounting that made the mortgage collapse happen.
Not really, they are the government! They are not responsible for anything.
Perhaps you'd like to get your shıt together and actually say something about Scamislaw. Do you "REALLY trust" this asshοle?
That joke about eating Doner is either the internets award winner or in seriously bad taste (pun stolen from Isaac Asimov). I can remember heading up I-80 in the eastern Sierras and being turned back by the highway patrol because of an early season snowfall. I doubled back and actually stayed in the town of Truckee, which figures centrally in the Donner party account. Getting into weather at an altitude above 8000 feet can be serious in that part of the world. A little further south of that route, they close the Tioga Pass for most of the winter due to snow, but it's at 10,000 feet, and about 80 miles east of there, they close Titus Canyon (in Death Valley) during the summer because of the heat. The world record high temperature is at Badwater, on the valley floor, but Titus Canyon, although mostly unrecorded, is said to be worse.
people are dying, like my mom did and grandmother before that.
Yeah, my mother died too. And my grandmother before that. My great-grandparents and great-great-grandparents are also all dead. I'm beginning to see a pattern.
That joke about eating Doner is either the internets award winner or in seriously bad taste (pun stolen from Isaac Asimov).
Is it too soon? I could continue with jokes about it not being my idea of a party...
I recently stumbled upon an episode of a ghost-hunting TV show, in which Jack Osborne went to the site where the Donner party got stuck, in the winter, and tried to contact some spirits trapped there by spiritual indigestion or something. Their thermal camera went haywire, probably due to the cold, one of them got scratched by a twig, and something resembling teeth chattering was picked up on their audio recorder, so definitely ghosts. I'm not sure why, but I have some affection for such nonsense, such as the over-optimistically named 'FInding Bigfoot', now into its 5th season.
#19 I have to agree. Thinking we'll find "a cure" for cancer, when there are loads of different types of cancers, with different causes and different mechanisms, in different parts of the body, is pretty scamulous.
Of course, that's pretty much exactly what Burzynski does.
I thought the Donner party was the one Rudolph didn't get invited to.
I went to Change.org to sign a friend's petition, and the sponsored petition I was offered next was for the Burzinski clinic. When I searched for the direct link to the petition, it turns out there are a TON of petitions to "legalize antineoplastons" etc.
You ought To be ashamed of yourself. Don't you dare use my name for your so-called article. I promise you you have no idea what you are talking about. The Science is there and the FDA as well as the national Institute acknowledged it years ago, so do not speak about that which you do not know. I'm sorry you're so scared of something that works. You might want to do your research next time (my guess is you work for a drug company has so many of the people with this attitude do) it doesn't matter. They have been approved for phase III clinical trials - . this means they passed phase 1 (safety) as well as phase II (efficacy); frankly for those of us who can be cured this by this WHEN STANDARD MEDICINE ADMITS THEY HAVE NO CURE just do not speak at all will do yourself well.
I'm very, very sorry, Liza. You are surrounded by awesome friends of immense generosity and compassion. However, if the FDA allows you on the treatment, there will be no basis to protect other patients from this: https://theotherburzynskipatientgroup.wordpress.com/damning-fda-finding… The good news, however is that there are other trials into brainstem tumors open. You can review them here: http://clinicaltrials.gov/ct2/results?term=brainstem+glioma&recr=Open
@Liza - legitimate clinical trials don't charge their patients hundreds of thousands of dollars for unproven treatments...think about that....
"I promise you you have no idea what you are talking about"
Even though the author is an oncologist?
Also, if you dislike your name being used in an article then you should be going after those who released those press releases. If you make it public, then you do not have any cause to object to those who comment on your choices. Especially when that person is a qualified cancer doctor.
this means they passed phase 1 (safety) as well as phase II (efficacy)
Sadly, untrue. Phase-II trials were open for many many years but the results -- if Burzynski bothered to record them -- simply disappeared down the memory hole. Burzinski's own lawyer boasts about the fact that the trials were a joke, a way of getting around legal barriers and charging people for snake-oil.
They have been approved for phase III clinical trials
And now they're unapproved again. Perhaps they aren't safe or effective after all.
Sounds like Liza has been lied to by the clinic....
I'm sorry if my post has upset you. I realize that you probably won't believe this, but I wrote it for you and others in your horrible, horrible situation. I know, at least as much as it is possible to know without being in your shoes, how terrible your situation is. I can also sense how desperate you and your husband are, and i appreciate how Sammy Hagar thinks he's doing the right thing for you. I really hate that I'm one of the ones who has to say this, but Stanislaw Burzynski can't save you. There is no convincing evidence that he has been able to save anyone, his claims otherwise notwithstanding. I realize that you likely won't believe me, but I feel obligated to say it anyway. I am also very aware that, no matter how sensitive I try to be, I will be easily painted as the bad guy for saying this.
The Science is there
Where? Burzynski certainly isn't coughing it up.
and the FDA as well as the national Institute acknowledged it years ago
No, they haven't.
I’m sorry you’re so scared of something that works.
What "we," if I can risk speaking generally, are scared of is Burzynski continuing to be allowed to swindle desperate people and those who care deeply about them. Your decision is your decision, and it's a cruel one to have had imposed upon you and yours. As Bob Blaskiewicz notes above, though, there are legitimate clinical trials available. They don't make promises. Burzynski does, and afterward, his groupies make excuses.
They have been approved for phase III clinical trials – .
One such trial was approved. It closed without enrolling a single patient.
this means they passed phase 1 (safety) as well as phase II (efficacy)
Unfortunately, it doesn't. As Burzynski's own lawyer, Richard Jaffe, has freely admitted, the very existence of the phase 2 trials is "an artifice."
I'm sorry that I (and others) have to argue with you here, but repeating the Burzynski propaganda that you have been led to believe demands a response, as difficult as it is provide.
I’m sorry you’re so scared of something that works. You might want to do your research next time (my guess is you work for a drug company has so many of the people with this attitude do)
So, you brought out the hoary old pharma shill gambit. Consider this, if you will:
Pharmaceutical companies make a *lot* of different products. If they went out of the cancer chemotherapy business tomorrow, they would still have plenty of other products to offer, and the great majority of their employees would still have jobs. But Burzynski's sole business is treating cancer patients. If he stopped treating cancer patients tomorrow, he and all his employees would be out of work.
Who, then, has the greater incentive to ignore contrary evidence? To shade the truth in their own favor? To lie? Who is most likely to act the shill in this case?
Speaking of the pharma shill gambit, it's not really a good fit for Burzynski's position. The usual way it goes is, "Big Pharma is suppressing a cheap natural cure for cancer because it's cheap -- so they can't make a lot off it -- and it's natural -- so they can't patent it and so won't research it. Buy my book and this overpriced supplement, and tell Big Pharma to take a long walk off a short pier!"
But that doesn't work for Burzynski. His treatment isn't cheap, and natural or not, it can be patented because he did patent it. Big Pharma has every incentive to license it from him and he has every incentive to license it to them. If he cares about saving lives, he could save a lot more lives by licensing a working treatment so that it can be provided to millions than he can in his one clinic. If all he cares about is money, he'd make a lot more from licensing fees for a working treatment that could be used on millions than he does off his one clinic. The only incentive for him not to license it to Big Pharma, and Big Pharma not to license it from him, it is that it isn't a working treatment.
And speaking of patents, he's sat on his antineoplastons patents for so ling that the original patents have expired. Big Pharma could have gotten on the gravy train years ago with a working treatment based on antineoplastons without paying him or anyone else any royalties ... but they haven't. Because it isn't a working treatment.
Let's consider also the insurance companies. They won't pay for Burzynski's treatment. If it worked and was even comparable in price to the other treatments that they do pay for as doctors desperately try to find an effective treatment, what incentive would insurance companies have *not* to pay for it? They aren't wed to Big Pharma -- indeed they will often push people to generics instead of drugs under patent, thereby depriving Big Pharma of income. They don't pay for Burzynski's antineoplastons because they don't believe he has a working treatment. And they with their experts are in a lot better position to review the evidence than is a cancer patient who is desperate to find something, anything, that will work.
Speaking some more of the pharma shill gambit, since the standard form doesn't work for Burzynski, he and his minions have come up with another form, the "pride" form. That is, Big Pharma won't use his treatment because it was invented outside the mainstream and that hurts the pride of mainstream researchers.
The problem with this is that billions of dollars in profit will salve a lot of hurt pride. And Big Pharma companies exist to make money for their shareholders. If a Big Pharma company's board of directors allowed the company to disregard billions in potential profits for emotional reasons, that board of directors would be in big trouble from the shareholders. Does anyone really believe that in over thirty years *nobody* has thought to bring a shareholder's suit against a board of directors for disregarding potentially billions of dollars in profits for a working treatment for no good reason?
Someone would have brought such a suit. Unless, of course, those who have the time, expertise, and emotional distance which a desperate cancer patient lacks, have examined the evidence and determined that Burzynski does not have a working treatment.
Speaklng of legal actions, if the clinic is fraudulent, why hasn't it been shut down? Why isn't he (Burzynski) in jail, let alone have a medical license or even sanctions? Seriously curious as to what the prevailing 'wisdom' is here.
Orac's actually talked about that quite a bit. The following link is a pretty good analysis of why he's managed to keep on chugging along for so long (apologies that it's not a hyperlink: I'm either incompetent at HTML, or my browser just likes to crash when I try it):
Long story short, the Texas Medical Board (and most medical boards in general) is very hesitant to act unless it's an extremely clear-cut case of criminal activity, such as murder, sexual assault, etc; whereas the FDA is hamstrung by influential Burzynski supporters and the fact that he's very, very good at exploiting loopholes.
Well, that's unexpected. I just copied and pasted the web address and it linked it for me. I don't remember it doing that before.
I guess I probably am just incompetent :P
WordPress even adds the rel="nofollow" tag to the links it creates that way. :-)
IF: Long story short, the Texas Medical Board (and most medical boards in general) is very hesitant to act unless it’s an extremely clear-cut case of criminal activity, such as murder, sexual assault..
Sexual assault isn't a crime in Texas. I doubt the TMB even thinks murder is a crime.
indigo_fire, did you post the right link? that doesn't address my questions. I would expect at least sanctions or malpractice lawsuits. I don't see even those, though I didn't do an extensive search.
I fear kc is being deliberately obtuse.
I fear kc is being deliberately obtuse.
Yup. The scare quotes ('wisdom') and Just Asking Questions attitude are a dead giveaway.
I fear Johanna doesn't understand that ad hominem attacks are not refutation.
I fear Johanna doesn’t understand that ad hominem attacks are not refutation.
1. Johanna's comment is nowhere close to an ad hominem (by the way, what does that mean in your own words?)
2. A refutation of what? You've made no actual arguments so far. You observed that there haven't been sanctions or malpractice suits, and concluded...nothing.
Adam, I'm dead serious about shutting down the clinic if it's fraudulent. However, I'm not swayed by bad argumentation, or unsubstantiated opinion. Some people have made some references to legitimate, documented issues and they have credibility. Those of you who are incapable of such are inconsequential and a waste of time, and probably air.
Adam, my HS taught latin and I took debate, not to mention formal logic. If you don't understand it, google it.
Frankly now you're being deliberately obtuse, or sadly maybe it's not deliberate. look at the context of the discussion. and try again.
Politicalguineapig, please do not make statements like this: "Sexual assault isn’t a crime in Texas. I doubt the TMB even thinks murder is a crime." You know that they are not true and only cause unfriendly responses to you.
that doesn’t address my questions. I would expect at least sanctions or malpractice lawsuits. I don’t see even those, though I didn’t do an extensive search.
Then you didn't search very hard.
However, Texas is a very doctor-friendly and malpractice suit-averse state. There's a strict cap on pain and suffering damages; as a result few lawyers will take malpractice cases on a contingency basis. In other words, it's about as perfect a state for Burzynski as there is.
do you have links to sanction, malpractice, lawsuit information?
LW: How are they not true? If something isn't prosecuted, that's the same as it being legal.
Oh come on PGP, that's demonstrably false.
If all violations of a law must be prosecuted 100% of the time in order for those violations to be considered illegal acts then... the world is a lawless place.
Yes that's the right link, and it certainly does answer the part of your second sentence where you asked why he still has his medical license (which is under the purview of the Texas Medical Board) and whether he's sanctioned or in jail (which FDA actions against him would likely lead to).
If you think that that doesn't answer any of your questions, then you either need to formulate them better, or you're being obtuse.
i hate to feed trolls but here you are (again, since orac and others already gave you this info ) http://reg.tmb.state.tx.us/OnLineVerif/Phys_ReportVerif_new.asp
@brook, that produces an OLEDB error. And if all you can do is display bad links and bad manners, please go back to reading your graphic novels.
Guess I'm just obtuse Indigo, which is damn funny given where my IQ stands on a bell curve. Now if all you can do if post links to someone else's thoughts, I'm off to find someone who has a brain.
kc, have you read the FDA's inspection report?
"You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January I, 2005 and February 22, 2013."
kc: "I fear Johanna doesn’t understand that ad hominem attacks are not refutation."
kc: "Now if all you can do if post links to someone else’s thoughts, I’m off to find someone who has a brain."
Good luck with your search. And you can mail me a replacement irony meter c/o Orac.
Yes Adam, I've read some of those. I'm not disputing there are some serious issues there. I'm looking for tangible evidence of sanction, malpractice or lawsuit , hence my request enumerating them. Are there complaints? If there are complaints, why is the medical assoc. not investigating? Where are the lawsuits? For those too dull witted to recognize it otherwise, I am seriously asking why isn't the medical community policing itself? There's the first problem.
Tangentially, there are some serious admissions of corruption at the FDA. Again, for the dull-witted, I"m not saying that the substantiated corruption at the FDA is in anyway related to the BC issue, but it speaks to the credibility of the organization. Most of what I see here is the same lack of rigor that the clinic is (apparently justifiably) accused of. I see a lot of people talking, but few with anything to say.
@ Dangerousbacon, nice quip - who did you copy that from? Got any original thoughts?
Kc, my apologies. just go to the TX medical board (http://www.tmb.state.tx.us/) and search for Burzyinski. The pater's middle name is Rajmund.
What you got against graphic novels?
thanks Brook, I'll check it out.
re: graphic novels - nothing, they make excellent compost. :)
Kc, you want to know why "they" (I'm on a phone and must use shorthand) aren't prosecuting B.
Shouldn't you ask "them", perhaps? After all, I can't speak for the Texas Medical Board...
@johanna, I don't know who you are are what your background is. However, I'm throwing your comment back at you. if you find the time for meaningless posts, perhaps your time would be better spent lobbying those organizations who could positively affect the issues your profess to care about.
kc, what is your solution?
kc, if you don't think that FDA report is evidence of malpractice, I'm not sure what you think would be.
@chris, @adam, see my response to Johanna.
@AdamG, thanks for the link for the Texas Department of Criminal Justice. On page 30, they list numbers received with "offenses of record" including sexual assault, sexual assault on a child, and indecency with a child. They also include assault, and a sexual assault might be charged as assault instead or in addition, depending on now strong the prosecutor thought the evidence for the case was.
Politicalguineapig, you appear to be thinking of some case which you think should have been charged but was not. That can happen for a number of reasons, including a corrupt prosecutor who is paid off or simply indifferent to crimes against women.
But even if that is what happened in the case you are thinking of, that does not mean that every district attorney in the State is paid off or indifferent. And, if you learned of the case you're thinking of on the Internet, that may not be what happened at all -- descriptions of crimes on the Internet frequently bear only a passing resemblance to the actual evidence.
@kc, there's Lola Quinlan's lawsuit:
So, kc, have you written some letters?
Yes Adam, I’ve read some of those. I’m not disputing there are some serious issues there. I’m looking for tangible evidence of sanction, malpractice or lawsuit , hence my request enumerating them. Are there complaints?
If there are complaints, why is the medical assoc. not investigating?[/blockquote]
Assuming you mean the American Medical Association: Because that's not what it does.
Where are the lawsuits?
Most personal injury lawsuits are settled out of court confidentially and never become part of the public record.
However, there is -- as noted -- Lola Quinlan's suit.
Additionally, there are some patient lawsuits among the cases you'll find at the Harris County Clerk's Office website, which is here:
For those too dull witted to recognize it otherwise, I am seriously asking why isn’t the medical community policing itself?
The honor system is unreliable.
There’s the first problem.
Well....But we don't use the honor system to police the medical community in this country.
So, no. It's not.
@chris, I'm not the one(s) spending copious amounts of time spewing on the internet for no apparent reason other thane self gratification it seems. But yes, where I feel it's appropriate, I write letters, or try to do more than pontificate.
@ann, speaking of dull witted, I supposed you missed the link to the article orac posted that blamed in part the failure of the medical board for the egregious lack of action re: neurosurgeon and compared it to Burzynski? or the part where they can't investigate if there aren't complaints? I'm pretty much done responding to the sophomoric attempts at debate. It's like arguing with a 7th grader.
kc: I’m not the one(s) spending copious amounts of time spewing on the internet "
Please tabulate your contributions versus mine in the last twenty four hours. I believe you have posted more comments here than myself.
So what is your solution? What have you done to achieve that solution?
I would expect at least sanctions or malpractice lawsuits. I don’t see even those, though I didn’t do an extensive search.
It's very difficult to tease out, but from here it looks a lot like Count Scamula settled with Lola Quinlan. There were two causes in the 269th District, Nos. 201203429 and 201203429A. It looks like Scamislaw was not faring well in the former, leading to the severance attempt in the latter. The First Court of Appeals file for the (interlocutory, which is uncommon) appeal is here.
Most of these links go nowhere. Note also that Quinlan represented by her original attorney, Gibson, and Jaffe here, who was representing BRI in the original action. As with these documents, most of those in the 201203429A action are toast. I can't really see any way around it but a settlement. Moreover, if BRI was severed from the action, it's not going to show in the SEC filings.
^ "was represented"
One can search for the 269th District cases here (just use "Quinlan" and "Burz" as the party names). A login is required in order to view documents.
Ah, now I see that some of this ground has already been covered.
graphic novels – nothing, they make excellent compost.
I doubt it. All of these inks...
And you may think you are smart, but the above sentence show how small-minded you are.
Guess I’m just obtuse Indigo, which is damn funny given where my IQ stands on a bell curve.
Anybody with a passing familiarity with potential energy would realize that the only option here is 100.
As usually, I forget to check my esses before posting the above quip. The astute reader will realize my sentence has two places where it could have used an extra 's'. I'm fine with both, so pick the one you prefer.
"Quinlan represented by her original attorney, Gibson, and Jaffe here, who was representing BRI in the original action."
I wonder how that happened. I would have thought both parties would have objections to his switching sides.
@ann, speaking of dull witted,
I prefer to think of myself as literal-minded.
I supposed you missed the link to the article orac posted that blamed in part the failure of the medical board for the egregious lack of action re: neurosurgeon and compared it to Burzynski? or the part where they can’t investigate if there aren’t complaints?
No, I saw them. But the words you used were "medical association."
Thanks for your clarification. The amended answer is that the most recent investigation by the medical board of which I'm aware ended without a finding of fact on the substance of the issues charged because the defense successfully argued that Burzynski himself was not personally responsible for the actions in question.
You can read about the charges here:
Also, speaking of dull-witted and/or literal-minded:
I believe you misunderstood Orac's meaning. It's possible for them to investigate without complaints by third parties. And they may be doing so even as we type, for all I know. But it's not typical for them to do so, because they don't really have the resources, staff or funding for self-starting investigations. So they largely rely on the press and public.
That's also true for the FDA, the EPA and -- ftm -- the IRS and any number of other state and federal bureaucracies, to a greater or lesser extent. Enforcement dollars are limited. The squeakiest wheel gets the grease.
I’m pretty much done responding to the sophomoric attempts at debate. It’s like arguing with a 7th grader.
I didn't know I was debating. I just thought I was answering your questions. (You're welcome, by the way.)
But thanks for your candor and charm.
Yes, as a matter of fact, I have written to my elected reps and the Texas MB several times about SB's egregious ways.
But at the moment, I'm mostly occupied by trying to manage a full time job and providing support for my father while he's fighting leukemia, so I've had other things on my mind.
kc appears to believe s/he was debating two propositions:
1) I'm smarter than any of you.
2) the Burzynski clinic is not engaged in fraud.
Of course, kc only made insinuations as to the second proposition, Just Asking Questions instead of actually stating a claim, so it's not surprising that commenters thought they were answering questions instead of engaging in debate. I took debate in high school too, and we always stated the proposition we were attacking or defending, but I suppose different schools have different approaches.
Evidence for the first proposition: kc knows how to spell ad hominem. Evidence against: s/he doesn't know what it means (Johanna's comment on kc's behavior was not a logically invalid argument against a proposition because it was not an argument at all and kc had not presented a proposition as s/he was Just Asking Questions).
Evidence for the second proposition: (a) kc's assertion that if Burzynski were engaged in fraud, then there would be lawsuits and sanctions against him and (b) kc's claim that we were unable to produce evidence of lawsuits and sanctions against him.
Of course, we did produce evidence of at least one lawsuit: Lola Quinlan's. I notice kc didn't have a word to say about that. And Burzynski has been charged with insurance fraud, and more recently his antineoplaston operation has been shut down.
Moreover, the conditional statement doesn't even make sense. Was Al Capone guilty of nothing but tax evasion? The fact that the authorities can't seem to stop someone doesn't mean his actions are not fraudulent.
It always makes me laugh when someone makes themselves look a twit (an ill-mannered twit in this case) and then manages to look even more foolish by pompously explaining how clever and well-educated they are.
To say nothing of the illogic of hating on graphic novels in this context.
I'm sorry to read that about you dad.
To say nothing of the illogic of hating on graphic novels in this context.
It was just a roundabout way for kc to insult its opponents by implying they have the mind of a small child. But it just shows it doesn't go out much.
Maybe we should ask Darryl Cunningham to write a graphic novel on Burzynski.
One also cannot help noticing a certain pattern:
- straight answer by a regular: "it's just your opinion, don't you have facts?"
- link to another thread (full of links to facts): "it's just someone else's opinion, are you unable to have ideas on your own?"
- link to the FDA website: "Poo, they are corrupt, that they are saying has no credibility"
- link to a complaint, as asked: silence.
One is forced to conclude there is no pleasing kc.
Thanks. It's all very crazy but he's being treated at UCSF and I must say, if you're going to fight cancer, that's a great place at which to do it. Things are looking kind of bleak, but it's not too late yet. (So if I seem prickly, that's probably why...)
oh please, just call me a poopey-head, you know you want to. I'm going back to the grown up table now.
Of course, we did produce evidence of at least one lawsuit: Lola Quinlan’s. I notice kc didn’t have a word to say about that.
sorry, that should be quoted and attributed to LW.
Me think you have a thin skin...
oh please, just call me a poopey-head, you know you want to.
Heaven forfend. But if I did or said anything to give you that impression, by all means, please bring it to my attention so that I can apologize for the discourtesy.
I’m going back to the grown up table now.
As you wish.
I wonder how that happened. I would have thought both parties would have objections to his switching sides.
He didn't. If you look at cause 201203429A, Quinlan is represented by Scamislaw's attorney Hughes, with only Robin Reid still having Gibson as counsel. This is very good reason, if you ask me, to think that Quinlan had already agreed to a settlement from the Burzynski entities proper to keep BRI, which has to make public disclosures, out of it.
I'll note that kc flounced fairly promptly after having had evidence provided of what he was demanding. And, courtesy of Josephine Jones, there's more.
The Richert case (which doesn't name BRI) is now set for a November 3 trial.
And, courtesy of Josephine Jones, there’s more.
I was over at the Harris County Clerk's website compiling those, even as you posted. But if it's okay to just use Josephine Jones's excellent work, that list also occurs in a....Well. In a list form, in this post here:
Or, for ease of reference:
Has Burzynski been sued by patients?
Yes. The following patients (or their families) have all sued Burzynski: Kay Wimberley, Christina Bedient, Gail Middleton, Lilly Louise Adams, Lola Quinlan, Robin Reid (and more recently, Meridee Richert). Hamilton was wrong to claim that these lawsuits were all frivolous and accusatory and all dismissed. For example, Kay Wimberley’s parents, Stanley and Bernice Zabodyn, received a $300, 000 settlement.
However, it's also generally true that what's in the record isn't necessarily indicative. Settling out of court is more the rule than the exception.
"oh please, just call me a poopey-head, you know you want to."
All the best debaters close with that statement. It's like "Carthago delenda est", only more ... special.
Of course, I like to think that I or my commenters would use a higher class of insult.
I think it's conceivable that there might be times when "poopey-head" would simply be the mot juste, which would automatically imbue it with class.
I can't say I'm anticipating that, exactly. But neither am I ruling it out.
@helianthus - oh, I know why kc flung poo. Graphic novels just struck me as particularly funny in this setting. It wasn't even effective as an ad hominem attack. For all s/he/it knows, I could share their opinion. Or I could be Joe Sacco, Alison Bechdel, or David Selznick happily making my living writing great books. (I'm on one of the kiddos touch screen devices. I'm too lazy too learn how to neatly hyper link in apple so you'll have to do your own duck duck go)
Sometimes, if you throw a "poopey-head" into an argument it so surprises/distracts the other person that you both have time to consider what you're really arguing about.
Perhaps I had a deprived childhood -- and adulthood -- but I learned the word "poopie-head" on Respectful Insolence. I have not yet had occasion to use it.
Sometimes, if you throw a “poopey-head” into an argument it so surprises/distracts the other person that you both have time to consider what you’re really arguing about.
Hence the old mnenomic couplet:
To render minds occupi-ed
Call other people "poopey-head."
Or maybe I just made that up. I forget.
Il ne sait pas sur le pied
danser. I called him "Poopey-head."
“poopey-head” would simply be the mot juste, which would automatically imbue it with class.
Hmm, "pen cachu"
Nah, it just doesn't work in Welsh.
I'd like to address the folks who seemed to be convinced that S.R. Burzynski's Antineoplastons have never been scientifically tested and/ or that ANP has never been tested or passed any FDA approved clinical trials.
If you do your research, you'll find that ANP has undergone and passed Phase 1 and Phase 2 Clinical trials….for the less informed, Phase 1 means testing for safety, Phase 2, for efficacy (is it effective).
The FDA allowed a 10 person quota for children with DIPG (brainstem tumors) to have access to ANP but stopped access to new patients circa 2012.
In other words, there were and are still people receiving this "non-effective" drug as it appears to be keeping them alive well after their original prognosis..in some cases children surveying over two years after given 6 months to live.
Also, I read one persons blog inferring that people who choose not to be "guinea pigs" in a clinical trial by submitting themselves to unproven methods are infringing on getting pharmaceuticals tested properly…are you serious?
My wife has been to ALL the major cancer centers in the USA and ALL the doctors say there is no standard treatment that will save her life…and currently, there are no clinical trials proven effective (let alone safe) that can with inoperable brainstem tumorsr!
I'd like to think we have choice as Americans, i.e. decide how we want to live *or** die for that matter.
One must ask the question, "if Burzynski is a fraud or more importantly, if ANP is ineffective, why are human beings still receiving the drug?"
I'm sure my comments will not have any impact on the mentality on a website dedicated to drama and propaganda!
ORAC, "Big Brother Is Watching You!" G. Orwell, 1984
Her's some had evidence:
NARRATOR (reading along with title card of Dr. Nicholas Patronas): During this trial, one of the National Cancer Institute’s leading experts, Dr. Nicholas Patronas, a board-certified radiologist since 1973, professor of radiology at Georgetown University, and founder of the neuroradiology section of the National Cancer Institute [SOURCE: NIH Staff Pages]—recognized the absurdity of the Texas Medical Board’s case against Burzynski, put his own career on the line and flew himself to Texas to testify on Dr. Burzynski’s behalf. Dr. Patronas testified under oath his role at the National Cancer Institute.
NARRATOR (reading along with the official court transcript from the May 24, 1993 hearing): [SOURCE: Original complete court transcript of the entire testimony 1993] Q (Jaffe): Basically, just in layman’s terms, you do all of the imaging work and interpretation for the National Cancer Institute’s testing of drugs? A (Dr. Patronas): Exactly. That’s my job, to assess the effectiveness of the drugs that are given there. Q (Jaffe): Did there come a time when you became aware of Dr. Burzynski? A (Dr. Patronas): Yes, the National Cancer Institute asked me to join a group of other physicians and scientists, and come to Houston on a site visit to Dr. Burzynski’s Institute. I was called as an expert in assessing the images to evaluate the effectiveness of his treatment. The basic conclusion, was that in five of the patients with brain tumors, that were fairly large, the tumor resolved, disappeared. Q (Jaffe): And that’s part of what you do at the hospital, is to evaluate treatments on brain cancer patients? A: Well, since I am the neuroradiologist I see all brain tumors. And I see a large volume of them. Q (Jaffe): You testified that five of the patients had their tumors resolved, they all... A (Dr. Patronas): Disappeared. Q (Jaffe): Disappeared? Can you give us some kind of context of that? How often does that happen? Just by spontaneous remission? A (Dr. Patronas): I’m not aware that spontaneous remission occurs. The available treatments rarely produce results like that. The only medication, the only treatment, which I think is a last resort, is radiation therapy. Conventional chemotherapy is—provides very little, nothing, basically. So when this happens it is very rare. In these cases, all of the patients had already failed radiation. Q (Jaffe): What happens with these patients, who failed radiation, with brain cancer? A (Dr. Patronas): That’s it. They die. Q (Jaffe): You are saying, that if someone has already failed radiation, there’s not much else? A (Dr. Patronas): Nothing to offer, exactly. Q (Jaffe): And there is nothing that you can do at the National Cancer Institute? A (Dr. Patronas): Nothing we can do, not at this present time. Q (Jaffe): What about these five patients? How come they lived? A (Dr. Patronas): Well, it’s amazing, the fact that they are not handicapped from the side effects of any treatment, and the side effects of most aggressive treatments are worse than the tumor itself, so these particular individuals not only survived, but they didn’t have major side effects. So I think it’s impressive and unbelievable. Q (Jaffe): How many times have you seen this in your experience? How often does this happen? A (Dr. Patronas): I don’t. I have not seen it at any time. Q (Jaffe): Now, let me ask you your opinion or advice. Based on what you have seen, what would happen, let’s say, for some reason Dr Burzynski’s brain tumor patients can’t get his medicine anymore, and have to go off treatment. What’s going to happen to them? MR. HELMCAMP (prosecutor): Objection, Your Honor, not relevant. MR. JAFFE (defense): I think it is relevant. That’s really the issue we are advocating in this case. JUDGE: Overruled. A (Dr. Patronas): I think these patients will die. [SOURCE: Original complete court transcript of the entire testimony 1993 (same as above)]
@David - so what exactly has been Burzynski been doing for the last twenty years since then?
If you do your research, you’ll find that ANP has undergone and passed Phase 1 and Phase 2 Clinical trials
No doubt you can show the results from those Phase 2 trials.
“if Burzynski is a fraud or more importantly, [...] why are human beings still receiving the drug?”
The question kind of answers itself.
@David Lauser, let's accept, for the sake of argument, that twenty years ago Burzynski had a spectacularly effective treatment for incurable cancers.
Why didn't he publish the results of his trials? Why didn't he license it so thousands -- millions -- of sufferers could be saved? Before you reply that the evil FDA and the evil Big Pharma wouldn't let him, I remind you that there are hundreds of nations in this world that are not the U.S. and are not answerable to the FDA. There are clinics around the world offering pretended cancer cures that the evil FDA and the evil Big Pharma won't allow in the U.S.; why not Burzynski's?
I remind you that doctors, oncologists, even employees of the evil FDA and the evil Big Pharma, die of cancer or see their family members die of cancer. How is it that for twenty years, every single Big Pharma company -- and their Little Pharma competitors -- has ignored a cure which would make billions for them?
So as not to repeat myself, I'll point out my three comments starting at
I notice that no Burzynski defender has replied to them. Perhaps you'd like to.
@LW - not only that, but his patents have expired....at this point anyone could pick up the research and press on. So why haven't they?
Yep, I mentioned that in previous comments but, strangely, Burzynski defenders don't acknowledge it. Weird, isn't it?
Also, no discussion of Burzynski would be complete without this link:
The stories are painful to read, but are a must for anyone even considering dealing with Burzynski.
A quick note. You guys do realize that David Lauser is Liza Cozad's husband, don't you? Just to make sure you are all aware. Be civil. Mr. Lauser is going through a horrible time now with his wife. However, even though I recognize that and feel great sympathy for him, I can't let what he wrote about Burzynski go unanswered.
I fully understand his sadness and desperation. Although I haven't felt it for my wife, my wife and I did experience it when my mother-in-law's breast cancer recurred in a widely metastatic form. I understand the feeling of wanting to try anything and wanting to believe. Unfortunately, there's zero evidence that Burzynski can help Liza, and lots of evidence that he can't. Those clinical trials are shams, I'm afraid. If you don't believe me, believe Stanislaw Burzynski's lawyer. As I documented several months ago, here's what Burzynski's lawyer, Richard Jaffe, wrote about them in his book about defending alternative medicine practitioners. The longest chapter was about Jaffe's defense of Burzynski during the 1990s, and this is what Jaffe wrote about Burzynski's clinical trials:
So we decided to hit the FDA with everything at the same time. All of his current patients would be covered in a single clinical trial which Burzynski called “CAN-1.” As far as clinical trials go, it was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease.
The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.
CAN-1 allowed Burzynski to treat all his existing patients. That solved the patients’ problems, but not the clinic’s. A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!
Burzynski's ideas might have made sense at one time, but unfortunately they have failed the test of time and science. It pains me greatly to say this, because I know that's not what Mr. Lauser wants to hear, but it's true.
One other thing. That testimony from Dr. Patronas is over 20 years old. When Liz Szabo tried to contact Dr. Petronas for her USA Today story about Stanislaw Burzynski, she found that he didn't want to talk to her and basically hid behind NIH PR flacks, who gave Ms. Szabo a canned statement. It would appear that Dr. Patronas is no longer so enthusiastic about Burzynski. I only tell Mr. Lauser this because I think it's important for him to know if he's citing 20 year old testimony from him.
@Orac, I didn't know. Thank you.
@David Lauser, I apologize for my snarky tone. But I do urge you to read the stories at The Other Burzynski Patient Group.
Neuro Oncol. 2007 October; 9(4): 467–602. » MP-01. A CASE REPORT OF A COMPLETE RESPONSE AND 20-YEAR SURVIVAL OF A PATIENT WITH A RECURRENT DIFFUSE INTRINSIC BRAINSTEM ANAPLASTIC ASTROCYTOMA
Neuro Oncol. 2007 October; 9(4): 467–602.
MP-01. A CASE REPORT OF A COMPLETE RESPONSE AND 20-YEAR SURVIVAL OF A PATIENT WITH A RECURRENT DIFFUSE INTRINSIC BRAINSTEM ANAPLASTIC ASTROCYTOMA
Stanislaw Burzynski, Robert Weaver, and Barbara Szymkowski
Author information ► Article notes ▼ Copyright and License information ►
Review date: . Status:
High-grade diffuse intrinsic gliomas of the brainstem (HDBSG) that recur after radiation therapy carry a grave prognosis and have a median survival of less than 7 months. This presentation describes an unusually lengthy complete response (CR) of a 36-year-old female with HDBSG treated with Atengenal and Astugenal (ANP) which consist of synthetic analogs of naturally occurring phenylacetylglutamine, phenylacetylisoglutamine, and phenyl acetate.
The patient was diagnosed with a pontine glioma in June 1987 and biopsy performed on July 25, 1987, at UCSF confirmed an anaplastic astrocytoma. She was treated with hyperfractionated radiotherapy for a total dose of 76 Gy, which was completed on October 9, 1987. In February 1988, she developed diplopia, right facial paralysis and vertigo. A MRI of the head on February 25, 1988, showed interval enlargement of the tumor with extension to the right anterior pons and middle cerebral peduncle.
No further therapy was recommended at UCSF due to her tumor progression, and on May 23, 1988, she began treatment with ANP. On May 29, 1988, a low dose of methotrexate 7.5 mg PO daily (0.1 mg/kg/d) in five days on/off courses was added to ANP. On July 12, 1988, methotrexate was discontinued and she continued intravenous infusions of ANP only (the maximum dosage of Atengenal was 0.8g/kg/d and of Astugenal was 0.2g/kg/d). Intravenous ANP were discontinued on August 10, 1989 and replaced by oral ANP (the maximum dosages were 0.14g/kg/d).
All treatment was discontinued on January 21, 1990. Follow-up MRIs revealed gradual decrease and eventual disappearance of the tumor on January 23, 1989. Numerous subsequent MRIs confirmed CR. ANP was well tolerated with only minor reversible side effects including a skin rash, fever and slight leukopenia from which she recovered completely except for a mild right facial nerve paresis, which occurred after the initial tumor biopsy. She is currently doing well and has not suffered from any chronic toxicity related to ANP.
Periodical repeat MRIs of the head (the last on April 28, 2007) have shown no tumor recurrence. The National Cancer Institute (NCI) confirmed her diagnosis and CR during a site visit. ANP is a multitargeted therapy, which is currently pending use in Phase III trials in newly diagnosed diffuse intrinsic brainstem gliomas.
All treating "AMA" Certified Oncologists say my wife will die form her brain tumor and that there is no cure with standard medicine.
ANP has passed Phase 1 & 2 Clinical trails…with no significant side effects and Dr. Burzynski has offered all treatment at no cost, i.e free!
Even if it doesn't work, Liza has the right as a citizen to freedom of choice.
Hey, if she dies after treatment, then the FDA has more cannon fodder…yes?
I say it is suspect that there's such a block on getting access, especially when I know for a fact that there are patients receiving it now…this isn't for the general population per se…and we aren't trying to set a precedent….Liza deserves a shot at this even if it just to make her feel empowered!
I am truly sorry your wife is so sick. I don't know the pain and desperation you must be feeling, but I remember what it was like watching my sister-in-law die of cancer 3 years ago.
I definitely sympathize with you.
But unfortunately, Dr Burzynski hasn't published the results of any of those Phase 2 trials so we have no evidence how effective or ineffective the ANP treatment is.
And at least one person has died from ANP itself.
That is why the FDA has stopped him from accepting patients.
I wish there were a way to empower Liza and I wish there were a way for her to enroll in a different experimental trial.
Unlike Dr Burzinski, most such trials are at no cost to the patient.
But, I would ask if you would please, has the Burzinski clinic quoted a price to you for this treatment?
Again, you have my deepest sympathy and that of many other commenters at this site as well.
Dr. Burzynski has offered all treatment at no cost, i.e free!
If this is meaningfully true, as opposed to Burzynski's well-known attempts to segregate charges from himself and the Burzynski Clinic, the Burzynski Research Institute, and the grossly inflated charges from the in-house Southern Family Pharmacy, it reflects even more poorly on Burzynski. He's never offered charity care. If he suddenly is now, the only explanation is that he smells publicity: he wants to take advantage of you, who are in a very vulnerable position, in a different way.
"ANP has passed Phase 1 & 2 Clinical trails…with no significant side effect"
As squirrelelite points out, the results of those trials have never been reported. We have only rumors that they were successful. Why has Burzynski chosen never to report his results?
But also -- it is entirely false that there are no significant side effects. At least one patient died from hypernatremia; that's why the FDA finally took action. Even where the patient didn't die of the treatment, the only way to keep their sodium levels down was to drink enormous amounts of water, which of course had to be excreted -- meaning their final months were spent running to the bathroom, not getting enough sleep because of the constant need for urination ....
Again, I urge you to read the stories at The Other Burzynski Patient Group. Those stories are mainly in the patients' own words, describing what their treatment was like.
I do feel sympathy for the desire of an adult to make her own health choices, even if they appear very unwise. But that doesn't mean that people should not be able to comment on those choices, in hopes of dissuading others from making the same mistake. And it certainly does not mean that people should not be able to criticize those who offer false hope.
"“ANP has passed Phase 1 & 2 Clinical trails…with no significant side effect”
Sounds like Dr. Charles NIchols promoting the heart drug Provasic in "The Fugitive". :)
With few exceptions, Burzynski's patents have expired.
With few exceptions, so have his patients.
ANP has passed Phase 1 & 2 Clinical trials
You have been lied to - since Burzynski has not published the results of these these Phase II trials, ANP has not "passed" anything. The fact that he has not published the results is strong evidence that ANP has failed.
I started to write a response, but it got so long that I decided to turn it into a new post. Please click on the link below to see what I have to say. Best wishes to you and your wife:
What incredible arrogance, inflated ego, and insensitivity has been displayed here. The case against the treatment has been presented. The simple truth is that Liza Cozad apparently has no options. She is an adult. So long as she is fully informed, she should have the right to determine what happens to her. It may not be your choice, but that's precisely the point. It's not your choice to make for anyone but yourself. There is no attempt here to provide access to any one but her. If the clinic provides the treatment pro bono, there is no financial argument. Even if they do not, you have to right to decide how you spend your own money, not how anyone else spends theirs. Not to be callous, but where is the downside? She is terminally ill. At worst, she dies and provides more data against the clinic and fodder for bloggers ad nauseum. Why would any rational person think they have the right to impose their choices on Liza Cozad and why would any rational person accept it?
To quote CS Lewis: "Of all tyrannies, a tyranny sincerely exercised for the good of its victims may be the most oppressive."
What an incredible lack of reading comprehension, FTW.
The issue is that Burzynski is attempting to use emotionally charged cases (such as Liza) to circumvent the FDA's very reasonable (and evidence-supported) block of further ANP "one-person trials." If Burzynski had bothered at all to follow the well-justified clinical trial procedures, perhaps Liza and other patients could make a "fully informed" choice.
This may be a case where the slippery slope argument is actually appropriate.
One person has already died from the effects of this treatment. And many more have paid hard earned and donated money to be treated this way with no evidence of effectiveness.
So, the FDA has stepped in to stop the show.
But now Liza Cozad says, "I'm and adult and I'm dying anyway and I want to pay my money and take my chances Please give me the treatment."
So, the FDA gives in and says, "OK you can have it but no one else."
But then the next dying patient complains, "you let Liza have it, why not me?"
And so it goes on and on the way it has been for years.
So the FDA finally steps in and says, "Enough already, no more ANP treatments to anyone else."
Which is what they have done.
There is a way for Liza Cozad to get ANP.
It would require a researcher or institution not affiliated with SB to submit a new PII trial design to the FDA and request permission to proceed with a trial. They would not need SB permission as the compounds in question are no longer under patent. There is precedent for this, from the FDA website:
"In 1991, the National Cancer Institute (NCI) reviewed some of Dr. Burzynski’s cases and decided to conduct clinical trials on antineoplastons at cancer centers. By August 1995, only 9 patients had enrolled and the clinical trials were closed before being completed.
4 years, 9 patients. I believe this trial has been discussed here in greater detail . Strange that such an allegedly effective compound failed to generate any interest from oncologists or patients once it was out of the hands of SB himself. Strange only until you realize that SB is a scam artist.
I'm not being serious. I'd be surprised if you could find a willing oncologist with research capabilities who would be interested in pursuing this research dead end. Even if it came all bow wrapped with funding included courtesy of rock concert fund raisers.
The fact that no other place on the planet is pursuing this approach speaks to the paucity of real evidence that SB has put forth.
Either he is a scam artist spouting lies about the effectiveness of his treatments, or he is a monster for withholding this treatment from the world for personal gain. If you favor the later, then he is a foolish monster, because he certainly could have made a lot more money by licensing out this wonder treatment and selling it globally.
I found the results of the NCI trial that was abandoned after 9 patients.
Nine patients were treated, in six of whom the treatment response was assessable in accordance with protocol stipulations. No patient demonstrated tumor regression. Reversible grade 2 or 3 neurocortical toxicity, consisting of transient somnolence, confusion, and exacerbation of an underlying seizure disorder, was noted in five patients. Mean steady-state plasma concentrations of phenylacetate and phenylacetylglutamine after escalation to the target doses of A10 and AS2-1 were 177+/-101 microg/mL and 302+/-102 microg/mL, respectively. Patients who exhibited confusion tended to have higher phenylacetate levels.
Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy. Antineoplaston-related toxicity was acceptable in most patients with appropriate dose modification, although severe neurocortical toxicity may occur. Steady-state plasma concentrations of phenylacetate with use of A10 and AS2-1 were similar to those reported with use of similar doses of phenylacetate alone.
I’d be surprised if you could find a willing oncologist with research capabilities who would be interested in pursuing this research dead end.
Particularly given that they seem lately to be playing back up the angle that antineoplastoids are HDAC inhibitors rather than cytotoxic. (I note with mild amusement that this patent (non-Burzynski) disagrees in passing (¶ 259).
That ship has long left Burzynski past the horizon.