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Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA, this time with rock stars

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.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

145 replies on “Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA, this time with rock stars”

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).

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.

http://en.wikipedia.org/wiki/List_of_off-label_promotion_pharmaceutical_settlements

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’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.

jane,

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…

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?

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.

Mike,

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.

[/sarcasm]

@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.

Bob G.,

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.

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-findings-about-stanislaw-burzynskis-trials/ 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.

Liza,

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.

Liza,

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.

@kc

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):

http://respectfulinsolence.com/2013/11/15/stanislaw-burzynski-in-usa-today-abuse-of-clinical-trials-and-patients-versus-the-ineffectiveness-of-the-fda-and-texas-medical-board/

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 😛

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.

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.

http://respectfulinsolence.com/2013/09/20/patients-endangered-by-failure-of-medical-boards/

LW: How are they not true? If something isn’t prosecuted, that’s the same as it being legal.

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.

@kc

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.

@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: “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?

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…

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