Amidst all the sturm und drang after a recent post, I was reminded elsewhere on the blog why I do what I do. So I'm going to do more of it today.
You might recall Liza Cozad, wife of David Lauser, who is the drummer in Sammy Hagar's band. She has an inoperable brain tumor and wants to try Stanislaw Burzynski's antineoplastons. However, because of the partial clinical hold on his clinical trials, she can't get them. Unfortunately, now she and her husband have been using their names to lobby Congress to pressure the FDA to allow an exemption. I wrote a post about this around a month ago. The other day, Mr. Lauser showed up in the comments. I started to respond this morning, but the response grew so long that I just decided to turn it into a full post and link to it in the appropriate place in the comments. This is far more important to me than other things going on right now, and I hope you'll all understand why.
Dear Mr. Lauser,
As I said before, I'm truly, truly sorry about your wife. It really sucks. And, as I said before, I do to some extent understand what you're going through, although my mother-in-law wasn't nearly as young when her cancer recurred and went metastatic as your wife, who is a few years younger than even me, is. However, those who have responded to you are correct. I can't say whether you've been lied to or not or whether those who have told you all these glowing things about antineoplastons are true believers who think they're giving you accurate information. It doesn't really matter. What you're hearing is wrong, and it's far more likely that ANPs will harm your wife than help her. Worse, it is likely that ANPs would adversely effect your wife's quality of life in her remaining time, as other side effects of ANPs include fever, rashes, frequent urination (due to the enormous quantities of water she'll have to guzzle to keep her sodium levels down), and several others.
First off, toxicity. Were you aware that patients have died of hypernatremia (too much sodium) due to ANPs? Indeed, if you read the USA Today story about Burzynski from November (and I'm sure you have), you'll note that the reason the FDA put a partial clinical hold on Burzynski's trials is because a 6 year old boy, Josia Cotto, died of massive hypernatremia under Burzynski's care in the summer of 2012. If you look at the FDA report from the most recent inspection, you'll find that the FDA found that Burzynski underreported adverse events and played fast and loose with the Institutional Review Board (IRB), which is the committee that's the federal government requires every university and institute doing clinical research to have to oversee that research and protect patient interests and safety. It's supposed to be an objective body, one that has no ties to the investigator. That's not true for Burzynski. In fact, a crony of his from his days at Baylor in the 1970s, Charlton F. Hazlewood, is the chair of the Burzynski Research Institute IRB! In its report, the FDA was blistering, saying that the BRI IRB failed to protect patient rights and interests.
Second, the FDA also found that Burzynski often misclassified tumor response to ANPs, almost always in the direction of better responses. Consequently, even his claims are exaggerated. As Liz Szabo at USA Today documented, Burzynski is missing quite a few baseline MRIs used to evaluate response rates; so the FDA couldn't even go back and compare original scans to see if Burzynski was right. In addition, Burzynski has a well-known pattern noted by me (and others) of claiming that when a tumor starts to look liquid in the middle that it means the tumor is responding and dying. That is actually the normal course of progression of many tumors, in which the tumor grows faster than its blood supply can follow, resulting in the center of the tumor dying from lack of oxygen while the outer layers of the tumor keep right on growing.
None of us want anything bad for your wife. We'd actually all be very supportive if we thought there was the proverbial snowball's chance in hell that Burzynski could do what he claims. But we were all forced to come to the conclusion that he cannot, based on his history over 37 years, and his failure to publish the results of his clinical trials, which are shams. I'll repeat what I said last time: Don't believe me about this. 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!
This is likely why Burzynski has never published a completed phase II clinical trial, despite having opened 72 of them back in the mid- to late-1990s. Given how, alas, rapidly fatal many brain tumors are, 16 or 17 years represents plenty of time to have accrued patients and published. All we can conclude is that ANPs almost certainly do not work.
All of us actually think Sammy Hagar must be a stand-up kind of guy, a hell of a friend, to want to do concerts and raise money to help your wife out. Unfortunately, his good impulses have been yoked to a bad cause. Think of it this way. Contrary to what Burzynski or his fans have told you, ANPs are chemotherapy. There's nothing any more "natural" about them than there is about other chemotherapeutic agents derived from natural sources, such as taxol (derived from the Pacific Yew tree), vinca alkaloids (derived from the periwinkle plant), and topotecan (derived from the happy tree). Indeed, ANPs are a lot like taxol in that they originally came from a natural source, but then scientists found a way to synthesize them in the lab. All the word "chemotherapy" means anyway is the treatment of cancer with chemicals; so they're selling you a false dichotomy between "natural" and "chemotherapy." Also, if Burzynski wants to give your wife his "personalized, gene-targeted cancer therapy," please, please, please, run. In his hands, this means incompetently administered combinations of chemotherapy plus very expensive new targeted drugs that will drain your bank account, cause unpredictable side effects due to combining drugs that normally aren't combined, and be incredibly unlikely to save your wife's life. I know that's not what you want to hear, but it has to be said.
Finally, please consider this. If there’s anything worse than dying of a terminal illness, be it cancer or whatever. It’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit and even possibly having to pay for the medications causing the complications yourself. That's what Burzynski is offering your wife. I'm really sorry to have to tell you this, but I think a hard truth, respectfully and gently (I hope) administered, is better than a comforting fantasy, at least in the case of you and your wife.
Thank you for writing this letter Orac- It tells some hard truths.
I recently saw a Twitter conversation where a Burzynski patient was asked point blank why Burzynski hadn't published any of his dozens of antineoplaston drug trials. The answer received was "Big Pharma".
This is not a good answer- Burzynski has a web site- It would take only a few minutes to post the results of the trials. Or he could provide the results to KTVU tv, which recently interviewed David and Liza. http://www.ktvu.com/videos/news/marin-woman-gets-all-star-help-in-fight…
David wonders why some people have been able to get Antineoplastons but Liza can't, blaming FDA bureaucracy. But if Burzynski does have the cure for cancer, that doesn't explain why he failed to submit an application nor publish his trial results at any time over the last 40 years. Yes, he has published a few (flawed) papers but never the full results of a trial.
Even Dr. Oz questions the blame of the FDA and Big Pharma in an interview with Eric Merola: "Why would you bury a cure. Why not just make money off the cure?" Eric Merola responds by alleging more conspiracy theories rather than acknowledging any failure on the part of Burzynski to show efficacy of his treatments.
Dr. Andrew Vickers has performed studies on alternative medicines and he is no fan of Orac. But even he has written how Burzynski's numbers do not make any sense: "It is claimed that 7% of 62 evaluable patients had a minor response. However, no fraction of 62 rounds to 7%" and "a 91% survival rate for 19 patients is impossible, as it corresponds to 17.3 patients.”
“I am aware that Burzynski is presenting preliminary data, and I have made no comment or criticism concerning the failure to present inference statistics. Nonetheless, even for a preliminary report, I see no excuse for the use of idiosyncratic and highly inappropriate techniques of presentation, failure to incorporate basic statistical estimates, citation of studies in support of statements when those studies have no bearing on the referring statements, inclusion of obvious mathematical errors, and citation of data for nonexistent control groups.”
Wishing a full recovery to Liza.
I wish the parachuter, who accused you of not caring about people suffering and dying unnecessarily, would read this post. Because if you did not care, why would you be trying so hard to help Mr. Lauser?
And, Mr. Lauser... please, sir, believe what Orac is saying. All of us recognize how f'ing terrible this is for you and your wife. None of us want her to suffer; we want her to live as long, comfortable, and happy a life as she can. You both deserve for her to have that. But what Burzynski offers will not give you that. The terrible side effects are not offset by any possible benefit: it's all risk, no benefit. Please, read what Orac has written, again, if you still aren't sure. Please look into science-based care designed to minimize harmful side effects and create the opportunity for that happy, comfortable life.
Burzynski's own lawyer says they made up all those trials so Burzynski could treat anyone he wanted with antineoplastons.
If you are trying to get antineoplaston treatment, and you believe that antineoplastons "passed all trials", then ask for a reprint of the paper reporting the results of the trial covering your condition. That's all -- just that one trial.
And if the response is that Big Pharma and the FDA conspired to prevent publication, then surely the paper was submitted before being rejected. As Mike said above, Burzynski could just publish these papers on his website, though for some reason he hasn't, but surely he would be willing to provide just one report to a prospective patient.
If he's not willing, what does that tell you?
I have a cousin, living far away, who was treated for lung cancer: He had what appeared to be a year long period of remission and then, a new recurrence. He's had difficulty with chemotherapy on his latest go-round. He's a terrific, independent person who had success creating and running his own business.
If I knew he was interested in what Dr B has to offer, I would tell him to read what Orac has written. ( Probably, I'd also tell him that B is a charleton who harms people- even children- that I'd fear for him if he went there).
He deserves better -even if he can't be saved.
ClinicalTrials.gov lists 40 antineoplaston trials. The status of most of them is listed as "unknown." One is listed as completed (melanoma), with the last patient data obtained in 2005. Results are not posted there. Neither the FDA nor "Pharma" has the ability to prevent Dr B from updating these postings.
Well and compassionately put. Thank you.
Good luck, Orac. I can't remember the source (Francis Bacon?) but as someone once said, "Man believes to be true what he wishes to be true."
"A man hears what he wants to hear and disregards the rest."
Simon & Garfunkel, The Boxer
repost from original thread:
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."
FTW - because, based on the information provided by her husband, she isn't making an educated decision. She is being lied to and given false hope.....that is the real problem.
David Lauser made the reasonable (in my view) argument that oncologists have nothing to offer his wife, so as a matter of freedom, she should be allowed to try something unconventional like antineoplastons.
I do agree with that. An adult should be allowed to do what she wishes with respect to her health, be it antineoplastons, magic water, laying on of hands, whatever.
em>However, a citizen's freedom to choose a treatment does not justify allowing someone to lie to her about the benefits of that treatment.
Consider someone urging you to invest your life savings in their company. The law requires them to give you a prospectus that honestly discloses the condition of the company and the prospects of your ever making anything back on your investment. I once heard a law professor joke that the average prospectus might as well read, "you'd be crazy to invest in this company", but people invest anyway, and that's okay if they've been honestly been told the condition of the company and the risks involved.
Imagine that you were invited to invest your life savings in a company that you read about on the Internet. Would you be happy if there were no prospectus at all, just the claim that, "We've made a substantial profit every year for thirty-five years"?
If someone pointed out that the company never once submitted their books to an independent auditor, or even a CPA, and they've destroyed a lot of the records so you just have to take their word for it, would you invest in that company anyway? Or would you want to investigate further? Would you think the law should allow someone to urge you to invest in that company without such a disclosure?
In the case of Burzynski, an honest evaluation appears to be that he has been treating people with his antineoplastons for decades under dozens of "Phase II" clinical trials, but in that time he has never once reported the full results of any of those trials so that independent researchers could evaluate those results (peer review). Furthermore, the FDA report appears to say that the results of at least some of the trials can't be evaluated because the necessary records are missing. And yet he wants people to place not just their life savings but their lives in his hands.
If prospective patients knew the true state of Burzynski's research, if they had the equivalent of a prospectus, and they went to him anyway, that would change the debate entirely. But since people continue to make false claims about his research (even if they believe the claims to be true), and he does not correct them (whether or not he is the source of the false claims), people like Orac continue to try to give prospective patients an honest evaluation.
No one answered you on the last thread so I thought I might here. Liza has choices - she has the choice not to take ANPs based on the available evidence. She has the choice not to risk avoidable side effects from a treatment that appears to have no effectiveness. I don't think anyone here is forcing her to do anything or to impose their choice on Liza. All they are doing is sincerely wishing that she makes a properly informed choice.
As for me, I watched my dad die of cancer last year. It is an ugly and unpleasant way to go but I am glad that he didn't choose a pathway that could only make it worse.
let me fix that for you:
So long as she is fully informed
She's not, Burzinsky's a liar.
Why would any rational person think they have the right to impose their choices
Do we fucking look like we're doing anything beside presenting the missing data to have Liza reconsider her treatment choice.
Not to be callous
No, you're being callous and insensitive because you don't recognize that the clinic is presenting their data through rose-colored glass which doesn't even register as truly informed consent. Furthermore, you don't seem to have any awareness that the scientific process is based on publishing data (or patents for that matter) so what do you have the necessary 2 brain cells to rub together to understand that a secret miracle cure is darn near impossible to do for an ethical scientists? Hell she/he is going to publish the cure and reap a nobel prize.
I think their complaint about tyranny is based on the fact that the FDA shut down the so-called clinical trials.
@Mike, #1 -- nice to see Sammy Hagar care, but when he asks "what's the harm?" the report might have found a specialist to answer, like Orac has: unnecessary and unproved drugs can cause damaging and painful side effects. And no one needs more pain, not Lisa, nor her loving husband.
“A man hears what he wants to hear and disregards the rest.”
"Lie, lie lie.
Lie lie lie lie lie lie lie lie, lie lie lie,
Lie lie lie lie lie lie lie lie lie lie lie lie."
At worst, she dies and provides more data against the clinic and fodder for bloggers ad nauseum.
Of course. More data to be ignored, and bloggers which you are dismissing as arrogant.
Let's keep the statu quo.
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?
It's Burzynski who has imposed his choices on those seeking treatment from him who are unable to get it.
He knew the rules. They were not impossible to abide by, by any means. Nothing and nobody prevented him from observing them. He chose not to.
If Burzynski treated 963 people with ANP in 1997 and by his own website's claim, over 8000 total, isn't it odd that we only hear about a half a dozen odd cases? He should be able to tell us how many of those 8000 are living, how long they lived, and how many had tumors shrink. If he did this-- and if it was >5%, then he would probably get the drug approved by filing a New Drug Application and there would be no question of access to the drug (although some patient advocates have railed against such modest results). Actually he didn't need to treat 8000 to test this-- usually 40 is enough for a phase II trial, and, well, for 72 clinical trials, it would only require 2880 patients! He's already treated thousands more people than needed to reach a conclusion about whether it works!
Instead we somehow hear of about 10 among those 8000. Does that mean it works in 10/8000 = 0.12%? Or does that mean that 0.1% are misdiagnosed, have spontaneous recovery or some other rare oddity? I can't tell, but it doesn't look promising.
Have Burzynski publish results showing 400 out of the 8000 = 5% had amazing results, and it would be meet the minimum to appear convincing.
"Not to be callous, but where is the downside? She is terminally ill. At worst, she dies and provides more data against the clinic . . ."
Do you really think being terminally ill means that dying people are just throw away commodities?
All of this "do we have the right". . "liberty or death". . . . is not useful to a patient who is within weeks of dying. Maybe there are vast numbers of patients who are thinking, "I'm dying so I want family, friends, caregivers to make a stand for ______-":
But my belief is that the majority of terminally ill patients are not feeling desperate to make any kind of a stand at all.
They would like to live, and live with a decent quality of life. Barring that, they'd like to die with a minimum of suffering. That's it.
If someone is determined to be treated with ANPs -- phenylacetic acid and PA-glutamate -- do they really need to involve Burzynski? I mean, it's not as if he's the original source of the stuff, now that he's stopped extracting / synthesising it himself, and turned to buying it from pharmaceutical warehouses. It's not that he adds any subtleties in his prescriptions, which are always the same. And it's certainly not as if he's monitoring his patients' conditions to check how well they're handling the side-effects.
Wouldn't it be easier to get on the phone to Sigma-Aldrich or such as and order a few kilograms of PA, then pay an impecunious vet or med student to fit you with a Hickman line?
@herr doktor bimler, I was thinking the same thing. He patented the process, but the patent has expired so anyone can read the patent, see what he claimed worked, and just do it. If the stuff weren't so hideous that you need a Hickman line, any layman could run an IV. An ethical doctor could even try to run real clinical trials -- the sort of things Burzynski hasn't been running. One could imagine all these people raising money for the ghoul, instead donating the money for a genuine trial -- which would answer the question of whether the stuff works.
Of course I don't speak for the FDA, but it seemed to me that their objection was that Burzynski wasn't running real trials and that patients weren't protected. Unlikely though it appears that antineoplastons do a bit of good, it is astronomically more likely that that homeopathy does any good. Maybe somebody could apply for a grant to run a real trial.
Anyway, antineoplastons don't appear to be any worse than the Gerson protocol, and a trial of that was funded.
I'd disagree. The Gerson protocol doesn't predictably produce such toxic effects.
Oh, hell. More credulous reporting:
The downside, as you would know if you had read Orac's post, is that instead of spending the remainder of her life with her family and friends in as much comfort as possible, or maybe going someplace she's always wanted, if Cozad takes your advice, she would be in a clinic somewhere, away from home, and suffering unnecessary pain beyond that caused by the cancer.
Nobody is saying she doesn't have the right to make that choice. What Orac and other people here are saying is that Cozad has the right to make an informed choice, not buy Burzynski's expensive, painful snake oil.
I’d disagree. The Gerson protocol doesn’t predictably produce such toxic effects.
I had the impression that the worst adverse events were due to overdoses, and it seemed to me that the probability of overdoses could be greatly reduced by proper procedures (checklists, written or online schedules, individually packaged doses). I'm not a doctor however.
I fear that the pressure on the FDA will become too much and they will throw up their hands and say, "Fine, go right ahead." And an endless stream of desperate victims will continue to suffer because of the false hope Burzynski feeds them.
Well said, Orac.
There is a particular cruelty about false hope of prolonging life, and that is exactly what Burzynski is offering. By deliberately offering false hope, he is engaged in calculated cruelty.
MadisonMD @ 20 makes the conclusive case. If Burzynski has treated 8,000 people, he could have published his data on his own website: nobody is stopping him doing that. If his treatments have any efficacy at all, he could do better than dribbling out an anecdote or two on camera: he would have 400 or more such anecdotes, backed up by case data showing positive outcomes. The difference between a few and 400 tells you everything you need to know.
FTW @ 10: For 'incredible arrogance, inflated ego, and insensitivity,' to which we can also add 'calculated cruelty,' nothing beats holding out false hopes of survival.
Hope is a wonderful thing. Trying to demonstrate to a person that the hope they have is based on someone viciously lying to them, is not so wonderful: it's a difficult, distasteful, and unpleasant task. In the end it's their life, and in the end we all die. But a death complicated by needless cruel suffering at the hands of a con artist is all the more tragic. That's what we're speaking out against.
One more thing.
Assume all these fundraising concerts occur, and raise the money. All the people who attend the concerts will be hoping and praying for Ms. Cozad, and for Burzynski's 'treatments' to work.
But when the treatments don't work, the people who went to the concerts will also be seriously let down. That's a small measure of cruelty delivered to each of them.
For some of them, conspiracy theories about Big Pharma may ease the cognitive dissonance. Some of them will end up going down the rabbit hole of alt med and suffering health consequences for doing so.
The majority, once they find out that their hoped-for miracle was cruel quackery, will get soured on going to any more fundraising events for people who need expensive medical care, or for medical research such as to seek cures for other life-threatening illnesses.
Every con artist who succeeds, also contributes to the erosion of the framework of trust and mutuality upon which every civilised society depends. In the end that's another part of Burzynski's legacy: spreading cynicism in the tragic aftermath of false hope.
What Orac says above is correct. Burzynski recently accelerated my father's death with his stupid miracle drug. My goal is to use my dad's experience to help educate others and hopefully prevent a similar nightmare. More to come.
I would also encourage anyone considering Burzynski to ask themselves why he often requires his patients to purchase their medications from the pharmacy that he owns, at colossal markup. If it were really about the treatment rather than Burzynski's obscene profits, it shouldn't matter where the drugs are purchased. But it does to Burzynski. If someone can offer an explanation for this other than that "he is a crook," I'd like to hear it.
I'm really sorry to hear about your father, ConcernedRelative, and my thoughts are also with Ms. Cozad and Mr. Lauser.
ConcernedRelative @ 31: Sorry to hear about your dad.
Orac frequently has blog entries updating the situation with Burzynski, so keep in touch with this blog and you can post to those entries, where more people will see what you have to say. Things move pretty quickly here, so posts you make to any entry that's more than a few days old may not reach as many people.
There's a lot of solidarity and mutual support here among people who have loved ones who were harmed by various forms of 'alt med' ('alternative medicine' quackery). It would be a good thing if folks who had personal experience with Burzynski were able to get together online, whether here or somewhere more private (don't use Facebook for that, they change their 'privacy' policies frequently, and very often the result is that peoples' personal & private information gets broadcast to the world).
Here's an article published today about Ms. Cozad that refers to Orac, this blog and the posts on the subject. Unlike much of the credulous reporting on the subject, this one is much more critical of Burzynski. The writer actually says he uses Quackwatch and RI as research sources.
You know the writer is on the right track because Eric Merola complains on his Facebook page that he "gets the majority of his facts wrong..."
Note that Mr. Lauser shows up in the comments, as does Merola himself to pimp his Burzynski movies and of course, his new laetrile oeuvre.
Wow, It appears my wife's dilemma and quest for life has caused quite a fuss….it appears we've hit a nerve?
My guess is our press and investigations threaten people like ORAC, BORAT and/or Dr. NO or whoever they are…
I've found in life , the louder people cry when trying to defend their position, usually the bigger the lie….I'll rack that up as a plus in our favor…the truth hurts! ;->
This is obviously a biased website…frankly, I realize that the internet cannot be taken seriously at times…
I assume the testimony below will be viewed as a fabrication:
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)]
My guess is our press and investigations threaten people like ORAC, BORAT and/or Dr. NO or whoever they are…
You haven't conducted any "investigations." Burzynski's scam has been a topic of discussion here well before your dreadful situation arose.
I assume the testimony below will be viewed as a fabrication
No, but Patronas isn't exactly singing the same tune these days. If you're just going to repeatedly quote from the Merola advertorial, I'd submit that you're not really interested in an objective view.
"Wow, It appears my wife’s dilemma and quest for life has caused quite a fuss….it appears we’ve hit a nerve?"
No, some people are trying to save your wife from unnecessary misery and you from being fleeced by the Burzynski con. They also dislike scam artists in general, so there's that.
You are both quite free to make your own decisions.
A few months ago, I learned that a friend of mind has stage 4 lung cancer, metastasized.
Chemo didn't work.
He's done radiation to the extent it was applicable.
Still not cured.
A week ago he started on a Tyrosine-kinase inhibitor known as Ariad AD 26113*, a genetically engineered drug produced by a capitalist pharma research company.
He was previously too weak to get out of bed. He can now do a 2 hour gym workout and runs 2 miles. He expects to be up to a 5k this week and back to 10K before long. Price of drug and all incidentals: Free.
*Not available in stores or Whale.to.
Let me first say that I am very, very sorry to hear about your wife's diagnosis. I know you view Burzynski as your best hope for your wife and that you undoubtedly want what he is offering to be true. But I would encourage you to ask yourself just one question: why hasn't Burzynski published the complete results of any of his 60+ trials from the past 30 years?
He needn't publish them in any journal; he has a web site. All he needs to do is put the results up so others can evaluate and replicate his findings. If he did so, then he would benefit so many more cancer patients around the world, if what he is selling has any merit to it. More physicians worldwide would then be able to use the same treatment and work toward approval and insurance coverage.
Please, just think about that. As to Orac, I highly doubt he is at all threatened by your pursuit of Burzynski's treatment for your wife. His mother-in-law died from cancer. Please take his letter in the manner he stated.
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
I find myself wondering why the lawyers called upon a radiologist -- rather than, say, an oncologist -- to testify on a question of oncology.
Dear Mr. Lauser -
I am very sorry about your wife. I work as a pharmacy tech and one of my jobs is mixing chemo. Perhaps the only thing worse than having cancer is the helpless feeling that comes when someone you love has cancer.
But Burzynski is a con artist. At work, if we were as careless as he is all of us would be looking for new jobs and the hospital would be up to its eyeballs in lawsuits.
That's what has us upset.
As #22 Herr Doktor pointed out, if you believe ANP will help your wife go for it. Just leave Burzynski out of the process.
Wishing the best for you and your wife.
Very sad to see another celebrity endorse the worst type of quackery to fleece the most vulnerable among us. Without a lick of science education David Lauser is choosing to be a strong advocate based solely on a propaganda film and despite the lack of scientific evidence from Burzynski and despite the warnings from numerous medical experts on this forum. While I sympathize for his situation with his wife, by buying into the false claims and supporting this Texas Quack, he is unwittingly dooming more people to the high debt which is all that Burzynski really offers. Liz Szabo the reporter with USA Today who wrote about Burzinsky tried to contact Dr. Patronas and described their interaction thusly: "As I looked at Burzynski’s endorsements, they fell through, either because they couldn’t be verified or because people apparently now don’t want to publicly be associated with Burzynski’s claims. His supporters like to quote some early supporters at NIH. For example, Dr. Dieter Schellinger. He is now elderly and said he has no memory of Burzynski. Dr. Nicholas Patronas is still at NIH, but did everything he could to avoid being quoted about Burzynski, and basically said any of his earlier comments were about preliminary work from the 1990s, and not meant to assess efficacy......the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer." Mr Lauser if you really care about your wife and those in her same condition then do your homework. Stop taking the easy way out and viewing propaganda videos on the internet. This is no way to find treatment for a loved one with a serious disease.
First of all if you did your homework you would know the truth. Both National Cancer Institute and the FDA have the data to show the success rates :-)
Why hasn't it been published you ask? The same reason this whole fiasco is the way it is. Big pharmaceuticals. They have submitted their results to the mainstream publication for years. And they refused to publish the results. So they would love to have them published...
Second I don't know if you do but so many of you on the Internet that are "anti-Burzynski" work for the pharmaceuticals (and we all know that), if you like for all of you that don't know we can send you the data on the trial results. In fact a former National Cancer Institute I don't know if he's an employee anymore after this but he testified before Congress about the efficacy of this drug -BASED ON THE RESULTS :-)
Now I'm going away again. I never read all this negative crap you people post anyway, and n I tell my husbands to stay away as well, but he's his own person.
Finally, it's sad that you are all so threatened by something. It's not your life, and if iyou were in my shoes I would respect your decisions, because until I've walked a mile….
And what would Jesus do?…
It won't be reading any comments coming back so say whatever you like. But again, what would Jesus do...
"It won’t be reading any comments coming back so say whatever you like. But again, what would Jesus do…"
If he were a real medical researcher (perhaps with a last name Mendez or Cortez), he would not make claims without evidence like,
"They have submitted their results to the mainstream publication for years. And they refused to publish the results. So they would love to have them published…"
" In fact a former National Cancer Institute I don’t know if he’s an employee anymore after this but he testified before Congress about the efficacy of this drug -BASED ON THE RESULTS"
Unless you provide sources and documentation there is no way to verify those statements. Just like there is no way to verify Burzynski's results because not only has he not published them, he has even destroyed many of the records.
@Chris - if Liza has such an in with Dr. B, she should convince him to publish his results here.....
Liza -- Burzynski's patents have expired. If ANP's do work, why hasn't Big Pharma (who could make millions of dollars off of a successful cancer cure) swooped down and gobbled this up?
Oh, and Liza? Jesus would probably horsewhip Burzynski right out of the temple.
"I don’t know if you do but so many of you on the Internet that are “anti-Burzynski” work for the pharmaceuticals (and we all know that)"
Wait...so you don't know...but you do know? I sense confusion.
"I never read all this negative crap you people post anyway"
If you don't read it, how do you know it's "negative crap"? For all you know, we're constantly singing the praises of Saint Stanley.
"(I) won’t be reading any comments coming back so say whatever you like"
Well, I don't think Jesus would preach at people and then ignore what they say.
How sad. I'm sorry Liza is so determined to waste her time and money.
BTW, Liza. I don't work for Big Pharma. I work for Big Insurance. If Burzynski's stuff worked, and was cost-effective (i.e. cured more effectively or was cheaper than current treatments) we'd be all over it. We have had patients on his protocol trying to get the services paid for. But since HIS chemotherapy has not been shown to be any more effective than regular chemotherapy, why should we pay for it? He's more expensive and so far as we know, far less effective.
All of them are now dead. Most had to quit the treatment because of the horrible side effects of the ANPs.
I respect as an adult, you have the right to make your own health decisions. You don't have the right to make them in the public forum and influence others to follow in your mistaken footsteps.
Shay @49 -- On first glance I misread your first sentence as "Burzynski's patients have expired."
Too true, alas.
Why hasn’t it been published you ask? The same reason this whole fiasco is the way it is. Big pharmaceuticals. They have submitted their results to the mainstream publication for years. And they refused to publish the results. So they would love to have them published…
He has a web site. Encourage him to just post the completed trial results there, with all of the supporting data and methods so that other researchers can evaluate them.
I'm sorry you won't be coming back to read this, but I hope you do. Then you can go to Burzynski and ask him: "Why don't you just put the full trial results of your 60+ studies up on your web site? That would help so many other people!"
Finally, it’s sad that you are all so threatened by something. It’s not your life, and if iyou were in my shoes I would respect your decisions, because until I’ve walked a mile….
And what would Jesus do?…
I don't think anyone here disrespects you. I certainly don't. In fact, I wish and hope for the very best for you.
But the question I ask myself is:
"What would I do if I had the data to prove I'd discovered a safe, effective treatment for cancer that no one else knew about, but the establishment ignored and scorned me?"
And the answer is that I would make it public. Nothing and nobody would be able to prevent me from doing so, this being the internet age.
Because I'd be complicit in the unnecessary deaths of people all over the world otherwise. It would be a moral imperative.
I imagine that any decent human being in those circumstances would do the same.
As someone here (Krebiozen? Narad?) has pointed out, either Burzynski is a shameless con artist OR he is a greedy bastard who refuses to share information on a therapy that could save hundreds of lives.
Either way, not my candidate for sainthood.
You know, I truly wish Ms. Cozad every health, happiness and reward that life has to offer.
In fact, it's not like I wish Burzynski ill, per se. I don't know the man. It's his conduct I have a problem with.
Because (more or less as you say):
The absolute best-case scenario is that the reason Ms. Cozad can't freely exercise her choice to be treated by him is that he recklessly ran such a shoddy study that he was unable to set the FDA straight when they said:
“You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [....] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.”
And that wouldn't reflect well on him if it were true. To put it mildly. Lives are at stake.
The alternative explanation is that he failed to ensure the safety and welfare of his patients.
I don't see another. The FDA didn't shut him down for doing anything a wrongly accused person wouldn't be able to disprove. It's either documented. Or it's not.
If it is, then he's the one responsible for making treatment unavailable. But other than that, this is not about patients' choice in any way..