My response to David Lauser re: Liza Cozad, Stanislaw Burzynski, and antineoplastons

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.

The direct link to the FDA report can be found here, and direct links to the two most recent warning letters to Stanislaw Burzynski and the BRI can be found here and here.

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.

And:

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.

Best wishes,
Orac