It's hard for me to believe that it's been almost three years since I first started taking an interest in the Houston cancer doctor and Polish expat Stanislaw Burzynski. Three long years, but that's less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet, just a much smaller precursor, and disco ruled the music charts. It's even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn't paid much attention to him much earlier in my blogging career. After all, I'm a cancer surgeon, and here's been this guy treating patients with advanced brain cancers with peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on "clinical trials." It might be a cliche to quote the Dead this way, but what a long, strange trip it's been. Because there was been a major development in this saga whose context you need to know to understand, I'm going to do a brief recap. Long time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven't already, read this summary of Burzynski's history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I'm so pissed.

When last we left Stanislaw Burzynski, for the first time in 37 years, he had published what was purported to be the complete results of one of his phase I/II clinical trials. The results were—shall we say?—underwhelming. Before that he had published 42.5% of one of his phase I/II trials, with even more unconvincing results. Meanwhile, since he received that warning letter from the FDA late last year, he's been trying to enlist patients, both cute children and the semi-famous, to persuade legislators to pressure the FDA to let his clinical trials open again after they had been put on a partial clinical hold in the wake of the death of a child from hypernatremia (too much sodium in the blood), as reported by Liz Szabo in USA TODAY, all the while charging patients large sums of money, while bragging that he didn't charge for the actual ANPs. For those unfamiliar with the story, a partial clinical hold means that Stanislaw Burzynski can't enroll any new patients on clinical trial but can continue to treat patients already enrolled.

Three months ago—has it been that long already?—I noted with dismay that, under the onslaught of sympathetic cancer patients who understandably but incorrectly believe that Burzynski is their last chance to live, the FDA had started to show signs of caving on the issue of the partial clinical hold. Ultimately, the FDA did cave, although in the most weaselly way imaginable, stating that Stanislaw Burzynski could again enroll patients under compassionate use exemptions (also known as single patient INDs), even though the FDA warning letter had found gross deficiencies in the Burzynski Research Institute Institutional Review Board (BRI-IRB), which is run by an old crony of Burzynski's who just so happens to be chair of the board of directors of the BRI and was found to be negligent in protecting patients by playing fast and loose with the regulations for enrolling patients on single patient INDs. The condition was that Burzynski himself or anyone working for him couldn't be the physician treating the patients, leaving the patients to find a doctor willing to oversee the administration of ANPs.

And so it was for three months, with desperate patients with terminal brain tumors scrambling to find some doctor willing to do the paperwork to get the FDA to allow him to administer ANPs and also willing to work with such a disreputable character. McKenzie Lowe's family, for instance, managed to find a retired family practitioner named Terry Bennett to agree to this. (More on this later.) Then, yesterday, this bombshell landed, courtesy of Liz Szabo again, in a story entitled FDA gives controversial doc green light to restart work:

The Food and Drug Administration has given a controversial Houston doctor the green light to resume administering experimental cancer treatments. The FDA has lifted restrictions on a clinical trial run by Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. Burzynski, 70, has wrangled with state and federal medical authorities for nearly 40 years over his claims that he has discovered natural substances that can fight certain cancers.

You might think that my reaction upon reading this would be "WTF?" It wasn't. However, that was only because I had had that reaction two days ago, when I read a press release from the BRI, Burzynski Research Institute, Inc. Announces Lifting Of The FDA Partial Clinical Hold - Phase 3 Clinical Study Agreed Upon:

The Burzynski Research Institute, Inc. (BRI) announced today that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted. The FDA has determined that under its IND the Company may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial. The FDA's decision to lift the clinical hold marks an important step in the development of Antineoplastons for the treatment of various forms of brain tumors in the US. At the same time, the Company is evaluating possible next steps for the Antineoplastons clinical program given the current progress and anticipated resource requirements of the ongoing program.

That was when I had my "WTF?" moment. However, noting the obviously intentionally vague language of the press release, I decided to wait until I could learn more and obtain confirmation rather than to blog the press release. For one thing, Burzynski could just be spinning furiously, and there could be a lot less to this press release than meets the eye. It wouldn't be the first time. Also, perhaps, even a Plexiglass box of blinky lights can experience a bit of denial. I just couldn't believe that the FDA would so horrifically fail patients with brain cancer yet again the way it now has. I could sort of see why the FDA issued its previous ruling that allowed other doctors to enroll patients in single patient INDs of ANPs. At the time, the FDA was under a lot of pressure from legislators being contacted by constituents about families in their state or district with brain cancer who wanted to be treated by Burzynski. Its cynical solution must have seemed downright Solmonic at the time to the administrators who thought of it. But this? There's nothing in the press release that says that the conditions that led to the partial clinical hold were resolved. Yesterday, however, there was this in Szabo's story:

In a statement issued Wednesday), the FDA confirmed that it has lifted its restrictions on Burzynski because he answered all of their questions. In particular, Burzynski addressed "common and serious (and in some cases fatal) adverse drug reactions, as well as accurate information on how often tumors shrink after treatment with antineoplastons."

Notice something missing? I did. The FDA said nothing about the BRI-IRB, which was soundly chastised for approving single patient INDs without full meetings of the committee. It also said nothing about the massive conflicts of interest that exist in the IRB and how it can't possibly be independent. Sure, if Burzynski talked the talk adequately, I might see how the FDA might be either snowed or too tired to fight any more. I could see—but not approve—how they might be tempted to let him open his bogus clinical trials again—but only if Burzynski were forced to use a truly independent IRB, not his crony-packed IRB that basically rubber stamps whatever it is he wants to do with no questions and no evident effort to protect the welfare and rights of clinical trial subjects. Any IRB worth its salt will refuse to approve a clinical trial now and then and/or issue warnings to principal investigators for inadequate documentation, too many adverse events, etc. Has the BRI-IRB ever done this? Not as far as anyone I know can tell. Of course, it's not really up to the FDA to oversee the function of IRBs. Rather, it's more a function of the Office of Human Research Protections (OHRP). Long have I wondered: Where the heck as the OHRP been all these years?

It's not as though Burzynski isn't up to his old tricks again, either. Even with another physician overseeing the treatment of McKenzie Lowe, he's managing to find ways to charge patients huge sums of money, even as he isn't charging them for the ANPs. Indeed, the other day, Dr. Bennett, the physician who is overseeing the treatment of McKenzie Lowe whom I mentioned near the beginning of this article, was featured in an article in a local newspaper Dr. feels misled in cancer treatment costs. The money quotes are here:

But there was something Bennett didn't know. Bennett's decision was based, in part, on a newspaper article that said Burzynski had agreed to donate the medicine required for McKenzie's treatment. But what Bennett didn't know is that Burzynki planned to charge the family for the clinical costs associated with the therapy. LaFountain said the first month's bill is expected to be $28,000. Every month after that is expected to cost $16,000. The treatment usually lasts eight to 12 months. And health insurance won't cover a dime of it.

And here:

Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie's therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same. Instead, said Bennett, “I'm supposed to be the bag man for all of this. They want me to collect the 30 grand for the family and send it to Burzynski.”

Elsewhere, Bennett said, “It meets all the criteria for a bait and switch operation." Yes, even Dr. Bennett found out the hard way how the Burzynski Clinic operates. None of this is anything new. Burzynski has been trying to dodge this tactic for years by saying that he doesn't charge patients for his actual drug, the ANPs, giving the impression that he's not charging them much of anything. However, the reality is that costs can rapidly add up to hundreds of thousands of dollars, which is why fundraisers by families of Burzynski patients have been a feature surrounding the Burzynski Clinic operation for decades, as I've documented time and time and time again.

This is a doctor who wants to help and is willing to take risks, even if inappropriately in this case, and he feels used by Burzynski. Indeed, his comparing himself to a "bag man" is a particularly apt metaphor, because that's what he is in this: A bag man. It's his job to collect the cash from the family of a dying child and ship it to his master in this case. Ironically, this news story appeared on the very same day as Burzynski's press release, and, of course, Szabo's story appeared yesterday. Did the FDA know Burzynski was doing this? It strains credulity to think that the FDA didn't know about this abuse of a desperately ill child's family, given that information regarding how it will be paid for is part of a single patient IND application, indeed part of all clinical trial applications. Indeed, that Burzynski gets away with this is yet more evidence that his IRB is nothing more than a rubber stamp, because any independent IRB would ask some very hard questions about such an arrangement. Very hard questions indeed. It's painfully obvious that the BRI-IRB has never asked hard questions any IRB should be asking about any clinical trial Burzynski has proposed or about how his clinical trials are being carried out.

It's even worse than that, though. Check out what I found on a website devoted to penny stocks, Burzynski Research Institute (BZYR) Reignites On FDA Approaval:

Focusing since 1967 on the isolation of various biochemicals produced by the human body as part of the body’s possible defense against cancer, the penny stock of Burzynski Research Institute, Inc. (BZYR) has exploded on the scene thanks to the efforts of CEO and President Stanislaw R. Burzynski, M.D., Ph.D. After notification that the U.S. Food and Drug Administration lifted its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections, shares of BZYR stock begun to trade and are putting on a good show thus far. Although only around 25 million shares issued and outstanding do not belong to the founder who is determined to treat of various forms of brain tumors, the large jump upwards has made this little biotech burz-worthy.

You know, with all the typos and English that sounds as though it were written by someone who isn't a native English speaker, this made me suspicious that Burzynski or someone from Burzynski's clinic wrote it. Either that, or the web page is written by non-English speakers, which seems likely given that I found the same sorts of weird-sounding sentence constructions in other articles and I know Burzynski's people can produce serviceable English prose when they need to. Be that as it may, I have little doubt that the Burzynski clinic is trying to take advantage of the FDA decision to bolster its flagging finances, which have been reportedly hurting since the partial clinical hold was placed. Whether this article on a website hawking penny stocks has anything to do with it, I don't know, but its appearance right around this time sure doesn't seem coincidental to me.

So what happened? Why did the FDA cave so ignominiously? How could it ignore 37 years of Burzynski's therapeutic misadventures and abuse of science and the clinical trial process? I have a few ideas, but none of them are satisfying, and all of them are speculation, ranging from educated to, well, just speculation. Back in the 1990s, it was powerful legislators like Joe Barton leaning on the FDA to let Burzynski be Burzynski. Today, there are no visible and obvious champions in Congress for Burzynski. Even so, that doesn't necessarily mean that such congressional patrons don't exist, given the campaign waged by patient families and the Burzynski clinic to get people to write their Congressmen and Senators. Another likely possibility is that the FDA is just tired. If it shuts Burzynski down, it will be portrayed for years as the bad guy denying patients a chance at life, and there will be an enormous court battle. If it decides to fight, the FDA could end up with years of litigation, and, given the FDA's unfortunately limited budget, it has to pick its battles. Does it help the the FDA mission overall if it drains so many resources fighting what it likely views as small fry like Burzynski that it finds late in the fiscal year that it can't afford to go after a large drug company over lack of resources? I don't know, but given how long Burzynski's been at it, the FDA's decision is still an extreme dereliction of its duty to the public.

Whatever the reason that the FDA caved, we'll probably never know. We can make FOIA requests, but the FDA is notoriously tight with the information it permits to be releases because it's forbidden from releasing information that might endanger trade secrets of the companies it regulates and it appears to take a fairly expansive view of what constitutes such information. At least, we'll probably never know unless we can get a powerful Senator or Congressman (or two) interested and as outraged as we skeptics are. A Congressional investigation, as unlikely as that sounds, is probably the only thing that will get to the bottom of the FDA's utter failure. It's clear that in this case the FDA is no longer able or willing to protect the safety, finances, or rights of patients with advanced brain cancers.

ADDENDUM: My partner in this endeavor, the man who handles the skeptical activism while I try to handle and explain the science, Bob Blaskiewicz, asked me to post a message for him. So here it is:

Tonight, Thursday, June 26, I will be giving a presentation about Burzynski to the Skeptical Society of St. Louis. I would like very much to have a representative of Sen. McCaskill attend, as she did such an able job dismantling Dr. Oz last week. It's clear that this nightmare will not end until the FDA's bizarre relationship with the clinic is investigated by legislators. Please contact her St. Louis office and ask them to go out of their way to send a representative to the talk, which will be at 7PM at Pat's on Oakland (in Dogtown, if anyone asks). Things are coming to a head and we need skeptics to ACT now more than ever to stop a medical ethics scandal that involves 8 times as many subjects as the Tuskegee Experiment. Thanks!

Sen. McCaskill's office:

Phone:314-367-1364

Fax:314-361-8649