I hate to end the week on a down note, but sometimes it's necessary. It's been a while since I've written about Stanislaw Burzynski. I'm sure you recall Burzynski. He's a hero in the alternative medicine world, having been cast as a martyr to The Man (i.e., the FDA and Big Pharma) because of his selling of a dubious cancer cure that he calls antineoplastons. Although he's been selling his questionable cancer treatments for thirty years now, he's recently been in the news a lot lately thanks to a credulous paean to his activities in the form of a movie that was released in 2010 called, unimaginatively enough, Burzynski: The Movie. As I pointed out late last year in my review of the movie, it is indeed a credulous paean that portrays Burzynski as a Brave Maverick Doctor battling The Man, all in order to bring The One True Cure for Cancer to the people. He was also featured in Suzanne Somers' encyclopedia of cancer quackery Knockout, which could best be viewed as advertising for every major cancer quack you can think of. Burzynski is also known for siccing his attack poodle on skeptical bloggers who have the temerity to criticize Burzynski for peddling an unproven cancer cure, charging his patients for taking part in his clinical trials, and his "personalized medicine for dummies" approach to targeted therapy.

All the while, patient after desperate cancer patient is drawn like flies to the proverbial lantern to Burzynski's clinic in Houston, lured by the promise of a cure for the incurable, willing to pay hundreds of thousands of dollars to realize that promise, no matter how many fundraisers are required or how many journalists throw away basic journalistic skepticism to pen what are in essence commercials for Burzynski's clinic. Meanwhile, his patients drop like flies. I realize that the vast majority of these patients would have died anyway. That Burzynski failed to cure them is not the issue. The issue is how he sells a useless therapy, how he represents his therapy as "natural" but uses lots of chemotherapy anyway, how he uses extremely expensive cocktails of targeted therapies with unknown toxicities, and how he charges patients hundreds of thousands of dollars for taking part in his clinical trials, which have yet to validate his antineoplastons as efficacious and safe after 20 years of trying. In other words, Burzynski charges huge sums of money for false hope.

And now another young cancer patient has paid the price. Let's jump back in time a couple of months:

The Mackey family in Danvers is in the midst of a battle that no family ever wants to find themselves in — a fight against a relentless brain tumor in their oldest daughter, Rachael Mackey, 28. A Danvers native and graduate of Danvers High School, Class of 2002, Rachael, was just beginning to create her life, graduating from Bryant College and working as a model as she traveled the world and developed her own small business, when she began to experience intense headaches. Doctors trouble shooted the headaches treating Mackey for potential migraines and even prescribing eye glasses to see if that would help, but the headaches would not dissipate. “It was like having a four-month headache,” Rachael said. “There was so much pressure in my head.” Her mother Kathy Mackey said that when Rachael was slated to travel to Indonesia, her family encouraged her to have an MRI before she left.

The news wasn't good. Mackey had a 7 cm grade II oligoastrocytoma. In 2010 she underwent a craniotomy to remove the tumor. Unfortunately, as these tumors are wont to do, her cancer recurred in December 2011. Mackey underwent a second surgery in June, but apparently her surgeons were unable to resect the tumor. Consequently, it was recommended that she undergo chemotherapy and radiation, and it was estimated that there was only about a 3% chance that the tumor would responde significantly to the regimen.

Now put yourself in Mackey's place. You're 28. You're a beautiful young woman. You're faced with a horrific, almost certainly fatal diagnosis. Your life is likely to be measured in months—possibly even weeks—rather than the decades more 28-year-olds expect to live. No career. No marriage. No children. No dreams realized. I get it, at least as much as anyone who hasn't faced such a diagnosis can get it. You want to live. You're willing to do almost anything to live. Heck, I'm well into my middle age now, and I would still want to live. I'd probably want to live even if I were 80, although perhaps not as strongly anymore, having had a good life.

Enter Burzynski and his antineoplastons:

During their research, they discovered an alternative cancer therapy in Houston, Texas, that was reported to have some success in treating brain tumors. The Burzynski clinic, run by Stanislaw R. Burzynski, MD, Ph.D, has been a source of controversy within the medical community. Many doctors deem the gene targeted therapies as misguided, yet many patients claim it saved their lives when other traditional treatments could not. After enduring two major brain surgeries and given the low success rates and horrible side effects that radiation and chemotherapy would have, Mackey wants to try the program at Burzynski Clinic. "I like that they treat the cause and stimulation of your cancer — not just the symptoms,” Mackey said who at the moment is asymptomatic. “Because without treating the cause, the tumor will just continue to come back. Our goal is to defeat the tumor and not have to worry about it for the rest of my life.” The clinic has currently been approved for Phase III Clinical Trial for Antineoplastons treatment and Mackey’s brain tumor met the criteria to be accepted as a patient in the trial.

There's that damned phase III clinical trial again! I would almost kill to find out how that particular trial was ever approved. (That's metaphorical, people. I wouldn't actually kill anyone, but leave it to a Burzynski fan to try to quote mine me.) The reason, of course, is that Burzynski wields that phase III trial like a club against his critics, with its implication that because the FDA approved his trial there must be something to it. Personally, having pored over Burzynski's publications, I just don't see it, which is why I'd love to see the preliminary data and rationale upon which Burzynski got this trial approved. I also can't help but note that if you go to ClinicalTrials.gov and look up Burzynski's phase III trial, you'll see that it was approved in December 2010 but is still, nearly two years later, not recruiting any patients. This is quite unusual. Most investigators can't wait to accrue patients to their clinical trials, and most institutional review boards (IRBs) and clinical trial offices get very antsy if a trial is open for a year and isn't reaching its accrual targets, much less not accruing even one patient. I've seen it many times at the two cancer centers where I've worked. I suppose that's the advantage of owning the "research institute" and the IRB. I'm sure no one's giving Burzynski any crap about not having opened his phase III trial yet other than cranky skeptical bloggers like myself, and, with his money flow continuing apace, Burzynski can afford to ignore us.

Be that as it may, I also hate how Burzynski claims to treat the cause of cancer more than oncologists. Let's just put it this way. In the unlikely event that antineoplastons actually demonstrated significant antitumor activity, they'd be chemotherapy, every bit as much as doxorubicin, taxotere, or cyclophosphamide. To label them as somehow "natural" and "nontoxic" is nonsense, a lie. It's also about as unethical as one can imagine to do what Burzynski does, which in this case was to charge Mackey $30,000 for her initial treatment and then $7,000 a month after that, with an estimated total cost of $100,000.

As so many other Burzynski patients have done, Mackey and her family took to fundraising, holding a yoga fundraiser and a golf fundraiser, among other fundraisers, and, of course, taking to the web and Twitter. Knowing that Mackey died on October 28, it's truly saddening to read her Twitter feed and blog. While I encourage you to read Mackey's Twitter feed and her blog, I would strongly discourage any of you from commenting there with anything other than messages of sympathy and support. Remember, the family has just lost a daughter at far too young an age. There is nothing to be gained from recriminations and criticisms on her blogs. I trust that most of you won't even think about doing that once you see her story in more depth.

Bob Blaskiewicz over at Skeptical Humanities has started a Storify page that chronicles Rachael Mackey's experiences with the Burzynski Clinic. It begins with a CT scan that showed that Mackey's tumor had started to grow again and continues with her video blogs:

Here she is after the antineoplaston therapy has started. Note that it's dated a mere eight days before her death:

About a week after starting antineoplaston therapy), about a day before she posted the above video, Mackey Tweeted:

Unfortunately, she was mistaken about the significance of her symptoms. Eight days later, Rachael Mackey died. We don't know the details. We don't need to know. She had a terminal cancer, and most likely it was simply progression, although one can't rule out the possibility that the antineoplastons hastened her death. They are not nearly as nontoxic as Burzynski claims, as I've documented multiple times before. We can never know, however. Chances are, this unfortunate young woman simply died of her disease and the antineoplastons did nothing to slow its progression.

Burzynski fans frequently attack a straw man in which skeptics are said to blame Burzynski for the deaths of patients like Rachael Mackey. They like to present Burzynski as taking on hopeless cases, all in the name of advancing cancer care by "personalizing" it (although, one should note, that "personalization" and "targeting" almost always includes antineoplastons in Burzynski's hands, which doesn't represent much in the way of "personalization" to me). He's presented as the Brave Maverick Doctor willing to take on The Establishment because, well, he just cares so deeply about his patients, and, given the really sick patients who flock to his clinic, Burzynski can't really be blamed if nearly all of them die, can he? It's not fair, right? After all, nearly all of them would have died anyway with conventional therapy, right?

Not exactly.

When it comes to caring for patients with advanced cancers, there's more to consider than whether the patient lives or dies or how long she lives. In the case of terminally ill patients who can't be saved, there are two goals that are foremost. First, we want to prolong life as much as we can, as long as the side effects are not prohibitive. Then, if it's not possible to prolong life (or not possible to do so without unacceptable side effects), there's palliation, which is arguably the most important of all. It's also something that "conventional medicine" is becoming better and better at. There's the chance to die at home with dignity. There's not being forced to exhaust all of one's resources (and often much of one's family's resources) and having to go to great lengths in the final months or even weeks of one's life to raise tens or hundreds of thousands of dollars to pay for Burzynski's treatments before death arrives. There's providing a realistic picture of what the patient is likely to expect, so that she can put her affairs in order before she is unable to do so and make informed decisions about her health care. As difficult as it is, that's real empowerment, not the false empowerment given when someone like Burzynski tells a patient that he can possibly save her where conventional medicine cannot. These are not insignificant things to cancer patients and their families. They are also exactly the things that Burzynski robs his patients of.