I’m depressed as I write this, because I have some very sad news to relate to you. It appears that Laura Hymas died on Sunday morning. I learned this on Twitter yesterday from a source I trust, not to mention from mentions on Ben Hymas’s Facebook page, in which friends are commenting on how they remember her. Apparently, her brain tumor recurred, and ultimately she entered hospice and was reported to be in her “final stages” a week ago. My sympathy goes out to her family. She died at far too young an age. No one deserves to have her life cut so short by such a deadly brain tumor, particularly a young mother recently married.
Hymas, as you might recall, has been held up as a success story by a doctor about whom I’ve blogged on numerous occasions over the last two or three years. I’m referring, of course to Stanislaw Burzynski, a doctor who is not an oncologist—and not even board certified in internal medicine—but claims to have discovered a treatment for the deadliest cancers that is far superior to the standard of care, even going so far as to claim to be able to cure a cancer that’s never been cured before, namely diffuse intrinsic pontine glioma (DIPG). As I’ve pointed out before, this claim is false, at least the part about there being no record in the medical literature of anyone having ever survived DIPG. That’s not the only—shall we say?—liberty with the truth that Burzynski and his supporters have used, but I’m not really in the mood to go too much into the detail of why I consider Burzynski to be a despicable human being, other than to mention how his supporters have used the story of Laura Hymas to promote his treatment with antineoplastons. Indeed, she is prominently featured in Eric Merola’s latest paean to the brave maverick doctor in a segment in which a recording she took of a conversation between her and her NHS oncologist in which she and her family tried to persuade him to be the U.K. doctor monitoring her as she takes antineoplastons. It’s a harrowing scene in that I saw a doctor trying desperately to do the right thing, despite extreme pressure from the patient.
As recently as November, Ms. Hymas was still being touted as a success story, cured by Stanislaw Burzynski when no one else could cure her, leading to credulous stories in the British press like this one, entitled Young mother with brain cancer given just a year to live BEATS the disease and gets married after having controversial treatment in the US. And, I must admit, that of all the Burzynski “success stories,” that of Laura Hymas puzzled me more than most. Of all the many patient anecdotes presented by Burzynski and his propagandist as “success stories,” Hymas’s story was the one the came the closest to actually sounding as though there might be something to it, although I still couldn’t rule out that her good fortune was a result of the conventional therapy she had before she discovered Burzynski. Then she dropped out of site not long after her wedding, and I got worried. I had a bad feeling about her, and I really hate it when my bad feelings turn out to be right.
As I said, I’m saddened to learn of her death. It doesn’t matter that she was used by Burzynski. She really believed that Burzynski had saved her, making it difficult, if not impossible, for me to be too hard on her, just as I find it difficult to be too hard on any of Burzynski’s patients, preferring to put the blame squarely where it belongs: On Burzynski. I also feel obligated to discuss her death. Given how many of Burzynski’s previous “success stories” who ultimately turned out not to be anything of the sort were forgotten by Burzynski after their deaths, never to be mentioned again, instead to have all memory of them other than by their families wiped from the Internet and no mention of their deaths, we skeptics honor them by remembering them and, to the extent we can learn it, how they died, because it’s certain that Burzynski and his supporters won’t. In fact, they’ll do their best to bury the memories of former “success stories” who died.
Just to show you how despicable the Burzynski propaganda machine is, though, I can’t help but point out that it is still going full tilt. Just yesterday, as the news of Laura Hymas’s death was hitting Twitter and Facebook, the pro-quackery organization known as the Alliance for Natural Health (ANH) used Burzynski again to promote yet another bad, bad law known as the Compassionate Freedom of Choice Act:
Recently, by working together, we made great strides in helping dying patients win access to potentially lifesaving treatments. It was your messages, together with those of other grassroots activists, that convinced the FDA to grant 12-year-old McKenzie Lowe a right of access to Dr. Stanislaw Burzynski’s innovative antineoplaston treatment.
As you may recall, the FDA had insisted that the treatment go though the agency approval process. Although the treatment had proven effective in earlier years and had passed the agency safety tests, it had not completed the whole process. The FDA had the authority to grant “compassionate use” to patients who asked for it and would clearly die without it, but chose not to grant it.
Despite our recent victories, the fact remains that the compassionate exemption rule is broken beyond repair—after all, these patients needed government permission to try to save their own lives, and the government couldn’t care less.
That’s why we’re thrilled that last Thursday, Rep. Morgan Griffith (R-VA) introduced the Compassionate Freedom of Choice Act of 2014. The bill eliminates the requirement for an FDA okay, and streamlines physician and patient access to experimental drugs. It would ensure that dying patients and their families—who don’t have the time or the strength to do so—won’t have to wage fruitless bureaucratic wars.
The ANH is describing, first, how the FDA caved under pressure, in essence wiping its hands of the issue of whether to allow compassionate use exemptions (a.k.a. single patient INDs) for Burzynski’s antineoplastons. Basically, the FDA ruled that, even though Burzynski has been cited numerous times for serious FDA violations and his antineoplaston trials are on partial clinical hold, patients can still receive antineoplastons on a single patient IND, just as long as the physician administering them is not Stanislaw Burzynski or someone who works for him. As I pointed out at the time, it was an astoundingly cynical decision and a massive propaganda victory for Burzynski.
But what about this H.R. 4475, this “Compassionate Freedom of Choice Act of 2014″? Unfortunately, the text of the bill is not yet published. That means we can only take the word of Rep. Griffith and speculate. To me, this bill sounds as though it could be a lot more problematic than the “right to try” bills I discussed not too long ago. Those bills, as I mentioned, are state bills. They don’t change federal law, and the FDA would still have jurisdiction over anything that had any interstate commerce component whatsoever. Unless a pharmaceutical company is in the same state as the patient, the FDA has jurisdiction. Actually, the FDA has jurisdiction anyway, because it has jurisdiction over drug approval in the US, and no drug company is likely to grant access to unapproved pharmaceuticals if it thinks that it will harm its chances of approval for its drug. So changing the law for a state is unlikely to have much of an effect in terms of opening up access to experimental drugs. Changing federal law, on the other hand, could make a difference.
The law, as described, is designed to “allow the manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients who execute an informed consent document, and for other purposes.” According to Griffith:
The Compassionate Freedom of Choice Act removes disincentives for drug companies to grant exemptions. For example, the current application for expanded access requires a drug company to share information—which we all know drug companies don’t do very well. It also requires, among other things, a detailed description of how and where a drug will be produced; complex pharmacological and toxicological information; and, if enough patients ask for the drug, a whole new Investigational New Drug (IND) application by the drug company.
Under the new bill, drug companies can still deny dying patients access to experimental treatments. But if they don’t have the FDA in opposition, drug companies may be much more willing to say yes. For example, drug companies are often afraid that if a patient dies under expanded access treatment, it will affect the eventual approval of the drug. With less risk and less paperwork, drug companies are more likely to increase patient access to experimental drugs.
It’s hard to tell exactly how this bill would affect access to experimental drugs without knowing what “disincentives” it removes and its specific language. I can say, however, as I’ve pointed out before that in the case of most experimental drugs that have only passed early stage testing (as in phase I clinical trials), the likelihood of doing no good or even causing harm is likely to be much higher than the likelihood of doing any good. Such a bill, depending on its wording, has the potential to do great harm. Moreover, such bills are custom-made to allow someone like Stanislaw Burzynski, who has long been supported by the ANH, continue to ply his trade.
Another way that we can honor Burzynski patients like Laura Hymas is to do our utmost to make sure that doesn’t happen.