About four months ago, the skeptical blogosphere was abuzz about a tragic story. The story was that of a Belgian man named Rom Houben, who had been unfortunate enough to have been in a motor vehicle collision and suffered serious brain injury. That brain injury left him in a comatose state, which had been diagnosed as a persistent vegetative state. What brought him worldwide prominence was a claim by neurologist Steven Laureys that he was not in a persistent vegetative state at all, but was rather fully conscious and “locked in,” meaning that he could see, hear, and feel everything but could not move any part of his body. Unfortunately, part of the methodology by which Dr. Laureys came to this conclusion was through the woo known as facilitated communication. It was recently definitively shown (once again) that Houben was not communicating through facilitated communication, but the concept of being “locked in” both fascinates and horrifies me. I have a hard time imagining a worse fate, and stories of the locked-in hold a special fascination for me.
That’s why I was disturbed to find out about a woman in Toronto named Alda Byers who is definitely locked in and has resulted in yet another round of bad reporting, which renders the tragedy even more hard to take. The case of Alda Byers involves what is likely (but not certainly) quackery coupled with a number of thorny ethical issues that are hinted at, but barely touched upon, in a story by Michele Mandel entitled Trapped in her own body, docs won’t help: Woman denied stem cell treatment that offered hope. The title alone was painful to read because it paints the doctors who won’t help Byers pursue stem cell woo as being heartless and blocking her from her last chance at a cure from her horrific state.
The story begins:
Freedom flickered so elusively close, with a joyous new wiggle of her toes, with the thrilling turning of her head.
For Alda Byers, imprisoned by a rare, paralyzing brain stem stroke, a controversial stem-cell treatment in Mexico last fall seemed to deliver on its promise of improvement.
But now all her progress has come to an abrupt end and her family believes it’s Canadian medical reticence that is standing in her way.
The pretty 52-year-old remains trapped in her hospital bed at West Park, her world confined by walls brightly decorated with loving cards and dozens upon dozens of photos of her family, friends and beloved dog.
Yes, the article itself, in the name of “human interest,” has let us know that the Canadian medical establishment is apparently too uncaring to help the Byers family achieve its ends and save the unfortunate Mrs. Byers from her fate. The article even continues with a real, live, honest-to-goodness testimonial:
With the help of hundreds of friends, they held two fundraisers and put together the thousands of dollars they needed to get her a stem-cell transplant last September in Cancun.
At first, the results were astounding.
She could suddenly move her neck from side to side. She could open her mouth and form an “O”. She could wiggle her toes and fingers. She could laugh and even breathe on her own for short spells. For someone who couldn’t move at all, it was a breathtaking promise of what lay ahead.
Soon after arriving back at West Park, with Byers happily demonstrating her new tricks for all her visitors, they received a follow-up e-mail from her Mexican doctor: to continue the stem cells’ work, she’d need to take a cocktail of drugs for the next six-to-eight weeks.
They never anticipated any problem with a Toronto doctor writing the prescription. The three drugs — erythropoeitin, filgastrim and somatotropin — are not rare or experimental. The first two are generally used for anemia, renal failure and chemotherapy, the third has been used in children and athletes as a growth hormone.
Even though these are drugs that are approved and available and even though doctors can prescribe drugs off label, apparently the family has had difficulty finding a doctor willing to prescribe the drugs requested. This is not surprising, given that these are powerful drugs with serious potential side effects, particularly the first two. Indeed, one wonders why the clinic in Mexico peddling this stem cell woo would consider erythropoietin, which stimulates red blood cell production, and filgastrim, which stimulates white blood cell production, to be essential to its protocol. These are not generally substances that would stimulate the growth of new neurons from stem cells; any effect that they might have on stem cells would be to promote differentiation into hematopoietic cells. In the absence of evidence demonstrating the efficacy of whatever “stem cell” protocol the Mexican clinic had prescribed and absent a demonstration that this protocol required these drugs, the Canadian physicians approached to prescribe them were right to be wary and reluctant.
When I first saw this story, I did a little Googling to learn about Byers’ story. I found out that the specific clinic to which her family took her last summer was that of Calvin Cao from Stem Cell Therapy International Inc., in Tijuana. It’s a highly dubious-appearing clinic whose website contains several the hallmarks of quackery, specifically claims of efficacy for many, many conditions, including diabetes, cirrhosis, and neurological conditions, among the more common diseases. Amazingly, SCTI also claims efficacy of its particular stem cell woo for adhesions of the abdominal cavity after surgery and the “rejuvination” (spelling error copied from the website) of women after menopause, both applications I haven’t heard before for stem cells. The latter of these is described using word salad devoid of any real science behind it:
We developed the regimen of biological preparation introductions, its characteristics and necessary dosage. As opposed to the treatment of androgenous disorders, in this case we used 10-12 week preparations with XX genotypes. Before carrying out treatment with preparations, a profound study of somatic and gynecologic anamnesis in view of contra-indications to hormonal therapy, mammography and bio-chemical examination, ultrasound of organs of the small pelvis on the 5-7th days of the menstrual cycle are made.
From what I can figure out, SCTI seems to be using some sort of cell-based bioidentical hormone therapy, but it’s hard to tell from the word salad science on its website. Regardless, apparently its woo is not limited merely to stem cell woo.
Not surprisingly, I could not find on its website a single instance of peer-reviewed research directly supporting the efficacy of the “biological preparations” administered by SCTI. The website cites thousands of articles apparently culled from PubMed searches on certain keywords, but it doesn’t provide, as far as I can find, a single example of a well-designed clinical trial published in a peer-reviewed journal demonstrating that their methodology has a measurable therapeutic effect on the conditions for which SCTI claims efficacy for its methods. They make the excuse that the real reports that allegedly show the efficacy for their methods are all in Russian and German and not indexed in MEDLINE and further brag that “an estimated 20 million patients worldwide received in the U.S.S.R. developed live human placental tissue implantations with various kinds of trophoblastic cells.” Given the amount of Russian stem cell quackery out there, I’m not sure I’d be bragging that this is the primary evidence of efficacy for SCTI’s preparations if I were Mr. Cao.
Also nowhere on the SCTI website could I find evidence that any of its preparations actually contain real human stem cells, pluripotent cells that can be induced to differentiate into many, if not any, organ. In fact, I’d be highly suspicious of their preparations and that they can even make stem cells suitable for attempts at stem cell therapy. The website lists a lot of “applications” for their stem cells, but don’t include a link to a single scientific paper supporting these claims. There is no detailed outcome data to show that they have results better than what could be expected using the standard of care, much less high quality data from randomized clinical trials demonstrating efficacy of their stem cell preparations. In brief, SCTI shows all the hallmarks of peddling pseudoscience to the Byers, all for $50,000 for six daily injections of “stem cells,” a sum that ballooned to $150,000 when all other expenses, including a private plane for transportation, were added in.
Regardless of one’s opinion of the SCTI clinic (and I have made my opinion of the extreme dubiousness of any of its claims known), the question remains of what to do with Mrs. Byers now that she has returned and her husband is claiming significant improvement. First, we must remember that there appears to be no objective evidence of concrete improvement other than the word of Byers and her husband. We have no detailed neurological examinations documented before and after the treatment, for example. While it is possible that the improvement claimed are real and due to the “stem cell therapy,” it is also unlikely. We have no idea whether some of these movements were possible before the treatment and the perceived improvement the result of expectation effect and confirmation bias or whether there was a real improvement. Again, there is no reported objective documentation of these improvements, and there needs to be. I can understand Mr. Byers’ frustration here:
It’s like hitting your head against the wall,” says Byers, 60, waving a thick file of e-mails from physicians turning them down.
“Everybody wants case studies,” he complains. “But somebody with a brain stem stroke is one in a million and how many of them have undergone stem cell treatment? None.”
On the other hand, this is a bit of a straw man. I’d bet that most of those doctors who want case studies would understand that locked in syndrome is (mercifully) rare and would be willing to accept evidence from case studies of stroke victims who suffered less devastating neurological damage than locked-in syndrome or victims of spinal cord injury. For example, if a stroke victim with a complete hemiparesis of one side of their body were to demonstrate documentable, objective improvement in the affected side after the stem cell therapy, that would be a legitimate case study that might convince me there was something going on worthy of further study. If a patient with a complete transection of his spinal cord and complete paralysis below the waist for three years suddenly could move his feet after stem cell therapy by SCTI, that would be suggestive evidence that might convince me that it’s worth continuing with the SCTI stem cell therapy in Mrs. Byers’ case, given that her current condition is so horrific and there is currently nothing medicine can do to ameliorate or reverse it. I can find no such case studies with any objective documentation of improvement in neurological function beyond what could be expected in the natural course of their condition in patients with severe neurological injury like stroke or spinal cord transection.
In the case of Mrs. Byers, there are at least two major ethical considerations at play, along with the problem of pitting science-based medicine versus stem cell hucksters selling what is likely to be false hope. First, there is the ethical precept of “First, do no harm.” Prescribing drugs like erythropoietin has a real risk of doing harm. Also impacting the case is the ethical precept against performing experimentation on humans without sound science and extensive preclinical data to prove a reasonable degree of plausibility. In this, the stem cell therapy offered by SCTI fails utterly, given how little evidence appears to support it. Even worse, SCTI charges $50,000 per round of treatments for what is at best a highly experimental treatment not ready for prime time and at worst pure quackery. Without strong evidence for the efficacy of such a treatment, it is in general unethical to charge so much money for it, and it pains me to see these stem cell clinics taking advantage of patients as sad and desperate as Alva Byers.
I could understand it if a physician, hearing Mr. Byers’ plea, decided that Alva’s condition was so terrible that he might as well grant their wishes and prescribe the drugs SCTI requested. I might disagree, but I could understand someone who says, in essence, that Mrs. Byers’ current condition is a fate worse than death and, even if there really hasn’t been any evidence of objective improvement due to the alleged stem cell therapy, there’s nothing to lose by giving her the three drug cocktail that’s supposed to keep the stem cell treatment going. What I can neither understand nor forgive are companies like SCTI peddling unproven and likely ineffective varieties of “stem cell” therapy to desperate patients like Mrs. Byers, all in order to separate them from their money.
Nor can I forgive reporting as irresponsible and supportive of companies like SCTI victimizing patients like Mrs. Byers as demonstrated by Michele Mandel. Such reporting serves no purpose other than to encourage other desperate patients to seek out companies like SCTI and be separated from their money as well.