Being a cancer surgeon, I realize that my tendency is to view my blogging material through the prism of cancer, particularly breast cancer, my specialty. it's easy to forget that there are diseases every bit as horrible, some arguably even more so than the worst cancer. When I think of such diseases, it's not surprising that amyotropic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease after its most famous victim. It's a progressive degenerative neurologic disease that affects the motor neurons, resulting in progressive muscle weakness throughout the body. Eventually, victims of this disease lose the ability to walk, use their arms, talk, and, near the end, breathe on their own. Most people with ALS die from respiratory failure within three to five years of diagnosis, with a median survival of around 39 months. While it's true that Stephen Hawking, another famous victim of ALS, has lived with the disease more than 50 years, he is a very unusual case. only around 4% survive longer than ten years. If there's a disease besides certain kinds of deadly cancer, like pancreatic or esophageal cancer, that scares the crap out of me, ALS is it.
Given the dire prognosis of ALS and the horrible way the disease relentlessly progresses, it just as unsurprising that its victims are desperate for anything that might slow the relentless deterioration of their muscle function caused by the disease. Unfortunately, that all too often means quackery. As of now, there's only one drug (riluzole) that's known to slow the progress of the disease and to prolong survival. Unfortunately, the effect is modest; so the search for better treatments goes on. While it goes on, there are victims of the disease like Lynne Grainger, who do what patients with with brain tumors who have become attracted to Stanislaw Burzynski do: Raise money to pursue unproven treatments. Unfortunately, that's exactly what Lynne Grainger is doing. Diagnosed with ALS in 2012 and rapidly deteriorating, she is trying to take a "holistic" approach. Her website describes her undertaking craniosacral therapy. This article describes her quest for a cure:
In line with her desire to take a holistic approach, she consulted Dr. Ruan Jin Zhao of the Center for Traditional Chinese Medicine in Sarasota. Zhao began acupuncture treatments, but was frustrated by how little he could offer.
“As a doctor, a diagnosis like this is very painful,” says Zhao, who remembers the names of all seven patients with ALS he has treated, none still living. “And especially with her, because she is so sweet, so good, always so present, and has a great spirit for living. As soon as I met her I could feel that. For this kind of soul, I want to do everything I can.”
On the one hand, it's tempting to feel a bit of schadenfreude for Ruan Jin Zhao. You mean there's actually a disease that acupuncture can't treat? I thought that acupuncture was good for everything that ails you, be it infertility, pain, menopausal symptoms, cancer, the need to quit smoking, and whatever. You mean it can't treat ALS? Who knew? I mean, Zhao's Center for Traditional Chinese Medicine claims to be able to treat arthritis, diabetes, cancers, asthma, hepatitis B and C, herpes, HPV, the flu, lupus, fibromyalgia, and many other diseases. Sadly, all Zhao can ofter is a kind word, because acupuncture is quackery. If that theatrical placebo brings Grainger a feeling of relief, I have a hard time being too critical.
Unfortunately, the search for a cure lead her to quackery:
Grainger also began alternative treatments — injections that had to be ordered from Switzerland, expensive supplements, aimed at cleansing her body of toxins and restoring her immune system, even a $5,000 machine (purchased by an ex-boyfriend) designed to tap into and heal the body's “frequencies.”
I can't be sure what that machine she got a hold of was, but my guess is that it was a Rife generator, which is based on the pseudoscience of radionics, which claims that diseases can be diagnosed and treated by tuning in on radio wave-like frequencies allegedly emitted by diseased organs and disease-causing agents. The ideas are, like most quack ideas, simple, persuasively compelling, and wrong. The claim is that all parts of the body emit electrical impulses with frequencies that vary with health and disease. Based on this, or so it was claimed, illnesses could be diagnosed by "tuning in" on a patient's blood or handwriting and treated by feeding back the correct vibrations into the body with a similar device.
Vibrations. It had to be...vibrations.
As critical as I am of this sort of quackery, make no mistake, Grainger's situation was even worse than just having ALS. She developed breast cancer. Although it was early stage and she didn't require chemotherapy, she did opt for a double mastectomy with reconstruction. After her last reconstruction her speech and walking became more compromised and her fatigue worsened, which is not uncommon after major surgery in patients with ALS. Also, although the article doesn't say this is the case for certain, it does state that Grainger believes that the reason she hasn't been eligible for any clinical trials for ALS is because of her history of cancer.
It was at this point that, well, I'll let the article tell it:
That left just one option: stem cell treatments available only outside the country.
But after spending than $30,000, she had used up all of her savings; she'd even moved in with Daudrumez for their first time in their relationship so she could rent out her own home for additional income.
So four months ago, she started a www.gofundme.com campaign aimed at raising the $45,000 she would need for a series of three treatments in Mexico, using stem cells grown from her own fat.
“People ask me, 'Why are you doing this?' ” she says. with halting, indistinct words. “But you have to navigate your own way. I know the body can heal, but sometimes, if it's very far gone, it can take a lot of work.”
Here's a good rule of thumb. If a clinic in Mexico, Central or South America, or Eastern Europe (among other places) is offering something that it calls "stem cell therapy" and is charging tens of thousands of dollars for it, chances are that what is being delivered contains neither stem cells nor effective therapy. Still, curious at what this therapy might be, I sought out Grainger's GoFundMe page, where there's a heartbreaking video of her asking for money with slurred speech juxtaposed with and older video of her bicycling. The procedure is described this way:
She is seeking stem cell treatment from a U.S. based lab, which does the actual procedure in Mexico. The whole thing costs $60,000. We did a fundraiser in March and April and now we are planning a cycling event. At this point, because of the constraints of time and organization, we can only do a "friendly ride" or "ride with friends" to benefit Lynne with donations. The thing is, we don't have much time before summer and also the beginning of her treatment.
Here's another hint. If the lab is in the US but the procedure is done in Mexico, you can be pretty sure it's not scientifically supported. It turns out that the company is a company called CellTex in Houston, where the procedure was described by Grainger thusly:
Let the healing begin! I had my fat extracted from a local plastic surgeon (Dr. Scott Engel). It was shipped on ice (seriously) to CellTex in Houston. There the lab begins the process of growing/banking stem cells, which will be for my treatment. It’s a process, but I should get my first treatment in May. Still fundraising as each treatment is $13,500 plus travel, etc. Regenerative medicine comes with a price. So, watch for a music fundraising event April 30th or go online to donate.
I hadn't heard of CellTex; so I checked out its web page. Basically, it's a stem cell banking company that is very careful to state that it does not treat patients or provide any health care services. However, apparently, if you can find a willing surgeon to remove some fat from your abdomen, CellTex will isolate "stem cells" from that fat and then grow them up if you need them. To me this is basically semantics; in essence CellTex is providing a biological treatment, whether it is administering it or not. Thus, to me CellTex is a medical company. As for Dr. Engel, apparently he is a believer that stem cells from abdominal fat can be useful and that these stem cells "rejuvenate the skin" when fat grafting is used as a filler. Maybe they can be, but if they are no treatment has been validated for them yet. Certainly no treatment for ALS based on stem cells has as yet been validated in a clinical trial.
In any case, although CellTex is very careful to inoculate itself against charges of practicing medicine or using an unapproved biological to treat disease through its disclaimer on its website. It also basically admits that stem cell treatment is unproven for most claimed indications by emphasizing that their stem cells are safe, touting a study from 2011 performed in South Korea. Basically, it was an animal study in which these stem cells were injected into immunodeficient mice and then into eight patients with spinal cord injury. No specific toxicity was observed. CellTex also touts "dozens of other clinical trials" that have demonstrated safety and "hundreds" of pre-clinical animal studies. In other words, there are no studies suggesting efficacy—for anything. But, hey, CellTex is sponsoring clinical trials. It is very vague about what these trials will be testing, but, damn if it's not sponsoring clinical trials. They've even been reviewed by an IRB! Too bad there isn't any evidence of a clinical trial demonstrating that these mesenchymal stem cells can impact the course of ALS.
I don't know for sure what quack clinic in Mexico has enticed this desperate woman to spend tens of thousands of dollars, but I rather suspect I know what clinic it is. Because I can't be sure, however, I won't name the company. I will, however, point out just how incredibly dubious CellTex is. The reason that CellTex is sending its patients to Mexico to receive stem cells is simple: It got busted by the FDA for administering stem cells to patients on US soil at its facility in Houston when a patient named Debbie Bertrand blogged about her experiences during a five-injection treatment with cells prepared at CellTex. The FDA was not amused. It also found significant deviations from current good manufacturing practice during an inspection in 2012. Nor were legitimate stem cell researchers amused:
Stem-cell scientists contacted by Nature are concerned by Celltex's activity. “Because we know so little about mesenchymal stem cells and whether they are indeed effective for treating any condition, I'd be very wary of how they are being infused into patients, and certainly concerned if practitioners are charging patients for medical procedures that haven't been proven to work and could in fact be harmful,” says George Daley, director of the Stem Cell Transplantation Program at Harvard Medical School in Boston, Massachusetts, who helped the ISSCR to draft its guidelines. In the opinion of Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at the University of California, San Francisco, “the very nature of Celltex's business plan, which involves charging patients considerable fees for so-called treatments for diseases and disorders for which there is no good clinical evidence of efficacy, crosses an ethical line”.
So, I would argue, is charging a dying woman desperate to live longer tens of thousands of dollars for a procedure that has not been demonstrated to have any efficacy against her disease. It gets even worse, though. CellTex hired bioethicist Glenn McGee to try to show the world that it was abiding by ethical standards in human research. He resigned after only three months on the job. Of course, one of the company's founders trots out the same old excuse used by unscientific practitioners the world over for why he can't do clinical trials:
Lotfi says that most of his patients claim to get better after the treatment, but he admits that there is no scientific evidence that the cells are effective. “The scientific mind is not convinced by anecdotal evidence,” he acknowledges. “You need a controlled, double-blind study. But for many treatments, that's not possible. It would take years, and some patients don't have years.”
“The worst-case scenario is that it won't work,” he adds. “But it could be a panacea, from cosmetics to cancer.” He says that Celltex is conducting a trial in which patients “will be their own control”. “If you can compare before and after and show improvement, there's no need for a placebo,” he explains. “How can you charge people, and then give them a placebo?”
I am still flabbergasted that anyone could have said something revealing such ignorance of placebo effects, the clinical trial process, and why doing placebo-controlled trials is important for many outcomes with a subjective component. While it is possible to do trials in which patients serve as their own control, it's not really an appropriate trial design, however, to demonstrate conclusively the efficacy of a treatment intervention like stem cell therapy. Moreover, what Lotfi said about there not being time for a trial is utter nonsense, given the near-miraculous improvements claimed. If the improvement is that dramatic, it wouldn't take long to do a clinical trial at all.
So how is CellTex getting away with it? Come on? Do you have to ask? It's Texas, home of some of the laxest (read: close to nonexistent) regulation of medicine in the country, home to Stanislaw Burzynski. Moreover, CellTex appears to be connected, counting Governor Rick Perry as one of its enthusiastic clients.
Which brings us back to Lynne Grainger. To me, she's no different than any patient of Stanislaw Burzynski I've discussed or any Burzynski patient whose story has been documented at The Other Burzynski Patient Group, and the promises made, either by CellTex or whatever quack clinic in Tijuana is using the stem cells that CellTex banks, are no different than Burzynski's claims. No, I take that back. Burzynski has actually done some clinical trials. True, he's never published a completed trial and what he has published is unimpressive, but he's one up on CellTex in that department.
My heart goes out to Lynne Grainger every bit as much as it has gone out to every Burzynski patient I've ever blogged about. She is a woman in the prime of her life facing a fatal illness and a horrible death. It's just depressing how there always seems to be someone willing to take advantage of the desperation of people like her who only want to live.
A current affairs show here (Australia) recently aired a story on a woman with MS who travelled to Russia for "chemotherapy and stem cell treatment". It showed her, pre-treatment, hardly able to mobilise with assistance, and post-treatment, jogging on the beach with her husband (and later, evangelising to a group of MS sufferers). There were plenty of hallmarks of woo, but sadly, you can understand why people will see that and think it will be the answer to their disease, and that the evil Australian doctors are standing in the way of their recovery. Sigh.
I have a colleague who was diagnosed with ALS. In the span of a few months, they went from being able to walk to being bed-bound and unable to move. But they are getting good supportive care to get the best quality possible out of the remaining time. Such a frightening disease.
These charlatans absolutely sicken me with how they prey upon the sick and dying.
kaitch @1: That sounds like HSCT (hematopoietic stem cell transplant) which is a legitimate treatment that stops the progression of a specific type of MS. Chemotherapy is administered to destroy the patient's immune system, then the patient's own stem cells are transfused to (hopefully) rebuild a new immune system that won't aggressively attack nerves. It only works for a few and can't repair the nerve damage already done. So the treatment certainly won't have been responsible for this woman's return to mobility, even if she had the kind of MS that its suitable for.
Zhao began acupuncture treatments, but was frustrated by how little he could offer.
“And especially with her, because she is so sweet, so good, always so present, and has a great spirit for living. As soon as I met her I could feel that. For this kind of soul, I want to do everything I can.”
OK, note for oneself. Be nice to your doctor if you want him to show you the good stuff in the back room.
She is seeking stem cell treatment from a U.S. based lab, which does the actual procedure in Mexico. The whole thing costs $60,000.
It sounds like Ms. Grainger is dealing with people in the nocturnal aviation business. At least they seem to be charging on a per treatment basis, so that they will get their money in 3-4 installments rather than up front, but that sentence alone should be setting off any functioning scam detector alarm.
I can understand why Ms. Grainger might fall for this. She is a desperate person who has already done some desperate things, so her scam detector might legitimately be out of commission. What I don't get is why anybody else around her, who doesn't have her excuse for a nonfunctioning scam detector, is falling for this.
I have to agree with Orac - if there's a disease out there that scares the crap out of me, it's ALS.
Unfortunately Ms. Grainger is desperately seeking a cure that doesn't currently exist, and trying to buy more time that she, unfortunately, doesn't have.
(very) long time lurker, first time poster.
Thanks for covering this, Orac. It hits close to home. ALS runs in my family, and I've tested positive for the most common genetic cause of it; baring being hit by a bus, that's how I'm likely to go. ALS scares me; its cousin, frontotemporal dementia, scares me more, a lot more.
I agree, it is likely that her prior cancer excluded her from legitimate clinical trials.
“How can you charge people, and then give them a placebo?”
In that case, if the treatment fails, no profit should be due to CellTex. A fair contract would specify the cost charge of treatment, together with proof of legitimacy. If the treatment fails, it means it is, at best, no more effective than a placebo. Conditions would set out payments for partial or complete success. Clear failure is obvious: unchanged or increased rate of deterioration following treatment. How can you give them a placebo, or worse, and then charge them?
“How can you charge people, and then give them a placebo?”
Says the guy who does precisely that, for a living.
Unfortunately Rick Perry is not the former governor. He's still the governor of Texas. And his likely successor is no better.
Do you know what is worse than getting a placebo in a clinical trial? Impoverishing your family and friends to spend $60k on unproven, untested, potentially unsafe experimental or outright scam. Stem cells are incredibly complicated and difficult to understand, so they are still being looked at in basic science medical research labs. There is still disagreement on how to handle stem cells, how to grow more, how to create them from mature differentiated cells, and how, where, and when to use them in treating diseases. Some specific cell lines show promise in rebuilding heart tissue- this is translational research in the very early stages of medical care, and as far as I know, that's the most advanced work. Anyone saying they are ready for use in human treatment as standard of care is at best overly optimistic and jumping the gun, and at worst selling the biological equivalent of quantum snake oil.
Still holding out hope for Team Wendy! I would really love to see TX have a true progressive governor again. That state of my birth is in sorry shape right now and unless the leadership changes unlikely to improve. I agree with others ALS (and also pancreatic or ovarian cancer) scare me most. I also hope not to have to suffer dementia or Alzheimer's but in that case I hope to have lived a full life before that.
"I also hope not to have to suffer dementia or Alzheimer’s but in that case I hope to have lived a full life before that."
That's exactly why frontotemporal dementia scares me more than ALS. Not all who develop dementia are elderly. Median age of onset for FTD is 55.
A friend of mine took care of her mother through the onset of FTD to the end of her life. The friend blogged about her experiences and, oy, I wouldn't wish it on my worst enemy...
I get the gist of this article pointing; a finger and shaking your head at scandalous treatments taking advantage of ordinary people put in extraordinary situations. However, during some points amidst your article it comes across a bit like YOU [an educated medical "professional"] can't believe how simple-minded and obvious these hoaxes are, and that only a desperate dying oblivious human who's fate is obviously doomed, would fall for this kind of nonsense.
As a fellow medical "professional", I admire the courage of this woman and patients of her mental and physical toughness alike. We owe Ms. Grainger a little bit of credit. I'm sure her "scam radar" is in perfect tune. In fact, I'm even sure she recognizes the quirkiness to which several of these methods operate. BUT, she is volunteering herself to TRY and EXPERIMENT on HER OWN terms. It is this kind of What if-never settle for no-in pursuit of constant possibilities-no matter how true or unreliable they may seem-mentality, that progresses science everyday.
As educated as you may be, there is a reason they still call it PRACTICING MEDICINE.
And unlike us, she is practicing for the greatest opportunity of all, her life.
A quibble on your limited definition of practice as taken that MDs are amateurs merely because they use the word "practice". Presumably, you also find it hilarious that lawyers "practice" law(har har.) For reference, I might recommend browsing the history of the word, http://dictionary.reference.com/browse/practice
While a staple of lame comedians and certainly belonging in any parent's joke repertoire, the confusion of practice as in training and practice as engaged in professional pursuit is no more than a joke.
Your point though, that Grainger is experimenting with her own life is understood and not the issue here. What I believe the point is, is that this clinic is charging a fairly large sum of money to put her in a one woman clinical trial with, seemingly, no oversight.
Now, were this an actual clinical trial and Grainger was being offered a part in it, without incurring personal cost, that would significantly change the discussion. Especially if there were promising evidence in animal models which lead to the a trial in the first place.
Certainly, no one here blames Grainger for taking what steps she feels is necessary. I don't know I wouldn't do the same, facing that kind of prognosis. What we can, and will, blame and despise is the people who are willing to prey on people who are already suffering unfairly.
YOUR SCUM ORAC
@Paul - thank you for your insightful comment.......
@ Paul: What Lawrence just stated.
P.S. Learn the difference between your and you're.
Perhaps Paul is Orac's pool boy (every pharma shill has one. Actual pool is optional.) and merely offering comment on his day's labors.
Paul - what about Orac's scum? Are you delivering it?
No, no. Paul has offered up his scum, and now invites Orac to do likewise. As in "your serve" in tennis, "your round" at the pub, "your turn" in a board game, "your deal" with cards. Paul seems friendly. He's shared his scum, now Orac should share his, then it's scum for all!
I'm surprised Orac doesn't just throw in the towel when he is faced with such eloquent opponents, and such devastating arguments.
Reply @Private Obvious.
I'm not going to list my job experience or current occupation.
But many colleagues in the healthcare industry agree that with something as complex as health and all the constant variables that accompany this profession AND because we are still learning incredible amounts on a daily basis, we are in fact PRACTICING. There is no such thing as a routine patient.
I made no such comment about law. I have no experience in that subject matter and that is why I did not comment about practicing law.
ALS, with all the it's complexities and the understanding we have yet to begin and especially because this particular pt. is courageous [not desperate] enough to share her research/ battle with the public, perhaps everyone should think for a second on the tone in which we speak out or criticize others in, from the comforts of our own good health.
Point in case, this article dabbles the line of criticism. I feel that should not be hard to recognize.
I respect your opinion though. Have a great day.