At the end of part one, Tim Caulfield, keynote speaker at the conference, was addressing the problem of illegal stem cell clinics worldwide…
Tim Caulfield looked up. “So what’s the harm?” he asked.
I wasn’t sure if anyone in the audience was supposed to answer the question, but I did not have a good feeling about whatever was coming next.
Sure enough, the next slide was one I wish I had never seen.
“This was a donor-derived brain tumor following a neural stem cell transplant,” said Tim. He clicked to the next slide. “Here’s one from a thirteen-year-old boy with ataxia treated with neural stem cells. Four years later, brain and spinal tumors appeared.”
I fought the urge to cover my eyes.
“One woman grew a nose in her spine after a treatment in Portugal for a spinal cord injury.”
At least there wasn’t a slide for that one.
“There were some deaths in Korea at an illegal stem cell clinic, and of course, there was the very well-known case where one woman had a bone growing in her eyelid after an MSC stem cell treatment.”
That was a story that I did not ever, ever need to hear, I thought. But wait. I did need to hear it, and I did need to know. That was the entire point of going to this conference.
“And for this, treatments are $20-30,000 and up, per time,” Tim went on. “You see why this kind of thing does harm to the whole field of stem cell research.”
“But, wait,” said the man sitting in front of me. “Wait, wait.”
I wasn’t exactly sure what we were waiting for, but I had a feeling that we were about to find out. The man stood up. He was barely balanced on the balls of his feet, bursting with suppressed energy.
“People get desperate, okay?” said the man in an energetic voice. “Patients get desperate. We’re willing to try anything.”
“I understand that,” said Tim. “People constantly ask me what types of stem cell treatments have actually approved. Very few. This is the state of science: there’s a tremendous disconnect between what is available—treatment for a couple of very rare cancers, some rare types of skin grafts, bone marrow transplants, the only applications that are approved now—and what is promised by stem cell clinics.”
Great. So we basically had what existed in 1956, when the FDA first approved bone marrow transplants. But he wasn’t really talking about why.
“The drivers tend to be hype, commercialization pressure, and early polarization.”
I guessed that he meant the original polarization about the entire issue of embryonic stem cells, which was kind of getting at the issue in an indirect way. Sort of.
“And we do need to address the polarization of this issue. If you look on patient blogs, you see a lot of anger and impatience. Patients see themselves as pioneers–”
“Patients are pioneers,” insisted the man.
I wondered who he was. He didn’t seem like an academic; one thing I’d gotten from a masters’ degree in social work, at least, was the ability to spot those.His dark hair was smooth and sleek, his suit expensive, his shoes shined. Someone from a stem cell clinic, maybe? It was hard to believe that a clinic owner would have gotten through the gatekeepers here, or would have had any interest in doing so, knowing that everyone involved would love to rip him to shreds. A businessman from a legitimate industry involved with stem cells? That seemed the most likely hypothesis, but even it didn’t cover all the bases.
“This is how we’re trying to address it,” said Tim.
The bouncy-ball man eventually subsided back into his seat. I raised my hand.
“Hi. I’m Cathy Danielson. I’m on one of the main regenerative medicine investor sites,” I ventured to say. “Investorstemcell.com. How would you address the concerns of investors in the field?”
“Um…” Tim seemed a little flustered. “That would take some time. Maybe we should talk later… but basically, I think that there needs to be a realistic understanding of how this is all going to play out, from an investment standpoint or any other. Hype is natural, but the natural curve hasn’t happened with stem cells.”
As he went on, he seemed to be implying that the process of patenting stem cell treatments and keeping information proprietary and private was a little dubious at best. Fine. I could certainly see his point there. But I thought that it also just might be a little too easy for scientific experts to say this. How else could anyone expect businesses to behave when only the business world had ever stepped up to the plate to fund the original embryonic stem cell research?
Funding from the federal government had been blocked again and again and again and again and again, like a hideous version of Groundhog Day. The most recent attempt had been Shirley vs Sibelius, which had always struck me as a whiny scientist claiming that funding embryonic stem cell research was going to overtake his precious, pet adult stem cell projects. The case didn’t stay on such an individual level for long. It quickly mushroomed into a federal judge ruling that any hESC research was banned under the provisions of the original Dickey-Wicker amendment (an unfortunate name if there ever was one. Here’s the original brief, if anyone has a lot of time on their hands to read it. You might want to save it for the next time you’re stuck at the airport.
A preliminary injunction was issued prohibiting the federal government from funding research involving human embryonic stem-cells (yet again. Groundhog Day Version 34782301.0) However, this one was even worse; it prohibited even the limited kind of hESC research allowed by George W. Bush. This would have destroyed the new NIH funding rules about hESC research. Supposedly, the problem was cleared up in 2013, when the case had been dismissed by a U.S. Court of Appeals. I didn’t believe for a second that all of the problems had somehow magically gone away, leaving the two opposing sides to hold hands, toast marshmallows over a campfire, and sing Kum Ba Ya. The appeals process was still ongoing, and it had to be only a matter of time before a completely new challenge popped up.
Anyone who doesn’t believe that this is possible needs to take a good, long look at what just happened in Oklahoma. The state House of Representatives passed a ban on embryonic stem cell research. Yes, you read that right. If passed into law, the bill would make it a felony crime to perform embryonic stem cell research in Oklahoma. Now, it’s not that I think this is really going to pass the senate, and even if it did, it’s very doubtful that it would trump federal law. No. The disturbing part is that this got anywhere near as far as it did to begin with. In March 2015, a state house voted 80-13 for a bill that would ban all embryonic stem cell research. The implications of this fact are staggering—and terrifying.
Private funding is what we have. It is the only kind that has ever been reliable in the sense that it has always existed, but that’s not much in the way or reliability. By its very nature, this kind of funding is uncertain and can disappear without notice. I thought of the way that Geron had been forced to stop its revolutionary stem cell study on spinal cord injuries at the end of 2011 because of fatal funding problems. I thought of Octata, always fighting for pennies, spinning out research on a shoestring. A few years before, Dr. Robert Lanza had bought bottled water from Safeway with his own money for his lab experiments for months on end. They had never yet been able to get Francis Collins or CIRM to recognize their methods of extracting blastomeres to use embryonic stem cells, which meant that this technique wasn’t eligible for any kind of government funding. They’d fought tooth and nail for every advance they had ever made, scrambling for every cent to fund their revolutionary work. Of course these companies wanted to keep their intellectual property. There was no way to reasonably expect anything else from them.
I left the opening night presentation with a lot to think about. One point kept coming to my mind, even though it had never really been addressed. The stem cell clinics on which Tim Caulfield had heaped so much scorn did deserve it. I couldn’t deny that. Part of me kept wanting to believe, but I knew better. They were cruelly promising impossible cures, in my opinion. And yet they only existed in the present because of the past history of the controversy of embryonic stem cell research, even assuming this controversy was over—which I knew it was not. Past ethical issues had created present ones. Without over forty years of savage attacks on embryonic stem cell research, we would then have real, FDA-approved cures. And nobody would be trying to charge thirty thousand dollars a treatment for fake ones.
TO BE CONTINUED…
Tomorrow: Part 3. In which I learn the true identity of a mysterious man and see the future of medicine. Also, turkey sandwiches are eaten.
I survived the disease, and I now have the only remission on record. But a remission is not a cure. The stem cell drug I need for a real cure is now rapidly moving towards approval in the rest of the world, but in the USA, it—and all other cellular therapies-- are still stuck behind prejudice, ignorance, and lack of funding. Hundreds of millions of desperate patients with incurable diseases need these drugs.
That’s why I’ve gone on to fight for greater public education on stem cell drugs, knowing that our laws must be changed so that all of us can get access to the best treatments instead of our health and our lives being held hostage by special interests.
I’m now a patient advocate whose work on stem cells and patients’ rights has been published in outlets such as the Oregonian. I am a manager at popular science and financial blog www.stemcellinvestor.com and a frequent speaker at many venues across the spectrum, including churches, scientific conferences, and atheist groups, and everything in between. I’m also an advocate for Right to Try laws that would allow access to experimental medication for terminal patients at the state level. Read the entire story in my upcoming book, And the Blind Shall See: A Skeptic Patient Surprised by Faith, Science, Family, and Miracle Cures.
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