Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Tuesday, July 05, 2016

The Business of Extending Life

"There is a widespread misconception that if there is a clinic in the United States -- making these claims about stem-cell therapy, then that must somehow be legitimate or credible."
"[Yet American regulators] all too often are missing in action and standing on the sidelines [rather than ensuring facilities are safe and effective]."
"There is such a profound gap between the claims they are making and the current reality of stem-cell research. It's really premature to hit the marketplace."
Leigh Turner, professor, University of Minnesota Center for Bioethics

"These clinics are leveraging all the excitement around stem cells. The phrase 'stem cells' is a great marketing tool."
"But we have to do the good science, we have to make sure it's safe and effective."
Tim Caulfield, health-policy professor, University of Alberta

"I am not aware of any established, effective treatments of brain injury from stroke using adult neural stem cells. The problem is, when you inject these stem cells into a patient’s spine, there is currently no way for you to know, or for you to control, what area of the body those stem cells will migrate to. Ideally they would migrate to the site of the injury, but they might go anywhere. And as long as the patient is alive, there is no way to know where those neural stem cells actually went [other than post-mortem looking for that information in t he brain]."
Dr. Larry Goldstein, Department of Cellular and Molecular Medicine, Department of Neurosciences, Director of the UC San Diego Stem Cell Program, and Director of the Sanford Stem Cell Clinical Center, at the UCSD School of Medicine

Canadian hockey icon Gordie Howe was known to be in grave condition. He had undergone at least one ischemic stroke, and dementia was taking its dread toll on his health. His family feared he was near death. The executive of a San Diego company, Stemedica, recommended that the family look into having adult stem cells the company developed and manufactured be inserted to help stem and reverse the tide of his swiftly progressing health breakdown. It was subsequently arranged for Mr. Howe to receive treatment in Tijuana, Mexico by a company counterpart, Novastem.

Two types of adult donor stem cells (mesechymal and neural stem cells) were given to the 86-year-old Mr. Howe. His family has been profusely grateful to the company that has offered its expertise and product to aid the elderly man who had been so close to death. As soon as the first of a number of gratis treatments had concluded, his son, a radiologist, gushed about how much better his father was doing, as though the result of an initial treatment would be immediate and notable, without a period of grace and a professional evaluation. Which has led many to believe the Howe family is cashing in on an experimental fantasy that science has not yet proven.

On the other hand, it's understandable that someone suffering from a chronic disease or illness that is taking away their quality of life, causing them pain and misery and ultimately shortening their life, would want to attempt any protocol that seems promising, even without the assurance that it has passed regulatory standards, in the hope that it will work a miracle for them. And unscrupulous companies investing in stem-cell therapeutic 'solutions' to dread illnesses are merely conducting business in the good old capitalist way, while federal regulators are looking elsewhere.

And while respected and legitimate scientists believe that stem cells, which are non-specific [biologically unassigned] can be transformed into a number of different types, having huge potential for what medical science names "regenerative medicine" to grow new tissues in replacement of damaged or diseased body parts, rigorous, reproducible results through recognized experimental protocols must first demonstrate that the outcome matches the promise.

A small Ottawa trial that was recently reported on, suggests that a high-risk stem-cell therapy can overcome multiple sclerosis, but much more work must be done in these initial stages even while other applications of the technology are promising, but are yet at an early stage of development. Dr. Turner and his co-author of their recently-published study, Paul Knoepfler, a stem-cell scientist at University of California, found that the stem-cell enterprises they looked at were unapproved by the Food and Drug Administration. Moreover, there is a lack of scientific evidence to demonstrate that their procedures work, claims aside.

Their study is the first to document a huge rise in the number of stem-cell clinics in the United States. They identified around 351 businesses set up to take advantage of a new direction in science, not yet formally quantified and qualified, persuading patients that there is hope for them, should they only seek out the therapy these clinics are offering, and at a steep price, in the tens of thousands of dollars. Ethically, the free enterprise system of unbridled capitalism is not supposed to operate within the careful and prescribed precincts of medical care.

Canadians are beginning to respond to the allure of their promise, but they've travelled to places like China and Mexico for treatments whose value is questionable and where safety of the procedure undergone is dubious. Now that these enterprises are spreading throughout the United States, they're more accessible to Canadians geographically, and naive people believe that if they're located in the United States they must be safe and reliable. Lax regulations and health-medical consumer demands are on the increase, by desperate patients.

To help with the sometimes staggering costs, people have been turning to crowdfunding to give them the opportunity to travel and to start stem-cell treatments. The California Stem Cell Treatment Center advertises treatment of serious illnesses, from congestive heart failure to stroke. It has engaged a company representative, a Vancouver-based cosmetic surgeon to act in their interests in Canada. The trend is troubling in the opinion of mainstream health professionals.

There are risks associated with the treatments; in Florida one doctor had his license revoked in 2013 when two of his stem-cell patients died after treatment, one having suffered a stroke after being injected with unfiltered bone narrow into her bloodstream. Patients, on the other hand, feel anxious, that the treatment is out there for them, but that regulators are too slow, and waiting for scientifically backed government-approved treatment will turn out to be too late to be of any benefit to them.

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