© Andy Alfaro Modesto Bee fileEscalon Physical Medicine in Escalon, Calif.
Stem cell research holds promise for treating numerous medical conditions by restoring or replacing the "master cells" that mature into the bones, blood and the organs of the human body. The FDA has warned that untested stem-cell cures are being marketed to patients and may have harmful effects. FDA approval guarantees that a drug or medical treatment has gone through a rigorous review process and clinical trials.
Senate Bill 512, signed by Gov. Jerry Brown this week, requires medical practices to post notices and provide handouts to patients if their stem cell treatments are not FDA-approved.
Sen. Ed Hernandez, D-West Covina, said more than 100 clinics in the state are offering non-approved stem cell therapies. "Patients spend thousands of dollars on these treatments, but are totally unaware of the potential risks and dangerous side effects," said Hernandez, the bill's author.
A news release cited a study published last year in the journal Cell Stem Cell, which found patients were seeking alternative stem cell treatments for Alzheimer's disease, Parkinson's and common ailments such as arthritis. In some cases, patients have suffered from increased pain, tumors and blindness.
In world-first trials scientists are using embryonic stem cells to treat Parkinson's and blindnessThe California legislation was supported by the International Society for Stem Cell Research, which called the bill an important step to helping patients know the risks of unproven stem cell treatments. Another supporter was the California Institute for Regenerative Medicine, created by voters in 2004 to fund stem cell research.
The SB 512 requirements go into effect Jan. 1.
An Internet search reveals some offices in the Northern San Joaquin Valley offering stem-cell-related therapies, including injections to treat osteoarthritis and fat grafting for skin renewal.
The website for Renewal Medical Clinic in Turlock says that stem cell therapy and platelet rich plasma treatments stimulate natural mechanisms to heal injuries. When contacted this week, the center said it is not doing stem cell therapy.
Escalon Physical Medicine promotes amniotic stem cell injections for arthritis and treatment of joint problems. According to the clinic's website, the stem cells are taken from the placenta and amniotic fluid during cesarean births. The Escalon clinic claims the injections reduce inflammation and restore degenerated tissue, and it posts testimonials from patients.
The clinic is a chiropractic office that converted to integrative or alternative medicine. Its medical director is an emergency medicine physician who studied at an integrative medicine center in Arizona.
One problem with amniotic stem cells is that patients are told they're injected with living stem cells when most of the products contain no living cells after processing.
Dr. Paul Knoepfler, a stem cell researcher at University of California at Davis, said clinics using amniotic stem cell products with no living cells might claim they can ignore SB 512 on the premise that FDA approval isn't necessary. Any products with live stem cells would need approval from the FDA, so patients of those clinics should be informed the therapy is not FDA-approved, said Knoepfler, who writes a blog tracking stem cell clinics.
Knoepfler said the new law should provide patients with more facts about the treatments offered at clinics. After a first violation, practices that ignore the noticing requirements can be fined $1,000 for each additional violation.
For the most part, the FDA has approved stem cell transplants for leukemia and gene therapy products for treating other blood disorders.
Mike Bystrom, case manager for the Escalon clinic, said the practice has informed patients its treatments are not approved by the FDA. He said the clinic also uses stem cells derived from umbilical cord blood, the patient's own fat, bone marrow and platelet-rich plasma.
"We have not had any adverse reactions," Bystrom said. "We have been able to change people's lives by decreasing pain and allowing them to re-engage with daily activities."
Records show that Bystrom had his chiropractic license revoked by the state in 2006 and his petition for reinstatement was granted in August.
According to news reports in March, three older women lost their sight after stem cells were injected in their eyes at a Florida office. The supposed treatment was for macular degeneration.
The FDA has barred the use of an unproven treatment by StemImmune Inc. of Southern California that was offered to cancer patients at California Stem Cell Treatment Centers.
Knoepfler said one concern with stem cells is they may remain in the body for years after injection. A person who has a harmful reaction to a prescription drug can simply stop taking the pills, but not so with stem cell injections.
"They are pretty much experimenting on patients who are willing to try things that seem to be high risk," Knoepfler said.
Well, I've answered my own question, eh? To keep the system as is, which is to protect and serve - not the citizenry, as we witnessing increasing rates of cancer - and cancer mortalities - but to big medicine and Big Pharma. (Note: said mortality seems to me to usually be expedited by the 'treatments' and yet the cause of death is always listed as being the cancer, and not these all-too-often-deadly "treatments.")
What is particularly absurd is how doctors all too often follow the treatments' statistical protocols as Gospel, - which usually reflect little, if any, subdifferentiation of treatment for a a 98 lb 80 year old lady patient, who is not a 165 lb average American, (195 lb?), and she all too often gets the exact same amounts and radiation duration and strength as the others who outweigh her two to one!
Finally, research about all of the cancer cures found with painless sound and lower frequency EMF's back in the thirties through nineteen fifties There are some good videos and articles how these folks were hounded out of their professions, and their fantastic discoveries and inventions destroyed.
R.C.