So here we go again - patients trying to be heard only to be told they have no clue what they're talking about and that it's just the placebo effect at work. There is also the accusation that US Stem Cell put them up to this - all 100 of them. I feel for them that they are in jeopardy of losing their banked stem cells, but knowing the FDA, even if they win in court, where would they be allowed to use the cells?
By RON HURTIBISE
SOUTH FLORIDA SUN SENTINEL
JUL 09, 2019
https://www.sun-sentinel.com/business/fl-bz-us-stem-cell-patients-beg-court-to-preserve-banked-tissue-20190709-fqvoosptyvb4jazca6fdexirf4-story.html
Frank Poucher, a retired Air Force colonel from California, insists that the two stem cell treatments he has received for his Stage 4 congestive heart failure helped him regain his quality of life.
“If it wasn’t a miracle, it was a remarkable improvement,” the 79-year-old said in an interview. Many physicians, scientists, and regulators from the U.S. Food and Drug Administration would disagree, saying there’s no proof stem cell treatments work as marketed for any of a wide variety of conditions.
Poucher is one of about 100 clients of Sunrise-based U.S. Stem Cell and associated clinics who are seeking to amend a court ruling that ordered the destruction of all of their stored stem cell tissues by July 25.
The order was part of an June 25 injunction by U.S. District Judge Ursula Ungaro to permanently stop the clinic from marketing stem cell treatments that have not been approved by the FDA.
The FDA sought the injunction in May 2018, saying U.S. Stem Cell failed to heed earlier warnings to stop marketing stem cell treatments that have not been subjected to clinical drug trials.
U.S. Stem Cell, the FDA said, was processing body fat into a stem cell product and injecting it intravenously and directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (known as Lou Gehrig’s disease), chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis.
Thousands of patients received the unapproved treatment, the U.S. Department of Justice said. Several suffered adverse consequences. Three elderly women with macular degeneration lost their vision after having stem cells injected into their eyes in June 2015. The clinic stopped eye injections after their cases were publicized but continued using the procedure for other conditions.
U.S. Stem Cell sent statements to its patients notifying them that the injunction prohibits the company from receiving, processing and distributing tissue-derived stem cells. The company also said it was required to destroy the stem cells stored in its tissue bank within 30 days of the June 25 ruling “unless this injunction is modified.”
The statement directed patients to speak with their personal attorneys or write to the court “if you wish to be heard on this destruction order.” In a follow-up letter to patients, the company provided the name of an Aventura-based attorney familiar with the injunction in case they decided to contest the destruction order.
Since the order, 94 letters have been sent to the federal court overseeing the case in Miami, according to the case file accessible through the court’s online filing system. Five letters were added to the file prior to June 25.
Letter writers include Josephine Spataro, of Danville, Calif., who wrote that two stem cell treatments left one of her knees “free of pain and completely functional” compared to her other knee “which is still somewhat painful” three years after a conventional knee replacement.
Another letter, from Genevieve Fleischman of Fort Myers, said recurring stem cell treatments have resulted in improvements for a friend with ALS, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.
Virginia Porowski, of Wake Forest, N.C., wrote that she was diagnosed with multiple sclerosis in 2017 and has “experienced tremendous healing and brain restoration” since she began receiving stem cell treatments from tissue banked at U.S. Stem Cell in October 2018.
“My healing has been beyond anything that traditional medicine could have ever offered me,” she wrote. “Using my stem cells has healed my brain fog, completely restored strength to my right hand and healed my nerves and their roots.”
Boucher, the retired colonel, said he paid U.S. Stem Cell $11,000 from his military pension to have his stem cells extracted and stored. He considers the stem cells his personal property, similar to sperm stored at a sperm bank.
Although he admits that his cardiologist doesn’t believe his stem cell treatments worked, Boucher said he experienced a dramatic improvement after each of his two treatments.
“Within two weeks [after the treatments], I went from barely able to get out of my chair to playing golf with a cart,” he said. “I wasn’t short of breath, and I could sleep without a CPAP,” a machine that treats sleep apnea by forcing air through a patient’s mask while they sleep.
Boucher said he received a second treatment about six months after the first, when the improvements started wearing off. With improvements from the second treatment now starting to fade away, he says he’s likely travel to Mexico to have more stem cells extracted and banked.
But Michael Carome, a physician who directs the health research group for the nonprofit consumer advocacy group Public Citizen (citizen.org), contended that Boucher and the other letter writers are acting “at the behest of” U.S. Stem Cell.
“The company is obviously taking advantage of these patients, just as they were taken advantage of in the first place with treatments that are unproven and shown in some cases to do harm,” he said.
The patients’ letters provide no evidence that the treatments work, he said, adding that any improvements experienced by the patients are likely a result of the placebo effect — in which patients given a fake treatment can stimulate healing because they believe the treatment will work.
While placebos don’t cure underlying conditions such as tumors, they can work on symptoms such as perception of pain, stress-related insomnia and cancer-treatment side effects such as fatigue and nausea, according to a May 2017 blog post on Harvard Medical School’s website.
Carome said that only one use of stem cells has been proven effective: Stem cells taken from bone marrow or circulating blood can repopulate bone marrow — the soft, spongy tissue inside bones — and make new blood cells. This treatment is typically reserved for patients who receive large does of chemotherapy to treat a variety of cancers, Carome said.
By RON HURTIBISE
SOUTH FLORIDA SUN SENTINEL
JUL 09, 2019
https://www.sun-sentinel.com/business/fl-bz-us-stem-cell-patients-beg-court-to-preserve-banked-tissue-20190709-fqvoosptyvb4jazca6fdexirf4-story.html
Frank Poucher, a retired Air Force colonel from California, insists that the two stem cell treatments he has received for his Stage 4 congestive heart failure helped him regain his quality of life.
“If it wasn’t a miracle, it was a remarkable improvement,” the 79-year-old said in an interview. Many physicians, scientists, and regulators from the U.S. Food and Drug Administration would disagree, saying there’s no proof stem cell treatments work as marketed for any of a wide variety of conditions.
Poucher is one of about 100 clients of Sunrise-based U.S. Stem Cell and associated clinics who are seeking to amend a court ruling that ordered the destruction of all of their stored stem cell tissues by July 25.
The order was part of an June 25 injunction by U.S. District Judge Ursula Ungaro to permanently stop the clinic from marketing stem cell treatments that have not been approved by the FDA.
The FDA sought the injunction in May 2018, saying U.S. Stem Cell failed to heed earlier warnings to stop marketing stem cell treatments that have not been subjected to clinical drug trials.
U.S. Stem Cell, the FDA said, was processing body fat into a stem cell product and injecting it intravenously and directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (known as Lou Gehrig’s disease), chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis.
Thousands of patients received the unapproved treatment, the U.S. Department of Justice said. Several suffered adverse consequences. Three elderly women with macular degeneration lost their vision after having stem cells injected into their eyes in June 2015. The clinic stopped eye injections after their cases were publicized but continued using the procedure for other conditions.
U.S. Stem Cell sent statements to its patients notifying them that the injunction prohibits the company from receiving, processing and distributing tissue-derived stem cells. The company also said it was required to destroy the stem cells stored in its tissue bank within 30 days of the June 25 ruling “unless this injunction is modified.”
The statement directed patients to speak with their personal attorneys or write to the court “if you wish to be heard on this destruction order.” In a follow-up letter to patients, the company provided the name of an Aventura-based attorney familiar with the injunction in case they decided to contest the destruction order.
Since the order, 94 letters have been sent to the federal court overseeing the case in Miami, according to the case file accessible through the court’s online filing system. Five letters were added to the file prior to June 25.
Letter writers include Josephine Spataro, of Danville, Calif., who wrote that two stem cell treatments left one of her knees “free of pain and completely functional” compared to her other knee “which is still somewhat painful” three years after a conventional knee replacement.
Another letter, from Genevieve Fleischman of Fort Myers, said recurring stem cell treatments have resulted in improvements for a friend with ALS, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.
Virginia Porowski, of Wake Forest, N.C., wrote that she was diagnosed with multiple sclerosis in 2017 and has “experienced tremendous healing and brain restoration” since she began receiving stem cell treatments from tissue banked at U.S. Stem Cell in October 2018.
“My healing has been beyond anything that traditional medicine could have ever offered me,” she wrote. “Using my stem cells has healed my brain fog, completely restored strength to my right hand and healed my nerves and their roots.”
Boucher, the retired colonel, said he paid U.S. Stem Cell $11,000 from his military pension to have his stem cells extracted and stored. He considers the stem cells his personal property, similar to sperm stored at a sperm bank.
Although he admits that his cardiologist doesn’t believe his stem cell treatments worked, Boucher said he experienced a dramatic improvement after each of his two treatments.
“Within two weeks [after the treatments], I went from barely able to get out of my chair to playing golf with a cart,” he said. “I wasn’t short of breath, and I could sleep without a CPAP,” a machine that treats sleep apnea by forcing air through a patient’s mask while they sleep.
Boucher said he received a second treatment about six months after the first, when the improvements started wearing off. With improvements from the second treatment now starting to fade away, he says he’s likely travel to Mexico to have more stem cells extracted and banked.
But Michael Carome, a physician who directs the health research group for the nonprofit consumer advocacy group Public Citizen (citizen.org), contended that Boucher and the other letter writers are acting “at the behest of” U.S. Stem Cell.
“The company is obviously taking advantage of these patients, just as they were taken advantage of in the first place with treatments that are unproven and shown in some cases to do harm,” he said.
The patients’ letters provide no evidence that the treatments work, he said, adding that any improvements experienced by the patients are likely a result of the placebo effect — in which patients given a fake treatment can stimulate healing because they believe the treatment will work.
While placebos don’t cure underlying conditions such as tumors, they can work on symptoms such as perception of pain, stress-related insomnia and cancer-treatment side effects such as fatigue and nausea, according to a May 2017 blog post on Harvard Medical School’s website.
Carome said that only one use of stem cells has been proven effective: Stem cells taken from bone marrow or circulating blood can repopulate bone marrow — the soft, spongy tissue inside bones — and make new blood cells. This treatment is typically reserved for patients who receive large does of chemotherapy to treat a variety of cancers, Carome said.