Here is the text of email that stem cell scientist Jeanne Loring sent to Sara Sheehan in connection with the controversial "HealthRevolution" documentary.
"Dear Sara:
"When I was interviewed at the World Stem Cell Summit, I was misled about the context in which my interview would be placed. I was told that it would be an educational video about the progress of legitimate stem cell therapies.
"I am a staunch and outspoken opponent of clinics that flout the FDA regulations for stem cell treatments, and have met many people who have paid many thousands of dollars to obtain unregulated (and therefore unsafe) treatments that claim that stem cells will magically cure any disease.
"As I have explained many times, to print reporters, community groups, and in video interviews, as a scientist with a moral compass, I cannot condone exploitation of desperate people who are led to believe that they will be cured or even helped by a clinic or a pill or any purported therapy that is not based in science.
"I know you are young, but this is equivalent in history to the Laetrile scam of the 1970s. Thousands of desperate people emptied their wallets and obtained this alleged therapy before the FDA stepped in and banned it. Many were crushed and bankrupt; some died.
"'Stem cell' clinics are worse, because they can market their useless and dangerous products to a far larger audience.
"FDA leaders Scott Gottlieb and Peter Marks have denounced these unregulated clinics as “bad actors”, and I would go further - I think they are criminals.
"I use pluripotent stem cells to generate real cell types to replace cells that have died in disease. I have not seen any evidence that extracts from fat, or bone marrow, or products derived from placentas and umbilical cords have any medical value.
"You have placed my interview among those of people who are charlatans and thieves, and I request that you remove all reference to me in the video and on your website.
"I understand that you are good and honest film makers, so this should not be a difficult request. Please respond that you have removed me and I will not trouble you further."
"Sincerely,
"Jeanne Loring"
Sunday, June 16, 2019
Text of Cell Surgical Network Letter re "Healthcare Revolution" video
Here is the text of the letter sent out today to scientists and others who were concerned about appearing in a controversial video about stem cell therapies.
Stem Cell Researchers Backing Away from Documentary Touting 'Greatest Paradigm Shift in Medical History'
What do Maria Millan, CEO of the $3 billion California stem cell agency, Larry Goldstein of UC San Diego, Thomas Murphy of Harvard/MIT and Mark Berman of Cell Surgical Network have in common this morning?
They are all loosely listed as "trusted sources" on a website ballyhooing a 10-part documentary involving stem cells. All are identified as taking part in the documentary. Berman's firm, however, is a target of the Food and Drug Administration, which is seeking to halt the enterprise's "unproven and potentially dangerous treatments."
Erin Allday of the San Francisco Chronicle reported on the connections in a story this weekend that said some of the scientists involved in the documentary, scheduled to be released tomorrow, want out of the online video because it is partly funded by Berman's firm.
The documentary is titled "The Healthcare Revolution." The Internet address of Berman's firm is stemcellrevolution.com." It also offers a book called "The Stem Cell Revolution." The business has offices in Beverly Hills and Rancho Mirage, Ca., and is linked to reportedly dozens of similar enterprises.
Allday quoted Berman as saying in an email to patients last week,
"This Must See Documentary Series Unveils the Greatest
Allday's story said some of the scientists involved in the documentary now say "they weren’t aware of who was backing the project when they agreed to participate...Some scientists said they fear the documentary may promote what they consider junk science."
Allday continued,
One scientist who was scheduled to appear in the documentary is Jeanne Loring, professor emeritus at Scripps Research in La Jolla. She told Allday, “I am a stalwart and outspoken critic of unapproved stem cell therapies. I don’t belong in their company."
She said the producers of the video agreed to remove her from the documentary.
More than 80 physicians and scientists are listed as "trusted sources" or experts on the video website along with a number of major academic institutions, including Stanford, Harvard, John Hopkins, Yale and Oxford. Also listed is Kristin Comella, chief scientific officer of U.S. Stem Cells, Inc., which earlier this month lost a key ruling in lawsuit filed by the FDA against it.
They are all loosely listed as "trusted sources" on a website ballyhooing a 10-part documentary involving stem cells. All are identified as taking part in the documentary. Berman's firm, however, is a target of the Food and Drug Administration, which is seeking to halt the enterprise's "unproven and potentially dangerous treatments."
Erin Allday of the San Francisco Chronicle reported on the connections in a story this weekend that said some of the scientists involved in the documentary, scheduled to be released tomorrow, want out of the online video because it is partly funded by Berman's firm.
The documentary is titled "The Healthcare Revolution." The Internet address of Berman's firm is stemcellrevolution.com." It also offers a book called "The Stem Cell Revolution." The business has offices in Beverly Hills and Rancho Mirage, Ca., and is linked to reportedly dozens of similar enterprises.
Allday quoted Berman as saying in an email to patients last week,
“We have a wonderful docuseries coming out. It’s a whole production, not just about us. It’s going to enlighten people."The website of the documentary features ebullient language about stem cells. "Stem cell technology that is said to be 10, 20 years down the road is actually here -- NOW!" reads one sentence on the video site. The largest headline on the site said in bold red type,
"This Must See Documentary Series Unveils the Greatest
Paradigm Shift in Medical History"
Allday's story said some of the scientists involved in the documentary now say "they weren’t aware of who was backing the project when they agreed to participate...Some scientists said they fear the documentary may promote what they consider junk science."
Allday continued,
"In fact, many of the scientists listed on the website have said repeatedly that stem cell therapies are still years away from being ready for patients. They have said that the hundreds of providers treating patients at for-profit clinics are selling 'snake oil' products that are worthless and potentially unsafe. No stem cell therapy currently sold at for-profit clinics has been approved by the FDA."The Chronicle article said the California stem cell agency did not know who was financing the documentary when it agreed to participate. A spokesman for the agency, known formally as the California Institute for Regenerative Medicine, told Allday that the agency agreed to participate because it would provide an opportunity to promote its work and warn against dubious clinics.
One scientist who was scheduled to appear in the documentary is Jeanne Loring, professor emeritus at Scripps Research in La Jolla. She told Allday, “I am a stalwart and outspoken critic of unapproved stem cell therapies. I don’t belong in their company."
She said the producers of the video agreed to remove her from the documentary.
More than 80 physicians and scientists are listed as "trusted sources" or experts on the video website along with a number of major academic institutions, including Stanford, Harvard, John Hopkins, Yale and Oxford. Also listed is Kristin Comella, chief scientific officer of U.S. Stem Cells, Inc., which earlier this month lost a key ruling in lawsuit filed by the FDA against it.
Wednesday, June 12, 2019
California's Slow Pace on Stem Cell Snake Oil: State Medical Regulators May Take First Stab This Summer
California regulation of an industry that sells dubious and risky "stem cell" treatments now appears to be solely in the hands of the state Medical Board, which has been mulling the matter for at least 11 months.
Both nationally and in California, the number of unregulated clinics has risen sharply with estimates of more than 1,000 nationwide, with the largest number in California.
Jonathan Thomas, chairman of the $3 billion state stem cell agency, has described the fast-growing clinics as snake-oil enterprises.
The clinics peddle what they call stem cell treatments to desperate patients. The treatments cost thousands of dollars. Some patients have reported losing their vision as a result. Last December, the federal government reported that 12 persons were hospitalized because of infections from treatment by a California clinic. Some of the material involved was contaminated with fecal bacteria.
The New York Times reported this week that across the nation the clinics have "attracted huge numbers of patients, who pay thousands of dollars for unproven, risky procedures." The Times piece echoed a bleak national picture that was painted earlier by the Washington Post.
A spokesman for the California Medical Board, Carlos Villatoro, said this week that a task force of the board is expected to hold its first meeting this summer to deal with stem cell clinics. "The task force should be meeting soon and potentially holding an interested parties meeting, hopefully before the next board meeting," he said in an email to the California Stem Cell Report.
The next board meeting comes in August. The task force consists of two members of the state board:
Randy Hawkins of Los Angeles, who is a clinical assistant professor of medicine at the Charles Drew University of Medicine and Science in Los Angeles, and Howard Krauss of Santa Monica, Ca., who is a clinical professor of ophthalmology and
neurosurgery at the John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica.
Both nationally and in California, the number of unregulated clinics has risen sharply with estimates of more than 1,000 nationwide, with the largest number in California.
Jonathan Thomas, chairman of the $3 billion state stem cell agency, has described the fast-growing clinics as snake-oil enterprises.
The clinics peddle what they call stem cell treatments to desperate patients. The treatments cost thousands of dollars. Some patients have reported losing their vision as a result. Last December, the federal government reported that 12 persons were hospitalized because of infections from treatment by a California clinic. Some of the material involved was contaminated with fecal bacteria.
The New York Times reported this week that across the nation the clinics have "attracted huge numbers of patients, who pay thousands of dollars for unproven, risky procedures." The Times piece echoed a bleak national picture that was painted earlier by the Washington Post.
The next board meeting comes in August. The task force consists of two members of the state board:
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| Randy Hawkins, LA Sentinel photo |
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| Howard Krauss, PNI photo |
State legislation to deal with the burgeoning problem is moribund and may or may not be resurrected.
Art Torres, vice chairman of the board of the California stem cell agency, has been working on the measure (AB617). He served for 22 years in the state legislature and is a former head of the California Democratic Party.
Last month, Torres described the stem cell clinic measure as "dead." He said the reasons for its demise are "unclear," along with the failure of another bill dealing with sickle cell disease. Torres told the board,
Torres later told the California Stem Cell Report that it was possible that the content of the bill could be amended into another measure that is farther along in the legislative process. But he said that no clear pathway to final passage was evident.
In New York, the state attorney general has charged one stem cell clinic with fraud. In California, Attorney General Xavier Becerra has remained mum on the subject.
Art Torres, vice chairman of the board of the California stem cell agency, has been working on the measure (AB617). He served for 22 years in the state legislature and is a former head of the California Democratic Party.
Last month, Torres described the stem cell clinic measure as "dead." He said the reasons for its demise are "unclear," along with the failure of another bill dealing with sickle cell disease. Torres told the board,
"They haven't told us why they opposed it, and even the author of the bills can't figure out why their bills remained in what's called the suspense file of the Assembly Appropriations Committee."
Torres later told the California Stem Cell Report that it was possible that the content of the bill could be amended into another measure that is farther along in the legislative process. But he said that no clear pathway to final passage was evident.
In New York, the state attorney general has charged one stem cell clinic with fraud. In California, Attorney General Xavier Becerra has remained mum on the subject.
Sunday, June 09, 2019
Captain Kirk, Snake Oil and Stem Cell Treatments
It's time for stem cell whack-a-mole.
That's the game where regulators -- coming in late -- try to prevent snake-oil clinics from harming desperate patients with purported stem cell treatments and ripping off them for thousands of dollars.
That's the game where regulators -- coming in late -- try to prevent snake-oil clinics from harming desperate patients with purported stem cell treatments and ripping off them for thousands of dollars.
More than 1,000 dubious clinics are estimated to exist across the country with the largest number in California, which is lagging in its regulatory efforts. More spring up every day with even Captain Kirk of Star Trek weighing in on the alleged benefits of the unregulated procedures.
William Wan of the Washington Post captured the national scene in an article late on Friday. He said don't get too excited about a favorable court decision involving one operation in Florida, which claims to turn body fat into beneficial stem cells.
Wan wrote,
William Wan of the Washington Post captured the national scene in an article late on Friday. He said don't get too excited about a favorable court decision involving one operation in Florida, which claims to turn body fat into beneficial stem cells.
Wan wrote,
"(T)he company said it would follow the federal judge’s ruling and stop selling the fat-based procedure. But it quickly followed up with a clarification: It would continue offering stem cell treatments, but instead of fat, rely on patients’ bone marrow and other tissues to harvest the cells it claims can cure conditions as varied as spinal cord injuries and erectile dysfunction.
"'It’s a bit like playing whack-a-mole,' said Peter Marks, FDA’s top official for biologic products."The situation has been building for long time. Wan wrote,
“After years of largely ignoring the issue, the FDA is finally making more of an effort, but it’s not as if this marketplace is melting away,” said Leigh Turner, a bioethicist at the University of Minnesota.
"Because no one had documented exactly how many stem cell clinics existed, Turner — working with collaborators (UC Davis researcher Paul Knoepfler) — began tracking them in a database several years ago. In 2009, there appeared to be only two in the United States; by 2017, there were at least 700. Turner believes there are currently more than 1,000."
"Turner compared the for-profit stem cell industry to a balloon. As the FDA and consumer advocates squeeze one end, other parts of the enterprise expand. 'For every one that’s disappeared, we’re finding seven more that are popping up.'"
Wan noted another effort in California that could affect a number of clinics.
"Meanwhile, the government is pushing forward in a second federal court lawsuit against another stem cell business in California. That lawsuit has the potential to halt the fat-based stem cell treatment in multiple clinics because the government filed it against a company called Cell Surgical Network, which serves as an umbrella for dozens of affiliated clinics around the country."
An attempt to step up state regulation in California, however, has ground to a halt. Legislation (AB617) by Assemblyman Kevin Mullin, D-San Mateo, is now not even on life support. It is buried in the Assembly Appropriations Committee. Its content could surface in another measure that still has some technical life in the Capitol, but the outlook is more than dim.
The scene is not much brighter with California's medical board. Last year said it would look into the dubious clinics. In April, it said hearings might begin no later than early this month. Nonetheless, a check of the agency's web site this weekend did not turn up any notice of such a meeting.
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