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Irv and his buddies are at it again
This is actually two articles. The first one is the ominous ISSCR warning this time from a group of British health officials. The second article is in response to the first. The British officials say unlicensed clinics are taking advantage of publicity about stem cells. I say that regulatory agencies and Big Pharma are taking advantage of patients by setting themselves up to have only certain clinics that will be licensed and undoubtedly owned by many who are now trying to prevent competition that the offshore clinics bring to the industry.
Unlicensed clinics contribute to stem cell confusion
Posted by MEREDITH MELNICK Tuesday, August 31, 2010
Stem cell research is on the tip of everyone's tongue and regularly in the news, but a panel of British health officials warns that a global crop of unlicensed clinics is taking advantage of all the publicity.
Clinics in places as varied as Mexico, Thailand, Germany, Russia and China offer stem cell therapies with high price tags and little clinical evidence to back them up. Because such clinics are not illegal, experts in the emerging field of regenerative medicine are combating the misinformation with a guide to good quality treatment.
If you are thinking about trying stem cell therapy for anything from autism to diabetes to lupus, it might be worth your while to peruse the Task Force on Unproven Stem Cell Treatments' website, part of The International Society for Stem Cell Research. Five of their tips:
1. "There are different types of stem cells ? each with their own purpose"
While embryonic stem cells that only exist in the first few days of development are able to create many different types of ?daughter cells,? most stem cells in a fully-formed body are tissue specific. That means that blood-forming stem cells create blood cells; bone-forming stem cells create bone cells. Something is wrong if a clinic is treating one part of your body with stem cells that originated in a different part of your body.
2. "Just because people say stem cells helped them doesn't mean they did."
Many of the clinics offering unrecognized treatments offer extensive ?testimonial? pages. But there are many reasons why someone may feel better after a stem cell treatment. The ?placebo effect' is one, but there are also natural changes in the lifespan of a chronic condition. For example, parents who swear a treatment cured their daughter of autism may instead be noticing her natural progression as she matures or undergoes behavioral modification therapy.
3. "Just because stem cells came from your body doesn't mean they are safe."
As soon as cells are extracted from your body, they can be manipulated and can lose their ability to curb growth, similar to cancer cells. So even though the cells you are treated with may be your own, they are substantially different. In a few cases, reintroduced stem cells caused tumors to develop.
4. "Currently, there are very few widely accepted stem cell therapies."
With the exception of tissue and bone grafting, a few immune disorders and blood cancers like leukemia, there are no diseases for which stem cell therapies are a reliable treatment. For other conditions, especially those labeled incurable by most of the medical establishment, stem cell therapy is experimental at best.
5. "An experimental treatment offered for sale is not the same as a clinical trial."
They may be experimental, but treatments offered at for-profit clinics are not necessarily controlled, prescreened for dangers or subject to the same ethical sanctions as a high quality research study or clinical trial. Ask to see reviews by independent boards or regulatory agencies. If there are none, consider the downsides of this lack of accountability.
Stem cell firms defend record after criticism
? Wed Sep 1
LONDON (Reuters) ? Cell therapy companies in China and Germany who were criticized by British experts warning of the dangers of "stem cell tourism" defended themselves on Wednesday, saying their safety records were good.
Beike Biotech, which operates in China, said in a statement that all its stem cells are administered by experienced physicians who work in and for leading hospitals in China.
"Beike boasts an impeccable safety record, and it enjoys the support of various branches of the Chinese government and of leading Chinese universities and hospitals," the company said in a statement emailed to Reuters in London.
A panel of British health experts said on Tuesday they were concerned about a growing level of international "stem cell tourism" where patients travel abroad to private clinics to have treatments that are not licensed by drugs regulators in Europe or the United States.
The experts said they were particularly concerned about a firm in Germany called XCell-Center and about Beike, which offers stem cell treatments for a range of conditions including brain injury, cerebral palsy, multiple sclerosis, spinal cord injury and optic nerve damage.
A spokesman for XCell said in a statement that its stem cell preparations are made from bone marrow and intended for "autologous" use, or use by patients from whom they came.
"These preparations are medicinal products for innovative new therapies," the statement said, adding that they were covered by European regulations on advanced therapy medicinal products and "do not require a permit issued by the European Commission to be marketed."
Stem cells are the body's master cells that give rise to many different tissues and blood cells. They are standard treatments for leukemias and a few other genetic diseases, but their use in treating other conditions such as Parkinson's, spinal injury or optic nerve damage is as yet unproven.
The British experts said they had been prompted to speak out about the risks of traveling abroad for stem cell treatment because of a flood of requests they get from patients who read about apparently dramatic cures on websites and in the media.
The International Society for Stem Cell Research has previously warned of private stem cell clinics around the world seeking to exploit desperate patients oblivious to the risks.
Beike Biotech said in its statement said there was a cultural difference between the attitudes of scientists in China and those in the West with regard to stem cell treatments.
"In the West, stem cell treatment is treated like a drug, not a therapy. It requires phase I, II and III trials before Western doctors and scientists will accept its effectiveness," it said.
"This has limited the availability and increased the cost of stem cell therapy in the West, causing considerable frustration for many patients who cannot afford to -- or do not want to -- wait until the treatments are proven by Western standards."
(Reporting by Kate Kelland; Editing by Charles Dick)
First treatment in 2007. Pioneering ever since.
Last edited by barbara; 09-01-2010 at 08:16 PM.
Good post! I also heard that Britain has issued some very critical statements regarding people going to India for various types of surgeries and stem cells were not specified recently as being targeted. Some go to India for plastic surgery for a medical vacation.
The India medical associations are insulted by these statements and denounce them. In fact the India doctors are really upset over this labeling that their doctors are being cast in a negative light. Should be an interesting fight.
But really what it boils down to is people's rights are being taken away from them, especially if these therapies are working and showing benefit.
Beike socks it to them
I contacted Jon Hakim, Marketing and Business Development Executive, for Beike and he sent the following:
I think the tide is changing a little bit. The thing is that we do have
publications and we are ISO 9001 certified for our stem cell processing but they want to ignore it. We actually have one publication in Nature Case Studies. Take a look at http://www.beikebiotech.com/index.ph...&Itemid=100012.
I wonder how long they can go on ignoring this stuff.
Also we are about to put a press release out about a
safety paper we did with meristem. I will send it to you. That will be
followed up by a release about when Jia Bao who is e premier of
china came to visit Beike.
We will have quite a few more papers out later this year on ms and
other related diseases.
First treatment in 2007. Pioneering ever since.
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