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“Pay-to-participate” stem cells studies: an interview with Leigh Turner

In this interview, Leigh Turner, Associate Professor, University of Minnesota Center for Bioethics, School of Public Health and College of Pharmacy, discusses his recent paper, published in Regenerative Medicine, on “pay-to-participate” stem cells studies.

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Jul 19, 2017

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Go to the profile of Falk Heinrichsohn
Falk Heinrichsohn over 2 years ago

I like just to reflect on the statements regarding unproven, paid clinical trials and its registration. Dr. Turner is right as his statement is based on present regulation, which was adjusted by regulators in the beginning of the 20ties century to protect consumers. What this means today, is that Institutes or the industry are paying for an approved clinical trial to get eventually an approved product to the market, which in principle also has a patented basis and is then commercialized by the Industry or the Institute who has filled the clinical trial and its relevant patent. This can be seen as the standard operating procedure in this field, and it appears sometimes that anything which has the capability to disrupt it is not welcomed.   When it comes to regenerative medicine and stem cells there is certainly a problem with this procedure. The industry or Institutes still try to do the same procedure without realizing, better accepting that stem cells are natural cells in a human body having a natural capability to home into problem areas of the body and to start their natural regeneration activity. This process cannot be patented and therefore the Industry and Institutes opt to highly manipulated gene technology in order to get a patented product. Nothing wrong with this, if it is addressing in the end the well-being of a patient at economically viable costs. 

Unfortunately, as seen in Europe, with approved gene manipulated products who did have a price tag of 1.2 Million respectively about 600.000 Euros per treatment had been approved a few times only as the insurance companies claim it’s not sustainable in the present structure and a dramatic increase of insurance premiums is also not feasible. 

In many countries, Point of Care treatments in the responsibility of a physician and is legally accepted, based on the already globally well documented and available scientifically proven know how that own stem cells have the capability to help a person to improve its natural regenerative capability with next to zero side effects. This Point of Care treatment, also described in the World Medical association and accepted by more than 100 countries, is also accepted by the FDA - Dr. Turner forgot to mention this - and in principle those clinics are doing nothing else than increasing the quantity of own stem cells, which had been lost, better used up over time by the body in a medical procedure.  Certain walks of life are not pleased with this simple concept of regeneration as they claim those physicians are bypassing FDA regulations and the required clinical trials before products are administered to a patient. What is however neglected in all this statement is, that the clinical trial path was and is designed for products, industrialized produced and sold to many clients with the same or similar symptoms at a profit by the industry. Again, nothing wrong with this, but what those clinics are performing is something completely different. What they, if at all produce, is owned by the patient, because this are his / her cells, there is no industrial process involved nor the intention to sell the product to others. It is a medical procedure performed 100 times daily all over the globe to give back purified cells from the same body to the same body. Industry and Institutes therefore do not invest into clinical trials of a medical procedure as the chances to get a patent is slim, and as patients should not pay for clinical trials it becomes a vicious circle. A patient who needs help and can pay for it as a medical procedure should not be limited by regulations developed for the industry.  As regulators in open minded advanced medical countries do interpret regulations different in favour of patients, resulting that in our global environment patients do the same as industry, they look for opportunities to solve their problem. The industry goes to cheap labour countries to improve profitability, patients go to clinics able to help them with their medical conditions not possible in their home country.

Are their problems with this, of course? You always will have somebody not performing well and as it’s a medical procedure, a few cases had been widely publicized, but what those sensational statements did not mention is, that millions of people had been globally treated with own and third-party stem cells, without any serious side effect, whilst at the same time, beside those few sensationally mentioned cases for stem cell treatments, about 200.000 people due to FDA approve drugs and their side effects dye every year in the US alone. You can find it in the relevant government statistics….where you also will find the handful of cases with stem cells. Question should be allowed to ask where starts Ethic concern and where does it end? Again, do not say Dr. Turner is wrong in his assessment, but the basis for this assessment is outdated and should considered to be adjusted like already done in Japan, South Korea, Panama, Australia and many other countries to mention a few. Even in the US, in Texas the interpretation of FDA guidelines had been recently challenged, beside a medical procedure with stem cells, according to FDA regulation 1271 15b is officially - as in many other countries- also in the US permitted. 

Therefore, Ethical concerns based on existing regulations do not, as mentioned before, address the root problem in the US and such statements made in the name of Ethics are increasing confusion at all levels of society.  Many global societies and regulators have however,  in the name of patients and the open-minded philosophy to improve quality of life of patients, changed their regulation in order to address this root problem not science related, but regulatory related. It may take time until regulation, also in the US and the EU is catching up to reflect that they should support patients and their need with new emerging science, already advanced in other countries and not follow blindly existing regulations, trying to legitimate and impose the real ethical concerns of industrialized produced products, also for cellular treatments in a point of care setting as a medical procedure.

Therefore, any ethical concern has to address those international valid and local well experienced facts too, which obviously had been forgotten in the assessment of Dr. Turner.