The Yomiuri Shimbun Twelve clinics in Tokyo, Osaka and elsewhere have practiced regenerative medicine using umbilical cord blood (see below) from third parties despite not having registered with the government, and the Health, Labor and Welfare Ministry is investigating with an eye toward criminal prosecution.
In relation to this, it has been discovered that rare cord blood from a private blood bank was used for private medical treatments, including cancer treatment and cosmetic procedures, whose efficacy and safety were uncertain, and that were not covered by the public health insurance system. We asked three experts in this field about the current situation and problems surrounding regenerative medicine.
(From The Yomiuri Shimbun, July 28, 2017)
Regenerative law must be publicized better
Misao Fujita / Program-Specific Associate Professor at Kyoto University
The phrase “regenerative medicine” has a connotation of something advanced, so people may regard it as a “dream treatment.”
However, it is worth noting that regenerative treatments with dubious effectiveness and safety are conducted under such catchphrases to treat cancer or achieve cosmetic results, with the fees not covered by the public health insurance scheme. There have been cases where the recipients’ health was harmed.
I began researching the ethical problems of regenerative medicine after a 2010 incident in which a South Korean man suffering from diabetes died after undergoing a treatment that involved administering his own fat stem cells to him at a clinic in Kyoto.
In May 2014, I conducted online research studying the actual situation of regenerative medicine not covered by the public health insurance system. At least 74 clinics were conducting such treatments, with three using umbilical cord blood, and claiming they would do such things as treat cancer, despite having no scientific backing. I felt if this problem was left ignored, it would undermine public trust in legitimate research on stem cell therapies, so I decided to warn people about the issue by speaking at academic society meetings and through theses.
The Law on the Safety of Regenerative Medicine came into effect in November of the same year, obligating all medical institutions conducting regenerative medicine to notify the central government. Under this law, regenerative medicine is classified into three categories, depending on the risk it poses to the patient’s life and health, with Category 1 having the highest risks and Category 3 the lowest.
The latest incident, in which umbilical cord blood procured from third parties was being administered to patients, falls under Category 1. Under the law, medical institutions are not allowed to conduct such treatments unless the institution is checked by an expert committee and the government. However, it is difficult to conclude that this vital law is sufficiently familiar to the public. In a survey conducted by the Japanese Society for Regenerative Medicine in 2015 and 2016, those who said they “have heard the name [of the law], but do not know the contents” or “don’t know about it at all” accounted for about 30 percent of the organization’s members, and about 90 percent of ordinary people. It is essential for the government and the organization to work together to do more to disseminate information regarding the law.
Government checks are not required for treatments that fall under Categories 2 and 3, which are regarded as having relatively low risk, if they pass the examination of the expert committee. However, some are suspected to have questionable scientific grounds, and the Japanese Society for Regenerative Medicine has expressed concern. Numerous notifications have been made for Categories 2 and 3, with the government requiring medical institutions to make an annual report on incidents of failing health, the number of cases implemented and an assessment of scientific validity. The government should evaluate the contents of the collected reports from the viewpoint of their scientific validity and disclose the results to the public.
A multifaceted approach is also needed to take measures against this issue. It would be best if counseling services emerged in our society to help support patients’ earnest desire for a cure. There is also the idea of regulating — through the Law Against Unjustifiable Premiums and Misleading Representations, or the revised Medical Service Law — websites and other media that carry exaggerated descriptions of treatment benefits despite poor scientific grounds.
Journalism plays an important role as well. In Europe and the United States, the media has sometimes cornered suspicious clinics with their reporting.
■Fujita, 48, specializes in bioethics and clinical psychology. She serves as chief of the Uehiro Research Division for iPS Cell Ethics at Kyoto University’s Center for iPS Cell Research and Application.
(This interview was conducted by Yomiuri Shimbun Staff Writer Hideki Tsujita.)
Bring private blood banks under control
Hidehiko Saito / Chairman of Board of Directors of Japan Marrow Donor Program
The umbilical cord blood used in the unregistered medical activity was said to have come from a private cord blood bank in Ibaraki Prefecture that went bankrupt in 2009. Public cord blood banks and academic societies have pointed out the dangers of the private bank business for over a decade, so I realized that the situation they feared has finally come to pass.
Cord blood contains a lot of stem cells that make blood and has been used in the treatment of leukemia in Japan since the 1990s. Public blood banks handle cord blood donated by new mothers that is safely put into frozen storage and provided impartially to patients with conditions such as leukemia. There are currently six such organizations nationwide.
In contrast, private banks store the cord blood of individuals for a fee, on the premise that it will be used for the child of the new mother if the child gets sick in the future. Storage fees range from ¥200,000 to ¥400,000 for 20 years.
The law for appropriate provision of hematopoietic stem cells to be used in transplants, which took effect in 2014, introduced a permit system for public banks and made strict quality control compulsory, including testing for infectious diseases when collecting cord blood.
However, private banks, which operate on the premise that the blood will be used by the donor or their relatives, are not subject to the law and have no standards for quality control. There are even doubts about whether private banks properly explain to depositors the usefulness of cord blood and how they handle personal information.
More than 10,000 cord blood transplants to leukemia patients have been conducted via public banks in Japan, the highest number in the world. Treatment results are comparable to those for bone marrow transplants. However, the number of people requiring cord blood transplants for the treatment of leukemia and other diseases, is one in 100,000, and the amount required to meet that demand is already secured in public banks. For individuals, there is very little benefit in depositing in a private bank.
As advertised by private banks, future medical developments may see an expansion of regenerative medicine using stem cells such as those found in cord blood, but at the present time neither the efficacy nor safety of such treatment has been established. It is also unclear whether current refrigeration technology can preserve the quality of cord blood for 20 years.
Furthermore, there are no rules on how private banks should handle cord blood and protect personal information in the event of bankruptcy, like the latest case. The cord blood that was used appears to have been sold for high prices of ¥1 million to ¥2 million, but was consent obtained from the person who deposited it? How is personal information protected? Following the revelation of this problem, the government has finally started a fact-finding investigation into private banks, but it should have done so much earlier.
Until now, the government has been reluctant to regulate the private banks, but since the use of stored cord blood by third parties has come to light, private banks must also be quickly licensed and subject to quality control and other regulations.
■Saito is an honorary director at the Nagoya Medical Center. He was the first chairman of the network of cord blood banks in Japan, which disbanded in 2014. He is 78.
(This interview was conducted by Yomiuri Shimbun Staff Writer Yuji Kimura.)
Provide clearer clinical research information
Hiromi Todoroki / Chief Director of Nonprofit Organization Kibo no Ka
I cannot forgive this kind of unlawful medical care. The patients involved in this case will have to endure endless anxiety because they were administered cells from a third party without the safety tests prescribed by law.
When my late husband was diagnosed with intractable scirrhous gastric cancer in 2013, he received care not covered by health insurance, while undergoing chemotherapy at a hospital that provided treatment under the public health insurance system. He purchased supplements and received vitamin infusions as well. At the time, my husband and I were both filled with anxiety. If there had been something to clutch onto, we would have grabbed anything.
I’m sure this state of mind is experienced by many cancer patients. So if we had heard from a doctor at a private clinic about a case where the “cancer has disappeared” or “a patient who was given three months to live has recovered,” we would have jumped at it. Even knowing there was little scientific evidence behind it, unlike treatments covered by medical insurance, we would have hoped it would work for us.
Many of the cancer patients who received treatment with other people’s cord blood appear to have been in the late stages of the disease. Perhaps they felt abandoned after being told by their doctors, “There’s nothing more we can do for you.”
Most patients do not tell their main physician that they are receiving treatment not covered by health insurance, as they fear having that treatment summarily rejected or shrugged off with “do whatever you want.” If the patients in the current case had consulted their attending physician, they would have known in advance that the treatment was illegal.
I want the psychology of patients and their families who run to expensive, uncertain private treatment to be examined closely. Just saying “patients need to do their research to prevent getting cheated” or insisting that regulations be strengthened will not protect patients. It is crucial for medical staff to quell patients’ anxieties and confusion and not abandon patients. Doctors, nurses, even a medical institution receptionist like me can do it. I want them to regularly ask things like, “Is there anything worrying you?” or “What would you like to do now?”
Another problem is that many patients put their hopes in expensive medical treatment not covered by health insurance without realizing that receiving treatment as part of clinical research is an alternative to medical treatment under the public insurance system.
Clinical research is conducted after a review of safety and ethics. A system has been established that carefully checks patients’ physical conditions and can respond quickly to any side effects. Also available are clinical trials conducted by private companies and other organizations, and advanced medicine under development.
A system also exists to allow the use of unapproved treatment or drugs upon request from a patient, along with medical treatment covered by the public health insurance system. The differences between them are difficult to understand, and it is difficult to find clinical research studies you can join.
It is imperative to improve the websites where patients and their families can search for information on clinical research, and to establish a mechanism to guide people to treatment that is undergoing clinical research and is likely to be acceptable to the medical personnel closest to their case.
■Todoroki and her husband established a patients association based on their experience of searching for treatment methods for her husband, who suffered from intractable scirrhous gastric cancer. She is a former teacher at a private kindergarten. She is 55.
(This interview was conducted by Yomiuri Shimbun Staff Writer Kumiko Nakajima.)
■Umbilical cord blood
Blood from the umbilical cord and placenta. It contains stem cells that can change into various cells and is used as part of blood cancer therapy to restore the body’s ability to make blood. In May to June this year, the Health, Labor and Welfare Ministry ordered 12 clinics to cease practicing regenerative medicine in violation of the law on the safety of regenerative medicine, after the clinics allegedly administered cord blood to patients without proper registration.Speech