New medical treatments becoming problematic

The Yomiuri Shimbun

By Ryuya Hara / Yomiuri Shimbun Staff WriterCancer treatments not authorized in Japan — such as injecting genes purported to prevent cancer cells from multiplying into patients’ bodies, or cultivating patients’ immune cells in vitro and returning them to their bodies — are becoming problematic. Despite being untested in terms of safety and effectiveness, they are provided as costly treatments that patients must pay for out of pocket as they are not covered by health insurance. In some cases, problems arise between medical institutions on one side and patients and their families on the other. Therefore, medical societies and other related organizations feel the need to call attention to such treatments.

Patients taken advantage of

In June 2014, a 52-year-old male patient, who was informed he had six months to live after he suffered a relapse of tongue cancer, paid ¥5.46 million to a clinic in Tokyo to receive treatment via intravenous drip a total of 10 times. The drips were purported to contain genes that would prevent the cancer from spreading.

During the treatment, a university hospital exam revealed that his cancer was growing. The clinic, however, did not recognize the result and urged him to continue the treatment. The man and his family grew suspicious of the clinic’s treatment and decided to stop treatment.

The clinic’s treatment had no effect and the man died in September that year.

“A life can’t be replaced, so we thought we should just pay” whatever the cost, the man’s widow said. “That’s where we got taken advantage of.”

The clinic explained to the man and his family that liposomes, or lipid-based capsules containing genes that can prevent the spread of cancer, were being administered intravenously, and that the genes were manufactured in the office building that houses the clinic.

Experts on cancer treatment expressed skepticism about the intravenous drips. They said the chances of such medicine actually reaching the cancer via the intravenous injection were very low. Some of them also had suspicions about the clinic’s ability to manufacture the medicine.

Fumihiko Wakao, director of the National Cancer Center’s Center for Cancer Control and Information Services, said, “Words like ‘gene therapy’ evoke an impression of cutting-edge science, and patients end up believing it’ll be effective.”

The man’s wife laments: “The clinic’s explanation that damaged genes would be fixed was very persuasive. I wish we had gotten a second opinion.”

The wife sued for a refund of the medical charges, compensation for mental suffering and other costs. The clinic has fully recognized her claims. It did not respond to requests for comment from The Yomiuri Shimbun.

Gaining attention due to Opdivo

Similar to gene therapy, immunotherapy is also widely used as a cancer treatment not covered by insurance. This includes treatments in which a patient’s immune cells are multiplied outside the body and then returned to the body in what can be described as “cancer-vaccine treatment,” wherein particular substances produced by the cancer are administered to heighten immunity.

Immunotherapy began gaining ground as sales began of immune checkpoint inhibitor drugs, such as Opdivo, in 2014. The drugs deactivate the defenses cancer cells use to keep themselves from being attacked by immune cells. This treatment is covered by insurance when applied to skin, lung and other cancers, and its high therapeutic effectiveness has drawn great response.

Immune checkpoint inhibitors vastly differ from existing immunotherapies, but clinics providing immunotherapy emphasize the effects of their own particular treatments provided together with the inhibitors. Other facilities are also getting in on the act.

“We explained to our patients that the effectiveness hasn’t been fully proven,” a cell therapy doctor in Tokyo said. “However, some patients still decide to try it because their attending doctors have told them, ‘There’s no cure,’ and they’ve been shown no other options. Most of the medical fees, which are said to be expensive, comprise payments for cell processing, patent fees and other costs.”

Noninsured cancer immunotherapy is also provided at about 20 percent of government-designated core hospitals for cancer treatment, according to a survey in October by the Health, Labor and Welfare Ministry. Some such hospitals even offer expensive treatments not covered by insurance. For that reason, the ministry intends to carry out immunotherapy for cancer treatment at these core hospitals, in principle, as clinical research with the aim of establishing a medical treatment.

Need to prove effectiveness

Cancer treatments proven sufficiently safe and effective will be covered by insurance and widely used. Gene therapy and immunotherapy for cancer are practiced in Japan through clinical studies, but their effectiveness has not yet been established.

With regard to cancer gene therapy, the Japan Society of Gene and Cell Therapy calls on patients to tread carefully if they are planning to undergo unauthorized treatment. In an expert panel meeting held in October to review government guidelines on gene therapy for research purposes, there were calls for some form of regulation on treatments not covered by insurance.

As for immunotherapy, the National Cancer Center includes information for the general public on its website, Cancer Information Service, which was revamped in March last year. It specifies that, aside from immune checkpoint inhibitors and certain medicines that strengthen immunity functions, other forms of immunotherapy have not been confirmed effective. Treatments whose effectiveness has been proven are shown with charts separately from the treatments whose effectiveness has yet to be proven.

The cancer immunotherapy guidelines issued in December 2016 year by the Japanese Society of Medical Oncology contain a similar explanation. Among immunotherapies, the guidelines point out the necessity to scientifically prove the effectiveness of cell therapies.

“Whether [immunotherapies] are statistically seen as effective compared to past cancer treatments should be examined, and the results should be made clear,” said Nobuyuki Yamamoto, a professor of respiratory medicine and medical oncology at Wakayama Medical University who was responsible for drafting the guidelines.

Cell therapy falls under the law on ensuring the safety of regenerative medicine, which came into force in 2014, and facilities culturing cells and providing treatment need to report to the government after an inspection by a third-party agency.

Although uniform transparency has been secured, “There have been cases in which some medical institutions misuse government-approved treatments,” said Yoshiki Sawa, director of the Japanese Society for Regenerative Medicine and a professor of cardiovascular surgery at Osaka University. “The inspection system must be reinforced.”

Doctors are given broad discretion in terms of the medical practice they provide. Gene therapy and immunotherapy not covered by insurance are provided based on such discretion.

Wakao, who was in charge of revamping the National Cancer Center’s website, pointed out: “All doctors are not always going to provide the correct explanation. If ethically dubious treatment is provided without insurance coverage, some form of restrictions must be created for such treatment.”Speech

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