01 Investigation
Written by: Li Yinglin, Lao Xianliang
2021-04-12 07:00
Last update date: 2021-04-12 07:00
"Immune cell therapy" has become a new method for patients to fight cancer in recent years. "Hong Kong 01" revealed that a specialist for the elderly, Yang Bin, used "allogeneic NK cells" from Shenzhen to treat cancer for patients at a price of more than 100,000 yuan per injection. Brand drugs, smuggling drugs, etc., involve at least five crimes.
"Hong Kong 01" contacted the Shenzhen laboratory involved, and the person in charge admitted that he sold cell products to distributors, but bluntly said that the transportation of cell products has strict requirements on temperature, which would be very dangerous if involved in smuggling.
After the DR medical cosmetology accident in 2012, the authorities enacted regulations governing advanced therapies. It took six years to start consultations. It was finally passed in the Legislative Council last year, but it is still in a transitional period and needs to be officially implemented.
"Immune Cell Therapy" series of investigation reports:
Immune Cell Therapy | Geriatrics called celebrity cancer treatment Shenzhen smuggled preparations 100,000 per shot
Immune Cell Therapy | Hong Kong Doctors Smuggling Cells Involved in Multiple Crimes, Shenzhen Laboratory Boss Reveals the Shade
Immune Cell Therapy｜Deconstruction of NK, CIK, CAR-T Therapy There is only one legal clinic in Hong Kong
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Yang Bin, a geriatrician who opened a clinic in Causeway Bay, promoted "NK cell immunotherapy" to treat cancer by pretending to be friends and relatives. He claimed to be "allogeneic cells", that is, cells drawn and made from other people’s cord blood. The Shenzhen laboratory, with four needles per course of treatment, asked for a price of 500,000 yuan, and claimed that a well-known artist was his patient.
"Hong Kong 01" revealed at least five crimes.
Allegation 1: Illegal drug preparations
The Department of Health stated that there are currently no registered pharmaceutical products containing NK cells or CIK cells in Hong Kong, which is in violation of the Pharmacy and Poisons Ordinance.
Allegation 2: Smuggling
The Department of Health stated that the failure to issue import permits for pharmaceutical products containing NK cells or CIK cells involved a violation of the Import and Export Regulations, with a maximum fine of 500,000 yuan and imprisonment for two years.
Customs stated that it will continue to monitor the relevant situation and follow up if any violation of the Import and Export Ordinance is found.
Allegation 3: Illegal importation of blood products
According to the Prevention and Control of Disease Ordinance, anyone who imports blood or blood components into Hong Kong without approval is subject to a maximum fine of $5,000 and imprisonment for two months upon conviction.
Allegation 4: The clinic performs operations without a license
Yang Bin claimed to perform blood sampling and reinfusion treatment at his clinic in Causeway Bay. The Department of Health stated that hemodialysis and other procedures require a day medical center license, but the clinic has not applied for it, which violates the "Private Medical Institutions Ordinance."
Allegation 5: Illegal organ trading
Umbilical cord blood is regulated by the "Human Organ Transplant Regulations" and commercial sales are prohibited. Yang Bin said that the "alogenous NK cells" from the Shenzhen laboratory were drawn from the cord blood of other people.
Legislative supervision after the 2012 DR accident is still to be gazetted and implemented
In fact, improper immune cell therapy has caused serious accidents.
In 2012, DR Medical Beauty Group launched the CIK cell health treatment program. The blood of the guests was drawn, and the CIK cells were cultured in a local laboratory, and then returned to the guests. Due to blood contamination, one person died, one had to be amputated to save his life, and the other was permanent. Disabled, the doctor involved, the founder of the beauty group, and the male laboratory assistant were all convicted of manslaughter.
The government enacted regulations to regulate advanced therapies afterwards, and consulted at the end of 2017. In July last year, the Legislative Council finally passed the "Pharmacy and Poisons (Amendment) Ordinance 2020", which included advanced therapies under the supervision of pharmaceutical products and gave the industry about one year to adapt The period is now pending gazetted by the Secretary for Food and Health.
Shenzhen laboratory boss: Distributors have sold to the medical beauty industry
Yang Bin claimed that "allogeneic NK cells" came from the Shenzhen laboratory "Zhongjia Biomedical Technology", and there are strict restrictions on the export of cell products. Allogeneic cells are organ transplants, and the supervision is stricter. The smuggling of cell products to Hong Kong is also suspected of violations. Mainland law.
In fact, immune cell therapy is also in the clinical research phase in the Mainland, and government hospitals prohibit charging for such treatment.
Qu Shoukang, executive director of "Zhongjia", said bluntly that there are many gray areas.
▼Comparison of several immune cell therapies▼
Smuggling is dangerous during transportation
He claimed to cooperate with the government hospital in Shenzhen for clinical research, but he also sold the products to distributors, and the distributors sold them to the medical cosmetology industry. Each course of treatment ranged from tens of thousands to hundreds of thousands of yuan. He also pointed out that even if fees are not allowed , Its company also has a way to receive money.
Qu Shoukang also emphasized that the transportation process of cell products has strict requirements, and it would be very dangerous if it involves smuggling.
In September 2020, the State Food and Drug Administration approved Zhongjia’s medical device products for cultivating NK cells, T cells and stem cell culture media for "recording", stating that "cultured cells are used for in vitro diagnosis".
(Website of the State Food and Drug Administration)
Regulatory loopholes in the Mainland repeatedly explode immunotherapy incidents
In recent years, it has been continuously revealed that medical aesthetic hospitals have violated regulations to solicit business, and there have been repeated medical accidents. The most famous is the "Wei Zexi Incident" in 2016.
Wei Zexi, a post-90s young man with terminal synovial sarcoma, went to Beijing Armed Police Second Hospital to receive CIK therapy. He spent 200,000 yuan in his savings, but eventually died ineffective.
The incident involved false advertisements and outsourcing of the operating room of the Armed Police Hospital.
▼The 2012 DR tragedy convicted three people for manslaughter ▼
▼Revisit the investigation report of ``Drying Salt Water Beauty''▼
[Drop salt water beauty] Intravenous beauty infusion is suspected of containing steroids, the doctor reprimands incredible
[Drop salt water beauty] Nurses who are not registered in hotel rooms give injections to spas involved in illegal medical practice
[Hanging salt water beauty] Madonna Rihanna pursues Australian clinic and was ordered to close after accident
▼Review the investigation report of ``Smuggling Blood Test''▼
Directly attacked by Hong Kong doctors assisting pregnant Lu’s "Blood Test" by signing a blank referral letter and was approved for violation of professional ethics
Intermediary falsifies blood test report, saves laboratory test fee, innocent fetus abortion
Immune Cell Therapy | Geriatrics called celebrity cancer treatment Shenzhen smuggled preparations 100,000 per shot
Immune Cell Therapy｜Deconstruction of NK, CIK, CAR-T Therapy There is only one legal clinic in Hong Kong
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