Japan lacking in regulating human tissue use in transplants

July 18, 2012


With advances in technology and medicine, people are becoming more valuable dead than alive, their body parts stripped to supply the active global trade in human tissue, such as skin, bones and tendons.

Collected from cadavers, these valuable body parts are used as materials in pharmaceutical products in everything from dental implants and cosmetics to sports medicine.

The increased demand for such tissue, however, has led to an increase in questionable practices for obtaining human tissue from cadavers.

The International Consortium of Investigative Journalists (ICIJ) looked into the hidden practices used and has compiled a report, which can be read at: http://www.icij.org/tissue

The Asahi Shimbun has also looked into the use of human tissue in Japan and has found there are no legal regulations.

No laws in Japan for controlling use of human tissue

Because the Ministry of Health, Labor and Welfare has made mandatory the confirmation of donors related to pharmaceutical products such as skin sheets made from human tissue, there have only been a few cases of approved use and they all have involved tissue from Japanese donors.

Moreover, the Japanese Society of Tissue Transplantation has guidelines for the use of human tissue for transplants. The guidelines are as strict as those for approved pharmaceutical products and as a result, tissue banks in Japan only handle those from Japanese donors whose identities have been confirmed.

However, in medical treatment cases outside of the national health insurance program, there are no limits on doctors importing from abroad medical materials made from human tissue for treatment of patients. There are also no laws in Japan for controlling use of human tissue, such as skin and bones.

Unlike organs, such as the heart and lungs, which are strictly regulated under the Law on Organ Transplantation, there is no ban on the buying and selling of human tissue. Under the current situation, the health ministry cannot accurately estimate the extent of, or even know, if there is the import of such tissue from abroad.

Soichiro Kitamura, a president emeritus of the National Cerebral and Cardiovascular Center who is knowledgeable about tissue transplants, said, "While there will continue to be a need for human tissue in future treatment of burn patients, for example, there will also be a need to prevent the use of human tissue from abroad for which the origins are unclear. Legal revisions should be made so regulations conform to the Law on Organ Transplantation."

Japanese doctors depend on FDA for implant materials

A dentist in the Tokai region showed an ocher-colored thin strip measuring about one centimeter by two centimeters. The material crumbled into tiny particles when touched. Although the material did not give off any strong odor, it was granular material formed from freeze-dried cadaver bone.

The material is used to form the bone anchor for dental implant operations. For some teeth, the material is considered more suitable than artificial ones.

The dentist explains what the material is made of to his patients and he uses the material made from human bone in about 10 percent of the 1,000 or so cases he handles over the course of a year.

Because similar products are not sold in Japan, all the materials have to be imported. The product the dentist showed was bought from South Korea for about 10,000 yen ($130).

The box containing the material had a certification seal from the U.S. Food and Drug Administration (FDA). There was also a certification form inside the box that contained not only the product number but also showed the source of the material had never been infected with HIV or hepatitis. The manufacturer explained that it was possible to identify the donor of the bone.

The dentist said, "There are no problems with safety because of the FDA approval and because no accidents have yet to occur."

Fumihiko Watanabe, president of the Japanese Society of Oral Implantology, said, "There is some danger of infectious disease through the use of products made from human bone. Because there is no approval from the health ministry, the only thing the society can do is ask individual doctors to acquire the consent of the patient and assume responsibility when using the product."

In some cosmetic medicine cases, doctors have used their own prerogative to import human tissue for use in treatment.

For example, human skin is among the ingredients used in collagen products that are said to be effective in smoothing out wrinkles. More recently, there has been a decline in the use of such products because of greater use of hyaluronic acid, which is considered safer and cheaper.

(This story was compiled by Nobuya Sawa, Ayako Tsukidate, Ryota Kyuki and Kosuke Tauchi)

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Editor's note: The Asahi Shimbun has decided to enter into a collaborative relationship with the ICIJ, which was established by the Center for Public Integrity (CPI) to serve as its international reporting arm. The CPI was established in 1989 in the United States as a nonprofit investigative journalism organization.

The CPI has uncovered a number of major stories, including one about inflated billing by Halliburton, the major U.S. energy company, for contracts related to Iraqi reconstruction.

The ICIJ has also worked closely with The Washington Post and The Associated Press.

Major media outlets around the world have increasingly begun publishing articles from investigative journalism organizations, such as the CPI. While the articles are provided free of charge, one condition for publication is clearly stating that the report is from the ICIJ.

This is the first instance in which The Asahi Shimbun has been provided a report from the ICIJ.

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The inside of a "human tissue bank" in Ukraine (Provided by ICIJ)

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