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[Special] New drug candidate secretly prescribed in Oriental medicine
  • By Song Soo-youn
  • Published 2018.07.06 14:55
  • Updated 2018.07.09 12:10
  • comments 0

There is a problem existing only in Korea due to the nation’s dual medical systems of general medicine and Oriental medicine. A new drug candidate, which failed to be developed into a medication, can become an Oriental herbal medicine if an Oriental medicine practitioner prescribes it. This is possible because Oriental medicine practitioners are allowed to keep their recipes of herbal medicine as a secret. Physicians in general medicine cannot prescribe a new drug candidate, of course, because it is a candidate, not a drug.

Under the provision on the reporting and approval of herbal medicines, the government excludes components that appear in hundreds of years old books about Oriental medicine such as Dongui Bogam, or Principles and Practice of Eastern Medicine. Due to the provision, herbal medicines are exempt from clinical trials, and Oriental medicine practitioners treat their patients with their secret methods.

Medical experts have continuously criticized the provision, saying it violates the people’s rights to health. In December 2015, three professionals, including Gang Seok-ha, president of the Institute for Science-Based Medicine, filed a petition with the Constitutional Court to review the constitutionality of the provision. However, the court ruled on May 31 that the provision was constitutional.

“Oriental herbal medicines, exempt from the safety and efficiency assessment, are limited to those whose safety and efficacy are confirmed and whose risks are relatively low,” the court said.

In reality, however, many herbal medicines, still available to patients through Oriental medicine, fail to be developed as a treatment.

The latest example is the herbal cancer pill NEXIA. The treatment developer and Oriental medicine practitioner Choi Won-cheol conducted phase-2 trials on investigational drug AZINX75 twice to develop NEXIA into a pharmaceutical product. However, the two studies ended earlier than expected. Choi closed his business at NGC Clinic and NGC Oriental medicine clinic, located in Dankook University’s Nexia Global Center, in June 2016. Not only the medical community but patient groups raised suspicions over Nexia’s efficacy and demanded verifiable checks.

Another case is the Oriental herbal drug Cheonjisan. In June 1996, the Korean Doctors’ Weekly reported that Cheonjisan, which used to be known as “miraculous anticancer agent,” had no effect to fight cancer. A man surnamed Bae who sold the ingredient was sentenced to two years in prison, three years on probation, and a fine of 10 million won ($8,961).

Cheonjisan, which seemed to have disappeared into history, is now being developed as an anticancer agent called “TetraAs.” Bae founded a biotech firm Chemas to develop TetraAs. The company has completed only a phase-1 study.

“We conducted phase-2 trials at two university hospitals but discontinued them because we couldn’t recruit patients. We plan to do the phase-1 study all over again overseas because conditions are too strict in Korea,” an official at Chemas said.

TetraAs is still at the experimental stage, but some Oriental medicine practitioners had prescribed it under the name of “Hanbang (Oriental medicine) Cheonjisan” to cancer patients until last year. Seven Oriental medicine clinics formed “The Network of Hanbang Jeonjisan Oriental Medicine Clinics” to prescribe the investigational drug.

“We are dispensing Cheonjisan in the same way that the drug developer did and prescribing it. We are making it jointly with the developer,” said the owner practitioner of the Oriental medicine clinic, which was the base for the network.

Currently, the network of the seven Oriental medicine clinics is gone. Some of them are providing different medical service under a different clinic name or have moved to other places.

Some other Oriental medicine doctors are prescribing dubious herbal agents as hydrocephalus treatments, or herbal eye drops to treat eye fatigue, using secret remedies.

The government belatedly started to standardize Oriental medicine, but the medical community is skeptical about its effect. The Ministry of Health and Welfare plans to develop Oriental medicine standardized medical care guidelines for 30 major diseases by 2020, in collaboration with the Oriental Medicine Standard Clinical Care Guideline Development Project Agency. The ministry also plans to verify the Oriental medicine skills objectively and reflect them in the medical system.

However, physicians in Western medicine said the government should come up with a system to verify Oriental herbal medication and secure their safety and efficacy first.

“In medicine, an investigational drug goes through animal tests and phase-1,2,3 trials to prove that it is safe. Then, the verified treatment is prescribed to patients,” said Bang Sang-hyeok, vice president of the Korean Medical Association. “Running a system to allow herbal medicines to be prescribed to patients without any assessment is like giving up on public health.”

Bang went on to say, “Not a single country witnesses this kind of situation in the world. Only Korea is having this problem.” Every nation has traditional medicine, but most of them naturally disappeared or remained as folk remedies, he noted.

“Korea is the only country to put the government’s health insurance budget into the traditional medicine, which is like putting the clock back,” Bang said.

soo331@docdocdoc.co.kr

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