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Anti-Alzheimer drink has no efficacy: civic group
  • By So Jae-hyeon
  • Published 2018.10.24 15:22
  • Updated 2018.10.25 14:00
  • comments 0

Medical experts are increasingly raising suspicions over whether Handok’s new drink Souvenaid has efficacy to improve memory in patients with dementia and Alzheimer’s disease.

Some even suspect that the Ministry of Food and Drug Safety was conniving at the pharmaceutical company’s promotion of the controversial drink.

Barun Medicine Institute, a civic group of medical professionals, called for the government to reconsider designating Handok’s Souvenaid as “food for special medical purposes.” The group also argued that the food and drug safety ministry and Handok might have a collusive tie.

“The government allowed Handok to advertise as if Souvenaid’s efficacy has been verified under the name of food for special medical purposes and as if the drink could be an alternative to medications. This is a grave issue,” the Barun Medicine Institute said. “We filed a petition, requested an information disclosure, and analyzed related papers.”

The group said it has Handok was able to roll out Souvenaid with the government’s granting unfair benefit and easing regulations.

According to the institute’s analysis, the medical drink did not show any evidence of dementia preventing and treating effect in clinical trials in patients with mild cognitive impairment and Alzheimer’s disease.

“Despite the lack of evidence, Handok promoted Souvenaid’s efficacy because it overestimated a few of a little positive result in the analysis of additional variables in some studies,” the civic group said.

In December 2016, the government amended the addendum of the Food Sanitation Act’s Enforcement Rule to allow food for special medical purposes to have disease labels for food takers.

However, the results of the institute’s petition filing at the food and drug safety ministry showed that the government did not review any related data, the group said.

“Considering that Handok’s Souvenaid was the only drink that sought approval as ‘food for special medical purposes,’ that the food ministry refused to disclose data on the procedure of the Souvenaid import, and that the ministry said there was no problem in Handok’s advertisement, the food ministry is excessively protecting Handok’s stance,” the institute said.

The institute urged the government to reconsider the deregulation policy that allows the labeling of diseases in food for special medical purposes from scratch.

The government should prohibit drugmakers from using the names of diseases for the advertisement of food for special medical purposes sold under a vague standard, the group said. The government should also stop Handok’s advertisement of Souvenaid which could confuse the public as a pharmaceutical product, it added.

In August, Handok released Souvenaid to target patients with mild cognitive impairment and mild Alzheimer’s disease.

The company promotes that the drink provides nutrients that may lack in patients with mild cognitive impairment and mild Alzheimer’s disease. The advertisement says the drink arrived in the market after four multinational, multi-center clinical trials conducted on 1,322 patients.

sjh@docdocdoc.co.kr

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