German Behind Kava Ban Admits Facts Weren’t Clear

admin's picture

Professor says minor issues were blown up to justify regulation

By Sophie Budvietas

APIA, Samoa (Samoa Observer, Jan. 4, 2015) – The man responsible for banning ava in Germany, costing the regional industry $6.9 billion tala [US$2.9 billion], has back flipped on his original decision.

In an article published in Apotheke Adhoc last month, Professor Harald G. Schweim is quoted as saying the facts behind the ban were not as clear as originally assumed.

Prof. Schweim was the President of the country’s medical regulatory body the Federal Institute for Drugs and Medical Devices – in German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) – when the 2002 ban was instigated.

Chairman of the International Kava Executive Council (I.K.E.C.) Tagaloa Eddie Wilson says the public comments made by the Prof. have given the ava industry here in the Pacific hope.

He says the original article focussed on the current tendency of blowing up the significance of small safety issues to overwhelming proportions in order to justify regulatory action taken for consumer protection.

"Even though in most cases the alternatives tend to be much more dangerous than the examined issue itself," Tagaloa says.

"Prof. Schweim blamed the authorities and the politicians for just making a show to justify their existence."

"In this context the journalist specifically asked about kava [sic], as this was banned under the responsibility of Prof. Schweim."

In the article, translated by I.K.A.C.’s leading scientist Dr. Mathias Schmidt, Prof. Schweim confirmed he was head of BfArM when the first decision on ava was issued.

"At that time there was allegedly evidence of a women requiring a liver transplant and succumbing from it later," Prof. Schweim said. "At that point we decided that the manufacturers should produce new studies."

"When I left BfArM the situation escalated in a fight with companies and associations."

"It then became clear that the facts were not as originally assumed."

"The latest court decision is therefore correct and embarrassing for BfArM - even more embarrassing is that they intend to fight against it."

The court decision the Prof. makes reference to is the European nation’s Federal Administrative Court (F.A.C.) when it lifted 12-year ban imposed by Germany’s Federal Institute for Drugs and Medical Devices (BfArM), on ava products last year - finding the ban both unreasonable and unlawful.

According to the Council’s lawyers, the F.A.C. ruled if risk associated with ava could not be clearly and scientifically corroborated, then there is no justification for the withdrawal of marketing authorisations.

This means that in a benefit to risk ratio, the risk must be assessed in context, especially if the therapeutic alternatives (offered when a drug is removed from the market) bear a greater risk.

When ava products were pulled from the market the substitute offered up by BfArM was benzodiazepine.

The Council’s lawyers said, it was here the Court found BfArM had erred when it described benzodiazepines as a harmless alternative.

According to Lance P. Longo, M.D., University of Wisconsin Medical School, Milwaukee and Brian Johnson from the Harvard Medical School, Boston, Massachusetts benzodiazepine therapy can give rise to physiologic and psychologic dependence based on the drug's dosage, duration of therapy and potency.

Despite these findings, the BfArM appealed against the Court’s ava decision in the Higher Administrative Court for the Land of North Rhine-Westphalia.

This appeal is still ongoing.

Tagaloa says the interview with Prof. Schweim would be used in the next hearing of the Court of Appeal.

"(We) consider this latest development as a perfect start for 2015 to all fighting for a comeback of kava," Tagaloa says.

Rate this article: 
No votes yet

Add new comment