Specious Deliberation Over PPA

At a meeting of the Central Pharmaceutical Affairs Council (CPAC), held in February and April of 2001, where members was reported to have decided to allow the sale of phenylpropanolamine (PPA) as a medicine for the cold despite the possibility of cerebral apoplexy from its use, it is revealed that some of them objected to prohibiting PPA from being sold as a medicine only because “there is no substitute medicine,” which is contradictory to what has been known.

CPAC is the Korea Food and Drug Administration (KFDA)’s advisory organization that primarily covers pharmaceutical affairs. Depending on CPAC’s green light on PPA, KFDA allowed the sale of medicines that contain less than 100mg PPA per daily dose on July 2001.

This fact was revealed after an examination of records on four PPA-related meetings of CPAC in 2001 and 2002 which Dong-A Ilbo obtained yesterday.

According to the records, at a CPAC’s meeting of a committee for medical safety measures and the effect of medicines held on February 14, 2001, member A, professor of a college of pharmacy, said, “Complete prohibition of PPA is impossible because we have no substitute medicine.” Member B, professor of a college of pharmacy, also said, “We do not have substitute medicines, especially for coryza.” In this meeting, where seven members took part, there was no objection to PPA sales, and the conclusion of the meeting was “PPA should be continuously used in medicines for the cold.”

However, it is not true that we have no surrogate medicines for PPA. In fact, from several decades ago, pseudoephedrine has been used as a substitutive medicine throughout the world. Therefore, there was no problem in finding substitutive medicines at that time.

At the second meeting on PPA, held on April 19, 2001, they continued this position. Member C said, “It is difficult to find substitute medicines for the cold now,” but member D mentioned the existence of pseudoephedrine for first time by saying, “Pseudoephedrine’s side effects are as serious as PPA’s.” However, his saying that “the side effects are as serious as PPA’s” is an exaggeration.

Tae-Hoon Lee jefflee@donga.com