Tue, 19 Dec 2000

Prudence or negligence?

Every once in a while a public announcement is released by the FDA, the American federal food and drug administration which, among other things, controls which drugs and medications are or are not allowed to freely circulate for public consumption in the United States and cautions the public in that country against any improper use of the drugs.

Most recently, the FDA ordered all drugs containing phenylpropanolamine, or PPA, withdrawn from the shelves after research established that prolonged use or an overdose of the substance could induce hemorrhagic stroke in certain people.

Earlier, the agency issued a similar warning against the use of ginko biloba, which is extracted from the bark of a tree of the same name. In Indonesia, ginko biloba is advertised as a "traditional" medication to assist better brain functions and as an agent to promote blood flow in the body. Ginko is present in the memory-booster Cerebrovit, whose maker already withdrew its misleading advertisement last week.

Used indiscriminately, however, ginko can cause side effects, especially when mixed with other medication, including bleeding under the skin and nose bleeds. Eleven cases of those side effects have so far been reported from Germany and France, seven of which were caused by the use of ginko together with other medications such as anti-coagulants and oral contraceptives, and four by ginko biloba alone.

Of course, such reports tend to be technical and at least some knowledge of the procedures and the terminology used is needed by the layman trying to interpret them. That is why the cooperation of the medical profession, the pharmaceutical industry and the advertising business is needed if those findings are to be of any use to the public at large.

Thus last week, the Director-General for Food and Drug Control (POM) in Jakarta reprimanded producers of medicines containing ginko biloba for providing inadequate information to the public on the substance and the companies have been asked to withdraw all misleading advertisements of these products.

A similar problem exists with over-the-counter medicines containing phenylpropanolamine (PPA), which is present in many popular anti-flu and cough-repressing medicines, 189 brands of which are at present being freely sold in this country. In countries such as the U.S. and Singapore, where drug circulation is under strict government control, such drugs are barred from circulating.

POM, the Ministry of Health's directorate-general for food and drug control, however, sees as yet no need to go that far and is confining itself to ordering pharmaceutical companies to reduce the PPA content in their products from 25 milligrams to 15 milligrams, the maximum tolerable amount being 60 milligrams a day. Of course, the directorate-general also prohibits all misleading advertisements and makes it compulsory to provide the public with true and adequate information about any counter- indications.

The question is, can such measures be expected to effectively protect consumers in this country? The Indonesian Consumer Foundation (YLKI) believes they cannot. "It is obvious that the Ministry of Health is ignorant for permitting such advertisements for ginko biloba," says YLKI chairperson Zoemrotin K. Soesilo. "It is difficult to control since drugs in Indonesia are distributed all the way down to cigarette kiosks. So, what's the guarantee that people will have safe medicine with adequate labeling of counter-indications?"

Probably not much as long as pharmaceutical companies remain preoccupied with profits more than with the public's welfare. It is no secret that some of them, or their detail men and women, have in the past shown a remarkable flair for collaborating directly with physicians in selling their products. The government is right in saying that there is no need to create unnecessary public concern. At the same time, however, it must be strict in seeing to it that pharmaceutical companies comply with the rules.