Did Czechs hear about Lipobay threat too late?

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Bayer, the famous drug producers announced that their product Lipobay, used by patients with high cholesterol levels, had serious side effects and that they were immediately taking it off the market. That was last Wednesday, but in the Czech Republic, the first public warning came only on Friday, and even then it was unofficial, and via the media. The drug, sold in this country under the name Cholstat, was still available in certain pharmacies during the weekend. Olga Szantova has the story.

There has been much criticism of the situation in the press, which has been stressing that 52 patients who had taken the drug in various countries had died and blamed the state institutions in charge of health care and drug distribution of threatening the lives of Czech patients. I asked the spokesperson for the State Institute for Drug Control, Blanka Pospisilova, why it had taken so long for the drug to be taken off the shelves of Czech pharmacies.

"I think that the reaction was fast enough, because we reacted immediately on Friday, when we sent the rapid alert to the health councilors."

But the first international announcement was on Wednesday.

"We received the announcement from the registration decision holder, the firm Laboratories Fournier in written form on Friday."

So that the two days were lost in the company that imports the drug?

"Yes, but I think it was not critical for patients that were using the medicinal product."

A point shared by other experts. For example, the chairman of the Czech Cardiological Society, Dr. Jaromir Hradec says that there had been no serious side effects of the drug recorded in the Czech Republic, because the doctors here prescribed it in much smaller doses than their counterparts abroad. The fact that Cholstat, or Lipobay, to use the drug's international name, can have serious negative effects on muscle tissue, especially when taken with other drugs or in large doses, was generally known and Czech doctors had taken this into account when prescribing it.

But even though it did not develop into a serious situation in this country, what would happen in cases where a quick reaction from health authorities was necessary? What is the system?

"According to the act on pharmaceuticals, the registration decision holder is responsible and he has the duty to announce and to recall all medicinal products from the market. They do that through wholesalers of drugs and they have to recall it immediately when there is a case of serious adverse reaction. The State Institute for Drug Control should react only when the registration decision holder does not react immediately, or not properly."

Is the Czech system in such cases fast enough?

"I think that it is comparable to the European Union. It is not possible, when we have more than 1900 pharmacists in the Czech Republic, to tell all of them immediately that something is wrong. If there is a dangerous case, a really dangerous case, then it is necessary to use the media. And we did that. We sent the statement of the State Institute for Drug Control immediately on Friday to the Czech Press Agency."

So, how are drugs selected for distribution in the Czech Republic?

"Every drug available, or, more precisely, every medicinal product on the Czech market must be registered by the State Institute for Drug Control. It means that the registration decision holder, or the applicant for registration should send to our institute not only the application but documentation on the product. There are very many rules. The act on pharmaceuticals is harmonized with the legislation in the European Union."

Author: Olga Szantová
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