Miguel A.García

While the pharmaceutical company Bayer ask consumers to be calm concerning the withdrawal of its product against cholesterol Lipobay, it already faces two lawsuits in the United States and the German Government's accusations of having hidden data about the risks of this medicine. The North American authorities already sued in 1999 Bayer accusing it of minimising the risks of its medicine. 

Now, the lawyers of two affected people request millionaire compensations and it is expected a wave of accusations that will stagger the pharmaceutical company. Also in Spain the first lawsuits take place against Bayer for its medicine Lipobay and all the lawsuits will be based on the report that forced the medicine’s withdrawal. As it seems, the company knew since last June the possible secondary effects of the medicine, but it didn't inform to health authorities until the medicine was withdrawn. The German Ministry of Health qualifies this fact as unacceptable, since the company knew that the preparation was dangerous, after carrying out a report dated last 15 June. However, the results of this report were not shown until 10 August, that is to say, two days after the medicine’s withdrawal took place. The German Ministry of Health considers that Bayer has not fulfilled its responsibility regarding patient’s health, putting their life in danger to such an extent that Lipobay has caused 52 deaths. News on the medicine’s withdrawal have caused psychosis among patients taking Lipobay and any muscular trouble is related with its possible secondary effects. Bayer stands for Lipobay now and people distrust any medicine of the company. In Spain 200.000 people have been treated with Lipobay and four deaths are related to the consumption of this anticholesterol, and according to the Spanish Medicine Agency, until last 18 June, 34 cases of rabodomiolisis (muscular problems) were associated to the component of Lipobay, cerivastatina, and in 65% of the cases, the patient followed a treatment that combined cerivastatina with gemfibrozilo, another component administered in order to lower cholesterol. It is known that in the United States 700.000 people consumed the medicine, and other 500.000 in France, in total, about 6 million people world - wide. In Germany Bayer distributed its medicine for free, in the framework of a pilot program, shortly before its withdrawal from the market and when its risks were already known. But the polemic about medicines’ safety doesn't end in Lipobay. The pharmaceutical multinational Johnson & Johnson warns against the anti-arthritic Remicade, after verifying that the medicine has reactivated tuberculosis in 84 patients, 14 of them have died. More than 170.000 people have been treated world-wide with Remicade in order to fight against some variants of the illness of Crohn and rheumatoid arthritis. In addition, another similar medicine is under suspicion, the Embrel, manufactured by Inmunex, and whose secondary effects can be the same. Seven out of the 84 cases of tuberculosis as a result of Remicade have been recorded in Spain. At the same time, two pharmaceutical laboratories have requested the Ministry of Health the authorisation to substitute one of the active principles (the fenilpropanolamina) that makes up the formula of the main flu remedies. According to the Ministry of Health there is not risk in this active principle, whereas laboratories allege commercial reasons. The fact is that a study carried out by the University of Yale on a possible connection between the use of fenilpropanolamina and the appearance of cerebral haemorrhages whose results were known in December 2000, indicates that the relationship benefit-risk is unfavourable and its use should be avoided in the case of being administered as a medicine mitigating appetite, but should not when it is administered as decongestant in flu remedies. Also, the president of the National Association of Advertising Pharmaceutical Specialities states that this application is carried out to modify the formula and that there have always been changes in this sense and that the problem deals with economic and commercial reasons, and in any case it is about safety reasons or product’s efficiency. On the other hand, the director of Farma-industry defends the good operation of the monitoring system in Spain and states that the recent withdrawal of some medications is a sign of it. For this reason he requests clam and that social alarm is not promoted, since once the medicines is commercialised, they are controlled by the Administration and by laboratories. But the efficiency of the monitoring systems of medicines’ safety has created doubts at an European level. In Spain, for example, only a 31% of the studies on commercialised medicines seeks to research their safety. Most of the studies simply seek to induce their prescription among doctors. These data appear in a report of the Advisory Committee of the Spanish Medicine Agency that proposes new guidelines for these studies. Precariousness in therapeutic information, in monitoring and safety of new medicines exists, in spite of legislative efforts of the European Union. The tendency of withdrawing those medicines whose adverse effects have been proven should change toward the demand of responsibilities, mainly because it is citizen's health that is in risk.