Page 1 – It's not until a person dies that Bayer invades
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Actually, this article is only a leaflet. The piece of paper that you can fold so hard and that most people barely read. The piece of paper that, by law, has to find all that a drug can do to the body in the worst case scenario. Often there are things that are very, very unlikely and that have the potential to panic individual people.
It's about such a note. More precisely, that of Iberogast, a herbal tincture that is advertised with the healing power of nature and yet can be harmful. And here it becomes more fundamental. It is also about a toothless drug agency and a pharmaceutical company that harms itself with a maddening blockade attitude, especially on itself and its credibility. An attitude that was abandoned only with the death of a patient.
Iberogast, distributed by Bayer, is intended to help against stomach problems. The group is to take 120 million euros annually with the bitter, brown drops, which are purely vegetable. Something that Bayer actively advertises: "The combination of 9 medicinal plants is fast and effective." Bayer just knows that a majority of Germans, according to surveys, attach great importance to taking herbal or gentle medicines. The problem here: Vegetable and gentle can not simply equate.
Celandine can add to pregnant women and people with liver damage One of the nine herbs that according to Bayer in Iberogast is celandine. In high doses it leads to liver failure and could be dangerous for breastfeeding, pregnant women and their unborn children. For this reason, already in 2008, the Federal Institute for Drugs and Medical Devices (BfArM) initiated a phased procedure against celandine-containing drugs. Medicines high in the herb had to be completely off the market. In the case of medicines containing little celandine, such as Iberogast, manufacturers must at least receive warnings that breastfeeding, pregnant women and people with liver problems should avoid the drug. All manufacturers followed, except Steigerwald, which manufactured Iberogast and was later bought together with the Bayer product. She – and later Bayer – refused and contradicted the presentation of the BfArM. The reason: Iberogast is not pure celandine, but a combined preparation and its potential health risks could not assess the BfArM due to lack of data.
The Federal Institute then remained apparently idle for the time being. It decided not to force the Iberogast manufacturer by immediate enforcement to include the instructions. And in this stalemate it remained almost ten years. On request, the spokesman for the Bfarm Maik Pommer said that BfArM could not have acted against Iberogast between 2008 and 2017 because Steigerwald and Bayer would have been defeated in a legal dispute on the basis of the then available case reports. Thus, the opposite of the BfArM deemed necessary measures would have been achieved: The decision from 2008 would be obsolete and the security information contained therein completely out of the world. Therefore, the BfArM collected further information on the harmfulness of Iberogast. It would not be until 2017, Pommer said, that four case reports on the health effects of Iberogast, including a postoperative liver failure (American Journal of Gastroenterology: Sáez-González, 2016), have been prepared for legal proceedings and have been resting for almost ten years Contradiction Bayers back.
Bayer complained anyway (ZEIT ONLINE reported). The process is still going on today. This week, however, the company unexpectedly called in, the BfArM announced that Bayer "at the urging of the BfArM to the changes in the risk and safety information procedure for Iberogast order[setzt]"The reason: A patient who had taken Iberogast is said to have suffered from a liver failure and ultimately died from it." The BfArM had threatened Bayer with immediate effect.