Patient safety versus industry interests?
According to the CDU/CSU parliamentary group, is a ban on titanium dioxide in medicines not on the agenda?
Patient safety continues to have no priority over the interests of the pharmaceutical industry
The health policy spokesman for the CDU/CSU parliamentary group and member of the Health Committee, lawyer Tino Sorge from Magdeburg, stated in a statement on September 9, 2022 that, according to current information, titanium dioxide should only be used in medicinal products in the smallest possible quantities, with the greatest caution and stricter regulations control is used. The excipient, which is used in around 91,000 human medicines and around 800 veterinary medicines and which has been banned in food throughout the EU since 2022 due to unclear health risks, would be required for tablets, among other things, which would have to have a protective film for an optimal effect. Incidentally, continues Tino Sorge, the quality and safety regulations for pharmaceutical production are many times stricter than those for food production.
The statement is remarkable in that the publicly accessible information on the contents of medicinal products does not contain any information on the quantities of auxiliary substances used, only general information on use. Consequently, the statement that titanium dioxide was used in the smallest possible quantities is not verifiable and unproven. It can also be seen that the CDU/CSU parliamentary group is currently not considering a ban on titanium dioxide in medicines. This also coincides with an earlier statement by the CDU member of the Bundestag Erwin Rüddel, who remarked that the small amounts of titanium dioxide in medicines do not pose a health risk, but without specifying which amounts should be considered small or not small.
The FDP representative on the Health Committee, Maximilian Funke-Kaiser, had already stated in January 2022 that the European Medicines Agency (EMA) appealed to pharmaceutical manufacturers in 2021 to develop a substitute. Funke-Kaiser remarked at the time that there were already examples of how this could work. For example, there are ?Ibuprofen“ alternatives that do not require titanium dioxide, and if this development progresses, a ban on titanium dioxide could also be implemented. The representative of B90/Greens in the health committee, Dr. Janosch Dahmen, also in January 2022, had already suggested the development of an exit scenario that gives drug manufacturers the opportunity to reformulate their preparations on a science-based basis and explains that drugs for which alternatives to titanium dioxide already exist can be started very quickly. The SPD deputy Heike Baehrens, also a member of the Health Committee of the german parliament, was more specific in her statements by stating that almost all oral dosage forms, i.e. tablets, soft capsules, hard capsules, granules etc. are affected and had declared her hope that that it would quickly come to the conclusion of review procedures involving the federal ministries involved, the Federal Office for Risk Assessment (BfR) and the EMA. The health politician Prof. Dr. Andrew Ullmann (FDP), who, referring to his medical expertise, thinks a ban on titanium dioxide in food is a good thing, also welcomes the fact that the pharmaceutical industry is called upon to examine alternatives and to discuss a titanium dioxide ban in medicines again in three years at the latest will. The State Secretary in the Federal Ministry of Health, Prof. Dr. Edgar Franke, also underlined and, with reference to the effective ban on titanium dioxide in food, cited the possible genotoxicity that had not been ruled out.
The starting point for the now around 15 individual statements from politics and industry was the question raised by DOPANET Knowledge & Communication in Berlin in the summer of 2021 about prioritizing patient safety in the context of suspected health hazards from titanium dioxide in medicinal products. The science journalist Martin Rücker, who then took up the topic at the time, was recently honored with the ?Ulrich Schwabe Preis“ for his MEDWATCH article on titanium dioxide in medicinal products. The Europe-wide ban on titanium dioxide in food has been in effect since the beginning of 2022 and has not changed the structure and breadth of the range of products. The food industry has changed the content structures without loss. The pharmaceutical industry has so far shown little willingness to remove titanium dioxide from the formulations.
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For more informations: www.titandioxid.org
Andrew Ullmann Prof. Dr. Edgar Franke, MdB Tino Sorge Maximilian Funke-Kaiser European Medicines Agency Martin Rücker MedWatch
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