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Employees of the renowned journal “Science” accuse the US drug approval authority FDA of negligence in following up on clinical studies. According to the study published this Thursday in “Science”, the FDA controls the studies mostly commissioned by pharmaceutical companies in a lax, slow and non-transparent way. The rapes were increasingly inconsequential. Some of the studies decide whether the drugs would be used in humans.
The authors of an article published in the renowned magazine “The New England Journal of Medicine” (NEJM) also raise accusations against the US authorities:
Without transparent and scientifically sound processes, the FDA is playing on the trust it has built over the past century. Clinicians and patients must be able to trust that any approval is based on a careful evaluation of all available data and that the agency’s decisions are well-founded and objective.
According to their own information, “Science” employees Charles Piller and Meagan Weiland viewed about 1,600 internal pharmaceutical authority documents from a period of approximately ten years to 2019. FDA experts have documented sometimes “dangerous and illegal “in clinical studies However, the authorities only sanctioned companies in exceptional cases and forced them to make improvements.
For example, it was often of no consequence if study participants were not adequately informed about risks or if surveys were not carefully documented. According to the research, the number of warnings issued by the US authorities has decreased significantly in recent years.
While the authority issued 99 warning letters for serious violations in President Barack Obama’s first three years in office (2009 to 2011), there were 36 in his last three years in office (2014 to 2017) and only twelve during those years. first three years. Donald Trump. The number of processes controlled by the FDA under Trump has increased significantly. The government budget has also increased over the years.
FDA: Trump administration does not affect work
The US authority stated in “Science” that the number of such warnings could “decrease and increase.” The Trump administration has no influence on his work. In relation to a possible approval of a corona vaccine, FDA chief Stephen Hahn had repeatedly emphasized the authority’s political independence: The FDA will adhere to its known and strictly scientific procedures when approving a vaccine.
Wolfgang Becker-Brüser, physician and editor of the trade journal “Arznei-Telegramm”, rates the FDA’s influence on global drug safety as high. “The practice of drug approval in the US will certainly have an impact on the quality of drugs in Germany.”
There is a “globalized drug market”, which is why the various pharmaceutical authorities work closely together, including the FDA with its European counterpart, the European Medicines Agency (EMA). At the same time, the authorities are also in a competitive relationship, for example when it comes to the speed with which drugs or vaccines are approved. The EMA could come under pressure from early decisions by the FDA to also approve drugs “prematurely.”
“If one of the partners is weak and not working properly, the others also come under pressure,” said Becker-Brüser. The EMA is repeatedly criticized for working too slowly, and slowness can be a sign of thoroughness.
