Studies on HES infusion agents falsified for years?
Scandal of potentially dangerous drip infusions. Infusions based on hydroxyethyl starch (HES) have been used for decades in emergency and intensive care medicine as so-called colloidal volume substitutes (blood plasma substitute). In the event of massive blood loss or impending hypovolemic shock, they are intended to stabilize the patient's condition. However, the opposite may be the case.
Several recent studies have indicated that "HES could have an unfavorable benefit-risk ratio in the therapy of critically ill patients," reported the Federal Institute for Drugs and Medical Devices (BfArM). In a recent article, the news magazine "Focus" even came to the conclusion that "there is a lot to be said for the risks being hidden for a long time by fake studies." In March, the BfArM initiated a risk assessment process at European level in order to Check the ratio of HES preparations thoroughly. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency then recommended, after an initial assessment in June 2013, that approvals for HES infusion solutions should be suspended.
Increased mortality from HES infusion agents? The Federal Institute for Drugs and Medical Devices recommends that physicians no longer use the common HES infusion solutions. In a conversation with "Focus", BfArM President Walter Schwerdtfeger advises the emergency medical centers and clinics to stock up more infusion solutions than HES. "You have to be prepared for the fact that the approval of HES at European level will be limited or suspended in the next few months," Schwerdtfeger continued. The PRAC concluded in June that HES infusions have a higher risk of kidney damage and increased mortality compared to so-called crystalloid infusion solutions. Use in patients with sepsis in particular had proven to be unfavorable in the recent studies.
Falsified studies on HES infusion agents? In its current article, the “Focus” concludes that “a series of older examinations by the German physician B., who have since been withdrawn due to scientific misconduct,” contributed to the widespread use of HES infusions for more than 40 years. Prosecutorial investigations are also underway, with bodily harm forming one of the suspicions. The doctor did not want to comment on the paper, but according to the "Focus" is "married to a former high-ranking employee of the HES world market leader Fresenius (Bad Homburg)". Here it is suspected that there might have been a conflict of interest. Fresenius spokesman Matthias Link did not comment on this for "data protection reasons", but the company apparently sees its infusion agent wrongly in the pillory. "We demand a reassessment," quotes the "Focus" the Fresenius spokesman. The negative verdict of the first instance EU body gives a wrong impression, because if at all, the new studies would only have increased the risk if HES was used against an impending sepsis, explained Link.
If the preliminary negative benefit-risk assessment of the HES infusion agents is confirmed, a timely loss of approval can be expected. But the question arises how many people have actually been harmed by appropriate infusions in the past decades. (fp)
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