Medical scandal Dangerous HES infusion media

Studies on HES infusion drugs fake for years?

09/07/2013

Scandal about potentially dangerous infusions from the drip. Infusions based on hydroxyethyl starch (HES) have been used for decades in emergency and intensive care medicine as so-called colloidal volume replacement (blood plasma substitute). In case of massive blood loss or imminent hypovolemic shock, they should stabilize the condition of the patients. However, it may be the opposite.

Several recent studies have suggested this, „that HES could have an unfavorable benefit-risk ratio in the treatment of critically ill patients“, reported the Federal Institute for Drugs and Medical Devices (BfArM). The news magazine „Focus“ comes in a recent article even to the assessment, it speaks „much that the risks were long obscured by fake studies.“ In March, the BfArM initiated a risk assessment process at European level to thoroughly review the benefit-risk balance of HES preparations. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency had subsequently recommended a suspension of marketing authorizations for HES infusion solutions following an initial assessment in June 2013.

Increased mortality from HES infusion?
The Federal Institute for Drugs and Medical Devices recommends that doctors no longer use common HES infusion solutions. BfArM President Walter Schwerdtfeger advises the emergency doctors and clinics in an interview with the „Focus“, reinforced to stock other infusion solutions than HES. „You must be prepared to limit or suspend HES approval at European level in the coming months“, continued Schwerdtfeger. The PRAC concluded in June that HES infusions are associated with a higher risk of kidney damage and increased mortality compared to so-called crystalloid infusion solutions. In particular, the use in patients with sepsis had proved in the recent studies as unfavorable.

Studies on the HES infusion counterfeited?
The „Focus“ comes in his current article to the conclusion that „a series of older, meanwhile withdrawn investigations of the German physician B due to scientific misconduct.“ contributed to the more than 40 years of widespread use of HES infusions. Public prosecutorial investigations are also underway here, whereby bodily injury constitutes one of the suspicious facts. The physician did not want to comment on the newspaper should, the „Focus“ however, according to „married to a former high-ranking employee of HES world market leader Fresenius (Bad Homburg)“ his. This suggests that there might have been a conflict of interest. Although the Fresenius spokesman Matthias Link took this out „Privacy“ no position, but the company sees its infusion apparently unjustly pilloried. „We demand a reassessment“, he quotes „Focus“ the Fresenius spokesman. The negative ruling of the EU's first-instance panel arouses a false impression, because if anything, the new studies would have revealed an increased risk only if HES were used to counter sepsis, said Link.

If the preliminary negative benefit-risk assessment of HES infusion media is confirmed, a prompt loss of approval is expected. But the question arises, how many people have actually been harmed in recent decades by appropriate infusions. (Fp)

Image: Herbert Käfer