Press review

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Analyses reveal holes in Merck's proof of bioequivalence Levothyrox study

Country : France

Keywords :
PARIS, 23 Aug (APM) - Analyses published in pharmaceutical journals Clinical Pharmacokinetics and La Revue du practicien have revealed holes in the bioequivalence study Merck KGaA ran comparing the old and new versions of its Levothyrox drug (levothyroxine), reports Le Figaro on Friday (p.6).
Merck carried out a bioequivalence study involving 204 patients to prove the two formulations had average bioequivalence, despite reports of adverse events from 32,000 patients. The researchers pointed out that this study involved considerably more patients than a typical bioequivalence study, which is normally conducted on 20 to 30 patients.
Not only would a larger study be more expensive, the daily continued, but the increased sample size would mask the change in patient response to the two formulations.
The researchers concluded in their analyses that if the bioequivalence study had involved 24 patients, the bioequivalence rate would have been 10.2%, while in studies involving 48 or 98 patients, the rate would have been 42.3% and 87.8% respectively.
One of the researchers is quoted in the newspaper as saying it is always possible to show average bioequivalence, simply by increasing the number of subjects in the study.
Merck responded by saying the sample patient size had been approved by French and European health authorities and that its methodology was solid and in line with scientific consensus.

French hospital doctors call for drug manufacturing to be moved back to Europe

French hospital doctors wrote an opinion piece for Sunday newspaper the Journal du dimanche (JDD) saying they are alarmed over the increase in drug supply tension and drug stockout warnings, reported Liberation on Monday (p.15) (APMHE 64096).
The doctors said that 868 drug supply tension and drug stockout warnings reported in 2018 was twenty times higher than in 2008, and that such warnings were very rare a decade ago.
To counter this increase, they called for pharma companies to create stocks of the most crucial drugs and repatriate raw material production back to Europe, as they are currently often manufactured in Asia.
Les Echos also reported on the story on Monday (p.3) and added in a brief on Tuesday (p.3) the pharma industry had responded to the op-ed saying drug stockouts are phenomena for which there is no unique and simple solution.

Bayer sells animal division

Bayer is selling its animal health business to U.S. company Elanco a $7.6 billion deal, reported Le Figaro on Wednesday (p.22) (APMHE 64103).
Elanco is the last and most important spin-off Bayer announced in November 2018, when the pharma also announced it was cutting 1,200 posts.
The group's head Werner Baumann is reported as saying that the changes are necessary and will allow Bayer to improve its performance.
The changes will also improve Bayer's performance on the stock market, which has been shaky since Bayer bought Monsanto for $63 billion last year.
Les Echos also reported on the story on Wednesday (p.15, p.26), as did La Croix (p.9) and Le Monde on Thursday (p.6).
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