miércoles, 21 de abril de 2021

AstraZeneca reputation en "caida libre"...




Covid-19, en principio, fué una excelente oportunidad para la reputación de la industria farmacéutica y algunas de ellas en particular.


Covid-19 una oportunidad...para la reputación.

Pero las circunstancias no fueron tan propicias o las urgencias llevaron a errores

A series of unforced errors by the British pharma company has turned hope into hesitancy.

Mene Pangalos, head of biopharmaceuticals research for AstraZeneca Plc, went to bed on Monday, March 22, feeling good for the first time in a while. After working around the clock through the weekend, he’d just announced better-than-expected interim results from the company’s large U.S. vaccine trial: The shot was safe and 79% effective at preventing cases of symptomatic Covid-19. Positive news, at last, after months of questions about everything including safety and supply shortfalls.

But at around 5 the next morning, Pangalos was jolted out of bed in the U.K. by a call from AstraZeneca Chief Executive Officer Pascal Soriot, ringing from Australia to ask what on earth was happening. The U.S. National Institute of Allergy and Infectious Diseases (Niaid) had just issued a late-night statement announcing that the safety board overseeing the trial was concerned AstraZenecamay have included outdated information” in its results, which “may have provided an incomplete view of the efficacy data.” Niaid, which is part of the National Institutes of Health, urged the company to release up-to-date figures as soon as possible.

While they were asleep in Europe, Pangalos and his team had received a harsh email from the Data and Safety Monitoring Board, the independent committee of experts appointed by the NIH to oversee the trial. The DSMB accused the company of releasing “potentially misleading” figures, saying the data were “the most favorable for the study as opposed to the most recent and most complete.” The experts added that “decisions like this are what erode public trust in the scientific process.” Astra executives were stunned. No one had reached out to them to discuss the concerns first, and Niaid’s decision to publicize the independent committee’s critique of the interim results was unprecedented.

The contents of the DSMB’s letter quickly leaked to the Washington Post and the New York Times. Within hours, Anthony Fauci, director of Niaid, was on Good Morning America, talking about the flap. “It really is unfortunate that this happened,” he said. “This is really what you call an unforced error, because the fact is this is very likely a very good vaccine, and this kind of thing does nothing but really cast some doubt.”

Astra had received approval the Friday before from the safety board to conduct its interim analysis, based on 141 verified Covid cases dating to Feb. 17. The board had advised the Astra team to be mindful of the unverified cases that had come in since then, to be sure they wouldn’t produce a significantly different efficacy figure, according to people familiar with the discussions. The team had looked at the cases, but, believing that their potential effect on the efficacy number was negligible, they hadn’t mentioned in their statement that the final percentage might change.


Astra’s next major hurdle will be to secure an emergency use authorization from the FDA. The company plans to submit data for review in the first half of April, but a final ruling could take weeks. Astra executives are under no illusion that the process will be smooth. They must continue to work with the DSMB, and they have one of the most complex datasets of any Covid vaccine developer, with thrombotic events and real-world evidence from millions of people vaccinated. They also got a new challenge at the end of March when one of their main subcontractors in the U.S., Emergent BioSolutions Inc., mixed up ingredients from Johnson & Johnson and AstraZeneca, a major manufacturing error. Emergent will now exclusively produce J&J doses while U.S. officials work to find AstraZeneca new manufacturing capacity. Many people inside Astra are deeply distressed by the extent of the criticism they’ve taken while trying to lead the way to a nonprofit vaccine that could help end the pandemic. As one executive puts it when asked if they’d do it again: 

Not in a million years. All we’ve had is grief.”


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