IN SHORT: Pharma companies have finally banded together to ask the FDA to better regulate any new drug approvals including a possible new COVID vaccine. Why? Six in 10 Americans worry political pressure from the administration will lead the FDA to rush vaccine approval before confirming it’s safe and effective, the Kaiser Family Foundation has found. And only about 4 in 10 would get the vaccine, even if it were free if the FDA approved it before the election.
According to The Washington Post “the chief executives of nine drug companies publicly pledged to “make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.” Moreover, they vowed not to seek FDA approval before vaccine safety and efficacy had been established in Phase 3 trials — the industry standard — implying that they would do this even if the Trump administration allowed (or encouraged) them to cut corners”.
What in the hell took them so long? Were they really that blind as to what was happening before?
The Economist hit the nail on the head “Mr. Trump has already successfully harried the FDA to authorize drugs, such as hydroxychloroquine, with no scientific evidence for their efficacy. He has accused the regulator (unfairly) of being part of a “deep state” effort to try to slow down vaccine development until after the election. It looked like part of a strategy to get the regulator to hurry up.
Big pharma is clearly worried. Drug firms stand to lose a great deal if their products are seen as being waved through prematurely. The industry relies on the FDA to make business possible. In the same way that people fly because they trust the aviation regulator, they take medicines because these are believed to be safe and effective. Take away the trust and the medicines’ makers would suffer.
Transparency vs. the Media
Much was written and headlined when someone in an AZ trial got ill. Some said that AZ should have been more transparent but before we can be transparent we need ALL the facts.
STAT News reported, “the participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.”
The fact is that in ANY clinical trial studies can come to a screeching halt when someone gets very sick. You would have never known this from the sensational media headlines though. Rather than inform and educate most just installed more fear of a possible vaccine. According to a CBS News poll, just 21% of people would get a COVID vaccine when initially available.
It’s mess
Right now our country continues to be divided and the FDA has been politically compromised. Trust IS an issue at a time when trust in pharma was already in the toilet.
DTC marketers now have another huge challenge. They have to reassure a skeptical public that their drugs are safe and effective. They are going to have to enlist HCP’s and insurers at every patient touchpoint.
I don’t understand why it took so long for pharma to see this storm coming. My guess is they were afraid of retribution by Trump who likes to take revenge on companies who he feels “betray him”. When will they learn that doing the right thing should always come first.