Post by icemandios on Sept 1, 2021 17:59:16 GMT
September 1, 2021 06:49 AM EDTUpdated 11:11 AM FDA+
Opinion: Time for Biden to explain the political meddling in Covid vaccine reviews
Zachary Brennan
Senior Editor
Back when former President Trump was in office, the FDA’s top vaccine official, Peter Marks, often told the public: You’ll know if there’s political meddling in our vaccine reviews because if there is, I’ll resign.
Yesterday, two of the most senior vaccine officials under Marks — Marion Gruber, a 32-year veteran of FDA, and Phil Krause, her deputy director — both decided to call it quits.
Insiders said they left almost exactly for the reasons that Marks said he would depart for: the White House broadcasting to the world when booster shots would be available, well before the FDA had even conducted its review of the data on boosters.
An industry consultant who requested anonymity but works closely with CBER said there’s been a lot of turnover there of late: “Almost every person on every review team in the last 2.5 years is brand new and many senior people have departed. This isn’t unexpected. A friend who was a former senior official in CBER told me that he left because he ‘got tired of taking abuse from 22 year old Congressional staffers.'”
Still, White House officials sought to calm the waters, and FDA’s spokesperson said in an email, “We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines.”
Jeffrey Zients, the White House’s Covid-19 response coordinator, tried to calm the tensions around these two top CBER departures in yesterday’s press briefing, telling reporters, “We have been — also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”
The damage is done. With just about 3 weeks left before the boosters are supposed to be ready for administration, the FDA is apparently still organizing an adcomm to discuss the boosters, according to a New York Times report. On Monday, the CDC’s vaccine advisory committee suggested that it might only recommend boosters for high-risk people, like seniors and health care workers, which again seemed to poke at the Biden administration’s plan to stick to this eight-month booster schedule for everyone.
And while neither Gruber nor Krause’s retirement is a sign that the vaccines might be unsafe, or that the full approval for Pfizer’s vaccine might now have been unjustified, they do raise questions about political meddling, which only serves to feed these conspiracy theories and embolden anti-vaxxers to make up reasons for their departures.
The Biden administration needs to be transparent here to save the public’s trust in the FDA. With vaccines coming soon too for children under the age of 12, this is a crucial moment in this pandemic for the Biden administration to come clean.
And while acting FDA commissioner Janet Woodcock wished Gruber and Krause well in their departures, it does appear now that Woodcock’s standing with the administration on the booster shot deadline ended up undercutting her FDA colleagues.
Woodcock also sent a memo to staff yesterday, pledging her “full support and complete confidence” in the staff reviews of vaccines.
But Woodcock may be in the lame duck period of her role as acting commissioner, given the recent reports that she’s on the way out in mid-November, further adding to the need for the Biden administration to nominate someone to fill that position as soon as possible, and stop neglecting one of America’s most important public health agencies during a once-in-a-lifetime pandemic.
Opinion: Time for Biden to explain the political meddling in Covid vaccine reviews
Zachary Brennan
Senior Editor
Back when former President Trump was in office, the FDA’s top vaccine official, Peter Marks, often told the public: You’ll know if there’s political meddling in our vaccine reviews because if there is, I’ll resign.
Yesterday, two of the most senior vaccine officials under Marks — Marion Gruber, a 32-year veteran of FDA, and Phil Krause, her deputy director — both decided to call it quits.
Insiders said they left almost exactly for the reasons that Marks said he would depart for: the White House broadcasting to the world when booster shots would be available, well before the FDA had even conducted its review of the data on boosters.
An industry consultant who requested anonymity but works closely with CBER said there’s been a lot of turnover there of late: “Almost every person on every review team in the last 2.5 years is brand new and many senior people have departed. This isn’t unexpected. A friend who was a former senior official in CBER told me that he left because he ‘got tired of taking abuse from 22 year old Congressional staffers.'”
Still, White House officials sought to calm the waters, and FDA’s spokesperson said in an email, “We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines.”
Jeffrey Zients, the White House’s Covid-19 response coordinator, tried to calm the tensions around these two top CBER departures in yesterday’s press briefing, telling reporters, “We have been — also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”
The damage is done. With just about 3 weeks left before the boosters are supposed to be ready for administration, the FDA is apparently still organizing an adcomm to discuss the boosters, according to a New York Times report. On Monday, the CDC’s vaccine advisory committee suggested that it might only recommend boosters for high-risk people, like seniors and health care workers, which again seemed to poke at the Biden administration’s plan to stick to this eight-month booster schedule for everyone.
And while neither Gruber nor Krause’s retirement is a sign that the vaccines might be unsafe, or that the full approval for Pfizer’s vaccine might now have been unjustified, they do raise questions about political meddling, which only serves to feed these conspiracy theories and embolden anti-vaxxers to make up reasons for their departures.
The Biden administration needs to be transparent here to save the public’s trust in the FDA. With vaccines coming soon too for children under the age of 12, this is a crucial moment in this pandemic for the Biden administration to come clean.
And while acting FDA commissioner Janet Woodcock wished Gruber and Krause well in their departures, it does appear now that Woodcock’s standing with the administration on the booster shot deadline ended up undercutting her FDA colleagues.
Woodcock also sent a memo to staff yesterday, pledging her “full support and complete confidence” in the staff reviews of vaccines.
But Woodcock may be in the lame duck period of her role as acting commissioner, given the recent reports that she’s on the way out in mid-November, further adding to the need for the Biden administration to nominate someone to fill that position as soon as possible, and stop neglecting one of America’s most important public health agencies during a once-in-a-lifetime pandemic.