While most Trump Administration agencies can be described as chaotic and secretive, the FDA is bending over backwards to be transparent, explain their thinking, spell out what we do and don’t know, and explain how we’ll attempt to answer the questions. It feels weird to say it, but I have trust in the Trump FDA.
This was a step in the right direction. I think if you want really want to move the needle of trust this needs to be a true town hall meeting where you take questions from the public and medical health professionals.
town hall noun [C] (MEETING): a public meeting at which a politician or official speaks about his or her policies and answers questions from members of the public .
IMO, it would be great to have a summary table like GRADE to transparently show the evidence , and importantly the quality of evidence or certainty, like Low, high and so forth. D Usually things get lost or ignored when you write a wall of text. If the certainty is low or very low, the recommendation of weak or against the intervention will make sense to everyone.
Great plan. You’ve taken to account people who want it no matter what and they can get it. And the anti-VAX don’t need to think about it anymore. They can get mad about something else. Brilliant strategy.
The new policy is a welcome change. However, uncertainties remain that prompt hesitation on endorsing the boosters. Does the FDA believe that the covid boosters are safe? Many challenges to vaccine safety have been raised. Is the FDA planning on responding to these challenges? How are citizens supposed to know whether these challenges have merit? Also is there data regarding protective efficacy and side effects in people over 65 and in immunocompromised patients or other at risk groups for whom boosters are recommended? The fact that the vaccines induce antibodies in these groups does not provide insight into either of these questions. Without data it is not possible to know whether any protective effects will be cancelled out by side effects.
I confess I'm not impressed (and disappointed) with Prasad's (and Makary's) rationale for limiting vaccines to age 65+ individuals and discussing additional eligibility without any documentation of its effectiveness for these people. This is someone who abides by clinically relevant science and scientific studies to support clinical practice. Is this the way he will lead the FDA when addressing vaccine (and biological agent) approval for the US, which had been done by a non-political, scientific body? Where is the support for vaccination of caregivers to those people at highest risk (elderly, immune-compromised, chronically or acutely ill, doctors and nurses)? Indeed, moving forward to evaluate evidence, you leave at-risk people unprotected, and will likely provide rationale for anti-vaxxers, citing your premise (without evidence) that it is only appropriate for "some". They will avoid MMR (and other vaccines that have made a difference in incidence and transmission) like the plague!
I am encouraged by the FDA Direct podcast as one avenue for transparency from FDA. I feel like my “friends and colleagues” that I trusted during the pandemic are now in leadership roles that will improve government policies (Dr Makary and Dr Prasad—I followed them on YouTube early on—I was immediately skeptical of the “vaccine”)
While most Trump Administration agencies can be described as chaotic and secretive, the FDA is bending over backwards to be transparent, explain their thinking, spell out what we do and don’t know, and explain how we’ll attempt to answer the questions. It feels weird to say it, but I have trust in the Trump FDA.
This was a step in the right direction. I think if you want really want to move the needle of trust this needs to be a true town hall meeting where you take questions from the public and medical health professionals.
town hall noun [C] (MEETING): a public meeting at which a politician or official speaks about his or her policies and answers questions from members of the public .
https://dictionary.cambridge.org/us/dictionary/english/town-hall
IMO, it would be great to have a summary table like GRADE to transparently show the evidence , and importantly the quality of evidence or certainty, like Low, high and so forth. D Usually things get lost or ignored when you write a wall of text. If the certainty is low or very low, the recommendation of weak or against the intervention will make sense to everyone.
Great plan. You’ve taken to account people who want it no matter what and they can get it. And the anti-VAX don’t need to think about it anymore. They can get mad about something else. Brilliant strategy.
The new policy is a welcome change. However, uncertainties remain that prompt hesitation on endorsing the boosters. Does the FDA believe that the covid boosters are safe? Many challenges to vaccine safety have been raised. Is the FDA planning on responding to these challenges? How are citizens supposed to know whether these challenges have merit? Also is there data regarding protective efficacy and side effects in people over 65 and in immunocompromised patients or other at risk groups for whom boosters are recommended? The fact that the vaccines induce antibodies in these groups does not provide insight into either of these questions. Without data it is not possible to know whether any protective effects will be cancelled out by side effects.
I think this is a great start to collecting actual data on the vaccine. And Vinay did not drop a single F-bomb!
I confess I'm not impressed (and disappointed) with Prasad's (and Makary's) rationale for limiting vaccines to age 65+ individuals and discussing additional eligibility without any documentation of its effectiveness for these people. This is someone who abides by clinically relevant science and scientific studies to support clinical practice. Is this the way he will lead the FDA when addressing vaccine (and biological agent) approval for the US, which had been done by a non-political, scientific body? Where is the support for vaccination of caregivers to those people at highest risk (elderly, immune-compromised, chronically or acutely ill, doctors and nurses)? Indeed, moving forward to evaluate evidence, you leave at-risk people unprotected, and will likely provide rationale for anti-vaxxers, citing your premise (without evidence) that it is only appropriate for "some". They will avoid MMR (and other vaccines that have made a difference in incidence and transmission) like the plague!
I’m grateful to see some common sense in all of this chaff that our gov throws out in exchange for money.
I am encouraged by the FDA Direct podcast as one avenue for transparency from FDA. I feel like my “friends and colleagues” that I trusted during the pandemic are now in leadership roles that will improve government policies (Dr Makary and Dr Prasad—I followed them on YouTube early on—I was immediately skeptical of the “vaccine”)