Early this coming week, I’ll be conducting a video Q&A with FDA Commissioner Robert Califf for MedPage Today which will be cross-posted here on Inside Medicine. As readers of Inside Medicine, I want to know what issues you’d like to hear Dr. Califf address. I’ll consider asking any question that I get from readers via email, or see on Twitter, Facebook, or Instagram, but I’ll be able to give closer consideration to premium subscribers who leave their questions in the Comments section below.
Apr 1, 2023·edited Apr 1, 2023Liked by Jeremy Faust, MD
Why do medical authorities like the FDA defer to the DEA on medical questions related to use of controlled medical substances and shouldn't the FDA have final say on these supplies, given that it is concerned with patient health and has medical expertise and law enforcement doesn't?
Epidemiologists, ID doctors, immunologists around the world including CDC, WHO, Canada, and UK state the need for spring boosters for the millions of seriously immune compromised people, but in the US neither FDA or CDC have given the final go ahead so we can’t actually acquire the booster. (Our pharmacies, for the first time, have it but won’t give it. Our internists, the same, even after phone calls from our specialists.) Many of us like myself (Progressive MS impacting breathing muscles, Common Variable Immune Deficiency, RA, heart/BP issues) had our last booster going on 8 months ago. We must schedule our vaccines around our DM drugs that knock our cell counts down. We are watching hospitals, states, and Fed protections requiring safety measures like masks, etc. being removed. We are still working, contributing to community, and raising families, but we are also the ones STILL dying of COVID. The boosters are available, we know that side effects are minimal. and the benefits still worth it, so why are we vacillating on this? We are out of time. (Thank you so much for this opportunity to finally have our voices heard.)
Yes the US is negligent in giving any direction for spring Covid boosters. The Covid vulnerable are forgotten and left on our own. This should be your first question.
When will the FDA recognize that often *stopping* certain medications (opioids, benzodiazepines, stimulants, for ex) is at least or even more dangerous than starting them? Why aren't patients protected from abrupt cut-offs that could kill them by suicide or drive them to deadly street drugs? Why is it just assumed that abandoning these patients is OK, especially if they have addictions, when data now shows that doing this is far more likely to kill them than continuing to prescribe?
What power does the FDA have to compel insurance companies to continue covering Narcan as it moves OTC, and to prevent the manufacturer from jacking up prices?
See EpiPens as exhibit A, which are still too expensive in an immoral, worst case capitalist maneuver:
“When Mylan bought the device from a competitor in 2007, the cost for a set of two auto-injectors was about $94. Today, the cost for an EpiPen kit (pair of two pens) is over $700. This affects many patients with a history of anaphylaxis, as over 3.6 million prescriptions for the EpiPen were written last year and more will continue to be written”
As Paul Sax has commented: interferon lambda is the best COVID drug you can’t get-- the FDA refuses to consider it because the testing wasn’t done by a manufacturer. As the tool box shrinks, please consider it and the antiviral from Japan.
1. With the end of the NHE and PHE, what is happening with the Biden administration's "Project Covid Shield?"
2. How will funding come for new vaccines and oral pills that target transmission? Are there any in development?
3. With respect to the bivalent booster, it protects against the original Wuhan and B.A. 4/5 strains, but those strains don't appear to be circulating in the U.S. right now, it's 71.1% XBB.1.5 and 3.9% XBB 1.5.15, if I get a 2nd booster at age 65, how protective will it actually be?
4. What is Cuba's Soberana02 and Soberana-Plus vaccine? Will the US import it?
5. The WHO is reporting 35 cases of Marburg Virus in Equatorial Guinea, with 27 deaths. Given the potential for high fatalities, how worried do we need to be about International spread?
6. Back to Covid: As a senior, I mask, vax and boost. Given this will be my 7th vaccine, do I need to worry about immune imprinting?
7. Will the fall vaccine be full doses of an omicron specific monovalent vaccine versus the single half dose that is in the current bivalent booster?
8. If they do it like the flu vaccines, how do they plan to choose the vaccine strain for Fall boosters, because it seems like SarsCoV2 variants are outpacing our current vaccines and boosters?
9. With the GOP seeming to oppose all Covid funding and mitigations, what assurances can the FDA provide that they're still working on better vaccines and treatments for transmission, severity, death and long Covid given that public health has become so politicized, unfortunately? It still matters to me - I don't want to catch Covid or have long Covid.
Morning Dr. Faust, It appears that the great majority of your commentators are asking the same important questions. Primarily, since 65-75% of continuing Covid deaths appear to be concentrated in the over sixty-five year old population, and that population is quickly moving past the sixth month point when any immunity from their sixth vaccination is essentially gone, I’d like to know how any US government healthcare official does anything everyday when they go to work except advocate for allowing the use of the bivalent stock of vaccine to be made available to seniors? Logically, no drug company will spend any of its development funds towards the next vaccine without a government guarantee of purchase, and the Congress is deadlocked against any expenditure whatsoever with the looming public food fight display over the fabricated debt ceiling, so it appears to me that every Congressional representative has simply concluded that the AARP folks are on their own from now on.
I read reports from the EWG (Environmental Working Group) and am concerned about pesticides such as glyphosate, which is sprayed on oats. Also concerned about our use of pesticides in general. The US seems to lag behind other countries in prohibiting the use of dangerous agricultural chemicals. I understand why...it's all about crop yields. Nonetheless, how can the FDA continue to allow the use of these sprays that are proven health hazards?
This test is available in Europe. It would be nice for it to be approved in the U.S., too: Fluorecare 4-in-1 Rapid Test for RSV/Influenza A+B/Covid - Sensitivity: 92.93% - Specificity: 100%
Thank you Dr Faust for the opportunity to be heard
Are ANY pharmaceutical companies even trying to develope more advanced vaccines for newer variants and also new antivirals since we have barely any. Many can't use Paxlovid. It seems like prevention and treatments are just drying up...WHY?
It looks like they just approved COVID + flu at home tests. What about at home RSV, strep, others? Seems like this would relieve some pressure on over booked pediatric/PCP offices, make it easier for parents, and help reduce spread. We were way too slow to start using rapid antigens for COVID.
Will the FDA ever approve a second six month bivalent booster for the immunosuppressed and people over 70 as Canada and Britain have done?
Definitively will ask
Why do medical authorities like the FDA defer to the DEA on medical questions related to use of controlled medical substances and shouldn't the FDA have final say on these supplies, given that it is concerned with patient health and has medical expertise and law enforcement doesn't?
Superb q
Epidemiologists, ID doctors, immunologists around the world including CDC, WHO, Canada, and UK state the need for spring boosters for the millions of seriously immune compromised people, but in the US neither FDA or CDC have given the final go ahead so we can’t actually acquire the booster. (Our pharmacies, for the first time, have it but won’t give it. Our internists, the same, even after phone calls from our specialists.) Many of us like myself (Progressive MS impacting breathing muscles, Common Variable Immune Deficiency, RA, heart/BP issues) had our last booster going on 8 months ago. We must schedule our vaccines around our DM drugs that knock our cell counts down. We are watching hospitals, states, and Fed protections requiring safety measures like masks, etc. being removed. We are still working, contributing to community, and raising families, but we are also the ones STILL dying of COVID. The boosters are available, we know that side effects are minimal. and the benefits still worth it, so why are we vacillating on this? We are out of time. (Thank you so much for this opportunity to finally have our voices heard.)
Yes the US is negligent in giving any direction for spring Covid boosters. The Covid vulnerable are forgotten and left on our own. This should be your first question.
Also, what about availability of a nasal spray/gel to prevent covid, as is available in Israel?
Great question. Dr Eric Topol has been advocating for two years for nasal vaccines.
When will the FDA recognize that often *stopping* certain medications (opioids, benzodiazepines, stimulants, for ex) is at least or even more dangerous than starting them? Why aren't patients protected from abrupt cut-offs that could kill them by suicide or drive them to deadly street drugs? Why is it just assumed that abandoning these patients is OK, especially if they have addictions, when data now shows that doing this is far more likely to kill them than continuing to prescribe?
What power does the FDA have to compel insurance companies to continue covering Narcan as it moves OTC, and to prevent the manufacturer from jacking up prices?
See EpiPens as exhibit A, which are still too expensive in an immoral, worst case capitalist maneuver:
“When Mylan bought the device from a competitor in 2007, the cost for a set of two auto-injectors was about $94. Today, the cost for an EpiPen kit (pair of two pens) is over $700. This affects many patients with a history of anaphylaxis, as over 3.6 million prescriptions for the EpiPen were written last year and more will continue to be written”
As Paul Sax has commented: interferon lambda is the best COVID drug you can’t get-- the FDA refuses to consider it because the testing wasn’t done by a manufacturer. As the tool box shrinks, please consider it and the antiviral from Japan.
We need advanced vaccines and treatments!!
1. With the end of the NHE and PHE, what is happening with the Biden administration's "Project Covid Shield?"
2. How will funding come for new vaccines and oral pills that target transmission? Are there any in development?
3. With respect to the bivalent booster, it protects against the original Wuhan and B.A. 4/5 strains, but those strains don't appear to be circulating in the U.S. right now, it's 71.1% XBB.1.5 and 3.9% XBB 1.5.15, if I get a 2nd booster at age 65, how protective will it actually be?
4. What is Cuba's Soberana02 and Soberana-Plus vaccine? Will the US import it?
5. The WHO is reporting 35 cases of Marburg Virus in Equatorial Guinea, with 27 deaths. Given the potential for high fatalities, how worried do we need to be about International spread?
6. Back to Covid: As a senior, I mask, vax and boost. Given this will be my 7th vaccine, do I need to worry about immune imprinting?
7. Will the fall vaccine be full doses of an omicron specific monovalent vaccine versus the single half dose that is in the current bivalent booster?
8. If they do it like the flu vaccines, how do they plan to choose the vaccine strain for Fall boosters, because it seems like SarsCoV2 variants are outpacing our current vaccines and boosters?
9. With the GOP seeming to oppose all Covid funding and mitigations, what assurances can the FDA provide that they're still working on better vaccines and treatments for transmission, severity, death and long Covid given that public health has become so politicized, unfortunately? It still matters to me - I don't want to catch Covid or have long Covid.
I’m very interested in an answer to PSPM’s question 3.
Morning Dr. Faust, It appears that the great majority of your commentators are asking the same important questions. Primarily, since 65-75% of continuing Covid deaths appear to be concentrated in the over sixty-five year old population, and that population is quickly moving past the sixth month point when any immunity from their sixth vaccination is essentially gone, I’d like to know how any US government healthcare official does anything everyday when they go to work except advocate for allowing the use of the bivalent stock of vaccine to be made available to seniors? Logically, no drug company will spend any of its development funds towards the next vaccine without a government guarantee of purchase, and the Congress is deadlocked against any expenditure whatsoever with the looming public food fight display over the fabricated debt ceiling, so it appears to me that every Congressional representative has simply concluded that the AARP folks are on their own from now on.
Thank you for inviting us to pose questions. I wish this was the norm in healthcare.
I read reports from the EWG (Environmental Working Group) and am concerned about pesticides such as glyphosate, which is sprayed on oats. Also concerned about our use of pesticides in general. The US seems to lag behind other countries in prohibiting the use of dangerous agricultural chemicals. I understand why...it's all about crop yields. Nonetheless, how can the FDA continue to allow the use of these sprays that are proven health hazards?
This test is available in Europe. It would be nice for it to be approved in the U.S., too: Fluorecare 4-in-1 Rapid Test for RSV/Influenza A+B/Covid - Sensitivity: 92.93% - Specificity: 100%
What does he think he can do to help gain back trust in the public health system as the FDA is a vital part of it.
Thank you Dr Faust for the opportunity to be heard
Are ANY pharmaceutical companies even trying to develope more advanced vaccines for newer variants and also new antivirals since we have barely any. Many can't use Paxlovid. It seems like prevention and treatments are just drying up...WHY?
It looks like they just approved COVID + flu at home tests. What about at home RSV, strep, others? Seems like this would relieve some pressure on over booked pediatric/PCP offices, make it easier for parents, and help reduce spread. We were way too slow to start using rapid antigens for COVID.
I have a suggested additional "Covid related" topic, "Long Term Covid".
:
Could you ask about how we get a mucosal vaccine like Germany's - it seems promising. https://www.cnn.com/2023/04/03/health/nasal-vaccine-sterilizing-immunity/index.html