Hey everyone - RFK Jr (Team MAHA) is crowdsourcing recommendations for people who should be involved in the next Administration. Vinay has already been nominated, the link to upvote Vinay here:
"A total ban on the “revolving door.” Government agencies benefit from having staff with industry experience and vice-versa. "
I don't think we mind if someone comes from Pharma and works in a gov't agency bringing their expertise. But they should sell all Pharma stock, and not be allowed to return. There needs to be zero conflict of interest. No spouses still working in Pharma either. But for sure, approving drugs and then going to work for those companies in the future is a big no-no. No company's going to hire you if you were a PIA in the approval process. So, let's make sure you never have to worry about that.
Those who abused the system ruined it for the rest of you. I'm sorry.
Fundamentally we should remove the FDAs monopoly on violence, they should not be able to prevent market access for any claim. Make them compete with other governmental standards like CE Mark or NGO standards that would emerge organically to satisfy market needs for devices that focus on early detection and prevention of disease. We need new business models that focus on prevention of Chronic disease, and that requires significant deregulation of a perversely incentivized sickcare system that feeds like a vampire on illness. The reforms needed go far beyond the corrupted FDA, we need massive action to turn this sinking ship around.
Just as those who can’t afford representation in a court of law are afforded free counsel, for a small business the cost of getting through the unnecessary and capricious gauntlet of the FDA is the $350/hr Charon consultants you must hire to guide you through that arcane and inefficient by design river Styx that is FDA approval.
Simplify approvals for low risk devices and drugs, get them to market quickly by helping them through the approval process instead of trying to kill them. And fund this with higher fees on Big Pharma/Med companies like Pfizer and Medtronic.
Jessica is right about the right to work... Banning the revolving door wouldn't survive litigation. IMO user fees, even after thinking about her reasons for opposing a ban, are a bad thing. They make pharma the "client" of the FDA, rather than the American drug consumer. "Timely review" is an interesting thing... It feels as if FDA is prioritizing speed over safety (think about Phil Krause, but it's probably not limited to the obvious example of the corona shots), and the rhetorical posture of "we owe you a turnaround in X days" is already super-entrenched and built into an edifice. It's somebody's job to prepare those reports that show how well FDA is abiding by its commitment to its customers (pharma), and as anyone who has worked in business knows. you care about and you act on the things you measure and track.
A thought related to the item about enforcing postmarketing commitments (LOLOLOLOL... I've been following this stuff, too) is that NCVIA of 1986 was supposed to create active follow-up on safety at a level that was never done. I mean, did this ever happen: "Requires the Secretary to conduct studies on pertussis, rubella, and radiculoneuritis vaccines and publish the results of such studies.
"Directs the Secretary to study the risks to children associated with each vaccine listed in the Vaccine Injury Table and establish guidelines respecting the administration of such vaccines. Directs the Secretary to periodically review and revise such guidelines." (https://www.congress.gov/bill/99th-congress/house-bill/5546)
I don't know that HHS has ever done its own safety studies on vaccines, which means that the only studies we have (correct me if I'm wrong) are the ones submitted by drug sponsors for BLAs. So we have comedy like Gardasil using an aluminum-containing placebo.
It's a weird and bizarre corner of pharma where we have both mandates and zero liability. I don't know how that's not an unconscionable contract with the American people. The other drugs broadly given to healthy people, birth control pills, are neither mandated nor excused from liability. Somehow their manufacturers manage not only to thrive financially, but also to innovate (low-estrogen, long-acting implantable, etc.).
Excellent. Also, make drug and alcohol treatment ACTUALLY TREATMENT. Masking the symptoms of addiction with drugs and no treatment is akin to giving insulin and needles to a diabetic with no further education and wishing them luck.
Recently I've been thinking about all of the issue of most of the main trials are nowadays written and funded by the industry.
Although banning the funding from the industry would probably be utopic, what would you think about a system were the pharmaceutical company would fund the trial but all of the writting and designing proccess would have to be totally independant from them? For example, they would have to delegate it to a university or other agency, preferably a team with EBM experts. Is there anyone studying or defending this system? Would it be utopic? Maybe yes, but it's an ideia.
Hey everyone - RFK Jr (Team MAHA) is crowdsourcing recommendations for people who should be involved in the next Administration. Vinay has already been nominated, the link to upvote Vinay here:
https://nominees.mahanow.org/t/vinay-prasad/1757
Done!
"A total ban on the “revolving door.” Government agencies benefit from having staff with industry experience and vice-versa. "
I don't think we mind if someone comes from Pharma and works in a gov't agency bringing their expertise. But they should sell all Pharma stock, and not be allowed to return. There needs to be zero conflict of interest. No spouses still working in Pharma either. But for sure, approving drugs and then going to work for those companies in the future is a big no-no. No company's going to hire you if you were a PIA in the approval process. So, let's make sure you never have to worry about that.
Those who abused the system ruined it for the rest of you. I'm sorry.
Fundamentally we should remove the FDAs monopoly on violence, they should not be able to prevent market access for any claim. Make them compete with other governmental standards like CE Mark or NGO standards that would emerge organically to satisfy market needs for devices that focus on early detection and prevention of disease. We need new business models that focus on prevention of Chronic disease, and that requires significant deregulation of a perversely incentivized sickcare system that feeds like a vampire on illness. The reforms needed go far beyond the corrupted FDA, we need massive action to turn this sinking ship around.
Just as those who can’t afford representation in a court of law are afforded free counsel, for a small business the cost of getting through the unnecessary and capricious gauntlet of the FDA is the $350/hr Charon consultants you must hire to guide you through that arcane and inefficient by design river Styx that is FDA approval.
Simplify approvals for low risk devices and drugs, get them to market quickly by helping them through the approval process instead of trying to kill them. And fund this with higher fees on Big Pharma/Med companies like Pfizer and Medtronic.
Allow doctors to own hospitals
Jessica is right about the right to work... Banning the revolving door wouldn't survive litigation. IMO user fees, even after thinking about her reasons for opposing a ban, are a bad thing. They make pharma the "client" of the FDA, rather than the American drug consumer. "Timely review" is an interesting thing... It feels as if FDA is prioritizing speed over safety (think about Phil Krause, but it's probably not limited to the obvious example of the corona shots), and the rhetorical posture of "we owe you a turnaround in X days" is already super-entrenched and built into an edifice. It's somebody's job to prepare those reports that show how well FDA is abiding by its commitment to its customers (pharma), and as anyone who has worked in business knows. you care about and you act on the things you measure and track.
A thought related to the item about enforcing postmarketing commitments (LOLOLOLOL... I've been following this stuff, too) is that NCVIA of 1986 was supposed to create active follow-up on safety at a level that was never done. I mean, did this ever happen: "Requires the Secretary to conduct studies on pertussis, rubella, and radiculoneuritis vaccines and publish the results of such studies.
"Directs the Secretary to study the risks to children associated with each vaccine listed in the Vaccine Injury Table and establish guidelines respecting the administration of such vaccines. Directs the Secretary to periodically review and revise such guidelines." (https://www.congress.gov/bill/99th-congress/house-bill/5546)
I don't know that HHS has ever done its own safety studies on vaccines, which means that the only studies we have (correct me if I'm wrong) are the ones submitted by drug sponsors for BLAs. So we have comedy like Gardasil using an aluminum-containing placebo.
It's a weird and bizarre corner of pharma where we have both mandates and zero liability. I don't know how that's not an unconscionable contract with the American people. The other drugs broadly given to healthy people, birth control pills, are neither mandated nor excused from liability. Somehow their manufacturers manage not only to thrive financially, but also to innovate (low-estrogen, long-acting implantable, etc.).
Excellent. Also, make drug and alcohol treatment ACTUALLY TREATMENT. Masking the symptoms of addiction with drugs and no treatment is akin to giving insulin and needles to a diabetic with no further education and wishing them luck.
It is a very difficult topic.
Recently I've been thinking about all of the issue of most of the main trials are nowadays written and funded by the industry.
Although banning the funding from the industry would probably be utopic, what would you think about a system were the pharmaceutical company would fund the trial but all of the writting and designing proccess would have to be totally independant from them? For example, they would have to delegate it to a university or other agency, preferably a team with EBM experts. Is there anyone studying or defending this system? Would it be utopic? Maybe yes, but it's an ideia.
I'm hopeful that we will see some big and necessary reforms under Trump.