D. Prasad....regarding your concerns that Jha might have undermined his credibility.... There's nothing to be concerned about. He ABSOLUTELY destroyed is credibility. See? nothing at all to be worried about! LOL. (what a bunch ass-hat clowns!)
I'm not worried about Ashish Jha's and Bob Califf's credibility. They can worry about their own credibility. I no longer look to them for guidance and trust.
Thank you for being a champion for EBM and patients, Vinay.
I agree that these studies absolutely should be done, but I'm doubtful they will be, since there is no incentive to fund them. In the meantime, Vinay, if you had an elderly grandfather with immune suppression who has no known history of Covid but is vaccinated, and he got infected with Covid, what do you recommend? Wait it out? Paxlovid on the chance it's more effective than placebo in such a person? (Maybe it is, maybe it's not; we don't know). Or maybe just give a placebo? It's all well and good to say "more research is needed," but people are still dying, and at-risk folks still need to know what to do in the meantime. Leaving them hanging isn't particularly helpful.
People still die and you don't do them favors by giving them unproven treatments.
If you don't prove effectiveness with trials, then unless you are banking on a miracle placebo effect--and that only works if the treatment doesn't make things worse--but then you only know that if you prove effectiveness and safety with trials...
You need to prove safety and effectiveness with studies.
As Vinay has said in past podcasts and videos, placebos don't work in cancer, so it doesn't make sense to use a treatment which is essentially a placebo (or makes things worse) in that condition.
Brad, and, as Vinay has also pointed out, many of these anticancer drugs have painful side effects while doing little to help the patient live longer or better. It’s hard to stomach sometimes what vulnerable patients are put through.
As a person with recurrent aggressive B cell lymphoma (and a graduate in bioethics from Columbia), I have been in the midst of discussions about “iffy” cancer treatments. I just finished a CAR T treatment that was a Ph 1/2 clinical trial. It remains to be seen how successful it will be... but my thought was that every data point may help future patients. I also had no other options in early 2023.
The grey area is where patients believe they have a real “chance” to stay alive regardless of the harms to their quality of life. I believe the physician must be open and honest about the harms/benefits. Patients and families can decide their priorities.
It gets complicated because of the impact on Medicare/insurance. Would patients opt for “iffy” treatments if they had to pay more for them?
I have to agree with Dr. Buratovich. I think Vinay's purpose was to bring to light the continued lack of quality testing, the fat pockets of Pharma, and a direction medicine seriously needs to shift. It's one doctor speaking out against Godzilla and King Kong. Robin Quivers says, "So you start one person at a time. Change one person, you can change a village."
But giving patients false hope with untested or poorly validated therapeutics is equally bad. Sure, if an elderly patient was very sick and the potential benefit outweighed the risks, most clinicians would probably treat them with a therapeutic agent that might work. But in such cases it is incumbent on the clinician to say that such an agent has not been properly vetted in the fires of double-blinded placebo-controlled clinical trials. I think the issue, in my view, is the lavishing of funds and confidence on expensive agents that may be no better than mom’s chicken soup and not nearly as safe. Honesty about the shortcomings of our vaccines and therapeutics is in short supply and needs a “booster.”
Seriously on point. What about the “new C19 booster” that is coming this fall? There is zero consensus on it. Give it to elderly and/or immune compromised people? Is it harmless but perhaps without benefit as well?
I agree full stop. This booster is being released and copiously funded with zero, zip, nil, nada human data while we’re being told, “of course it works! Just trust us.” No, in fact I do not trust you all. Trust is earned and you all have done little to either earn, engender, or preserve my trust. See Marty McKary’s op ed in the WSJ today.
I agree that transparency about the lack of validation on the current strain is important, and is actually ethically required. But that's true of an extremely large number of treatments, not just Covid, as the article points out. The problem with Covid and other viruses is that anti-virals are only effective for a short time, so you have to make a decision quickly. Probably all/most treatments are past their "expiration point" by now. The safety issue is a bit easier to clarify, since data is continuously collected on SAE's, even after the studies have ended. The doctor walks a fine line between providing transparency without destroying a patient's expectations for improvement which, as we all know, is an important aspect of EVERY treatment, even those with up-to-date RCT validation. Yes, we want to know that a treatment is more efficacious than a placebo, but at the same time, we also want to harness the power of the placebo effect with every treatment, which at this point, we have no clue how it works. We just know that it often does.
All good and fair points. Crashing a patient’s hope for improvement is indeed a poor way to practice medicine. I suppose it’s one of the reasons why medicine is as much an art as it is a science, as our dear savant Adam Cifu keeps demonstrating in one thoughtful post after another.
I agree 100%! 😁 As Vinay points out, there's a boat-load of research that should be re-done for current times. If only each trial didn't cost millions! 😫
Ignorance is strength, medical style
D. Prasad....regarding your concerns that Jha might have undermined his credibility.... There's nothing to be concerned about. He ABSOLUTELY destroyed is credibility. See? nothing at all to be worried about! LOL. (what a bunch ass-hat clowns!)
I'm not worried about Ashish Jha's and Bob Califf's credibility. They can worry about their own credibility. I no longer look to them for guidance and trust.
Thank you for being a champion for EBM and patients, Vinay.
I agree that these studies absolutely should be done, but I'm doubtful they will be, since there is no incentive to fund them. In the meantime, Vinay, if you had an elderly grandfather with immune suppression who has no known history of Covid but is vaccinated, and he got infected with Covid, what do you recommend? Wait it out? Paxlovid on the chance it's more effective than placebo in such a person? (Maybe it is, maybe it's not; we don't know). Or maybe just give a placebo? It's all well and good to say "more research is needed," but people are still dying, and at-risk folks still need to know what to do in the meantime. Leaving them hanging isn't particularly helpful.
People still die and you don't do them favors by giving them unproven treatments.
If you don't prove effectiveness with trials, then unless you are banking on a miracle placebo effect--and that only works if the treatment doesn't make things worse--but then you only know that if you prove effectiveness and safety with trials...
You need to prove safety and effectiveness with studies.
As Vinay has said in past podcasts and videos, placebos don't work in cancer, so it doesn't make sense to use a treatment which is essentially a placebo (or makes things worse) in that condition.
Brad, and, as Vinay has also pointed out, many of these anticancer drugs have painful side effects while doing little to help the patient live longer or better. It’s hard to stomach sometimes what vulnerable patients are put through.
As a person with recurrent aggressive B cell lymphoma (and a graduate in bioethics from Columbia), I have been in the midst of discussions about “iffy” cancer treatments. I just finished a CAR T treatment that was a Ph 1/2 clinical trial. It remains to be seen how successful it will be... but my thought was that every data point may help future patients. I also had no other options in early 2023.
The grey area is where patients believe they have a real “chance” to stay alive regardless of the harms to their quality of life. I believe the physician must be open and honest about the harms/benefits. Patients and families can decide their priorities.
It gets complicated because of the impact on Medicare/insurance. Would patients opt for “iffy” treatments if they had to pay more for them?
I have to agree with Dr. Buratovich. I think Vinay's purpose was to bring to light the continued lack of quality testing, the fat pockets of Pharma, and a direction medicine seriously needs to shift. It's one doctor speaking out against Godzilla and King Kong. Robin Quivers says, "So you start one person at a time. Change one person, you can change a village."
But giving patients false hope with untested or poorly validated therapeutics is equally bad. Sure, if an elderly patient was very sick and the potential benefit outweighed the risks, most clinicians would probably treat them with a therapeutic agent that might work. But in such cases it is incumbent on the clinician to say that such an agent has not been properly vetted in the fires of double-blinded placebo-controlled clinical trials. I think the issue, in my view, is the lavishing of funds and confidence on expensive agents that may be no better than mom’s chicken soup and not nearly as safe. Honesty about the shortcomings of our vaccines and therapeutics is in short supply and needs a “booster.”
Seriously on point. What about the “new C19 booster” that is coming this fall? There is zero consensus on it. Give it to elderly and/or immune compromised people? Is it harmless but perhaps without benefit as well?
I agree full stop. This booster is being released and copiously funded with zero, zip, nil, nada human data while we’re being told, “of course it works! Just trust us.” No, in fact I do not trust you all. Trust is earned and you all have done little to either earn, engender, or preserve my trust. See Marty McKary’s op ed in the WSJ today.
Same.
Thanks..... heading to the WSJ now
I agree that transparency about the lack of validation on the current strain is important, and is actually ethically required. But that's true of an extremely large number of treatments, not just Covid, as the article points out. The problem with Covid and other viruses is that anti-virals are only effective for a short time, so you have to make a decision quickly. Probably all/most treatments are past their "expiration point" by now. The safety issue is a bit easier to clarify, since data is continuously collected on SAE's, even after the studies have ended. The doctor walks a fine line between providing transparency without destroying a patient's expectations for improvement which, as we all know, is an important aspect of EVERY treatment, even those with up-to-date RCT validation. Yes, we want to know that a treatment is more efficacious than a placebo, but at the same time, we also want to harness the power of the placebo effect with every treatment, which at this point, we have no clue how it works. We just know that it often does.
All good and fair points. Crashing a patient’s hope for improvement is indeed a poor way to practice medicine. I suppose it’s one of the reasons why medicine is as much an art as it is a science, as our dear savant Adam Cifu keeps demonstrating in one thoughtful post after another.
I agree 100%! 😁 As Vinay points out, there's a boat-load of research that should be re-done for current times. If only each trial didn't cost millions! 😫
https://www.sofpromed.com/how-much-does-a-clinical-trial-cost