FDA head asks for investigation into Aduhelm drug approval(businessinsider.com)
businessinsider.com
FDA head asks for investigation into Aduhelm drug approval
https://www.businessinsider.com/fda-head-asks-for-investigation-into-aduhelm-drug-approval-2021-7
168 comments
I'm sure there have been many controversial FDA decisions before, but this one seems significantly different. The reactions from normally even-keeled medical journalists have been blistering [0] and it's apparently already set a precedent that has resulted in other similar therapies which have also not shown any sign of improving outcomes, starting to be approved as well [1].
[0] https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...
[1] https://blogs.sciencemag.org/pipeline/archives/2021/06/24/op...
[0] https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...
[1] https://blogs.sciencemag.org/pipeline/archives/2021/06/24/op...
I think the FDA board resignations and general scientist outcry is notable and not routine, but it didn't set the precedent on it's own, it's been a trend long in development.
From January 2020 (17 months before aduhelm approved):
https://www.npr.org/sections/health-shots/2020/01/14/7962270...
FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find
> Almost half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to the study published Tuesday in JAMA, the journal of the American Medical Association. And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment.
> …Drugmakers also began paying the FDA fees to fund the review process after AIDS activists protested the agency's sluggishness in the 1980s… "There is some concern about the incentives that this is created within the FDA," Darrow says. "And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry."
["surrogate measures" is a complaint with aduhelm approval, when they say there was no "evidence showing the drug slowed the disease", they mean the approval was based only on surrogate measures.]
From January 2020 (17 months before aduhelm approved):
https://www.npr.org/sections/health-shots/2020/01/14/7962270...
FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find
> Almost half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to the study published Tuesday in JAMA, the journal of the American Medical Association. And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment.
> …Drugmakers also began paying the FDA fees to fund the review process after AIDS activists protested the agency's sluggishness in the 1980s… "There is some concern about the incentives that this is created within the FDA," Darrow says. "And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry."
["surrogate measures" is a complaint with aduhelm approval, when they say there was no "evidence showing the drug slowed the disease", they mean the approval was based only on surrogate measures.]
PDUFA and MDUFA (user fees) have no influence on FDA decision making. They are basically pocket change compared to the cost of bringing something on to market. Many think the fees are too low and ought to be increased.
Surrogate measures are a trade off that we as a society have decided to make to reduce regulatory burden and accelerate brining new therapies to market. Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently. In some cases it is clear that the surrogate is a good endpoint. In others maybe less so. Regulators have the tough job of balancing the risks, benefits, and science when making the call on whether to accept one.
Generally FDA is doing many things to streamline and accelerate the regulatory process. This is good. We want them to innovate and take advantage of new scientific knowledge and technological breakthroughs.
Finally I would say that the real precedent for this was the decision for the Duchenne Muscular Dystrophy drug (also happened on Woodcock’s watch). I kind of had this sinking feeling this was about to happen when I saw that she was acting commissioner. Say what you will about Trump, but Gottleib was a damn good appointment - at least until he got fired for going after vaping. Azar was a pussy and basically an empty suit.
Surrogate measures are a trade off that we as a society have decided to make to reduce regulatory burden and accelerate brining new therapies to market. Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently. In some cases it is clear that the surrogate is a good endpoint. In others maybe less so. Regulators have the tough job of balancing the risks, benefits, and science when making the call on whether to accept one.
Generally FDA is doing many things to streamline and accelerate the regulatory process. This is good. We want them to innovate and take advantage of new scientific knowledge and technological breakthroughs.
Finally I would say that the real precedent for this was the decision for the Duchenne Muscular Dystrophy drug (also happened on Woodcock’s watch). I kind of had this sinking feeling this was about to happen when I saw that she was acting commissioner. Say what you will about Trump, but Gottleib was a damn good appointment - at least until he got fired for going after vaping. Azar was a pussy and basically an empty suit.
> trade off that we as a society..
>Regulators have the tough job of balancing the risks, benefits, and science when making the call on whether to accept one.
I am curious. How much of the society was involved in making this decision. We can all agree that there is enormous financial pressure from the industry to make such decisions go in its favour, and virtually none to go in favor of the public.
So isn't there a chance that eventually such trade offs will go in a direction that is harmful to the public?
>Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently.
Sure, but we don't do things this way. You can always find someone who benefits from a community wide applied bad idea. Does not justify the bad idea sadly.
This kind of short term, localised thinking might allow the regulatory process to bend heavily under the aforementioned financial pressures, in favour of the industry, and result in great public harm that might go unnoticed for a very long time..
I am curious. How much of the society was involved in making this decision. We can all agree that there is enormous financial pressure from the industry to make such decisions go in its favour, and virtually none to go in favor of the public.
So isn't there a chance that eventually such trade offs will go in a direction that is harmful to the public?
>Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently.
Sure, but we don't do things this way. You can always find someone who benefits from a community wide applied bad idea. Does not justify the bad idea sadly.
This kind of short term, localised thinking might allow the regulatory process to bend heavily under the aforementioned financial pressures, in favour of the industry, and result in great public harm that might go unnoticed for a very long time..
Right, that's the opinion that supports the FDA here, that probably most readers are used to hearing. It is, however, decreasingly the universal consensus among doctors, scientists, and others, there is much more dissent these days, opinion that the FDA is approving drugs they shouldn't be -- as demonstrated by the very unusual resignations from the FDA committee. Those scientists thought it was more questionable than your story.
As far as patient advocates, as many pieces point out, one of the historical things was AIDS activism for availability of drugs. I was struck by this from a recent piece about ACT UP, from one of the activists at that time:
«Today, Franke-Ruta is a journalist, and she spoke to Schulman about the wider implications of some of act up’s success. “I don’t think that we realized at the time that this was part of the broader gutting of the FDA that we’ve seen since; that there was a lot of political agendas that we just happened to be in sync,” she said. After President Donald Trump touted the promise of hydroxychloroquine as a treatment for covid-19, the F.D.A. issued an emergency-use authorization for the drug, which was shown to be useless for the purpose. (The agency withdrew the authorization three months later.) “Sometimes it seems like it’s gone too far in the other direction,” Franke-Ruta went on. “But there’s a really strong pharmaceutical lobby against the FDA as well that I don’t think we were aware of.”»
And from the article's author, editorializing a bit:
«In retrospect, one can ask whether act up’s victories on the research front pushed the F.D.A. too far. The drugs-into-bodies approach to fast-tracking—the use of “surrogate endpoints” (like T-cell counts or viral load), for example, rather than clinical benefits in actual people—can be valuable, especially for patients who are facing death and have no good alternatives. This approach at least offers desperate patients a chance, while allowing scientists to gather meaningful data. But, today, a number of drugs, for everything from asthma to periodontitis, have won approval before benefits in human patients were established, and critics argue that drug approval is too often based solely on benefits shown in biomarkers rather than in bodies. “Right to try” legislation, meanwhile, enables the sale of drug candidates without even involving the F.D.A. When restrictions are weakened, experimental drugs—many of which end up proving useless or worse—become harder to distinguish from effective medicine.»
https://www.newyorker.com/magazine/2021/06/14/how-act-up-cha...
As far as patient advocates, as many pieces point out, one of the historical things was AIDS activism for availability of drugs. I was struck by this from a recent piece about ACT UP, from one of the activists at that time:
«Today, Franke-Ruta is a journalist, and she spoke to Schulman about the wider implications of some of act up’s success. “I don’t think that we realized at the time that this was part of the broader gutting of the FDA that we’ve seen since; that there was a lot of political agendas that we just happened to be in sync,” she said. After President Donald Trump touted the promise of hydroxychloroquine as a treatment for covid-19, the F.D.A. issued an emergency-use authorization for the drug, which was shown to be useless for the purpose. (The agency withdrew the authorization three months later.) “Sometimes it seems like it’s gone too far in the other direction,” Franke-Ruta went on. “But there’s a really strong pharmaceutical lobby against the FDA as well that I don’t think we were aware of.”»
And from the article's author, editorializing a bit:
«In retrospect, one can ask whether act up’s victories on the research front pushed the F.D.A. too far. The drugs-into-bodies approach to fast-tracking—the use of “surrogate endpoints” (like T-cell counts or viral load), for example, rather than clinical benefits in actual people—can be valuable, especially for patients who are facing death and have no good alternatives. This approach at least offers desperate patients a chance, while allowing scientists to gather meaningful data. But, today, a number of drugs, for everything from asthma to periodontitis, have won approval before benefits in human patients were established, and critics argue that drug approval is too often based solely on benefits shown in biomarkers rather than in bodies. “Right to try” legislation, meanwhile, enables the sale of drug candidates without even involving the F.D.A. When restrictions are weakened, experimental drugs—many of which end up proving useless or worse—become harder to distinguish from effective medicine.»
https://www.newyorker.com/magazine/2021/06/14/how-act-up-cha...
I hope that the FDA has learned from the U.S. Federal Aviation Administration and the Boeing 737 MAX catastrophy. Credibility is easy to be lost and hard to be gained again.
The FDA hardly had a good reputation in the first place. The Vioxx fiasco was not too long ago.
Are you arguing that vioxx should not have been banned? Iirc the FDA did not ban vioxx, it was a voluntary withdrawal.
[deleted]
Many deaths linked to Vioxx could have been avoided if the FDA had done its job. Incompetence seems to be a feature of federal agencies.
What job is that? Long term studies showed it’s no more risky than ibuprofen for long term use. I’m not sure there’s a pain killer we’ll ever have that isn’t bad for you when taken in high dosage for years at a time.
https://en.m.wikipedia.org/wiki/Rofecoxib
https://en.m.wikipedia.org/wiki/Rofecoxib
>Credibility is easy to be lost and hard to be gained again.
I disagree. If you have media in your team, this is easy, given some time. Particularly in current times when you have a treasure trove of possible distractions that you can make the media throw at a gullible public.
If one looks closely, then I think CDC/FDA etc have lost credibility a long time back. The real events portrayed in documentaries like "What lies upstream" and movies like "Dark Waters" should be enough to reject these agencies outright.
What is enormously surprising to me is that, not only we consider them very credible, but are also willing to consider their word as unfailable and final in many cases.
Even more sad thing is that the power of CDC/FDA extends even to many developing countries, so this affects much more than their home country.
[1] https://www.imdb.com/title/tt5165878/
[2] https://www.imdb.com/title/tt9071322/
I disagree. If you have media in your team, this is easy, given some time. Particularly in current times when you have a treasure trove of possible distractions that you can make the media throw at a gullible public.
If one looks closely, then I think CDC/FDA etc have lost credibility a long time back. The real events portrayed in documentaries like "What lies upstream" and movies like "Dark Waters" should be enough to reject these agencies outright.
What is enormously surprising to me is that, not only we consider them very credible, but are also willing to consider their word as unfailable and final in many cases.
Even more sad thing is that the power of CDC/FDA extends even to many developing countries, so this affects much more than their home country.
[1] https://www.imdb.com/title/tt5165878/
[2] https://www.imdb.com/title/tt9071322/
They already have a problem with p-hacking
Nitpick, I have a great deal for respect for Derek but he isn't a journalist (and nor does he claim to be).
It's just a column.
But that's not to say the reactions from journalists weren't critical. Adam from Stat had some choice words about the decision.
It's just a column.
But that's not to say the reactions from journalists weren't critical. Adam from Stat had some choice words about the decision.
My personal opinion: I respect the opinion of a medicinal chemist working in the field of drug discovery more than I do a journalist. The insider who works in the field understands the issues and problems of getting drugs to market more than an outsider.
In other words, it's a column by a guy who spent his career in drug discovery. Not merely a journalist.
Yeah, Derek Lowe is a professional drug researcher who "moonlights" as a popular science writer.
If the other drug researchers are sticking necks out to say this is bullshit, it's pretty like that ... this is bullshit. The situation he describes that all the other companies had already failed to their useless drugs approved. Now that one useless drug slips through, all the others are going try and do that.
If the other drug researchers are sticking necks out to say this is bullshit, it's pretty like that ... this is bullshit. The situation he describes that all the other companies had already failed to their useless drugs approved. Now that one useless drug slips through, all the others are going try and do that.
Derek always had a well informed take, but asking scientist about a regulatory decision is like asking a engineer about a legal decision. Informed, but not an expert.
I'm not sure that's a useful distinction, it's not a chartered profession. Someone who writes a weekly column for money is a journalist in the way that someone who writes software for money is a programmer.
There’s a pretty big distinction in the journalism world. It’s more like saying anyone who uses a computer for work is a programmer.
Yeah, but nobody listens to the guy that calls JavaScript coders "not real programmers" because JavaScript is a 'scripting language'.
The point is, it doesn't seem like a useful distinction.
The point is, it doesn't seem like a useful distinction.
what qualifications is a journalism supposed to have? Humanities? when you write about Science having some actual experience doing science is helpful.
A government agency requesting an investigation into its own actions from an inspector general is not that weird. It can happen for a variety of reasons.
Sometimes, the agency is confident that it handled things correctly, so they want an auditor to come in to prove it to the public and reassure everyone that nothing untold happened. Other times, the agency suspects internal wrongdoing but lack the resources to investigate it without disrupting their day-to-day operations. It can also be a political move from a presidential appointee when they suspect that the investigation will uncover that it was their predecessors fault.
At the end of the day, though, inspectors general have wide latitude to investigate what they choose. HHSOIG would probably have investigated this anyway, so it’s just a good PR move for the agency to invite the scrutiny.
Sometimes, the agency is confident that it handled things correctly, so they want an auditor to come in to prove it to the public and reassure everyone that nothing untold happened. Other times, the agency suspects internal wrongdoing but lack the resources to investigate it without disrupting their day-to-day operations. It can also be a political move from a presidential appointee when they suspect that the investigation will uncover that it was their predecessors fault.
At the end of the day, though, inspectors general have wide latitude to investigate what they choose. HHSOIG would probably have investigated this anyway, so it’s just a good PR move for the agency to invite the scrutiny.
To almost all of the questions, 90%+ of the advisory board voted no/uncertain, yet FDA completely overrode/ignored their advice... I would understand if it was 50/50, but what's the point of getting an independent board if all of them tell you no and you still say yes?
> In his resignation letter, Kesselheim said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history.”
> In his resignation letter, Kesselheim said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history.”
It's especially conspicuous given how lucrative this specific drug is expected to be.
The drug Humira for example is a drug with a similar cost and schedule that is used to treat chronic auto-immune diseases. Humira was similarly a first of its kind drug that for the disorders it is used to treat. It became perhaps the most lucrative drug in U.S. history eventually leading to the company that made it spinning it off into its own company. It has sent pharmas across the world scrambling to enter the market, with many of them doing quite well too. And dementia is an even bigger market than autoimmune disease.
The drug Humira for example is a drug with a similar cost and schedule that is used to treat chronic auto-immune diseases. Humira was similarly a first of its kind drug that for the disorders it is used to treat. It became perhaps the most lucrative drug in U.S. history eventually leading to the company that made it spinning it off into its own company. It has sent pharmas across the world scrambling to enter the market, with many of them doing quite well too. And dementia is an even bigger market than autoimmune disease.
90% of all drug candidates that are brought to the FDA for approval fail one of the FDA’s required studies. It is probable that some of the 10% that pass and are approved are marginal, and someone at the FDA has to make a judgement call. Thus it is likely that occasionally a drug is approved which later turns out to be ineffective or even dangerous. But it seems to happen fairly rarely, and it’s quite rare that people resign in protest.
It looks like in this case it was known to be ineffective when it was approved. I thought the FDA was supposed to protect us from snake oil like this?
Yea, that’s what I mean. If the evidence was merely equivocal, as in there was some evidence in favor but not as much as expected, then nobody would have resigned. In this case their last study was “halted for futility”, which makes the approval pretty egregious.
It’s an Accelerated Approval by the FDA. “to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint”
It’s not full approval, it’s conditional approval based on the possibility of clinical benefit.
It’s not full approval, it’s conditional approval based on the possibility of clinical benefit.
Should not be reimbursed then.
Medicare can make a determination on reimbursement. They can choose not to reimburse or reimburse for a limited group.
https://www.cms.gov/Medicare/Coverage/DeterminationProcess
https://www.cms.gov/Medicare/Coverage/DeterminationProcess
When this came up originally here on HN, the point was made that it was known to be effective in reducing plaques (IIRC; against a symptom anyway), but was not known to be effective or ineffective against Alzheimer's.
reducing plaques is useless if it results in no different cognition outcome. you are supposed for actual patient benefit not for mere theoritical value.
They are - it’s also a thing that corruption happens. There has been a lot more corruption than usual the last 4+ years in gov’t offices, and it will be a long time before it’s all identified.
FDA's state of compromise goes a lot farther back than 4 years.
ref: https://www.forbes.com/sites/matthewherper/2016/09/20/approv...
ref: https://www.forbes.com/sites/matthewherper/2016/09/20/approv...
Just go back to the history of anti-depressants 20+ years ago. Technically they don't work any better than placebo.
What evidence is there that there has been an abnormal amount of corruption?
What is the normal baseline?
What is the normal baseline?
I suspect the baseline is measured in outraged Twitter posts per hour.
This is some data about corruption over the years
https://trac.syr.edu/tracreports/crim/646/
https://trac.syr.edu/tracreports/crim/646/
It may also just be that more corruption is being exposed.
What I couldn't tell was whether the "scientific advisors" are FTEs or some other role. It would take a lot for someone to give up a government job/pension, so three resignations of that nature would be incredible. But if these are just part-time consultants, the statement would be less notable.
These are outside advisors, probably about 1/2 of them or more are academics as well as patient advocates, etc. They maybe paid some amount, but its not their primary income source.
Government STEM positions tend to be under paid vs the private sector. A lot of these people are taking a pay cut because they want to serve the greater good or work on an interesting problem.
It depends on the position, TE are probably less than tech sector, but salary for PhDs in basic sciences are great in government (ie, biology PhD starting at gs12/13 is $120-150k).
So if you want to do “science” then a government job is likely one of the highest paid jobs you can get.
So if you want to do “science” then a government job is likely one of the highest paid jobs you can get.
You may have misread the pay schedule. You'd have to be a GS14 in San Francisco to make $150k. In most of the country a GS12-qualified biologist would only bring in six figures at the highest stepping. Good universities and national labs (contractors, not DOE employees!) pay way better.
Yes, you’re right and I overestimated the pay. But it’s still good. It does vary by location [0], but is still good compared to universities, I’m not sure about National labs. For example, the first regional pay table for Albany has gs13s starting at $93k and topping out at $121k [1] and San Francisco starts at $112k and tops out at $146k [2].
[0] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[1] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[2] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[0] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[1] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[2] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
If it's a fake drug that's been priced at a level to break American health care [1], they could potentially be this kind of employee that actually care or perhaps they just considered the corruption too obvious even for the FDA and wanted to clear themselves of charges.
[1] https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-dr...
[1] https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-dr...
It is also possible that some which are rejected can actually help people, but that the study targeted the wrong outcomes or included subjects with the wrong disease. Alzheimer's is especially difficult because there are many dementias with the same symptoms and different causes.
In 2011 an ex-FDA advisor who had voted to approved LASIK eye surgery, published a letter to FDA asking them to immediately recall LASIK as there was data they were ignoring that they shouldn't have been ignoring; https://www.phillyvoice.com/former-fda-adviser-lasik-dangers...
I cite a specific example of issues in the past in regards to FDA, specifically addressing the question asked, and HN downvotes it. Nice.
There are so many things in this story that doesn’t make any sense. It feels like there must be some missing piece somewhere. I think that might also be the reason for the investigation.
> Recent advances in amyloid imaging have made it possible to observe Aβ amyloid accumulation in the patient's brain. As a result, it has been found that there are many normal patients with amyloid deposits, and also AD patients with very few amyloid deposits (Edison et al., 2007; Li et al., 2008). [0]
How long is it going to take for the scientists who have built their career on the amyloid hypothesis to die out so new ideas can be investigated?
[0] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl...
How long is it going to take for the scientists who have built their career on the amyloid hypothesis to die out so new ideas can be investigated?
[0] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl...
One has to only look at the dumpster fire that is the USDA nutritional guidelines to know "never".
"Die out". Everybody dies eventually. It's just a long process waiting for science to progress by funerals.
Indeed, plate tectonics (sort of, Wegener had the idea but no evidence/proof) and hand washing for doctors/surgeons both faced widespread opposition, just off the top of my head.
mRNA is another example
Not to worry, there are plenty of opportunists who will line up to carry the torch once the older ones die.
What's wrong with the USDA nutritional guidelines?
I think the OP might be conflating the USDA nutritional guidelines with the food pyramid, which was rather blatantly bullshit and influenced by the agricultural industry.
Where can I find a science-based food pyramid chart?
It is beyond the limits of science. The experiment to determine an optimal food pyramid has too many confounding variables and the experiements necessary to validate them would probably not pass an IRB and cost hundreds of billions of dollars.
> What's wrong
Diabetes and obesity are still rampant, so I'd say something is certainly wrong.
Diabetes and obesity are still rampant, so I'd say something is certainly wrong.
I’m not a fan of the guidelines myself (too carb-heavy, IMO). However I don’t think obesity and diabetes are rampant among people who eat 2000 calories and exercise 30 minutes per day.
>However I don’t think obesity and diabetes are rampant among people who eat 2000 calories and exercise 30 minutes per day
And this is where the issue gets complicated. Why do people eat more than 2000 calories / day and exercise less. Are they lazy and stupid, or is there something deeper.
Personally, I think the most compelling argument appears to be that high insulin levels hijack the hypothalamus through hormonal disregulation. The hypothalamus of these insulin resistant people drives them to over eat and expend less energy because it thinks they are underfed.
This model suggests severely restricting carbohydrate in order to drive down insulin levels.
And this is where the issue gets complicated. Why do people eat more than 2000 calories / day and exercise less. Are they lazy and stupid, or is there something deeper.
Personally, I think the most compelling argument appears to be that high insulin levels hijack the hypothalamus through hormonal disregulation. The hypothalamus of these insulin resistant people drives them to over eat and expend less energy because it thinks they are underfed.
This model suggests severely restricting carbohydrate in order to drive down insulin levels.
You make it more complicated than it is: we have easy access to tons of calories, our lives don’t require us to move a lot and we are hardwired to find/eat calories and store them in the body for worse times.
Low-carb certainly isn’t the solution. For some it is, but not for most.
Low-carb certainly isn’t the solution. For some it is, but not for most.
[deleted]
I don't think the people having diabetes and obesity are sticking to the guidelines.
How is dairy, a food that was almost unobtainable before agriculture (that 60% of the world is intolerant to) a part of the food pyramid most people NEED two-three servings a day of?
[deleted]
The problem is obviously a type error (not different from the use of a Social Security Number as a National Identification Number).
The government will pay for medication “that works”.
It determines that medication is one “that works” by seeing if the FDA approves it.
The FDA doesn’t want to always be too slow to approve medication so sometimes it wants to approve medication as “doesn’t hurt”.
Ultimately, the problem is that American policy relies on categories rather than spectra. My personal belief is that this is because the bureaucrats and policy makers are taking advantage of common American knowledge of categories vs spectra. So it needs some categorization mechanism and since one exists, they use that one. Presumably, out there is a bureaucrat with the same impulse as the engineer reading your PR who says “We already have a function to calculate radians to degrees. Why don’t we use that?”
In comparison, the NHS will measure how much to spend on a treatment based on an adjusted QALY measure (that boosts the value of the last few months). X QALYs are worth Y pounds.
Almost all American policy, by comparison, is category-based.
Other examples:
- immigration: America does categories (so either family or employment or refugee) while other nations use scores (if you both have family and employment you get some boost from both rather than the US max(categories)) system
- social security: Thresholds on disability and poverty are cliffs resulting in marginal income improvement resulting in marginal post-support income decrease. These should scale down, not drop off based on in-category/out-category
The government will pay for medication “that works”.
It determines that medication is one “that works” by seeing if the FDA approves it.
The FDA doesn’t want to always be too slow to approve medication so sometimes it wants to approve medication as “doesn’t hurt”.
Ultimately, the problem is that American policy relies on categories rather than spectra. My personal belief is that this is because the bureaucrats and policy makers are taking advantage of common American knowledge of categories vs spectra. So it needs some categorization mechanism and since one exists, they use that one. Presumably, out there is a bureaucrat with the same impulse as the engineer reading your PR who says “We already have a function to calculate radians to degrees. Why don’t we use that?”
In comparison, the NHS will measure how much to spend on a treatment based on an adjusted QALY measure (that boosts the value of the last few months). X QALYs are worth Y pounds.
Almost all American policy, by comparison, is category-based.
Other examples:
- immigration: America does categories (so either family or employment or refugee) while other nations use scores (if you both have family and employment you get some boost from both rather than the US max(categories)) system
- social security: Thresholds on disability and poverty are cliffs resulting in marginal income improvement resulting in marginal post-support income decrease. These should scale down, not drop off based on in-category/out-category
No, the govt will not look to the FDA to see if it works, it can do it’s own assessment. The FDA determines if the benefits outweigh the risks. Benefits can be marginal and not worth paying for. That’s not the FDA’s job.
And odd you’d call the US out when QALYs can be very subjective and the QALY thresholds in the UK create hard limits to price that don’t always make sense (as QALY doesn’t capture all benefits).
And odd you’d call the US out when QALYs can be very subjective and the QALY thresholds in the UK create hard limits to price that don’t always make sense (as QALY doesn’t capture all benefits).
Unfortunately the link is unavailable in Poland:
https://imgur.com/a/48MFia6
Odd; it works for me.
Link to pdf with prescribing information highlights which includes a small bit of detail about Aduhelm's mechanism of action and other details:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76...
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76...
[deleted]
Full headline (presumably cut for HN length restrictions) is:
> The head of the FDA is calling for an investigation into her agency's controversial decision to approve a new Alzheimer's drug
> The head of the FDA is calling for an investigation into her agency's controversial decision to approve a new Alzheimer's drug
That decision was so overtly concerning, I already knew what the headline was about.
I'm suspect that a lot of lesser, bad behavior had to go unchallenged, for us to wind up with a decision that was this blatantly corrupt.
I'm suspect that a lot of lesser, bad behavior had to go unchallenged, for us to wind up with a decision that was this blatantly corrupt.
The HTML doc title fits the 80 char limit so we've switched to that.
The baseline reaction I'm seeing from commenters is appalling. This drug has been shown to NOT be particularly dangerous in clinical trials, while having a biochemical effect on amyloid protein buildup, which has strong correlations with degenerative brain diseases. It's another tool in the arsenal. There's no evidence that it cures one of the worst diseases around, but that shouldn't be the requirement for whether the public (only after having it prescribed by a medical doctor, mind you), has access to a drug.
How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal? The FDA should exist to prevent fraud and monitor quality, and nothing else. In this case, it would be highly reasonable to restrict the claims of the drug based on the study. But to ban it? What gives you or them the right to protect people from themselves?
How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal? The FDA should exist to prevent fraud and monitor quality, and nothing else. In this case, it would be highly reasonable to restrict the claims of the drug based on the study. But to ban it? What gives you or them the right to protect people from themselves?
The risk/benefit model is broken here: Some risk and no benefit. I'm not going to even address the cost - the benchmark for benefit is incredibly low. All BioGen needed to show was that their drug delayed progression of cognitive impairment for a few months, and they couldn't do it.
The FDA acknowledged as such in their conditional approval, weakly suggesting expanded access might allow BioGen to demonstrate this in a larger population. This would lead Medicare to pay for an extensive, unethical study fueled by nothing more than the hopes of desperate patients and their caregivers.
The FDA acknowledged as such in their conditional approval, weakly suggesting expanded access might allow BioGen to demonstrate this in a larger population. This would lead Medicare to pay for an extensive, unethical study fueled by nothing more than the hopes of desperate patients and their caregivers.
> while having a biochemical effect on amyloid protein buildup, which has strong correlations with degenerative brain diseases.
That correlation has actually been turning out to be very weak. The very studies conducted to test this drug are some of the proof (reducing amyloid buildup doesn't affect disease progression), And there is also mounting proof from brain imaging that Amyloid buildup exists in the brains of many people with no mental problems.
And in general, if we know the drug does nothing at all, why allow the company to force doctors to prescribe it (by marketing to desperate patients)?
The drug can still be used in new research. But unless and until research shows that it has an effect on some disease, it should be illegal to market it as medication. At best it could be sold as a supplement, for those gullible enough to try it.
That correlation has actually been turning out to be very weak. The very studies conducted to test this drug are some of the proof (reducing amyloid buildup doesn't affect disease progression), And there is also mounting proof from brain imaging that Amyloid buildup exists in the brains of many people with no mental problems.
And in general, if we know the drug does nothing at all, why allow the company to force doctors to prescribe it (by marketing to desperate patients)?
The drug can still be used in new research. But unless and until research shows that it has an effect on some disease, it should be illegal to market it as medication. At best it could be sold as a supplement, for those gullible enough to try it.
Don't forget that it also has major side effects such as brain swelling and bleeding... If I recall something like 40% of patients? So it's not without risks
> it should be illegal to market it as medication
That's exactly what I stated. But banning substances outright is anti-science and anti-freedom. Just prevent fraud, and make sure it isn't poison.
That's exactly what I stated. But banning substances outright is anti-science and anti-freedom. Just prevent fraud, and make sure it isn't poison.
FDA approval is needed to seek something as medication. If they want to package it as a supplement, they can sell it today.
The problem with this particular drug is that there is no evidence that it leads to longer or better lives for the patients who have taken it. Therefore there is no real reason to prescribe it for Alzheimer's, but it will be prescribed and it will cost American taxpayers billions.
The solution seems to be to ban medicare/medicaid from paying for any treatment that isn’t proven to work.
It's not just a problem for Medicare/medicaid. BioGen will be allowed to push this through their marketing to desperate patients and caregivers, who will nag their doctors into prescribing it, even though they could just as well drink a glass of water.
The doctor is the final decision maker on prescribing. If they don’t think it’s effective then don’t prescribe it?
Then the doctor gets bad reviews for refusing to prescribe FDA-approved medicine to desperate patients. The doctor themselves may not have looked deeply into this, and just know that it is an FDA approved medication, so it must be effective, right?
That’s their risk to take.
That's the whole problem. The company can now point to its FDA approval and say, "See? It's proven to work!"
It hasn't been, and probably doesn't, but now they can get billions from Medicare for it.
It hasn't been, and probably doesn't, but now they can get billions from Medicare for it.
That’s the point of an Accelerated Approval though.
And no, it won’t cost billions. That’s a scare tactic. Medicare can choose not to reimburse.
And no, it won’t cost billions. That’s a scare tactic. Medicare can choose not to reimburse.
> How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal?
It doesn’t cost $55,000 a year to smoke weed, and if nothing else weed will get you high. Most people have a problem with Medicare paying for this drug, not people taking the drug itself.
It doesn’t cost $55,000 a year to smoke weed, and if nothing else weed will get you high. Most people have a problem with Medicare paying for this drug, not people taking the drug itself.
lend000(3)
Ah, I was wondering where this kind of comment would be, after the last time this drug approval came up.
"There's no evidence that it cures one of the worst diseases around...The FDA should exist to prevent fraud and monitor quality..."
Then the FDA is doing exactly it's job. If there's no evidence that it works, then selling it would be fraud, right?
"There's no evidence that it cures one of the worst diseases around...The FDA should exist to prevent fraud and monitor quality..."
Then the FDA is doing exactly it's job. If there's no evidence that it works, then selling it would be fraud, right?
I have no problem with this drug being put in the same category as marijuana. If people want to synthesize it in their basements I wouldn’t support throwing them in prison.
Is the aduhelm company publicly traded? Seems like a lot of fun volatility upcoming on binary outcomes
If I was a gambling man, which I am, I would add this to my paid newsletter and call it investing (with contradictory and nullifying disclaimers of course)
If I was a gambling man, which I am, I would add this to my paid newsletter and call it investing (with contradictory and nullifying disclaimers of course)
NASDAQ:BIIB
Great. Speaking from first- and second-hand experience, the FDA is way more loosey-goosey than people think as long as you’re paying the right people.
What experience have you had? How many INDs, 510ks, etc have you worked on? Because this does not line up with my experience at all. IME FDA is very anal about even the appearance of the conflict of interest, and loosey-goosey is the last descriptor you would ever want to use for any interaction with FDA.
That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications.
My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications.
My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
Cuz it's a hard job. Try telling someone in a position of serious power who is going to loose his kid next year to back off. Who wants that job? Put your hand up.
Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved.
I'll put my hand up to perform ethically at my job and not allow regulatory capture.
I'll put my hand up to perform ethically at my job and not allow regulatory capture.
> Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved.
We'll see. What's playing out now is exactly how robust institutions work. Individual components can be corrupted, but the institution has a whole holds because of checks and balances.
Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear (namely, inclusion of Scientific Advisors in the review process, public records, and political accountability at the top).
When an unconstitutional law is passed, it's law. Until a court strikes it down. If an unconstitutional law is passed and then struck down by a court, that's not the system failing. That's individuals within the institution failing but the institution as a whole working exactly as intended.
> I'll put my hand up to perform ethically at my job and not allow regulatory capture.
But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. Which, speaking as someone who has turned down similar types of government jobs because I could make 5x in the private sector, is quite a bit more of a sacrifice than I think you realize. (This isn't meant to excuse unethical behavior, btw, it's just that your comment is literally not responsive to GP's and GP is exactly right -- those jobs suck and if we want fewer failures like this one maybe we, the people, as the employer, should be at least paying market rate.)
We'll see. What's playing out now is exactly how robust institutions work. Individual components can be corrupted, but the institution has a whole holds because of checks and balances.
Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear (namely, inclusion of Scientific Advisors in the review process, public records, and political accountability at the top).
When an unconstitutional law is passed, it's law. Until a court strikes it down. If an unconstitutional law is passed and then struck down by a court, that's not the system failing. That's individuals within the institution failing but the institution as a whole working exactly as intended.
> I'll put my hand up to perform ethically at my job and not allow regulatory capture.
But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. Which, speaking as someone who has turned down similar types of government jobs because I could make 5x in the private sector, is quite a bit more of a sacrifice than I think you realize. (This isn't meant to excuse unethical behavior, btw, it's just that your comment is literally not responsive to GP's and GP is exactly right -- those jobs suck and if we want fewer failures like this one maybe we, the people, as the employer, should be at least paying market rate.)
> But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day.
That doesn't seem to be what he asked. He asked us to Try telling someone in a position of serious power who is going to loose his kid next year to back off.
It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug, ostensibly in blatant and clear violation of their own protocols. Presented with that non-sequitur, I chose to restate the event in play.
That doesn't seem to be what he asked. He asked us to Try telling someone in a position of serious power who is going to loose his kid next year to back off.
It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug, ostensibly in blatant and clear violation of their own protocols. Presented with that non-sequitur, I chose to restate the event in play.
Yes, he was giving yet another reason no one wants to do that particular job.
I was given another.
So, it's a shitty job because people yell at you for <=$100K (his reason) and also you could be making $500+k elsewhere (my reason).
> It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug
Your basic complaint is that those particular government workers were either corrupt or incompetent. I don't disagree with that assessment.
But if you can't understand why people take industry jobs for $500K instead of government jobs for $100K, especially when the government job additionally requires "telling someone in a position of serious power who is going to loose his kid next year to back off", then I'm not really sure what to say.
And if you can't understand how "the job is shit and doesn't pay well" has downstream effects like incompetence and corruption, then, well, I'm not really sure what to say.
Most problems with failed governance in the USA basically boil down to "Want competence and ethics? Pay market rates & don't fucking outsource." See also: the Obamacare website debacle.
I was given another.
So, it's a shitty job because people yell at you for <=$100K (his reason) and also you could be making $500+k elsewhere (my reason).
> It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug
Your basic complaint is that those particular government workers were either corrupt or incompetent. I don't disagree with that assessment.
But if you can't understand why people take industry jobs for $500K instead of government jobs for $100K, especially when the government job additionally requires "telling someone in a position of serious power who is going to loose his kid next year to back off", then I'm not really sure what to say.
And if you can't understand how "the job is shit and doesn't pay well" has downstream effects like incompetence and corruption, then, well, I'm not really sure what to say.
Most problems with failed governance in the USA basically boil down to "Want competence and ethics? Pay market rates & don't fucking outsource." See also: the Obamacare website debacle.
>Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear..
The damning thing is the point it got up to, before the "checks and balances" came into play that we have to consider this as an exception rather than the rule.
IMHO The scientific advisory resigning is itself the point where the failure of the process became apparent. Because, I am pretty sure "if you disagree then you should resign", is NOT part of the approval process. I mean, it is not within the framework that you are trying to portray as being robust.
The damning thing is the point it got up to, before the "checks and balances" came into play that we have to consider this as an exception rather than the rule.
IMHO The scientific advisory resigning is itself the point where the failure of the process became apparent. Because, I am pretty sure "if you disagree then you should resign", is NOT part of the approval process. I mean, it is not within the framework that you are trying to portray as being robust.
What's the alternative? Allow snakeoil? Now insurance has to cover it, incentivizing the creation of more ineffective drugs? Trust in efficacy is critical.
With cancer drugs at least, efficacy trials are regularly scoped to a fairly narrow portion of the patient population along things like the presence of specific mutations, whether those mutations are germline or somatic, previous treatment types administered and staging. Efficacy found for one combination of the above generally isn’t seen as transitive to the rest.
The solution now seems to be to simply not allow that medication to be used if the patient doesn’t match the parameters of the trial. Some portion of those people then die because the current ‘standard of care’ is the same toxic shit they have been pumping i to veins for the past 30 years to little or no effect.
The solution now seems to be to simply not allow that medication to be used if the patient doesn’t match the parameters of the trial. Some portion of those people then die because the current ‘standard of care’ is the same toxic shit they have been pumping i to veins for the past 30 years to little or no effect.
If you're going to make a comment like that it would be better to share some of the experiences—it would add substance, and be much more interesting.
What does that mean for the Covid vaccines?
A lot of simultaneous trials have been run globally, and the only contra indication so far seems to be a slight clot risk with AstraZeneca.
You might be able to buy off the FDA, but it's a lot more work to buy off all the regulatory authorities of the world, at short notice.
You might be able to buy off the FDA, but it's a lot more work to buy off all the regulatory authorities of the world, at short notice.
>You might be able to buy off the FDA, but it's a lot more work to buy off all the regulatory authorities of the world, at short notice.
That is kind of naive. Because you don't buy off FDA, you keep it on your payroll.
If you don't already have it on your pay roll, then you make deals with someone who already have it on their payroll.
Is that so hard to see?
That is kind of naive. Because you don't buy off FDA, you keep it on your payroll.
If you don't already have it on your pay roll, then you make deals with someone who already have it on their payroll.
Is that so hard to see?
>A lot of simultaneous trials have been run globally..
Where can I read about all these studies, indvidually, say for example, for Moderna vaccine?
Where can I read about all these studies, indvidually, say for example, for Moderna vaccine?
[deleted]
Not a lot. Notably, phase 3 trials of the various covid vaccines generally show that they work, and regulators have been reluctant to approve vaccines that appear to only marginally work (in fact, regulators have gotten stricter about this; in 2020 there was the general expectation that a vaccine that was 50% effective would work, but in practice a number of candidates hitting that sort of level have not gone forward, because the alternatives are so much more effective).
Nothing, I believe. Every drug approval isn't suspect. Just the ones where pharma lobbyists get to spend the power they bought thru beefy campaign contributions.
Also - Covid vaccines were under intense public and medical scrutiny, during every bit of their development.
Good government and transparency tend to go together.
Also - Covid vaccines were under intense public and medical scrutiny, during every bit of their development.
Good government and transparency tend to go together.
Maybe nothing, maybe a lot. Big pharma has huge influence in the government. The vaccines are authorized under emergency use, which is predicated on not having alternatives. That there is a campaign to discredit cheap off patent alternatives (Ivermectin) is at least concerning.
There's a "campaign to discredit cheap off patent alternatives" because they don't actually work and people are going out and poisoning themselves with pills made for horses.
Did you have the same amount of confidence in your opinion when the lab leak theory was forbidden to discuss? If people are going to farm stores for medicine, that's a reflection on the absolutely deplorable state of credibility that the medical establishment has earned themselves over the past year. Doing more of the same isn't going to magically make trust in authority reappear, it's going to erode it even more.
Taking a horse quantity of any drug is unwise, even one that won the 2015 Nobel Prize (Ivermectin). It still needs large scale RCTs for Covid-19 use, but there are some small trials that at least indicate it should be taken seriously and not outright discredited and smeared.
"Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization."
https://academic.oup.com/ofid/advance-article/doi/10.1093/of...
"Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low."
https://www.sciencedirect.com/science/article/pii/S187140212...
"Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization."
https://academic.oup.com/ofid/advance-article/doi/10.1093/of...
"Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low."
https://www.sciencedirect.com/science/article/pii/S187140212...
I see a choice of going down the Invermectin rabbit-hole where the framing and presentation feels a lot like an MLM campaign (except saturated w/ conspiracy) - or walking into a local store and getting sound ~95% efficacy w/ a pair of free Moderna shots.
The latter really seems more compelling to me.
The latter really seems more compelling to me.
These shots are not FDA approved yet. Usually that's compelling enough to look for and consider alternatives. Especially existing cheap off patent drugs that have been used billions of times over the course of decades and recently won the Nobel Prize. If that plus many doctors and small trials indicate promise with Covid-19, we should take that seriously. That's all.
"The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19."
https://www.fda.gov/media/144638/download
None of this is to say that the vaccines aren't safe or shouldn't be used. They should be, especially for those at risk. The vaccines may well be better than Ivermectin and so far it appears that way. But there is some nuance here and it's valid if people want an alternative until the shots are FDA approved and have long term data. Many are not engaging in critical thinking when it comes to this issue and suddenly have complete trust of big pharma. Which I find bizarre.
"The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19."
https://www.fda.gov/media/144638/download
None of this is to say that the vaccines aren't safe or shouldn't be used. They should be, especially for those at risk. The vaccines may well be better than Ivermectin and so far it appears that way. But there is some nuance here and it's valid if people want an alternative until the shots are FDA approved and have long term data. Many are not engaging in critical thinking when it comes to this issue and suddenly have complete trust of big pharma. Which I find bizarre.
"...recently won the Nobel Prize..."
William C. Campbell and Satoshi Ōmura won the Nobel Prize "for their discoveries concerning a novel therapy against infections caused by roundworm parasites". Not viral respiratory system infections.
William C. Campbell and Satoshi Ōmura won the Nobel Prize "for their discoveries concerning a novel therapy against infections caused by roundworm parasites". Not viral respiratory system infections.
> Many are not engaging in critical thinking when it comes to this issue and suddenly have complete trust of big pharma.
I wasn't first in line to get any of these vaccines. Distrust of anything new is pretty rational!
But hundreds of millions of doses delivered, with a complication rate significantly less than the disease itself... that's pretty powerful evidence, no?
Especially compared against drugs that have yet to convincingly beat placebos in any large trial?
Personally, I find it bizarre that anyone can weight those two sets of evidence so differently.
I wasn't first in line to get any of these vaccines. Distrust of anything new is pretty rational!
But hundreds of millions of doses delivered, with a complication rate significantly less than the disease itself... that's pretty powerful evidence, no?
Especially compared against drugs that have yet to convincingly beat placebos in any large trial?
Personally, I find it bizarre that anyone can weight those two sets of evidence so differently.
Yes, but you also have to weigh the fact that we don't know what the long term effects may be. Some people would rather trust their immune system, with or without drugs that have been in use for decades. That's not my personal calculation, but I can see why others would net out that way. Particularly women who are concerned about the possible effects on fertility.
>But hundreds of millions of doses delivered, with a complication rate significantly less than the disease itself... that's pretty powerful evidence, no?
Yes. But there is a problem. This implies an unrestricted flow of information. If there is censorship (self and imposed) going on, then you cannot take this perception for granted.
Is there censorship going on regarding these issue. Absolutely, there is. I think we can all agree on that.
So how much is the ongoing censorship skewing the issue? We have no idea. May be the censorship is done in good faith for noble ends, but may be it is not, again we don't know.
Also as seen in Vioxx issue, even a 100000 additional heart attacks can go un-noticed in a country, even without explicit censorship. We know smoking causes cancer now. But decades ago, people have been smoking for a long time without actually noticing the problem on large enough scale.
This why we do systematic research based on data collected in large scales.
Also one have to wonder why the systems such as VAERS depend on voluntarily reporting, that gives very little credibility to the data collected. Why is not made mandatory to report on adverse events? If you go to the VAERS cdc page, the covid vaccines are not even included in the list of vaccines to include for VAERS reportable events as prescribed by law.
So according to some studies, less than 1% of actual events in reported in VAERS. Even with such a low amount of reporting, we know that reports of blood clots and heart inflammation is concerning. So what is the true picture?
So the point that I am trying to make is that, "We have used these things, or have been using these things for a while without problems", is a poor proof of safety.
Yes. But there is a problem. This implies an unrestricted flow of information. If there is censorship (self and imposed) going on, then you cannot take this perception for granted.
Is there censorship going on regarding these issue. Absolutely, there is. I think we can all agree on that.
So how much is the ongoing censorship skewing the issue? We have no idea. May be the censorship is done in good faith for noble ends, but may be it is not, again we don't know.
Also as seen in Vioxx issue, even a 100000 additional heart attacks can go un-noticed in a country, even without explicit censorship. We know smoking causes cancer now. But decades ago, people have been smoking for a long time without actually noticing the problem on large enough scale.
This why we do systematic research based on data collected in large scales.
Also one have to wonder why the systems such as VAERS depend on voluntarily reporting, that gives very little credibility to the data collected. Why is not made mandatory to report on adverse events? If you go to the VAERS cdc page, the covid vaccines are not even included in the list of vaccines to include for VAERS reportable events as prescribed by law.
So according to some studies, less than 1% of actual events in reported in VAERS. Even with such a low amount of reporting, we know that reports of blood clots and heart inflammation is concerning. So what is the true picture?
So the point that I am trying to make is that, "We have used these things, or have been using these things for a while without problems", is a poor proof of safety.
When the FDA finally grants full approval to the vaccines the goalposts will just move again to something else.
We recently learn of strong indicators that the Ivermectin studies were entirely fabricated, much of it was content that was plagiarized from other studies.
https://grftr.news/why-was-a-major-study-on-ivermectin-for-c...
If a long life has taught me anything, it's that puzzlingly loud claims of conspiracy are often generated noise to conceal the fact that something simply isn't true.
https://grftr.news/why-was-a-major-study-on-ivermectin-for-c...
If a long life has taught me anything, it's that puzzlingly loud claims of conspiracy are often generated noise to conceal the fact that something simply isn't true.
One bad study that didn't even get past preprint? Try the ones here from reputable journals.
https://covid19criticalcare.com/ivermectin-in-covid-19/
The 2015 prize was for its use against worms: https://www.isglobal.org/en/healthisglobal/-/custom-blog-por...
It's not clear how that relates to respiratory medicine.
It's not clear how that relates to respiratory medicine.
Of course. Veterinary pharmaceuticals have very different manufacturing standards, approvals, and dosages. It's unfortunate that so many have been pushed into this path by authoritarians who have in under a year turned the medical establishment's credibility into a pile of dust.
It's not holding up so well in RCT's, like this one[1] that was just discussed on TWiV 778[2].
BTW, I've joined the legions who are addicted to TWiV. It's a time commitment for sure, but it's fascinating how different the perspective is on important topics (like delta variant) than the mainstream press.
[1]: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s128...
[2]: https://www.microbe.tv/twiv/twiv-778/
BTW, I've joined the legions who are addicted to TWiV. It's a time commitment for sure, but it's fascinating how different the perspective is on important topics (like delta variant) than the mainstream press.
[1]: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s128...
[2]: https://www.microbe.tv/twiv/twiv-778/
[1]: "The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3–6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32–1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes."
Only a very low dose of Ivermectin was used. From the study limitations..
> Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
I think one would at least use any of the protocols that were being used by the doctors who are seeing an efficacy.
> Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
I think one would at least use any of the protocols that were being used by the doctors who are seeing an efficacy.
Folks you need to realize the difference between 'material discussion' within the scientific community etc. and 'drug populism' i.e. people making stuff up on Twitter and that information flowing to millions.
Nobody is 'smearing' the drug or even the people talking abot it.
They're saying 'stop telling the public about it because it's not approved yet and potentially dangerous'.
Whatever Donald Trump says - people believe. And they will go out in droves, self diagnose, self medicate, demand doctors prescribe them the 'cure' (when the doctor knows they shouldn't) etc..
And the amount of stupid conspiratorial memes that come up are pretty shocking. I avoid FB fro this reason and TikTok had a bunch of that for a bit, but I think they've shut down Ivermectin talk.
I quite like Joe Rogan, but he's not a doctor, and neither is his partner in goofydom Brett Weinstein, they have zero medical credibility on the issue, they should straight up not be talking about the drug.
If there is some kind of coverup, or there's hard evidence and the FDA is refusing to look at it, or if someone in Big Pharma bribed someone else ... then that's a story, but this is not that.
Oxford has just launched a trial for Ivermectin, and there are others. When the results come in, and if it works and is safe, then CNN et. al. will talk about it and parameterize it appropriately. We'll all hear about it pretty quickly.
The CDC can't stop Joe Rogan from talking about it and the haven't tried, but they can say 'STFU' until we have done the actual science, which is reasonable.
Nobody is 'smearing' the drug or even the people talking abot it.
They're saying 'stop telling the public about it because it's not approved yet and potentially dangerous'.
Whatever Donald Trump says - people believe. And they will go out in droves, self diagnose, self medicate, demand doctors prescribe them the 'cure' (when the doctor knows they shouldn't) etc..
And the amount of stupid conspiratorial memes that come up are pretty shocking. I avoid FB fro this reason and TikTok had a bunch of that for a bit, but I think they've shut down Ivermectin talk.
I quite like Joe Rogan, but he's not a doctor, and neither is his partner in goofydom Brett Weinstein, they have zero medical credibility on the issue, they should straight up not be talking about the drug.
If there is some kind of coverup, or there's hard evidence and the FDA is refusing to look at it, or if someone in Big Pharma bribed someone else ... then that's a story, but this is not that.
Oxford has just launched a trial for Ivermectin, and there are others. When the results come in, and if it works and is safe, then CNN et. al. will talk about it and parameterize it appropriately. We'll all hear about it pretty quickly.
The CDC can't stop Joe Rogan from talking about it and the haven't tried, but they can say 'STFU' until we have done the actual science, which is reasonable.
> I quite like Joe Rogan, but he's not a doctor, and neither is his partner in goofydom Brett Weinstein, they have zero medical credibility on the issue, they should straight up not be talking about the drug.
By this logic, this applies to every single person that aren’t doctors who shouldn’t be talking about the vaccine or the drugs. This includes data scientists and politicians. I’ve watched Dr. Pierre Kory’s full interview with Brett and seems clips of his testimony in front of the senate. He is extremely credible and should have a voice in this as a COVID-19 critical care doctor and who has done meta analysis of the drug (https://covid19criticalcare.com/wp-content/uploads/2020/11/F...). I think people like Joe and Brett help amplify voices of people like Dr. Pierre Kory similar to politicians who amplifies Dr. Fauci
By this logic, this applies to every single person that aren’t doctors who shouldn’t be talking about the vaccine or the drugs. This includes data scientists and politicians. I’ve watched Dr. Pierre Kory’s full interview with Brett and seems clips of his testimony in front of the senate. He is extremely credible and should have a voice in this as a COVID-19 critical care doctor and who has done meta analysis of the drug (https://covid19criticalcare.com/wp-content/uploads/2020/11/F...). I think people like Joe and Brett help amplify voices of people like Dr. Pierre Kory similar to politicians who amplifies Dr. Fauci
So I think you might be misunderstanding my point a bit.
Scientists and Doctors should be talking about it in scientific forums and communities. Politicians should be reiterating the 'current consensus'.
People shouldn't be talking about it in public / tabloid forums because the information is vague, misrepresented and will be taken entirely out of context.
I totally support people taking contrarian positions.
I think we should probably assign people towards being 'The Devil's Advocate'.
The issue is not 'freedom of expression and open dialogue' - it's one of 'crude populism and misinformation'.
It's about how information is propagated, and how people react to it.
Scientists and Doctors should be talking about it in scientific forums and communities. Politicians should be reiterating the 'current consensus'.
People shouldn't be talking about it in public / tabloid forums because the information is vague, misrepresented and will be taken entirely out of context.
I totally support people taking contrarian positions.
I think we should probably assign people towards being 'The Devil's Advocate'.
The issue is not 'freedom of expression and open dialogue' - it's one of 'crude populism and misinformation'.
It's about how information is propagated, and how people react to it.
Even if ivermectin were as effective as some people would like to believe, and widely used for COVID, it wouldn't be an alternative to the vaccines in the sense of preventing their emergency use authorization.
Perhaps but being honest instead of resorting to the smear tactics of the past year would help start rebuilding the ruins of the medical establishment's credibility. What good is it to keep pushing out disinformation "for the public's own good" when it results in more and more people looking to alternative (and often very dubious) sources of medical advice?
What we need is a policy of absolute honesty with a one-strike-and-your-out-forever punishment for any health authority that engages in propaganda, even if they had good intentions. Credibility matters. It matters a lot. All of these coy little word games and character assassinations being conducted in the name of the common good is achieving the exact opposite result. As it stands now, the credibility of the medical community might be forever tarnished especially since there appears to be no attempt to get it back but rather endless doubling downs on the slime tactics that should be to exclusive province of political campaign directors and used car salesmen.
What we need is a policy of absolute honesty with a one-strike-and-your-out-forever punishment for any health authority that engages in propaganda, even if they had good intentions. Credibility matters. It matters a lot. All of these coy little word games and character assassinations being conducted in the name of the common good is achieving the exact opposite result. As it stands now, the credibility of the medical community might be forever tarnished especially since there appears to be no attempt to get it back but rather endless doubling downs on the slime tactics that should be to exclusive province of political campaign directors and used car salesmen.
> What we need is a policy of absolute honesty with a one-strike-and-your-out-forever punishment for any health authority that engages in propaganda, even if they had good intentions.
Won't work, unless there are multiple health authorities – but the average person isn't going to keep track of the reputation of multiple small health authorities, so the authorities will have comparatively less reputation at stake.
You are onto something, though. Consider fleshing it out a bit before reading what other people are talking about. (ROT13: cerqvpgvba-onfrq zrqvpvar)
Won't work, unless there are multiple health authorities – but the average person isn't going to keep track of the reputation of multiple small health authorities, so the authorities will have comparatively less reputation at stake.
You are onto something, though. Consider fleshing it out a bit before reading what other people are talking about. (ROT13: cerqvpgvba-onfrq zrqvpvar)
"All of these coy little word games and character assassinations being conducted in the name of the common good is achieving the exact opposite result."
You aren't kidding. That whole hydroxychloroquine thing was a mess.
You aren't kidding. That whole hydroxychloroquine thing was a mess.
The problem is people irrationally believe that a 'vaccine is unsafe' but at the same time 'some other drug is safe' and might therefore take the drug.
My father is kind of scared of the COVID vaccine - understandable.
But he gets his 'flu shot' (and a bunch of other things) by the doctor all the time.
He has zero problem running all the other tests, taking pills and taking the 'flu shot' which is literally a vaccine!
But he also reads stupid conspiracy theory stuff on Facebook and watches Fox News, and I believe to this day he has not been vaccinated.
That's how powerful misinformation can be.
My bet is that he'll probably take Ivermectin if he's heard about it on Facebook a bunch of times as being that 'safe drug that the government tried to hide'.
My father is not a dumb man, and neither are most of the people involved in this - but about 40% of the population can't effectively deal with information. They will take the drug depending whether Biden or Trump told them to take it.
My father is kind of scared of the COVID vaccine - understandable.
But he gets his 'flu shot' (and a bunch of other things) by the doctor all the time.
He has zero problem running all the other tests, taking pills and taking the 'flu shot' which is literally a vaccine!
But he also reads stupid conspiracy theory stuff on Facebook and watches Fox News, and I believe to this day he has not been vaccinated.
That's how powerful misinformation can be.
My bet is that he'll probably take Ivermectin if he's heard about it on Facebook a bunch of times as being that 'safe drug that the government tried to hide'.
My father is not a dumb man, and neither are most of the people involved in this - but about 40% of the population can't effectively deal with information. They will take the drug depending whether Biden or Trump told them to take it.
>My father is kind of scared of the COVID vaccine - understandable.
>But he gets his 'flu shot' (and a bunch of other things) by the doctor all the time.
Does make a lot of sense to me. Because not all vaccines are the same. Infact their contents can be vastly different (It has to be, given that they protect against different diseases, you know).
So Just because you are Ok with one vaccine, does not mean that you should be Ok with all vaccines.
Sounds like common sense to me. Don't you agree?
>But he gets his 'flu shot' (and a bunch of other things) by the doctor all the time.
Does make a lot of sense to me. Because not all vaccines are the same. Infact their contents can be vastly different (It has to be, given that they protect against different diseases, you know).
So Just because you are Ok with one vaccine, does not mean that you should be Ok with all vaccines.
Sounds like common sense to me. Don't you agree?
There are rational reasons to be hesitant even if on the whole, they don't fully add up (individual situations notwithstanding).
But the hesitancy I've witnessed is not based on a kind of logic or reasoning, rather just an 'instinct'.
If all you read is weird FB posts, tabloids then the sum totality of the 'decision' will just be 'no'.
Fox News I think illustrates how this can happen. Fox hasn't taken a Covid or vaccine denying position. In fact, you could probably find that officially they have been 'on the side of the vaccine'. But since so much of the coverage is questioning, cynical, downplaying and contrarian - and - they have not actually been overtly supporting the vaccine programs ... it's easy for people to be 'net vaccine hesitant' if that's their information source.
So while at the very same time that a news organization can be '100% technically correct' on everything, the channel might become noisy and the net result is lack of clarity.
My father doesn't have an argument about 'it was made too fast', it's more like 'Oh, there's that goddam Fauci again, telling us what to do!'. He personally dislikes Dr. Fauci, at least in part because of the media he's consuming.
He believes that coronavirus is real, and oddly, has even been in the hospital for some minor things where there were insane protocols he was more than fine with following (i.e. masks everywhere, everyone taking it seriously) - but at the same time, when the subject comes up he says 'Oh it's a bunch of bull**t' , kind of in a huff. Also - he lives in rural area that has mostly not been affected.
Public Communications is not about making just rational arguments - it's about information clarity, emotions, credibility, how much fog and misinformation is thrown about, all of the specious and frankly totally false bits of Social Media etc..
CNN went to somewhere in the Midwest and interviewed a bunch of people in a small town and they largely reacted the same way:
"We just do thing differently here"
"It's not a big deal for us"
"We just don't need it"
While the 'it was made very rapidly' logic (and other reasonable arguments) are sometimes made ... that's really not it.
That's why in a crisis, information discipline is so important.
I firmly believe that if Republican apparatus and media were very committed to vaccination especially with public messaging, then about 25% more Americans would be vaccinated.
Imagine if the President of the USA was using his Twitter to try to get people vaccinated. Imagine if he held 'vax rallies' where free tickets went to anyone vaxxed. Imagine if he asked Country Music stars to support the effort. Instead of 'technically supporting vaccination while publicly being cynical about it'. That's what it boils down to.
But the hesitancy I've witnessed is not based on a kind of logic or reasoning, rather just an 'instinct'.
If all you read is weird FB posts, tabloids then the sum totality of the 'decision' will just be 'no'.
Fox News I think illustrates how this can happen. Fox hasn't taken a Covid or vaccine denying position. In fact, you could probably find that officially they have been 'on the side of the vaccine'. But since so much of the coverage is questioning, cynical, downplaying and contrarian - and - they have not actually been overtly supporting the vaccine programs ... it's easy for people to be 'net vaccine hesitant' if that's their information source.
So while at the very same time that a news organization can be '100% technically correct' on everything, the channel might become noisy and the net result is lack of clarity.
My father doesn't have an argument about 'it was made too fast', it's more like 'Oh, there's that goddam Fauci again, telling us what to do!'. He personally dislikes Dr. Fauci, at least in part because of the media he's consuming.
He believes that coronavirus is real, and oddly, has even been in the hospital for some minor things where there were insane protocols he was more than fine with following (i.e. masks everywhere, everyone taking it seriously) - but at the same time, when the subject comes up he says 'Oh it's a bunch of bull**t' , kind of in a huff. Also - he lives in rural area that has mostly not been affected.
Public Communications is not about making just rational arguments - it's about information clarity, emotions, credibility, how much fog and misinformation is thrown about, all of the specious and frankly totally false bits of Social Media etc..
CNN went to somewhere in the Midwest and interviewed a bunch of people in a small town and they largely reacted the same way:
"We just do thing differently here"
"It's not a big deal for us"
"We just don't need it"
While the 'it was made very rapidly' logic (and other reasonable arguments) are sometimes made ... that's really not it.
That's why in a crisis, information discipline is so important.
I firmly believe that if Republican apparatus and media were very committed to vaccination especially with public messaging, then about 25% more Americans would be vaccinated.
Imagine if the President of the USA was using his Twitter to try to get people vaccinated. Imagine if he held 'vax rallies' where free tickets went to anyone vaxxed. Imagine if he asked Country Music stars to support the effort. Instead of 'technically supporting vaccination while publicly being cynical about it'. That's what it boils down to.
>But the hesitancy I've witnessed is not based on a kind of logic or reasoning, rather just an 'instinct'.
What about the advocacy? I would go further and say that not even advocacy, but the general behaviour to trust the authority, is an instinct, rather than rooted in logic or rationality.
Because there is really no reason to trust CDC/FDA, after so many instances where these have caught to act diametrically opposite to the interests of the public (For some examples, look at real event portrayed in documentaries like 'what lies upstream' and 'Dark Waters'). Time and again, these agencies get away with little more than a pat on the wrist.
But people still, instinctively trust them. It is very sad, as you say.
>He personally dislikes Dr. Fauci
To be frank, it is hard to like someone who declares himself as the embodiment of scientific truth.
What about the advocacy? I would go further and say that not even advocacy, but the general behaviour to trust the authority, is an instinct, rather than rooted in logic or rationality.
Because there is really no reason to trust CDC/FDA, after so many instances where these have caught to act diametrically opposite to the interests of the public (For some examples, look at real event portrayed in documentaries like 'what lies upstream' and 'Dark Waters'). Time and again, these agencies get away with little more than a pat on the wrist.
But people still, instinctively trust them. It is very sad, as you say.
>He personally dislikes Dr. Fauci
To be frank, it is hard to like someone who declares himself as the embodiment of scientific truth.
Trust is first founded in reality, but then instinct, that's the whole point of trust.
Once you trust someone, then you don't have to scientifically validate everything they say.
Also - there's tons of coverage of the vaccine. There are dozens of rich nations, each with dozens of Health Agencies doing public work, it's impossible to keep a secret.
You're borderline conspiracy theory if you think there's 'no trust' in the CDC/FDA. There's tons of trust.
What's 'sad' is people' inability to grasp that institutions are not perfect. Police, government, military, etc..
The US has military has committed some pretty terrible atrocities, and yet 'trust' in it is very high.
Same with police: they've been known to arbitrarily kill and imprison people unnecessarily - and yet they have high levels of trust.
The CDC are Health Officials for God's sake, that people wouldn't trust them as much as the military is sad.
"To be frank, it is hard to like someone who declares himself as the embodiment of scientific truth."
Now you're resorting to crude populism ... He's done no such thing.
When you're talking daily to wall of reality and science-deniers, it will get frustrating.
I don't care about Dr. Fauci, but his opponents try to create contrarian conditions regarding him in an attempt to get clicks and rile people up. They're vile.
Once you trust someone, then you don't have to scientifically validate everything they say.
Also - there's tons of coverage of the vaccine. There are dozens of rich nations, each with dozens of Health Agencies doing public work, it's impossible to keep a secret.
You're borderline conspiracy theory if you think there's 'no trust' in the CDC/FDA. There's tons of trust.
What's 'sad' is people' inability to grasp that institutions are not perfect. Police, government, military, etc..
The US has military has committed some pretty terrible atrocities, and yet 'trust' in it is very high.
Same with police: they've been known to arbitrarily kill and imprison people unnecessarily - and yet they have high levels of trust.
The CDC are Health Officials for God's sake, that people wouldn't trust them as much as the military is sad.
"To be frank, it is hard to like someone who declares himself as the embodiment of scientific truth."
Now you're resorting to crude populism ... He's done no such thing.
When you're talking daily to wall of reality and science-deniers, it will get frustrating.
I don't care about Dr. Fauci, but his opponents try to create contrarian conditions regarding him in an attempt to get clicks and rile people up. They're vile.
> The problem is people irrationally believe that a 'vaccine is unsafe' but at the same time 'some other drug is safe' and might therefore take the drug.
It's wild to see people grasping at random anti-parasitics as some sort of miracle cure when (if you're over the age of the 12 and in the US) you can literally walk into any pharmacy and get a real miracle cure for free.
It's wild to see people grasping at random anti-parasitics as some sort of miracle cure when (if you're over the age of the 12 and in the US) you can literally walk into any pharmacy and get a real miracle cure for free.
Your father is erring toward things that have been proven over time. The flu shot has decades of use and data. So does Ivermectin (the open question is how effective it is wrt Covid-19). They are proven safe. They are FDA approved, Covid shots are not. It is perfectly rational to seek treatments that are FDA approved and have been used for decades.
100% agree that 40% or even more now can’t effectively deal with information, nor can think critically for themselves. It’s so politicized that you are either camp A or B (liberal or conservative). One side being ‘vaccine is the only way’ and the other is ‘vaccine unsafe, other drugs are safe’. There seems to be very little people in the middle who can say ‘vaccines are generally safe but we don’t know the long term side effects so we must look at alternatives now for those that choose not to take it or cannot take it for medical reasons’. Also it’s important for people to assess their own risk profile to make the decisions for themselves (if they decide not to take it).
>vaccines are generally safe
I am not sure how that can be correct. Because each vaccine is different, and can vary drastically in what the contain.
Now, if you say, all FDA approved vaccines are generally safe, then that might make a little more sense. Then you are at least qualifying something apart from just the name "vaccine".
I am not sure how that can be correct. Because each vaccine is different, and can vary drastically in what the contain.
Now, if you say, all FDA approved vaccines are generally safe, then that might make a little more sense. Then you are at least qualifying something apart from just the name "vaccine".
Ivermectin is not and cannot be a vaccine. Even the people promoting it only claim an improvement in symptoms. And I've not seen an explanation of how it's alleged to work?
Is this sort of thing common? Seems like an investigation is definitely warranted if this type of resignation is a rare as I would imagine it be.