OT: Controversial FDA decision, yesterday, to approve Biogen's monoclonal antibody Alzheimer's drug aducanamab

[RU848789]

Yesterday's FDA decision to approve Biogen's monoclonal antibody Alzheimer's drug aducanamab was as controversial as any decision I've seen in a long time, as the approval came despite the FDA's own advisory panel recommending heavily against approval several months ago. At first, Biogen halted two trials when there didn't appear to be a benefit, but Biogen's reanalysis of the phase III data in early stage patients at the highest dose did indicate some cognition efficacy.

Given the complete lack of effective drugs for this horrible disease, my guess is that the FDA erred on the side of let's see if this thing might really work in larger numbers of patients, while requiring Biogen to perform a confirmatory clinical trial in parallel with approving the drug.

Lots of differing opinions on this one, as per the two articles linked below. At $56K per year for treatment, the drug will certainly be a multibillion dollar blockbuster (as even modest hope of a cure will spur desparate patients) and may spur other Pharma companies to relook at their drugs that were targeted at reducing beta amyloids (proteins in the brain thought to be associated with or even cause Alzheimer's) and did so, but without clinical benefit.

https://www.nature.com/articles/d41586-021-01546-2

https://www.nytimes.com/2021/06/08/business/aducanumab-alzheimers-cost.html

@LETSGORU91 @RUfubar @ArthrodocRC72 - any thoughts? I know there are some other docs on the board, but their usernames escape me right now.

 

[RUSK97]

So much work in this disease space has been dedicated to the reduction of the amyloid plaques. One massive P3 failure after another is making me wonder if we're looking under the wrong rock. I want to be hopeful in the case of aducanumab, but I'm not holding my breath.

 

[Knight Shift]

Yesterday's FDA decision to approve Biogen's monoclonal antibody Alzheimer's drug aducanamab was as controversial as any decision I've seen in a long time, as the approval came despite the FDA's own advisory panel recommending heavily against approval several months ago. At first, Biogen halted two trials when there didn't appear to be a benefit, but Biogen's reanalysis of the phase III data in early stage patients at the highest dose did indicate some cognition efficacy.

Given the complete lack of effective drugs for this horrible disease, my guess is that the FDA erred on the side of let's see if this thing might really work in larger numbers of patients, while requiring Biogen to perform a confirmatory clinical trial in parallel with approving the drug.

Lots of differing opinions on this one, as per the two articles linked below. At $56K per year for treatment, the drug will certainly be a multibillion dollar blockbuster (as even modest hope of a cure will spur desparate patients) and may spur other Pharma companies to relook at their drugs that were targeted at reducing beta amyloids (proteins in the brain thought to be associated with or even cause Alzheimer's) and did so, but without clinical benefit.

https://www.nature.com/articles/d41586-021-01546-2

https://www.nytimes.com/2021/06/08/business/aducanumab-alzheimers-cost.html

Approvals like this makes many people wonder if the system is rigged, influenced and/or broken in several ways.

We don't agree, but IMO, the data on statins is very sketchy, and it is over-prescribed. I switched family doctors after my family doctor would offer me a script for a statin after every annual checkup. My new family doc did the same thing, and he agreed to reconsider after I asked for a CAC scan, which showed zero plaque. He agreed that we would reconsider in 5 years. There are classes of people (one being lean mass hyper-responders) who have frighteningly high cholesterol but live long and healthy lives. On the other hand, large numbers of people with acceptable cholesterol numbers die of CVD. Maybe some day, the medical community will be able to figure out the additional or actual factors that cause CVD.

Back to the OP, Peter Attia had a podcast today on the topics of dementia and Alzheimer's.

 

[RU848789]

Approvals like this makes many people wonder if the system is rigged, influenced and/or broken in several ways.

We don't agree, but IMO, the data on statins is very sketchy, and it is over-prescribed. I switched family doctors after my family doctor would offer me a script for a statin after every annual checkup. My new family doc did the same thing, and he agreed to reconsider after I asked for a CAC scan, which showed zero plaque. He agreed that we would reconsider in 5 years. There are classes of people (one being lean mass hyper-responders) who have frighteningly high cholesterol but live long and healthy lives. On the other hand, large numbers of people with acceptable cholesterol numbers die of CVD. Maybe some day, the medical community will be able to figure out the additional or actual factors that cause CVD.

Back to the OP, Peter Attia had a podcast today on the topics of dementia and Alzheimer's.

View embedded media

The data on statins isn't sketchy, but like any pharmaceutical, which addresses a very complex medical issue, like cardiovascular disease, the best we can do right now is mega-clinical trials where we find moderate to strong signals, which are statistically meaningful when looking at large population subgroups. We have that for statins. Unequivocally. The data on statins, ever since the landmark 4S study for simvastatin, has indicated high likelihood of benefits with low likelihood of risks, which is completely different from what we're seeing for this Alzheimer's drug.

The JUPITER trial in particular provided stark evidence of their benefit in even patients with normal cholesterol levels, but elevated C-reactive proteins (including in women and minorities), as per the excerpt below, while numerous randomized controlled clinical trials have shown major benefits in people with high cholesterol.

https://my.clevelandclinic.org/health/articles/17506-statin-medications--heart-disease

The Jupiter Trial was a randomized, double-blind, placebo-controlled, multicenter trial that involved 1,315 sites in 26 countries. Participants were randomly chosen to be part of one of two groups: those who took rosuvastatin (Crestor) 20 mg daily or those who took a placebo (a pill containing no drug). The trial was scheduled to run for five years, but it was terminated after 1.9 years because there was an overwhelming amount of data that showed that participants who were taking a statin had a reduced risk of CVD.

The trial showed that compared to patients taking the placebo, patients taking a statin had a 54% lower chance of heart attack, 48% lower chance of stroke, 46% lower chance of needing angioplasty or coronary artery bypass surgery, and a 20% lower chance of dying from any cause. In addition, among patients taking a statin, their level of ultra sensitive C-reactive protein was reduced by 37%, and their LDL cholesterol levels were reduced by 50%.

The Jupiter trial also provided the first results to show that statins are highly effective in female and minority patients — groups typically excluded in clinical trials. The take-home message from this study is that patients with higher-than-normal levels of ultra-sensitive C-reactive protein levels, even those with normal cholesterol levels, may benefit from statin therapy.

Having said all of that, you're right that one can't "know" on an individual level who they will work in and who they won't work in and there will clearly be people with very specific conditions who might not be helped by statins at all, since the trials haven't looked at every subgroup, as well as people who have significant side effects (especially myopathy) from statin therapy. Knowing the clinical data, I didn't even have to be "asked" to take it - I asked for years ago, once I saw that my cholesterol levels were borderline high. There's no guarantee for me personally, but I'll go with the probabilities every time.

 

[KeithK7624]

Let’s be real. I’m sure Big Pharma could cure cancer if they wanted to. But they make billions by not having the cure.

 

[RU Cheese]

You both can be correct. There is an unprecedented body of evidence supporting statins B/R profile. That doesn't mean GPs should dole them out like candy.

I'm deeply disappointed by adacanumab's approval. I think this is cherry picking data at its best, with a deeply unproven (or disproven) mechanistic hypothesis, for a truly terrible disease. I wouldn't be surprised to see LT studies show no benefit, of course, assuming BIIB ever completes them.

MRKs BACE inhibitor had far better results Re amaloid reduction. Is that now going to be resurrected too?

 

[Knight Shift]

Back to overprescription and the lazy approach, here's some reading.

IMO, the prescription of statins is lazy and borderline malpractice if the doctor has not ordered a CAC test:

Atherosclerosis | Journal | ScienceDirect.com by Elsevier

Read the latest articles of Atherosclerosis at ScienceDirect.com, Elsevier’s leading platform of peer-reviewed scholarly literature

www.journals.elsevier.com

"Our results show that the burden of subclinical atherosclerosis, as
measured using CAC scores, is heterogenous among MESA participants
with LDL-C ≥190 mg/dL. CAC was absent in nearly 37% of the cohort
and CVD risk factors varied by the presence of CAC, and that the yearly
risk for future CVD events is low (< 1% per year) in individuals with
LDL-C ≥190 mg/dL who have zero CAC."

"Other studies have demonstrated that discordance between risk
level and atherosclerosis measured by CAC exists [18]. In a study of
5534 participants from MESA, individuals with multiple lipid abnormalities
(LDL-C ≥130 mg/dL, HDL-C<40 mg/dL in men,<50
mg/dL in women, triglycerides ≥150 mg/dL) had a relatively low CVD
event rate (6 per 1000 person-years) if CAC was not detected [6]."

Very high LDL cholesterol: The power of zero passes another test

In the current issue of Atherosclerosis, Sandesara et al. [1] shed additional light on the understanding of risk in individuals with very high LDL-C and no previous cardiovascular event identified in the Multiethnic Study of Atherosclerosis (MESA). Primary prevention strategies to reduce...

www.atherosclerosis-journal.com

"However, the objective of those prevention strategies is the reduction of
cardiovascular events and mortality, not the sole change in values of
biomarkers, such as LDL-C levels. Thus, all guidelines on risk stratification
recommend the estimation of individual cardiovascular risk using some
validated tool to define the use of lipid lowering medications [2]."

"However, this strategy also assumes that those individuals
with very high LDL-C are a homogeneous high-risk population that is
more likely to benefit from aggressive treatment irrespective of their
calculated risk, despite the lack of evidence to support this. In fact,
recent studies suggest that coronary atherosclerosis is not a simple
function of lipid levels but a multifactorial disease. Blankstein et al.
reported that nearly 1 in 2 individuals with ‘normal’ LDL-C have coronary
atherosclerotic disease as measured by coronary artery calcium
(CAC) testing [8] and conversely we have shown that even among those
with genetically confirmed FH, nearly half show no detectable CAC and
appear to have favorable intermediate term prognosis [9]."

There are other markers too beyond CAC that are excellent markers of CVD risk, including Lp(a) and hsCRP. But most medical practitioners are lazy sheep and prefer to use a sledgehammer approach to drive in thumbtacks.

And back to the OP. What a broken healthcare system we have--it's only gotten worse in the last 10 years:

 

[newell138]

Let’s be real. I’m sure Big Pharma could cure cancer if they wanted to. But they make billions by not having the cure.

your tinfoil hat is too tight.

 

[Randal7]

We all have a right to make choices on whether to take or not take a drug.
I have a strong bias against statins and the medical community's propensity to overpeddle them on patients. My mother's family doctor started pushing them on her at age 80, which is freaking ridiculous. She switched doctors, and she turns 93 at the end of this month. Yes, one or two data points is not a RCT, but there is plenty of data in the literature showing that the data on statins is mixed. It is a shame that the medical community is too lazy (and perhaps to greedy) to parse though the subgroups and to arrive at a more nuanced prescription approach. But its dollars over data, just like the push to prescribe the covid vaccine to young children.

CVD is progressive and largely subclinical (unless you are one of the "lucky" ones who has stenosis via atherosclerosis and shortness of breath as a signal). We've done a great job with CVD despite the fact that we're living longer, and, as a result are more prone to dying of a major adverse cardiac event.

This sums it up (https://sphweb.bumc.bu.edu/otlt/mph-modules/ph/publichealthhistory/publichealthhistory9.html)

Since 1950, age-adjusted death rates from cardiovascular disease have been cut by more than half. Some of the key public health factors contributing to this decline include the decline in tobacco use, changes in the U.S. diet, and better early detection and treatment of those at risk of cardiovascular disease (e.g. individuals with hypertension, high cholesterol, etc.)

Data on statins really isn't mixed. It's a key therapy. You don't have to agree (or take it) but those are good products.

 

[rubaseball78]

Approvals like this makes many people wonder if the system is rigged, influenced and/or broken in several ways.

We don't agree, but IMO, the data on statins is very sketchy, and it is over-prescribed. I switched family doctors after my family doctor would offer me a script for a statin after every annual checkup. My new family doc did the same thing, and he agreed to reconsider after I asked for a CAC scan, which showed zero plaque. He agreed that we would reconsider in 5 years. There are classes of people (one being lean mass hyper-responders) who have frighteningly high cholesterol but live long and healthy lives. On the other hand, large numbers of people with acceptable cholesterol numbers die of CVD. Maybe some day, the medical community will be able to figure out the additional or actual factors that cause CVD.

Back to the OP, Peter Attia had a podcast today on the topics of dementia and Alzheimer's.

View embedded media

While I don't have an opinion of the efficacy of statins, I agree with what you did. People need to take ownership and be involved in the decision making as to what is being prescribed. I moved in with my mother last September because she was struggling (health, covid isolation, etc.). At the time she was taking 11 medicines. When I went through them and looked them up, she was taking a drug for high blood pressure and another for low blood pressure. My take was everytime she showed a symptom, another drug was added. Another drug was a chemo drug for a blood disorder. The diagnoses on the disorder is that it will be 15-20 years before she has any problems (she's 89). Something else will bump her off before the blood disorder so why is she taking this heavy duty chemo drug? She is now down to 2 medicines after having numerous discussions with the doctors.

 

[mildone]

your tinfoil hat is too tight.

C'mon now. It's hardly a conspiracy theory to recognize that corporations, particularly publicly held corporations, allow profitability and stock market health to greatly influence the direction of their invested efforts and capital. Businesses are in business to make money. Everything else is secondary because without making money, the business cannot survive. It's not just Pharma, but much of the medical industry that profits so greatly from focusing their effort on stupid-expensive treatment approaches, rather than prevention, of cancer. Just too much money, and too many jobs that depend upon this situation.

Not saying nobody's researching cancer "cures". Just saying that it's not paranoia to recognize the business conflict between profitability and focusing too hard on cancer prevention. We will get there eventually, I suspect. But it will likely be via something that has high recurring costs, as opposed to a one-time low-cost DNA tweak.

 

[newell138]

C'mon now. It's hardly a conspiracy theory to recognize that corporations, particularly publicly held corporations, allow profitability and stock market health to greatly influence the direction of their invested efforts and capital. Businesses are in business to make money. Everything else is secondary because without making money, the business cannot survive. It's not just Pharma, but much of the medical industry that profits so greatly from focusing their effort on stupid-expensive treatment approaches, rather than prevention, of cancer. Just too much money, and too many jobs that depend upon this situation.

Not saying nobody's researching cancer "cures". Just saying that it's not paranoia to recognize the business conflict between profitability and focusing too hard on cancer prevention. We will get there eventually, I suspect. But it will likely be via something that has high recurring costs, as opposed to a one-time low-cost DNA tweak.

His statement was stupid, "they could cure cancer if they wanted to"

 

[Purple-Ed]

Let’s be real. I’m sure Big Pharma could cure cancer if they wanted to. But they make billions by not having the cure.

His statement was stupid, "they could cure cancer if they wanted to"

His statement was waaaaaaaaay beyond stupid. Were talking

Alex Jones stupid.

 

[mildone]

His statement was stupid, "they could cure cancer if they wanted to"

I would argue that his statement was greatly oversimplified and quite cynical; but not necessarily stupid, depending on how we define his terms.

Fact is, nobody really knows for sure what might've happened by now if curing cancer was as profitable as treating it. To know for sure, the world would've had to have thrown all available resources at the problem since discovering it. And, as we all know, that hasn't happened. Imagine what might've happened by now, for instance, if we had taken 33% of our annual defense budget and redirected it towards researching a preventative cure for cancer.

All we can really do is make educated guesses based on available evidence. That evidence suggests the cure isn't nearly as easy to find as he makes it out to be. For example, not all researchers across the globe have the same profit motive as "Big Pharma". So there has been lots of research into cures. Stands to reason that if it was easy to cure, researchers with less of a profit-motive would've shown more progress towards, or even found, a preventative cure by now.

But again, all research requires funding. And the funding for cancer treatments, last time I looked, is much more heavily weighted towards treatments and other profitable ventures (not an entirely bad thing as people already have cancer and we'd like to help them survive it) as opposed to being 100% focused on a cure. Finding a cure, while being a wonderful thing for humanity in general, would be a terrible thing for the vast profit generator that is cancer treatment.

So if one takes "they" to mean "the world", and if one assumes that the implied period of his statement is "since cancer was first discovered", then it's entirely possible (albeit perhaps not likely) that given an entirely different approach to the problem than the world has followed, and with far greater funding towards a cure, we might've found one (or more) by now.

Saying it's certain would be dumb, sure. But it's just just as dumb to claim it impossible had far greater resources been thrown behind the effort right from the start. It's simply not deterministically provable either way.

 

[newell138]

^^over explaining, way too long to read^^

 

[mildone]

^^over explaining, way too long to read^^

His post was no more stupid than a post calling his post stupid is stupid. That dumbed down enough for you? 😉

 

[theRU]

Anybody here read grain brain?

 

[RU848789]

C'mon now. It's hardly a conspiracy theory to recognize that corporations, particularly publicly held corporations, allow profitability and stock market health to greatly influence the direction of their invested efforts and capital. Businesses are in business to make money. Everything else is secondary because without making money, the business cannot survive. It's not just Pharma, but much of the medical industry that profits so greatly from focusing their effort on stupid-expensive treatment approaches, rather than prevention, of cancer. Just too much money, and too many jobs that depend upon this situation.

Not saying nobody's researching cancer "cures". Just saying that it's not paranoia to recognize the business conflict between profitability and focusing too hard on cancer prevention. We will get there eventually, I suspect. But it will likely be via something that has high recurring costs, as opposed to a one-time low-cost DNA tweak.

Poor analysis. While it's certainly true that profits are necessary for corporations, if Pharma didn't want to prevent disesases, we wouldn't have vaccines, as those eliminate huge income streams related to disease treatment and replace them with smaller income streams from what are usually one-time (albeit for everyone or at least most people). But preventing cancer is light years more difficult than preventing most infectious diseases (not to say vaccine development is easy - just look at HIV) from viruses or bacteria, given how little we truly know about the genesis of cancer (which is really dozens, if not hundreds of separate diseases). Treating cancers, once formed, while difficult, is at least easier than preventing cancers.

But, like vaccines, there will still be plenty of money, glory and whether you believe it or not "humanity" (most people I knew in the industry were truly trying to improve health and wellness by making medicine for sick people) involved in preventing cancers and there are tons of people in R&D looking for ways to prevent cancers (the Gardasil vaccine which prevents infection with HPV and prevents cervical cancer is one of the first to do this). Also, while treatments have been far from perfect, there have been numerous major breakthroughs over the past 5-10 years, especially with immunotherapies and combination therapies, so that shouldn't be ignored.

 

[Knight Shift]

Put down the tin foil hat. Statins are one of the most well-research classes of drugs in the history of humanity. The benefits of statins are overwhelming.

Learn to read. Overpeddled. Context matters.

 

[T2Kplus20]

Learn to read. Overpeddled. Context matters.

Not overpeddled, learn the facts. The class is also completely generic and costs are minimal. Statins are one of the biggest success stories in the history of medicine.

 

[RU848789]

Anybody here read grain brain?

Haven't read it, but am familiar with it and, IMO, it's simply unproven hearsay. Whenever people claim miraculous results, but don't publish them in the medical literature, major red flags should be raised.

https://www.thecut.com/2015/06/problem-with-the-grain-brain-doctor.html

 

[RU848789]

Put down the tin foil hat. Statins are one of the most well-research classes of drugs in the history of humanity. The benefits of statins are overwhelming.

Uh-oh, we agree on something other than vaccines and Schiano, lol.

 

[T2Kplus20]

Uh-oh, we agree on something other than vaccines and Schiano, lol.

But Merck still sucks! LOL.

 

[RU848789]

But Merck still sucks! LOL.

And Novartis wishes it could suck as badly as Merck, lol.

 

[Knight Shift]

Not overpeddled, learn the facts. The class is also completely generic and costs are minimal. Statins are one of the biggest success stories in the history of medicine.

You're being obtuse as usual. You're a pharma guy, right? Learn how to read.
There is no need to peddle statins to people over 80 years old.
There is no need to peddle statins to an otherwise healthy individual with a zero CAC score, unless you have some sort of profit motive.
Overpeddled. Too many doctors are the sheep of Big Pharma.

 

[Knight Shift]

But Merck still sucks! LOL.

Well, we agree on that much.

 

[T2Kplus20]

And Novartis wishes it could suck as badly as Merck, lol.

Pharma market is booming (expect Merck). One of my old buddies is now the CCO of a very promising gene therapy company. He wants me to join to build my function department from scratch. Love the idea, but crazy high risk, high reward. I don't mind risk, but this may be even too much for me to go for.

 

[T2Kplus20]

Well, we agree on that much.

+1
Merck is the Penn State of pharma! 😜

 

[RU848789]

Well, we agree on that much.

So, you have no appreciation for any of Merck's accomplishments? Like...

• Being the first company to distribute the smallpox vaccine in the US
• Publishing the Merck Manual since 1898
• Collaborating with RU's own Dr. Waksman in bringing the lifesaving (especially for tuberculosis) antibiotic streptomycin to market, one of the greatest manufacturing accomplishments ever.
• Being the first company to synthesize cortisone, allowing use of this steroid in many applications
• Developing the world's first vaccines for measles, mumps and rubella (and combining them in the MMR vaccine).
• Being the first company to develop and bring to market statins for cardiovascular disease (even if you think they've been overprescribed, they've prevented millions of heart attacks and strokes by now, as a drug class).
• Developing Crixivan, the first drug that actually saved HIV patients' lives (and other successful HIV drugs since then)
• Developing vaccines for pediatric pneumonia, HPV, Ebola and more, again, saving many lives.
• Bringing to market numerous other pharmaceuticals, which have helped patients control high blood pressure (vasotec and losartan to name two), diabetes (Januvia), asthma (Singulair), and more.
• Being one of the world's foremost developers of effective and lifesaving antibiotics, including imipenem in the late 80s, ertapenem in the early 2000s, and relebactam a couple of years ago.
• Bringing Keytruda to market, which is currently the world's biggest selling and most effective oncology drug, saving countless lives.
• Developing and bringing to market countless animal health products, including Heartgard and Bravecto.
• Being extraordinarily active in philanthropy for decades, donating nearly $1 billion over that time, including supplying Mectizan for free since 1987 to much of the third world to prevent river blindness.

Or are you just fixated on the VIOXX scandal, which was a black eye, certainly, but seems well outweighed by the list above, in the grand scheme of things, over the past 100+ years.

 

[RU848789]

You both can be correct. There is an unprecedented body of evidence supporting statins B/R profile. That doesn't mean GPs should dole them out like candy.

I'm deeply disappointed by adacanumab's approval. I think this is cherry picking data at its best, with a deeply unproven (or disproven) mechanistic hypothesis, for a truly terrible disease. I wouldn't be surprised to see LT studies show no benefit, of course, assuming BIIB ever completes them.

MRKs BACE inhibitor had far better results Re amaloid reduction. Is that now going to be resurrected too?

On the latter point, that's why I asked my question in my first post on companies looking again at some of those drugs. I worked a bit on Merck's BACE inhibitor, which we had a lot of hope for...

 

[newell138]

Poor analysis. While it's certainly true that profits are necessary for corporations, if Pharma didn't want to prevent disesases, we wouldn't have vaccines, as those eliminate huge income streams related to disease treatment and replace them with smaller income streams from what are usually one-time (albeit for everyone or at least most people). But preventing cancer is light years more difficult than preventing most infectious diseases (not to say vaccine development is easy - just look at HIV) from viruses or bacteria, given how little we truly know about the genesis of cancer (which is really dozens, if not hundreds of separate diseases). Treating cancers, once formed, while difficult, is at least easier than preventing cancers.

But, like vaccines, there will still be plenty of money, glory and whether you believe it or not "humanity" (most people I knew in the industry were truly trying to improve health and wellness by making medicine for sick people) involved in preventing cancers and there are tons of people in R&D looking for ways to prevent cancers (the Gardasil vaccine which prevents infection with HPV and prevents cervical cancer is one of the first to do this). Also, while treatments have been far from perfect, there have been numerous major breakthroughs over the past 5-10 years, especially with immunotherapies and combination therapies, so that shouldn't be ignored.

Thanks, i knew you would take him behind the woodshed

 

[greenknight]

Having taken care of my mother for 8.5 yrs with Alzsheimers I hope they find an answer but dont think this will be it. Life saver drupal for me was Risperdal helped immensely with mood swings and anger while not disrupting her personality. Nightmare drug was zoloft which turned her into a zombie. No personality, emotion or expression. Got her off that fast. Had her on Aricept for a while but ended up taking her off that drug did nothing to slow disease all hype no noise

 

[rurahrah000]

There is no doubt that Pharma companies have a perverse incentive to covert diseases into chronic diseases rather than curing them. Look no further that Gilead. They cured Hepatitis C which should be one of the greatest achievements of the 21st century, but their stock has been stuck. Anyone who has had conversations with Pharma CEOs outside of the public eye will tell you that most are interested in only making money.

 

[newell138]

There is no doubt that Pharma companies have a perverse incentive to covert diseases into chronic diseases rather than curing them. Look no further that Gilead. They cured Hepatitis C which should be one of the greatest achievements of the 21st century, but their stock has been stuck. Anyone who has had conversations with Pharma CEOs outside of the public eye will tell you that most are interested in only making money.

what a crock of shit

 

[UMRU]

Yesterday's FDA decision to approve Biogen's monoclonal antibody Alzheimer's drug aducanamab was as controversial as any decision I've seen in a long time, as the approval came despite the FDA's own advisory panel recommending heavily against approval several months ago. At first, Biogen halted two trials when there didn't appear to be a benefit, but Biogen's reanalysis of the phase III data in early stage patients at the highest dose did indicate some cognition efficacy.

Given the complete lack of effective drugs for this horrible disease, my guess is that the FDA erred on the side of let's see if this thing might really work in larger numbers of patients, while requiring Biogen to perform a confirmatory clinical trial in parallel with approving the drug.

Lots of differing opinions on this one, as per the two articles linked below. At $56K per year for treatment, the drug will certainly be a multibillion dollar blockbuster (as even modest hope of a cure will spur desparate patients) and may spur other Pharma companies to relook at their drugs that were targeted at reducing beta amyloids (proteins in the brain thought to be associated with or even cause Alzheimer's) and did so, but without clinical benefit.

https://www.nature.com/articles/d41586-021-01546-2

https://www.nytimes.com/2021/06/08/business/aducanumab-alzheimers-cost.html

@LETSGORU91 @RUfubar @ArthrodocRC72 - any thoughts? I know there are some other docs on the board, but their usernames escape me right now.

Joel Perlmutter (Washington Univ) and David Knopman (Mayo) both resigned from the FDA advisory committee over this decision. They are both phenomenal neuroscientist/neurologists. They certainly know a lot more about this than the rest of us.

With that said, there are drugs that do not give statistically significant results, but work extremely well for a few people. It took Jim Allison 20 years to get his immunotherapy drug (Yervoy) approved because the data did not fit the guidelines a the time for a successful response. Now Allison won the Nobel Prize, 20% or more of melanoma patients who would be dead are still alive and companies are making billions of dollars.

 

[theRU]

Haven't read it, but am familiar with it and, IMO, it's simply unproven hearsay. Whenever people claim miraculous results, but don't publish them in the medical literature, major red flags should be raised.

https://www.thecut.com/2015/06/problem-with-the-grain-brain-doctor.html

What part exactly are you referring to as hearsay? The keto diet?

 

[RUInsanity]

I would argue that his statement was greatly oversimplified and quite cynical; but not necessarily stupid, depending on how we define his terms.

Fact is, nobody really knows for sure what might've happened by now if curing cancer was as profitable as treating it. To know for sure, the world would've had to have thrown all available resources at the problem since discovering it. And, as we all know, that hasn't happened. Imagine what might've happened by now, for instance, if we had taken 33% of our annual defense budget and redirected it towards researching a preventative cure for cancer.

All we can really do is make educated guesses based on available evidence. That evidence suggests the cure isn't nearly as easy to find as he makes it out to be. For example, not all researchers across the globe have the same profit motive as "Big Pharma". So there has been lots of research into cures. Stands to reason that if it was easy to cure, researchers with less of a profit-motive would've shown more progress towards, or even found, a preventative cure by now.

But again, all research requires funding. And the funding for cancer treatments, last time I looked, is much more heavily weighted towards treatments and other profitable ventures (not an entirely bad thing as people already have cancer and we'd like to help them survive it) as opposed to being 100% focused on a cure. While finding a cure, while being a wonderful thing for humanity in general, would be a terrible thing for the vast profit generator that is cancer treatment.

So if one takes "they" to mean "the world", and if one assumes that the implied period of his statement is "since cancer was first discovered", then it's entirely possible (albeit perhaps not likely) that given an entirely different approach to the problem than the world has followed, and with far greater funding towards a cure, we might've found one (or more) by now.

Saying it's certain would be dumb, sure. But it's just just as dumb to claim it impossible had far greater resources been thrown behind the effort right from the start. It's simply not deterministically provable either way.

His post was no more stupid than a post calling his post stupid is stupid. That dumbed down enough for you? 😉

Even if the motive was purely profitability (which its not) "Big Pharma" is not comprised of one large publicly held corporation - rather like any other industry, it is a group of competing corporations. From a purely financial perspective - to think that a any company would stifle the chance to be at the forefront of a breakthrough cure and the potential revenue windfall that might come with it .....is plainly stupid.

To think that every Pharma company is run by a Mr. Burns and his evil plans and schemes to block potential cancer cures is emblematic of the issues taking over this country with people clouded in conspiracy theories.

 

[newell138]

Even if the motive was purely profitability (which its not) "Big Pharma" is not comprised of one large publicly held corporation - rather like any other industry, it is a group of competing corporations. From a purely financial perspective - to think that a any company would stifle the chance to be at the forefront of a breakthrough cure and the potential revenue windfall that might come with it .....is plainly stupid.

To think that every Pharma company is run by a Mr. Burns and his evil plans and schemes to block potential cancer cures is emblematic of the issues taking over this country with people clouded in conspiracy theories.

For some reason some people think pharma should have no profits.

 

[mildone]

Even if the motive was purely profitability (which its not) "Big Pharma" is not comprised of one large publicly held corporation - rather like any other industry, it is a group of competing corporations. From a purely financial perspective - to think that a any company would stifle the chance to be at the forefront of a breakthrough cure and the potential revenue windfall that might come with it .....is plainly stupid.

To think that every Pharma company is run by a Mr. Burns and his evil plans and schemes to block potential cancer cures is emblematic of the issues taking over this country with people clouded in conspiracy theories.

His statement was so oversimplified as to be interpretable in wildly different ways. You, and others, have chosen to interpret it a certain way. But that doesn't preclude all other possible interpretations. That's the problem with making wildly oversimplified statements of any kind, without taking the time to provide more details to help people understand the intended interpretation.

I've provided another valid interpretation of what he said. And that interpretation makes what he said not only not stupid, but arguably, if not provably, true. I've provided a perfectly reasonable rationale for why it's impossible to know if we couldn't have cured cancer already. If you want to ignore that rationale, fine.

Also, you're making a potentially incorrect assumption that finding a preventative cure for cancer will prove to be some kind of financial windfall for whomever discovers it. It may. It may not. It all depends on the nature of the cure. And this goes to the point I've been making. If you're in the business of selling stuff to prevent people from getting sick, or help treat them when they are sick, and you have alternate methods of doing so, more often than not, the method provided will be the one that produces the greatest return on investment.

If you want to argue that the entire medical community is wholly unconcerned with profit, well, good luck with that argument.

Lastly, you, and others, are arguing that the various individuals involved in fighting cancer aren't putting profits ahead of people's suffering. But nobody here has argued that they *are* doing that. I believe that the vast majority of individuals working to combat cancer are good people who would LOVE to see it cured forever, regardless of the financial impacts of doing so.

I also don't think the majority individuals who worked in cigarette manufacturing are evil. Even though the industry once did everything in it's power to hide the known deadliness of smoking. If only life was as simple as "people are generally good" so everything people do winds up being for the greater good.

 

[mildone]

Thanks, i knew you would take him behind the woodshed

Ironic considering how you seem to live behind the woodshed with your pants down. If you ask me nicely, I'll explain the metaphor for you, seeing as how you struggle with reading and all.