1. While you mention failings of the FDA, at least it used to be seen as a counterbalance to error and malfeasance in medicinal science. At this point, no federal government agency ("deep state") in the U.S.A. can be trusted for anything. I hope the E.U. can pick up the slack.
2. I worked for Pfizer for a little while. I felt proud to be helping to do science and fight disease, as were my colleagues. At the same time, we had management that wanted us to participate in social media and political lobbying, as if we were just citizens, but not on our own. Only with approved messages. All of my colleagues thought this was reprehensible At the same time, this was the place where they could do science, and fight disease.
Good points. You nicely illustrate the dynamic tension here: between 'management' who are driven (and sadly, willing) to trade off short-term profit for long-term opprobrium; and a large number of people under them who simply want to do good.
The decline of the FDA is a whole series of posts on its own; I'll try to move towards solutions in Part 8/8.
I've been a skeptic for years, having briefly studied Trad. Chinese medicine & having direct experience with being cured of (purportedly incurable) HSV-1 by an herbal cleanse back in the '90s. I came across Dr. Hershel Jick's apology for the infamously abused letter in the NEJM from 1980. back in '17. About the same time I came across the infamous letter to investors from Goldman Sachs: https://www.cnbc.com/2018/04/11/goldman-asks-is-curing-patients-a-sustainable-business-model.html
Until we organize the medical system to compensate based on outcomes rather than treatments, we will be doomed to being perpetually pushed to become addicted to the products of Big Pharma.
*Only then* did we get to this 8-part series ( https://drjo.substack.com/p/sex-lies-and-robots ), which isn't complete yet. I'm sure you'll agree that it's not enough just to criticise, especially where there *are* good, science-based pharmaceutical treatments. We need to tease out the good and the bad, and more than this, try to address the systemic illness that ails our current medical systems. (Naturally avoiding the temptation to throw up our hands and take refuge in things that can't work, don't work or are even harmful—pretty much all of 'alternative' medicine).
Yeah, we do need to fix things. It won't be easy :)
Thank-you for your attention to my comment. I was trained in physics (dropped out of a PhD program). While I greatly value the scientific method, it is limited to what can be objectively & repeatedly measured. I am convinced that much of medicine is still an art & the placebo effect seems to be as beneficial as many of the drugs being marketed.
As I'm fond of saying: "I don't care what letters you put after your name, much of what is being marketed as modern medicine (at least in terms of chronic care) is, at best, barely removed from quackery. Yes, we have become very good at stitching up broken bodies but persistent conditions are much more problematic.
Regarding "alternative" medicine? My experiences are certainly much different than yours. True, there are a lot of people sticking needles in patients after taking a weekend workshop but my TCM teacher (Paul Pitchford) did some amazing things.
I tore (partial) a tendon in my foot. Excruciating pain. 30 minutes after hobbling into his office, I walked out pain free. However, for about 6 months after, when running & making a hard turn on that foot, I felt a twinge. My late wife had chronic struggles with pneumonia which he effectively treated with acupuncture (although he did admonish her to not hesitate to seek allopathic help if it got worse).
The problem with most "alternative" care is that there are no standards of care to separate the quackery from the effective. Allopathic care at least makes an attempt to do such. The level of efficacy is a subject of debate.
And yes, it does seem as if the profit motive has sadly diminished the conscientious care in allopathy that I like to think was more prevalent in my youth.
You've got me worried now, especially the section on the 'xxxnemab' drugs. I have been prescribed Evolocumab for high cholesterol. The effect has been remarkable. It's not been fully approved by the English NICE, so it's prescribed privately. I've also recently been suffering from slight memory loss - my doctor calls it 'normal age-related cognitive decline'. Is Evolocumab in the same class as lecanemab or is the name a co-incidence?
"mab" just means that it is an antibody based drug.
The nice thing about antibody based drugs is that they are easy to design when you have discovered a target to which they fit.
Your drug may be fine. Whether it is fine or not has to do with whether the mechanism and target role in that mechanism is well understood, the side effects are acceptable, and that the safety and effectiveness have been adequately vetted.
The problem is exactly as Dr. Jo has mentioned. If the science was done dishonestly, or is based on previous science which is disproved, you are, at best, paying for a placebo, and at worst something that is harming you more than helping you.
Thanks for your reply, it's much appreciated. My LDL, caused by familial hypercholesterolemia, has gone from 'off the charts' to the low end of normal and I hadn't noticed any particular side effects. However, the age-related cognitive decline is new, and I'm only 72, but my GP says it's nothing to worry about and it might even be stress from moving house and may resolve. He's prescribed word games and computer games!
Hi Jean, Jeremy has nailed it (Pretty much took the words out of my mouth). There is a host of *good* monoclonals that have revolutionised the management of many diseases, from rheumatoid arthritis to inflammatory bowel disease to advanced melanoma. The tricky bit is teasing out where pharmaceutical companies have been fibbing.
If you e.g. go to PubPeer and try searching for evolocumab, you will find some studies with question marks against them ( https://pubpeer.com/search?q=evolocumab ) but I'm not aware of huge, overt badness there. There is clear evidence that PCSK9 inhibitors are potent at lowering cholesterol, but of course this is a surrogate end-point. There was a 2022 re-analysis of the FOURIER trial that raised some questions cf. https://pmc.ncbi.nlm.nih.gov/articles/PMC8748321/ but the recent VESALIUS-CV seems to contradict that, albeit in a somewhat different population. If there is a catch, it's likely that you're paying a huge number of $$$ for a single QALY, see e.g. https://www.ncbi.nlm.nih.gov/books/NBK611322/
This also depends a lot on your specific risk profile. At the end of the day, it's **really important** to discuss the pros and cons with your prescribing physician. (And BTW, there is evidence that keeping your mind active delays onset & progression of dementia; there are worse ideas than playing lots of games :)
Thankfully, the NHS is paying for the meds. I know they're costly - I have to get the prescription directly from the consultant, and it comes with a leaflet telling the pharmacy how to get the cost back straight away. The consultant is quite keen to reduce my cholesterol because I had a quad bypass 3 years ago and the surgeon reported that nearly all my arteries were blocked and/or malformed (as is my heart). I can't tolerate statins.
Thanks for the references, I'll indulge in some light reading over Christmas.
Two comments.
1. While you mention failings of the FDA, at least it used to be seen as a counterbalance to error and malfeasance in medicinal science. At this point, no federal government agency ("deep state") in the U.S.A. can be trusted for anything. I hope the E.U. can pick up the slack.
2. I worked for Pfizer for a little while. I felt proud to be helping to do science and fight disease, as were my colleagues. At the same time, we had management that wanted us to participate in social media and political lobbying, as if we were just citizens, but not on our own. Only with approved messages. All of my colleagues thought this was reprehensible At the same time, this was the place where they could do science, and fight disease.
Hi Jeremy,
Good points. You nicely illustrate the dynamic tension here: between 'management' who are driven (and sadly, willing) to trade off short-term profit for long-term opprobrium; and a large number of people under them who simply want to do good.
The decline of the FDA is a whole series of posts on its own; I'll try to move towards solutions in Part 8/8.
Regards, Dr Jo.
I've been a skeptic for years, having briefly studied Trad. Chinese medicine & having direct experience with being cured of (purportedly incurable) HSV-1 by an herbal cleanse back in the '90s. I came across Dr. Hershel Jick's apology for the infamously abused letter in the NEJM from 1980. back in '17. About the same time I came across the infamous letter to investors from Goldman Sachs: https://www.cnbc.com/2018/04/11/goldman-asks-is-curing-patients-a-sustainable-business-model.html
Until we organize the medical system to compensate based on outcomes rather than treatments, we will be doomed to being perpetually pushed to become addicted to the products of Big Pharma.
Hi David,
Just in case some readers of your comment get the wrong end of the stick ...
If you've been following my posts from some time back, you will spot a very specific progression. First I've tried to sketch out the principles of good science ( https://drjo.substack.com/p/mostly-wrong and several of the following posts) including an appreciation of what 'Medicine' can and cannot do (e.g. https://drjo.substack.com/p/take-medicine-then ); then I took a big stick to over-zealous use of Medicine ( https://drjo.substack.com/p/the-palace-of-iatrogenesis ) followed by a dissection of a lot of pseudoscientific garbage: attempts at longevity (Starting here: https://drjo.substack.com/p/chopping-off-the-philosophers-stones ) and all sorts of silliness including homeopathy ( https://drjo.substack.com/p/fermi-and-the-homeopaths ), unthinking acceptance of 'herbs' ( https://drjo.substack.com/p/herbs-gotta-be-good-right ), and a lot of other quackery ( https://drjo.substack.com/p/healing-energy ).
*Only then* did we get to this 8-part series ( https://drjo.substack.com/p/sex-lies-and-robots ), which isn't complete yet. I'm sure you'll agree that it's not enough just to criticise, especially where there *are* good, science-based pharmaceutical treatments. We need to tease out the good and the bad, and more than this, try to address the systemic illness that ails our current medical systems. (Naturally avoiding the temptation to throw up our hands and take refuge in things that can't work, don't work or are even harmful—pretty much all of 'alternative' medicine).
Yeah, we do need to fix things. It won't be easy :)
Regards, Dr Jo.
Thank-you for your attention to my comment. I was trained in physics (dropped out of a PhD program). While I greatly value the scientific method, it is limited to what can be objectively & repeatedly measured. I am convinced that much of medicine is still an art & the placebo effect seems to be as beneficial as many of the drugs being marketed.
As I'm fond of saying: "I don't care what letters you put after your name, much of what is being marketed as modern medicine (at least in terms of chronic care) is, at best, barely removed from quackery. Yes, we have become very good at stitching up broken bodies but persistent conditions are much more problematic.
Regarding "alternative" medicine? My experiences are certainly much different than yours. True, there are a lot of people sticking needles in patients after taking a weekend workshop but my TCM teacher (Paul Pitchford) did some amazing things.
I tore (partial) a tendon in my foot. Excruciating pain. 30 minutes after hobbling into his office, I walked out pain free. However, for about 6 months after, when running & making a hard turn on that foot, I felt a twinge. My late wife had chronic struggles with pneumonia which he effectively treated with acupuncture (although he did admonish her to not hesitate to seek allopathic help if it got worse).
The problem with most "alternative" care is that there are no standards of care to separate the quackery from the effective. Allopathic care at least makes an attempt to do such. The level of efficacy is a subject of debate.
And yes, it does seem as if the profit motive has sadly diminished the conscientious care in allopathy that I like to think was more prevalent in my youth.
You've got me worried now, especially the section on the 'xxxnemab' drugs. I have been prescribed Evolocumab for high cholesterol. The effect has been remarkable. It's not been fully approved by the English NICE, so it's prescribed privately. I've also recently been suffering from slight memory loss - my doctor calls it 'normal age-related cognitive decline'. Is Evolocumab in the same class as lecanemab or is the name a co-incidence?
"mab" just means that it is an antibody based drug.
The nice thing about antibody based drugs is that they are easy to design when you have discovered a target to which they fit.
Your drug may be fine. Whether it is fine or not has to do with whether the mechanism and target role in that mechanism is well understood, the side effects are acceptable, and that the safety and effectiveness have been adequately vetted.
The problem is exactly as Dr. Jo has mentioned. If the science was done dishonestly, or is based on previous science which is disproved, you are, at best, paying for a placebo, and at worst something that is harming you more than helping you.
Thanks for your reply, it's much appreciated. My LDL, caused by familial hypercholesterolemia, has gone from 'off the charts' to the low end of normal and I hadn't noticed any particular side effects. However, the age-related cognitive decline is new, and I'm only 72, but my GP says it's nothing to worry about and it might even be stress from moving house and may resolve. He's prescribed word games and computer games!
Hi Jean, Jeremy has nailed it (Pretty much took the words out of my mouth). There is a host of *good* monoclonals that have revolutionised the management of many diseases, from rheumatoid arthritis to inflammatory bowel disease to advanced melanoma. The tricky bit is teasing out where pharmaceutical companies have been fibbing.
If you e.g. go to PubPeer and try searching for evolocumab, you will find some studies with question marks against them ( https://pubpeer.com/search?q=evolocumab ) but I'm not aware of huge, overt badness there. There is clear evidence that PCSK9 inhibitors are potent at lowering cholesterol, but of course this is a surrogate end-point. There was a 2022 re-analysis of the FOURIER trial that raised some questions cf. https://pmc.ncbi.nlm.nih.gov/articles/PMC8748321/ but the recent VESALIUS-CV seems to contradict that, albeit in a somewhat different population. If there is a catch, it's likely that you're paying a huge number of $$$ for a single QALY, see e.g. https://www.ncbi.nlm.nih.gov/books/NBK611322/
This also depends a lot on your specific risk profile. At the end of the day, it's **really important** to discuss the pros and cons with your prescribing physician. (And BTW, there is evidence that keeping your mind active delays onset & progression of dementia; there are worse ideas than playing lots of games :)
Thankfully, the NHS is paying for the meds. I know they're costly - I have to get the prescription directly from the consultant, and it comes with a leaflet telling the pharmacy how to get the cost back straight away. The consultant is quite keen to reduce my cholesterol because I had a quad bypass 3 years ago and the surgeon reported that nearly all my arteries were blocked and/or malformed (as is my heart). I can't tolerate statins.
Thanks for the references, I'll indulge in some light reading over Christmas.