I find it misleading to call drugs tools. It is not uncommon to find unexpected uses for drugs.
Here is an example I just saw in a documentary last week:
Avastin, a treatment for certain types of cancer, was found out to cure AMD very cost-efficiently. Novartis was so miffed that they successfully lobbied for forbidding using Avastin in AMD cases, then they repackaged it into Lucentis and now they sell it at 40 times Avastin’s price. It’s the same product, but doctors are forbidden to use the cancer treatment to cure people’s eyes. (Correction: Novartis and Roche tried to have the use of Avastin in AMD cases outlawed in France, but failed. Still, doctors are discouraged from doing that by the complexity of administrative procedures, and presently the overwhelming majority of case are treated with Lucentis.)
Likewise, Pfizer and Merck and all the rest of these big pharmaceutical companies designed their vaccines and drugs to fight COVID-19, and gathered lots of flagship-quality evidence to bolster their claimed success. Nobody with serious standing challenges these claims.
If they are so confident that their vaccines are stellar successes, why did they specify in their contracts with European governments that they could not be held liable for side effects?
Novartis was so miffed that they successfully lobbied for forbidding using Avastin in AMD cases
Can you be more specific to what you are referring to? What specific regulatory are you calling “forbidding using Avastin in AMD cases”. What forbids off-label use here?
My bad, I rewatched the documentary and it’s actually less clear. The two swiss labs Novartis and Roche, who respectively commercialize Lucentis and Avastin in Europe (undistinguishable treatments both created by Genetech, an American lab bought back by Roche—also, Novartis owns 33.33% of Roche), tried a legal action against France. I assume it was to outlaw the use of Avastin in the eyes. But it eventually failed. However, in the meantime, the habit had taken root to use Lucentis to cure AMD. It’s not explained exactly why. The interviewed person says “the difficulty nowadays for the healthcare system, is that they set up a system that is so complex for eye doctors to manage that in the end, everyone gave up.” I interpret that as “it’s possible, but there’s so much red tape that it’s impractical”. I will correct my original comment.
The two swiss labs Novartis and Roche, who respectively commercialize Lucentis and Avastin in Europe (undistinguishable treatments both created by Genetech, an American lab bought back by Roche—also, Novartis owns 33.33% of Roche), tried a legal action against France. I assume it was to outlaw the use of Avastin in the eyes.
That seems unlikely to me. Our health system doesn’t work in a way that there’s a normal process for outlawing drugs for being used for certain purposes.
Let’s start with, Lucentis and Avastin are similar but the are not undistinguishable. They are both monoclononal antibodies against the same target but not the same. That’s why you have for example two different English Wikipedia pages for them which you don’t have for drugs were the same substance gets marketed under different brand names.
When repacking a drug that intravenously into one that’s optimized for intravitreal delievery it’s plausible that some optimization can be made. Wikipedia suggests that there’s review that even suggests low certainty evidence that there are clinically relevant differences. While those difference might be just the result of p-hacking it’s plausible that they are real.
Even the French Wikipedia doesn’t go into detail but a more likely scenario is that someone in the French health service thought that covering Lucentis with public health insurance is a waste of money when Avastin exists that costs 1⁄40 as much and that they ran a lawsuit to get French public health insurance to cover Lucentis.
If money wouldn’t be any concern, then the act of repackaging drugs to be better for a given clinical application makes a lot of sense. The key issue is how much profit a company deserves for doing that and the amount feels excessive for the service that’s provided.
If they are so confident that their vaccines are stellar successes, why did they specify in their contracts with European governments that they could not be held liable for side effects?
Courts of law can make companies liable for “side effects” whether or not there’s scientific evidence that the “side effects” are caused by the drugs.
If you for example look at LYMErix it’s not clear that the side effects were really that severe but they were still enough to get the vaccine withdrawn.
If they are so confident that their vaccines are stellar successes, why did they specify in their contracts with European governments that they could not be held liable for side effects?
I mean, that’s just good practice. No one can be 100% sure of anything, and you always want to take as little liability as possible...particularly when the costs of taking less liability are low.
I find it misleading to call drugs tools. It is not uncommon to find unexpected uses for drugs.
Here is an example I just saw in a documentary last week:
Avastin, a treatment for certain types of cancer, was found out to cure AMD very cost-efficiently. Novartis was so miffed that they successfully lobbied for forbidding using Avastin in AMD cases, then they repackaged it into Lucentis and now they sell it at 40 times Avastin’s price. It’s the same product, but doctors are forbidden to use the cancer treatment to cure people’s eyes. (Correction: Novartis and Roche tried to have the use of Avastin in AMD cases outlawed in France, but failed. Still, doctors are discouraged from doing that by the complexity of administrative procedures, and presently the overwhelming majority of case are treated with Lucentis.)
If they are so confident that their vaccines are stellar successes, why did they specify in their contracts with European governments that they could not be held liable for side effects?
Can you be more specific to what you are referring to? What specific regulatory are you calling “forbidding using Avastin in AMD cases”. What forbids off-label use here?
My bad, I rewatched the documentary and it’s actually less clear. The two swiss labs Novartis and Roche, who respectively commercialize Lucentis and Avastin in Europe (undistinguishable treatments both created by Genetech, an American lab bought back by Roche—also, Novartis owns 33.33% of Roche), tried a legal action against France. I assume it was to outlaw the use of Avastin in the eyes. But it eventually failed. However, in the meantime, the habit had taken root to use Lucentis to cure AMD. It’s not explained exactly why. The interviewed person says “the difficulty nowadays for the healthcare system, is that they set up a system that is so complex for eye doctors to manage that in the end, everyone gave up.” I interpret that as “it’s possible, but there’s so much red tape that it’s impractical”. I will correct my original comment.
That seems unlikely to me. Our health system doesn’t work in a way that there’s a normal process for outlawing drugs for being used for certain purposes.
Let’s start with, Lucentis and Avastin are similar but the are not undistinguishable. They are both monoclononal antibodies against the same target but not the same. That’s why you have for example two different English Wikipedia pages for them which you don’t have for drugs were the same substance gets marketed under different brand names.
https://go.drugbank.com/drugs/DB01270 and https://go.drugbank.com/drugs/DB00112 give you the sequences of the antibodies and even without comparing every letter you see that the molecular weight of one is a third of the other.
When repacking a drug that intravenously into one that’s optimized for intravitreal delievery it’s plausible that some optimization can be made. Wikipedia suggests that there’s review that even suggests low certainty evidence that there are clinically relevant differences. While those difference might be just the result of p-hacking it’s plausible that they are real.
Even the French Wikipedia doesn’t go into detail but a more likely scenario is that someone in the French health service thought that covering Lucentis with public health insurance is a waste of money when Avastin exists that costs 1⁄40 as much and that they ran a lawsuit to get French public health insurance to cover Lucentis.
If money wouldn’t be any concern, then the act of repackaging drugs to be better for a given clinical application makes a lot of sense. The key issue is how much profit a company deserves for doing that and the amount feels excessive for the service that’s provided.
Courts of law can make companies liable for “side effects” whether or not there’s scientific evidence that the “side effects” are caused by the drugs.
If you for example look at LYMErix it’s not clear that the side effects were really that severe but they were still enough to get the vaccine withdrawn.
I mean, that’s just good practice. No one can be 100% sure of anything, and you always want to take as little liability as possible...particularly when the costs of taking less liability are low.