Every penny spent sustaining ultra-high-priced branded therapy is a penny not spent elsewhere in the health system—on earlier diagnosis, surgery, radiotherapy capacity, nursing staff, or access to basic medicines in other disease areas.
This article is an excellent exposition of the phony arguments used by the pharmaceutical companies. A pathologist friend told me forty years ago that the great bulk of pharmaceutical "research" involves trying to attach methyl groups or other non-reactive elements to existing drugs in order to get around the patents. So much of the wailing and gnashing of teeth over the high costs of research is somewhat self-serving. I suspect that the greatest part of their expenses go to buy off politicians and create deceptive advertising to fool the public and much of the medical profession. Since the company for the drug in question made nearly half of its total income on this one drug in the past year, I suspect that they have more than recouped their expenses. One can make a case for eliminating patents completely but that may be a bridge too far for most people. They should, at least, be severely limited.
Patent protection is to protect profits for the pharmaceutical companies, not to provide research budgets.
It would appear to be intellectually fraudulent to extend patent protection for the original moiety due to a changed delivery method. The patent for the new delivery method should cover that formulation only, and the unmodified drug should be available for generic production. The novel delivery formula ( subq, nasal, oral, etc. ) would have to prove enough added value to justify increased prices. Let the market decide.
The underlying problem is regulatory capture by the pharmaceutical industry. There is no appetite to change patent laws by Congress people who are recipients of generous campaign contributions by pharma groups
All true but the concept of regulatory capture causes some misunderstanding of the source of the problem. Most people think that the regulatory departments and commissions were initiated by well-intentioned people looking out for the interests of the general public. The fact is that practically all of them were lobbied for and created by the large firms in their respective industries in order to hamper competition from their smaller competitors. The best history on this phenomenon is "The Progressive Era" by Murray Rothbard. The details on the creation of the FDA are a real eye opener.
FDA’s Marty Makary was recently on the Patrick Bet-David podcast and suggested Congress needs to address the patent laws. The whole episode was interesting and engaging.
A safer alternative to AZT was withheld from patients until the AZT patent expired. Disregard for patient safety, convenience and financial concerns is nothing new.
The issues here are important and not new. I would be interested in hearing from someone who could speak to these ethical problems from an alternative viewpoint. As a pharmacologist-physician with a 'compationate conservative' viewpoint, I find these marketplace ethical questions difficult to resolve...
It’s true that the subcutaneous version of pembrolizumab will make visits easier for a lot of people. I’m glad to have it. But the timing is exactly what you’d expect in a system where extending a patent is more profitable than bringing the next major advance to the clinic. And think about how many patients could have benefited if they brought it earlier.
This isn’t a new story. Companies respond to the incentives we put in front of them, and we shouldn’t be surprised when their strategy matches the rules of the game.
We can do better if we center this on the patient. If a new formulation shows up right as exclusivity is running out, then the value needs to be clear in ways that matter to real people. Fair pricing. Better access. Solid data across the cancers where the original drug is already standard.
This needs to happen on the regulatory side—FDA and EMA can set clearer expectations about what qualifies for extended protection. If a change is mostly convenience, that’s fine, but the benefits and the costs should be aligned.
We depend on pharma for the breakthroughs that have changed survival across so many cancers. But we also need a system where the rewards match meaningful progress, and where patients aren’t the ones absorbing the downside of strategic timing.
If the overall benefit or efficacy is achieved regardless of the route of administration, I feel the patent expansion is greed. Thank you for this article.
We often hear that the pharmaceutical companies need this income to fund new R&D, and while partially true, most of those R&D dollars come from taxpayer grants and not from pharmaceutical profits.
This article is an excellent exposition of the phony arguments used by the pharmaceutical companies. A pathologist friend told me forty years ago that the great bulk of pharmaceutical "research" involves trying to attach methyl groups or other non-reactive elements to existing drugs in order to get around the patents. So much of the wailing and gnashing of teeth over the high costs of research is somewhat self-serving. I suspect that the greatest part of their expenses go to buy off politicians and create deceptive advertising to fool the public and much of the medical profession. Since the company for the drug in question made nearly half of its total income on this one drug in the past year, I suspect that they have more than recouped their expenses. One can make a case for eliminating patents completely but that may be a bridge too far for most people. They should, at least, be severely limited.
Patent protection is to protect profits for the pharmaceutical companies, not to provide research budgets.
It would appear to be intellectually fraudulent to extend patent protection for the original moiety due to a changed delivery method. The patent for the new delivery method should cover that formulation only, and the unmodified drug should be available for generic production. The novel delivery formula ( subq, nasal, oral, etc. ) would have to prove enough added value to justify increased prices. Let the market decide.
The underlying problem is regulatory capture by the pharmaceutical industry. There is no appetite to change patent laws by Congress people who are recipients of generous campaign contributions by pharma groups
All true but the concept of regulatory capture causes some misunderstanding of the source of the problem. Most people think that the regulatory departments and commissions were initiated by well-intentioned people looking out for the interests of the general public. The fact is that practically all of them were lobbied for and created by the large firms in their respective industries in order to hamper competition from their smaller competitors. The best history on this phenomenon is "The Progressive Era" by Murray Rothbard. The details on the creation of the FDA are a real eye opener.
FDA’s Marty Makary was recently on the Patrick Bet-David podcast and suggested Congress needs to address the patent laws. The whole episode was interesting and engaging.
Thanks for the podcast tip!
The subject of patents comes up at the 46:26 timestamp
A safer alternative to AZT was withheld from patients until the AZT patent expired. Disregard for patient safety, convenience and financial concerns is nothing new.
Sad
The issues here are important and not new. I would be interested in hearing from someone who could speak to these ethical problems from an alternative viewpoint. As a pharmacologist-physician with a 'compationate conservative' viewpoint, I find these marketplace ethical questions difficult to resolve...
It’s true that the subcutaneous version of pembrolizumab will make visits easier for a lot of people. I’m glad to have it. But the timing is exactly what you’d expect in a system where extending a patent is more profitable than bringing the next major advance to the clinic. And think about how many patients could have benefited if they brought it earlier.
This isn’t a new story. Companies respond to the incentives we put in front of them, and we shouldn’t be surprised when their strategy matches the rules of the game.
We can do better if we center this on the patient. If a new formulation shows up right as exclusivity is running out, then the value needs to be clear in ways that matter to real people. Fair pricing. Better access. Solid data across the cancers where the original drug is already standard.
This needs to happen on the regulatory side—FDA and EMA can set clearer expectations about what qualifies for extended protection. If a change is mostly convenience, that’s fine, but the benefits and the costs should be aligned.
We depend on pharma for the breakthroughs that have changed survival across so many cancers. But we also need a system where the rewards match meaningful progress, and where patients aren’t the ones absorbing the downside of strategic timing.
Just my two cents.
A well written article and comment. More examples of the merits of Sensible Medicine.
If the overall benefit or efficacy is achieved regardless of the route of administration, I feel the patent expansion is greed. Thank you for this article.
We often hear that the pharmaceutical companies need this income to fund new R&D, and while partially true, most of those R&D dollars come from taxpayer grants and not from pharmaceutical profits.