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what seems to happen is the drug is trivially tweaked or a new delivery system is created, they get a new patent, then dump marketing & lobby dollars to secure the revenue stream.

The new patent on Ketamine for depression is an example.

Ketamine is already used to treat depression and it’s a cheap generic drug.

The nasal spray being touted is many times more expensive and is really just a marketing play.

There are lots of marketing plays on existing, well-established technology. That's like half the things Silicon Valley develops. So what?

With regard to the Ketamine example, what the drug company is selling is a nasal spray (versus the traditional method of using an IV), and freedom from the stigma of taking a "party drug": https://www.theverge.com/2019/3/11/18260297/esketamine-fda-a....

Ketamine has long been prescribed off label for depression, so I'm not clear on how this is freeing people freedom from the stigma.

The "so what" is that the current system prevents people from getting affordable access to drugs.

This may not matter to you, and that is certainly well within your rights, but many people do seem to care about ensuring other humans aren't priced out of medicines that may help.

Ketamine delivered by IV can continue to be prescribed for depression (and if it can't, that's an FDA issue, not a patent issue). What exactly is your problem with the situation?

I offered the Ketamine example of how a company will try to patent a new delivery system of existing generic drugs as a way to increase the price.

Ketamine as a generic work and is available in lozenges, IV, and other ways. This nasal spray is being marketed as a breakthrough for depression (even though it isn't), costs more, and because there are no marketing dollars behind the other equally effective method, people will likely end up using this branded version.

I would consider a change from ingestion via IV to insufflation is a pretty major development and all around improvement on the existing drug and.method of administration. If someone managed to create an ingestable pill or nasal spray for insulin they'd win a Nobel prize. While the scale and importance of that discovery is greater, the fact that such a switch in delivery method is that significant leads me to believe this controversy surrounding a nasal spray is more outrage porn than actual reality.

> If someone managed to create an ingestable pill or nasal spray for insulin they'd win a Nobel prize.

We already had inhalable insulin in 2006 (Exubera) and again in 2014 (Afrezza), both of these medications were withdrawn from the market for lack of sales. And yet people still get upset when Pharma spends money on marketing...

Fair enough. The policy question is should we be paying our tax dollars ($700 per dose!) to reduce people's stigma?

There was a similar example with anticoagulants where the generic (warfarin) required monthly blood tests, so the drug company developed a version that doesn't require the monthly blood tests, and charges $5k/yr more for it. Is it good public policy to spend $5k/yr per patient to avoid a monthly blood test? We don't have that conversation in the US, and it costs us.

Note that patient doesn't see the $5k/yr increase. They just pay the $35/mo co-pay instead of the $15/mo co-pay. However, the rest of us do pay that cost. Again and again and again.

Not sure where I stand on the issue, but the response to

>There are lots of marketing plays on existing, well-established technology. That's like half the things Silicon Valley develops. So what?

The "what" is that here, peoples' health is at stake, and simply taking a market-driven approach may not be to the benefit of society.

> You can make improvements to the product, and patent those changes

Yes, that’s exactly what Feldman & the article said. The patent applications for “new” drugs use an existing base drug, modify it in some way that can be called an improvement, and get the drug protected for a 2nd or 3rd time. The point is that the modification is not improving the drug itself the majority of the time, but some secondary component or the delivery mechanism. Do you have any actual evidence that contradicts the idea of evergreening? Here’s a direct link to Feldman’s research: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3061567

> As a threshold matter, no scientist or engineer would say that incremental improvements don’t count as “innovation”.

“Innovation” in this context is referring to research to create brand new drugs, which is what big pharma cites as their reason for needing to charge high prices, and what the patent system requires when filing protections on new drugs. The point is that, despite minor innovations to drugs, they’re not meeting the innovation level that both the companies themselves are claiming they have, and that should be required for patents.

> If the change doesn’t actually result in a therapeutic benefit, then doctors shouldn’t prescribe the new drug over the generic. For various reasons, doctors have little incentive to do that.

Yes, exactly. In theory, generics should easily win when they’re available due to their lower cost. What you’re gently glossing over in your comment is the active incentives big pharma is injecting into the system to secure a place for their higher cost drugs. Some doctors & hospitals & insurance companies are being paid extra, directly and indirectly, to not offer generics.

> But the newer iterations are at least a little bit better, and who wants to give their kid with Type-1 diabetes anything but the latest and greatest version?

Well, that actually depends on the free flow of information. If the new drug is a combination of two existing drugs, you can call it “better”, but in reality it may be 10x the price and no actual therapeutic benefit compared to what was already there. This exists in many drugs, for example existing pain killers being combined with existing anti-nausea drugs, and then a high premium is charged for the combo. The point is that the high premium is completely unnecessary to the patient’s relief.

> If the change doesn't actually result in a therapeutic benefit, then doctors shouldn't prescribe the new drug over the generic.

There's also the issue of additional state regulation for some drugs. For instance: Adderall. The DEA limits production of amphetamines, and of course Shire (the former patent-holder for Adderall) is going to prefer to produce its patent-protected version over the generic version. For long after there were generic version of Adderall available, Adderall XR ("extended release") was still under patent. Supplies of Adderall were low nationwide, and doctors were pressured to prescribe the XR version to limit abuse potential.

> who wants to give their kid with Type-1 diabetes anything but the latest and greatest version?

Lots of people. FYI, this is the strategy of several generics shops. The challenge is doctors' reluctance to prescribe them.

Patients need education and advocates. Not everyone is smart enough or motivated enough to challenge their doctor’s initial prescription, but an advocate could help.

Maybe there is a business model in advocacy as a service.

This is very true when it comes to evergreening.

Yes, a drug company can make a minor tweak to a drug and patent it. However, unless doctors prescribe it, that strategy will fail.

>If the change doesn't actually result in a therapeutic benefit, then doctors shouldn't prescribe the new drug over the generic. For various reasons, doctors have little incentive to do that. The main thing is that neither the doctor nor the patient are paying for the drug. When you're not paying, you have no incentive to prescribe the "older model."

The golf trips, lunches from drug reps, free samples for poor/indigent patients, and speaking fees paid from drug companies to doctors sure doesn't hurt either.