This old drug was free. Now it’s $109,500 a year | Hacker News Reader

This old drug was free. Now it’s $109,500 a year

washingtonpost.com

70 pointszeep30 comments

This kind of insanity makes me wish we would just abolish the legal notion of intellectual property already. It flies in the face of everything that the free market stands for by actively blocking competition. Yes, you can come up with all sorts of contrived allegories for why IP might be beneficial, but all of those fail in practice and are vastly outweighed by IP being used anticompetitively.

This article hits especially close to home since I have a very rare eye condition that's destroying my sight, but the drug to adequately treat it costs $67k a year and isn't covered by insurance because of the high cost. So now I'm left making the most of my new life on significantly cheaper but less effective drugs.

These situations with old drugs are more a matter of FDA certification than IP.

While I can't speak as much to the case in article, my problem is due to IP restrictions. Though companies buying the rights to daranide sounds an awful lot like IP too.

How would you propose recouping the cost of developing a New Chemical Entity into an approved drug without the exclusivity provided by IP?

Finance it out of taxes. This isn't a new chemical entity, it's an old chemical entity certified for a new purpose. The costs seem high to an individual but by corporate standards a few million is peanuts.

Parent is speaking of a different drug than the article, and it sounds like they are speaking of a new drug.

tbh I think parent is trying to change the subject away from the topic of the article.

Perhaps so. It’s difficult to discuss anything adjacent to healthcare when it intersects with our lives in such a personal way. It’s really challenging to bridge the knowledge and experience gap as well. Insiders are the first to declare the system we have now as flawed, but it’s a very complicated machine to change. We are trying!

edit, to speak to the complexity. Up until yesterday, if you asked me if the industry should cease direct to consumer marketing, I’d say “hell yes, I’ll push the big red button myself”. Yesterday however, while watching late night TV (which I rarely do), I happened to pay attention to an ad (which I rarely do) for a biologic that could really help out a friend with a miserable chronic condition. Don’t know if it will work or not until they try, but they are exactly the right population for the treatment. None of their physicians suggested it, I didn’t think of it despite being vaguely familiar with this area of medicine, but the DTC ad was an inspiration. I still think on the balance that DTC marketing is bad, but this personal experience makes me question if the possibility of occasional successes overrides. I have no idea, but I spend a lot of time nursing my beer in the corner the pub trying to figure things out.

Financing out of taxes is a guarantee it will be a lot more expensive. Suddenly a company has all the motivation to build a multi-billion drug that tends to 10 patients, as long as the state picks up the bill.

Hello? We're talking about a drug that already exists. I'm fine with the manufacture-only part of it being done by a publicly owned entity.

If you look up the budget numbers for how these pharma companies operate, very little money goes into R&D as a fraction of revenue. The supposedly high cost of bringing a drug to market is a talking point used to justify high prices, not something that is necessarily based in reality. They are absolutely not barely breaking even.

Much of large pharma R&D effectively happens through asset acquisition of smaller entities, and I don’t think that is reflected well by budget numbers.

Tufts numbers are generally regarded as high. Booth at Atlas puts the cost ranging from $300M for a drug that can be developed on a lean process (like Eli’s Chorus) to $1.6B for something developed by large pharma. Regardless of where in the range you are, it’s risky and it isn’t cheap.

Which brings me to my original question: if not assisted by the exclusivity provided by IP, how should drug development costs be paid for? And beyond that, how should lifecycle costs be paid for?

I don't know all of the ins-and-outs of funding, but this[0] study says that there are other countries developing NMEs at a proportionately faster rate than the US.

From the discussion section:

>Pharmaceutical innovation is an international enterprise. Although the United States is an important contributor to pharmaceutical innovation, we found that more than 20 countries contributed to the development of the 288 NMEs with patents at the time of approval. More than 171 companies were involved in the development of these NMEs, and the vast majority of companies were multinationals with facilities located in more than 2 countries. We also found that the United Kingdom, Switzerland, Belgium, and a few other countries innovated proportionally more than their contribution to the global GDP or prescription drug spending, whereas Japan, Spain, Australia, and Italy innovated less.

Granted I know that GDP isn't the end-all be-all for determining how drugs can be financed, but I think there is something to learn from the study and how other countries do business while continuing to innovate.

[0]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2866602/

It's similar to IP, but it isn't IP, it's a grant of exclusivity from the FDA. They publish the info:

https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.c...

I wonder if they could tie the exclusivity period to net revenues or something.

The problem is not IP but your FDA. I could send it to you for much lower price but it's not allowed.

Free market works truly great when there is a free market, but considering the fact that medicine in general can never be a one unless we all take a risk of snake oil and arsenic sellers, it's crazy to think people don't get pushed over. It's some sort of crazy utopia of Americans, where the ideology is more important than outcome. Capitalism is good because majority of the time it works the best. Not with medicine.

This is a separate issue from large emergency medical bills. You can get a drug prescribed for a chronic condition just about anywhere, but if it's produced by a monopolist then you're forced to pay whatever absurd price the manufacturer demands. Adequate competition without IP restrictions can drive drug prices very, very low. This can be seen in the Indian pharma industry.

There is no adequate competition, this is an orphan drug that will sustain at most one producer. Fun fact: most generics are sourced to very few producers because margins are so low, competition is working.

There are similarities to fine chemical shortages: http://blogs.sciencemag.org/pipeline/archives/2010/06/16/spa...

The world can do without sparteine, but orphan drugs call for regulation as natural monopolies, or even government subsidies.

This is the problem right here: "Although Keveyis is actually a decades-old drug, its federal approval for periodic paralysis came with a seven-year period of exclusive marketing rights."

A decades-old drug should not have any IP left.

The exclusivity period is intended to incentivize developing old drugs for new indications. What would you suggest instead of the exclusivity window?

What “development” are you referring to, exactly? The alternate indications in many cases are already well known (as they were in the referenced article).

The clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketing surveillance activities (Phase IV) that are required. The alternate indications may be well-known but marketing for an off label indication is not permitted (as in, they actually jail CEOs and executives for that).

Government manufacturing of generics by the CDC or NSF. It is the only method by which you can guarantee supply as well as ensure transparency in the process.

I can't say I understand why you selected those two organizations: the CDC doesn't have pharma manufacturing expertise that I am aware of (interested to hear of what you know on that angle); the NSF is non-medical and it's a grant agency, no labs. I should also note that even if they were chartered for this sort of work and were working on it, they would face the same source material supply problems facing commercial groups that result in some supply interruptions, and the basket of problems associated with manufacturing small amounts of drugs.

There are many non-profit and academic institutes that are working on the problem of generic drug costs holistically, including figuring out how to produce APIs (in pharma, API is active pharmaceutical ingredient) from plentiful source materials and how to produce the APIs by flow processes so that small quantities of drugs are more economical to produce. They're doing good work but it's a hard problem, experienced execs and leaders are difficult to come by, and getting funding in biotech is far more difficult than getting funding in IT. They do receive support from NIH, FDA, DARPA (making drugs at a CSH in the middle of Afghanistan is useful), big pharma (being able to make drugs cheaper is generally of interest), and philanthropic groups. Many smart and talented people are "on it!", good progress is being made, but it is a hard problem.

Basically, this is the pharma - health insurance industry nexus, that jacksup prices of drugs, making it looks like an amazing deal for those getting the drugs through insurance.

For a new patient needing this drug, he/she would think "wow, I pay only $1000 a month of insurance, and I'm getting $109,500 a year worth of drugs for $5000 only."

Without fixing pharma+healthInsurnace nexus, healthcare in the US feels like a ripoff, whether you are rich or poor.

I'm not sure how Single payer could ever be less efficient then our current system.

>Anderson, for example, pays nothing.

Buried in this article is the fact that the person they introduced at the beginning of the article is still paying nothing for this drug. Seems like much ado about nothing.

Everyone else in the insurance pool is paying more than they need to as a result.

http://archive.is/BOf2k

if you get stuck behind the paywall like me

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