EpiPen Maker Quietly Steers Effort That Could Protect Its Price • Hacker News Board

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#141

Post by gizmo » Fri, Sep 16, 2016, 9:32 PM UTC

harryh wrote: post #122

FireBeyond wrote: post #90

Earlier quoted context omitted.

Ask yourself, why is the United States the only country in the world where advertising prescription medicine to consumers is allowed? Why is it even needed? I know some people say "education", but that's backward. You have a problem. You go to your physician. He works out a treatment plan for you. For drugs advertised for specific conditions? To enlighten you to alternatives? You can oftentimes assume that alternativ…

why is the United States the only country in the world where advertising prescription medicine to consumers is allowed? Because the US has the strongest freedom of speech protections in the world.

Freedom of speech is for humans, not for corporations. Otherwise you also have to accept the bizarre citizens united decision that permits companies to spend an unlimited amount of money to campaign on behalf of political candidates.

Extending personhood rights to corporations is a really bad idea.

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#142

Post by rayiner » Fri, Sep 16, 2016, 9:32 PM UTC

criddell wrote: post #136

rayiner wrote: post #120

Earlier quoted context omitted.

You're confusing different things. Hatch Waxman does not extend the patent term for orphan drugs. It allows the patent term at the time of FDA approval to be extended to account for unusual approval delays, but only up to the point there is 14 years left post-approval. That has nothing to do with extending the patent term for modifications to the drug, as you state above. As to orphan drugs, Hatch Waxman does not ext…

> As for Shkreli--he's an asshole, but it makes no sense to focus narrowly on isolated abuses. I take it nobody in your family was affected by the price of a Daraprim tablet going from around $10 to $700 per pill? > The big problem here is that manufacturers of generics have almost zero ability to invest in even minimal R&D. Because that's not what they do. That's like complaining that Belkin makes lightning cables a…

> I take it nobody in your family was affected by the price of a Daraprim tablet going from around $10 to $700 per pill?

No, but I buy Epipens for my daughter. That fact is, of course, irrelevant. Systems shouldn't be designed by hyper-focusing on corner cases.

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#143

Post by gizmo » Fri, Sep 16, 2016, 9:45 PM UTC

witty_username wrote: post #96

ceejayoz wrote: post #91

Earlier quoted context omitted.

> The government will spend more money, but the public will get it for free. You know where the government gets its money, right?

So what if taxpayers are paying for it? Companies need to make a profit. Is there a specific reason why the price is unreasonable? (don't anchor the previous price)

The epi-pen equivalent costs a lot less in Europe. See for instance the Emerade Injector, $48 USD for an adult dose. Regulatory hurdles are worse in the US, but you can't explain a 6-7x price difference that way.

http://www.emerade.com/hcp/adrenaline-auto-injector

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#144

Post by FireBeyond » Fri, Sep 16, 2016, 9:53 PM UTC

aianus wrote: post #134

FireBeyond wrote: post #132

Earlier quoted context omitted.

Your deductible is not your co-pay. Deductibles, co-pays, and co-insurance are all separate things with specific definitions: A deductible is a portion of covered medical expenses that the insured must pay. It is specifically defined as the amount of covered benefit that must be incurred and paid by the insured before benefits become payable by the insurer. Key in the above is "a portion of covered medical expenses".…

> This is all separate to your claim: of course, if your doctor agreed to charge you $x+200 (leaving aside the reality of negotiated and contracted fee schedules) and refund you that $200, then absolutely yes - this is insurance fraud. If you charge $X more for an Epipen vs. the market rate for a generic epinephrine autoinjector but offer a $X discount for uninsured persons (or a smaller $Y discount for those with co…

What you need to remember in this case is that the delineation comes FROM the insurance company. They wash their hands of the co-pay entirely and say "no, we+your deductible are covering this (part of the cost)". That becomes the insurance benefit in total. Your co-pay also comes out of your pocket, entirely separately.

There's no fraud, because that's how the insurer defined the separation themselves (for other reasons).

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#145

Post by SilasX » Fri, Sep 16, 2016, 10:11 PM UTC

mikeyouse wrote: post #137

SilasX wrote: post #121

Earlier quoted context omitted.

>Why is it even needed? Because, contrary to popular belief, doctors aren't gods, and have about the same fraction of slackers as any other occupation. Unless we're ready to have a really aggressive program for revoking licenses of doctors who don't keep up with modern advances, they can and do miss available treatments. "Hm, I could eagerly search all the latest treatments that might be relevant to my patents, or I…

Doctors / nurses / pharmacists are required to submit dozens of hours of continuing medical education every year to maintain their licenses. There is an approximately 0% chance that a patient with no background in medicine will learn something useful from a TV Commercial that everyone in the treatment plan doesn't already know.

You're seriously claiming that no doctor has ever modified a treatment plan due to research provided by a patient?

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#146

Post by shanacarp » Fri, Sep 16, 2016, 10:12 PM UTC

SubiculumCode wrote: post #74

StefanKarpinski wrote: post #30

How can any article about this issue not mention the word "patent" anywhere? Why is a 1970s technology still under patent? Patents are supposed to allow recouping of R & D costs, not grant an effectively permanent monopoly that can be sold over and over again until someone greedy enough does the inevitable – if we grant that sort of long-lived monopoly, what else can we possibly expect to happen? Reform the broken pa…

I attended a recent talk of a leader in bringing drugs to market (not naming names). The current trend in pharma is moving away from R&D to S&D. i.e. Search and Develop. They search for promising molecules developed by startups or by government, then develop that into a final product manufacturing process. Most of the research drug failures are committed by third parties and do not cost big pharma anything...shoukd n…

Very true, and radically underdiscussed as an issue.

Part of me really wants to know if it is Actually Cheaper for BigPharmaCo to offset research costs to university/government/startups and then do a Merger/Acquisition to get the promising drug past a certain phase (what have you) vs costs to do research in house.

Is lawyering and banking the process to get a drug to market BEFORE final approval really that much cheaper, or is this an accounting slight of hand issue? What is the actual cost minus marketing to develop a drug and bring it to market that created this situation.

Furthermore, what is the cost of marketing on the books for drug companies that also would drive R&D into third parties. Marketing costs are really not cheap - and they have been rising, especially as more prescription drugs are advertised to consumers. How much of this cost is also driving cost cutting/offset of risk?

(especially wondering since these issues appear appears the recall + no more manufacturing of Avui-Q. The auto-injector issues that caused the recall were untraceable/not replicatable at the Sanofi factory - and seem to be based on descriptions user error driven - and lower than the user error/failure rate of EpiPen. Meanwhile, Sanofi isn't the inventor - Kaléo/pair of brother founders is/are, and they brought nearly the exact same injector technology to market by themselves for heroin overdose. Sanofi just licensed the technology - and in the wake of the recall, decided to forfeit the license. I'm wondering how much of that deal's provisions killed the Auvi-Q, since it appears the issues behind the injector are long term fixable and profitable)

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#147

Post by criddell » Fri, Sep 16, 2016, 10:14 PM UTC

rayiner wrote: post #142

criddell wrote: post #136

Earlier quoted context omitted.

> As for Shkreli--he's an asshole, but it makes no sense to focus narrowly on isolated abuses. I take it nobody in your family was affected by the price of a Daraprim tablet going from around $10 to $700 per pill? > The big problem here is that manufacturers of generics have almost zero ability to invest in even minimal R&D. Because that's not what they do. That's like complaining that Belkin makes lightning cables a…

> I take it nobody in your family was affected by the price of a Daraprim tablet going from around $10 to $700 per pill? No, but I buy Epipens for my daughter. That fact is, of course, irrelevant. Systems shouldn't be designed by hyper-focusing on corner cases.

It's not irrelevant nor is it much of a corner case. I too buy Epipens.

The nice thing about corner cases is that sometimes they are the tip of the proverbial iceberg. Maybe a market solution only fails in a couple of corner cases or maybe there's a fundamental problem with trying to apply market solutions to something like healthcare.

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#148

Post by shanacarp » Fri, Sep 16, 2016, 10:14 PM UTC

vonmoltke wrote: post #102

bradleyjg wrote: post #39

Earlier quoted context omitted.

Patents do play a role here, though not the largest role. Both Teva Pharmaceuticals and Sandoz were sued when for patent infringement when they announced plans to introduce competitors to Epipen. [1] https://www.bloomberg.com/news/articles/2012-04-26/mylan-pfi... [2] http://www.law360.com/articles/181459/king-pharma-sues-sando...

They were, if I understand the background correctly, trying to make a workalike competitor, which King/Mylan asserts they cannot do without violating a patent on the current EpiPen injector. The only thing stopping them from making a non-workalike is getting doctors to prescribe it instead of EpiPen, since pharmacies can't autosubstitute in that case.

Why does workalike matter?

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#149

Post by shanacarp » Fri, Sep 16, 2016, 10:18 PM UTC

maxerickson wrote: post #4

Does the FDA have the authority to deny marketing approval for minor improvements? Mylan pushed generics off the market by making a better cap or something, the FDA should just say no, that improvement is nice but it isn't enough to give you exclusive marketing rights. If you want to incorporate it into your product, license it to your competitors for cheap.

Follow-up question based on your question:

Medical Devices ALSO need approval from the FDA.

Why is the Epi-Pen body not approved separately from the Drug, allowing the body to be sold without epinephrine and to be filled with whatever, including generic epinephrine from a vial?

Re: EpiPen Maker Quietly Steers Effort That Could Protect Its Price

#150

Post by mikeyouse » Fri, Sep 16, 2016, 10:26 PM UTC

SilasX wrote: post #145

mikeyouse wrote: post #137

Earlier quoted context omitted.

Doctors / nurses / pharmacists are required to submit dozens of hours of continuing medical education every year to maintain their licenses. There is an approximately 0% chance that a patient with no background in medicine will learn something useful from a TV Commercial that everyone in the treatment plan doesn't already know.

You're seriously claiming that no doctor has ever modified a treatment plan due to research provided by a patient?

I'm seriously claiming that no patient committed to modifying their treatment plan has ever started that process due to a TV commercial and that the societal loss from doctors acquiescing to patient demands for treatment for Restless Leg Syndrome or whatever other made-up disease far outweighs the benefits from airing said commercials.

Any patient engaged enough and knowledgeable enough to participate in improving their care plan is also knowledgeable enough to know that TV commercials for drugs are complete garbage and offer 0 substantive benefit.