But how hard would this really be for an established pharmaceutical company, given that the drug is old, out of patent, and already approved, and an established pharmaceutical company presumably already has the expertise and manufacturing/distribution capacity needed? It doesn’t seem like those were significant hurdles for this company to overcome; or if they were, maybe some portion of the price hike is justified?
I hope I’m not coming off as an ass, I just genuinely want to understand the situation better and you seem to know a lot more than I do. I appreciate your willingness to engage in dialogue with me
All pharmaceuticals manufacturing is subject to FDA shenanigans. So, say Eli Lilly decides to make this drug with the intent to sell it at cost. Nobody would do that. This is just a thought exercise. They will have to get an ANDA approval and then be subject to all the inspections, reporting and other safety stuff the FDA requires. It’s not trivial. And it takes time. The fastest they could possibly have it for sale would be about a year start to finish, and I highly doubt that. https://www.fda.gov/Drugs/DevelopmentApprovalProcess
The page you linked to seems, to my untrained eye, to be describing the process for approval of new drugs. Is this approval process applicable to this drug, which is 40 years old, already approved and on the market, and out of patent protection? If so, then wouldn’t the company in the article have to go through this process as well? That would seem to justify at least part of their price markup.
I think this one would be considered new, as in a new generic. New manufacturer, presumably new name, new production process, even though it’s an old drug. The site is specifically about generics. If the company the pharma bro bought already has an established pipeline, then they wouldn’t have to do this aspect. But they are still on the hook for all the safety checks.
Valid criticism! I was expressing my disappointment with the people whose fondest wish is to sell out, rather than any dislike for one specific buyer.
I could talk for hours about the direct and purposeful evil that Microsoft has sponsored in the marketplace (the marid fiasco, the halloween documents, ie bundling shenanigans, their various accounting and licensing practices, etc. ad infinitum) but it seems to me that the company has had much more admirable behavior since Ballmer left. Sure, they are rent-seekers - MSOffice 365 is a pretty pure play in that arena, as is Azure - but they are providing real value for rent, at least in the case of Azure. And they are encouraging interoperability with non-MS systems instead of sabotaging it, they are hiring and supporting decent human beings like Jeff Snover, and in general just being a more admirable and less predatory organization.
Yes, I believe so. Paul Allen and Bill Gates wrote it as I recall. Allen is Microsoft’s actual founder; he came up with the name and persuaded Bill Gates to drop out of college in order to run the company. Allen himself lists Gates as a co-founder, despite their disagreements, because he’s a hoopy frood that way.
EDIT: Man, the above is way off-topic. Let me drag it back home…
I appreciate how media exposure of people like Martin Shkreli is acquainting the public with how our medical-industrial complex works. Kudos to bOINGbOING and others who have carried these stories!
Nah, Shkreli was basically like all of the other cartoon villains that run big pharma. The difference is that he decided to backstab his fellow baddies which is why he got hit with the charges he got. He thought wrongly that he could screw over the other rich dudes without getting punished. Now he knows better and will probably write a tell all book about it in a decade.
I’m just speculating here - I don’t have any specialized knowledge or anything. Pharmaceuticals aren’t charities so I only have to assume that since the patents have been expired for a while so if nobody else is making them it’s because there’s not enough profit in it to make it worthwhile to go through the years of regulatory headaches and manufacturing challenges.
Well, maybe now that the prices have skyrocketed a pharmaceutical will consider producing it, but it’ll likely be too late for those that need this drug and can’t afford it anymore by the time it’s legally available.
ETA I’m hope I’m not coming off like I’m defending big pharma here. Fuck 'em. I’m just trying to explain some likely reasons why, “one does not just ‘make generic drugs’”.
It’s good with bad, right? They make stuff that people need. I mean, there are a lot of essentials that we can’t get any other way. And the FDA is really the only thing standing in between companies cutting their compounds with strychnine before bottling it and selling. Yet, as has been pointed out, the FDA can be manipulated. Drug companies and other interests are the manipulators. So, it’s a mishmash of desired behaviors and undesirable. Punish the bad. Punish the politicians who fail to punish the bad.
(Punish the voters who vote for the politicians who fail to punish the bad? YMMV)
Here’s another example of this racket in action. Tamiflu just had a patent expiration in 2016. An Indian company makes a generic. The FDA has not approved it for sale in the USA. Roche makes Tamiflu. Cipla makes Antiflu. They are both Oseltamivir. They work the same, because they are the same. Same molecule! It’s for severe flu and a couple other antiviral uses.
Right. I think one can have all kinds of issues with Microsoft, but guys like DiCrisci and Shkreli are in a whole different league.
The FDA is demonstrably corrupt
Care to demonstrate this? Here’s a list of the current FDA board members: https://www.fda.gov/oc/advisory/scimem.html
Do you believe that the head of Harvard’s Department of Health Care Policy is in the pocket of guys like DiCrisci?
It’s on a whole 'nother level of corrupt. I personally know two high ranking former FDA officials. They are decent people, more interested in promoting research than anything. Were they corrupt?
On the level of, “Hey let me pull the car around to the alley and you can put the box in my trunk,” they were not that.
On the level of, “Wire the funds to my Swiss account and I will make sure X happens,” they were most likely not that either.
On the level of “How can I wield my influence to score maximum dollars for my research institution and pharma friends,” yes, because that’s how the game is played.
On the level of “Big business owns me and I have to do whatever they say,” that would be a gross misstatement of how this reality works.
On the level of “I am going to stonewall anything that helps people and promote only things that help my business friends,” I would say they were somewhat complicit, but not as an outright stated goal, and often took up issues to make their industry oversight meaningful in the true sense.
When you’re in the Vatican, do you chant Satanic Verses? Probably not. You’ve been indoctrinated. You chant the Catholic ones, no matter what you happen believe, once you get that high up in the ranks.
I’m not saying this is right. Read my earlier answer about Tamiflu.
I think Drug Companies and the FDA are doing 50/50 a great service and a terrible disservice to us. There are shades here to appreciate and try to understand why the High Holy Church of Pharmaceuticals functions the way it does.
This is circular reasoning. You can’t invoke corruption as the reason they are not approving drugs, then turn around use the nonapproval as evidence of corruption.
@Medievalist’s phrase was “demonstrably corrupt”…unless he was just being hyperbolic, a demonstration would need more than this.
Also, thank you for the opportunity to inject three conic sections (counting the ellipsis) into the discussion.
While I’m no expert on patents, I did attend a course that had a lecture from the patent lawyer of a “small” business, at least as small as a fastener manufacturing plant can be, but the point is that why you need a patent lawyer is to essentially turn instructions for doing something into the most vague legaleez possible while still having something resembling the product feasibly able to be produced on the other end. The example they gave was for the creation of an alloy. They would give the exact ingredients, the amounts, but for temperature they would give a range. Given the right amount of ambiguity, this can extend the patent’s lifetime by years or even decades if the lawyer is talented enough.
For a “small” business that can be the difference between surviving, or being another burnt out factory complex. The same thing applies to any patent by any company, big or small, but the fact is that we can’t compete with the cost of manufacturing in the developing world and at this moment I’m not sure I see another way to do things across the board.
The case of pharmaceuticals being price gouged is related, but the way patents work is a complicated issue. Yes the game is rigged, if it wasn’t, we might just lose.
If there’s an available US version (even if identical, and produced in the same factory prior to being exported to said foreign country), there are a metric shit ton of regulations against importing the drugs in question. (think the whole hullabaloo about importation of “dangerous” Canadian drugs some years back).
We used to do “Mexico runs” for low concentration enrofloxacin solution. (can easily be compounded into oral solutions for exotics.) In the US, you can only get injectable forms for animal use. In Mexico, there’s an oral solution (for poultry [scary eh?]). Declared it every time going across the border. No customs agent ever even cared to ask for an rx. or the like (which would have been an interesting conversation… “No, I don’t have a prescription. Why? Because I have a DEA license…”. Had to drive across the border physically though because having it shipped was a big no-go.
