Author Topic: The "Ask millahh about Pharma" thread!  (Read 1035 times)

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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #35 on: July 02, 2017, 04:05:44 PM »
So what's the story with branded generics? Seems to create another pricing tier, even though a true generic could already be on the market. My kidney docs weren't keen on generics, but they put me on a BG (Hecoria) rather than generic tacrolimus. Didn't seem to make much sense, since it didn't cost that much less than prograf.

Ok, had to actually dig on this one a bit.  There are three rough categories (and here's where I have to pick my examples carefully, so as not to out who I work for!):

ē   Can be a generic just like any other, but someone decides to slap a brand name on it and promote it.  Iím honestly not sure I understand the business model here
ē   Take an off-patent molecule, and reformulate it to have different release properties, or combine it with another drug, and in doing so impart a desirable benefit to the patient.  Birth control drugs are great examples of this, as there are really only a few molecules out there, but people do all sorts of creative things with route of delivery, dose level, release profile, and combinations.  At least some clinical work is needed, but you can potentially generate IP around both the formulation and the ďmethod of useĒ if you design your studies right (e.g. you show better efficacy or lower side effects)
ē   You formulate a product using a different salt form of the drug (e.g. a bromide instead of a chloride).  This is sort of a watered down version of the previous bullet. Again, if you can demonstrate a reason why someone should take your version instead of the generic of the original, then you can have a viable product.

So, in some cases itís making a new product out of an older drug, and in some cases, itís more just marketing.  But either way, the company is putting their name behind it in a way that the standard generics donít.  And it turns out that I worked on one w/o realizing it technically fell into this category...

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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #36 on: July 02, 2017, 04:11:22 PM »
I too get pretty tired of all the bullshit conspiracy theories about how we've actually cured most major diseases, but they'll never get to market because we can make more money treating people indefinitely than to outright cure them.  To believe that is to be so paranoid that you have no faith in humanity, or you're just an idiot.  The result is the same and either way, I have no tolerance for such foolishness.  I can believe that one or two guys are that morally bankrupt and might reach positions of power.  The Shkrelis of the world.  I cannot believe that an entire industry, dozens of companies, has somehow secretly gotten together to collude, all outside of the watchful eyes of the FDA.  Just not possible.

But yeah, it's a cure.  Hepatitis C virus is the latest biggie that we're all making progress on.  Take our stuff for 8 to 12 weeks, and if it works, you're cured.  No more HCV.  So with 50,000 down and even more by our competitors, the market has something like a self-reducing effect.  I don't know what it's called, but I'm sure there's a name for it.  After the big hit (which took place over the past few years), now most of "low-hanging fruit" (which is a crude term to use for patients, but that's what they are) has been picked.  The ones which were easiest to cure have been cured.  Gilead got out there first, but we're gaining market share; it's just that the market is shrinking because that's how it works.  You say "recently" but it's been a few years now.

So our next-generation drug is different.  Higher efficacy, shorter term (straight 8 week treatment and you're done), and can be used on nearly 90% of diagnosed patients.  Our first one was only for patients who couldn't take some of the others, or for whom they weren't effective.  The new one covers more indications and is designed to be the one you take first.  Again, there's a term for that but I don't know it.

Yeah, I'm IT; I provide the zillions of gigabytes of data for these guys.  Boring as shit, but I work with some cool people and my work helps cure people, so it's pretty cool.

Working with that much data, are you within Biostats?  Trial database management?  Or something else?

And I'll admit that you schooled me on the HCV drugs   :lol  I only keep half an eye on the Gilead and their liver stuff because they are a major rival of ours for something that is still in the pipeline.

Perhaps it's selection bias, but I never get anyone talking to me about conspiracy theories or that pharma is soulless/wrong...but I also recognize that I spend most of my time around other scientists and professionals, and they have a grasp on this reality.
« Last Edit: July 02, 2017, 06:21:02 PM by millahh »
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #37 on: July 02, 2017, 06:51:11 PM »

Well, the obvious and most basic is that for a company to invest $2.6 BILLION in something, they have to have some path to get at least $2,600,000,001 in return (and likely a lot more than that).  So how do you incent companies to make that investment proactively, and in cases where there is no possibility of $2,600,001 let alone $2,600,000,001.   In the rail industry, for example, there are grants and subsidies available to pursue R&D in areas that are of interest to the government - and by extension, society - that might or might not ever be a focus of effort via a pure "invisible hand" structure. We're willing to get involved politically (which is not the same as "politicize") pharma, with respect to guaranteeing certain profits, and guaranteeing certain price protections, so why not influence other variables in that equation, like R&D?

Ok, this gives me a bit more to work with, and there are a few different things here:

ē   There are some cases where the govít will do the research themselves.  For example, there is a nuclear countermeasures program, where the govít (NIAID, specifically) identifies drugs that are in development that may be helpful in event of a nuclear event.  Nobody develops drugs specifically for that case, but there are a number of drugs for indications which are similar to the after-effects of high doses of radiation, and so can be reasonably hypothesized as being useful in a disaster.  The govít will buy some drug off the innovator, do some animal work to see if it would be expected to work in humans (since you canít ethically radiate the shit out of a human subject, then dose them to see if they donít die).  If it looks good, the govít will buy drug from the manufacturer (at nominal cost) after it has entered routine commercial production, and keep a rotating stock ready.
ē   In the case of orphan indications, a much higher price can be commanded, the development pathway is shortened, and there can be extended IP protections, all making it easier to decrease development costs and make some profits.  Regulators and insurers understand that without this, some patients will just be SOL. 
ē   There could be scenarios where a company (and letís be realistic here, their investors) may tolerate a price cap.  Companies typically have areas of specialty, and if carrying that niche drug strengthens their position in the specialty and their relationships with the specialist community, they may see those synergistic benefits as making it worth it.
ē   The optics of doing some ďpublic serviceĒ work could potentially go a long way, a bit like pro bono workÖthough itís much more of a long-term commitment of resources

In your railroad example, can those technologies then be applied outside the US?  I can still imagine objections being raised to the company profiting off of ex-US sales when the R&D was subsidized by US taxpayers, but no one really benefits from restricting it to the US.
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Offline Orbert

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Re: The "Ask millahh about Pharma" thread!
« Reply #38 on: July 02, 2017, 08:04:35 PM »
Working with that much data, are you within Biostats?  Trial database management?  Or something else?

And I'll admit that you schooled me on the HCV drugs   :lol  I only keep half an eye on the Gilead and their liver stuff because they are a major rival of ours for something that is still in the pipeline.

Perhaps it's selection bias, but I never get anyone talking to me about conspiracy theories or that pharma is soulless/wrong...but I also recognize that I spend most of my time around other scientists and professionals, and they have a grasp on this reality.

I'm not on the R & D side; I support S & M (Sales & Marketing).  So I do work with data, but it's the boring kind.  Feeding segmentation data and targeted marketing stuff to the sales reps so that they can harass doctors into buying our stuff instead of someone else's.  They have their iPads and tablets with the sales app that makes pretty graphs and pictures and maps and puts gigabytes at their fingertips.  It all runs so fast because the data is pre-crunched; I do the pre-crunching.  Hey, if they're willing to pay me to do this, I'm willing to take their money to do it.  In some ways, even pharma companies are just businesses.  We make stuff and sell it to make money.

I wasn't trying to school you on the HCV stuff, just clarify the situation and provide some clues.  I'm not online anywhere that connects me to the company I work for except I think LinkedIn, but by now if you wanted, you could figure out who I work for.  If you wanted to bother. :p

The conspiracy theory shit is just stuff I've seen online over the years.  Chemtrail-level paranoid idiocy.  It just sticks with me and annoys me more than most other stuff because it pertains to the work I do.  Kinda like when people say teacher's have the easiest jobs.  Only six hours a day and summers off.  Fuck them, they have no idea what teachers do.  I was a secondary teacher for six years, so that stuff pisses me off.

Offline Stadler

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Re: The "Ask millahh about Pharma" thread!
« Reply #39 on: July 03, 2017, 07:56:19 AM »
(since you canít ethically radiate the shit out of a human subject, then dose them to see if they donít die).

Why not? 

I KID!  I KID!

Quote
In your railroad example, can those technologies then be applied outside the US?  I can still imagine objections being raised to the company profiting off of ex-US sales when the R&D was subsidized by US taxpayers, but no one really benefits from restricting it to the US.

Well, generally, yes, though it's not always possible (specs for rail lines differ radically from country to country, and between freight and passenger).   Buit then again, the average Joe a) doesn't know that their tax dollars are being used to fund new bogies (the assembly that holds the wheels you see on the side of a train), or b) whether those bogies are in production for use in the U.S. or China, or Europe).   

Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #40 on: July 04, 2017, 03:50:35 PM »
(since you canít ethically radiate the shit out of a human subject, then dose them to see if they donít die).

Why not? 

I KID!  I KID!


That actually raises another interesting topic (and unexpectedly steers us right to Godwin's Law)...all of our modern patient protections are essentially a response to Nazi medical experimentation (twin studies an otherwise), with the blueprints laid out in the Nuremberg Code:

Quote
1. The voluntary consent of the human subject is absolutely essential.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
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Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #41 on: July 05, 2017, 08:06:45 PM »
I can't believe this thread has been up for like two weeks, on this part of the forum, and no one has asked anything pertaining to medical marijuana & the pharma industry...
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Offline El Barto

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Re: The "Ask millahh about Pharma" thread!
« Reply #42 on: July 05, 2017, 09:19:20 PM »
So what's the story with branded generics? Seems to create another pricing tier, even though a true generic could already be on the market. My kidney docs weren't keen on generics, but they put me on a BG (Hecoria) rather than generic tacrolimus. Didn't seem to make much sense, since it didn't cost that much less than prograf.

Ok, had to actually dig on this one a bit.  There are three rough categories (and here's where I have to pick my examples carefully, so as not to out who I work for!):

ē   Can be a generic just like any other, but someone decides to slap a brand name on it and promote it.  Iím honestly not sure I understand the business model here
ē   Take an off-patent molecule, and reformulate it to have different release properties, or combine it with another drug, and in doing so impart a desirable benefit to the patient.  Birth control drugs are great examples of this, as there are really only a few molecules out there, but people do all sorts of creative things with route of delivery, dose level, release profile, and combinations.  At least some clinical work is needed, but you can potentially generate IP around both the formulation and the ďmethod of useĒ if you design your studies right (e.g. you show better efficacy or lower side effects)
ē   You formulate a product using a different salt form of the drug (e.g. a bromide instead of a chloride).  This is sort of a watered down version of the previous bullet. Again, if you can demonstrate a reason why someone should take your version instead of the generic of the original, then you can have a viable product.

So, in some cases itís making a new product out of an older drug, and in some cases, itís more just marketing.  But either way, the company is putting their name behind it in a way that the standard generics donít.  And it turns out that I worked on one w/o realizing it technically fell into this category...
Hecoria fell into the second category, as I believe it was just a tweak to the release mechanism. Not sure why my docs went that route, as they're alright with me taking generics now.

I can't believe this thread has been up for like two weeks, on this part of the forum, and no one has asked anything pertaining to medical marijuana & the pharma industry...
Is there much of a connection? I figure guys like you are studying the bejeezus out of cannibinoids. Certainly wouldn't surprise me if your industry lobbied pretty heavily to keep grass schedule 1. I guess I've just always thought of RJR and Altria as being the secret players in the dope game. Seems a natural fit.
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Offline Stadler

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Re: The "Ask millahh about Pharma" thread!
« Reply #43 on: July 06, 2017, 10:51:27 AM »
I can't believe this thread has been up for like two weeks, on this part of the forum, and no one has asked anything pertaining to medical marijuana & the pharma industry...
Is there much of a connection? I figure guys like you are studying the bejeezus out of cannibinoids. Certainly wouldn't surprise me if your industry lobbied pretty heavily to keep grass schedule 1. I guess I've just always thought of RJR and Altria as being the secret players in the dope game. Seems a natural fit.

If I'm a leader at RJR or [insert Millah's Pharma company] I'm immediately reaching out to the other to form a cooperation agreement to combine forces.  RJR brings the production aspect, as well as the packaging and distribution, and Pharma brings the regulatory approval process expertise and their own packaging and distribution (depending on the ingestion mechanism used).    This is a text book opportunity for a joint venture or cooperative. 

Offline Cool Chris

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Re: The "Ask millahh about Pharma" thread!
« Reply #44 on: July 06, 2017, 12:12:40 PM »
What's going on with the severe uptick in opiod use, addiction, and fatalities? I want to blame it all on loser junkies. Others want to blame it all on those pesky Docs who prescribe, or over-prescribe, opiod-based meds. Reality is somewhere in the middle. Thoughts?
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Re: The "Ask millahh about Pharma" thread!
« Reply #45 on: July 06, 2017, 12:13:48 PM »
I can't believe this thread has been up for like two weeks, on this part of the forum, and no one has asked anything pertaining to medical marijuana & the pharma industry...

I just assumed they were at war with each other.  Granted, I can't find it now, but I found an article about a pharm company doing the R&D for a synthesized CBD pill. 

But please go ahead if you got any insight into these two industries though, this whole thread has been an interesting read.

Offline millahh

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Re: The "Ask millahh about Pharma" thread!
« Reply #46 on: July 14, 2017, 01:09:29 PM »

Well, generally, yes, though it's not always possible (specs for rail lines differ radically from country to country, and between freight and passenger).   Buit then again, the average Joe a) doesn't know that their tax dollars are being used to fund new bogies (the assembly that holds the wheels you see on the side of a train), or b) whether those bogies are in production for use in the U.S. or China, or Europe).

I'll get caught up on long responses this weekend, but in the meantime, here's an example of exactly the type of scenario Stadler described, getting a bit messy:

http://www.fiercepharma.com/vaccines/sanofi-never-rejected-a-zika-vaccine-fair-pricing-request-exec-says?mkt_tok=eyJpIjoiT1RZd1ltSTBOVEUyTkRnMyIsInQiOiJYSGlaTUhvTEFiV2VIbk1Ca3dlOEloZzhXTkhSK3BcL2hIK0VuVzBcL013STlVRmlcL0JHU1VvWENGYUxuN29JcllVaWJQb0ROU0gxbmRlY21tYUJOTXVtRmFFM3BWZjRaK2VVcEt0cnJiOCtCZUdBQ3hqUHl5U2xwZ1N6TzBZQkdvVCJ9&mrkid=641494&utm_medium=nl&utm_source=internal

(and I learned something from it!)
Quote from: parallax
WHEN WILL YOU ADRESS MY MONKEY ARGUMENT???? NEVER???? THAT\' WHAT I FIGURED.:lol