# AbbVie's new treatment for gouging Crohn's patients



## JMC (Mar 8, 2016)

Abbvie, currently gouging an eye watering *$14 Billion* a year from Humira has just bought a new biologic therapy which currently is in stage 2 trials for the treatment of Crohn's disease.   

http://www.pharmalive.com/abbvie-co...ringer-ingelheims-psoriasis-and-crohns-drugs/

Why does this story bother me?  Why is this story not attracting outrage as the actions of Martin Shkreli did only recently over HIV treatments? 

Abbvie is a company that generates nearly $20 Billion in revenue every year (https://en.wikipedia.org/wiki/AbbVie_Inc.).  Nearly three quarters of that revenue comes from a* single drug*, Humira, the patent on which is about to expire.  They need a new golden goose therefore, otherwise their huge revenue streams will collapse as a stream of bio-similar (https://en.wikipedia.org/wiki/Biosimilar) Humira drugs appear and patients who previously could not access this treatment due to cost can get it.  This is good news, right?  No. 

Abbvie employs 28,000 smart, highly educated people.  _Yet not a single one of them has an incentive to cure Crohn's_.  Why would they want to do that when a 25 year patent on a biologic maintenance treatment could generate in the region of *$300+ Billion* over its lifetime?

Compare this with the actual funding available to research a cure into Crohn's.  I have looked very, very hard and can tell you that the total available to fund a cure globally is less than $100 Million annually.  Possibly, a lot less.  Let's look at those number side by side:

Maintenance drugs (25 years): $300,000,000,000
Cure (25 years research):        $    2,500,000,000

Less than 1% of the money generated by keeping us sick, but alive, is spent spent on finding a cure.  Doing so makes good business sense, it is capitalism in action, healthy people don't need expensive treatments.  

Yet, morally and ethically this is outrageous.  Surely, this needs to change and we, as the sufferers of this disease, need to be doing more about it.


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## wildbill_52280 (Mar 8, 2016)

I would hope the new drug they develop to replace humira is actually more effective, otherwise you may have this strange relationships with doctors where they are always pushing the more expensive yet less effective products to patients, that would be a shame.


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## my little penguin (Mar 8, 2016)

Not going to be popular 
But our family adores humira 
It is a drug designed to help not one but many diseases 
My son has many medical things going on including 
Crohns AND Juvenile Spondyloarthritis .
So while we could control his crohns by just formula or other drugs 
His Juvenile Spondyloarthritis can only be fixed by a limited few biologics including humira without making his crohns worse as a result.

Add in the new drug you posted targets IL-23 which is really good news for Arthritis.
Drug companies are not foundations or charity they are businesses who happen to make drugs and because they push forward my kid is benefiting .

He has had this disease for 5 years and been on humira for 3.
There are many ugly diseases out there and many of them benefit from the new drugs.
So you have made my day.
Options are very limited and scary when you are dx at the ripe old age of 7 and have failed misted drugs by age 9.


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## Clash (Mar 8, 2016)

Jury is still out on whether we adore humira for CD but we do adore it for JSpA!

If humira doesn't work for both JsPA and CD for my son it gives me hope that there is yet another biologic out there that could be approved soon for both dxes.


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## Maya142 (Mar 8, 2016)

We are also BIG Humira fans! My younger daughter has both Crohn's and AS and I agree, there are not very many drugs that help with both - Remicade, Humira, Cimzia are approved. Simponi is approved for Ulcerative Colitis and AS but not Crohn's yet.

She did BEST on Humira - her AS was under control and she was able to live like a normal kiddo. 

My older daughter just has AS and is still on Humira and doing GREAT!

My husband also has AS. These drugs did not exist when he was diagnosed. He has had 5 hip replacements, fused SI joints, a partially fused spine and a fused ankle. I hope we will manage to avoid that for my girls - both have partially fused SI joints but NO spinal fusion.

Like I said, we are so very grateful that these drugs exist and I think they could have saved my husband a lot of pain.

Incidentally, we see a researcher for AS (all three of them are in a study) and he told us about this new drug - says it works great (so far) for BOTH Crohn's and AS. We are excited and hopeful.


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## smt (Mar 8, 2016)

JMC said:


> Abbvie, currently gouging an eye watering *$14 Billion* a year from Humira has just bought a new biologic therapy which currently is in stage 2 trials for the treatment of Crohn's disease.
> 
> http://www.pharmalive.com/abbvie-co...ringer-ingelheims-psoriasis-and-crohns-drugs/
> 
> ...


Thank you JMC for this very reasonable post.

The discussion is about Crohn's, of which AS is a co-morbidity in many cases. If maintenance drugs for both help people, that is appreciated. However, as you have pointed out, it is a crying shame that about 1% of the revenue stream is spent on finding a cure. It truly is.

The larger point is that while drug firms are not charities, they have an incentive in not finding a cure (I am not talking of a particular firm or a particular drug). It is also a fact that in many cases there are conflicts of interests. So much so, that it is probably a  sacrilege to talk about a possible "cure" for Crohn's.

Please also factor in the fact that the new drugs are not available (as they are very very expensive) to the majority of humankind. We see here a small fraction of people on this planet, and these drugs are available only to them. I am happy if that helps them, but it is to be appreciated that probably, just probably a real cure would come quicker if drug firms spent a little more money on research for a cure, besides being cheaper for a patient.


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## Beach (Mar 9, 2016)

Interesting.  It is a problem, all around, that few seem all that concerned about changing the system.  

From what I've read I believe all drug companies do that, with patents but also coming out with copy drugs or referred to it as Me Too drugs.  I've seen some write that to get rid of many newer expensive Me Too drugs the FDA and other regulatory authorities should require the new copy drug to be tested against the older often out of patent drug.  If the new proposed drug is better than the old drug then it could be approved.  If not better it should be turned down.  

Of course drug firms lobby heavily against having Me Too drugs reliably direct tested against the older (in this case relatively ) less expensive drugs.  Pharmaceutical companies will also wine and dine/ pay off doctors to prescribe the newer more expensive Me Too drugs.    

Former New England Journal of Medicine editor Dr. Marcia Angell wrote a book about the problems she saw with Me Too drugs.  She, along with a number of others in similar positions, also wrote about the enormous problems seen with the reliability of study information.  

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.” Dr. Marcia Angell.

"The Truth About the Drug Companies: How They Deceive Us and What to Do About It"

http://www.amazon.com/gp/product/B0...=1457523243&ref_=sr_1_1&s=digital-text&sr=1-1



> During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change.
> 
> Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers.
> 
> ...


I don't know if this was posted earlier but also I did see this in the news recently.  

"Injectable 'biologic' drugs are busting Medicare's budget"

http://www.businessinsider.com/injectable-biologic-drugs-are-busting-medicares-budget-2015-11 

& a claimed to be less expensive Me Too biosimilar.  

"Amgen files for U.S. approval of biosimilar to Humira"

http://www.businessinsider.com/r-amgen-files-for-us-approval-of-biosimilar-to-humira-2015-11


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## xeridea (Mar 9, 2016)

The answer, in my opinion, is two-fold:

1. Sensible patent reform. 
2. Abolishing capitalism, which by necessity, must pursue profits.

I think we'll find a cure for cancer before either of the above two happen.


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## JMC (Mar 9, 2016)

xeridea said:


> The answer, in my opinion, is two-fold:
> 
> 1. Sensible patent reform.
> 2. Abolishing capitalism, which by necessity, must pursue profits.
> ...


I agree with 1, but don't think 2 is necessarily the answer. 

What I believe needs to be acknowledged, is that maximising profits, one of the basic tenets of privately and share holder owned companies in a free market, cannot solve all problems.  Maintaining the health of a nation requires that you _minimise costs_, not maximise profits.  We need companies or organisations that succeed by producing good health, not huge piles of cash.  How you do that, I am not sure, but it is clear that the current pharmaceutical industry is a long way from the optimal solution.


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## irishgal (Mar 9, 2016)

When I first heard about biosimilars a few months ago I was horrified. It was in the context of the Remicade patent expiring, and the drug company was now going to push out a biosimilar version of Remicade. Two comments in regard to all of this: If the docs are smart they will just prescribe the generic Remicade and not be fooled by the biosimilar. Secondly, I hope to all that is holy the company making Remicade will not pull it from the market and replace it with a biosimilar, It seems like something big pharma would do - just refuse to make the generic when the patent life runs out. 

I'm glad that Humira and these other biologics are working so well for some pediatric patients above with multiple issues. That's awesome! ANYTHING you can do to keep your kid healthy is excellent, and I'm right there with you since I'd want the same for my kid. I wish these drugs had worked for me, and I know they haven't worked for many others as well. For those of us who run out of options, after trying everything, it would be nice if someone out there was searching harder for a cure. I applaud the groups who put aside large financial gain and work for the patients - and hope that if they are successful they will benefit as much as the pharmaceuticals.


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## xeridea (Mar 10, 2016)

Oh, here's some gasoline for your fire, JMC.


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## stylinmama (Mar 11, 2016)

If drugs companies actually cared we would all be a lot better off. Remicade has been shown to be very little help in crohns patients, and yet it is approved for use in crohns. Meanwhile the anti-MAP drugs have been 30% BETTER at treating crohns than remicade is  (it's somehwere in that range, I can't seem to find the research paper that compares the two this morning). Meaning that anti-MAP works for whatever percentage that remcade works for PLUS another 30% on top of that with LESS side effects. Yet here we are....not able to easily access the protocol for MAP.


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## FrozenGirl (Mar 11, 2016)

I don't think there is a single drug out there for Crohns with higher than about a 40-50% response rate so we kind of have to approve the 30% drugs because none of that have huge percentages of people they work on but we new options so...,


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## stylinmama (Mar 11, 2016)

But there is actually, the protocol for MAP easily has a 50% success rate if not higher which is better than remicade which I believe is sitting somehwere around the 25% success rate. 

I read one study on MAP treatment and crohns that had an 80% remission rate. Very very small study, but something to think about. Another one that most drs tend to say that disproves the MAP theory altogether actually had a 66% remission rate within 16 weeks in participants. In another study there was a reduction in infalmmation in 89% of participants with only 2 of the 19 steroid dependent patients remaining on steroids. So 17 of them were able to come off of steroids after being completely dependant on them. That's remarkable if you ask me! And yet another study that obtained remission in patients (confirmed with colonsocopy!) in 50% of patients up to 10 years later. 

There's many many many more studies that conclude the same results. MAP treatment is far superior to remicade.


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## my little penguin (Mar 11, 2016)

Funny thing about statistics percentage depends on sample size
So remicade is 30% for a very large sample size - numerous studies 
You can't really compare it to any other smaller sample size drugs as Apple to apples.
Not saying map doesn't work or won't have higher numbers just saying you can't make that comparison until you get a larger sample size

One last question which really is the important one
Not all crohns drugs treatment work for everyone so finding one that works for you is really the important thing.
Do you take the map protocol and does it work for you ?

I know it has worked for ore than a few on here


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## stylinmama (Mar 11, 2016)

I wish I could take the protocol!! Given my history and what has and hasn't worked for me, I'm very confidant that I have MAP and that is what is causing my crohns. If only I could find a Dr willing to prescribe the protocol. 

There is a fairly large phase 3 trial going on now with the anti-map protocol. Again, I'm confident it will come out with better results than most of the options out there now.


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## smt (Mar 11, 2016)

my little penguin said:


> Funny thing about statistics percentage depends on sample size
> So remicade is 30% for a very large sample size - numerous studies
> You can't really compare it to any other smaller sample size drugs as Apple to apples.
> Not saying map doesn't work or won't have higher numbers just saying you can't make that comparison until you get a larger sample size
> ...


"Funny thing about statistics percentage depends on sample size"

I cannot understand what is being meant by this.

In statistics, what matters is statistical significance, and if a study is statistically significant, then it passes muster. This depends on a number of factors, including population variance and sample size. If a peer-reviewed publication has accepted a study, then I would assume that it fulfills these criteria and would think no one is comparing "Apple to apples", whatever that means.


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## my little penguin (Mar 11, 2016)

Stylinmama. Tagging Irishgal I think she know who does map and how etc...
Hope that helps


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## GotCrohns (Mar 11, 2016)

Hey JMC,

i get where your coming from but would ask that you take a step back and keep in mind that when Abbie paid for early prototypes of the drug (from BASF) if I'm not mistaken, they and their shareholders took a huge risk and many doomed them to failure. 

Thing have changed a lot since Doctors Banting, Best, McLeod and Collip discovered insulin. After hearing the news about insulin August Krogh and his wife Marie (a doctor and newly diagnosed diabetic) travelled to the University of Toronto where Marie received insulin from Dr. McLeod. By the time they left Toronto, Krogh had bought the licensing rights to manufacture insulin in Denmark. I believe the licensing fee paid to the University of Toronto was $1.00. The goal was to make insulin available to diabetics at the lowest possible price. Today the company that Krogh helped form is Novo Nordisk. They have 40,000 employees and facilities in 8 countries and also operate a Non-Profit Foundation. 

I guess the takeaway from this story is that almost 100 years later there is still no one-time cure for diabetes. I agree with you; it is a shame that biologics are so expensive.  At the same time I know people who receive Humira and Remicade at a very low price through programs offered by Abbie and Janssen. I don't think comparing sales to research dollars is a valid comparison. I've never heard someone comparing the cost of chemo drugs with money raised for cancer research. Lets continue to raise awareness of immunological diseases and do everything we can through Crohn's and Colitis to raise more funds for research in the hope that some day biologoics or newer drugs will be as accessable as insulin,  a cure is found and nobody has to suffer the effects of these awful diseases.


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## JMC (Mar 11, 2016)

stylinmama said:


> I wish I could take the protocol!!


These links should be helpful:
http://thecrohnsinfection.org/treatment-of-crohns-via-anti-map-therapy/
http://crohnsmapvaccine.com/map-specialists-2/


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## stylinmama (Mar 11, 2016)

Well that was an interesting thing to find out. Apparently my GI is on the list of places for the clinical trial. Too bad she won't see me and will be leaving for MAT leave within the next few weeks.


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## irishgal (Mar 11, 2016)

my little penguin said:


> Funny thing about statistics percentage depends on sample size
> So remicade is 30% for a very large sample size - numerous studies
> You can't really compare it to any other smaller sample size drugs as Apple to apples.
> Not saying map doesn't work or won't have higher numbers just saying you can't make that comparison until you get a larger sample size
> ...


I actually agree with this post and it makes an important point which was recently brought up when I talked to a clinical trials designer and reviewer who did the critical Selby review on The Crohns Infection. They said comparing remission rates and trials side by side is generally not done. Now, that seems counterintuitive to patients who want to know which treatment works best, but since each study is designed with certain strict parameters, that then differ from other studies, comparing studies with accuracy is difficult. The side by side chart of AMAT, Remicade and Humira on The Crohns Infection is solely to point out that AMAT (even in the very flawed Selby study) seems to work when the numbers are crunched on an ITT analysis, and that the AntiTNFs have inflated remission rates when using the same ITT analysis. 

Honestly, Selby study should just be thrown out completely and RedHill (when it releases results) should become the new standard. FULLY agree that everyone needs to find a treatment that works for them, and until we get a cure, that will likely differ from person to person. I had amazing success with AMAT and failed the antiTNFs. Others have failed AMAT and loved different treatments. The goal is to have informed patients who can sift through the research and decide which option works best for them alongside their doc. I just wish more docs would take another look at AMAT and use it as an option, if only for the patients who have failed everything else. 

stylinmama - feel free to PM me with anything I can help with. Maybe another Gi in the same practice will know the research and can discuss AMAT with you. Many times docs in the same practice meet and share their cases and ideas, so hopefully you will find someone who can at least discuss it in an informed manner.


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## JMC (Mar 16, 2016)

GotCrohns said:


> i get where your coming from but would ask that you take a step back and keep in mind that when Abbie paid for early prototypes of the drug (from BASF) if I'm not mistaken, they and their shareholders took a huge risk and many doomed them to failure.


I understand the economics of the pharmaceutical industry, it is a game of expectation - probability of success multiplied the income that can be generated.  If they "bet" on 10 drugs, they accept 9 will fail, hoping 1 will be a huge blockbuster covering all of their other losses.  I get it and it is the wrong way to get the outcome we want - drugs which cure, because healthy patients are not a source of large revenues.



GotCrohns said:


> I guess the takeaway from this story is that almost 100 years later there is still no one-time cure for diabetes.


Maybe because, like Crohn's, the research has not targeted the right things... 



GotCrohns said:


> I don't think comparing sales to research dollars is a valid comparison. I've never heard someone comparing the cost of chemo drugs with money raised for cancer research.


There is a difference, Cancer patients generally die or get better fairly quickly, Crohn's can go on for decades generating huge sums of money for pharmaceutical companies.  My point was one about basic economics, there is no financial incentive to cure Crohn's, quite the opposite in fact and this is clearly reflected in the time, effort and money put into researching credible cures.




GotCrohns said:


> Lets continue to raise awareness of immunological diseases and do everything we can through Crohn's and Colitis to raise more funds for research...


Do you know what percentage of the funds raised through, for example, CCUK is spent on medical research into a cure?  _*It is below 15% (£400k, of £3,7M raised), according to their own publicly available accounts.*_  85% of what you donate is spent on non-research staff salaries, generous pensions, offices and PR to raise "awareness".  It's a disgrace.




GotCrohns said:


> ...in the hope that some day biologoics or newer drugs will be as accessable as insulin,  a cure is found and nobody has to suffer the effects of these awful diseases.


There is research going on _right now_, which is starved of funding which could lead to a cure.  I stopped hoping a few years ago and started to get involved, anyone with Crohn's who is serious about a cure needs to be doing that as it will never come from any of the national not-for-profit organisations or big pharma.


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## smt (Mar 16, 2016)

JMC said:


> Do you know what percentage of the funds raised through, for example, CCUK is spent on medical research into a cure?  _*It is below 15% (£400k, of £3,7M raised), according to their own publicly available accounts.*_  85% of what you donate is spent on non-research staff salaries, generous pensions, offices and PR to raise "awareness".  It's a disgrace.


Truly a crying shame.


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## FrozenGirl (Mar 16, 2016)

I might be naive but I still think a cure could come out of for profit companies. I mean look at Hepatisis C, before they had meds that suppressed it, now they have meds that have a 90+% cure rate. That's amazing. So while I am a generally cynical person I still have a bit of faith. Will the cure be cheap? No. But will it exist one day? Hopefully.


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## Zim (Mar 17, 2016)

FrozenGirl said:


> Will the cure be cheap? No.


According to Dr. Amy Hermon-Taylor, full course (two separate shots) of vaccine against MAP is going to cost £4000 (or $5750). (Source: *http://thecrohnsinfection.org/the-map-vaccine-dr-amy-hermon-taylor/*)

Is it a big price for getting your life back? I can't say so.

Just for the reference, *single* entyvio vial is $5000, and hospital expenses in the US can make the cost ot the infusion twice as big.


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## smt (Mar 17, 2016)

Zim said:


> According to Dr. Amy Hermon-Taylor, full course (two separate shots) of vaccine against MAP is going to cost £4000 (or $5750). (Source: *http://thecrohnsinfection.org/the-map-vaccine-dr-amy-hermon-taylor/*)
> 
> Is it a big price for getting your life back? I can't say so.
> 
> Just for the reference, *single* entyvio vial is $5000, and hospital expenses in the US can make the cost ot the infusion twice as big.


That is less than INR 4,00,000. The average per capita income in India was $1200 or so in 2014. To western patients this is a small amount, not to us Indians.

I sincerely hope that some arrangement exists for patients from low-income countries who are deserving.


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## xeridea (Mar 17, 2016)

Zim said:


> According to Dr. Amy Hermon-Taylor, full course (two separate shots) of vaccine against MAP is going to cost £4000 (or $5750). (Source: *http://thecrohnsinfection.org/the-map-vaccine-dr-amy-hermon-taylor/*)
> 
> Is it a big price for getting your life back? I can't say so.
> 
> Just for the reference, *single* entyvio vial is $5000, and hospital expenses in the US can make the cost ot the infusion twice as big.


I think it's oversimplifying it to say that the cost for *any* curative treatment for Crohn's will be under $6,000. There's a method to the madness of drug pricing.


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## JMC (Mar 17, 2016)

Zim said:


> According to Dr. Amy Hermon-Taylor, full course (two separate shots) of vaccine against MAP is going to cost £4000 (or $5750). (Source: *http://thecrohnsinfection.org/the-map-vaccine-dr-amy-hermon-taylor/*)
> 
> Is it a big price for getting your life back? I can't say so.
> 
> Just for the reference, *single* entyvio vial is $5000, and hospital expenses in the US can make the cost ot the infusion twice as big.


I think this is the manufacturing costs of the vaccine, not sure what the cost will be to patients, but hopefully it will be low enough to be accessible to everyone.


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## FrozenGirl (Mar 17, 2016)

xeridea said:


> I think it's oversimplifying it to say that the cost for *any* curative treatment for Crohn's will be under $6,000. There's a method to the madness of drug pricing.


Interesting article, I knew R and D costs and effectiveness came into it but I never thought about insurers. Though now I'm curious if the process if different in places that have universal healthcare....


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