2 much of a dick to be free

12/17/2015 10:11:37 AM

Hahahahah

http://www.dailymail.co.uk/video/news/video-1237876/Video-supposedly-shows-Martin-Shkreli-rejecting-FBI-call.html

Quote :

"Video supposedly shows Martin Shkreli rejecting 'FBI call' on a livestream."

LOL how the hell did that get released to the world???

12/18/2015 9:34:44 AM

Guy was live streaming shit all the time.

You couldn't make up a funnier string of events.

12/19/2015 8:06:27 AM

http://money.cnn.com/2016/08/22/news/companies/bernie-sanders-pfizer-pharmaceuticals/index.html?iid=hp-stack-dom

Git 'em Bernie!

129k for a doss of this drug for prostate cancer? Really?

Sure, there are lots of costs associated with these drugs, but the article states that it was developed at a public university, using public grant money. Soooo.....wtf.

8/22/2016 3:34:00 PM

nothing will come of this because he's an ideological prop. the dustpan of the party. I feel so bad for ever falling victim to it.

[Edited on August 22, 2016 at 3:39 PM. Reason : j]

8/22/2016 3:38:58 PM

the epi-pen i just bought was almost twice the cost of the epi-pen i bought 2 years ago, i still bought it because insurance will reimburse me but fuck that, I'm buying a another brand next time

8/22/2016 3:57:19 PM

FDA approval should be optional

8/22/2016 8:41:28 PM

Quote :

"git 'em Bernie! 129k for a doss of this drug for prostate cancer? Really? Sure, there are lots of costs associated with these drugs, but the article states that it was developed at a public university, using public grant money. Soooo.....wtf. "

You don't understand the half of it. Here it is in a nutshell:

1. Drug discovery - normally requires tons of screening and testing processes

2. Drug development - taking a lead and developing it into a potent inhibitor

3. Synthesis Streamlining - bring the synthesis of this inhibitor down to 5 to 10 chemical steps

4. Process Development - Being able to make multiple kilogram batches, not just grams

5. Metabolitic stability and deliverability - going from an ITC cell to delivery in an actual human body. The big problems here are 1) is the inhibitor even going to make it to the target and 2) will it be selective against all the other receptors in the body.

6. Raw Material Production - Must pass extremely tight purity tests and analyses of the toxicity of impurities

7. Tablet / deliverable production - All engineering/manufacturing to turn a powder into pill or tablet

9. Tablet Stability - Entire divisions and departments in pharma are needed to ensure that the tablet doesn't break down before the expiry date.

10. large scale / continental production of the product

As you can see, what people refer to as "drug development" is usually only steps 1 and 2 of this very simplified 10 step procedure to actually develop a drug.

This doesn't include FDA testing and screening.

Also, for every project that makes it through to the market, the number is something like 10x fail and get thrown away.

So yeah, it is a fairly under appreciated amount of work.

Quote :

"This. Fuck pharma. I don't disagree with companies recouping their costs + profit, but when citizens of one country pay $100,000 for treatment and those of another pay $1000, someone's getting fucked hard. "

Let's put it this way. Let's say you like coffee a lot and spend a year's worth of buying and trying different coffee beans and brewing methods until you have your perfected, delicious recipe. So, you make a batch.

But is that the end of the road, or do you want more? You probably want more right? Yes... yes you do. But now, you don't have to develop it because you are a good coffee bro and took notes and shit, you just have to produce it again.

This is where you can get into differing prices per country, in regards to pharmaceuticals. Once the drug is established, then production factories set up in different parts of the globe can produce to varying standards and cost in that country, which in turn can make the price vary.

I am not saying that that accounts for it all, but it is definitely factor. Drugs by US firms are not made solely in the US and then shipped over seas. There are hubs in each of the major continental regions that take over batch production every year according to regional standards and costs.


[Edited on August 23, 2016 at 2:14 PM. Reason : a]

8/23/2016 1:59:36 PM

[Edited on August 23, 2016 at 2:14 PM. Reason : dp]

8/23/2016 2:09:31 PM

Yeah, but it's a lot harder to get indignant and feel like you're self righteously outraged if you understand the totality of something.

It's quite possible that big pharma is out of control, in fact it's highly probable that they are involved on price fixing, monopolistic behavior, and rent seeking behavior via bribes, donations and political influence. But if I learned all that the crux of my complaint wouldn't be "the price is too damned high!"

8/23/2016 2:22:22 PM

I'm sympathetic to Pharma's research and regulatory costs, they are very high compared to just about any industry.

But don't be deluded into thinking that's where they sink all of their profits. Across the board nearly every major Pharma company has announced multi-BILLION dollar stock repurchase programs in the last few years. Many have been sinking billions into their own stock for the last two decades. An estimate I recently saw for Phizer indicated they had spent close to 70% of company profits on stock repurchases over the last decade. They're ensuring their stock meets the next quarter growth goals (bonuses yo) by overcharging the sick and dying. It's fucking disgusting.


**logs into scotttrade to pick up a few more pharma stocks**

8/23/2016 2:59:02 PM

those stocks will all burst when the revolution happens.

8/23/2016 4:39:11 PM

There are high costs, and then there are "cost as much as a small house for one treatment" high costs.

Biologics? They are very difficult to emulate in order to come up with a generic, and they are at least $1200/month. Granted, Humira isn't a life or death drug, 1200 is prohibitively expensive for many people, even people with insurance.

8/23/2016 4:57:58 PM

when is something priced reasonably?

8/24/2016 10:09:15 AM

^^as an example, Humira is owned by Abbvie, from quick googling they've announced somewhere between 5 and 8.8 billion in stock repurchases in the last two years (hard to tell exact amount since they put no time limit on one of the 5 billion announcements and I'm not sure if there is overlap in the announcements), they reported a total of 900 million per year spending on R&D.

^when the price is set by a well-functioning market

8/24/2016 11:25:26 AM

I guess it depends on how much profit the company is deriving from that 129k. To me, these types of pharmaceutical prices don't and can't apply to a normal market. It isn't like I want Taylor Made golf clubs over Titleist because I like the name better. It is a life or death situation, this is the only company that makes this drug, and I can't go "shop around" for it. So how much profit should they be allowed to make? Should their profits be regulated since a normal market doesn't apply?

8/24/2016 11:32:41 AM

Exactly! Market failures occur. They are real and the individual outcomes are bad for way too many. We should take steps to minimize those failures.

8/24/2016 11:39:49 AM

There are some very serious IP laws that need to be re-examined moving forward. I believe strongly in allowing inventors and developers to recoup costs and have a chance to not just break even, but to profit.

However we currently allow, for example, nearly unlimited copyright (I know patents and copyright are different) extension and in addition to patent times being really long, we also have the FDA doing things like determining who can and cannot make things that are no longer the exclusive domain of the patent holder. We also have a wide variety of things that honestly should be non-prescription still on the Rx lists. We don't allow enough experimental drug treatment, especially terminal patients who have nowhere else to turn.

The drug companies are hardly a shining example of ethical corps, but there are a lot of ways that our government exacerbates things. It's a horrible case of cronyism run amok.

8/24/2016 11:57:28 AM

I'd agree, but that still won't solve the problems of people not acting rationally when they are sick/dying or the massive information asymmetry that occurs across the healthcare industry between consumers and producers.

Just face it, healthcare lacks many of the requirements that we classically (by definition really) require to be present in a "free" market.

8/24/2016 12:08:25 PM

oh for sure. Price gouging laws are generally a good thing even though they run contrary to a classical free market system, but there hasn't been anything even vaguely resembling a free market for drugs in at least a hundred years if there's ever been one.

8/24/2016 12:15:46 PM

Something else interesting - The CEO of Mylan, the manufacturer of EpiPens, is the daughter of WV senator Joe Manchin. Mylan began raising the price of the EpiPen after "successfully pushing legislation to encourage use of the EpiPen in schools nationwide."

The phrase I quoted in the last sentence, as well as pretty much this whole post, was taken from the Bloomberg article on the subject of Heather Bresch, Mylan's CEO.

Now I'm not saying (and neither is the article) that Manchin's influence got the legislation to put the pens in schools passed, but it does seem kinda fishy. I hope Manchin at least has the decency to recuse himself when his daughter is called to Capitol Hill for questioning over the 400% price increase.

[Edited on August 24, 2016 at 3:26 PM. Reason : s]

8/24/2016 3:26:04 PM

The government, by virtue of regulations, makes drug prices so high, that's why I believe the market place will mostly never favor the common person.

Sometimes companies have to create a entirely new department to meet the demands of regulation imposed by the FDA.

[Edited on August 24, 2016 at 7:27 PM. Reason : /]

8/24/2016 7:26:30 PM

There is nothing free market or libertarian about the government throwing a drug maker's competitors in prison.

8/24/2016 11:05:13 PM

And in terms of the EpiPen, the generic version didn't get approved by the FDA. I find that a little suspicious. I need to research why exactly the generic brand didn't get approved. And Mylan's only other competitor went out of business. So without any further research done on the matter, it would appear that our government has given Mylan a monopoly for the "epinephrine administration" market.

Ampoules of epinephrine cost like $10 dollars. So you're paying 590 for springs and plastic?

8/25/2016 10:18:23 AM

^ from what I read, the generic was not dispensing reliable dosage every time.

PS- The cnbc interview was really frustrating.

http://www.cnbc.com/2016/08/25/mylan-expands-epipen-cost-cutting-programs-after-charges-of-price-gouging.html

8/27/2016 1:26:17 AM

Quote :

"The government, by virtue of regulations, makes drug prices so high, that's why I believe the market place will mostly never favor the common person"

So the government is to fault for the EpiPen price hikes we're discussing ITT?

And why would any market place ever favor the common person? That's not what it's designed to do.

8/27/2016 11:24:37 AM

yes and no

the government is responsible because it allows and enables monopolies that allow it, they are not responsible because of some inherent nature of government were if the government didn't exist and there was a pure free market this wouldn't be an issue

8/29/2016 8:21:29 AM

So it looks like these stories going public is doing some good - MyLan is now going to release a generic that is *only* $300.

8/29/2016 1:42:18 PM

So perhaps someone more knowledgeable can explain this to me. They are creating a generic of their own product that is half the cost, why would anyone buy the non-generic then?

8/29/2016 2:44:00 PM

^I was curious about that as well, but then I got to thinking about all of the store brand foods. I mean, food lion doesn't have a production line for every single food lion branded item. They just commission the name brands to take their lesser-quality products and slap a food lion label on them. I guess it is the same kind of deal here.

8/29/2016 2:49:47 PM

Store brand food is different, I used to work for Pepsico and saw how they did private label foods/beverages and they would always alter it a bit. Like for chips, they might add less salt or not fry them in the same way or something else that makes them a little less desirable. Generic medication on the other hand is the same thing.

8/29/2016 3:22:44 PM

I wonder if the patent for the formulation expired? If they don't hold the patent anymore any company can prepare a different formulation with the active ingredient, and since it's already FDA registered, it doesn't need to go through the same regulatory standards anymore, so generic can be cheaper. Pfizer makes the brand formulation and will make the generic as well. I am still scratching my head with this. Maybe someone at my job can help answer this.

8/29/2016 9:28:44 PM

^ http://www.nytimes.com/2016/08/25/business/mylan-raised-epipens-price-before-the-expected-arrival-of-a-generic.html

[Edited on August 29, 2016 at 9:41 PM. Reason : rinse, repeat]

8/29/2016 9:41:32 PM

Quote :

"They are creating a generic of their own product that is half the cost, why would anyone buy the non-generic then?"

Because doctors don't know about the generic substitute, so they write the prescription brand explicit (there is a term for it in the industry I can't quite recall). Also, customers don't know the generic is identical, so will object to their pharmacist if they try to substitute (this isn't the box I got last time!). Either way, $300 is still an absurdly high markup for what is being purchased.

Quote :

"I wonder if the patent for the formulation expired? If they don't hold the patent anymore any company can prepare a different formulation with the active ingredient, and since it's already FDA registered, it doesn't need to go through the same regulatory standards anymore, so generic can be cheaper."

The drug is old and readily available from any number of manufacturers at absurdly cheap prices. What is at issue here is the plastic delivery device known as the epipen, which allows patients to self administer a given dosage of the drug. This plastic pen is under patent, so attempting to manufacture identical piece of plastic is very illegal until the patent expires. Until then, the only way to clone the epipen is to create a new device and get it verified from scratch by the FDA, an absurdly expensive hurdle only one company was able to clear, only later to be shut down completely by the FDA after a few dosage irregularities.

But the economics is interesting. It will cost a company hundreds of millions to get a product approved by the FDA and to market, only to be able to compete against the existing epipen, which has brand recognition and can slash prices to nothing tomorrow. The real mystery is why so many companies have pending applications with the FDA for their own epipen designs. If the outrage over the epipen gets fervent enough, maybe the FDA can be shamed into approving one or more of those applications. Although I seriously doubt it will happen.

8/30/2016 10:29:03 AM

Why should a company not be able to protect their interests when they have discovered/developed something that is a game changer?

8/30/2016 5:00:07 PM

^^ I wasn't sure if EpiPen referred to the whole unit or just the plastic injector. I thought the patent may have run out for the epinephrine formulation. Pfizer manufactures the drug for Mylan. But Pfizer also bought Meridian Medical Technologies which will be making the generic device for Mylan. They were making the Epipen brand for them as well.

8/30/2016 9:51:05 PM

http://www.nbcnews.com/business/business-news/how-mylan-s-multimillion-dollar-marketing-convinced-us-we-need-n637781

Quote :

""One element of Mylan's outreach efforts is to advise patients to double up on EpiPens—information that is parroted by doctors, parents and school nurses who repeatedly fear that "something could go wrong with your first attempt at giving the shot." ...(snip)... Though a small number of patients do require a second dose, it would appear the device is mainly sold in packs of two due to imperfect product design: A recent study conducted by the American Academy of Allergy, Asthma & Immunology that compared the EpiPen to a competing product, the Anapen, concluded that the EpiPen is the most difficult type of auto-injector to use. The study showed that even after one year of training on the product, 14 percent of parents still accidentally stuck the needle in their own thumb instead of in their child's leg, as compared to zero percent of parents using the Anapen (which is not available in the United States). In fact, the emergency device is so difficult to use that Mylan employs a special team of trainers to teach school staff and first responders how to use it; those teams have also come under scrutiny: At least one of the three authors of a 2012 paper that said people forget how to use EpiPens after about three months and require additional retraining disclosed financial ties to Mylan in a subsequent academic study, according to ProPublica."

Any redesign of the Epipen, even by the designer of the original Epipen, would require a full from scratch re-approval by the FDA. As such, not only is no one willing to spend a fortune to get through FDA approval and compete against the flawed Epipen on price, the makers of the Epipen themselves are unwilling to spend a fortune to get through FDA approval to fix the flaws in their own product.

The FDA is the problem here and people are dying because of it: either due to being trapped with a poor design or from being unable to afford the monopoly pricing.

Of course, the patent issue is also a problem, as it also costs a lot to do a patent search and even then you might still get sued.

8/31/2016 10:30:24 AM

It's the FDA's fault they made a shitty injector the first time through?

8/31/2016 10:38:19 AM

I'm usually not one to tout other countries over our own, however I feel like Europe's versions of the USDA and FDA are far superior to our own.

8/31/2016 10:38:52 AM

counterpoint: I'm never again allowed to donate blood because I lived in London and they had the whole mad cow disease when I lived over there

[Edited on August 31, 2016 at 11:31 AM. Reason : .]

8/31/2016 11:30:44 AM

^^

I work in big Pharma in Europe, and the FDA still has a ton of say over here because of the abundance of American products. A lot of this then filters over to European products.

Most of the regulations and colloquiums of Pharma (as a whole) are terms and guidelines that originated and are mostly still used by the American Pharma industry.

[Edited on August 31, 2016 at 3:06 PM. Reason : k]

8/31/2016 3:03:44 PM

It's some doctor's blog, but this is actually a pretty useful rundown of the FDA's culpability in this epipen outrage. It's been linked to by a few journalists on twitter.

http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-drugs-vs-chairs/

8/31/2016 4:13:54 PM

I think the FDA shares some culpability, but comparing it to chair sales is fucking stupid and I'm guessing so is that author. Duuuurrrrr. Chairs accidents kill 50 people a year, durrrrrrr, meanwhile something like 15,000 people are hospitalized for anaphylaxis a year.

The FDA has a well known backlog of product approval, most of this due to funding issues (Thanks GOP!) and that should be addressed ASAP. Otherwise the main issue in regards to Epipen is the FDA siding to far on the side of safety. The FDA, much like the voxsplaining author, has to account for the lowest common denominator. Their rejections of the TEVA product were most likely (from what I've read) due to the FDA expecting similar use instructions so any dumbass trained in Epipen could also use the TEVA product. Simultaneously TEVA has to avoid patent infringement, seems impossible.....

Again I think the FDA shares some culpability. They should go ahead and assume that after a short proliferation of the competing products even the terminally stupid should be able to comprehend competing instructions for the two different products.

The answer IS NOT to allow a manufacturer to fill pens with piss water or allow products that overdose just so we can lower the cost of the pens.

8/31/2016 6:26:47 PM

Then this story is confusing. Are they coming out with the generic version of the autoinjecter or the drug itself?

http://www.stltoday.com/business/local/st-louis-area-manufacturer-of-epipens-to-produce-mylan-s/article_6f8b3a18-aa47-5487-86ef-6c4602313aa2.html

8/31/2016 6:49:17 PM

Quote :

"Also, for every project that makes it through to the market, the number is something like 10x fail and get thrown away."

currently it's even more bleak ... about 1 in 5000 drugs will make it through trials, to approval, and to market.

8/31/2016 7:23:27 PM

Fuck it.

[Edited on August 31, 2016 at 8:29 PM. Reason : Fjdjfk]

8/31/2016 8:28:48 PM

Re: LoneShark's article.

I watched the interview by CNBC again, she def drilled it home.

http://www.cnbc.com/2016/08/25/mylan-expands-epipen-cost-cutting-programs-after-charges-of-price-gouging.html

1:09 …to ensure that everyone who needs an EpiPen, has an Epipen
2:50…EpiPens need to be everywhere
3:00…when you have severe allergic reactions you need EpiPens in seconds
5:32…if I reduce the list price I couldn’t ensure that everyone who needs and Epipen gets one
7:00…we want everyone who needs an EpiPen to have one
8:00…EpiPens need to be everywhere
9:00…access to EpiPens
17:00…ensure nobody goes without an EpiPen
18:30...make sure that parents know they have access to EpiPens

8/31/2016 11:52:21 PM

The drug is not on patent, the dose in an epipen is a dollar, maybe less. For whatever reason the FDA has not approved other delivery methods. Mylan has successfully lobbied to get these things all over the place, mandate that schools have them, etc.

It's not just a casemail of a greedy company although that's a large part of it. It's also that the gov. Has enabled a monopoly.

[Edited on September 1, 2016 at 3:09 AM. Reason : Cghhh]

9/1/2016 3:09:24 AM

But let's be clear that the alternative to a monopoly could very likely be a company selling a product that either doesn't apply a dose or applies way too much of a dose, resulting in likely terrible outcomes for individuals.

9/1/2016 6:30:24 AM

If FDA funding is an issue, and we're going to blame the GOP for lack of funding, let's look at the bills providing the funding, and see how much pork is involved in those bills.

9/1/2016 8:21:32 AM