The Suddenly $750 Pill

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johnfajardohenry
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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Thu Mar 02, 2017 10:27 am

PaleoLiberal wrote:It is quite clear that the process is serious flawed. There is nothing to prevent price gouging in the US. Also, since a medicine for acne or ED used in the US will be more profitable than a medicine for a disease ravaging Africa, guess which one gets more research?


Let's say that BigPharmLabs Inc develops a new drug to cure AIDS. It cost $2bn to get approved. It costs $200,000 to make enough to cure a person but only if they can make enough to supply the entire planet. If the $2bn has to be absorbed over a smaller output, perhaps the cost goes to $300 or even $400m. That is just cost. Add, say, 10% for profit to get the selling price.

In the US we are pretty wealthy and can pay, via insurance and/or govt for this.

What about in Africa, or other countries? They can't. They will pirate the drug. Legally in the case of Canada, India and some other countries that can ignore patents if they don't like the price. Or perhaps illegally by China or other countries.

So now the market is only the US which raises the price to US patients.

And worse, once Canada is making it for cheap, people who would normally pay the fair price of the drug will go to Canada to buy it. That increases US cost and price, sending more people to Canada and so on.

So yeah, focus on drugs like ED and Acne that won't be pirated as much and where the costs and maybe some profits can be recovered.

johnfajardohenry
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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Thu Mar 02, 2017 10:29 am

Mad Howler wrote:Oh yeah & lest you forget - there is this ancient expectation to first do no harm.
Whatever, so much surrounding expectation of goodness has been driven out of US.
'Tis something to ponder over - though



Aren't do no harm and expectation of goodness contradictory?

John Henry

jonnygothispen
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Re: The Suddenly $750 Pill

Postby jonnygothispen » Thu Mar 02, 2017 11:53 am

You're empathizing with an industry that controls Congress via campaign donations specifically so they can get more government cheese, & charge the highest prices tolerable, & then expecting a solution from those who are victimized by that process.

Mad Howler
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Re: The Suddenly $750 Pill

Postby Mad Howler » Fri Mar 03, 2017 12:15 am

johnfajardohenry wrote:Aren't do no harm and expectation of goodness contradictory?

John Henry


Do not be the guy whose advocating for a read of 1984,
It's a shit boring book.

Henry Vilas
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Re: The Suddenly $750 Pill

Postby Henry Vilas » Fri Mar 03, 2017 8:27 am

When pharmaceutical companies greatly increase the price of a drug that has been on the market for a number of years, it isn't to recover the cost of R & D. It's because they can. A single payer approach is the only way to control the price.

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Re: The Suddenly $750 Pill

Postby PaleoLiberal » Fri Mar 03, 2017 8:49 am

Henry Vilas wrote:When pharmaceutical companies greatly increase the price of a drug that has been on the market for a number of years, it isn't to recover the cost of R & D. It's because they can. A single payer approach is the only way to control the price.


Lots of truth to this.

There is a distinction between recovering R&D prices on one hand, and getting a virtual monopoly over a medication for the purpose of jacking up the price. Getting back to the $750 pill, that was a completely egregious case of profiteering off of sick people held hostage to one company. That is a situation which calls for regulation.

Oddly enough, for some reason the "Pharma Bro" who jacked up the prices is now becoming a hot item on the lecture circuit for college conservatives. The college conservatives seem to like putting out speakers who will shock others, just to get a reaction. I guess Milo ain't shocking enough.

johnfajardohenry
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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Fri Mar 03, 2017 10:54 am

PaleoLiberal wrote:
There is a distinction between recovering R&D prices on one hand, and getting a virtual monopoly over a medication for the purpose of jacking up the price. Getting back to the $750 pill, that was a completely egregious case of profiteering off of sick people held hostage to one company. That is a situation which calls for regulation.


Doesn't it call for less regulation rather than more? You are right that there is no R&D in the sense that we have been talking in recent notes. The active ingredient is approved as to be safe and effective. Joes Pharmco would not have to do any work to prove that.

But, Joes Pharmco would still have to prove to the FDA that it is safe and effective the way they make it. Sometimes very subtle differences in the raw materials used, both active and inactive, in blending methods, compression, packaging and so on can keep the drug from working as it is supposed to. Could even cause harmful side effects.

That is not generally a problem but Joes Pharmco still has to prove to the FDA that it is not. This costs, at the very least, hundreds of thousands and more probably millions. That cost has to be recovered in the Joes price.

So not billions in R&D but not nothing either. Then, once FDA approval is obtained, ongoing regulatory costs plus all the other normal costs of manufacturing.

And for a drug that has a very small total market. A couple hundred thousand doses a year, IIRC? (That's about 45 minutes on a typical small tablet press) And for which Shrekli can cut the price and drive Joes out of business with a loss.

Maybe the law should be that once the drug is approved, as this one was years ago, no further approval is needed to make is. Joes would still need to comply with all the FDA's normal manufacturing requirements (GMPs), of course.

Probably not a lot of risk doing it this way. But there is some. How much risk is acceptable in pursuit of lower prices?

I wonder how many people besides the govt. are actually paying the $750? A patient can buy it from a compounding pharmacist in their hometown for a buck or two. (Not regulated by FDA) Or they can buy it by mail from Canada for a couple of dollars. I believe I posted actual prices earlier. Not, technically, legal but nobody has ever been prosecuted.

The Epipen also has low cost alternatives. The reason that is so expensive is most likely due to the regulatory scam Senator Joe Manchin's (D-WV) family is running on the govt. I talked about the details earlier here.

John Henry

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Re: The Suddenly $750 Pill

Postby PaleoLiberal » Fri Mar 03, 2017 10:58 am

Good ideas.
Make it easier for others to compete with drugs out of patent.

johnfajardohenry
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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Sat Mar 04, 2017 11:53 am

This discussion got me wondering how big compounding pharmacies (regulated by state pharmacy boards) could be before they became "manufacturers" (Regulated by FDA)

Pretty big, it turns out. And they can sell across state lines throughout the country.

WebMd has a pretty good article. http://www.webmd.com/brain/news/2012101 ... armacies#1 Wikipedia also has some info.

Costs are low because the pharmacist, and the non-pharmacist assistants, can take a pinch of this and a dash of that and make up a medicine with no need for any regulatory approval.

Regulation of the facility is pretty low too, at least compared to an FDA regulated plant.

That can lead to things like this, from the WebMD article:

Oct. 10, 2012 -- How did a single pharmacy in Massachusetts put 13,000 people in 23 states at risk of deadly fungal meningitis?

New England Compounding Center (NECC) is a compounding pharmacy. It has now recalled the 2,410 different drugs it sold in all 50 states. Fungal contamination of at least one product -- single-shot syringes filled with a steroid preparation -- is responsible for the meningitis outbreak.

This raises serious questions about compounding pharmacies, which make some 3% of drugs dispensed in the U.S.


I've been working with sterile drugs for 35+ years. Both terminally sterilized after production and aseptically produced where the components are sterilized beforehand and then combined aseptically, to produce a sterile final product. Neither is a technology that I would want to leave in the hands of a pharmacist in a non-industrial grade facility.

Another thing that jumped out at me was the 2,410 different drugs this company sold. That many different products seem likely to lead to mixups and cross contamination. It would be interesting to know what kind of controls, if any, they have in place. FDA tends to limit the number of different products, especially different types of products, that can be made in a single plant. It also has strict (and expensive) regulations about controls to prevent cross contamination and mixup.

While I might worry about an large scale compounding pharmacy, I suspect that I could feel comfortable with a small scale compounding pharmacy. Say in a hospital for patients, or a drugstore compounding onsite for customers. Never had occasion to use one though. If I do, I will certainly think about it.

We can have high drug safety or cheap drugs. We can't have both. The US, for various reasons, has chosen to err on the side of safety. Could we be a little less overcautious and have lower prices? Of course.

Should we? And how? That would be an interesting discussion.

John Henry

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Re: The Suddenly $750 Pill

Postby Henry Vilas » Sat Apr 01, 2017 7:31 am

Thirteen lots of Mylan's EpiPen and EpiPen Jr. are being voluntarily recalled by the manufacturer, the US Food and Drug Administration said Friday.

"This recall is due to the potential that these devices may contain a defective part that may result in the devices' failure to activate," the FDA said in a news release.


As the price goes up, quality control goes down.

As an aside, are Trump's proposed budget cuts going to affect the FDA, as he doesn't like regulatory agencies?

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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Wed Apr 05, 2017 3:01 pm

I think we all agree here that the cost of pharmaceuticals is too high and that makes the price of pharmaceuticals too high.

President Trump sounds like he is serious about doing something about it with his pick for head of FDA. I clipped this a couple weeks ago but helping President Trump make America great again has been keeping me on the hop. Maybe this will bring some anti-Trumpers to the bright side.

The high costs of the clinical trials favor large pharmaceutical companies while innovative small companies must continually raise capital since they cannot generate revenues from drug sales until they secure FDA approvals. Moreover, investors are not eager to fund radical innovations that face the added risk of uncertain FDA testing demands.

If confirmed, Gottlieb will be in a position to change these incentives and introduce a new regulatory paradigm focused on competition to accelerate innovation, dramatically shorten the time from development to patient access, and sharply reduce the prices for new drugs — all to the ultimate benefit of patients. Rather than settling for the status quo that rewards delayed access and excessive caution, he can promote early access and fast learning.


http://thehill.com/blogs/pundits-blog/h ... -sooner-at

Good for him. Cutting the approval cost and especially reducing the approval time, will go a long way to cutting the cost of making drugs.

John Henry

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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Wed Apr 05, 2017 3:05 pm

Henry Vilas wrote:Thirteen lots of Mylan's EpiPen and EpiPen Jr. are being voluntarily recalled by the manufacturer, the US Food and Drug Administration said Friday.

"This recall is due to the potential that these devices may contain a defective part that may result in the devices' failure to activate," the FDA said in a news release.


This is why the pen can only be sold in two-packs in the US. Even when made under perfect quality assurance, they will still fail. Some, perhaps many, of the failures will be due to how the pens are handled and stored by the customer as they carry them around in a pants pocket, tool box, purse or book bag.

If one fails, the second one provides a backup.

I don't see the advantage to the pen over a plain old preloaded syringe. Simple, reliable, fail proof and proven technology. Easy and cheap to make. Price to consumer about $20 for 2.

John Henry
Last edited by johnfajardohenry on Wed Apr 05, 2017 3:24 pm, edited 1 time in total.

johnfajardohenry
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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Wed Apr 05, 2017 3:22 pm

I had an interesting conversation with a client last week. One of the big pharmas.

They make self-stick bandages (Like Curities or Bandaids) they also make a Neosporin like ointment to put on a cut before you put the bandaid on. Seems like a natural fit to put a dab of the ointment on the bandaid before sealing it up and the company has been doing this for a couple years.

Here's the problem: Bandaids are classified as a "medical device" and are regulated under one set of GMPs (Good Manufacturing Practices as the FDA rules are called)

The ointment is a classified as a drug and is regulated under the much more comprehensive, and expensive to comply with, drug GMPs.

So is the bandaid with the ointment a drug or a device? The company had been claiming it is a device. Just a better bandaid. FDA is now claiming that, because of the ointment, it is not only a drug but is also a drug delivery device.

FDA and the company are arguing about it and who knows how it will turn out. If it does turn out to be a drug, it will need to be manufactured in a drug plant. If the bandaid does turn out to be a drug and/or a drug delivery device, a lot of testing to prove safety and efficacy will likely be required.

If you go to the drugstore and find that a box of ointment impregnated bandaids now cost $15 while a tube of ointment and regular bandaids together cost less than $5, you'll know what happened.

If I were FDA, I am not sure how I would rule. I can certainly see their point about the combo being a drug. OTOH, regulating it as such seems like overkill. I'm glad it is not my problem.

John Henry

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Re: The Suddenly $750 Pill

Postby gargantua » Wed Apr 05, 2017 4:38 pm

I had to do a lot of scrolling to get to the Quick Reply box today.

johnfajardohenry
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Re: The Suddenly $750 Pill

Postby johnfajardohenry » Mon May 15, 2017 7:52 am

Scott Gottlieb got confirmed last week as FDA Commissioner. I'd written about him here previously.

viewtopic.php?f=40&t=61502&p=849495&hilit=750+gottlieb#p849495

Sounds pretty good to me.

John Henry


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