Miscellaneous And Off Topic Subjects

[Dr. Strangelove]

74% of Americans still say Trump should release his tax returns, including 49% of Republicans

http://www.cbsnews.com/news/poll-most-americans-still-think-trump-should-release-his-tax-returns/

[Dr. Strangelove]

In March 2014 Trump, in a number of interviews, called Russia our biggest geopolitical foe and urged Obama to pass sanctions

1) What's changed?

2) Does Trump actually have core beliefs, or just expediency?

http://www.cnn.com/2017/01/16/politics/kfile-trump-russia-sanctions-2014/index.html

[Jeff Buchanan]

jeff..

You read reports or hear "experts" talk about how the US pays for cost of drug development and the rest of the world benefits. From your perspective, is that true? Seems logical based upon what you just wrote. Basically, big pharma is going to get their money from someone.. so if one area squeezes, the balloon expands someplace else.

One of the pharmaceutical industries common harangues is that price controls of any type would discourage the development of new drugs. The argument goes that it is very costly to bring a new drug to market and the risk of failure is high. If, after 4-6y of testing, a new drug comes to market with the potential for greatly reducing morbidity and mortality for a particular disease, the reward for having taken that risk should be substantial. There is something to this.

Some may have heard of HARVONI? (ledipasvir 90 mg/sofosbuvir 400 mg). Gilead Pharmaceuticals brought this drug through the maze and it hit the market about 3 years ago. It treats and essentially cures Hepatitis C a viral infection for which there is no vaccine to prevent it. It can be deadly. Some 20% of infected and untreated persons develop liver cirrhosis from it. From there it's just a matter of time until you die. So, this drug is a big deal..... it cost $84,000 for 12 weeks of treatment.

No one knows how much Gilead spent to develop the drug and whether or not there is profiteering in Gilead's case. My sense is that the price is not in line with the costs of development and production.

The question you are asking, E, does not have a simple answer. That is because (1) most countries outside the US with national health care systems have strict price controls in place for drugs. (2) New drugs like Harvoni are patented and in Harvoni's case, Gilead is the only authorized producer of the drug. (3) Pharmaceutical Corporations are international in character if not in name. The net effect of these things is that it's impossible to nail down whether or not a benefit in terms of drug savings accrues to foreign governments for drugs being developed in the US.

The salient issue is transparency in the pharmaceutical industry. It is entirely possible for these companies to demonstrate what the cost of bringing a drug to market actually is; once this is known and becomes public knowledge, profiteering ends or at least is curtailed. Needless to say Big Pharma has spent billions on lobbying the US congress to never consider doing this in any way, shape or form. It is possible that this kind of hammer is in Trump's tool chest. He could use it as leverage to extract some kind of a deal with Big Pharma. He did campaign on doing something about the anti-competitive nature of the drug industry.

[iam416]

Gilead just got hit with a $2.5B damage award for patent infringement resulting from its sales of Hep C drugs. My former colleagues won it. Really happy for them.

And I want no part of the government setting acceptable profits. If they want to leverage their negotiating power to force the price down, fine.

[Da Geezer]

Thanks for your posts, Jeff. Really complicated stuff.

And hey, Stan, good to hear from you. I figured you and your dog probably were in a deep funk after the election. Ah,...yes,...a man and his dog........

[iam416]

Also, costs for generic production are fairly straightforward. Very limited regulatory costs. Potential patent litigation costs/delay. Mostly manufacturing ramp up costs.

[Dr. Strangelove]

[ame]https://twitter.com/spectatorindex/status/821130424856391685[/ame]

[Jeff Buchanan]

Also, costs for generic production are fairly straightforward. Very limited regulatory costs. Potential patent litigation costs/delay. Mostly manufacturing ramp up costs.

Which brings up the question of Generics in general and why it takes so long for them to reach the market.

I hesitate to post this because the answer involves patent law which I have no knowledge of. Basically, when a drug is invented the company producing it applies for both a patent and exclusivity rights in selling it. These are two separate things governed by separate statutes and the length of both are determined by two separate government agencies.

The US has the most generous drug patent lengths (20y following invention - and it can take 8y to get a drug to market) of any industrialized nation having a pharmaceutical industry. It is why Pharmaceutical companies with foreign registry, apply for US patents and introduce their drugs in the US market. This is done both to recover the costs of developing the drug and to optimize profits.

Apparently, it is a tangled regulatory web that I can't hope to understand, won't pretend I do and won't take the time to do so. All in all, drug price critics contend that it is this regulatory web of patents and exclusivity rights that delays the introduction of cheaper, generic bioequivalent drugs to the US market. There is also a good deal of legal - meaning legitimate - hanky-panky such as the concept of "pay for delay" where pharmaceutical companies will pay generic drug makers to not produce and market a generic even when it comes off patent/exclusivity.

There's some legitimate basis for this too. I can name and provide figures (but won't) on well known drugs that went generic in the last ten years devastating the bottom lines of major pharmaceutical companies. If you don't have something new or remodeled (another way to get a patent extension) in the pipeline, you're screwed. So, I have some empathy (but not much) for Big Pharma in doing this kind of thing. For me, the industry is so complicated that asking questions like I started this post off with can't be easily answered. It is also why seemingly straight forward and simple solutions like, "well, lets just compete the MMR vaccine with anyone that wants to produce and market it," aren't as straight forward and simple as they seem to appear.

[hack]

When you have an activity that is both a public good AND a for-profit activity, striking a balance between those dual bottom lines is an extremely difficult activity. In some cases there's a good argument for the non-profit/endowment model. Like media. Drugs aren't such, I have always presumed.

[Dr. Strangelove]

Gateway Pundit: purveyor of fake news. I have a feeling both Geezer and Hannibal are big fans

http://www.redstate.com/kimberly_ross/2017/01/16/gateway-pundit-purveyor-fake-news-lashes-redstate-calling/

Also, I found this link by following Jonah Goldberg, Talent's boy. So kudos to him.

[Dr. Strangelove]

Trump's heroes: himself and his dad

[ame]https://twitter.com/ddale8/status/821012282872307712[/ame]

Trump's brilliance shines

[ame]https://twitter.com/ddale8/status/821018763164340226[/ame]

[WM Wolverine]

Were fucked

[Dr. Strangelove]

Teresa May officially confirms that the UK has to leave the EU single market.

[Dr. Strangelove]

Trump enters office as the least popular President-Elect since at least the 70's, with significantly lower approval ratings than everyone from Carter to Obama

http://abcnews.go.com/Politics/trump-remains-unpopular-presidency-hand-poll/story?id=44815005

[iam416]

Basically, when a drug is invented the company producing it applies for both a patent and exclusivity rights in selling it. These are two separate things governed by separate statutes and the length of both are determined by two separate government agencies

Patents confer the exclusive right to sell.

The US has the most generous drug patent lengths (20y following invention - and it can take 8y to get a drug to market) of any industrialized nation having a pharmaceutical industry. It is why Pharmaceutical companies with foreign registry, apply for US patents and introduce their drugs in the US market. This is done both to recover the costs of developing the drug and to optimize profits.

Patents aren't extrajudicial. They apply only to the country that issues them. Companies apply for US patents because they want to sell in the biggest market in the world. US companies apply for EU (and Japanese) patents because the markets are big enough to justify the efforts. They even apply in China where the law is remarkably, ummmm, inconsistent.

I can name and provide figures (but won't) on well known drugs that went generic in the last ten years devastating the bottom lines of major pharmaceutical companies

That's the bargain. You come up with a great idea, we will grant you a patent, but after 20 years from filing it'll be public.

Patent life is measured by when you file. It's 20 years from filing. It typically takes 3 years to get issues -- so you're usually looking at 17 years of patent life. Pharma companies also have the significant FDA framework to get through with "New Drugs" that costs millions and millions and takes years. I can tell you, having representing the company that came up with Celebrex, it costs tons of money.

The US also provides, as you alluded to, an "Abbreviated New Drug Application" (ANDA) for generics re FDA. Basically, you file a 510(k) and say your drug is the same as the one that was previously approved after exhaustive and costly clinical trials, and you get approved quickly.

There are two games Big Pharm plays. First, when they talk about costs, they will invariably include marketing costs. They SPEND on marketing. Second, when they try to game the patent system by filing on minor improvements to their underlying invention to extend the life of the patent and then they use a provision in the ANDA portion of Patent Law to keep generics off the market for up to 30 months -- which could means BILLIONS.

The first part, there's nothing you can really do. The second part involves tweaking and adjusting.

Finally, if they can't keep the generics out, they try to have their 2nd generation drug ready to go. This drug is likely no different than the original. BUT, they'll market the shit out of it and try to convince the public (and doctors) that it is a considerable step forward. The original, afterall, is now generic.

Personally, I prefer the US system to other systems. But, I know how the system is gamed -- a bit -- having done it...heh.