Prescription drug prices discussion

[zork 629]

Prescription drug prices discussion, I'll start with this stunning graphic:

Are the raw material prices for insulin exploding in cost?  Did new regulations increase the cost to account for the 400% rise in prices for the competing brands over the last ~15 or so years?  Did the factories that make the drugs represented in the graphic shut down due to age causing a consistently growing shortage even if the demand was increasing due to the epidemic diabetes(of all kinds but especially type II) in the USA?  Is this price gouging?  

What do you have to say on the topic and please feel free to interject other prescription drug commentary wrt to supply, demand, prices, licenses, etc, etc.

That graph is shocking for a fairly common drug.

[Blotto 23434]

Profits motherfucker. We argue incessantly in this country about who pays for healthcare, rather than why the cost of healthcare explodes exponentially. Our politicians in DC are taken well care of.

[David Dennison 18661]

Here's a pretty good explanation of why it's happening.

[TwiceHorn 31283]

Well, it does go to show that drug costs aren't solely driven by patents.

 

If I had to guess, it would be the tremendous market distortions present in healthcare.  I mean, seriously, how do you even determine a price of a drug?  Almost no one pays "retail" for a drug.

 

I do see that there was a price-fixing suit brought a couple of years ago over insulin prices.  Haven't found any outcome.

[zork 629]

Why no generic versions?  

[maninblack 7974]

Why no generic versions?  

Government

[TwiceHorn 31283]

20 minutes ago, zork said:

Why no generic versions?  

I would hazard a guess that getting an FDA approved manufacturing facility online raises too much of a barrier to entry.  There apparently are insulin-variant patents still in force, and docs are only prescribing the proprietary versions, despite limited or non-existent superiority.

Insulin was first isolated in the 20s and any patents on plain old insulin expired in the 40s.  That form of insulin is public domain, as would be everything discovered/patented for the next 40-50 years.  Plenty of room for generic, meaning unpatented, versions.

 

It appears that Novo Nordisk, one of the "price gougers," also sells a relatively economical form of insulin called Novolin, but it is injected with conventional syringes, whereas the more newfangled ones are administered by pump or single-use pens (ala epipen).  Not having to inject conventionally probably explains why Novolin isn't as popular as the others.

Edited July 15, 2018 by TwiceHorn

[Anastasis 23394]

 

https://www.bloomberg.com/news/articles/2018-07-19/trump-administration-reviewing-proposal-to-curb-drug-rebates

The Trump administration moved swiftly in the past 24 hours to implement pieces of its plan to bring down drug prices, taking some major actions just a few days after a public comment period on the plan ended.

The Health and Human Services Department on Wednesday night submitted a proposal to the White House that would curb kickback exemptions that allow drugmakers to offer insurers and pharmacy-benefit managers rebates widely blamed for keeping drug prices high. Earlier that day, the Food and Drug Administration released a plan to boost the market for so-called biosimilars, which are generic copies of expensive drugs that contain living organisms.

 

On Thursday, FDA Commissioner Scott Gottlieb also said the agency would consider allowing importation of drugs from other countries under certain conditions, including when a generic-drug company that is the sole provider of a medication significantly raises the price of that drug. Astronomical price increases on sole-source generic drugs are what thrust “Pharma Bro” Martin Shkreli into the spotlight a couple years ago.

 

 

[SquishMitten 10401]

Seems as good a place as any to mention my most recent wtf moment.

Went to refill a 3-month script the other day, but I was about 2 weeks early. Because of that, my insurance declined paying for it...cost, $458 (and it's the generic version of the medication). When I balked at this, the pharmacist says "let me apply a coupon and see what the price is" ...new cost, $8. Less than my gotdamn copay would've been had insurance covered it. Absurd. 

 

[Lagunamadre 1975]

I honestly think that big Pharma knows that their run is coming to an end, when both sides of the isle think you are rotten you can expect politicians to start coming after your ass soon. As long as it is the wild wild west, as it is now, they are going to try to squeeze out as much profit as possible while they still can. 

 

[bad_teammate 13132]

Nationalize the pharmaceutical industry.

[TwiceHorn 31283]

1 hour ago, Anastasis said:

 

https://www.bloomberg.com/news/articles/2018-07-19/trump-administration-reviewing-proposal-to-curb-drug-rebates

The Trump administration moved swiftly in the past 24 hours to implement pieces of its plan to bring down drug prices, taking some major actions just a few days after a public comment period on the plan ended.

The Health and Human Services Department on Wednesday night submitted a proposal to the White House that would curb kickback exemptions that allow drugmakers to offer insurers and pharmacy-benefit managers rebates widely blamed for keeping drug prices high. Earlier that day, the Food and Drug Administration released a plan to boost the market for so-called biosimilars, which are generic copies of expensive drugs that contain living organisms.

 

On Thursday, FDA Commissioner Scott Gottlieb also said the agency would consider allowing importation of drugs from other countries under certain conditions, including when a generic-drug company that is the sole provider of a medication significantly raises the price of that drug. Astronomical price increases on sole-source generic drugs are what thrust “Pharma Bro” Martin Shkreli into the spotlight a couple years ago.

 

 

Oddly enough, it seems this Gottlieb fella might be on the up and up.  He trashed all the big-tobacco-bought regs against vaping, too.

[TwiceHorn 31283]

14 minutes ago, SquishMitten said:

Seems as good a place as any to mention my most recent wtf moment.

Went to refill a 3-month script the other day, but I was about 2 weeks early. Because of that, my insurance declined paying for it...cost, $458 (and it's the generic version of the medication). When I balked at this, the pharmacist says "let me apply a coupon and see what the price is" ...new cost, $8. Less than my gotdamn copay would've been had insurance covered it. Absurd. 

 

Yeah, several years back a pharmacist at Walgreens suggested I join their prescription club (was free).  I had a couple of scrips for cold/flu/allergy type things, not long term drugs, but they were cheaper than the copay in the club.  Now I have no copays.  In fact, I have no drug coverage at all until we've spent $14k in a year on medical bills.  Thanks a lot, Obama.

[Anastasis 23394]

5 minutes ago, TwiceHorn said:

Oddly enough, it seems this Gottlieb fella might be on the up and up.  He trashed all the big-tobacco-bought regs against vaping, too.

It's not a particularly high hurdle to clear, but Gottlieb is probably Trump's best appointment. 

[Anastasis 23394]

20 minutes ago, SquishMitten said:

Seems as good a place as any to mention my most recent wtf moment.

Went to refill a 3-month script the other day, but I was about 2 weeks early. Because of that, my insurance declined paying for it...cost, $458 (and it's the generic version of the medication). When I balked at this, the pharmacist says "let me apply a coupon and see what the price is" ...new cost, $8. Less than my gotdamn copay would've been had insurance covered it. Absurd. 

It directly relevant to the discussion of rebates.  Retail Rx pricing is 10x more nonsensical than provider and facility pricing. 

[Anastasis 23394]

7 minutes ago, TwiceHorn said:

Yeah, several years back a pharmacist at Walgreens suggested I join their prescription club (was free).  I had a couple of scrips for cold/flu/allergy type things, not long term drugs, but they were cheaper than the copay in the club.  Now I have no copays.  In fact, I have no drug coverage at all until we've spent $14k in a year on medical bills.  Thanks a lot, Obama.

Also relevant to the discussion of rebates. 

[Anastasis 23394]

20 minutes ago, Lagunamadre said:

I honestly think that big Pharma knows that their run is coming to an end, when both sides of the isle think you are rotten you can expect politicians to start coming after your ass soon.  

I can think of a few million reasons that they won't. 

[pyrohornIII 4809]

A good article on Big Pharma and what could be done.   My brother was a sales rep and my SIL is a pharmacist.  They always throw out the "but research costs need to be covered" argument when discussing pricing on meds.  This says the opposite.  But since BP has been indoctrinating  us with their story for decades, it is hard to get out any other viewpoint. 

https://www.stltoday.com/opinion/columnists/only-a-healthy-democracy-will-save-us-from-big-pharma/article_cccf0305-b72a-59ad-a3ae-fabe7f88d369.html

A quote from the article:

" Drug development and manufacturing used to be considered part of the American “common good.” Two key developers of insulin — Frederick Banting and John Macleod — refused to put their names on the original insulin patent. Jonas Salk, inventor of the polio vaccine, also rejected patenting for his breakthrough; it was just too important for public health to belong to any one person or company.

As a nation, we have always invested heavily in medical research, because we believe that breakthroughs should benefit everyone. In fact, the underlying research behind almost all of today’s medicines was conducted by academic or government researchers with taxpayer-funded grants. But thanks to an obscure provision of the 1980 Bayh-Dole Act, publicly funded researchers can patent their discoveries and sell them to private drug firms, who can then — as my patients know too well — set whatever price they like. Congress could easily change this law so that tax-funded breakthroughs actually benefit the American people, not just corporate bottom lines.

By failing to invest in the public good of pharmaceutical research, we’ve let drug companies set the research agenda. Instead of solving major health problems like Alzheimer’s or Parkinson’s, private firms often just make minor tweaks to existing formulas to extend the patents — and profitability — of their products. In fact, 90 percent of newly approved drugs offer few or no new health benefits, but still win the patents and market exclusivity that keep prices sky-high. "

The author is part of Physicians for a National Health Program:

http://www.pnhp.org/pharma

[RPM 26230]

On 7/19/2018 at 1:58 PM, SquishMitten said:

Seems as good a place as any to mention my most recent wtf moment.

Went to refill a 3-month script the other day, but I was about 2 weeks early. Because of that, my insurance declined paying for it...cost, $458 (and it's the generic version of the medication). When I balked at this, the pharmacist says "let me apply a coupon and see what the price is" ...new cost, $8. Less than my gotdamn copay would've been had insurance covered it. Absurd. 

 

I use the VA for about 99% of my meds so the cost is minimal. I did a TeleDoc thru my work insurance the other day for an abrasion that was getting infected and I didn't want to wait weeks for a VA appointment. TeleDoc cost me $4. I have prescription coverage, but was in a hurry to get to work and couldn't find my card in the CVS drive-thru. The antibiotics (generic) were $90 for a 10 pills.

[BNB 100]

Yeah, go on goodrx.com
Or get the app. It is rediculous. I had one drug that was going to be 600 dollars. Looked it up. Got a coupon. $30

[thrillhammer 683]

On ‎7‎/‎14‎/‎2018 at 8:16 PM, maninblack said:

Government

wut?

[Clob94 121]

On 7/14/2018 at 8:06 PM, TwiceHorn said:

Well, it does go to show that drug costs aren't solely driven by patents.

 

If I had to guess, it would be the tremendous market distortions present in healthcare.  I mean, seriously, how do you even determine a price of a drug?  Almost no one pays "retail" for a drug.

 

I do see that there was a price-fixing suit brought a couple of years ago over insulin prices.  Haven't found any outcome.

I was diagnosed as an asthmatic as a child. Spent time in and out if hospitals until 3rd grade. When Ventolin came along, it was a life saver. I still remember the inhailor price when I was a kid..... $22 dollars. 

 

I got older and with my insurance I could buy it at $12 once the patent expired. 

 

It's $75 without insurance and $35 with it. 

 

Why?? 

Not because they changed the drug..... oh no. Simply because they put a little counter on the back side that shows you how many puffs you have left. Any life long asthma sufferer can simply feel the weight of the inhailor and know when it's time for a new one. 

 

Horse shit deal by them. 

[TwiceHorn 31283]

1 hour ago, thrillhammer said:

wut?

Not entirely wrong.  As mentioned, in addition to approving new drugs (which are usually patented), the FDA must approve manufacturing facilities and processes for many drugs.  It isn't as costly as a new drug application, but it isn't cheap either.  It is a significant barrier to entry for new competitors to make unpatented drugs.  And, it functions as a non-time-limited effective monopoly on unpatented drugs. 

The drug Shkreli arbitraged was this way.  So is HP Acthar, another one recently arbitraged by a small manufacturer then purchased by a big pharma.

The Ventolin inhaler may be patented but there should be other versions of it available, like insulin.  Docs just aren't prescribing it, either out of ignorance or with a gentle nudge from pharmaceutical companies.

 

No more patent reform, please.  The last round, at the behest of big tech, has turned into an epic boondoggle that fucks a bunch of little guys with no discernible benefit except maybe internally at big tech companies.

 

Edited July 24, 2018 by TwiceHorn

[Anastasis 23394]

1 hour ago, Clob94 said:

I was diagnosed as an asthmatic as a child. Spent time in and out if hospitals until 3rd grade. When Ventolin came along, it was a life saver. I still remember the inhailor price when I was a kid..... $22 dollars. 

 

I got older and with my insurance I could buy it at $12 once the patent expired. 

 

It's $75 without insurance and $35 with it. 

 

Why?? 

Not because they changed the drug..... oh no. Simply because they put a little counter on the back side that shows you how many puffs you have left. Any life long asthma sufferer can simply feel the weight of the inhailor and know when it's time for a new one. 

 

Horse shit deal by them. 

Another factor in this specific example is conversion to HFA from CFC based propellants as result of international ozone layer environmental agreements. 

[pyrohornIII 4809]

Since we don't have a health care thread, I keep putting stuff here.

Here's a good article on administrative costs in the US healthcare system. 

What they don't mention is how many jobs have been created by this boondoggle.  So part of cleaning the system up should take into account how to handle the people who would be displaced. 

Used to be when we went to the doctor, a nurse would pull our file and everything we had ever seen the doctor about was in there.  The advent of computers added two new layers at least, those who operate the computers, and those who develop and service the software.   Then you still have to have a paper backup, but security rears its head and now you have companies solely in the business of destroying paperwork. 

Plus back in those simpler days, regular office visits were paid out of pocket, it wasn't usually a hardship for the visit or the meds.  Insurance wasn't a big player on the lower level, it was used more for catastrophe and cancer, big dollar stuff.  Therefore you didn't have all insurance paperwork to deal with.   The amount of administration added to deal with bureaucracy and rules/regulations (each entity has their own unique set) of both private and government systems is staggering.  

https://www.nytimes.com/2018/07/16/upshot/costs-health-care-us.html?mc=contentTWdom&ad-keywords=auddevgate

Spoiler

The Astonishingly High Administrative Costs of U.S. Health Care

Hidden from view: The complexity of the system comes with costs that aren’t obvious but that we all pay.

By Austin Frakt

• Image

Medical records at a health center in Rogersville, Pa., last year. American health administrative costs are largely hidden from view of the public. CreditBrendan Smialowski/Agence France-Presse — Getty Images

It takes only a glance at a hospital bill or at the myriad choices you may have for health care coverage to get a sense of the bewildering complexity of health care financing in the United States. That complexity doesn’t just exact a cognitive cost. It also comes with administrative costs that are largely hidden from view but that we all pay.

Because they’re not directly related to patient care, we rarely think about administrative costs. They’re high.

A widely cited study published in The New England Journal of Medicine used data from 1999 to estimate that about 30 percent of American health care expenditures were the result of administration, about twice what it is in Canada. If the figures hold today, they mean that out of the average of about $19,000 that U.S. workers and their employers pay for family coverage each year, $5,700 goes toward administrative costs.

Such costs aren’t all bad. Some are tied up in things we may want, such as creating a quality improvement program. Others are for things we may dislike — for example, figuring out which of our claims to accept or reject or sending us bills. Others are just necessary, like processing payments; hiring and managing doctors and other employees; or maintaining information systems.

That New England Journal of Medicine study is still the only one on administrative costs that encompasses the entire health system. Many other more recent studies examine important portions of it, however. The story remains the same: Like the overall cost of the U.S. health system, its administrative cost alone is No. 1 in the world.

Using data from 2010 and 2011, one study, published in Health Affairs, compared hospital administrative costs in the United States with those in seven other places: Canada, England, Scotland, Wales, France, Germany and the Netherlands.

At just over 25 percent of total spending on hospital care (or 1.4 percent of total United States economic output), American hospital administrative costs exceed those of all the other places. The Netherlands was second in hospital administrative costs: almost 20 percent of hospital spending and 0.8 percent of that country’s G.D.P.

At the low end were Canada and Scotland, which both spend about 12 percent of hospital expenditures on administration, or about half a percent of G.D.P.

Hospitals are not the only source of high administrative spending in the United States. Physician practices also devote a large proportion of revenue to administration. By one estimate, for every 10 physicians providing care, almost seven additional people are engaged in billing-related activities.

 

It is no surprise then that a majority of American doctors say that generating bills and collecting payments is a major problem. Canadian practices spend only 27 percent of what U.S. ones do on dealing with payers like Medicare or private insurers.

Another study in Health Affairs surveyed physicians and physician practice administrators about billing tasks. It found that doctors spend about three hours per week dealing with billing-related matters. For each doctor, a further 19 hours per week are spent by medical support workers. And 36 hours per week of administrators’ time is consumed in this way. Added together, this time costs an additional $68,000 per year per physician (in 2006). Because these are administrative costs, that’s above and beyond the cost associated with direct provision of medical care.

In JAMA, scholars from Harvard and Duke examined the billing-related costs in an academic medical center. Their study essentially followed bills through the system to see how much time different types of medical workers spent in generating and processing them.

At the low end, such activities accounted for only 3 percent of revenue for surgical procedures, perhaps because surgery is itself so expensive. At the high end, 25 percent of emergency department visit revenue went toward billing costs. Primary care visits were in the middle, with billing functions accounting for 15 percent of revenue, or about $100,000 per year per primary care provider.

“The extraordinary costs we see are not because of administrative slack or because health care leaders don’t try to economize,” said Kevin Schulman, a co-author of the study and a professor of medicine at Duke. “The high administrative costs are functions of the system’s complexity.”

Costs related to billing appear to be growing. A literature review by Elsa Pearson, a policy analyst with the Boston University School of Public Health, found that in 2009 they accounted for about 14 percent of total health expenditures. By 2012, the figure was closer to 17 percent.

One obvious source of complexity of the American health system is its multiplicity of payers. A typical hospital has to contend not just with several public health programs, like Medicare and Medicaid, but also with many private insurers, each with its own set of procedures and forms (whether electronic or paper) for billing and collecting payment. By one estimate, 80 percent of the billing-related costs in the United States are because of contending with this added complexity.

“One can have choice without costly complexity,” said Barak Richman, a co-author of the JAMA study and a professor of law at Duke. “Switzerland and Germany, for example, have lower administrative costs than the U.S. but exhibit a robust choice of health insurers.”

An additional source of costs for health care providers is chasing patients for their portion of bills, the part not covered by insurance. With deductibles and co-payments on the rise, more patients are facing cost sharing that they may not be able to pay, possibly leading to rising costs for providers, or the collection agencies they work with, in trying to get them to do so.

Using data from Athenahealth, the Harvard health economist Michael Chernew computed the proportion of doctors’ bills that were paid by patients. For relatively small bills, those under $75, over 90 percent were paid within a year. For larger ones, over $200, that rate fell to 67 percent.

“It’s a mistake to think that billing issues only reflect complex interactions between providers and insurers,” Mr. Chernew said. “As patients are required to pay more money out of pocket, providers devote more resources to collecting it.”

A distinguishing feature of the American health system is that it offers a lot of choice, including among health plans. Because insurers and public programs have not coordinated on a set of standards for pricing, billing and collection — whatever the benefits of choice — one of the consequences is high administrative burden. And that’s another reason for high American health care prices.

 

 

Austin Frakt is director of the Partnered Evidence-Based Policy Resource Center at the V.A. Boston Healthcare System; associate professor with Boston University’s School of Public Health; and adjunct associate professor with the Harvard T.H. Chan School of Public Health. He blogs at The Incidental Economist. @afrakt

 

[pyrohornIII 4809]

Koch-backed study finds ‘Medicare for All’ would save U.S. trillions

An estimated cost of $32.6 trillion over 10 years is less than the US would spend over the next 10 years under the current system.

 

Hidden in those lines is the idea that the current system that doesn't cover all Americans is projected to cost us more than a single payer system that would cover everyone. 

 

https://thinkprogress.org/mercatis-medicare-for-all-study-0a8681353316/

It is just crazy to think we could have better healthcare across the board for everyone at a lower cost than what we have now. 

Included in the article is a discussion about how opponents try to use sticker shock to dissuade people from even looking at the list of things this system could provide versus what they are getting now. 

And I am not saying that this is the answer, but damn, we should be at least talking about it instead of trying to protect a bloated, top heavy,  dysfunctional system.  We are doing the same thing on energy. 

[Anastasis 23394]

Bozo and I had some back and forth on administrative healthcare costs in the tax reform thread. Administrative costs aren't the primary problem. Yes we have an some inefficiencies that could be addressed.  But the real cost centers are hospitals, providers, Rx, and devices. Three of those four operate at mid double digit margins. The underlying causes of the administrative inefficiencies are broad, but IMO, is primarily related to government involvement and the billing scheme that CMS created. You do have a point thought about all the new industries that spin up to supports claims adjudication, compliance, fraud and grievances, etc.  Anyways, here is that exchange from the other thread. 

 

On 7/11/2018 at 8:38 PM, Bozo_Casanova said:

Yeah, imagine what it would be like if we spent less on healthcare paperwork. What a nightmare that would be.

 

On 7/13/2018 at 8:24 AM, Anastasis said:

"I am from the government and I am here to reduce your paperwork."

 

On 7/13/2018 at 9:18 AM, Bozo_Casanova said:

Funny. 
I am from reality and I'm here to reduce your ignorance.
As you know, our system is so bad it's even more duplicative and wasteful than government programs. 

 

On 7/13/2018 at 10:22 AM, Anastasis said:

You won't get any argument from me that our overall health care provisions is inefficient and has a fundamentally flawed incentive structure. Those data support the conclusion on inefficiency overall. Also according to that chart, the US-based compulsory health insurance schemes (what we think of as government schemes, CMS) appears to be less efficient than the government schemes of almost every other country on the chart (Few exceptions when you combine government and cumpulsory: Mexico, Germany, Slovak).  And within the US, the compulsory government scheme is roughly similar in efficiency, at least in terms of their contribution to overall admin share of NHE, to the voluntary health insurance schemes (private insurance).  Seems to me that what we have is a fundamental problem in the administrative efficiency of healthcare delivery, which is amplified by the somewhat unique private/government mix in the US versus the rest of the world. Wonder if that broad inefficiency has anything at all to do with the healthcare financial paperwork that have reference numbers that start with letters like HCFA and CMS, the associated regulatory burden, and compliance overhead. Nah probably just a coincidence. 

 

Meh, I've outlined a universal healthcare scheme on this board that would bring our administrative overhead down, would generate more market dynamic, align incentives with outcomes rather than services, and provide a social safety net. But it, nor any other reasonable and balanced approach, won't happen.  If you dream of a day when we get a single payer system, or at a minimum a public option, it is coming.  And if I had to wager, 5 years after that rolls out, we'll still be sitting at 8% +/-.    

 

On 7/13/2018 at 10:32 AM, Bozo_Casanova said:

I think we mostly agree on how to provision and pay for care, and you are probably right about how much we would would wind up spending on administration in the aggregate with a public payor, although I'd be willing to bet that the public payor would probably wind up in the 5% range and the private sector would drive the number up. 

As you know, my preference is an almost totally private universal solution, as outlined in Wyden Bennett. I think that's the best path for our country and would put the most downward pressure on cost while providing higher service to nearly everyone. But at this point I'd take a public option or even a vertical "single payer" system as a next step. We've just got to find a way to bring cost down. 

 

On 7/13/2018 at 11:00 AM, Anastasis said:

WB would have been light years better than ACA. I wholeheartedly agree that we have to bring down costs, but in the grand scheme of things, administrative expenses aren't driving NHE.  It's like talking about Departments of Agriculture and Energy expenditures in a discussion about how to rein in federal spending.  The cost centers are hospitals, devices, providers, and Rx drugs. Three of those four, hospitals, devices, and Rx drugs operate at low to mid double digit margins compared to admin cost centers operating at low to mid single digit margins. If you want to control healthcare costs over the next 25 years, you have to tackle drug and hospital pricing and implement strategies to manage utilization of the high cost services and optimize outcomes when high cost services are required.  Of course, the investments associated with doing those things is something that you would mark to the administrative side of the ledger and frame as "wasteful". 

 

 

[hayden_horn 11360]

On 7/24/2018 at 7:47 PM, Anastasis said:

Another factor in this specific example is conversion to HFA from CFC based propellants as result of international ozone layer environmental agreements. 

would a change like this reactivate a patent or result in a new patent?

[pyrohornIII 4809]

The new patent would be on the delivery system instead of the drug, right? 

[Anastasis 23394]

5 minutes ago, pyrohornIII said:

And I am not saying that this is the answer, but damn, we should be at least talking about it instead of trying to protect a bloated, top heavy,  dysfunctional system.  We are doing the same thing on energy. 

I agree that we need to scrap the current system.  I have outlined this in greater detail previously, but I think that we can get there "quite simply" by converting Medicare into a universal catastrophic coverage program, decoupling (what would now be) supplemental private insurance coverage from employment to create a functional market that all Americans can access, extending access to HSA accounts to all Americans, providing a robust safety net for individuals living in poverty, require price transparency, reform aspects of the FDA and patent law, make smart public health investments in comparative effectiveness and cost effectiveness research, etc.  There are functional solutions that can merge a universal coverage backstop with a private free market dynamic.  Problem is, too many entrenched interests with deep lobby pockets and a totally dysfunctional political system.     

[Anastasis 23394]

15 minutes ago, hayden_horn said:

would a change like this reactivate a patent or result in a new patent?

11 minutes ago, pyrohornIII said:

The new patent would be on the delivery system instead of the drug, right? 

 

 

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0148939

Is Patent “Evergreening” Restricting Access to Medicine/Device Combination Products?

For example, in 2008 when the United States’ Food and Drug Administration (USFDA) mandated that all metered-dose inhalers stop using ozone-depleting chlorofluorocarbon (CFC) propellants, pharmaceutical companies switched to hydrofluoroalkane (HFA) propellants [2]. Albuterol, for example, is a common medication prescribed for both asthma and COPD, and is old and off-patent, but new HFA-compatible valves, elastomers, and surfactants were needed to comply with new FDA requirements, resulting in new patentable devices [3]. The new, proprietary HFA-based albuterol-containing products entered the market at double or triple the price of the old, generic CFC-based products [4]. Similar price movements have been observed for human insulin, which despite being an old and off-patent has no generic competition in the United States [5].

Edited July 31, 2018 by Anastasis

[Bozo_Casanova 26285]

Adding some clarity w/r/t my point - I fundamentally agree with Anastasis about this topic, and he's right about where the "margins" live.
That being said: my perspective is that healthy margins on high quality care are incentive to deliver and improve care, because healthy margins indicate opportunity for innovation and disruption. We should put price pressure on care as consumers where substitutional or other options exist because we want to preference things that occupy the highest point on a value/price curve, but, our system works well when it rewards those who create and deliver really good shit to the market.  High margins are not, in and of themselves, indicative of poor value to the market. 

Administration and overhead, on the other hand, is a cost center. It's not evil. It is necessary to provide and deliver the care we want. But a healthy market is constantly searching for ways to capture and eliminate unnecessary cost from the creation and delivery of goods to the end point because it directly subtracts from the market's ability to reward the best value. We shouldn't starve overhead to the point that it inhibits the delivery of care (that's what happened to the VA, essentially), but we should never allow overhead to reward its own growth, which is what has happened in the privately insured healthcare market. People have stopped buying care. They buy policies now, and the carriers work hard to maximize their own administrative role.  

[52-80 19096]

just buy your counterfeit meds from the indian labs on the dark web

[Nice Guy Eddie 13414]

I find the entire healthcare financial system to make little sense.  I'm sure that if viewed in silos and over time, it makes perfect sense how it ended up where it is, but no one would have designed our current state from the beginning.  

For me, the biggest problem is that costs are so hidden from consumers that everyone expects a doctor visit to cost $30 (or thereabouts.)   We expect a doctor to cost the same as we pay the guy to mow our yard.  Obviously we pay premiums, co-pays, deductibles, etc. but who really knows the total that we're paying.   Insurance needs to shift to catastrophic coverage only, and healthcare providers need to be able to communicate prices to consumers on demand.    Then consumers can decide if they want the service or not.  And then the provider receives payment immediately upon delivery.

Obviously there are emergencies or procedures where the costs can't be predetermined or approved in advance but those are the exceptions that can be handled as such.

Trust adults to be adults and communicate the service they are offered, benefits, risks, costs, options, etc.  Then they can decide if they want to purchase the service or product.  Healthcare can closely follow basically every other type of trade when it comes to payment.  

[Anastasis 23394]

4 minutes ago, Bozo_Casanova said:

Adding some clarity w/r/t my point - I fundamentally agree with Anastasis about this topic, and he's right about where the "margins" live.
That being said: my perspective is that healthy margins on high quality care are incentive to deliver and improve care, because healthy margins indicate opportunity for innovation and disruption. We should put price pressure on care as consumers where substitutional or other options exist because we want to preference things that occupy the highest point on a value/price curve, but, our system works well when it rewards those who create and deliver really good shit to the market.  High margins are not, in and of themselves, indicative of poor value to the market. 

Totally agree. I would not harp on pharma margins if there were not example after example after example of bringing products to market that offer minimal incremental benefit over existing treatments. That needs to be addressed by FDA and patent reforms, IMO. Yes, there are lots of ground breaking treatments as well, e.g. novel DA Hep C treatments that basically offer a cure to a previously incurable disease, the benefit of which is often outweighed by a fucking pricing scheme that requires utilization management or your actuarial calculations collapse.

What we need is a fundamental realignment of incentives across the board. Providers, patients, pharma, hospitals. Incentives need to be aligned with the provision of high quality, cost effective care that results in meaningful clinical outcomes that improve health and well being. Achieve those aims, and you have earned your return.  

15 minutes ago, Bozo_Casanova said:

Administration and overhead, on the other hand, is a cost center. It's not evil. It is necessary to provide and deliver the care we want. But a healthy market is constantly searching for ways to capture and eliminate unnecessary cost from the creation and delivery of goods to the end point because it directly subtracts from the market's ability to reward the best value. We shouldn't starve overhead to the point that it inhibits the delivery of care (that's what happened to the VA, essentially), but we should never allow overhead to reward its own growth, which is what has happened in the privately insured healthcare market. People have stopped buying care. They buy policies now, and the carriers work hard to maximize their own administrative role.

I think that you take an overly narrow view of what is involved in the administration component.  Yes, probably the majority is rote paper pushing, call centers, fraud detection, regulatory compliance, etc.  But a significant component is also related to developing and implementing strategies to manage high cost disease states, utilization of high cost services, and to optimize outcomes when high cost services are required.  IMO, we need to invest more on the latter, and to remove the inefficiencies that exist in the former. I think that the best way to achieve that is via market dynamics and competition. But they are both part of the administrative center.

[TwiceHorn 31283]

1 hour ago, hayden_horn said:

would a change like this reactivate a patent or result in a new patent?

It would not "reactivate" an old patent.  It is conceivable that the combination of albuterol or salbuterol (the active ingredient) with a non-chlorofluorocarbon propellant might be patentable and therefore the subject of a new patent application. But, since it is known to replace CFC propellants with hydrofluoroalkane propellants in other aerosol applications, one might think this would be obvious and unpatentable.  Unless there was some "trick" in formulation or chemistry to make the active ingredient compatible with the propellant.

[TwiceHorn 31283]

1 hour ago, Anastasis said:

That needs to be addressed by FDA and patent reforms, IMO.

Please no.  We can't stop granting patents for shitty inventions.  There are more than 10,000,000 US Patents.  I'd estimate that 9,500,000 of them are for shitty, useless inventions, and probably only about 100,000 ever amounted to a commercially significant invention during the term of the patent.  The problem is that you must file a patent application before you know how good an invention really is.  The alternative of delaying patent applications until commercial or other viability is proven is unacceptable.

Drugs that provide only incremental improvements over prior standard of care need to be exposed as such and doctors need to stop prescribing them.  That isn't addressed by the patent system.

Also, that article contains a lot of misinformation and misapprehension of patents.  Primarily, it assumes that any patent granted actually "covers" a commercial product, which is a gross error.

Edited July 31, 2018 by TwiceHorn

[TwiceHorn 31283]

43 minutes ago, Anastasis said:

I think that you take an overly narrow view of what is involved in the administration component.  Yes, probably the majority is rote paper pushing, call centers, fraud detection, regulatory compliance, etc.  But a significant component is also related to developing and implementing strategies to manage high cost disease states, utilization of high cost services, and to optimize outcomes when high cost services are required.  IMO, we need to invest more on the latter, and to remove the inefficiencies that exist in the former. I think that the best way to achieve that is via market dynamics and competition. But they are both part of the administrative center.

This is an interesting and I think insightful observation that relates, again, to the problem that the US innovates medically at a higher rate than the rest of the world, generally speaking.  Yes, even though a lot of those medical innovations are worthless, many aren't and they become available here first and are expensive, both because of the free market here and also because of the massive free-rider problem outside the US (plus the luxury that other countries have of not adopting until later and less costly).  There is a significant overhead component to that in addition to just basic cost.

[Anastasis 23394]

27 minutes ago, TwiceHorn said:

Please no.  We can't stop granting patents for shitty inventions....The alternative of delaying patent applications until commercial or other viability is proven is unacceptable.

Drugs that provide only incremental improvements over prior standard of care need to be exposed as such and doctors need to stop prescribing them.  That isn't addressed by the patent system.

I can see your point to an extent.  Here is how I would approach it.  I am specifically targeting "me-too" type drugs, patent extension strategies that include enantiomer development (cetirizine vs. levcetirizine, albuterol vs. levalbuterol, citalopram vs. escitalopram), metabolites (paliperidone vs. risperidone), extended release formulations (Seroquel vs. Seroquel XR for example), combinations of existing meds, reformulations, etc. Those are just a few examples, some better than others, but plenty more where those came from.  There are clear criteria that could be developed to flag NDAs for products that are not likely to bring substantive incremental benefit in terms of safety or efficacy to the market. I think that you give innovator products full patent protection, and me-too extenders that meet those criteria, you give a very limited period of patent protection.  Give the me-toos an opportunity to demonstrate incremental benefit, pre-defined at the time the NDA is approved, and if they meet the endpoints they get bonus patent life. Default should be null assumption of incremental benefit, if they can scientifically reject that null, they should get rewarded for innovation. 

I do agree strongly that providers and consumers have responsibility as well for the cost effective use of treatments.  That is why price transparency and market dynamic that Eddie alludes to is important. But also why pharma advertising, esp DTC advertising needs to be heavily restricted. 

[TwiceHorn 31283]

Here's the deal.  For true add-ons, the second application, for the add-on drug, is related to the earlier application for the original drug.  Under legal standards for related applications, they are given the same filing or priority date.  Patents expire 20 years from their priority date.  So patents for add-on drugs expire at the same time as the original patent.  It's been that way since 1995.  Prior to that, you could "extend" patent protection for a basic drug by filing an add-on application.  All those patents expired in 2015, at the latest.

 

If it's not an add-on, but a new molecule with essentially the same effect, then it could be subject to its own, non-add-on patent, with a term that does not expire when the original patent expires.  It would be patentable if the new molecule is not obvious in light of the old one. It does not in any way "extend" the patent on the original composition, and is an activity that should be rewarded by a patent, because, in the final analysis, the more effective molecules we have at patent expiration, the better off we are.

 

So, for the most part, you have a solution looking for a problem.  The "problem" of inventing a new inhaler for an old drug again is not a patent problem.  Someone needs to sell the old drug in an old inhaler.  Perhaps the patent holder should be forced to do so.

 

NDAs and patent applications are mostly unrelated.  We don't need to create a new relationship there.  There is already a provision for extending the patent term of important pharmaceuticals that were subject to regulatory delays, ie the FDA.

 

I see most of the problem with incremental drug innovation, or non-innovation, as it were, as being a deceptive marketing practices problem and a willingness by the medical profession to be deceived, and a lack of cost-consciousness.

 

The fundamental problem is not one of patents, it is one of availability.  The basic patent (and any add-on patents) will expire 20 years from the filing date thereof.  The world will then be free to make, use, sell, offer to sell, and import the subject of the expired patent.  If no one does that, that isn't the patent system's fault, that's some other something's fault.  A patent grants only the right to exclude others.  Exemplia gratia:  insulin is public domain.  The patents on new formulations with no benefit don't affect that fact.  If no one is selling or prescribing public domain insulin, that's a problem, but it isn't the patent system's problem.  Same with s/albuterol.

Edited July 31, 2018 by TwiceHorn

[Anastasis 23394]

7 minutes ago, TwiceHorn said:

If it's not an add-on, but a new molecule with essentially the same effect, then it could be subject to its own, non-add-on patent, with a term that does not expire when the original patent expires.  It would be patentable if the new molecule is not obvious in light of the old one. It does not in any way "extend" the patent on the original composition, and is an activity that should be rewarded by a patent, because, in the final analysis, the more effective molecules we have at patent expiration, the better off we are.

Your perspective makes a lot of sense, and we agree on a lot.  And I am not telling you anything you don't already know, but there are overlays that involve not only the chemical entity, but manufacturer and formulation processes as well that are used to extend single source market life.  And a whole slew of legal maneuvers to create barriers to generic entry, and in some cases what appears to be collusion with the generic manufacturers. But can you clarify the section quoted above in the context of some real world examples? How were the following agents treated in terms of their patent coverage and on what basis? Each of these, based on the little I know, have a rather interesting legal history related to the their patent protections and the different argument used by the manufacturers to extent their single source market time. Basically double dippling (or at least 1.5x dipping) on the initial R&D investment. 

Celexa (citalopram) vs. Lexapro (escitalopram)

Claritin (loratidine) vs. Clarinex (desloratidine)

Risperdal (risperidone) vs. Invega (paliperidone)

 

[TwiceHorn 31283]

I'll use (es)citalopram as an example.  According to various sources and confirmed by patent records, to a degree.  Citalopram was first synthesized in the 70s by Lundbeck.  Following normal timelines (synthesis, patent application, approval), the basic patent expired in the early aughts.

Escitalopram is a stereoisomer of citalopram with similar? effects, synthesized in the 90s and subsequently patented.  Because it is a different molecule than citalopram, it was not an add-on patent and not related to the citalopram filings.  Now, whether it deserved another patent being merely a stereoisomer of the original molecule is something I can't opine on, I defer to you entirely.

But.  the subsequent patent on escitalopram did not affect the expiration of the citalopram patent.  Citalopram appears to have been in the public domain for the entire life of the escitalopram patent. 

So, Forest Labs/Lundbeck/Allergan received a second 20 year monopoly on escitalopram  That much is true.  But it is a different molecule.. During that second monopoly, citalopram was public domain.  No one had any more claim to exclusivity to it as a result of the patent(s).

If citalopram was unavailable or monopolistically expensive during the term of the patent(s) for escitalopram, it was from some market failure other than the patent system.

The days of adding simethicone to immodium to create an add-on (continuing patent application is the accurate term) patent to the basic immodium patent and thereby getting a few extra months or years of patent term (for that particular product) are pretty much over.  Those kind of patents all expire on the same day 20 years after their original filing date.

So, my point is, as exemplfied above,  it is rare that the patent system is to blame for doing anything other than operating as intended:  granting temporary 20-year monopoiies to developers of useful, novel, and unobvious subject matter.

[FondrenRoad 4378]

11 minutes ago, TwiceHorn said:

I'll use (es)citalopram as an example.  According to various sources and confirmed by patent records, to a degree.  Citalopram was first synthesized in the 70s by Lundbeck.  Following normal timelines (synthesis, patent application, approval), the basic patent expired in the early aughts.

Escitalopram is a stereoisomer of citalopram with similar? effects, synthesized in the 90s and subsequently patented.  Because it is a different molecule than citalopram, it was not an add-on patent and not related to the citalopram filings.  Now, whether it deserved another patent being merely a stereoisomer of the original molecule is something I can't opine on, I defer to you entirely.

But.  the subsequent patent on escitalopram did not affect the expiration of the citalopram patent.  Citalopram appears to have been in the public domain for the entire life of the escitalopram patent. 

So, Forest Labs/Lundbeck/Allergan received a second 20 year monopoly on escitalopram  That much is true.  But it is a different molecule.. During that second monopoly, citalopram was public domain.  No one had any more claim to exclusivity to it as a result of the patent(s).

If citalopram was unavailable or monopolistically expensive during the term of the patent(s) for escitalopram, it was from some market failure other than the patent system.

The days of adding simethicone to immodium to create an add-on (continuing patent application is the accurate term) patent to the basic immodium patent and thereby getting a few extra months or years of patent term (for that particular product) are pretty much over.  Those kind of patents all expire on the same day 20 years after their original filing date.

So, my point is, as exemplfied above,  it is rare that the patent system is to blame for doing anything other than operating as intended:  granting temporary 20-year monopoiies to developers of useful, novel, and unobvious subject matter.

Well yeah. Outright collusion between Lundbeck and generic producers kept generics off the market in the EU. The EU fined Lundbeck for it. 

Forest chose the old fashioned route and bribed doctors to prescribe the brand name as well as to push it for off label use. They got sued and lost on the latter.  They also published bs studies claiming generics weren't as effective as name brand. 

[Anastasis 23394]

59 minutes ago, TwiceHorn said:

Escitalopram is a stereoisomer of citalopram with similar? effects, synthesized in the 90s and subsequently patented.  Because it is a different molecule than citalopram, it was not an add-on patent and not related to the citalopram filings.  Now, whether it deserved another patent being merely a stereoisomer of the original molecule is something I can't opine on, I defer to you entirely.

Citalopram is a racemic mixture consisting of two enantiomers, s-citalopram and r-citalopram. The enantiomers are non superimposable mirror image molecules, like your two hands. From my perspective. Isolating s-citalopram from the racemic mixture citalopram and calling it a new molecule is like cutting off your left hand and calling your right hand a "new hand".

My argument, along lines previously laid out, would be that such an "advance" would merit only very limited patent protection, unless a significant and meaningful clinical advantage can be demonstrated. The purpose of patents, in my non-legal mind, is to reward and to compensate for innovation and the risk taking required to develop that innovation. With the cases that I laid out, the R&D risk is minimal.  Escitalopram is an example based on the stereochemistry, the other two are active metabolites (if you take loratadine for example, your body converts it to desloratadine which is an active metabolite). Their activity was well understand prior to initiating the registration trials.  The development of these types of agents is a very low risk endeavor relative to a true innovator product.  As such, they do not warrant the same patent protection as an innovator product, IMO. 

59 minutes ago, TwiceHorn said:

So, my point is, as exemplfied above,  it is rare that the patent system is to blame for doing anything other than operating as intended:  granting temporary 20-year monopoiies to developers of useful, novel, and unobvious subject matter.

In these specific examples, I would argue that none of the three criteria you lay out are met.  They are not very "useful", at least to the extent that they provide significant incremental utility compared to the original products.  At best there are only limited niche cases where they offer benefit over existing options. They are not particularly novel.  They are all based on steriochemistry slight of hand or isolating compounds that your body produces anyways when the innovator compound is ingested. And they are not non-obvious.  The structure of all these agents is strongly derivative of the innovator compound and obvious when the pharmacology and biochemistry is well understood. My point being, if this is the intended operation of the patent system when it comes to drug development, it is in need of reform.   

Edited August 1, 2018 by Anastasis
spelling is for nerdz

[TwiceHorn 31283]

3 hours ago, FondrenRoad said:

Well yeah. Outright collusion between Lundbeck and generic producers kept generics off the market in the EU. The EU fined Lundbeck for it. 

Forest chose the old fashioned route and bribed doctors to prescribe the brand name as well as to push it for off label use. They got sued and lost on the latter.  They also published bs studies claiming generics weren't as effective as name brand. 

And this is my point. The problems there were unrelated to the patent system. It has been my contention all along that it is deceptive practices by pharmas and other market distortions, rather than the patent system that causes the problems. 

[TwiceHorn 31283]

3 hours ago, Anastasis said:

Citalopram is a racemic mixture consisting of two enantiomers, s-citalopram and r-citalopram. The enantiomers are non superimposable mirror image molecules, like your two hands. From my perspective. Isolating s-citalopram from the racemic mixture citalopram and calling it a new molecule is like cutting off your left hand and calling your right hand a "new hand".

My argument, along lines previously laid out, would be that such an "advance" would merit only very limited patent protection, unless a significant and meaningful clinical advantage can be demonstrated. The purpose of patents, in my non-legal mind, is to reward and to compensate for innovation and the risk taking required to develop that innovation. With the cases that I laid out, the R&D risk is minimal.  Escitalopram is an example based on the stereochemistry, the other two are active metabolites (if you take loratadine for example, your body converts it to desloratadine which is an active metabolite). Their activity was well understand prior to initiating the registration trials.  The development of these types of agents is a very low risk endeavor relative to a true innovator product.  As such, they do not warrant the same patent protection as an innovator product, IMO. 

In these specific examples, I would argue that none of the three criteria you lay out are met.  They are not very "useful", at least to the extent that they provide significant incremental utility compared to the original products.  At best there are only limited niche cases where they offer benefit over existing options. They are not particularly novel.  They are all based on steriochemistry slight of hand or isolating compounds that your body produces anyways when the innovator compound is ingested. And they are not non-obvious.  The structure of all these agents is strongly derivative of the innovator compound and obvious when the pharmacology and biochemistry is well understood. My point being, if this is the intended operation of the patent system when it comes to drug development, it is in need of reform.   

What you are really driving at is that you believe that these molecules are not patentable and you contend that they are obvious.  I am not sufficiently technical in the area to argue with you on that. 

The standard for obviousness is whether a person of ordinary skill in the relevant art would adapt or combine existing knowledge to obtain the patented invention without undue experimentation.  And, most importantly, not employing hindsight bias.

The language you use describing the situation suggests that you employ some hindsight reasoning, acquired after patented technologies become understood and commonplace, whereas, at the time of patenting, I'm not sure the actual effects of the molecules are known, understood, or predictable. However, the (es)citaprolam example is somewhat unusual in that 20 years elapsed in the interim between development/patenting of the first and second molecules.  Sounds like a good case could be made that escitaprolam was obvious over citaprolam.  I think the more typical case is that a second, similar molecule is developed shortly after the original, so there isn't the benefit of decades of use of the original in discovering its properties and metabolites, etc.  But even in that case, the patent on the second molecule only covers the second molecule, it doesn't extend or otherwise affect the patent on the first molecule.

We have long rejected having different obviousness standards for different technologies, as has most of the civilized world.  It has been something contemplated and studied for the better part of a century, at least.

More importantly, though, in an ordinary market, having a patent on an obvious variation of something is not very valuable, because the basic thing of which it is a variant  is either unpatented or subject of a patent that will expire earlier than the patent on the obvious thing.  To use our example here, if escitalopram offers no advantages over citalopram, having a patent on it is near worthless.  It's like having a patent on Betamax, no one gives a fuck because the standard product is fine (let's not get into standards-essential patents, which get treated somewhat differently).

It only seems to matter in the pharma market, where other, non-patent forces permit effective monopolization of unpatented drugs.  So, again, it's not the patent system's fault.

That is, having a shitty patent on a shitty product like escitaprolam or the current shitty insulin variants, in an ordinary market, is more an academic or theoretical problem than anything else, because the basic product is just as effective and unpatented or soon will be.   And ordinary competition dictates that someone will come to market with the unpatented product at a good price and sell the shit out of it. The problem arises when the unpatented product is unavailable or scarce, which is not a problem with the patent system.

The problem is that the pharmas, with the complicity of the FDA and physicians, steer the market toward the patented product for no justifiable reason.

Edited August 1, 2018 by TwiceHorn

[Anastasis 23394]

I don't know the ins and outs of the legal standards for obviousness. What I know is that the development and marketing of these types of agents does not represent innovation, and IMO, does not warrant full patent protection unless they can demonstrate pre-defined outcomes in terms of actually moving the ball forward in safety and/or efficacy terms. 

19 minutes ago, TwiceHorn said:

More importantly, though, in an ordinary market, having a patent on an obvious variation of something is not very valuable, because the basic thing of which it is a variant  is either unpatented or subject of a patent that will expire earlier than the patent on the obvious thing.  To use our example here, if escittalopram offers no advantages over citalopram, having a patent on it is near worthless.  It's like having a patent on Betamax, no one gives a fuck because the standard product is fine.

Healthcare is not an ordinary market, and has few of the dynamics that a true consumer driven free market require.  If it was a true free market dynamic, where the consumer was engaged in a price transparent decision making process where they were empowered and capable of making rational decisions, I could live with it.  If you want to pay $350 for a months supply of escitalopram when it was branded instead of $7.50 for generic citalopram will achieve the same effect, go for it.  But that's not how it works in reality.  If we want to, as as society, manage our national health expenditures, we have to move the system towards a place where those dynamics can play out to the extent possible. And we need to discourage practices that promote wasteful, non-cost effective treatments. Patent law abuses are, in the grand scheme of things frankly, a relatively minor contributor.  I would much rather tackle price transparency to be honest. The patent issues will shake themselves out when we remove the cloud that obscures pricing.  As it stands now, nobody knows the true cost of betamax ($$$$) or VHS ($), but betamax has the weight of a multiple billion dollar marketing spend 

[Anastasis 23394]

1 hour ago, TwiceHorn said:

And this is my point. The problems there were unrelated to the patent system. It has been my contention all along that it is deceptive practices by pharmas and other market distortions, rather than the patent system that causes the problems. 

There is definite merit to this. I think that to some extent the various issues inter-relate, but your point is well made. 

Edited August 1, 2018 by Anastasis

[TwiceHorn 31283]

5 minutes ago, Anastasis said:

I don't know the ins and outs of the legal standards for obviousness. What I know is that the development and marketing of these types of agents does not represent innovation, and IMO, does not warrant full patent protection unless they can demonstrate pre-defined outcomes in terms of actually moving the ball forward in safety and/or efficacy terms. 

Healthcare is not an ordinary market, and has few of the dynamics that a true consumer driven free market require.  If it was a true free market dynamic, where the consumer was engaged in a price transparent decision making process where they were empowered and capable of making rational decisions, I could live with it.  If you want to pay $350 for a months supply of escitalopram when it was branded instead of $7.50 for generic citalopram will achieve the same effect, go for it.  But that's not how it works in reality.  If we want to, as as society, manage our national health expenditures, we have to move the system towards a place where those dynamics can play out to the extent possible. And we need to discourage practices that promote wasteful, non-cost effective treatments. Patent law abuses are, in the grand scheme of things frankly, a relatively minor contributor.  I would much rather tackle price transparency to be honest. The patent issues will shake themselves out when we remove the cloud that obscures pricing.  As it stands now, nobody knows the true cost of betamax ($$$$) or VHS ($), but betamax has the weight of a multiple billion dollar marketing spend 

True that.  But even if there were price transparency, and concern, say to/by physicians, I'm not sure pharma wouldn't be doing underhanded shit to steer the market toward patented products that have no or very little independent merit.

[TwiceHorn 31283]

8 minutes ago, Anastasis said:

I don't know the ins and outs of the legal standards for obviousness. What I know is that the development and marketing of these types of agents does not represent innovation, and IMO, does not warrant full patent protection unless they can demonstrate pre-defined outcomes in terms of actually moving the ball forward in safety and/or efficacy terms. 

Healthcare is not an ordinary market, and has few of the dynamics that a true consumer driven free market require.  If it was a true free market dynamic, where the consumer was engaged in a price transparent decision making process where they were empowered and capable of making rational decisions, I could live with it.  If you want to pay $350 for a months supply of escitalopram when it was branded instead of $7.50 for generic citalopram will achieve the same effect, go for it.  But that's not how it works in reality.  If we want to, as as society, manage our national health expenditures, we have to move the system towards a place where those dynamics can play out to the extent possible. And we need to discourage practices that promote wasteful, non-cost effective treatments. Patent law abuses are, in the grand scheme of things frankly, a relatively minor contributor.  I would much rather tackle price transparency to be honest. The patent issues will shake themselves out when we remove the cloud that obscures pricing.  As it stands now, nobody knows the true cost of betamax ($$$$) or VHS ($), but betamax has the weight of a multiple billion dollar marketing spend 

Just for the record, the problem is that patents must be filed early in the development process by law (particularly if foreign patents are to be validly obtained) BEFORE the applicant has any knowledge of commercial viability or much more than the barest evidence of clinical efficacy (if you claim it cures cancer, you need some evidence of that fact).  You cannot change the contents of a patent application after filing.  Patents are granted on their technical difference from prior art alone.  This is why the vast, vast majority of the the 10,000,000 US Patents have been worthless.  When and if the market spoke, it gave a resounding thumbs down.

 

I would wager that pharma files thousands of patent applications on compositions that never seek, much less receive, FDA approval.

 

We really don't want to go down a path where patents are considered on some basis other than differences from the prior state of the art.