How do we partner with Pharma?

[Arnie Pye]

You got kicked off T3? That’s so cruel. It’s so cheap now too. Someone at NHS is a very poor negotiator. Can you buy it online?

I have my frustrations too, because the government here once considered banning thyroid meds. But ultimately the patients and doctors won, and thyroid meds are a common occurance now. It’s just crazy, some if the decision making. I humorously say, “lets ban all psych meds!” Well more seriously they can’t, because it’s THE cash cow at every big Pharma.

I was never allowed on T3 or any other thyroid medication. My TSH was described as "bordeline underactive" or was over the range for nearly 25 years, but never reached the dizzy heights of 10 which is what it has to be for overt hypothyroidism to be diagnosed in the UK. People who are overtly hypothyroid are, with very few exceptions, only ever prescribed Levo in the UK. NDT isn't licensed, and T3 has been banned by almost the entire NHS because it costs £9.22 per tablet here, even though it is reasonably cheap elsewhere in the world.

I started treating my own thyroid a few years ago by buying thyroid medications online, which has the potential to be very dodgy, and it is getting harder and harder to pay for the products because more and more banking facilities are being withdrawn from businesses which sell prescription drugs without prescriptions.

The quality of education of doctors on the thyroid is truly abysmal in the UK. On the thyroid forums I read it is quite common for members to join who have had to be stopped from taking prescribed carbimazole because their doctor thought a TSH of 50+ was hyperthyroid! Many doctors don't believe secondary or tertiary hypothyroidism actually exists. They don't test for it because they think it is vanishingly rare - a good way of making a disease disappear.

Some people have had to be dissuaded from getting their thyroid nuked because they have a very low TSH due to secondary or tertiary hypothyroidism. Doctors think TSH is the only thing that counts. If you've got a low TSH and low Free T4 (they almost never test Free T3) then your low Free T4 is irrelevant - you must be hyperthyroid because of your low TSH.

Which country are you from @MErmaid ? Why would any country want to ban all thyroid meds? What possible reason could they come up with for doing something so stupid?

Edit : More and more people with thyroid problems are being informed that they are mentally ill rather than have their thyroid treated (or treated adequately).

 

[Inara]

Didn’t Ron Davis invent something that he couldn’t patent or profit from, because he worked in academia? I think someone took his idea and made millions in the private sector.

The "problem" with patent applications is they must fulfill certain requirements: the idea must be new, include an inventive step and must be commercially applicable.

"New" means the idea mustn't be published elsewhere. "Published" includes most talks or presentations, any posters, any articles, anything printed in a book, leaflet, on the internet etc.

I think there are certain restrictions from the side of the academia. Actually, you get paid by 'public funds', so the knowledge you created should be for everyone. I guess you are not allowed to commercialize your findings, and I don't see how a patent could be a public asset.

That might be different if your funds came from an organization or company - then the organization/company would own the patent. E.g. the OMF funds Ron Davis et al., the OMF could hand in a patent application and name Ron Davis as inventor. But OMF would own the patent and all the rights. Ron Davis would have the right to get his share of possible profits.

Second, no pharma company (or anybody else) can just take your idea, copy and patent it (problem: it wouldn't be new). BUT they can develop a slightly different idea and try to get a patent for that (THE problem here: inventive step).

Short: You can ALWAYS hand in a patent application. To get the patent granted is something completely different.

My personal opinion about patents: If you want to do good for the general public you don't choose the patent path. It's nasty. It's solely about money. It's about making the most of an idea - exclusively. You don't share. You sell (e.g. licenses). You go to court. Such processes are pretty expensive, so the bigger fish wins in general. In the US, a process easily costs at least a million dollars.

 

[Jonathan Edwards]

The "problem" with patent applications is they must fulfill certain requirements: the idea must be new, include an inventive step and must be commercially applicable.

Not really, you can patent any darn thing if you have enough lawyers, as the big Pharma companies do. You can patent using a particular dose of something, even if it was obvious to use that dose and nobody knows if it any better than any other. Believe me, I am in the middle of cases where this happens.

Publishing stuff in advance has different implications in different countries but it does not matter much. You can always patent some twist you did not present. The problem is that Pharma will have patented that with a blanket application they have been sitting on just in case it was needed.

In fact universities now patent whatever they can. Some friends of mine managed to patent a treatment around the time I was working on mine. I think it has brought in several tens of millions to UCL. That is good for the public because it supports research. It is not the way academia was supposed to work but now that we have the iniquity of Pharma lawyers I think we are entitled to play them at their own game.

And Pharma can easily take your idea and patent it. They did exactly that with rituximab. And the patent courts took no notice because they think their job is to keep big business happy. It is a bit different in Europe, where the patent was quashed pretty much as soon as it mattered. The US patent is still not quashed twenty years on and I strongly suspect it will not be. The revolving door means that people go from Pharma to regulatory authority to legal system and round and round. It stinks, but at least I managed to make $20,000 this year from telling them so. Genetic offered me $120,000 to keep my mouth shut but I am not very good at that.

So having disagreed with all the beginning paragraphs I absolutely agree with the last!!

 

[Inara]

Not really, you can patent any darn thing if you have enough lawyers, as the big Pharma companies

Regarding patent law, novelty, inventive step and commercial applicability are mandatory to get a patent granted.

You can hand in any idea. Your application must fulfill certain formalities, but that's it. It isn't even expensive to file a patent application in one country or EU.

Of course, during the application process you have communications with the patent department. Often, inventive step is a problem, so you argue why "your" idea is inventive. Actually, that's not always easily done. Concerning this it does happen that the department "gives up" and gives you the patent - in the end, you are a customer and there may come the day when a court may have to decide whether your granted patent holds all requirements. So it doesn't necessarily mean anything to have a granted patent.

I agree that we filed ideas that weren't very grand. But here you really had to fight to get them granted, which didn't happen on a regular basis. And I'm sure they would have fallen before a court. But it wasn't the company's aim to only create high-quality patents.

I don't know the particulars about the rituximab case. I am certain that Pharma copies ideas. BUT they will have had to develop another process of producing the substance and/or another molecule structure and/or another dosage, another way of application etc. - or else novelty is not given. (I am sure you published your results before a patent application.) Then remains the inventive step - and this is where it can get dirty. One person may say sth. is inventive, another won't. In a way it's subjective. This is why it gets expensive: back and forth, back and forth.

Patent business in the US is difficult, harsh and disgusting. Just my opinion.

I am not saying it's ok what happened. Actually, law often is unjust in my opinion. And as I said, personally I mislike the patent industry.

 

[Jonathan Edwards]

BUT they will have had to develop another process of producing the substance and/or another molecule structure and/or another dosage, another way of application etc. - or else novelty is not given.

No they just claimed it was them that invented it. And nobody noticed. Until other companies wanted a slice of the cake. The patent office knew nothing of my invention because they never bothered to look for the literature. They just believed the company.

Patent business in the US is difficult, harsh and disgusting. Just my opinion.

Exactly what I have found.

 

[Inara]

No they just claimed it was them that invented it. And nobody noticed. Until other companies wanted a slice of the cake. The patent office knew nothing of my invention because they never bothered to look for the literature. They just believed the company.

Okay, the patent office didn't search thoroughly. Not an exception.

But why could that hold before court? I am sure you could prove that you had the idea before them, no? A talk, a paper, anything? That really surprises me...It seems like a clear case at first glance. So either there's more or there's corruption or...?

 

[MErmaid]

Okay, the patent office didn't search thoroughly. Not an exception.

But why could that hold before court? I am sure you could prove that you had the idea before them, no? A talk, a paper, anything? That really surprises me...It seems like a clear case at first glance. So either there's more or there's corruption or...?

It’s the same thing in other industries. Our courts are tied up involving cases of ongoing patent infringement related to hitech, like a chip design. The corporation that employs the most number of dedicated attorneys, sitting at desks, on multiple floors in a hi rise building, usually wins. The taxpayer gets to foot the bill for the court system, the attorneys make lots of money, and the big corporations keep paying nice quarterly dividends to their shareholders. It’s some kind of restored balance of order we have come to expect. Once in a while, the big Corp settles the case, for let’s say for $7M, a relatively small amount, that is simply viewed as “no big deal”, just the cost of running a corporation.

 

[MErmaid]

Which country are you from @MErmaid ? Why would any country want to ban all thyroid meds? What possible reason could they come up with for doing something so stupid?

I am in the US. I can’t find a link, but I recall it was liothyronine (T3) sometime in the early 2000’s. Why would the US government consider ban T3, who knows? But if I can find some online info, at a later date, I will post it.

It’s a big challenge to stay healthy here. You have to go out of your way to avoid all of the pitfalls. I thought I had things pretty much figured out... I was fit and healthy...and then one day whamo... it was the same story that we all share. Went to bed feeling great, then woke up the next morning in a nightmare scenario.

 

[MErmaid]

Genetic offered me $120,000 to keep my mouth shut but I am not very good at that.

I would have held out for more, $120,000 is a bit insulting.

 

[Inara]

The corporation that employs the most number of dedicated attorneys, sitting at desks, on multiple floors in a hi rise building, usually wins.

That's something I always thought to be true - and honestly, still do, but in my (not so small) company I always heard US courts favor the "small guy"; possibly due to "the American dream"? I never understood though, but that seemed to be the experience of seniors.

There were bigger problems with "trolls": corporations that buy patents, but don't produce, in order to find companies that infringe the patent. It's a model to make good money in the US. In EU it's not possible to do that.

 

[Valentijn]

... but in my (not so small) company I always heard US courts favor the "small guy"; possibly due to "the American dream"?

In some situations courts will favor the little guy to some extent, typically because he has less power than big businesses. This especially happens in contract law, from what I recall, due to customers/renters/employees/etc often having little choice but to sign unfair contracts, combined with a general lack of access to routine legal advice. Basically contract law is based upon the assumption that both parties can bargain with each other and alter the contract, but that is often not the case.

I doubt it would have much impact on patent cases, however, unless the big business is trying to bully people with litigation or the threats of it, or are in the business of making bullshit patent claims.

 

[Inara]

I doubt it would have much impact on patent cases, however, unless the big business is trying to bully people with litigation or the threats of it, or are in the business of making bullshit patent claims.

I can only speak of the cases I know of, and I never had the impression the company want to bully anyone. And I think no company would spend millions of dollars in bullshit patents and litigation. Again, I can only speak from my experience, but I know my company is a little different than others, also concerning working conditions. So, definitely no general statement from my side. I am also no "big fish" in the business, so...

 

[Jonathan Edwards]

I would have held out for more, $120,000 is a bit insulting.

Actually I quite enjoyed that conversation. I think I said 'Well, in fact they owe me half a million before even having the pleasure to speak to me, but it won't make any difference'.

 

[Jonathan Edwards]

I can only speak of the cases I know of, and I never had the impression the company want to bully anyone. And I think no company would spend millions of dollars in bullshit patents and litigation. Again, I can only speak from my experience, but I know my company is a little different than others, also concerning working conditions. So, definitely no general statement from my side. I am also no "big fish" in the business, so...

You should come to some of my lawyer meetings. We are talking patents worth $10B+ to the holder. The last one I did was the biggest in pharmaceutical history I am told. Spending a million or so is standard I would think. These companies file several patents, most of which they never activate. Bullying is their stock in trade.

 

[MErmaid]

Bullying is their stock in trade.

Yes, a “bullish” market !!!!

 

[MErmaid]

“Bullying” is both rewarded and encouraged. Big corps think only in terms of sales, profits, and shareholders; focusing on one financial quarter at a time. As long as an action is barely one small step back from crossing the ultimate line of being “caught” (illegal activity), then it’s expected employees must fully engage and push as hard as possible.

“Bullying” = “Power” = “Success”

 

[dannybex]

I know you re keen to get pharma involved, but remember pharma is a business.

If they think they can make money they will be all over it in an instant.
If there is too much risk they will stay away.

A good example of this is the failed retroviral hypothesis that Judy Mikovits to this day continues to peddle, even writing a nonsensical book claiming that "they" stopped her research because she found the 'truth' -- that retroviruses were/are causing ME/CFS, fibromyalgia, autism, MS, ALS, Parkinson's -- pick a disease and I'm sure she'll find a connection, even though she has no research -- and never did -- to back that up.

Yet if there had been even a remote suggestion after the dozen plus replication studies that there was indeed a retroviral involvement in ME/CFS, the pharmaceutical companies would've flooded her with millions of dollars -- whether she was fired, was jailed, whatever -- in order to help them greatly expand their market, and their profits.

As we all know, that didn't happen.

 

[MErmaid]

A good example of this is the failed retroviral hypothesis that Judy Mikovits to this day continues to peddle, even writing a nonsensical book claiming that "they" stopped her research because she found the 'truth' -- that retroviruses were/are causing ME/CFS, fibromyalgia, autism, MS, ALS, Parkinson's -- pick a disease and I'm sure she'll find a connection, even though she has no research -- and never did -- to back that up.

Yet if there had been even a remote suggestion after the dozen plus replication studies that there was indeed a retroviral involvement in ME/CFS, the pharmaceutical companies would've flooded her with millions of dollars -- whether she was fired, was jailed, whatever -- in order to help them greatly expand their market, and their profits.

As we all know, that didn't happen.

Thanks for reminding me, in case this comes up in conversation.

 

[ahimsa]

I'm not sure this is related, but since we're talking about patents and drug pricing, did anyone see this NY Times article?

https://www.nytimes.com/2018/01/18/health/drug-prices-hospitals.html

Fed Up With Drug Companies, Hospitals Decide to Start Their Own

A group of large hospital systems plans to create a nonprofit generic drug company to battle shortages and high prices.

For years, hospital executives have expressed frustration when essential drugs like heart medicines have become scarce, or when prices have skyrocketed because investors manipulated the market.

Now, some of the country’s largest hospital systems are taking an aggressive step to combat the problem: They plan to go into the drug business themselves, in a move that appears to be the first on this scale.

...

 

[MErmaid]

I'm not sure this is related, but since we're talking about patents and drug pricing, did anyone see this NY Times article?

https://www.nytimes.com/2018/01/18/health/drug-prices-hospitals.html

Thanks for posting. It’s great to see new ideas emerging, and new paths forming.

I especially enjoyed this quote:

“This is a shot across the bow of the bad guys,” said Dr. Marc Harrison, the chief executive of Intermountain Healthcare, the nonprofit Salt Lake City hospital group that is spearheading the effort. “We are not going to lay down. We are going to go ahead and try and fix it.”