Trump says Big Pharma is ‘getting away with murder’ - Page 2 - Politics Forum.org | PoFo

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#14762557
As always, what Trump says is irrelevant as long as it isn't put into law.

We will see how he will use his veto power.

Kaiserschmarrn wrote:While I do feel a bit of Schadenfreude about the above quote, the reality is that the way we have set up and regulated medical research/the pharma industry has massively distorted incentives. In other words, Big Pharma is just doing what it's supposed to do and it's up to us to give it the right incentives and if that is not possible for governments to sufficiently supplement in that area. One of the most ridiculous recent cases I've come across is Roche's drug Rituxan which has had extremely promising results in MS for which it isn't reimbursed. Since Rituxan's patent is expiring soon, Roche has developed a new drug which is slightly different to Rituxan and funded a massive trial which, unsurprisingly, also had extremely good results. Obviously, they are trying to crowd out Rituxan, which will almost certainly get much cheaper in the future, with this new very expensive patented drug. That Roche has a rational incentive to do this, shows how skewed and wrong their incentives are. And that's not even getting into the lack of incentives for finding cures for diseases.


The question is of course why doctors prescribe the more expensive medication.
#14762616
One Degree wrote:You should see the price on some of the drugs just for nausea in cancer patients. Thousands of dollars per month. Our insurance denied the only one that worked for my wife, so I said fine we will find a way to pay for it, so I went to the pharmacy and asked them how much it would be. If I remember correctly it was $8,000 per month and this was 9 years ago.

You completely missed my joke :)

Also, lol at the idea that what a president who has the legislature and judiciary says is irrelevant.
#14762623
Zagadka wrote:FFS, stop saying things I agree with, asshole

Haven't you got it yet? He's another Liberal like George Wallace who's decided he's never going to be "out-Niggered."

I mean he's not just like George Wallace, he's virtually following Wallace's play book word for word.
#14763366
AFAIK wrote:@Kaiserschmarrn

Any suggestions for how you'd like to see things structured?

In this case the solution seems straightforward: someone should have conducted a phase III trial years ago. Since there were no financial incentives, it would have had to be publicly funded, ideally as a cooperation of several countries. There actually have been several trials by universities but none of them meets the requirements that would be necessary for approval. One wonders how much thought goes into this and what these trials were for. I guess we now know what we lose out on and if we are lucky they may be the basis for an expansion of compassionate treatment programmes. I think this can to some extent be generalised so that governments look out for situations where the private sector games the system or has no financial incentives. In cases such as the above this would be a relatively low risk strategy where public funds could go a long way in terms of financial return, and even the possibility of governments stepping in would quite likely discourage or stop companies like Roche trying for what isn't much more than a patent extension.

But the problem doesn't lie solely with pharma companies either. They claim (1, 2) that a lot of basic research, which they base their drug development on, cannot be replicated/reproduced, and their claims are not entirely unfounded (1,2,3). While I have expressed some Schadenfreude in my first post, it should also be acknowledged that pharmaceutical companies are not only encouraged to act like they do, but the problems with basic research skew their incentives even more towards incremental change as opposed to new innovation.

And then there is the difference in scrutiny that is applied to publicly and pharma funded research, with the former getting off on the flimsiest of excuses (e.g. science is hard - well, no shit). This 358 piece is, apart from the excuses/defence, a very good article on how easy it is to get things wrong in science, including human fallibility, the effect and prevalence of which most of the general public and scientists themselves underestimate. One example how bad things are in reality is the problem of multiple comparisons leading to false positives. This problem and its solution has been known for decades, yet we still find, at least in certain fields, that many - potentially up to one third of - published papers don't correct for multiple comparisons (1, 2). In the 21st century there exists absolutely no excuse to make this mistake, and this is only one problem that is easy to spot and correct for. A very similar but distinct and much more difficult problem is researchers degrees of freedom or the Garden of Forking Paths. Add to this publication bias and it relatively easy to find evidence that humans can "feel the future". Note that research like this often appears in flagship journals of the respective field.

This, among other things, results in pharma funded research almost certainly being vastly superior to publicly funded research in terms of quality of evidence. However, even in the strictly regulated and scrutinised area of pharmaceutical research there are some researchers degrees of freedom, and hence even if the trial protocol is pre-registered there remains the possibility of tinkering with the study design and data along the way during an analysis in order to optimise efficacy, safety, tolerability, etc. leading to slightly or somewhat better results. And that leads me back to the original case and incremental drug development. The authorities should, in my view, also be more skeptical when faced with slight or moderate superiority studies when it comes to approval and reimbursement. It's impossible to say how common this is, but there is certainly a risk that the claims of superiority, especially if small, are not actually real but partly or wholly the result of smart decisions during the analysis.

Overall, when I say governments should step up, this is conditioned on governments first getting their act together themselves, not only for the reason mentioned above, but also because if governments get it wrong the effects are much more serious and far-reaching. The centralised nature of government decision making and the resources it has at its disposal lead to the effects - good and bad - to cascade through the system and to last for a long time, e.g. the skew in medical research funding will have an effect for decades.

Rugoz wrote:The question is of course why doctors prescribe the more expensive medication.

The old drug is not approved for MS, so it's rarely paid by insurance. There have been several smaller trials, including a phase II trial by Roche (then Genentech), for the old drug with excellent/very promising results, but a phase III trial is needed for approval. After they realised the potential, they opted to develop a "new" drug which was sufficiently different so that it could get a new patent but whose treatment mechanism is equivalent. Essentially, rituximab could have been available to MS patients years ago had Roche conducted a phase III trial and sought approval for MS. There have been multiple other publicly funded studies which have confirmed that the drug works great, however, none of them meets the requirements for approval. It's being used off label and through compassionate treatment programmes, but these obviously only cover relatively few patients. The phase III results for the new drug have recently been published and are unsurprisingly excellent. So it looks like they'll get approval / reimbursement and it's probably going to become one of the standard treatments.

There are now "generics" (biosimilars) of rituximab, one of which has been approved a few weeks ago for two rituximab indications - a cancer and RA - in the EU. Their approval, which was to be expected at one point, was probably what motivated Roche to abandon rituximab. A biosimilar could try to get approval for MS but it's going to take them years due to the manufacturing process of biologics being much more difficult and sensitive to small variations that could lead to different efficacy and safety profiles.
#14763525
Kaiserschmarrn wrote:There are now "generics" (biosimilars) of rituximab, one of which has been approved a few weeks ago for two rituximab indications - a cancer and RA - in the EU. Their approval, which was to be expected at one point, was probably what motivated Roche to abandon rituximab. A biosimilar could try to get approval for MS but it's going to take them years due to the manufacturing process of biologics being much more difficult and sensitive to small variations that could lead to different efficacy and safety profiles.


Ok, but then the question is why no other company wants to fund the trial for the old drug that has not been approved yet for MS. If trials are so expensive and make up a large part of the cost of bringing a new drug to the market, maybe there should be patents for successful trials.

As for incremental innovations. Healthcare providers must ignore such drugs if the improvement does not justify the additional cost (easier said than done of course).
#14763548
Rugoz wrote:
Ok, but then the question is why no other company wants to fund the trial for the old drug that has not been approved yet for MS.

I don't understand the question. What would any other company have to gain from doing so? This is a drug that Roche sells and will sell in the future.

Rugoz wrote:
If trials are so expensive and make up a large part of the cost of bringing a new drug to the market, maybe there should be patents for successful trials.

I'm again unsure what you mean. What would be patented and how would that prevent a similar situation?

Rugoz wrote:As for incremental innovations. Healthcare providers must ignore such drugs if the improvement does not justify the additional cost (easier said than done of course).

Can you give me a source for this? I'm not aware of drugs not getting approval or reimbursed just because they have a similar profile to a drug that is already present in the market. To my knowledge, what is usually difficult for slightly/moderately superior drugs is getting a better price during negotiations.

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