The opportunity is a generalized approach to solving these diseases which i think we are getting to finally. Thats the true promise of digital technology.
Thats how incentives gets aligned.
With no prospects for profits, big pharma neglects new infectious diseases
111–120 of 128 posts
Re: With no prospects for profits, big pharma neglects new infectious diseases
#112Earlier quoted context omitted.
Depends on the drug. Small molecules, sure? Complex biologics? Even other large pharma companies can have challenges making those.
Could you give an example of what makes complex biologics difficult, is it the actual process or just the fact that IP is not shared easily and the hurdles to get licensing in place.
Because they're produced by biological processes (grow cells that produce the protein and purify it), you don't really have atom level control and replicability of the end product - there's a lot of variability. So, the exact process that it's produced with is regulated and tracked, and there will be IP over that process as well. You can see the impacts of that in how much harder biosimilars are to develop than generics
Re: With no prospects for profits, big pharma neglects new infectious diseases
#113Earlier quoted context omitted.
Well, if capitalism is the problem, then why don't the socialist/communist countries develop the drug instead? Or alternatively, the community could come together and they could work on coming up with the treatment as a group. But we all know that neither of these are likely to happen. Researchers need money to live, labs need money to run.
Because there is no such countries until someone can prove otherwise (which will not happen because they don't exist). Big capital put this idea inside the heads of many people living in the West and until today they really believe there is countries who are socialist/communist. Neither the GDR nor the UDSSR or China are examples for countries like that and people who know about politics, economy and society know thi…
> Because there is no such countries until someone can prove otherwise (which will not happen because they don't exist).
It won't happen because you'll shift the goal posts.
A common dodge is that they're state socialism. The problem with this dodge: it's definitely true that state socialism is impure. But, it's 90% of what you want, and it fails catastrophically. Then the answer is, "well, it can only work if it's 99%!"
The regulated markets we have in Western nations, however, are 90% of an ideal "truly free market" and they work quite well. And we find that incremental reforms that deliver to people a little bit more of their economic liberties also improve people's lives bit by bit. Markets have the property that the freer they are, the more benefits they provide.
The other dodge is that "it wasn't socialism's fault," especially with Venezuela. Yes, they had an economy centered around oil and that was a problem. The issue was that socialist-inspired reforms made it worse, especially nationalizing the oil companies and price controls. Markets thus have an additional property that they are robust, they allow people to route around problems and mitigate them. Planning is brittle because it necessarily centralizes power, and it tends to fail because planners can't respond to crises in a decentralized manner the way a market naturally does.
The third dodge, common now thanks to Sen Sanders, is the Scandanvian nations show that socialism works. But their economies work because they took the opposite approach of 10% socialism. That's not great for apologia since it follows that socialism only works when you hardly do it.
> Big capital put this idea inside the heads of many people living in the West and until today they really believe there is countries who are socialist/communist.
No one who read the dictionary[2] is claiming that there were any communist nations, since a defining aspect of communism is the absence of the state. You can have lots of communists (persons whose end goal is communism) in a socialist nation, of course, since, as Lenin noted, the purpose of socialism is communism.
And Lenin introduced state socialism, not some mad capitalist, and he believed it was, if not proper socialism, a clear stepping stone to socialism. The nations definitely called themselves socialist, and socialists all over the world agreed and while things appeared to be going well, they were bragging about how this proved socialism worked.
But it wasn't working because the planners were lying. Socialists here lied and covered up tremendous deaths[1]. And it's only when the problems couldn't be hidden that they became not socialist anymore.
[1]: https://en.wikipedia.org/wiki/Walter_Duranty#The_Holodomor_(...
[2]: That does leave a lot of people claiming it, of course.
Re: With no prospects for profits, big pharma neglects new infectious diseases
#114Earlier quoted context omitted.
[flagged]
Godwin's law in action, this seems like an incredibly bad faith argument. Why not compare it to the NHS or other nationalised industries instead without going straight to shouting nazi...
Because it's a flawed thought process and I'm not gonna sugarcoat it so feelings don't get hurt.
Re: With no prospects for profits, big pharma neglects new infectious diseases
#115I thought the "party line" was that private industry doesn't accomplish much if anything, so isn't "big pharma" irrelevant? It makes more sense to demand higher taxes and more basic research.
The problem is that regulation is so expensive there isn't any financial motivation in researching does that are unlikely to generate massive revenue. The reason for this is FDA is fundamentally extremely conservative. The people that run the regulatory system are just faceless bureaucrats and are risk adverse. Their pay is based on seniority and there isn't any financial motivation for them to take risks or stand ou…
Generics still have a huge effect in driving down prices and patent cliffs for small molecules are as devastating as they have always been for big pharma. It makes sense that it's not easy to create a new generics company because it's such a perfect expression of the free market - fierce competition leads to the profits being competed away. It couldn't be cheaper to start a generics company (and there's plenty popping up overseas) - but there just isn't that much money in it unless you already have the infrastructure or have a competitive advantage in cost
Re: With no prospects for profits, big pharma neglects new infectious diseases
#116Earlier quoted context omitted.
You can have a stringent safety process without having any efficacy process. The FDA has no incentive to approve drugs but plenty to deny them so delay is the order of the day. Delay in approving new effective drugs costs lives. The FDA has not shown any willingness to pull back on regulations during the current COVID crisis, nor have they historically shown any such willingness. Politicians have forced them to. They…
I'm not clear on whether you're arguing that the FDA should not be requiring efficacy? The FDA makes exceptions on cases of urgent need, and not having efficacy as a bar would reduce the reward for innovation - why would you spend all the time and effort to development a treatment for a disease if vitamins with no efficacy are already filling the market? False hope is dangerous, and healthcare is uniquely suited to a…
The FDA should not require efficacy testing. If it’s safe let patients and their doctors do what they want. In practice that’s what they do anyway, see off label prescribing which is around one fifth of all prescriptions in the US. Removing efficacy testing would double or more the number of new drugs available.
Fraud is already illegal. Doctors can already be sued for malpractice. Testing for efficacy makes no sense in a world in which off label prescribing is routine.
> Assessing the FDA via the Anomaly of Off-Label Drug Prescribing —————— ——————
> Once a drug has been approved for some use, the FDA has almost no control over how that drug is actually prescribed. The prescribing of drugs for non-FDA-approved uses, called “off-label prescribing,” is widespread. Drugs prescribed off-label have not met the FDA’s requirements for proving efficacy in the off-label applications. The practice of off-label prescribing therefore raises interesting questions. Why does the FDA, in effect, require that some drugs be tested for efficacy but not others? If there are good reasons for the FDA to have strong pre-approval powers regarding efficacy, shouldn’t FDA post-approval powers be commensurate? Alternatively, if there is good reason for widespread off-label prescribing, doesn’t this call into question the FDA’s pre-approval powers?
https://www.independent.org/publications/tir/article.asp?id=...
> There are also scientific reasons to replace Phase 3. The reasoning behind the Phase 3 requirement — that the average efficacy of a drug is relevant to an individual patient — flies in the face of what we now know about drug responsiveness. Very few drugs are effective in all individuals. In fact, most are not effective in large portions of the population, for reasons that we are just beginning to understand.
> It’s much easier to get approval for drugs that are marginally effective in, say, half the population than drugs that are very effective in a small fraction of patients. This statistical barrier discourages the pharmaceutical industry from even beginning to attack diseases, such as Parkinson’s, that are likely to have several subtypes, each of which may respond to a different drug. These drugs are the underappreciated casualties of the Phase 3 requirement; they will never be developed because the risk of failure at Phase 3 is simply too great.
http://www.washingtonpost.com/wp-dyn/articles/A43257-2003Nov...
Re: With no prospects for profits, big pharma neglects new infectious diseases
#117Earlier quoted context omitted.
I'm not clear on whether you're arguing that the FDA should not be requiring efficacy? The FDA makes exceptions on cases of urgent need, and not having efficacy as a bar would reduce the reward for innovation - why would you spend all the time and effort to development a treatment for a disease if vitamins with no efficacy are already filling the market? False hope is dangerous, and healthcare is uniquely suited to a…
The FDA should not require efficacy testing. If it’s safe let patients and their doctors do what they want. In practice that’s what they do anyway, see off label prescribing which is around one fifth of all prescriptions in the US. Removing efficacy testing would double or more the number of new drugs available. Fraud is already illegal. Doctors can already be sued for malpractice. Testing for efficacy makes no sense…
Off label use is allowed. Marketing for off label use is absolutely not allowed. Claims of off label efficacy are not remotely allowed. And the FDA has post approval powers to revoke approval for drugs not found effective. Doctor's autonomy leads to off label being allowed, and some of the legal arguments for it involve freedom of speech, not medical optimality.
Phase 3s already are no longer required, it looks like the article you linked was written in 2003? That was literally almost 17 years ago when we'd just barely sequenced the first human genome. There are entire fields of medicine - precision medicine - that literally address the whole subgroup question. Companion diagnostics are routine, rare disease approvals are up, plenty of Huntington trials in progress - that article might as well be about an alien civilization with how different things are today. Value based pricing, redefining cancer into separate genetically defined baubgroups and developing drugs for each, Gene therapy, ... It's no longer easier to get approval of a drug that's marginally successful in a large population, smaller populations with large effects make it way easier to see responses. And the 21st century cures act in 2016 evolved the regulatory landscape even more - it's like comparing Sputnik with the ISS. Yeah, they're both sattelites, but the field has come a long way in the time between the two.
Re: With no prospects for profits, big pharma neglects new infectious diseases
#118In the 1960s big increases in regulations on new drug development led to big cost increases, and hence less interest in non-blockbuster treatments.
It's also lead to unprecedented investment and development of drugs for rare diseases. Some 45% of drugs approved last year are for rare diseases. The key with those is that high pricing let's those rare disease drugs be blockbusters - you can still make enough money in a disease with only a few thousand patients in the US if you're able to charge whatever you want. We've seen less interest in drugs that can't be blo…
Avoiding another thalidomide is not the only objective in drug discovery. Arguably the pace of progress[1] in medicine has been made slower because of the extreme cost of regulation. How many thousands are dying because they will be treated by drugs that could have been but are not because of regulation. I don't know, and I doubt anyone does. Ultimately this is problem with a regulatory body who's incentives are tied (or more tied) to only one of two competing bad outcomes. Its really easy to never have another thalidomide, but we should aim higher than that.
[1] One example of this is dietary treatments for disorders. It is very difficult for these to become standard of practice, because no company will want to fork over the $$$ to do a clinical trial to prove that a specific dietary intervention improves outcomes. When after its all done people can just do the intervention on their own and not pay the company money. This biases treatment towards pills that can be prescribed and patented.
Earlier I said think of the thousands of lost lives, but it might truthfully be millions considering the damage caused by type II diabetes which pharmacological interventions are relatively impotent to treat.
Re: With no prospects for profits, big pharma neglects new infectious diseases
#119In the 1960s big increases in regulations on new drug development led to big cost increases, and hence less interest in non-blockbuster treatments.
Sure, but as a result we don't have problems like thalidomide popping up every decade or so. There are benefits (and drawbacks) to having a much more stringent approval process. And probably worth adding that in public health emergencies, the FDA is more than willing to pull back on regulations in the interest of the public good.
Avoiding another thalidomide would be all well if weren't for the fact that for many disorders the prognosis provided by standard practice is absolutely terrible.
Re: With no prospects for profits, big pharma neglects new infectious diseases
#120Earlier quoted context omitted.
> Basically, rather than paying for drugs on a per unit basis, you pay a lump sum for access to the drug. Hmm... a system where uncommon but extreme spikes in the cost of care are artificially distributed so that an entire society can bear them as a group... that sounds oddly familiar...
Please put the invisible hands of the market over your ears and wait for the drugs to trickle down. Jokes aside - while people are justifiably pointing out the community healthcare angle, arguably this problem is exacerbated by the American FDA drug approval model, ie no corporation will fund clinical trials unless they're guaranteed a profit monopoly.
> no corporation will fund clinical trials unless they're guaranteed a profit monopoly.
Every single major pharmacy company is actively developing treatments And doing clinical trials where they are in sharp competition and don’t have a monopoly. Obvious example that’s always picked up in US is diabetes. No one has a monopoly on insulin or insulin analogies and you have several corporations constantly competing and innovating improving the treatments.
The reasons for lack of development in some areas is not risk aversion from the pharma companies, it’s just that there simply isn’t a business case for investing there as oppose to other areas in the current setup.