9 ms·

I worked in diabetes for a decade so thought I'd chime in. This is an admirable project with very low prospects of making a difference in the lives of people wi

I worked in diabetes for a decade so thought I'd chime in. This is an admirable project with very low prospects of making a difference in the lives of people with diabetes. I don't doubt this group will be able to show "success" in the form of simple clinical results. I have the highest doubts that they'd have the resources to do the broad-based clinical trials required to go to market. Look up "Eroom's Law" which is "Moore's Law" spelled backwards: http://www.nature.com/nrd/journal/v11/n3/fig_tab/nrd3681_F1.html http://www.nature.com/nrd/journal/v11/n3/fig_tab/nrd3681_F1.... Basically, the increases in pharma regulation means it takes longer and gets more expensive to create a new drug each year. This is a cool science project, but the reporting around it is sensational and not helpful to the millions of people with diabetes who have their cranks yanked regularly about miracle cures, cost-saving fantasies, etc. To address some raised in sub-threads: + You can get extraordinarily cheap drugs in India, the rest of the developing world, and in parts of Europe. The "greedy" drug companies adjust pricing to what local markets can bear. So instead of letting poor people die en masse they mark the drugs down and pass the cost onto the developed world. Fair trade IMO. + The reason there are so few generic insulins is that they are hard to make consistently enough to please the FDA and European regulators. Companies like Teva and Perrigo are multi-billion dollar manufacturers of generic drugs who would love to get get into this game, but as noted, biosimilar drugs, especially ones as powerful as insulins, are a lot harder to copy than aspirin.

EmlynC 11y ago
This is a really solid response. I'm a Pharmacologist and I've worked in a number of Biotechs. I have been part of pricing discussions to value our drugs and your assessment is correct — price discrimination, as in most industries, is based on what a particular market can bear. Factors that influence this are the way that healthcare systems are run (i.e. public healthcare, insurance based), the cost of compliance and competition. I wouldn't say that the industry subsidises poor countries via sales in the developed world, it's more a case of it's better to be paid something rather than be paid nothing. I personally, however, do like the happy side-effect this has for patients in poor countries. Increased regulation costs more to comply with and that cost of course is born by the consumer. The cost of regulatory compliance also varies on the market you sell to, the US being one of the most expensive. Just as with software or hardware, the price reflects the cost of production and maintaining the product. Notably with biologics (Insulin, any hormone ...) as opposed to small chemical entity (paracetamol, aspirin etc) is that broadly they are harder to keep in their stable active form. The are heat sensitive, chemically sensitive and have a tendency to stick to themselves. This tends to increase the cost of storage, logistics and compliance. It also means that if you can make a worthwhile biologic it will generally experience less competition.
- vdaniuk 11y ago
  >happy side-effect this has for patients in poor countries Sometimes I wonder if some HN comments are being posted from an alternate universe...
- deleted 11y ago
  [deleted]
EmlynC 11y ago
This is a really solid response. I'm a Pharmacologist and I've worked in a number of Biotechs. I have been part of pricing discussions to value our drugs and your assessment is correct — price discrimination, as in most industries, is based on what a particular market can bear. Factors that influence this are the way that healthcare systems are run (i.e. public healthcare, insurance based), the cost of compliance and competition. I wouldn't say that the industry subsidises poor countries via sales in the developed world, it's more a case of it's better to be paid something rather than be paid nothing. I personally, however, do like the happy side-effect this has for patients in poor countries. Increased regulation costs more to comply with and that cost of course is born by the consumer. The cost of regulatory compliance also varies on the market you sell to, the US being one of the most expensive. Just as with software or hardware, the price reflects the cost of production and maintaining the product. Notably with biologics (Insulin, any hormone ...) as opposed to small chemical entity (paracetamol, aspirin etc) is that broadly they are harder to keep in their stable active form. The are heat sensitive, chemically sensitive and have a tendency to stick to themselves. This tends to increase the cost of storage, logistics and compliance. It also means that if you can make a worthwhile biologic it will generally experience less competition.
golergka 11y ago
Your comment seems to imply that said regulations are tougher than needed, and that if "FDA and European regulators" would loosen their standards, it would be a good thing. Did I understand it correctly? Why is it so?
- replicatorblog 11y ago
  That's my perspective. Regulators are heavily incentivized to prevent deaths, even small numbers, that will generate headlines and political pressure. There is no political voice for much larger numbers that would be aided by new drugs that come to market quicker in a looser regulatory scheme. That said, I understand why the laws have been shaped the way they have.
facepalm 11y ago
The regulations might be partly in place to protect the big players from pesky small competition? I have no way to judge that, though. But if that's the case, perhaps the regulations can be changed.
- refurb 11y ago
  The regulations are in place partly because as soon as any approved drug starts to show serious side effects, people (including Congress) start pointing fingers at the FDA and talk about their failure to protect the public.
- replicatorblog 11y ago
  This is definitely the case. There's a term called "Regulatory Capture" that describes this phenomena. I think it's less active scheming to stomp down startups and more a natural outgrowth of a world where the larger companies find it easier to comply with marginal increases in regulatory scrutiny than to fight the PR/lobbying war to oppose them.
  - refurb 11y ago
    You think big pharma encourages more regulation by the FDA? Jesus, they have a hard enough time getting approved under current rules. It would be a death sentence for them if they made them more stringent. Every big pharma/biotech I've worked for has always pushed the FDA to make exceptions to the rules. They certainly aren't push for more of them.
coldpie 11y ago
> not helpful to the millions of people with diabetes who have their cranks yanked regularly about miracle cures, cost-saving fantasies, etc. As a Type 1 Diabetic, this cracked me up. I regularly get sent articles and have conversations with friends about "research on such-and-such cure for Diabetes!" Ten-to-fifteen years, right? Add it to the pile. Call me when something's on the market.
- replicatorblog 11y ago
  Totally—who knew cinnamon was the cure for diabetes all these years! If only Big Pharma wasn't suppressing these kitchen cures!
Natanael_L 11y ago
> and pass the cost onto the developed world. > cost Typically for most drugs it really just means they extract less profits from developing countries (slim margins), not that they sell for a loss, while making lots of money with large margins in developed countries.
- deleted 11y ago
  [deleted]
ZLeviathan 11y ago
wow! guess what? I just learned something from the Master!

EmlynC 11y ago

This is a really solid response. I'm a Pharmacologist and I've worked in a number of Biotechs. I have been part of pricing discussions to value our drugs and your assessment is correct — price discrimination, as in most industries, is based on what a particular market can bear. Factors that influence this are the way that healthcare systems are run (i.e. public healthcare, insurance based), the cost of compliance and competition. I wouldn't say that the industry subsidises poor countries via sales in the developed world, it's more a case of it's better to be paid something rather than be paid nothing. I personally, however, do like the happy side-effect this has for patients in poor countries. Increased regulation costs more to comply with and that cost of course is born by the consumer. The cost of regulatory compliance also varies on the market you sell to, the US being one of the most expensive. Just as with software or hardware, the price reflects the cost of production and maintaining the product. Notably with biologics (Insulin, any hormone ...) as opposed to small chemical entity (paracetamol, aspirin etc) is that broadly they are harder to keep in their stable active form. The are heat sensitive, chemically sensitive and have a tendency to stick to themselves. This tends to increase the cost of storage, logistics and compliance. It also means that if you can make a worthwhile biologic it will generally experience less competition.

vdaniuk 11y ago
>happy side-effect this has for patients in poor countries Sometimes I wonder if some HN comments are being posted from an alternate universe...
deleted 11y ago
[deleted]

EmlynC 11y ago

golergka 11y ago

Your comment seems to imply that said regulations are tougher than needed, and that if "FDA and European regulators" would loosen their standards, it would be a good thing. Did I understand it correctly? Why is it so?

replicatorblog 11y ago
That's my perspective. Regulators are heavily incentivized to prevent deaths, even small numbers, that will generate headlines and political pressure. There is no political voice for much larger numbers that would be aided by new drugs that come to market quicker in a looser regulatory scheme. That said, I understand why the laws have been shaped the way they have.

facepalm 11y ago

The regulations might be partly in place to protect the big players from pesky small competition? I have no way to judge that, though. But if that's the case, perhaps the regulations can be changed.

refurb 11y ago
The regulations are in place partly because as soon as any approved drug starts to show serious side effects, people (including Congress) start pointing fingers at the FDA and talk about their failure to protect the public.
replicatorblog 11y ago
This is definitely the case. There's a term called "Regulatory Capture" that describes this phenomena. I think it's less active scheming to stomp down startups and more a natural outgrowth of a world where the larger companies find it easier to comply with marginal increases in regulatory scrutiny than to fight the PR/lobbying war to oppose them.
- refurb 11y ago
  You think big pharma encourages more regulation by the FDA? Jesus, they have a hard enough time getting approved under current rules. It would be a death sentence for them if they made them more stringent. Every big pharma/biotech I've worked for has always pushed the FDA to make exceptions to the rules. They certainly aren't push for more of them.

coldpie 11y ago

> not helpful to the millions of people with diabetes who have their cranks yanked regularly about miracle cures, cost-saving fantasies, etc. As a Type 1 Diabetic, this cracked me up. I regularly get sent articles and have conversations with friends about "research on such-and-such cure for Diabetes!" Ten-to-fifteen years, right? Add it to the pile. Call me when something's on the market.

replicatorblog 11y ago
Totally—who knew cinnamon was the cure for diabetes all these years! If only Big Pharma wasn't suppressing these kitchen cures!

Natanael_L 11y ago

> and pass the cost onto the developed world. > cost Typically for most drugs it really just means they extract less profits from developing countries (slim margins), not that they sell for a loss, while making lots of money with large margins in developed countries.

deleted 11y ago
[deleted]

ZLeviathan 11y ago

wow! guess what? I just learned something from the Master!