3 ms·

> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the n

by DanBC 7y ago

> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the new patents provide no new benefit, don’t use them? Have a look at Avastin (Bevacizumab) and Lucentis (ranibizumab). https://www.nih.gov/news-events/news-releases/avastin-lucentis-are-equivalent-treating-age-related-macular-degeneration https://www.nih.gov/news-events/news-releases/avastin-lucent... AMD is a leading cause of blindness. Avastin is a cancer medication that was found to be effective to treat Age-related macular degeneration (AMD), although it wasn't licenced for that usage. The makers reformulated and came out with Lucentis which they licenced for use with AMD. Lucentis is considerably more expensive than avastin. https://www.bbc.co.uk/news/health-30138097 https://www.bbc.co.uk/news/health-30138097 > Lucentis typically costs about £700 for an injection, but the price for Avastin is about £70. In the UK the drug companies not only forbade off-label use of avastin, but they went to court to prevent this use. They lost. https://www.hsj.co.uk/finance-and-efficiency/breaking-nhs-wins-landmark-legal-battle-against-drug-companies/7023422.article#.W6TH58DoL6U.twitter https://www.hsj.co.uk/finance-and-efficiency/breaking-nhs-wi...

Consultant32452 7y ago
It sounds to me like the cost to get a drug certified for use is the problem here. In the US it's literally a billion dollars. If it were cheaper, it would be worth paying for certification of a new use for an existing out of patent drug by a generic manufacturer.
- mandevil 7y ago
  So called "Off-Label" usage is totally legal in the US right now, for free. Drug companies get in trouble for advertising off-label use (that is totally verboten, the FDA regulates drug company advertising and so it can only be done for something the FDA has approved), but your doctor can prescribe something for off-label use totally legally at any time. Estimates are that about 20% of all prescriptions are for off-label use. Also, the billion dollar number is for developing a new medicine, and includes the costs of all the attempts that failed along the way, not for running tests to get an already approved drug certified for a new usage.
refurb 7y ago
There is a bit more to the story. Avastin and Lucentis have the same mechanism of action - inhibiting VEGF. However, they are not the same molecule, Avastin is an antibody and Lucentis is an Fc fragment. Doctors thought to themselves “if the target is the same, why not use Avastin for AMD”? There was no clinical data to support it, so the docs had to do it themselves. There was a ton of use even before any conclusive data. The company said “we do t recommend using Avastin in the eye as we didn’t manufacture it for that use”. Legally, they couldn’t support it other (off-label). Eventually some large scale trials were run by doctors that showed they were basically equivalent, but there were also cases of blindness due to improper injections of Avastin.
- DanBC 7y ago
  > The company said “we do t recommend using Avastin in the eye as we didn’t manufacture it for that use”. Legally, they couldn’t support it other (off-label). They didn't have to support it. But they actively opposed it by taking the NHS to court.

by DanBC 7y ago

Consultant32452 7y ago

It sounds to me like the cost to get a drug certified for use is the problem here. In the US it's literally a billion dollars. If it were cheaper, it would be worth paying for certification of a new use for an existing out of patent drug by a generic manufacturer.

mandevil 7y ago
So called "Off-Label" usage is totally legal in the US right now, for free. Drug companies get in trouble for advertising off-label use (that is totally verboten, the FDA regulates drug company advertising and so it can only be done for something the FDA has approved), but your doctor can prescribe something for off-label use totally legally at any time. Estimates are that about 20% of all prescriptions are for off-label use. Also, the billion dollar number is for developing a new medicine, and includes the costs of all the attempts that failed along the way, not for running tests to get an already approved drug certified for a new usage.

refurb 7y ago

There is a bit more to the story. Avastin and Lucentis have the same mechanism of action - inhibiting VEGF. However, they are not the same molecule, Avastin is an antibody and Lucentis is an Fc fragment. Doctors thought to themselves “if the target is the same, why not use Avastin for AMD”? There was no clinical data to support it, so the docs had to do it themselves. There was a ton of use even before any conclusive data. The company said “we do t recommend using Avastin in the eye as we didn’t manufacture it for that use”. Legally, they couldn’t support it other (off-label). Eventually some large scale trials were run by doctors that showed they were basically equivalent, but there were also cases of blindness due to improper injections of Avastin.

DanBC 7y ago
> The company said “we do t recommend using Avastin in the eye as we didn’t manufacture it for that use”. Legally, they couldn’t support it other (off-label). They didn't have to support it. But they actively opposed it by taking the NHS to court.