3 ms·

>> Does the FDA have the authority to deny marketing approval for minor improvements? They certainly don't. Look at Nexium, it is something close to a blatant

>> Does the FDA have the authority to deny marketing approval for minor improvements? They certainly don't. Look at Nexium, it is something close to a blatant scam but the FDA approved it and between Medicare and Medicaid alone the federal government has rewarded the scammers (AstraZeneca) with billions of dollars never mind private insurance companies.

maxerickson 10y ago
Nexium doesn't appear to be relevant to the question I am asking, as Omeprazole was not pulled from the market when it was released (it's maybe a similarly stupid situation). The additional issue with auto-injectors is that knowing how to correctly use a particular one is important, so there is a legitimate reason to make sure that generics work the same way as the branded version. This means that if the branded version adds a patented safety feature, then there won't be generics for a while.
Alex3917 10y ago
It's not just Nexium, the majority of the best selling drugs in the U.S. are no more effective than placebos or generics.
JustSomeNobody 10y ago
Honest question, how is Nexium a scam?
- ceejayoz 10y ago
  https://en.wikipedia.org/wiki/AstraZeneca#Nexium https://en.wikipedia.org/wiki/AstraZeneca#Nexium Nexium is just pre-broken-down Prilosec, which had just run out of patent protection. They then manipulated the results to make it look more effective so they could market it as such: > AstraZeneca's scientists had misrepresented their research on the drug's efficiency, saying "Instead of using presumably comparable doses [of each drug], the company's scientists used Nexium in higher dosages. They compared 20 and 40 mg Nexium with 20 mg Prilosec. With the cards having been marked in that way, Nexium looked like an improvement – which however was only small and shown in only two of the three studies."
- bradleyjg 10y ago
  Omeprazole is a mixture of two mirror image molecules. One of the two versions is the active and the other isn't (for 97% of the population). When the patent was running out on omeprazole AstraZeneca patented esomeprazole, which is just the active isomer. In order to show improvement over omeprazole they did clinical trials that used a higher effective dose of esomeprazole than omeprazole. The FDA, for reasons unknown, let them get away with this fraud and approved the drug. The government has spent literally billions of dollars buying esomeprazole when a double dose of omeprazole is the same damn thing for 97% of the population. I caveated my original statement ("something close to") because there might be some role for esomeprazole as a second line drug for the 3% of the population that is sensitive to the other isomer, but even there a perfectly fine alternative would just be a lower dose of omeprazole. Nexium is 18th on the list of drugs by global sales in 2014. These are not small potatoes.
  - sseagull 10y ago
    >One of the two versions is the active and the other isn't (for 97% of the population) My understanding is that the inactive form is actually metabolized into the active form by the body. There is some argument that this happens differently in different people. But if AstraZeneca knew this (which they almost certainly did), why didn't they release esomeprazole at the beginning? They released omeprazole first, then sat on esomeprazole until the omeprazole patent was about to expire. It's obvious why they would do that.

maxerickson 10y ago

Nexium doesn't appear to be relevant to the question I am asking, as Omeprazole was not pulled from the market when it was released (it's maybe a similarly stupid situation). The additional issue with auto-injectors is that knowing how to correctly use a particular one is important, so there is a legitimate reason to make sure that generics work the same way as the branded version. This means that if the branded version adds a patented safety feature, then there won't be generics for a while.

Alex3917 10y ago

It's not just Nexium, the majority of the best selling drugs in the U.S. are no more effective than placebos or generics.

JustSomeNobody 10y ago

Honest question, how is Nexium a scam?

ceejayoz 10y ago
https://en.wikipedia.org/wiki/AstraZeneca#Nexium https://en.wikipedia.org/wiki/AstraZeneca#Nexium Nexium is just pre-broken-down Prilosec, which had just run out of patent protection. They then manipulated the results to make it look more effective so they could market it as such: > AstraZeneca's scientists had misrepresented their research on the drug's efficiency, saying "Instead of using presumably comparable doses [of each drug], the company's scientists used Nexium in higher dosages. They compared 20 and 40 mg Nexium with 20 mg Prilosec. With the cards having been marked in that way, Nexium looked like an improvement – which however was only small and shown in only two of the three studies."
bradleyjg 10y ago
Omeprazole is a mixture of two mirror image molecules. One of the two versions is the active and the other isn't (for 97% of the population). When the patent was running out on omeprazole AstraZeneca patented esomeprazole, which is just the active isomer. In order to show improvement over omeprazole they did clinical trials that used a higher effective dose of esomeprazole than omeprazole. The FDA, for reasons unknown, let them get away with this fraud and approved the drug. The government has spent literally billions of dollars buying esomeprazole when a double dose of omeprazole is the same damn thing for 97% of the population. I caveated my original statement ("something close to") because there might be some role for esomeprazole as a second line drug for the 3% of the population that is sensitive to the other isomer, but even there a perfectly fine alternative would just be a lower dose of omeprazole. Nexium is 18th on the list of drugs by global sales in 2014. These are not small potatoes.
- sseagull 10y ago
  >One of the two versions is the active and the other isn't (for 97% of the population) My understanding is that the inactive form is actually metabolized into the active form by the body. There is some argument that this happens differently in different people. But if AstraZeneca knew this (which they almost certainly did), why didn't they release esomeprazole at the beginning? They released omeprazole first, then sat on esomeprazole until the omeprazole patent was about to expire. It's obvious why they would do that.