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This dissipates any doubt I had about the influence of lobbying. FDA, a federal agency that is fully aware of the harmful and addictive nature of opioids (and

This dissipates any doubt I had about the influence of lobbying. FDA, a federal agency that is fully aware of the harmful and addictive nature of opioids (and its impact on the public health system) approves one of the most powerful opioids ever, disregarding the fact that its unique advantage is the fact that this is a non-intravenous administered opioid... Ohh, and the argument for approving is basically that they believe is good to have more alternatives to existing opioids. Really? Like is not fentanyl strong enough to address every possible medical use case for a powerful opioid?

chimeracoder 8y ago
> This dissipates any doubt I had about the influence of lobbying. Who are you accusing of lobbying here? It's pretty clear from the article that the primary advocate for this drug is the military (DoD). > Like is not fentanyl strong enough to address every possible medical use case for a powerful opioid? Strength is not something that's assessed along a one-dimensional axis, much as popular reporting on opiates and pharmaceuticals would have you believe.
- deleted 8y ago
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- whoisjuan 8y ago
  > Who are you accusing of lobbying here? AcelRx, the pharmaceutical company that produces and distributes DSUVIA. You understand how lobbying works right? Even if the Department of Defense is advocating for the use of a drug, they don't have any input on the safety of whatever they are advocating for. This is the role of the FDA. AcelRx happens to have something that the DoD wants so they lobby for its approval. In this case, DoD, FDA, and AcelRX are all different parties but is clear that AcelRX is the only party that will benefit financially from this. Just from an anectodical perspective, so you can understand how this works, check ACRX stock closing price today. It closed 16% up today. Just because the DoD is advocating for this drug, that doesn't mean that there's no pharmaceutical lobbying behind this. By that logic then all defense contractors and weapon manufacturers wouldn't have to lobby as much as they do.
  - chimeracoder 8y ago
    > You understand how lobbying works right? Yes, I do. There's no need to be condescending. > clear that AcelRX is the only party that will benefit financially from this The DoD benefits as well. > Just because the DoD is advocating for this drug, that doesn't mean that there's no pharmaceutical lobbying behind this. Thr converse applies too. Just because FDA approved a drug that the military wanted, that doesn't mean that the approval was the result of their lobbying.
joering2 8y ago
Many years ago my friend doctor patented a brilliant but simple device for holding on broken joints together. Because he seen so many open joints, he took advantage of this knowledge and it was light years comparing to other devices that were made from bulky material, expensive and painful to wear. All other doctors-friends tap him on the back and looked in his eyes like he's already a billionaire. "You only have to file with FDA and you good to go!", they say. Seven years later and $450,000 in FDA fees and lawyers, he did not get anywhere! But he was lucky enough to stop there, as he met some lawyer that used to work for FDA before. That layer told him even back in 70s everyone within agency knew the goal of FDA is NOT to protect citizens and their health; but rather to protect big pharma, or pretty much every corporation with big enough pockets, from disrupting market and as a result messing around with their bottom line. This lawyer told my friend that this is as hard-core "capitalism Americana" as it can ever get! Maybe we don't have Standard & Oil and Rockefeller in full charge taking advantage of capitalism's cons, but indeed it shakes you to the core when you educate yourself how broken the system IS. Edit: to expand on FDA goal - when you file for approval for a big enough disruptive product, they will find all sort of downsides to drag your feet. The good rule of a thumb is if you are rejected the second time, you most likely won't get anyway ever. So FDA's job is to come up with good enough excuse to put your product/approval down with as sounded reason as possible. Followup: if you love these kind of stories and dirty rabbit holes, lookup how Aspartame was initially approved by FDA. Goosebumps and head shakes guaranteed!
etrevino 8y ago
I can't speak for this drug, but different opioids are processed by different liver pathways. Some people don't properly metabolize something like Oxycodone, but handle morphine just fine. So that's part of it. The other issue is that in specific cases (for instance, in battlefield medicine) you may need something that hits harder and faster than fentanyl. Again, I don't know this particular drug, but it may also last longer than fentanyl, which wears off quite quickly.

chimeracoder 8y ago

> This dissipates any doubt I had about the influence of lobbying. Who are you accusing of lobbying here? It's pretty clear from the article that the primary advocate for this drug is the military (DoD). > Like is not fentanyl strong enough to address every possible medical use case for a powerful opioid? Strength is not something that's assessed along a one-dimensional axis, much as popular reporting on opiates and pharmaceuticals would have you believe.

deleted 8y ago
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whoisjuan 8y ago
> Who are you accusing of lobbying here? AcelRx, the pharmaceutical company that produces and distributes DSUVIA. You understand how lobbying works right? Even if the Department of Defense is advocating for the use of a drug, they don't have any input on the safety of whatever they are advocating for. This is the role of the FDA. AcelRx happens to have something that the DoD wants so they lobby for its approval. In this case, DoD, FDA, and AcelRX are all different parties but is clear that AcelRX is the only party that will benefit financially from this. Just from an anectodical perspective, so you can understand how this works, check ACRX stock closing price today. It closed 16% up today. Just because the DoD is advocating for this drug, that doesn't mean that there's no pharmaceutical lobbying behind this. By that logic then all defense contractors and weapon manufacturers wouldn't have to lobby as much as they do.
- chimeracoder 8y ago
  > You understand how lobbying works right? Yes, I do. There's no need to be condescending. > clear that AcelRX is the only party that will benefit financially from this The DoD benefits as well. > Just because the DoD is advocating for this drug, that doesn't mean that there's no pharmaceutical lobbying behind this. Thr converse applies too. Just because FDA approved a drug that the military wanted, that doesn't mean that the approval was the result of their lobbying.

joering2 8y ago

Many years ago my friend doctor patented a brilliant but simple device for holding on broken joints together. Because he seen so many open joints, he took advantage of this knowledge and it was light years comparing to other devices that were made from bulky material, expensive and painful to wear. All other doctors-friends tap him on the back and looked in his eyes like he's already a billionaire. "You only have to file with FDA and you good to go!", they say. Seven years later and $450,000 in FDA fees and lawyers, he did not get anywhere! But he was lucky enough to stop there, as he met some lawyer that used to work for FDA before. That layer told him even back in 70s everyone within agency knew the goal of FDA is NOT to protect citizens and their health; but rather to protect big pharma, or pretty much every corporation with big enough pockets, from disrupting market and as a result messing around with their bottom line. This lawyer told my friend that this is as hard-core "capitalism Americana" as it can ever get! Maybe we don't have Standard & Oil and Rockefeller in full charge taking advantage of capitalism's cons, but indeed it shakes you to the core when you educate yourself how broken the system IS. Edit: to expand on FDA goal - when you file for approval for a big enough disruptive product, they will find all sort of downsides to drag your feet. The good rule of a thumb is if you are rejected the second time, you most likely won't get anyway ever. So FDA's job is to come up with good enough excuse to put your product/approval down with as sounded reason as possible. Followup: if you love these kind of stories and dirty rabbit holes, lookup how Aspartame was initially approved by FDA. Goosebumps and head shakes guaranteed!

etrevino 8y ago

I can't speak for this drug, but different opioids are processed by different liver pathways. Some people don't properly metabolize something like Oxycodone, but handle morphine just fine. So that's part of it. The other issue is that in specific cases (for instance, in battlefield medicine) you may need something that hits harder and faster than fentanyl. Again, I don't know this particular drug, but it may also last longer than fentanyl, which wears off quite quickly.