5 ms·

> you're now obligated to prove that your product works And that's a bad thing?

by jasonhansel 5y ago

rmellow 5y ago
For business? Absolutely
- qwerty456127 5y ago
  Also bad for the people who might benefit from the product even though it didn't help a statistically significant portion of people in an expensive clinical trial.
  - tekknik 5y ago
    I wonder how many non smokers we have in this thread making decisions for others. If only we’d think of the children! Screw the adults struggling with nicotine addiction, they should go back to cigarettes or just quit (like they’ve been trying to for years). Why do people have to stick their noses in things that don’t affect them?
deleted 5y ago
[deleted]
theli0nheart 5y ago
> And that's a bad thing? If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval. It will also greatly affect access to the product, as not everyone has access to good doctors, and most items that are FDA-regulated requires prescriptions. For a product which is a superior, healthier option to cigarettes, it's a massive regulatory burden that could kill the business. I can't imagine anyone would defend that as preferable to the status quo.
- acituan 5y ago
  > If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval Question stands, is that a bad thing? Besides not everything FDA approved becomes a prescription medication. On topic; nicotine gums and patches as smoke cessation products are widely available as OTC.
  - twojacobtwo 5y ago
    I think the implication is that a product can do some harm, while reducing the overall harm in the system. In this case, vaping might cause some harm, but it potentially reduces the overall harm by doing much less harm than cigarettes. I believe the comment is saying that, by pushing for regulatory approval, the product may never enter the market and would thus not be able to reduce the overall harm being done. In this case, we would certainly have to consider the potentially increased harm of non-smokers taking up vaping to assess the overall harm being done, but I see the merits of the basic argument at least.
    - deleted 5y ago
      [deleted]
  - TedDoesntTalk 5y ago
    > Nicotine gums and patches as smoke cessation products are widely available as OTC. The first nicotine gum, Nicorette, began as a prescription-only product in the US.
- deleted 5y ago
  [deleted]
elif 5y ago
See marijuana if you believe regulators will actually listen to a preponderance of evidence. FDA/pharma executives are a revolving door, and therefore concerned chiefly with the health of pharma rather than humans.
- deleted 5y ago
  [deleted]
- folli 5y ago
  Recent developments (see aducanumab) have shown that the FDA mainly cares about safety but much less so about efficacy.
- fragmede 5y ago
  There are (AFAIK) 3 cannabis derived products that the FDA has approved. Given the large cost required to get a new patentable drug through the FDA, it doesn't come as a surprise that no one's willing to foot that bill. What the DEA (a totally different governmental organization with different motivations and biases) thinks about marijuana is reprehensible, however.
  - elif 5y ago
    https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process https://www.fda.gov/news-events/public-health-focus/fda-and-... Exactly. They have approved 3 niche pharmaceutical industry replacements. Meanwhile they have kept their head in the sand regulating the 26 state cannabis industry, and we have no universal standards for contaminants, potency, etc. beyond state imposed regulations. The CBD industry, which has been commercialized in most states, is also totally unregulated.
mumblemumble 5y ago
There's an interesting tradeoff there. Getting through clinical trials to prove it works is expensive, though that's realistically more an annoyance to the company than a problem for the public. But once you have gone through all of that, you're probably looking at the product now being sold for a higher price (increased barriers to entry means more competition), and possibly only by prescription. Which might severely reduce availability to less-wealthy smokers. Which, I think at this point, is most smokers. On the other hand, that would also severely reduce availability to kids who aren't already addicted to some other tobacco product. So there's that. Long story short, I can imagine a lot of valid arguments pointing in every which way here.

> you're now obligated to prove that your product works And that's a bad thing?

rmellow 5y ago

For business? Absolutely

qwerty456127 5y ago
Also bad for the people who might benefit from the product even though it didn't help a statistically significant portion of people in an expensive clinical trial.
- tekknik 5y ago
  I wonder how many non smokers we have in this thread making decisions for others. If only we’d think of the children! Screw the adults struggling with nicotine addiction, they should go back to cigarettes or just quit (like they’ve been trying to for years). Why do people have to stick their noses in things that don’t affect them?

deleted 5y ago

[deleted]

theli0nheart 5y ago

> And that's a bad thing? If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval. It will also greatly affect access to the product, as not everyone has access to good doctors, and most items that are FDA-regulated requires prescriptions. For a product which is a superior, healthier option to cigarettes, it's a massive regulatory burden that could kill the business. I can't imagine anyone would defend that as preferable to the status quo.

acituan 5y ago
> If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval Question stands, is that a bad thing? Besides not everything FDA approved becomes a prescription medication. On topic; nicotine gums and patches as smoke cessation products are widely available as OTC.
- twojacobtwo 5y ago
  I think the implication is that a product can do some harm, while reducing the overall harm in the system. In this case, vaping might cause some harm, but it potentially reduces the overall harm by doing much less harm than cigarettes. I believe the comment is saying that, by pushing for regulatory approval, the product may never enter the market and would thus not be able to reduce the overall harm being done. In this case, we would certainly have to consider the potentially increased harm of non-smokers taking up vaping to assess the overall harm being done, but I see the merits of the basic argument at least.
  - deleted 5y ago
    [deleted]
- TedDoesntTalk 5y ago
  > Nicotine gums and patches as smoke cessation products are widely available as OTC. The first nicotine gum, Nicorette, began as a prescription-only product in the US.
deleted 5y ago
[deleted]

elif 5y ago

See marijuana if you believe regulators will actually listen to a preponderance of evidence. FDA/pharma executives are a revolving door, and therefore concerned chiefly with the health of pharma rather than humans.

deleted 5y ago
[deleted]
folli 5y ago
Recent developments (see aducanumab) have shown that the FDA mainly cares about safety but much less so about efficacy.
fragmede 5y ago
There are (AFAIK) 3 cannabis derived products that the FDA has approved. Given the large cost required to get a new patentable drug through the FDA, it doesn't come as a surprise that no one's willing to foot that bill. What the DEA (a totally different governmental organization with different motivations and biases) thinks about marijuana is reprehensible, however.
- elif 5y ago
  https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process https://www.fda.gov/news-events/public-health-focus/fda-and-... Exactly. They have approved 3 niche pharmaceutical industry replacements. Meanwhile they have kept their head in the sand regulating the 26 state cannabis industry, and we have no universal standards for contaminants, potency, etc. beyond state imposed regulations. The CBD industry, which has been commercialized in most states, is also totally unregulated.

mumblemumble 5y ago

There's an interesting tradeoff there. Getting through clinical trials to prove it works is expensive, though that's realistically more an annoyance to the company than a problem for the public. But once you have gone through all of that, you're probably looking at the product now being sold for a higher price (increased barriers to entry means more competition), and possibly only by prescription. Which might severely reduce availability to less-wealthy smokers. Which, I think at this point, is most smokers. On the other hand, that would also severely reduce availability to kids who aren't already addicted to some other tobacco product. So there's that. Long story short, I can imagine a lot of valid arguments pointing in every which way here.