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On March 23 2018 00:17 Mohdoo wrote:Interesting development that is relevant to me personally https://www.politico.com/story/2018/03/21/drugs-right-to-try-congress-434677My impression from the article is that this would be rolling back "protections" for people wanting to be experimented on because they're totally fucked anyway. A family member of mine passed away after trying to find experimental drugs. There was an insane amount of red tape and in the end, they died. He basically had the perspective of "nothing can be worse than what I am currently going through, so I may as well show up and see what they've got" Never managed to get anything. I can't emphasize enough how doomed this family member was. I really wish he was given the ability to just roll the dice. Overall, I would like to see significantly relaxed rules around human testing.
I think the article brings up the crux of the point though:
But Democrats continued to push back against the law Wednesday. Rep. Frank Pallone (D-N.J.), ranking member of the House Energy and Commerce Committee, said right-to-try doesn’t address the true barrier facing patients requesting experimental drugs — resistance from drug companies — and thus offers patients little more than "false hope."
A patient dieing while taking your drug before it's cleared by the FDA, no matter how doomed they were to begin with, is really bad for the company researching and developing the drug.
I don't know enough about whether the legislature is a good idea or not, but I would not at all expect to see patients get more access to experimental drugs because it's a huge risk to the company attempting to research the drug. I'd be very wary though because the legislation potentially creates weird incentives (like leaving drugs in an experimental stage intentionally).
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On March 23 2018 00:17 Mohdoo wrote:Interesting development that is relevant to me personally https://www.politico.com/story/2018/03/21/drugs-right-to-try-congress-434677My impression from the article is that this would be rolling back "protections" for people wanting to be experimented on because they're totally fucked anyway. A family member of mine passed away after trying to find experimental drugs. There was an insane amount of red tape and in the end, they died. He basically had the perspective of "nothing can be worse than what I am currently going through, so I may as well show up and see what they've got" Never managed to get anything. I can't emphasize enough how doomed this family member was. I really wish he was given the ability to just roll the dice. Overall, I would like to see significantly relaxed rules around human testing.
I’d like to see something like that right to try bill passed too. Still extend protections to consumers so they are informed of the stage of testing and potential side effects and other risks.
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there's already expanded access/ compassionate use. a patient and their physician have to do some paperwork, but virtually all requests are approved. most approvals are done in under 30 days, and you can get them expedited even more.
the purpose of the paperwork is to require the researcher/pharma sponsor to provide the patient and their doctor with information for informed consent, instead of them promising "hey we can cure your stage 4 cancer just take this drug we promise" (usually treatment with experimental biologics is free or very cheap for the patient).
"right to try" effectively already exists. "right to do shit that no one knows will work and probably won't" would be a better way of describing this legislation. it also threatens to really undermine the role of the FDA, as there's a high likelihood that many companies will just try to circumvent them under these provisions.
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On March 23 2018 00:31 ticklishmusic wrote:
there's already expanded access/ compassionate use. a patient and their physician have to do some paperwork, but virtually all requests are approved. most approvals are done in under 30 days, and you can get them expedited even more.
the purpose of the paperwork is to require the researcher/pharma sponsor to provide the patient and their doctor with information for informed consent, instead of them promising "hey we can cure your stage 4 cancer just take this drug we promise".
It is clearly situational. My family member tried. He also had an illness that was very fast acting and 30 days would have been an extremely unreasonable amount of time. He was a very smart, wise person. Even with the risks, if a doctor told him "I don't have time to explain, but if you inject this shit into your arm every 30 minutes for a day, you will either die miserably or be somewhat saved", he would have snatched the needles out of the doctor's hand and started injecting. He wouldn't have even read the label. His situation was very grim and he truly had nothing to lose.
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United States41117 Posts
I guess we'll know if it's true in a few hours.
John Dowd resigned Thursday as President Trump's lead attorney in the Russia inquiry, according to several reports, in a major shake-up of the legal team defending the president in the special counsel's investigation.
The New York Times first reported Dowd's resignation, according to "two people briefed on the matter." The Washington Post also subsequently reported the news, citing "three people familiar with the decision."
Dowd and Ty Cobb, another attorney for the president, did not immediately respond to requests for comment from BuzzFeed News.
Dowd's resignation comes five days after he had to walk back comments he made to the press saying he and the president wanted Acting Attorney General Rosenstein to shut down special counsel Robert Mueller's inquiry in light of Attorney General Jeff Sessions firing former FBI deputy director Andrew McCabe. Although he initially told the Daily Beast he was "speaking on behalf of the president, in his capacity as the president’s attorney," Dowd later said he was not speaking for Trump.
Earlier this month, Trump denied reports he was unhappy with his legal team.
Source
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On March 23 2018 00:38 Mohdoo wrote:Show nested quote +On March 23 2018 00:31 ticklishmusic wrote:
there's already expanded access/ compassionate use. a patient and their physician have to do some paperwork, but virtually all requests are approved. most approvals are done in under 30 days, and you can get them expedited even more.
the purpose of the paperwork is to require the researcher/pharma sponsor to provide the patient and their doctor with information for informed consent, instead of them promising "hey we can cure your stage 4 cancer just take this drug we promise". It is clearly situational. My family member tried. He also had an illness that was very fast acting and 30 days would have been an extremely unreasonable amount of time. He was a very smart, wise person. Even with the risks, if a doctor told him "I don't have time to explain, but if you inject this shit into your arm every 30 minutes for a day, you will either die miserably or be somewhat saved", he would have snatched the needles out of the doctor's hand and started injecting. He wouldn't have even read the label. His situation was very grim and he truly had nothing to lose.
you can literally have the physician call the FDA for pre-auth, then submit the paperwork later.
i just really don't like having the FDA taken out of the loop. i'm sympathetic to 'every moment matters', but i think the existing provisions are pretty good already, and we need to balance it with patient safety (ie involving the FDA).
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On March 23 2018 00:38 Mohdoo wrote:Show nested quote +On March 23 2018 00:31 ticklishmusic wrote:
there's already expanded access/ compassionate use. a patient and their physician have to do some paperwork, but virtually all requests are approved. most approvals are done in under 30 days, and you can get them expedited even more.
the purpose of the paperwork is to require the researcher/pharma sponsor to provide the patient and their doctor with information for informed consent, instead of them promising "hey we can cure your stage 4 cancer just take this drug we promise". It is clearly situational. My family member tried. He also had an illness that was very fast acting and 30 days would have been an extremely unreasonable amount of time. He was a very smart, wise person. Even with the risks, if a doctor told him "I don't have time to explain, but if you inject this shit into your arm every 30 minutes for a day, you will either die miserably or be somewhat saved", he would have snatched the needles out of the doctor's hand and started injecting. He wouldn't have even read the label. His situation was very grim and he truly had nothing to lose.
there's always somethin gto lose; there's no real limit to how much pain you can be in/suffering you can have.
trying stuff with no real chance of working out of sheer desperation isn't a good system.
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On March 23 2018 00:42 ticklishmusic wrote:Show nested quote +On March 23 2018 00:38 Mohdoo wrote:On March 23 2018 00:31 ticklishmusic wrote:
there's already expanded access/ compassionate use. a patient and their physician have to do some paperwork, but virtually all requests are approved. most approvals are done in under 30 days, and you can get them expedited even more.
the purpose of the paperwork is to require the researcher/pharma sponsor to provide the patient and their doctor with information for informed consent, instead of them promising "hey we can cure your stage 4 cancer just take this drug we promise". It is clearly situational. My family member tried. He also had an illness that was very fast acting and 30 days would have been an extremely unreasonable amount of time. He was a very smart, wise person. Even with the risks, if a doctor told him "I don't have time to explain, but if you inject this shit into your arm every 30 minutes for a day, you will either die miserably or be somewhat saved", he would have snatched the needles out of the doctor's hand and started injecting. He wouldn't have even read the label. His situation was very grim and he truly had nothing to lose. you can literally have the physician call the FDA for pre-auth, then submit the paperwork later. i just really don't like having the FDA taken out of the loop. i'm sympathetic to 'every moment matters', but i think the existing provisions are pretty good already, and we need to balance it with patient safety (ie involving the FDA).
Fair enough. I just think there should be conditions which, when met, mean the FDA is completely out of the picture. Let's say someone becomes terminal after 15 days of an infection spreading. They are on day 8. Some pharma company is 100 miles away. That dude should be able to drive to the pharma company, be like "y'all want some of that sweet human testing?", prompting the entire research team to come flooding out of the building. That data could accelerate their research by years. Human testing is so unbelievably rich in information in early testing that most pharma companies would be fools to turn it down, assuming no legal repercussions and whatnot.
Hell, even throw in an NDA. The family can not sue, or even tell people the family member used the treatment.
My point is that some people are so, so fucked that even with a 10% chance to live and signing away all legal protections or even the ability to say what happened, my family member would have signed up. He's dead now. He would have risked suffering more if it meant maybe living. There are conditions where the FDA being involved makes no sense.
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On March 23 2018 00:49 Mohdoo wrote:Show nested quote +On March 23 2018 00:42 ticklishmusic wrote:On March 23 2018 00:38 Mohdoo wrote:On March 23 2018 00:31 ticklishmusic wrote:
there's already expanded access/ compassionate use. a patient and their physician have to do some paperwork, but virtually all requests are approved. most approvals are done in under 30 days, and you can get them expedited even more.
the purpose of the paperwork is to require the researcher/pharma sponsor to provide the patient and their doctor with information for informed consent, instead of them promising "hey we can cure your stage 4 cancer just take this drug we promise". It is clearly situational. My family member tried. He also had an illness that was very fast acting and 30 days would have been an extremely unreasonable amount of time. He was a very smart, wise person. Even with the risks, if a doctor told him "I don't have time to explain, but if you inject this shit into your arm every 30 minutes for a day, you will either die miserably or be somewhat saved", he would have snatched the needles out of the doctor's hand and started injecting. He wouldn't have even read the label. His situation was very grim and he truly had nothing to lose. you can literally have the physician call the FDA for pre-auth, then submit the paperwork later. i just really don't like having the FDA taken out of the loop. i'm sympathetic to 'every moment matters', but i think the existing provisions are pretty good already, and we need to balance it with patient safety (ie involving the FDA). Fair enough. I just think there should be conditions which, when met, mean the FDA is completely out of the picture. Let's say someone becomes terminal after 15 days of an infection spreading. They are on day 8. Some pharma company is 100 miles away. That dude should be able to drive to the pharma company, be like "y'all want some of that sweet human testing?", prompting the entire research team to come flooding out of the building. That data could accelerate their research by years. Human testing is so unbelievably rich in information in early testing that most pharma companies would be fools to turn it down, assuming no legal repercussions and whatnot. Hell, even throw in an NDA. The family can not sue, or even tell people the family member used the treatment. My point is that some people are so, so fucked that even with a 10% chance to live and signing away all legal protections or even the ability to say what happened, my family member would have signed up. He's dead now. He would have risked suffering more if it meant maybe living. There are conditions where the FDA being involved makes no sense.
I see no reason to cut the fda out of the picture entirely; I mean it's their job. overseeing drug research is what they're for.
and human testing can easily end up in some VERY unethical thins being done, so it's very important to have oversight.
and it's not like there are 10% chance to live if you get the test drugs; if the odds were that good they'd have been approved for human testing in extreme cases long since.
at any rate; this doesn't sound like a good place to assess the actual merits fo the policy, given the emotional baggage involved.
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Forgive me if this post is a bit long. I don't think it quite justifies its own thread, since my main point is regarding black representation in US politics. This was just a really cool experience and I wanted to share:
I had an interesting experience in Chicago recently. I spent most of my formative years in Oregon, an extremely white state. Before moving to Oregon, I lived in significantly more diverse areas, but I didn't have the same level of awareness of society and all that sort of stuff. In Oregon, we have black people, and some of them "act more black" than others, but I don't know how to quite put this, but being in Chicago, I was given an extreme amount of insight into why black people have such a difficult situation in Oregon and Washington.
In Chicago, it felt to me like there were essentially 2 parallel societies and cultures. One of them black, the other everything else. And it's not like it was a low income sort of thing, like poor vs rich. Whether wealthy or poor, there was a common social link between black people in Chicago. There is just an extremely well developed, full, vibrant black culture in Chicago. Everything from how they talk, where they eat, what they do was a complete story. In Oregon/Washington, it is like black people are caught in between. There are not enough black people to form their own culture/society, but they plain and simply do not naturally meld with "other" cultures. To me, it feels like black people naturally gravitate into their own distinct culture and this culture is only able to fully flourish when there is a high enough % of the population that is black. It was really wonderful to see and made me realize just how poorly represented black people must feel in the pacific northwest. It's not like they are some foreign alien race, just kind of different. And in a really great way. Their culture was so vibrant, fresh and energetic. I'm not sure if I am doing a good job at describing this. Probably not since it is early in the morning. But I was just really interested to see why black people so often feel like outcasts in white dominated areas. For more than just racism, too. It's like they have to put on a mask every day. But in Chicago, everything about black culture felt very natural and fluid. They all seemed legitimately happier and and more comfortable. In Oregon, it always feels like black people are (understandably) uncomfortable living in a society that simply does not reflect them.
It also added a lot of credit to many things GH says about the democratic party. But I am not entirely sure how that would ever be fixed other than just cramming a bunch of black people into the party leadership. It feels like there is some critical threshold that must be crossed in order for blackness to be "actually" fully expressed and appreciated within a society or group of people. It makes sense why black people would feel so poorly represented. It's like there is this natural tendency for culture which is just not the same as white culture. I hope what I am saying doesn't come across as racist. Maybe it is bad to say there is something distinct there, but I am trying to say this distinctness should be appreciated and respected. It is a really, really, really good thing in Chicago and it makes me sad to realize black people in the pacific northwest do not get this same feeling of community and belonging as they do in Chicago.
It's not just that black interests aren't properly represented. Their culture isn't properly represented either, and the effects of that are probably a lot more widespread than I realize. In summary, I would say the feelings of "otherness" that black people feel is often understated and underappreciated. I think it is important that people understand black culture is worthy of acknowledgement in itself. Seeing the difference between Portland and Chicago was just fascinating. I feel like I still don't fully understand what I learned. All I know is I had no idea previously. A lot to ponder. There is an entire black culture that just doesn't get represented or appreciated nearly as much as it should be in "mainstream media".
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"Right to try" is all well and good if you trust physicians working with drug companies (or, more charitably, the drug companies informing the physicians) not to exaggerate the potential benefits of the experimental treatment to gather more human data.
I trust very few companies to not exaggerate potential benefits of phase II drugs without any government oversight. Especially because the way they look for active compounds systematically results in overestimating benefit and safety.
And when the bill (or at least the bill I found) makes it so the drug company will have no liability whatsoever and forbids the FDA from saying "hey, you tried this drug on a guy and his face melted off, you better stop testing" but DOES allow the positive results to be used in the review documents I get incredibly spooked.
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I know this thread is new, but we should have more posts like Mohdoo’s above, which is in the running for best post so far. A good read and better for discussion that most of the garbage we post here. 
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On March 23 2018 01:21 Plansix wrote:I know this thread is new, but we should have more posts like Mohdoo’s above, which is in the running for best post so far. A good read and better for discussion that most of the garbage we post here.
I'm trying really hard to see past the "My Trip to the Zoo" feeling of the post, and I'm just not a fan of "the blacks" type talk, I prefer black people/communities/cultures/etc... So I'm just going to let that settle down and read it again later and see how I feel about it then.
I can tell he was trying though so I'll do my best.
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On March 23 2018 01:35 GreenHorizons wrote:Show nested quote +On March 23 2018 01:21 Plansix wrote:I know this thread is new, but we should have more posts like Mohdoo’s above, which is in the running for best post so far. A good read and better for discussion that most of the garbage we post here. I'm trying really hard to see past the "My Trip to the Zoo" feeling of the post, and I'm just not a fan of "the blacks" type talk, I prefer black people/communitie s/culture s/etc... So I'm just going to let that settle down and read it again later and see how I feel about it then. I can tell he was trying though so I'll do my best.
I'll edit it to have that type of language when I'm at a computer. I guess the reason it has a "trip to the zoo" feel is because it was very different from what I've experienced. It wasn't a zoo and my point is that black culture deserves more respect, consideration and understanding. And the way I normally type I generally just say "Hispanics" instead of Hispanic people. I'm Hispanic. I'm not trying to dehumanize or something.
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On March 23 2018 01:35 GreenHorizons wrote:Show nested quote +On March 23 2018 01:21 Plansix wrote:I know this thread is new, but we should have more posts like Mohdoo’s above, which is in the running for best post so far. A good read and better for discussion that most of the garbage we post here. I'm trying really hard to see past the "My Trip to the Zoo" feeling of the post, and I'm just not a fan of "the blacks" type talk, I prefer black people/communitie s/culture s/etc... So I'm just going to let that settle down and read it again later and see how I feel about it then. I can tell he was trying though so I'll do my best.
If it were a journalist, I would agree with you. But Mohdoo says he is unsure he is articulating his points well, which I believe we can take in good faith. I think any critique you have about how he framed it wouldn't be ignored.
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As a total outsider i find all this stuff about "black culture being lived" really strange. It sounds like what i hear and feel from kurds and eastern europeans here but nowhere near to that level and most of them are only "here" since 20-40 years.
Color seems to matter for some reason.
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On March 23 2018 00:40 {CC}StealthBlue wrote:I guess we'll know if it's true in a few hours. https://twitter.com/Acosta/status/976845907781177347Show nested quote +John Dowd resigned Thursday as President Trump's lead attorney in the Russia inquiry, according to several reports, in a major shake-up of the legal team defending the president in the special counsel's investigation.
The New York Times first reported Dowd's resignation, according to "two people briefed on the matter." The Washington Post also subsequently reported the news, citing "three people familiar with the decision."
Dowd and Ty Cobb, another attorney for the president, did not immediately respond to requests for comment from BuzzFeed News.
Dowd's resignation comes five days after he had to walk back comments he made to the press saying he and the president wanted Acting Attorney General Rosenstein to shut down special counsel Robert Mueller's inquiry in light of Attorney General Jeff Sessions firing former FBI deputy director Andrew McCabe. Although he initially told the Daily Beast he was "speaking on behalf of the president, in his capacity as the president’s attorney," Dowd later said he was not speaking for Trump.
Earlier this month, Trump denied reports he was unhappy with his legal team. Source
Seems confirmed at this point.
https://www.nytimes.com/2018/03/22/us/politics/john-dowd-resigns-trump-lawyer.html
I'm sure his new lawyer that he plucked off of Fox News will be ready to tackle the upcoming challenges.
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On March 23 2018 01:35 GreenHorizons wrote:Show nested quote +On March 23 2018 01:21 Plansix wrote:I know this thread is new, but we should have more posts like Mohdoo’s above, which is in the running for best post so far. A good read and better for discussion that most of the garbage we post here. I'm trying really hard to see past the "My Trip to the Zoo" feeling of the post, and I'm just not a fan of "the blacks" type talk, I prefer black people/communitie s/culture s/etc... So I'm just going to let that settle down and read it again later and see how I feel about it then. I can tell he was trying though so I'll do my best.
Edited my main post to reflect the language you described. Thanks for your feedback. I honestly wrote my post with you in mind because you've often argued in favor of a lot of the ideas I feel I am trying to present. I thought you'd be interested to hear about the experience of someone who hadn't really had much insight into black culture and suddenly got an injection of it.
On March 23 2018 02:41 crms wrote:Show nested quote +On March 23 2018 00:40 {CC}StealthBlue wrote:I guess we'll know if it's true in a few hours. https://twitter.com/Acosta/status/976845907781177347John Dowd resigned Thursday as President Trump's lead attorney in the Russia inquiry, according to several reports, in a major shake-up of the legal team defending the president in the special counsel's investigation.
The New York Times first reported Dowd's resignation, according to "two people briefed on the matter." The Washington Post also subsequently reported the news, citing "three people familiar with the decision."
Dowd and Ty Cobb, another attorney for the president, did not immediately respond to requests for comment from BuzzFeed News.
Dowd's resignation comes five days after he had to walk back comments he made to the press saying he and the president wanted Acting Attorney General Rosenstein to shut down special counsel Robert Mueller's inquiry in light of Attorney General Jeff Sessions firing former FBI deputy director Andrew McCabe. Although he initially told the Daily Beast he was "speaking on behalf of the president, in his capacity as the president’s attorney," Dowd later said he was not speaking for Trump.
Earlier this month, Trump denied reports he was unhappy with his legal team. Source Seems confirmed at this point. https://www.nytimes.com/2018/03/22/us/politics/john-dowd-resigns-trump-lawyer.htmlI'm sure his new lawyer that he plucked off of Fox News will be ready to tackle the upcoming challenges.
If I were a guessing man, one of two situations occurred:
1. Trump made a request of Dowd that he could simply not agree to
2. Trump is insisting on taking action that Dowd does not think he can protect Trump from the effects of
As I understand, lawyers in these situations either actively do things or protect their clients from the things their client does. A lawyer bows out when they either feel unable to protect or unable to comply. It doesn't seem common for a lawyer to quit because of bad chemistry or something. They seem to serve much more of a tool purpose.
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On March 23 2018 02:45 Mohdoo wrote:
If I were a guessing man, one of two situations occurred:
1. Trump made a request of Dowd that he could simply not agree to
2. Trump is insisting on taking action that Dowd does not think he can protect Trump from the effects of
As I understand, lawyers in these situations either actively do things or protect their clients from the things their client does. A lawyer bows out when they either feel unable to protect or unable to comply. It doesn't seem common for a lawyer to quit because of bad chemistry or something. They seem to serve much more of a tool purpose.
The chemistry between lawyer and client, particularly in the type of role that Dowd was serving, is really important. There's room for substantial disagreement between lawyers and their clients, but the relationship is not going to work and not be productive if the attorney and client don't get along and don't see eye-to-eye on certain things.
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