What's messing with your Groove?

[GGT]

I was talking with an old friend the other day, about the horrible challenges she and her partner have faced taking care of their elderly parents over the years. Without going into the details....it's clear that the US for-profit Health Care Industry has FAILED, and no amount of "charity" or subsidies for private Insurance can fix it.

Minx, I'm glad your mom got the care she needed, despite the ambulance debacle. Things probably wouldn't have turned out so well if she lived in the US.

[Hazir]

I've been a vegetarian for about 48 years now. I never was a big fan of fake meat of any kind either. But about 15 years ago two products hit the market from an Israeli company that were quite palatable ; sausages and a burger that was tasty but not overly meaty.

With veganism spreading more and more, both those products have disappeared. The sausages due to a change of recipe, resulting in a product that tastes like a mixture of ground cardboard and chalk. The burgers have entirely disappeared and were replaced with alternatives that look more like meat (that's not a selling point for me) but are also advertised as being meatier. That last word alone is enough for me to feel an intense disgust when I even think of trying them out.

[Hazir]

I had a checkup with a cardiologist the other day. After a bunch of tests she talked me through the results. She also asked me a bunch of questions, including the usual ones about family. Turns out this woman was working at the ICU where my sister died, during her shift.

[GGT]

Our planet had its highest recorded average temp in history, but there are still climate deniers making public policy. Like Gov. Abbott of Texas rescinding a law mandating water breaks for outdoor workers. WTF?

[LittleFuzzy]

So we've put my grandmother in hospice. She turned 98 at the beginning of the month. She just stopped being willing to eat. Watching this decline is awful and I can barely begin to imagine what it's like for her. And it's got me feeling conflicted about my opinion on euthanasia. Because I do think that her being able to choose a more peaceful and quick death than this would be kind and better. But she's also been telling us that she doesn't want to be here on Earth anymore for at least 10 years, since her favorite brother died (she's the youngest of 7, and her last sister died ~five years ago and she has outlived all her cousins as well) and I'm quite positive she would have chosen to die some time ago if she could have even it was very much premature. She'd shown significant emotional and mental improvement over the course of a year once my mother got her going to the geriatric gym she discovered after retiring. But Covid stopped that and grandma started declining again.

[Hazir]

So we've put my grandmother in hospice. She turned 98 at the beginning of the month. She just stopped being willing to eat. Watching this decline is awful and I can barely begin to imagine what it's like for her. And it's got me feeling conflicted about my opinion on euthanasia. Because I do think that her being able to choose a more peaceful and quick death than this would be kind and better. But she's also been telling us that she doesn't want to be here on Earth anymore for at least 10 years, since her favorite brother died (she's the youngest of 7, and her last sister died ~five years ago and she has outlived all her cousins as well) and I'm quite positive she would have chosen to die some time ago if she could have even it was very much premature. She'd shown significant emotional and mental improvement over the course of a year once my mother got her going to the geriatric gym she discovered after retiring. But Covid stopped that and grandma started declining again.

I wish you a lot of strength dealing with that LF. I don't know if it's much help - if at all - but the way I understand it stopping with eating is a relatively soft way of ending it for the person wo decides to go that way. But I realize that doesn't make it easy on those around.

[LittleFuzzy]

She passed two evenings ago. 37 years to the day after my grandfather died

[Loki]

Sorry for your loss.

[wiggin]

I am beginning to understand complaints about the administrative state.

[Loki]

On the flip side, I got to see lobbyists - most of whom used to be workers in the same field - argue against a policy that will clearly save many lives on the grounds that it will cost the industry they now represent 0.1% of revenues.

[wiggin]

On the flip side, I got to see lobbyists - most of whom used to be workers in the same field - argue against a policy that will clearly save many lives on the grounds that it will cost the industry they now represent 0.1% of revenues.

Oh, this isn't anything like that. My boss and I made decisions several years ago that cost well over $1 million (figure a single digit percentage of all of the capital we have raised to date). We based those decisions on agency recognized international standards, agency published guidance on said standards, agency feedback to submitted plans, advice of agency accredited contractors, and scientific judgment. We went above and beyond requirements to demonstrate that our proposed technology did not pose a safety concern. And yet we're now being asked at the eleventh hour for a series of data that are (a) in direct contradiction with published standards and agency guidance and (b) wouldn't be meaningful or improve the patient safety profile. Not only that, it would delay our timeline by a minimum of 6 months and cost hundreds of thousands of dollars - both of which are very challenging for a startup to swallow.

The core issue here is arbitrariness and predictability. If there are standards, they should be followed. And if the agency wants to change guidance, they should publish clear changes rather than legislating on a case by case basis, throwing out years of carefully acquired data because they feel it isn't sufficient. The success of a submission to this agency shouldn't hinge on which reviewer you are lucky enough to be assigned; it should be clear and predictable.

Obviously when dealing with issues as complex and unique as we are handling, there needs to be some leeway for reviewers to think critically and ask solid scientific questions that are outside the scope of the as-written standards. But when all agency feedback (and guidance documents!) until a final decision is 'nonbinding' it's impossible for a company to make reasonable or predictable plans, especially when so much of the data take years to collect. Clear directives would help immensely, but they just don't exist - or, rather, they theoretically exist based on published standards and guidance, but effectively aren't worth the paper they're written on because the agency disregards clearly written criteria because they feel like it.

The consultants and lawyers who saw the volume and quality of data we provided were astonished at the requests we received given the submission pathway we're on. We provided way more data (with far more detail and care) that was necessary, because we were determined to do things right and prove to ourselves (even more than the agency) that our technology is sound. But apparently it's still not enough.

Oh, and they don't even read the submission in its entirety. About half of the questions were answered by pointing them to the relevant page and telling them to read.

To say that the last 6 weeks of my life have been frustrating would be a massive understatement.

[Loki]

No disagreement there. Thanks to worker turnover, there's remarkably little institutional memory in some agencies. Without that, demands at least seem arbitrary because they weren't made before. Plus some workers are obviously incompetent. Sorry you have to deal with such people. From my experience, your only chance of getting a reversal would to have a trade group get in touch with agency leadership. Or have your congressmen/senators write an angry letter. Maybe contact the SBA.

[wiggin]

No disagreement there. Thanks to worker turnover, there's remarkably little institutional memory in some agencies. Without that, demands at least seem arbitrary because they weren't made before. Plus some workers are obviously incompetent. Sorry you have to deal with such people. From my experience, your only chance of getting a reversal would to have a trade group get in touch with agency leadership. Or have your congressmen/senators write an angry letter. Maybe contact the SBA.

Well, we're throwing the kitchen sink at the problem. Part of the problem is that this corner of the agency has never handled a submission type like the one we are pursuing (which is intended to be a fast track for early stage technologies so that they can get into the clinic in the US faster) and they don't know how to review it appropriately. We've seen (and heard from partners) that the agency has major training issues, where standardizing training and making reviews predictable is very challenging, especially with high staff turnover and reviewers who are relatively junior with little to no industry experience.

Fortunately, we have a number of pathways to pursue. First, we're engaging directly with the review team about our concerns. So far that has been unsuccessful but we have hope that there might be some internal deliberations on their side (and attempts to save face) that might get some traction. Second, we happen to have a line to a very senior leader in their management structure, who is professionally invested in the success of the fast track program and would like to see us succeed (and who has told us to reach out to him if we need help). That will be avenue #2. Then, there's a formal dispute resolution process inside the agency that we might be able to avail ourself of. Our congresswoman is also very invested in the success of our industry in general (it's a major employer in her district) and has a senior role in the House and decent constituent services - we may engage with her as a last resort. Lastly, we do have other options (non-US) that we're pursuing, and we can always just tell the agency 'tough luck' and leave in a very loud huff (which the agency would like to avoid).

The problem is that these options are all pretty confrontational/aggressive and can poison the well for the future. We're trying to go with a collaborative tone for now, but at some point I suspect we'll be exploring some of these avenues. There are expensive lawyers involved. It's a very frustrating process that appears to be doing little to improve patient safety and just raise barriers for the sake of being difficult.

[Loki]

Well, we're throwing the kitchen sink at the problem. Part of the problem is that this corner of the agency has never handled a submission type like the one we are pursuing (which is intended to be a fast track for early stage technologies so that they can get into the clinic in the US faster) and they don't know how to review it appropriately. We've seen (and heard from partners) that the agency has major training issues, where standardizing training and making reviews predictable is very challenging, especially with high staff turnover and reviewers who are relatively junior with little to no industry experience.

Fortunately, we have a number of pathways to pursue. First, we're engaging directly with the review team about our concerns. So far that has been unsuccessful but we have hope that there might be some internal deliberations on their side (and attempts to save face) that might get some traction. Second, we happen to have a line to a very senior leader in their management structure, who is professionally invested in the success of the fast track program and would like to see us succeed (and who has told us to reach out to him if we need help). That will be avenue #2. Then, there's a formal dispute resolution process inside the agency that we might be able to avail ourself of. Our congresswoman is also very invested in the success of our industry in general (it's a major employer in her district) and has a senior role in the House and decent constituent services - we may engage with her as a last resort. Lastly, we do have other options (non-US) that we're pursuing, and we can always just tell the agency 'tough luck' and leave in a very loud huff (which the agency would like to avoid).

The problem is that these options are all pretty confrontational/aggressive and can poison the well for the future. We're trying to go with a collaborative tone for now, but at some point I suspect we'll be exploring some of these avenues. There are expensive lawyers involved. It's a very frustrating process that appears to be doing little to improve patient safety and just raise barriers for the sake of being difficult.

The thing about high turnover is that anyone you piss off won't be around to hold it against you next time around. I wouldn't be very optimistic about option 1. People need a reason to back down. Those who make unreasonable demands probably don't think their demands are unreasonable.

The lawyer option will unfortunately tie you up for years, generally defeating the purpose.

[wiggin]

I am not referring to a breakthrough designation (which has well-known pitfalls), but a specific submission program that has been relatively successful in other parts of the center.

The thing about high turnover is that anyone you piss off won't be around to hold it against you next time around. I wouldn't be very optimistic about option 1. People need a reason to back down. Those who make unreasonable demands probably don't think their demands are unreasonable.

The lawyer option will unfortunately tie you up for years, generally defeating the purpose.

I think that some of the review team will stick around (especially management) and we don't want a reputation as 'difficult' unless we need to. Re: option 1 I'm also pessimistic, but we did give them an off-ramp to back down without losing face (essentially, we executed a rapid turnaround on a request for a new risk analysis using an external expert who is well known to the agency). This potentially gives them the option to back off without appearing to change their minds. So far they haven't bit. We're concerned we may be at the mercy of one or two reviewers who have specific issues of interest to them where they believe standards are not adequate, and they're going to die on this particular hill. We'll have to see.

Re: lawyers, not worth our time to e.g. litigate. The lawyers are mostly there to provide appropriate guidance and language during an appeals process (and to provide weight to our arguments given their extensive history with the agency). But yes, any outcome that takes more than a few months to resolve means we take our ball and go play elsewhere.

[Aimless]

No disagreement there. Thanks to worker turnover, there's remarkably little institutional memory in some agencies. Without that, demands at least seem arbitrary because they weren't made before. Plus some workers are obviously incompetent. Sorry you have to deal with such people. From my experience, your only chance of getting a reversal would to have a trade group get in touch with agency leadership. Or have your congressmen/senators write an angry letter. Maybe contact the SBA.

Joining the Breakthrough Devices program is a double-edged sword, partly because it invites additional (bureaucratic as well as scientific) scrutiny by its very nature—ie. even under the best circumstances—and partly because the program itself has (like its sister program for pharmaceutical therapies) come under scrutiny because of concerns about quality of evidence. I don't think anyone should enter the program with an expectation of predictability and certainly not with an expectation of coasting through it with ease, unless they're talking about predictability wrt the structure of interactions with the agency. There's some indication that it may be beneficial to businesses that seek "Breakthrough Device" designation for their products, even though the marketing approval rate (since inception) is still at like 8% or so. If you have access to stat news you can read about their investigation here: https://www.statnews.com/2022/04/18/...investigation/ (I didn't save the article and don't have access atm)

Dunno how many products with BD designation flunk out (don't think that data is public), but, frustrating though it may be, I don't think there's any reason to lose hope at this late stage, given the unique merits of the product.

[GGT]

I'm sorry about your grandma, Fuzzy.

You said it made you re-think euthanasia, but it also makes me re-think longevity. There's something wrong with our society that values length of life at the cost of quality of life. My sister is dealing with her 93 yr old mother-in-law who has vascular dementia with paranoid psychosis. She's been saying for at least 10 yrs that she wants to die, begging anyone who'd listen to help her die; last time I saw her she grabbed my arm and pleaded to help her die. I'll never forget the desperate look in her eyes.

Their Greek culture doesn't believe in nursing homes, so they've taken extraordinary (and very expensive) measures to keep her "at home". They're even flying her between PA and Texas every few months so her sons can share the "duty" of taking care of her, but it's a real mess. I've tried to help them out a few times...but my overwhelming emotion was...this dear woman needs help in dying, not extending her life.

[GGT]

Taking these real challenges into account, I wonder what anyone thinks of the 8 Billion people on this planet who might also want/expect to live as long as possible?

[Nessus]

It's a self-solving problem, eventually. Too bad about all the corpses, but it's not like that's stopped civilized peoples before.

[Being]

It's a self-solving problem, eventually. Too bad about all the corpses, but it's not like that's stopped civilized peoples before.

The other day I watched a lizard eat another lizard.

[Loki]

The crazies in the House couldn't do one thing right and give me a brief vacation.

[Aimless]

The crazies in the House couldn't do one thing right and give me a brief vacation.

Oh no mate you with the government now??

[wiggin]

The crazies in the House couldn't do one thing right and give me a brief vacation.

I was kinda annoyed because we busted our butts to get a regulatory submission into the government machinery before the assumed shutdown (since once the clock starts, they're bound by it, whether they're paid or not), but now all of our efforts to turn the submission around in record time look pretty silly.

[Loki]

I'm from the government, and I'm here to help.

[Aimless]

Terrible, absolutely terrible news

[Loki]

Just wait until you see how many people expected a vacation this week and therefore take leave.

I'm also curious what happens to all the contractors who didn't expect to get paid for the next few weeks.

[EyeKhan]

Been dealing with my parents end of life. Fucking terrible. Big Eye Opener. There is NO REWARD for longevity. Fuck long life, fuck the death industry, fuck the human condition. Humanity top to bottom start to finish is a fucking disaster. Utterly pointless, all of it.

[Aimless]

Been dealing with my parents end of life. Fucking terrible.

I'm really sorry to hear this mate. I hope you (and they) have the support you need, at least.

[LittleFuzzy]

The ER admitted my mother at 2am this morning, saying she needed emergency surgery. It is now 6pm, and they just took her off the "npo" order and gave her a (liquid) dinner which is an admission that the surgery isn't gonna happen for at least another 12 hours

[Loki]

Shitty way to end a year. I hope she's gotten the surgery by now.