I am dying of squamous cell carcinoma, and potential treatments are out of reach • Hacker News Board

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#151

Post by noduerme » Sat, Jul 22, 2023, 6:02 PM UTC

chroma wrote: post #34

tux3 wrote: post #3

There seems to be a growing sentiment that FDA delenda est , but if we don't fix the underlying problem that led to this situation, it will just come back. As the author says, no one ever blames the FDA for the people it failed to save. But approve something without the certainty that it isn't potentially going to kill someone, and there will be hell to your doorstep. Even if you want the experimental treatment, you…

For those who are curious, the term was coined on this blog post[1]: > The Copenhagen Interpretation of quantum mechanics says that you can have a particle spinning clockwise and counterclockwise at the same time – until you look at it, at which point it definitely becomes one or the other. The theory claims that observing reality fundamentally changes it. > The Copenhagen Interpretation of Ethics says that when you…

So, observing a problem is no more complicated than becoming aware that it exists. That's the only interaction necessary to invoke ethical liability. How does then pretending you didn't observe it release you from anything?

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#152

Post by eilertokyo » Sat, Jul 22, 2023, 6:03 PM UTC

Retric wrote: post #102

nextos wrote: post #49

Earlier quoted context omitted.

Immunotherapies are still immature but far from snake oil at this stage. They routinely achieve miraculous remissions but also lead to many adverse events. For most late stage tumors, chemotherapy will only, at best, increase life expectancy a bit. In my opinion, the choice is obvious.

Imminotherapies very quickly kill a significant percentage of the people who try them. So it’s a complicated balancing act when someone is likely to die in say 1-2 years but also likely to survive another 6 months. For people who are likely to die very soon the case is more clear cut, but the people developing these treatments don’t have the resources or infrastructure to try and treat more than a tiny handful of peo…

Your comment makes something that happens quite rarely (1-5% based on agent, and not quickly) seem like it happens quite frequently.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#153

Post by indrora » Sat, Jul 22, 2023, 6:03 PM UTC

A_D_E_P_T wrote: post #72

There's a very easy regulatory solution: Roll the drug approval process back to the way things were done prior to 1962. Back then, safety testing was all that was required. Efficacy testing -- which is difficult, expensive, arguably unethical in itself, and in some cases effectively impossible -- was not required. Drugs cost ~20-50x less to bring to market, and were brought to market faster. Indeed the 40s and 50s ar…

Ah yes, let’s go back to the days of Thalidomide.

For those that don’t know, the 1962 change is the Kefauver–Harris Amendment, which was a response to one of, if not the, largest overall global crisis of conscience in the medical field. From Wikipedia: “When first released, thalidomide was promoted for anxiety, trouble sleeping, "tension", and morning sickness.” After some time it became increasing obvious that while it worked, it caused birth defects in pregnant or soon to be pregnant women, with its manufacturers actively trying to quash the information about such cases; again, from Wikipedia: “Use of thalidomide in pregnancy can cause fetal abnormalities such as phocomelia (malformation of the limbs). In males who are taking the medication, contraception is essential if a partner could become pregnant.”

Thalidomide disfigurements were disturbing. Children born with these disfigurements were not linked to Thalidomide until much later. Thalidomide was in fact not allowed a safety regulation by the FDA initially. It wasn’t until the company producing it, Grünenthal, pressured the FDA. You see, the FDA reviewer for the medication was leery about it after some reports had floated over her desk about a possible remote risk that this could potentially cause birth defects. Grünenthal’s international licensee to the US refused to explain multiple papers that linked Thalidomide usage in pregnant women to birth defects.

As it turns out, not only had Grünenthal known about the issue they had actively worked to silence the information, a ploy that worked until a major change in leadership in Germany.

It was denied usage in East Germany.

For a longer documentary on the subject and how it changed medical safety testing, Plainly Difficult has a very good video on it: https://youtu.be/Vi03zz6eCik

(Note: I am explicitly ignoring the context that the Thalidomide development program was run by an actual Nazi who was responsible for unethical and frankly awful experience on unwilling human subjects in concentration camps. If anything, it only amplifies his concern to hide adverse effects, which he did quite successfully until the company was given what can only be considered “A slap in the face”.)

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#154

Post by GuB-42 » Sat, Jul 22, 2023, 6:04 PM UTC

sleight42 wrote: post #110

melling wrote: post #21

Earlier quoted context omitted.

This has been a common complaint for decades. We always want to try rush experimental drugs/procedures that “show promise”. How often do these drugs, etc turn out to effective? 25 years ago we wanted to rush gene therapy and that didn’t turn out well. Someone died. It probably set back gene therapy: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC81135/ I think the solution is to invest more into medical research now, t…

Just "invest more"? Who does the investing? Not "The Market". The incentive isn't to cure but to treat. The Market wants (repeat) customers. The government? At least, in the US, we've been dismantling the government's ability to do this since at least Reagan. Even our so-called Liberals aren't pushing hard here. You'd have to look to the "fringe" Progressives within the Democratic Party to even come close. And why? B…

> The incentive isn't to cure but to treat. The Market wants (repeat) customers.

I am fed up with this argument.

Compared to a recurring treatment, a cure will:

- destroy the competing recurring treatment

- sell particularly well initially, when you still have the patent, potentially at a high price

- not stop the influx of repeat customers, since as long as people are alive, they will need medicine, and people who are now healthy because you cured them will be more likely to have a well paying job that will pay for expensive drugs

If that argument was true, no one would do vaccines, especially considering that most vaccines are not particularly expensive.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#155

Post by eilertokyo » Sat, Jul 22, 2023, 6:05 PM UTC

Unclear to me why clinical trials seem unavailable to him, which is how he would gain access to these treatments. The major cancer centers generally will have options for his exact situation, though sometimes they require he finish conventional and salvage treatments first.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#156

Post by dionidium » Sat, Jul 22, 2023, 6:07 PM UTC

riffraff wrote: post #14

tux3 wrote: post #3

There seems to be a growing sentiment that FDA delenda est , but if we don't fix the underlying problem that led to this situation, it will just come back. As the author says, no one ever blames the FDA for the people it failed to save. But approve something without the certainty that it isn't potentially going to kill someone, and there will be hell to your doorstep. Even if you want the experimental treatment, you…

I remember at least three instances in my country where the authorities were forced to allow people to use experimental treatments due to media clamor. In all three instances, the result was that the treatments were snake oil and people died that might have lived otherwise. It's easy to say "people who have no other options should get access to experimental treatments" but the problem is that people who have other op…

> It's easy to say "people who have no other options should get access to experimental treatments" but the problem is that people who have other options want those too, because nobody wants to go through chemotherapy or whatever.

I reserve for myself the right to try to save my own life, even if that means some people who can't handle that responsibility make things worse for themselves. I can't get from, "but other people might hurt themselves" to "therefore you simply have to die, sorry."

No, I think we just have to be straightforward about this; I don't want anybody to purchase snake oil, but that possibility does not move me to eliminate options for myself or my family.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#157

Post by ejstronge » Sat, Jul 22, 2023, 6:08 PM UTC

peyton wrote: post #141

yladiz wrote: post #122

Earlier quoted context omitted.

C’mon, it’s extremely disingenuous to compare abortion and contraception with untested treatment.

It’s unfair to call treatments untested. Medications are tested extensively. The FDA could work with sponsors to come up with a range of risk profiles and expand access.

> The FDA could work with sponsors to come up with a range of risk profiles and expand access.

They indeed do this and have various avenues for treatments to be approved on expedited timelines.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#158

Post by newZWhoDis » Sat, Jul 22, 2023, 6:08 PM UTC

mustacheemperor wrote: post #129

nine_k wrote: post #112

Earlier quoted context omitted.

I'd say that people should be allowed to try whatever treatments they agree to have, in order to save their lives, and also in other cases. One cannot say with a straight face that a woman has sovereignty over her body and thus contraception and abortions should not be banned, and preclude that same woman from getting a treatment that can possibly save her life but has not been approved yet.

If the treatment needs to be administrated by a doctor, it demands the resources of the hospital and connected system, for a novel process. It does introduce a real risk factor for the rest of the healthcare provider’s system and the other people counting on it. I don’t see the comparison you’re making at all, really - a novel treatment has completely different context from an abortion. Talking about immunotherapies…

If I’m terminal and my doctor and I want to try the treatment, who are the feds to tell me no?

Screw ‘em

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#159

Post by ilamont » Sat, Jul 22, 2023, 6:09 PM UTC

How horrible and frustrating. There is a fast-track approval procedure described here, I wonder why it doesn't apply to these treatments?

https://www.fda.gov/patients/fast-track-breakthrough-therapy...

There is some important context for the following comment:

“If anything goes wrong,” he argued, “think how bad it will look that we approved the drug so quickly.”

In the 1980s, when the comment was made, there were still people at the FDA who remembered the Thalidomide disaster, which would have been a lot worse had the FDA approved the drug. In the U.S. several thousand women took thalidomide during the clinical trials, and some doctors took it, too:

In one case, a doctor had been using thalidomide himself and prescribing it to his wife. In addition to the wife’s loss of vision, the doctor mentioned peripheral neuritis, nerve pain that is a side effect of thalidomide.

The other report is even more alarming — a nurse had given birth to a baby without arms or legs and, as a registered nurse, “she may have had access to the item.” (1)

Other countries including Canada, Taiwan, Japan, and West Germany did approve the drug or allowed it to be sold.

On December 2 1961, the drug was taken of the German and British markets, after several doctors brought up concerns as it appeared more and more plausible that thalidomide, when taken by pregnant women, was responsible for severe birth defects. Thought the Government of Canada was informed of these suspicions about the possible teratogenic effects of thalidomide, we had to wait until March 2 1962 for the Canadian authorities to react and, in their turn, withdraw thalidomide from the market. As unbelievable as it can appear, thalidomide was legally available in Canada for three full months after being withdrawn from its origin country. (2)

1. https://www.nytimes.com/2020/03/23/health/thalidomide-fda-do...

2. https://thalidomide.ca/en/the-canadian-tragedy/

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#160

Post by chroma » Sat, Jul 22, 2023, 6:09 PM UTC

maxbond wrote: post #123

chroma wrote: post #113

Earlier quoted context omitted.

I’m saying that the FDA’s strictness cuts both ways. My beta blocker example was not a hypothetical. Europe approved the use of beta blockers to prevent heart attacks a decade before the US. Although the FDA approved propranolol in the 1960s, and timolol for glaucoma in 1978, they didn’t approve beta blockers for prevention of second heart attacks until the 1980s. This resulted in the deaths of over 80,000 Americans.…

It's one thing to say they should approve drugs faster and another thing to say they should rubber stamp anything that Europe and Canada approve.

It seems that if the Canadian and European regulatory bodies are incompetent or too quick to approve meds, it would show up in some statistics, right? Maybe their life expectancies would be lower or they would have higher rates of certain kinds of deaths. Yet if anything, it’s the US that lags in those areas.

There are tons of examples of the FDA failing to approve things, resulting in Americans dying unnecessarily. A more recent example was Omegaven, an IV nutritional fluid.[1] The FDA took 14 years to approve it, resulting in hundreds of infant deaths. Before its approval, only a few infants at Boston Children’s Hospital managed to get it. The staff there had to get FDA approval to import the fluid from Europe for every infant they wanted to treat, resulting in a lag time of several days. Even though it was clear that Omegaven was much more effective than previous IV nutrition, the FDA’s bureaucratic hurdles prevented it from being adopted sooner.

1. https://astralcodexten.substack.com/p/adumbrations-of-aducan...