FDA Wants Safer Cancer Drugs, But Some Startups Fear Unintended Consequences (wsj.com) 37
For decades drugmakers have taken a more-is-more model when dosing cancer drugs in clinical trials. U.S. regulators want them to reconsider that approach. From a report: Companies with cancer drugs in clinical trials must strike a balance between doses high enough to thwart tumors, but low enough to avoid intolerable side effects. For years, Food and Drug Administration officials have expressed concern that cancer drug doses are often too high, leading to unnecessary side effects.
An FDA program launched in 2021, Project Optimus, requires companies to re-examine how they set doses of cancer treatments. This typically involves larger clinical trials to test doses to find those that optimally balance safety and efficacy. Entrepreneurs support the aim, but some fear the initiative will add time and cost to drug development, putting startups at a further disadvantage to larger competitors. [...] The FDA says it encourages drugmakers to discuss dosing plans with the agency and that new medications can still be brought to patients quickly.
An FDA program launched in 2021, Project Optimus, requires companies to re-examine how they set doses of cancer treatments. This typically involves larger clinical trials to test doses to find those that optimally balance safety and efficacy. Entrepreneurs support the aim, but some fear the initiative will add time and cost to drug development, putting startups at a further disadvantage to larger competitors. [...] The FDA says it encourages drugmakers to discuss dosing plans with the agency and that new medications can still be brought to patients quickly.
Seems like a simple standard to me (Score:3)
Proposed standard: A drug must have a better outcome than not using the drug, and an equal or better outcome than using an existing alternative drug. This calculation may include, unfortunately, affordability.
In fact, is that not already the standard for medical trials and drug approvals?
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Drugs should not be where all the money is going for cancer treatment, It should be Gene therapy, advanced culturing of anti cancer viruses and nano machines but big pharma wants to pump some pills and chemicals to kill 1/10th the cells in your body just in hopes that the drugs kill some cancer too.
Fuck cancer, and fuck big pharma. I hope this makes the industry change.
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Proposed standard: A drug must have a better outcome than not using the drug, and an equal or better outcome than using an existing alternative drug. This calculation may include, unfortunately, affordability. In fact, is that not already the standard for medical trials and drug approvals?
The topic is specifically about cancer drugs? Cancer treatments like chemotherapy are very risky and venture outside "safe". Chemotherapy, if you look at it one way, is selective poisoning of a body. Ideally doctors don't want any poison in a body but cancer drugs in chemotherapy try to poison the cancer more than the rest of the body. However, chemotherapy is not a painless or inexpensive or 100% successful treatment in all cases. Better outcome depends on the person and situation. There are people who opt
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Nothing in your post negates my point. The standard still works.
People elect to decline chemo all the time because their cancer is unlikely to be destroyed and while they may get some extra time, they'll be miserable during it. Those same drugs may be worth it to someone who is more likely to be cancer free after treatment and could tolerate short term misery for years more of healthy living afterwards.
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Nothing in your post negates my point. The standard still works.
Except the part where you ignored that cancer drugs are INHERENTLY unsafe.
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I did not ignore that, and that has no effect on the standard of 'is the outcome better or not?'. Most medications have small chances of serious side effects and everything, even water, is fatal if you overdose. Radiation and chemo are no different in that respect... the whole idea is to kill the cancer faster than the patient. A better outcome than just letting the cancer kill the patient.
You can type in all caps all you want, it doesn't change a thing.
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I did not ignore that, and that has no effect on the standard of 'is the outcome better or not?'.
WTF are you smoking? Patients suffering from normal effects of cancer drugs is something that has to be monitored all the time. One of those effects is death.
Most medications have small chances of serious side effects and everything, even water, is fatal if you overdose.
Again you seemingly fail to comprehend that by their nature cancer drugs have LARGE chances of side effects by their nature.
Radiation and chemo are no different in that respect... the whole idea is to kill the cancer faster than the patient. A better outcome than just letting the cancer kill the patient.
Your lack of comprehension is troubling.
Re:Seems like a simple standard to me (Score:4, Insightful)
Even healthcare systems that are actually "systems" and actually attempt some degree of cost/benefit rationality (in this case, Germany) still struggle with this:
https://www.scientificamerican... [scientificamerican.com]
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Of course - I use dimenhydrinate and acetylsalicylic acid for different things, and for similar conditions two people may find different medications work for them.
Then what you (should) end up with is two approved medications with prescription guidelines to help identify when to switch to something else.
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So what do you do with that? You approve both, but then insurance requires the cheapest effective one to be tried first.
There are many reasons to hate health insurance companies. However, this idea of pursuing and favoring the cheapest effective medication is a great idea and an obvious idea. If the medication is effective and cheaper, you obviously go with that. If it's not effective, then you consider the more expensive alternative.
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Look at the recent Boeing or Intel articles for examples of what happens when specialist decisions are made by distant accountants / MBAs.
Anonymizing and generalizing some real-world SNAFU medical decisions: Because of history X, doctors know procedure Y is unlikely to work for this patient, even though it is generally effective for other patients with this condition. However insurance requires Y to be tried before Z, because Y is 50% cheaper. Never mind that the weeks long delay caused by mandatory insu
My Dad's cancer treatment wrecked him (Score:5, Insightful)
My dad developed cancer for the 2nd time a few years ago. His cancer treatment ended up wrecking him, he's in constant pain now. Would lower doses have still killed the cancer but not given him the apparently permanent intestinal problems? I don't know, but I think that studying the issue is good.
Dad's issues are bad enough that I think that "quality vs quantity of life" is a valid topic.
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It's a very important discussion, but I don't think a doctor or politician should determine the outcome. Different people put different values on living and quality of life and deserve to be given the data required to make an informed choice.
How the hell someone mortally ill is supposed to do so dispassionately and come to a decision they won't regret i have no idea.
My sympathies for your father, and to you. My family faces similar issues and there's no comfortable answer that everyone (but mainly the sic
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Part of the problem is that the outcome is unknown. The best the doctor can do is lay out the risks. Dad rolled the gamble - successfully killed the cancer (for now), but ended up having to stop the treatment early because, well, it was wrecking the intestinal tract.
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Mom had a brain tumor removed, got almost the entire thing and she was still relatively functional, a little slurred and slower but still able to get herself around
the following year and a half of chemo, killed her. My dad looks back and says "if we better understand what we were doing, we would have skipped the chemo" she went from a mostly functioning adult woman to a potato and by then it was too late to change anything.
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I can only see limiting cancer drugs to very low dosage being bad. It'll be worse for patients, and pharma companies will be less inclined to spend even more money on cancer research given the lower likelihood of success.
Cancer drugs are the bread and butter of most pharma companies revenue. All the other stuff usually makes up a ton of money, but nothing comes close to cancer because everybody gets it so the sales are perpetually endless. The cost of researching a cancer drug is outrageous though because y
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This isn't about limiting cancer drugs to "very low dosage" though, it's about widening studies to better determine what the ideal dosage is, balancing tumor-killing with negative side effects.
As for cancer drug approval, the FDA tightened the limits quite a while ago - it used to be that a drug just needed to show that it shrunk tumors on average. Today, they need to show they shrink tumors either better than other drugs or with less side effects.
This is just expanding the requirements a bit more. Yes, i
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Instead of empowering consumers to make informed decisions, the FDA imposes broad, one-size-f
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delay access to potentially life-saving drugs.
The problem with this is that while it does indeed delay access to potentially life-saving drugs, it also prevents "hopeful" things like marketing treatments like injecting bleach solutions up your butt to treat everything from cancer to autism. In the latter case, often to non-consenting children.
Thalidomide is an excellent example of a "potentially" drug that could have stood to have just a little more study done before it was widely prescribed.
Now, could the FDA be reformed to be much better? Certainly
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Nobody has time for that amount of review and risk analysis. Especially when you'd also need to sort through the astroturf reviews and analysis that say all is good.
No disrespect toward you or your dad, but I disagree. I'd definitely trust a private company similar to the way Consumer Reports work much more than the government that's proven they'll get right in bed with industry to get things approved or paper over risk. Private for-profit companies have a better motive. Just because we don't have great examples right now, in a world with the FDA, doesn't mean we wouldn't see competition emerge in an actually competitive environment.
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"...last I checked..."
No one is buying that you ever checked once. Not your style.
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He's already in like the 3% survival rate category, I'm willing to say that it most likely saved his life.
That's why I said it needs studying to determine if a lower dose is as effective without as much in the way of side effects. Or if you're going to see the side effects regardless, might as well go with a higher dose to kill the cancer.
And good on identifying that it's all a gamble.
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That's the nature of cancer drugs. Cancer is your own cells multiplying uncontrollably. Drugs that target cancer inevitably will target your healthy cells as well.
It's why chemotherapy, while extremely effective, has very nasty side effects (and going bald is the only one they can really control with a wig).
The same drugs that poison your cancer cells are basically poisoning your real cells as well - the hope is the cancer dies off first before your body's cells do.
It's a truly quality of life thing, and ma
Old cancer drugs (Score:2)
That's actually more the old chemotherapy drugs. These days they have "biologics", dad's treatment was designed to supercharge the immune system to better target the cancer cells. It worked, but his gut was collateral damage.
They're better than the old chemotherapy drugs, but still have a mess of issues.
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Nothing About Feds is Quick (Score:1)
Every single time you have to go talk to the feds about compliance, it takes weeks, if not months to get any type of approval.
There is no single person or group that is paying any attention to you and your needs. These folks are federal bureaucracy workers. They'll get to you when they get to you. Lobbyists and/or paid staff that spend their entire lives communicating with the feds is the only way to grease the wheels. Companies with more resources are the ones that can fund a department like this.
I
Safer goes against the health startups' creed (Score:2)
Move Fast and Break People.
truism is a "model"? (Score:2)
"...drugmakers have taken a more-is-more model..."
Since when is truism a "model"? More is literally more.
Make therapeutic drug monitoring standard first? (Score:2)
It seems insane to me that therapeutic drug monitoring is not standard for chemotherapy (ie. blood testing to see how fast the body clears the drug to get a consistent blood level). There are other sources of variability, but this is such low hanging fruit.
FDA Wants Safer Cancer Drugs, But (Score:1)
Interesting problem (Score:2)
There's obviously many options here, and the odds are close to certainty that even I list all the ones I can think of, the experts in the field will be able to list a decent number I had no idea existed.
However, there's one given: any cancer cells that survive will be cancer cells that can resist the treatment. Chemotherapy loses effectiveness, so you want it to clear the cancer in as few doses as possible.
The only way to reduce side effects is to reduce the exposure to healthy cells.
The drugs are already d