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A cancer trial’s unexpected result: Remission in every patient

nytimes.com

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Re: A cancer trial’s unexpected result: Remission in every patient

#161

Post by BurningFrog »

josho wrote: post #158
BurningFrog wrote: post #156

Earlier quoted context omitted.

After Phase 2, the drug has been proven safe. In a sane and humane system, sick people would then be allowed to try it.

Pharma would market a phase 2 trial drug as a “potential revolution in treatment. Only a select few can receive this treatment and as a result it costs 10x more than existing drugs. Ps. We don’t guarantee results.” Is that really the outcome you want?

What I want is fewer people to die while waiting for the FDA to take years to approve already existing drugs.

You seem to care more about marketing than people's lives. We all have different priorities.

Re: A cancer trial’s unexpected result: Remission in every patient

#162

Post by BurningFrog »

scoopertrooper wrote: post #160
BurningFrog wrote: post #156

Earlier quoted context omitted.

After Phase 2, the drug has been proven safe. In a sane and humane system, sick people would then be allowed to try it.

I just gave you a document containing 8 case studies where drugs were found to be not safe after having passed Phase 2 trials.

That happens after Phase 3 trials too.

This is about probabilities, and when lives are at stake, you should take some chances.

Re: A cancer trial’s unexpected result: Remission in every patient

#163

Post by kradeelav »

BurningFrog wrote: post #161
josho wrote: post #158

Earlier quoted context omitted.

Pharma would market a phase 2 trial drug as a “potential revolution in treatment. Only a select few can receive this treatment and as a result it costs 10x more than existing drugs. Ps. We don’t guarantee results.” Is that really the outcome you want?

What I want is fewer people to die while waiting for the FDA to take years to approve already existing drugs. You seem to care more about marketing than people's lives. We all have different priorities.

(Not the OP) In a macro sense, I'd agree with you; no stranger to having to weigh the risks/rewards of experimental drugs.

But at the same time, I do get why extensive approval is needed - deaths can and often do occur from allergic reactions and/or side effects to medicines, and the idea is to hopefully lower the ratio of that happening. At some point more people "will" die from allergic reactions/side effects than the time it takes to get approval.

Re: A cancer trial’s unexpected result: Remission in every patient

#164

Post by pkaye »

xmodem wrote: post #151
pkaye wrote: post #63

Earlier quoted context omitted.

> That's always stuck with me -- the problem with American healthcare is the American interpretation of capitalism. Dude was living off of government research grants. Do the drug companies in Europe do any different though?

I mean, sort of? Except, not really, because, "what the market will bear" is determined by what governments can negotiate - there's no Medicare Part D tying their hands.

But the companies are still greedy in Europe. Zolensma one of the most expensive drugs is from Europe. Those companies sell it for what its worth. When Joe Biden proposed covid vaccine patent waivers, European leaders were quick to suck with with the corporations in opposition.

Re: A cancer trial’s unexpected result: Remission in every patient

#165

Post by lmm »

josho wrote: post #158
BurningFrog wrote: post #156

Earlier quoted context omitted.

After Phase 2, the drug has been proven safe. In a sane and humane system, sick people would then be allowed to try it.

Pharma would market a phase 2 trial drug as a “potential revolution in treatment. Only a select few can receive this treatment and as a result it costs 10x more than existing drugs. Ps. We don’t guarantee results.” Is that really the outcome you want?

Fewer people dying and more people overpaying for ineffective treatment is potentially a good tradeoff. As a society we already funnel massive amounts of cash to new medical treatments, we just do it in a really inefficient way.

Re: A cancer trial’s unexpected result: Remission in every patient

#166

Post by gamblor956 »

BurningFrog wrote: post #162
scoopertrooper wrote: post #160

Earlier quoted context omitted.

I just gave you a document containing 8 case studies where drugs were found to be not safe after having passed Phase 2 trials.

That happens after Phase 3 trials too. This is about probabilities, and when lives are at stake, you should take some chances.

I would agree that drugs which have passed Phase 2 trials should made available to "mercy" patients during Phase 3 trials for patients that were not able to get into the trial...at cost to the pharmaceutical company that hopes to sell the drug/

This would eliminate the profit motive that other commentators have noted would be a huge issue.

Re: A cancer trial’s unexpected result: Remission in every patient

#167

Post by ufo »

BurningFrog wrote: post #156
scoopertrooper wrote: post #141

Earlier quoted context omitted.

70% of Phase 2 trials fail and 50% of Phase 3 trials fail[1]. Why should the default to be to approve drugs in the early stage of human experimentation? Here are some interesting case studies of drugs graduating from Phase 2 trials only to fail Phase 3 trials on efficacy and safety grounds: https://www.fda.gov/media/102332/download [1] https://www.parexel.com/application/files_previous/5014/7274...

After Phase 2, the drug has been proven safe. In a sane and humane system, sick people would then be allowed to try it.

The alternative is worse, unfortunately. See the recent Aduhelm debacle for example, with big pharma profiting from desperate people, with a drug that doesn't work.

Re: A cancer trial’s unexpected result: Remission in every patient

#168

Post by peter_l_downs »

zzzeek wrote: post #32

My dad was fortunate enough to get into a trial at Sloan for Obinutuzumab for Chronic Lymphocytic Leukemia. At the moment, after 6 weeks of treatment, the percent of cancerous cells in his bone marrow has gone from 95% to 5%. The treatment was very intense as it overloads the kidneys on the first few treatments due to the dramatic amount of cells being flushed out. This is a cancer for which there was not much treatm…

That's amazing news. A close friend of mine recently died of this same leukemia (pretty sure.) I wish you and your family the best of luck.

Re: A cancer trial’s unexpected result: Remission in every patient

#169

Post by snowwrestler »

rzz3 wrote: post #149
scoopertrooper wrote: post #141

Earlier quoted context omitted.

70% of Phase 2 trials fail and 50% of Phase 3 trials fail[1]. Why should the default to be to approve drugs in the early stage of human experimentation? Here are some interesting case studies of drugs graduating from Phase 2 trials only to fail Phase 3 trials on efficacy and safety grounds: https://www.fda.gov/media/102332/download [1] https://www.parexel.com/application/files_previous/5014/7274...

Because (at least) for people with a high risk of dying, and operating under well-informed consent, that decision should be between patients and their doctors alone.

Such patients have opportunities to access experimental drugs, either in clinical trials, or through compassionate use waivers.

https://www.cancer.gov/about-cancer/treatment/drugs/access-e...

Re: A cancer trial’s unexpected result: Remission in every patient

#170

Post by brigandish »

goodpoint wrote: post #51
brigandish wrote: post #42

Earlier quoted context omitted.

> That's always stuck with me -- the problem with American healthcare is the American interpretation of capitalism. What should it cost instead? > Dude was living off of government research grants. Let's imagine his work comes to fruition. The drug is expensive but efficacious - is this not a good thing? Should the government have not helped fund this drug because now it's expensive? The alternative is a world withou…

> What should it cost instead? To patients? It should be free. To society? The initial research cost plus the bare manufacturing cost.

> To patients? It should be free.

Someone has to pay. Who pays?

> To society? The initial research cost plus the bare manufacturing cost.

And we're back to a society which is poorer in terms of both health and wealth.

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