In a small study, 100% of patients with advanced rectal cancer were cured, with no serious side effects.
So, are we going to get it to market as fast as it can be produced? Nope, the FDA is going to demand a much larger study with diverse participants before beginning its evaluation process. At best, it will be available in 2 to 3 years.
Can’t take any chances that there might be adverse side effects, can we?
Really? What side effects would there be that are worse than ass cancer?
New life saving drugs should be available to fully informed patients immediately, more thorough studies can be done in parallel with saving the most lives.
Tidewater News and Opinion Forum 
The NYT piece is behind a paywall for me.
I take it the drug is dostarlimab and it hasn’t entered FDA Phase I testing yet. That would mean, I think, that 2018’s “right-to-try” law doesn’t apply. So the issue at hand is that we need a “right-to-try” option that isn’t dependent on FDA action.
I’m OK with that. In principle, a physician should be able to prescribe any treatment he wishes.
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It appears that the statements of fact about the FDA’s approach to this treatment and to these findings are the product of your imagination. There is certainly no discussion of such delays in the story you linked to.
Facts that you make up sure are handy for confirming your pre-conceived ideas.
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Care to make a bet on when the drug is in wide use?
But no, the FDA timeframe is not on the NYT piece. It was on a panel discussion on TV which cannot be cited,
But 2 years would be breathtakingly fast for the FDA absent Trump standing over them with a club.
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“Trump standing over them with a club.”
You are quite the fantasist.
Back when Trump blew the pandemic response you were shifting the blame to the FDA which, according to you then, he could not control. But now they need him to whip them into shape over their IMAGINED response to this new evidence?
Whatever someone opined on a TV panel is not evidence. You have clearly jumped the gun with your predictions of countless lost lives.
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In what fantasy world did Trump blow the pandemic response?
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His leadership failings, lies and demonization of essential public health measures (“#LIBERTY”) caused avoidable deaths in the hundreds of thousands. That would be here in the real world. Grow up.
https://www.businessinsider.com/analysis-trump-covid-19-response-40-percent-us-deaths-avoidable-2021-2
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I see, in the fantasy world of vague notions.
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…” in the fantasy world of vague notions.”
Sounds like a very apt description of TFG’s term in office.
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We did get vaccines in record time.
We will see, but as far as I am concerned, every person who dies from now on due to rectal cancer, or has to live their life with a colostomy, is the fault of the FDA.
Use of the drug should be the patient and doctor’s choice, and no one else.
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“We did get vaccines in record time.”
Yes, we did. Thanks to research and efforts in other countries. OWS was the right move. But, anyone in the White House who did not do the equivalent of OWS in those circumstances would have been derelict. On this matter, Trump was not derelict.
“Use of the drug should be the patient and doctor’s choice, and no one else.”
Just like Laetrile? Or Thalidomide? Or Clark Stanley’s Snake Oil?
Of course, there can be delays while new treatments can be shown to be safe and effective and – with hindsight – one can say that those delays cost lives. But with foresight you can also say that uncountable lives will be lost if people rely on medicines that are not safe and/or not effective in lieu of treatments that are. You may believe – because you hate the government – that FDA has the balance wrong. That they do more harm than good. I disagree.
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Checking further, it may come a bit quicker, as dostarlimab has been approved for other uses.
Getting approval for a new use will probably go a bit faster, but I’d still bet on a year.
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Well, seeing as how the cure for that cancer called liberalism still hasn’t been approved after all of these years, I’m not betting on anything being approved for democrat cancer, I mean ass cancer, er same thing, any time soon.
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As a survivor of “ass cancer” I take offense at your equating the two.
The real “cancer” on this country are the Trumpists, racists, bigots, and heavily armed idiots who believe the government is out to get them.
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I agree that’s a false equivalency
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Thanks, I think.
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As an “ass cancer” survivor I find hope for others who come after me with this drug.
NONE of us know how quickly this will get approval. We can speculate all we want, but the study was too small to provide any real data that can be used to determine SAFETY of the drug. The efficacy APPEARS to be real (100% is GREAT!), but longer term issues still may arise.
Zantac, which I took for several years ended up being the probable cause of my cancer. (Testing ruled out genetics, even though the first marker considered was Ashkenazi Jews, which I am 49%) was found to be a cause of several cancers after years of prescription and OTC use.
Drug safety is important and should not be taken lightly or politicized.
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Still, would you require even ONE more patient to endure what you have if they make the informed choice to use this new treatment?
There is certainly risk, but the alternatives, as you well know, are life changing.
Should not the patient be the one to weigh those risks?
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I would prefer that the SAFETY of any drug be confirmed prior to wide-spread use. There are a lot of variables in cancer treatments between individuals that need identified for safety purposes. My oncologist had several options, and based on testing of the tumor and other factors, he recommended the safest, best chemo treatments (with a little radiation mixed in) for ME. He also told me that my reactions and side effects could be different for any of his other patients.
And on a side note, I only have a permanent colostomy BECAUE the radiation treatments, while very targeted, cause ischemia in the rectal tissue, causing me to not be able to have a normal BM after the reversal of the ileostomy that was used while going through treatment.
“Should not the patient be the one to weigh those risks?”
The doctor should be able to give a full explanation to the patient to form an informed decision. The thing about a cancer diagnosis is that emotion takes over BIGLY. Information, as much as possible, needs to be available. Not just “This worked 100% of the time on x-number of patients.” It sounds good, but what kind of long term effects can and do occur and at what rate? IF the treatment saves you for, say 10 years, but 10 years down the road you lose the use your penis to side effects, is that anyway to live? (I can tell you, life is OK, but not all the way)
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“Should not the patient be the one to weigh those risks?”
And there is no reason why a current patient could not volunteer, at the suggestion or even urging of his doctor, to participate in the further testing of the drug.
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Participating in a double blind study in which you might get the placebo(and thus NO TREATMENT) is not a treatment choice.
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I think those placebo trials are not conducted when there is already compelling evidence that the drug being tested is very beneficial. Or they are stopped when early returns show that it is. You have a vivid imagination, but I doubt that anyone will be testing this particular therapy by withholding it. More likely it will be quickly used on a much larger sample of patients to see if the results from the small group are replicated.
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That is exactly how double blind studies, the only kind the FDA will accept, are done.
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” double blind studies, the only kind the FDA will accept, are done.”
That is a FALSEHOOD.
You frequently make the same error. Stating something to be a fact when you THINK it should be a fact but don’t really know.
I won’t call it dishonest – more like lazy. It took me about thirty seconds to learn that the FDA recommends AGAINST double blind placebo studies for oncology cases for obvious ethical reasons.
https://tinyurl.com/msp9wjwv
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That is good news I had not checked the rules since well before August 2019
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“That is good news I had not checked the rules since well before August 2019”
Hmmm. What rules are you referring to? As far as I can tell, there have NEVER been rules that REQUIRED cancer therapies be tested with against placebos. Clinical trials are designed with a variety of factors and circumstances peculiar to the drug or device being tested. Ethical considerations or other reasons can exclude placebos as part of the design and that has been the case throughout the history of the FDA. Double blind trials are considered strong evidence, but that is different than their being required.
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