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Many cancer drugs remain unproven 5 years after accelerated approval, study finds

21 Comments
By CARLA K. JOHNSON

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21 Comments
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43% of the drugs demonstrating being useful seems like a very positive development. This means countless of patients were treated years in advance compared with the usual approval method. As long as the safety is confirmed (so patients are not worse by being treated with the new options) at least this part is still justified.

On the other hand companies dragging their feet after getting the accelerated approval and not making a clear determination about the usefulness of the drugs is something that should be improved immediately, one thing is to give patients a shot for something that have a good chance of being useful, another completely different is to keep profiting from them when the data do not support the role of the drugs.

-3 ( +3 / -6 )

On the other hand companies dragging their feet after getting the accelerated approval and not making a clear determination about the usefulness of the drugs is something that should be improved immediately,

If they could prove the usefulness of a new product, they would. If they are dragging their feet, it's likely because they know it's not as useful as initially advertised. Any problematic data will be swept under the rug...

-1 ( +3 / -4 )

The new study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approval. Of those, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials.

Only 43% demonstrated clinical benefit?

This program should be scrapped if that's the case.

This obviously leads to more deaths compared to when all cancer sufferers use approved drugs.

Why allow drug companies to profit at the cost of people's lives when there are already a lot of approved drugs?

-3 ( +1 / -4 )

Any problematic data will be swept under the rug...

There is no way to "sweep the data under the rug" when it is already being used by the public, the rates of benefit are available for anybody to examine, companies can "hide" their own analysis, but the government can replicate that without problem and make a decision when companies delay theirs.

Only 43% demonstrated clinical benefit?

This program should be scrapped if that's the case.

Why is that? thanks to the program patients were able to benefit much sooner from new drugs 43% of the time, in the case of cancer this can mean the difference between life and death for them. What would be the justification of scrapping something that saved lives in half of the cases?

This obviously leads to more deaths compared to when all cancer sufferers use approved drugs.

That makes absolutely no sense, the drugs are not replacing effective treatments already available, the whole point of an accelerated approval is that there is no effective option.

Why allow drug companies to profit at the cost of people's lives when there are already a lot of approved drugs?

Mostly because the approved drugs are not saving lives, so a much better option is required as soon as possible.

-1 ( +4 / -5 )

Lol using not fully approved drugs instead of using approved drugs saves lives? Hahaha

-1 ( +2 / -3 )

Better scrap the fda altogether if they are approving drugs that are not saving lives lol

-1 ( +2 / -3 )

Lol using not fully approved drugs instead of using approved drugs saves lives? Hahaha

instead of inexistent approved drugs, that is the whole justification of the accelerated approval, to have something to fufill a need, pretending the drugs are replacing existing options is what makes your criticism invalid and false.

Better scrap the fda altogether if they are approving drugs that are not saving lives lol

The drugs are saving lives, making imaginary accusations just because you could not understand the article is not valid.

-2 ( +3 / -5 )

Patients get access to drugs earlier, but the tradeoff means some of the medications don’t pan out. It's up to the FDA or the drugmaker to withdraw disappointing drugs, and sometimes the FDA has decided that less definitive evidence is good enough for a full approval.

There's positives and negatives to this in the search for a cure for cancer, for which yet there is none, but at the same time it's good to see the FDA backing these drugs in the efforts by medical professionals.

-2 ( +3 / -5 )

There's positives and negatives to this in the search for a cure for cancer, for which yet there is none, but at the same time it's good to see the FDA backing these drugs in the efforts by medical professionals.

It would be a search for another cure for one of the many different diseases categorized inside the cancer category, and you are confused, the FDA do not "backs" the companies, all development and testing is done independently, the FDA role is only to decide if the drugs are approved or not after all the effort is already done.

2 ( +6 / -4 )

It would be a search for another cure for one of the many different diseases categorized inside the cancer category, and you are confused, the FDA do not "backs" the companies, all development and testing is done independently, the FDA role is only to decide if the drugs are approved or not after all the effort is already done.

No, and of now there is no cure, according to the medical field. Why deny the science?

currently isn’t a cure for cancer, 

https://www.healthline.com/health/is-there-a-cure-for-cancer

There's positives and negatives to this in the search for a cure for cancer, for which yet there is none, but at the same time it's good to see the FDA backing these drugs in the efforts by medical professionals.

The FDA is taking the right approach in backing these treatments; one day we'll get there.

-5 ( +2 / -7 )

I have been cancer-free for five years.

2 ( +5 / -3 )

I have been cancer-free for five years.

That's great and for you and people like you, let's hope some day the medical experts find a cure for cancer.

-5 ( +2 / -7 )

No, and of now there is no cure, according to the medical field. Why deny the science?

As the reference already brought, this is not something realistic, each cancer is a different disease, so it makes no sense to pretend one single cure can apply to the whole category.

https://www.worldwidecancerresearch.org/news-opinion/2021/march/why-havent-we-cured-cancer-yet/

Cancer is not just one disease

To understand why we haven’t cured cancer yet, the most important thing to know is that cancer is not one disease. Instead, it’s an umbrella term for more than 200 distinct diseases

Persisting on a demonstrated misunderstanding makes no sense, unless your purpose is to mislead people to share that mistake.

The FDA is taking the right approach in backing these treatments; one day we'll get there.

The FDA is not backing any treatment, that is another misunderstanding you like to repeat, even when it is easy to disprove every time.

That's great and for you and people like you, let's hope some day the medical experts find a cure for cancer.

There are many cures for many types of cancer already, doctors are now much more confident to declare cancer patients as cured.

-2 ( +2 / -4 )

Readers, please stop arguing over whether or not there is a cure for cancer. The same few of you do it every time we post a story on the subject.

“It might be shrinking of tumor. It might be how long the tumor stays stable,” Litton said. “You can provide the data you have, but you shouldn’t overpromise.”

The US needs more legislation to monitor these drugs so that patients are not being given false hopes as to the efficacy, as they seek treatments as no cure lingers in the background.

Congress recently updated the program, giving the FDA more authority and streamlining the process for withdrawing drugs when companies don’t meet their commitments.

The FDA has been backing many treatments and to give the FDA monitoring authority is a step in the right direction for patient care.

-2 ( +2 / -4 )

The patients are informed without problems that the drugs are in accelerated approval, and since the monitoring is part of what the FDA does, this being subpar would mean the agency is failing in their duties.

-2 ( +2 / -4 )

It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval.

The FDA is doing fine, backing these drugs in the first place. We need the drug companies to step up their game and provide better evidence as both institutions strive forward to the goal of finally finding a cure for cancer.

-2 ( +1 / -3 )

The FDA is doing fine, backing these drugs in the first place.

What does that mean, "backing" something "in the first place"? What do you think the FDA is and does?

-1 ( +1 / -2 )

What does that mean, "backing" something "in the first place"? What do you think the FDA is and does?

This is a complex topic it seems.

How about letting us know what you think?

-2 ( +1 / -3 )

How about letting us know what you think?

Judging from your constant harping on "FDA backing", I think that you are under the illusion that the FDA is more than a regulatory agency and actually has something to do with the development of drugs.

-1 ( +1 / -2 )

Judging from your constant harping on "FDA backing", I think that you are under the illusion that the FDA is more than a regulatory agency and actually has something to do with the development of drugs

That would make no sense, this mistake has already been corrected in the comments, why would anybody persist in a mistaken claim without even arguing how that is the case? Specially after claiming that the FDA failed in its role of monitoring the drugs it approved.

-2 ( +1 / -3 )

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