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(Guardian)   Over half of new cancer drugs 'show no benefits' for survival or well being. Of 48 cancer drugs approved between 2009-2013, 57% of uses showed no benefits and some benefits were 'clinically meaningless'. Happy Breast Cancer Month   ( theguardian.com) divider line
    More: Sad, Cancer, cancer drugs, survival, The Canon of Medicine, survival benefits, Forty-eight cancer drugs, Better, Pharmacology  
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504 clicks; posted to Geek » on 05 Oct 2017 at 11:20 AM (2 weeks ago)   |   Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2017-10-05 09:48:01 AM  
Ineffective treatments are a critical component of the billable hours shell game that is for-profit medicine.
 
2017-10-05 10:36:28 AM  
And yet they got approved by the FDA and are being pushed by oncologists nationwide for top dollar prices
 
2017-10-05 10:58:31 AM  
For those who don't RTFA, this in in Europe, the drugs were approx by the European Medicines Agency.
 
2017-10-05 11:03:06 AM  
Back in my Hill staffer days, I had a meeting with some pharma company about a drug they had.  There were plenty of articles and studies on it (not that they brought this up in the meeting, of course) that showed that the drug had a negligible effect on extending lifespan (definitely not curing) of the people with the condition it was supposed to treat.  Oh, and it cost WAY more - as in many times more - than the other treatment.  They were lobbying because Medicare was likely to discontinue covering reimbursements for the drug, and naturally, that was bad.  Their arguments for the necessity of keeping Medicare coverage were nearly nonsensical.
 
2017-10-05 11:30:17 AM  

rcain: And yet they got approved by the FDA and are being pushed by oncologists nationwide for top dollar prices


"Forty-eight cancer drugs were approved by the European Medicines Agency between 2009 and 2013 for use as treatments in 68 different situations." You know, the Europeans, who do medicine so much better than the nasty for-profit USA.
 
2017-10-05 11:32:12 AM  

ToastmasterGeneral:   Their arguments for the necessity of keeping Medicare coverage were nearly nonsensical.  involved very large checks.

 
2017-10-05 11:51:25 AM  

rcain: And yet they got approved by the FDA and are being pushed by oncologists nationwide for top dollar prices


They show benefits for the unearned income stock owners sitting on their fat asses.
 
2017-10-05 11:52:22 AM  
I'm going to paraphrase/butcher something I read in the comments to this story on another site, but someone who purported to be a cancer researcher added nuance with the following points

1) To see true efficacy of cancer drugs, you need to have a 5-10 year study.  So sometimes you see some promising early results, and therefore there is a push to approve it for a chance to save lives.  The fact that 5 or 10 years studies subsequently demonstrate that the drug is be less effective than was initially hoped does not mean that the approval was in bad faith or incorrect at the time it was made.

2) there are drugs where statistics misrepresent their value.  For example, you could have a drug that's extremely effective for 5% of cancers, but not effective for 95%.  A study like the one in the article would suggest that it's useless, when in fact, it is an extremely useful drug to have in the arsenal.

3) there were some other points I don't remember
 
2017-10-05 11:55:09 AM  

lindalouwho: For those who don't RTFA, this in in Europe, the drugs were approx by the European Medicines Agency.


Are you trying to say that it's different in America?
 
2017-10-05 11:56:50 AM  

SaladMonkey: I'm going to paraphrase/butcher something I read in the comments to this story on another site, but someone who purported to be a cancer researcher added nuance with the following points

1) To see true efficacy of cancer drugs, you need to have a 5-10 year study.  So sometimes you see some promising early results, and therefore there is a push to approve it for a chance to save lives.  The fact that 5 or 10 years studies subsequently demonstrate that the drug is be less effective than was initially hoped does not mean that the approval was in bad faith or incorrect at the time it was made.

2) there are drugs where statistics misrepresent their value.  For example, you could have a drug that's extremely effective for 5% of cancers, but not effective for 95%.  A study like the one in the article would suggest that it's useless, when in fact, it is an extremely useful drug to have in the arsenal.

3) there were some other points I don't remember


To expand on that point,  in the case of the drug that is effective 5% of the time, you will only need one 95% effective drug to handle 95% of the cases but you may need 3 or 4 drugs that are 5% effective to address multiple reason primary drug is ineffective.
 
2017-10-05 12:08:24 PM  

Tr0mBoNe: Ineffective treatments are a critical component of the billable hours shell game that is for-profit medicine.


Kickbacks for politicians.
Cancer organizations profit.
Advertising profit.
Pharmaceutical profit.
Insurance profit.

There is no up side to an actual cure.
 
2017-10-05 12:13:27 PM  
My mother in law started chemo yesterday, so this is sadly relevant to my interests

//FOLFIRINOX, and she hopes it just gives her a few more months.......
//F*CK CANCER
//F*ck it with a salty cactus
 
2017-10-05 12:19:40 PM  

yet_another_wumpus: ToastmasterGeneral:   Their arguments for the necessity of keeping Medicare coverage were nearly nonsensical.  involved very large checks.


Ha, not to us.  And the drug was removed from Medicare's reimbursement.  However this was an exceedingly cut and dry case, and there wasn't much Congress could have done at that point.  What they wanted, which we didn't do, was a letter to the Centers for Medicare and Medicaid Services expressing our support for the drug and r concern with its potential removal.  But in this case, with the public data already out there like that, no amount of Congressional letters would've likely made any difference in the Centers' decision.

/And besides, if you're meeting with a staffer, odds are you're not at the writing big checks stage yet.
 
2017-10-05 12:22:17 PM  

SaladMonkey: 2) there are drugs where statistics misrepresent their value.  For example, you could have a drug that's extremely effective for 5% of cancers, but not effective for 95%.  A study like the one in the article would suggest that it's useless, when in fact, it is an extremely useful drug to have in the arsenal.


This is really all you need to know. A drug may work fairly well on one particular line of cancerous cells. However even the cells in that particular line are not all the same, so the drug kills some cells and not others. So a drug may give you a 99% reduction in cancer cells, but that 1% is still there and thriving.
On top of that... What works on henrietta's cervical cancer cells may not work the same on maryetta's cervical cancer cells because the cancer came from a different genetic profile as a starting place.

even when a single tumor metastasizes, the cells that take root in your lungs have to be different to survive there compared to the cells that take root in your bones. Cancer just sucks. It's not about profit or marketing (though those do play into it), it's about the fact that every farking cancer cell is different, and they have potential to be stem cells and make new tumors.
 
2017-10-05 12:35:48 PM  

ThatGuyOverThere: So a drug may give you a 99% reduction in cancer cells, but that 1% is still there and thriving.


My wife had been on chemo for the last year. The first and third treatments did not work at all, or stopped working almost immediately. The second treatment work 7-8 months, where the average was about two years. She never made it to the fourth (which was going to be a quality of life treatment). She had a very aggressive breast cancer that she thought she had knocked out 5 years ago but after 4 years the sucker got the upper hand.
 
2017-10-05 01:35:34 PM  

damageddude: ThatGuyOverThere: So a drug may give you a 99% reduction in cancer cells, but that 1% is still there and thriving.

My wife had been on chemo for the last year. The first and third treatments did not work at all, or stopped working almost immediately. The second treatment work 7-8 months, where the average was about two years. She never made it to the fourth (which was going to be a quality of life treatment). She had a very aggressive breast cancer that she thought she had knocked out 5 years ago but after 4 years the sucker got the upper hand.


There are no words for how terrible that is.  i'm sorry.
 
2017-10-05 01:37:13 PM  

meat0918: My mother in law started chemo yesterday, so this is sadly relevant to my interests

//FOLFIRINOX, and she hopes it just gives her a few more months.......
//F*CK CANCER
//F*ck it with a salty cactus


Best luck. My dad is in Chemo now too. Seems to be working so far
 
2017-10-05 01:53:04 PM  

ds615: There is no up side to an actual cure.


Except, you know, the part where cancer will need to be constantly cured because its a genetic illness inherent to our process of DNA replication.  Cancer will someday be cured, but it will never be eradicated.  Pharma companies may do a lot of shifty crap, but don't act like there is some huge conspiracy to avoid curing cancer.  The potential profit from a cancer cure is LITERALLY INFINITE as long humanity (and a way to make the cure) exists.
 
2017-10-05 02:55:38 PM  

ds615: Tr0mBoNe: Ineffective treatments are a critical component of the billable hours shell game that is for-profit medicine.

Kickbacks for politicians.
Cancer organizations profit.
Advertising profit.
Pharmaceutical profit.
Insurance profit.

There is no up side to an actual cure.


They must be out there somewhere, but I've yet to personally meet any doctors deliberately giving out ineffective treatments to pad their pockets. There are a few examples of TV doctors (on par with televangelists/faith healers) who are doing this with "natural" products and patent medicines.

There are lots of options for endstage cancer treatment that are pretty terrible. Usually they are for when you're out of options but there is some reasonable probability of more time, quality of life, symptom control, etc.
 
2017-10-05 03:14:29 PM  

knobmaker: lindalouwho: For those who don't RTFA, this in in Europe, the drugs were approx by the European Medicines Agency.

Are you trying to say that it's different in America?


It's different in America.
 
2017-10-05 03:22:11 PM  
They showed plenty of benefits, for the people who make money off of them.
 
2017-10-05 03:30:32 PM  

drwiki: ds615: Tr0mBoNe: Ineffective treatments are a critical component of the billable hours shell game that is for-profit medicine.

Kickbacks for politicians.
Cancer organizations profit.
Advertising profit.
Pharmaceutical profit.
Insurance profit.

There is no up side to an actual cure.

They must be out there somewhere, but I've yet to personally meet any doctors deliberately giving out ineffective treatments to pad their pockets. There are a few examples of TV doctors (on par with televangelists/faith healers) who are doing this with "natural" products and patent medicines.

There are lots of options for endstage cancer treatment that are pretty terrible. Usually they are for when you're out of options but there is some reasonable probability of more time, quality of life, symptom control, etc.


Your comment is probably very accurate in that the cast majority of doctors are doing their very best to help their patients.

The problem is doctors don't  develop new cures and treatments companies do. Phase 3 clinical trials to bring a drug I to general use are horrendously expensive. There is little incentive for big pharma to spend huge amounts of money laying the groundwork for really innovative treatment, which may be more effective but are also inherently higher risk (financial risk, the chance the money devoted to the research produces a viable and profitable product).

Their best I treat lies in exploiting know pathways and playing it safe, making baby steps. If a new drug results in a.sligjt advantage, it may completely replace a competitor.

But there has been amazing progress in cancer research. I am alive because if it. So maybe we should not be completely jaded either.
 
2017-10-05 03:31:22 PM  

Kit Fister: They showed plenty of benefits, for the people who make money off of them.


For one, the drugs are probably 3 x as expensive.
 
2017-10-05 03:43:11 PM  
The future of cancer treatment is immunotherapy. Drugs designed specifically for the patient to make the immune system destroy cancer cells. Drugs like Keytruda will replace chemotherapy and surgery.
Cancer will probably become a chronic disease where you'll have to take medication for it your entire life.
 
2017-10-05 03:45:08 PM  

ThatGuyOverThere: SaladMonkey: 2) there are drugs where statistics misrepresent their value.  For example, you could have a drug that's extremely effective for 5% of cancers, but not effective for 95%.  A study like the one in the article would suggest that it's useless, when in fact, it is an extremely useful drug to have in the arsenal.

This is really all you need to know. A drug may work fairly well on one particular line of cancerous cells. However even the cells in that particular line are not all the same, so the drug kills some cells and not others. So a drug may give you a 99% reduction in cancer cells, but that 1% is still there and thriving.
On top of that... What works on henrietta's cervical cancer cells may not work the same on maryetta's cervical cancer cells because the cancer came from a different genetic profile as a starting place.

even when a single tumor metastasizes, the cells that take root in your lungs have to be different to survive there compared to the cells that take root in your bones. Cancer just sucks. It's not about profit or marketing (though those do play into it), it's about the fact that every farking cancer cell is different, and they have potential to be stem cells and make new tumors.


Have you been staring at an Oklahoma map all day?

/swapping the 'i' and 'y' notwithstanding
//agree with the post, but was amused by the specificity of the names
///you forgot Norman's prostate cancer
 
2017-10-05 03:45:40 PM  

rcain: And yet they got approved by the FDA and are being pushed by oncologists nationwide for top dollar prices


TFA is about the EMA, not FDA
TFA is about the EMA, not FDA.

It's usually harder to get approval in the U.S. for a given cancer drug, because you have to show a real benefit to overall survival of the patients in most cases.  However, the reason drugs often get approved in spite of a marginal benefit is that there is nothing else to do for many aggressive cancers - the patients are desperate.
 
2017-10-05 03:45:55 PM  

damageddude: ThatGuyOverThere: So a drug may give you a 99% reduction in cancer cells, but that 1% is still there and thriving.

My wife had been on chemo for the last year. The first and third treatments did not work at all, or stopped working almost immediately. The second treatment work 7-8 months, where the average was about two years. She never made it to the fourth (which was going to be a quality of life treatment). She had a very aggressive breast cancer that she thought she had knocked out 5 years ago but after 4 years the sucker got the upper hand.


Fellow farker, I am very sorry to hear
 
2017-10-05 03:53:28 PM  

damageddude: ThatGuyOverThere: So a drug may give you a 99% reduction in cancer cells, but that 1% is still there and thriving.

My wife had been on chemo for the last year. The first and third treatments did not work at all, or stopped working almost immediately. The second treatment work 7-8 months, where the average was about two years. She never made it to the fourth (which was going to be a quality of life treatment). She had a very aggressive breast cancer that she thought she had knocked out 5 years ago but after 4 years the sucker got the upper hand.


I'm sorry for your loss.

The real game changer here is going to be the ability to characterize individual cancers and design therapies that target each type of tumor cell.  This is especially true of breast cancer, most people know about the BRCA gene and estrogen-dependent cancers, but that's just the beginning of what we'll be seeing in the next 20 years.
 
2017-10-05 04:21:04 PM  

lindalouwho: knobmaker: lindalouwho: For those who don't RTFA, this in in Europe, the drugs were approx by the European Medicines Agency.

Are you trying to say that it's different in America?

It's different in America.


Yeah, it's worse.  I think the only first-world country that allows drug advertising besides us is New Zealand.
 
2017-10-05 04:29:29 PM  

knobmaker: lindalouwho: knobmaker: lindalouwho: For those who don't RTFA, this in in Europe, the drugs were approx by the European Medicines Agency.

Are you trying to say that it's different in America?

It's different in America.

Yeah, it's worse.  I think the only first-world country that allows drug advertising besides us is New Zealand.


?? Not talking about advertising...
 
2017-10-05 05:13:15 PM  

damageddude: ThatGuyOverThere: So a drug may give you a 99% reduction in cancer cells, but that 1% is still there and thriving.

My wife had been on chemo for the last year. The first and third treatments did not work at all, or stopped working almost immediately. The second treatment work 7-8 months, where the average was about two years. She never made it to the fourth (which was going to be a quality of life treatment). She had a very aggressive breast cancer that she thought she had knocked out 5 years ago but after 4 years the sucker got the upper hand.


That's awful and i'm very sorry for you.
I have a friend who did her somewhat controversial dissertation on cancer "cell population heterogeneity" a few years back. Controversial because she had a very compelling argument that cancer research is doing a bit of a disservice to actual people by ignoring the fact that if most cells die and some survive... you didn't fix the problem. A lot of people don't like the fact that some "kid" showed them to be wasting time when lives are on the line.
I honestly never had the stomach for cancer research because the problem is freaking overwhelming to me. Some people are made of sterner stuff, so all we can do is hope that some day they figure out more than they know now. I mean, they're learning new stuff and refining treatments, so it's moving in the right direction, slowly.

olrasputin: Have you been staring at an Oklahoma map all day?

no?
I said "henrietta" because of the HeLa cell line's origin from a black woman named henrietta, and "maryetta" because maryetta is a black woman who I shared lab space with (not on cancer research). I guess it was kind of an inside joke to myself that i didn't think anybody would question the specifics of :-/
 
2017-10-05 08:21:33 PM  

lindalouwho: knobmaker: lindalouwho: knobmaker: lindalouwho: For those who don't RTFA, this in in Europe, the drugs were approx by the European Medicines Agency.

Are you trying to say that it's different in America?

It's different in America.

Yeah, it's worse.  I think the only first-world country that allows drug advertising besides us is New Zealand.

?? Not talking about advertising...


So what do you base your opinion on?
 
2017-10-05 10:48:18 PM  
I program/build specifically with an outpatient oncology module (as well as other applications) within an EHR, and am constantly hustling to get new treatment's into the system when our oncology pharmacy staff requests once approved.  I also read through and build out current research protocols.

Its fast paced, exciting and pretty technical work, which that part I love; when i took a chance on entering the field I found out I was made for frantic, complex problems that also need eyes for the details (because if you accidentally add a zero in the wrong place, and no one catches it, my mistake could easily kill someone)

However, the crushing realities of constantly combing through charts as well, and seeing a myriad of horrid diseases covering people from 18 to 80, and also being among the weeds to know the exorbitant costs of the drugs, not to mention spending too much time thinking about the A/B arms of the trials (luck of the draw, A gets the new drug, B gets placebo) gives a fella  strange perspective on life and healthcare in general.

I've been exposed to so much of this that I'm pretty well determined to live my life to the fullest, and at the same time have an exit strategy in the back of my head if I were to get one of these ailments. Of course Some of them, depending on your age, can achieve fairly long term remission. At a heavy price of (in some cases) extremely long term treatment.

 seeing what people go through and the financial ruin the whole process causes, makes me wonder if (in my case) its really worth it to keep on trying to live if you have the unfortunate reality of cancer;  Obviously that's situational, and for people with kids and a robust family your drive would be higher to try and get through it.
 
2017-10-06 07:30:48 AM  

jjorsett: rcain: And yet they got approved by the FDA and are being pushed by oncologists nationwide for top dollar prices

"Forty-eight cancer drugs were approved by the European Medicines Agency between 2009 and 2013 for use as treatments in 68 different situations." You know, the Europeans, who do medicine so much better than the nasty for-profit USA.


First, few cancer patients actually complete treatment for a variety of reasons, most common is a bad infection with C. Difficile bacreria in the gut.  Another is resistance to changes in lifestyle (basically no meat and very low fat diet, and of course no smoking).
So of the patients who actually complete their treatment regimen in full, do they live longer or better than those that drop out?  If the drugs show no benefit then of course they should lose their approval for sale and marketing by regulatory authorities.
 
2017-10-06 02:23:14 PM  

SaladMonkey: I'm going to paraphrase/butcher something I read in the comments to this story on another site, but someone who purported to be a cancer researcher added nuance with the following points

1) To see true efficacy of cancer drugs, you need to have a 5-10 year study.  So sometimes you see some promising early results, and therefore there is a push to approve it for a chance to save lives.  The fact that 5 or 10 years studies subsequently demonstrate that the drug is be less effective than was initially hoped does not mean that the approval was in bad faith or incorrect at the time it was made.

2) there are drugs where statistics misrepresent their value.  For example, you could have a drug that's extremely effective for 5% of cancers, but not effective for 95%.  A study like the one in the article would suggest that it's useless, when in fact, it is an extremely useful drug to have in the arsenal.


So, both those arguments are how you identify a terrible scientist.

1)  Long term studies generally show downstream side effects of a medication/treatment.  You can't say that about cancer medications and here's why:

Best case scenario (which will NEVER happen) when your cancer is caused by a single mutation.  Say there's a cancer that's caused by a mutation in the P13K pathway that is inhibiting apoptosis.  So they develop a drug that blocks that pathway the cancer goes into remission.  You're going to live!  Years pass, your cells divide.  You still have the cancer cells living in your body, dividing like the rest of the cells.  Then one morning, 3 years later, one of the cells divides and introduces a point deletion in the P53 gene.  Oops.  It just turned off a major apoptotic pathway.  Suddenly it doesn't need that P13K pathway to become cancerous.  Time for chemo.

Looking objectively, without understanding the mechanisms behind what's going on you could say, "Yeah that drug is no longer effective after 3 years".  However that is an ignorant statement.  The drug works just fine, but the system that drug works in is highly plastic and can work around the effect of the drug.  This is one of the reasons why the currently marketed generation of cancer therapeutics have phrases like "lived on average X period of time" in their disclaimers.  That's because cancer is the net result of multiple mutation events and defects in cellular regulation.

2)  Absolutely nothing is being misrepresented.  Say there's a single molecule that is 100% effective  (its name is ethanol) against all forms of Ash-cancer (which happens to love alcohol). There are 9,999 other molecules known to have existed.  So you can say 0.01% of all known molecules are effective against Ash-cancer.  Now imagine a case where there are 10 different molecules people are claiming and marketing to treat Ash-cancer of which 2 are ethanol.  Our of that pool of 10 medications 20% are actually effective.
Okay, so intro stats out of the way we get to the actual problem with the article.  Regulatory oversight, and by extension clinical drug trials are designed to weed out the 8 of the 10 above medications that do fark all.  The fact that 8 were approved to treat Ash-cancer shows a systematic failing on the regulatory agency.  However you still look at that result and say, "holy crap we have 2 new treatments for a type of cancer".
 
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