Over Half of New Cancer Drugs 'Show No Benefits' For Survival Or Wellbeing (theguardian.com) 123
New research published in the British Medical Journal finds that most cancer drugs that have recently arrived on the market have come with little evidence that they boost the survival or wellbeing of patients. The Guardian reports: Forty-eight cancer drugs were approved by the European Medicines Agency between 2009 and 2013 for use as treatments in 68 different situations. But the study, which looked at the clinical trials associated with the drugs, reveals that at the time the therapies became available there was no conclusive evidence that they improved survival in almost two-thirds of the situations for which they were approved. In only 10% of the uses did the drugs improve quality of life. Overall 57% of uses showed no benefits for either survival or quality of life. The team then looked to see whether the picture improved over time. The team found that after a follow-up period of between three to eight years, 49% of approved uses were linked to no clear sign of improvement in survival or quality of life. Where survival benefits were shown, the team said these were clinically meaningless in almost half of the cases.
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What about it? It isn't effective against cancer and is much less effective in improving quality of life for terminal cases compared to known medication.
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I also have not had terminal cancer (not even once actually). Relevance?
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That's not a treatment for cancer, that's a treatment for pain and anxiety. For pain and anxiety there is good evidence that it is effective. For cancer I know of no studies that indicate it has any effect in either direction.
So what, this is because you believe efficacy tria (Score:1)
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Not if some other treatment would have helped, but now it's too late. And these drugs are expensive. If there's good money to be made cranking out safe but ineffective drugs then that's what will happen.
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If the other treatment was already available they'd be using it, wouldn't they?
So you're looking at where notGoodDrug comes out the week before excellentDrug drug. Bit of an edge case.
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Looking at it wrong (Score:5, Informative)
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Serious question, why are you like this? What are your goals here? Why assume someone is a communist just for criticizing a pharmaceutical company? I'm just baffled by the depths of your anger and feel like I must be missing something.
Re: Looking at it wrong (Score:1)
Some men just want to watch the world burn.
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Sure, but isn't that answer kind of a cop-out? Like, WHY do they want to watch the world burn? Is it due to bitter loneliness, broken dreams, or were they just born a
douchebag?
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Different AC, jumping in with a hypothesis.
People of above-average intelligence are constantly confronted with other people doing things that are stupid. It is a daily occurrence, and it often has direct harmful impact. When co-workers, especially managers, do obviously stupid things, it can make things suck at work and increase the workload required.
Similarly, when drivers do stupid things, it puts you at risk. When voters do stupid things, it puts evil people in power over you, and so on.
In such an env
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I'm sure that's some of it, but I was really puzzled by this seemingly knee-jerk reflex, that any criticism of a corporation must mean the person is a communist. Do people really think that, or was this just a troll thing to say?
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On the one hand, I don't think there are many people who honestly believe that *any* criticism of a corporation must mean one is a communist.... ...but the Ayn Rand fans of America have been feeling a lot of heat lately from advocates of more socialist policies. There is a strong liberal movement to reject all things Trump, and to decry capitalist policies as fundamentally evil, and to seek to replace them with more socialist policies. This naturally creates a defensive over-sensitivity in the rival group
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Re: Looking at it wrong (Score:5, Insightful)
How many lives were saved or improved by 50% of cancer treatments having a positive effect?
Probably not as many as you might think. Prolonging suffering is considered a "positive effect" from a drug company's perspective, and medicating someone to the point that they're not aware of much is technically effective against pain.
It's hard to objectively measure quality of life - quantity is much easier to measure.
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How many lives were lost by people on treatments that did absolutely nothing, and have never been shown to have ever done anything, when they could have been on one that at least showed it was effective sometimes? He's complaining about useless products bilking people out of not only money, but time in their lives where they don't really have all that much time left for no other reason that because these companies are greedy fucks
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Shows great wellbeing to the financial survival of big pharma.
Well "big pharma" makes medicine to make money, if they don't make money then they can't make things like antibiotics that save lives, or common cold medicine that make us feel better and more productive.
If there is a problem with the medicines we get in the USA its from the FDA. The FDA refuses to allow many many drugs to enter the market because they haven't proven effectiveness. Well, it's impossible to prove effectiveness unless allowed to test the drugs on real and actual people. Sure, we're going t
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You are shown evidence that big pharma is selling bogus medicine. They are charging thousands to dying people and only giving serious side-effects in return and you defend this practice.
You are defending people that are not just holding people hostage, but shooting the hostage after they are paid.
You are a poor human being and I hope you will have to pay the same piper you defend.
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Historical evidence, proves that most quality drug development is done by government contracting to universities. The pharma's the lobby to buy it on the cheap and inflate profits. The worst drug development come from pharmas direct, who after large investment in crap drugs, lie, cheat and steal to get them to market whether or not they fail. As they get bigger, they just lie, cheat, steal and kill more and more and get worse and worse. Now they rely more of lobbyists, than they do on researchers, for their
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"two bitches took the drug and then went out, had unprotected sex, got pregnant and then when they had flipper babies played the lawsuit lotto got a fortune and caused the drug to be taken off the shelves in the USA" then you win a cigar!
The only lawsuit I'm digging up in any searches is an ocular injury.
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Another part of the problem is we've already solved the big problems, what's left are the increasingly rare diseases.
Just to clarify... the big problems: Leading causes of death in the US - Heart disease, Cancer (malignant neoplasms), Chronic lower respiratory disease, Stroke (cerebrovascular diseases), Alzheimer's disease, Diabetes, Influenza and pneumonia..... none of them a rare disease.
The people in "big pharma" aren't evil for making a profit, any more than you are evil for getting paid for whatever you do to pay your bills.
Yet this isn't about big pharma making drugs... it's about them creating absolute frauds and calling them drugs, and yes, that's evil because those can take away a persons chance to use an effective drug. I get it... some people are
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The second cause on your list, cancer, is not a single disease. Cancer is a group of diseases, and the treatments for them vary based on the type. We've got so good at this that we're doing genetic testing on the cancers to see which drugs would be most effective on it. Now that we've sliced it that thin it doesn't look like a single disease any more. Cancer is now an ever increasing number of diseases, each one increasingly rare.
How does choosing to take an experimental drug take away the choice to tak
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Obama's laws made most existing policies illegal. Increasing expenses made still more policies illegal. The government is the aggressor in this cluster-f***, and insurance companies are complicit in that they allowed themselves to be bribed by the Democrat's Fascist plan.
Or do you think that it's insurance companies that vote laws into existence?
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I think there's also an economics argument.
Curative drugs that eliminate disease or produce significant remissions or reductions in illness aren't recurring growth income. You can take them once or very infrequently. Drugs which treat symptoms or only provide short-term gains have to be taken regularly and these drugs have greater per patient consumption and thus greater revenue for drug makers.
Drug makers this have a perverse incentive to merely maintain static illness in patients because it's the most p
Or maybe... (Score:2)
Shows great wellbeing to the financial survival of big pharma.
In part.
But these numbers also result from the fact that most cancer drugs coming on the market are experimental and while the science might suggest a solution, it doesn't always pan out. Cancer is a difficult problem.
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But these numbers also result from the fact that most cancer drugs coming on the market are experimental and while the science might suggest a solution, it doesn't always pan out. Cancer is a difficult problem.
Spot on. Two of my grandparents died from cancer, one had bladder cancer with a 1yr survival rate and went for the interferon clinical trials. He was still alive nearly a decade later after that, it was a type of aggressive skin cancer that killed him though. Broke off, got into the blood, hit the bone and disintegrated his spine in a matter of weeks.
My grandmother had stage 4 lung cancer with a survival period of less then 3 months. They did a biopsy, and gave her the option of an experimental treatmen
No benefits (Score:1)
Overall 57% of uses showed no benefits for either survival or quality of life.
Almost the same ratio for Republicans in the U.S. House and Senate. </non-sequitur-political-rant>
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Fantastic... you decided to compare the crushed optimism of cancer patients.. with the election results of the United States almost a year ago. Back under the bridge Troll... we won't pay your taxes.!!!
Hey anonymous fuckhead. My wife died of a brain tumor in 2006 *and* I didn't vote for Trump, so I understand crushed optimism.
How can this be? (Score:1)
Doesn't Europe have the equivilent of our FDA? There are reasons the drug approval process is so arduous here, and this is one of them.
Re:How can this be? (Score:4, Interesting)
Doesn't Europe have the equivilent of our FDA? There are reasons the drug approval process is so arduous here, and this is one of them.
No, no it really isn't. You can bring out a derivative of an old drug without having to prove its efficacy. All you have to prove is that it doesn't kill significantly more people than the prior form, and bob's your uncle. This is due to legislation bought by the Big Pharma cartel, as a benefit to entrenched players. Bringing a new drug to market is very difficult. But most drugs brought to market each year are derivatives.
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Surely Europe can fix this problem, can't it? They are a union after all.
Re:How can this be? - because model is wrong. (Score:2)
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Yes you can bring out new medication if it's proven relatively safe compared to old medication _and_ is proven effective for treating Y. Then the larger trials begin with willing participants getting the medication in exchange for tighter control of their well-being. After X years when it is proven to be more efficient and with less side-effects it may become the medication of choice for treating Y, the side-effects and interactions with other diseases etc. is all better known so that in cases where older (
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Yes you can bring out new medication if it's proven relatively safe compared to old medication _and_ is proven effective for treating Y.
No. In the USA you do not have to prove anything regarding efficacy, not even that it is as effective as the drug it's based upon. In fact, you don't have to prove that it's effective at all.
And no - it isn't due to "big pharma".
Who do you think buys the laws?
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The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.
It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval,[1][2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications. -- wikipedia
Get approved by any of 28 countries (Score:5, Informative)
There are similarities and differences. Before the EU was formed, each of the 28 countries already had their own approval process. After the formation of the EU, which is principally an economic and trade alliance, a drug approved in ANY EU country could be sold in ALL EU countries. Therefore a pharmaceutical company could choose which of the 28 countries would likely approve the drug most easily / quickly / cheaply. Commonly, a pharmaceutical company will apply in two or three countries at once and see which one approves it first.
Some drugs are now required to go through one of several centralized EU approval processes instead - and there are four for them to choose from. Being run by the EU, the heritage of these agencies is based on promoting commerce between EU countries - the EU is not focused on consumer protection and safety.
In the US, a maker has to get approval from the FDA. They don't get to choose different agencies to seek approval from.
The DA started as a consumer protection agency, trying to make sure drugs were safe. Later, they got mandate to make sure they are effective. The FDA doesn't have the heritage of coming from an organization trying to promote commerce, like the EU does.
Therefore historically it's been easier and cheaper to get drugs approved in Europe than in the US. Europeans got cheaper medicines faster, Americans got better, more expensive medicine. (The difficult and expensive FDA process isn't a total waste).
In the last few years, there has been pressure on both sides of the Atlantic to be more like the other guys. Americans want cheaper drugs, sooner. Europeans want want better, safer drugs. I guess the grass is always greener on the other side of the fence. So each process has become more like the other and the difference isn't as extreme as it once was.
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a drug approved in ANY EU country could be sold in ALL EU countries.
Seriously? There is no process for determining if a drug is safe for all EU citizens before it is sold to all EU citizens?
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If I understand correctly (I’m no expert, I was reading about it out of curiosity), there are several routes possible:
The European Medicine Agency [europa.eu] (EMA), located in London, processes applications, carries out a scientific assessment and issues a recommendation which, if favourable, leads to the European Commission granting a European marketing authorisation, valid in all Member States. This procedure is compulsory for products derived from biotechnology, for orphan medicin
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We can all agree with the "more expensive" part of that claim. But "better"? I think that statistics suggest the opposite.
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Therefore historically it's been easier and cheaper to get drugs approved in Europe than in the US. Europeans got cheaper medicines faster, Americans got better, more expensive medicine. (The difficult and expensive FDA process isn't a total waste).
I disagree with this. I don't think I've seen much in the way of "unsafe" products in the EU. Useless maybe, but certainly not unsafe as the products that are likely to have a positive effect on people end up being the same regardless where you buy them.
I certainly don't think paying $400 for an Epipen vs $40 makes it any different at all, and on the experimental side of the scale, deaths or problems from approved drugs in Europe are pretty much non-existent as is the ludicrous practice of marketing drugs d
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I'm not really sure where you got that idea but it does not seem to correlate with my everyday experience.
Bank Accounts (Score:1)
It improved bank accounts of the big pharma.
That's what kind of people they are.
Martin Shkreli was just blatant and showed their true nature which they hide in public normally. He didn't.
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Left out third reason. (Score:3)
Three reasons to use drugs:
1) Quality of life improves vs existing treatment.
2) Improved life expectancy improves vs. existing treatment.
3) Saves money improves vs. existing treatment without decreasing life expectancy. Many drugs use the non-existence of competition to charge ridiculous amounts of money. Sometimes new drugs are made just to compete with them.
They answered 2 of the 3 possible reasons. Need to prove the third was not valid.
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I didn't think this was comparing these treatments to all other treatments, rather, it was comparing them to no treatment whatsoever.
Re:Left out third reason. (Score:5, Informative)
No cancer patient gets just one drug. A typical regime is surgery, radiation, plus a cocktail of multiple drugs.
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No cancer patient gets just one drug. A typical regime is surgery, radiation, plus a cocktail of multiple drugs.
Aggressive treatment with intent to cure, maybe. But someone in my family has myelomatosis (bone marrow cancer), no surgery, no radiation, not sure about the cocktail right after the initial discovery but at least the last three years it's a single drug (against the cancer anyway) and it's palliative. He's over 80 now so basically they're going to suppress that as long as they can, if it mutates or spreads to somewhere else they'll treat that but it's "good enough" relative to his remaining life expectancy
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It is typical that after the initial treatment they reduce the drugs, sometimes down to only one. But during initial treatment, it is almost never just one drug. Even for the very old.
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That's my point. The study did not talk about the money at all, it just mentioned the quality and the expectancy. So if the study did not use the accepted standard practice of estimating cost, than having 'no net difference' could be a HUGE benefit if it cost even 10% less.
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Nonsense! (Score:1)
For who? (Score:1)
FDA (Score:2)
Why spend $2 billion on FDA approval when you can make more money selling twigs and leaf extract from a random shrub growing next to a toilet in the Amazon? If you donâ(TM)t feel like going to Brazil, a plant near a port-a-potty at the online shopping company Amazonâ(TM)s warehouse will do.
Big organic and big nutraceutical companies make far more profit than any pharmaceutical and do zero peer reviewed research.
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Well, this is exactly what the Goop web site does. It openly sells snake oils, makes lots of money and the only wellbeing they care about is the wellbeing of their bank accounts.
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yeah, but it extends the suffering (Score:2)
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studies are funny things (Score:3, Insightful)
Studies are funny things.
For example, everyone loves the meta studies that "show that antidepressants don't work", but psychiatrists in clinical practice know that they work, for most people with clinical depression.
But the different classes of antidepressants work (or don't) for different people, so you frequently have to try one, see if it works, and then if it does not, try another, until you find the class that does work for this patient.
And, many studies are rather poor at qualifying who actually has true, persistent clinical depression.
So the "startling" conclusion is that a population that sorta has clinical depression but many of them really don't, is helped rather measurably little by trying one antidepressant.
I don't know if something similar is going on with this cancer drug story, but it could be.
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they don't know that as well as they might think - that's what the "evidence based medicine" thing is partly about.
In an area that is as loaded with emotions as medicine is (combined with a "slight" tendency of doctors to have huge egos) confirmation bias and other errors of perception run amok.
Not to mention the muddy data/results/experiences you get because of the placebo effect.
No wonder that, fo
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they don't know that as well as they might think - that's what the "evidence based medicine" thing is partly about.
In an area that is as loaded with emotions as medicine is (combined with a "slight" tendency of doctors to have huge egos) confirmation bias and other errors of perception run amok.
Not to mention the muddy data/results/experiences you get because of the placebo effect.
No wonder that, for centuries (if not millenia) even well-meaning doctors kept on killing their patients with their treatments.
Since you completely ignored what I pointed out about the situation, I'll leave you to it.
Yup (Score:2)
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I am totally confused by your post. It seems like you misread the article and took it to mean the exact opposite, based on some preconceived notion.
I bring this up every time an American points to how many new drugs they get as opposed to most single payer systems.
Your statement implies that you believe that Americans are boasting about getting more drugs. But Americans get fewer new drugs, not more.
There's a reason WHY the single payer systems aren't approving them.
The Europeans systems ARE approving them. That's the problem. And it has nothing to do with single payer or not, it has to do with the lack of regulatory oversight in some small European nations.
"Show no benefits" - are you sure? (Score:2)
That doesn't matter (Score:2)
What matters is that they make more profit for the drug manufacturers. Improving patient outcomes is just incidental.