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Medicine Science

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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Over Half of New Cancer Drugs 'Show No Benefits' For Survival Or Wellbeing

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  • My any chance do you work for a big pharma company? Make drugs available when they show promise and they are proven safe but before they are proven effective. Drug companies hate this because the current system kills small drug makers when they canâ(TM)t realize a profit for 10 years (assuming a fair FDA process theyâ(TM)ll never get) Let cancer effectiveness work properly, put genetic information about the cancer and patient into a database, go over the drugs effects and gather data while telli
    • Maybe we need warning labels on new drugs, warning about drugs with no demonstrated benefits. Letting people take drugs without a proven benefit is fine (everyone is different, it might help YOU), just ensure they know. Of course that does undermine the entire premise of the "War on Drugs".
      • The claim for the "War on Drugs" was the prevention of the use of some drugs already demonstrated to degrade mental performance. Efficacy or toxicity are dealt with by other laws.
    • Sometimes it's better to risk approving it a little early even though it might be a placebo, instead of not approving it when it could possibly save lives. Once it's shown to be relatively harmless, it seems alright to let the doctor decide whether to use it or not.
      • Sometimes it's better to risk approving it a little early even though it might be a placebo, instead of not approving it when it could possibly save lives.

        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.

        • 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.

        • That doesn't make sense: approving the drug doesn't mean anyone will use it, but if it is not approved, then no one will use it. We have experts, doctors trained for many years, to evaluate drugs and figure out which ones to use and not use.
  • Looking at it wrong (Score:5, Informative)

    by AHuxley ( 892839 ) on Thursday October 05, 2017 @10:18PM (#55319187) Journal
    Shows great wellbeing to the financial survival of big pharma.
    • 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

      • by Anonymous Coward

        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.

      • Its not big pharma that is the issue, its the fact that so many want to play lawsuit lotto. Let me give an example I know personally.

        A relative was eaten alive by psoriasis, I mean he looked like he had been burned and it would rip and bleed everywhere if you looked at him funny. Then out comes this new drug and it worked like magic, the catch? You had to watch a video and get not one but TWO lectures from your doctor about not having children for 10 years after quitting this drug because it could cause fli

        • by rtb61 ( 674572 )

          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

        • by pnutjam ( 523990 )
          I'd love to see a citation on that. Sounds like the classic hot coffee lawsuit.
          • by pnutjam ( 523990 )
            I only see references to Soriatane, which has a 3 year recomendation of no pregnancy and birth control, pregnancy tests, etc. I'm not surprised by your wild inaccuracy. A cursory search seems to indicate it's still available, maybe not insurance carrier will cover it in your rural area.
              • by pnutjam ( 523990 )
                3 years, not 10 for no pregnancy, and no reference to:

                "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.

      • by meglon ( 1001833 )

        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

        • 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

        • by swb ( 14022 )

          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

    • 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.

      • by Mashiki ( 184564 )

        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

  • 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>

  • 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)

      by drinkypoo ( 153816 ) <martin.espinoza@gmail.com> on Thursday October 05, 2017 @10:45PM (#55319299) Homepage Journal

      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.

      • by EzInKy ( 115248 )

        Surely Europe can fix this problem, can't it? They are a union after all.

      • instead of studying drugs only prior to approval, drug efficacy, should, as a matter of course be studied all the time (even long after it is approved.) Do you want a sample of a few hundred people? or a few million? Information about who (in an anonymized way) is getting what combinations of drugs should be raw data for regulators, and researchers to mine. Big Pharma should contribute to the cost of the monitoring. One has to test for basic lack of danger to get into the market, fine, but keep testin
      • by Megol ( 3135005 )

        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 (

        • 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?

          • 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

    • by raymorris ( 2726007 ) on Thursday October 05, 2017 @11:25PM (#55319423) Journal

      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.

      • by EzInKy ( 115248 )

        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?

        • If I understand correctly (I’m no expert, I was reading about it out of curiosity), there are several routes possible:

          1. 1. The centralised procedure
            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
      • Americans got better, more expensive medicine.

        We can all agree with the "more expensive" part of that claim. But "better"? I think that statistics suggest the opposite.

        • Actually, the statistics suggest exactly what the poster you responded to said. In 2007 (the last year I saw statistics for), the 5 year prognosis for someone in the U.S. diagnosed for any serious disease was in the top 5 for any country in the world (depending on the disease), and number 1 for many of them. No other country came close to that.
      • 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

      • by dabadab ( 126782 )

        the EU is not focused on consumer protection and safety.

        I'm not really sure where you got that idea but it does not seem to correlate with my everyday experience.

  • 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.

    • In some respects, he did the world a great service by revealing the nature of that industry to more people than had previously been arsed to give a damn. If he was any smarter, he might have actually tried to play it off like that.
      • Also conceivable that what passes for "morals" inside his skull might have prevented him from doing something so... dishonest.
  • by gurps_npc ( 621217 ) on Thursday October 05, 2017 @10:38PM (#55319275) Homepage

    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.

    • by spun ( 1352 )

      I didn't think this was comparing these treatments to all other treatments, rather, it was comparing them to no treatment whatsoever.

      • by gurps_npc ( 621217 ) on Thursday October 05, 2017 @11:39PM (#55319447) Homepage

        No cancer patient gets just one drug. A typical regime is surgery, radiation, plus a cocktail of multiple drugs.

        • by Kjella ( 173770 )

          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

          • 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.

    • That's not how it works though. Deciding whether or not to provide a drug is based upon how much you get out of it and how much it costs. Most of these cancer drugs are complementary therapies added to existing routine treatments. You are looking at incremental gains, but basing decisions on how much better someone is and how much extra you need to spend to do it. Quality of life and "life expectancy" are combined as quality adjusted life years. If you live one extra year at half the normal quality of
      • 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.

        • I'd be very surprised if there is ever a new drug that comes out that is less expensive than a drug that has been around for years. Mostly because the parent has usually run out on the old drug and generics are being made.
    • Given the fact that there is a parent on the new drug I would think 3) would go without saying.
  • Pharmaceutical companies and their shareholders has enjoyed a remarkable increase in the quality of their lives, in no small part due to these new drugs.
  • I'm sure they show great benefit for the survival and/or wellbeing of the pharmabros.
  • 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.

    • by Anonymous Coward

      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.

    • Take a look at Life Extension magazine. Articles frequently have between 100 and 200 citations. The Life Extension Foundation also funds some original research.
  • My dad is going through radiation/chemo for bladder cancer. 3 weeks in, and his hair is starting to fall out. Good spirits though...said it would cut down on shampoo & combing his hair in the morning.
  • by cascadingstylesheet ( 140919 ) on Friday October 06, 2017 @09:42AM (#55321041)

    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.

    • > but psychiatrists in clinical practice know that they work, for most people with clinical depression.

      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
      • 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.

  • I bring this up every time an American points to how many new drugs they get as opposed to most single payer systems. There's a reason WHY the single payer systems aren't approving them.
    • by MobyDisk ( 75490 )

      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.

  • ...because the drug companies sure are benefiting
  • What matters is that they make more profit for the drug manufacturers. Improving patient outcomes is just incidental.

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