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Over Half of New Cancer Drugs 'Show No Benefits' For Survival Or Wellbeing (theguardian.com)
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.
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 telling people itâ(TM)s a trial and letting their doctors choose whether to use it. Or whine that some people had drugs given to them that werenâ(TM)t proven effective...
Shows great wellbeing to the financial survival of big pharma.
Domestic spying is now "Benign Information Gathering"
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".
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.
Time is what keeps everything from happening all at once.
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.
excitingthingstodo.blogspot.com
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.
"First they came for the slanderers and i said nothing."
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.
There is no XUL, only WebExtensions...
Also conceivable that what passes for "morals" inside his skull might have prevented him from doing something so... dishonest.
There is no XUL, only WebExtensions...
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.
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.
If you want news from today, you have to come back tomorrow.
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.
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 testing afterward... phase V surveillance should be much more universal and rigourous, and not left upto vendors. There is also the issue of "off-label" prescriptions. If such prescriptions really are helpful, then long term comprehensive surveillance should demonstrate an effect, and make it easier to add a recommendation. If people want to know what drug combinations are being prescribed together, in order to prioritize which grouping to study.
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.
It must have been something you assimilated. . . .
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.
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.
Obviously, you've never had the good shit.
This is my signature. There are many like it, but this one is mine.
Given the huge black markets where it remains illegal and the number of countries or states that have voted to legalize marijuana, I would say that you a wrong on both accounts.
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.
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.
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.
Laws are rules for the court, but merely a bottom bar to hit for life. Think beyond laws in your actions always.
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.
Confucius say, "Find worm in apple - bad. Find half a worm - worse."
...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.
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.
"First they came for the slanderers and i said nothing."
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.
I think we've pushed this "anyone can grow up to be president" thing too far.
That's what prunes are for.
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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.
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You appear to be referring to CimaVax. Trials are underway.
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I also have not had terminal cancer (not even once actually). Relevance?