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FDA Approves Vaccine For Prostate Cancer
reverseengineer writes "The US Food and Drug Administration has given its first first approval for a therapeutic cancer vaccine. In a clinical trial 'involving 512 men, those who got Provenge (sipuleucel-T) had a median survival of 25.8 months after treatment, while those who got a placebo lived a median of 21.7 months. After three years, 32 percent of those who got Provenge were alive, compared with 23 percent of those who got the placebo. ... "The big story here is that this is the first proof of principle and proof that immunotherapy works in general in cancer, which I think is a huge observation," said Dr. Philip Kantoff, chief of solid tumor oncology at the Dana-Farber Cancer Institute in Boston and the lead investigator in Dendreon's largest clinical trial for the drug. "I think this is a very big thing and will lead to a lot more enthusiasm for the approach."'"
According to my calculation, if the null hypothesis were true (i.e. the vaccine were just a placebo) there would be about a 1 in a million chance of a result this extreme (4.85 standard deviations above the mean). So it is highly significant statistically speaking. Whether it is clinically significant or not is a different question, of course.
You are an idiot and have no clue what 'the placebo effect' even is, and some of the pills during her regiment are not medical effective and are there just to keep her in the habit. That is NOT a placebo effect.
"Girls who get Pregnant like symptoms when they really want to be pregnant. People who catch an actual cold when they call in sick for work faking it"
neither of those are a placebo effect.
People like you are driving us back to the dark ages.
The Kruger Dunning explains most post on
jenny mccarthy told me vaccines give me prostate cancer
no thanks, i'll pass. i get my health advice from mtv hosts
intellectual property law is philosophically incoherent. it is your moral duty to ignore it or sabotage it
That's not what he meant, and this isn't the same context and you know it.
SHAME on you for trying to pollute political discourse.
The Kruger Dunning explains most post on
That was just the median. What you should focus on more is the 3-year survival rate: 34% vs 23% -- almost a 50% increase in long-term survival.
I am the richest astronaut ever to win the superbowl.
Several major points:
1. There were 512 people in the trial. Assuming that these were split into two groups, that n=256. Of course it depends on the standard deviation, but you could get your p value very low with an n like that.
2. Human trials of drugs that treat potentially fatal conditions are generally only allowed for patients who've failed "best available" therapy at least once, because it would be unethical to deny standard therapy to someone in a trial. The relative risk reduction may get better when used outside the context of the trial because of that. Or not. Remains to be seen, as usual.
3. As our understanding of the immune system and the molecular processes underlying cancer improves, we will slowly unravel a huge potential for case-by-case-based treatment of cancer. As a matter of fact, I believe a recent study I am too lazy to look up to link has shown that people whose cancer therapies relied on analyzing the biochemistry of each individual tumor resulted in about a 50% increase in 5-year survival, compared to conventional pathology-based treatments. The future is bright for oncology.
4. The caveat of #3 is that such treatments are expensive, and will get progressively more expensive based on the degree of testing and individualization required (until the wide use and technology make them cheaper of course). This will necessarily introduce a further divide into the available treatments for the rich and the poor, and contribute to the class struggle that's already rather inflamed. The problem is that there's no OTHER way - giving everyone $100'000 treatments would bankrupt us rather quickly. Instead, similar to the case with electronics, we will simply have to suffer through the period of expensive first-adopter treatments, until the improvements in laboratory techniques and high-throughput testing make such treatments increasingly affordable.
If you assume each person has (independently) a 0.23 probability to survive 5 years, then the overall distribution must be binomial with standard deviation sqrt(n*p*(1-p)).
I also hope it gets rid of prostate exams :)
Never antropomorphize computers, they do not like that
Is it just me or do those numbers look too close to be statistically significant?
The summary mentions a sample size of 512. The standard error of the mean decreases by the square root of the sample size. For 95 % certainty, if the standard deviation of their measured data is less than (32 percentage points - 23 percentage points)*sqrt(512)/1.96 = 104 "percentage points", which is quite likely, (see a tutorial), then you *can* say that this is statistically significant.
If you want some real details and not my back of the envelope calculations of dubious quality, you can see the actual slides [PDF], which does have details on the statistical significance of the results.
Long story short, they're significant at the level tested (95 %, generally good enough for these kinds of studies).
>> Standing on head makes smile of frown, but rest of face also upside down.
Saw palmetto doesn't do crap. And it's never been "proven" to prevent prostate enlargement or cancer. It's nothing but hearsay.
Propecia on the other hand (the stuff for baldness) has been shown to help the prostate.
"I disapprove of what you say, but I will defend to the death your right to say it." - historian Evelyn Beatrice Hall
You got a (well conducted, well documented, and peer reviewed) study to cite on the saw palmetto helping cancer survival rates?
Cause I'm pretty sure that's bullshit.
Bright indeed. The immune system has an amazing ability for specificity. Once we master the art of training the immune system to recognize and kill cancer cells the fight will be over. Interestingly, there was a cancer treatment in the late 1800's that relied on injecting cancer tumors with an infectious serum designed to elicit an immune response. The treatment had some success but was dangerous as the patient ran the risk of death from infection. I really think immuno therapy is the future of cancer therapy.
I have mod points. The reign of terror begins now.
4. The caveat of #3 is that such treatments are expensive, and will get progressively more expensive based on the degree of testing and individualization required (until the wide use and technology make them cheaper of course). This will necessarily introduce a further divide into the available treatments for the rich and the poor, and contribute to the class struggle that's already rather inflamed. The problem is that there's no OTHER way - giving everyone $100'000 treatments would bankrupt us rather quickly. Instead, similar to the case with electronics, we will simply have to suffer through the period of expensive first-adopter treatments, until the improvements in laboratory techniques and high-throughput testing make such treatments increasingly affordable.
But they can't. When Western Digital finally comes out with a Petabyte drive, it will cost a high price, but the next week, Seagate comes out with a Petabyte drive. Competition increases, prices drop, and the drives become increasingly affordable. In medicine, the patents are extended a little further. The patent holder can charge whatever he wants, because he needs to make back the money he spent on risky research, but for the next n+[too many] years, he gets to hold the sick of the world hostage. Well, what if company B wants to design a competitor drug?
1. Good luck to them.
2. View the #2 in your post. They have to struggle in a market that's immediately artificially saturated by Company A's wonder drug. This is like Pepsi trying to show up and claim "we can quench your thirst", but regulations say that, for the first n number of years, people have to drink a full coke before they can drink a Pepsi. Hope you're still thirsty after that coke, and if you're not, then hopefully the pepsi will quench your thirst when the coke did not!
And there, spelled out in soda, we have the well-meaning recipe for disaster in American healthcare -- the one that isn't fixed by the government plan, but needs to be before the government plan sends us headlong into a depression because of this unresolved bug.
I am the richest astronaut ever to win the superbowl.
I'm trying to figure out if "Provenge" is the most awesome or terrifying name for a drug I've ever heard. Also from the wikipedia page it "consists of a mixture of the patient's own blood cells" and their special "fusion protein".
I'm going with terrifyingly awesome!
I just hope the commercials feature Chuck Norris.
2. View the #2 in your post. They have to struggle in a market that's immediately artificially saturated by Company A's wonder drug. This is like Pepsi trying to show up and claim "we can quench your thirst", but regulations say that, for the first n number of years, people have to drink a full coke before they can drink a Pepsi. Hope you're still thirsty after that coke, and if you're not, then hopefully the pepsi will quench your thirst when the coke did not!
And there, spelled out in soda, we have the well-meaning recipe for disaster in American healthcare -- the one that isn't fixed by the government plan, but needs to be before the government plan sends us headlong into a depression because of this unresolved bug.
That's not at all a good understanding of the market or of biomedical research.
Anyone else is free to come up with a treatment that works better using the same principles. It just can't be the same exact protocol.
Similarly, to spell it out in soda for you, Pepsi can't produce soda using Coke's recipe and charge less for it.
Drug patents are woefully short-lived in the US, and only give the company a few years (unlikely to reach a decade, even under the fastest FDA review) to make their research money back, make a profit, and finance further research. For all the negative press patents get, the are still essential for stimulating development by rewarding innovation.
Unlike other IP, however, drug patent periods haven't been climbing up in duration, and as a result we can all enjoy levostatin, ezomeprazole, and the rest of the drugs that used to be sought-after prescription drugs, and are now cheap generics.
Actually I am wrong.
As some people have pointed out below, the sample who received the vaccine was only of size 256, not 512. So the p value is not 1/1000000 but more like 3x10^-4. Still significant, but not what I said before. Sorry.
Bright indeed. The immune system has an amazing ability for specificity. Once we master the art of training the immune system to recognize and kill cancer cells the fight will be over. Interestingly, there was a cancer treatment in the late 1800's that relied on injecting cancer tumors with an infectious serum designed to elicit an immune response. The treatment had some success but was dangerous as the patient ran the risk of death from infection. I really think immuno therapy is the future of cancer therapy.
To be honest I find that unlikely. Unfortunately there is a reason why that cancer spread - it has already managed to evade the immune system.
Immune therapy is but one of the treatments that become available once you understand tumor biology. Even more promising are drugs that can have direct effects on the multiple pathways that have been disrupted or bypassed by the cells on their way to becoming cancerous. As we gain more complete understanding of these molecular mechanisms, as well as enhance our ability to identify the mutations or dysfunctions in each individual tumor, we'll be able to target them efficiently. For instance, we may be able to fix the "suicide" pathways (yes, I know it's called apoptosis) that were necessarily disabled in a particular tumor, and by treating the problem cause the tumor cells to destroy themselves and they were programmed to do by evolution.
It was the treatment of tonsillar squamous cell carcinoma but I can't find the reference at present. Read about it in med school.
However, may I draw your attention to a couple of other cancers that seem to benefit from localised immune activation due to injected bacteria:
Stomach: http://www.nature.com/bjc/journal/v84/n4/abs/6691599a.html
Mouth: http://www.springerlink.com/content/rw3kk056t4014t5j/
Bladder: http://www.ncbi.nlm.nih.gov/pubmed/20205607
Propecia on the other hand (the stuff for baldness) has been shown to help the prostate.
Not surprising at all. Proscar, a prostate medication, had the side effect of making people grow extra hair. So Merck marketed a lower dose of the same substance, and called it Propecia.
Lose = not win
I am currently in a country with socialized medicine. The grandparents of my wife came to witness the birth of their great-grandson. My wife is anemic on a good day. She's turned away from donating blood almost every time unless she remembers to take an iron pill the day before and eat an abnormally large breakfast. In pregnancy, it gets worse. When she had a kid in the US, they held her in the hospital because her count was low. They wouldn't let her go. She had no symptoms of anything, but they didn't release her until her insurance ran out, then, without having the issue fixed, they discharged her. They treated the "disease" of anemia without regard to the patient. There were no symptoms and no reason to hold her other than one test.
In this country, she was anemic the whole time of pregnancy, including during and after birth. She was asked whether she had symptoms. She suffered no dizziness, no fainting, or anything else. So they cleared her for release while failing a blood test. Her grandmother had a fit. She gets a new pill for every test she fails (regardless of whether it is even causing her symptoms) so, by God, that's just how it's done. To not give my wife something was neglect or malpractice or something, according to Grandma. I'd be interested in seeing the average number of pills per week of an American vs a European. My perception is that the US will be leading by far, even though the live expectancy doesn't reflect any better care.
In the US, they treat the test results, regardless of the condition of the patient. Outside the US, they treat the patient, using the test results as a tool to that end. That difference alone is a major factor as to why the US has the most expensive health care on the planet, yet a middle of the pack (for industrialized nations) life expectancy. Cutting the medication of everything, and instead identify problems with patients (rather than just failed tests) and treat the person, not just the diseases will reduce cost and improve care.
But, the "easy way" is to give a pill for every failed test and then you can't be sued. That takes less time and effort too. The cost isn't borne by either the doctor or the patient, so neither really care it isn't cost effective. And you get an over-medicated society in poor health. I'd guess that Obama's comment is along those lines, where he wants to cut costs and improve service at the same time.
P.S. Comp Sci. Comp Eng is 50% comp sci and 50% EE, so EE+comp sci is everything comp eng can do plus more.
Learn to love Alaska
Ahhh yes, but if the hypotenuse to the quasar were perpendicular to the linear equation then wouldn't the gravitation of the median be devised by the quandary?
As someone who got hooked on ciggies about six years ago and actually enjoys the habit, news like this is promising to me. I hope the science behind this vaccine can be generalized to other forms of cancer, including lung cancer. I understand the reasons for banning smoking all over the place for reasons other than health, but it would be great to have advances in health technology to negate the effects of smoking. Since I have yet to quit and am not motivated to try again, I'm kind of banking on it.
Your brain is not a computer.
Only on Uranus (or prostate)...
you lost me when you started talking about herbal cancer cures. what a load of shit.
If you mod me down, I will become more powerful than you can imagine....
Dendreon said Thursday the drug will cost $93,000 per patient. Their stock was up today.
And it can make you impotent. Which is great because now that your new hair can attract women, you can't take advantage of the situation.
well research shows that the more you have sex and masturbate when you are young increases your chance of prostate canacer, and with teens having sex at a younger and younger age i think this company will be making some good money from this later down the road. http://www.sciencedaily.com/releases/2009/01/090126082343.htm
I other OLD news, men who ejaculate 5 times per week had a 66% less chance of prostate cancer EVER in their life than men who only did once or less per week. They has to be started young and you must continue this into your 50s. 3 different studies on this from 3 different universities in 3 different countries and all 3 go roughly(damn near the same) the same results even though they went about different ways of testing. They one test alone was a periodic questioner that followed over 30,000 men. Is that a good sample size? There seems to be a semi linear link, so each day you clean the pipes per week gives you and ~X% reduced chance of getting this dreaded disease.
I say an orgasm of prevention is worth more than a pound of cancer.
The current theory is that the prostate is great at concentrating carcinogens because of how it excretes and re-absorbs fluids which essentially filters and captures bad crap. Gotta flush it out.
Remember, a 66% reduction of the chance of cancer is like saying "you have a 200% INCREASED chance of caner if you don't".
P.S. remember to tell your wife to put out or close the door, because you're busy curing cancer.
Again fucking statistics used as proof. No knowledge of how chemicals interact within the body, how and why the reactions that cause cancer occur, no fucking nothing. Just the damn statistics.
Again someone who has no idea how drug development and clinical trials work shooting his mouth off.
The correlation between ignorance of statistics and using "correlation is not causation" as an argument is close to 1.
If they had used this reasoning and allowed insurance to pay for full service massage parlors in the health care bill, it would have passed without anyone complaining. Now there's change I would believe in!
Is that not his point? He wants to know more about how the drugs were developed and why they work they way they do.
No, I don't think he does. His contempt for the single most important item to be reported in any clinical trial says he doesn't really give a damn, but just wants to indulge in an ill-informed rant.
The correlation between ignorance of statistics and using "correlation is not causation" as an argument is close to 1.
5 times a week?!?
How am I ever going to keep count, let alone get the number down to 5?
Crumb's Corollary: Never bring a knife to a bun fight.
But further down this thread there's a study showing the opposite for those under 40. http://www.sciencedaily.com/releases/2009/01/090126082343.htm
There was never a time in written history when we all died at 40 or so. The average lifespan figure was strongly skewed by a high infant mortality.
While cancer becomes more common in old age, it is hardly a disease of old age. Children get it, young adults get it, middle aged people get it and old people get it. Most notably for your argument, it happens all too often before age 40.
It's a clinical trial, so it doesn't matter why it works. It's a study to determine if it works.
They could have designed it based on deep knowledge of the workings of body chemistry, or they could have noticed that people on a treatment for something else don't seem to die from prostate cancer as often as you would expect and decided to try and confirm that with absolutely zero knowledge of mechanism.
It doesn't fucking matter, because explaining the workings isn't the aim of the trial.
But in this particular case the article does explain the workings*, so you are not only retarded but also illiterate.
* Extract the immune cells from the patient. Grow them while exposing them to a protein specific to the cancer cells. Put them back into the patient. So the mechanism is obvious - convincing the patients immune system (well the bit you grew in a dish anyway) that the cancer cells are bad and hence using the normal immune response of the body to attack them. Of course that convincing part is likely tricky to actually do, but irrelevant to the mechanism in the body.