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FDA's Refusal to Approve New Cancer Vaccine - The Plot Thickens - Part I
lawyersandsettlements.com — FDA collusion
EviePringle- 800 diggs
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- Cliffhucker, on 11/28/2007, -6/+28Evelyn,
I think this would be a great feature story for 60 minutes or 20/20. You have done most of the ground work/outline already in your articles you have written thus far. keep up the great journalism.- scott2007, on 11/29/2007, -1/+1This isn't journalism. This looks like a PR site for law firms: "Online Legal Marketing Ltd."
- GodKiller, on 11/28/2007, -27/+3You can't have a vaccine against cancer because cancer is not an infections agent. Now a way to truly cure cancer would be to alter the dammaged DNA so that it either causes cell cytolysis or repairs the DNA. This would be possible in the near future via an artificially constructed retro-vectors (viruses).
- brooklyn137, on 11/28/2007, -0/+25You are correct if you are talking about traditional vaccines. But Provenge and some others in testing are what are called a therapeutic vaccines. The immune system targets an infectious agent by identifying a protein unique to that infectious agent and attacking entities with that marker. Therapeutic vaccines work by identifying a protein (antigen) unique to, or relatively unique to, cancer cells, taking dendritic cells, the library of the immune system, and fusing the marker to the dendritic cell. The immune system then identifies the cancer as an invader and attacks it. It works especially well on metastases.
You are correct about the promise of gene therapy but it depends on what you mean by near future. - ShnowDoggie, on 11/28/2007, -0/+3You are incorrect.
1. Some cancers are 100% caused by a virus, and are spread from person to person.
2. See Brooklyn's comment - floorman56, on 11/29/2007, -1/+1it also seems this drug ...Doesn't work AT ALL
Conclusions: Neither study D9901 nor study D9902A met any study objectives A review and analyses of the data submitted, including sensitivity analyses and review of death events, supported the finding of an increase in the median survival reported by the sponsor in APC8015 arm compared with the APC-Placebo in study D9901. However, the lack of a pre-specified primary method for survival analyses renders it difficult to estimate the type I error of this survival analysis. In addition, the six month difference in median survival times between D9901 and D9902A despite similar study design, inclusion criteria, and baseline characteristics, suggest that the eligibility criteria did not define a homogeneous population in these small studies. These observations increase the possibility that the survival difference in D9901 might be attributable to chance.
Safety and tolerability: APC8015 was generally well tolerated; approximately 90% of subjects in the two studies received the 3 infusions specified by the protocol. The most frequently reported adverse events in APC8015 treated subjects were transient chills, fatigue, and pyrexia. However, the increased CVA frequency reported in subjects treated with APC8015 constitutes a potential safety concern.
http://seekingalpha.com/article/30897-update-on-de ...
- brooklyn137, on 11/28/2007, -0/+25You are correct if you are talking about traditional vaccines. But Provenge and some others in testing are what are called a therapeutic vaccines. The immune system targets an infectious agent by identifying a protein unique to that infectious agent and attacking entities with that marker. Therapeutic vaccines work by identifying a protein (antigen) unique to, or relatively unique to, cancer cells, taking dendritic cells, the library of the immune system, and fusing the marker to the dendritic cell. The immune system then identifies the cancer as an invader and attacks it. It works especially well on metastases.
- Shigglyboo, on 11/28/2007, -0/+12I heard some time ago there was a new cancer treatment that restarted the mitochondria and enabled infected cells to die and stop the spread. whatever happened to that? and yeah, profit has no place in healthcare. should all the people and companies be compensated? absolutely. but we need more people like Jonas Salk, who refused to allow his polio vaccine to be patented.
- MonsterChaOS, on 11/28/2007, -16/+6They should just legalize marijuana already!
- jeffiek, on 11/28/2007, -8/+15A patient is dying a. A doctor has medicine. A gang (see note) stops the doctor from saving the patients life.
My God! What is wrong with people? Have Americans become so callous to life that they fail to see the immorality of denying a person the right to choose their own treatment? Take the power to deny life away from the FDA.
While I personally believe we should just lock the door to the FDA and throw away the key, I realize that others are too afraid. For God's sakes, if you can't do that, at least take away their power to deny treatment. If you must have an FDA, then bind its authority. Limit it to publishing recommendations and warnings. But don't let them continue to kill people.
What is it? Why do people keep supporting a government that is immoral? This is not new, the FDA has been at this for a long time. The Republicans like the FDA, the Democrats like the FDA, the Libertarians don't like the FDA.
And people call the Libertarians crazy. Go figure.
Note: http://www.hyperdictionary.com/search.aspx?define= ...
2 [n] an organized group of workmen.
Gang is a perfectly legitimate description of the FDA. They're organized, they're a group, and they work. Don't blame me, I didn't invent English- blesbok, on 11/28/2007, -7/+3Yes, taking away the FDA is a great idea. Why don't we just let companies release anything they want without strict testing? I think it would be great to have people keeling over left and right from unregulated drugs. Also, this medicine won't save anything, it will just prolong the inevitable.
I ***** hate liberals like you, because you spurt off without any concept of anything. Have you been to a biology class since high school?- jeffiek, on 11/28/2007, -5/+4"release anything they want without strict testing"
So I suppose you would be the one stupid enough to take them? I sure wouldn't. I would INSIST that the manufacturer provide reputable proof.
What I would NOT do is support an organization that KILLS people through inaction just so that I can be too lazy to take responsibility for my own life. I value my life, but not so much that I will stand by and sanction the death of others.
YOU are an accomplice to all that have been denied life saving medicine. YOU are coward enough to hide behind a government bureaucracy. YOU don't have the nerve to look the dying patient in the eye and say "Here's the medicine. You can't have it". Instead, you'll let someone do it for you.
May God have mercy on your soul.- blesbok, on 11/28/2007, -2/+8Ya, the difference between you and I, is that you sit there with your tinfoil hat and talk, while I save lives.
The FDA does not work through inaction. It takes years to recognize the side effects of some of these drugs. If you bothered to do some research, you would see that this drug is in a stage 3 trial, which it has to go through to prove efficacy and determine side effects. Just like every other drug. You can't give 100 people a drug for a week and say that it works. Just like any other business, what is stopping a manufacturer from pulling this "reputable proof" out of their ass? The FDA that is what is stopping them. God I hate ***** retards who pass their beliefs off as truths. You know nothing of drug trials, nor of FDA approval. You just want to hate something that you don't understand because it has to do with the government.- scubasteve377, on 11/28/2007, -1/+2"Just like any other business, what is stopping a manufacturer from pulling this "reputable proof" out of their ass? The FDA that is what is stopping them."
*****. That would be fraud and fraud is a crime. You don't need the FDA to tell you that. The free market works without the need for easily corruptible regulatory agencies, but truth in advertising and informed consent are a must. That is the proper role of government in the market: to prosecute fraud and other such abuses. Beyond that, people should be able to make their own choices. We don't need the FDA (or most of the other federal three letter acronyms).
- scubasteve377, on 11/28/2007, -1/+2"Just like any other business, what is stopping a manufacturer from pulling this "reputable proof" out of their ass? The FDA that is what is stopping them."
- kurocrow, on 11/28/2007, -3/+0Awesome, it's like a steel cage death match except with proselytizing. Overgeneralization! Ad hominem attack! Straw men strewn left and right! Insincere hopes about God and mercy!
- blesbok, on 11/28/2007, -2/+8Ya, the difference between you and I, is that you sit there with your tinfoil hat and talk, while I save lives.
- CorpT, on 11/28/2007, -4/+3If I want to take the drug without strict testing, why shouldn't I? If I want to wait for the strict testing, why shouldn't I? I don't need the government to protect me from myself.
- TheRealM3D, on 11/28/2007, -3/+2Europe gets all kinds of new and experimental medical procedures much faster because they do not have an FDA that jams up the process. People over there aren't any worse off than we are. You're a total moron if you think allowing an agency with little oversight and lots of conflicts of interest continue to control the American medical world. We're dying and they're getting rich off it. They aren't interested in curing cancer or even changing the way we treat it because that's a multi-trillion dollar industry and they stand too much to lose from REAL results.
And I'm not even a liberal. I just see evil scam artists for what they are.- floorman56, on 11/29/2007, -0/+3Europe gets all kinds of new and experimental medical procedures much faster because they do not have an FDA that jams up the process
And the U.S. didn't have Thalidomide babies
- floorman56, on 11/29/2007, -0/+3Europe gets all kinds of new and experimental medical procedures much faster because they do not have an FDA that jams up the process
- jeffiek, on 11/28/2007, -5/+4"release anything they want without strict testing"
- HappyScrappy, on 11/28/2007, -1/+5I guess Libertarians prefer snake oil and people getting ill or dead from "medicines" that don't work or worse.
Look up Thalidomide.- blesbok, on 11/28/2007, -1/+1Believe me, I know what thalidomide is, although it is regaining use. The big thing with thalidomide were its teratogenic effects, but as long as the person is not pregnant it isn't a bad drug. But look at something like tegaserod. Sure, it looks like a great drug, but it took 20k people in a study to realize that it had a 10x increased risk of heart attack and stroke. Now you tell me, would you rather have a stroke or constipation?
- HappyScrappy, on 11/30/2007, -0/+1I realize there are uses for it now, 30 years later. But I'm referring to the incidents where it was prescribed for morning sickness. It was a disaster, but not in the US, as we had not approved it. Partially through luck I assure you, but even a 90% effective safety net is a lot better than none.
- razor150, on 11/28/2007, -0/+1Enough "Medicine" gets through the FDA that kills people, Can't imagine what it would be like without it.
The FDA does need an overhaul though.
- blesbok, on 11/28/2007, -1/+1Believe me, I know what thalidomide is, although it is regaining use. The big thing with thalidomide were its teratogenic effects, but as long as the person is not pregnant it isn't a bad drug. But look at something like tegaserod. Sure, it looks like a great drug, but it took 20k people in a study to realize that it had a 10x increased risk of heart attack and stroke. Now you tell me, would you rather have a stroke or constipation?
- tehbored, on 11/28/2007, -0/+1Taking power away from the FDA won't do *****. We need to take power away from the corporations and create a single player healthcare system.
- Pake, on 11/29/2007, -0/+1"A patient is dying a. A doctor has medicine. A gang (see note) stops the doctor from saving the patients life."
So, if the patient ends up dying from the medicine, do you allow the family to sue the doctor and the pharmaceutical company? Should you be allowed to sue the doctor or pharmaceutical company when other negative side-effects come up over lack of testing a product? The FDA is trying to hold the pharmaceutical companies to standards so that people aren't dying from lack of testing.
- blesbok, on 11/28/2007, -7/+3Yes, taking away the FDA is a great idea. Why don't we just let companies release anything they want without strict testing? I think it would be great to have people keeling over left and right from unregulated drugs. Also, this medicine won't save anything, it will just prolong the inevitable.
- Scopitone, on 11/28/2007, -4/+39FDA - "Why cure it when you can simply treat the $ymptons"?
- bigjimslade, on 11/28/2007, -17/+17
This is *****. The second the FDA approves a drug that ends up harming people...here come the lawyers. It's science. "Collusion?" Go on, tin hat boys.- williamdyer, on 11/28/2007, -3/+8Yeah, it's completely impossible that Big Pharma bribes the FDA to both slide through their favored potions AND block competitors. Totally not possible.
- mydigga, on 11/28/2007, -1/+8I'm pretty sure you can't get any less healthy than death. So terminally ill people should be allowed to choose to take a promising drug not yet approved by the FDA. I think that is the point everyone is trying to make.
- Pake, on 11/29/2007, -1/+2Terminally ill should definitely be allowed to take it, but they should have to waive all rights to sue in the process. Nothing worse when sometime ends up failing, even though the patient and the family knew there was a possibility, and the family goes on a suing spree and screws everyone else in the process.
- mydigga, on 11/29/2007, -0/+1Not all rights... if later it is determined someone covered up a fatal flaw in the product then they should still have the right to sue.
- Pake, on 11/29/2007, -1/+2Terminally ill should definitely be allowed to take it, but they should have to waive all rights to sue in the process. Nothing worse when sometime ends up failing, even though the patient and the family knew there was a possibility, and the family goes on a suing spree and screws everyone else in the process.
- fatdog789, on 11/28/2007, -1/+5The point is that the FDA is trying to determine WHETHER OR NOT THE DRUG ACTUALLY WORKS. It can't do that if people who would die anyway take it, because that could skew the results: there would be no way to know why the person died.
It's not a matter of letting them take the drug, it's about NOT ***** UP THE DATA.
Anecodotal positive data is almost always considered an outlier, but anecdotal negative data is usually taken seriously and may even be incorporated into the safety/efficacy analysis.- fonguleverybody, on 12/10/2007, -0/+1You're an idiot. Why would they use the data collected on the person that died anyway? Obviously you don't include just anybody that decides to take the vaccine into account. On the other hand, you may be right... the data collection is probably way more important than freedom of choice in a free society.
- DefaultGen, on 11/28/2007, -4/+9"The cost of Taxotere is $2,500 a dose, according to the October 1, 2006, New York Times, while the average survival benefit is only about 2½ months. Between one and 2% of the men who receive the treatment die from it."
They'd rather profit off of this than approve something that works better? What the hell is wrong with people?- whyufail, on 11/28/2007, -3/+3You can rarely consider the people that make these decisions for companies "people". Praise be to god money.
- halkeye93, on 11/28/2007, -7/+1Don't you guys think there are enough people in this world already. I mean why wouldn't we want some to die off?
- toasty168, on 11/28/2007, -1/+5would you want to die off to protect the profits of some pharmaco?
- psion01, on 11/28/2007, -1/+5You go first.
- texpundit, on 11/28/2007, -1/+1REALLY REALLY REALLY late term abortion?
/runs for dear life.
- Dysarthria, on 11/28/2007, -10/+26Lets see...
An unscientific advertisement regarding an unproven cancer vaccine on a website created by lawyers inviting people to sue the FDA.
Yeah, this pretty much hits "Maximum" on the ***** detector.- djrocksteady, on 11/28/2007, -5/+3care to back up your ***** claim and do some debunking, or do you just enjoy being a defeatist?
- Dysarthria, on 11/29/2007, -0/+2My ***** claim? I'm not making any claim. Let the lawyers present data regarding their assertions instead of BS arguments. The FDA has pulled lots of pricey drugs from the market in recent years because they were found to be dangerous after they were released (Vioxx and Tysarbri just to name two). Its the only thing protecting us from Big Pharma BS in asserting what their drugs can and can't do. It ain't perfect, but I'd rather have an imperfect FDA process than a bunch of lawyers who are probably on the take from the drug company looking out for me right.
- Lukas2000, on 11/29/2007, -2/+1I would need a bulldozer to digg this comment as much as it deserves to be dugg.
- mjurmann, on 11/29/2007, -0/+2Unproven? Look at the 30 + people walking around 3 years after taking Provenge and you tell me its unproven.
You're just as narrow minded as the fools a the FDA. Go take your statistics and shove them. - raptor000000, on 11/29/2007, -0/+2Fail.
Maybe do a little research next time -- apparently, it's a treatment that works. http://www.google.com/search?hl=en&ned=us&q=Proven ...
- djrocksteady, on 11/28/2007, -5/+3care to back up your ***** claim and do some debunking, or do you just enjoy being a defeatist?
- toasty168, on 11/28/2007, -6/+7corporate ***** whores. wholesale corruption and hypocrisy fueled by the illusion of profit and power. pathetic, worthless human beings.
- FukUrCouch, on 11/28/2007, -3/+4Can't they let people sign a waiver or something to at least let them try it? maybe put the people wanting the drug in a "clinical study" to be able to try the drug..
- williamdyer, on 11/28/2007, -5/+2No, apparently they can't. Sit down and die quietly.
- Lukas2000, on 11/29/2007, -0/+2you can try whatever drug you want with your own money. the only issue is that insurance companies won't pay for a treatment not approved by the FDA.
- Lionhart, on 11/28/2007, -7/+1"In a study that compared the vaccine to a placebo, after 3 years, 34% of the patients who received Provenge were still alive compared to 11% of the patients in the placebo group."
So wait. These people volunteer for this experimental cancer treatment in hopes to save their lives and they get lied to and given a placebo while thinking they are taking the actual treatment just to test the placebo effect. Isn't that just a bit messed up?- williamdyer, on 11/28/2007, -0/+6No, that's good science. That's also why some studies get wrapped up quick if the effect is obvious.
- jeffiek, on 11/28/2007, -0/+5No. They don't get lied to. They volunteer to take the risk that their medicine is a placebo. God bless 'em.
It's a sad, but inescapable fact, that there needs to be a placebo in order to have a "control group" against which the actual medicine can be compared.
The real crime here is that after all that, the FDA says "it's not enough. We won't let anyone else take it." VOLUNTARILY. They don't care how many die waiting. - matttaylor314, on 11/28/2007, -0/+2In cancer studies, there's always an active comparator that is usually described as "best standard care." In the case of Provenge, I think the studies were between chemotherapy plus Provenge or chemotherapy plus a placebo. Ethical review boards don't allow actual placebo-controlled trials in cancer anymore for the most part.
I'm a medical writer. I deal with medical studies all day.
- whyufail, on 11/28/2007, -7/+5Two words, Ultra Violet. Yes, I'm sorry I made you all remember that movie, but still. We live in a world controlled by corporations who's only motivation is profit above all else. What did you expect?
- sparr, on 11/28/2007, -7/+2I might have more sympathy if the company that developed Provenge wasn't in this for the money just like the Toxotere(?) folks. If you REALLY want to save cancer patients' lives, publish the secrets to MAKING the new drug. The FDA won't be able to stop people from saving lives if everyone can make it.
open "source" pharmaceuticals ftw.- williamdyer, on 11/28/2007, -0/+3If the drug is patented, it must be described in the patent so that someone "skilled in the art" could reproduce it.
- jeffiek, on 11/28/2007, -2/+3"publish the secrets to MAKING the new drug."
Of course, why didn't I think of that? After all, the money for research grows on trees. Why would anyone want to make back their investment? - skeeterbug84, on 11/28/2007, -1/+4Unlike writing code, there is MILLIONS in research that goes into these products. There has to be a way to make that money back, or where would it come from? If you really want to save lives, get the special interests out of the FDA.
- shotgunefx, on 11/29/2007, -0/+2Well even more goes into marketing. Half of the drug "improvements" are gimmicks so they can charge a premium again after the generics hit.
Just by the fact that we pay so much more than pretty much the rest of the world, pretty much tells you that they are gouging the ***** out of us.
Take Prilosec, it cost about $4 a pill before it went OTC, after OTC, ~ $0.70 cents if that. Obviously P&G was raping people, the insurance didn't want to get raped anymore, and they convinced the FDA to let them off the hook. I think lobbying was just as important (likely more so) in that decision as the health of the people. Same with Claritin
- shotgunefx, on 11/29/2007, -0/+2Well even more goes into marketing. Half of the drug "improvements" are gimmicks so they can charge a premium again after the generics hit.
- blesbok, on 11/28/2007, -1/+3Ya, I think they should just start handing out billion dollar checks too. I mean who wants to actually make the money back on a $500+ million dollar investment? Stupid businesses and their logic.
- maiku00, on 11/28/2007, -6/+6let me guess- w/out even reading the article or comments, I am 99% sure that the reason the FDA won't approve it is because they cannot make money off of it.
- glucoseboy, on 11/28/2007, -0/+5FDA doesn't make money on drug sales.
- blesbok, on 11/28/2007, -1/+4Or because there is a 1/50 chance of dying from the treatment, which opens everyone up to a HUGE lawsuit.
- aak4, on 11/28/2007, -4/+6RU-486 (the abortion pill) got approved on the "fast track approval under an accelerated process enacted by Congress to ensure that drugs that treat a devastating disease would become available more rapidly." But this vaccine is getting bogged down? Something seems dysfunctional here.
- blesbok, on 11/28/2007, -1/+1It doesn't cure anything, it prolongs the inevitable.
- catalysis, on 11/28/2007, -1/+2You need to prove saftey for a fast-track approval and this vaccine hasn't come close to meeting those requirements.
- skinny01, on 11/29/2007, -0/+1Conspiracy theorists may say population control. Approve drugs that take life (abortion), halt progress of drugs that help extend life. Still equals out to less people.
- sakuraz, on 11/28/2007, -0/+3Reminds me of the Boston Legal Episode
I love shatner - OswaldKenobi, on 11/28/2007, -3/+5Can someone provide the FDA letter? The article is incredibly biased. I would like to know the exact reason for rejecting approval of the drug straight from the FDA's mouth before I pass judgment.
- blesbok, on 11/28/2007, -0/+21/50 patients die from the treatment
- matttaylor314, on 11/28/2007, -0/+3here's the issue in a nutshell:
Trial data on the drug have indicated mixed results. Provenge failed to slow the progress of advanced prostate cancer in 2 late-stage trials, but 1 analysis showed that Provenge increased median survival by 4.5 months relative to placebo.
Dendreon (manufacturer of Provenge) wants it approved, FDA isn't sure if it's effective or not - Grym11, on 11/28/2007, -0/+2http://content.ll-0.com/dnl/CancerLetterApr17.pdf
The article certainly did mischaracterize what Dr. Scher was saying. Apparently, even the main researcher behind Provenge admits there were problems with the experimental design and that the data was not statistically significant by scientific standards. - brooklyn137, on 11/28/2007, -0/+0the letter is confidential between the FDA and the company. Theoretically the company could reveal it but I don't remember a company doing so.
- Pinkertinkle, on 11/28/2007, -5/+5Biased article written by money grubbing sue happy lawyers and not scientists or doctors. BURIED.
- karolisonline, on 11/28/2007, -4/+3Same in Europe. Lithuanian scientists invented medicine that is curing cancer, but big farmacy companies forced europe drug commission to ban this drug. Sadly, but this is how it works. Big daddy don't wont us to heal, because it would cut revenues of most profitable business in the world, business that is even more profitable than narcotic trafficking.
- Flashman, on 11/28/2007, -1/+2If I had end-stage prostate cancer, and I was pretty much going to die, I'd go anywhere and take anything. So the company should manufacture its drug in Mexico underneath a shell corporation, and sell it to medical tourists.
- stonner, on 11/29/2007, -0/+0It's that mindset that allows quacks, psychic surgeons, and other assorted scum to make millions.
- glucoseboy, on 11/28/2007, -3/+11this is the 2nd time this story's been on digg and it's flat out wrong. Look at the company's own website.
http://investor.dendreon.com/ReleaseDetail.cfm?Rel ...
There is no conspiracy, the FDA isn't holding back the drug. There are 3 phases to drug approval, the company has gone through 2 and is starting their Phase 3 "pivotal" trial. They've just finished enrolling the 500 patients in November. Since this is a prostate cancer trial, it's going to be a couple of years before they get enough data to evaluate. Then it goes to the FDA for review and approval.
Please stop digging this article. There is no conspiracy here! Just a lot of misinformation and hysteria drummed up by lawyers.- matttaylor314, on 11/28/2007, -3/+2only sane comment I've seen here
- wonderworm, on 11/28/2007, -1/+2Your links back up the "lawyers" side of the story. Quit trying to mislead digg readers you chump. 17-0 for safety and 13-4 for efficacy and the doctors on the panel DO perform research for Provenge competitors so at minimum they should have recused themselves from the approval panel.
- glucoseboy, on 11/29/2007, -0/+117-0 for safety and 13-4 for efficacy: That means proceed to the next phase of research, not that the drug is ok to use.
Please educate yourself on how drug development works before making assumptions about who is misleading whom.
- glucoseboy, on 11/29/2007, -0/+117-0 for safety and 13-4 for efficacy: That means proceed to the next phase of research, not that the drug is ok to use.
- brooklyn137, on 11/28/2007, -0/+1The current study, the impact study, is the third phase three study. The first two, 9901 and 9902a were the basis of the companies BLA which the FDA ruled on in May.
- glucoseboy, on 11/28/2007, -2/+4whoops, here is the correct link:
http://investor.dendreon.com/ReleaseDetail.cfm?Rel ... - shotgunefx, on 11/28/2007, -3/+2I'd like to see someone address the points in this comment on a previous provenge story.
http://www.digg.com/health/Shame_on_the_FDA?t=1078 ...
No doubt pharmaceuticals are about money and only money, but that doesn't necessarily mean that this is the case here.
A much bigger problem for myself is how R&D is only thrown at high return investments. That's fine and good for the private sector, but why doesn't the government pick up the slack? Much of these profitable drugs start off with tax payer funding and are simply handed over to the private sector to make a ton of cash.
Take heart disease, a top killer. There is evidence that synthetic HDL would save lives, they've been able to synthesize it for years, but no one ever did. Why? No money in it, can't patent it. But the government spends how much treating it? So why not put up the money? Because it would compete with the drug companies.
Not until they found some people in with a mutant variant, it probably doesn't work any better, but you can patent it. And viola, "ApoA-I Milano".
Check out the story.
http://archive.newsmax.com/archives/articles/2004/ ...
"Researchers still argue over whether ApoA-I Milano is a better artery cleaner than the normal version, but it hardly matters. The ordinary kind cannot be patented, so it will never be developed as a drug..."
The story is shocking not in it's content, but that someone actually came out and said it. To hear what you've also kind of suspected, admitted. It's also doubly shocking as no one ***** cared! It didn't even blip. Just about everyone knows someone who has died of heart disease, yet the news passed it right by. There should have been outrage. National discussion. - gkircheis, on 11/28/2007, -1/+0It may sound stupid, this reminds me of the story in ghost in the shell: standalone complex.
- catalysis, on 11/28/2007, -3/+6Even if a patient is dying, you cannot just give them unproven drugs. It is unethical, ask any doctor. The FDA has a fast-track approval process for special cases but this vaccine is clearly not one of those cases.
- fatdog789, on 11/28/2007, -0/+1Such as the cervical cancer vaccine, which was fast-tracked because it had a proven efficacy in the high 90's with low risk of side effects (relative to the disease vaccinated against).
This drug, however, isn't proven to work, has a high risk of death against a low chance of success, and that's with the study ***** up to be most generous to the drug as possible. - brooklyn137, on 11/28/2007, -0/+0This drug was fast tracked.
- tehbored, on 11/29/2007, -1/+2Pffft. Tell that to Dr. House.
- shotgunefx, on 11/29/2007, -0/+3Well, I agree to a point but I can see onen exception for terminal patients. There are some some possible treatments while maybe not that promising, that utilize well understood compounds with really no risk. So if they have no recourse, and it can't harm them, I don't see the harm, and it would bear out efficacy or lack there of, providing valuable data, while not causing any real harm.
As a for instance, CLA, you know it's not going to hurt, maybe it will help, maybe it won't, but it's not going to hurt anything to try and you would learn something from it.
I'd also like to see if something like PEI (percutaneous ethanol Injection) could be applied to the whole body (obviously not in such quantities), I know someone who did just that to his mother (after testing on himself), her cancer went into remission, she died from a botched surgery later on. Maybe it was coincidence, but no one cares to find out as alcohol is not exclusive enough. I mean how much money does it take to get a couple hundred rats, some ethanol and do a study? And I can see why the private sector doesn't, but what about Cancer charities? Why aren't they supporting the less profitable but promising treatments? It's not like the effect of alcohol on the body isn't well understood. My mother wanted to try it when she was dying, and we would have but by the time I heard about it, other complications made it problematic. (Yes I know it would have been highly illegal, I didn't care)
Though on that same note, I'd want strict restrictions on it in the sense of such treatments being marketed as false hope to desperate people.
- fatdog789, on 11/28/2007, -0/+1Such as the cervical cancer vaccine, which was fast-tracked because it had a proven efficacy in the high 90's with low risk of side effects (relative to the disease vaccinated against).
- imcybersmart, on 11/28/2007, -0/+2conclusion: FDA likes cancer
- roccanet, on 11/28/2007, -1/+2Of course - anything that even slightly skews big insurance and government actuarial tables will be lobbied against.
When less people die of cancer - or in general when people live longer - the insurance industry and the government loses money.
(Once you stop paying taxes and working - uncle sam would love you to take a very early dirtnap friends)
If this is a drug that can help people with terminal cancer live longer - then what's the risk to patients of approving it?
This smells really fishy to me...certainly after the internal medical group overwhelmingly voted to approve it.
This needs to be investigated IMO....
- shotgunefx, on 11/29/2007, -0/+2From my own experiences, I have no doubt about the greed of the industry, but I don't agree on the cancer point at all.
It costs insurers big time. I don't think the platinum based chemo my brother had, or the numerous surgeries, drugs, the pain pump, etc made them any money at all. Quite the opposite.
- shotgunefx, on 11/29/2007, -0/+2From my own experiences, I have no doubt about the greed of the industry, but I don't agree on the cancer point at all.
- becauseiplayddr, on 11/29/2007, -0/+0wow... what has the world come to these days? damn rap music screws up everything.
- PerfectTommy, on 11/29/2007, -0/+2This is what you get when you staff Federal Agencies with former corporate lobbyist who used to lobby the same Federal Agency for which they now work. Gotta love those Neo-Cons.
- bernandoo, on 11/29/2007, -2/+5nobody knows what the hell they're talking about... the drug showed NO STATISTICAL benefit in two studies. meaning the FDA didn't want consumers paying $5000 a DOSE for something that showed NO BENEFIT. the culture of fear and conspiracy on digg is usually hilarious, but seriously.. do your own due diligence.
- bernandoo, on 11/29/2007, -0/+1http://www.thestreet.com/pf/newsanalysis/biotech/1 ...
- ShaneMcDeath, on 11/29/2007, -0/+2http://caretolive.com
- xrevision, on 11/29/2007, -1/+0How has the research been conducted? What method is being used? Is it even a double blind study? Are the patients randomly assigned? How big is the sample size? These are all questions we are taught to ask in medical school. Also, drugs take years to come onto the market, and to get into these clinical trials you usually need to know somebody who is running the whole thing. Clinical trials are not exactly the best source of information unless they have been set up correctly.
- mjurmann, on 11/29/2007, -0/+1A lot of stupid, uneducated things said here by people who obviously know nothing about this vaccine. Some of you should do yourselves favors and actually research something before you start typing - unless of course you enjoy looking ridiculous.
Provenge works - the FDA doesn't. Its just that simple. - intangible, on 11/29/2007, -0/+1And so many of you people want to put these type of people in charge of all health coverage in the country... What's wrong with you?
Oh wait, they're already in charge, look at the government's creation and requirement of HMOs. We already have socialized healthcare.
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