What is Digg?153 Comments
- Error601, on 11/24/2007, -5/+29All those words yet no rational argument.
- iloveazngurlzs, on 11/24/2007, -3/+21Can we get a reputable news source or some info on this drug?
We cant really judge because of the lack of info. - vault, on 11/24/2007, -2/+16Why didn't they approve it? Or do they just want more results and more information before they do?
- naturemade, on 11/24/2007, -1/+10There is no information in this story at all except about them suing the FDA...
- taquitohater, on 11/24/2007, -1/+10Thinking outside the box != believing everything you're told. Thinking outside the box usually involves asking questions and researching, finding other ways to do things. How exactly is believing everything put forth on that Anti-FDA site thinking outside the box?
- WhiteRaven, on 11/24/2007, -1/+8Error601 is correctly pointing out a complete lack of information in this article. We can not make moral OR rational judgments without information. The article never bother to explain the actual subject of the case, it only derided the outcome.
For example, "their terminal condition is DIFFERENT". Different how? - shotgunefx, on 11/24/2007, -1/+8The site should really do it's work to back up their claims.
Not that I find the fact that politics might play a role in a drugs release hard at all to believe from my personal experience.
The only thing I found so far digging (which I shouldn't have to if you are trying to convince me, but i digress)
From... http://www.ufscc.ufl.edu/Professional/cancernews.a ...
"Dendreon’s final three-year study of Provenge®, a prostate cancer vaccine, has shown that the drug improves survival. The 127 men with hormone refractory prostate cancer participating in the study tolerated the therapeutic vaccine well.
The phase III study, D9901, showed a median survival of 25.9 months when using the Provenge®, compared to 21.4 months with the placebo. ... The Provenge® had 34 percent of its patients alive at 36 months, while the placebo group saw only an 11-percent survival rate.
In a separate phase III study, D9902A, Provenge® did fail to meet the primary endpoint. Dendreon is currently conducting another phase III study, D9902B, under a special protocol assessment with the FDA."
Now the last paragraph is interesting because it says the D9902A failed to meet it's end point.
But if you look up the results, it still improved survival. Another trial is progress apparently (D9902B).
http://investor.dendreon.com/ReleaseDetail.cfm?Rel ...
Now if my cursory look is correct, it looks like it has few side effects and has been shown to improve survival in all cases. If that's the case, then for terminally ill people, it really should be fast tracked for those cases. It's a supplement to chemo. If it doesn't help them much, they are going to die anyway, if it does, it's more evidence that it's effective and will save more lives, faster.
I look at it this way, when medicine offers no hope, terminal patients should have the option of longer shots if there is a good possibility (meaning data of some sort) that it may help them and they are well informed of the risks involved. - inactive, on 11/24/2007, -1/+8I don't think a website that has a clear anti-FDA agenda can be considered an unbiased source...
- jbmcb, on 11/24/2007, -0/+6It doesn't really matter if it's for terminally ill patients or not - if a medication shortens the life of someone, or causes any sort of discomfort or harm because of improper trials (that the company is required to carry out) that company will be sued into oblivion, with a couple lawsuits aimed at the FDA for good measure. People just don't care - somebody dying = paycheck.
- hassanchop13, on 11/24/2007, -7/+13are you implying some type of conspiracy or something? then in 2 weeks, you'll be suing for malpractice when something goes wrong and call for more testing, etc (viox anyone?). Believe it or not, the FDA isn't trying to ruin your life. unless you have some type of proof or are in the medical field, dont waste everyones time.
- hassanchop13, on 11/24/2007, -2/+8i looked at it, and a site with ads for overstock on one side and google on the other side and a group i never heard of doesnt exactly strike me as the most reputable site, especially considering half the content links i see around the site are to more FDA bashing
- WhiteRaven, on 11/24/2007, -1/+6buried a third time for not providing any citations or really, any information at all.
- desu43fnoc, on 11/24/2007, -3/+8There's no profit in healthy people. There's no business in keeping people healthy if they're already healthy. The FDA would be out of business if everyone was fine and dandy with everyone pushing daisies when it was time.
They want people scared and in the unknown. It makes their jobs seem so much more important and gives them more job security.
This is the problem with these nationalized bureaus. If it was privatized and allowed to be set in a world of competition like the cable companies, perhaps they'd do a better job. Then again, we don't want the health-care fiasco we have now. The answer is somewhere in the middle... - WhiteRaven, on 11/24/2007, -1/+6Please provide a direct source of information about the trials. The article is suspiciously devoid of direct citations. Where are the studies and findings published?
- shotgunefx, on 11/24/2007, -0/+5As someone who's family turned into a cancer cluster in the last six years, they need to cite things. You are going to make claims like that, then you need to back them up or everyone is going to think it's tinfoil hat time.
Having said that, it looks like at least some of the facts are actually there, just the web site sucks. Here is a waiver that one of the doctors (Dr. Scher) could to excuse his finacial conflict of interest as he has grants working on a different drug for prostate cancer.
http://caretolive.com/2007-4291-w-07-Sche-208r.pdf
(Damn caretolive, why am I doing your leg work!) - vault, on 11/24/2007, -0/+5I'm sorry to hear that.
- RobotBuddha, on 11/24/2007, -0/+5"Why do some people insist on putting down something that is fighting for the good of mankind?"
It might be because they've seen miracle cures that "Big Pharma doesn't want you to have" shown time and time again to be snake oil when people tried using it on a widespread scale off-label. It could be because many of the posters are coming from a background which included a basic education in how studies are set up, and see the linked article's lack of such as a danger sign of quack medicine.
I actually changed majors because I didn't like the way the health care system in general was set up in the US, and didn't want to support it. But you don't create change with rants and emotional appeals. That's not how science works, or how any rational decision making process should. It comes from a systematic, logical, methodologically sound experimental design and examination of the resulting data.
Now, that could actually be somewhere on the site. After a quick skim looking for it, I found it too reminiscent of past claims which turned out to be largely people wishing for something to be true based on data that only looks impressive to someone who's never had any real education in how studies are conducted. Again, I'm not saying that this is the case here. Just that it's the appearance a lot of us are taking away from it. If they wanted to change that, the way isn't by yelling on the internet. It's by writing a paper, with proper citations, of a high enough quality to be published in a major journal. It doesn't have to actually get there, mind you. But it does have to be of that quality of anyone is really expected to take the argument seriously. - HerrEisenheim, on 11/24/2007, -7/+11My father was just diagnosed with prostate cancer a few days ago. Flies to NYC to see some top doctors on Sunday.
- inactive, on 11/24/2007, -0/+4Yes, we do. Some of these dangerous drugs can take months or YEARS to show their harmful effects. Your canary-in-the-mineshaft model relies on the fact that the drugs would have to harm someone before they would come to public attention as unsafe. Who is going to differentiate between the "safe" drugs and the non-safe ones to the layman? The doctors being paid (receiving free "gifts") by the pharmaceutical corporations? Who's going to pay for the private consumer reviews? The companies that make the drugs themselves, or will some magical watchdog advocacy group come in and fill the gaps without financial compensation?
Your libertarian fantasy land model relies on honest corporations as well as assuming that each consumer would be enough of an expert to differentiate between the potentially thousands of unsafe drugs on the market. - Eccles, on 11/24/2007, -0/+4My dad was diagnosed with it over five years ago. He was treated with radioactive "seeds" by some place in Atlanta, and has apparently made a complete recovery. So sometimes things go well.
- WhiteRaven, on 11/24/2007, -1/+5Okay... that site is just going to make people think you're a crackpot. It's ugly, disorganized and hysterical (as in crazy panic, not humorous). Any legitimate sources of information?
- Humptydank, on 11/24/2007, -0/+3I have no doubt that you have the best interests of patients and perhaps loved ones at heart when you pursue your efforts, and I hope you take this as constructive criticism, but you really are hurting your cause with the polemicist rhetoric you're indulging in.
When you use phrases like "smoke them out of their bunkers" and work in Wall Street conspiracies and saying that the FDA doesn't have our health at interest "often," then all you really will get are the "little people." People who read rah-rah language and automatically press Digg. They leave just as fast as they arrive.
But by recognizing that the drug has a very spotty history in trials, yet you feel that the benefits outweigh the risks for late-stage patients, you have a chance at getting people who might be much more valuable -- intelligent, thoughtful advocates who might put some weight behind your cause.
I'll be totally honest and tell you that even if I agreed with every word you said, and decided to join the cause, it wouldn't be with you because your writing and web site sound like something that might be stapled to a tree on a college campus.
If the forces arrayed against you are really as vast as you would present, then you'd better button up and become a more sophisticated, thoughtful, and formidable opponent. - ChuckFreck, on 11/24/2007, -2/+5I see your point, but Provenge was not shown to be a cure. It did not reverse the progress of the disease. The study showed that it seemed to lengthen the life of some individuals but the FDA concluded that the study was not statistically rigorous enough. And the drug does cause strokes in some people so it is not completely safe. Currently the FDA is being hammered on by Congress because of past problem drugs. If you want to make these kinds of drugs easier to approve then write your congress-critters.
- inactive, on 11/24/2007, -6/+9Buried for sensationalist headline and description not relevant to the content of the blog article. Buried again (morally) for the blog writer comparing the legal struggles of terminally ill patients to MLK and the plight of the civil rights movement.
- ocyan, on 11/24/2007, -0/+3At question here is whether or not Provenge has shown “substantial evidence” that it is an active agent that shows clinical benefits to patients. A very good discussion of what “substantial evidence” meant was given by Dr. Robert Kane of the Division of Drug Oncology Products in the FDA in the link below:
http://www.fda.gov/cder/Offices/OODP/presentation/ ...
The Provenge BLA (Biologic License Application) was controversial because it was based on the survival finding in the phase-3 trial, D9901, with supportive data from a smaller trial, D9902a. Both trials tested Provenge on the late stage prostate cancer commonly called HRPC (Hormone Refractory PC) or AIPC (Androgen Independent PC). At issue was that survival was not pre-specified as an endpoint in both D9901 and D9902a even though the trial protocol required that survival was monitored for each patient for three years. Instead, the trials’ primary endpoint was Time To Progression which, in 1999, when D9901 was started, was thought of as a good “surrogate endpoint to survival” that could be achieved early for approval. Circa 2004, the FDA and the scientific community, after extensive discussions of the pros and cons of TTP as an endpoint in HRPC and, considering that Taxotere was approved based on a survival finding, recommended that survival should be used as an endpoint for future trials in HRPC. A summary of the discussion of various endpoints for PC is below:
http://www.fda.gov/ohrms/dockets/ac/05/briefing/20 ...
So now back to the hard data on Provenge. The pivotal trial, D9901, which the BLA was based on did miss its primary endpoint TTP, albeit by only a small margin, p-value .052 vs the conventionally required .05. However, survival which was required to be followed for three years per protocol showed substantial evidence with p-value .01 with hazard ratio 1.7. The latter meant that at any given time a patient on the treatment arm had 42% less risk of dying than a patient on the control arm. The median survival for the treatment arm was 25.9 months vs 21.4 months for the control arm. At 3 years, 34% treated patients were still alive vs. 11% control patients. The second smaller trial D9902a, failed to achieve statistical significance but again showed median survival benefit 19 months vs. 15.4 months and 32% vs 21% survival rates at 3 years.
The FDA statisticians have deeply analyzed the data from the trials. Despite issues concerning conventional statistical considerations, below is a direct quote from the conclusion of their Statistical Review:
http://www.fda.gov/ohrms/dockets/ac/07/briefing/20 ...
“It may be important to weigh the following points while considering the unfavorable strength of statistical evidence: 1) showing statistically significant difference in overall survival in Study 9901 and showing a trend toward improvement in overall survival in the second study; 2) showing a trend in favor of APC8015 arm in all comparisons for other important endpoints; 3) the safety profile of the product; 4) other existing effective treatments for the targeting patient population.”
Aside from D9901 and D9902a, Dendreon have also conducted a variety of studies of Provenge in the Androgen-Dependent stage of PC (ADPC). In particular, the phase-2 studies D9905 and P-16 and phase-3 study P-11 all showed prolongation of PSA doubling time, i.e., a slowing down of the disease. In addition, early data from P-11 showed that there was a 27% benefit in delaying the Time To Distant Metastasis, a clear clinical endpoint. See for example:
http://investor.dendreon.com/ReleaseDetail.cfm?Rel ...
Now, going back to Dr. Kane’s discussion of “substantial evidence” of clinical benefit to patients, there was no question that Provenge has shown that even if the statistics might not have been pristine due to an unfortunate choice of the primary endpoint TTP instead of survival at a time when the science did not progress sufficiently. But after all, TTP, was designed to be surrogate to survival and survival benefit was shown so why should that matter? Further, Dr. Kane’s slide 49 in the presentation with the link above clearly stated that even if the statistical evidence might be controversial, the clinical benefit could still sway in the direction of approval. But how would the FDA assess that? The standard mechanism was to convene an Advisory Committee to evaluate the data. At the March 29th 2007 meeting, the FDA Advisory Committee met and voted 13-4 that Provenge showed “substantial evidence of efficacy” and 17-0 that it was a safe drug.
Given the volumes of data already available on Provenge and the votes from the Advisory Committee which composed of world experts in immunology and cancer treatment, the conclusion must be that Provenge met the “substantial evidence” requirement and should be approved or at the very least conditionally approved with continuing monitoring. Late stage PC patients whose survival time may be as short as a year time should be able to get access to it now to have a chance to save their life. Yet the FDA turned its back on patients and required new trial data which would not be available for at least another year and perhaps even 3 years. That is the true issue here! - mjurmann, on 11/24/2007, -0/+3This is crap and has nothing to do with Provenge. Please go away.
- ChuckFreck, on 11/24/2007, -3/+6From wikipedia: On May 9, 2007 DNDN dropped to just over $7 per share when the company received a letter from the FDA demanding more results and information before approval. The Seattle Times reported that layoffs are likely and quoted an industry analyst as saying that Dendreon will probably lay off half of its current workforce of 250.
So the FDA has not said it would never approve the drug, just that they want more trials. Some people want the FDA to be liberal with drug policy, some want conservative drug policy. No matter where they draw the line some people will disapprove. But the FDA does have to draw a line somewhere. Usually doctors weigh in on the side of the Hippocratic Oath -- do no harm. - inactive, on 11/24/2007, -2/+5That almost made sense except from the start of the first sentence.
the FDA is NOT the one making money off of the drugs. It's the PHARMACEUTICAL corporations that make the drugs that do. They're the ones that make the money off of keeping people Dependant on drugs to keep them healthy.
But of course it's in vogue on digg to bash the US government at every opportunity, no matter how factual it is. - inactive, on 11/24/2007, -3/+6Yeah, so we could have our provenge. We would also have the thousands of drugs that were tested to be to unsafe by the FDA on the market with absolutely no requirement that they even list what is inside of them.
- sweetsaprik, on 11/24/2007, -1/+4"The original question posed to the panel was, "Does the submitted data establish the efficacy" of Provenge? But during the voting, several members said they were having trouble with the meaning of "establish." That may have been a reflection of the mixed results Provenge showed in clinical trials. So the question was changed to ask whether the data showed the drug was "substantially effective." That weaker formulation won a strong majority. In two studies, the company failed to demonstrate the drug could slow the progression of prostate cancer, the No. 2 killer of men in the United States. However, in a three-year analysis of 127 men with late-stage cancer, the median survival time for patients receiving Provenge was 4.5 months longer than patients taking a placebo."
http://seattletimes.nwsource.com/html/businesstech ...
I can see both sides of this. I'm not sure I'd want to wait for them to quibble over how effective it might be if I knew I'd be dead by the time they came to a conclusion, so I see why people would want the drug, but I also see why the FDA wouldn't want to release it until it's proven itself effective. That said, the site reads like it was put up by one of the pissed off investors desperate to sell their product to people who are even more desperate to not die. - catalysis, on 11/24/2007, -2/+4That seems more like an opinion piece than a synopsis.
- info4u, on 11/24/2007, -0/+2I should have said 30,000 American men will die of PC each year. This Immunotherapy could help the rest of the world as well.
- thecoolestguy, on 11/24/2007, -2/+4It's not a free society when the government treats adults like children, telling them what drugs they can and can't ingest. RP2008. End tyranny.
- chaosium, on 11/24/2007, -0/+2The drug comes from big pharma.
- hammerattack, on 11/25/2007, -0/+2It's amazing that an article about testicular cancer should involve so much histrionics.
- inactive, on 11/24/2007, -2/+4The FDA should be abolished.
Government takes your money, under the guise of protecting the public.
Then keeps medicine from people who need it.
Do we not own our bodies? Can we not educate ourselves and determine our own risks? - stox, on 11/24/2007, -2/+4As much as I hate to defend the FDA, Provenge is a special case. The phase III trials failed to meet their endpoints, but did still indicate that the drug might have effect. During the Advisory Council meeting, the drug was initially turned down. This was because the data did not prove the drug worked as defined for the study. When the question was changed to, "Does it look like the drug probably works?," the motion passed. However, the policy of the FDA is to only approve drugs that have been proven to work. Bottom line, by the current criteria, Provenge is in need of more testing.
There are serious ethical dilemmas that need to be debated. Pushing a drug out to market too fast can have some very severe consequences, but so does restricting them from those who are terminal. - shotgunefx, on 11/24/2007, -2/+4Well, I can tell you this much, many members of the FDA have ties with the very companies and drugs they are regulating. There are obscene amounts of money on the table, if you don't think there is at least one person is corrupt, you have a better outlook on human nature than I.
Here's an interesting article from April on the subject by someone who was actual on the FDA advisory panel.
http://health.yahoo.com/experts/healthnews/4311/fd ... - Humptydank, on 11/24/2007, -1/+3Another trial has been approved because it needed to be. The segment below is pasted from a Motley Fool review of Dendreon stock. I'm pasting this because it's a good blend of medical accuracy and non-heavy-duty medical jargon. I'm happy to post heavy duty medical sources if asked.
"Before the FDA issued an approvable letter in May to Dendreon for its potential prostate cancer treatment Provenge, Dendreon had completed two small 127-person and 98-person phase 3 clinical trials that were labeled the D9901 and D9902A studies.
In the D9901 study, Provenge failed its primary endpoint of slowing down prostate cancer, but was successful on improving 36-month survival, even though that was not a pre-specified endpoint of the study. Why does this matter? Non-statisticians may not see the importance of pre-specifying study endpoints, but one of my favorite quotes goes something like this: "An exact answer to a wrong question can always be made precise." And then there's always the "three kinds of lies" made famous by Mark Twain: "lies, damned lies, and statistics."
Due to its smaller size, Provenge fared even worse in the D9902A study; it failed on the same progression-free survival endpoint and also showed an inability to improve overall survival in a statistically significant manner. Some people like to point out that the 3.3 months improvement in median survival time that patients experienced in the D9902A study is meaningful, even though it wasn't statistically significant.
But let's shape the D9902A trial results in another way. If we use survival confidence interval data from a FDA briefing document, we see that if the study was run 100 times, then 95 of those times the placebo patients would have median survival times in the 12.8 month-to-25.4 month range. Unfortunately, 95 of those times the Provenge patients would have median survival times in the 13.6 month to 31.9 month range. So if randomness wasn't in Dendreon's favor in this study, placebo patients could easily have lived nearly twice as long as the Provenge patients (depending on the sample used). Yikes!
Even after correcting for study imbalances in the D9902A trial, using what statisticians call a Cox model, the FDA states "there is not enough evidence in support of (Dendreon's) finding of statistically significant difference between the (Provenge treated patients and placebo group) in overall survival."
Dendreon just completed patient enrollment this week in another phase 3 study that will serve to either put Provenge on the market or seal its fate among the "hoped for but failed" drug candidates"
-------
From: "Dendreon, World's Scariest Stock"
http://tinyurl.com/2okhmg - mjurmann, on 11/25/2007, -0/+2The thing is, the article is about prostate cancer, so its nice to know that you didn't read it yet you're making such ignorant statements.
Go figure. - mjurmann, on 11/24/2007, -1/+3Whats it like to be a disgusting human being?
- mjurmann, on 11/24/2007, -2/+4Thats the point - the FDA is tied up with big pharma.
- Provenge17, on 11/24/2007, -0/+2From the mouths of Provenge/Prostate Cancer Survivors:
http://www.youtube.com/watch?v=f30cedqwQUQ
http://www.youtube.com/watch?v=y3U5i5EZvro&feature ...
Provenge is not the only FDA casualty:
http://www.youtube.com/watch?v=vFvcSTgYFS0&feature ... - RobotBuddha, on 11/24/2007, -1/+3Exactly. As much as the emotional appeals that usually pass for articles in the health section of digg are good at firing up emotions, that's not science. Science is evidence, logic, citations allowing people to actually debate rather than argue. The blogger might be right, the FDA could, but there just isn't anything there with which to judge.
- shotgunefx, on 11/24/2007, -1/+3A scam artist that should ***** off and die.
http://en.wikipedia.org/wiki/Kevin_Trudeau - jdoe562, on 11/24/2007, -0/+2$$
- WhiteRaven, on 11/24/2007, -3/+5You speak of three letters voicing opposition to the treatment. To properly make your case, you need to discuss the *content* of those letters. Vault asked why the FDA did no approve the treatment. You did not answer the question. You mention letters that presumable contain the arguments against the treatment but do not have the intelectual honesty to tell us what those arguments are. Instead, you accuse one of the letter writers of having a conflict of interest... and again, decline to actually provide the relevant information as to what the conflict is.
At best, you are poor at making arguments. At worst, you are intentionally avoiding relevant issues.
Please consider this an honest, unbiased assessment of both your post and the article itself. The argument in favor of the treatment just never gets off the ground because there is no acknowledgment of the charges made against it. - phorbo007, on 11/24/2007, -3/+5
The average life expectancy for a terminal prostate cancer victim is about 19 months. The only FDA approved treatment for these patients is a chemotherapeutic drug with severe side effects and which only extends life expectancy some 10 weeks. The present chemotherapy for these patients is so toxic and marginally effective in fact that most terminal prostate cancer patients choose not to take any chemotherapy at all. Recently, in early trials, a novel immunotherapy drug (that trains the patients own body to fight the cancer cells) with almost zero side effects named Provenge resulted in substantially improved extension of life expectancy. After 36 months of beginning the study, the number of Provenge patients still alive was three times the number of prostate cancer patients receiving conventional chemotherapy.
On March 29, 2007 an FDA advisory committee of 17 experts met to review the application of this revolutionary drug named Provenge. The panel met to discuss, then vote and recommend on the issues of a) Safety of Provenge, and b) Efficacy of Provenge. This FDA panel of experts voted to recommend Provenge for Approval by the FDA by an overwhelming margin. On the matter of safety, the vote was 17-0 for Provenge. On the matter of Efficacy, the vote was 13-4 for Provenge.
In May the maker of Provenge was informed by the FDA that this incredibly safe and effective therapy would not be approved for treatment of this extremely desperate group of cancer patients. The FDA cited "internal discussions and decisions" without disclosing so much as a single citation of what these discussions or decisions were, other than to say these nameless officials did not feel there was "enough evidence that Provenge actually worked" for the end stage cancer patients.
However, the FDAs own biostatistician concluded (at the March 29 advisory committee) that the probability of these findings being reproducible and not due to chance were approximately 97.5%, indicating that a miracle treatment for patients with essentially no hope was now available for terminal prostate cancer patients.
In summary, end stage prostate cancer patients have essentially NO effective treatment available to them and can expect to die approximately 19 months after progressing to the end stage. A revolutionary immunotherapy which has been shown to triple survival rates after 3 years of beginning treatment and which was overwhelmingly endorsed by the FDAs own panel of experts will now be turned away for more exhaustive study, possibly until 2010. During this time as many as 80,000 endstage prostate cancer patients with absolutely no viable treatment alternative will die much sooner than they otherwise would if they had access to Provenge. - ComstockGordon, on 11/24/2007, -0/+2A few years ago me and my friends were having a discussion about cancer meds and I remember saying that if a cure was ever found the government would never let it be released because it would cripple social security and pensions. I guess I was pretty close.
- Provenge17, on 11/24/2007, -1/+3In the recently passed Prescription Drug User Fee Act Reauthorization bill, pharmaceutical companies will pay the FDA approximately $393 million in user fees in fiscal year 2008, compared with $305 million in FY 2007.
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