gdp's Comments

Big Government : FDA Rationing Battle Continues

Wed, 18 Aug 2010 18:38:53 +0000

There were two big trials that just had results released: RIBBON and AVADO. In AVADO, the increase in progression-free survival (meaning how much longer they lived without the tumors getting larger) in patients receiving Avastin vs those who weren't was around .8 months (so about 3 weeks). In RIBBON, the progression-free survival rates were a little better, but the actual survival benefit for both trials was zero. Null. Zilch. People did not live longer. So what patients are paying for is about 2 months of not having tumors getting larger. It doesn't mean that their quality of life is better (they still have cancer and the side effects of Avastin are pretty bad), it just means the disease didn't progress. They didn't live any longer, however. So are you willing to spend $80k on a drug that doesn't make you live a day longer than if you hadn't taken it?

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Thu, 29 Jul 2010 02:18:06 +0000

Why do you continue to change the parameters of the argument every time you're proven wrong? You say it's not expensive and I show that you're wrong. You then start talking about the British health system (for whatever reason) and I show you how your argument is wrong there. And now you start talking about RomneyCare in Massachusetts even though that has nothing to do with any of this. I guess this is the Breitbart way, though. You're wrong and you deflect, deflect, deflect.

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 21:52:00 +0000

And all I can say is that Obama's healthcare system is nothing like the British one and what NICE does has no relevance on what is happening in the US. And it's not that you have to go blind before you get the medicine; the government just won't pay for it. We have that here, too. If a drug is not indicated for a specific disease, insurance companies very often will not pay for it. Which is why Avastin is costing you $55 per injection instead of a $20 co-pay.

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 21:44:09 +0000

But the care he's talking about is specifically for scare medical interventions. That's what the article is about. In fact, the first sentence of the abstract is: "Allocation of very scarce medical interventions such as organs and vaccines is a persistent ethical challenge." That's what he's talking about. He's not talking about knee replacements or bypass surgeries. So you must not have read his paper. As far as life expectancy, I did a 30-second google search and found this: http://papers.ssrn.com/sol3/papers.cfm?abstract_i...

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 21:08:09 +0000

Emaunel did not call for depriving the elderly of care. What he said was when there are medical procedures that are already limited -- like in organ transplants -- we should give them first to younger patients instead of the elderly. Those such instances are commonplace already. It's why any patient -- if they get to be too sick -- is taken off transplant lists. It just happens that more elderly people get to that point than younger people. But drugs like Avastin are readily available and there has never been rationing. You can't compare a marketed drug and a kidney. And that meme of the US having the longest life expectancy except for accident and murder has proven to be false. There are not that many accidents and murders in the US that would push it past 28 (or so) other countries.

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 20:17:49 +0000

A year's worth of Avastin can cost as much as $100,000 for cancer, where the dosage is significantly larger than in macular degeneration. In doing just a minuscule amount of research, I found that the typical Avastin dose for macular degeneration is 1.5 mg every 4 weeks. For breast cancer, it's 10 mg per kg every other week. So for a 130 pound woman, that's 680 mg every 2 weeks. 1.5... 680... Do you see why one is more expensive than the other?

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 19:52:30 +0000

I did read the article. Take this part: "Standard practice for evaluating drugs is to use data-driven objective endpoints to evaluate effectiveness and safety. In the case of Avastin, the FDA has arbitrarily and unilaterally stopped using this objective criterion and are applying a highly subjective criterion of “clinically meaningful”—to cut costs." False. The evaluation by the advisory panel is based data from two trials: AVADO and RIBBON. Both trials showed no extended overall survival. That's why they're considering taking away the breast indication. More: "No one disputes that the drug helps extends life for terminal patients." For some cancers it does, but not for breast cancer. And more: "While six months might not be significant to a statistician or a bureaucrat, for the families of a loved one or a dying patient, it’s a lifetime." Avastin doesn't extend survival in patients with breast cancer at all, so it certainly doesn't do it for 6 months. Should I continue?

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 17:12:48 +0000

There are no data showing that this drug extends survival in patients with metastatic breast cancer, people. This is yet another argument where there is nothing to complain about, but you continue to do so. This is why people on the left laugh at you. You're arguing a point with nothing to back you up, yet you think that if you repeat the talking points that Obama/Pelosi/Reid are trying to kill us all, you think you'll win by scare tactics.

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 16:49:14 +0000

But this has nothing to do with Obamacare or healthcare reform in any way. You're being overly paranoid. This is about a group of people -- none of whom are part of the FDA, by the way -- who looked at data and made their opinions known. The members of this committee were not political appointees and they have no left- or right-leaning agendas. They were trying to to see if this drug was effective and safe in fighting metastatic breast cancer. This drug is likely not going to be approved for this one type of cancer because it doesn't work in this one type of cancer. Get it? It has nothing to do with Obama. It has nothing to do with a doctor/patient relationship. Get over yourself.

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 15:52:13 +0000

Actually, clinically significant is what is used to determine the efficacy of every single drug out on the market. In layman's terms, it means that you treat a group of patients with standard of care or placebo or some sort of drug that is currently approved and you treat another group of patients with your experimental drug. If group a (the current standard of care) extends life 15 months and group b (the new drug) extends it by 15.5 months, the likelihood is that that data are not clinically significant. Significance is usually measured as a P value, and any P value that is lower than .05 means that the data is good. That says that if you run this same experiment 100 times, the same result will be repeated 95 of them. The lower the P value, the greater the likelihood of something being beneficial for a lot of people. You, the consumer, will not have to really figure this out. This is the job for your doctor, for people in the scientific community, for people at drug companies, for people in the FDA. You should know that when a drug comes to the market, it has to reach certain levels of safety and efficacy. Unfortunately, it doesn't always protect us from everything (as we've seen recently with some drugs), but it should make people feel pretty safe.

Big Government : ObamaCare: The Government’s Rationing Toolbox Exposed

Wed, 28 Jul 2010 14:51:13 +0000

Sigh. You've pretty much got everything wrong here. Avastin's indication to treat breast cancer was originally fast-tracked a few years ago based on some preliminary data. What that meant was it had shown benefit in other cancers (lung, renal, colorectal) and there was some data that showed that it could be beneficial for breast. So, without a full submission to the FDA, it was approved pending further studies. Last week, data from the RIBBON trial were released and it showed that Avastin didn't really help women with metastatic breast cancer compared with currently available therapy. When you added the cost of the drug (which is really, really expensive, by the way) and its toxicities (which there are many), the advisory board (not the FDA) recommended that the preliminary indication for breast cancer be removed. Why? Was it because of Obamacare? Was it because we want to limit treatment for sick people? No, it was because the panel -- which is not the FDA, but a group of physicians and scientists who study this stuff, convened to give their opinion to the FDA to help in making a decision -- saw that the drug showed no significant increased survival over what is currently prescribed. To me, it looks like this FDA advisory group is protecting the population from paying for a drug that doesn't work, that is expensive, and toxic. Avastin will still be available and will still be used to treat many patients with many different types of cancer and it will continue to help people extend their lives (albeit only for a few months).