Posted on 12/22/2010 5:14:11 AM PST by PhatHead
Last week, the Food and Drug Administration (FDA) revoked its regulatory approval of the drug Avastin to treat late stage, metastatic breast cancer. Each year, the practicing oncologists chosen by 17,500 American women to save them from their life-threatening, heavily progressed cancer prescribe Avastin to treat them.
The FDA explained that it was revoking approval of the drug for that use because it decided that the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Risk? The drug is prescribed for women who are otherwise going to die from cancer unless the drug saves them at least for a time. The far greater risk to these women is from the FDA, not the drug.
As The Wall Street Journal said last Friday in response to the FDA's explanation:
Ponder that [word] "sufficient." The agency is substituting its own judgment about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
(Excerpt) Read more at spectator.org ...
"Ignorant liberals running your mouths about insurance company rationing, take note of how this works. No insurance company has the power to weigh costs against benefits, and tell you that your health if not your life is not worth the money. But the government has now arrogated to itself the power to do precisely that. That is the meaning of the Avastin decision."
They said it wouldn’t happen.
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aside from the rationale used to justify the decision, which I agree is troubling, the other side of the coin is: why should drug companies be allowed to market expensive and possibly dangerous drugs that don’t do much good to people often desperate for help?
Obviously they do help some women or doctors would not prescribe them. These women are facing death. Would you give them no options but that?
There was a time not long ago when this particular drug was approved only for breast cancer. If you received it for use on a different sort of cancer you had to pay for it yourself ~ unless your insurance company was willing to do so.
Along the way it was determined (based on independent use by private sector oncologists treating formerly wealthy patients) that it was more beneficial for cancers other than breast cancer and FDI evaluated its further utility the same way it had done in the past.
The price has been coming down in fact.
What I found disturbing about the FDA decision is that it failed to reflect the differing interactions between the drug and BRCA1 and BRCA2 gene mutations in patients with uterine and general endometrial cancer. So, did they keep track of those situations or not?
I can assure everyone that when you have a family member with these cancers you spend a lot of time reading about them and catching up on current and more ancient research.
This stuff is 'spensive! Muy! And, it may work the first time and not again. It may continue to work for months and months, or even a couple of years.
The treatment regime is less rigorous than other more commonly used drugs in roughly the same class, and that right there can be seen as a "benefit" even if the drug itself is doing nothing at all.
Before this particular drug came along most of these people died within a relatively short period of time. With the restrictions now in place most of them continue to die. Some few don't, and may even improve.
Better drugs are needed. Unfortunately cancer research will languish as money previously used for that purpose will be diverted to scheduling physicians to make annual physical exams for people who don't bother showing up to receive them.
That's the real legacy of ObamaKKKare.
Really, how STOO-PID™ is that! The person is gonna friggen die shortly. But this is even worse!
My insurer, United Health Care does it whenever they want, they send a notice that they will no longer pay for a certain drug but have your doctor prescribe a different (cheaper) drug in its place.
Sure, you can still get the drug if you want to pay the entire cost.
P.S. If I manage to send this reply and you reply in turn, don't expect an answer. F.R. is so screwed up and slow that I'm done for today, maybe the problem will be fixed by tomorrow.
I've been trying for about ten minutes to send this reply and then added the "P.S."
My insurer, United Health Care does it whenever they want, they send a notice that they will no longer pay for a certain drug but have your doctor prescribe a different (cheaper) drug in its place.
Sure, you can still get the drug if you want to pay the entire cost.
P.S. If I manage to send this reply and you reply in turn, don't expect an answer. F.R. is so screwed up and slow that I'm done for today, maybe the problem will be fixed by tomorrow.
I've been trying for about ten minutes to send this reply and then added the "P.S."
My insurer, United Health Care does it whenever they want, they send a notice that they will no longer pay for a certain drug but have your doctor prescribe a different (cheaper) drug in its place.
Sure, you can still get the drug if you want to pay the entire cost.
P.S. If I manage to send this reply and you reply in turn, don't expect an answer. F.R. is so screwed up and slow that I'm done for today, maybe the problem will be fixed by tomorrow.
I've been trying for about ten minutes to send this reply and then added the "P.S."
My insurer, United Health Care does it whenever they want, they send a notice that they will no longer pay for a certain drug but have your doctor prescribe a different (cheaper) drug in its place.
Sure, you can still get the drug if you want to pay the entire cost.
P.S. If I manage to send this reply and you reply in turn, don't expect an answer. F.R. is so screwed up and slow that I'm done for today, maybe the problem will be fixed by tomorrow.
I've been trying for about ten minutes to send this reply and then added the "P.S."
My insurer, United Health Care does it whenever they want, they send a notice that they will no longer pay for a certain drug but have your doctor prescribe a different (cheaper) drug in its place.
Sure, you can still get the drug if you want to pay the entire cost.
P.S. If I manage to send this reply and you reply in turn, don't expect an answer. F.R. is so screwed up and slow that I'm done for today, maybe the problem will be fixed by tomorrow.
I've been trying for about ten minutes to send this reply and then added the "P.S."
My insurer, United Health Care does it whenever they want, they send a notice that they will no longer pay for a certain drug but have your doctor prescribe a different (cheaper) drug in its place.
Sure, you can still get the drug if you want to pay the entire cost.
P.S. If I manage to send this reply and you reply in turn, don't expect an answer. F.R. is so screwed up and slow that I'm done for today, maybe the problem will be fixed by tomorrow.
I've been trying for about ten minutes to send this reply and then added the "P.S."
My insurer, United Health Care does it whenever they want, they send a notice that they will no longer pay for a certain drug but have your doctor prescribe a different (cheaper) drug in its place.
Sure, you can still get the drug if you want to pay the entire cost.
P.S. If I manage to send this reply and you reply in turn, don't expect an answer. F.R. is so screwed up and slow that I'm done for today, maybe the problem will be fixed by tomorrow.
I've been trying for about ten minutes to send this reply and then added the "P.S."
It didn’t take long, did it?
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