Posted on 08/16/2010 1:35:14 PM PDT by Nachum
Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope. The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform:
Death panels deciding that some lives aren’t worth the cost of expensive new treatments.
Plus they are thinking about limiting mammograms for women.
Imagine if these decisions were coming from a white Republican male.
This is the truly evil thing, the FDA is about to yank this drug because 0bamacare cannot pay for it, but they don't care about people who could use the drug and are willing to fork over the money to pay for it.
Most Americans will never become aware of the implications of the Marxist Muslim’s health plan and its death panels until they themselves - or their parents - are euthanized.
Freedom of the Press in America is dead de facto. All the main stream media continually protect the Marxist Muslim and his hairbrained schemes from public scrutiny.
The list, ping
The serf population has to managed somehow.
The latest debate over Roche’s Avastin—whether the FDA should yank its approval for breast cancer use—shows how pulling a drug off the market is a lot more complicated than keeping it off the market to begin with.
Avastin got the breast cancer nod under the fast-track approval program based on just one study showing it staved off tumor growth for about five months. Now, the company has come back with required follow-up studies—two trials that suggest Avastin keeps tumors at bay a month and a half, rather than five. The FDA’s advisory committee reviewed the data and voted 12-1 to revoke the indication; the agency is set to decide by Sept. 17.
That’s how the program is supposed to work. If a drug proves less effective than initially thought, the FDA does an about-face. But in practice, the very suggestion that the FDA would revoke that approval has patient groups and opportunistic politicians up in arms. Not to mention Roche, which is lobbying to keep the indication.
Cost is key. The FDA isn’t supposed to consider cost, and the advisory panel billed its decision as a risk-benefits analysis, with Avastin’s apparently diminished benefit on one side and its not-inconsiderable side effects on the other. But if the indication is lost, insurers likely won’t pay. And everyone knows—even the FDA advisory panel—that Avastin is a pricey treatment. Whether the FDA’s final decision is tainted by the cost question, if it follows the committee’s recommendation, it will be accused of “rationing.”
http://www.fiercepharma.com/story/fda-panel-votes-yank-avastin-indication/2010-07-21
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FDA panel votes to yank Avastin indication
Even if the FDA does decide to yank the breast cancer indication, Avastin will still be approved for colon, lung, kidney and brain cancers. And doctors would still be able to use it off-label in breast cancer. But doctors might not want to. And, as the NYT points out, insurers might not pay. Hence the projected $1 billion sales drop, Sanford C. Bernstein analyst Tim Anderson tells Bloomberg. Eliminating U.S. breast cancer sales could cut Roche’s earnings by about 5 percent, he said.
“We are disappointed by the committee’s recommendation and believe Avastin should continue to be an option,” says Sandra Horning, head of clinical development hematology/oncology at Roche, in a statement, promising to keep pushing FDA toward keeping the indication. The FDA is set to decide by Sept. 17.
http://www.fiercepharma.com/story/fda-panel-votes-yank-avastin-indication/2010-07-21
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Oh Those Death PanelsPosted by LOGAN PENZA in At TMV.
Aug 16th, 2010 When critics of health care reform created the “death panel” label to describe the unelected and unaccountable boards that would decide what potentially life-saving procedures would be worth funding, “hyperbole” was among the nicest accusations lobbed in their direction. We were assured that the whole idea of “death panels” or anything that would deny care because of its cost was pure fiction invented by evil Republicans to scare people. Bad Republicans! Bad, bad Republicans!!! (Cue the usual one-sided litany of partisan evils.)
Just like the claims of cost savings, however, it is becoming apparent that the truth is exactly as scary as the fiction. The FDA is considering denying Medicare funding for the anti-cancer drug Avastin because it deems the cost to be more than the worth of the number and length of lives saved.
Yep. Read it again, if you want. The FDA is considering an arbitrary dollar value beyond which it will refuse to allow government funds to be spent to even try a treatment that has known curative effects (just not as much as they think would make it worthwhile). Also, since insurance companies routinely mirror Medicare guidelines (not to mention the incentives in health care reform for companies to dump their health care benefits and force employees on to the government program), the extended effect would be to deny Avastin to everyone, not just Medicare patients. It also represents a very dangerous shift in the scope of the FDA, where an unelected administrative agency tasked only with ensuring safety and effectiveness is now being used in the politically dicey area of calculating which lives are worth saving and which ones should be written off.
http://themoderatevoice.com/82925/oh-those-death-panels/
Why Should Politicians and Bureaucrats Decide Whether Breast-Cancer Patients Can Take Avastin?
Posted by Michael F. Cannon
Today’s Washington Post contains an article titled, “FDA Considers Revoking Approval of Avastin for Advanced Breast Cancer.” An excerpt:
The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?
A better question is: why should the government be the one to strike that balance? Why shouldn’t some women be able to sign up for a health plan that covers Avastin, while others are free to make a different choice?
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I bet they wouldn’t dare try to take a morning after pill off the market even if it proved it killed women!
July 29, 2010, 12:23 PM ET.
Senator Slams FDA Advisory Committee’s Avastin Decision
An FDA advisory committee’s vote to revoke the approval of Roche-Genentech’s Avastin for treating breast cancer has drawn rough words from a Republican senator. David Vitter of Louisiana called the decision “essentially government rationing.”
The advisory panel last week voted 12-1 to remove the breast cancer indication from the drug’s label. If the FDA follows the advice of its committee — as it often does — the drug could still be marketed to treat colon, lung and other cancers. New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.
“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.
http://blogs.wsj.com/health/2010/07/29/senator-slams-fda-advisory-committees-avastin-decision/
ObamaCare: The Government’s Rationing Toolbox Exposed
by Capitol Confidential
The FDA attempt to de-label Avastin for breast cancer patients is the first skirmish of the rationing wars. The battle must be fought and won. This isn’t an issue of government paying the cost of these late stage drugs. This is an issue of the government manipulating data to deny care to late stage cancer patients—even those with private insurance.
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.
No one disputes that the drug helps extends life for terminal patients. The FDA is arguing that it just doesn’t do it for long enough to be worth the cost. So now the FDA is deciding how much life is “meaningful” and what it is worth? This should be a decision for patients, doctors and family members and the FDA should not be replacing their own value judgments about how much time is ‘meaningful’. 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.
10 News asked a doctor at Moffitt Cancer Center about what this means for treatment. Dr. Hatem Soliman says the survival benefit of the drug could be obscured in some cases, because many progressing patients go on to get other lines of therapy, and some patients have greatly benefited from the drug while others haven’t had success. He says in order for targeted drugs like Avastin to be prescribed to the right patient, better designed research trials are needed for personalized medicine.
Here’s Dr. Soliman’s complete response:
“We have seen the recommendations of the FDA panel regarding Avastin in metastatic breast cancer. The data they are referring to is not new but has been something which has been debated for quite some time among oncologists.
“I have always felt that Avastin benefits select patients to a great extent, and others not so much. I have had multiple patients who have responded very well to abraxane and Avastin for example, whereas some other did not derive as much response.
“What the FDA looks at are patients in aggregate. So failing to show a survival benefit in metastatic breast cancer does not mean that nobody treated with the drug had a meaningful clinical response. Often the survival benefit is obscured by the fact that many of the progressing patients went on to get other lines of therapy.
“In any case the issue with all these targeted drugs is we need better biomarkers to pick which patients are more likely to benefit from them to get the most for our buck.”
http://www.wtsp.com/news/mostpop/story.aspx?storyid=140009&provider=top
At what point could this be considered murder?
Will the FDA’s ‘Drug Czar’ Decide to Let My Dying Mother Suffer More?
By Holly Pitt Young
Published August 12, 2010
FoxNews.com
If you or a loved one have ever heard, from a physician, “All we can do at this point is manage your cancer,” you know the terribly frightened and desperate feeling those words evoke. You immediately know that you’ll do anything – anything – to change reality. You ask, perhaps beg, if there is something that can be done – even though the doctor’s statement was so plain. As reality sinks in, you start to ask and learn about “managing” pain and life with terminal cancer.
I have heard those words spoken to my mother, who is living with Stage IV cancer. Life has, in some ways, become very simple for her. She has told me she wants just two things: less pain and more time.
There are drugs that can offer those things to my mother and other terminally ill cancer patients.
Unfortunately, whether they will have access to them is increasingly decided by a single individual, named Dr. Richard Pazdur, in Washington, D.C. Dr. Pazdur is known as the Food and Drug Administration’s “Drug Czar.” This one man can impact thousands of lives by simply re-categorizing drugs. He doesn’t need approval from Congress. He doesn’t need input from the public. He simply decides based on his own subjective judgment.
Why do all insurance programs have to be equal? A person who pays thousands of dollars for their own policy just might deserve to have better options. Maybe a person who receives "free" health care insurance could go to a clinic instead of being allowed to choose a private physician. They might have to wait in line. They might be given free meds. Maybe those meds will even be generic! Gasp!
Why can't I have better options since I use (lots of) my own money to pay for my own health care and my own health care insurance? I'm also paying for the people on subsidies!
I know! I am a heartless fool!
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