More on Avastin
We previously reported on the FDA decision to withdraw approval of this drug for breast cancer patients (giving insurers — including Medicare and Medicaid — the freedom to refuse to pay what could be as much as $100,000 year) and that led to a spirited round of comments. Here’s a follow up item:
Late last week, the Food and Drug Administration received a letter from Susan B. Komen for the Cure, the pink ribbon-bedecked juggernaut among breast cancer treatment advocacy groups, demanding the agency maintain its approval of Genentech’s Avastin for women with life-threatening metastatic breast cancer. “We recognize the benefits of Avastin overall are modest for women with metastatic breast cancer,” Koman chief Nancy G. Brinker said in the letter. “However, we do know that for some women, Avastin offers a greater than modest benefit.”
Full article on how politics is driving up costs of breast cancer drugs.
I feel the same way I felt the last time I saw your post on this subject. Patients, consulting with their doctors, should decide whether to take this drug. Not the FDA.
I agree with Nancy.
From your cited article.
“If the FDA caves to the pressure and allows Genentech to keep advanced metastatic breast cancer on the Avastin label, it will be one more indication that the nation still isn’t serious about controlling health care costs by complying with science-based medicine.”
There is no scientific basis for using the medicine. I believe that patients should still have the right to use medicines that do not work, but they should pay for it. IOW, they do not have the right to force others to pay for that care.
Steve
John, you keep of harping on the Avastin decision, pointing out every unqualified publicity hound who objects to the recommendation. For all of you who don’t remember here are the details. An initial set of studies demonstrated that Avastin didn’t increase survival for women with breast cancer but suggested that it lengthened progression free time by some six months, inferring better quality of life for those six months. After that, a set of studies were preformed to examine the progression free duration. Those studies demonstrated that the progress free time with Avanstin was actually on the order of a month, that Avanstin may have actually decreased survival and its side effects reduced quality of life. In summary, breast cancer patients are worse off when give Avastin.
The Komen Foundation is an unqualified publicity hound? I thought they funded cancer research.
John. Komen is sort of like NCPA, they do both advocacy and research. Just like every horror of health care reforms helps your fundraising, every miracle cure denied story helps their fundraising.
Given the fact that oncologists make more money when they give more expensive drugs (they make a percentage on their drug costs), you would think they would be shouting from the rooftops to object the recommendation, but you don’t see that, they realize it just makes their patients suffer more for no reason.
Let me second artk. None of my oncologists are using the drug. When someone says the decision should be between a patient and their doctor, the physician still needs some objective criteria to inform that decision. It really cannot be based on some vague feelings. When there is not sufficient data to merit using a drug, it should not usually be used. Now, if a doctor wants to offer the drug to a patient with the full understanding that it probably will not work, but there is nothing else to offer, I have no problem with that, but I see no reason why insurance should necessarily have to pay for it.
Steve
There have been papers in the last couple of months reporting on clinical trials with bevacizumab. They report benefit from combining bevacizumab with taxanes.
What about gefitinib,a drug that lacked a “scientific basis” after FDA studies, even though results improved for some patients. Turned out that genetics influenced its activity. Which shows that if the biology isn’t understood, FDA clinical trials are statistics, not science.
The no off-label drugs movement has a long history in Medicaid. People in favor of centralized control worked to force only on-label formularies on Medicaid patients. Universities charge big fees for advising state Medical Boards on what to allow and what to exclude. It is a great way to cut expenditures because the patients have, literally, no choice.
Problem is that off-label use is common. This makes sense given that when drugs are approved for clinical use widespread experiment and observation shows that drugs passing RCTs can be of benefit in other ways. A paper by Lat et al. found that in a 24 hour period 36 percent of medication orders for adult ICU patients were off-label.
Thank you Dr Gorman MD, the fact is that studies focused bevacizumab with taxanes for breast cancer show patients to die as soon or sooner with a lower quality of life. With the exception of those few oncologists who think getting their percentage of a very expensive medicine is more important the the welfare of their patients, you’ll find they will follow the research.
There are a lot of reasons for off-label use. Almost none of the drugs I use for kids is really on label. Drug companies do not want to do studies on kids. Same for pregnant ladies. Sometimes we find that a drug we are using for one reason, works well for other problems. So, docs take these drugs and do the studies themselves. They publish the results. Other docs read these studies. If the results are good, we use them regardless of whether or not it is FDA approved. And, we get paid for using them. We have evidence for their efficacy. If the drug is not FDA approved AND no one has done studies showing that the drug works, we usually do not use the drug. If we do, we usually do not expect to get paid for it.
Might Avastin work if paired with the correct drug? Beats me. It has worked well for other cancers, but then I cannot think of any drug that works well for every kind of cancer. I would prefer to see published literature on such pairings. That is a general principle for all of medicine I would suggest.
Steve
Just as we offered Genentech an opportunity to respond to the critics, we also offered the Komen Foundation an opportunity to respond.
Oh and artk, we have always favored reform of the health care system. RADICAL REFORM. More radical, for example than ObamaCare. We do not favor senseless, harmful reform, however.
artk–run a “bevacizumab AND taxanes” search in PubMed. Read the abstracts of the papers that pop up. Some researchers appear to be reporting data that disagree with your assertions.
We recognize the benefits of Avastin overall are modest for women with metastatic breast cancer. However, we do know that for some women, Avastin offers a greater benefit — but we do not yet know how to determine which patients will experience greater benefits. We have much more to learn about the drug and how individual patients respond to the drug, such as why some women receive greater benefit while others do not.
Moving into the world of personalized medicine, cancer treatments will be more tailored to the characteristics of patients’ individual tumors. Yet, due to the current state of the science, we don’t always know which patients will benefit most before a drug is made commercially available. As with all medicines, we encourage a thoughtful discussion between a woman and her doctor that carefully considers the benefits and the risks.
FDA approval is not a requirement for a doctor to prescribe a drug. However, the panel’s decision could limit the so-called “off-label” use of Avastin for metastatic breast cancer — or ovarian cancer, for which Avastin is currently prescribed off label — if third party payers refuse to cover the cost of treatment.
We are supportive of the drug development process and the route of accelerated approval for treatment of diseases such as metastatic breast cancer. We hope that drug manufacturers will continue to develop medications for the treatment of metastatic breast cancer, and would not want this decision to mean that drug development for breast cancer comes to a crashing halt. We will only succeed in finding new treatments for cancer by bringing new drugs to the clinic.
As patient advocates, we call on all stakeholders — government, private industry, academia and the nonprofit community — to invest in the development of biomarkers and new drugs and to get the new technology and treatments to patients’ bedsides as safely and as quickly as possible.
Further, we hope women who are currently being treated with Avastin for metastatic breast cancer or ovarian cancer continue to have access to the drug, and that third-party payers continue to cover it.
My wife has metastatic breast cancer – liver, lungs, and bones. She almost died in February due to complications. Now she can hike 7-9 miles, 2400′ elevation gain. She has no side effects. She is one of the people responding very well. Now we are looking at financial devastation.