The votes are in, and the Food and Drug Administration’s Advisory Committee said unanimously that the approval of Avastin (bevacizumab) for the treatment of metastatic breast cancer should be withdrawn.
The decision did not go down quietly, with women loudly voicing their disagreement, and one saying that this shouldn’t be happening in the United States of America. I could not sit there and hear the cries without feeling their pain and anguish. [more]
But the FDA advisors were very clear in their assessment: despite treating thousands of women, there was no group of women who appeared to benefit from the drug. The side effects are real and the potential harms significant, and to have the drug remain on the market could mean that many women would continue to be exposed to the drug and possibly die as a result, without hope of true benefit.
As one might anticipate, that did not sit well with the survivors in the audience and their supporters. In a response which anticipated the protest, one of the advisory committee members implored women to look carefully at the evidence and realize that the data from the trials did not support their belief that … Continue reading →
I attended a hearing today held by the Food and Drug Administration outside of Washington DC on the question of whether or not Avastin® (bevacizumab) should retain approval for the treatment of metastatic breast cancer. As one might expect, the experience ran the gamut from deeply felt emotions to cold hard statistics.
The presentations by patients and physicians for the most part opposed the FDA decision to remove the breast cancer indication, while an occasional person supported the FDA based on their interpretation of the data. For the patients and their supporters, it was the reality that many of them were alive and well with few symptoms, which they and their physicians attributed to the fact that Avastin® had a significant treatment benefit for their breast cancer.
But the FDA told a different story. [more]
The data from clinical trials, after looking at thousands of patients treated with Avastin® in addition to more standard chemotherapy showed no meaningful clinical benefit. At one point, an FDA representative said that they were looking for only one trial that had some sort of benefit, whether improved performance free survival, overall survival, or quality of life. But in their review, no … Continue reading →
“Poverty is a carcinogen.”
Those were the words of Dr. Samuel Broder when he was director of the National Cancer Institute in 1989.
As amply documented in the annual “Cancer Facts and Figures 2011” released today by the American Cancer Society, cancer shows that poverty remains one of the most potent a carcinogen-rivaling tobacco and obesity-as we have ever seen.
We have heard lots and lots about how cell phones and Styrofoam cause cancer. But do you hear anyone talking about the huge impact of poverty and limited education on cancer?
If you don’t hear anything about a true carcinogen that statistics show causes 37% of the deaths from cancer in people between the ages of 27 and 64, then maybe you have the answer to a very important question: If we are serious about reducing the burden and suffering from cancer, why aren’t we paying attention to those most in need? [more]
The report is one that is eagerly awaited every year by researchers, the media and many others. It is the source for a lot of the mind-numbing cancer statistics that you see all year long, such as “The American Cancer … Continue reading →
That is a number I want you to think about. And as you think about it, consider the implications for your health, your wallet and your state budget.
$10.28 is the amount of money it costs for the health and economic consequences of smoking a pack of cigarettes. Yes, that’s right: our economy and our health care gets dinged $10.28 for each pack that someone smokes, every day, 365 days a year, for however many years. That’s a lot of money.
Who pays that cost?
We all pay those costs in salaries and wages (the money that is lost in productivity, health insurance premiums, etc) that we would otherwise have for investment in business or improved wages for workers. We all pay those costs in higher taxes it costs our state and federal governments to provide health care and other benefits for caring for those unfortunate folks who suffer from the debilitating effects of smoking.
More important than the money, however, is how much we “pay” in personal “costs” when someone we love or someone we know dies as a result of tobacco, a product that when used as intended will kill half of … Continue reading →
Good things-hopefully-come to those who wait.
That time-worn phrase may well apply to today’s announcement by the Food and Drug Administration (FDA) that they have (finally) updated the regulations as to how sunscreens must be tested and labeled to provide consumers with accurate information as to what is actually inside the sunscreen package.
Why the patience piece? Because we have been operating for decades in the United States without effective, modern oversight of claims made by some sunscreen manufacturers. Hopefully today’s announcement by the FDA is the beginning of the process to correct that problem.
Too many people believe that what the claims they read on the sunscreen label-with words such as “sun block”, water resistant, SPFs approaching 100-are in some way regulated by someone when in fact they actually are not. Today’s announcement should help clear some of that confusion.
And, lost in all the babble is the fact that sunscreen is just one part of an effective approach to engage in sunsafe behavior. [more]
Key highlights of this new regulation included requirements that sunscreens must meet to be labeled “broad spectrum,” which means that a sunscreen blocks both UVA and UVB rays. UVA … Continue reading →
I am on the plane home from the 2011 American Society of Clinical Oncology annual meeting trying to figure out the best way to write a “wrap up” blog about my sense of what I learned and saw in Chicago over the past 4 days.
I wish I could tell you all the highlights of all the new studies and all of the exciting breakthroughs, but I can’t. Realistically is it impossible to attend all the sessions, read all of the thousands of abstracts and view the additional thousands of posters that are presented at this meeting. There is so much information that trying to get one’s arms around even a fraction of what is available is a monstrous effort.
I will leave it to others to write the headlines and the stories about what they think the latest and greatest research and/or treatment may be, and how it will impact the future of cancer care (they are frequently wrong).
For me, what is more important is the general sense of where we are today and where we are headed when it comes to reducing the burden and suffering from cancer. Are we really making progress, or … Continue reading →
I don’t often write blogs about articles that appear in newspapers, but in this case I am going to make an exception for today’s excellent front page story in the Wall Street Journal by Ron Winslow discussing the coming of age of genetics and genomics in diagnosing, treating and predicting the behavior of the disease we now know as cancer.
But even though Mr. Winslow may have pre-empted the thought that for me the seminal theme of this year’s annual ASCO meeting in Chicago was related to the impact of genetics on cancer research and treatment, his well-written “scoop” won’t prevent me from weighing in with my opinion that this year represents another one of those seldom moments when we reach a tipping point in cancer research and the application of that research to the diagnosis and treatment of cancer.
It was obvious literally from very beginning of the meeting when Dr. George Sledge–the President of ASCO–addressed thousands of cancer professionals from around the world and talked about the impact of the forthcoming era of personalized medicine.
In the past, we have had the chemotherapy era, where we were able to put combinations of toxic drugs together … Continue reading →
Each year, I come to the annual meeting of the American Society of Clinical Oncology (ASCO) not entirely certain what will be the blockbuster story. Once I arrive, I start to hear the buzz about certain presentations that someone or other thinks will be really important. But at the end of the meeting, I usually have the sense that–for better or worse–much of the buzz doesn’t translate into really meaningful advances in the treatment of cancer.
But this year–for me at least–there is one presentation that has and will continue to have far reaching impact. And that is the presentation this afternoon of two studies that confirm–at last–significant advances in the treatment of melanoma.
The two studies, which involve the use of a new drug called vemurafenib and another drug called ipilimumab (which was recently approved by the Food and Drug Administration for treating advanced melanoma and was the topic of one of my ASCO blogs last year), clearly show that we are at long last making progress in the treatment of advanced melanoma, which is a cancer that one of the experts here at the meeting said earlier today, was “the cancer that gives cancer a … Continue reading →
So this is June, I am in Chicago and that can mean only one thing: it’s time for the annual meeting of the American Society of Clinical Oncology, a gathering attended by tens of thousands of physicians, health professionals and exhibitors from around the world.
It’s also the time of the year when there are many reports of cancer breakthroughs, some of which will stand the test of time and others which will never get traction in the rapidly expanding world of cancer diagnostics and therapeutics.
I just attended a lecture which brought home to me once again that when we focus our science and our efforts on tackling the scourge of cancer, we truly can make some significant progress. When you break down the barriers, collaborate among experts, and ignore the boundaries, you can make a difference, reduce suffering and save lives. Such is the case with multiple myeloma. [more]
The lecture by Kenneth Anderson MD, a leading researcher in multiple myeloma at the Dana Farber Cancer Institute in Boston, was the result of an award Dr. Anderson received from ASCO. Dr. Anderson is someone I have known and “followed” since our paths first crossed … Continue reading →