Why Does The FDA Approve Cancer Drugs That Don’t Work

BRIAN KLEPPER

Posted 10/23/15 on The Health Care Blog

A new study in JAMA Internal Medicine finds that two-thirds of cancer drugs considered by the US Food and Drug Administration (FDA) over the past five years were approved without evidence that they improve health outcomes or length of life. (This study closely corroborates and acknowledges the findings published last year by John Fauber of The Milwaukee Journal Sentinel and Elbert Chu of MedPage Today.) Follow-up studies showed that 86 percent of the drugs approved with surrogate endpoints (or measures) and more than half (57%) of the cancer drugs approved by the FDA “have unknown effects on overall survival or fail to show gains in survival.” In other words, the authors write, “most cancer drug approvals have not been shown to, or do not, improve clinically relevant end points.”

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Will Specialty Drug Pricing Be The Straw?

Published 5/27/15 in Employee Benefit News

ALP_H_BK_0010Over the next few years, drug manufacturers will release a host of new drugs that are more complex and, in many cases, more effective than we’ve had access to in the past. There will be better solutions for common problems, and new solutions for uncommon ones. Specialty drugs, many of them “precision therapies,” will offer tremendous promise for better health outcomes across the breadth of human health and treatment.

Not surprisingly, most of these drugs will have breathtaking price tags, often a high multiple of conventional drugs. Specialty drugs are an exploding growth industry, with spending rising almost 20 times as fast as conventional drugs. Unless something changes, in just another five years we’ll likely spend more on specialty than non-specialty drugs. Or, for that matter, on doctors.

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On Compassion

Dov Michaeli

Posted 5/12/13 on The Doctor Weighs In

For Joel Klepper, who can do it all

My friend’s son, Joel Klepper, a student at the University of Oregon, sent his father a summary of a talk by the Dalai Lama at the university. I am not going to quote the whole report, brilliant as it is. But a few choice paragraphs illuminate the thought-provoking talk of this awe-inspiring religious leader. Here is the Dalai Lama on religion and compassion:

“He started by pointing out that all of the world’s major religions have compassion and love as their defining message, and pointed to the many people that all of the major religious traditions have produced who have used it as inspiration to devote their lives to compassion and the good of humanity. He was careful to differentiate between religion and religious institutions, saying it was the latter that was susceptible to corruption, and therefore it is the institutions that drive people away, but that generally that people don’t tend to have a problem with most core tenets, but that also as human understanding advances, it is critical that religion adapt itself, and not become mired in tradition or dogma when they clash with reality. Throughout, he was big on practicality and realism”.

The most surprising to me was the broad-mindedness of the leader of Tibetan Buddhism:

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On Seeing The Dalai Lama

Joel Klepper

Brian’s Note: My son Joel is a 34 year old 2nd-round student studying conflict resolution at Portland State University in Oregon. On Saturday, he went to an all day event that featured the Dalai Lama. Here is his report. 

The Dalai Lama was amazing and everything I could have hoped for: warm, intelligent, modest and thoughtful. And funny. The venue was a sold out auditorium of 11,000. He began at 9:30 am in a panel discussion with two prominent environmental activists and Gov. Kitzhaber, who also really impressed me.

They talked about the environment, and identified our nation’s (and the worldwide) culture of endless, ever-expanding consumption as the root of the issue, with nods to the political realities of trying to re-engineer a currently existing economy towards a more sustainable model. The Dalai Lama mentioned how he speaks to scientists all over the world to get an idea of the latest understanding and technologies, but was quick to defer to experts on specifics, citing his lack of knowledge. He also spoke on income disparity, and how after a certain point, more money does nothing to increase your happiness, because it does nothing to address core human needs, and can actively work against you. He even went as far as to say that he was a Socialist and an economic Marxist, but that those ideologies cannot work without guaranteed and real freedom as an indispensable part of that framework.

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Is Genomic Medicine Clinically Useful Yet?

Brian Klepper

Posted 7/16/12 on Medscape Connect’s Care and Cost

The news of my wife Elaine’s primary peritoneal cancer 27 months ago began a fevered effort to learn all we could about her disease and our options. Peritoneal cancer, which is close in form and behavior to ovarian, is rooted in the abdominal lining. “Gold standard” treatments notwithstanding, the prognosis isn’t good. After a 12-36 month remission in which tumors are inactive, the disease generally returns, and a high percentage of women are gone within 5 years of diagnosis.

Cancer elicits a primal fear that can provoke fantasy and baseless speculation. Cancer patients in remission have told us they are cured. Others, well-meaning, have announced they know someone with “exactly what you have,” and that theirs went away by applying a strict dietary or spiritual discipline.

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Cancer Survivor on N-of-One’s Direct-to-Patient Ombudsman Model

Kevin Davies

Posted 5/31/12 on Bio-IT World

The long-term success of N-of-One, a Waltham Mass.-based company offering personalized cancer information, will undoubtedly be shaped by the vision of its newly appointed CEO, Christine Cournoyer, and strategic partnerships with companies like Foundation Medicine, announced this week.

But ultimately it comes down to whether the company’s original direct-to-patient strategy works for cancer patients like Elaine Waples.

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Second Opinions: How Should You Choose?

Dov Michaeli

Posted 5/9/12 on The Doctor Weighs In

Incredulous Dov

I have frequently been asked to render judgment on another doctor’s diagnosis, or treatment plan. Other times I am asked anxiously: “should I get a second opinion”? The implicit assumption in this sort of questions is that “two heads are better than one.” Or stated more broadly, we put our faith in the “wisdom of the crowd,” whether the “crowd” is made up of two or two-thousand individuals.

I have to admit I’ve had some nagging doubts about this all-encompassing wisdom. For instance, wisdom of the crowd has been amply documented in estimation tasks (“how many people in this crowd?  What is your estimate of the completion date of the project?”). The reason this works is that it exploits the benefit of error cancellation; the outlier estimates on either side cancel out each other and we end up with the consensus opinion, that is closest to the truth. But how do you decide when the issue is not quantitative? Think of the virtually unanimous opinion of the White House crowd to go to war in Iraq. Where was the “wisdom” there? More interesting, we could drill deeper and ask why is it that the crowd reached such a wrong decision? Wisdom of the crowd was hailed as a source of near-magical creativity and unparalleled wisdom and forecast accuracy. Some of these attributions have proved to be unfounded. For instance, with respect to creative potential, groups that engage in brainstorming lag hopelessly behind the same number of individuals working alone. The key to benefiting from other minds is to know when to rely on the group and when to walk alone. Wouldn’t it be nice if we had some sort of an algorithm to guide us in making this decision?

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