Category: Life Sciences

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.”

Continue reading “Why Does The FDA Approve Cancer Drugs That Don’t Work” →

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.

Continue reading “Will Specialty Drug Pricing Be The Straw?” →

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:

Continue reading “On Compassion” →

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.

Continue reading “On Seeing The Dalai Lama” →

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.

Continue reading “Is Genomic Medicine Clinically Useful Yet?” →

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.

Continue reading “Cancer Survivor on N-of-One’s Direct-to-Patient Ombudsman Model” →

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?

Continue reading “Second Opinions: How Should You Choose?” →

You Seem Distracted: The Effects of Loss

Dov Michaeli

Posted 5/2/12 on The Doctor Weighs In

Incredulous Dov

We all know the feeling; we experience something terribly unpleasant, such as loss in of a friend or a family member, betrayal by a spouse or a close friend, significant loss of money. Are your senses as sharp as normal, or are you distracted, having difficulty analyzing situations and making decisions?

You are not alone. Even animals show what on the surface seems to be poor decision-making. Shock an animal with an electric current and it will tend to cower in a corner, trying to avoid not only a repeat of the shock, but any potentially negative stimulus. This kind of behavior is not maladptive. In fact, it is adaptive. How so? Because in a dangerous environment there is no time for the brain to analyze situations and judge their degree of risk. The animal that reacts defensively and fast will survive. The one that lingers to assess the situation is likely to perish.

Continue reading “You Seem Distracted: The Effects of Loss” →

Is Sugar Carcinogenic?

Dov Michaeli

Posted 4/30/12 on The Doctor Weighs In

Last Sunday on his show on CNN, Dr. Sanjay Gupta interviewed pediatrician, Dr. Robert Lustig, who made the assertion that sugar is toxic, and probably carcinogenic. This attention-grabbing statement had earned him a wide following on UTube. But is it true? Let’s examine the evidence.

How is sugar used in the cell?

Every cell in our body needs energy in order to survive and perform its functions. Our biochemistry has evolved over billions of years to extract energy from simple sugars, like glucose and fructose. I mentioned the evolutionary ancient-ness (is this a word?) for a reason. In the beginning (relax, I am not getting into the creation debate) the atmosphere was poor in oxygen. Yet cells had to extract energy from their nutrients. The solution? Extract energy from glucose without the participation of oxygen. This process is called anaerobic glycolysis, and even today, there are anaerobic bacteria that survive solely through glycolysis. This process nets a measly 2 ATP molecules (these are the molecules that store the energy necessary to drive chemical reactions in the cell), and two 3-carbon molecules of pyruvic acid.

Continue reading “Is Sugar Carcinogenic?” →

The FDA Fails to Stop Deceptive Dementia Drug Advertising

Kenneth Lin

Posted 3/27/12 on The American Family Physician Community Blog

In the March 15, 2011 issue of American Family Physician, Drs. Mark Graber, Robert Dachs, and Andrea Darby-Stewart analyzed an industry-funded trial that compared the effects of two daily doses of the Alzheimer’s disease drug donepezil (Aricept): a new 23 mg version and the existing 10 mg version that would soon lose its patent protection. Despite the trial authors’ finding that the higher dose of donepezil slightly improved cognitive outcomes, AFP Journal Club commentators determined that this difference was clinically unimportant, and was greatly outweighed by the higher frequency of adverse effects in patients using the higher dose:

First, the authors did four comparisons. Three were negative and only one was positive. And the one that was positive was only two points different on a 100-point scale. So, although this is statistically significant, it is clinically meaningless. There is no discernible benefit for the patient or caregivers. … Also, the drop-out rate in this study was an astounding 30 percent in the higher-dose group and 18 percent in the lower-dose group.
Continue reading “The FDA Fails to Stop Deceptive Dementia Drug Advertising” →

Vitamin E Supplements May be Hazardous to Bone Health

Dov Michaeli

Posted 4/2/12 on The Doctor Weighs In

Incredulous Dov

Vitamin E is a fat-soluble vitamin that has antioxidant properties. It is present in vegetable oils (safflower, sunflower, corn, soybean), nuts (almonds, peanuts, hazelnuts), sunflower seeds, and green leafy vegetables (spinach, broccoli). A balanced diet provides all the vitamin E you need, but most people take supplements of the vitamin, on the assumption that if a little is good, more is better. Is it really so? Let’s examine the evidence.

Continue reading “Vitamin E Supplements May be Hazardous to Bone Health” →

Will the Quantified Self Movement Take Off in Health Care?

Kent Bottles

Posted 4/02/12 on Kent Bottles Private Views

“If you cannot measure it, you cannot improve it.” Lord Kelvin

“Asking science to explain life and vital matters is equivalent to asking a grammarian to explain poetry.” Nassim Nicholas Taleb

Of course the quantified self movement with its self-tracking, body hacking, and data-driven life started in San Francisco when Gary Wolf started the “Quantified Self” blog in 2007. By 2012, there were regular meetings in 50 cities and a European and American conference. Most of us do not keep track of our moods, our blood pressure, how many drinks we have, or our sleep patterns every day. Most of us probably prefer the Taleb to the Lord Kelvin quotation when it comes to living our daily lives. And yet there are an increasing number of early adopters who are dedicated members of the quantified self movement.

“They are an eclectic mix of early adopters, fitness freaks, technology evangelists, personal-development junkies, hackers, and patients suffering from a wide variety of health problems. What they share is a belief that gathering and analysing data about their everyday activities can help them improve their lives.”

Continue reading “Will the Quantified Self Movement Take Off in Health Care?” →

Exercise, Diabetes, Cancer and Autophagy: A Fascinating Connection

Dov Michaeli

Posted 3/27/12 on The Doctor Weighs In

I can already see the yawn forming: exercise again? we know it; it’s good for you, it makes you feel better because of endorphins, it makes your cardiovascular function better because it strengthens your cardiac muscle and improves your circulatory system, and it may even protect you from cancer. But have you thought about what could be the common denominator to the beneficial effects of exercise? If you did, and came up with a blank, I don’t blame you. Until recently we didn’t have a good answer, but now the outlines of an answer are forming. So here goes.

Bariatric Surgery To Cure Diabetes: 2 Compelling Studies But There Are Still 4 Reasons For Health Skepticism

Jaan Sidorov

Posted 3/27/12 on The Disease Management Care Blog

Mrs. Jones (name changed) was obese. Her weight remained persistently high despite education and entreaties about diet and exercise. She hated taking all those medications. She dreaded bathing suits.

And then…. she had bariatric surgery. She shed pounds faster than Supreme Court justices spanking a health insurance mandate. Instead of having a corpulent and unhealthy patient, the Disease Management Care Blog had a svelte and healthy patient.

Based on witnessing first hand patient transformations like this, the DMCB knows that bariatric surgery for obesity works.

Continue reading “Bariatric Surgery To Cure Diabetes: 2 Compelling Studies But There Are Still 4 Reasons For Health Skepticism” →