Posts Tagged Barack Obama

“Precision medicine”: Hope, hype, or both?

The cost to sequence a whole genome has been plummeting impressively since 2007.

The cost to sequence a whole genome has been plummeting impressively since 2007.

I am fortunate to have become a physician in a time of great scientific progress. Back when I was in college and medical school, the thought that we would one day be able to sequence the human genome (and now sequence hundreds of cancer genomes), to measure the expression of every gene in the genome simultaneously on a single “gene chip,” and to assess the relative abundance of every RNA transcript, coding and noncoding (such as microRNAs) simultaneously through next generation sequencing (NGS) techniques was considered, if not science fiction, so far off in the future as to be unlikely to impact medicine in my career. Yet here I am, mid-career, and all of these are a reality. The cost of rapidly sequencing a genome has plummeted. Basically, the first human genome cost nearly $3 billion to sequence, while recent developments in sequencing technology have brought that cost down to the point where the “$1,000 genome” is within sight, if not already here, as illustrated in the graph above published by the National Human Genome Research Institute. Whether the “$1,000 genome” is truly here or not, the price is down to a few thousand dollars. Compare that to the cost of, for instance, the OncoType DX 21-gene assay for estrogen receptor-positive breast cancer, which costs nearly $4,000 and is paid for by insurance because its results can spare many women from even more expensive chemotherapy.

So, ready or not, genomic medicine is here, whether we know enough or not to interpret the results in individual patients and use it to benefit them, so much so that President Obama announced a $215 million plan for research in genomic mapping and precision medicine known as the Precision Medicine Initiative. Meanwhile, the deeply flawed yet popular 21st Century Cures bill, which passed the House of Representatives, bets heavily on genomic research and precision medicine. As I mentioned when I discussed the bill, it’s not so much the genomic medicine funding that is the major flaw in the bill but rather its underlying assumption that encouraging the FDA to decrease the burden of evidence to approve new drugs and devices will magically lead to an explosion in “21st century cures,” the same old antiregulatory wine in a slightly new bottle. Be that as it may, one way or the other, the federal government is poised to spend lots of money on precision medicine.

Because I’m a cancer doctor, and, if there’s one area in medicine in which precision medicine is being hyped the hardest, it’s hard for me not to think that the sea change that is going on in medicine really hit the national consciousness four years ago. That was when Walter Isaacson’s biography of Steve Jobs revealed that after his cancer had recurred as metastatic disease in 2010. Jobs had consulted with research teams at Stanford, Johns Hopkins, and the Broad Institute to have the genome of his cancer and normal tissue sequenced, one of the first twenty people in the world to have this information. At the time (2010-2011), each genome sequence cost $100,000, which Jobs could easily afford. Scientists and oncologists looked at this information and used it to choose various targeted therapies for Jobs throughout the remainder of his life, and Jobs met with all his doctors and researchers from the three institutions working on the DNA from his cancer at the Four Seasons Hotel in Palo Alto to discuss the genetic signatures found in Jobs’ cancer and how best to target them. Jobs’ case, as we now know, was a failure. However much Jobs’ team tried to stay one step ahead of his cancer, the cancer caught up and passed whatever they could do. (more…)

Posted in: Basic Science, Cancer, Clinical Trials, Science and the Media

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The new Surgeon General nominee and CAM: Is there a problem here?

Our fearless leader, Steve Novella, has informed me that he is traveling today. Unfortunately, I am preparing a talk for later today, and no one else seemed able to come up with a post; so I decided to adapt a recent post from my not-so-super-secret other blog and see what a different readership thought of it. I realize that I’m risking subjecting you all to Gorski overload, but, hey, if the world needs more Mark Crislip, why wouldn’t the world need more David Gorski too? Steve will return next Wednesday, as usual.

I don’t normally give a lot of thought to the Surgeon General because, quite frankly, in recent years it hasn’t been a position of much authority or influence. That’s why I didn’t noticed late last week that President Obama had nominated a new Surgeon General. Normally, my failure to notice isn’t such a big deal, because there really hasn’t been a Surgeon General who has really been particularly well-known or had much of an impact since Dr. C. Everett Koop, although back when President Obama first took office Dr. Sanjay Gupta’s name was floated as a possibility for the position. Obviously, he didn’t get it. (I’m guessing that being a neurosurgeon and CNN’s chief medical correspondent probably pays much better than being Surgeon General.) To be honest, I didn’t even know that the prior Surgeon General had stepped down, but apparently she did in July, leaving the position filled by an interim Surgeon General until a new one could be nominated.

The other day, I learned whom President Obama nominated to be her successor, Dr. Vivek Murthy, a faculty member at the Harvard Medical School:

President Obama will nominate Dr. Vivek Murthy of Harvard Medical School and Brigham and Women’s Hospital as surgeon general of the United States, the White House announced Thursday night.

Murthy is a hospitalist at the Brigham and is co-founder and president of Doctors for America, a Washington, D.C.-based group of 16,000 physicians and medical students that advocates for access to affordable, high quality health care and has been a strong supporter of the Affordable Care Act.

If he’s confirmed by the Senate, Murthy would replace acting surgeon general Boris Lushniak. The surgeon general serves a four-year term and the post is essentially a bully pulpit to speak out on public health issues.


Posted in: Acupuncture, Politics and Regulation, Public Health, Science and the Media

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Dismantling NCCAM: A How-To Primer

Two of the earliest posts I wrote for Science-Based Medicine were entitled The infiltration of complementary and alternative medicine (CAM) and “integrative medicine” into academia and The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Both were intended as a lament over how not only is pseudoscientific quackery, much of it based on a prescientific understanding of how the human body works and disease occurs, finding its way into some of the most prestigious academic medical centers in the U.S. (for example, Georgetown and Beth Israel) but it’s even finding its way into the heart of the U.S. military.

Worse, aiding and abetting this infiltration is the federal government itself in the form of NCCAM. As I discussed in my usual excruciating detail in my original post and as Steve Novella, Kimball Atwood, and I have subsequently discussed many times on this very blog, particularly recently (so much so that I’m thinking of giving NCCAM its very own category here on SBM), NCCAM not only funds studies of dubious “alternative” therapies, such as reiki and homeopathy, that estimates of prior probability alone would argue to be so close to impossible as to be not worth spending millions, much less thousands, of dollars upon, but it also promotes quackery by funding “fellowships” at various institutions to teach “complementary and alterantive medicine” (CAM) sometimes also called “integrative medicine” (IM). Given that it spends over $120 million a year on mostly dubious studies and CAM promotion, we all have called for NCCAM to be defunded and disbanded.

Nearly a year has passed since I wrote those two posts. Ironically enough, at the time I wrote my first post about NCCAM for this blog, I pointed out that at first I had disagreed with my co-blogger Wally Sampson and his call to “defund” the NCCAM in an article published on Quackwatch nearly five years ago. My original reason was that I thought that there was value in studying these therapies to find out once and for all whether these therapies do anything greater than placebo or not. I now admit that I was very naive, and this was how I admitted it:

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine.

Nothing has changed since I wrote those words–except for one thing. We now have a new President who stated in his inaugural address:

We will restore science to its rightful place, and wield technology’s wonders to raise health care’s quality and lower its cost. We will harness the sun and the winds and the soil to fuel our cars and run our factories. And we will transform our schools and colleges and universities to meet the demands of a new age. All this we can do. And all this we will do.

As Kimball Atwood put it, Yes We Can! We Can Abolish the NCCAM! The big and as yet unasked (and unanswered) question is: How? Neither defunding nor dismantling NCCAM will be easy, and we have to think about how to preserve the functions of NCCAM that might be worth saving.

Posted in: Medical Academia, Politics and Regulation, Public Health, Science and Medicine

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Robert F. Kennedy, Jr., vaccines, the EPA, and the interface with science-based medicine and public policy

This blog is entitled Science-Based Medicine for a reason, and that’s because we here at SBM believe that the best method to result in the most efficacious treatments for the most people is through the application of science to the evaluation of the biology, pathophysiology, and treatment of disease and disorders.

I may (or may not) be departing a bit from the views of my co-bloggers with this belief, but for purposes of this blog I consider “medicine” to go far beyond what we as physicians do when we undertake to treat patients. In fact, in my view, the purview of science-based medicine should not be so limited but should include any area where decisions, actions, or policy have a direct impact on health. Thus, my definition of science-based medicine encompasses environmental policy, because of the profound effect on human health environmental pollution and toxins can have. Unfortunately for those of us who don’t like its messiness, such a view drives me even more directly into politics than previous issues I’ve taken on. Like Dr. Novella, I rarely write about politics, but when it directly impacts science-based medicine. Mostly, such discussions here on SBM have involved the regulation of the medical profession by government, as Dr. Atwood discussed recently (1, 2, 3) in the context of the difficulties medical boards have in preventing quackery to my discussion of how a quack like Dr. Rashid Buttar could continue to practice in North Carolina, despite his despicable preying upon desperate cancer patients and the parents of children with autism, not to mention the frequent criticisms of the National Center for Complementary and Alternative Medicine. Dr. Sampson, on the other hand, was more than willing to examine a much more explicitly political issue, namely the number of Iraq War dead (1, 2), and that provoked a bit of disagreement with our commenters, not to mention me.

Recently, hot on the heels of the election of Barack Obama in the Presidential election last week, an issue relevant to several aspects of where science-based medicine intersects public policy popped up. Steve Novella has already commented on it on his own blog, as have numerous other medical bloggers, science bloggers, and political bloggers but I feel justified in commenting on it here, for the reasons that I’ve just mentioned. The controversy is that antivaccine activist and true believer in the scientifically discredited notion that mercury in the thimerosal preservative in vaccines causes autism, Robert F. Kennedy, Jr., is being seriously considered by Barack Obama either to head the Environmental Protection Agency or even to be Secretary of the Interior. Like our fearless leader Steve, I believe that such a selection would be an unmitigated disaster for science policy in government.

Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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