Cancer Research, Metastasized

It is crude but true that cancer makes for profitable business. The FDA approved 19 new drugs in 2012 and three this year, according to CenterWatch: Kadcyla ($9,800 per month), Pomalyst ($10,5000 per 28 days), and Stivarga ($9,350 per 28 days). There is no doubt a need for more and better cancer treatments. No doubt.

But two new studies in the past month cast light on the trouble of pushing research harder than perhaps it should be pushed. In an article entitled “Characteristics of Oncology Clinical Trials: Insights From a Systematic Analysis of ClinicalTrials.gov” published in JAMA Internal Medicine, a number of authors conclude that the research on which cancer treatment is based  often lacks the statistical rigor and robustness of treatment for other diseases. “An inherent tension arises between the desire to use new, life-saving treatments and the imperative to develop the evidence that patients, clinicians, regulatory agencies, and advocacy groups need to make sound decisions.” said Bradford Hirsch, lead author of the study, in a press release. “Unfortunately, the high prevalence of small studies that lack rigor limits the ability to assess the evidence supporting specific treatments.”

And released just yesterday in PLOS-One, a new study targets the widespread lack of reproducibility that afflicts much of the oncology literature:

When asked if investigators had ever tried to reproduce a finding from a published paper and not been able to do so, 54.6% (237/434) of all survey respondents said that they had, with 58.5% (154/263) of faculty having experienced the inability to reproduce data, and 48.5% (83/171) of trainees having the same experience. Of note, some of the non-repeatable data were published in well-known and respected journals including several high impact journals…

Upon finding results from a paper that could not be repeated the question arises; “what to do with that contradictory data?” When survey respondents were asked if they contacted the authors of the research paper, 78% (71/91) said that they had, but the ultimate results of that contact were very mixed…Overall, only 33.3% of respondents were ever able to explain or resolve their discrepant findings. This implies that 66.7% of conflicting results between research groups were not resolved through communication with the authors of the original publication.

These complementary problems run deep through the cycle that connects R&D with commercial markets, and solutions on any meaningful scale may require systemic examination and overhaul. But little choice exists. As one of the papers concludes, “the lives of our patients depend on it.”

Politics

“I’m cowardly. I should stop paying my taxes. I know that the government in Washington is full of terrible people with terrible plans. They will murder people here and abroad to gain more power. Those who have dominated our country most of my adult life are interested in maintaining an empire, subjugating other people, enslaving them if need be, and finally killing those who protest so that wealthy and powerful Americans can go on enjoying their advantages over others. I’m not doing a thing about it. I’m not a man of action; It finally comes down to that. I’m not so profoundly moral that I can often overcome my fears of prison or torture or exile or poverty. I’m a contemplative person who goes in the corner and writes. What can we do? I guess we can hang on and encourage each other, dig in, protest in every peaceful way possible, and hope that people are better than they seem. We can describe ourselves as horribly racist people, which we are, as imperialists, which we have been and are, but we can also see ourselves as bountiful, gracious, full of wit, courage, resourcefulness. I still believe in this country, that it can fulfill the destiny Blake and Whitman envisioned. I still believe in American poetry.”

 – Philip Levine

Hanford’s a Damnford Mess

Hanford, if you haven’t heard about it, is one of the world’s largest nuclear waste sites. The plant closed after more than forty years of plutonium refinement, first for World War II as part of the Manhattan Project, later as Cold War tensions ebbed and flowed (and nuclear stockpiles only flowed). The Department of Energy in 1989 took up the immense responsibility of tidying the place.

I spoke with a lot of people about the long-running efforts to remediate Hanford — the huge cost overruns, the chronic safety concerns (internal and external), the general wariness that there is no good technological solution within reach. (I did find differing opinions on this final point, but they were certainly the exception.) Nobody would go on-record. A sensitive issue, I was told, which is often gentle press euphemism for FUBAR.

At the end of January, the European Environment Agency released a very long report entitled “Late lessons from early warnings: science, precaution, innovation.” In brief, the report discusses how past mistakes in innovation and invention might inform a more cautious future arc of technology. A philosophical and far less wonkish discussion rooted in the same idea appeared here on March 14, 2011, three days after the Fukushima disaster. The gist:

Japan’s present disaster may or may not be transformative, but what it will be is a reminder of how often failure comes, and with consequences we should expect, but do not. I wonder if it is possible to imagine a world in which failure is normalized, part of the narrative, expected and in which we choose our strategies to return positively even when things, as they say, fall apart.

Without belaboring the point, perhaps the problem of Hanford is not the result of a few specific policies, the specific wartime urgency, the specifics of new work on new technology. Perhaps the problem of Hanford is much larger and far-reaching.

Killing to Conserve

I wrote about bees recently. They are dying off, which is not news, but scientists don’t ultimately have a good idea of which species are dying off, or how fast, or where or under what conditions. ”My sense is that we don’t actually know where there are declines,” said Gretchen LeBuhn, a biologist at San Francisco State University. With others, she recently devised a relatively inexpensive system to start making these unknowns known, to start a systematic search for answers.

But exposed in the course of writing this article was a rift within the conservation community that I didn’t previously know about: must we kill off animals — in this case, bees — in order to learn more about them? (Particularly ironic in the case of animals whose populations are threatened.) The debate seems to burn rather hot, and there is no easy resolution.

Knowledge is never free. What it costs is an interesting question.