It was interesting to hear the President become archly ambitious about the oncological equivalent of a moonshot during his most recent State of the Union address. The President said veep Joe Biden would take the lead on an effort to break down "silos of data," which Biden said recently would halve the time needed to make advances in cancer care, and those in the private sector might be wondering how much of this talk of silos has to do with NIH's draft clinical trial data disclosure rule.

By some accounts, that $264 million bolus the National Cancer Institute received as a result of last year's budget deal is accompanied by a $350 million shot for research into Alzheimer's disease, so it's nice to see these neurodegenerative states get a little attention. My initial impression regarding this moonshot talk was that the White House would inevitably call for more money for NIH cancer research, and as has been widely reported in the past couple of days, the President wants Congress to agree to pony up $1 billion for the cancer moonshot.

The Congressional Budget Office is sending a distinct set of signals about the affordability of all this. According to the agency's most recent projections, mandatory spending is already set to rise by $168 billion during the current fiscal year, while discretionary spending is predicted to jump by $32 billion. That net $200 billion increase will go a long way toward raising the federal deficit to $544 billion, an increase of more than $100 billion from the previous fiscal cycle, according to CBO.

Granted that $200 million of the President's $1 billion is already in the hopper, but let's not forget a few things we learned about the departure of House Speaker John Boehner. Boehner had grown fed up with trying to corral a fractious GOP, which has a lot of very hawkish members where the deficit is concerned. The new speaker, Paul Ryan, vowed that a lot of things – including budgets – would revert to normal order, meaning more input from the rank and file.

Now that the CBO report has detailed that the U.S. government's debt levels have hit a record (and whopping) $19 trillion, deficit hawks have even more reason to be up in arms. As the saying goes among those who would shoot the moon, "Houston, we have a problem."

Data sharing and academe

Speaking of silos of data, the notice of proposed rulemaking from NIH regarding clinical trial data disclosure is not necessarily the darling of device makers for obvious reasons, but it's interesting to hear about the concept of data sharing generally from physicians involved in academic research. They're not sure they like it, but it might not be politically advantageous to give voice to any such misgivings.

The International Committee of Medical Journal Editors (ICMJE) penned a piece recently in the Annals of Internal Medicine announcing a policy that would require academic researchers to disclose de-identified, patient-level data within six months of a study's appearance in a member medical journal. The list of member journals includes the New England Journal of Medicine, the Journal of the American Medical Association and the Lancet, so this is a big deal.

The subject came up in the second half of January in an editorial in NEJM in which two of the journal's editors expressed reservations about the policy, although they were clearly not adamantly opposed. Among the concerns expressed in the NEJM piece were that secondary users of the data might not have the context for the decisions made by the clinical researchers in designing the trial, but they also opined that a new class of "research parasites" could emerge that would use the data in ways that might be seen by the study's organizers as potentially problematic.

That editorial sparked quite a bit of blowback, apparently, and Jeff Drazen, one of the authors of the first NEJM editorial, walked back the remarks in an editorial dated only four days later, stating that NEJM would of course comply with the policies spelled out in the Annals piece.

The NPRM dealing with disclosure is still up in the air, but one wonders if device makers will be in a big hurry to see their study results in the journals affected by the ICMJE policy. It's one thing to publish the results of a pivotal trial in a journal because you presumably have your PMA ready to go at FDA, but what about first-in-human and other early feasibility studies? Will device makers demand that trialists find other journals for publication of the results of these studies?