The Department of Health and Human Services (HHS), the parent department of the National Institutes of Health (NIH), has issued proposed rules concerning the transparency of clinical trials data (H/T Nature News, ScienceInsider). The proposed rules should be published in the Federal Register soon, and with the 90 day comment period, submissions will likely be due around February 19. NIH also released a Draft Policy, and is asking for comments by February 19.
The proposed rules are quite lengthy (over 400 pages); so lengthy that it might be folly to consider the NIH Draft Policy as an effective summary. The main purpose of both is to increase the amount of data that is reported and available to the public (through ClinicalTrials.gov). Adverse effects and negative results would be disclosed under these proposed policies.
However, as NIH Director Collins explains in a blog post, the NIH policy goes further than the HHS proposed rules. The policy would apply to all clinical intervention trials that NIH funds (not just drugs), while the HHS rules are focused on summary data of certain clinical trials for drugs and therapies.
While an intention behind both policies is to close reporting loopholes, it’s not clear how effective the new policies will be in addressing the significant under-reporting of clinical trials data. Ideally more results will be submitted to ClinicalTrials.gov and more results will be made available faster than they currently are. But reporting on these policies suggests that the amount of data still not reporting is quite large, and these new policies may make only a dent.
In March 2013 the Office for Human Subjects Research Protections (OHRP) at the Department of Health and Human Services (HHS) found that some of the informed consent provisions associated with the a study at the University of Alabama, Birmingham were lacking. In June OHRP sent a subsequent letter to the researchers indicating it would put its planned sanctions on hold.
In between March and June, HHS and National Institutes of Health officials interacted with OHRP staff, and that interaction prompted allegations of improper influence. The HHS Office of the Inspector General found no evidence of wrongdoing in its investigation.
But that doesn’t end the story, since OHRP put its actions on hold. That hold ended on Friday. Rather than implement sanctions against the researchers, OHRP has issued a call for comments on proposed informed consent guidelines. The proposed guidelines affect the application of human research protections to cases of ‘standard of care research.’ The major questions concern what risks could be considered ‘reasonably foreseeable’ and how those risks should be described to prospective subjects.
In the case of the SUPPORT study that prompted this whole process, there was disagreement over whether or not the study protocols put subjects at risks that warranted disclosure. OHRP felt that since the risks were greater than what subjects would reasonably expect without treatment, notice was required. Others argued that because the treatment under study was within the standard of care for the condition, that no disclosure was required.
OHRP is taking comments until December 24, and will issue final guidance sometime in early 2015.
I think I’m raising questions more than offering perspective with this post, but there are some things about the latest developments in the Ebola cases diagnosed in the United States.
(That’s right, it’s not an outbreak. The situation is West Africa certainly is. Four cases in a country that sees a few thousand times that many deaths from the flu does not qualify as an outbreak.)
Based on the latest declared case, a doctor in New York City that had been working in West Africa, the governors of New York and New Jersey declared quarantines above and beyond the recommended Centers for Disease Control monitoring (though the CDC is considering changing those guidelines). As the politicians have more than public health on their mind, I can understand why they might go above and beyond what is medically necessary. After all, Americans are scaredy cats, happy to act on fear before thinking things through. Why not placate their fear, and worry about the possible negative consequences (people simply traveling around the quarantine zone, fewer military and aid workers going to West Africa, reduced disclosures of exposure, etc.)
But the terms of the quarantine, or at least the pronouncements of New York Governor Andrew Cuomo about said quarantine, make me think that at least one of the politicians involved is either unclear on public health or simply doesn’t care. Continue reading
The current administration loves its open innovation platforms and competitions. To help combat the Ebola outbreak in West Africa (not to be confused with the isolated cases in the United States), the Department of Defense, Office of Science and Technology Policy (OSTP), Centers for Disease Control (CDC) and U.S. Agency for International Development (USAID) have collaborated on the Ebola Grand Challenge.
They want your help for two aspects of the challenge. First, submit your ideas for innovations or challenge grants online. Second, participate in the online discussions around the topic (I’d recommend donning your online flame retardant outfit first). The organizers have designated three missions (and a fourth category for any other ideas) of interest: strengthen health care capacities, promote care-seeking, and boost tracking and communication. In each case, they are looking for both existing research and potential ideas that could apply to the current outbreak. No formal expertise required.
Meanwhile, I’d encourage you to avoid U.S. media on this story, as it reminds me of that quote from Hamlet – “a tale told by an idiot, full of sound and fury, signifying nothing.”
Ebola is not the only virus on the government’s mind these days. Earlier today (H/T ScienceInsider) the Office of Science and Technology Policy and the Department of Health and Human Services announced a pause in new funding for gain-of-function research on influenza, SARS and MERS. Gain-of-function research tries to make existing viruses more pathogenetic or transmissible. Additionally, the government will encourage those involved in current gain-of-function research to pause said research.
The government has also initiated a deliberation process it intends to complete in the next year. Both the National Research Council and the National Science Advisory Board for Biosecurity will work on recommendations that would inform a federal policy on gain-of-function research.
This is not the first time the government has tried to address the matter of gain-of-function research. However, the current focus on Ebola and the recent problems with lab security of viruses could (and perhaps should) boost the scrutiny of this process. As ScienceInsider has reported that many groups have been advocating for some kind of pause or deliberative process to think through gain-of-function studies. But there could be resistance, if the incredulous Tweet included at the end of the piece is any indication. It is a Tweet, but it mischaracterizes the nature of the pause. It does not call for a moratorium on deadly pathogen research, but a pause on research that would increase the lethality or ease of spread of certain pathogens. Unfortunately, the current perceptions of viruses and efforts to stop them make me think that most will not try to properly parse the nature of the proposed pause.
Given the difficulty this country is having in following protocol with Ebola cases, having tools to provide context and to sift through the sensationalism is pretty important. Thanks to Alexis Madrigal and his Five Intriguing Things list, I found out about Ebola Deeply.
The site is part of a larger digital journalism effort called News Deeply. The focus is providing digitally curated collections of news, background information and other context. For instance, with Ebola Deeply you can see a case map (hey, Americans, we currently have less than 0.05 percent of the total cases in this outbreak), glossary, collections of medical reports, stories of survivors, a history of the virus (and attempts to eradicate it), and basics about the virus (which likely need to be repeated…daily).
A side note – actor Jeffrey Wright is one of the advisors for Ebola Deeply. His other connections with the virus include producing a video on people affected by Ebola as well as his work in Africa connected to his nonprofit. He is particularly interested in filling in gaps in Western media coverage of the virus, so I’m not surprised to see him involved here.
On September 30th the White House hosted a conference on the BRAIN (Brain Research Through Advancing Innovative Neurotechnologies). A multi-agency public-private initiative started in 2013, BRAIN started with a $100 million commitment between the National Institutes of Health (NIH), the National Science Foundation and the Defense Advanced Research Projects Agency (DARPA).
One of the announcements from the September 30th event was that more agencies are joining the effort. The Food and Drug Administration and the Intelligence Advanced Research Projects Activity make five agencies involved in BRAIN, to the tune of $200 million in research and development funding for fiscal year 2015. NIH announced the first round of its funding, $46 million, at the Conference. While not a funding agency, the Presidential Commission for the Study of Bioethical Issues presented at the event. The second volume of their neuroscience report should be ready in the spring of 2015.
Private sector activity was also highlighted at the event, noting the $30 million commitment of the National Photonics Initiative, as well as new efforts from Google, GE, GlaxoSmithKline and Inscopix. Several universities and foundations announced their new commitments as well, including the University of Texas System, the Simons Foundation, and original foundation partners the Kavli Foundation and the Howard Hughes Medical Institute. The list of participating groups is quite lengthy, you should check out the event’s fact sheet for a complete list and additional details.
An event like this may draw more attention for the governmental activities, but the number of non-governmental parties to the BRAIN Initiative is significant, and worth keeping in mind as time moves forward, and a subsequent Presidential administration may not be as supportive of the governmental end of this project as the current administration is.