One of the Centers at the National Institutes of Health (NIH) changed its name. The newly christened National Center for Complementary and Integrative Health was formerly known as the National Center for Complementary and Alternative Medicine. The change was implemented as part of the massive budget bill just signed by President Obama.
The ‘alternative medicine’ in the Center’s (now) former name has raised my eyebrow on occasion. Certainly the U.S. government doesn’t approach alternative therapies the same way as in the U.K. (where homeopathy can be espoused by Members of Parliament). Here’s the official explanation for its absence:
Why does the new name include “Integrative Health” instead of “Alternative Medicine”?
Large population-based surveys have found that the use of “alternative medicine”—unproven practices used in place of conventional medicine—is actually rare. By contrast, integrative health care, which can be defined as combining complementary approaches into conventional treatment plans, has grown within care settings across the nation, including hospitals, hospices, and military health facilities. The goal of an integrative approach is to enhance overall health, prevent disease, and to alleviate debilitating symptoms such as pain and stress and anxiety management that often affects patients coping with complex and chronic disease, among others. However, the scientific foundation for many complementary approaches is still being built.
As the research mission of the center will not change, the name change may be strictly cosmetic. But if my eyebrow-raising at the mention of ‘alternative medicine’ in the context of a federal research institute is common, a name change may make a lot of public relations sense.
In what passes for a breakthrough, the Senate managed to pass a controversial nominee for the position of Surgeon General. Vivek Murthy was confirmed as the newest Surgeon General, roughly 13 months after he was nominated and nearly a year and a half after his predecessor stepped down.
While his age (37) may have given Senators cause to balk at confirming him, Murthy’s statements on guns – that gun violence should be considered a public health concern – brought strong opposition courtesy of the National Rifle Association. The logjam on Murthy’s nomination (and the nominations of others) broke as a result of complicated procedural wrangling that the Senate seems to prefer to passing legislation.
Murthy has said in advance of his confirmation that he intends to focus on obesity while Surgeon General. That will likely not dissuade those concerned about any effort to regulate guns, and if the NRA carries through on its threats, Senators that supported the confirmation will be targeted by the organization when they are next up for election.
The National Institutes of Health (NIH) has issued a request for comments on a draft policy concerning Institutional Review Boards (IRB). The NIH proposes allowing multi-site research studies to use a single IRB for approval. The idea is that concentrating the human subjects review approval to one IRB would reduce the administrative burden. It is even possible that a single IRB review for multi-site research might increase protections by focusing the oversight to a single body.
Comments are accepted on the policy through January 29, 2015.
This draft policy reflects changes proposed in 2011 when the Department of Health and Human Services proposed changes to the Common Rule – the suite of regulations on oversight of human subjects research. IRB approval is just one facet of those changes, so maybe there are additional policy proposals coming. Even in today’s dysfunctional environment, 3 years is a long time to wait.
This time the apparent shuffling is in Canada.
This commentary in The Toronto Star notes a plan by the Canadian government to change the status of the country’s Chief Public Health Officer (CPHO). Part of the current omnibus budget legislation before the Canadian Parliament, the Officer would no longer be the chief executive of the Public Health Agency (PHA), but simply an officer. A President would be appointed to run the PHA. Presumably this would mean that the President would become the public health face of the agency and the government, with the CPHO holding a strictly advisory role.
Not being a Canadian or engaged with public health, I don’t have the authors’ background with the circumstances that brought about the PHA and the CPHO in the first place. I do note that this is a relatively new (about 10 years) position, and that it is rare to find appointed science advisory positions – certainly in the United States – that also have significant managerial and/or executive responsibilities. Certainly the environment for scientists in Canada suffers from concerns (and not just the perception) about how the government (the Prime Minister mainly) uses them and their work. It’s not surprising to see reactions to this move as yet another example of a government minimizing the role of science in policy and in dealings with the public.
But is it possible that the proposed new arrangement for the Public Health Agency could address the continued problems it faces? If there’s good communications between the President and the CPHO (who would have institutional memory, at least as long as the current occupant remains), why couldn’t they work together to better serve the Canadian people? Put another way, if they omnibus bill passes, as the authors expect it to, how could this arrangement work out for the best?
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