Following the disclosure in 2010 that several Guatemalans were exposed to sexually transmitted diseases without their consent, several parties initiated a class action lawsuit against the government. That lawsuit was eventually dismissed over the inability to sue the U.S. over actions conducted in another country. For details on the experiments, consult the report from The Presidential Commission for the Study of Bioethical Issues.
The plaintiffs have not given up, yesterday they filed suit against Johns Hopkins University for its role in the exposures. Several Johns Hopkins researchers held positions in panels that reviewed federal funding for the studies at issue in the suit. Other defendants include the Rockefeller Foundation and Bristol-Meyers Squibb.
The suit is filed against these defendants apparently due to the affiliation several officials involved in the exposures had with the named institutions (or in the case of Bristol-Meyers Squibb, its predecessor companies). Both Johns Hopkins and The Rockefeller Foundation have denied that their institutions were involved in the experiments. Bristol-Meyers Squibb officials have declined to comment as of this writing. The suit alleges that the experiments were used as clinical trials for the predecessor companies’ products.
With the dismissal of the previous lawsuit, it is not clear that the current matter will be any more successful. Arguably the plaintiff’s case here will be harder, as holding an institutional affiliation will not likely be sufficient to demonstrate the institution was responsible for the conduct of particular individuals working for other organizations.
Today the Presidential Commission for the Study of Bioethical Issues released the second volume of its Gray Matters report, the ninth report by this commission. The report was requested by the President following the announcement of the BRAIN Initiative. He requested that the Commission identify a set of core ethical standards to influence neuroscience research and to address some of the debates emerging from applications of that research.
Volume One, released in May 2014, focused on how to fully integrate ethics into neuroscience research throughout the research cycle. Volume Two concerns ethics in applications of neuroscience research, with an emphasis on three topics that have attracted some level of debate: cognitive enhancement, the capacity of a being to consent (to research conducted on them), and neuroscience in the law. Through these cases the Commission wanted to tease out relevant ethical considerations and related tensions brought out by the potential impacts of these technologies.
There are fourteen main recommendations in the report:
Prioritize Existing Strategies to Maintain and Improve Neural Health
Continue to examine and develop existing tools and techniques for brain health
Prioritize Treatment of Neurological Disorders
As with the previous recommendation, it would be valuable to focus on existing means of addressing neurological disorders and working to improve them.
Study Novel Neural Modifiers to Augment or Enhance Neural Function
Existing research in this area is limited and inconclusive.
Ensure Equitable Access to Novel Neural Modifiers to Augment or Enhance Neural Function
Access to cognitive enhancements will need to be handled carefully to avoid exacerbating societal inequities (think the stratified societies of the film Elysium or the Star Trek episode “The Cloud Minders“).
Create Guidance About the Use of Neural Modifiers
Professional societies and expert groups need to develop guidance for health care providers that receive requests for prescriptions for cognitive enhancements (something like an off-label use of attention deficit drugs, beta blockers or other medicines to boost cognition rather than address perceived deficits).
I recently read this article from Futurity reporting on cyborg beetle experiments conducted at the University of California at Berkeley. The study is available in Current Biology (subscription required for the full article), and focused on determining the muscles involved in steering beetles in flight. There’s video.
I’ve posted before about cyborg beetles, and my misgivings about making cyborg beetle kits available for the general public. I wasn’t quite as bothered by experiments in laboratory settings, but the notion of people conducting home surgery to attach mechanical parts to living creatures still strikes me as a bit cavalier.
I recognize that other animals are used in scientific experiments, so why is this different? Are the mechanical changes in these experiments somehow qualitatively different than the genetic modifications to mice that can result in wholly new traits (or parts) for the animal?
I think, besides the possibility of backyard surgery, it comes down to remote control. That these beetles, as well as other insects (and some higher animals, it turns out) are being manipulated gives me pause. I still see the value in it, but whatever ethical discussions are going on about this research are not visible to those of us not working in the field.
I think it might make public acceptance of this research a bit easier to let people know what considerations and discussions have gone into this research before we see remote-control cyborg gerbils available at your local pet store at some point a few years from now.
Recently the Union of Concerned Scientists (UCS) issued a new edition of its report Grading Government Transparency (H/T Nextgov). The first edition came out in 2013, and it expands on a previous report, Freedom to Speak?, from 2008, that focused on agency media policies (15 agencies and 2 federal departments). Grading Government Transparency includes social media policies along with traditional media policies.
The scorecards from the 2013 and 2015 reports suggest slight improvement in policies, or at least maintaining the status quo. Agencies in the report that didn’t have social media policies in 2013 have them now, so the progress is forward.
The report recommendations in 2015 aren’t that different from 2013. The UCS still encourages agency media policies to place free and open communication ahead of political principles. As the organization strongly advocates for a fundamental right to scientific free speech, this is not a surprise.
For agencies where there was improvement in agency policies, the UCS noted several key changes in many cases: the existence of a social media policy, whistleblower protections, a personal-views exception (provisions that allow for government scientists to state personal opinions if they are clearly noted as their personal opinion and do not use unreasonable amounts of government time or resources), and a dispute resolution process.
What is still lacking in many cases, according to UCS, are a right of last review (of written product going under their name or relying on their research) and a right to access drafts and revisions of written materials using contributions from the scientists’ research.
The agencies and departments covered in the report are only part of the government, and do not cover all scientists and engineers employed by the government. And I don’t think the UCS finds every agency’s grades in the reports satisfactory. So there remains work to be done. Media and social media policies for scientists and engineers need to be in more agencies, and need to be strengthened in those where they already exist.
Earlier today the Presidential Commission for the Study of Bioethical Issues released a brief (90 pages, so your mileage may vary), Ethics and Ebola. The report is intended to provide an assessment of the current Ebola outbreak (particularly of the response to cases diagnosed in the U.S.) and recommendations for becoming better prepared for future outbreaks.
The report’s recommendations cover how to prepare for outbreaks, ethical reasons for intervention in outbreaks, guiding principles for deciding to use restrictive public health measures (such as quarantines), and how to conduct research (if warranted) in outrbeak situations. The recommendations are summarized below: Continue reading
The Presidential Commission on Bioethical Issues met earlier this month in Washington, D.C. The meeting focused on two major topics – medical emergency research and neuroscience. The first day dealt with medical emergency research and was heavily influenced by the ongoing Ebola epidemic in west Africa. The Commission heard from researchers, public health personnel and practitioners on the epidemic in Africa, efforts intended to prevent the spread of the virus in the United States, and the ethical issues associated with research on something like Ebola during an epidemic or other medical emergency.
The Commission is conducting a review of the U.S. response to the Ebola epidemic, with a focus on three issues:
- The ethics of placebo-control trials in the context of public health emergencies;
- The ethics of U.S. public policies that restrict association or movement; and
- The ethical considerations relevant to collecting and storing biospecimens during a public health emergency and sharing them for future research.
On the second day, the meeting shifted to the Commission’s ongoing work in neuroscience. The Commission intends to release volume two of its report Gray Matters sometime in the spring. Volume 1 was released in May 2014, and focused on the integration of ethics into neuroscience education. Volume 2 will tackle neural modifications, neuroscience in the legal system, and how neural capacity can affect the ability to consent in neuroscience research.
The next meeting will take place in Philadelphia May 27 and 28.
While the confirmation challenges continue, at least one high-level science and technology appointee is stepping down. Margaret Hamburg, Commissioner of the Food and Drug Administration, will step down at the end of next month (H/T ScienceInsider). Even with slightly less than two years remaining in the Obama Administration, there is a chance Dr. Hamburg’s successor may not be confirmed before a new President is sworn in. (I am encouraged by indications that a nominee has already been identified.)
Hamburg’s tenure is one of the longest in the agency’s history. When she took over, the agency was struggling, with ethical challenges over drug approvals. The agency is currently in the middle of regulatory changes for food safety oversight and medical device approvals, and it has not been perfect. There were complaints over the agency’s inaction over compounding pharmacies (which are not presently regulated by the FDA), and Hamburg was overruled by Health and Human Services Secretary Sebelius over Plan B emergency contraception (though the courts eventually sided with the FDA).