CIA Torture as Human-Subjects Research

•June 8, 2017 • Leave a Comment

In the piece linked below, the author (a professor of sociology at the University of California) argues that modern norms governing human-subjects research are actually stronger, or at least more clear, than those governing government-sanctioned torture. Some of us professionally involved in research ethics governance might not agree that norms of that discipline are beyond debate. Also, we might wonder whether ‘exporting’ the norms of research ethics for use in prosecuting torture is likely to be good for research ethics, or will it end with a reversal: Some will begin with the premise that the CIA’s torture/research program is justified by its public-interest objectives. And if the CIA can, er, ‘break new ground’ in the ethics of research, then why can’t others?

The CIA Didn’t Just Torture, It Experimented on Human Beings by Lisa Hajjar (for The Nation)

… No one has been held accountable for torture, beyond a handful of prosecutions of low-level troops and contractors. Indeed, impunity has been virtually guaranteed as a result of various Faustian bargains, which include “golden shield” legal memos written by government lawyers for the CIA; ex post facto immunity for war crimes that Congress inserted in the 2006 Military Commissions Act; classification and secrecy that still shrouds the torture program…

…Rather, because the concept of torture has been so muddled and disputed, I suggest that accountability would be more publicly palatable if we reframed the CIA’s program as one of human experimentation. If we did so, it would be more difficult to laud or excuse perpetrators as “patriots” who “acted in good faith….”

Slow progress on Zika vaccine development – and at the expense of Ebola funding?

•August 13, 2016 • Leave a Comment
197-Zika_Virus-ZikaVirus copy 2.jpg
The Zika Virus – Image by David Goodwill (RCSB Molecule of the Month 197, June 2016)
[CC BY 4.0 (http://creativecommons.org/licenses/by/4.0)%5D, via Wikimedia Commons

A recent PBS Newshour story highlights just some of the challenges in getting a vaccine for Zika tested and out on the market. The article confirms that about 30 vaccines are being developed and tested. Currently there is a multi-centre open-label Phase 1 clinical trial underway using the GLS-5700 vaccine, developed by Inovio. The study has been approved not only by the FDA but also by Health Canada, and trial sites include Miami, Philadelphia and Boston.

But the article highlights the challenges of getting vaccines to market, the main one being the incredible time, expertise and costs that testing involves that means few others than the biggest pharmaceutical companies can realistically “get in the game”. As well, the so-called success rates of getting vaccines of this type to market are slim: consider some similar stories of SARS, H1N1, Ebola virus disease and West Nile. In fact, the PBS article suggests that some of the work to develop the Zika virus is being funded in part, by borrowing from funds previously set aside for research and development of an Ebola vaccine and support and rebuilding of Ebola-ravaged areas. With Ebola fading in the memories of policy makers and politicians in terms of urgency and Zika presenting a conceivably more “right now” time-sensitive urgency, it’s easy to see how the attention of those in power would shift quickly. The worry is, of course, that funds taken from one to fund the other, will never be replaced and with another outbreak of Ebola, we may be, in some senses, in a similar place to where we were before – with no viable, safe and effective vaccine and without sufficient rebuilding of necessary public health infrastructure.

In terms of Ebola, “we’re not done,” Dr. Anne Schuchat (Principal Deputy Director of the CDC) said in one interview, “People think we’re done with Ebola, but of course we’re not done.” And with the knowledge that Ebola, in some form, lives on in survivors, it’s realistic to assume that we’ll very likely be dealing with this virus again – in some form. The majority of places most affected by Ebola continue to face serious challenges in rebuilding infrastructure, strengthening public health units, providing assistance to survivors and families and enhancing preventative care and will need continued investment in these areas and more.

As Health and Human Services Secretary Sylvia Mathews Burwell states, “we don’t have the option to set one aside in the name of the other,” calling for full funding for both Zika and Ebola responses.

Bad Behaviour by Pharma, and Unforeseen Consequences

•April 17, 2015 • Leave a Comment

This is a must-read for anyone interested in the ethics of drug development and clinical trials.

It explores how genuinely bad behaviour on the part of pharmaceutical companies can lead to overreaction by journalists and the public, sometimes with tragic consequences.

By Matthew Herper, writing for Forbes.com: How Marketing And Media Muddled The Truth About The Heart Drug Vytorin

Big bad drug companies make it easy to fall into a kind of conspiracy-thinking mentality. If Roche and Glaxo are going to behave like lying, data-burying scoundrels, their drugs must be useless, right? But, because medicines have to prove themselves in both a regulatory gauntlet and the market, that’s not always so. And we can be misled by that kind of thinking….

Is there a “Right to Try” Experimental Drugs?

•April 14, 2015 • Leave a Comment

From The State Journal-Register (Springfield, IL)
Patient freedom, ethics at the heart of ‘Right to Try’ push in Illinois

Some doctors worry that an effort to grant terminally ill people more access to unproven drugs might offer them false hope or even be harmful, but advocates for a “right to try” say patients should have more opportunities for treatments that could extend their lives.

Legislation with bipartisan support that was approved by Illinois House and Senate committees would create a Right to Try Act, letting patients seek treatments with their doctor’s consultation that have passed only the first phase of U.S. Food and Drug Administration testing…

Should a University President Resign over Research Ethics?

•April 12, 2015 • Leave a Comment

In this newspaper editorial, a former governor of Minnesota says that the current president of the University of Minnesota needs to go, because of how he has mishandled controversy over research ethics at the university:

Markingson case: University of Minnesota can’t regain trust under current leadership

…During his first year at the university, Kaler had to make a major decision. Prudent management would have involved meeting with Elliott, learning about the specific ethical issues related to Markingson and broader concerns about psychiatric clinical research, and dealing with the growing scandal. But Kaler chose instead to perpetuate the prevailing coverup. He opposed any independent review, never responded to the charges made in the media, ignored or dismissed critics, and stood firm in his belief that it would all blow over.

In so doing, President Kaler tarnished his office and abandoned the principles of truthfulness, openness and integrity….

Ethics of Research on Complementary & Alternative Medicine

•April 11, 2015 • Leave a Comment

Here are three related items to bring to your attention:

On the blog of Policy Options magazine, here’s a very good piece by our pal Tim Caulfield, called Homeopathy and the ethics of researching magic. And via the same outlet, here’s my piece in which I partly disagree with Tim: Homeopathy and Research Ethics.

And just recently, An anonymous Canadian foundation grants $3 million to study naturopathic oncology. But such a study could not be done in Canada because it a study funded by an anonymous source would violate the Tri-Council Policy Statement. Page 29 of the Policy Statement makes clear that informed consent must include identity of the funder or sponsor.

Johns Hopkins University Sued for $1bn Over Guatemalan Study

•April 6, 2015 • Leave a Comment

This story is pretty much a ‘perfect storm’ of research ethics problems: international research, on vulnerable populations (orphans, prisoners and mental health patients), lack of consent, and questionable institutional responsibility for the actions of now-dead researchers.

From The Guardian: Guatemalans deliberately infected with STDs sue Johns Hopkins University for $1bn

…Nearly 800 plaintiffs have launched a billion-dollar lawsuit against Johns Hopkins University over its alleged role in the deliberate infection of hundreds of vulnerable Guatemalans with sexually transmitted diseases, including syphilis and gonorrhoea, during a medical experiment programme in the 1940s and 1950s….