Robert Morris and Koko are Violators of International Standards

The Declaration of Helsinki is the bedrock of international principles in human research, and the foundation of governmental practices, including the ICH E6 Good Clinical Practice. The core principle is respect for the individual (Article 8), their right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. Principles that Dr Robert Morris violated when his firm, Koko, used artifical intelligence to engage in medical research on uninformed participants. The man, and his company, deserves the full force of international censure, including disbarment by the NHS and all other international bodies with even a shred of oversight on healh practices.

I’m infuriated by this. AI is already an ethically ambigious area full of concerns, and for this callous individual and his company to waltz in and break a fundamental principle of human research is unconsciouable.

Another reason why we need serious regulatory oversight of AI. We won’t see this from the US, so hopefully the EU gets their act together and pushes forward. GPDR may not be perfect but we are in a better place with something rather than nothing, and as the actions of callous companies like Koko show we are in desperate need for protection when it comes to the ‘promises’ of AI.

Also, shame on Stonybrook’s Institutional Review Board. While not a case of IRB shopping, they sure did their best to avoid grappling with the issues behind the study.

I am pretty sure this AI counts as software as a device, in which case a whole lot of regulations were broken.

“Move fast and Break Things” is a horrible mantra, especially when health and well being is involved. Robert Morris, like Elizabeth Holmes, are examples of why we need a strong oversight regime when it comes to scientific research and why technology on its own is never the solution.

The Supreme Court’s Decision in Dobbs v. Jackson Women’s Health is a Bleak One for the Life Sciences Industry

I think it is no secret that I inherently view Quality as a progressive endeavor, and do not see eye-to-eye with colleagues who are conservative. How anyone can take our anti-Taylorist endeavor and not get to stands like the importance of human rights and the need to center those whose rights are challenged – like women – is beyond me. How can we stand for autonomy and not fight for the autonomy of all.

The silence of quality organizations is deafening.

What I want to write about now is how the roll-back of Roe in Dobbs should be a real clarion call to the life science industry, which needs to stop funding conservative politicians because those politicians do not have our best interests at heart.

The fight over Mifepristone and Misoprostol has already begun. The religious conservatives will go after it, and this reactionary court will need to gut the FD&C and the rest of the regulatory regime behind drugs in this country to let that happen. This will be really bad. It will cause life science companies to pull research, clinical trials, and manufacturing from this country as we will no longer be the gold standard in the life sciences. We will be a joke.

Take action:

Give to abortion funds
Check your company’s PAC and see exactly who it is giving to and make noise that funding anti-abortion, anti-science politicians is not acceptable
Support your colleagues. If you are male-identifying realize that most of your colleagues just got gut-punched today. Support them.

Sackler family sweetens deal to $6billion

I will not be happy with this story until every member of the Sackler family who was involved in the decision-making at Perdue is in jail and the family has lost every dollar they made. But I am heartened to see the failure of their failed bankruptcy ploy leading to the addition of another 1.5 billion in settlement.

Sackler family members to contribute up to $6 billion in latest agreement to resolve opioid claims

For the regulatory state to function there needs to be teeth, and quite frankly we do not see the teeth nearly enough.

Toyota is a horrible exemplar

Just like the immense sins of Jack Welch and GE will always tarnish six Sigma it is past time to realize that the conservative, looking backwards to Toyota of much of Lean thinking is a mistake that limits adoption and more importantly innovation.

As a company there is much at Toyota that is just wrong. The 2020 recalls were significant, but frankly not the first year the company has been having major quality contorl issues.

But more important is the fact the company is a liar and a supporter of authoritarianism. As a promponent of the pillars of Lean thats just damn hypocritical. After the failed coup of Janaury 6th, Toyota pledged to no longer fund anyone who supported the attack against US democracy. As of June they are the top fundraiser to those Republicans, giving to nearly a quarter of the 147 GOP politicians who objected to certifying the election results.

Toyota is showing us who they are. A company that stands apart from the principles so important to the Quality profession.

A Quality Mindset leads to Abolishing the Police

As we watch the closing arguments of the Derek Chauvin trial, it is not difficult to see systemic problems with policing in America. One only need to look at stories like:

Patrick Rove, long-time police union president, accused of child abuse and with credible questions of how he was so thoroughly protected by the police hierarchy
Baltimore police planting toy guns on people they shot
The continued excuses of “human error” and “you need to walk in our shoes”, for example the recent killing of Daunte Wright

Read the Wikipedia entry on United States Police Brutality, which provides an excellent problem statement.

For root cause analysis, read the University of Chicago study that found that America’s biggest police forces lack legality, as they are not answerable to human rights compliant laws authorizing the use of lethal force.

It is impossible not to reach the conclusions that the culture is rotten, there are inherently bad actors, and institutional resistance to change is standing in way of improvement.

Given the continued failures in implementing change, it is time to shift the resistors out of police departments. The only way to effectively do that seems to radically restructure the police, breaking their responsibilities up and sending those responsibilities to organizations better suited for these duties.

This is why I stand for police abolition.