The stick is broken, regulatory agencies are toothless

Admit it, we’ve all been through GxP training that utilizes the stick. I’m assuming many of you have designed it. It might have looked like this:

Perhaps you have went over the hundred-and-fifty-plus years history of regulatory action, discussing Elixir Sulfanilamide, thalidomide, and a dozen other noteworthy cases that shared the modern regulatory environment.

Or perhaps you just like to show a slide with recent headlines on it.

Let’s put aside all the excellent research about the power of positive messaging etc. Valid stuff but not the point I’m trying to make.

The point I want to make in this post is that the regulatory stick has long been broken. Companies suffer at most a slap on the wrist, fines that are weeks or months of profit. But real repercussions are absent.

The Sackler family walks away with billions, MacKenzie gets a slap on the wrist, and other companies are all protected from their deliberate actions in fueling the opioid epidemic.

J&J avoids all real accountability for knowingly causing cancer.

The list goes on.

Frankly, I think this is really bad for our industry. If the price of being caught is pennies to the dollar earned, it has become merely a cost of doing business.

This erodes trust in the safety of our drug supply. And if the last year hasn’t brought home the importance of that trust, you may be hiding under a rock.

We need more perp walks. We need a real system of deterrence that involves arrests and punishments that match the crimes. We can’t even count on the one form of deterrence left, liability lawsuits because companies are playing shenanigans with bankruptcy laws.

We talk about how quality culture starts at the top. But as we see again and again, the top only cares about profit.

That makes me fundamentally worry about the safety of our drugs and medical devices. And if I someone who has dear friends who work at large and small pharma worry, I must admit I can understand why people start to hold suspicions.

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.

Product Drift

As we continue to have multiple biosimilar and potential interchangeable approvals for the same reference product, it is important to consider how product drift will impact biosimilar products approved at different times, as well as the characteristics of the biosimilar product itself.

Ha Kung Wong (2019). Will product drift cause a rift? PharmaManufacturing

Excellent article on biosimilars and product drift. The rush for biosimilars needs to always remember how biologics are extremely sensitive to changes in the manufacturing process. Biosimilars require the most robust of quality systems and I worry that companies attracted to them for their price savings might cut corners.

A great primer on the topic is: Ramanan, S. & Grampp, G. Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing. BioDrugs (2014) 28: 363. 

Let’s make sure that we don’t get another Thalidomide, we don’t need other examples for our GxP classes and new employee orientations.

John Oliver on Medical Devices

I firmly believe that quality and ethics go hand-in-hand, and frankly it shakes some of my confidence on my profession when I read of organizations that supposedly subscribe to quality principles and standards (such as the ISOs) still not meeting the grade.

There are four widely accepted principles in biomedicine, which applies equally to medical devices and pharmaceuticals:

  • Principle of respect for autonomy
  • Principle of nonmaleficence
  • Principle of beneficence
  • Principle of justice

It seems a failure of ISO 13458 that adherence to this quality standard does not lead to results aligned to these four principles. It should surprise no one who knows me that this is one of the reasons I support strong regulations in this space.

Sources

  • Beauchamp T, Childress J. Principles of Biomedical Ethics, 7th  Edition. New York: Oxford University Press, 2013