When things go seriously bad

An owner and four former employees of a now-shuttered Framingham compounding pharmacy were convicted Thursday of federal charges related to a 2012 meningitis outbreak that’s killed more than 100 people who took tainted drugs made at the facility, authorities said.

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

To say that the crimes of the  New England Compounding Center have changed the very regulations for compounding pharmacy in this country is no overstatement. For those of us in other  regulated industries, and for those in quality in other fields, this is an important case to reflect on.

According to prosecutors, pharmacists “knowingly made and sold numerous drugs” in an unsafe manner. “The unsafe manner included, among other things, the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers. They also approved the use of expired drug ingredients, and the mislabeling of those drugs in order to deceive customers.”

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

It is important to reflect that we in Quality, that everyone in our industries, has a commitment to the health and well-being of our customers that is nothing less than a moral imperative. That the imperative question for us and our organizations is always “Have I done enough to ensure the best quality and safety.”

There have now been 11 employees or executives of the drug compounding company convicted of ignoring safety precautions and forging documents to allow contaminated drugs to be manufactured and shipped.

Shira Schoenberg “Former compounding center employees convicted in deadly meningitis outbreak ” Boston Business Journal (2018)

Prominent Doctors Aren’t Disclosing Their Industry Ties in Medical Journal Studies. And Journals Are Doing Little to Enforce Their Rules

Prominent Doctors Aren’t Disclosing Their Industry Ties in Medical Journal Studies. And Journals Are Doing Little to Enforce Their Rules
— Read on www.propublica.org/article/prominent-doctors-industry-ties-disclosures-medical-journal-studies/amp

People need to realize the only way to truly build trust is through transparency. If there is nothing to hide, don’t hide it.

DIY medicines -another compounding pharmacy disaster?

Meet the Anarchists Making Their Own Medicine” mostly avoids bringing the typical “technology can solve anything” silicon-valley messianic fevor to an interesting idea, that of micro-pharmaceutical manufacturers.

“Unless the system is idiot proof and includes validation of the final product, the user is exposed to a laundry list of rather nasty stuff,” DeMonaco told me in an email. “Widespread use [of Four Thieves’ devices] would provide an entire new category for the Darwin Awards.”

Discussing at the high level the risks of DIY drug synthesis, the article points to compounding pharmacies as a lesson on how to do this right. Not sure I agree, as compounding pharmacies have had a slew of problems in recent years, and frankly quality systems still need improving.

I do think we will see more and more hospitals turn to small scale manufacturing. Hopsitals are more used to the idea of quality systems and can build the encessary systems and processes to do this safely.

Quality, the Pharmaceutical Industry, and Public Trust

By-and-large the last few decades have been solid ones for the pharmaceutical industry. The public has largely trusted that what we make is safe, efficacious and in general a quality product. That is, after all, what the regulations are designed to do. And we, as quality professionals, together with our peers, have demonstrated a real passion for the patient.

But as the recent St Louis verdict against Johnson & Johnson shows, the industry has a growing issue with the public’s perception that pharmaceutical corporations need to stop placing profits over safety.

As the New York Times says:

Johnson & Johnson and its peers were once lauded as a collective of hero-innovators and credited with bringing an avalanche of lifesaving, world-changing technology from lab bench to patient bedside. Today they are more readily associated with rampant price gouging, the worst drug overdose epidemic in modern history and a steady beat of cases similar to the talc-cancer one, in which profitable products caused real harm.

We also have the FDA catering to industry, the revolving door between the FDA and industry, and a growth of scary pseudo-science that continues to erode trust (vaccine deniers are fairly highly placed in the current government).

As quality professionals, it is our responsibility to “Hold paramount the safety, health, and welfare of individuals, the public, and the environment.” Whether it’s in our companies, our professional associations, or our connections with the community we need to be striving to be the voice of science, of quality and of integrity.