Compounding Pharmacies: Another De/inadequate Regulation Nightmare

Physicians around the country are dealing with a iatrogenic disaster.  281 people with difficult to treat fungal meningitis and 28 deaths so far.  This was a completely preventable and unnecessary complication of our  belief that we need less regulation and the ill fated notion that less regulation=freedom.  In this case that freedom is literally killing people.

The problem is that a large compounding pharmacy in Massachusetts marketed a a contaminated drug used to treat problems with spinal joints.  The fungal contamination then apparently entered the spinal canal causing the meningitis for which there a limited and relatively ineffective treatments.

There is been a long history of conflict between the FDA and compounding pharmacies.

The deadly meningitis outbreak linked to contaminated pain injections has prompted calls for tighter federal regulation of compounding pharmacies, which have periodically been blamed for crippling and sometimes fatal injuries. But this isn’t the first time Congress has pushed for more authority over the industry.

Such efforts stretch back to the 1990s, and after vigorous pushback by compounding pharmacists, they have left a patchwork of incomplete, overlapping laws, contradictory court rulings and overall uncertainty about how much power the Food and Drug Administration has to regulate compounders.

And:

The International Academy of Compounding Pharmacists has spent more than $1 million lobbying Congress in the past decade and has a track record of defeating measures opposed by the industry. A 2003 provision to set up an FDA advisory committee to oversee compounders was killed by then-House Majority Leader Tom Delay, (medicynical emphasis) who said it would createunnecessary federal interference. Delay represented Sugar Land, Texas, the headquarters of the compounding academy.

Medicynical Note:  These cases of meningitis signal a failure of regulation.  Responsibility lies with the companies involved, those procuring substandard drugs, congress, the courts and ultimately the FDA.

This brings to mind the medicynical contention that we have a non-system of health care but do have a medical industrial complex that is better at generating revenue than caring for people.  

American exceptionalism has led us down the path of the most expensive, most inefficient and perhaps the most error prone health care in the industrialized world.  

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s