This blog post is about the declining environment in which we are obviously living. There is now a nationwide outbreak of fungal infections caused by a pharmacy that was compounding the steroid used to do spinal pain relief injections. 75 healthcare facilities in 23 states are affected, and people have already died from it. The number of patients affected continues to grow, and at the time of this writing, over 100 have been identified. I love the irony in our inability to understand a large and dangerous problem until it blows up in our faces. We babble on about generic manufacturing in China, India and wherever people get together to make a substance that physicians then give to humans and expect a result. It is obviously a daunting task to police this and to get it right. It needs to be right, but we will have to accept that the system is deeply flawed and clearly needs rapid rethinking. How this is to be accomplished with a group of people who believe that government has no purpose in our lives, I do not know.
How am I supposed to protect myself from fake or dangerous drugs? Start my own lab? How am I supposed to protect my patients? Honestly I, like you, had no idea that a "pharmacy" could "compound" a drug and then sell it all over the country. I thought, silly me, when I wrote a prescription that needed two components, the pharmacist at the corner store made it and handed it to you, the patient. Who is in charge here? It seems no one is - a classic loophole in the law.
It seems the FDA is not in control of pharmacies that make compounds containing drugs and sells them to any eligible person or entity across the country. It seems the states are in charge of pharmacies, and we know how that goes. It seems that this process is not manufacturing. Really? The most distressing thing is that in this flat world, we as physicians don't even know what the origin is or who created the substances that we are using to treat patients anymore. If you (the physician) think you do, you are fooling yourself. When I ask for a drug in the cath lab, I don't ask its pedigree. Where did it come from? Who made it? At a certain level, how are physicians supposed to work if we can't trust what we use? A race car driver gets into his car, a pilot gets into his plane with the expectation that the equipment works and has been manufactured according to a plan and has been vetted. How am I to know that anything works and won't kill someone anymore?
We as a nation went to the moon. We can do anything we want. As my readers know, I love the metaphor of the burning platform. This platform is a raging inferno, and we are now in deep trouble. We the people need to take up the call and respond. We need to email and write anyone and everyone: senators, congressman, the President, the FDA - everyone - and demand that we protect the integrity of the compounds we use to treat people. We will have to pay for it. We have to figure this out. Believe me, the next event is out there waiting. We have Homeland security. We need Medical-land security.