Jan and I decided to read something a bit different and increase our nonfiction reads and so we settled on Kill Shot, a new book that really brought home a very valuable but frightening lesson to the both of us. Do any of us honestly know where our drugs are made? Do we ever think to ask? Should we be more aware of the things that are being put inside our bodies?
Marialyce and I were in a slump with several disappointing fiction reads in a row. We decided to turn our attention to a few non-fiction titles. This was one of those books, one that highlighted a horrifying case of medical fraud and greed that cost lives and resulted in untold suffering.
As an RN, I’m familiar with compounding pharmacies, which makes custom mixes of medications, but little did I know that the abuses outlined in this book went unchecked for so long. As a patient who has received countless joint steroid injections, I’m even more horrified – and angry.
In 2012 there was a fungal microbe that contaminated thousands of vials of methylprednisone acetate produced by the New England Compounding Center (NECC). This is a drug injected to provide back and joint pain relief.
The CDC and FDA began investigating a multi-state series of cases of fungal meningitis that eventually sickened hundreds of patients and left countless others permanently disabled. Many died, and are still dying. The fungus was particularly lethal when injected into the epidural space of their spine where it traveled to their brain, causing devastating disabilities, and in many cases, death. In these pages we get to know many of these victims and their families, making it personal.
The investigation traced the contaminated vials to the NECC in Framingham, MA. The conditions in the lab where the drugs were made were contaminated, and failed to meet the most basic of clean conditions. Records were falsified, they failed to recall known contaminated vials, expired ingredients were used, vials were mislabeled, and the atmosphere in the lab was unprofessional and demonstrated a wanton disregard for the human lives at stake.
The pharmacists who owned the company became very wealthy from the business, making millions of dollars. When they knew they were in trouble they took great pains in moving money around and hiding their assets. One owner was arrested in the airport as he was attempting to flee the country.
There was a trial but due to some misunderstandings on the part of the jury the individuals involved were acquitted of murder and got off with light sentences considering the gravity of their crimes.
I wish I could say this was a one-off with no possibility of this happening again, but I can’t. Since this case, more compounding pharmacies have been cited for unsafe practices.
The author ends his book with a list of questions for patients to ask their physician if they are prescribed injectable drugs made in a compounding pharmacy. However, as a nurse and part of a medical family, I can guarantee that the physician would have no idea. The onus and responsibility of the safety of our drugs should not rest on the shoulders of patients and doctors. This pharmacy was licensed. Are doctors supposed to travel and independently inspect every pharmacy where the compounded drugs they use are dispensed? Obviously the fact they are licensed is no assurance of safety.
This is a case of pure corporate greed combined with bureaucratic failures and a lack of oversight from the very agencies who are supposed to protect us.
The laws need to be changed and the agencies responsible for ensuring the safety of our drug supply needs to be fully funded to prevent this from ever happening again. The burden should be on the state and federal inspections and licensing departments.
Honestly, before reading this book, I didn’t even know what a compounding drug factory was. Where my drugs came from never even crossed my mind. However in 2012, a deadly fungus microbe was, through negligence and unclean facilities, managed to infect hundreds of people. The bulk of these drugs were made in a facility called the New England Compounding Center, exposing some 14,000 people to a fungus that traveled up their spine creating havoc eventually entering their brains.
People became ill and the doctors were baffled. The illness resembled in a way, meningitis but that is carried by a virus and that virus was not detected in the bodies of the affected. It was a race to pinpoint the why as people were dying a horrible death, loss of motor functions, loss of the ability to breathe, and ultimately death.
Horrible as it was, once the disease was tracked to NECC, the owners, Barry Caden, Gregory Conigliaro, Glenn Chin, Robert Ronzio who had gained millions of dollars, multiple million dollar homes and the like, were both arrogant, haughty, and fraudulent The really salient and disgusting fact was that they knew their facility was unclean, harbored next to a recycling center with tons of old mattresses in their yard.
A trial was eventually held and due to misunderstanding in orders to the jury from the judge, the owners and the board got off with slightly more than a slap on the hand, even though the charge was murder. While some did serve a limited amount of time, it still didn’t come close to the suffering, the misery, the loss that so many endured while these heinous people grew very wealthy. To this day, some are still dying from this fungus that for many were injected into their spine to alleviate pain.
This powerful story begs one to demand the pertinent agencies to take efficient and active involvement in the assembling of drugs. It reveled so well the deficiencies that both the federal and state governments make as they fail to take sufficient measures to ensure these life threatening drugs are not made in a careless and reckless manner. We desperately need to demand our governments look into this with regularity and pass laws that bring these negligent and greedy drug makers very stringent and fitting punishments. They do hold the lives of the people in their hands and we have always trusted their effectiveness and the manner in which they monitor drug manufacturing. It is truly a heinous crime for some to make drugs that they know may someday cause and probably do cause such horrible outcomes. In the eve of so many new drugs and new drug making procedures, this is a priority. The people have always placed their faith and trust in the drugs they take. This book is a wake up call that we should pay extreme attention to the process to monitor drug makers as it seems to be severely broken.
We need Congress and the various agencies to take a very active role in how and where are drugs are manufactured. It is of great concern to many that countless numbers of our current drugs are made in China. We are playing with people’s lives and of course the cost to people and their love ones do not have a price.
Thank you to Jason Dearen for bringing this topic to light.
and here’s the author:
I am a Knight Science Journalism Fellow at MIT. Prior to coming to Cambridge I worked as a correspondent for The Associated Press, based in Florida and San Francisco. I am a member of AP’s Global Environment team, a group of journalists who work in different places around the country and globe who cover issues related to climate, industrial pollution, wildlife management, etc…
My focus has been on stories that look at the intersection of the environment and public health. Most recently this was a series and data project looking at the threat climate change poses to people who live around toxic waste sites and other polluted dumping grounds.
Narrative writing is my passion. I’m now working on a book for a Penguin imprint, Avery, that tells the story of a disease outbreak, and the unregulated drug manufacturing industry that caused it. I grew up in California.
When I’m not working I enjoy surfing/swimming, playing the guitar, drinking beer with friends and cooking.