FDA Must Take More Than a Mere “watchdog” Stance

John Richard High was a great man. He was intelligent, witty, honest, loving, kind, compassionate... and he always had a word of comfort or ready smile for those he loved. His was not an easy life; he had struggled and had made his fair share of mistakes as well. However, he had taken responsibility for those mistakes and was working on positive changes to improve his life. Incarcerated since 2009, John was enthusiastically looking forward to going before the parole board in 2013. He had hopes of an early release in the same year, or at least being a free man again by his scheduled release date in 2014. John was a writer. He had written poetry and a number of other works. His first book in a planned trilogy had been published; the second was nearly finished. I had planned to help him get more of his work online and into other markets. John, however, will not be here to see his dreams come full circle...

Injured in a car accident as a teenager, John suffered from chronic pain. Before prison, he took narcotic painkillers daily. He was responsible; never an abuser or addict. In prison, however, doctors prescribed the Fentynal pain patch. On September 18, 2011, John went to sleep and never woke up. He was found in his cell, unresponsive, and rushed to the emergency room. He was pronounced dead at 4:30 pm. For 62 long days, his family and I grieved and longed for answers. Healthy 30-year-old men do not just drop dead without cause. Many scenarios ran through my mind: suicide, murder, illness, natural causes... never did it cross my mind that the cause of death would be as simple as the medication he used every day. The toxicology results revealed that John died of a Fentanyl pain patch overdose. On one hand, I was relieved that it was not death by his own hand or death caused by another inmate or a prison guard. On the other hand, I was angry and baffled. John did not have to die. His death was tragic and senseless; caused by a medication that the FDA not only approved, but allowed to remain on the market despite their knowledge that the Fentanyl pain patch is a dangerous and deadly drug.

A whole new can of worms has been opened...

I recently wrote a letter to the FDA, introducing them to John and his cause of death. I posed many questions about their "watchdog" stance and the Fentanyl pain patch. I supported my claims with as much independent research as possible. What I found out made my blood boil and strengthened my resolve to see to it that this killer drug be banned once and for all.

During clinical trials, 10% of participants experienced the worst possible side effects (confusion, nausea, vomiting, weakness, fatigue, etc. 3% experienced common side effects. Given the fact that clinical trials utilize a small sample of the population to represent the majority, 10% experiencing the worst side effects is too large a percentage (Salko Law, n.d.). Unfortunately, I was never able to find exact statistics on the number of Fentanyl pain patch deaths to date. However, I did discover that by 2008, there had been 1000+ deaths associated with this drug. While a handful of those deaths can be attributed to misuse, the majority are the result of a manufacturing defect in which the medicated gel leaks, causing a fatal overdose in the unsuspecting victim (Blizzard Law, n.d.). The FDA is well aware of this concern. Yet, rather than taking action to ban the pain patch from the market, the FDA has maintained their "watchdog" stance, merely issuing warnings about potential risks on Fentynal pain patch labels (Salko Law). In 2008, the FDA did issue a temporary recall, and acknowledged that Fentanyl pain patches were being improperly prescribed ("Fentanyl pain patch - Recalled," n.d.) but the fact remains that this life threatening painkiller is still available.

The FDA's actions are not sufficient in this matter. Merely keeping a watchful eye on the manufacturers is not enough. Issuing label warnings is ineffective as well; there is no way to know in advance which box of pain patches is defective. The only way to make this discovery is often after it's too late to save a life. How many more people have to fall victim to a drug determined to commit genocide on those suffering from chronic pain? When will the FDA live up to its promise to be the "consumer watchdog of the U.S. healthcare system"?

John's dreams will come true. I am going to keep my promises to publish his work and will honor him every way that I can. I am also seeking justice; not only for John, but for other victims of the Fentanyl pain patch and for potential victims as well. I hold responsible the prescribing physician, the Department of Corrections (state name withheld), prison medical staff, the FDA, and the pharmaceutical company/manufacturer. I believe a public admission of gross negligence, oversight, and indifference is in order. A public apology is also necessary, though the word "sorry" is not likely to make up for the loss of a loved one. As for reparations, my concerns have nothing to do with money. However, there are plenty of Fentanyl class action lawsuits handling that particular angle. I won't rest until justice is served. America confidence in the U.S. healthcare system, pharmacueticals, and the FDA is waning. Incidents lie that with the Fentanyl pain patch will not improve this dwindling confidence.

1. Pain Patch