A few years ago I blew a gasket in my abdomen and after emergency surgery woke up in intensive care. The hospital was part of a local chain owned and managed by an order of physically tiny but frightfully efficient Catholic nuns. So, the first thing that catches my eye after I claw my way up to semi-consciousness is an old school Catholic crucifix up on the wall. We’re not talking a dry, Protestant two-pieces-of-crossed wood here but an anatomically detailed Jesus in agony nailed in place complete with a tiny crown of thorns.
As I blinked in disorientation at the cross, Jesus began dancing his torso from side-to-side in time with Monty Python’s Always Look at the Bright Side of Life which began playing loudly in my head. For my entire time in intensive care, I couldn’t understand anything anyone said to me because I couldn’t hear them over the endlessly looping song. Every time I looked at the crucifix, Jesus started dancing.
A couple of days later, after I had been moved to an ordinary room, I woke up from a fitful sleep and attempted to escape the hospital. I dragged myself out of bed trailing leads and IVs, screaming in pain and losing my gown in the process. It was quite a shock for the nurses. I even attempted to operate my cell phone and call 911. Why did I do that?
Simple: I thought I was a small Cajun piglet escaping the laboratory of a mad Nazi scientist operating out of a bordello in the French Quarter of New Orleans. True story.
Anyhow, long story short, that is how I began to suspect that morphine and I didn’t get along.
Less humorously, towards the end of my hospitalization, I experienced a crushing depression combined with extreme agitation. I recognized that as a false emotion but I had to constantly struggle not to simultaneously weep and scream at the staff. It was a very unpleasant couple of days. I still have nightmares about it. Not about anything else related to the surgery, just that horrible sense of despair combined with an angry compulsion to do something about it.
All the strangeness ended when they took me off morphine, and when I went back in for my follow up surgery they gave me Demerol instead and that worked fine. Since then I’ve refused morphine and pretty much explained to care givers that I would rather crawl across broken glass than ever take morphine again.
Now, I have an unrelated chronic condition that causes joint and muscle pain, hypotension and disturbed sleep. I did a sleep study and they found I had restless-leg syndrome. I tried some of the meds for the condition but one of the side effects of all of them is orthostatic hypotension. Since I already had hypotension, when I tried to treat my restless leg syndrome, I often found myself at random suddenly on the floor.
So, in the end, I resorted to using hydrocodone to control the pain so I could sleep and just had to live with the restless-leg syndrome. I usually took just one at bedtime, but at times the pain grew so bad I had to take a couple overnight and a couple more during the day. After about three days of this, I began to experience depression combined with agitation.
After an embarrassingly long time, I eventually put two and two together and realized that, since morphine and hydrocodone are chemically similar, that I probably had the same negative reaction to both.
I did some research and in September of 2010 went to my doctor and requested Darvocet which is an old-school pain killer that belongs to another branch of the opiate chemical family tree.
It worked wonders! I could take a dose every four hours if needed without any mental or physical side effects. My mood improved and I began to suspect that even the low doses of hydrocodone had been having a depressing effect.
I began to sleep surprisingly well, even better than I did when I had no pain. I went back to my research and found that Darvocet has shown success in treating restless-leg syndrome. By chance, I had found probably the only existing drug I could take for restless-leg syndrome that wouldn’t cause random fainting!
My life got a lot better. I was largely pain free, I could sleep soundly and I stopped kicking my dogs. Everything was great!
…for about 3 months and then the explicative-deleted FDA banned Darvocet!
Son-of-a-…..! Turns out after 50 years of use they suddenly decided that Darvocet was too dangerous! Seems it can cause heart problems (mostly in the elderly) and (anecdotally) suicide.
Now obviously, the incidence of these problems must be very low. Darvocet came on the market in 1957. It was one of the half-dozen drugs that JFK was hopped up on during the Cuban Missile Crisis. Even though the FDA is a government agency, I don’t think even they could miss serious problems with a drug for 50 years.
No, it turned out the problem with Darvocet wasn’t major, in fact, that was why it had never been noticed before. Only new, computerized, data-mining epidemiology studies were able to find the small numbers of people who had cardiac problems while taking the drug.
The reasoning of the FDA seems to have been that there are alternative pain killers to Darvocet so even though the risk is small, it is unnecessary because safer alternative exist. You know, the old if-it-saves-just-one-life excuse.
In my bitter imagination, I see the committee members sitting around the meeting table and chuckling, “After all, how many people out there can there be who don’t tolerate other pain killers and who also have hypotension and therefore can’t take other treatments for restless-leg syndrome?”
Well, there’s at least one, you f*ckheads!
This is why one-size-fits-all government regulation is bad for the individual. Perhaps the ban will statistically save lives, but if it does it will do so by making people like myself worse off.
I’m not going to die or anything but I haven’t had a really good night’s sleep since the FDA banned Darvocet back in November. Not sleeping well causes a serious decrease in the quality of life. I’m more irritable, have a harder time concentrating and statistically, years of poor sleep will shorten my lifespan. Owing to the emotional side effects, I refuse to take more than two hydrocodone a day and only at night. If I hurt during the day, I just tough it out.
My case is trivial compared to that of the “super-responders” to the breast cancer drug Avastin. Because cancers are so closely tied to genetics and the specific mutations that cause each subtype of cancer, a cancer drug can work wonders for some people while doing little for everyone else.
However, by its very nature as a government agency, the FDA must average the good and bad of every drug it regulates across the entire affected population which can include hundreds of millions of people. If the average harm is larger than the average benefit, the drug is banned.
There is no role for individualism at the FDA. The FDA thinks of us as if we were soldiers. If some of us must suffer and die for the greater good, so be it. I can’t have the one pain-killer/restless-leg-syndrome drug that works for me and Avastin super-responders can’t have Avastin because in both cases the FDA has judged the greater good demands we suffer. Our unit has been ordered to make the suicidal charge up the hill and that’s that.
We need to change the role of the FDA. If, in the past, the practicalities of disseminating information about drugs and drug risk necessitated a one-size-fits-all, statistical approach to regulation, we can safely say such a practical need no longer exist in the Internet age. Today, individuals and doctors can easily find information detailing the risks and benefits of any particular drug for any particular set of circumstances.
The only legitimate role left to the FDA is one of being a (theoretically) honest monitor of drug research. Instead of banning drugs, the FDA should confine itself to issuing Internet accessible summations of a drugs benefits and risks. The decision of what risk to take for what benefits, should always be the individual’s.
Of course, the real problem today is socialized medicine. With 47% of the US population dependent in whole or in part on government health care and with the micro-regulation of insurance industry by the states, the dictates of the FDA decide what treatments people will get and what treatments they won’t. The FDA is increasingly being pushed into the role of controlling cost for the government and not providing the best care for the individual (even if it really ever had that role in the first place.)
We need a radical overall of how we manage and pay for health care in America. For historical reasons, we will probably need to still have the government pay for the medical care for a lot of people but we need to move the decision of tradeoffs in medical decisions out of the hands of a small number of “experts” and into the hands of the individual citizen where it belongs.
I don’t want the FDA to decide that it’s in the best interest of society that I someday be drugged into running around stark naked while believing I am a Cajun piglet chased by a dancing Jesus on a crucifix.
And trust me, you don’t either.