How They Plan To Sell Even More Drugs Next
I remember my respected psychopharmacology preceptor always had a pile of a bit out of date copies of the Wall Street Journal sitting around the house. I asked him why — about the third time I saw them sitting around his living room. He explained to me then it was the thing you really had to read to know what was going on in the pharmaceutical industry.
I remember I rolled my eyes heaven ward. I was too busy memorizing molecular structures and trying to understand potential mechanisms of drug-drug interactions. I still do a bunch of that sort of thing. I do it more quickly than I did at that time, but I still do it. Oh, I will find on line pretty much anything I can in “Newsfeeds” and such, but it is more to condemn than to follow these days, from what I know and can see. Basically, my problem is that they seem to keep making better sounding drugs. But from what I read, I don’t usually see them as a clear CLINICAL improvement over what I have seen in the past. In other words, I don’t think they are making people “more better” in terms of having more efficacy or less side effects or such. I just can’t find it in statistics in general, and sometimes even wonder if statistics are not a tad “Gerrymandered.”
Actually that is one of my favorite terms. I learned about Elbridge Gerry in my home state of Massachusetts when I still had a fair amount of beliefs in politics and government. He was fifth vice president of the United States under James Madison. In the 18th and 19th century he was the alleged inventor of “Gerrymandering” — manipulating the voting districts to win an election. “Gerrymandering” is a much politer word than “manipulate,” perhaps because it requires at least a little knowledge of American history. If you are wondering about his party, I avoid being political as best I can, but as James Madison’s vice president he was known as a “democratic republican,” so there.
In 1997 our friends at the FDA made it legal to advertise prescription drugs to the public. I have a vivid memory of a somewhat psychotic (generally paranoid and afraid, occasionally hearing things) young man who saw me for medication. He requested Zoloft. Zoloft is an antidepressant. A psychotic patient ought generally to be treated with an antipsychotic, to shut up the voices and quell the fears and such. The television commercials for Zoloft featured a happy bouncing apostrophe. My patient wanted to be happy and bouncing, like the cute white Zoloft apostrophe. It took a fair amount of explanation on my part to get this stalwart young man to understand that there was no way he was going to get Zoloft. Whatever I am, I think I am a difficult psychiatrist to Gerrymander, at least when it comes to pharmaceuticals.
Lest you think that was an isolated case, not long after the internet started becoming popular, another schizophrenic young man asked me to remove his psychotropic drugs and put him on shark cartilage. He was pretty convinced that it would be effective — since he was reasonably certain that sharks did not get schizophrenia. Once again, it took a long explanation to avoid getting Gerrymandered. I have grudgingly accepted that newer and more expensive drugs will be advertised to patients. I have only found one way to avoid some pretty basic long explanations of beginning pharmacology. I explain there is a significant price increase associated with their prescription. I can usually fix things as well or (probably) better with cheap generics anyway.
Now I have learned — from the LA Times mind you — that our friends at the FDA are looking at advertising off-label uses of drugs. Not to the profession, mind you, but to patients directly. A lot of drugs seem to become useful for something other than the intent of their development. For example olanzapine or Zyprexa, the popular Eli Lilly antipsychotic, was found useful as an antimanic/mood stabilizer. All it takes is some money invested, some clinical trials, the FDA approves the study, and doctors freely use it for both sets of symptoms. Doctors often, from the literature, use drugs for indications that are “off-label (not listed on the labeling or the box), meaning they have not been reviewed for that use by the FDA.”
It is perfectly OK for doctors to do that — Medical Doctors. But not for anyone else. Doctors often discover additional uses for a drug through constant usage. That’s how we discovered that plain aspirin can prevent heart attacks and strokes (by reducing blood clots). Now it is frequently recommended (since it is non-prescription). I helped a lot of patients who had a side effect of sexual disfunction from their antidepressants by telling them that over-the-counter benadryl (an allergy/cold medication) would solve the problems. I even told drug reps, who passed it along to their other customers. Some of the off-label information may be in the academic medical literature. Not many front line docs read a lot of that — OK, maybe some fanatics like me. This basically means that any drug company would be able to advertise any drug for anything it pleases.
The doctors would be confronted by patients like my schizophrenics who liked the happy bouncing Zoloft white comma and shark cartilage. The poor doctors have so many things to do they cannot check the literature or other sources while the patient is there. I am not too worried about disclaimers on TV commercials about the drug causing death or destruction. Patients have been tuning those out for years, even when reviewed in a doctor’s office, signing pretty much anything they are asked to on the informed consent. We have been making patients into sheep for a long time. I know some people are scared of psychotropics, and become very delighted to learn that for most complaints (not, alas, schizophrenia) I offer natural alternative psychopharmacology. Somehow, with the natural stuff I worry less about creative use of pharmaceuticals. I once prescribed ingesting coconut oil to a lovely young lady who proceeded to use it as a hair treatment. Not all side effects are bad, after all. Her hair looked marvelous.
Filed under FDA, News, prescription drugs by on Aug 25th, 2017.
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