I used to really enjoy going to the kind of tiny circuses that tour the small towns in rural areas. Much of my adult life has been as a wandering gypsy doctor through such areas and it seems that many of the little towns had little to offer and went wild when the circus came to town – no matter how modest the offerings were.
Of course I had experience with the really big shows. When I was a kid my folks took me once to the Greatest Show On Earth — Ringling Brothers, Barnum and Bailey — where I think now the plethora of amusements in three rings is probably best suited for those who really enjoy their attention deficit disorder.
But it was in a tiny field in France by a beach on the English Channel that I saw a lovely one ring circus. I was most impressed with the lion tamer — a person of African descent, large and muscled and handsome — but I was close enough to see each time he put his head in the lion’s mouth, and he did it multiple times.
The old, indifferent lion had no teeth, but the effect was still thrilling.
The image was vivid, and I have not thought of it for many years.
I think of it when I hear talk about the Food and Drug administration (FDA).
The FDA has no teeth, and as you can tell from the interview below, is simply
Warning: Daily use of aspirin can lead to side effects which may include total loss of impulse control, man boobs, toe hair, and third nipples. Please consult your doctor before taking this and other over the counter medicine.
Well, not really. But your really should know the risks and benefits of anything you take, even if it’s over the counter, even if it’s aspirin. I have an early memory, and I cannot have been beyond high school or early college, for I was still going to Friday night services with my Parents-of-Blessed-Memory. My father would not let me in the choir with the other retired senior types with weak voices; but, it seemed to amuse him to no end when I out sang them and the cantor from the congregation. The cantor had some kind of a congenital dislocation of the hip and some kind of back pain and I don’t know what else. My parents had discouraged my still premature medical curiosity and told me not to ask him. Read more on To Aspirin or Not To Aspirin; That Is the Question…
Well, it turns out there aren’t really gators in Gatorade. The drink was named as such because a University of Florida coach – team name Gators – worked with a researcher to find a way to replenish fluids in his heat exhausted, wilting athletes. And Gatorade was born. Read more on What’s In Gatorade? Gators?…
I’ve got to admit, I must have already been living in the world of alternative medicine by the time the FDA approved Xyrem. As far as I can figure, it’s exactly the same as the street drug GHB. Us pharmacology types call this gamma hydroxybutyric acid. In a stable salt form that people can take as a prescription drug, it can also be called sodium oxybate. Among other sets of cognoscenti with whom I would usually not hang out — read “on the street” — it is known as various other things that those initials can stand for such as “Georgia Home Boy” or “Grievous Bodily Harm,” a lovely term from old British law. There have been a couple of high profile American cases where Xyrem was used as a date-rape drug. The FDA has warned against taking dietary supplements that contain it. It’s the very same chemical as GHB. It is also an FDA approved prescription drug. Read more on Topic: Xyrem and Doctors…
Why would a pharmaceutical manufacturer want to change a drug from prescription to over the counter (OTC)?
Well, one thing I’ve learned in my lifetime is – When the Question is “WHY?” then the answer is “MONEY.”
Oh, sure – in our economically-ignorant country, many people think – “Whee! I can buy any drug I want without spending money on a doctor’s appointment and without having to get a prescription! ”
These people are prime candidates for the Darwin Awards.
Yes, believe it or not, the “RX to OTC Switch” can actually HURT patients.
Drug patents expire relatively quickly, competitors are waiting at the gates with generic equivalents, and when a drug becomes OTC, there is a chance that insurance does not cover it.
This makes insurance companies and government programs (Medicare, Medicaid/Medi-Cal, etc.) very happy. They are so strapped for cash that even paying for a cheaper generic is a strain on the budget. When this kind of money is involved, you can bet that lobbyists are pressuring the government to ease their restrictions so that drugs once considered risky enough to warrant a prescription so that not just anybody can have access will be available to anyone who can walk into a drug store or click on a shopping cart on the web.
Patients will have to pay for OTC meds in cash money and doctors usually do not bother prescribing an equivalent drug. If they do not already know of an equivalent, they will probably — and generally do — just tell a patient to go buy it over the counter.
A patient who cannot afford the drug will go off it.
OK – so what’s the big deal if a cold medicine, allergy remedy or hair-restoring pill is no longer a prescription drug?
I mean, what’s the worst that could happen? You should start smelling great? Believe me, I’ve had some people in my office that could use some abusive bathing.
But on a serious note, there have been some street drugs that are sold as bath salts and those can cause a lot of problems.
As far as the FDA is concerned, soap, bath oil, and legitimate bath salts aren’t regulated. As for the Fair Trade Commission, there are some labeling requirements for products that make a claim (such as moisturizing the skin).
But the bath salts that have the feds worried now are a legal high – and they want to make all “highs” illegal. Read more on Stimulating Bath Salts — Avoid At All Costs…
My psychopharmacology preceptor told me a long time ago that the best and most efficient way to know what is happening in pharmacology is to check out the business news. He was right.
I want to applaud the FDA for doing something perhaps a bit audacious, surely without precedent, but something I consider correct and appropriate.
They declined acceptance of Contrave, a pill for obesity, and requested a longer term and larger study.Bravo. It’s rare that I give the FDA a “standing O.” The folks at Orexigen pharmaceuticals concocted Contrave — an amalgam of 400mg. of Wellbutrin sustained release and a couple of different doses of naltrexone, 48 and 16 mg. Here is the clinical trials record if you are interested. Read more on Prescription Diet Drug Makes Food Taste Horrible…