FDA: A Toothless Old Lion

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

not empowered to do much about — for example — people dying from a dietary supplement.

Yes, there is a supplement — a “dietary supplement” — that is supposed to help people do the last part of their workout — run a little more, lift a little more.

It has killed at least two members of the US armed forces that I know about, and it has been removed from sales at the post exchanges (The PX is like a Wal-Mart for the military base and has lots of special discounts for our service people).

You read me right — something that has been pulled from the post exchange shelves might have killed two soldiers; this was done as a precautionary measure.

Unfortunately, there has been no scientific investigation — guess that would have been expensive.  Danger removed, and that satisfies the authorities, I suppose.

As a veteran and a patriotic American, it saddens me that all of the killing of our troops does not have to be left for the enemy.

No, I was not this cynical until I became a psychopharmacologist in the world of prescription drugs.  After two decades of that, I was so disillusioned that I left that to become a natural alternative medicine doctor.

The irony of it all is that the safest drug I can legally prescribe now is marijuana, which the very authorities who issue a free-pass to dangerous and deadly medicines and over-the-counter remedies are trying with all of their power to suppress and convince a gullible public of non-existent dangers.

For the record — in case anybody actually cares — Eli Lilly promoted the substance in question.  In my academic days, I was part of the investigative team conducting clinical trials for Eli Lilly and similar multinational pharmaceutical companies.  One of the drugs I worked on was approved by the FDA and marketed as an antipsychotic drug under the trade name Zyprexa (generic name Olanzapine).  It was later found – after being on the market for ten years — to have dangerous and potentially lethal side-effects.  One of them was promoting obesity and making a higher risk of diabetes and other complications.

The FDA response to these reports was to require Lilly to print a warning on the medicine box surrounded by a thick black border.  This is called a “black box” warning and is about as effective as those warnings on cigarette packages.

The drug is still on the market and heavily prescribed for schizophrenia and other psychotic disorders.

The drug that allegedly has killed a couple of our nation’s heroes in uniform is 1,3-dimethylamylamine — a nasal decongestant and vasoconstrictor (blood vessel constrictor) developed in the World War II era.

So it has been around and been used for around 75 years.  This is hardly a pedigree of safety, as cocaine has been so used, and still was, when I did my rotation in ear-nose-and throat, my first postgraduate training in the U.S.A. back in the early 1980s.

The Ministry of Health in New Zealand banned this stuff.

I know they are a little bitty country compared to us, but their ministry can ban things and our FDA folks can’t.

Yes, although you may believe I am wrong, the FDA cannot ban drugs or over-the-counter remedies. They can suggest that a company withdraw the products or quit manufacturing the products, but the FDA is a toothless old lion – and usually under a lot of pressure from politicians and swayed by drug-company lobbyists to do what is best for drug companies – and not for the citizens of the USA.

Some people claim that 1,3 dimethylamylamine is a natural product, made from lovely and fragrant geraniums.  I am not a real expert in plant stuff, but if there is any of this in geraniums, I cannot turn up any real proof.   Awww – how could a pretty little flower be bad for you?

Even if this is true, it is not an argument for safety.

I mean, opium poppies are also beautiful flowers.  That does not make them “good stuff.”

When I was little, we had a garden full of geraniums.  My grandmother of blessed memory did tell me they were poisonous and I should not eat them.  I remember the remark only because I never thought of eating flowers before that moment, and I remembered the remark the moment I was confronted with a narcissus in a salad at some prissy drug company banquet.

As far as I can figure, the nasal spray stuff suspected in the soldiers’ deaths is basically an amphetamine.

There are multiple levels of issues here.  The “idolatry of the body,” as the old chaplain in Fargo, North Dakota would have called this, has caused many young males to choose some pretty dangerous supplements.  I have struggled with young male patients to avoid dangerous drugs that may help them have a better physique (i.e. “Look Hot!”).  Yet they seem to follow the advice of Billy Crystal’s character “Fernando” who was famous for saying “It doesn’t matter how good you feel as long as you look Mah-vel-ous!”

Ummmm … that was satire – on Saturday Night Live …. Not medical advice.  Mr. Crystal was going for laughs.

There are all kinds of supplements out there; many are good, some even very good and can work plenty better than prescription drugs.

There are also things out there that can kill you.

I use this blog to tell you about them when I know about them.  I’m also very open with my patients about what makes sense and what might be harmful.
The typical American solution is that we need more laws to protect us. They labor under the misconception that the government is there to protect us.

History shows us that the government will do nothing until after catastrophe strikes, and even then they cover-up and make excuses until enough people make enough trouble to threaten re-election or impeachment.

My response is that we need more people who want to do the right thing, and who value life.

Maybe we can do something on the political level. I really was never a political activist until recently, and so my husband and I started the American Natural Health Initiative (ANHI).

We should not be producing stuff that can kill folks and making it easily available to the general public.

Our government is supposed to be representative and a republic and it simply is not doing the job.

This reminds me of one of my favorite quotes from that great old cynic, Benjamin Franklin.

After he walked out of the 1787 Constitutional Congress, the good Dr. Franklin was asked what kind of a government we had.

I love his answer.

“A republic, if you can keep it.”