When Prescription Drugs Go Over-The-Counter

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.”

In this case, the most obvious reason is more money for pharmaceutical companies.  I certainly cannot think of anything — I mean any way shape or form — that can benefit patients.

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?

For psychotropics – drugs treating psychosis, depression, mania and the like — this can be a prescription for instant disaster.  Patients hear voices, have uncontrolled emotional states, when they go off drugs.  Last week I saw someone who for this reason alone started hearing voices telling him to kill his wife.  He went to the kitchen, got a knife, and when his wife called 911, got himself incarcerated.  They gave him the medicine in jail and now he gets it through the parole system.

This is the worst medical care plan I ever heard of.

But now, we are talking about a drug with wider distribution and a more frequent indication.  Lipitor (atorvastatin) has long been touted as the best seller of drugs in its class, namely drugs that lower cholesterol.  But with cheaper generics, the sales are down.  Pfizer is apparently not performing too well in the stock market department at this moment – and pray tell me, who the hell is? — and going OTC usually helps at least in this regard.

People should not go off any kind of prescription drug without having somebody monitor them.  After all, FDA requirements to get a drug on the market only cover what happens when you take a drug — not about how you get it out of your system.  There may be rebound reactions.

It is safe and wise to monitor someone – both while taking the drug and when getting off the drug.  But nobody seems to afford safe and wise any more.

This drug has side effects and plenty of it.

Flash back to me serving time in a smaller rural county in California.  A man who thought a local Physician’s Assistant (PA) was an MD and was his primary treatment professional told me his muscles hurt.  This man had never seen a real medical doctor, and like all too many chronic psychiatric patients, was treated poorly.  After all, if a “crazy” person complains of aches and pains – even chest pains – they are probably just imagining it.

This man was on both Lipitor and another drug that may have contributed to this situation.  A possible but usually allegedly rare side effect that the Lipitor alone could have caused, is muscle-wasting – when the muscles start breaking down and the body is flooded with protein from them.  These breakdown products go through the kidneys, where they can gum things up and people can actually die of renal failure.

I was just starting to access online databases in those days, but I knew I needed them.  This interaction was so bad the screen lit up red.
The real doctor (supposedly directing the PA) would not talk to me on the phone.  The PA did, but he had done this before and thought this was not so bad as I thought, and was stifling laughter.  After all, what does a shrink know about kidneys?

I sent a letter to the doctor, and copied the PA.  I tried to tell the poor intellectually-challenged patient.  Schizophrenics may have been kicked out by their families and may have no social support.

I wanted there to be a clear record in case anything terrible happened. But doctors know that “welfare patients” do not ever sue for malpractice, and there is seldom anyone who cares enough when they are dead.

I told my senior department head, who tried to tell me I had done everything anyone could, and discharged myself admirably, although this was not my worry, I should not obsess.

I do not know if this patient is dead or alive.  I moved on to more promising treatment facilities because of cases like this – many, many cases like this.

This is why they want to sell Lipitor OTC:

“Selling an over-the-counter version of Lipitor could help Pfizer’s bottom line as the company faces a ‘patent cliff’ that threatens to erode profits during the next few years. The company reported on Tuesday that its revenues in the second quarter fell one percent from a year ago to $17.0 billion.”

As I’ve previously noted, drug news is often printed on the financial page, not the health page.

Pfizer says they would likely sell the drug in “another form,” – which usually means a lower dosage.  Patients, although they lack in pharmacological training, often can add.  I have seen many double-up or triple-up on over the counters to get the equivalence of the prescription dose.

I am no friend of this whole group of drugs, called statin drugs.

Formerly prescribed mainly for senior citizens who have been historically prone to high cholesterol, they have now been marketed for adolescents, because people get high cholesterol at younger and younger ages.

I have seen evidence they have effects including making people tired, lowering their energy; some research that has even showed less energetic intellectual function.

Raised cholesterol is a factor in atherosclerosis and heart disease.  Okay, this part I buy.

But only a lazy doctor cannot think of at least three ways to lower cholesterol without drugs.  Why not just throw a pill at it – especially if the government or insurance is paying for the pill?

Exercise helps, to name one great solution.  My preference is ballet, but anything will do.

Natural compounds help.  Policosanols and red yeast rice come to mind.  They have both been well studied.

The statin drugs can – and do – cause liver damage.  I know – I was a victim and got hepatitis from Lipitor.  This is part of why I started researching alternative treatments, and I successfully controlled my own cholesterol levels with the methods listed above.

Dietary measures may help, but please — no one-size-fits-all.  They may include, for example not drinking alcohol, in many cases.  But people resist change and feel entitled to all the food and drink they want. It is much easier to tell someone to snarf a pill than to tell them — for example — to stop drinking.

Drugs in this class may cause the lowering of energy by depleting COQ10, which some specialists (and even a few family doctors) know enough to tell their patients to get.  But again, these remedies are not prescriptions, so more expense would be involved.  And today’s savvy consumers know that spending is a sin – even to save your own life.

I’m sorry – I don’t want to be known as the Sarcastic Shrink.  I just care a lot about people and how they are treated.

I despair because modern medicine has lost sight of the gold standard, the etiological treatment — Find out what causes something and then you can really treat it effectively.

Some species manufacture their own Vitamin C, but some cannot.  Among the “Can Nots” are the primates – which includes humans.  That’s why we need to ingest Vitamin C through our diet or taking supplements.

Low intake of this nutrient seems to create a form of Lipoprotein A that is associated with atherosclerosis in the human.  After all, other species who make their own vitamin C are otherwise similar to us do not seem to have the cardiovascular problems we humans have.

For more information on this, and a touching discussion of how mainstream medicine won’t listen to in its face evidence, check out Matthias Rath and the Rath foundation.  If you are interested, be prepared to encounter the barrage of attacks and disinformation about this man and his research – all directed bythe companies his ideas would put out of business.

I am the first to counsel avoiding making changes without medical supervision.  Cholesterol only changes slowly, so with any kind of medication change, have the level checked within three months.  And yes, you have to get your doctor to monitor you.  This is their job, and you need to remind them.

What you need as a human is your doctor’s care.  Take care and be well.

What none of us need is for Pfizer to maximize their profits.  Oh, I know all industries are out to maximize profits. However, most American businesses think their right to make a profit is written into the Constitution.

But sick patients or those who are trying to buy prevention need to take care of themselves.  Nobody else can be depended upon to do so.  Not the government and certainly not manufacturers of remedies.