Drug Profiteering and Phenytoin. A nasty little epilepsy drug, at a nasty big price!

Imagine you popped off to the supermarket to buy a loaf of bread. Your favourite loaf cost £1.50 last time, but today you discovered it cost nearly £4,000! Driving away you decide to fill your car with petrol at £1.10 per litre, but this discover that the cost is now nearly £3,000 per litre.

This kind of inflation is possible. But only if you are buying pharmaceutical drugs! Big Pharma knows no restraints when it comes to profiteering. It is used to a profit ratio of over 20% when most other industries are happy with 5-10%.

This particular story has been well publicised. The drug company Pfizer has been fined a record £84.2m by Britain's competition regulator for increasing the price of their anti-epilepsy drug, phenytoin sodium, by 2,600%! The Competition and Markets Authority (CMA) said that the US company "deliberately exploited" the British public, who of course pay for the NHS. It also fined the drugs distributor, Flynn Pharma, £5.2m. Of course, such massive fines are merely back-pocket cash for the drug companies, or as one company director said some years ago, they are an accepted part of their business costs!

And of course this is confirmed by the figures. The amount the NHS was charged for the drug went up from £2.83m to £67.50m in 2012, before being reduced to £54 in May 2014. This increased the cost to the NHS from £2m to £50m in 2012 and 2013, a profit of £96 million for these two years alone. By my calculation, that is a profit, even after the fine is paid!

So what exactly is this drug, Phenytoin? It is an anticonvulsant drug taken by about 48,000 patients in Britain to control seizures, or epilepsy. What is not so well known about the drug, and certainly not mentioned (as usual) by the mainstream media, is that it is a particularly dangerous drug, with particularly nasty side effects. Drug. com provides this summary information (go to the website for more detailed information).

          "Commonly reported side effects of phenytoin include: congenital anomalies. Other side effects include: hepatic necrosis, ataxia, confusion, constipation, depression, dizziness, drowsiness, fatigue, hypertrichosis, mental status changes, myasthenia, nervousness, numbness, tremor, tremor of hands, vertigo, excitement, irritability, mood changes, and restlessness."

     So the pharmaceutical industry wants us to pay nasty big prices for this nasty little drug!

So is it unusual for drug companies to behave in this way, charging excessive amounts for their drugs? Well not really. Last year a USA drug company was caught in a similar scam, involving Turing Pharmaceuticals, and the drug Daraprim. The price of this drug was raised overnight by over 5,000%. I will let the reader work out the increase on a loaf of bread, or a litre of petrol!

A spokesman for the CMA’s investigation is quoted as saying this about the increased charge for Phenytoin.

          "The companies deliberately exploited the opportunity offered by de-branding to hike up the price for a drug which is relied upon by many thousands of patients. These extraordinary price rises have cost the NHS and the taxpayer tens of millions of pounds."

So do the drug companies think they have done anything wrong? It appears not! Pfizer said they were making a loss on the drug before the 're-branding', and that the price set by Flynn was actually 25-40% lower than the cost of an equivalent tablet from another supplier. They felt that the CMA's findings were wrong. Flynn Pharma complained that the CMA has taken more than three and a half years to reach their decision which was based "on a wholly flawed understanding of the UK pharmaceutical market".

So both companies will appeal, and seek to overturn the CMA's findings in court. Perhaps the bread companies, and the petroleum companies should take note.

No time to write more. Sorry. I'm off to buy a loaf of bread, and fill my car with petrol before they put the price up!

Conventional Medical Monopoly and Big Pharma Profiteering

The Competition and Markets Authority, the CMA, described as Britain's competition watchdog, has accused two pharmaceutical drug companies of "excessive and unfair" prices for an anti-epilepsy drug. So given my blog yesterday (5th August 2015) about a monopoly in NHS healthcare provision, another aspect of the consequences of allowing a monopoly comes to the fore.

It costs us.

It costs patients in terms of our health, and it costs taxpayers in our pockets.

Big Pharma's monopoly position within the NHS is, of course, supported by our mainstream media, who are willing not only to publicise their over-hyped claims for their drugs and vaccines, but giving us with the impression that these drugs and vaccines are the route to good health, and that 'there is no alternative' to them.

The monetary cost of conventional drugs and vaccines are excessive, and they have been for a very long time. I recall, some years ago, when a drug company, which was facing huge compensation payments for the damage caused by one of their drugs, stated that these payments were not a problem as they were 'factored in' to the cost of every drug.

That is, drug companies are aware that their drugs will cause damage to patients, that the courts will fine them heavily, but they charge enough for the drugs to pay compensation!

What this means is that pharmaceutical companies can charge whatever they like for their drugs and vaccines. They operate within a monopoly. "There is no alternative"!

Normally, drug companies profit from the patents taken out on their drugs. A patent is a device that ensures that the inventor is guaranteed profit by removing all competition. Usually, the pharmaceutical industry justifies these excessive profits by pointing to the huge costs of developing a new drug or vaccine.

But this is not the case here. Phenytoin was first discovered in 1908!

The drug Phenytoin is currently prescribed to 50,000 people in Britain. It is manufactured by Pfizer, and marketed by Flynn Pharma. The drug, previously called Epanutin, used to cost the NHS £2.3 million per year. In 2013 it cost £50 million.

How did they do it?

The clue is in the sentence above. The name of the drug was changed! This is a popular device used by the pharmaceutical industry. They do it in order to obfuscate, to confuse, to pull the wool over the eyes of both doctors and patients. So, when one of their drugs or vaccines is found to be dangerous, they change the name, and call it something else.

For instance , the drug Thalidomide, perhaps the most infamous drug ever given to unsuspecting patients, is now called Thalomid, and is being prescribed to patients to treat cancer and leprosy.

Yet now, it would appear, when the Big Pharma industry wants to make bumper profits from sick people, they change the name of the drug, in this case from Epanutin to Phenytoin.

Actually, there should have been no such confusion. According to Wikipedia (never an entirely reliable, or unbiased source of information, but adequate in this instance) the drug, first discovered in 1908, was initially known then as Phenytoin. It was called Epanutin later. The name changed back more recently when Pfizer sold the British marketing rates to Flynn Pharmacy. And certainly, the increase in price was known to Wikipedia, if not to the NHS, some time ago.

     "The capsules are still made by Pfizer's Goedecke subsidiary's plant in Freiburg, Germany and they still have Epanutin printed on them. After Pfizer's sale of the UK marketing licence to Flynn Pharma, the price of a 28-pack of 25 mg phenytoin sodium capsules marked Epanutin rose from 66p to £15.74. Capsules of other strengths also went up in price by the same factor - 2384% costing the UK's National Health Service an extra £43 million (about $68.44 million) a year.

So what is the NHS paying for, and what are the consequences for British patients? Well, that is quite another story! Wikipedia tells us that in 2008, the drug was put on the FDA's "Potential Signals of Serious Risks" list! So what are these 'serious risk', for which we are paying so much to acquire? They are many and varied (and these are taken from a Wikipedia list)!

• severe low blood pressure, and abnormal heart rhythms.
• double vision, slurred speech, cerebellar ataxia, tremor.
• status epilepticus on sudden withdrawal.
• atrophy of the cerebellum.
• megaloblastic anaemia, aplastic anaemia, decreased white blood cell count, low platelet count.
• birth defects, 'metal hydantoin syndrome.
• gingival enlargement of the mouth.
• Hypertrichosis, Stevens-John syndrome, purple glove syndrome, rash, exgoliative dematitis, itching, excessing hairiness, coarsening of facial features.
• Lupus.
• Suicidal thoughts and behaviour.
• Decreased bone density and increased bone fractures.

So why have the FDA not acted on these 'serious risks'? 

So why did the NHS not spot that they were being overcharged by 2,384%?

So why do conventional doctors still prescribe such a dangerous, and hugely expensive drug?

So how can pharmaceutical companies continue to get away with profiteering from a drug they know can cause such serious harm to patients?

It is all connected with the monopoly of conventional, drug-based medicine, within the NHS.

It is time that the monopoly is challenged, that alternative therapies, such as homeopathy, are asked by the NHS if they can do better (both in terms of outcomes and cost) than the pharmaceutical industry in treating disease. It is time that the conventional medical monopoly is challenged, and patients are given a proper choice about how their illnesses are treated in future.

"First do no harm". A test Conventional Medicine regularly fails

Primum non nocere, or "First do no harm" is supposed to be a central feature of medical practice, enshrined within the Hippocratic Oath. Regular readers of this blog will know that conventional, drug/vaccine dominated medicine flouts this rule all the time, often with disastrous effects on our health and well-being.

Yet "First do no harm" is also a film made in 1997, starring Meryl Streep. It is a film about a young boy who develops epilepsy, and the efforts of his mother to seek safer and more effective treatment for him after conventional medical treatment proves to be not only ineffective, but seriously harmful, dangerous and life-threatening.

This is a well-known, and oft-repeated situation. Most people will probably have witnessed something similar with people they know after the medical treatment. 

The patient starts with a simple, often trivial complaint, and they take conventional drugs to treat it (or vaccines to prevent it), and far from being a benefit, the 'side-effects' of the treatment actually causes more serious harm to health, and more serious illness. (See my ebook, Drug Induced Illness).

So it is interesting to follow the progression of this particular story, which is based on actual events.

The reason for Robbie (the child) developing epilepsy is not mentioned. Epilepsy is known to result from a simple Vitamin D deficiency. Or it can be caused by stress. But conventional pharmaceutical drugs, like cough medicines, anti-histamines, antidepressants and antibiotics, are also known to cause epilepsy!

Diagnosis

Robbie is subjected to a variety of tests - a CT scan, a lumbar puncture, and an electroencephalogram, and he is diagnosed with epilepsy.

The problems with the diagnosis of epilepsy is that is is notoriously unreliable. The British Medical Journal reported in 2003 (326: 355) that epilepsy was misdiagnosed in about one-third of cases. It is interesting to note what what the magazine, What Doctors Don't Tell (WDDTY) said about this BMJ article:

"Neither report highlighted the terrible drug regimen that follows an epilepsy diagnosis.  So powerful are the anti-epileptics that some children have died while on them. To know that their child never had epilepsy in the first place may be too much for some parents to bear.

Antiepileptic Drugs

Immediately, drugs were prescribed for Robbie, beginning with Phenobarbital. This is an 'old' anticonvulsant drug with well known  Disease-Inducing-Effects (DIEs), including cognitive impairment and behaviour problems.

When this drug failed he is moved on to Phenytoin (Dilantin), a drug known to cause decreased co-ordination, mental confusion, and many other serious DIEs. For a list of the serious DIEs caused by this drug, click here.

Then, when this drug did not work, he was given Carbamazepine (Tegretol). The DIEs of this drug are probably even worse, and a list can be found by clicking here.

It is not just that these drugs did not work. Ineffectiveness is certainly one common feature of conventional medical drugs. But causing actual bodily harm, and serious harm to health, is another. After each drug it becomes quite clear that Robbie's health is actually getting worse, and that the cause of this deterioration was his medication. His epilepsy gets worse, and he develops a serious rash, known as Stevens-Johnson syndrome. 

The parents begin to understand that their son may become a vegetable as a result of the drugs he is being given, particularly when he goes into 'status epilepticus' - a continuous convulsive seizure that had to be stopped as a medical emergency. This was done by giving Robbie increasing doses of Diazepam (Valium) even though it does no good, even when given intravenously!

Eventually he is given Paraldehyde. In the film this drug is said to have possible fatal 'side-effects', and was seen to dramatically melt a plastic cup in which it had been placed! On this website, one of the DIEs is given as convulsions!

At some point we really should be asking what this medicine is all about, and whether the doctors who are using it really know what they are doing!

The failure of drugs led the neurologist in the film to suggest that Robbie should have surgery, involving the removal of the top of his skull, and inserting electrodes on the surface of the brain - to get a more accurate location of any seizure focus. His mother is aghast.

Meryl Streep, the mother, undertakes some library study, and through this discovers another treatment - the Ketogenic Diet. She suggests this to the neurologist, who says 'there is no evidence' to support it. By this the doctor meant that there have been no Randomised, Controlled Tests (RCTs) undertaken on it. The treatment, she said, was supported only by 'anecdotal' evidence - by which she meant that although individuals have been cured by the diet the drug companies had not carried out RCTs on it, and so, for the neurologist this was not 'evidence.

Later in the film, the neurologist was reminded of the uncomfortable fact that there were no RCTs on many of the drug treatments she had already used for Danny!

There is, of course, lots of money involved in peddling pharmaceutical drugs, but few profits, if any, for cures which involve diet. So such alternatives are not favoured by the conventional medical establishment.

Robbie's mother determines to get her son to the John Hopkins Hospital in Baltimore, where the Ketogenic diet was being used.

First she tried to secrete him out of the hospital, but was stopped, and warned that by doing this she could risk losing custody of her son, as the courts (heavily influenced by 'conventional medical advice' of course, might believe she is putting her son's health at risk by refusing conventional medical treatment.

However, with the help of a retired doctor, and a sympathetic nurse (far more help than would be available to the average parent) she does manage to take Robbie to Baltimore, and he is given the Ketogenic diet. The seizures begin to improve, and are eventually eliminated, and his mental faculties are restored.

Apparently the factual basis of this story arises from the experience of the film's editor, and the main question is asked was why he was not told about this treatment. He was apparently outraged that nobody had informed him of the diet, even when it was clear that the drugs were not working.

The Ketogenic diet was first develop by Russell Wilder, at the Mayo Clinic, in 1921. Although it was initially popular, it decline when new, 'effective' drugs (like Phenytoin) were discovered in the later 1930s, early 1940's  - that is, the drugs that were used in the film with Robbie! 

Wikipedia claims that, since the film, the diet is now being used in 75 epilepsy centres, in 45 countries. However, NHS Choices have a different story to tell!

"Anti-epileptic drugs (AEDs) are usually the first choice of treatment. About 70% of people with epilepsy have their seizures controlled with AEDs".

So let it never be said that the NHS, our doctors, and the Conventional Medical Establishment generally, do not use drugs whenever there is an opportunity to do so! Moreover, let us observe here that even when there are safer and more effective alternatives that can be used, drugs still remain the preferred option! Indeed, diet is mentioned on NHS Choices almost as an after-thought!

"Sometimes, a special diet is used for children whose seizures are difficult to control and do not respond to drug treatment.

Patients seeking treatment within the Conventional Medical Establishment - beware!