The MHRA – Nothing Changes

I have previously expressed concern about the fact that the MHRA (the powerful medicines regulatory agency in the UK) has received £980,000 from the Bill and Melinda Gates Foundation – which has a major interest in vaccine manufacture.

Those concerned about the integrity of the MHRA will be interested in the following paragraphs taken from my book Coleman’s Laws.

`High street shoppers are now encouraged to purchase cholesterol lowering drugs even though (as I first revealed in my book How to Stop Your Doctor Killing You in 1996) there is really no clear evidence proving that these drugs are both safe and necessary. Your friendly local pharmacist will sell you a test to find out if you have too much cholesterol and then, if you have, sell you just the drug to deal with it.

In April 2005, the Drug and Therapeutics Bulletin revealed that the British Government had re-classified the cholesterol lowering drug Simvastatin as an over-the-counter product, called Zocor Heart-Pro, available to be purchased without a prescription, although this decision was ‘not based on robust evidence of clinical benefit.

The Drug and Therapeutics Bulletin claimed that it had uncovered evidence that the medicines regulator (the Medicines and Healthcare products Regulatory Agency — MHRA) had inaccurately reported the consultation which preceded the re-classification.

In November 2003, the MHRA had published a consultation document on the proposed re-classification of this drug. One hundred responses were received from a wide range of professional organisations, patient groups and individuals. The MHRA announced that about two thirds of respondents were in favour of the proposal. Not true, according to the Drug and Therapeutics Bulletin.

‘...our analysis of the 80 responses that the MHRA has made available for public scrutiny indicates that 31% of these respondents offered at least some support for the re-classification, 35% clearly opposed it and the rest offered no clear opinion either way...Even if all 20 of the withheld responses are assumed to have been in favour of the re-classification, only 45% of all respondents at most could be described as supporting the proposal.

So, to put it politely, the MHRA had bent the truth.

Why would it do this?

Three reasons.

First, drug companies can make far more money when a drug is made available without prescription. They can sell their product to far more people and don’t have to worry about persuading doctors to prescribe it.

Second, the Government saves money because all the patients who take the drug have to pay for it themselves. In the UK, around 1.8 million people were taking statins when the drug was first made available without a prescription. The cost to the NHS was £700 million and rising fast. With drug company campaigns to persuade doctors to prescribe the drugs proving extremely effective it was estimated that the NHS bill would exceed £2 billion a year within a few years.

Thirdly, many of the people associated with the MHRA are alleged to have long-standing links with the drug industry. Some own shares in drug companies.

I have been writing about such matters since 1970 and so I wasn’t in the slightest bit surprised to hear that once again a Government agency had acted in a way designed to benefit a drug company and to put ordinary citizens at risk.

The Drug and Therapeutics Bulletin reported that no trials had assessed the drug’s long-term effectiveness in its target group — people likely to be at moderate risk of having a heart attack.

‘The lack of such research,’ said the Drug and Therapeutics Bulletin, ‘raises serious questions about whether people are unknowingly wasting their money — around £170 a year — on a treatment that might not work. Also, crucially, since people can be sold Zocor Heart-Pro without a detailed assessment that includes measurement of blood pressure and cholesterol levels, some could be wrongly classed and treated as being at only moderate risk of a heart attack, when in reality their risk is very much higher.’

Consumers finding a drug freely available without prescription would, of course, not be aware of the nature and extent of the problems associated with drugs of this type.

When NASA astronaut Dr Duane Graveline had a heart attack he was given a statin to reduce the risk of a recurrence. Six weeks after starting the drug he lost some of his memory for six hours. The loss was so severe that he did not recognise either his wife or his own home. On recovering, Dr Graveline took himself off the drug but, a year later, decided to try it again. He had another attack of what is known as ‘transient global amnesia’ (TGA) which wiped out every memory since early childhood. This attack lasted twelve hours. There are hundreds of examples of statins causing TGA. Quite apart from the fears and anxieties these attacks produce it is scary to think of the consequences if a surgeon or a bus driver had one of these attacks.

Amnesia isn’t the only problem linked to these drugs. One study found a 25% increase in newly diagnosed cancer among older people after four years treatment with a statin. The cancers which seem most likely to develop include cancer of the breast and cancer of the gastrointestinal tract.

Other side effects include congestive heart failure, neurological damage, extreme fatigue, nausea, muscle weakness, gastrointestinal problems and pain.’

Taken from Coleman’s Laws by Vernon Coleman – available as a paperback and an eBook on Amazon.