Safety of Medicines

Bill Presented — parliamentary Standards (Amendment) Bill – in the House of Commons at 4:06 pm on 20 July 2010.

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Motion for leave to bring in a Bill (Standing Order No. 23)

Photo of Sir David Amess Sir David Amess Conservative, Southend West 4:15, 20 July 2010

I beg to move,

That leave be given to bring in a Bill to make provision about methods of testing the safety of medicines;
and for connected purposes.

Hypochondria is not an attractive condition in anyone, but someone who is genuinely ill may be prescribed medicine and may benefit from it. I say to the Minister of State, Department of Health, my hon. Friend Mr Burns that I very much hope this 10-minute Bill will become law.

The development of medicines has helped millions of people to lead longer and more active lives. Medicines, however, are not risk free. Regrettably, there has been an increasing level of adverse drug reactions, which is obviously unacceptable. Action needs to be taken to improve the safety of medicines as far as possible.

Extrapolating the number of hospital admissions due to adverse drug reactions from a number of studies indicates, quite shockingly, that around a million Britons are hospitalised by prescription medicines every year, costing the NHS £2 billion. This is a figure the public purse can ill afford, and does not take into account, even in purely financial terms, the wider cost to society, such as the burden of lost productivity. It is true that some level of risk cannot yet be avoided, but the question I want to pose is whether it would be better to test medicines for safety differently, before they are released to the general public.

In 2005, the Health Committee-of which I was a member, as was the Minister of State-recommended that a public inquiry should be conducted every time a drug is withdrawn on health grounds to determine whether sufficient testing of the drug took place before its introduction into the market. It is a recommendation that has yet to be implemented.

So how are medicines tested for safety and what constitutes sufficient testing? The final stage of this lengthy process is human clinical trials, and several actions are necessary to improve their quality, including ensuring that the range of participants more broadly reflects the population the drug is intended to treat. For example, many drugs for the elderly are never tested on the elderly, and women are massively under-represented in clinical trials, meaning that the evidence base for their treatment is of lower quality than it is for men.

Before new medicines reach clinical trials, the Government require that they are tested for safety on animals, and it is these tests that are the subject of the Bill. Animal testing is, I believe, ethically problematic and many people feel strongly, as I do, that there is an ethical imperative to switch to non-animal methods-but that is not the reason for this Bill. The reason for it is that animal tests have let us down badly in their role of protecting us against dangerous drugs.

Painkiller Vioxx, withdrawn in 2004, was the biggest drug disaster in history, killing more than 100,000 people worldwide in its five years on the market. Clinical trials of Vioxx did, in fact, reveal up to a fivefold increase in the risk of a serious reaction, such as heart attack, heart failure or stroke. However, tests on animals indicated that the drug was safe, and some animal studies even found that it was protective to the heart, which supported the manufacturer's decision to market it.

In March 2006, six young men taking part in a clinical trial at Northwick Park hospital were nearly killed by a drug which had been tested in monkeys and shown to be safe, even at 500 times the dose that the men were given. Clearly the results from the monkeys had created a false sense of security. More comprehensive studies using human blood samples before the trial might have averted that terrible disaster. Since the infamous trial, several simple tests using human cells have been developed which can predict such dramatic reactions.

Those two examples are not isolated incidents. In fact, nine out of 10 new drugs that pass animal tests go on to fail in human clinical trials, either because they do not work on humans although they did work on animals, or because they are not safe when used on humans as they were apparently safe when used on animals.

The pharmaceutical industry needs new mechanisms. Many new technologies have been developed in recent years: for instance, a wide range of techniques using human tissues-including the interconnection of several different tissues to mimic the whole body in miniature-human DNA chips, computer modelling, and exciting new methods of testing minuscule, safe doses of new drugs in volunteers. A combination of those approaches promises to predict the effects of new drugs on humans more accurately than tests on animals ever could, with the bonus of significant savings in time and cost. It is astonishing that the regulations have not moved on in 42 years, especially given the way in which science has been revolutionised during that time.

Animal tests have never been compared with a set of those promising new technologies. My cross-party Bill calls for exactly that comparison to be conducted. A sample of drugs that turned out to have serious safety problems when they reached clinical trials, or reached the public market, will be tested. The tests will employ a set of those techniques, with their focus on human biology. The results will be compared with the existing results from the animal tests that were conducted before the drugs entered clinical trials. Thus no new human trials or animal tests will be needed. The process will reveal which set of tests is more successful at predicting the safety of medicines in humans.

The proposals that I have outlined have attracted a high level of support among scientists and in the House in previous sessions. Early-day motions have been signed by as many as 250 Members, and, more recently, by 243 Members. The sheer scale of adverse drug reactions and the fact that they are increasing at twice the rate of prescriptions means that we have an ethical imperative to examine the causes and take action to address this very serious public health crisis. I commend the Bill to the House.

Question put and agreed to.


That Mr David Amess, Mr Peter Bone, Peter Bottomley, Karen Bradley, Jackie Doyle-Price, Paul Flynn, Mr Mike Hancock, Dr Julian Huppert, Caroline Lucas, Grahame M. Morris, Mark Pawsey and Bob Russell present the Bill.

Mr David Amess accordingly presented the Bill.

Bill read the First time; to be read a Second time on Friday 22 October and to be printed (Bill 59).