Could this be the start of a Big Pharma boom?

pharma_2076042c Sometimes caution can be deadly, something that the Prime Minister has realised with his plans, announced yesterday, to streamline the current tortuous exercise in circumlocution that is the drugs regulatory process. There is no doubt that hundreds of terminally ill patients a year are dying and suffering unnecessarily early because they cannot have access to new drugs on safety grounds.

To add to this uncommon dose of common sense, Mr Cameron has also prescribed an injection of £180 million into medical research, a wholesale cutting of NHS red tape, and unveiled controversial plans to allow drug companies to access NHS clinical data – and patients – to speed up their studies.

The life sciences reforms, if implemented, add up to a substantial overhaul of the way novel treatments are regulated, as well as a, perhaps, belated recognition of the fact that while Britain may no longer have much of an indigenous automobile or shipbuilding industry, we still punch far, far above our weight in the world of “Big Pharma”. The idea is to carve a new research-friendly landscape that will allow the UK to reclaim its position at the top table.

Because if there is any industry in Britain that deserves government support, it is our drugs industry – a by-product of Britain’s extraordinary history of scientific research. The UK comprises less than one per cent of the world’s population and is only the sixth largest economy, yet, along with the United States, we are by far the biggest player in the world of scientific research (and we outgun even the Americans in many areas).

The pharmaceutical and medical research industry, in particular, is huge, employing 150,000 people in 4,000 companies and generating £19 billion a year turnover. Research funded by the Medical Research Council (MRC) alone has garnered no fewer than 29 Nobel Prizes.

Research currently under way sponsored by the MRC includes groundbreaking work on monoclonal antibodies (proteins created in the lab to fight a whole host of things, from cancer cells to viruses) that has been touted as the greatest breakthrough in medicine since the advent of antibiotics.

Treatments of cancers, arthritis, psoriasis, multiple sclerosis and even a cure or vaccine for Aids are just some of the possibilities being explored for this technology. GlaxoSmithKline, Britain’s largest research and development firm and the world’s third-largest drug company, has pioneered a new generation of monoclonal antibodies, called domain antibodies, that can be inhaled or absorbed through the skin, as well as being injected.

GSK labs in Cambridge are looking at ways to use these treatments to cure Type 1 diabetes and age-related macular degeneration, the leading cause of blindness in the West. British labs are also involved in revolutionary new HIV drugs, aimed specifically at children, and scientists at University College London are working on a new treatment for spina bifida based on the chemical inositol, a vitamin-like substance also used to treat depression.

But despite having access to some of the finest scientists and most well-equipped laboratories in the world, British Pharma is in serious trouble; last year the US giant Pfizer closed down its European flagship labs in Kent with the loss of 2,400 jobs, and the multinational company AstraZeneca, as well as GSK, have sacked staff and streamlined research. A decade ago Britain was home to 10 per cent of the world’s clinical trials; last year, we hosted just one per cent.

The cause? A combination of global recession, increased competition from developing countries such as India (which now hosts many of the trials that used to be carried out in the UK), combined with the threat of visa restrictions on non-EU scientists wishing to work in Britain, as part of the immigration-control drive.

Drug companies have long complained of a conservative culture in the NHS that delays the adoption of new treatments in this county, and of the “valley of death”, the name given to the chasm into which fall promising new treatments discovered at the pre-clinical stages. These usually involve animal “models”, and the research cannot progress into full human clinical trials because of the huge costs involved.

The support outlined by David Cameron, called the “Biomedical Catalyst fund,” will be open to universities and small and medium-sized enterprises. The Prime Minister also unveiled an “early access scheme” for new drugs, in which seriously ill patients can use new drugs up to a year before they are fully licensed.

The current drugs regulatory process consists of a three-stage clinical trial regime. Phase One determines the basic effects of the drug and is designed to spot any obvious safety issues and side effects. Phase Two determines with more accuracy the true efficacy of the treatment with larger sample sizes. Phase Three involves “trials of trials”, with groups of patients in several centres simultaneously monitored for possible side effects and efficacy.

It is this third phase, which can cost hundreds of millions of pounds and take decades to complete, that is being blamed by a growing number of scientists for an increasing time lag between scientific discovery and what your GP can prescribe.

While some life-saving drugs may be given to patients before Phase Three is completed, more usually the European Medicines Agency, which regulates drugs across the EU, or the Medicines and Healthcare Products Regulatory Agency, the UK watchdog, become involved before they can be prescribed in Britain.

Even when a drug has “passed”, it must be approved by NICE (the National Institute for Clinical Excellence), the rationing body, before it can be prescribed to patients on the NHS. This can take another 18 months. In fact, it can take 20 years from the discovery of a drug to getting it to market.

As Richard Parker, director of the Centre for Accelerating Medical Innovations said yesterday, “Patients are having to wait too long for new medicines because of the lengthy and extremely costly process for gaining full regulatory approval. The NHS ultimately has to pay for these costs in the price of new products.

“The UK must take a lead to make sure that we make maximum possible use of this early-approval route, particularly with cancer patients, when you have something that works that does not have any risks or side effects comparable to the cancer itself.

“It’s not just cancer: people are dying in their late teens of muscular dystrophy for want of an effective medicine when there are things we know in the pipeline.”

Professor Sir Peter Lachmann, founding president of the Academy of Medical Sciences, has long campaigned for the streamlining of a licensing process that he says is killing thousands of people a year. “I would support any move to make drugs available earlier in the development process,” he said, “subject to the patients being able to assess the risk-benefit for themselves and giving their free consent.”

Fears that allowing private firms to access medical records will breach confidentiality need to be addressed, says Dr Sarah Chan, director of Manchester University’s Institute for Science, Ethics and Innovations, who said yesterday that “when science is driven by private interests and motivated by private gain, we have no assurance that it will produce the benefits that should lead us, the public, to support it.” But Sir Mark Walport, director of the Wellcome Trust, said that data-sharing was vital. “A patient once said to me 'giving my anonymous data is the most painless thing I can do to help others get better.’”

The irony of all this is that it was probably the closure of the Pfizer laboratory in Kent that acted as a wake-up call to the Government. Without it, the slow decline may have been allowed to continue. If these plans become reality, some good may yet come out of that catastrophic event.

The Telegraph

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