September 8, 2008

‘Scotland Must Foster Drug Innovation’ The New Head of the Pharmaceutical Industry Association Believes That We Should Take Part in More Clinical Trials

By Helen Puttick

IT is, perhaps, an unusual move; from an organisation which fought for patients to one that often faces accusations of acting against their interests.

But Andy Powrie-Smith insists his surprise appointment as director of the Association of the British Pharmaceutical Industry is simply working for patients in a different way.

The new director was, when the announcement was made, the head of a charity, the British Lung Foundation Scotland - which fights for patients suffering a range of chest diseases which are not glamorous but frequently deadly.

In the past, he spoke of sufferers wishing they had cancer because cancer patients received better support.

These days, of course, his priorities are different, although he has crafted a slightly glib line about the switch: "In my last job I spent a lot of my time trying to get better services for patients and in my current job I spend a lot of my time trying to get better medicines for patients."

Last month Professor Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (Nice), which guides the English NHS on which new drugs to prescribe, warned companies were overpricing new treatments to boost their profits. His comments followed the furore about Nice rejecting four kidney cancer drugs because they did not offer good value for money. The equivalent body in Scotland, the Scottish Medicines Consortium (SMC), had already turned down three of the treatments.

Mr Powrie-Smith has an interesting perspective on this issue. He says such decisions not only affect the sick patients who cannot benefit from the medicine, they also have a wider impact.

He says: "Scotland needs to be seen as a place that fosters innovation, that grabs these new drugs. Obviously that is in a context of value for money.

"But if you want the best outcomes for patients, and you want new clinical trials to come to Scotland and you want all the developments and investments that come with that, you have got to be seen to support the innovation of new drugs by giving them to patients."

He tells me one of the objectives of the nation's life sciences strategy is to make Scotland "the best research lab in the world". Yet, he continues, the UK share of clinical research has fallen from 6per cent to 2per cent, a trend he believes is reflected north of the border.

To reverse this, he says, four areas need attention. These include the regulation of trials and how the Treasury encourages research and development, fields where Scotland has limited control.

However, he says global companies looking to invest also want to know if countries are using the medicines they are making and want patients to be receiving the latest treatment available. When conducting a trial, they have to compare their innovation with the existing gold standard.

On these fronts, Mr PowrieSmith says, Scotland offers a "mixed picture".

He praises the SMC for the transparency and speed of its decision- making, saying at one point it does a "fantastic job".

However, he also says: "At the moment there is probably a slight discord between the economic side of the life science agenda and what we are trying to achieve as a nation there. Our attitude and our decision-making process perhaps doesn't always support innovative new medicines at the moment, and how that is viewed by global companies who have the power to invest billions in terms of clinical research."

The cost-benefit analysis which is currently performed on new drugs, he says, means treatments for rarer cancers (such as kidney) will not receive SMC approval.

Instead, he would like to see different or wider criteria applied. "We are behind Europe in terms or our availability of cancer medicines, " he says. Even when the SMC does give positive advice, he adds, it does not necessarily mean the drug reaches the patient.

Pharmaceutical companies tell him there are big differences between the orders they receive from different health boards, with some purchasing new treatments well before others.

The lack of good data exposing the extent of this postcode lottery is a theme he returns to on a number of occasions, and MSPs and the SMC themselves have also highlighted the problem.

But what about the cost of drugs? The SMC and Nice do back many new medicines. At the same time, the health service has a finite amount of money and spending tens of thousands on a new treatment which may improve or extend life for a short spell comes at the expense of something else - specialist nurses for patients with a chronic lung problem, maybe. Can pharmaceutical companies that report massive profits justify the prices of the new cancer drugs?

Mr Powrie-Smith gives the expected reply: "The difficulty is the high research and development costs attached, particularly when it is a medicine that will not be used across a large patient group.

"You need to be able to recoup those costs to continue to innovate, to continue to make new drugs to bring to patients."

And what about keeping shareholders happy? He is unapologetic about this, saying the industry must be attractive to shareholders in order to create new drugs.

He talks about it being a highrisk business, with perhaps one in every thousand compounds tested ending up in the marketplace and a bill for GBP550m behind every new medicine which reaches patients.

He has other figures, too. The industry contributes GBP850m to the Scottish economy and has 8500 employees, but he sees other countries such as Singapore and Ireland doing much more to attract big players.

There are opportunities for Scotland to advance, however. Mr Powrie-Smith says a new deal on drug pricing, negotiated UK-wide, includes for the first time promises to support innovation and patient access to new treatments which will be taken forward by the devolved nations.

He is hoping to sit down with the Scottish Government to discuss this with them. Until this happens, his assessment of Scotland's position on the life science map is this: "We need to keep moving ahead, but at the moment we are not moving fast enough."

Healthy figures

The British pharmaceutical industry produced more than GBP14bn worth of exports last year, outstripping imports by GBP4.2bn.

There are 23 companies in Scotland specifically focused on drug discovery and development, and the industry's strengths include cancer treatment and antibiotics.

Scotland has been hailed as a world centre of excellence in drug research, with 34 university departments involved in pharmaceutical development. Several large companies have bases in Scotland, including Organon , Cyclacel and CXR Biosciences .

Britain is the world's fourth largest exporter of pharmaceuticals, behind only Switzerland, Germany and the USA.

Britain is one of the world's largest drugs markets, with the average person spending GBP195 per year on them. The British consume 19per cent of the world's top 100 prescription medicines.

The most recent figures show that the industry employs around 72,000 people in Britain .

The top pharmaceutical companies in the UK are Pfizer and GlaxoSmithKline. Both have annual sales of more than GBP1bn, with UK market shares of 9.3 and 9per cent respectively.

The top-selling products in the UK are Lipitol, a cholesterol- lowering medication that generates sales of around GBP455m per year, and Seretide, a treatment for asthma and pulmonary conditions.

Originally published by Newsquest Media Group.

(c) 2008 Herald, The; Glasgow (UK). Provided by ProQuest LLC. All rights Reserved.