It makes for interesting reading. Some of the medicines exceeded predicted use. These include the Z-drugs in insomnia, varenicline (Pfizer’s Chantix) for smoking cessation, entecavir (Baraclude, BMS) in chronic hepatitis C infection, ezetimibe (Zetia, Merck) in lowering cholesterol and hormonal therapies in breast cancer, and a handful of different drugs for treating osteoporosis.

Interestingly, the four Alzheimer’s disease treatments that have been the subject of so much litigation over access in the past couple of years were also prescribed more often than expected.

Conversely, several drugs were used less than had been predicted. Among these were the antibodies omalizumab (Xolair, Roche/Novartis) in asthma and natalizumab (Tysabri, Elan/Biogen Idec) in multiple sclerosis, drotecogin alfa (Xigris, Lilly) in sepsis, riluzole (Rilutek, Sanofi-aventis) in motor neurone disease, and the three antiobesity treatments orlistat (Xenical, Roche plus GSK’s otc Alli), sibutramine (Reductil, Abbott) and the now-withdrawn rimonabant (Acomplia, Sanofi-aventis).

The statistics were welcomed by the Association of the British Pharmaceutical Industry, but criticized the report because of the way some of the figures had been calculated – it thinks some of the predictions were too low in the first place. In addition, current data collection methods are unable to pinpoint what indication a medicine is being prescribed for, which can also skew results.

The group accepted that the data they were working with were not perfect, and that for future annual reports it hopes to improve data collection and reporting, and also include more drugs in the analysis. In particular, it says it needs to glean drug utilisation data from other sources, such as clinical networks or the industry.

Its director general, Richard Barker, said that ABPI would be the first to applaud if more patients were getting the medicines NICE has approved in most disease areas, but it wants these statistics to be compared with uptake in other European countries.

“Enthusiasm over the results is tempered by the knowledge that not only are there other medicines being prescribed less than predicted but also, even where uptake is generally good, there are still areas of the country where postcode prescribing is alive and well,” he said. “It is essential that the way of calculating the “predicted” use of medicine is as robust as possible.”

Latest government figures show a big rise in the number of animal experiments, but this is underpinned by an increase in investment in research

The number of animal experiments carried out in the UK last year topped 3.5 million, representing a 14 percent increase on the year before. However, industry claims this is a result of greater investment in R&D, and the fact that increasing amounts medical research is now being carried out into complex diseases.

“Because the UK is recognized as among the best in the world, investment within academia and industry is going up,” claimed a spokesman for the Association of the British Pharmaceutical Industry. “The advance of science has led to new classes of medicines that target disease with much greater accuracy. Most research is still done traditionally in test tubes, but this accuracy means new medicines have to be tested in the final stages on animals that are much closer to humans to show that they work and they are safe.”

The bare numbers are now back at the level they were in 1988, and more than three-quarters of the tests are on rodents. The figures show a dramatic increase in the use of fish – an 85 percent rise since 2007 – as a result of the growing reliance on zebrafish in early research. Many mice and fish are used simply to breed better models of serious illnesses such as cancer or Alzheimer’s, or to replace higher animals such as monkeys or dogs, according to UK pressure group Understanding Animal Research.

Home Office minister Lord West stressed that tests are only allowed to take place when there is no option and can be justified.

“As the regulator we ensure that a proper balance between animal welfare and scientific advancement is maintained; and that the regulatory system is effective, efficient and impartial,” he said. “Advances with non-animal test methods continue to be made, but at present licensed animal use remains essential to develop improved healthcare technologies.”

However, Michelle Thew, chief executive of the British Union for the Abolition of Vivisection, condemned the increase.

“This shocking rise in the numbers of animals subjected to experiments is an outrage,” she said. “The UK claims to have the tightest regulation animal testing in the world, but it is clear that this is empty rhetoric. We should be leading the way in reducing animal testing. Unfortunately, these latest statistics show there is a long way to go.”

Statins should be given to people with high blood pressure or diabetes, even if they don’t have heart disease, according to a study published in the British Medical Journal. While several studies have shown that statins benefit those with cardiovascular disease, this is the first large study which looked at statins as primary prevention in those who were otherwise healthy.

The international team of researchers looked at 10 trials, involving more than 70,000 patients, all of which compared statin therapy with placebo or a control group, and patients were followed for at least four years. They found that statins reduced deaths from all causes by 12 percent and—importantly—reduced the risk of major events such as stroke or heart attack by 30 percentin those without a history of heart disease. These risk reductions are similar to those seen previously in secondary prevention with patients who have established heart disease.

The data suggested that those over 65 with risk factors such as high cholesterol or diabetes were most likely to benefit from long-term statin use, although additional ways of predicting the risk would be useful in identifying those in greatest danger of developing cardiovascular problems. “Given the favourable effects of long term statin treatment, it would be wrong to deny these benefits to people at increased risk for cardiovascular disease,” the authors claimed.

Related articles:

• Statin Cuts Heart Attack Risk in Healthy Too (findmeacure.com)
• Statins ‘cut risk of dying by more than a tenth’ (telegraph.co.uk)
• Statins cut heart risks even in healthy patients (ctv.ca)

The European Commission has accused the pharmaceutical industry of delaying the entry of generic drugs to the market. As a result, it intends to step up its scrutiny of the sector under EU antitrust law. “We must have more competition and less red tape in pharmaceuticals,” claimed Competition Commissioner Neelie Kroes. “The inquiry has told us what is wrong with the sector, and now it is time to act. We will not hesitate to apply the antitrust rules where such delays result from anticompetitive practices.” The first of these antitrust investigations are already under way.

According to its final report on competition in the pharmaceutical sector, the cost of delayed generic entry is substantial. Based on a sample of medicines facing loss of exclusivity in 17 member states between 2000 and 2007, they found that patients waited an average of seven months for generics to become available after the patent expired. This increased spending by 20 percent.

The Commission cited a number of tactics that pharma companies use to delay generic entry. “[It] will be looking for things like false safety claims or obviously unfounded legal arguments on data exclusivity,” according to Christopher Thomas, a Brussels-based competition law partner at the law firm Lovells. “It is interested in settlements that both limit generic entry and have some element of value transfer to the generic company. That could be a cash payment, it could be a licence of some other product, and for me the most interesting thing is that within the Commission’s concept of a reverse payment settlement is a licence agreement enabling the generic company to enter the market early, before patent expiry, subject to the conditions of the licence agreement. The licence terms limit generic entry and the licence itself—the ability to go onto the market free of the risk of being sued—is the value transfer.”

It also expressed concerns about aspects of competition between originator companies. “This is rather vaguer and there will be fewer cases,” Thomas said. “What they have in mind is defensive patenting where it can be shown that the purpose of the patenting strategy is only to exclude a competitor without actually pursuing innovative efforts themselves. These are purely blocking tactics, though drawing the line between this and normal protection of a product is going to be very hard.” It also mentions refusal to grant a licence for unused patents. He adds that although this is mentioned in existing law, the circumstances of when it is actually unlawful is quite restricted.

The Commission also wants member states to actively encourage a greater use of generics. The report calls for them to introduce compulsory generic substitution for pharmacists, encourage doctors to prescribe the substance rather than the brand, and reimburse at the level of the lowest priced product. While some member states have had these policies for some time, Thomas said that it’s interesting the Commission is explicitly coming out in favour of these policies as part of a broader initiative to reduce drug costs for national health budgets. “To me, that’s the theme—when you look down the list of what the Commission is proposing, in reality they’re asking the member states to take action,” he said.

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• EU’s Neelie Kroes turns to Shakespeare to criticise ‘rotten’ drug industry (telegraph.co.uk)
• E.U. Warns Drugmakers on Blocking Generics (nytimes.com)
• EU warns of antitrust probes into drug makers (ctv.ca)