Independent Exclusive:

NHS pays millions of pounds more than it needs to for drugs

Many alternatives available for a small fraction of the price

The National Health Service is spending almost £25m a year on supplies of an antidepressant drug despite evidence that it has little clinical advantage over an almost identical medication which costs a fraction of the price.

An investigation by the Bureau of Investigative Journalism (BIJ) for The Independent has raised questions about the only independent study to find evidence that the drug, Cipralex, is clinically more effective than its out-of-patent predecessor, Cipramil. Both have a similar main ingredient but Cipralex costs £14.91, while the older Cipramil is available for just £1.31.

The inquiry sheds light on the lengths to which pharmaceutical companies go to extend the lives of drugs whose patents are about to run out.

Cipralex, or Lexapro, as it is known in the US, is one of the most widely prescribed antidepressants in the world, but has been criticised for being little different from Cipramil, whose patent expired in 2002.

There has only ever been one independent, direct comparative study which suggests that Cipralex is clinically more effective. The Bureau’s investigation has now established connections between an individual working for Lundbeck, the Danish company that makes both Cipralex and Cipramil, and Arbacom, a Russian company that sponsored the independent head to head trial.

That trial helped to make the case for the new drug to clinicians, costing the NHS millions of pounds more in prescription costs. Last year, the health service spent about £3.3m more on Cipralex than on Cipramil, although the older drug was prescribed nine times as often. A paper based on the Arbacom trial, which was published in November 2007 in the medical journal Clinical Therapeutics, acknowledged "Alexander N Postnov and Markus Kornfeld at Arbacom for their help in revising the manuscript". It appears that Mr Kornfeld may have assisted at the same time that he and his wife, Asa, were working for Lundbeck.

The BIJ has seen an email from Mr Kornfeld, dated August 2005, in which he sent a protocol for the trial to a Russian woman, copied to someone called "Alex", with a message listing errors in the protocol. In August 2005, Mr Kornfeld was a Lundbeck consultant and his wife was a senior employee.

Mr Kornfeld's email also forwarded a case-report form. The document's properties appear to show this was created only two days previously, and had been modified by a different Lundbeck employee. Mr and Mrs Kornfeld no longer work at Lundbeck and neither responded to requests for comment. Anders Gersel Pedersen, Lundbeck's executive vice-president for drug development, agreed that Mr Kornfeld was a consultant at the time but said nobody at Lundbeck, to the best of the company's knowledge, had known about the Russian Arbacom trial.

The BIJ was unable to contact anyone from Arbacom, which does not appear to have been named as a sponsor of any published research before or since. The bureau uncovered further connections between Lundbeck and Arbacom. While the Arbacom trial was under way, Lundbeck entered into a research contract for an epilepsy drug with another Russian company.

In 2006 and 2007, when the Cipralex trial was being carried out, Lundbeck negotiated a research contract for an epilepsy treatment, VLB01, with the Russian firm Valexpharm. Documents seen by the bureau attach a value of $2m to the deal. Mr Kornfeld and Alexander Postnov, who were acknowledged in the Clinical Therapeutics paper about the Cipralex trial, were sent the contract. It is not clear who Mr Kornfeld was working for at this time, but Mr Postnov was using his Arbacom email address. Valexpharm appears in some listings at the same address as Arbacom, and Valexpharm appears to have registered Arbacom's telephone numbers. Another employee apart from Mr Postnov appears to have worked for both firms.

A spokeswoman for Sistema, Valexpharm's parent company at the time of the trial, denied that Arbacom was related to Sistema in any way.

However, Valexpharm's current chief executive Alexander Bakhutashvili, a former president of Valexpharm's immediate parent company Binnopharm, described Arbacom as a "partner generic company".

Mr Pedersen insisted that there was "absolutely no linkage" between the epilepsy drug contract and Arbacom's Cipralex trial. He said Arbacom had been trying to prove that Cipralex and Cipramil were identical, with the aim of producing a cheaper version of the former. When the results came out proving the clear superiority of Cipralex, he said, Arbacom offered to sell the data to Lundbeck. "We told them to publish," Mr Pedersen said. The company ended up paying for Arbacom's data, he added, but this was its only involvement in the trial. "Regulators prefer studies done by pharmaceutical companies because they are rigorous," Mr Pedersen said. "There was no reason at all for us to be involved with the Arbacom trial."

But questions remain over whether Cipralex represents good value for money to the NHS. The drug has been cited as an example of "evergreening" – a strategy manufacturers use to extend the life of a drug patent. When a drug is about to go off-patent, which would allow it to be copied and sold in a cheaper generic form, the company slightly alters the chemical make-up of its drug and files a new patent. This version is then protected and sold as a new drug, although it often contains similar ingredients to the old one.

Cipramil's patent expired in 2002, at a time when it accounted for 80 per cent of Lundbeck's revenues. Just before this, Lundbeck released Cipralex on to the market. In an article in the British Medical Journal, a senior cardiologist argued: "When resources are limited, giving one patient an expensive drug with no added value when cheaper alternatives exist stops other patients getting treatments they need."

Lundbeck rejected suggestions of "evergreening" in the case of Cipramil and Cipralex. "That is simply not the case," said Mr Pedersen.

A spokeswoman from the Department of Health said: “We are modernising the NHS so we can give patients better access to the medicines they need. That is why we are changing the way drugs are priced to ensure they offer value for money.

“Doctors should be able to focus on what matters most - achieving the best health outcomes for their patient. Value-based pricing will ensure that the price the NHS pays for medicines is based on an assessment of their value, looking at the benefits for the patient, unmet need, therapeutic innovation and benefit to society as a whole.”

www.thebureauinvestigates.com

PROMOTED VIDEO
Life and Style
ebookNow available in paperback
ebooks
ebookPart of The Independent’s new eBook series The Great Composers
Latest stories from i100
Have you tried new the Independent Digital Edition apps?

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Recruitment Genius: Engineering Project Manager

    £35000 per annum: Recruitment Genius: This company is going through a period o...

    Recruitment Genius: Senior Software Developer - Java

    Negotiable: Recruitment Genius: This award-winning digital publishing solution...

    Austen Lloyd: Construction Solicitor - City

    Excellent Salary: Austen Lloyd: NON-CONTENTIOUS (0-2 PQE) - A rare opportunity...

    Recruitment Genius: Senior Financial Analyst

    Negotiable: Recruitment Genius: A Senior Financial Analyst is required to join...

    Day In a Page

    Isis hostage crisis: Militant group stands strong as its numerous enemies fail to find a common plan to defeat it

    Isis stands strong as its numerous enemies fail to find a common plan to defeat it

    The jihadis are being squeezed militarily and economically, but there is no sign of an implosion, says Patrick Cockburn
    Virtual reality thrusts viewers into the frontline of global events - and puts film-goers at the heart of the action

    Virtual reality: Seeing is believing

    Virtual reality thrusts viewers into the frontline of global events - and puts film-goers at the heart of the action
    Homeless Veterans appeal: MP says Coalition ‘not doing enough’

    Homeless Veterans appeal

    MP says Coalition ‘not doing enough’ to help
    Larry David, Steve Coogan and other comedians share stories of depression in new documentary

    Comedians share stories of depression

    The director of the new documentary, Kevin Pollak, tells Jessica Barrett how he got them to talk
    Has The Archers lost the plot with it's spicy storylines?

    Has The Archers lost the plot?

    A growing number of listeners are voicing their discontent over the rural soap's spicy storylines; so loudly that even the BBC's director-general seems worried, says Simon Kelner
    English Heritage adds 14 post-war office buildings to its protected lists

    14 office buildings added to protected lists

    Christopher Beanland explores the underrated appeal of these palaces of pen-pushing
    Human skull discovery in Israel proves humans lived side-by-side with Neanderthals

    Human skull discovery in Israel proves humans lived side-by-side with Neanderthals

    Scientists unearthed the cranial fragments from Manot Cave in West Galilee
    World War Z author Max Brooks honours WW1's Harlem Hellfighters in new graphic novel

    Max Brooks honours Harlem Hellfighters

    The author talks about race, legacy and his Will Smith film option to Tim Walker
    Why the league system no longer measures up

    League system no longer measures up

    Jon Coles, former head of standards at the Department of Education, used to be in charge of school performance rankings. He explains how he would reform the system
    Valentine's Day cards: 5 best online card shops

    Don't leave it to the petrol station: The best online card shops for Valentine's Day

    Can't find a card you like on the high street? Try one of these sites for individual, personalised options, whatever your taste
    Diego Costa: Devil in blue who upsets defences is a reminder of what Liverpool have lost

    Devil in blue Costa is a reminder of what Liverpool have lost

    The Reds are desperately missing Luis Suarez, says Ian Herbert
    Ashley Giles: 'I'll watch England – but not as a fan'

    Ashley Giles: 'I'll watch England – but not as a fan'

    Former one-day coach says he will ‘observe’ their World Cup games – but ‘won’t be jumping up and down’
    Greece elections: In times like these, the EU has far more dangerous adversaries than Syriza

    Greece elections

    In times like these, the EU has far more dangerous adversaries than Syriza, says Patrick Cockburn
    Holocaust Memorial Day: Nazi victims remembered as spectre of prejudice reappears

    Holocaust Memorial Day

    Nazi victims remembered as spectre of prejudice reappears over Europe
    Fortitude and the Arctic attraction: Our fascination with the last great wilderness

    Magnetic north

    The Arctic has always exerted a pull, from Greek myth to new thriller Fortitude. Gerard Gilbert considers what's behind our fascination with the last great wilderness