Drugs companies 'routinely withhold results of medical trials' from doctors, researchers and patients

Damning report by MPs warns that doctors and patients are being ‘undermined’ on treatment options

Drug companies have “routinely and legally” withheld the results of medical trials from doctors, researchers and patients for decades, MPs have said.

In a damning report, the Public Accounts Committee said it was of “extreme concern” that about half of all trial results for medicines available on the global market were not subject to public and independent scrutiny.

Warning that doctors and patients are being “undermined” in their ability to make informed decisions on treatment, the committee called on the Government to act to ensure that the results of all clinical trials of every medicine currently being prescribed are made available.

The report will significantly increase pressure on the world’s pharmaceutical giants to commit to full transparency over clinical trials.

Critics have accused “Big Pharma” of systematically putting profit before patients, withholding data that might undermine confidence in their blockbuster drugs.

MPs said that “trials which gave a favourable verdict” were “about twice as likely to be published as trials giving unfavourable results”.

The Association of the British Pharmaceutical Industry (ABPI), which represents leading UK firms such as GlaxoSmithKline and AstraZeneca, said that it was “misleading” to say data was being routinely withheld and that results from nine out of every 10 industry-sponsored clinical trials for “recently approved medicines” had been published.

Yet committee member Richard Bacon MP said that results of past trials on medicines still in use today could be of equal concern.

Tamiflu, which for years has been stockpiled by the Government for emergency use in the event of a flu pandemic, caused particular concern to the committee, which said it was “disturbed by claims that regulators do not have access to all the available information” about the drug.

The Department of Health spent £424m on Tamiflu between 2006 and 2013 – despite “a lack of consensus about how well [it] works”, according to Mr Bacon.

He said that the widespread lack of transparency was of “extreme concern” to the committee, adding that recent proposals by regulators and the pharmaceutical industry to open up access to clinical trial results were insufficient.

“The Department [of Health] and the Medicines and Healthcare products Regulatory Agency (MHRA) must make sure, both prospectively and retrospectively, that clinical trials are registered  and the full methods and results of all trials are available for independent wider scrutiny by doctors and researchers.”

The committee also criticised the health standards body the National Institute for Health and Care Excellence (Nice) and the MHRA for not routinely sharing information from manufacturers when licensing medicines.

Dr Ben Goldacre, a leading campaigner for transparency on clinical trials, who gave evidence to the committee, told The Independent that the public had been given “false reassurance” by the pharmaceutical industry and the medical establishment for at least 20 years. “Patients suffer and die unnecessarily because of this,” he said. “It’s fairly unusual that drugs that do more harm than good come to market, but it’s very common that we are persuaded to use the less effective of the available treatments because of withheld trial results.

“When we use the second- or third-best treatment in its class, we are inflicting unnecessary harm on our patients. That’s real avoidable suffering and death. That’s why it’s so tragic that the medical and academic community has failed to address this problem.”

The influential British Medical Journal has also been a vocal critic of the pharmaceutical industry’s stance.

Its editor, Dr Fiona Godlee, said: “The fact that the majority of clinical trials are funded by the people that make and sell the drugs is something that is hard to understand and yet it’s something that is accepted as ‘the way things are done’. At the moment it’s commercial implications that hold sway.”

A Department of Health spokesperson said that it was working with health organisations to make clinical trials more transparent. “All clinical trials conducted in the UK must now be registered on a public database.

“Patients have rightly been concerned about confidentiality in trials so we need to balance the need to make trials more open with making sure patient data is kept safely.”

Tamiflu: the £424m drug shrouded in secrecy

The Public Accounts Committee said it was “disturbed” by claims that regulators did not have access to all the available trial data on the anti-viral drug Tamiflu. There was “limited evidence and widespread disagreement among regulators and other bodies internationally on whether [it] confers any benefits on complications and mortality”, MPs added. Roche has now committed to publishing full clinical trial results on Tamiflu, and the PAC recommended the Department of Health review whether to spend a further £49m on stockpiles.

Life and Style
ebookNow available in paperback
ebooks
ebookA delicious collection of 50 meaty main courses
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
SPONSORED FEATURES

ES Rentals

    Independent Dating
    and  

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

    iJobs Job Widget
    iJobs General

    Recruitment Genius: Sales Executive or Senior Sales Executive - B2B Exhibitions

    £18000 - £30000 per annum: Recruitment Genius: A Sales Executive or Senior Sal...

    Recruitment Genius: Head of Support Services

    £40000 - £55000 per annum: Recruitment Genius: This is an exciting opportunity...

    Recruitment Genius: Warehouse Team Leader

    £22000 per annum: Recruitment Genius: This industry leading company produces h...

    Recruitment Genius: Business Development Manager / Sales - OTE £40,000

    £20000 - £40000 per annum: Recruitment Genius: This IT provider for the educat...

    Day In a Page

    A nap a day could save your life - and here's why

    A nap a day could save your life

    A midday nap is 'associated with reduced blood pressure'
    If men are so obsessed by sex, why do they clam up when confronted with the grisly realities?

    If men are so obsessed by sex...

    ...why do they clam up when confronted with the grisly realities?
    The comedy titans of Avalon on their attempt to save BBC3

    Jon Thoday and Richard Allen-Turner

    The comedy titans of Avalon on their attempt to save BBC3
    The bathing machine is back... but with a difference

    Rolling in the deep

    The bathing machine is back but with a difference
    Part-privatised tests, new age limits, driverless cars: Tories plot motoring revolution

    Conservatives plot a motoring revolution

    Draft report reveals biggest reform to regulations since driving test introduced in 1935
    The Silk Roads that trace civilisation: Long before the West rose to power, Asian pathways were connecting peoples and places

    The Silk Roads that trace civilisation

    Long before the West rose to power, Asian pathways were connecting peoples and places
    House of Lords: Outcry as donors, fixers and MPs caught up in expenses scandal are ennobled

    The honours that shame Britain

    Outcry as donors, fixers and MPs caught up in expenses scandal are ennobled
    When it comes to street harassment, we need to talk about race

    'When it comes to street harassment, we need to talk about race'

    Why are black men living the stereotypes and why are we letting them get away with it?
    International Tap Festival: Forget Fred Astaire and Ginger Rogers - this dancing is improvised, spontaneous and rhythmic

    International Tap Festival comes to the UK

    Forget Fred Astaire and Ginger Rogers - this dancing is improvised, spontaneous and rhythmic
    War with Isis: Is Turkey's buffer zone in Syria a matter of self-defence – or just anti-Kurd?

    Turkey's buffer zone in Syria: self-defence – or just anti-Kurd?

    Ankara accused of exacerbating racial division by allowing Turkmen minority to cross the border
    Doris Lessing: Acclaimed novelist was kept under MI5 observation for 18 years, newly released papers show

    'A subversive brothel keeper and Communist'

    Acclaimed novelist Doris Lessing was kept under MI5 observation for 18 years, newly released papers show
    Big Blue Live: BBC's Springwatch offshoot swaps back gardens for California's Monterey Bay

    BBC heads to the Californian coast

    The Big Blue Live crew is preparing for the first of three episodes on Sunday night, filming from boats, planes and an aquarium studio
    Austin Bidwell: The Victorian fraudster who shook the Bank of England with the most daring forgery the world had known

    Victorian fraudster who shook the Bank of England

    Conman Austin Bidwell. was a heartless cad who carried out the most daring forgery the world had known
    Car hacking scandal: Security designed to stop thieves hot-wiring almost every modern motor has been cracked

    Car hacking scandal

    Security designed to stop thieves hot-wiring almost every modern motor has been cracked
    10 best placemats

    Take your seat: 10 best placemats

    Protect your table and dine in style with a bold new accessory