Government minister demands ‘secret data’ from drug companies to be handed over to NICE

The big pharmaceutical companies are to be ‘shamed’ into handing over their secret data on the effects of antidepressant medications, amid growing concern that the ‘sunshine pills’ may not work as well as originally promised.

A government minister has taken the unprecedented step of calling on the drugs companies to give the data to the body that will review the current depression guidelines, the National Institute for Health and Clinical Excellence (Nice). Ivan Lewis, the minister with responsibility for mental health, said that ‘a failure to do so would leave the inevitable impression they had something to hide’.

Nice, the body that looks at the effectiveness of all treatments and recommends to the NHS how they should be used, is embarking on a fresh look at the antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Its most recent guidance was published four years ago. However, the organisation has no legal right to see unpublished data and can only request it from a company, which might refuse to give it if the findings were negative.

Backed by the government, Nice is now set publicly to ask for all the data, which would leave the companies facing huge criticism if they did not hand it over. The toughening stance towards the companies follows the publication last week of a major review that examined all available data on the drugs, including trials that had not been published.

It showed that antidepressants taken by millions of people worldwide did not appear to work well – unless they were being given to the most severely depressed patients. They found that when patients on the drugs were compared with those who were taking a placebo they showed similar rates of improvement.

The number of prescriptions for antidepressants hit a record high of more than 31 million in England in 2006, with more than four million people thought to be on them. Even though official guidance stresses they should not be a first-line treatment for mild depression, they are still being routinely prescribed.

Lewis said: ‘I have no doubt that medication can and does help some people with mental health problems. Equally a major expansion of psychological therapies that Alan Johnson [the Health Secretary] announced last week reinforces the need for an end to the “prescription not therapy” culture which has characterised our mental health system.

‘I would call on any company in possession of any relevant evidence to make it available to Nice. The failure to do so would leave the inevitable impression that they have something to hide.’

Dr Tim Kendall, head of the National Collaborating Centre for Mental Health, said it had proved impossible to get access to unpublished trials in the past. ‘We know that there have been thousands of trials since the drugs were licensed. We would like to use the data and recrunch it using our own methods and do a proper analysis.’

In 2005, the Labour manifesto included a promise to make it mandatory for companies to hand over published data, but under EU law Britain is unable to force foreign companies to do so.

13 Responses to “Government minister demands ‘secret data’ from drug companies to be handed over to NICE”

  1. truthman30 Says:

    So 17 years later NICE decide to demand the original SSRI clinical trial data from the drug companies…

    Why was it not requested under the FOI act sooner?..

  2. mjrobbins Says:

    Re: Truthman

    NICE have actually been very sensible all along. The revelation that anti-depressants aren’t much better than placebos is very old news, and NICE’s existing guidelines advise against using drugs for mild depression. Their latest move is in response to the University of Hull’s study, and to be fair they’ve acted within days.

    I’ve written a blog about this story myself, as I’m a scientist who used to suffer from depression. It’s at http://layscience.net/?q=node/35 if you’re interested.

  3. BOB FIDDAMAN Says:

    Ivan Lewis, the minister with responsibility for mental health, said that ‘a failure to do so would leave the inevitable impression they had something to hide’.

    No shit Sherlock!

    Fid

  4. Lynn Says:

    I hope more people in the U.S. government join efforts like this one.

  5. truthman30 Says:

    I will read your blog in depth later but one paragraph you wrote which struck me was :

    “We do have a problem here with Big Pharm though. Pharmaceutical companies were able to systematically manipulate the science literature to promote their products and squash unfavourable reviews. Some sort of intervention is required here from on high, and Ben Goldacre makes some interesting suggestions here (also includes some great references looking at Big Pharm tactics).”

  6. Martin Says:

    Re: Truthman

    “Pharmaceutical companies were able to systematically manipulate the science literature to promote their products and squash unfavourable reviews.”

    I do think it’s important to understand the context of this though. Anti-depressants *did* work (contrary to poor reporting), the scientific community *did* spot this a while back, and NICE *did* respond appropriately at every stage. Also no data was actually falsified, just occasionally omitted or duplicated. Big Pharm was able to manipulate the literature, not invent it.

    Obviously there’s a regulatory problem here, but I think it would be easy to run away with a couple of quotes and say “Oh My God the whole drug science industry is corrupt and dangerous”. That would in itself be a bit of a distortion of the facts.

  7. admin Says:

    Martin – I’m not sure where you’re coming from – take studies 329 & 377:
    In October 1998 an internal, confidential SmithKline Beecham document about studies 329 and 377 says “… the data do not support a label claim for the treatment of Adolescent Depression… efficacy had not been demonstrated.”

    Specifically about Study 329 “…the study failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures.” In other words – it didn’t work.

    About Study 377 we read “… failed demonstrate [sic] any separation of Seroxat/Paxil from placebo.” In other words – Seroxat didn’t work.

    “Data from these 2 studies are insufficiently robust to support a label change and will therefore not be submitted to the regulatory authorities.”

    Now we move on to March 1999, to a fuller manuscript of Study 329 being prepared for publication. This was written by Sally K Laden but was attributed to Marty Keller, Neil Ryan and colleagues. (I believe this is what is known as ghostwriting).

    If you go page 4 you will see the conclusion reads “Paroxetine is a safe and effective treatment of major depressive disorder in the adolescent patient.”

    You can see that Sally/Marty’s spin has quickly moved on from that of SmithKline Beecham only 5 months previously. In fact you might be forgiven for wondering how these two different conclusions could be reached from the same data…

    Now on to March 2001 – internally at least SmithKline Beecham seem to have understood what the data from Study 329 really said. In an email to Cohn and Wolfe, the company said: “Originally we planned to do extensive media relations surrounding this study [329] until we viewed the results. essentially the study did not really show Paxil was effective in treating adolescent depression, which is not something we want to publicize.”

    However, by August 2001 SmithKline Beecham Paxil Product Management was writing to all sales representatives selling paxil and telling them about Marty Keller’s “cutting edge, landmark study which was the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression.”

    Now that’s what I call distortion of facts…

    Read the whole story here:
    https://seroxatsecrets.wordpress.com/2007/06/15/and-while-were-talking-about-study-329-here-are-some-seroxat-secrets/

  8. BOB FIDDAMAN Says:

    So antidepressants for people suffering with mild to moderate depression are about as effective as taking a placebo?

    Basically then, are we to beleive that an antidepressant (or placebo) is merely doing the work of a shrink/counsellor?

    In essence, this seems to be the gist of things doesn’t it? Or have I got it all wrong?

    Take an antidepressant for mild to moderate depression and the patient ‘may’ feel they are getting better.

    Go talk to a shrink/counsellor and the patient (over time) will feel they are getting better.

    Take a placebo for mild to moderate depression and the patient ‘may’ feel they are getting better.

    I’m surprised there has been no entrepreneur who has latched onto this very lucrative market.

    Think about it. A drug that claims to cure your depression but really it’s a sweet – the patient, obviously does not know this.

    You could get past the FDA/MHRA with the ingredients of the drug as both regulators seem pretty useless when it comes to regulating the drugs we take anyway.

    If there were only such a market eh?

    It seems Pharma have the stranglehold on this too because basically their drugs to cure depression on placebos with chemicals.

    The only benefit seems to be long term adverse reactions. Maybe we should thank Pharma for showing us what addiction feels like, giving us sleepless nights, electric zaps jolting through our bodies, heightened aggression, feelings of suicide and homicide plus a host of other reactions that accompany these drugs?

    End of the day, Pharma and the regulators have lied to us all. For years they have touted ‘The benefits far outweigh the risks’ line.

    Their studies are akin to giving a small child a gun, leaving the child in a room and intermittently allowing a group of people into that room. Some of the people want to show the child love, others want to kill the child. The child does not know the good from the bad so shoots and kills 3 random people. Luckily for the child, he kills one child murderer – Phew! these guns can come in pretty handy, it saved the child from being murdered. Let’s publish the results, it don’t matter about the two innocent people that the child killed… at the end of the day, the gun saved this child’s life!

    An extreme analogy, I agree, but one that is the basis of clinical trials.

    Or am I wrong?

    Fid

  9. truthman30 Says:

    The way i see it is..

    Back in 1991 when GSK did clinical trials for Seroxat, they were competing for market share with Prozac, whether the drug worked or not for depression was not really the issue.
    They had aquired paroxetine from Ferrosan and they had invested so much in their clinical trails by then that they weren’t going to let a minor thing like “efficacy” get in the way of their new blockbuster.
    So.. They changed endpoints, doctored the reults to show paroxetine was more favourable , submitted only the “positive” clinical trials and hid the negative ones away.
    But it was really when they discovered the market for social anxiety disorder that they began to look for other ways to market Seroxat.. I would be interested to know what trials they did for Anxiety, PTSD and panic attacks? .. Because they pushed this poison for those “disorders” too..
    How ineffective was it for those conditions?…
    It all seems to ridiculous now when we look back at how this scam was perpetrated, how easily it was conceived, and without remorse, how easily GSK got away with it , but when seen in context it makes perfect sense.. The perfect crimes always do…

  10. Matthew Holford Says:

    Martin wrote:
    “…Obviously there’s a regulatory problem here…”

    The “problem,” such as it is, is endemic. Nobody misunderstands the issues, or if they do, then they’re beyond stupid, and shouldn’t be in the positions that they are. The control of original data permits all kinds of dubious activity. Why do we keep having these “shock, horror” stories of dangerous drugs. It’s very simple: the original data is not being scrutinized, and we know this, because the MHRA told the Health Select Committee so, a couple of years back.

    Should we move on, and discuss conflicts of interests, in the writing of “impartial” academic papers. Or suppressing negative data? What about dubious marketing practices, including bribery?

    As Mr Admin suggests, the combined effect of this business plan (because that’s the only description that seems to fit this course of conduct, that I can think of), permits shite to be characterized as excellence.

    Let’s not pretend that science is being pursued here, eh?

    Matt

  11. Lynn Says:

    Martin,
    The author on this website has written some helpful things about antidepressants and pharmaceutical companies. http://www.prozacbacklash.com

  12. Martin Says:

    Re: Lynn – many thanks for the link, I’ll have a look later.
    Re: Matt and Truthman – I’m not being funny, but I’m not sure what point you’re making in relation to my earlier comment? By no means am I underestimating the scale of the problem – the report by the MHRA today on GSK is shocking. You can be a pessimist and say “oh my god the whole drug industry is corrupt”, or you can look at some of the positives – medical authorities are tackling these problems and it’s getting progressively harder for them to get away with this kind of thing in 2008.

    If anyone’s interested, I’ve just blogged on the latest report from the MHRA on GSK here: http://layscience.net/?q=node/65

  13. Martin Says:

    Sorry – didn’t mean to include Truthman in that last “re:”.

    Re: Admin “I’m not sure where you’re coming from”, I think we’re on the same page, I think we just crossed wires a bit. I’ve just outlined the same story at layscience.net so I’m well aware of the facts of GSKs case. I was just trying to point out that I’m optimistic that the ways in which companies like GSK can manipulate date are shrinking in number, and that it wouldn’t necessarily be right to extrapolate from these cases and say the whole industry is corrupt from top to bottom (like some elsewhere are suggesting).


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