Beware of the Lundbeck Lollipop!

Lock up your children…Lundbeck are looking for volunteers!

In my last post I wrote about our meeting with Lundbeck in Copenhagen where we put some questions to Dr. Madsen and Mr. Schroll. Their answer to this one made me question my hearing and their sanity, so I had to ask it a second time to clarify….

Question 13. 

Why are you testing this drug, which is well known to be detrimental to children, on children as young as 7 in drug trials? Citalopram and Escitalopram!

Dr. Madsen and Mr. Schroll said that Lundbeck had previously done a number of trials on children and will be doing future trials on children as young as seven. They said that they are mandated by the medicines board to investigate pharmaceutical effects in children in order for them to get approval for any new drug. I asked was this just for childrens medication and was surprised when they said no, that this also included adult medication!

Don’t forget that these mind altering drugs are only approved for Major Depressive Disorder in Adults. Is it possible that a seven year old could have major depression? Even if that were true, would it be be possible to find enough children with Major depression to undergo the number of clinical trials trials it takes to get a drug approved?

I asked was the reason behind this because they were looking for approval for the under 18’s market to make more money. They said no!

I asked if they still intended to do drug trials on children, they replied… “If we want to have drugs approved then we will probably have to, yes”.

To be honest I could not believe what they were saying and so I asked the question again…

If you want to get approval for adult drugs you have to trial them on 7 year olds?

They answered…Correct.

Tony asked if they would they let their own children take part in a clinical trial…Both Dr. Madsen and Mr. Schroll declined to answer that one!

So that means that these Lundbeck drugs in the picture have also been tested on children.

What about the latest Lundbeck reported (by whom) wonder drug for alcoholics which is at the last stages of clinical trials, Nalmefene? I wonder was Lundbeck able to find enough 7-18 year old alcoholics?

The Danish medicines board need to put a stop to this NOW as this is nothing short of child abuse, and considering that the rules are the same for all the other drug companies based in Denmark, this includes Novo Nordisk, Leo pharma and a long list of Danish based pharmaceutical companies, Lundbeck are not alone in doing dubious drug trials on children.

Surely I can’t be the only person who thinks this is so so wrong? There are major protests when drugs are discovered to be tested on animals, so where are the protectors of childrens rights?


6 thoughts on “Beware of the Lundbeck Lollipop!

  1. They said that they are mandated by the medicines board to investigate pharmaceutical effects in children in order for them to get approval for any new drug.

    I don’t believe this. I can understand having to test drugs on children before they are approved for children but to test drugs on children just to see if they are safe is unconscionable. It is telling that neither Madsen or Schroll would agree to let their own children take part in a clinical trial.
    There was such an outcry in Australia against the testing of AstraZeneca’s antipsychotic Seroquel on children which psychiatrist Patrick McGorry was advocating that McGorry had to pull the trial after psychiatrists, psychologists and researchers from Australia, Britain and the US lodged a complaint with the ethics committee of Melbourne Health.

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  2. I know…I was sure I hadn’t heard correctly and that’s why I asked the question again. I also find it very strange and it goes to show, in Dr. Madsen’s case, how these pharmaceutical companies can make a doctor believe that this is acceptable practise. I also said I didn’t believe them!

    I’m ashamed to say that the guy you are refering to (Patrick Mc’Gorry) is Irish and I did read about that yesterday, and he was only testing on over 15s. What chance does a 7 year old have?
    http://www.theage.com.au/national/drug-trial-scrapped-amid-outcry-20110820-1j3vy.html
    Leonie

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    1. I doubt very much that it is a requirement that all drugs be tested on children before they can be approved. I think that your assessment is more accurate — that they are trying to expand their market.

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  3. Child abuse, human rights violation, this is unbelievably wrong on so many levels. What is the rationale for testing these drugs on children? And how can you justify putting these kinds of drugs into a developing brain when alcohol or tobacco are considered unsafe and legally prohibited.

    A mandate from the medicines board just means they have legal permission to do so, it doesn’t make it a requirement so why are they hiding behind that? How exactly do you diagnose depression in a 7 year old? And who would allow their child to participate in a clinical trial and why except for financial gain and if so, should they not be investigated by social services?

    Sorry I am relatively new to all of this but this is by far the most shocking thing I have come across. I would love to know what Unicef’s position is on this, surely they must be aware of it? And how can the Danish government possibly sanction this kind of behaviour?

    I hope the media picks up on this. I would imagine that even those who are pro-pharma and the use of anti-depressants would baulk at this. I am still shaking my head in disbelief. What’s next? The Dr Mengele Institute for Experiments on Children sponsored by Lundbeck, Lilly etc.?!

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  4. From an article in the Danish journal “Pharma”, February 2011: ” The EU directive (2006) now dictates that all companies who develop new medications at the latest on finishing phase 1 trials in adults submit a so-called PIP (Paediatric Investigation Plan) to the European medicine agency, EMA. A PIP can best be described as a kind of “script” on how the company is going to develop the medication in question for the use in children. That means, it’s a plan of the clinical trials to be conducted in children. (…) Only if the paediatric committee gives permission a company may omit to develop a children’s version of its drug. This applies if the drug treats a disease that only occurs in adults, like dementia for instance. In these instances the company is assigned a so-called waiver (dispensation).”

    “Stærkt behov for børneversioner af lægemidler”, http://www.pharmadanmark.dk/publikationer/Fagbladet-Pharma/2011-februar

    So, nope, they didn’t lie to you.

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