Wednesday, 5 September 2012

Survey results: alemtuzumab's market withdrawal


"It is clear that the majority of MSers who completed this survey disagree with Genzyme's decision and strategy to withdraw Alemtuzumab from the market."

"The depressing thing for me is that my attempt at explaining why Genzyme made their decision went down like a lead baloon; or may not at least 35% of respondents agreed or were unsure. Clearly Genzyme has a lot of work to do to get the MS community behind them."

You may be interested in the previous posts on this topic:


28 Aug 2012
Genzyme must resubmit Lemtrada application to FDA Boston Herald Sanofi subsidiary, Genzyme Corp. of Cambridge, said today it has received a refuse to file letter from the U.S. Food and Drug Administration for approval of ...
28 Aug 2012
The graph below compares the search volume index of alemtuzumab to CCSVI. To make the graphs readable I had to do a log conversion of the search volumes, which are given by week. To do the log conversion I simply ...
27 Aug 2012
Alemtuzumab: a refuse to file letter from the FDA. Cambridge, MA – August 27, 2012 – Genzyme has announced that it has received a "Refuse to File" letter from the U.S. Food and Drug Administration (FDA) in response to the ...
22 Aug 2012
Alemtuzumab remains in the news. Sanofi pulls Campath to clear way for higher-priced Lemtrada FiercePharma. Genzyme has been developing Campath-slash-Lemtrada for MS, hoping to become a big player in that disease ...

21 Aug 2012
"Yesterday's post on the withdrawal of alemtuzumab to prevent off-license use of the oncology version of alemtuzumab (Mabcampath) resulted in a flurry of discussion and criticism. With some of the latter occurring off-line.
20 Aug 2012
This means that alemtuzumab will no longer be available as a licensed product in the UK once existing supplies run out. This action is not being taken for any reasons related to product safety, efficacy or supply, but as part of ...
21 Aug 2012
Alemtuzumab is being pulled in the US as well. (Reuters) - Sanofi's rare disease unit Genzyme is pulling leukaemia drug Campath to prepare for its launch under a different dosage and as a multiple sclerosis treatment that ...
21 Aug 2012
When alemtuzumab-treated MSer's immune systems recover or reboot themselves, it begins to attack other parts of their body; most commonly the thyroid gland. Dr Coles, in Cambridge, believes that they can reduce the risk ...

15 comments:

  1. to say that patients have grown very sceptical of the MS "care" industry is an understatement.

    Not your fault - just the by-product of years of false promises and deception

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  2. Genzyme want to make sure there is a protocol in place so that all MSers treated with alemtuzumab get continuing care. I don't know of any neurologist in this country who in prescribing off label alemtuzumab was not going to do the continuing care- it would be more than his licence was worth not to. Also any MSer who was asking for alemtuzumab off licence would already have looked into its pros and cons, and would probably have more understanding of the current MS options for treatment than the general MSer, and would probably have had to jump through hoops to find someone willing to prescribe it. Now that has been taken away by Genzyme's decision, which is more about the money Lemtrada will bring in than customer care, whichever way they dress it up. It was- wait for the phase 3 trials to conclude, now it's- wait for the EMA's decision, and then- wait for NICE's decision. So what have you got to offer for early aggressive MS?
    Natalizumab, which comes with the risk of IRIS if you stop taking it- although it is thought that maybe you should have a holiday from it at some point- and PML, although that depends on your JV status, but just because you're negative one month doesn't mean you won't be positive the next, and can you take it for the next 10, 20 years?- who knows?
    Mitoxantrone- but you have a lifetime dose limit, and there is a risk of leukaemia and it's cardiotoxic.
    Fingolimod- cardiac problems in some. Not sure whether all PCT's are allowing its prescription yet.

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  3. I understood your explanation but Anon 9.34 is right - "any MSer who was asking for alemtuzumab off licence would already have looked into its pros and cons, and would probably have more understanding of the current MS options for treatment than the general MSer, and would probably have had to jump through hoops to find someone willing to prescribe it"

    Last year I picked rituximab rather than asking for alemtuzumab because I knew the possible side effects of alemtuzumab and the type of monitoring it needs. I doubt the neuros (not MS specialists) would have agreed if I had pushed for alemtuzmab. Even if they had agreed I would not have been confident they can handle it without pharma company training and support.

    But if a patient is being treated in a different type of place by a different type of team, why should they be denied?

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    1. I'm considering Rituxumab - can I ask when you took it, how you've been (MS and side effect-wise) and how your neuro decided on disease and need for retreatment (there's a much less clearly defined doseage/frequency regime it seems to me vs Alem). What made you decide Rituxumab was 'safer' than Alem? Less data of safety re: former it appears?

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    2. The rituximab was for my daughter (still a minor). She took the first course in Feb and the second course is this month 7 months after the first.

      There was an MRI in the 5th month and it was excellent - for the first time there were no new lesions at all. Of the older lesions, the newest ones have gone.

      I feel she does not get as tired as she used to. But symptoms haven't improved and she now has a dull headache every day. I don't know if that's an MS symptom or a rituximab side effect.

      A few weeks after the first course she had a relapse, which must have been on its way. At the moment she again has blurring in one eye. Not sure if it's a relapse, as she also had a cold and cough recently (first infection or illness since rituximab).

      About safety:
      Prof G has posted a lot on the possible complications of alemtuzumab (see the links above). Rituximab doesn't have any such complications. Neuro said the rheumatologists use it all the time and it is very safe.
      It does come with a scary PML warning, and there is no data about PML risk for MSers on rituximab. Among rheumatoid arthritis patients the PML numbers are very small.

      There's supposed to be a danger of opportunistic infections, but my daughter hasn't had any. Before the first course she was tested for many things (including hepatitis, TB). We got her a flu shot and got her up-to-date on vaccinations.

      There is also a danger of serious infusion reactions. My daughter was pre-treated with solumedrol etc and the infusion was given very very slowly. She had no problems.

      Re-treatment: As I found recently, this is a grey area even for RA. Our neurologist decided to do the re-treatment.

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    3. Thats very interesting - thanks for the reply. Would you be willing to share the name of your neuro?

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    4. You must be in the UK. It wont be much use

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    5. What I meant was that you are probably in the UK but we are not

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  4. Prof G,

    I think you are on thin ice defending Genzyme's position. You take 'consulting fees' from the company so are not going to bite the hand that feeds you.

    Imagine if Prof G, a neurologist, earning £125K a year (NHS consultant) was taken off the medical register (i.e. could no longer practice) and appeared 6 months later as Prof G, immunoligist, and earnign £500k a year. It's the same person (as is alemtuzumab), tiny bit of re-training, but now costs four times as much.

    Any fool could see that this was rip-off Britain at it's best i.e. someone selling the same old thing for four times as much. Let genzymes PR department do the dirty work. Professionally, I think the whole set up where doctors who get paid fees from the companies whose drugs they prescribe stinks. I'd argue that you either work for the NHS or a commercial company and having a foot in both camps is the worst scenario. You argue that there's no other system i.e. you have to do it this way. I think it the fees influence your judgement. You say when you have a conflict of interest, but never say how much you receive in consulting fees from the various companies. Given the revenues involved in MS drugs, I suspect the fees are very substantial. It's a pity that the system has to work this way. It's sad that a neuro comes out fighting for a company who are attempting to quadrple the price of an old drug and, by taking it off the market wil prevent cancer sufferers and MS sufferers from accessing it.

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    1. cancer sufferers will get it- maybe even for free-it will be given on a named patient basis. I also hope that MSers who have already received alem either on or off trial will be able to access it in the meantime if they need another dose. Frankly, being in with big pharma is the only way we are going to get new MS drugs, and I know they have to make a profit, so some sort of price hike was likely- and we don't know how much yet- it's taking it off the market that upsets me

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    2. Prof G is small fry. Rumour on the street is that Prof. Compston and Dr Coles have received upward of £2M from Genzyme to fund a Chair of Neuroimmunology at Cambridge.

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    3. A huge amount of money has gone into doing trials of alemtuzumab for MS.

      Think of it as spending a huge amount on remodelling and renovations of an old house, perhaps even more than the original value of the house.
      After that you can't sell it at the old price.

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    4. Anon: £2M is wrong it was actually $6M; that is $6,000,000! Possibly just enough to influence opinions?

      http://www.neuroscience.cam.ac.uk/news/article.php?permalink=fa17475030


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    5. It is not the amount that you need to worry about, but the knowledge that both Professor Compston and Dr Coles have a potential conflict of interest. Therefore you need to interpret their comments with this in mind. I have nothing against conflicts of interest, we all have them, what I am against in not declaring them. Hence my previous rants about Zamboni failing to declare his when he published his CCSVI paper.

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  5. To fund a chair.....The Prof Coles Chair of Neuroimmunology?

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