Thursday, 18 April 2013

BG12 generics: a German DIY kit

Don't formulate, or take, DIY-BG12. #MSblog #MSResearch

"Some of you may have have already clicked through the link (DMF DIY), that was posted yesterday on the blog, in a comment, and read the DIY instructions on how to formulate your own version of dimethyl fumarate or BG12 (Tecfidera)."



"I need to stress that this is not something you should be doing. DMF is being used in pharmacological doses and has a toxicity profile that needs to be monitored closely  There is no way to be sure if there are any impurities in this DIY-formulation. Commercial grade chemicals are not pure enough to be used in pharmacological preparations. The impurities may cause serious problems. The reason why the Pharma industry is so heavily regulated is to ensure the drugs that are sold meet strict quality guidelines and that there are no impurities in them."

"Some of you, as usual, will accuse me of supporting Pharma, which is definitely the case. Pharma is really the only show in town and without them drug innovation will grind to a halt. In addition, I have a responsibility to ensuring that the MSers in my care are safe and not taking any undefined risks, which you will be doing by self-formulating and taking DIY DMF capsules."

CoI: multiple

Other posts of interest

23 Jan 2013
"In response to the intense interest on the blog concerning Fumaderm and PML and its possible implications for BG12, we invited Professor Doctor Ralf Gold to contribute a guest post on this topic! I hope it answers some of ...
20 Jan 2013
Therefore there has only been 4 reported cases of PML on Fumaderm, one of which was on Efalizumab a known cause of PML, and one new case on a compounded formulation of fumarate. I hope this clarifies things for our ...
13 Jan 2013
"A form of BG-12 called fumaderm has been used in psoriasis for many years with no major adverse events emerging. I assume the FDA has looked at fumaderm's long-term safety profile and the BG-12 MS data and felt an ...

16 comments:

  1. Totally agree with you Prof G. Well said!

    ReplyDelete
    Replies
    1. Ditto; government has put regulations in place to protect us. Why bypass these and take risks? There are numerous examples of people dying from taking counterfeit drugs.

      Delete
    2. "Why bypass these and take risks?"

      Because you are an individual and live is a risk itself.
      It's ones own choice.

      Regulation just limits the choices you may have.

      Delete
  2. The BigPharma Alternative in practice!

    About time people start hacking these drugs. This is the best way to put pressure on pricing policy...

    in the hope Jürgen Erhardt stays out of court.

    ReplyDelete
    Replies
    1. Drug hacking! I am sure BigPharma would call this something else. It is almost certainly criminal.

      Delete
    2. you are right, $50,000-60,000 per annum for a pill is a criminal offense as 98% of the population lacks the means or the purchasing power to procure it.

      Since un-medicated MS leads to a premature death, BigPharma is a partner in crime.

      I would have certainly tried this procedure if I were un-medicated and un-insured.

      Delete
    3. $50,000-60,000 per annum is cheap; wait until Lemtrada hits the market!

      Delete
    4. I'm taking DIY pills for a year and it improved my state a lot, for the last 6 months I'm next to symptom-free. It costs me like $450/year. It's not illegal since DMF is not a controlled substance by any means, and since it's for personal use (selling them around would be a felony). Since I'm Serbian I really don't have other options to obtain DMF. I don't see up to 3% of impurities as a serious threat, and as of pills being bacteria-free, it's not necessary. Do you sterilize all your food before ingesting it? Guess not. I'm not saying you should make your pills with dirty equipment but DIY pills made by dr Juergen's recipe are reasonably clean and that works just fine.

      Delete
    5. It is not to be expected that dr. Jurgen Erhard is going to court. DMF is a completely free material, even it is a body owned substance and it cannot be patented. It is already 30 years in use against Psoriasis and Arthretic Psoriasis. The costs of 1 kg DMF are about $ 160. How BigPharma can pump this up to $50.000-$60.000 come close to crime and government should come into action.
      There is no reason to use the expensive version for MS, one could easily use the cheap version for psoriasis, the working substance in the various pills that contain DMF is DMF, all other substances in these pills are obsolete.
      The risk of PML is heavily overrated. In the recent 20 years of DMF use in the netherlands, there were only 2 problems with patients, one of them got PML. This was due to NOT following the protocol of half-yearly checking of a number of blood measurement, specifically the lymphocytes. Normal range of Lymphocytes is between 1-3, with using DMF it may go below 1, but it may NEVER be lower that 0,2 , in that case one should stop, at least temporarily, with DMF.

      Delete
    6. So you raise the point of cheap alternative to expensive pharma repurposed drug.

      The problem is that the pharma drug is licensed for the indication and the other is not and therefore Doctors are at risk if they prescribe off licence and importantly prescribe when there is a licensed alternative.

      What you would need if for someone to do the studies to licence the cheap version, then would it be cheap

      Delete
  3. Interesting.

    But I guess it's ones own choice. You can get DMF in pharmalogical purity on the market. What you can get inside your homemade capsules are bacteria and any other impurities.

    I think this is an interesting Big Pharma Alternative, IF you use the correct purity grade, weigh it exactly and fill the capsules with care.

    I like DIY too! :D

    ReplyDelete
    Replies
    1. Agreed Marck,

      but let's draw a decision tree:

      you are a Persian living in Iran under embargo and earn a wage of USD 300/month (Iran is a relevant example as I understand that it suffers from some of the highest rates of MS in the world)

      Interferon is not working on you, Copaxone not allowen in your country (made in Israel), Tysabri not offered in the country, Campath not trialed in the country and Gilneya/BG12/Lemtrada costing more than your flat.

      1) stay unmedicated with the quasi-certainty of disease progression

      OR

      2) Get yourself some DMF with some process risk (purity, bacterial...)

      What would you do?

      Delete
    2. I (bold, underlined, etc.pp.) totally would!

      But it is MY decision to do it. I can't speak for my neighbour nor the person living in the next big city.

      That is why I love this kind of DIY.

      And I read the page and he does a nice step by step instruction and takes care of a lot of things that have to be looked after when you transform an automated process to a manufacturing process in your kitchen.

      BTW, your decision tree isn't really a decision tree.. ;)

      Delete
  4. ...vorsprung durch technique :-)

    ReplyDelete
  5. Thank youuuu! God bless you.

    ReplyDelete
  6. I take DMF capsules for 1,5 years. Produced in a german pharmacy by doc´s prescription. I feel great !
    Tecfidera or whatever, for sure I will not change a da... thing !

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.