Speedier drugs approvals are not necessarily safer

#MSBlog: Speed or safety: choose your fire? 

EpubLexchin J. New Drugs and Safety: What Happened to New Active Substances Approved in Canada Between 1995 and 2010? Arch Intern Med. 2012 Oct 8:1-2. doi: 10.1001/archinternmed.2012.4444.

“A lot of readers of this blog complain about the slow progress of drug development and question why it takes years from the time drug trial results are know to approval of the drug. The latest research shows that drugs that are approved quickly are more likely to be linked to safety problems. The so called priority review process to help MSers gain quicker access to medications comes with a cost. In a publication by Joel Lexchin, a health policy researcher from Canada, showed that drugs approved by Health Canada between following rapid review were almost twice as likely to require a safety warning or get withdrawn from the market compared to drugs approved via the standard review process. Clearly there is a trade-off between rapid access and safety. Choose your fire?”

“Is this safety issue more likely to happen in the USA? The FDA approves drugs more rapidly than  the EMA or Health Canada.  The median review time for the FDA is a 3 months shorter than the other regulatory authorities (<9 months for the FDA, compared to ~12 months at the EMA and Health Canada). Are American citizens better off than Europeans or Canadians with regard to new drug approvals? Or is the FDA exposing MSers to greater risks? Choose your fire?” 

Read whole article: Elie Dolgin. FDA outpaces its global peers at drug reviews. Nature Med. 16 May 2012.

14 thoughts on “Speedier drugs approvals are not necessarily safer”

  1. I can't answer this. Genzyme has withdrawn the drug so we can't use it off license and the EMA may handcuff it for a very small number of MSers. I suspect the FDA will allow it a wider license. There is a chance it won't get a license without more safety data. You can't second guess the regulators. Patience. Is it a virtue?

  2. As far as I am concerned, all these drugs need to be booted into oblivion. They are means for pharmaceutical corporations to exploit already vulnerable sufferers by promising them efficacious ‘cures’ when, in reality, they are effectively screwing up your body by pumping it full of toxic crap. I still think prevention is the best cure. If one already has MS then live with it and try and stay positive. Adopt a good lifestyle and the rest will sort itself out.Despite my hostility to MS drugs, Prof G is using this post to get himself off the hook. MSers have every right to complain about the slowness of things when we consider that many of the medicines trialled to stem progression have already been approved for safety. They’ve been around for more than a generation. They are safe as houses; all you have to do is prove they work in stopping MS progression. In the two years that have passed since Promise 2010 you’ve been dilly-dallying, trying to strategise and what not. It’s only now you’re talking about testing them in living MSers, which will take at least three more years to complete. At that point regulators will mess things up further. If these potential licensed compounds are so hot, why not just give them off-license? Surely that is what any noble clinician will do? Duty of care, hey?Maybe these drugs are just hot air, like everything else in the world of MS. I have no doubt that MouseDoc and MouseDoc Part II: The Reckoning will rush to lambast me, but they do that all the time when one questions their rationales. MSers need neurologists like a moose needs a hat rack.

    1. That's your opinion and in my view it's very misguided. Your point around drugs having passed safety is true but you need to get approval for use in MS otherwise any adverse events would see you swiftly in the slammer. Not sure that's a lambasting? 😉

    2. Dr dre is free to express his opinion. And the rest of us are free to give our opinion of his opinion.I'm sure very few MSers agree with his monstrous advice to just accept their fate and forget about treatment. You certainly don't

    3. Look, before I respond, I don't want the CCVSVI crusaders to think I'm a member of their pointless movement. If anyone asked me what the best joke in MS research has been for the last few years then CCSVI will definitely be the punchline.From what I understand, Dr. Raju Kapoor has been researching phenytoin as a compound to finally stop MS progression for over 20 years now. If he's right, which he seems cocksure, then this is an already available treatment in neurological disorders like epilepsy. To withhold this licenced drug, despite good evidence to indicate it may work, is, in my opinion, absolute neglect on part of the neurology profession. To the Anonymous 12:30pm, you must be mentally incapacitated if you can't make sense of my earlier comment. Doesn't it anger you that phenytoin may stop your MS in its tracks but is being withheld? Are you happy about it? Do you want to get worse? Maybe you do.In fact, I honestly don't think MSers know what they want. They want drugs, but then they don't want drugs, and then they want CCSVI. No wonder progress is so slow. They change like the wind. Just live with it and hope for the best is my motto.

    4. Not sure the phenytoin in optic neuritis study has started yet. Prof G will know.To my mind there are many better candidates out there from our experimental studies but we need the money to put them into trials. This is the sticking point.Keep hoping for the best!

    5. Yep the trial is started last I heard there were about 40 volunteers so far. However, it was shown in the lamotrigine that MSers do not tolerate anti-epileptic doses. So safe in one circumstance is not necessarily safe in another.Now you mention phenytonin because you have heard about it, but now we make the case for amilioride and what about the case for other classes of drugs I could reel off there are quick a few. I think a cocktail would be better than one. Phenytonin was selected because you can load the drug quickly as we believe there is a window of opportunity. However there are other drugs in this class in my opinion are much more effective. However you to have the dose increased slowly as the drug induces enzymes that destroy the drug (it is called autoinduction).I would be gung -ho but I am not a neurologists and I do not have to deal with the consequences. However you need to get the data that it is actually doing some good and that is what you get from trials.What we need is the BPA, get a movement so these drugs can be prescribed whilst the trials are being done, but if the trials do not get done it is a bottomless pit.

    6. Make up your mind Dr Ðre. If all drugs are rubbish why are you angry about phenytoin? And who are you angry with? The neurologist who has spent 20 years working on it for his failure to get it into trials earlier?About Phenytoin being 'withheld' – lots of neuro have hunches about lots of drugs. Phenyoin hasnt even had a phase 2 trial so there is still no no evidence it will do anything for MS. It does have many side effects. But it is out of patent and probably not expensive. Persuade a doctor to write a prescription and buy it for yourself.

    7. Dear Anon 5:57pm,As you so astutely indicated in your comment, phenytoin is a risky proposition, as is most of the crap dished out in the name of MS treatment.Perhaps the concept of objectivity evades you, but for me, to present an argument from both sides is seen as a virtue in educated circles, not a handicap. I, myself, wouldn't take any of these pills or concoctions, but many of you will.I have a duty to question the science of things, to pull neurologists on their actions and their developments. You may prefer to be rampantly obsequious to their practices, but I choose to ask the questions about their doings and chastise them when I believe them to be backtracking. It's called intelligence.

    8. DD, I really hope you're doing something constructive with all your intelligence when you're not hanging around here chastising the people who have spent a good chunk of their lives trying to cure my disease. Because in that last comment you sound more like an attention hound than someone who knows anything at all about what goes on in educated circles.

  3. "Perhaps the concept of objectivity evades you, but for me, to present an argument from both sides is seen as a virtue in educated circles, not a handicap. I, myself, wouldn't take any of these pills or concoctions, but many of you will."WTF? So you won't take any DMD, but feel obliged to pass on your intelligence? What intelligence? I guess you've never had a relapse then, or another and another until your body is worn out just trying to walk? What then, if your neuro offers you a drug, that just may work. And then it does and many years later, you are still mobile? Oh, not Dr Dre. No Dr Dre would rather use his brain and stay seriously chronically ill. How do you know Dr Dre that a particular drug won't work? If you've never tried ANY of the DMDs/DMTs then how do you know?Guess what – I got lucky. The DMD I take works. Not that you'd care. But I do.

Leave a Reply

%d bloggers like this: