Patients Need To Know What Drugs Do Inside Our Bodies
Oral therapy Tecfidera (dimethyl fumarate) seems to be emerging as a first-line treatment for relapsing multiple sclerosis – according to Biogen, the company that developed it. That’s good news, and something we need to know.
The company agrees that for some time, the long-term effectiveness and safety of this oral therapy has remained unclear; even exactly how it works has also been largely unknown, as was reported on Multiple Sclerosis News Today. But the company also says that reports released during the last few months offer “encouraging” new findings into the drug’s long-term efficacy and safety; and others are beginning to uncover its workings.
Tecfidera was approved by the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of MS. But, it was not possible then to determine either the effectiveness or the safety in the longer term.
Now, three years later, Biogen is hailing the new research offering “encouraging” findings on both the long-term results of the drug and how it works. Well, that must be promising.
Need to know how drugs work
Ok, I am not a scientist but, as a mere patient, I do see how it is possible for a therapy to be approved for use with only short-term efficacy and safety being known, but I am still concerned that no one had a clear understanding of how it works before it was put out there. Surely, all patients have a right to expect that the scientists and medical professionals know what any drug is going to do inside our bodies.
Biogen announced positive results regarding the long-term effectiveness of Tecfidera during a presentation in April at the 68th annual meeting of the American Academy of Neurology, in Vancouver. The company said that newly diagnosed relapsing MS patients receiving the treatment maintained consistently reduced relapse rates, and that over 50 percent of them exhibited no relapses in six years of treatment. The drug’s long-term safety profile was also supported, the company said..
Now, there is no way that I am going to get involved in the science and technical stuff, which is beyond me. As an MS patient, I just want to know that any new drug is effective and safe to use – and that doctors can explain how it works.
Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Karen
I believe there needs to be a balance between timeliness and knowledge. Some of your other articles stress the importance of speed as it relates to access to therapies, so that needs to be kept in mind as well. If we waited until the drug is 100% understood, then we'd still be waiting since Biogen's website still says "While it is not known exactly how Tecfidera works in the body...". Personally, as a patient, I understand the risks of starting a new drug, and if it has cleared regulatory approval for safety, I'd rather start the option than wait another 10-15 years while the industry tries to fully understand the mechanisms behind the drug.
Cynthia
There would be no MS therapies on the market if they needed know how they work or for that matter countless other meds.
Every single MS med on the market is "thought to work" in some way. Even the interferons are largely still a mystery.
Stem cell therapies are thought to work in a variety of ways as well but again, there is no nanobot that can crawl around inside examining anything at low levels such as internal to cells in real-time.
The most recent rather interesting stem cell trial of aHSCT showed one person in 24 died as a direct complication of the transplant. Two others within three years but did not note if that was related to a medical condition or not. If it were medical then there is simply no way to know if the transplant was a factor.
If a patient dies of myocardial infarction be that a patient who had aHSCT or meds there simply is no mechanism by which to be certain if or if not the death was related to a med. There are not going to be autopsies that look that granular at causal evidence unless its perhaps glaring at them.
In the USA there is no way it would ever go to Phase III with that statistic though it might require Phase II all over again.
Of stem cell therapies taking place around the globe in Mexico, Russia etc. clinical data is not being gathered as would be the case in clinical trials or, if it is, they ain't talking.
What is known is that medications can be halted. Stem Cell's cant.
I have a little group of 8 ladies and one male. We exercise, we eat right, we are doing our own sort of trial. Every single one of us have saw significant gains. A year ago I was headed for a wheelchair. Now I feel better than I have since my diagnosis.
Terry
Well, I've been on Tecfidera since May, 2014 but took a break in November, 2015 as my hair started thinning. First just a bit, then alot. I went to the Tecfidera group on FB, and I wasn't the only one experiencing this problem. So I did what others were doing and started taking Biotin. After about 6 months, no improvement so stopped in November. My hair improved. This is not a noted side effect of Tecfidera. My neuro wanted me to start up again so I did in February, 2016 and we did base-line blood work. I've had problems with elevated Alk Phos for several years but that's it. In May, 2016 we did another liver panel and this time my GGT was greatly elevated...something new. So I stopped again. My MS was relapsing remitting for many years. I was diagnosed in 1988. But as time goes on, I don't have full blow exacerbations anymore, just disability that progresses on its merry way. I'm ready to just maybe try statins and see what they do.