Wednesday, April 22, 2015

Independent review of new MS Drugs--Must Read

Prescrire ("to prescribe" in French) is a French medical journal, which uses evidence based science to make recommendations on drugs.  It is written by health care professionals for health care professionals,  but it is unique in that it does not accept any pharmaceutical monies for advertising or for payment to reviewers.  This journal makes money by having 33,500 subscribers---medical professionals who turn to this journal for unbiased information. This is a completely independent journal---they have signed a "Non, Merci" (no, thank you) charter to maintain no conflicts of interest.  
http://english.prescrire.org/en/82/173/0/0/About.aspx

Prescrire’s subject matter mainly consists of critical reviews of medicines and other treatment options. Prescrire’s editorial staff is made up of healthcare professionals, most of whom are in active practice. Editors are specially trained and are free from any ties to pharmaceutical or other companies doing business in the healthcare arena. Prescrire’s reviews therefore help healthcare professionals to prescribe for their patients in an informed and fully independent manner.

Prescrire is also completely independent of all national and supernational institutions that determine or implement healthcare policy. Prescrire is therefore free to make recommendations in matters of ethics, public health and national and international healthcare policy.
Prescrire is written and edited by and for healthcare professionals. You could say that it’s just what the doctor ordered.
http://english.prescrire.org/en/82/169/0/322/About.aspx


And Prescrire's March issue has some startling information on MS drugs.  The reviewers names are not published (to keep them safe?) but they stand behind their recommendations.  Each article submitted has been reviewed by 20-40 other peer-reviewers.   And what they say is that when looking at all of the data we now have, these new drugs are too dangerous, with too many side effects and known and unknown risks.  That people with MS are much better off using the first line meds (interferon and copaxone), because these new, more powerful drugs have had biased trials, and have not proven any long term benefit.
1.  Tysabri and MS.  With longer follow-up:  even more toxic than suspected.
http://www.ncbi.nlm.nih.gov/pubmed/25897454
Post-marketing data confirm the adverse effects identified in clinical trials, including serious and life-threatening opportunistic infections, particularly progressive multifocal leukoencephalopathy in about two per thousand treated patients (an incidence twice as high as initially estimated), and potentially severe hypersensitivity reactions. An increased risk of cancer in the long term cannot be ruled out. Post-marketing data also show that natalizumab can cause severe liver damage. In addition, natalizumab withdrawal because of progressive multifocal leukoencephalopathy almost always triggers an immune reconsti- tution syndrome that can lead to neurological complications or even death. In practice, regardless of the severity of multiple sclerosis, it does not seem reasonable to expose patients to the many serious adverse effects of natalizumab for such an uncertain benefit.

2. Lemtrada and MS.  Biased evaluations, evidence of serious risks
Clinical evaluation in multiple sclerosis is based on three unblinded trials comparing alemtuzumab with interferon beta-1a. These trials were all biased in favour of alemtuzumab and thus fail to establish the potential value of this immunosuppressant. Overall, adverse effects, including the most severe, were more frequent with alemtuzumab than with interferon beta-1a. The adverse effects of alemtuzumab reported in these trials had already been observed in cancer patients. They included potentially severe reactions to the infusion, as well as a risk of infections and cancer due to profound and prolonged immunosuppression. At the dosage authorised in multiple sclerosis, autoimmune disorders such as thyroid disorders and immune thrombocytopenic purpura are particularly frequent and serious. In practice, patients with multiple sclerosis already have difficulty coping with the troublesome consequences of their underlying disease. They should not be subjected to the serious adverse effects of alemtuzumab, especially given the absence of any proven benefit.

3. Aubagio and MS.  just a metabolite of leflunomide.
Clinical evaluation of teriflunomide is based on a comparative trial versus interferon beta-1a in 324 patients and on two placebo-controlled trials in a total of about 2300 patients lasting 1 to 2 years. In these trials, oral teriflunomide at a dose of 14 mg per day led to a statistically significant decrease in the average annual number of relapses compared to placebo, but teriflunomide may be less effective than interferon beta. No impact on the progression of disability has been shown during less than 2 years of follow-up. The burdensome adverse effect profile of teriflunomide is similar to that of leflunomide and includes hepatotoxicity, infections, leukopenia, arterial hypertension, peripheral neuropathy and alopecia. The long half-life of teriflunomide (about 19 days) complicates the management of its adverse effects and multiple drug interactions, and has important implications for patients wishing to have children. Teriflunomide is teratogenic in animals and should not be used by pregnant women. Fetal toxicity via semen cannot be ruled out. In practice, the adverse effects of teriflunomide in multiple sclerosis are disproportionate to its efficacy. It is better to choose interferon beta, despite its limitations.

Their April issue includes a paper called "Tecfidera and MS: Too many Long-term Unknowns

I'm thankful that the researchers of Prescrire are speaking out and publishing their findings.   But I wonder how many neurologists will heed their warnings and inform their patients?  While the MS drug machine continues to crank along, now making 20 billion dollars a year in profits, people with MS are rarely given the facts.  These new drugs are exceedingly dangerous, and they do not prevent disease progression. 

Please spread the word in your own community and help others understand the risks of these drugs are known, while the benefits remain unproven. 

Take care of yourselves and be well,
Joan






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