Posted by: Christopher Maloney, Naturopathic Doctor | June 20, 2012

Jack Osbournes Multiple Sclerosis, Do We Really Have New Treatments That Work?

Despite Multiple Sclerosis

Despite Multiple Sclerosis (Photo credit: mtsofan)

Jack Osbournes Multiple Sclerosis Diagnosis: What Does It Mean? – Music, Celebrity, Artist News | MTV.com.

So Jack Osbourne was diagnosed with Multiple Sclerosis, which is really bad.  Except all the M.D.s were crowing that we’ve got all these new treatments.  So Jack can rest easy that modern medicine will take care of him.  Evidently we’ve licked MS at last.

As someone who follows the MS research, I was a little surprised at this.  Where was this stunning new reversing drug for Multiple Sclerosis?  Why wasn’t it plastered on the front page of every paper:  “We Beat M.S.!”

So I went looking.  And my short answer is what we’re dealing with is another clever gimmicked marketing scheme for another medication.

The miracle new drug is called:  fingolimod. Yeah, I’m not crazy about the name either, but I guess “MS Zapper” was already taken?  So is it the miracle promised?

First, the drug is new.  Most drugs have a two year honeymoon before the side effects start pouring in and it doesn’t work for all the people it is supposed to.  These guys did a one year trial, which outperformed the standard drugs (which don’t work that well).  Then they extrapolated out to ten years based on the one year trial.  It’s called guessing, but with a graph.  The best thing they did was to get a Cochrane meta-analysis done based on their one year study that shows their drug will outperform all the other drugs on the market based on their guess.  I was fooled at first by the meta-analysis until I read at the bottom that this drug is definitely better.  The really analyses don’t say things like that.  They say things like “may be promising, but more study is needed.”  So this analysis is marketing.

Can we say for certain that fingolimod is better?  No.  We can’t even say definitely if any of the existing drugs are better because we lack head-to-head trials.  So it’s pretty swift to claim your drug is the best when we haven’t compared it directly.

Why would someone claim victory before the race is run?  Money.  We’re talking half a million dollars a patient.  So I know the manufacturer is burying the M.D.s with marketing and getting people to switch.  At a half million a head every year,  they’ve got eighteen months before the honeymoon period wears off.  If they corner even a small part of the market, that’s billions.

So no, we don’t really have a new miracle drug.  We have some very sophisticated and directed marketing to get a piece of the M.S. pie, based on a time frame that is too short to really get any sense of the side effect picture from the drug.

If I was Jack, I’d go talk to long-term survivors who have used complete lifestyle changes to help prolong their health before I’d throw all my cards in with the new drugs.

Oh, but don’t believe me.  Here are the abstracts I used.  You might want to look at them before you switch.

Curr Med Res Opin. 2012 May;28(5):767-80. Epub 2012 Apr 24.

Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.

Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA.

Source

RTI Health Solutions , Manchester , UK.

Abstract

Abstract Objectives: Previous systematic reviews and meta-analyses of treatments in relapsing-remitting multiple sclerosis (RRMS) derived their findings from either placebo-controlled studies only or separately from head-to-head and comparative studies. The purpose of this study is to compare annualized relapse rates (ARR) of fingolimod versus all of the commonly used first-line treatments in RRMS using evidence from both placebo-controlled and head-to-head studies. In absence of the head-to-head data between fingolimod and the other treatments, these comparisons were formed using meta-analysis techniques for indirect treatment comparisons. Methods: A systematic literature review was conducted by searching MEDLINE, EMBASE, and the Cochrane Library with no limitations applied on publication language or dates. Included studies were randomized controlled trials evaluating one or more of fingolimod, interferon beta-1a, interferon beta-1b, or glatiramer acetate in RRMS populations. Primary outcome was ARR. Data extraction included author, year, treatment, dosage, mean age, percentage females, duration of disease, Expanded Disability Status Scale (EDSS) score at baseline, relapses in 2 years prior to baseline, trial duration, relapse-related outcome, and definition of relapse. The indirect treatment comparisons were performed using a mixed-treatment comparison framework. ARR was analyzed as a Poisson outcome. Results: The relative ARRs, for each treatment versus fingolimod, estimated from our meta-analyses were 1.43 (glatiramer acetate 20mg), 1.51 (interferon beta-1b 250mcg), 1.55 (interferon beta-1a 44mcg), 1.67 (interferon beta-1a 22mcg), 1.93 (interferon beta-1a 30mcg), and 2.32 (placebo). None of the 95% confidence intervals for these estimates overlapped unity, implying statistical significance of these findings. Limitations: The key limitations of this study are the persisting heterogeneity even after adjusting for covariates and the variability in outcome definition across the included trials. Conclusions: Our study demonstrated that fingolimod significantly reduces relapse frequency in patients with RRMS compared with current first-line disease-modifying therapies.

PMID: 22462530

Clin Ther. 2012 Apr;34(4):857-869.e9. Epub 2012 Mar 22.

Network analysis of randomized controlled trials in multiple sclerosis.

Zintzaras E, Doxani C, Mprotsis T, Schmid CH, Hadjigeorgiou GM.

Source

Department of Biomathematics, University of Thessaly School of Medicine, 2 Panepistimiou Str., Larissa, Greece. zintza@med.uth.gr

Abstract

BACKGROUND:

The optimal treatment of multiple sclerosis (MS) is not yet well-defined.

OBJECTIVE:

To estimate the relative effectiveness of treatments in MS, we performed a network of multiple-treatments meta-analysis of randomized controlled trials (RCTs) for relapsing MS using three main efficacy outcomes: relapse-free patients, patients without disease progression, and patients without magnetic resonance imaging progression.

METHODS:

We systematically searched PubMed and the Cochrane Central Register of Controlled Trials to identify English-language articles with RCTs that compared pharmaceutical treatments using the terms multiple sclerosis and randomized controlled trial. All RCTs that involved patients with definite relapsing MS and provided data for calculating the odds ratios for the main outcomes were considered. First, comparative effectiveness relative to placebo was assessed using direct analysis. Then, each therapy was compared with interferon beta-1b (250 μg)* in direct and indirect analyses. Effect sizes were estimated by applying a random-effects model.

RESULTS:

We identified 4165 titles; after screening, 109 articles were eligible for inclusion. In total, 26,828 patients were included. The network consisted of 145 treatments involving 59 direct comparisons with placebo and 8 direct comparisons with interferon beta-1b (250 μg). Two treatments showed better response compared with placebo (direct analysis) for all three efficacy outcomes: natalizumab (300 mg)(†) and fingolimod (0.5 mg). In comparing treatments with interferon beta-1b (250 μg), the network analysis revealed that no therapy shows better response for all 3 efficacy outcomes and alemtuzumab, 12 and 24 mg, have better response for 2 of the outcomes (relapse-free patients and patients without disease progression).

CONCLUSIONS:

Although some treatments seem to have better efficacy, the results should be interpreted with caution because the network was dominated by indirect comparisons. Data from the selected studies included in the network cannot be extrapolated beyond them. Large RCTs that make head-to-head comparisons between treatments are needed to draw safe conclusions for the optimal treatment of MS.

Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

PMID: 22444787

J Med Econ. 2012 May 14. [Epub ahead of print]

Cost-effectiveness of fingolimod versus interferon beta-1a for relapsing remitting multiple sclerosis in the United States.

Lee S, Baxter DC, Limone B, Roberts MS, Coleman CI.

Source

University of Connecticut School of Pharmacy , Storrs, CT, USA; and Department of Pharmacy, Hartford Hospital, Hartford, CT , USA.

Abstract

Abstract Objective: Fingolimod has been shown to be more efficacious than interferon (IFN) beta-1a, but at a higher drug acquisition cost. The aim of this study was to assess the cost-effectiveness of fingolimod compared to IFN beta-1a in patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) in the US. Methods: A Markov model comparing fingolimod to intramuscular IFN beta-1a using a US societal perspective and a 10-year time horizon was developed. A cohort of 37-year-old patients with RRMS and a Kurtzke Expanded Disability Status Scale score of 0-2.5 were assumed. Data sources included the Trial Assessing Injectable Interferon vs FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS) and other published studies of MS. Outcomes included costs in 2011 US dollars, quality-adjusted life years (QALYs), number of relapses avoided, and incremental cost-effectiveness ratios (ICERs). Results: Compared to IFN beta-1a, fingolimod was associated with fewer relapses (0.41 vs 0.73 per patient per year) and more QALYs gained (6.7663 vs 5.9503), but at a higher cost ($565,598 vs $505,234). This resulted in an ICER of $73,975 per QALY. Results were most sensitive to changes in drug costs and the disutility of receiving IFN beta-1a. Monte Carlo simulation demonstrated fingolimod was cost-effective in 35% and 70% of 10,000 iterations, assuming willingness-to-pay thresholds of $50,000 and $100,000 per QALY, respectively. Limitations: Event rates were primarily derived from a single randomized clinical trial with 1-year duration of follow-up and extrapolated to a 10-year time horizon. Comparison was made to only one disease-modifying drug-intramuscular IFN beta-1a. Conclusion: Fingolimod use is not likely to be cost-effective compared to IFN beta-1a unless fingolimod cost falls below $3476 per month or a higher than normal willingness-to-pay threshold is accepted by decision-makers.

PMID: 22583065

 

 


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