A case analysis of the betaseron decision

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A case analysis of the betaseron decision

1 Approved Answer

These results had been much anticipated by the MS community, as there are currently no proven effective treatments for Primary Progressive Multiple Sclerosis, and many previous PPMS drug trials have ended in failure. Though fast-track designation means that Ocrelizumab will have an expedited approval process, it does not guarantee that the drug will ultimately be approved.

The anticipation over Ocrelizumab, which was developed by Roche Pharmaceuticals subsidiary Genentech, stems from the fact that trial results appear to demonstrate the drug to be effective in slowing down progression of disability in PPMS patients.

The data set presented at ACTRIMS confirmed info originally released last year, but the numbers revealed at the recent conference provided more details on the patient population included in the study click here.

Specifically, results were provided for two different subsets of patients — those with enhancing lesions which signify acute immune activity within the central nervous system and those without enhancing lesions.

Well, if the numbers hold up it is great news, but there are certain aspects of the Ocrelizumab PPMS trials that raise some red flags. Ocrelizumab is a close cousin of the decades old drug Rituxan, which is also manufactured by Genentech. Both drugs work in almost the exact same fashion, by targeting and destroying immune system B cells, effectively ridding the body of the cells for periods of at least six or seven months.

Ocrelizumab, like Rituxan, is administered approximately every six months, in two intravenous doses given one or two weeks apart. Rituxan was originally intended for use against blood cancers, but was later found to be effective in treating a variety of autoimmune diseases, including Lupus, Rheumatoid Arthritis, and Relapsing Remitting Multiple Sclerosis.

The human immune system consists of a wide variety of cells, but is primarily made up of B cells and T cells. Back intrials of Rituxan on PPMS patients were deemed a failure, much to the intense disappointment of many patients, myself included. Subsequent analysis of the data generated by that failed trial, however, revealed that a subset of patients did seem to have a somewhat positive response to Rituxan — namely younger patients who displayed enhancing lesions, had been more recently diagnosed, and were less disabled than other trial participants click here.

A case analysis of the betaseron decision

Why invent a new version of an older, proven drug that uses the exact same mechanism of action as that older drug? Well, Genentech says it was done to develop a safer, more effective product, but a cynical person might point out that Rituxan had already proven itself to be relatively safe and quite effective but was due to come off patent inmeaning that its window for generating tremendous profits was rapidly closing.

By the time new trials were completed, Rituxan would no longer have patent protection. A new version of the drug, on the other hand, could be a golden egg laying goose.

Multiple Sclerosis in Older Adults: The Clinical Profile and Impact of Interferon Beta Treatment

But, of course, only a very cynical person would point that out, not someone is bright eyed and bushy tailed as me. Based on the lessons learned from the failed Rituxan trials, it looks like Genentech populated the Ocrelizumab PPMS trials with patients who were selected specifically because they were more likely to respond to treatment click here.

Treatment of acute exacerbations of multiple sclerosis (MS) when the acute relapse is characterized by functionally disabling symptoms with documented evidence of neurological impairment (persons who have previously responded in a relapse phase are more likely to do so in the future); or. As most patients know, diagnosing Multiple Sclerosis is no easy matter. Despite sophisticated diagnostic tools and techniques, such as MRI imaging, spinal fluid analysis, and visual and sensory evoked potentials, the diagnosis of MS remains one of exclusion, meaning that other likely diseases must be eliminated before a conclusive diagnosis of MS can be made. Describes the decision analysis, a systematic approach to the analysis of the problem. Working example illustrates the problems of structuring (decision trees), and the evaluation of the probability of the final grade, folding back the tree as a method of analysis and sensitivity analysis.

Knowing that this was sure to be a very important issue, why would Genentech go ahead with a trial that was underpowered in this regard? Seems kind of strange, no? What may ultimately turn out to be the most troubling aspect of the Ocrelizumab PPMS trial, however, is that 11 cancers were detected in patients taking Ocrelizumab, versus only two in the placebo group.

Eight of the cancers in the Ocrelizumab patients were breast cancers, versus zero in the placebo group. This is especially concerning because back inwhen Ocrelizumab was first developed, trials were started not only in MS but also on lupus and rheumatoid arthritis patients.

Both the lupus and rheumatoid arthritis trials were halted because of patient deaths due mostly to opportunistic infectionsbut the MS trials were allowed to continue because it was thought that MS patients would have a higher tolerance for risk click here.

Incidentally, in its over two decades of service, Rituxan has not been associated with the development of cancers or an alarming number of opportunistic infections, although rare instances of PML the brain infection that is so concerning in patients taking Tysabri have been seen in patients taking the drug.

However, given some of the questions regarding trial design and safety issues, it will be very interesting to see what the FDA decides. Another one time promising MS drug, Cladribine, was rejected by the FDA primarily because of cancers detected during drug trials click here.

For some expert opinions on Ocrelizumab, here are two videos. The first is a video of Ottawa MS neurologist Dr.Background:Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years.

There is a need for a reference tool compiling current data to aid professionals in treatment leslutinsduphoenix.comives:To develop an evidence-based clinical practice guideline for the pharmacological treatment of people with leslutinsduphoenix.coms:This guideline has been developed using the Grading of.

Interestingly, within a few days of my exam, a Harvard Med School study was released that addressed a similar question: Is there always a link between the level of physical disability in some MS. IBA-WORKSHOP CASE ANALYSIS PREPARATION FORM Name: Xu Shijie Student No: S Workshop No: 3 Case Study: THE BETASERON® DECISION (A)* What are some of the main ethical and/or CSR issues involved in this case or dilemma?

Economical Responsibilities: The price of Betaseron ® was expected to be about $10, per year for each patient. BerIex had patent . The Betaseron Decision Case Study Executive Summary: Berlex Labratories has developed a drug, Betaseron, as a treatment of Multiple Sclerosis.

The FDA has approved A Decision Making Model Analysis A Decision Making Model Analysis A decision making model is a systematic means of arriving at a decision. A decision making model is a. published. Kelompok 6 (Genap) “The Betaseron Decision” Nama Anggota Kelompok 6: Arfitra Siti Khairuma ().

The Betaseron Decision (A) The United States Food and Drug Administration’s (FDA) approval of interferon beta- 1b (brand name Betaseron), made it the first multiple sclerosis (MS) treatment to get FDA approval in 25 years.

The Betaseron(R) Decision (A) | The Case Centre, for educators