New MS Drug Fails Risk vs. Benefit Analysis

Lemtrada is a proposed new drug for the treatment of relapsing Multiple Sclerosis (MS). It is injected once a year (over the course of 5 days the first year, 3 days subsequent years). It has already been accepted in the European Union, Canada and Australia. However, the FDA has taken the position that the pharmaceutical company Genzyme “has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.” (Genzyme press release)

MS is a disease of the central nervous system. The membrane that protects nerve cells becomes damaged by inflammation and scarring. When the nerve covering is damaged the signals from the nerves slow down or stop. It’s unknown why the damage leading to MS happens, though it’s believed to be an autoimmune disorder. About 2.3 million people in the US have MS.

The most common type of MS Is relapsing-remitting. That is the type of MS that Lemtrada was developed to aide. People with MS may have long periods of time without symptoms even thought the disease might be progressing. Patients in the Lemtrada study were found to have fewer recurrances but it was not shown to slow the progression of the disease.

As FiercePharma reported: MS is such a difficult disease that sufferers will tolerate some risk for relief, but the side effects of Lemtrada include the chance of cancer and autoimmune and thyroid diseases.

Benjamin Greenberg, MD, was quoted by MedPageToday, “While there are very valid concerns about the data interpretation from the trial and safety profile of the drug, there are reasonable levels of efficacy data to support its approval.

“A very intense postmarketing surveillance program would be extremely useful for formulating long-term assessments of this medication,” Greenberg said.

Even one of the lead doctors on the trial stated concerns about managing and minimizing risk of Lemtrada. Robert Bermel, MD, of the Cleveland Clinic, who helped lead the drug’s pivotal trials, told MedPage Today that he expected approval would come with “a fairly detailed risk mitigation strategy [that] may require monitoring of blood and urine as frequently as once per month for up to 5 years. The logistics of how neurologists will coordinate the necessary monitoring remains unknown.”

He said one population for whom the drug could be well-suited is patients with aggressive MS who are poor candidates for natalizumab (Tysabri) because of latent JC virus infection, a risk factor for life-threatening progressive multifocal leukoencephalopathy. I’m honestly not sure what that all means, but what I get from it is there could be limited use for the subset of MS-diagnosed who can’t use other medicines and have an aggressive form of MS — not for all MS patients.

The medical community and the sufferers of MS rightly want as many drug and therapeutic options on their side as possible in the battle against MS. However, MS is such a challenge that patients might be tempted to “try anything” for immediate relief discounting the possibility that the treatment outcome could be worse than the original disease (or that it might compound problems). That consideration rightly belongs with the FDA and on the ethical conscience of every doctor. If a drug is at high risk of doing more harm than good, the FDA and the medical community must demand better from the pharmaceutical companies. 

More detailed information on MS can be found at the US National Library of Medicine.

The National Multiple Sclerosis Society offers information about MS, research, support groups and advocacy.

Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.

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