Corporate greed trumps noble intentions yet again in the world of Big Pharma. Sanofi, the world’s fourth-largest pharmaceutical company, recently withdrew the leukemia drug Alemtuzumab after 20 years of prescribing it, off label, to treat multiple sclerosis patients. Sanofi and subsidiary Genzyme cite intentions to apply for appropriate licensing—but before you applaud the companies for following regulations, keep in mind that they intend to rebrand and raise the cost of Alemtuzumab—by 15 to 20 times.
Off label Use
Prescribing drugs according to a physician’s instinct (or pocketbook) rather than according to the drug’s license is known as “off label” use. While perhaps deservedly frowned upon, neurologists began prescribing Alemtuzumab off label to MS sufferers after the New England Journal of Medicine published study results favoring alemtuzumab over another drug in the treatment of MS. Alemtuzumab also costs less, requiring two courses over two years.
Genzyme, however, will change that by rebranding alemtuzumab as Lemtrada and raising prices, halting supplies in the meantime because “any adverse event outside a clinical trial…may complicate the regulatory process.
“Until approved risk-management programs are established,” a Genzyme spokesperson continues, “the use of Lemtrada for MS should occur only in clinical trials.”
“Shows Little Regard for Patients”
Many neurologists have written letters of protest to the UK’s Health Secretary, Jeremy Hunt. According to professors Neil Scolding, Neil Robertson, and John Zajicek, UK patients with MS in the middle of treatment with alemtuzumab will “not be able to get their vital second course.” New patients would “miss their window of therapeutic opportunity,” as well.
Regarding the rebranding and price increase, the professors add, “It shows little regard for patients whose opportunity to alter the course of their disease is time-limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation.”
Genzyme’s parent company, Sanofi, is certainly not short in profits, which last year amounted up to nearly €6 billion (roughly $7.8 billion).
Sanofi isn’t the first pharmaceutical giant to use drugs’ supposed efficacy to make unwarranted profits to the detriment of patients, either. GlaxoSmithKline paid celebrity doctors like Dr. Drew to push harmful antidepressants for off label uses (including unfounded claims of weight management and erectile dysfunction), and Pfizer is undergoing clinical trials of Xalkori to treat a rare form of lung cancer—for over $100,000 per patient. Similarly to the initial case, KV pharmaceutical company offers a drug known as Makena which is meant to reduce the risk for premature births. But good luck using it if you’re interested, as the company recently raised the price from $10 to $1,500 per dose.
Earlier this year, however, Canadian and British scientists found that vitamin D—whether acquired through sunshine or supplements—may help prevent MS by affecting the gene that raises risk of MS development.
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