The acronym stands for progressive multifocal leukoencephalitis, a rare brain infection that can easily be mistaken for early dementia. However, in reality PML is a fast-moving and often fatal viral brain infection that attacks the white matter of the brain.While it is rare, the fact is that three Raptiva patients developed confirmed PML. All three patients died, and a fourth case is suspected but not confirmed. The issue prompted the US Food and Drug Administration (FDA) to pull the plug on Raptiva this past spring.
After June 8th, Raptiva will no longer be available for sale in this country. Doctors will not be in a position to prescribe it, either.
However, while Raptiva will no longer be for sale and will no longer be prescribed, will it actually be gone from medicine cabinets? While new prescriptions will no longer be written, will existing prescriptions with refill privileges be honored in jurisdictions beyond the US? One online pharmacy that identifies itself as Canadian currently has Raptiva available—of course, by prescription. It will be interesting to see if Raptiva remains available after June 8th.
Raptiva is also banned in Canada.
Raptiva (efalizumab) was approved by the FDA in 2003 for the treatment of psoriasis, and works by suppressing a patient's immune system. There is little doubt that Raptiva, which is taken by injection, was extremely effective in most patients for the control of even extremely problematic psoriasis. Message boards containing comments from psoriasis patients paint glowing pictures of skin once a bastion of flakes and redness transformed to healthy, glowing skin thanks to the intervention of Raptiva.
At the same time, however some patients relate horror stories of psoriasis coming back with a vengeance once Raptiva treatment was stopped. The latter observation was also hinted at as a possibility during the original clinical trials for Raptiva.
The fear is a rash of problematic psoriasis once Raptiva is no longer available by legitimate means after June 8th, as doctors together with their patients switch to alternative methods of control.
The PML Raptiva side effect has been linked to other drugs as well. However the symptoms of PML are unmistakable and heartbreaking. In New York, a 57-year-old lawyer who habitually breezed through the most challenging crossword puzzles in the New York Times suddenly and inexplicably could not summon the most basic of words to complete the task. And in Chicago an 83-year-old woman was seen to suddenly repeat the same phrase over and over.
When her doctor asked how she was doing during a subsequent examination she replied, "I am fine. I am fine. I am fine."
The two patients are part of a new study from the Northwestern University Feinberg School of Medicine RADAR project that is investigating the link of PML to the cancer drug rituximab. However the same rare brain virus linked to Rituxan is the same PML suspected in Raptiva.
And it can be nasty, but subtle at first. It is often misdiagnosed in its early stages as Alzheimer's disease, or depression. But an MRI brain scan and biopsy—as with the two patients noted above—revealed that brain tissue appeared to have been eaten away by the ravages of the PML virus.
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While critics of Raptiva will be relieved to see its ultimate removal from the market June 8th, it remains unfortunate for psoriasis patients that they will lose an effective treatment for their painful and often embarrassing psoriasis. Together with the threat of incurable PML hanging over their heads—especially for those patients who had been using Raptiva for 3 years or longer—is the loss of an effective drug to manage their psoriasis. For many, an emotional rollercoaster is in their future. Many will seek compensation from the manufacturer for their loss.