Washington, DCCanada is the latest country to bring the hammer down on the use of Raptiva after the psoriasis drug had been linked to 3 confirmed and one suspected case of progressive multifocal leukoencephalopathy (PML), a neurological condition that can result in reduced brain function and ultimately, death.
Three, of the four patients died. All four had been using the once-weekly injection of Raptiva for about 3 years.
The European Medicines Agency (EMEA) suspended sales of Raptiva just a few days after the US Food and Drug Administration (FDA) issued a public health advisory with regard to Raptiva. Health Canada followed suit, and in early March the Healthy Ministry of Kuala Lumpar also suspended the product. Merck Sdn Bhd, which holds the rights to the importation, sale and distribution of Raptiva in that country, was told in no uncertain terms by the Health Ministry there to halt all activity immediately.
This all comes after the FDA issued its health advisory in February with regard to Raptiva and the possibility for PML. As well, according to Business Monitor International the FDA is also recommending a suspension of marketing for Raptiva—short of suspending the drug altogether—although there is nothing on the official web site of the US Food and Drug Administration to confirm this.
Without doubt, there is a growing concern that Raptiva's benefits no longer outweigh the risks.
PML is a neurological disorder caused by the JC virus, the latter destroying the nerve cell protecting substance myelin. Up to 85 percent of adults carry the JC Virus, but it only becomes active when the immune system is severely oppressed. PML leads to a decline in neurologic function and eventually death, and no preventative therapy or cure currently exists.
Raptiva works by suppressing T-cells that cause inflammation associated with psoriasis. T-cells are part of the immune system, and according to an FDA press release, "by suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient's susceptibility to infections."
Raptiva was given a black box warning in October, and the FDA mandated the manufacturer of Raptiva—Genentech—to design a risk evaluation and mitigation strategy (REMS). A patient medication guide is part of that strategy.
A spokesperson for Genentech stresses that the company is "working diligently with the FDA to put the right plans in place that will help protect patient safety."
However, the federal agency's role and effectiveness in promoting, and ensuring a safe drug supply continues to be questioned by critics in the health care industry. The recent ruling by the US Supreme Court that allows patients to sue for damages allegedly caused by drugs approved by the FDA supports the view that just because the FDA approves a drug for use in the US, it cannot be assumed that the drug is safe.
It is also curious to note that the FDA, so far, appears not to have recommended the wholesale removal of Raptiva from the US marketplace, pending further study of the drug and its potential links to serious side-effects, including PML. So far the FDA has mandated a black box warning, has issued a public alert and has required various documents and analysis on the part of the manufacturer(s).
However, if the statement by Business Monitor International holds true, all the FDA is prepared to do at this point is to urge Merck and Genentech to suspend marketing of Raptiva. It appears unwilling to take the immediate action shown by Health Canada and the public health organizations of other countries to pull the product from the pharmacy shelves completely, without apology.
In other words, while Raptiva continues to be studied, it's still out there.
Little wonder that lawyers will be kept busy with Raptiva lawsuits.