Not Satisfactory
The story should have mentioned the side effects seen in clinical trials so far, as well as the risk that patients could suffer harms like those sometimes seen in people who have been given similar antiviral drugs.
These side effects are clearly spelled out in an FDA fact sheet prepared for patients and caregivers:
“The most common side effects of PERAMIVIR are:
• diarrhea
• nausea
• vomiting
• white blood cell count decreased
These side effects may go away after you stop receiving PERAMIVIR. These are not all the possible side effects of PERAMIVIR. Peramivir is still being studied so it is possible that all of the risks are not known at this time.
Other medicines that are used to treat people with 2009 H1N1 flu have side effects that may also happen in people who receive PERAMIVIR.
These side effects include:
• Signs of unusual behavior. People with the flu, especially children and adolescents, may be at a higher risk for seizures, confusion, or abnormal behavior early in their illness. These events may happen after starting PERAMIVIR or may happen if the flu is not treated. These events are not common. Patients should be watched for signs of unusual behavior.
• Allergic reaction or severe rash
Not a lot of people have taken PERAMIVIR for 5 days or longer. Serious and unexpected side effects may happen. The side effects of getting any medicine by vein are brief pain, bleeding, bruising of the skin where the needle enters, soreness and swelling at that spot, and possible infection at that spot.”
Patient fact sheet available at:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM187799.pdf
Provider fact sheet available at:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM187811.pdf
Not Satisfactory
The story did not point out that one of the supporters of faster and broader access to peramivir, Dr. Richard Whitley, has long been a booster of the drug, which is being commercially developed by a spin-off of the University of Alabama department he works in.
See Whitley comments in a 2005 article promoting the potential of peramivir:
http://main.uab.edu/show.asp?durki=87834
Here we also point out that the story profiled only one patient and includes a quote from the patient’s father crediting peramivir with saving his daughter’s life. The story does not give any examples of similar patients who either survived after getting approved drugs or who received peramivir and yet did not survive. Despite the clear caveats in the story, the reliance on only a single anecdote may give readers a skewed sense of the benefits of the unapproved drug.
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