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New Drug for H1N1 Flu Offers Hope
November 06, 2009
Good overall but with several significant flaws: no disclosure of conflict of interest in one key interviewee, reliance on a single sensational patient anecdote, and no information on harms.
Our Review Summary
This story about giving some people hospitalized with H1N1 flu emergency access to an unapproved antiviral drug, peramivir, does a good job of emphasizing how much is unknown about the potential benefits of the drug and that the drug will be offered to patients who don’t have other treatment options. The story also highlights the financial stakes for the company developing the drug and its investors… and how those conflicts can color the comments of those speaking about the drug.
However, the story introduces readers to only one patient and includes a quote from the patient’s father claiming the experimental drug saved his daughter’s life. There is no independent corroboration of that claim, nor are readers introduced to any patients who either received the experimental drug and did not benefit or received standard therapy and responded well.
Also, readers are not told that the president of the Infectious Diseases Society of America, who is quoted urging broader access to the drug, works in the University of Alabama department that developed peramivir and that the university has ties to the company that is trying to bring the drug to market.
Click on Criteria for definitions.
The story makes very clear that peramivir is experimental and is being offered only because some patients cannot take or aren’t helped by approved antiviral drugs.
The story says the federal government is paying about $2,250 per patient for a standard 5-day treatment course. It also notes that the approved alternative treatments are less expensive.
The story points out that the experimental drug is being offered only to patients who are already in the hospital and aren't being helped by approved drugs.
The story points out more than once that peramivir is still being tested and that questions remain about its potential effectiveness.
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:
Provider fact sheet available at:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM187811.pdfThe story is quite clear that peramivir is still being tested.
The story points out that the benefits of peramivir have yet to be proven and that it is being offered only because some patients are not helped by approved drugs or are they are so sick they need a drug that can be given intravenously. The approved antiviral drugs are currently available only in pill or inhaled form.
The story does not appear to rely on a news release.
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.
The story makes clear that the approved antiviral flu drugs are Tamiflu and Relenza.
Total Score: 8 of 10 Satisfactory
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