2009 FDA Drug Approvals - Untold Story of H1N1 Vaccines

Current issue of Nature Reviews Drug Discovery has very interesting article about 2009 FDA drug approvals. There is another interesting article - FDA drug approvals mostly flat in 2009 - which I also recommend. Nature Reviews article provides more details about drugs and it includes useful graph and tables. The second article published by Associated Press mentions about "black box" warning labels for drugs already on the market and phony swine flu remedies. However they both don't mention the FDA approval that had the highest impact which was approval of 2009 H1N1 influenza virus vaccines. I came across an interesting article with a shocking title - Thousands of Americans died from H1N1 even after receiving vaccine shots. I checked FDA NEWS RELEASE and it's interesting that the only scientific data mentioned there is preliminary and it only shows that "2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine". So we don't even know if this vaccine, that many companies made a huge profit in 2009, is better or worst than a sugar pill. Update: An article published in ScienceDaily with the title Influenza Vaccines: Poor Evidence for Effectiveness in Elderly. This is the only study mentioning influenza cases as a real outcome, as opposed to surrogate outcomes such as measurements of influenza antibodies in the blood.
See also:

• Comments under Dutch government wants to sell flu vaccines back.
• Swine Flu Immunity and Vaccine Programs.
  

Another interesting story that I shared in my Google Reader was that there is Little Evidence Tamiflu Works.

Finally, I also wanted to check to see how off-label drug use was covered in the news.

It might seem from this figure that off-label drug use was also mostly flat in 2009. However from the figure shown below you'll see that there was actually a spike in off-label drug fines fuelled by a record $2.3 billion fine to Pfizer.