The FDA mission statement reads in part:
“The FDA is responsible for protecting the public health by
assuring the safety, efficacy and security of human and veterinary
drugs, biological products …, our Nations food supply …”
“The FDA is also responsible for … helping the public get the
accurate, science based information they need to use medicines and
foods to improve their health.”
With that mission statement in mind, let’s take a look at this tragic situation:
As reported by the Associated Press on February 14th, 2005 –
Canada has ordered the removal of a drug for ADHD – Adderall XR,
Because of links to 20 sudden deaths and 12 strokes from people taking
this drug. 14 of these deaths were children and 2 of the 12 strokes
were children who were taking the drug.
None of these deaths or strokes took place in Canada and none
of the reactions were from misuse or abuse of the drug. The reactions
were from normal consumption of the drug.
Canada is also asking makers of similar drugs for treating
this condition, “to provide a thorough review of their worldwide safety
data.”
In stark contrast to the Canadian reaction, here is the statement from the United States FDA –
“The U.S. Food and Drug Administration, however, said it had
evaluated the same reports on Adderall XR and doesn’t think the data
warrants similar action in the United States.”
Let’s get this straight – Canada has ordered the drug to be pulled off the market in their country.
And the FDA says it is alright that 2 children have suffered strokes and 14 children have died from using this drug.
Canada cares about the health of its children and does not want any deaths to happen in their country.
However, the FDA has a very different view.
This is the FDA statement posted on their website last week:
The FDA says it “does not feel that any immediate changes are
warranted in the FDA labeling or approved use of this drug based upon
its preliminary understanding of Health Canada’s analysis of adverse
event reports and FDA’s own knowledge of the reports received by the
agency.”
When will the FDA care about America’s children?
When will the FDA care about the people of America?
Let’s review the FDA mission statement one more time.
“The FDA is responsible for protecting the public health by
assuring the safety, efficacy and security of human and veterinary
drugs, biological products …, our Nations food supply …”
“The FDA is also responsible for … helping the public get the
accurate, science based information they need to use medicines and
foods to improve their health.”
I’m not sure when you’ll be asking yourself, “Is the FDA really looking out for my health?”
Sources: Associated Press “Canada orders drug for ADHD off market”, February 14th, 2005.
Nutritional Health Alliance, Washington Update, February, 2005.
