In a September JAMA/archives journals (Archives of Internal Medicine), it was reported that so many adults think that ONLY the most effective drugs with no serious adverse effects are given FDA approval. If explanations were provided regarding the FDA’s uncertainties about drug benefits, perhaps it would affect your choice of drug treatment.
The cholesterol lowering drugs Zetia and Vytorin reached sales of $1.8 million before a study found no clinical benefit from their use. Also, the anti-inflammatory medicine Vioxx reached sales of $2.4 billion (six months after FDA approval) before it was taken off the market due to its association with heart attacks and strokes.
The article recommends that the FDA should more effectively communicate what it knows and does not know about how well the drugs may or may not work. It is clear that information about new drugs is inconclusive at best when they come to market. It is only after several years of data do the uncertainties become known.
Dr. Michael Carome, deputy director of Public Citizen’s Health Research said it best that “…patients need to be aware that almost any drug has potential side effects……for newly approved drugs, there’s often insufficient information about serious risks, some of which may have gone undetected during the approval process and won’t be detected until they’re used in the real-world setting on a wide-scale basis.” They support a “do-not-use-for-seven-years rule.”
Too many people place too much reliance on the FDA stamp of approval. A recent study found that people who receive the most information about a medicine were better able to make the best drug choices. The study revealed that people are not only concerned about potential harmful side effects, but also whether or not a new drug really works. The FDA is mandated to approve drugs within ten months of its submission or face funding cuts. The problem is that most of these medicines do not show their adverse side effects for many years.
It wasn’t until the cholesterol lowering drugs Zetia and Vytorin reached $1.8 million in sales in 2007 before a study found no clinical benefit from these drugs whatsoever. The anti-inflammatory medication Vioxx reached $2.4 billion in sales by 2003 before it was taken off the market (six months after FDA approval) due to its association with heart attacks and strokes.
Dr. Michael Carome, deputy director of Public Citizen’s Health Research group in Washington, D.C. states that “patients need to be aware that almost any drug has potential side effects.” “And for newly approved drugs, there’s often insufficient information about serious risks, some of which may have gone undetected during the approval process and won’t be detected until they’re used in the real-world setting on a wide-scale basis.” His organization supports a “do-not-use-for-seven-years rule.” Unless a drug is a breakthrough medication for a condition for which there is no previously good options, we recommend that people not take it for at least seven years.
Daniel Carpenter of Harvard University professor of government said, “the term ‘FDA approved’ gives patients a mental and emotional security about a drug.” But also thinks people may attach too much subconscious trust to the FDA stamp of approval.
Until the public is given honest information regarding medications prescribed to them, people are exposing themselves to chemicals which may cause more harm than if not taken at all. The problem is that most of these medicines do not show their adverse side effects for many years after they were approved. By then, so many people have already risked their health and in some cases it is too late.
