2008 Woodie Awards
All the News That Gives Us Fits: FDA Approvals Fall Short
Know Your Pills Before You Pop Them
Katharine Anderson
Issue date: 10/13/04 Section: Opinion
- Page 1 of 1
It's a common scenario for far too many students. First the sniffles and sneezes plague overloaded minds, then comes the need for antibiotics. In between term papers and studying we traipse to the doctor's office and get those trusty prescriptions.
But, are they really trusty?
The commonly used antibiotic erythromycin, when used in concert with newer drugs, sends the risk of cardiac arrest to five times higher, according to a study conducted by Dr. Wayne A. Ray, a Vanderbilt professor of preventive medicine.
The Food and Drug Administration's solution? The drug's labels already note the risk.
Although, according to an FDA spokesman, they are reviewing the study to see if additional label changes are needed.
How many patients actually read through the pages and pages of drug information that comes with prescriptions?
Not many.
Now, how many instead trust their doctors to explain the risks and prescribe accordingly?
Too many.
Think about it. How many patients does a doctor see in one day? If the waiting room is any kind of an indicator - too many. With every patient that is seen, the chances of a doctor overlooking a dangerous medication interaction increases.
And yet, patients still regard their prescriptions as safe, not reading the enclosed FDA warnings.
With the overwhelming demand for new prescription drugs, the FDA is under scrutiny for approving too quickly, without requiring the necessary extended clinical trials.
Vioxx, a popular arthritis pain reliever, was pulled from the market Sept. 30. The drug's maker, Merck & Co., cited an increased risk of heart attack and stroke in people who used the medication.
A 37-year-old man died from a heart attack in 2001 after taking Vioxx for a month.
More than three and a half years later, the drug is recalled.
For years researchers have been warning of a link between the drug and increased risk of heart attack and stroke. Merck ignored those reports, finding holes in the research and calling them inconclusive.
Maybe that's because Vioxx sales reached $2.5 billion last year.
Where was the FDA when all of these reports and clinical trials were being ignored?
The discontinuation of Vioxx occurred just weeks after Merck publicly defended the drug's safety and the FDA approved its use in children as young as 2 years old.
Obviously, the FDA approval process is lacking.
"More than half of all drugs introduced have a new side effect ... after approval with the current system. I find that disturbing," said Curt Furberg, a public health sciences professor at Wake Forest University School of Medicine, in an Associated Press article.
Frightening is more accurate.
Until FDA approvals improve and money is no longer a contender in the race for new medications, which may be never, consumers need to keep themselves informed.
Know your pills before you pop them.
But, are they really trusty?
The commonly used antibiotic erythromycin, when used in concert with newer drugs, sends the risk of cardiac arrest to five times higher, according to a study conducted by Dr. Wayne A. Ray, a Vanderbilt professor of preventive medicine.
The Food and Drug Administration's solution? The drug's labels already note the risk.
Although, according to an FDA spokesman, they are reviewing the study to see if additional label changes are needed.
How many patients actually read through the pages and pages of drug information that comes with prescriptions?
Not many.
Now, how many instead trust their doctors to explain the risks and prescribe accordingly?
Too many.
Think about it. How many patients does a doctor see in one day? If the waiting room is any kind of an indicator - too many. With every patient that is seen, the chances of a doctor overlooking a dangerous medication interaction increases.
And yet, patients still regard their prescriptions as safe, not reading the enclosed FDA warnings.
With the overwhelming demand for new prescription drugs, the FDA is under scrutiny for approving too quickly, without requiring the necessary extended clinical trials.
Vioxx, a popular arthritis pain reliever, was pulled from the market Sept. 30. The drug's maker, Merck & Co., cited an increased risk of heart attack and stroke in people who used the medication.
A 37-year-old man died from a heart attack in 2001 after taking Vioxx for a month.
More than three and a half years later, the drug is recalled.
For years researchers have been warning of a link between the drug and increased risk of heart attack and stroke. Merck ignored those reports, finding holes in the research and calling them inconclusive.
Maybe that's because Vioxx sales reached $2.5 billion last year.
Where was the FDA when all of these reports and clinical trials were being ignored?
The discontinuation of Vioxx occurred just weeks after Merck publicly defended the drug's safety and the FDA approved its use in children as young as 2 years old.
Obviously, the FDA approval process is lacking.
"More than half of all drugs introduced have a new side effect ... after approval with the current system. I find that disturbing," said Curt Furberg, a public health sciences professor at Wake Forest University School of Medicine, in an Associated Press article.
Frightening is more accurate.
Until FDA approvals improve and money is no longer a contender in the race for new medications, which may be never, consumers need to keep themselves informed.
Know your pills before you pop them.
