(Un)Safe at home
It was the one thing I thought we could still count on them for.
I mean, we know we can’t count on the FDA to ensure that the drugs put on the market are safe and effective (Vioxx, Avandia, Seroquel, and the list goes on). But I didn’t realize they were so firmly on the side of the drug companies that when something dangerous was discovered– and dangerous to our children, no less–that they wouldn’t sound the alarm–immediately and loudly.
No, in addition to other things we know we can’t rely on them for, we can add drug recalls to the list. Because the FDA betrayed our children when it came to the reporting of the Johnson & Johnson recall of Tylenol, Motrin, Zyrtec, and Benadryl for children and infants.
In a world where the FDA was actually here to protect us, the agency would have reported this in a far more urgent fashion, appropriate to the danger at hand.
But soon after the scandal broke, FDA Commissioner Dr. Margaret Hamburg told the media that “the potential for serious health problems is remote.”
Remote? Really? I don’t think so.
So let me sound the alarm the way it should have been.
A drug plant that supplies ingredients to Johnson & Johnson was shut down because FDA inspectors found evidence that specks and bacteria may have contaminated 44 different medicines. They also found that in some cases, active ingredients were possibly at higher levels than the amounts listed on medicine labels.
What a train wreck! I wonder if Dr. Hamburg knows what the word “remote” actually means.
Specks’n’stuff
Start with “specks.”
The world is full of little unidentifiable specks, right? But not in drug manufacturing plants. Or that’s what they’re SUPPOSED to strive for: a speck-free environment. But the FDA says that even after many customers complained about specks in the medicines, J&J did not follow up with an investigation.
Then there’s the bacteria. Now we’re getting serious. Medicine is the LAST place you expect or want to find bacteria–especially in very common over-the-counter medicines for children.
But here’s the most reprehensible, absolutely unforgivable detail about the bacteria issue: FDA investigators report that someone at the company knew about the potential bacteria contamination, but allowed the medicine to be used anyway.
There are not enough exclamation points on earth to express my anger that someone would knowingly allow bacteria- contaminated medicine for children to be wheeled out the door and sent to stores all over the world!
How is that not criminal behavior?
But never fear! The House Committee on Oversight and Government Reform has rushed in right on time at the 13th hour to launch an investigation (and get some air time during an election year).
Sure, it might be gratifying to see Toyota and Goldman Sachs executives slide on over to make way for squirming J&J execs in the congressional hearing hot seat. But really…what’s Congress going to do? Some representatives will lob a few zingers that might appear on the evening news. They might slap J&J on the wrist with a fine that’s meaningless to a drug company that makes billions every year. Then they’ll turn off the lights and cameras and everyone will go home happy.
Everyone, of course, except those kids who got a dose of specks and bacteria in their cherry-flavored Tylenol.
Pump up the urgency
Believe it or not, bacteria isn’t the scariest part of this whole nightmare.
The scariest? Dosage.
Let’s say you gave your little one cherry flavor Tylenol infants’ drops. You carefully followed the dosage guidelines, but soon your child developed a high fever and began vomiting. When you rushed him to the ER, doctors suspected liver damage. But the possibility that Tylenol was the culprit was dismissed because you followed the guidelines to a T.
The FDA tells us that there are no actual reports of a scene like this being played out–no adverse event reports have been filed. But why would there be? Nobody had any reason to suspect the Tylenol. NOW they know that the amount of acetaminophen might be higher than the amount listed on the label. But until the first week of May, doctors were completely in the dark about the danger.
Meanwhile, the FDA is fully aware that acetaminophen is very toxic in high doses.
So if FDA officials had reported this story responsibly, instead of saying that the risk of serious harm is remote, they would have sent urgent warnings, like: “Parents, run, don’t walk to your medicine cabinet immediately and toss that dangerous bottle in the trash! GO!”
THAT’S the level of urgency that was called for.
What’s the matter, FDA? Giant drug company got your tongue?
To Your Good Health,
Jenny Thompson
Sources:
“FDA Says Bacteria Found In Lots For Recalled Tylenol” Associated Press, 5/4/10, ap.org
“FDA: McNeil QA OK’d Use of Bacteria-Tainted Ingredients in Tylenol” George Miller, Fierce Pharma, 5/5/10, fiercepharmamanufacturing.com
