The FDA wouldn't do that!

Even McGoofy Is Right Sometimes
By Joseph Walther

The McGoofy Group met this past Saturday at Mamma Gina’s Pizza in the New Castle Farmers Market. Earl, the group’s leader, called the meeting “a serious emergency.” He emailed me about it. I replied, asking what issues they’d be discussion. I also asked him to explain the difference between an emergency and a “serious” emergency. He then replied, in rather agitated verbosity, that he wanted me to attend. I rushed right over.

In the interest of clarification for any of you first-time readers, the McGoofy Group consists of seven males. They meet monthly to discuss pressing worldly matters that they consider critical to the “American” way of life. Actually, Earl does the talking. The other six nod in raptured assent. I am there to ask an occasional impertinent question, such as “do you have any proof?” So, with this in mind, let me get to the issues of the last meeting.

The first words out of Earl’s mouth were, “It’s damn well time that we got rid of the mucking FDA. (He didn’t actually say mucking.) The others in attendance, particularly Larry, his brother Daryl, and his other brother Daryl, agreed.

By “agreed”, I mean that Larry and his brother Daryl moved their heads up and down in what looked like an affirmative response. Larry’s other brother Daryl just looked confused. Of course, to Earl, this is an automatic yes vote.

Unfortunately, however, one of the remaining three group members had spilled his Pepsi all over the table, thus causing the other two to bail out of the way. So these three probably didn’t even hear what Earl had told me.

In the mean time, being scared to death that Earl was about to call the matter to a vote, I jumped in quickly with, “Um, why, Earl?”

Earl: “Do you need me to draw you a picture?”
Me: “Why, yes, if you’d be so kind.”
Earl: “Jesus Mucking Christ, (He didn’t really say mucking.) do you know anything about politics, Mr. True Facts?
Me: “Not as much as you do, Earl, Just the same, though, I have this nasty habit of checking things out before I make an ass out of myself. So, Earl, why should we get rid of the FDA? Do you actually know how the FDA functions?”
Earl: “Everyone knows that the FDA is in bed with the drug companies…”

Earl’s voice trailed off as both of us aimed our focus on a small disruption at the end of our table. A petite, young Mexican girl was crying as her faced dripped some sort of liquid. And her VERY heavy mother seemed poised to cause serious bodily harm to a member of Earl’s group.

Apparently, the three involved in the earlier spilled Pepsi fiasco had finally settled into the discussion, only to have one of them, Bert, drop a slice of tomato pie down the front of his tee shirt. So, again, the other two had to divert their collective attention to a more pressing matter, such as laughing frantically at Bert. They were laughing so hard that the one called “Ramrod” was unaware of his impending doom.

You see, when Bert dropped the slice down the front of his tee shirt, Ramrod, in an irrepressible fit of laughter had spewed a mouthful of Pepsi all over a 12-year old girl sitting at an adjacent table. The girl’s 300-pound mother was not happy about it and began aggressively expressing her feelings in words and gestures.

I didn’t completely understand what she was saying because she spoke in Spanish with a few broken English words thrown in. All I know is that her eyes really stood out because they were blood red and staring daggers at Ramrod as she spoke to him. Also, there was a very big, deep purple vein bulging out from her right temple. I swear it was throbbing.

As she stood nose-to-nose, expressing her concerns to Ramrod, I could not understand everything she was telling him. But, her animation left little to the imagination. Here’s what it sounded like. “[Something] [something] tonto Americano! El tonto hombre. [Something] ass! Tonto [something] [something]! (It sounded like sock trucker!) [Something] [something] [something] I’m gonna [something] [something] your head [something] up your [something] [something] ass!”

While I’m not sure, it sounded like she was talking to Ramrod about some of the conclusions that she had drawn regarding his intelligence, his parents’ marital status, his sexual orientation, and her intent to send him into the bathroom through the adjoining wall instead of the door.

Thank God that a security guard showed up out of nowhere. Earl decided to adjourn the meeting. He and a couple of the others were trying to get Ramrod out of that wall, although I think he was bleeding too much. However, Earl promised me that he wouldn’t do anything rash until I had a chance to check out his claims about the FDA and get back to him.

As I was leaving, they were making outstanding progress at removing Ramrod from that wall. I could definitely see most of his lower body as I turned the corner by the pizza counter.

I’ll bet everything I have that this sort of thing never happens during the Federal Reserve meetings.

In keeping with my word to Earl, I began my search about noon today and, to my surprise, I was able to find some information about the FDA. I found an exposé titled, “10 voters on panel backing pain pills had industry ties.” It was a New York Times report written by Gardiner Harris and Alex Berenson. It involved Vioxx, Bextra, and Celebrex. Two of these have been the subject of major lawsuits, as well as subjects of intense criticism by many mainstream doctors.

The advisory panel appointed by the FDA to revaluate these drugs consisted of 32 members, 10 of which had received grants, research fees, of other monetary compensation from both Merk and Pfizer, the manufacturers. Here is a look at the vote to keep them on the market.

Drug Full Committee Committee minus

Name With conflicts conflicts of Interest

Vioxx 17 Yes 12 No 8 Yes 14 No
Bextra 17 Yes 13 No 8 Yes 12 No
Celebrex 31 Yes 1 No 21 Yes 1 No

I was able to discover some other facts, thanks to AARP’s bulletin vol. 47 no. 5. The FDA currently has a backlog of about 800 generic drugs awaiting evaluation. This is because, according to AARP, the FDA has 200 employees currently evaluating 975 generic drugs while 700 employees are evaluating about 150 new drugs. What’s going on, you ask!

Brand-name drug manufacturers pay the FDA user fees in order to help fast-track the evaluation of their drugs. Generic manufactures pay nothing. Interesting, huh? I wonder if the fact that the introduction of generics lowers the price of prescription medications exponentially has anything to do with this.

At any rate, to his credit, Earl may have a point on the FDA. I’m going to snoop around some more and see what I can find.

Right now, though, I have to go. I’m going to stop by the hospital and see Ramrod. I understand the surgery went well and that he should be out of traction in a week or two.

Have a great week.

Joseph Walther is a freelance writer and publisher of The True Facts. Send your comments. Just click here.