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Location: Blogs Jim Lassiter -- Good News/Bad News |
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| Posted by: jim |
4/15/2008 10:21 AM |
The Commissioner of the Food and Drug Administration just initiated a kind of weekly Blog within the FDA Website. You really ought to see what his first posting said.
Or you can read the summary here.
The seemingly positive application of only slightly dated technology (a kind of weekly blog posting) by the Commissioner of the Food and Drug Administration feels like a really good idea. Of course one must navigate directly to the FDA website in order to find this column. I suspect not every American does this but –more to this later – the column is visible and accessible via the worldwide web.
Dr. Andrew C. von Eschenbach posted his first such column and – well – there should be some fanfare for the initiation. If not for the initiation – perhaps for the message. Andy (as he apparently likes to be called judging by his column heading: "Andy’s Take") took as his first subject the position of "FDA—The Protector". After all, it has long been FDA’s position that they are the last line of defense between the innocent consumer and the nefarious elements that operate in the netherworld under FDA’s governance.
Let’s begin our review with the example Andy cites first in this, his first posting. He points directly to the adulterated dietary supplements that caused some notable adverse events owing to the presence of massively too much selenium. This sort of thing is fair game and FDA tooting its own horn about seizing the product once the challenge was found is fully appropriate. The example demonstrates how stuff works, and should work – with some caveats. If there had been enforced GMPs for the manufacture of these supplements, there would have been far less likelihood of a product presenting with a selenium potency on the order of 400 times label claim. Let’s set that aside for the moment and look at what followed this first column, first example and what Andy was trying to make of it. His message is clear and unambiguous in the very next paragraph:
“My take on this is that although the vast majority of companies are marketing safe and effective products, from time to time products will get into circulation that turn out to be dangerous to you.” (in the original posting "My take" was in boldface so as not to add ambiguity)
Without parsing the turnip too finely we appear to have a Commissioner of the United States Food and Drug Administration stating that dietary supplements exist which can be considered “safe and effective.” To say the least – this is a landmark determination. It is also a pronouncement that will likely prompt another “Letter to the Agency” by Congressman Waxman wanting to know precisely what Andy was thinking when he wrote the column. Dietary Supplements safe? Dietary Supplements effective? Think about the significance of this finding and pronouncement for a moment.
Time’s up. Let’s get to the other shoe that Andy dropped in his presentation. He goes on to cite the latest in (I know this is shocking in the Claude Raines sense of the word) inappropriately “fortified” sexual-performance-enhancing dietary supplements and FDA’s actions against them. In fairness, Andy also took the time to bash another industry (in this case medical devices) in his listing of actions taken. This other shoe however, I suspect Andy has some rather large feet too, comes in the form of the resurrection of MedWatch.
MedWatch never really died it was just inappropriately used against dietary supplements. The data gathered were not sifted through well enough before being presented to folks like say – Congressman Waxman in the past. The REALITY IS that MedWatch is the system we MUST use. The reinforcement of this comes from the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (aka the AER bill which we will call it for the duration of this post) that went into full effect less than six months ago. In his first column Andy is extolling the virtues of MedWatch and encourages the average consumer to contact MedWatch directly. Perhaps this overture to the common man is something that makes sense to Andy owing to the fact that there is this little ongoing dispute over what information the AER bill requires the dietary supplement industry to place on its labels. Perhaps Andy just wants to be in touch with the common man. Perhaps.
Let’s rewind the video tape on this one for just a moment. The last notable instance where consumer and lay input to the MedWatch system was “exported” for assessment was during the process of banning ephedrine alkaloids. If you do not recall – there were congressional hearings chaired by (you guessed it) Congressman Waxman. There were piles of data out of MedWatch presented by the Chairman pointing to the egregious harm these dietary supplements were doing. Unfortunately, once the data were analyzed it turned out that the reports (especially those that came directly from consumers) were not all that indicative of the reality of the events. Well, it looks as though Andy’s philosophy is “if it’s worth doing wrong; it’s worth doing twice.”
Stepping back for a moment, let’s look at the whole of Andy’s first post in light of the realities of today with deeper perspective coming from the illuminating glow of history.
1. Andy thinks dietary supplements (some of them at least) are safe and effective. I wonder which ones? No matter. The pronouncement itself is a landmark that should not be shuffled into the back of some file drawer but held onto and presented at appropriate moments going forward.
2. Andy thinks MedWatch is a great system. He cited examples of it working. I agree that in the instances Andy talks about it did work. I would also like to allow the AER bill to work for a while before we solicit input from every Tom, Dick and Nutjob with a dialing finger but – hey – Andy’s the Commish. The AER bill is in effect and MedWatch is the tool to capture the reporting of Serious Adverse Events (which by the way are clearly defined in the AER bill). This process is feasible, consistent and mandatory. On the other hand: What could go wrong with consumer input directly to MedWatch as Andy encourages? Anyone else remember some of the unfathomable reports that somehow linked back to ephedra supplements but were reported because, well, consumers contacted MedWatch?
3. Andy is justifiably proud of FDA’s role as watchdog and he just needs a little help. Like from all the consumers out there. Ignore the AER bill– WE WANT TO HEAR FROM YOU! HOUSTON – HELLO!
4. Congressman Waxman is setting the table and getting the seats lined up for the next round of MedWatch reports review and discussion. I hope we are too. Rest assured Andy will be there. |
| Copyright ©2008 Jim Lassiter |
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