Posts Tagged ‘ FDA ’
What You Should Know About Drug Studies
November 19th, 2009. By Kristine B
In light of the recent release of the results from the ARBITER 6-HALTS trial regarding Zetia and Niaspan, there may be questions about what drug studies are and why they are important. This week, Pleading Ignorance examines drug studies: what they do, what they don’t do and what you should know about them.
Drug Studies: What They Do (Timing is Everything)
The names of the drug studies are impressive, aren’t they? Names like 
ARIBITER 6-HALTS, ENHANCE, RECORD and so on. The fancy thing is that all the letters in the names mean something (an acronym!)—but no one ever remembers what the heck they mean, save of course the folks conducting the test. So the catchy name is fine for the rest of us. (By the way, ARBITER 6 HALTS stands for “Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6–HDL and LDL Treatment Strategies“—say that fast 6 times). Once you’re beyond the name though, it’s important to know at what point in time the study is being done—after all, the studies are designed to show something. The timing in which the drug is tested will clue you in to what information the researchers are looking for.
Drug studies that are done before the drug is approved by the FDA (known as clinical trials), are done to prove…
- that a new drug is at least as effective as an older drug
- that the new drug is more effective than just standard therapy alone, or
- that the benefits of the new drug outweigh the risks (see, they’re watching out for you!)
If the studies are done after the drug is approved, they may be done to…
Online Pharma Advertising…can’t wait
November 17th, 2009. By AbiK
Actually I can. You know how drug advertisements look in magazines—it can be like 3 pages of text (aka “product disclosure”) that runs on and on and interrupts whatever you’re reading. Heaven help you if you’re reading Reader’s Digest where 3 pages suddenly becomes 5 due to the smaller format. And if you do take a moment to glance at the ad, you’ve got to be thinking that something that takes that much explaining maybe shouldn’t be taken at all. Be that as it may, enter the brave new world of online advertising…
Well, there’s just no room online to be putting all that junk. Those tightly designed banner ads would become full-page ads with all the disclosure notices included and I guarantee that after coming face to face with a few “impressions” of those, you’ll never click on that website again.
And don’t the drug companies know it. But they need to be pushing their wares online—that’s where all the “growth” is these days. So now, get this—the drug industry’s big guys like Eli Lilly and Pfizer are turning to the FDA for guidance on how to push their goods online. Why? The current FDA guidelines for advertising in traditional print media (magazines, newspapers) or t.v. require all that disclosure information is shown prominently. But there aren’t really any guidelines set for new media—so everyone’s playing by the rules of traditional media, and clearly that’s not good.
Not good for who? Big pharma, but also the bigger online media companies. See the online
What’s in Your Kid’s Favorite Drink? (Big Brother wants to know…)
November 16th, 2009. By LucyC
College kids, caffeine and alcohol. How many red flags does that sentence raise for you? Well, it’s raised a few at the Food and Drug Administration (FDA), specifically, is adding caffeine to alcoholic beverages legal, and is it safe from a health perspective? Short answer: the Agency isn’t sure…or at least that’s how it appears.
So, last week the FDA issued a press release alerting the public about its latest course of action on this issue—which by the way is not new. The Wall Street Journal wrote a piece on this in August, stating “Last year, [2008] about a dozen attorneys general secured settlements with beer giants Anheuser-Busch InBev NV and MillerCoors LLC, which agreed to remove caffeine, guarana and other stimulants from drinks such as Sparks.”
But that’s another story. I digress. The FDA press release informed the public that it has issued letters to 30 manufacturers of caffeinated alcoholic beverages—basically putting them on advisement that the whole issue is under investigation. The crux of the matter is:
“Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the
Pet Turtles, Salmonella and the Ban No One Knows About
October 30th, 2009. By Hunter West
There’s a ban on small pet turtles?
Really?
Okay, so the ban is only on pet turtles less than four inches in diameter. The US Food and Drug Administration (FDA) enacted the ban after reports surfaced that children were putting the cute little things in their mouths. However, it wasn’t a choking hazard that seemed to drive the ban.
No, it was the fact that children became sick after coming into contact with their pet turtle in such an intimate fashion.
Sick with salmonella from turtles.
Turtles carry salmonella, it seems—originating in their feces, according to a recent MSNBC report. So children, by placing the baby turtles in their mouths, were coming into direct contact with salmonella.
So they were banned 34 years ago.
Just the small ones, mind you. In 1975.
Oh, you didn’t know either? Join the club. Few consumers know about the ban—and fewer vendors appear to be enforcing the ban, or complying with it. According to MSNBC small turtles
Lasik Surgery: FDA keeping a watchful eye…
October 19th, 2009. By AbiK
Lasik surgery’s been around for a while now (since the late 80’s, with the first Lasik laser being approved for use in 1998). And reports indicate some 6,000,000+ have had Lasik. I only know of one person who’s had it done and she raves about it. So much so that I even looked into it myself, but my ophthalmologist rejected me. It was worse than being dumped. So, while I cursed him at the time, the fact that the FDA is now beginning its study of Lasik long-term effects and post-procedure “quality of life” has me feeling a little better.
But it’s also got me thinking…what’s going on? Why now? The FDA doesn’t just casually decide to start snooping around in someone’s backyard…right?
Any time the FDA starts snooping around something (and this time it’s in tandem with their sending out warning letters to 17 Lasik facilities that were not properly reporting problems with Lasik procedures) I raise an eyebrow. Yes, I’m a bit jaded in the line of work I’m in. But you have to wonder why
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