Drugs/Medical Archive
“Oops” Not Welcome Here (your Hospital…your Drug Store…)
November 20th, 2009. By Hunter West
There are some jobs that should be held to a higher standard. Like holding public office, or serving as a priest, or acting as someone’s surgeon. Maybe you’re about to amputate a limb…and the patient assumes you know the correct one to remove.
Well, as experience has taught us—not always.
Here’s a couple of examples of ‘oopsies’ that are unforgivable. Imagine if this happened to you…
Oops #1: Wrong Kerry, Wrong Test
Kerry Higuera was three months into her pregnancy when she started to bleed. Fearing a miscarriage, she headed to her local emergency room. It seemed the prudent thing to do.
According to CNN she was put in a room that February morning last year in Arizona and was told to wait until a nurse came by to get her.
Soon enough a nurse poked her head in and said, “Kerry?” Kerry said yes, she was Kerry. Well, off they go to the CT scan room. “Is this really what I need to have done,” asks a reluctant Kerry, assuming that radiating her abdomen containing a three-month-old fetus can’t be healthy. The answer was yes. “This is what the doctor wants…”
You can imagine Kerry’s panic when, soon after having the CT scan on her abdomen Higuera was visited by the emergency room physician, two radiologists and someone representing the
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
Musing about Merck, Zetia and Gardasil
November 15th, 2009. By AbiK
So you caught the news recently that Merck’s Gardasil was approved by the FDA for use in boys ages 9 to 26. No one really expects much from this news—ie, doctors aren’t expected to be offering it to their male patients (or their parents as the case may be). But I find it interesting none the less.
First, the background…Gardasil is the vaccine that’s supposed immunize young girls (ages 9 - 26) from the HPV virus—aka, human papillomavirus, the sexually transmitted one that can lead to cervical cancer. There’s a lot of heated debate on Gardasil in girls–we’ve blogged on it as well–and the New York Times recently reported that in order to be effectively immunized with Gardasil, it requires a series of three injections, each costing $130 (translation, around $400; translation, it ain’t cheap).
But now let’s just take a look at that NYT report again. I read on through the whole article…la
Has Tylenol had its Day in the Sun?
November 12th, 2009. By janem
Bayer is likely seeing its Tylenol sales drop these past few weeks after the FDA finally took aim at acetaminophen over-the-counter (OTC) products and the media made it headlines.
Many consumers are loyal to certain brands and I’ve taken my fair share of Tylenol over the years, but for me, Tylenol’s had its day in the sun. What’s most disturbing is that the FDA has known since at least 1977 that severe liver damage can occur as a result of acetaminophen overdose. Back then, their advisers recommended explicit warnings not to exceed the dose or take acetaminophen for more than 10 days, but the FDA never took action.
So now the agency is making up for lost time and warning people that taking a few extra Tylenol pills here and there, thinking OTC meds are safe, could result in acetaminophen toxicity. Isn’t that like shutting the barn door after the horse has bolted? Since 1977!
And the German drug maker (with HQ in New Jersey) may soon take a dive in profits-there’s a new kid on the block touting a safe alternative to acetaminophen.
BioElectronics Corp. recently completed an acetaminophen comparison study and its results will be announced next Monday, November 16. Their timing is ripe to introduce ActiPatch and Allay, alternatives to Tylenol and other acetaminophen products.
“We believe this is important research especially considering the many health concerns expressed by the U.S. Food and Drug Administration relative to Tylenol, NSAIDs and other over the counter pain medications,” said Andrew Whelan, CEO of BioElectronics, Corp. ” We look forward to reviewing the full study data and submitting it to FDA in support of our current pending 510(K) applications and additional applications we plan to file in the future.”
In the meantime, no doubt consumers are studying labels on OTC meds more carefully these days, especially after the FDA’s recent announcement about the dangers of acetaminophen overdose in children’s meds. The FDA committee has insisted that all children’s and infant’s acetaminophen products be sold at the same concentration, simplifying dosing instructions. Currently the labels are confusing– there are several different strengths of liquids, chewables, and “Junior” tablets that give dosage instructions by weight and age.
What I find mind-boggling is how Bayer has controlled OTC pain meds for so long while there are safer alternatives.
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