Am I Missing Something Here?

[scotchnwater]

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I'm sure a lot of you saw this story today: http://www.msnbc.msn.com/id/29515991/

I know I'm just an intern, but at first glance (post-night shift in the ED) it seems like the OVERWHELMINGLY OBVIOUS problem here was that the drug was INJECTED IN AN ARTERY and not in a vein.

Maybe it's because I'm only AOx2 after a long night of pelvic exams and EtOH withdrawal, but I'm not understanding how this is falling back on the drug manufacturer. Wouldn't any number of drugs cause problems if they were injected arterially? For that matter, wouldn't any number of drugs cause problems if they were administered in an improper way - period? How does this fall on the shoulders of the manufacturers and not on the person who administered the dose?

Can someone smarter (and/or more oriented) than me please explain...

Edit: Here's a link to the story that talks more specifically about the lady who brought all this on:
http://www.msnbc.msn.com/id/29516155/

 

[Gern Blansten]

Phenergan injected into an infiltrated IV site can do this. I have seen some pretty dramatic pics. Injected into an artery, I am sure, would be much worse. But it doesn't have to be an arterial injection for it to happen.

 

[Planktonmd]

I'm sure a lot of you saw this story today: http://www.msnbc.msn.com/id/29515991/

I know I'm just an intern, but at first glance (post-night shift in the ED) it seems like the OVERWHELMINGLY OBVIOUS problem here was that the drug was INJECTED IN AN ARTERY and not in a vein.

Maybe it's because I'm only AOx2 after a long night of pelvic exams and EtOH withdrawal, but I'm not understanding how this is falling back on the drug manufacturer. Wouldn't any number of drugs cause problems if they were injected arterially? For that matter, wouldn't any number of drugs cause problems if they were administered in an improper way - period? How does this fall on the shoulders of the manufacturers and not on the person who administered the dose?

Can someone smarter (and/or more oriented) than me please explain...

Edit: Here's a link to the story that talks more specifically about the lady who brought all this on:
http://www.msnbc.msn.com/id/29516155/

This whole thing is about a bunch of lawyers trying to make money even if that meant making it more difficult for the average American to get safe and effective treatments.
The FDA is the reason why we are 15-20 years behind the rest of the advanced world when it comes to adopting new therapies and new medications, they single handedly are causing the death of thousands of American patients every year by not allowing them access to better and newer alternatives.
I wish there were some lawyers who would go after the FDA for unnecessarily delaying or withholding medications that could save lives, but they wouldn't do that, because there is no money in suing the federal government.

 

[CAPBonanza]

I didn't really get this either...$6.7 Million from Wyeth, plus I'm sure she got another hefty sum from the malpractice payout against the P.A. that pushed the phenergan. Deep pockets make attractive targets, I guess. However, The Supreme Court opened another huge can of worms. While I rarely if ever, defend drug companies, should they really be required to foresee every possible complication from a misused product?

 

[GoodmanBrown]

The FDA is the reason why we are 15-20 years behind the rest of the advanced world when it comes to adopting new therapies and new medications, they single handedly are causing the death of thousands of American patients every year by not allowing them access to better and newer alternatives.

Could you please give some examples of "advanced" countries that have way better therapies and medications? Every other country I know of approves medications way after the U.S. because they're costly and unproven.

Second of all, could you name some of the incredible drugs that are saving thousands of lives in these other countries? From most things I've read, for the vast majority of cases, the drugs that have been around for 10+ years would do just as good a job.

 

[Bertelman]

Could you please give some examples of "advanced" countries that have way better therapies and medications? Every other country I know of approves medications way after the U.S. because they're costly and unproven.

Second of all, could you name some of the incredible drugs that are saving thousands of lives in these other countries? From most things I've read, for the vast majority of cases, the drugs that have been around for 10+ years would do just as good a job.

Drugs are typically approved in Europe before the U.S. I may not agree that this disparity is causing the loss of thousands of lives per year, but the U.S. certainly has the most lengthy approval process.

"As we noted a few weeks back when J&J's Stelara for psoriasis was approved in Europe, it's become pretty common for drugs to make it to market in Europe before the U.S."

http://blogs.wsj.com/health/2009/02...-europe-first-lillys-blood-thinner-prasugrel/

 

[coprolalia]

Could you please give some examples of "advanced" countries that have way better therapies and medications?

Pretty much all of Western Europe.

Every other country I know of approves medications way after the U.S. because they're costly and unproven.

Wait... huh? Wrong! This statement makes no sense. Think about what you said here. The exact opposite is actually true. Just about every pharmaceutical companies files and gets approval for their medication in Europe before the U.S. Your assertion that the FDA approves major new medications before "every other country [you] know of" is actually more the exception than the rule, and not for the reasons you mention... unless, of course, every other country you know of is Canada and Mexico.

Second of all, could you name some of the incredible drugs that are saving thousands of lives in these other countries?

Here's a short list of just a few from this past month (at the top of the release):

http://www.emea.europa.eu/pdfs/human/press/pr/9779509en.pdf

From most things I've read, for the vast majority of cases, the drugs that have been around for 10+ years would do just as good a job.

First off, you should read more.

Secondly, your statement may be partially true for some conditions and certain instances where "me too" drugs (such as the n-th iteration of another beta blocker or another statin therapy), but the fact is Europeans have access to a far greater variety of drugs than we do. Intravenous acetaminophen is one immediate example. Suggamadex is another more recent one.

http://shearlingsplowed.wordpress.c...uggamadex-or-bridion®-is-non-approvable-ouch/

Now, you're not going to argue that suggamadex isn't a "potentially life-saving drug" or that there are other drugs that have "been around for 10+ years that would do just as good a job" are you?

Furthermore, they just don't have to worry about the lawyer vultures over there waiting to start a class-action lawsuit the minute they sniff even a potential adverse event that may (or may not) be directly related to a drug.

-copro

 

[Planktonmd]

Could you please give some examples of "advanced" countries that have way better therapies and medications? Every other country I know of approves medications way after the U.S. because they're costly and unproven.

Second of all, could you name some of the incredible drugs that are saving thousands of lives in these other countries? From most things I've read, for the vast majority of cases, the drugs that have been around for 10+ years would do just as good a job.

Copro answered your questions so I am only going to add 2 examples of the top of my head:
Amiodarone and low molecular weight heparins : look them up and see when they were approved in Europe and how many years it took for the U.S. to approve them.

 

[jwk]

Copro answered your questions so I am only going to add 2 examples of the top of my head:
Amiodarone and low molecular weight heparins : look them up and see when they were approved in Europe and how many years it took for the U.S. to approve them.

And don't forget sugammadex.

 

[lfesiam]

I'm sure a lot of you saw this story today: http://www.msnbc.msn.com/id/29515991/

I know I'm just an intern, but at first glance (post-night shift in the ED) it seems like the OVERWHELMINGLY OBVIOUS problem here was that the drug was INJECTED IN AN ARTERY and not in a vein.

Maybe it's because I'm only AOx2 after a long night of pelvic exams and EtOH withdrawal, but I'm not understanding how this is falling back on the drug manufacturer. Wouldn't any number of drugs cause problems if they were injected arterially? For that matter, wouldn't any number of drugs cause problems if they were administered in an improper way - period? How does this fall on the shoulders of the manufacturers and not on the person who administered the dose?

Can someone smarter (and/or more oriented) than me please explain...

Edit: Here's a link to the story that talks more specifically about the lady who brought all this on:
http://www.msnbc.msn.com/id/29516155/

Heard this on NPR. Was just thinking the same thing scotch.

 

[GoodmanBrown]

Pretty much all of Western Europe.

Ouch. I've been officially schooled. So, here's a question, how do approval and reimbursement work? The drugs are approved by a European body, but each country pays for them. So, what's the timeline for reimbursement? I snooped around the NHS's website, but couldn't find any area detailing which drugs are approved for reimbursement. My understanding is that most other countries approve reimbursement after the U.S. I'm thinking in specific of chemotherapy drugs (which is admittedly only one slice of the pie.).

 

[core0]

Copro answered your questions so I am only going to add 2 examples of the top of my head:
Amiodarone and low molecular weight heparins : look them up and see when they were approved in Europe and how many years it took for the U.S. to approve them.

On the other hand Thalidomide made the FDA look pretty good.

David Carpenter, PA-C

 

[coprolalia]

On the other hand Thalidomide made the FDA look pretty good.

David Carpenter, PA-C

Approved in Germany first (and well before the establishment of the EMEA), and the "thalidomide babies" you saw in North America from the early-60's were mostly Canadian. The FDA actually refused to license it in the U.S. Only 17 U.S. babies were born with the defects, as it was used as an "experimental treatment" still. As a result, FDA changed it's rules regarding testing in pregnancy. Also, thalidomide is on the market now as a prostate and multiple myeloma cancer treatment.

-copro

 

[jwk]

Approved in Germany first (and well before the establishment of the EMEA), and the "thalidomide babies" you saw in North America from the early-60's were mostly Canadian. The FDA actually refused to license it in the U.S. Only 17 U.S. babies were born with the defects, as it was used as an "experimental treatment" still. As a result, FDA changed it's rules regarding testing in pregnancy. Also, thalidomide is on the market now as a prostate and multiple myeloma cancer treatment.

-copro

Do dentists use it?

 

[escape78]

Could you please give some examples of "advanced" countries that have way better therapies and medications? Every other country I know of approves medications way after the U.S. because they're costly and unproven.

I.V Tylenol is another example