Are they going to BAN Neurontin?

[brain]

I've just wasted nearly 3 hours trying to do a research
on where the report on this BAN - in USA, CAN & International
in all search engines ... and I've come up clueless.

I am aware of lawsuits and other yadda, yadda, yadda's.

Ever since my son's friend's sister who's in college - in
the Med Field - had overheard that there's going to be
talks of a total ban on Neurontin completely. I told her
to find out where they're getting that information and
who her professor is and which school she's attending
to ... 'cause I'd like to know ...

There's been posting on EFA forum about Neurontin going
beyond what it's intended to be.

HECK - I even went to the FDA's website ....


But then again - there's been pressure on Zonegran, to
be a diet drug as well (but for all I know that theory lost
its case).


HELP! I'm hoping this isn't some wild gossip going on!


And no - I am not taking the drug - just concerned about
pushy Drug Makers - that's all ... if we're not careful, we're
going to be out of anti-epileptic drug's because of pushy Drug Companies
that's trying to make a profit off of anti-epileptic drug's on something else!

[Bernard]

I'm aware of the recent press on Neurontin, suicides and off-label promotion, but I have not heard anything (yet?) about it being banned.

[brain]

Here's an interesting old article:

http://eatthestate.org/02-43/DrugCompanyGuinea.htm

Drug Company Guinea Pigs

by Maria Tomchick

We're used to seeing advertisements for prescription drugs on TV followed by the "ask your doctor" tag. Many of us go to our doctors and demand a prescription, even telling them in no uncertain terms that we'll go to someone else if we don't get it. But if we knew more about how drug companies test their products, how the FDA approval process works, and what the side effects of prescription drugs are, we'd all be a lot more hesitant to demand a pill to solve our problems.

Before a drug company can apply to the FDA to approve a drug for sale, it must first test the drug for potency (to establish correct dosage), indications for usage (what illnesses the drug can be used to treat), and screen it for side effects and adverse reactions. These side effects may later be added to a special warning label that accompanies each prescription.

But the testing process is deeply flawed. There are no set standards for the minimum number of human subjects in each trial. There is no requirement for the company to test its drug in women, children, or the elderly--most volunteers are college-age men or, until recently, prisoners. And finally, there is little money or incentive for the FDA to check on the private laboratories where testing is done to make sure basic protocol has been followed.

AND ... here it comes in PHASES:

The whole clinical trial process has three distinct phases. Phase I includes the first human trials of a drug, where a small number of healthy people take the drug to screen it for side effects and establish a dosage (usually a maximum dosage, rather than a minimum). Most labs rely on healthy college-age male volunteers to establish dosages that later may be found to be too much for a smaller woman, child, or an elderly person with a slower metabolism to take.

Phase II is the testing of the drug on a small number of sick people. During this process, the dosage levels may be adjusted.

Phase III is supposed to be the first large-scale testing; it's done on sick people at the dose or dosages at which the drug will be sold. Increasingly, Phase III trials are being done on ever smaller numbers of people to save money. Also, the trials are often done in foreign countries, where the FDA can't send an agent to inspect the lab.

After Phase III, the drug company submits its application and data to the FDA. But the FDA's scope is severely limited; they can only review the data that drug companies give them. An FDA medical officer can't recommend changes in dosage or usages for the drug, and they can't make recommendations to doctors about which drugs are safer to use for a particular illness. The best that an FDA medical officer can do is approve the drug, wait for adverse reactions to show up in the general population, then either force the drug company to do more trials or withdraw the drug from the marketplace. By that time, the damage has been done.

To add to this problem, doctors are not required by law to prescribe drugs only for their FDA-approved indications. Off-label prescribing is a very common practice worldwide and, while it helps many people, it nevertheless is an enormous uncontrolled experiment.

HUMAN LAB RATS

Have you noticed there's been MORE commercials advertising
prescriptions now on television than ever before, it used to be
in the magazines where you would find that ... Today - there's
no ESCAPE from such!



(edited to put the emphasis in - sorry about that)

[brain]

Since my (deceased) Father was a retired Pharmacist at the Vet
Hospital, I called the former Administrator to gain access to the
current Federal Regulations in the "OFF LABEL REGULATIONS" :

Here's the Result:

SAE: A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. A serious adverse event includes any experience that:

        a. is life threatening;
        b. is permanently disabling;
        c. requires inpatient hospitalization;
        d. prolongs hospitalization; or
        e. (for drugs) results in congenital anomaly, 
            cancer or overdose.

Side Effect: Undesired effect of a treatment. Investigational new drugs and devices are evaluated for immediate and long-term side effects.

An investigational device that:

(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; 

(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; 

(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or 

(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

S-BD (Single-Blind Design) : Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-masked design."

This practice is still being in use - but with restrictions

[Birdbomb]

Have you noticed there's been MORE commercials advertising
prescriptions now on television than ever before, it used to be
in the magazines where you would find that ... Today - there's
no ESCAPE from such

The advertizing isn't limited to TV, pick up ANY magazine. I cancelled my Readers Digest subscriptions 5 years ago because of all the prescription drug ads. I like to read a few other women's magazines but they too have jumped on the big pharma band wagon. These ads pay for themselves many times over.

Big Pharma learned how to manipulate people into requesting their new more expensive drugs from their doctors. As does certain medical implants companies. It sells their product.

This is why there are hugh lawsuits against several companies, they promote off-label use KNOWING the drug may not even work on a particular disorder. Vioxx is a classic example. The original company sold out to Phyzier (simple partial?) but before they did, their reps promoted that drug to be the end-all cure-all. Phyzier paid the fines, but they reaped more profit then the punishment before the drug was pulled off the market. They still made a killing. But the cost was with lives.

There is nothing wrong with making $$$ but where is the line drawn? How far is too far? There is blood on the hands of big pharma/medical device companies hands. They reap the big bucks and we still suffer, sometimes even more than before.

[brain]

Bird, I've done all I could to refrain myself,
but I cannot hold myself any longer - but remember,
V-I-A-......A?? (I don't think I need to spell the
rest of the letters )

That thing was EVERYWHERE!

[Birdbomb]

I have racked my brain but I can't think of the drug you may be referring to. Is it viagra? That name is plastered all over the exam rooms in the primary care clinic of the Mike O'Challaghan Federal hospital. The clock, the tongue depressors, every damn thing in the room say VIAGRA!

These detail guys pass out all kinds of goodies to promote the "newest and bestest" drug on the market. That junk trickles down to the general public too. I have a bunch of sticky pads, pens etc, on my desk! It's bombardment on a sublimbinal level. Ingrain the name! It becomes household. You will ask the doctor for that drug/medical device. You will assimilate, to resist is futile......

[brain]

I have racked my brain but I can't think of the drug you may be referring to. Is it viagra? That name is plastered all over the exam rooms in the primary care clinic of the Mike O'Challaghan Federal hospital. The clock, the tongue depressors, every damn thing in the room say VIAGRA!

CONGRATS!
You just won a California King
Size VIAGRA Pillow!

<------- running off the thread!


Just teasing!!!

I'm literally sick of Viagra - and I'm sure tons of
women are too!




Sorry I mistyped it the first time around - was still sneezing,
'cause of pollen out here - almost all the pollen down here is
pretty much gone - nice and spring green!

[Bernard]

Want to know what the latest and greatest drugs are? Just manage a blog or post your email address somewhere on the web. The spam will come in droves - cialis, fentermine, zithromax, ambien, etc. etc.

[brain]

Want to know what the latest and greatest drugs are? Just manage a blog or post your email address somewhere on the web. The spam will come in droves - cialis, fentermine, zithromax, ambien, etc. etc.

Shhhhhhhh! I'm trying to get my good night's
sleep!