Posted by Caleb96 on November 27, 2003, at 10:16:41
In reply to Re: neurontin withdrawal » Caleb96, posted by Lynn O on November 27, 2003, at 1:30:50
Lynn:
No problem. I hope I was able to help a little.
This stuff I'm reading about Neurontin is very disturbing. I worked on my PhD in molecular biology for almost 3 years, so there basically nothing anyone can fake when it comes to science and get it past me. What REALLY disturbs me about Neurontin (gabapentin) is that the researchers have basically no clue how this stuff works on the cellular level. They don't know where or what it's binding to, or whether it works by some intermediate mechanism that doesn't involve direct binding to a neuronal receptor. Unfortunately, this is true of many (if not most) new drugs. Drugs like the benzodiazepines are extremely well understood with respect to their mechanism of action at the molecular level. But they've been around for 50 years, and basic researchers have had a chance to study them from every angle. I'm not saying the book is closed on benzos, but they're better understood than most drugs.
Right now, a company can submit a drug application to the FDA and say something like: "The molecular mechanism of Drug X is poorly understood at this time, but it is believed that X facilitates the binding of neurotransmitter Y to the receptor site Z on post-synaptic neurons." That statement is perfectly acceptable even though it could be translated "Our drug company doesn't have a damn clue how this drug is working."
Another one I love is "DRUG X is believed to mediate the sensitivity of ligand-gated chloride ion channels to binding with its endogenous ligand." Again this can be more clearly translated: "Mr. FDA Regulator, we don't have a clue how this stuff works, and we know you don't give a rat's ass anyway, so let's just skip this part and get on with the results from our six-week clinical trials."
I can tell you from my 16 years in the corporate world that most executives DO worry about the concequences of their actions. They don't want to do anything that's illegal or unethical, but when push comes to shove, they'll go right up to line. And if necessary, they'll stand in that grey area if it might cost them their jobs to do otherwise. They're no different from CPAs or trial lawyers. They look for every loophole in the book (or regulations) to expedite their plans. Unfortunately, there are a fair share of Ken Lays (of ENRON fame) out there who totally ignore the law and do anything to get rich.
Corporate executives look at financial statements and stock prices. Their primary allegiance is to the stockholders, not to their employees. Employees are an expendible liability (on the balance sheet) where they show up as "salaries paid" or some such entry. Corporate executives are "quarter-sighted." By that I mean they primarily look at the next financial quarter. This is very dangerous, as it tends to overvalue the present at the expense of the long run.
The reason we have no clue how Neurontin works is because research is expensive. It's a lot cheaper for a company to ignore the mechanistic aspect of a drug. "Let's just focus on the big-picture effects, if it works on the clinical level, and people don't get serious side effects or die, then run with it. Get it approved and start pushing it like the greatest thing since toilet paper."
You and I and virtually everyone on this web are guinea pigs for the drug companies. We're the ones who'll untimately determine the long term efficacy of all the psychoactive drugs that these companies are churning out. I have no doubt that some of these chemicals will be found to cause brain damage in the long run. Another might help Parkinson's patients or improve memory. It's a big game of roulette. Companies should be required to examine the molecular mechanism of their drug. Saying "the mechanism of this drug is poorly understood" is NOT acceptable. If they'd quit firing thousands of scientists to prop up sagging stock prices, they would have the resources to do the necessary studies.
I can just see massive class action lawsuits on the horizon. I think the FDA shoud require Pfizer to go back and demonstrate the efficacy of Neurontin. I'm not convinced it does anything, but I'm only one data point, and you can't extrapolate any useful conclusions from one point.
Regards,
Caleb
poster:Caleb96
thread:49557
URL: http://www.dr-bob.org/babble/20031126/msgs/284428.html