I must say I'm enjoying our conversation here. It definitely has my gears turning about some research ideas. If you don't mind me asking, what country are you living in just so I can get a better sense?
The problem is, as you said, pregabalin is a new drug. It only came on the market about a decade ago. So the proper research into its long term effects just doesn't exist.
You're telling me Lyrica/Pregabalin is becoming more common in Europe for anxiety than BZD. One list I'm looking at places Lyrica as the #80 most prescribed drug in the US (the list isn't the best as it separates the drugs by mfg as well). It also the 19th highest in revenue in the US. I would presume is enough data at this point for at least some preliminary research that *someone* could put together... assuming it hasn't already been done.
One problem is the clearly Pfizer does not want to prove evidence of addictive potential. Secondly, studies cost money and this drug is still very expensive. Testing for abuse, dependence, and addiction can be tricky since patients are always usually forthcoming about these factors and it may not be recognizable without the proper testing methods. Regularly checking the plasma concentration of the drug could give insight into this, but as you can imagine, blood tests are highly expensive and you'd need at least hundreds of patients to have sufficient power in a new study. My guess is researchers will likely hold off while Pfizer possesses the patent, expecting them to do the studies if publicity arises since Pfizer has the money and legal requirement. I'm sure a cost effective, retrospective study could easily be put together that might reveal some preliminary data. I'll have to do some research to see what's out there.
***I guess I alluded to this earlier, my guess is that most of the findings out there suggest abuse potential and potential withdrawal symptoms. Those two factors, even if occurring at the same time to the same patient, does not necessarily mean it has addictive potential. If this is what the preexisting data suggests, it may or may not be the complete reality, which is why I'm going to do some homework on this one. It does however prove a poor choice for people with substance use disorders, anyone who abruptly stops the medication, and unfortunately some people even if they taper. Like I said before, addiction is skipping work to buy drugs, going into debt, sacrificing necessities, taking illegal risks you wouldn't normally take, secrecy of using, etc. Addiction = compulsive behavior despite the consequences = irrational, harmful, self destructive.
I'll have to see if Pfizer has completed any Phase IV clinical trials. I would guess if they have at this point, they probably still focus primarily efficacy. They likely would only expanded their test populations to different groups than the original trials to prove it efficacy (ex. people with a specific age group, race, cooccurring health condition, etc).
That said, Lyrica/Pregabalin is a drug wouldn't generally recommend anyways. It's not approved for psychiatric use in the US, which is my specialty though I do have to deal with all medications on a daily basis. Lyrica is a far more expensive, more dependence forming, more potent version than it's "mother" Gabapentin (with as we've discussed a more intense discontinuation syndrome). Gabapentin is generally assumed to be relatively safe and quite effective in a variety of conditions. Dependence and abuse potential is there, but it's a commonly used drug with not a lot of known true addicts. Lyrica/Pregablin's patent expires the US ends in 2018 and EU in 2016 so generics will be available (and off label use will become easier). Canada has had a generic since 2013.
Since I'm in the US, I have more exposure to Gabapentin abuse as it's a common drug (it's been around for decades and is ranked #56, 127, 157, & 200 in prescriptions depending on the manufacturer). I've noticed it's abuse seems to be a regional thing within America. Right now I work in Massachusetts and there is a big Gabapentin abuse culture- not as a primary drug of addiction, but as an aside. I have dealt with a maybe 2 or 3 sole Gabapentin addicts. The street name is "Johnnies". I have only come across a few sole Gabapentin addicts. I have also worked nearby in Connecticut, New York, and Rhode Island, where this behavior is regarded as foreign, "pointless", and far less prevalent. Strange?
I should mention you can "get addicted" to anything. Last week I got paged to see a patient labeled in a cryptic message as a "Levaquin doctor shopper" (Levaquin = Levofloxacin, an antibiotic). I thought this was a typo. This guy was bad as any drug seeker I have ever met, if not worse end of the spectrum. Ultimately we determined he suffered from undiagnosed obsessive compulsive disorder. He was convinced he needed antibiotics otherwise he would get an infection (and die). Apparently doctors just kept writing him scripts for years until the ER referred finally him to us.
There is a great book called "In the Realm of the Hungry Ghosts" by Gabor Maté, a physician who supports and treats addicts in Vancouver. It's a fascinating read and great for those of us who have never suffered addiction. He postulates that virtually everybody has their own addiction- compulsive, detrimental behavior (in his case obsessively buying classical music CDs) and there is no such thing as "an addictive personality". It's a great book, not particularly dense but very informative, and one of the best addiction books I've read (and I've read dozens upon dozens). For anyone who is experiencing addiction or has trouble understanding a loved one's addiction, this is the book to read.
t's also uncontrolled in every country outside the US which makes it a lot easier to get.
I was not aware it's not scheduled in other countries, though I should have thought about that considering most US Schedule 5 drugs are not scheduled in other countries. Control/Schedule 5 is a small, odd class that pretty much only includes codeine products (which is OTC in many/most countries btw)
The same thing was claimed about benzos when they were first released. It took a long time for doctors to realise those things were as addictive as they are.
Sadly this is an all too common theme in pharmaceutical history. BZD's were approved in the early 1960's knowing their potential for abuse but assuming it to be a very low risk. It wasn't until the early 1980's that dependence/addiction was recognized as a widespread issue. Heroin, Cocaine, Oxycontin, Tramadol, etc are other examples.
This is a good point. But even at prescribed doses you get a bit of euphoria before you build up tolerance to those effects and there are people who have got up to taking grams for recreational purposes so I don't think it's too far to suggest people chase the high even if it's clearly irresponsible.
This is very true. That's also another important point that everybody has different perceptions of what is "euphoric". I took Lyrica and Gabapentin and in the beginning I felt- weird, not necessarily comfortable. An oxycodone table on the other hand is the best feeling for me. My sister refuses to take opiates because she hates the feeling. I would say, at least when it comes to Gabapentin, most users don't find the "high/euphoria" as satisfying as the minority that abuses it. For people with other substance abuse issues, typically any means of changing their state of consciousness is preferable to nothing if they don't have their drug of choice (though they will always want go back to their preferred substance).
I was mainly thinking of a month of diazepam use, that's what most people get here if they get benzos at all. One month of diazepam with no refills. Most people can use that as prescribed and not develop dependence.
Xanax/alprazolam, Ativan/lorazepam, and Klonopin/clonazpem could all cause dependence in under 4 weeks, again depending on dose, frequency, genetics, etc... Xanax being the #1 prescribed and the most addictive of all normally prescribed BZD in the US :roll eyes: Point of comparison- Valium's half life is about 3x longer than Xanax. Because of the longer half life, Valium is associated with less severe, later onset dependence issues. Remember that BZD should not be taken with alcohol, but people still drink with them. Alcohol will undoubtably expedite the process of dependence.
Interesting, I always thought it was the other way around and the US got new drugs before other countries... your culture loves its pharmaceuticals and the pharmaceutical companies seem to release new products in the US initially because it has the biggest market.
It's strange how it works. On average yes, the US is behind other countries when it comes to drug approval. I guess we want to wait to see if the drug is a disaster before we expose our patients
. This seems especially true with highly dangerous or experimental (meaning a new drug class) drugs- often oncology drugs. That is why you may hear of cancer patients flying abroad for treatment (that and also because it may cost less
) If a new SSRI came out, in that SSRI's are already well established, will probably come out about the same time. It's all political too, know that all of the top FDA officials have ties to drug companies. Once the drug is here though, there is apparently no problem in getting prescribed. Remember what the TV ads say, "ask your doctor about <insert drug name here>".
One of the founders of Alcoholics Anonymous was an advocate of LSD therapy because nothing else has ever matched its effectiveness at treating addiction.
Yes, I've read Bill Wilson was quite interested in the potential effects of LSD. If you've read the "Alcoholics Anonymous", Bill's had "white light" experience that lead him to devise the AA program (adapt really, since the idea already existed to an extent). This experience occurred under the treatment of "The Belladonna Cure" which was a combination of three plant extracts (two of which are hallucinogens) and some other products including Blue Mass (an old treatment for everything that contains Mercury).
I'm not sure LSD specifically would ever have a chance of getting approved. As I mentioned before, existing evidence has very clear in showing that the results are hard to anticipate. Controlling for a proper state of mind and environment would probably be impossible. I'm not sure if you've read of Ibogaine, it's a West African plant that has been shown to help in opiate addiction and possibly other substances, though proper studies haven't be implemented.
Alright, I'm going to have to stop here. Long story short, 2021 is a very ambitious goal...
