PTSD, and Alzheimer's Treatments- FDA-on-label or off label, formularies, studies

So what is new with the treatment of Post Traumatic Stress Disorder? Well we still have two government approved meds, one is Paxil (paroxitine) and one is Zoloft (sertraline). It has been over ten years since these were approved and have been indicated by the FDA for the treatment of PTSD. Sometimes they help and sometimes they make things worse. Basically most psychiatric meds out there have been used for somebody somewhere to treat PTSD.
A few basic facts:
Most people associate PTSD with veterans of combat wars. The truth of the matter is in shear numbers there are more civilians with PTSD than veterans. However for those military veterans whom have served in combat there is a much higher percentage of that sub population with PTSD than in the general population. Combat increases the possibility of developing PTSD. Not everyone whom has serves in combat gets PTSD.  The reason there are a larger number of civilians with PTSD is that there are simply more civilians  than those whom have served in the Military, by shear numbers.

The percentage of women with PTSD is higher than men 10% versus 5%. Most traumas being physical and sexual abuse and violence and the same for men as well as combat. Motor vehicle and work accidents are also not unusual sources for the trauma.

Most people that have experienced a psychological trauma (an event involving death or serious injury witnessed and involving certain responses like helplessness and terror) do not develop chronic long term PTSD. However about 30% of people do develop it. (Millions of people).

As far as treatments, remember the FDA does not do drug testing, they simply review what comes across their transom, IE mostly studies submitted by the industry (pharmaceutical). PTSD like Alzheimer's disease, is really hard to treat and no one med emerges as the gold standard. Therefore drug companies don't want to touch it. It is more lucrative to simply refine and develop another  med in say an illness that does already respond well to medications, like good old major depression.
It is hard to get a med that sort of works for some people, some of the time and spend billions on it only to have the FDA say "no-go drug company, it does not work well enough consistently". . The drug companies like to stick with things that they know will work, and the studies will show really good results so that the government will approve it. The  FDA does not say "Hey get more meds for PTSD and Alzheimer's", that is not in their cubicle or jurisdiction to do so, even though we all know we need to develop more and better meds to treat these two catastrophic illnesses.

We have lots of meds used "off-label". Example a patient with PTSD has tried paxil and zoloft and they get worse of they get side effects and can't tolerate the med, you can't really send that patient away for years, till we have a new FDA approved med we can offer. In other words there are lots of studies and data indicating efficacy and positive results on a certain med for say PTSD.
 Researchers like to get published, they like to refute each other, They like to get a name and get famous. Sometimes the drug company funds a study and shows great results and then others say it does not count because the drug company did the study and therefore the way the study was set up was not good science-- since the study  was designed to show the med worked.

Sometimes studies are set up with the hopes of showing a med does not work:

Why would that be? Well if a med is really expensive and a doctor knows it works for certain patients but say he or she works within a health system that has its own pharmacy formulary that only covers certain meds, then it may be too expensive to tpay for that med. So it is not listed  on the formulary. Therefore that doctor won't be able to get that med within that health system for that patient.
Now if you can get a big name, big time, researcher to set up a scientific study to show maybe that type of med is not effective, even though the doctor may have been using that med or combination of meds for years to help patients. Now the doctor can't get it because he wont' be going with the most recent studies and evidence.
It would make the doc look bad if he went against that most recent, vogue, trendy scientific study.
End result is doctor is not allowed to prescribe the med they know is best for their patient.
Remember formularies are negotiated between health care systems and insurance companies and have nothing to do with if a medicine being helpful or not. It is basically economical and not clinical. But if you can get a good study from a big name researcher behind it -to dispute a meds clinical efficacy, it just happens to be 'cooincidently' economically desirable and sweet for the health care system. The slug doctor and the poor patient are caught in their middle and not heard.
Remember also if a doctor is prescribing something "off label" that is for something not indicated by the government, even if they are trying to help their patient and there is a bad outcome, in some jurisdicitons, that doctor is liable and a bad doctor.Yet if the doctor knows there is an 'off-label" treatment that works well in may patients and they withhold it from the patient because the drug company did not push it through the government to get an indication, then it may be unethical for the doctor to withhold that "off-label" treatment if they know it has the potential to provide benefit.

Conversely when a med comes out on the market, that has gotten approval from the FDA for some indication or another, and even been advertised on TV,  the doctor may know in certain patients  or most patients that it does not work as well as the studies and the TV commericals show based on real life clinical experience then what does the doctor do? Direct to consumer advertising makes patient ask for meds by name. It builds instant credibility. If the governement approved it, and the doctor does not pracitce exactly what the govenremnt says, and what the TV commercials say, should you get a new doctor?