Showing posts with label meds. Show all posts
Showing posts with label meds. Show all posts

Friday, November 18, 2011

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?

Wednesday, October 13, 2010

antidepressants and suicide

Popular hype. do they increase risk of suicide? Not a new concept, been around since antidepressants were around. Yet some seem to find antidepressants more sinister than depression, schizophrenia, ptsd, hmmm they all have an increased risk of suicide right. Generally untreated mental illness can have a fatal outcome. Sometimes it is just really debilitating, and causes a lot of suffering.
so we have mixed reviews on antidepressants, some studies showing a slight increase in suicidal risk when on these meds.
Here is a fact, meds are not there to hurt people or make them worse or make somebody kill themselves.
There is very little data on if and how many lives antidepressants save. I mean think about it, how can we really research that.
Not to mention the fact that there is more media hype on the dangers of antidepressants than on the fact that alcohol is associated with most completed suicides.
Hmmmm.
So the meds prescribed by doctors to actually prevent suicide may increase the risk, even a little bit?
First of all if they were truly dangerous, would not your wonderful Federal Government that we all know love and trust pull them from the market??
Lets say you are a liberal and you love big government, you have a nice 401k and cheap or free health insurance, you have enough money to afford to be liberal, generally speaking, you by default hate doctors, are suspicious and mistrusting of them and perceived authority and you really groove on the concept of these meds being dangerous prescribed by mean non-caring doctors, okay fine, but you love government, and generally vote in the direction of bigger government. If that was the case, think about it, WOULDN'T THE GOVERNMENT PULL THESE MEDS OFF THE MARKET IF THEY WERE TRULY DANGEROUS???? oh sorry I forgot it is the big bad drug companies that are out of control, and the government just has to control them better?
Well you see all the political issues involved here.
Anyways, since the government put out stern warnings on suicide risk of these meds in people under say 24 years old, it scared the hell out of doctors and the teen suicide rate has been climbing ever since. SAD. Doctors afraid to treat, afraid of getting blamed and sued? Maybe who knows.
What is known clinically and generally still accepted is this, when you start and antidepressant the vegetative signs of depression improve before the cognitive signs. Generally in the first couple weeks.
This means a person with depression responding to antidepressants gets their energy back before there sad hopeless suicidal thinking improves. So they actually get enough energy in those first few weeks,  to kill themselves. A risky time. Not new, been around and clinically known like forever, The patient must be monitored closely in those first few weeks. Something your health care reform does not like much. The suicidal thinking does improve for many, if not most people that are depressed and get adequately treated. That is assuming you have the CORRECT diagnosis of major depression , the person is sober, and actually following a treatment plan prescribed, hopefully by a physician. It also helps for the person suffering to have a decent psychotherapist,  that does not have a chip on their shoulder about meds and psychiatry, and actually some understanding of the expectations and limitations of meds, and not just what they read on the internet or heard on TV. See my earlier blogs.
What if these meds really were meant to help people, actually saved some lives, and were prescribed by doctors who knew how to diagnose and treat and had their patients best interest at heart and were trying to help them because that was their profession and their vocation and that's what they do all day? That is just no fun to believe? Or we actually know better than that, cause we do.
I just wish we did not want to have are cake and eat it too. If we could just take these medications seriously for a minute, we devalue them, yet evetrybody wants to prescribe them with a minimal amount of training. So which is it? And yes we all know many terrible stories, of the bad med and the bad doctor and the terrible things that happened because of the meds. There are 100 of those stories to one, wear somone actually is allowed to speak out on how medicaiton actually helped them.
And no meds are not the panacea. no one is saying that. Frankly they have profound limitations but they actually do save lives whether we want to admit that part or not.

Friday, October 8, 2010

Some things you may not know about antidepressants.

Antidepressants have been around for fifty years. The first one was imipramine. How they work on the brain and central nervous system has not really evolved  much over the last fifty years. Our understanding of why and how they work has evolved, and the bottom line is we still don't know exactly why or how they work. They tend to effect neurotransmitters in the brain, that is the chemical connections between nerves. The three big neurotransmitter we know the most about are serotonin, norepinepherine and dopamine. The old and most of the newer antidepressants inhibit reuptake of these neurotransmitters into the pre-synaptic nerve. The original theory on why they work was related to the fact that you kept more serotonin or norepi around and this somehow helped treat depression.
Then in the 80's, 90's and into this century more attention was paid to the area on the nerve cell where these chemicals bind to. The so-called synaptic neuroreceptor.
For a long time it was felt that because you kept more of the neurochemcial around and it moved forward from the presynaptic to post synaptic nerve site, that somehow the neurorepceptors got desensitized or "downregulated".
Over the last 10 years the theory has evolved even more as to why these things work to treat depression and many anxiety disorders.
Now the science has led us to believe that the binding of the neurochemical (caused by keeping more of the chemical around) cause changes within nerve cell and somehow this affects the genetic coding of proteins within the cell, (remember RNA and DNA?) and somehow this causes an uptick or a positive swing in encoding for proteins within the cell that help protect the cell and treat the depression or anxiety problem.
The theory continues to evolve.
Some other facts- most antidepressants are prescribed by primary care physicians, internists, obgyns, and even pediatricians. Yes psychiatrists prescribe them all the time, but there are a lot less psychiatrists, and in terms of total volume of scripts, more come from primary care.
For many reasons, culturally speaking, it is much more socially acceptable to be depressed now. We are more open to talking about it and being aware of it. Depression is still debilitating and potentially fatal and we have a long way to go. Primary cares screen for it better now.
Within the demise and so called restructuring of the health care system in this country, there is much buzz and initiatives to screen earlier, treat and be aware of depression and its consequences.
The problem is now in screening for it, there is a tendancy to diagnose most mental health problems and simplify them simply into depression. The screenings will pick up symptoms of depression, but often not the specific and primary mental health problem. for examply Bipolar disorder (horribly misdiagnosed) and often missed and PTSD or post traumatic stress disorder, to name just a couple.
There are a whole host of antidepressants out there, the SSRI's which were developed back starting in the 80's with prozac, then in the 90's and into this century. Zoloft, Paxil, Luvox, Celexa and Lexapro.
The SNRI's which stands for selective noradrenergic serotinergic reuptak inhibitors, Effexor, Cymbalta, Pristiq. Basically these work pretty similarly to the old imipramines and elavils of the 60's and 70's, with a couple huge differences. The newer ones have way less side effects, and they are not so lethal alone in overdose. They are also felt to be more effective by many, compared to the old ones, -which may be a product of the fact that they are eaiser to take and tolerate and stay on since the side effects are better. The key to antidepressants working, is staying on the meds. They don't work if you don't take them.
Antidepressants have been used to treat chronic pain almost for thirty years. It was generally off label meaning the FDA did not approve or recognize these things in use for chronic pain. Then the popular media campaign came that "depression hurts" and cymbalta being approved for various pain problems a few years ago. Sometimes they really work well and sometimes not for chronic pain.
You do get more physical aches and pains and such if you are depressed. That is not new and has been known like forever in the medical world, well at least the psychiatric medical world.
Antidepressants are not there to hurt a patient or make them worse, and they do save lives. We are taught as a society to be afraid of them, suspicious of them and wary of them. Popular culture and media and the government regulation and subsequent media fiascos make this worse.
Conversely we are also taught and expect that these meds are a panacea, a cure a fix it all for all of our emotional and psyhoclogical pains. That simply isn't true. But with those two polar ends of the spectrum suspicion, fear,  and an attitude of this "should fix everything', you have the perfect storm.
There are many other antidepressants out there I did not mention, so that block certain receptor sites like Remeron and Serzone and Trazedone. They have also been around for years. Wellbitrin tends to block reuptake of dopamine and norepi. Some people generally like Wellbutrin becouse it does not affect weight gain like some of the others can. It sometimes does not work so well for anxiety symtoms often associated with depression.
There is a ton of information on antidepressants on the Internet. We tend to love the devaluation of them, and when we find a negative article on them we like to say "Aha I knew it" as if they are bad and there is some awful conspiracy. Some psychiatrists have even made a cool name for themselves in devaluing them. Very politically correct. We also tend to devalue them in this way:
Think about it: the average family doctor has a few weeks of training in psychiatry but they prescribe the most antidepressants.  Non-physicians prescribe them- nurses practicioners, in most states and also psychologists want to prescribe them and in a couple states they are actually legally allowed to.
 We convince ourselves that is all okay. It is not. This comes from the shortage of psychiatrists. Most doctors don't want to go into psychiatry. For a lot of reasons. It is very little pay compared to most medical specialties, with health care reform that will only get worse. Also people don't always get better, it takes a long time and a lot of psychiatric problems tend to be chronic and recurring.
so you will see more unqualified and marginally qualified people prescribing and treating psych disorders.
The sell-out blogs jump on the politically correct bandwagon of supporting psychologists and the so-called mid-level practitioners, prescribing, as well as non-psychiatric physician. With that comes an underlying devaluation of psychiatry in general. You are not allowed in this day and age to even consider that maybe a specialist in psychiatry should be treating many psych problems out there. That is so politically incorrect, you get lambasted and you are very unpopular, so most doctors can't even speak up any more. It is just the way the world is. But with the sort of disdainful reduced attitude towards psychiatry and mental health issues in general, and the lack of accurate information that is truly disseminated, it is easy to see why we are so wary of psych treatment.
Before I get hate mail yes there are good nurse practicioners out there, just like there are good physicians out there.
Generally the popular buzz is "doctors don't talk to their patients, but nurses do". I am sure that is true in some case, but we like to convince ourselves that this is the norm. It is probably going to get worse with health care reform.
Antidepressants are used in Alzheimer's, People with AD can get depressed, it make the AD worse. They often can't articulate it to us, becouse of the dementia, so it is often overlooked. You generally have to use much smalled doses of antidepressants in the elderly (like any med) sometimes if not carefully prescribed or prescribed wrong they can make things worse, and if diangosed right and carefully monitored they can help tremendously.
There is much more to talk about with antidepressants, the suicide issue (horribly misunderstood) side effects, target effects, (what they are actually supposed to do. All of the natural remedies, (chemicals also like the meds) they are a financial; boom to many and severly unregulated, but as a fairly uninformed society or shall I say misinformed, if we hear the world "Natural" we are profoundly reassured.  Stay tuned.

Monday, June 28, 2010

More on Medicine and agitation and Dementia

Alzheimer's disease affects the brain. It destroys brain cells. Loosing ones memory and the ability to reason is the hallmark of Alzheimer's disease. The brain whether we like it or not also regulates emotion and behavior. Essentially our ability to feel starts with the brain. One of the hardest and scariest parts of the whole process, (besides everything else) is the behavioral changes. A person with AD, can begin to behave in very strange and uncharacteristic fashions for themselves. It is bizarre and frightening quite often for family members. As the disease wears on the person with AD looses their ability to self-reflect-to have insight into their own behavior. It is not their fault and if they could they would hate it more than you do- but they can't.
It is also unique in that one day for no apparent reason the behavior can appear quite normal and baseline and it seems everything will be okay. The next day the behavior is strange, odd, bizarre, frightening, maybe hostile, maybe threatening. It is enough to drive a family member or loved one nuts. Yet the AD victim can't help it.
Hence emerges modern medicine. "Why can't the doctor do something?" "Help them doc!"
Keep in mind to this date yours and my Federal Government and its regulating body the FDA The Food and Drug Administration has approved no medication specifically for the treatment of agitation in Alzheimer's disease. Yet in modern society we use meds all the time.
Now I don't want to get all that hate mail, thinking I am pro-meds, "pill-pusher" "doctor does not take the time" "how can they just throw meds at my mother or father, they don't even know him or her" -I know. Believe me I am not pro-meds, I just happen to know the pragmatic realities, expectations and limitations of them because that's what I was trained in. I would rather see anything and everything that can be done other than meds to help the behavior to be more balanced and normal for that person. As family members know, simple reasoning does not always work with the AD victim. -It is not their fault.
As far as the specific meds, sometimes the cholinesterase inhibitors the Aricepts of the world can help the behavior,  sometimes they can actually make it worse.
The are indicated for AD not specifically for the behavior.
Sometimes the antidepressants can help the agitation the Zolofts of the world and sometimes they can make it worse. A person with AD can be depressed, but they can't necessarily tell you. But even if you can't make a clear diagnosis of depression sometimes the antidepressants help agitation. I talked about the atypical antipsychotics in the past. the risperidones of the world. Sometimes they help, sometimes a lot, the government and medicare are all over this with warnings about increased risk of stroke in psychosis with dementia, and the omnipresent diabetes risks.
the benzodiazepines, the Ativan's of the world sometimes help, and sometimes they disinhibit and make the person worse. They are cheap, addicting-not always a worry in dementia patients, and the primary care world loves them.
Then there are the Antiepileptic meds, the Depakotes of the world. Sometimes they can help a lot in low dose, but they can also cause worsening effects with sedation for example.
It is often a balance of calming the behavior without sedating the patient too much. Sedation seems to aggravate the already declining cognition and ability to think.
Ask what your doctor is prescribing and why. If you think your loved one needs meds for agitated behavior, ask the doc which med and why.
Low and slow is the key. It is an art and a science. It takes a little finesse and knowledge base, and in medicine that like anything else is variable. The meds are not going to work miracles, and your doc is probably not stupid or holding out in the best med for some ulterior motive. They are probably adequate and average at least. But if you don't trust her or him, then get another one. If you are only allowed to see a mid-level prescriber, such as a nurse practitioner or a physician assistant, and you would rather have your loved one see someone who went to medical school and had years of residency training then ask for one.
Remember the agitation is not the AD victims fault. Think of the brain as a stoplight at a major intersection 12 lane intersection. Then a storm wipes out the power. Everyone has to get to work. There is always the asshole who runs through the intersection, and then many more who are uncertain or scared to proceed.  It is chaotic.
If you ever rented a truck, say from Penske or U-Haul they have a governor on the engine, you can't go past 65, conversely it may be tough to get up a hill. The brain is the governor of behavior. AD is the storm that wipes out the traffic light, AD removes the governor on the truck and you got a run away truck. It is not the victims fault.

Friday, March 5, 2010

what are Antipsychotics?

Antipsychotics are a group of medications used to treat a whole host of disorders and symptomatology. Generally speaking they are terribly misunderstood, dreaded and the subject of much hatred and controversy. They stir up a lot more emotion than say an anti-hypertensive to treat high blood pressure or an oral hypoglycemic to treat type II diabetes. They are also responsible for saving many lives. They are also responsible for helping many chronically mentally ill people live and function outside of a state mental facility.
they have been around for a long time, the original developed in the early 1950's and that was Thorazine. A whole host of medications followed, the so-called typical antipsychotics or first generation antipsychotics. more common ones still frequently used (but not as much as 10 years ago) in psychiatry are Haldol, Prolixin, Navane, Stelazine, Loxapine, Mellaril. They treat psychotics symptoms such as hallucinations, (seeing things that are not there, or hearing voices of people that are not there) and delusions, false beliefs not grounded in reality (eg. the NSA planted a micochip in my brain and is monitoring me or I have a special power in that I can predict the future, or I am Jesus Christ) Delusions can be different types, paranoid or grandiose for example. Some people act on there delusions or hallucinations. Sometimes hallucinations tell people to hurt or kill themselves or hurt other people. The antipsychotics attenuate and sometimes take these symptoms away completely.These kind of symptoms are seen in people suffering from schizophrenia, schizoaffective disorder, and sometimes severe bipolar disorder or severe unipolar depression.
The first generation antipsychotics also have a host of potential side effects.
The most severe one in the sense of it being permanent even if you stop the medicine is called tardive dyskinesia. This is a movement disorder, that involves repetitive stereotypical movements, that are not controllable. Such as lip smacking, crossing and uncrossing ones legs, or finger tapping. The movement disorder doe not keep the person from sleeping and often it is more distressing to watch than for the person afflicted with it.
A second generation of meds was developed in the late 1980's and through current day. That is the so called atypical antipsychotics or second generation antipsychotics, these meds are much less likely and virtually some not at all likely to cause tardive dyskinesia.
They are generally much better tolerated by a person than first generation meds. They tend to cause much less apathy and bluntedness. In fact they often improve those symptoms which are seen in people suffering with schizophrenia. So you see another problem with the first generation meds was that some of the side effects, sluggishness, apathy for example were also symptoms of the illness of schizophrenia.
The second generation meds, main problem which class action law firms have jumped on suing the drug companies for is the association of these meds with the possible development of type II diabetes. That becomes a hotbed of political and economic controversy. It is often poorly understood by other areas of medical specialties outside of psychiatry.The second generation antipsychotics are Clozaril, Risperidone, Zyprexa, Seroquel, Abilify, Invega, and most recently Saphris. They were considered antipsychotics but most of them have been approved and indicated by the FDA for various phases of bipolar disorders. So they are not just considered second generation antipsychotics anymore.
The government body the FDA puts out a warning on these meds but does not pull them off the market, the warning is called an ASSOCIATION of these meds with the possible development of diabetes. Accordingly proper periodic blood monitoring is required, to check a fasting blood glucose for example. Its a quandary because type Ii diabetes is growing so fast (on or off these meds), but it has created much opportunity for some lawyers. It is sort of like suing McDonald's for spilling there hot coffee on yourself and burning yourself, or suing the fats food chain because you got fat and developed diabetes from eating french fries. It would be easy if these meds clearly caused diabetes and were considered unsafe then the government could just pull them off the market. The truth of the matter is these meds no matter how much we hate them or hate psychiatry have helped a lot of people and saved many lives. That part gets missed. And no it is not as simple as money changing hands with the government or the drug companies and there profits. If it was that simple things would be easier. and no doctors do not get kickbacks to prescribe. It is amazing how many people assume that. Don't you think with how vilified physicians actually are in society it would be a little more apparent if it was that simple?
The truth of the matter is at this point these types of meds are the best we have right now, and most doctors that prescribe them are not doing it for fun or experimenting, they are actually trying to help their patients. How does that point constantly get missed? i know why it does but it would take a book to write about it.

Talking about the book with the Lake Superior wind....... a calm day