Wednesday, January 07, 2009

Sowing the Seeds of Lexapro

ResearchBlogging.org

I'm reading an article with my jaw completely agape and I thought I'd share the pain. The good people at Forest Pharmaceuticals have put together a tragic waste of journal space. The editorial board at the journal Depression and Anxiety should call an emergency meeting to see how this thing got published. Any peer reviewer who put a stamp of approval on this should be forced to listen to Michael Bolton's Greatest Hits at maximum volume for 12 hours straight.

OK, so what am I having a fit about? Here's what happened in this so-called study. 109 primary care doctors were recruited to participate, for which they were doubtlessly paid a decent chunk per patient (not discussed in the manuscript). The lucky depressed patients of these physicians then received escitalopram (Lexapro) for six months. The manuscript mentions that the "investigators" (the primary care docs) "were not required to have previous clinical research experience to be selected for this study." Yeah, no kidding.

There was no control group, and there had already been dozens of studies on the effects of Lexapro in depression, so how are we getting any new info out of this study? Maybe because this is investigating Lexapro in primary care settings; maybe there was no research on that beforehand. Well, no. The manuscript writes that "The efficacy and tolerability of escitalopram in MDD have been extensively evaluated in primary-care settings," citing four relevant studies. So the study is actually not an attempt to answer a scientific question. So what, exactly, is this study?

Looks and smells like a seeding trial, about which Harold Sox and Dummond Rennie wrote:
This practice—a seeding trial—is marketing in the guise of science. The apparent purpose is to test a hypothesis. The true purpose is to get physicians in the habit of prescribing a new drug. Why would a drug company go to the expense and bother of conducting a trial involving hundreds of practitioners— each recruiting a few patients—when a study based at a few large medical centers could accomplish the same scientific purposes much more efficiently? The main point of the seeding trial is not to get high-quality scientific information: It is to change the prescribing habits of large numbers of physicians. A secondary purpose is to transform physicians into advocates for the sponsor’s drug. The company flatters a physician by selecting him because he is “an opinion leader” and incorporates him in the research team with the title of “investigator.” Then, it pays him good money: a consulting fee to advise the company on the drug’s use and another fee for each patient he enrolls. The physician becomes invested in the drug’s future and praises its good features to patients and colleagues. Unwittingly, the physician joins the sponsor’s marketing team. Why do companies pursue this expensive tactic? Because it works.
So these primary care doctors now feel like "researchers," even though their investigation had essentially zero scientific merit. That probably makes these "investigators" feel important -- and the association between feeling important/scientific and Lexapro is a feeling Forest was banking on to increase Lexapro prescriptions in Canada.

Findings: So what did this extremely important piece of seeding, er, research find? Get ready... Lexapro is safe and effective. To quote the authors: "Escitalopram was well tolerated, safe, and efficacious. Escitalopram can be used with confidence to treat patients with MDD in Canadian primary-care settings." And "As adherence to antidepressant treatment is paramount to achieving long-term recovery, the present results suggest that escitalopram should be considered among the first-line choices of antidepressant used in primary care." So with no control group, we can determine that a Lexapro prescription should be among the first things that come to mind when treating depression. This is mind-boggling. This journal often published good work, but this is among the most uninformative pieces of research I have read. Unless one is thinking about marketing, in which case it is very enlightening.


Citation: Pratap Chokka, Mark Legault (2008). Escitalopram in the treatment of major depressive disorder in primary-care settings: an open-label trial Depression and Anxiety, 25 (12) DOI: 10.1002/da.20458

16 comments:

Anonymous said...

Holy Cow you are right: this is a farce of a study. Yes, the efficacy evidence, as it is, already exists. And it does not enhance that question to conduct an open label, uncontrolled trial. So, that leaves the purpose to be: is it well-tolerated? They conclude: "Escitalopram was effective, well tolerated, and safe in the treatment of MDD...."
Hmm. Well-tolerated. How exactly was that measured? The proper way would be to actually measure how well it was tolerated. to achieve this measurement, you would administer a checklist of side effects (AKA "adverse events), and have each participant indicate whether they experienced the side effect or not. Finally you could include an overall measure of acceptability of the treatment. That is, IF the main reason for the study were to establish whether the treatment was "well-tolerated." So, how did they measure tolerability? "Non-specific questioning" by the clincian researcher, OR "spontaneous" (unsolicited, off-the-cuff) report from the patient. That does not equal a systematic assessment, such as: giving a checklist to each pt at each visit. So, what does well-tolerated mean? Well: ten percent discontinued because of side effects. 77% reported some 'adverse event,' and 75% of these were mild. So, the inverse of that REPORTED data is: 77% reported at least one adverse event, and 25% of those were at a severity ABOVE "mild." Thus, 14% of pts reported a side effect at a level greater than 'mild.' And this result was obtained when using a method that is recognized as being weak (when you solicit side effects, you get a lot more report than if you just ask: 'any problems?' or 'how's the medications?'). I would move this evidence out of the range of 'well-tolerated,' and maybe describe it as 'fairly well tolerated,' or as 'acceptable.' ANd make note that clinicians should be sur to monitor adverse events, since they may lead to discontinuation in approx one out of 10 pts.

CL Psych said...

Anonymous -- I'm sorry to see that you also endured the pain of reading through this exercise in marketing.

Yes, the assessment of side effects was far from optimal. The whole study is an object lesson in useless research.

Neuroskeptic said...

That this was done is perhaps not surprising, and I think it's silly to get angry at drug companies for trying to sell their products - they're companies, what do you expect? But I expect better from journals - what on earth happened at D&A?? That's the real question here...

therapyfirst said...

A couple of points to this that the more naive reader should be aware of, especially if you are a provider and not a psychiatrist:

1. Star D, the study that looked at the effect of antidepressants and what were alternatives/adjuncts, used citalopram (Celexa) as the first line agent, which is the original compound from which the bastard son, Lexapro, was formed. How interesting the investigators stopped at a dose of 60mg, which is a fairly good dose of Citalopram. If the equivalency of Lexapro to Celexa is about 10mg to 40mg repectively, then where is the logic of Lexapro being dosed at 30 to 40mg of late by some of my more maverick, or in my opinion, clueless and reckless colleagues? Did this study push those limits, with PCPs? If so, shameless and greedy by Forrest.

2. Why use non-psychiatrists as the dispensors here? Hmmm, remember that about 70% of antidepressant prescriptions written in the good ol' US of A are written by non-psychiatrists, like PCPs, Family Docs, OBGYNs, and I would bet Nurse Practitioners. So, using the seeding principle by our blog author here, just another way for this company to motivate/justify/encourage/indoctrinate physicians to use brand name meds for indications such providers have little expertise in treating in the first place.

Oh, a third point: At least where I live and practice, Lexapro is now a non-formulary med in many plans, so I have to fill out paperwork if I am stupid enough to write for it these days. Hmmm, and yet Celexa is a $4 Rx at Walmart or Target. Let's see, wait two or three days and then have a second or third tier copay for Lexapro, or, if Celexa, pick it up in 20 minutes.

Is there a choice here?

Yeah, keep exposing these fuckers for the falsehoods they preach. Sorry if harsh, but, so is life.

therapyfirst

NeuroPsych15 said...

Good catch. I thoroughly enjoy your "Research Blogging" posts. You're doing the lords work my man. Keep it up.

Neuroskeptic said...

tf: 1mg escitalopram is equivalent to 2mg citalopram, not 4mg, so 30mg is fine (=60mg), 40mg escitalopram is quite a lot (=80), but to be honest, 60mg is just a nice round arbitrary number anyway.

therapyfirst said...

Neuroskeptic:

Your equivalencies are based on what Non-Forrest literature?

People overall did not tolerate doses above 60-80mg of citalopram, and for some interesting reason, I seem to come into contact with a good number of people who do not do well with doses above 30mg of Lexapro. Care to provide some vignettes, maintaining confidentiality of course, that people who took more than 60mg of prozac or paxil enjoyed those doses for more than 6 months? The literature shows high doses of SSRIs do not do one well for long.

Look forward to your rebuttal.

therapyfirst

Zac Taylor said...

Unfortunately, this isn't surprising in the slightest. We learned more about Forest than Forest did about Lexapro.

I am not exactly anti-pharma, but this doesn't help their cause. I have currently been on Lexapro for 6 months and tried to wean off, with my last dosage ending a week ago, but to no avail. Insomnia, lucid nightmares, trailing, short term memory loss, and well, long story short, I'm back on it, to try again in the coming months.

I was better off before I took this crap. I've written a post about my experience of the last week on my blog called "How Lexapro is Making me Crazy."

Cheers! And looking forward to more informative studies from Big Pharma... :-)

Anonymous said...

Zac,

Not to get off topic but I wanted to respond to your post about tapering off of Lexapro since many psychiatrists are clueless about tapering patients properly.

The best way is to taper 10% of the current dose every 3 to 6 weeks. Do not do any of this every other day stuff as that will put you in withdrawal.

Your body needs time adapt to the neurochemical changes that psych meds make in your body. If you taper too quickly, that is like putting the car in reverse at 60 miles per hour.

You're in luck since Lexapro comes in the liquid form. But if for some reason liquid isn't feasible, get digital scale from EBay (around $30) and measure the dose that way.

Or get the prescription filled by a compound pharmacist who will make the doses you can;t get at your local CVS. The downside is it can be expensive if insurance doesn't cover it.

Again, I apologize to the rest of the posters for this off topic post. But I just feel that the subject of tapering properly is sadly neglected in this psychiatric community.

AA

Neuroskeptic said...

I never said taking above 60 mg citalopram (30 mg Lexapro) was a good idea. But 60 mg is clearly an arbitrary cut-off that someone made up because it's a nice round number. I mean it would be more convincing if it were a mg/kg figure, to start with, and there is a good literature on drug metabolism / transporter gene polymorphisms and how they affect the pharmacokinetics of antidepressants.

So while I don't know of any, I'm sure there are people who would benefit from >60 mg.

therapyfirst said...

I would like to note two things from the above comments:

1. Patients can tolerate 15-25% decreased in dose if the ceiling dose is fairly high for at least the first two to three dose tapers, usually by 2-3 weeks at a time. I don't know why AA is advising 10% for 3-6 weeks unless there is more info at hand that ZT did not provide in his comment here (I assume specifics are in his blog, sorry I did not read it). Slower tapers have their place, but should not be the standard of care for all people, as who is going to stick out a taper for up to 8 to 12 months depending on the initial dose being lowered.
The compounding idea is good, but is it realistic based on the way most pharmacists practice these days? Good luck in seeking this out, but it has promise.

2. NS: what is this "nice round number" phrase about? If anything, a nice round number for celexa would be 80mg, as it would seem convenient to use two 40mg tabs as a ceiling, but, STAR D didn't, so maybe 60mg had significance because patients didn't tolerate higher doses. Like, what I have seen in my practice experience? And, what source do you know of that is outside Forest-generated lit that claims 1mg Lexapro is = 2mg Celexa?

I would like to read the sources behind the above commentors' positions. It is not you are wrong, I would just like to know where the facts reside.

Marissa Miller said...

This is a great line: "Any peer reviewer who put a stamp of approval on this should be forced to listen to Michael Bolton's Greatest Hits at maximum volume for 12 hours straight."

I just can't imagine how this "trial" is considered legitimate without a control group.

Anonymous said...

TF.

You might want to go to Zac's blog to read what he said about my comments. He wondered if I was a psychiatrist or pharmacist since he felt it was the most helpful information he had received.

You keep putting down what I say for no reason at all. If you really are as informed as you claim to be, why don't you go to Paxil Progress Boards and similar type boards and read the stories of people who tapered at the rates you suggest.

Anecdotal you say? Where is your hard core evidence that your method is more effective?
How many patients have you tapered off of meds doing it your way and how many have stayed off of psych meds?

The administrator of the Paxil Progress board, Laurie Yorke, who is an RN by the way, witnessed her son, Ryan, become psychotic on a Paxil reduction rate from 50mg to 39mg. He is fine now that he is off Paxil but it was a tough road.

People will stick out a slow taper when they realize that tapering too fast kills their quality of life.

Anyway, TF, instead of just dismissing people like me since we're not MDs, why don't you do a real study and compare the success rates of people who tapered at my suggested rate vs. yours? Let's do a real study and see what really works.

Actually, this challenge if for any researcher who visits this board .

Of course, I am living in fantasyland because I doubt anyone including you will take me up on it. But what the heck.

AA

therapyfirst said...

AA:
I am not going to get into a debate about who is right or wrong, because depending on each individual situation, one of us would be if we stuck to one paradigm for an application. That was my point, which, by the way I read your most recent rebuttal, you seemed to miss my concensus.

Telling everybody to taper at the slow rate you subscribe to will be eventually more a struggle than a benefit. For those who have true withdrawal features early on with tapering should then consider your position. That was the point.

Drugs like Paxil, Effexor, and lamictal, for the more common meds of consequences, should be tapered at a reduced rate than other psychotropics. To answer your question, I have tapered several dozen people who legitimately needed to get off meds with a good success rate, probably better than 80+%, and depending on the individual, some went on other meds, and others didn't. I am not running clinical trials in my practice, so I don't write down each and every statistic, so, sorry I am not as detailed as you would prefer.

As I said in my posting Jan 12, it is not that you are wrong, I was just interested in the sources that drive your paradigms. Thank you for replying.

And, by the way, I just read my Jan posting again and I read it to say your position has merit. Sorry I don't accept it as gospel, but I did say it had validity. Seems like you are looking for more debate. Tomato, to-motto, that's my realization here.

Read the recent issue of Rolling Stone, Ben Wallace's piece on page 56. I bet you'll like it.

mommy said...

I have been very interested in all comments. Just a little personal info about my journey with the meds this article was published about. I have been taking Celexa 40mg for GAD going on 6+ yrs. Recently the Celexa stopped working. All my anxiety was back x10. I was told by PCP that Celexa was not working for many people, due to the "generic manf" making the drug diluted, and that some drs. were doubling Celexa doses to give the same effects. I was also advised to try Lexapro, it was suppose to be "better, "cleaner" than Celexa. I was given 40mg of Lexapro daily + Xanax to use as needed. This dose was not working great so it was uped to 60mg daily. As you all know how expensive Lexapro is that gives me a bill of $290.00 per month. I have since made a switch back to Celexa generic 80mg daily, and have not had to use any Xanax to help control any "break through" attacks.

Anonymous said...

In the 1930s, physicians approached the mental illness of depression a bit differently that we do today. While acknowledging a likely cause of depression in one of their patients is often due to some great misfortune, they seemed to focus on what is called a complex. A complex is disturbances of ideas and impulses that are the cause of consistent habitual patterns of thought, feelings, and behavior.
An example of this state of mind of one who is depressed is one who experiences an exaggerated or obsessive concern or fear. And the etiology for this mental disorder was often undefined. People react differently to life stressors in their life, so depression cannot be empirically determined.
In the 1930s, psychotherapy such as cognitive therapy was recommended for treating the depressed patient, and not pharmacological therapy. Also considered for the depressed patient was positive lifestyle changes that would lessen the pain that the depression was causing them. Try and be grateful, they would tell their patient, as well as thankful and appreciative for whatever good may be in their life, and normally the depressed patient would eventually recover.
Times have changed since then.
Presently, serotonin-enhancing drugs are the therapeutic regimens for those who are suspect of having a depressed state, or perhaps the patient simply asks for these types of drugs due to their perception that they are depressed. Furthermore, and remarkably, various other mood disorders one may have can be treated with these drugs, typically called SSRIs.
What is remarkable is that the mood disorders which will be discussed later are subject to debate and have also been brought to the attention to so many others through disease awareness campaigns by the makers of these SSRI drugs. So mental flaws claimed to be relieved by SSRI drugs may not be the case at all.
With depression, the most severe cognitive and behavioral malfunctions are expressed in what is called a major depressive disorder, which is also called clinical depression or major depression. Symptoms of this type of depression, which is the most concerning to health care providers in particular due to its severity, include decreased or flat affect, decreased interest in activities once enjoyable, self perceptions of worthiness, guilt, regret, helplessness, and hopeless by the sufferer, to name a few of the diagnostic features that may be present with one who has such a major depressive disorder.
The disease has a vexing insistence on staying with the victim for a lengthy period of time- often continuing to progress symptomatically in severity and discomfort. This disease is very disabling, and cannot be lifted by one’s will, so all health care professionals likely agree that depression is a potentially serious condition with their patients. Suicidal ideation and attempts are associated with major depression.

These SSRI drugs mentioned earlier are known by some health care providers as third generation anti-depressants. Such drugs, drugs that affect the mind, are called psychotropic medications. SSRIs also include a few drugs in this class that include the addition of a norepinephrine uptake inhibitor added to the SSRI in one capsule, and these drugs are referred to as SNRI medications. The combination of two different drugs has made them the top class of prescriptions for psychological misalignment.
There are several available SSRIs presently, yet it is believed that only two SNRIs are available, which are Cymbalta and Effexor.
Some consider these classes of meds, the serotonin enhancers in these medications, have been considered the next generation mood enhancers- after the benzodiazepine hype decades ago, which was followed by what were called trycyclic drugs for depression for some time.
Furthermore, regarding SNRIs, adding the additional agent of norepinepherine is presumed to increase the effectiveness of SSRIs by some, yet not everyone claims relief from these types of drugs.
Some Definitions:
Serotonin is a neurotransmitter thought to be associated with mood. The hypothesis was first suggested in the mid 1960s that this neurotransmitter may play a role in moods and emotions in humans. Yet to this day, the serotonin correlation with such behavioral and mental conditions is only theoretical. In fact, the psychiatrist’s bible, which is known as the DSM, states that the definite etiology of depression remains a mystery and remains unknown with complete certainty. So a chemical imbalance in the brain is not proven to be the cause of mood disorders, it is only suspected as a result of limited scientific evidence. In fact, diagnosing mental diseases such as depression is based on subjective assessment only, as interpreted by the prescriber, so one could question the accuracy of such diagnoses.
Norepinepherine is a stress hormone, which many believe help those who have such mood disorders as depression. Basically, with the theory that by adding this hormone, the SSRI will be more efficacious for a patient prescribed such a med, as suggested earlier.
And the depressive state of a patient certainly can be aggravated by another mood disorder at the same time with some patients. Anxiety usually exists with one who has a major depressive disorder. An objective diagnosis of such a mental condition is rather impossible to assess objectively. Therefore any diagnosis made for a mental abnormality lacks complete accuracy and assurance.
Such illnesses can only be assessed conceptually, so the diagnosis or impression concluded by the patient’s health care provider is dependent on subjective criteria expressed by the suspected patient that is not mentally sound. At times, there have been screening programs that have been used for identifying depressed patients have proven to be largely ineffective.

A social patient history is uncertain and tricky as well, some have said, yet is obtained often from such patients. There is no objective diagnostic testing for any mental malfunction to validate as to whether or not such a disease is present. A health care provider has to assess as to whether certain non-verbal or vocalized features are present with a patient in order to conclude confidently that one may have in fact some degree or level of depression.
To assess a suspected depressed patient is further complicated by the fact that the exact cause of major depression is unknown. Research says that there is a strong genetic component to this illness.
The diagnosis of depression as well as mood disorders that may exist within patients has increased quite a bit over the past few decades. Some have asked themselves, as well as others- actually how many people are really and actually depressed?
What is believed is that if one determined to be cognitively impaired from a mental paradigm, then this may be in fact major depression. If this mental disorder is determined by a health care provider, it is possible that pharmacological therapy may be considered reasonable and necessary, as well as psychotherapy either suggested to be performed with or in place of medicinal therapy.
Studies show that both therapies working together may be of most benefit for the depressive patient, yet it is not a guaranteed protocol for treatment in this way.
It has been reported that around 10 percent of the U.S. population will at some point be affected by an episode of what may be a major depressive disorder. This is much greater in number than just a few decades ago.
Perhaps media sources are to blame, by suggesting to their viewers that they may in fact be depressed. So the diagnosis and medicinal treatment have remarkably increased in a relatively short period of time in the United States. Of course, the expansion of those claimed and determined to be depressed does not sadden the makers of these drugs used to treat this mental disorder one bit, I’m sure.
Some have said that so many more people seek treatment now for what they believe is a major depressive disorder they are experiencing, when in fact it may be possibly intense sadness, perhaps, due to a loss of some sort in their lives. There is a difference, and health care providers should have the appropriate tools and knowledge to discriminate between the two states of mental conditions.
Sadness is not a medical problem. Symptoms associated with an unfavorable mental state need to be excessive and chronic to be considered to have in fact the medical problem of a major depressive disorder, as stated by others.
In Time magazine’s June 16th 2008 cover story, it was reported that the military personnel in the Iraq war are pounding down SSRIs often. Every time there is a new war, there is a new drug, it seems. Yet the story may illustrate the frequent usage of these types of medications in a variety of different areas for different reasons.

Some reasons may be valid and appropriate, yet others perhaps may not be reasonable for such medicinal therapy. However, as illustrated in this situation, they appear to be accepted as a treatment option without reservation.
In regards to those pharmaceutical companies who make and market such psychotropic drugs in the manner that their manufacturers do is largely unknown to others, such as with screenings performed essentially by front groups, and so forth.
However, what is known is that the psychiatry specialty, as they often treats and manages depressed patients, is the one specialty that receives the most monetary funding that is paid to them by these certain pharmaceutical companies for ultimately what they hope will be continued and additional support of the psychotropic meds that they currently promote to these doctors.
Needless to say, the desire and the aspect of the pharmaceutical industry clearly is primarily concerned with encouraging as much use out of their products as possible- with both doctors and patients being the route of that increased use they desperately hope will occur.
Regardless, SSRIs and SRNIs are the preferred treatment methods if depression or other mood disorders that are suspected and determined by the health care providers who treat such patients. Yet these drugs discussed clearly are not the only treatments, medicinally or otherwise, for depression and other related and suspected mental disease states, moods, or disorders. Patients should be aware of this fact as well as caregivers. And they may not be aware of the options available to them.
For example, tens of millions of prescriptions are written by health care providers for these types of medications for their patients.
These drugs are not inexpensive, either, as it is not unusual for a patient to pay greater than one hundred dollars to have their prescription filled for only a month’s worth of these particular drugs.
Presently, there are about ten different SSRI/SRNI meds available, many of which are now generic, yet essentially, they appear to be similar in regards to their efficacy and adverse events. The newest one, a SNRI called Pristiq, was approved in 2008, and is believed to be launched as a treatment for menopause.
The first one of these SSRI meds was Prozac, which was available in 1988, and the drug was greatly praised for its ability to transform the lives of those who consumed this medication in the years that followed. Some termed Prozac, ‘the happy pill’.
In addition, as the years went by and more drugs in this class became available, Prozac was the one of preference for many doctors for children. A favorable book was published specifically regarding this medication soon after it became so popular with others.

Furthermore, these meds have received upon request of their makers to the FDA to have additional indications besides depression for these types of drugs they produce and market, and the indications they have received are for some really questionable conditions, such as social phobia and premenstrual syndrome.
Also included with indications that now exist with these types of medications are the quite devastating conditions of what may be mild anxiety and shyness, yet the makers of these drugs consider such patients as having chronic anxiety with severe anxiety disorder, which others have said is rather obsurd.
And it gets worse with the indications received for these types of drugs, which now include Obsessive-Compulsive Disorder, Panic Disorder, Agoraphobia, Post Traumatic Stress Disorder, Bulimia, and any form of stress disorders in general. I understand they are seeking indications for pain management as well with these SSRI or SRNI pharmaceuticals.
Likely, they will get the indication for their drugs to treat such creative cognitive states apparently others have in great numbers.
With some of these indications for these classes of drugs, I question as to whether or not they are actual and treatable disease states or medical problems. Yet with additional indications for particular drugs in these classes of medications, one can be assured that the market for these drugs will continue to grow- as more are prescribed to those patients who are progressively asking for them specifically for relief they anticipate they will receive from taking these drugs.
What such patients are not aware of is that studies have shown that this class of medications is only effective in roughly half of those who take them. And some of the indications granted to drugs in these classes of medications may be considered disease mongering tacitly performed by the makers and marketers of these drugs to again grow the market share for particular drugs of this type.
This is combined with drug companies who make these types of meds either forming or creating front groups in order to have more diagnosed with various medical problems that may not exist so their medication can be utilized more.
And as mentioned earlier, such pharmaceutical companies have been known to either create or support front groups to ultimately encourage who may be normal people to get evaluated for the diseases indicated with these medications. Of course, such tactics implemented by such pharmaceutical companies are deceptive, inappropriate, unreasonable, unnecessary, and potentially if not actually dangerous to others.
Perhaps of greater concern and danger with these particular psychotropic medications involve the adverse effects associated with these types of drugs, which include suicidal thoughts and actions, violence- including acts of homicide, and aggression- and this is only to name a few. Such events are devastating and have been demonstrated by those who have or are taking these types of drugs. It has been reported that the makers of such drugs are suspected to have known about these toxic and dangerous effects of their drugs and did not share them with the public in a timely and critical manner until forced to do so.
While most SSRIs and SNRIs are approved for use in adults only, prescribing these meds to children and adolescents has drawn the most attention and debate with others for understandable reasons, which have included those in the medical profession as well as citizen watchdog groups.
The reasons for this attention are due to the potential off-label use of these meds in this population of children, yet what may be most shocking is the fact that some of the makers of these meds did not release clinical study information about the risks of suicide as well as the other adverse events related to such populations, combined with the true decreased efficacy of SSRIs in general, which is believed to be only less than 10 percent more effective than a placebo.
Paxil caught the attention of the government regarding this issue of data suppression some time ago, this hiding of such important information- Elliot Spitzer specifically was the catalyst for this awareness, as I recall. Furthermore, that drug is in the spotlight once again years later. Some believe the drug maker knew about possible risk to the youth as early as 1991. Yet did not disclose such danger associated with their drug to the public or the FDA, and this was done with intent.
And there are very serious questions about the use of SSRIs in children and adolescents regarding the possible damaging effects of these meds on them as they get older- these children and teenagers who are prescribed these drugs. Others are asking if this is really necessary- and are these drugs doing more harm than good for their children.
For example, do the SSRIs correct or create brain states considered not within normal limits, which in effect would possibly cause harm rather than benefit a patient on such a drug? Are adolescents really depressed, or just experiencing what was once considered normal teenage angst? Do SSRIs have an effect on the brain development and their self identity of such young people? Do adolescents in particular become dangerous or bizarre due to SSRIs interfering with the myelination occurring within their still developing brains?
No one seems to know the correct answer to such questions, yet the danger associated with the use of SSRIs does in fact exist, as demonstrated by others. It is observed in some who take such drugs, but not all who take these drugs.
Yet health care providers possibly should be much more aware of these possibilities, possibly, along with the black box warning now on SSRI prescribing information for the youth that has existed since 1994. There are other medications health care providers could prescribe for such patients that have no less benefit for them then the serotonin drugs discussed.
Finally, if SSRIs or SNRIs are discontinued by a patient rapidly, abruptly, and without medical supervision, withdrawals experienced by many of these patients are believed to be quite brutal that follow soon after this drug is not taken anymore by a former patient. This in itself may be a catalyst for one to consider or attempt suicide, others have suggested. Many are aware and understand that discontinuing these SSRIs and SSNIs leaves the brain in a state of neurochemical instability for some great length of time as the neurons need to recalibrate after existing in a brain over-saturated with serotonin and neuron alteration.
This occurs to some degree with any psychotropic medication, yet the withdrawals can reach a state of danger for the victim in some classes of meds such as SSRIs and SNRIs, it is believed. And this seems to concern many, yet does not inhibit health care providers for continuing to select such therapy with these drugs for their patients.
SSRIs and SRNIs have been claimed by doctors as well as patients to be extremely beneficial for the patient’s well -being regarding their apparent mental issues that resolve in time. Yet overall, the factors associated with this class of medications may outweigh any perceived benefit for the patient taking such a drug that can harm themselves and others.
Before these medications mentioned were developed, doctors praised trycyclics, another class of anti-depressants mentioned earlier, in a similar manner since their advent in the 1950.
Considering the lack of efficacy that has been demonstrated objectively with these new serotonin specific psychotropics, along with the deadly adverse events with these SSRI and SSNI meds only recently brought to the attention of others, other pharmacological and non- pharmacological treatment options should probably be considered, but that is up to the discretion of the prescriber.
And the perception of the benefits derived by these types of drugs may be flawed, as there has been no decrease in incidences of suicide or remission of depression since these drugs have been available, many have concluded.
Yet antidepressants in general have been considered by others to create amotivational syndrome, which is a lack of interest in various activities, as well as creating a state of flat affect of users of antidepressants.
Furthermore, recent studies have suggested that the supplement, St. John’s Wart, has shown to be as effective as medicine for major depression. Deficiencies in vitamins B12 and Folate have been suggested as a cause for depression as well. One study showed that a small jog performed by a depressed patient offered similar if not greater relief than a SSRI drug.
It is my hope that such a prescriber rules out possible other etiologies for their patients’ mental conditions before they conclude that such a patient is suffering from true mental illness requiring the medications mentioned earlier, such as asking their patients about life stressors and other medications these patients have taken or are presently taking. Because at times, a doctor can in fact do harm without intent.
“I use to care, but now I take a pill for that.” ---
Author unknown*

Dan Abshear