Yes, according to this article in yesterday's NEJM:
http://content.nejm.org/cgi/content/short/358/3/252
Talk about publication bias. According to Erick H. Turner, M.D. and coauthors, the selective publication of only "positive" trials, in addition to publishing in a positive light studies that the FDA considered "negative" leads to a 32% increase in the apparent efficacy of antidepressant drugs, on average (range 11-69%). Once again, profit trumps science, safety, and patient and public health.
What can we do about it? First, reduce by one third the effect size of any antidepressant results you see in an industry-sponsored clinical trial. Next, carefully consider whether whatever [probably modest] effect remains is worth the side effects (e.g., increase in suicide), cost, and nuisance of the drug. Third, prescribe generic agents. Fourth, don't allow pharmaceutical reps to speak with you about new products. Fifth, consider alternative treatments.
I am reminded of a curious occurrence relating to a drug that I think is definately worth the cost, side effects, and nuisance associated with it: Chantix (varenicline) - Pfizer's smoking cessation drug. In JAMA in July 2006,
(http://jama.ama-assn.org/content/vol296/issue1/index.dtl)
two nearly identical articles described two nearly identical studies, which shared many of the same authors. What was the intent of this? Why not conduct one larger study? Was the intent to diversify the risk of failure and allow for selective publication of positive results? I'm very interested in any information anyone can provide about this curious arrangement, which appears to be without precedent. Please leave your comments below.
Friday, January 18, 2008
Have the Peddlers of Antidepressants (Big Pharma) been Successful in Suppressing Negative Trial Results?
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Current Depression Medications: Do The Benefits Outweigh the Harm?
Presently, for the treatment of depression and other what some claim are mental disorders, some of which are questionable, selective serotonin reuptake inhibitors are the drugs of choice by most prescribers. Such meds, meds that affect the mind, are called psychotropic medications. SSRIs also include a few meds in this class with the addition of a norepinephrine uptake inhibitor added to the SSRI, and these are referred to SNRI medications. Examples of SNRIs are Cymbalta and Effexor.
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 the DSM, states that the definite etiology of depression remains a mystery and is unknown. So a chemical imbalance in the brain is not proven to be the cause of mood disorders, it is only suspected with limited scientific evidence.
Norepinephrine is a stress hormone, which many believe help those who have such mood disorders as depression.
And depression is only one of those mood disorders, yet possibly the most devastating one. An accurate diagnosis of these mood conditions lack complete accuracy as they can only be defined conceptually, so the diagnosis is dependent on subjective criteria, such as questionnaires. There is no objective diagnostic testing for depression. Yet the diagnosis of depression in patients has increased quite a bit over the decades.
Several decades ago, less than 1 percent of the U.S. population were thought to have depression. Today, it is believed that about 15 percent of the population have depression at some time in their lives. Why this great increase in the growth of this condition remains unknown and is subject to speculation. What is known is that the psychiatry specialty is the one specialty most paid to by certain pharmaceutical companies for support of their psychotropic meds, as this industry clearly desires market growth of these products, as this objective is part of their nature. Regardless, SSRIs and SRNIs are the preferred treatment methods if depression or other mood disorders that may be suspected by a doctor.
Over 30 million scripts of these types of meds are written annually, and the franchise is around 20 billion dollars a year, with some of the meds costing over 3 dollars per tablet. 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 being promoted for 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.
Furthermore, these meds have received additional indications besides depression for some really questionable conditions, such as social phobia and premenstrual syndrome. With the latter, I find it hard to believe that a natural female experience can be considered a treatable disease. Social phobia is a personality trait, in my opinion, which has been called shyness, which probably should not be labeled a treatable disease as well. There are other indications for certain behavioral manifestations as well with the different SSRIs or SRNIs. So the market continues to grow with these meds. Yet, it is believed that these meds are effective in only about half of those who take them. The makers of such meds create such conditions besides depression for additional utilization of these types of medications, and are active and have been active in forming symbiotic relationships with related groups, such as providing financial support for screenings for the indicated conditions of their meds- screening of children and adolescents in particular, I understand.
More concerning, however, is the adverse effects associated with these types of meds, which include suicidal thoughts and actions, violence, including acts of homicide, and aggression, among others. While most are approved for use in adults only, prescribing these meds to children and adolescents has drawn the most attention. The reasons for this attention are the off-label use of these meds in this population, 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, including the decreased efficacy of SSRIs in general, which is believed to be less than 10 percent more effective than a placebo. Paxil caught the attention of the government regarding this issue some time ago for hiding such important information, for example, some time ago.
And there are very serious questions about the use of SSRIs in children and adolescents regarding the effects of these meds on them. For example, do the SSRIs correct or create brain states considered not within normal limits? Are adolescents depressed, or just experiencing what was once considered normal teenage angst? Do SSRIs have an effect on the brain development and their identity? Do adolescents in particular become dangerous or bizarre due to SSRIs interfering with the myelination occurring in 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. It is observed in some who take such meds, but not all who take these meds.
Finally, if SSRIs are discontinued, withdrawals are brutal, and may be a catalyst for suicide in itself, as not only are these meds habit forming, but discontinuing these meds leaves the brain in a state of neurochemical instability, as the neurons are recalibrating upon discontinuation of the SSRI. This occurs to some degree with any psychotropic med, yet the withdrawals can reach a state of danger for the victim in some classes of meds such as SSRIs.
SSRIs and SRNIs have been claimed by doctors and patients to be extremely beneficial for the patient’s well -being regarding the patient’s mental issues where these types of meds are used, yet the risk factors associated with this class of medications may outweigh any perceived benefit for the patient taking such a drug. Considering the lack of efficacy that has been demonstrated objectively, along with the deadly adverse events with these meds only recently brought to the attention of others, other treatment options should probably be considered, but that is up to the discretion of the prescriber.
“I use to care, but now I take a pill for that.” --- Author unknown
Dan Abshear
Here is another relevant like relating to the effect of "grey literature" on point estimates of treatment effects in meta-analyses:
http://www.thelancet.com/journals/lancet/article/PIIS0140673600027860/abstract
At times antidepressants fail to show the desired results or they take a longer time. In such a case the patient tends to suffer the most. In order to stop such a state of events the scientists have come up with a new method to buffer up the delay caused by the antidepressants. S-adenosyl-l-methionine (SAMe) is a naturally-occurring substance that has a very positive effect on depression. Antidepressants like xanax are also known to be very good for depression. http://www.xanax-effects.com .
The superb working mechanism of _Pfizer’s anti-smoking medicine chantix makes it a highly sought after drug in the market and further Chantix information available in the website http://www.chantixmagic.com/ make it apparent that the drug acts as a better quit smoking medication that Zyban and other smoking cessation treatments. So, get hold of Chantix right now and trigger off smoking cessation!
Chantix is available in all licensed pharmacies in many countries of the world. It is also available online as many licensed sources sell it by providing professional services. This process may require you to do an online consultation that is a process similar to doing a face-to-face consultation with a doctor, but cannot replace it. http://www.chantixhome.com/
Anxiety disorder is considered to be one of the worst mental conditions that affect human beings by making them prone to baseless and groundless worries but with the arrival of anti-anxiety medications like xanax in the pharmaceutical market, successful treatment of anxiety related disorders has become an instant possibility. But, instead of straightway moving ahead to use Xanax and other medicines to treat anxiety such as Buspar and Tenormin, you can log in to http://www.pill-care.com and get hold of fundamental tidbits on these medicines first.
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