Thursday, May 15, 2008

A List of Unconflicted Experts Produces an Unexpected Response

We previously discussed an article by Jeanne Lenzer and Shannon Brownlee in Slate The article discussed a show broadcast on many US National Public Radio (NPR) stations which portrayed a rather benign view of the side-effects of anti-depressant medications. Not revealed to listeners was that the show was partially funded by a company that manufacturers such medication, and all the participants in the show had some financial relationships with such companies.

We suggested that the audience deserved to know about such conflicts of interest, and that had the show's producers felt compelled to reveal them, maybe they would have thought twice about not including without such conflicts.

To demonstrate that it is possible to find such experts, at the end of the article, Lenzer and Brownlee noted they had compiled a list of experts who had no ties of any sort to pharmaceutical companies or device manufacturers over the last five years, and were going to make the list available to journalists. (Full disclosure: I am not on that list because I own 3200 shares of one pharmaceutical company, Elan. That alone was enough to disqualify me from the list, which shows how rigorous Lenzer and Brownlee were in selecting unconflicted experts.)

As discussed on the Hooked: Ethics, Medicine and Pharma blog by Dr Howard Brody, Lenzer and Brownlee were both deluged with requests from journalists for this list of unconflicted experts, but also by somewhat ominous demands for the list by people who may be tied to the pharmaceutical industry. Brody noted that it is not unheard of for industry to try to intimidate people it feels are hostile to its interests. (For some of our posts about related cases, look here and here.) He concluded, " industry appears to feel threatened by this list in a way that is quite unprecedented and unexpected. How and why that is so is worth pondering." Stay tuned on this one.

1 comment:

Anonymous said...

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