Saturday, September 1, 2012

Emotional Lability in People with Multiple Sclerosis Scores Another Windfall for Big Pharma


MS is a nasty disease. There are over 50 symptoms associated with the MonSter. An often hidden little secret is the profound emotional toll that often accompanies the diagnosis. Most people newly diagnosed know very little about the disease. The past three years has yielded ample evidence that even the MS “experts” have been on the wrong track for decades. Fear of the unknown and the relapsing remitting nature of symptoms add significantly to emotional issues. Some emotional problems noted in people with MS are: • Major depressive episodes as well as less severe depressive symptoms • Grieving for losses related to the disease • Stress and reactions to stressful situations • Generalized distress and anxiety • Emotional lability or mood swings • Pseudobulbar Affect - uncontrollable laughing and/or crying • Inappropriate behavior such as sexual aggressiveness • Depression Approximately 10 percent of people with MS experience uncontrollable episodes of laughing and/or crying that are unpredictable and seem to have little or no relationship to actual events or the person's emotions. A person may sob uncontrollably without feeling sad, or laugh inappropriately in a situation that isn't funny. Damaged nerve endings in the emotional pathways of the brain are thought to be responsible. It is important for family members and caregivers to know this, and realize that people with MS may not always be able to control their emotions. Emotional lability causes rapid and unpredictable changes in emotions. Loved ones and friends report that the person is often irritable or angry. The stress of the disease often accompanied by some level of disability and changes in the brain itself makes emotional turmoil difficult for both the person with MS and their caregivers. All members of the family are likely to be affected by these mood swings. People with MS never know when and if another exacerbation will occur or how severely they may be affected in the future. They do not even know how they will feel in the afternoon or one day to the next. The loss of function and altered life circumstances cause distress and anxiety. Neurologists have a plethora of drugs to treat this condition. ”The treatment of these problems is complex. The person with MS may require some form of psychiatric medication, perhaps along with psychotherapy. Family members will probably need supportive counseling since these behaviors are often shocking and disruptive. In some cases, the affected individual may require supervision to prevent the manifestation of the behaviors in question.” (Our best buddies at the NMSS) Cognitive dysfunction caused by MS may result in poor judgment and even sexual disinhibition. The behavior is not deliberate or under the person’s control. It is not a sign of lack of control or poor moral character. Pseudobulbar Affect (PBA) –( uncontrollable laughing and/or crying). If you have a lesion between your cortex and brainstem then the emotional expression can be entirely separated from the conscious awareness of it. Is commonly treated with amitriptyline, levodopa, desipramine, fluoxetine, and fluvoxamine. Nuedexta was approved 2 years ago to treat PBA. It is a combination of 20 mg dextromethorphan and 10 mg quinidine, two existing, generic—or cheap—drugs, and costs from $3000-$5000 per year. The mark up is to cover the costs of clinical testing, marketing, and shareholder profits. A paper in the Annals of Neurology from 2007 shows that a number of medications, including SSRIs like citalopram, and tricyclic antidepressants (TCAs), are effective in managing the symptoms of PBA, so why the need for a new drug? Avanir manufactures this drug. It was approved for a neurological syndrome whose major manifestation is “affective instability”. The proper diagnosis of PBA requires far more than that, yet doctors are trying to prescribe it off-label for the affective lability seen in many other conditions (bipolar disorder, schizophrenia, autism, dementia, childhood irritability, blah, blah, blah. ..) Expect Avanir to try to get Nuedexta approved for all of these conditions. The trials which led to Nuedexta’s approval showed only slight improvement vs. placebo in patients with PBA due to multiple sclerosis and ALS. It was not compared to SSRIs or TCAs. Avanir’s investor materials already state that the company will seek approval for multiple sclerosis-related pain, and for behavioral symptoms in dementia. http://stevebmd.files.wordpress.com/2011/04/nuedexta-april2011.pdf
Once again the drug companies want to take advantage of our ignorance to make a few billion dollars for Phat Pharma.
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