Vraylar Vagaries & Verities

Television Advertisement for Vraylar, 2018

A great pile of aluminum foil-wrapped sandwiches surrounds the manic mother who stands at her kitchen counter atop a pyramid of playing cards in beautiful suburbia.  Bipolar I Disorder could topple her reality, perhaps smothering her in ham sandwiches, but there is a solution in Vraylar, a drug from Forest Laboratories Holdings Ltd, an Allergan affiliate. In a second video, a woman in her office on top of a similar stack of playing cards, madly posts “Post It Notes” to a window wall. Vraylar will calm her down. Bipolar Disorder is endemic in 21st Century America. If you’re going to have a mental health issue, this is a good one to have.

Celebrities have admitted to being bipolar, and “Silver Linings Playbook” portrays a bipolar man who falls in love with a depressed woman. Jennifer Lawrence, who plays the woman in this offbeat romantic comedy, won the Academy Award for Best Female Actor in 2013.  The entertaining attention and the Vraylar commercials trivialize a serious mental condition. They make Bipolar I Disorder an attractive alternative if you are going to be crazy.  Patients eager to improve their perceived or diagnosed screwed-up lives can ask their doctor to give them Vraylar.  No more sandwich marathons. No more blizzards of “Post It Notes.”  You can live happily ever after with the help of a pharmaceutical.

The trouble is that Bipolar I Disorder is a serious mental condition. Many afflicted with Bipolar Disorder commit suicide. Many engage in behavior that is extremely dangerous. Illegal drug use, extreme risk taking, violent irritability, and a grandiose sense of self can lead to living on the edge of disaster.  The thrills of these behaviors are far more problematical than excessive “Post It Notes,” and creating too many sandwiches.  The person who loves to be besieged with ideas or gets off in marathon lunch-making is but a tip of the iceberg. Bipolar Disorder people love the up of mania. They want to go even higher, which can lead to psychotic behavior and dangerous actions. Still they love the up.  Unfortunately, I know. I have been there. The illness came close to destroying my life. The ups are followed by severe downs that are characterized by severe depression, isolation, and morbid thoughts of death. I call this the “Bipolar Coaster.” Once I attempted suicide but was saved in a hospital where my stomach was pumped. Many times, I have been close to killing myself. A particularly close encounter was the thought of jumping off a bridge into on-coming freeway traffic. Standing on the bridge, I decided I couldn’t risk someone’s else life by my body falling on or in front of their car. The Vraylar commercials fail to portray this other side of manic/depressive illness. The iceberg crushes the unwary.

This is not to say Vraylar is useless. I discussed Vraylar with my psychiatrist not to use, but to understand the effectiveness of the drug. She prescribes the drug for patients who have a combination of anxiety and depression. For these people, Vraylar has a calming effect. However, like all psychiatric prescriptions, one size does not fit all. What works for one person doesn’t for another, and could create conditions of undesirable side effects. I know because it took a long time for me, working with my doctor, to find the right drugs that worked long term and did not make me gain excessive weight or increase my manic behavior. Taking one of the first drugs prescribed for me, my weight escalated by 60 pounds. The Vraylar commercial doesn’t reveal that the use could be ineffective, or counter-effective.

The side effects of Vraylar can be catastrophic like:  stroke in elderly patients with dementia, tardive dyskinesia,  a condition in which the patient experiences uncontrolled movements of the body and face, muscle stiffness, or feelings of restlessness that can become permanent, problems with metabolism, Neuroleptic Malignant Syndrome (NMS) (a potentially fatal condition in which high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; or sweating that can lead to death. Per government regulation these side effects and more common ones are verbalized in the commercial, but they are quickly passed through as the benefits are extolled and visualized.

There is the question of cost. Vraylar is very expensive. A month’s supply is over $1,000. Contrast this with Lamotrigine, which costs about $7 a month with insurance. The high cost of Vraylar would force most health insurance companies to try to demand the patient take a drug of lower cost.  Unless you have a good plan or are rich, Vraylar will set you back more than $14-1/2 grand a year.

Then there is the issue of “Big Pharma,” which may or may not be a problem for you. It is for me. Allergan, the company marketing Vraylar, is the world’s 20th largest pharmaceutical company with revenue at $15.9 billion in 2017, an operating income of $5.9 billion, and a net income of $4.4 billion a year. This translates into 27.6% profit per year.  Pharmaceutical Companies are very profitable. Allergan’s most important drug now is Botox, the beauty treatment popular from Hollywood to Bollywood. Sales were $3.2 billion, and Botox’s market share is 70%, but the drug is under pressure.  A new competing drug is coming to market, and its effects last longer.  The treatment, called RT002, lasts six months compared to three or four months for Botox. Thus, Allergan is seeking new money makers.

Vraylar is one of the new money makers. Vraylar’s net revenues grew 72.2% in the second quarter of 2018 to a $114.2 million increase from the prior year’s second quarter. Allergan, an Irish-headquartered corporation, with its affiliate Forest Laboratories, licensed Vraylar from Gedeon Richter PLC, who developed Cariprazine for the treatment of schizophrenia.  Allergan, renaming the drug, is looking to expand the use and develop a large American market, of which the television advertisements are an important part. However, the corporation’s reputation is not very good.

Allergan ranks in the middle of the twenty best and worst pharmaceutical companies according to the Reputation Institute.  Its Rept Trak score is 71.8. Its affiliate Forest Laboratories, headquartered in New York, was sued for systematic gender unfairness. The U.S. District Court for the Southern District of New York found Forest Laboratories guilty, after six years of litigation, of discrimination against its female employees. This is the court in which Michael Cohen (Trump’s lawyer) pleaded guilty.  I guess his pockets were not deep enough to sustain six years of lawyers’ fees. In 2018, Allergan, along with several other drug manufacturers and distributors, was sued by several municipalities and states in the U.S. owing to the company’s manufacture of opioids. After Trump’s tax cut, Allergan’s Board of Directors authorized repurchase of its stock. No benefits were given to its employees.  Allergan is driven to strong growth, i.e. profit. Vraylar patients beware.

 

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