Prescribing Abilify — Are Physicians Careful Enough?


By Bob Aronson

final cartoonThis blog is a wake-up call for those who take anti-depressants.  It is an attempt by Bob’s Newheart to draw attention to the drugs, the prescription process and some of the side effects they present.  We will focus in particular on the Bristol Meyers Squibb antipsychotic, Abilify.

This post does not pretend to offer a scientific evaluation of the drug.  We have neither the expertise nor the facilities to accomplish that.  Through research, though, we can offer readers some selected information upon which they can make their own judgments.  Specifically we looked into what the drug is intended to do, what it does, what unintended consequences have resulted and, of course, the profitability of the medication.

I was drawn to this subject because I have taken Abilify and suffered serious side effects.  I will detail them and offer other examples both scientific and personal later in this post.

Abilify is becoming a very commonly prescribed anti-depressant.  While there are many possible side effects this warning from the U.S. Food and Drug Administration (FDA) stands out.

FDA WARNINGS: INCREASED MORTALITY IN ELDERLY

PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and

SUICIDALITY AND ANTIDEPRESSANT DRUGS

See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with

Antipsychotic drugs are at an increased risk of death. ABILIFY is

not approved for the treatment of patients with dementia-related

psychosis. (5.1)

Children, adolescents, and young adults taking antidepressants for

Major Depressive Disorder (MDD) and other psychiatric disorders

are at increased risk of suicidal thinking and behavior. (5.2)

Not only does Abilify cause concern for elderly patients, it should be a cause of concern for all patients for many reasons including one that affected me, Tardive Dyskinesia.  Remember that term…we’ll be returning to it, but first I want to re-visit the subject of depression and what it is.

Many awaiting organ transplants and recipients as well suffer from serious bouts of depression.  They often will attribute their sunken feelings with being told that they have an end-stage disease.

Strangely, many patients who have received the “gift of life” also feel depressed and some even become suicidal.  Many believe they are depressed due to guilt.  Guilt caused by the belief that they received organs ahead of patients who were sicker and more deserving.

To the lay person the explanations given by pre and post-transplant patients make sense but medical science and research has told us for a very long time that the moods they describe may be the result of chemical imbalances.  Well, that may not be true.  Here’s what the Harvard Medical school has to say about depression and what it is.

cartoon...depression“Research suggests that depression doesn’t spring from simply having too much or too little of certain brain chemicals. Rather, depression has many possible causes, including faulty mood regulation by the brain, genetic vulnerability, stressful life events, medications, and medical problems. It’s believed that several of these forces interact to bring on depression.

To be sure, chemicals are involved in this process, but it is not a simple matter of one chemical being too low and another too high. Rather, many chemicals are involved, working both inside and outside nerve cells. There are millions, even billions, of chemical reactions that make up the dynamic system that is responsible for your mood, perceptions, and how you experience life.

With this level of complexity, you can see how two people might have similar symptoms of depression, but the problem on the inside, and therefore what treatments will work best, may be entirely different.” You can read all the details of the Harvard explanation here http://www.health.harvard.edu/newsweek/what-causes-depression.htm

If you read between the lines of the Harvard explanation you can quickly come to the conclusion that physicians who treat depression are involved in educated guesswork as they try to find the right drugs to relieve depression symptoms.

I have been treated for depression for years and whether the treatment was offered by my family physician or by a licensed, board certified Psychiatrist the approach is the same.  They ask some key questions about lifestyle, what’s bothering you, how you feel and why and then say, “We’ll try a few things to see what works.  Let’s get you started on (drug).  It takes from 2 to 5 weeks for an effect to be felt but call me in a couple of weeks to let me know how you are doing.”

Obviously physicians have more knowledge about things medical than we do but when it comes to depression it can be a big guessing game.  There are scores of drugs that can be used depending on your symptoms but don’t be surprised if the most highly skilled psychiatrist armed with the best questions has difficulty deciding what’s best for you.  Even the famed Mayo Clinic says,

“Antidepressants are a popular treatment choice for those with moderate or severe depression. Although antidepressants may not cure depression, they can reduce your symptoms. The first antidepressant you try may work fine. But if it doesn’t relieve your symptoms, or it causes side effects that bother you, you may need to try another.

But don’t give up. A number of antidepressants are available, and chances are you’ll be able to find one that works well for you.”

So when you begin taking an anti- depressant you should not expect immediate positive results because you may get no relief at all — or worse yet, you could suffer some very negative side effects.

There are several different types of anti-depressants and they, like all drugs, bring with them side effects of which can be quite serious.  The problem is that because no two people have the same physical and mental make-up it is impossible to predict who will react negatively to a medication, who will react positively and who will have no reaction at all.  You can find more information about the types of drugs and their side effects here.  http://www.helpguide.org/mental/types_of_antidepressants.htm.

And that leads us to our reason for writing this blog.  Abilify and drugs like it can help a person feel wonderful abilifyor make you absolutely miserable and cause permanent damage…  I took Abilify and had a horrible reaction to it as did others I know.

Before I go on I feel compelled to point out that my case and other individual cases do not constitute medical evidence.  Individual cases are classified as anecdotal and while they may sound convincing are not considered medical proof so I will do my best to combine anecdotal and real medical evidence.

You should know, too, what anti-psychotic drugs like Abilify are and what they do.

According to Medicine Net dot com:

http://www.medicinenet.com/script/main/art.asp?articlekey=26299 The first antipsychotic medications were introduced in the 1950s. Antipsychotic medications have helped many patients with psychosis lead a more normal and fulfilling life by alleviating such symptoms as hallucinations, both visual and auditory, and paranoid thoughts. However, the early antipsychotic medications often have unpleasant side effects, such as muscle stiffness, tremor, and abnormal movements, leading researchers to continue their search for better drugs.

“The 1990s saw the development of several new drugs for schizophrenia, called “atypical antipsychotics.” Because they have fewer side effects than the older drugs, today they are often used as a first-line treatment. The first atypical antipsychotic, clozapine (Clozaril), was introduced in the United States in 1990. In clinical trials, this medication was found to be more effective than conventional or “typical” antipsychotic medications in individuals with treatment-resistant schizophrenia (schizophrenia that has not responded to other drugs), and the risk of tardive dyskinesia (a movement disorder) was lower. However, because of the potential side effect of a serious blood disorder–agranulocytosis (loss of the white blood cells that fight infection)-patients who are on clozapine must have a blood test every 1 or 2 weeks. The inconvenience and cost of blood tests and the medication itself have made maintenance on clozapine difficult for many people. Clozapine, however, continues to be the drug of choice for treatment-resistant schizophrenia patients.

Several other atypical antipsychotics have been developed since clozapine was introduced, they are risperidone (Risperdal), aripiprazole (Abilify),  olanzapine (Zyprexa), quetiapine (Seroquel), and ziprasidone (Geodon). Each has a unique side effect profile, but in general, these medications are better tolerated than the earlier drugs. Click on the links above to each drug for more information about side effects.

All these medications have their place in the treatment of schizophrenia, and doctors will choose among them. They will consider the person’s symptoms, age, weight, and personal and family medication history”.

Now let’s get back to those side effects I alluded to earlier in this post.

Patients who take Abilify and some other prescription drugs can develop Tardive Dyskinesia which presents as involuntary, repetitive tic-like movements primarily in the facial muscles or (less commonly) the limbs, fingers and toes. The hips and torso may also be affected. 

Symptoms of tardive dyskinesia can develop and persist long after use of the medication causing the disorder has been discontinued. Tardive dyskinesia can appear similar to other types of disorders, most notably Tourette’s syndrome and can become a permanent medical condition.  

While taking Abilify I developed Tardive Dyskinesia and fortunately quit taking it in time to prevent the affliction from becoming permanent.  The above description does not do justice to it.  When it affected me it was accompanied by confusion, agitation and uncontrollable and very visible tremors around my lower jaw to the point where my teeth could be heard hitting each other despite major efforts on my part to prevent the occurrence.  Furthermore the drug caused tremors in my hands and hips which disappeared once I quit taking the medication.  I felt as though I was disassembling.

Not all patients are affected by dyskinesia.  Some have experienced other side effects.  One friend who we will call “Bill” wrote the following.

I started off on the lowest dose, 2 mg but I felt as though I was going to crawl out of my skin so I cut the dose in half on my own.

While I did not have the movement issues consistent with Tardive dyskinesia.  I did experience a terrible feeling of anxiety and depression unlike any I had experienced in the past.  I can describe the feeling in no other way than to say I felt like my mind was coming unglued.

My physician explained that he thought the dose was too low so we increased it again to 2mg which is a very lose dose but — things got much worse.   I could no longer handle the effects on my mind and body and stopped taking it.  The effects went away the next day.

Perhaps Abilify works for some but for me it was disastrous. Good thing I have a medical background and sense enough to stop taking it. Too often the docs give you something like this and say see me in 2 months, or longer.”

It is important to note here that the drug label clearly says that no one should just stop taking Abilify.  To discontinue use one should taper off slowly under a physician’s watchful eye.  Unfortunately as with Bill, he was unable to see a physician and the effects were so bad he felt compelled to take action himself.

Two stories do not constitute medical evidence but a CNN report says,

“The growing use of a popular drug in the long-term treatment of bipolar disorder is based largely on a single, flawed clinical trial that may be steering doctors and patients away from drugs with a more established track record.”

The CNN expert who studied the studies that got Abilify FDA approval said, “

“The medical research does not appear to justify the widespread use of Abilify for maintenance therapy,” says psychiatrist Alexander C. Tsai, M.D., one of the lead authors of the review and a visiting researcher at Harvard University.” We failed to find sufficient data to support its use.” http://www.cnn.com/2011/HEALTH/05/03/abilify.use.questions/

Bristol Meyers Squibb is the American manufacturer of the drug.  They spend a lot of money on advertising and it pays off.  Abilify was the second-biggest selling drug in their portfolio In 2011 when the antipsychotic generated nearly $2.8 billion in sales, or roughly 13 percent of net sales second only to the $7.1 Billion generated by Plavix.

According to Pharmalot http://www.pharmalive.com/feds-subpoena-bristol-myers-over-abilify-marketing

In September 2007, Bristol-Myers Squibb agreed to settle charges of giving kickbacks to docs and overcharging the government. Among the infractions alleged by the federal and state governments was off-label promotion of its Abilify antipsychotic, and the drugmaker subsequently paid $515 million and signed a five-year corporate integrity agreement.

At the time of the settlement, Bristol-Myers was charged with directing its sales force to call on child psychiatrists and other pediatric specialists, and reps then urged physicians and other health care providers to prescribe Abilify for children. The drug maker also was charged with creating a specialized long=term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder (back story and the CIA).

The bottom line is this.  Abilify can help.  The problem is that medical science cannot say with certainty who it will help, what conditions it will alleviate and most importantly when and if the side effects will show up.  All they can say is Abilify MIGHT help some patients.

If your physician prescribes Abilify for you it is imperative that you have access to him/her while you are taking it so that if you are negatively affected you can be directed on how best to quit taking it without causing further damage.

One has to wonder about the impact of prescription drug advertising.  It is obviously done to get patients to put pressure on physicians to prescribe drugs that cannot be bought over the counter.  One also has to wonder about the practice of providing physicians with samples to pass out to patients and finally — one has to wonder what’s in it for the physician who prescribes the meds.  Lots of questions — not too many answers.

-0-

scooter half size for wordpressBob Aronson is a 2007 heart transplant recipient, the founder and primary author of the blogs on this site and the founder of Facebook’s over 3,000 member Organ Transplant Initiative group.

Now retired and living in Jacksonville, Florida with his wife Robin he spends his time advocating for patients with end stage diseases and for organ recipients.  He is also active in helping his wife with her art business at art festivals and on her Rockin Robin Prints site on Etsy. 

Bob is a former journalist, Governor’s Communication Director and international communications consultant.

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About Bob Aronson

Bob Aronson is a former journalist, a Minnesota Governor's Press Secretary and talk show host. For nearly a quarter of a century, he led the Aronson Partnership, a Minnesota-based communications consultancy that prepared corporate and government executives for crisis situations, regulatory testimony, media interviews and Presentations. Among his clients were all three U.S. Mayo Clinic locations, 3M, general Mills, CH2M Hill, the U.S. Department of Energy and scores more. In 2007 bob had a heart transplant after suffering from idiopathic dilated cardiomyopathy for 12 years. Shortly after he got his new heart he founded the now 4,300 member Facebook support group, Organ Transplant Initiative. At the same time, he established the Bob's Newheart blog where he has posted nearly 300 columns on organ donation, transplantation and other health related issues. The Viewpoint blog was started in late 2016 and bears the name of the Radio Talk show Bob did from 1966 until 1974, when he resigned to become Minnesota Governor Rudy Perpich first Press secretary. Bob and his artist wife Robin, live in Jacksonville, Florida with their two dogs, Reilly and Ziggy. Bob is also a woodworker and makes all of the furnishings for Robin's art festival booth. He also makes one of a kind jewelry or "memories" boxes that he donates to select transplant patients, caregivers, donor families and others who have somehow contributed to making life easier for the ill, the elderly and the less fortunate. Bob is in the final stages of editing two full-length novels that will be available on Kindle when ready for release sometime in early 2017. One is a sci fi novel about an amazing discovery near Roswell, New Mexico and you will be surprised to find it has nothing to do with the Roswell story everyone knows. It features a woman scientist who investigates impact craters for the U.S. Department of the Interior, Dr. Rita Sylvester and her female student intern. The other book is a political thriller that introduces a new hero to the genre, Fargo Dennison.

Posted on January 1, 2014, in The Practice of Medicine and tagged , , , , , , , , , , . Bookmark the permalink. 1 Comment.

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