The United States Department of Justice recently announced that global health care giant, Johnson & Johnson, and its subsidiary, Janssen Pharmaceuticals, was ordered to pay a whopping $2.2 billion to “resolve criminal and civil liability relating to the prescription drugs Risperdal, Invega, and Natrecor, including promotion for uses not approved safe and effective by the Food and Drug Administration, and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider, Omniccare.”
“As patients and consumers, we have a right to rely upon the claims drug companies make about their products,” said assistant attorney general for the Justice Department’s Civil Division, Stewart F. Delery.
Johnson & Johnson’s promotion of Risperdal particularly targeted the most vulnerable members of our society: children and the elderly. J&J was well aware of serious health risks for the elderly, and worked to cover up research findings about those risks.
The company’s sales force promoted Risperdal at nursing homes, urging doctors to prescribe this drug to treat anxiety, agitation, and depression — all conditions not approved for use by the FDA.
There are literally hundreds of lawsuits and thousands of quiet settlements (AKA payoffs) involving Risperdal every year. The FDA first approved Risperdal in 1993 for adults, and it wasn’t approved for use in children until 2006. The drug was prescribed to children as early as 2003.
It has often been used as a “chemical restraint” in both adolescent group homes and nursing homes.
In response to a case in 2012, former FDA director David Kessler said, “The promotion of non-approved uses by a manufacturer of powerful drugs is most concerning. Janssen’s promotion of Risperdal for non-approved uses in our most vulnerable populations is deeply troubling.”
There was a time — back when all the baby-boomers were growing up — when we went to our family doctor for all our medical and health needs. He made house calls. More often than not, families went to the same doctor from birth to old age. When he said, “Here, take two of these,” parents had faith that they could trust his advice and recommended course of treatment.
Life is a lot more complicated now. The Marcus Welby style family doctor no longer exists. More often than not, medical decisions are made by insurance companies and health care providers rather than by doctors.
According to a recent Mayo Clinic study, 70 percent of Americans take at least one prescription medication daily, and 20 percent of Americans are taking five or more prescription medications daily. These numbers seem to rise with age.
We no longer have the luxury of blind faith when it comes to our health care, especially when someone says, “Here, take two of these.”
A Profound Experience
I was motivated to write this story after an experience that profoundly illustrates this point.
I recently retired from a career as a behavioral psychologist working with military families. I relocated from San Diego to Southwest Louisiana. I had always planned to enjoy my retirement in the country, but I picked this location so I could be close to my older brother, Tony, and his wife of 30 years, Anne. Anne was diagnosed with end-stage renal failure four years ago, and has been in kidney dialysis three times a week since. I figured they could use my help.
Before I moved to SWLA, I came out to do some reconnaissance. I knew from phone calls that Tony was at his wit’s end, exhausted from the lengthy, thrice-weekly commutes, and frustrated with trying to navigate the maze that is our health care system. Anne spent upwards of 20 hours a day in bed. She no longer cooked, read or socialized. Tony wasn’t comfortable leaving her alone for more than an hour or two. He hadn’t been able to go for an all-day motorcycle ride with his friends in well over two years. For a man who has been riding Harleys for more than 50 years, this was akin to a slow death.
I did my research on kidney failure and prepared myself for the physical changes I expected to see in Anne. I was not at all prepared for the declining level of Anne’s cognitive functioning. She exhibited memory loss that disrupted her daily life, often asking the same questions over and over. She had difficulty completing familiar tasks and solving problems. She was constantly losing things, and couldn’t retrace her steps. She had completely withdrawn from any social life, and the changes in her mood and personality were profound. She was exhibiting increasingly poor judgment, and got lost in familiar surroundings, so Tony no longer allowed her to drive.
I returned to California with a concern that Anne fit the diagnostic criteria of mild Alzheimer’s, and that we needed to get some cognitive testing as soon as I returned.
Three months later, I made the move to Louisiana. I watched Anne put catsup on her pancakes. I watched her get ready to go to dialysis three times on the wrong day. I watched her eat everything that dialysis patients should not eat. I watched how much time she spent sleeping and how poorly she managed her meds.
Then, about a week after I arrived, I watched her hug the commode and lose the contents of her stomach, her eyes rolling back in her head.
Tony was freaking out, afraid she was taking too many pills, and was experiencing an overdose.
I gathered up all her meds and started a systematic check. What I found absolutely shocked me. Her health care providers had her on 11 different prescription medications, of which only five were directly related to her high blood pressure or her kidney failure. There was one for asthma. Then there was a dopamine-raising med prescribed for restless leg syndrome, presumably so she could sit still in the chair during dialysis. There was pain medication she could take up to six times a day, and an anti-inflammatory with warnings about kidney damage.
Six different meds came with drowsiness or dizziness warnings as well.
She was being prescribed 60 Alprazolam a month for anxiety. “Alprazolam” is generic for Xanax, a drug so dangerous that it needs a separate article.
I counted the pills and discovered she had taken more than half the contents of the bottle of 60 in just five days. She had no clue how many she had taken. She didn’t even know the pill was Xanax.
According to the Center for Disease Control and Prevention, “deaths from drug overdose have been rising steadily over the past two decades and have become the leading cause of injury death in the United States.” A total of 80 percent of drug overdose deaths are unintentional, and 60 percent are related to prescription medications.
The CDC goes on to say, “in 2011, about 1.4 million emergency room visits involved the use of pharmaceuticals. Among those visits, 501,207 were related to anti-anxiety and insomnia medications, and 420,020 were related to opioid analgesics.”
The final prescription I found (and I did save the worst for last) was Risperidone, the generic name for Risperdal. Having spent a long career in the mental health field, this one really jumped out at me.
Risperidone is a hardcore antipsychotic medication used to treat schizophrenia and bipolar disorder. It comes with major warnings regarding renal dysfunction. It is “undialysable.” The risks are classified as “severe potential hazard, high plausibility.”
The prescription also comes with cautions about use in patients with high blood pressure and elderly patients with dementia. This is the same drug Johnson & Johnson had been peddling for 20 years now. Apparently, our medical professionals didn’t get the memo.
All that being said, I took control of Anne’s meds and made an appointment to meet with the doctor the next day. During the course of our conversation, I had to ask numerous times why he was prescribing Risperidone. The first answer he gave me was, “for her nerves …” Wrong answer.
We discussed the pills she was already taking for her nerves and I asked again. His next reason was, “so she will sit still in the chair.” Wrong answer again. A drug that is used in this way is called a chemical restraint; that is certainly not the intended use of Risperidone.
We discussed the other medication she was already taking so she could sit still in the chair, and I asked again, but why Risperidone? His third answer really floored me. He responded, “because her husband thinks she has Alzheimer’s or dementia.”
Super wrong answer. First of all, no powerful antipsychotic drug should ever be prescribed without a proper diagnosis. Second, Risperidone should never be used in elderly dementia patients,
At this point he threw up his hands in frustration and said “It is not my specialty. I will give you a referral.” Right answer … finally.
Sickness And Withdrawal
In the days after Anne’s meds were corrected, I sent my brother on a week-long road trip, and sat with Anne through sickness, withdrawal and recuperation (all of which are a lot easier without a grumpy, 72-year-old biker underfoot).
In the weeks that followed, I watched 75 percent of the concerns I had about Anne’s cognitive functioning disappear. She has since gotten up and about; she is socializing a little bit, and getting her sense of humor back. She is coherent.
Yes, she still has dialysis three times a week; that will never change. But sometimes she is up to shopping afterwards.
I don’t believe for one minute that Anne is the only elderly patient this mismanagement of meds has happened to. I worry that others are less cognizant than they could be because of pharmaceuticals. I hope everyone examines the meds that they and their loved ones are taking.
With ever-rising health care costs, a thriving pharmaceutical industry, and a health care system that is in complete disarray, the task of caring for elderly family members becomes more challenging every day. We must be vigilant in thoroughly researching any pharmaceuticals before we give them to our parents or children or take them ourselves. Drugs.com is an excellent source for precautions for the use of prescriptions.
The baby boomers have become a mostly retired, senior population. Medical science has improved dramatically over the years, keeping boomers up and running (often with rebuilds and replacement parts) long after the warranty has expired. And there’s a pill for everything…
Sources
For a reliable source to research any drug, go to Drugs.com.
To view the complete Department of Justice Press Release, go to: www.justice.gov/opa/pr/2013/November/13-ag-1170.html.
Court documents relating to the J&J settlement can be viewed online at: www. justice.gov/opa/jj-pc-docs.html.
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