Johnson & Johnson, Omnicare, Risperdal and what it means to you

I just about fell off my chair Saturday morning when I read in the New York Times about Johnson & Johnson giving kickbacks to geriatric pharmacists to encourage doctors to prescribe Risperdal for their patients with dementia. I knew that there were issues with "Big Pharma," but I could not imagine, or did not want to imagine, that the issues were so blatant, with so much "chutzpa" on the part of the pharmaceutical companies that they would actually give kickbacks for prescriptions.

According to the complaint brought against Johnson & Johnson by two ex-employees of Omnicare, "Johnson & Johnson, based in New Brunswick, N.J., and two of its subsidiaries, Ortho-McNeil-Janssen Pharmaceuticals and Johnson & Johnson Health Care Systems, paid tens of millions of dollars to induce Omnicare to buy and recommend Risperdal for elderly patients as well as the drug maker’s prescription pain relievers Duragesic and Ultram, and the antibiotic Levaquin."

Some explanation is in order for us laypeople, so let's pull this statement apart.

Risperdal is an antipsychotic medication prescribed for people with schizophrenia. Schizophrenia is a debilitating mental disease affecting approximately 1% of the US population, or about 2 million people. According to about.com, symptoms include: confusing, or even shocking, changes in behavior; sudden onset of severe psychotic symptoms (acute phase of schizophrenia); psychosis (state of mental impairment marked by hallucinations and/or delusions -- being "out of touch with reality"); social isolation or withdrawal; unusual speech, thinking, or behavior.

One could be forgiven for thinking that these symptoms sound suspiciously like some of the behaviours associated with dementia, because they do. For people with Schizophrenia, medications such as Risperdal reduce psychotic symptoms and allow people with this disorder to function better in their day-to-day activities. Side effects of Risperdal include sudden involuntary movements of the head, neck, arms or eyes; dizziness; hyperactivity; fatigue; abdominal pain; fever; and nausea.

So the logic could in fact follow, that if elderly people with dementia exhibit some of the same symptoms as people with Schizophrenia, and if Risperdal helps to lessen the psychosis in people with Schizophrenia, then Risperdal would be a good thing to prescribe for people with dementia. Right? Wrong. Because one other side effect of Risperdal is that it can kill people with dementia. I downloaded the prescribing information from the Risperdal.com web site, published by Janssen (a subsidiary of J&J), and right there it says, at the top, in big bold letters:

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
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. RISPERDAL® is not approved for use in patients with dementia-related psychosis.

Hmmmm. Well, in fairness to all, the complaint covers the years 1999-2004, while Johnson & Johnson was not required to carry the warning against use with dementia patients until 2005. But it IS still prescribed, a lot. My mother was on it. We kept taking her off of it. Her nursing home kept putting her back on it.

I looked up the other medications mentioned in the complaint. Duragesic is a powerful pain-killer, administered by a patch for those dealing with chronic pain. Ultram is a narcotic-like drug used to provide extended pain relief and has its own lovely side effects. What stood out for me about Ultram is that it should not be taken by those who have ever been addicted to drugs or alcohol. I'm guessing no one would have bothered to ask a family care giver about the patient's previous drug and alcohol use prior to prescribing that drug. It also should not be given to people who have recently taken anti-psychotic drugs such as... Risperdal. Finally, Levaquin is an antibiotic used to treat skin infections, bladder infections and the like. You can google these drugs... there is lots of information about them on the Internet.

OK, so now who is Johnson & Johnson? As the New York Times article said, they are based in New Brunswick, NJ. It is the second largest pharmaceutical company in the world, and make such popular brands as Tylenol, which they have had to recall due to unusual smells coming from the bottles. Their revenue in 2008 was $63.7 billion, with net income of $12.9 billion. They have over 118,000 employees and are a holding company for more than 250 companies operating in just about every country of the world. Their web site is http://www.jnj.com/. Actually, if you take a look at all the products they sell, you will be as amazed as I am as to the company's influence on our lives.

Now on to Omnicare. Who are THEY? Omnicare is the largest provider of pharmacy services to nursing homes in the United States and Canada. They provide medications to 1.4 million elderly nursing home residents.

Pharmacy services? Yes, this was a new one on me too. You mean the nursing homes don't just go to Walgreen's with a prescription like the rest of us? It gets better.

Omnicare provides pharmaceuticals and related ancillary pharmacy services to long-term health care institutions. Its clients include primarily skilled nursing facilities (SNFs), assisted living facilities (ALFS), retirement centers, independent living communities, hospitals, hospice, other health care settings and service providers. According to their web site, customers of Omnicare Senior Pharmacy Services benefit from personalized service provided by each of its local pharmacies, including specialty unit-dose packaging, delivery, 24-hour/7-day availability, pharmacist consulting, medical records, infusion and respiratory therapy, and medical supplies. OK, that sounds legitimate. So what did they do wrong?

As far as I can tell from their web site, Omnicare acts as a middle person between the pharmaceutical companies (I assume they represent more companies than just Johnson & Johnson) and the nursing homes, assisted living, independent living, long term care facilities and memory care units. They purchase medications from the pharmaceutical companies, repackage them in easy-to-understand packaging that helps to monitor and administer dosages, and then sell them to the nursing homes. The company has Omnicare Consultant Pharmacists who educate the nursing home doctors and staff in what medications are appropriate for the various illnesses experienced by the elderly. The nursing home staff can consult directly with Omnicare to determine appropriate medications, and then purchase the medications from Omnicare.

Business-wise, the idea is sound: Johnson & Johnson does not need to have employees that specialize in geriatrics and in distributing to nursing homes. They outsource that function to Omnicare. The nursing homes don't need to wade through the multitudes of medications available but can hone in on just those for the elderly. Omnicare even provides a drug "bible" of sorts, the Omnicare Geriatric Pharmaceutical Care Guidelines^®, which they say is the "cornerstone of their effective management of pharmaceutical care of the elderly." The catalog lists drugs as "preferred, acceptable or unacceptable" and provides cost information, "making it easy for a physician to choose the most cost-effective among clinically equivalent or superior drugs." I wonder what rating Risperdal gets? Preferred? Acceptable?

But what happens when the pharmaceutical company starts paying the consultant pharmacists to promote a particular drug directly to a nursing home doctor? There's the problem.

It has long bothered me that one of the prime sources of education for physicians about the medications they prescribe is the companies that create the drugs in the first place: the pharmaceutical companies. Doctors don't have a lot of time to take intensive classes and to keep up-to-date with all the new medications available. So, pharmaceutical companies provide information sessions to doctors, in convenient locations such as hospitals, to introduce them to new medications. Their representatives make regular visits to doctors' offices, bringing samples and information on the latest medications. You must have heard about the trouble pharmaceutical companies have gotten into in the past, providing education sessions in luxury resorts and paying for the doctors to attend. If our kids go to the local mall, and one store is handing out candy with every t shirt purchase, and the other store is handing out nothing with every t shirt purchase, which store do you think they will purchase from? Which store will they tell all their friends about?

In a similar fashion, Omnicare pushed the merchandise being handed out with candy. According to the NY Times article, "The complaint charges that Omnicare’s pharmacists engaged in intensive efforts to persuade physicians to prescribe the drugs [Risperdal etc.] from 1999 to 2004, a period in which the pharmacy’s annual purchase of Johnson & Johnson medications nearly tripled to more than $280 million, from about $100 million. During the same period, the pharmacy’s annual purchase of Risperdal rose to more than $100 million."

Here's what is really awful though. In an effort to ensure that elderly nursing home residents are not over-medicated or medicated for the purposes of restraining them or making them more compliant, nursing homes are required by the federal Department of Health and Human Services to have each resident's medications reviewed monthly by an independent consulting pharmacist. Johnson & Johnson targeted those so-called "independent" consultants who were entrusted with reviewing the medications and with providing advice to physicians about proper medications for the elderly. Of course I have a problem with these "independent" consultants working for the company that is distributing the medications.... don't you?

Johnson & Johnson is not alone in being rapped on the knuckles for using the population of vulnerable elderly nursing home residents as a dumping ground for their drugs. According to the same NY Times article, "Last January, the drug maker Eli Lilly pleaded guilty to a misdemeanor and paid $1.415 billion to settle criminal and civil charges that the drug maker had marketed its antipsychotic Zyprexa for the treatment of elderly people with dementia."

So what does this mean to you, Care Partner, with a loved one with dementia in a memory care unit?

If you are not doing so already, request a list of the medications that your loved one is currently prescribed. Then research each and every medication on that list. Look in particular for Risperdal and other anti-psychotic drugs Google them. Understand why they are used and what the side effects are. If you do not understand why your loved one was prescribed a certain medication, query the on-site nurse or physician. You can ask for him or her to be taken off a medication if you feel it is wrong. From that point on, ask to be consulted before your loved one is prescribed any additional medication. Review medications monthly just in case something slipped through without your knowledge.

The other two things that you need to understand are with regards to the behaviours that your loved one with dementia are exhibiting.

Are they sleeping more? Seem more confused than ever? Dazed? Dizzy? Check their medications. The side effects of many of the medications used as anti-depressants and to control behaviour in people with dementia are confused for symptoms of dementia. At one point, my mother was so unresponsive I thought she was dying... nah, it was just the sleeping pills being used to keep her drowsy, thus making her "less trouble" for the hospital staff.

Second, understand that your nursing home DOES have an alternative to using medications to control behaviours (FYI, while some behaviours can be violent and present a danger to other residents, "behaviours" also include anger and calling out for help... perhaps we all need to be drugged!), and so do you. Lakeview Ranch in Darwin, MN uses positive communication methods and validates the feelings of the person with dementia, recognizing that there must be an underlying cause for the behaviour. They have had huge success in reducing negative behaviours without the use of medication, and have reduced the use of anti-psychotic medications by 36% in their residents.