Bill Wiggins believes a powerful antipsychotic medication helped save his wife, Kathye.
Helen Shields believes one of these drugs helped kill her mother, Helen Marciniszyn.
Two families, two drugs, two stories that capture the extremes of a debate about using these medicines to treat the diseases of aging when there are no other effective alternatives.
Kathye Wiggins took Johnson & Johnson's Risperdal. Marciniszyn took AstraZeneca's Seroquel. Both drugs are atypical antipsychotics, a category of psychotropic drugs that also includes Zyprexa from Eli Lilly & Co., Abilify by Bristol-Myers Squibb Co., and Pfizer Inc.'s Geodon.
The federal government approved atypicals in the 1990s to treat schizophrenia and bipolar disorder. Since then, they have become popular for treating disorders including autism and Alzheimer's, despite mixed evidence that they help and ample evidence that they hurt.
Doctors prescribe atypicals for these illnesses because they may calm people and help them sleep. Also, patients with Alzheimer's and dementia can lose touch with reality, as schizophrenics do, so, in theory, atypicals could help.
Sales of atypicals rose to $14.36 billion in 2008 from $8.4 billion in 2003, according to data provider IMS Health.
Elderly patients have been a major source of that growth. Studies suggest that 20 percent to 30 percent of nursing-home residents take an atypical, despite not having a psychosis diagnosis.
In Pennsylvania and New Jersey, about 16 percent of all such patients on Medicare or Medicaid take some type of antipsychotic, according to federal figures. The numbers jump to more than 40 percent when the category is narrowed to patients with cognitive impairment or behavior problems.
The drugs have life-threatening side effects, especially in the elderly. Several studies have said they increase the risk of heart attacks, stroke, and premature death in this group. The atypicals now carry a so-called black box warning - the most serious required by the U.S. Food and Drug Administration - saying patients with dementia who take them are "at increased risk of death."
There is also potential for abuse.
In February,, California's attorney general charged three staff members at a nursing home with using Risperdal and Zyprexa to sedate patients and make them easier to manage. In a separate case in January, Lilly agreed to pay the federal government $1.4 billion to settle charges that it illegally marketed Zyprexa for use by the elderly.
Deciding whether to use a drug always involves weighing benefits against risks, but that calculation is especially complex when it comes to using atypicals for Alzheimer's and dementia.
"These drugs are our friends as well as our foes," said Carol Lippa, director of Drexel University's Dementia Neurology Research Laboratory. "You don't want to use them if you don't have to."
The controversy is hardly new and is expected to grow as the population ages. Diseases such as Alzheimer's and dementia have always posed challenges to caregivers. There are no substantive treatments. The FDA has not approved atypicals to treat Alzheimer's or dementia, but doctors, lacking alternatives, often prescribe them.
Patients with Alzheimer's and dementia wander, curse, or attack families and nursing aides. Many need 24-hour one-on-one care, a challenging standard in a busy family or understaffed nursing facility.
Historically, these patients were tied down or otherwise physically restrained, which now can be illegal. Various pills, including the atypicals, often have seemed more humane.
Before the atypicals arrived, geriatric experts worried about the use of earlier antipsychotics such as Haldol. Atypicals have grabbed the spotlight recently, but many doctors say they also worry about the overuse of antidepressants and anti-anxiety drugs in the elderly.
As evidence surfaced in the 1980s that some elderly patients were being medicated into submission, Congress passed laws making overuse of psychiatric drugs, or "chemical restraint," illegal.
"It seems pretty clear from the research that all too often these atypicals are being used to calm people down," said Thomas Snedden, director of Pennsylvania's prescription-drug programs, known as PACE, for low-income residents ages 65 and older.
Laws trying to ensure proper use of psychiatric drugs require that nursing homes carefully monitor them, checking to see how patients respond and trying to reduce the dose or wean patients off them.
Doctors and other experts on the elderly believe atypicals fill an important niche but recommend using them with extreme caution, a difficult challenge in an era of busy families and overworked nurses and aides.
Elaine Leventhal, director of the Gerontological Institute at the University of Medicine and Dentistry of New Jersey, said caregivers should try to manage behavior before turning to medications. She recommends that the family stay for dinner the day a relative is admitted to a nursing facility and visit as often as possible to ease the transition.
If patients become upset, staff should try to figure out why, Leventhal said. Is a roommate screaming? Does the patient need to do something other than sit all day?
Kathye Wiggins, of Yardley, was the kind of mother who led Girl Scout troops and coached softball teams.
"She was one of my best friends," said her daughter, Corri Workman. When Wiggins began forgetting things in her late 40s, her family dismissed it as a symptom of menopause.
Then, on a trip home to Ohio after her mother died, Kathye couldn't find her way back to the hotel, so her husband, Bill, asked her doctor for a thorough checkup.
When the doctor asked Kathye to count backward from 100 by threes, she stopped at 97. In 2001, doctors at Penn's Memory Center diagnosed Alzheimer's disease.
She was 53.
"She was so young, you kept hoping they were wrong," Workman said.
Bill Wiggins had one goal - to continue caring for his wife in their home.
"She'd do it for me," he said simply as Kathye sat silently on their couch, vacant eyes gazing at the floor.
He doesn't believe that even the best nursing home could take care of her properly. She wanders. She no longer speaks. She can't feed herself or tell anyone if she has gone to the bathroom.
Bill Wiggins found caregivers to help while he worked out of his house as a salesman. While he was in Florida for business in early 2007, Kathye, who had been growing increasingly aggressive, started thinking that the woman caring for her had broken into the house. She attacked her.
The aide called Workman, who was 32 weeks pregnant with twins. Workman dashed to her parents' home, calmed her mother down and, that evening, went into labor. Workman doesn't know whether the stress contributed to the premature births. Her twins are fine now.
For Bill Wiggins, it was a breaking point. He had pressed on when the caregivers he hired did little work. He had lived with the stress of wondering how he would continue to pay for Kathye's care. This was too much.
Kathye's doctor, Jason Karlawish of Penn's Memory Center, was frustrated, too. He reserves atypical antipsychotics for the most severe cases. He always tries to rule out alternative physical explanation for the patient's symptoms. Diseases such as pneumonia, for example, can make an older person delusional.
For Kathye, Karlawish believed there was no other choice.
"You're talking about a set of patients who are on the razor's edge of risk," he said.
Risperdal didn't fix everything, but gradually, Kathye grew calmer. After several months on the drugs, she developed Parkinsonian symptoms - twitching, difficulty walking that caused her to fall - that are a well-known side effect of antipsychotic drugs.
Karlawish began reducing the Risperdal slowly, using feedback from Bill to prevent behavioral flare-ups. Today, Kathye is off the medicine. She is calm, but some of the Parkinson's symptoms remain.
"I knew it was a dirty drug," Bill Wiggins said, "but I was concerned about her safety and less concerned with the side effects."
Bill Wiggins has found a new caregiver, Christine Quoikapor, who, he said, "has been a godsend." He leaves the house now with far less worry.
"It's an imperfect world," Bill Wiggins said. "You could really drive yourself crazy trying to second-guess yourself. And I've done a lot of that, frankly. I know she would not want to be as she is. There are days that I ask myself - am I extending something that she doesn't want by the way I've been taking care of her? It's one of those things where you do whatever you think is right and hopefully it is. But at the end of the day, you won't know."
Helen Marciniszyn was the kind of mother and grandmother who baked cookies, counted them out, and put an equal number in a tin labeled with each granddaughter's name.
"She stayed home and took care of the family," said her daughter Helen Shields, who lives in Middletown, Del.
When her mother began having trouble taking care of herself in 2000, Helen Shields quit her job as a doctor's receptionist to care for her. For eight years, Shields drove an hour each way to and from her mother's Chester home.
In 2006, when her mother was 89, her memory had dimmed so much that she recognized almost no one except her daughter. Marciniszyn was eating poorly, and her daughter and son decided she would be better off in a nursing facility.
They chose New Seasons at Glen Mills, an assisted-living facility that promised good medical care and stimulating activities.
On Feb. 10, 2006, one day after New Seasons admitted Marciniszyn, Richard Dimonte Jr., a Media doctor, prescribed Seroquel for her. She was a new patient to Dimonte, who never examined her and prescribed the drug over the phone, according to a 2007 lawsuit that Shields filed against New Seasons and Dimonte.
Documents from New Seasons do not list a reason for the Seroquel prescription, Shields' lawyers, Robert L. Sachs Jr. and Chad Galvin, said. Dimonte, through his lawyer, declined to comment because the matter is in litigation.
On Feb. 20, 2006, Dimonte added Ativan, an anti-anxiety drug, to Marciniszyn's prescriptions, court documents say. Seroquel, along with other antipsychotics, and Ativan sedate users, creating a risk of falling, especially in the elderly.
Five days later, Marciniszyn was found on the floor of her room at New Seasons.
When an ambulance arrived, emergency workers found her sitting in a wheelchair in the nursing office.
They transported her to Riddle Memorial Hospital, where an X-ray showed a fracture in her right femur. She had surgery to fix her right hip on March 9, 2006 and died April 8 as a result of injuries from the fall. The hospital is not a defendant in the suit.
Independence Blue Cross, which owned New Seasons at Glen Mills when Marciniszyn was there but has sold it, said it would defend itself against the suit but would not comment further because federal regulations forbid discussing patients.
Shields says no one told her when Dimonte prescribed Seroquel and Ativan to her mother. In her suit, Shields also alleges that New Seasons did not hire and properly train enough staff to care for her mother and other patients.
"How often does something like this happen?" Shields asked, explaining why she sued. "People are just not aware of what's going on."
Contact staff writer Miriam Hill at 215-854-5520 or hillmb@phillynews.com.
Inquirer staff writer Mari Schaefer contributed to this article.
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