In treating disabled people in New York, potent drugs and few rules

From The NY Times:

Something was happening to Katie Strignano (pictured).

After she was moved into a state-run group home, the 26-year-old woman, who is severely mentally retarded, started gaining weight, drooling, breaking out in pimples and pulling out her hair, leaving a bald spot the size of a softball on her head.

Her mother, Debra Strignano, suspected that someone had increased her daughter’s medication without her family’s consent.

When she asked for a copy of a consent form she had once signed for her daughter, she discovered it had been altered, tripling the daily dosage of Clonidine, which is used to control attention deficit disorder. The drug, and four others her daughter was taking, have myriad potential side effects, including rapid weight gain, skin rashes and drowsiness.

In response to questions from The New York Times, state officials said they would investigate how the consent form was changed and whether Katie Strignano was receiving the appropriate dose of medication.

“Everything with them is, let’s sedate the kid instead of trying to solve the problem,” Ms. Strignano said. “They want to dope her up; they want her to sit there like she doesn’t exist.”

Tens of thousands of powerful pills created to treat serious mental illnesses like schizophrenia are given to developmentally disabled people in the care of New York State every day.

But a review by The Times of previously unreleased records, as well as interviews with state employees, clinicians, family members and outside experts, reveals that the psychotropic medications, which alter the brain’s chemistry, are often dispensed sloppily, without rigorous or regular review, by general practitioners with little expertise in the area.

And low-level workers at state group homes are frequently given discretion to increase the medication “as needed,” despite their lack of significant training.

Psychologists who have worked inside the system describe a culture in which the drugs are used to control the disruptive behavior of the developmentally disabled — people with conditions like autism, Down syndrome and cerebral palsy — an approach increasingly discredited in the field.

The problem is that people with mental retardation, because of their condition and diminished intellectual capacity, commonly exhibit symptoms similar to those seen among people who have impulse control, anxiety or attention deficit disorders.

Psychiatrists and psychologists interviewed by The Times said those symptoms were best treated through therapy and one-on-one guidance of the developmentally disabled. But state records indicate that the doctors are often instead treating them with the psychotropic drugs, which do not address their underlying problems and can be harmful.

“It’s a mistake,” said Dr. Andrew Levitas, an associate professor of psychiatry at the University of Medicine and Dentistry of New Jersey who specializes in developmental disabilities. “Using antipsychotics to suppress behavior is an old practice used by people who aren’t acquainted with the advances in the field.”

The Times review found that 4 of the top 10 medications or supplements given to the developmentally disabled in the state are psychotropic, according to Medicaid records. In fact, developmentally disabled residents of group homes in New York are more likely to be given Ativan, an anti-anxiety drug that has a tranquilizing effect, than multivitamins, the records show.

Concern about drug use was one of the most frequently raised issues in inspection records reviewed by The Times; in the last five years, all nine state residential institutions for the developmentally disabled have been repeatedly cited by Health Department inspectors for failing to provide proper oversight of psychotropic drugs.

The drugs can have serious consequences. Risperdal, the second most frequently prescribed, was developed to treat psychotic disorders and has been approved for controlling aggression among people with autism. But its side effects can be extreme, including breast growth in adolescent boys, which in a small number of cases require mastectomies.

And even the use of the drugs to control behavior is questionable. A 2008 study published in the medical journal The Lancet found that psychotropic drugs like Risperdal were less effective at treating behavioral outbursts than placebos.

Dr. Roy Q. Sanders, who is the medical director of the Marcus Autism Center in Atlanta and has worked in New York, said, “I tell people all the time that the medications are really blunt tools when it comes to making substantial differences in behavior in developmentally disabled individuals.”

To be sure, the issue is a complicated one: developmentally disabled people are more likely than the general population to suffer from mental illness.

But the records examined by The Times show that some developmentally disabled residents received psychotropic drugs without ever getting a clear diagnosis of mental illness. Even among those who have a mental illness, the records indicate that the state’s use of the drugs can be overly aggressive.

During the last few months, as The Times has sought information about the state’s use of medications, the Office for People With Developmental Disabilities has acknowledged that there are problems, and began to develop sweeping guidelines for the use of medication. The new rules say medications “shall not be used for disciplinary purposes” or “as a substitute for supervision.”

“We know that less intrusive techniques work,” said Courtney Burke, commissioner of the Office for People With Developmental Disabilities, which oversees thousands of group homes and larger state facilities.

Ms. Burke said her agency was developing software to track the use of psychotropic drugs better and was creating a position, a chief of pharmacy, to oversee how drugs are used. New regulations, she added, would “help move the system to one that does not rely on medication or physical intervention.”

The Clinician’s View

Diana Valitutto, a former state psychologist, said she resigned from the Office for People With Developmental Disabilities in 2004 after concerns she raised about the use of psychotropic medications were ignored.



State law says that “no medication shall be used for the convenience of staff” and that “special attention shall be given to those individuals receiving psychotropic medication.”

But oversight is limited. Although psychotropic drug use is supposed to be regularly reviewed, records show those reviews are seldom rigorous. The bar is higher in Massachusetts, for example, where state officials must have the approval of a judge to use drugs classified as antipsychotic.

“It’s worked well to protect people with mental health and cognitive impairments over the years,” said Marianne Meacham, general counsel at the Department of Developmental Services in Massachusetts. “It’s somewhat burdensome, but it’s definitely an important protection.”

In New York, Ms. Valitutto grew so worried about the overuse of drugs that she went to the Commission on Quality of Care and Advocacy for Persons With Disabilities, a state oversight agency, with examples of residents on what she believed were overly aggressive regimens of psychotropic medications.

“I saw people being medicated to control behavior to such a degree that to me it was obviously and clearly affecting their health, their safety, their quality of life, their ability to participate in the daily activities of living, and in some cases threatened their lives,” Ms. Valitutto said.

Ms. Valitutto said there was little consistency in how drugs were used: In central New York, she said, they were dispensed carefully and ethically. But that was not the case in the Albany area. A retired state psychologist who was approached independently by The Times vouched for Ms. Valitutto’s professionalism and offered a similar account, saying the residents in that region were often treated with multiple medications from the same class, a practice discouraged by the medical establishment.

“We would always go to drugs,” the psychologist said. “Once you get a client on a lot of medications, it’s hard to know what’s working and what’s not, and it’s hard to get them off.”

The commission, which declined to comment, never took any action on the concerns brought forward by Ms. Valitutto, and she resigned.

A Chronic Problem

Every year, the State Health Department inspects New York’s nine large residential facilities for the developmentally disabled. A review of 2,000 pages of inspection records found repeated violations of basic protocol for drug treatment at all of them.

A resident at Bernard Fineson, a state institution in Queens that is perennially cited for violating drug administration policies, was on a drug diet of Risperdal, Ativan and the antiseizure medication Depakote, but inspectors wrote that “there is no evidence of a team review regarding justification for the current medication regime.” A resident at a Hudson Valley institution was on seven psychotropic drugs, along with Benadryl; inspectors worried that “there was no process evident that evaluated the risks of the untreated behaviors against the risks of the medication.”

At an institution in Broome County, inspectors reviewing the records of several patients could not even figure out what behavioral problems were being treated with drugs like Depakote, lithium, Thorazine and Zoloft.

The nonprofit facilities overseen by the state are not much better.

During a recent six-year period, Living Resources, a nonprofit organization in Albany that cares for about 300 people, was cited for 11 violations related to misusing drugs to control inappropriate behavior. That is the most of any nonprofit provider in the state in that period of time, according to inspection data analyzed by The Times.

“We have a lot of people that we care about and care for,” said Fredrick W. Erlich, the Living Resources chief executive officer, adding, “We are going to make mistakes.”

In search of alternative approaches, state officials are now studying the practices of the ARC of Delaware County, a small nonprofit group serving the developmentally disabled in the Catskills. The group has a policy banning what they call “pharmacological restraints,” or the use of drugs for reasons beyond treating medical problems.

“We’re not antimedication, but we believe people need the least amount to take the edge off so they can be available for teaching, and ultimately as they learn, those medications get reduced and eliminated,” said George Suess, chief executive of the ARC of Delaware County. He added that his residents “are functioning, they are learning, they are not zombied out, sitting in a corner like vegetables.”

A Sister’s Keeper

Taraneh Vargha’s sister was on so many psychotropic medications at her group home in the Finger Lakes region that her hands would shake, her body temperature fluctuated, her heart raced and her chest ached. She had tardive dyskinesia, a disorder characterized by involuntary repetitive movements that is common among people on high dosages of antipsychotic medications.

The sisters are both Iranian-born American citizens and members of the Bahai faith, whose members have been persecuted in Iran since the Islamic Revolution in 1979. Ms. Vargha’s sister received a number of shifting diagnoses over the years, including autism-related disorders, mild mental retardation, post-traumatic stress, bipolar disorder and schizophrenia.

At the same time, state officials conceded in records obtained by The Times that they did not really know what her diagnosis was; assessing her has been complicated by the fact that Ms. Vargha’s sister is far more fluent in Persian than English.

Despite confusion about her diagnoses, there has been clear concern expressed in state records about the volume of drugs she was being given. None was more prevalent than Geodon, an antipsychotic made by Pfizer. Ms. Vargha protested after her sister, 47, was given as much as 360 milligrams per day; the maximum dosage recommended by the Food and Drug Administration is 160 milligrams.

In a statement, Easter Seals, which operates a clinic that prescribed the medication to Ms. Vargha’s sister, said the choice to provide such a high amount of Geodon was “not uncommon” and done “with close monitoring.” It added, “We do not believe the dosage prescribed was a mistake, but that it was done consistent with appropriate protocols.”

The Times asked Dr. Levitas about such a dosage.

“It is not only not accepted, it is dangerous,” he said, adding, “I’ve never seen Geodon used at that dose before.”

The Office for People With Developmental Disabilities reviewed the case after being approached by The Times and is referring it to the Commission on Quality of Care. “What we have found,” the office said, “is sufficiently concerning that we have determined an independent, external review is necessary.”

Records obtained by The Times show state officials expressing alarm, even if they took little action.

“The Geodon is well above (i.e. 3x above) the typical upper level for this med. This is of great concern,” says a report in August 2008, drafted by an oversight committee in the Finger Lakes division of the Office for People With Developmental Disabilities. “This is a very large dose of Geodon,” said another report from September of that year. And yet it continued. A review by the Health Department said the Geodon dosage in 2009 was “excessive and much above the F.D.A.’s limits.”

Geodon dosages were drawing scrutiny from federal prosecutors at the same time. In 2009, Pfizer paid $301 million to settle allegations by the Justice Department that company representatives marketed the drug for unapproved uses and encouraged doctors “to prescribe the drug at substantially higher than approved dosages.”

Like all psychotropic medications, Geodon has potential side effects, like anxiety and weight gain, and far more serious risks, including vision problems. And Ms. Vargha’s sister was also taking four other psychotropic drugs, each with its own potentially damaging consequences.

Ms. Vargha fought for years before her sister’s dosages were reduced. “Why on earth would we give psychotropic medications to a population that is already vulnerable and struggling to use their brain?” she wrote in a letter to the state this year. “Why do we want to numb and dumb them more?”

Three months ago, increasingly desperate, Ms. Vargha, 56, removed her sister from the group home, and took her to her house.

When a reporter visited Ms. Vargha’s home recently, her sister was disoriented and briefly mistook the reporter for an Iranian policeman. At night, she walks the hallways, speaking Persian.

“She’s getting better, she’s eating now a bit, but she doesn’t sleep,” Ms. Vargha said. She hopes to get her sister back on her feet soon and move her into a group apartment in Rochester — where she hopes her sister can regain some sense of herself.

“My sister came with so much hope to this country, America, the land of freedom,” she said. “When she became a citizen, she put both arms up and said, ‘I love this country.’ ”

She added, “I want her to experience what she believed in.”