In Treating Disabled, Potent Drugs and Few Rules
Autor: ALECXANDRA ITO | Publicado: 2011-12-26T12:20:00-02:00

December 22, 2011From New York TimesBy DANNY HAKIMSomething was happening to Katie Strignano.        
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.        
While she said she believed drugs were justified at times, she added,  “from my experience, they don’t make genuine permanent changes in  behavior, they simply control the client for the time being.”        
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.’&nbsp;”        
She added, “I want her to experience what she believed in.”        
 Russ Buettner contributed reporting.