Illness adds to indignity for unwitting trial subject
When Bertram Corbin was in the hospital last spring, his sister got some upsetting news: Corbin -- a childlike man who had spent much of his life in psychiatric hospitals -- had contracted a rare form of cancer.
His life unspooled in front of her: The clever, quiet boy who grew up with six siblings in Mission Hill; the mental illness that overcame him with such violence at 13 that his father once had to tie him to a chair with rope; and the years at Medfield State Hospital, when she would bring him hot dogs and hambugers, stone-cold and wrapped in foil, and he would look as happy as she had ever seen him.
Now, the doctor told her, he might be dying of lung cancer.
Only last week did Tanya Jackson learn that the cancer diagnosis was only one part of what was wrong with her younger brother last spring. According to a state investigation, his doctor at the Solomon Carter Fuller Mental Health Center, a state psychiatric facility in the South End, had switched his antipsychotic medication -- not for medical reasons, but so that he would be eligible for a clinical trial sponsored by a drug company. What some doctors attributed to cancer symptoms was in fact a potentially lethal reaction to the new medication, according to a report by the Disabled Persons Protection Commission.
The report, made public by the Globe last week, described what it called a series of ethical violations that took place at Fuller, where four patients underwent medication changes in anticipation of the drug trial and one became dangerously ill. Although the patients' names were blacked out in the report, Bertram Corbin's legal guardian, attorney Leon Drysdale, acknowledged that he was the patient who became sick.
And Jackson, reading the newspaper account, learned only then that her brother had been ushered into a clinical trial. She had spoken to his doctors three times since the medication change and not once did they mention the sickness that had resulted from it.
"When you go to a doctor, you put your trust in what they say, and what they're going to do for you," said Jackson, 48, a property manager in Wilmington, Del. "Your average person doesn't understand medical lingo. You expect them to do the right thing for you and your loved ones."
Representatives of the Department of Mental Health and Boston Medical Center, whose doctors staff Fuller, would not comment on Corbin's care. Both doctors named in the commission's report are planning to appeal investigators' findings, said BMC spokeswoman Ellen Berlin. The Department of Mental Health suspended the clinical study in February, after Corbin's illness came to light.
In a community fueled by scientific research, medical professionals last week expressed shock at the breakdown of the structures that protect people from being used as experimental subjects. But Jackson and other family members were focused on a flesh-and-blood patient -- a 43-year-old man still known by his childhood nickname, Bertie.
Bertram Corbin grew up about a mile from some of the facilities where he was treated, but a world apart. His relatives had no name for the illness that came over him, as suddenly as a blow to the head, when he was 13: His grandmother went to her grave believing that someone had slipped him a drug, said his great-aunt, Virginia Nichols, who is 82. As far as his siblings knew, he disappeared from the house because of discipline problems, said Jackson.
"It wasn't something that was understood," she said. "To us [his behavior] was more being disobedient."
In fact, while his grandmother prayed over him at the Baptist church, he was at McLean Hospital in Belmont. Diagnosed with schizophrenia and mild retardation, Corbin needed assistance with everyday tasks like taking a shower and getting dressed. At Medfield State Hospital, where he moved in 1992, he improved vastly on the antipsychotic Clozaril, acquaintances said.
Still, he was not capable of making decisions about his medical care, said Edith Greene, who was his guardian for the decade he spent at Medfield.
"If you said to Bert, `Do you want to take the pink pill or the purple pill?' he would just say, `Yeah,' " Greene said.
When staff at the Fuller asked him what he was there for, Corbin gave an answer that spoke volumes about his mental state, according to the Disabled Persons Protection Commission report: He said he had been sent there "to watch television."
When Medfield closed, Corbin was moved to a different kind of facility. The Solomon Carter Fuller Mental Health Center, which houses some of the state's most chronically mentally ill patients, sits in the heart of an academic community. A clinical trial promised to bring prestige to the hospital, making it "more attractive" to medical residents, its medical director later told investigators.
A year ago, Corbin's psychiatrist, Dr. Valentina Jalynytchev, sat him down and asked if he wanted to change medications.
The trial she was helping set up was relatively straightforward: Janssen Pharmaceutica had asked investigators, among them Boston Medical Center's chief of psychiatry, Dr. Domenic Ciraulo, to test the company's guidebook for switching patients from oral Risperdal to Consta, the company's long-acting injectible form of the same drug. To be eligible, subjects needed to be stable on Risperdal.
Even though Corbin had been successfully treated for a decade with a different drug, Jalynytchev began looking at him as a potential test subject, according to the commission's report. On Oct. 31, 2002, Jalynytchev carefully wrote down the results of her conversation with him: "Pt. was discussed about concerning clinical trial of risperidone (Consta-long acting injectible form. He was explained risk and benefit of this medication." Although she noted that enrolling Corbin in the study would require a call to Greene, the doctor never made that call. Five days later, she began switching his medication.
Reached by phone this week, Jalynytchev said she could not comment on Corbin's case because of patient confidentiality rules.
Near the end of January, the quiet, cooperative patient began to change: Feverish, he was spitting into a water fountain, and so confused that "he had to be redirected three times to put his pants on correctly." He picked up a table and tried to throw it at staff. He was sent to BMC's emergency room, where a doctor diagnosed him with neuroleptic malignant syndrome, a dangerous side-effect of medication changes. Its first signs are fever and changes in mental status, and it progresses to a temperature so elevated it can cause irreversible brain damage.
Over the course of the next three months, Corbin was so sensitive to medications that antipsychotics were discontinued and doctors prescribed electroconvulsive therapy to manage his psychosis. At Carney Hospital, a doctor wrote that he was "urinating in bed and defecating in his room," according to the commission's report. One medical professional who cared for him during that period, who spoke on condition of anonymity, said he was restrained physically or chemically for most of a two-week hospital stay.
"All the patients in the hospital were really fond of him, but when I saw him, he was really behaving like a monster," the person said. "There was a serious change in his personality."
Meanwhile, the people connected with Corbin -- his family members, his guardian, and his court-appointed lawyer -- had been told nothing about the Janssen trial, the medication change or the neuroleptic malignant syndrome, or NMS, that resulted from it. It was February, three months after his medication had been changed, by the time Greene got a call from a physician who said her ward was suffering from NMS.
"I was surprised and I was angry," she said. "I was kind of dumbfounded."
But no one feels more betrayed than Tanya Jackson, who keeps going over the conversations she had with her brother's caregivers this year. They were sometimes technical, and sometimes casual, talking about psychiatric medication "like it was aspirin," Jackson said. In the spring, a caregiver called her with the frightening news that he might have cancer of the lung sac -- a diagnosis that may still prove correct.
But at no point did anyone explain that her brother had become a test subject, Jackson said.
"It's frightening to think that somebody -- a doctor -- would abuse another life in that way," she said.
Jackson, along with Corbin's legal guardian, is planning to pursue a malpractice claim against her brother's caregivers.
Back at Fuller, Corbin has been reintroduced to antipsychotics and improved with electroconvulsive therapy, according to the commission's report. Jackson said her brother sounded normal when she spoke to him on the telephone last week, asking her for "hot dogs and hamburgers."
Sources at the hospital disagreed about whether he has been permanently harmed, and one person who works with him regularly said he has returned to the baseline stability he had achieved before the medication change. After the Globe published details of the switch, though, hospital employees contacted the paper to complain that the medication changes undermined patients' confidence that their doctors have their best interest in mind.
"Half of our work is skill," said one Fuller staff member, who spoke on condition of anonymity. "The other half is the trust that patients put in you."
Ellen Barry can be reached at barry@globe.com.
