MARIA Santana and her family are raging mad.
They’re angry because yesterday their worst nightmare was confirmed by the city’s medical examiner.
Maria’s brother, Joseph Santana, a physically healthy mental patient at the state-run Bronx Psychiatric Center, died during an experiment that subsequently exposed him to a deadly cocktail of anti-psychotic drugs.
Those drugs – which include a mysterious experimental drug called “M.100907” – triggered seizures that subsequently suffocated his brain.
“I’m just so damn angry … I knew it was the drugs that killed him,” said Santana, 40, breaking down in tears.
“As doctors they should’ve known what the side effects are before they give drugs to anyone … We want to make sure this doesn’t happen to anyone again.
Santana died after he was given M.100907 for several days and then taken off the drug because he went into a seizure.
His doctor, Nigel Bark, who heads research, took him off M.100907 and put him on Olanzapine – an anti-psychotic drug – and Ativan, a muscle relaxer.
“He died as a consequence of the medication he was given,” which prevented oxygen from getting to his brain, the medical examiner’s spokeswoman, Ellen Borakove, said.
Roger Klingman, spokesman for the state Office of Mental Health, which runs the Bronx Psychiatric Center, claims all federal and state guidelines were followed.
When informed of the medical examiner’s finding, he said, “We are in the midst of a review of this case, and we can’t comment further at this point.”
Joseph Santana’s Oct. 13 death is becoming the battle cry for city mental-health advocates who for years complained of the not-so-kosher practices of researchers.
The advocates now believe they have their proof. For once they have: a dead body; a critical medical examiner’s report; hospital and government officials ducking for cover; and a grieving family looking for blood.
“People have died in experiments, but they [researchers] say it was not related to the experiment,” said Cliff Zucker, a lawyer for Disabilities Advocates Inc. a non-profit advocacy group investigating the death.
Joseph Santana – a mental patient since 1986 – enrolled in the experiment in early October. It vexed Maria Santana because she thought her brother was not mentally able to make such a decision.
That’s problem No. 1.
“What is known so far raises a lot of red flags and requires an investigation into whether or not Santana was capable of giving informed consent to this research, and was he adequately informed of the risk,” Zucker said.
The risks? When I called the state and federal government I couldn’t even find out what the side effects of M.100907 are.
The U.S. Food and Drug Administration, which is supposed to monitor the experiment, couldn’t talk about it yesterday.
Klingman said the consent procedure was followed.
Santana’s seizure occurred after he took M.100907 for several days. He was rushed to Jacobi Medical Center.
Bark – who I’m told is very respected in his field – kept his promise when he told the family he wasn’t going to give Joseph Santana M.100907 again.
So he prescribed Olanzapine and Ativan instead.
Problem No. 2:
Mental patients should undergo a wash-out – a cold-turkey process that gets the old drug out of the system – before the new one goes in.
Depending on the drug, a proper wash-out could take one to two weeks.
Given that the second seizure occurred only a week after the first one, it seems unclear whether the procedure was followed properly.
“They were just pulling him on and off drugs not taking into consideration his medical needs.” said Vera Hassner-Sharav, who heads Citizens for Responsible Care and Research.
Problem No. 3:
State regulations require researchers to inform immediate-family members if their loved one’s medication – experimental or not – is being changed, Klingman said.
The Santana family not only didn’t know Joseph Santana was about to take M.100907 “they didn’t even tell us he was on the Olanzapine,” Maria Santana claimed, struggling to pronounce the word.
Klingman said he thought Santana’s family was informed.
“This demonstrates how patients in state-run hospitals are in danger, and their families are not being told what their relatives are being used for,” Hassner-Sharav said.
The medical-research community – by law – has the right to protect the privacy of patients, including those involved in experiments.
But they sometimes abuse this privacy privilege when things go bad.
Now that the Santana case is out in the open, they should come clean, or better yet, just clean up their act.