From Alliance For Human Research Protection

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ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

FYI

Today's column, "A Mix of Medicines That Can Be Lethal," by Jane Brody in
The New York Times should be posted in every doctor's waiting room and in
every hospital emergency room. It should have been published on the front
page .

Brody focuses on the alarming increase in patients presenting at hospital
emergency rooms with Serotonin Syndrome, a potentially lethal form of drug
poisoning mostly triggered by antidepressants --in particular the "selective
serotonin reuptake inhibitors" (SSRIs):

"Now, with the enormous rise in the use of serotonin-enhancing
antidepressants, often taken in combination with other drugs that also raise
serotonin levels, emergency medicine specialists are trying to educate
doctors and patients about this not-so-rare and potentially life-threatening
disorder. In March 2005, two such specialists, Dr. Edward W. Boyer and Dr.
Michael Shannon of Children's Hospital Boston, noted that more than 85
percent of doctors were "unaware of the serotonin syndrome as a clinical
diagnosis."

"Although serotonin poisoning can be caused by an antidepressant overdose,
it more often results from a combination of an S.S.R.I. or MAOI with another
serotonin-raising substance. Patients at particular risk, some experts say,
are those taking combinations of antidepressant and antipsychotic drugs
sometimes prescribed to treat resistant depression . All it may take is a
small dose of another serotonin-inducing drug to cause the syndrome."

"Serotonin syndrome can occur at any age, including in the elderly, in
newborns and even in dogs. Since 1998, the poison control center at the
American Society for the Prevention of Cruelty to Animals has gotten more
than a thousand reports of the ingestion of antidepressant medications by
dogs, which can develop symptoms rapidly and die. The syndrome can also
occur weeks after a serotonin-raising drug has been discontinued. Some drugs
remain active in the body for weeks"

Brody's column begins with 18-year old Libby Zion who died as a result of
maltreatment by doctors at New York-Cornell Medical Center in 1984. The
doctors failed to recognize the signs of serotonin syndrome from her
prescribed antidepressant, Nardill; they prescribed a narcotic (Demerol)
which raised the level of circulating serotonin to dangerous levels; their
coup de grace was the use of restraints: "When she became agitated, a
symptom of serotonin toxicity, and tried to pull out her intravenous tubes,
she was restrained, and the resulting muscular tension is believed to have
sent her fever soaring to lethal heights."

Libby Zion's case became a cause celebre because her father, Sidney Zion, a
reporter for The Times, sued the hospital.

Twenty-three years later, four-year old Rebecca Riley was a catastrophic
casualty of psychiatry's irresponsible prescribing practices.
Psychiatry's dependence on drug industry financial rewards and
psychiatrists' reliance on drug sales reps for information about the drugs
they prescribe has led to irresponsible, even abusive prescribing practice.
It is not an overstatement to say that psychiatrists are probably the least
knowledgeable medical doctors who are indiscriminately prescribing toxic
drugs and lethal drug combinations. Neither young or old are safe.

After Rebecca died, investigators discovered that her two siblings, ages 6
and 11, were prescribed the same toxic 3 drug cocktail—and the parents were
on psychiatric drugs as well. Whatever other abuse may have occurred, the
drugs prescribed for this family was a set up for tragedy--the youngest, the
most vulnerable, was the direct casualty of current prescribing practices by
US psychiatry.

Dr Lawrence Diller, a behavioral-developmental pediatrician, and author of
"The Last Normal Child," and "A Prescription for Disaster," called the
extensive prescription of psychotropic medications for children," a hidden
time bomb that could explode with still more casualties."

"Catastrophic side effects may be rare, but they become predictable when we
treat so many children with so many drugs."


Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org



http://www.nytimes.com/2007/02/27/healt ... 0&en=80b0d
e431a079486&ei=5089&partner=rssyahoo&emc=rss
THE NEW YORK TIMES
February 27, 2007
Personal Health
A Mix of Medicines That Can Be Lethal

By JANE E. BRODY

The death of Libby Zion, an 18-year-old college student, in a New York
hospital on March 5, 1984, led to a highly publicized court battle and
created a cause célèbre over the lack of supervision of inexperienced and
overworked young doctors. But only much later did experts zero in on the
preventable disorder that apparently led to Ms. Zion's death: a form of drug
poisoning called serotonin syndrome.

Ms. Zion, who went to the hospital with a fever of 103.5, had been taking a
prescribed antidepressant, phenelzine (Nardil). The combination of
phenelzine and the narcotic painkiller meperidine (Demerol) given to her at
the hospital could raise the level of circulating serotonin to dangerous
levels. When she became agitated, a symptom of serotonin toxicity, and tried
to pull out her intravenous tubes, she was restrained, and the resulting
muscular tension is believed to have sent

[admin]

What Killed Rebecca Riley?

Sept. 30, 2007
--------------------------------------------------------------------------------
(CBS) On Dec. 13, 2006, police responded to a 911 call and found a
little girl lying dead on the floor next to her parents' bed. The
autopsy revealed that she had died from an overdose of psychiatric
drugs. Rebecca Riley was being treated for bipolar disorder, or manic
depression, even though she was just four years old.

If that sounds unusual to you, it's not. As Katie Couric reports,
until recently the disorder was believed to emerge only in adults.
Now, it is estimated that there are nearly one million children
diagnosed as bipolar, making it more common than autism and diabetes
combined. And to treat it, doctors are administering some medications
that have yet to be approved for children. In the case of Rebecca
Riley, that cocktail of medications proved fatal and now her parents
have been charged with her murder.


--------------------------------------------------------------------------------

Carolyn Riley is now in jail in Boston awaiting trial and is being
medicated for depression. She told 60 Minutes her daughter's problems
began when Rebecca was only two years old. Carolyn took her to a
psychiatrist because she had difficulty sleeping and seemed
hyperactive.

"Constantly getting into things, running around, not being able to
settle down," Riley remembers.

"Did you ever think, 'Well, she's two and a half years old.' There's
this thing called the terrible 2's. Did you think this could, in fact,
be normal?" Couric asks.

"Yes," Riley tells Couric. "The psychiatrist said that she thought
that it was more than just normal."

The toddler who could barely speak in full sentences was diagnosed
with bipolar disorder after several sessions over eight months. She
had just turned 3. And she wasn't the only one in the family: her
ten-year-old brother and four-year-old sister were already being
treated for the same illness by the same doctor at Tufts-New England
Medical Center. Rebecca was eventually prescribed three medications to
stabilize her mood: Seroquel, an anti psychotic; Depakote, an anti
seizure drug; and Clonidine, a blood pressure medication --
medications that would ultimately prove fatal on Dec. 13th.

Riley says she thought Rebecca had just a little bit of a cold and
gave her daughter "Children's Tylenol Plus Cough & Runny Nose."

In the middle of the night, Riley remembers her daughter didn't want
to go to sleep. "So I brought her in the room. She was right beside me
on the floor. And I laid down and went to sleep," she recalls.

Before she put her to bed that night, next to her on the floor, Riley
says she gave her daughter half a Clonidine.

Asked why, Riley tells Couric, "Because she hadn't been able to get to
sleep since six o'clock."

"Then what happened?" Couric asks.

"Then I woke up to the alarm in the morning. And knelt down to wake
her up. And there was no waking her up," Riley replies.

Riley says she knew at that point that her daughter had died. Carolyn
Riley and her husband Michael were charged with first-degree murder.

The prosecutor alleged at their arraignment in February that they were
overdosing Rebecca by repeatedly giving her more medication than she
was prescribed. "It was used on Rebecca, her sister and her brother
for one simple purpose by these defendants: to knock them out and make
them sleep," the prosecutor claimed.

But the Rileys claim that they were following doctor's orders. 60
Minutes wanted to talk to the psychiatrist, Dr. Kayoko Kifuji, but she
declined. Instead 60 Minutes got a statement from her hospital: "The
care we provided was appropriate and within responsible professional
standards."

60 Minutes did obtain a copy of Rebecca's medical records. In them,
Dr. Kifuji notes Rebecca's increased risk of mental illness because of
her family history. She diagnosed Rebecca after Carolyn said her
daughter was - quote - "driving me crazy" and her mood switches within
a minute. She would eventually prescribe the preschooler more than ten
pills a day.

Riley says she did feel that that was a lot of pills for a little
girl, but she says she went ahead and gave Rebecca the prescriptions.
"I trusted the doctor," she says.

Dr. Kifuji has stopped practicing, pending a ruling by the state
medical board. But her lawyer has said she was just practicing
mainstream psychiatry. It's now estimated that nearly one million
children like Rebecca Riley have been diagnosed with bipolar disorder,
or manic depression. And while some psychiatrists told 60 Minutes that
early diagnosis is saving lives, a growing number of doctors say it is
being over-diagnosed.

60 Minutes went to talk to one of the leading proponents of the
diagnosis of bipolar disorder in children and whose research Dr.
Kifuji has said influenced her. He is Dr. Joseph Biederman, professor
at Harvard and head of child psychopharmacology at Mass General
Hospital.

"Previous studies that were conducted in the '70s and '80s determined
it was very, very rare for a child to have bipolar disorder. And now
you're saying up to a million children are running around with this,"
Couric remarks. "Why such a sea change?"

"The idea is rare if you define it in very strict ways," Dr. Biederman
explains. "Our contribution has been to describe the many ways that
this condition may emerge in children that may make it a little bit
more diagnosable and less rare than people have thought about it."

The classic adult definition for manic depression or bipolar disorder
is dramatic mood swings from severe highs to severe lows, which can
last for weeks or months. Dr. Biederman's definition for children,
though, is much broader. It emphasizes extreme irritability and at
least four other symptoms such as recklessness, sleeplessness and
hyperactivity. And while most doctors now believe that a child can be
bipolar, there is no definitive medical test.

Now there's a cottage industry of bestselling books, magazine covers
and Internet sites where you can test your child online. But even the
top researchers can not agree on exactly what bipolar disorder looks
like in children or at what age it can be diagnosed.

"The average age of onset is about four," Biederman says. "It's
solidly in the preschool years."

"What about those who say, 'Oh, come on Dr. Biederman, a preschooler
displaying these characteristics is often acting like a preschooler,'"
Couric asks.

"Absolutely not," Biederman says. "The bar to consider a diagnosis in
a very young child is very high."

Asked if he worries that his work is being used or applied too broadly
and that too many children are being diagnosed as a result, Biederman
tells Couric, "I am not so concerned if a practitioner recognizes that
the symptoms have to be severe, debilitating, devastating, to consider
the diagnosis."

Rhys Hampton was three years old when he began to have violent and
explosive outbursts. After a year of treatment, his mother, Diana,
says a psychiatrist told her he thought Rhys was bipolar.

"Would you describe his behavior as behavior that is extraordinary,
severe, dangerous, and effects every, single aspect of his life?"
Couric asks.

"Yeah. Every single aspect of his life," Hampton says.

"Bipolar disorder is also described as manic depression. Did he ever
get depressed? Did he ever get sad?" Couric asks.

"He would tell us, you know, 'You don't love me.' 'You don't like me.'
'I don't like myself.' 'I hate myself.' 'I'm stupid.' 'Nobody likes
me.' 'I wanna die.' Four-year-olds don't talk like that," Hampton
says.

After Rhys' psychiatrist suggested a fourth medication, the Hamptons
said "Enough."

They took their son to Seattle Children's Hospital, where they were
told Rhys wasn't bipolar. He now takes medication for hyperactivity
and a sleep disorder. And he's learning to deal with his explosive
moods through a behavioral program.

"I mean, there's no comparison to the child that we're parenting
today, as opposed to the one that we had last year," Hampton says.

Dr. John McClellan, who's familiar with Rhys' case, says the
children's psychiatric hospital he runs in Washington state is filled
with kids who have been misdiagnosed as bipolar. He says it has become
a catchall for aggressive and troubled children.

"I think it's a problem to label kids with a major adult psychiatric
disorder when they're five years old or when they're three years old,"
Dr. McClellan says. "Little kids are not adults. And little kids do
things that if an adult did them, it would be evidence of a mental
health problem."

"Having said that, if someone is bipolar and it presents later in
life, doesn't it make sense that these issues exist really from
birth?" Couric asks.

"No, that does make sense," McClellan says. "The problem is symptoms
like irritability or recklessness or high energy when you're an
eight-year-old don't necessarily predict in the long run developing
bipolar disorder. Some might. Do you expose all those kids to
medications to prevent the one kid that's going to get it?"

"Not that I don't use medicines, I do but the average kid comes into
my hospital now on four different medicines. We had one kid that was
recently admitted to our in-patient program that was on 12
psychotropic agents. At some level, there needs to be something else
that's used besides just continuing to add medication after
medication," McClellan says.

Dr. McClellan says we don't really know how these drugs interact or
effect developing brains because most are being used off-label, which
means they haven't been approved by the FDA for use in children.

"Does it disturb you or worry you that many of these medications, most
of these medications are being used off-label, and have not been
tested in children?" Couric asks Biederman.

"Yes. I recognize the fact that we have a gap in knowledge," Biederman
says. "But the patients that come to me, and the families in tears and
despair with these type of problems, I in good faith cannot tell them,
'Come back in ten years until we have all the data in hand.' I still
need to use medicines that I am assuming that if they work in adults,
with appropriate care and supervision, may also work in children."

Many parents told 60 Minutes their children are so out of control and
disruptive, medication is the only option. A parent who took her
children to Biederman's Mass General clinic, Maria Lamb says she
depends on medication for eight-year-old Annie and nine-year-old
Casey, who his mother says would rage for hours when he was just two
years old. Casey was recently admitted to a psychiatric hospital when
he was taken off one of his medications.

"I don't think they would be able to function. I wish they could. It
was a last resort, seeing the kind of rages they would have,
destroying their room, kicking the door off the hinges," Lamb says.

But during one recent visit, Maria's worried that Annie is eating
incessantly. Dr. Biederman's partner Dr. Janet Wozniak says it could
be a side effect from one of Annie's three medications and suggests
another medicine may help.

"Actually its most common usage has been to help people with alcohol
addictions resist alcohol. But it seems to also have an effect on food
cravings," Dr. Wozniak remarked.

One of the biggest problems with these medications is side effects,
including major weight gain, hand tremors, shakes, drooling and muscle
spasms. And side effects are at the heart of the Rebecca Riley case.

Carolyn Riley tells Couric she never observed any sluggish or
lethargic behavior in her daughter.

"This is what her preschool teacher said. She was like a floppy doll.
So tired, she had to be helped off the bus. She had a tremor and had
to go to the bathroom almost constantly. So how could she have these
side effects at school, and yet, you never observed them at home?"
Couric asks.

"I don't know," Riley replies. "She never acted like that at home at all."

But the prosecutor is charging the Rileys with murder because, he
says, they ignored the warning signs and instead just kept giving
Rebecca more pills than she was prescribed, even in the last few days
of her life. And key to the case: 200 additional pills Carolyn Riley
got from the pharmacy. She insists she was only replacing pills that
were lost or damaged.

"For those who see you as somebody, who just wanted her kids to be
less annoying and bothersome, who gave them too many pills because she
couldn't deal with it, you would say?" Couric asks.

"I don't know. They weren't annoying. They were my life," she says.

"According to the medical examiner, her heart and lungs were damaged,
and this was due to prolonged abuse of these prescription drugs,
rather than one incident. Prolonged abuse of these prescription
drugs," Couric remarks.

"Yes. And the doctor had Rebecca on .35 milligrams, daily, for months.
And I didn't know anything about dosages. How much was fatal," Riley
says.

The medical examiner ruled that Rebecca died of a drug overdose from a
mix of medications. And that the amount of Clonidine alone would have
been fatal.

Today, awaiting trial, Carolyn Riley says she now knows more about
bipolar disorder than she ever did when her daughter was alive.

Asked if she thinks Rebecca was really bipolar, Riley says, "Probably not."

"What do you think was wrong with her, now?" Couric asks.

"I don't know," she says. "Maybe she was just hyper for her age."



Produced By Kyra Darnton
(c) MMVII, CBS Interactive Inc. All Rights Reserved.