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Roche puts Accutane profits over
Lives of Consumers
August 31, 2006. By Evelyn Pringle
In 1985, Accutane's package insert directed at doctors
first mentioned reports of depression in patients taking
the acne drug, which means that more than 20 years ago,
Hoffman-LaRoche at least suspected there might be a
risk of depression and suicide by persons taking the
drug.
However, Roche's financial records show
that the company is not about to let a little thing
like the death of its customers get in the way of corporate
profits, because the drug is still a best seller and
young people with no history of depression who take
it are still killing themselves.
On November 14, 2004, BBC News reported
that Jon Medland, 22, in the final year of medical school
at Manchester University, hanged himself at his student
lodgings on January 13, 2004 while on Accutane.
When questioned about the incident, Roche
told BBC News that the drug carried a warning of possible
mood changes and depression, but said "no causal
link had been established between the drug and either
depression or suicide."
Less than a year later, in September 2005,
BBC News reported that David Roberts, 21, had been on
the drug for two months when he hanged himself near
his Liverpool home.
And once again, according to BBC News,
"Roche insists there is no proven relationship
between the drug and depression."
However, David's father, Fred Roberts,
said he could think of no other explanation for the
tragedy. "David was the most happy-go-lucky, carefree
lad you could ever hope to meet. He had plenty of friends,
he enjoyed going out, he had a happy family life."
"His acne wasn't severe at all. He
had a few spots and, like any young person, he wanted
to get rid of them."
"The change in him was so sudden,"
Mr Roberts said, "there's no other reason for it
than the effect of this drug."
On January 15, 2006, 15-year-old Justin
Zimmer, of Menasha, Wisconsin, shot himself and his
parents blame Accutane.
Justin's parents and a friend told the
Appleton Post Crescent on July 18, 2006, that he gave
no indication that he was depressed and that he was
all excited about getting his driver's license in a
couple of weeks.
Roche's comments to the BBC are clearly
dishonest considering that in 1986, doctors were notified
that Accutane users who became depressed saw their depression
lift when they stopped taking the drug but return when
they were placed back on the medication. Doctors were
also informed that simply stopping Accutane therapy
might not be sufficient to treat the depression and
that follow up on the depression might be necessary.
In 1998, the FDA notified doctors that
Accutane, "may cause depression, psychosis, and
rarely, suicidal ideation, suicide attempts and suicide."
The agency issued a MedWatch alert in
February 1998, that said due to the adverse event reports
received, the FDA felt there was sufficient cause to
strengthen the warning on the Accutane label to include
the risk of psychosis and suicidal thoughts and actions.
The February 23, 1998, FDA Memorandum,
"Isotretinoin and Depression: Spontaneous Report
Data," listed 31 cases of suicide, suicide attempt
or suicide ideation associated with Accutane. Of those
cases, 12 were suicides, 9 were male, 2 were female,
and 1 unknown, and the average age was 17. The event
occurred on average, 88 days after the patient started
taking the drug.
The FDA acknowledged in the memorandum
that for "the majority, there was no antecedent
history of depression and the patients were not noted
or known to be depressed in the time period prior to
their suicide."
During a US House Oversight and Investigation
Subcommittee hearing on the Safety Issues Relating to
Accutane, on December 11, 2002, internal documents from
the nation's regulatory agencies were entered into the
record that revealed that public health officials had
been voicing concerns about patients committing suicide
while on Accutane for well over a decade.
For instance, a 1998 memo from the FDA's
medical officer in charge of Accutane states: "Given
all the pieces of evidence available, it is difficult
to avoid the conclusion that Accutane can adversely
affect the adult human brain in clinically significant
ways and that Accutane use is associated with severe
psychiatric disease in some patients."
The memo recommends "active consideration
of removal of Accutane from the market."
But instead of removing the drug from
the market, on February 25, 1998, the FDA required Roche
to add the following bold-face warning to drug's physician
package insert:
"WARNINGS - Psychiatric Disorders:
Accutane may cause depression, psychosis and, rarely,
suicidal ideation, suicide attempts and suicide. Discontinuation
of Accutane therapy may be insufficient; further evaluation
may be necessary. No mechanism of action has been established
for these events."
"ADVERSE REACTIONS - In the postmarketing
period, a number of patients treated with Accutane have
reported depression, psychosis and rarely, suicidal,
ideation, suicide attempts and suicide. Of the patients
reporting depression, some reported that the depression
subsided with discontinuation of therapy and recurred
with reinstitution of therapy."
In perverse twist of logic, in the same
year, Roche began actively marketing Accutane as a treatment
for depression, under the theory that it could help
people who were suffering from depression due to poor
self-image as a result of acne.
On March 5, 1998, Roche received a letter
from the FDA stating that such promotion was false and
misleading, and that Accutane had never been approved
for the treatment of depression, and that in fact, just
the opposite was true. The letter stated in relevant
part:
"Roche ... has not systematically
studied the ability of Accutane to modify or prevent
such illnesses as depression and has presented no basis
for asserting that Accutane is effective in improving
the psychosocial and emotional well-being of such patients.
"This claim is particularly troublesome
in light of information recently presented in a Dear
Doctor letter, that Accutane may cause depression, psychosis,
and rarely, suicidal ideation, suicide attempts and
suicide."
The FDA also instructed Roche to "prominently
disclose information about the psychiatric disorders
described in the warnings section of the revised labeling"
in Accutane advertisements.
In September 1998, the FDA presented an
Advisory Panel with 37 cases of suicide attributed to
Accutane since 1983. However, the number was later changed
to 44 suicides after Roche corrected its calculations.
The Adverse Event Reporting System (AERS)
is a computerized database of post-marketing adverse
events, designed to support the FDA's post-marketing
surveillance program of all approved drugs.
The reports in AERS are evaluated by agency
reviewers in the Center for Drug Evaluation and Research
(CDER) and the Center for Biologics Evaluation and Research
(CBER) to detect safety signals and to monitor drug
safety.
The results of a review of AERS by congressional
staffers working on behalf of Congressman, Bart Stupak
(D-MI), revealed during an October 5, 2000, hearing,
reported 54 more suicides by persons on Accutane after
the FDA issued its MedWatch in 1998.
In 2004, the Alliance for Human Research
Protection, asked Keith Altman, an Adverse Drug Reaction
Statistics Analyst, to analyze the FDA's Medwatch database
for drug-linked suicides by children under the age of
18. The analysis found that between 1989 and June 2003,
there were 216 reports of drug-linked suicides, and
72 were associated with Accutane.
The Alliance points out that MedWatch
reflects approximately 1% of actual adverse events,
so 72 Accutane suicide reports could represent as many
as 7,200 suicides.
Congressman Bart Stupak, lost his son,
BJ, to suicide on Mother's Day, May 14, 2000, at the
age of 17, from a self-inflicted gunshot wound and BJ
was on Accutane at the time of his death.
On December 11, 2002, Rep Stupak told
the audience at the Safety Issues Surrounding Accutane
Hearing that, "Anyone who knew BJ could not understand
why a young man with such an outgoing personality and
bright future would end his own life."
"BJ taking his own life," Rep
Stupak said, "is contrary to everything he believed
in!"
After his suicide, BJ's mother, Laurie,
checked out Accutane on the Internet and found many
adverse events associated with the drug that they was
never told about.
But the most disturbing find she said,
was the February 1998 MedWatch stating, "The FDA
is advising consumers and health care providers of new
safety information regarding the prescription anti-acne
drug Accutane (isotretinoin) and isolated reports of
depression, psychosis, and rarely suicidal thoughts
and actions."
"After we found the MedWatch,"
Rep Stupak said, "I wondered why the FDA put out
this warning, 18 years after the drug was approved?"
"More important," he continued,
"why weren't these warnings on BJ's Accutane package
which had been revised 4 months after the MedWatch was
issued?"
Two other couples testified at the hearing
about their sons who had no history of depression, but
yet committed suicide while taking Accutane. The spontaneity
of the suicides became the center piece of discussion
between committee members and witnesses during the hearing.
Susan and Martin Turney from Watertown,
New York testified about their 16-year-old son, Matthew,
who took his own life on March 14, 2001, and was on
Accutane at the time of his death.
In retracing the days leading up to Matt's
death, nothing indicated that anything was wrong. The
night before the suicide, everything was normal his
parents recalled. The family had a nice dinner together,
talked about the day's events and joked and laughed
with each other like always.
The next morning, Matt got up for school
as usual. Before leaving to catch the bus, he looked
at his father, smiled and said "Good Bye,"
and yelled, "Good Bye Mom. I love you," to
his mother who was in another room, just like he did
every morning.
By all accounts, Matt was fine at school
that day. He talked to his guidance counselor about
a program she had recommended for the next year. He
asked a girl to a dance and she agreed to go. He took
a couple of tests and did well.
On the bus ride home, Matt sat with his
friends and laughed and fooled around just like any
other day. He got off the bus and stopped to pick up
the newspaper and mail as usual. He took off his shoes
in the entryway, placed the mail and newspaper on the
kitchen counter as he always did, and went into his
room and hung up his coat.
His parents say it is at this point that
Matt's normal routine changed. He did not turn on the
TV, or get a snack or check his email as usual. Instead,
he apparently went into the master bedroom, unlocked
the gun case, took out a gun and shot himself.
His father came home from work and yelled
"Hello" to Matt, but got no response so he
went looking for him and found Matt on the floor of
the bedroom with no heartbeat.
While answering questions from police
at the hospital, Matt's parents were asked if Matt was
taking any medication and they said Accutane. As soon
as they answered, they remembered a TV Dateline program
about the parents whose son committed suicide while
on Accutane.
After watching the program Matt and his
mother had went to the Dermatologist to discuss the
story and their concerns about Accutane. The Dermatologist
said that there had been a couple of unsubstantiated
cases of depression and suicide, but that there was
no scientific proof that Accutane could cause it and
that Matt "didn't fit the profile anyway."
Matt's parents told the committee how
they later found out that Accutane was supposed to be
reserved for the most severe cases of nodular, cystic
acne and provided the panel with a school picture of
their son taken about 2 weeks before he started on Accutane
that showed he did not have a severe acne problem.
"After talking to all of Matt's friends,
family, teachers, and co-workers," his father told
the committee, "we confirmed what we had already
known, Matthew was not depressed!"
"His sudden death came as a shock
to every person who knew Matt, including us, his parents,"
he said. Matt's suicide was "spontaneous,"
his parents said:
"There was no depression. There was
no warning. There was nothing for us to look for. There
was no reason for his death, other than Accutane."
Michael and Caroline Bencz also testified
at the hearing about how their son, James, committed
suicide without any sign that he was depressed or troubled.
They told the panel that at the time of his death, he
had everything to live for stating:
"James was not the person anyone
would expect to commit suicide. He had friends and family.
He had financial and personal success. He had plans
for the future - both near and long term.
"The week James died, he was to leave
on a skiing trip to Austria with a few of his firefighter
buddies. James had plans for his future, and death was
not in that plan."
"He was witty, humorous, talented,
a great sportsman, intelligent, and highly competitive,"
his parent said, "but most of all, above all that,
a wonderful human being.
In late 2001, they told the panel, they
learned that a doctor prescribed Accutane for James.
These parents also provided the committee with a picture
of their to show that he never had a severe acne problem.
All they could figure out was that maybe the skin diving
suit he wore may have irritated his skin on his neck
and back.
The last day they heard from James, on
February 23, 2002, he called to say he did not feel
well, that he had a headache. His last words to his
parents were: "I don't feel too good, I'm going
to try to get some sleep."
Over the next few days they did not hear
from James which was very unusual. It was not like him,
his parents said, to disappear for days at a time without
letting anyone know where he was.
When he did not turn up, a massive man
hunt was conducted, and he was eventually found on March
4, 2002, at the bottom of a lake, with a 44 pound barbell
strapped to his body. A lake where James and his sister
used to sit as children skipping rocks.
He died, his father told the committee,
"under circumstances so bizarre for someone like
James - a diver, a firefighter, and an athlete - with
so much to live for, and so many future plans."
"We wish every minute of every day
that we had never heard of that drug," they told
the committee. "It took our son, our life as we
know it, and left us with huge craters in our hearts
that can never be filled in again."
These reports of inexplicable suicides
were alarming to members of the committee. "Is
it possible that this medication has an effect, an action
that results in spontaneous, impulsive, self destructive
behavior that is different from that which occurs from
a clinical depression?," Congressman Ted Strickland
(D-OH), who has a PhD in psychology, asked.
"I know of no clinical concept of
depression that has an instantaneous onset and what
we've heard described are people who are emotionally,"
Rep Strickland said, "psychologically healthy with
none of the clinical signs of depression spontaneously
doing something to themselves."
"So I'm wondering," he concluded,
"if we are dealing here with something other than
depression, and that we ought to recognize that."
The FDA Office of Drug Safety keeps a
monthly cumulative count of psychiatric adverse event
reports in AERS. According to Dr Janet Woodcock, Director
of the Center for Drug Evaluation and Research, at the
hearing, as of November 30, 2002, AERS contained 3,104
reports with at least one reported psychiatric event.
The FDA is aware of 173 reports of suicide
in association with Accutane, she told the panel. She
noted that the FDA had requested quarterly summaries
of psychiatric events from Roche and said the most recent
summary through August 2002 indicated approximately
6,000 additional reports that include psychiatric events
Because the 173 cases of suicides ware
based on self reporting, experts say that figure is
highly suspect and that being as few as 1% of suicides
are reported as adverse events, it could mean that the
actual number of suicides may be as high as 17,000.
During his December 11, 2002 statement
to the committee, Congressman Stupak pointed the finger
of blame directly at the FDA when stating:
"Accutane is a powerful, dangerous
drug with devastating consequences for some patients.
The birth defects caused by Accutane are horrific. The
FDA's response to the birth defects and psychiatric
events has been inadequate, irresponsible and unacceptable.
Thousands of babies, teenagers, and young adults have
died prematurely.
"While the FDA has been aware of
the birth defects since at least 1982 and the psychiatric
injuries since 1985, their responsibility to protect
the public has been inconsistent and without direction."
There is no debate about whether Accutane
is a moneymaker. According to the Associated Press on
August 21, 2006, patients usually take it for up to
a year at a cost of $10 to $15 per day. And in the December
11, 2002 hearing, Congressman Stupak turned the attention
of the committee to Roche's conduct of putting profits
before people and stated:
"They have done everything possible
to prevent the American people from learning of the
psychiatric injuries and deaths associated with Accutane.
Even, today ... Roche will deny any casual effect of
Accutane with the abortions, deaths, and suicides caused
by their product."
"We cannot allow the drug manufacturer
and the FDA to continue to turn a blind eye to the lives
lost, families devastated and dreams dashed by an acne
drug," he said.
"The American people, our children,"
he said, "are not collateral damage in the scheme
of corporate profits!"
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