Debate of SSRI Side-Effects: Violence and Suicide_NYT

February 20, 2008

ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure,

and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYI Two

articles in today's New York Times, " Reports of Gunman's Use of Antidepressant

Renew Debate Over Side Effects, " and " Midlife Suicide Rises Nearly 20%, Puzzle

Researchers, " represent a watershed for the Times. Implicit in these reports are

two evidence-based acknowledgments. Antidepressants, which had been touted as an

effective treatment in reducing suicides, have been proven to increase the risk

of suicide. What's more these drugs have been implicated in deadly violence.

The Times acknowledges the undeniable, but long denied, link between use of SSRI

antidepressants drugs and unprovoked explosive violence: " Over the years, the

antidepressant Prozac and its cousins, including Paxil and Zoloft, have been

linked to suicide and violence in hundreds of patients. " Indeed, a website

maintained by two mothers on a truth mission, Sara Bostock and Rosie Meysenburg,

www.ssristories.com, lists 2,000 news reports linking SSRIs to violence. These

drugs' label warnings were only added after critics of pharmaceutical industry's

concealment of drug hazards brought to public light the nature and severity of

these drugs' adverse side-effects. Indeed, both the FDA and the MHRA in the UK

failed for over a decade to examine the safety data in their own file drawers.

The Prozac label--which is identical for all SSRIs--warns about a cluster of

drug-induced withdrawal symptoms that are associated with violent outbursts:

" Discontinuation of Treatment with Prozac - During marketing of Prozac and

other SSRIs and SNRIs... there have been spontaneous reports of adverse events

occurring upon discontinuation of these drugs, particularly when abrupt,

including the following: dysphoric mood, irritability, agitation, dizziness,

sensory disturbances (e.g., paresthesias such as electric shock sensations),

anxiety, confusion, headache, lethargy, emotional lability, [i.e. suicidal

behavior] insomnia, and hypomania. While these events are generally

self-limiting, there have been reports of serious discontinuation symptoms.

Patients should be monitored for these symptoms when discontinuing treatment

with Prozac. " The concealment of these drugs' lethal effects for over a decade

led unsuspecting physicians to prescribe them widely. The consequences of such

uninformed prescribing can be counted in preventable human casualties. SSRI

antidepressants have been linked to a string of US school shooters--including

Kazmieczak, who shot and killed five students ant Northern Illinois

University. Ms. Bostock, an observer and suicide survivor, told the Times: " my

main wish is that medical professionals, regulatory authorities and other

scientists will examine closely the entire medical and treatment history of the

perpetrators of these violent incidents in which innocent people are victims.' "

By contrast, the Times reports that " psychiatrists say the debate on such side

effects, particularly suicide in the last four years, has driven patients from

drugs that could help save their lives. " That claim is without scientific

foundation: help save lives how-by increasing the risk of suicide? The claim is

a faith-based position that defies the documented evidence. Another Times

report focuses on the finding of a new five-year analysis of the nation's death

rates, recently released by the federal Centers for Disease Control and

Prevention. This study found that the suicide rate among 45-to-54-year-olds

increased nearly 20% from 1999 to 2004--and for women 45 to 54, the rate leapt

to 31%. During these same years, sales and prescription data for SSRI

antidepressants skyrocketed--as documented by IMS Health, see:

http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_18731_7705677

8,00.html and

http://ahrp.blogspot.com/2007/05/eternal-sunshine-20-things-you-need-to.html

The alarming INCREASE in suicides among middle aged persons during a period of

INCREASED use of SSRI antidepressants refutes propaganda masquerading as

scientific reports-including FDA's limited focus on children and young adults.

The authors of several reports attempt to control the commercial damage in the

wake of valid safety information. These authors claimed that the recently added

Black Box warnings about the increased suicide risk were the CAUSE for increased

suicides. Two such reports were published in Feb. 2005: Julio Licinio, MD,

and Ma-Ling Wong, M.D., of UCLA. Nature Reviews Drug Discovery. posted online at

<www.nature.com/cgi-taf/DynaPage.taf?file=/nrd/journal/v4/n2/abs/nrd1634-fs.

html Gibbons, Ph.D., of University of Illinois, Chicago, and J.

Mann, M.D., a professor of psychiatry at Columbia and chief of psychiatric

research at New York State Psychiatric Institute. Arch Gen Psychiatry, posted

at: http://archpsyc.ama-assn.org/cgi/content/abstract/62/2/165 These authors

claimed that most persons who did commit suicide did so because of untreated

mental illness. Their judgment may have been clouded by conflicts of interest.

The Times reports that C. Leon, a professor of biostatistics in

psychiatry at Cornell, suggested that a drop in the use of hormone replacement

therapy after 2002 might be implicated in the " puzzling 28.8 percent rise in the

suicide rate among women ages 50 to 54. " He is quoted speculating: " It may be

that without the therapy, more women fell into depression. " Psychiatrists in

the service of industry refuse to acknowledge the evidence and alter

psychiatry's practices accordingly, exhibit their utter disregard for science.

In so doing they demonstrate an affinity to the Flat Earth Society and other

adherents to junk science. Contact: Vera Hassner Sharav veracare@...

212-595-8974 http://www.nytimes.com/2008/02/19/us/19depress.html THE NEW YORK

TIMES Reports of Gunman's Use of Antidepressant Renew Debate Over Side Effects

By BENEDICT CAREY Published: February 19, 2008 P. Kazmierczak stopped

taking Prozac before he shot to death five Northern Illinois University students

and himself, his girlfriend said Sunday in a remark likely to fuel the debate

over the risks and benefits of drug treatment for emotional problems. Over the

years, the antidepressant Prozac and its cousins, including Paxil and Zoloft,

have been linked to suicide and violence in hundreds of patients. Tens of

millions of people have taken them, and doctors say it is almost impossible to

tell whether the spasms of violence stem in part from drug reactions or the

underlying illnesses. " It's a real chicken-and-egg sort of situation, " said

Dr. Jane E. Garland, director of the Mood and Anxiety Disorders Clinic at BC

Children's Hospital in Vancouver, British Columbia. Dr. Garland said some

people could and did become agitated and unpredictable in response to the drugs,

usually just after starting to take them or soon after stopping. " But it's

hard to make a case for a withdrawal reaction here, because Prozac comes out of

the system gradually, " she said. The girlfriend, Baty, said in an

interview on CNN that Mr. Kazmierczak took Prozac to battle anxiety and

compulsive behavior but that it " made him feel like a zombie and lazy. " She

said that in the days leading up to the shooting he was not behaving

erratically, as university officials had suggested. Much of the debate over the

side effects of antidepressants focuses on erratic behavior like the cautious

college student who stabs herself or the good husband and father who buys a gun

and shoots himself. The drug labels warn about agitation and severe

restlessness, and display a prominent caution that the medications increase the

risk of suicidal thinking and behavior in some children and young adults.

Psychiatrists said Monday that stopping an antidepressant could cause effects

like lightheadedness, nausea and agitation as the brain adjusted. Among the most

commonly prescribed drugs, Prozac is the least likely to cause withdrawal

effects because it stays in the system longest, the doctors said. " A small

dose of Prozac is what you might use to block withdrawal symptoms when you take

a patient off one of the other drugs, " said Dr. Klein, an emeritus

professor of psychiatry at Columbia who has consulted with drug companies.

Sara Bostock, of Atherton, Calif., whose daughter committed suicide shortly

after taking Paxil, acknowledged that the interaction between drug effects and

underlying emotional distress was hard to untangle. Ms. Bostock wrote in an

e-mail message, " As an observer and suicide survivor, my main wish is that

medical professionals, regulatory authorities and other scientists will examine

closely the entire medical and treatment history of the perpetrators of these

violent incidents in which innocent people are victims. " She is a founder of

ssristories.com, a Web site that has tallied 2,000 news reports of violent acts

in which people were thought to be taking antidepressants or had recently

stopped them. " If it weren't for us, many of these stories would be lost to

oblivion forever, " Ms. Bostock said. Psychiatrists say the debate on such side

effects, particularly suicide in the last four years, has driven many patients

from drugs that could help save their lives. The psychiatrists emphasize that

patients should be closely monitored for changes in behavior when starting or

tapering off a medication. Advocates on both sides agree that catalogs of

violent acts are not enough and that news reports are incomplete. Only more

thorough investigation and careful tracking of drug side effects, they say, will

clarify the links between drug treatment and violent behavior. Dr.

Stone, a professor of clinical psychiatry at Columbia, maintains a database of

1,000 violent crimes, including mass murders, going back decades. In many cases

the accused had stopped taking drugs for schizophrenia, Dr. Stone said. " I

only have a handful of cases, " he added, " where the person was on an

antidepressant. " ~~~~~~~~~~~~~~~~~

http://www.nytimes.com/2008/02/19/us/19suicide.html?sq=suicide & st=nyt & scp=2 &

pagewanted=print THE NEW YORK TIMES February 19, 2008 Midlife Suicide Rises,

Puzzling Researchers By PATRICIA COHEN Neal can instantly tell you the

best night of her life: Tuesday, Dec. 23, 2003, the Hinsdale Academy debutante

ball. Her father, Neal, a 54-year-old political columnist for The Chicago

Sun-Times, was in his tux, white gloves and tie. " My dad walked me down and took

a little bow, " she said, and then the two of them goofed it up on the dance

floor as they laughed and laughed. A few weeks later, Mr. Neal parked his car

in his garage, turned on the motor and waited until carbon monoxide filled the

enclosed space and took his breath, and his life, away. Later, his wife, ,

would recall that he had just finished a new book, his seventh, and that " it

took a lot out of him. " His medication was also taking a toll, putting him in

the hospital overnight with worries about his heart. Still, those who knew him

were blindsided. " If I had just 30 seconds with him now, " Ms. Neal said of her

father, " I would want all these answers. " Mr. Neal is part of an unusually

large increase in suicides among middle-aged Americans in recent years. Just why

thousands of men and women have crossed the line between enduring life's burdens

and surrendering to them is a painful question for their loved ones. But for

officials, it is a surprising and baffling public health mystery. A new

five-year analysis of the nation's death rates recently released by the federal

Centers for Disease Control and Prevention found that the suicide rate among

45-to-54-year-olds increased nearly 20 percent from 1999 to 2004, the latest

year studied, far outpacing changes in nearly every other age group. (All

figures are adjusted for population.) For women 45 to 54, the rate leapt 31

percent. " That is certainly a break from trends of the past, " said Ann Haas, the

research director of the American Foundation for Suicide Prevention. By

contrast, the suicide rate for 15-to-19-year-olds increased less than 2 percent

during that five-year period - and decreased among people 65 and older. The

question is why. What happened in 1999 that caused the suicide rate to suddenly

rise primarily for those in midlife? For health experts, it is like discovering

the wreckage of a plane crash without finding the black box that recorded flight

data just before the aircraft went down. Experts say that the poignancy of a

young death and higher suicide rates among the very old in the past have drawn

the vast majority of news attention and prevention resources. For example, $82

million was devoted to youth suicide prevention programs in 2004, after the

21-year-old son of Senator Gordon H. , Republican of Oregon, killed

himself. Suicide in middle age, by comparison, is often seen as coming at the

end of a long downhill slide, a problem of alcoholics and addicts, society's

losers. " There's a social-bias issue here, " said Dr. C. Caine, co-director

at the Center for the Study of Prevention of Suicide at the University of

Rochester Medical Center, explaining why suicide in the middle years of life had

not been extensively studied before. There is a " national support system for

those under 19, and those 65 and older, " Dr. Caine added, but not for people in

between, even though " the bulk of the burden from suicide is in the middle years

of life. " Of the more than 32,000 people who committed suicide in 2004, 14,607

were 40 to 64 years old (6,906 of those were 45 to 54); 5,198 were over 65;

2,434 were under 21 years old. Complicating any analysis is the nature of

suicide itself. It cannot be diagnosed through a simple X-ray or blood test.

Official statistics include the method of suicide - a gun, for instance, or a

drug overdose - but they do not say whether the victim was an addict or a

first-time drug user. And although an unusual event might cause the suicide rate

to spike, like in Thailand after Asia's economic collapse in 1997, suicide much

more frequently punctuates a long series of troubles - mental illness, substance

abuse, unemployment, failed romances. Without a " psychological autopsy " into

someone's mental health, Dr. Caine said, " we're kind of in the dark. " The lack

of concrete research has given rise to all kinds of theories, including a sudden

drop in the use of hormone-replacement therapy by menopausal women after health

warnings in 2002, higher rates of depression among baby boomers or a simple

statistical fluke. At the moment, the prime suspect is the skyrocketing use -

and abuse - of prescription drugs. During the same five-year period included in

the study, there was a staggering increase in the total number of drug

overdoses, both intentional and accidental, like the one that recently killed

the 28-year-old actor Heath Ledger. Illicit drugs also increase risky behaviors,

C.D.C. officials point out, noting that users' rates of suicide can be 15 to 25

times as great as the general population. , a vigorous fisherman

and hunter, began ordering prescription drugs like Ambien and Viagra over the

Internet when he was in his late 40s and the prospect of growing older began to

gnaw at him, said his daughter, Ray , who appears on the

television soap " Guiding Light. " Five days before his 50th birthday, he sat in

his S.U.V. in Bloomfield Hills, Mich., letting carbon monoxide fill his car.

Cronin was 43 and working in a gym when she gulped down a lethal dose of

prescription drugs in her Denver apartment in 2006, after battling eating

disorders and depression for years. Looking at the puzzling 28.8 percent rise

in the suicide rate among women ages 50 to 54, C. Leon, a professor of

biostatistics in psychiatry at Cornell, suggested that a drop in the use of

hormone replacement therapy after 2002 might be implicated. It may be that

without the therapy, more women fell into depression, Dr. Leon said, but he

cautioned this was just speculation. Despite the sharp rise in suicide among

middle-aged women, the total number who died is still relatively small: 834 in

the 50-to-54-year-old category in 2004. Over all, four of five people who commit

suicide are men. (For men 45 to 54, the five-year rate increase was 15.6

percent.) Veterans are another vulnerable group. Some surveys show they account

for one in five suicides, said Dr. Ira Katz, who oversees mental health programs

at the Department of Veterans Affairs. That is why the agency joined the

national toll-free suicide hot line last August. In the last five years, Dr.

Katz said, the agency has noticed that the highest suicide rates have been among

middle-aged men and women. Those most affected are not returning from Iraq or

Afghanistan, he said, but those who served in Vietnam or right after, when the

draft ended and the all-volunteer force began. " The current generation of older

people seems to be at lesser risk for depression throughout their lifetimes "

than the middle-aged, he said. That observation seems to match what Myrna M.

Weissman, the chief of the department in Clinical-Genetic Epidemiology at New

York State Psychiatric Institute, concluded was a susceptibility to depression

among the affluent and healthy baby boom generation two decades ago, in a 1989

study published in The Journal of the American Medical Association. One possible

reason she offered was the growing pressures of modern life, like the changing

shape of families and more frequent moves away from friends and relatives that

have frayed social support networks. More recently, reports of a study that

spanned 80 countries found that around the world, middle-aged people were

unhappier than those in any other age group, but that conclusion has been

challenged by other research, which found that among Americans, middle age is

the happiest time of life. Indeed, statistics can sometimes be as confusing as

they are enlightening. Shifts in how deaths are tallied make it difficult to

compare rates before and after 1999, C.D.C. officials said. Epidemiologists also

emphasize that at least another five years of data on suicide are needed before

any firm conclusions can be reached about a trend. The confusion over the

evidence reflects the confusion and mystery at the heart of suicide itself. Ms.

Cronin explained in a note that she had struggled with an inexplicable gloom

that would leave her cowering tearfully in a closet as early as age 9. After

attempting suicide before, she had checked into a residential treatment program

not long before she died, but after a month, her insurance ran out. Her parents

had offered to continue the payments, but her sister, Gifford, said Ms.

Cronin did not want to burden them. Ms. Gifford added, " I think she just got

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February 20, 2008