Health

Fed up with the FDA, activists to protest against harmful antidepressants

By Evelyn Pringle
Online Journal Contributing Writer

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August 12, 2005�Activists who are fed up with waiting for the Food and Drug Administration (FDA) to take proper action to protect the public from dangerous psychotropic drugs, are holding a three-day rally in front of the White House to condemn the FDA's failure to act on the matter.

On August 24, 25, and 26, between 9 am and 5 pm, prominent activists from all over the nation will join victims and family members who have lost love ones due to these drugs to raise public awareness about their potential dangers.

They will specifically target the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which include: Paxil, Prozac, Zoloft, Wellbutrin, Luvox, Citalopram, Celexa, Lexapro, and Paroxetine.

Allen Routhier who lost his 40-year-old wife, Diane, two years ago to suicide while she was on the antidepressant Wellbutrin, will be leading the rally along with his two sons.

Linda Hurcombe will also be attending from the UK. Linda is an editor and educator, and author of the book, "Losing A Child." Her daughter, Caitlin, died at 19.

Other attendees include Mark Taylor and his mother, Donna. Mark was shot during the Columbine rampage by Eric Harris who was on an SSRI at the time.

Another leader in the fight against the over-prescribing of these drugs, who will attend the rally is the world renowned expert on SRRIs, Dr. Anne Blake Tracy, director of the International Coalition for Drug Awareness.

Dr. Tracy is the author of Prozac: Panacea Or Pandora? a book written after five years of research on approximately 1,000 patients taking SSRIs on a long-term basis.

She has specialized in adverse reactions to SSRIs and has testified before the FDA and congressional committees on their adverse affects. Since 1992, Dr. Tracy has also served as an expert consultant and

witness in SSRI related civil and criminal court cases all around the world.

A full force of advocacy groups will be represented with members of Mothers Against Manufactured Madness, Alliance to Stop Psychiatry's Influence in Religion and Education, and Mindfreedom.

An important part of the message that the public needs to know is that drug makers have known about the adverse affects of SSRIs prior to receiving FDA approval. For example, in March 1985, three full years before Prozac was approved, Dr Richard Kapit reviewed the drug and warned it posed a risk of worsening "vegetative aspects of depressive illness" for some patients. He noted that out of 1,427 exposures "there were two completed suicides" and �13 patients who attempted suicide.� He stated that "it may be appropriate" to include a "warning" on the label "that certain signs and symptoms of depression may be exacerbated by this drug."

Drug makers have also known that SSRIs are practically useless in treating children. For instance, in December 2004, ABC News uncovered documents that revealed GlaxoSmithKline, the maker of Paxil, failed to disclose the results of studies as far back as 1997, which determined that Paxil had little or no effect in treating depression in children and also showed the company was aware of suicide-related behaviors in young patients taking the drug.

Yet in 2001, Glaxo sent out a memo to its sales force touting the drug's "remarkable efficacy and safety in the treatment of adolescent depression."

One advocacy group, recently accused the FDA of covering up Prozac's dangerous side effects for 14 years. And as a result, their spokesperson says hundreds of people have been victims of murder and suicide.

Bonnie Leitsch is the founder of "Prozac Survivors Support Group," and along with Dr. Tracy, is calling for immediate federal action to warn the public that this class of antidepressants not only can induce suicide in adult patients, but can also cause psychosis and acts of violence.

The FDA cannot continue to play dumb. Leitsch's group has 14-year-old film footage of the 1991 FDA hearings, where dozens of family members testified about relatives who had either killed themselves, or loved ones, or who had attempted suicide which they directly attributed to being on SSRIs.

The Prozac Survivors group points to Magdalena Lopez as an example of violence caused by SSRIs. The 30-year-old Indiana mother recently murdered her two young sons while on one of the drugs.

At least 80,000 women each year in this country are being prescribed these drugs during pregnancy, according to researchers' estimates. SSRIs are still being prescribed to pregnant women even though a May 2005 study published in the Journal of the American Medical Association reported that pregnant women who take SSRIs late in pregnancy raise the risk that their babies will suffer jitteriness, irritability and serious respiratory problems during their first couple of weeks.

Leitsch finds it unacceptable that pregnant women and new mothers are still being prescribed drugs that have been known to induce violence and suicide for more than a decade. "In 1991, there was evidence of 500 deaths associated with antidepressants presented to an FDA Advisory Committee hearing investigating Prozac," she said.

"The failure to issue the warning has led to more suicides, homicides, school shooters and mothers killing their own children," she added. According to Lietsch, 36 million Americans are taking the antidepressant drugs.

"These are extremely dangerous drugs that should have been banned, as similar drugs were in the past. Federal investigations into the violence-inducing effects of these drugs are long overdue," Tracy said. "The scientific evidence behind this has been out there for decades. All anyone ever had to do was read it," she said.

The group provided details of several other high profile cases where mothers have killed their children:

• In October 2002, Annie Mae Haskew smothered her 10-week-old son after being diagnosed with postpartum depression and placed on antidepressants.
   
• Andrea Yates drowned her five children in the family bathtub in November 2004, while taking the antidepressants Effexor and Remeron, prescribed at maximum dose.
   
• Dena Schlosser killed her 10-month-old daughter in November 2004 by severing the baby's arms after being diagnosed with postpartum depression, hospitalized and prescribed psychiatric medication for depression.
   
• On July 26, 2004, Mary Ellen Moffitt suffocated her 5-week-old infant and herself. She had been diagnosed with postpartum depression and was taking Paxil.
   
• Emiri Padron smothered her baby daughter on June 22, 2004, and then stabbed herself twice in the chest. Emiri was receiving psychiatric treatment and investigators found Zoloft in her apartment after the incident.

Late last year the FDA directed manufacturers to add a "black box" warning to the health professional, labeling of all SSRIs to describe the risk of suicide in children, and emphasize the need for close monitoring of patients when started on these drugs.

On July 1, the FDA advised health care providers and adult patients to be aware of the following:

• Adults being treated with antidepressant medicines, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.
   
• Close observation of adults may be especially important when antidepressant medications are started for the first time or when doses for the specific drugs prescribed have been changed.
   
• Adults whose symptoms worsen while being treated with antidepressants, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.

Advocates say these warnings are not only far too late, they contain far too little. Leitsch says the FDA has an obligation to do more. "They must warn the public that not only can the drugs include suicide�but heinous acts of violence�mothers killing their own children, or children killing other children,� she said.

Another protest against SSRIs is already scheduled to take place on September 26 through the 28th at GlaxoSmithKline, maker of Paxil, One Franklin Plaza, 200 N 16th Street and 1600 Vine Street in Philadelphia, Pennsylvania.

Last and probably least, yours truly shall also attend the rally.

Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption.