Monday, April 07, 2008
Mom Crusades To Ban Ssris
By Jackie Jadrnak /
Journal Staff Writer
Warnings against possible dangers of suicide among people using antidepressants have multiplied in recent years, even as new evidence is arising to contradict that concern.
What’s a depressed person or a prescribing physician supposed to do?
The answer from medical organizations and a couple of local psychiatrists boils down to this: Be careful, be vigilant, but don’t be afraid to get treatment for the problem.
The New Mexico Health Policy Commission is going to take a crack at some of these questions this summer with a task force created through passage of Senate Memorial 9 in the last legislative session.
Commission director Liz Stefanics said the task force won’t tackle every question raised about antidepressants, which the U.S. Food and Drug Administration has been looking at for years. The memorial specifically asks whether physicians should be required to get continuing medical education on how to monitor risks associated with antidepressants.
The legislative action was spurred by an Albuquerque mother, Camille Milke, who has become an activist against antidepressants since the suicide of her 21-year-old daughter Sarina on Oct. 28.
Milke said her daughter was being treated for anxiety by a nurse practitioner and got prescriptions for six drugs — two antidepressants, two anti-anxiety drugs, an anti-convulsive drug and a painkiller — within a nine-day period about a month before her suicide.
She died of carbon monoxide poisoning, sitting in her running car in a closed garage. Milke said an autopsy showed alprazolam, an anti-anxiety drug, and Lexapro, used to treat both depression and anxiety, in Sarina’s blood.
Milke said she believes a side effect of the drugs led to her daughter’s suicide.
“She was not suicidal,” Milke said. “She went to a Halloween party that night ... Friends who saw her that night said she was laughing, she was having a blast. She was making plans for the next day.”
Milke said she has gathered between 1,200 and 1,300 signatures on a petition to abolish antidepressants through her Web site, www.copesfoundation.com. The foundation Milke formed — Coalition of Parents Enduring Suicide — solicits contributions for an eco-retreat Milke said she hopes to create to offer nondrug, natural treatments to people suffering from emotional and addictive disorders.
Milke believes SSRIs — selective serotonin reuptake inhibitors, a type of antidepressant that is thought to delay the breakdown in the brain of the chemical seratonin — are dangerous.
The U.S. Food and Drug Administration has enough concern about the drugs that it has included a “black box” warning that says, in part, “Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior... Pooled analyses ... have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants.”
The FDA initially called for the warning in 2004 on 10 SSRIs when they were used in people younger than 18. It later expanded the warning up to age 24 and applied it to all antidepressants.
Now there’s a move to expand the warnings to anti-convulsive drugs, used to treat epilepsy and other seizure disorders, according to Dr. Jan Fawcett, professor of psychiatry at the University of New Mexico.
There’s one important thing to realize, though, he said.
“The studies do not show there are more suicides, but a higher rate of threats or behaviors” after people start taking antidepressants, he said.
Some analyses published in the last couple of years show suicide attempts actually peak right before a person goes on treatment and decline afterward — and that’s true for all types of treatment, Fawcett said.
Other studies across populations have shown suicides decreasing after the advent of SSRIs, then rising after the “black box” warnings appeared and prescriptions declined among youths.
It’s possible that certain individuals may be more susceptible to agitation and anxiety that arise occasionally as side effects, leading to threats or attempts of suicide, Fawcett said.
Some research suggests that people with a certain genetic trait may be more sensitive to the effects of serotonin, which increases with antidepressants, he said. Also, 7 percent of Caucasians lack an enzyme used to metabolize serotonin, which can lead to high blood levels if they are taking antidepressants, he said.
Dr. Stephen Adelsheim, a pediatric psychiatrist who serves as a consultant to the state’s Behavioral Health Purchasing Collaborative and as director of UNM’s Center for Rural and Community Behavioral Health, said only one of his patients has displayed the warned-against side effects to these drugs.
“I take prescribing medication very seriously,” he said. “At this point, my years of clinical experience indicate that, when monitored appropriately, the medications are really helpful and they really do save lives.
“The risk-benefit analysis seems really clear that treating people with antidepressants seems to decrease the risk of suicide and improves mental health status,” Adelsheim said. “What seems important is early and close monitoring.”
It’s not clear how closely patients are followed by their prescribers, especially when the drugs are prescribed by primary care doctors and other nonpsychiatrists.
“I think they’re used a little too casually,” Fawcett said.
Accurate diagnosis also is key, Adelsheim said, noting that bipolar patients, who might appear to be suffering from depression if they seek help in that phase of their cycle, can become manic when they take antidepressants.
The standard of care also calls for depressed patients to receive nondrug therapy to help change their thinking patterns and behavior, he said.
Last Updated: March 15, 2008 - 3:24 PM
By Dave Maass
Published: March 5, 2008
Lawmakers tackle biopolar/antidepressant controversy.
When Brokeback Mountain star Heath Ledger was found dead of an overdose on the floor of his SoHo flat, one could have expected a national dialogue to emerge on whether America is suffering from cultural over-medication.
Sarina Cuoco's suicide turned her mother into an activist.
But as coroners determined that a combination of antidepressants and prescription-strength painkillers may have caused the 28-year-old Australian's death, the media instead turned to speculation on Ledger's vague relationship with former child star Mary-Kate Olsen.
In New Mexico, however, Ledger's name was invoked in the rooms of the Roundhouse as Senate committees debated a bill to study the correlation between antidepressants and suicidal behavior. Specifically, Senate Memorial 9, which passed on Feb. 8, targets cavalier prescription practices among New Mexico's medical community.
While Ledger's death may have pushed SM 9 past the finish line, the legislative effort began in October 2007 during the days after a 21-year-old Albuquerque woman, Sarina Cuoco, committed suicide. She, too, had been prescribed a cocktail of antidepressants and anti-anxiety
On the memorial Web site (iloveyousarina21.last-memories.com) for Cuoco, her mother, Camille Milke, explains that she found six different pills in her daughter's home, all of which were allegedly prescribed within the month by a nurse practitioner whose daughter had acted as Cuoco's therapist.
"The day after my daughter died, I promised her that I'd get her voice heard," Milke tells SFR. "I promised her that I was going to spend my life bringing down everybody who brought her to her demise: the nurse practitioner, her therapist, Walgreens and all the drug companies."
Milke is planning a class-action lawsuit and criminal complaints, but almost immediately after Cuoco's death she identified the 2008 legislative session as a target. She inundated lawmakers and the press with e-mails (since Jan. 1, SFR received 103 unique e-mails) and Sen. Joe Carraro, R-Bernalillo, who carried SM 9, says he had to ask her to step back and let the legislative cycle work. Yet, he adds, by the end of the session, hardly a lawmaker in the Roundhouse wasn't aware of "Sarina's Voice," the informal organization formed by Milke and her husband, Brian Milke.
"These drugs certainly do help some people, but clearly, there are too many of these drugs being prescribed," Carraro says. "The mind is a mysterious and fragile part of our body and we have to be very careful what we do that will affect the emotions and capability to discern reality."
SM 9 calls for the New Mexico Health Policy Commission to convene a task force to determine if there is a correlation between antidepressants and suicidal behavior. The task force will ultimately decide whether to recommend changing the law to require mandatory continuing education for anyone who prescribes antidepressants.
For now, Milke says she's satisfied with the legislation.
"Today is 122 days since my daughter took her life," she says. "I think we've gotten a lot done in that time that a lot of other people have done in a matter of years. I mean, it's absolutely huge, but I will continue working on trying to abolish suicide-causing antidepressants until the day I die."
The question of whether antidepressants may cause suicidal behavior has been a matter of controversy for more than 30 years. Some doctors and pharmaceutical companies deny any causality.
In 2005, the Federal Drug Administration decided to require certain antidepressants be packaged with "black box" warnings about suicide risks among children and adolescent patients. Last year the FDA strengthened its position, calling for warnings on all antidepressants.
Suicide-prevention advocate Gail Griffith was living in Santa Fe when she wrote Will's Choice about her teenage son's attempted antidepressant overdose. She's pleased to learn of the legislation but, as a consumer representative on the FDA's Psychopharmacological Drugs Advisory Committee and a board member of the American Foundation for Suicide Prevention, she says she can't back Milke's call for a full ban on antidepressants. Nor can Griffith support Milke's advocacy of "natural remedies."
"People have this unfounded faith in natural products," Griffith says.
"Depression is a serious illness. You wouldn't pooh-pooh chemo or radiation if you were treating cancer, so I don't think it's fair to suggest there aren't pharmacological remedies that are applicable."
After her success in New Mexico, Milke says she's taking on Congress, particularly Sen. Hillary Clinton, D-NY, and Sen. Barack Obama, D-Ill, who have signed on to legislation that could potentially expand the use of antidepressants to treat postpartum depression.
"It's hard to get people to take us seriously because they instantly say, 'You know what? You should go to therapy,'" Milke says. "Yeah, OK. Well, that helped my daughter a whole lot, didn't it? I'll go to therapy and they'll put me on antidepressants."
Task force to study the link between suicide and antidepressants
Senate Memorial 9, sponsored by State Sen. Joe Carraro (R-Albuquerque), passed the Senate on Thursday.
The memorial creates a task force to study the correlation between antidepressant use and suicidal thoughts and behaviors.
The task force would subsequently determine the level of expertise necessary to prescribe antidepressant pharmaceuticals. The task force would also recommend solutions should a link be determined.
The FDA, in 2004, issued a labeling requirement for “antidepressant drugs” that not only included the pharmacological class of serotonin re-uptake inhibitors (SSRIs) but also the other pharmaceuticals generally classified as antidepressants. The black box warning is part of the labeling requirements that the dispensers of antidepressants are required to include when dispensing an antidepressant to a patient. The literature on the link between antidepressant use in the young n children and adolescents up to age 25 — and suicides and or suicidal behavior is not consistent in supporting whether or not there is a link.