Two Moms And Their Private Screening: Snubbed By The FDA?
5 CommentsBy Ed Silverman // June 11th, 2007 // 7:47 pm
Two New Jersey moms, who call themselves parents’ rights advocates, will testify tomorrow morning at an FDA meeting on Med Guides, which are supposed to be distributed with certain drugs, including antidepressants, but apparently aren’t making their way into patient hands. And the women have been behind an effort to get the FDA to find out why.
Lisa Van Syckel, who testified before at a recent congressional hearing on drug safety, and Laurie Yorke, a registered nurse, both have children who attempted suicide while taking Glaxo’s Paxil antidepressant. So they want to get their message across to Washington insiders and are holding a private screening tomorrow night at the L’Enfant Plaza Hotel in Washington DC of “Prescription Suicide,” a documentary about side effects.
They’ve invited members of Congress, their staffs, PhRMA lobbyists and FDA officials. So far, no one from the FDA has replied, nor have NJ Senators Frank Lautenberg or Bob Menendez. However, staffers from the Senate Finance Committee, headed by Chuck Grassley, will be there, as will someone from Nancy Pelosi’s staff. The moms hold out hope that Henry Waxman will send someone.
Andrew, CPhT
Man I’m glad my pharmacy chain prints out med guides with the prescription label. I will admit that it has really helped compliance in my pharmacy. (Though, I don’t know why they don’t just include this information with the “Patient Info sheet” that’s been put in the rx bag for years.)
Laurie
Andrew, our goal is to have the medication guide to be given to the patient BY the doctor. One on one, face to face, so the information is given and understood prior to prescribing.
The pharmacists have been awesome, for the most part, but we don’t think it’s enough to have the guide in the bottom of the pharmacy bag. It’s way to important. The patient has the right to discuss this with the prescribing doctor.
jason
How many meds have med guides? My guess is way too many. That is the problem, we have watered them down. If a doctor is not having a good conversation with a family about a child’s depression, and how it can give them more energy (energy to attempt a suicide) that is the wrong doctor to see.
It is about time for patients and families to take responsibility for themselves. I hope the screening goes well and people realize that the gov’t and FDA can’t protect us from everything. Everything worth anything in life is a risk/reward balance, that includes life saving medicines.
Laurie
“how it can give them more energy (energy to attempt a suicide) that is the wrong doctor to see.”
The suicidality is not just with depression. It goes across the diagnosis spectrum. The FDA advisory panel determined a “causal link” between antidepressants and suicidality. There have been suicides on antidepressants for those diagnosed with Irritable Bowel, headaches, school phobia and warts….yup, warts.
The FDA responsibility is to warn about risks. Unless a parent can do their own clinical trial, this will always be the FDA’s job. A parent can only make that risk/benefit decision with ALL of the information available.
Lisa Van Syckel
Jason,
You should have attended the FDA Med Guide Hearing,It was quite educational!!