Antipsychotics No Better Than Generic For Kids
9 CommentsBy Ed Silverman // September 15th, 2008 // 8:13 am
A new study in the American Journal of Psychiatry found that Lilly’s Zyprexa and Johnson & Johnson’s Risperdal caused more side effects and were less effective for children with schizophrenia than a 30-year-old generic pill that costs about one-fourth of the widely marketed atypical antipsychotics, according to Bloomberg News.
About half of the children and teenagers taking molindone experienced fewer symptoms, compared with 46 percent of those taking Risperdal and 34 percent of those taking Zyprexa, the study found. Zyprexa costs $215 for the lowest dose used in the study, Risperdal is priced at $123 and molindone is $56, according to Drugstore.com, Bloomberg writes.
Most children failed to improve on any of the drugs, but side effects were more common in those taking the newer ones. Zyprexa, in particular, caused weight gain and unwanted boosts in insulin, blood fat and liver function tests. In fact, the independent board monitoring patient safety stopped recruiting patients to take Zyprexa after noting few children benefited while many gained weight.
The study reviewed data for 116 children ages 8 to 19 who were given molindone or one of the two newer drugs - Zyprexa, which generated $4.8 billion in sales in 2007, or J&J’s Risperdal, with $4.7 billion in revenue, Bloomberg points out. [Here is the study]. The trial is the latest to find that atypical antipsychotics don’t produce greater benefits for patients of varying ages, the news service writes.
“This is yet one more study which has failed to find any significant area of advance or superiority of the second- generation medicines,” Jeff Lieberman, senior author and a professor of psychiatry at Columbia University, tells Bloomberg. The drugs sell because of “very aggressive marketing campaigns and a wish among patients there was something better out there.”
Last year, the FDA approved Risperdal for treating adolescents with schizophrenia and bipolar disorder, but Lilly’s Zyprexa isn’t approved for any pediatric use. Still, prescriptions given children for five newer antipsychotics more than doubled to 4.4 million 2003 and 2006, according to 2007 data provided by Wolters Kluwer to Bloomberg.
Levels of a hormone, prolactin, rose among patients taking Risperdal. This could trigger early menstruation in girls and cause growth of breast tissue in boys, Lieberman said. “When it comes to the weight and metabolic side effects of the newer antipsychotic drugs, the younger you are, the more susceptible you are,” he tells Bloomberg.
The latest study results reflect the difficulty of helping youngsters with early signs of serious mental illness, and point to the need for newer, better drugs, Tom Insel, director of the National Institutes of Mental Health, tells Bloomberg. “It is time to realize that the compounds we have now help some patients get better but they really don’t help many to get well.”
Lisa Van S
FDA’s Tom Laughren should be fired, and his medical license revoked!
Salmon
Lisa,
Whether you’re correct or not is unrelated to this article.
No one in FDA at this time can require that a drug be more efficatious. Only that it be safe and effective. Safety has to be assessed in context of all the other data including safety relative to placebo, other drugs, and the risks of not treating, as well as appropriate monitor and screening, etc. Effective has to be relative to placebo which we don’t have in this study, but would have been useful. If placebo response is 25% or 30% then the marginal difference and safety for Zyprexa becomes an even bigger issue. Plus we need repeated studies and more details.
I’m not saying you’re not right about Tom Laughren but you have to consider that even if someone (including Tom Laughren) had wanted to have done something because of relative efficacy their hands would have been tied.
What’s more troubling is the two recent turn downs of antipsychotics in the past year or so where there has been mention of some toxicity but the main point being drummed on by the sponsors is that they were turned down because they weren’t as efficatious. If this is true then the companies can appeal the decisions and can easily have them overturned. It seems to me that we’re not getting the whole story.
Given the pro-pharma environment at FDA and the financial positions of pharma I find it hard to believe anyone is going to turn down a $1 - $2 billion/year drug because it isn’t as efficacious. Even in iloperidone’s case FDA requiring more studies strikes me as suspicious it’s a common industry practice that when you have a serious toxicity you do more studies. That is enroll enough extra subjects to drop the rate but not enroll enough (or specific type of subject (e.g. asian for stevens johnsons) so you’re likely to likely detect another case.
Salmon
Lisa Van S
Salmon.
Dr Laughren knew, as early as 1996 that antidepressants, in particular, Zoloft, were ineffective and incresed harm;”He” chose to stay silent. Children were harmed, and many died due to the suicidal side effects, including his own daughter’s 12 year old classmate. The likes of Dr. laughren is what is wrong with FDA. When it comes to the FDA and Safety of Psychotropic drugs in children, Dr. Laughren becomes a topic of discussion, He’s fair game.
Daniel Haszard
Lilly Zyprexa ‘ Chemical Straitjacket’ Use by Children.
Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use. Eli Lilly has been charged in allegedly pushing the drug for children in more than one state.
A report by Dr. Cooper at Vanderbilt University states that 2.5 million children are now taking atypical antipsychotics.
St. Petersburg Times Reports on Zyprexa A risky drug may get wider marketThe FDA may approve Zyprexa for kids, despite its significant side effects in adult use.
http://www.youtube.com/watch?v=uuK1t474ei4
Daniel Haszard Zyprexa patient who got diabetes from it.
Salmon
Lisa,
You’re mixing antidepressants and antipsychotics and then you say Zoloft is ineffective. My question is based on what? Since it’s approved, without evidence to the contrary (which may exist but I’m not familiar with and I’m pretty knowledgable) I have to assume that there was some evidence of efficacy. Maybe it was ineffective in a subpopulation and if so what patient population is it ineffective in? If it’s ineffective for all population groups then file a citizen’s petition. Even if a study in 1996 showed a drug was ineffective additional studies that were selectively designed may have had different results and allowed approval later. My point is by mixing inappropriately you’re hurting your cause by destroying your credibility and appearing as simply having a vendetta against Laughren.
It may make you feel good but it’s not going to help you protect other kids and you’ve got to ask yourself what is more important.
Salmon
Anne
I
see nothing wrong with Lisa S’s credibility. She has been highly effective in getting the New Jersey Legislature to act to protect children from psychotropic drugs, and she is a parent whose own child suffered harm.
You say it is next to impossible to get the FDA do do anything pro-active to protect children or adults from psychotropic drugs, be they SSRI’s, SNRI’s, or atypical antipsychotics. I believe that you are correct and can only hope that a Democratic president will stick to his promise to clean up the federal government. Pharma runs the FDA, and President Bush and Pharma are best friends.
At this point, IMO, it is worth working on attorneys general. Among the more effective tasks they could undertake are, on a state by state basis, banning atypicals just as has happened with SSRIs, until the age of 24 unless it can be proven without a shadow of a doubt that a late teen - young adult with schizophrenia cannot manage on anything else. A similarly-aged person with manic depression could manage, and not die, on lithium. Another thing the federal AG could do is make the atypical makers give a hefty sum to every family whose family member was killed by whichever drug did it. I know a family now who lost their only child and, due to the pitiful settlement they got from Lilly, may slide into bankruptcy. It shouldn’t just be state and federal governments and stockholders who should be paid back, it should be the families.
Lisa Van S
Salmon,
“Zoloft”, has “never” been FDA approved for child and adolescent MDD. If you are a Physician, I’d like to refer you to the 2008 PDR. Abilify and Seroquel carry a black box warning for hostility and increased risk of suicidality. They carry the same Black Box warning that antidepressants do.
And my reference to Dr. Laughren and 1996?
I refer you to testimony, given under oath, before the Energy and Commerce, subcommitee of Oversight and Investigations Hearing held on Sept 23, 2004.
May I suggest, that before you question my credibility, that you do your homework. If you are a Physician, and treat child and adolescent Patients, I suggest educating yourself.. No Excuses!!!
Lisa Van S
SALMON,
MAY I ADD, YOUR LACK OF KNOWELEDGE IN THIS AREA,.. IS ABSOLUTELY FRIGHTNING!!!!
Boo
Sorry Lisa,
Suicide is up in children and adolescents since the black box warnings.