For those who follow the mental health news, a big news release was issued recently:
FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents.
Per the news release:
"The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.
Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up."
For those of you who don't know how the approval process works, here is a good thumbnail from an article done by Loren R. Mosher, Richard Gosden and Sharon Beder called Drug companies and Schizophrenia: Unbridled Capitalism meets Madness. There is a bias to the article, and it focuses on schizophrenia, but it's still applicable to bipolar disorder, and an informative read:
"The American process will be described but it is roughly similar in all western European countries. For a new drug, two studies must be submitted to the Food and Drug Administration (FDA) indicating the drug is better than placebo and is without serious adverse effects for condition "X". The drug need not be more effective than ones already available for condition "X". Data from "failed studies"-those showing no significant drug placebo differences- are not supplied to the FDA. If approved, the drug can be marketed for condition "X". The companies can later apply, by submitting new studies or new analyses from old studies for the drug's indications to be extended to new conditions or new populations (e.g., youth, the elderly). This opens a new market. The "new indications" technique has proved to be highly successful with the SSRI's: first approved only for depression but now approved for obsessive compulsive disorder ("OCD"), post traumatic stress disorder, and various anxiety disorders.
Of great importance is the fact that once a drug is on the market an individual doctor can legally prescribe it for "off label"(unapproved) indications..."
So what has happened here is the manufacturer, Janssen, has taken the time and huge expense to pursue the approval process with respect to Risperdal and youth. This is understandable, as it potentially opens up a whole new market for them. Or does it? I would imagine many, if not most, medical professionals who would prescribe Risperdal for youth are already doing it off-label. And another thing, Risperdal goes off-patent soon, next year if I'm not mistaken. Janssen has little time to recoup their investment. So what gives?
www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf
The FDA tells us the safety for schizophrenia was based on 3 studies. One was placebo-controlled (6 weeks), one low-dose controlled (8 weeks), and one open-label (6 months).
The safety for bipolar disorder was also based on 3 studies. One was placebo-controlled (3 weeks), one was the same "long-term" open-label study mentioned above (6 months), and one was a "pharmacokinetic" study (length of study not mentioned).
WHY DID THE FDA OMIT THE LENGTH OF THIS STUDY? THE ANSWER CAN BE FOUND IN ANOTHER FDA DOCUMENT:
http://www.fda.gov/cder/foi/esum/2007/020272s046_risperidone_clinpharm_BPCA.pdf
"The population pharmacokinetic study was done in 472 children and adolescents patients, ages 6-18. Study durations were from 12-21 days."
THERE YOU HAVE IT:
AS LITTLE AS 12 DAYS! 3 WEEKS AT THE MOST!
This allows the FDA to declare with a straight face:
"There were no reports of tardive dyskinesia in the pediatric study populations."
If you want to see the real-world incidence of tardive dyskinesia caused by Risperal in children, you won't find it ANYWHERE on the FDA web site. But you will find a glimpse here:
http://www.psychdrugdangers.com/risperdal.html
For a real-world look at Risperdal prescribing patterns in a state Medicaid program, go here:
http://www.psychdrugdangers.com/psychotropicages0-18.html
The above web page lists all 7,327 New Jersey Medicaid Risperdal prescriptions for children under age 18 written in 2006. The Risperdal prescriptions are sorted by age and dosage.
Note the number of children on Risperdal rises steadily until ages 11 or 12, then the numbers begin to decline. This is NOT because the number of children on antipsychotics begins to decline. Risperdal is the GATEWAY antipsychotic, but after a year or two the kids are often switched to a different antipsychotic (usually Seroquel or Abilify first, then Zyprexa or Geodon, and/or back to Risperdal later).
Meanwhile all sorts of other psychiatric drugs are thrown into the mix, and before you know it these kids are REALLY sick... thanks to the wonders of modern medicine, and thanks to all the doctors who write all the prescriptions, and thanks to all the taxpayers who foot the bill.
In October 2006 the FDA approved Risperdal for autistic irritability in children, based on two 8-week trials of 76 kids on Risperdal and 80 kids on placebo, detailed here:
http://www.fda.gov/MedWatch/safety/2006/Oct_PIs/RisperdalTabs_PI.pdf
Adverse Reaction Risperdal Placebo
Tremor 12% 1%
Dystonia 12% 6%
Automatism (tics) 7% 1%
Dyskinesia 7% 0%
Parkinsonism 8% 0%
Reviewing these trial results, I have a question:
How is it that 6% of the kids on placebo develop dystonia, while only 1% develop tremor? Can anyone out there offer possible explanations???
One more thing:
The average dose in the Risperdal autism trials was under 2mg/day. The FDA approved Risperdal for kids over age 5, 0.5 mg/day for 15-20 kg body weight, and 1mg/day for those over 20 kg. Look again at the New Jersey Medicaid prescriptions for Risperdal, and count the number of 2mg, 3mg and 4mg scrips. Not to mention all the kids under age 5 on doses ranging from 0.25mg to 3mg.
When the FDA approves a psychiatric drug at a certain dose for a certain age, history shows that doctors often ignore the FDA guidelines.
On the subject of Risperdal's pediatric dosage, the author of the FDA report had this to say:
"While I believe we should certainly label the drug with the information learned from the clinical trials, and even identify target doses of 3 mg/day for pediatric schizophrenia and 2.5 mg/day for pediatric bipolar I disorder, I think it would be too restrictive to the prescriber to limit the dose to a maximum when we know that doses up to 6 mg/day were also shown to be efficacious in the same studies that demonstrated efficacy for the lower dose ranges."
Yes that's what FDA Deputy Director, Dr. Mitchell V. Mathis really said. You can read his full report here:
www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf
Ben Hansen
Traverse City, Michigan
Institute for Nearly Genuine Research
www.bonkersinstitute.org
Ben - I have to be honest, when I saw the name of your website I wasn't sure if you were on the level. But your research is extensive and interesting.
I'm a person who has a high level of distrust for the business practices of "Big Pharma", but I'm not ready to jump in and proclaim them to be totally evil.
2 blogs I visit regularly that you may want to check out are <a href="http://www.furiousseasons.com/">Furious Seasons</a> and <a href="http://bipolarsoupkitchen-stephany.blogspot.com/">Soulful Sepulcher</a>. While I don't always share their enthusiastic anti-pharma mind set, I very much respect the work they are doing, and I look to them to get a different take on psychiatric news. Authors Philip or Stephany may be interested in seeing your research.
Thanks for taking the time to comment, and I look forward to your contributions in the future.
Hi John, I just noticed this comment when doing a google search for my blog! I would like to re phrase the "anti pharma" label, and direct it to what it represents for myself. It is pro-truth, and pro-data and anti-misleading the public with often skewed studies and data bases, sometimes key data is left out that could have saved lives such as with Paxil, Zyprexa and more. I am familiar with Ben, and most likey have those abstracts and such in my OCD>Childhood BP series, as I picked away at the evolution of the Childhood bipolar disorder evolution, I did it via researching. Where I found the oldest study was done for Risperdal by Joseph Biederman in 1999, and yet it was used in kids [like my daughter]then and long before the recent FDA approval, without long term effects known to the growing child's brain and body, this is alarming, and it still is to me quite frankly. I'd rather be considered a watch dog for safety, and ethics, because leaving out information that ultimately caused the public harm is something all of us should be concerned about with regard to Pharma. "Pharma" has not taken an oath to first do no wrong, they are an industry and a savvy one at that, which often leaves people injured as a result of misconduct. Another blog to take a look at regarding Scienfic Misconduct, is that one authored by a scientist Aubrey Blumsohn. His blog is on my blogroll and is worth reading to see how corrupt some of these practices are with leaving out data that could have changed and saved lived. Also, Seroxat Sufferers Stand Up, authored by Bob Fiddaman, is all about Paxil, and it's quite eye opening with regard to that drug as well with data "left out".
I appreciate very much your respect and sending people my way to take a look at my blog. As an FYI to your readers here, I take psych meds myself. I'm concerned with the dangers in the background of how these companies get the product out there, and as you can read, there is a reason Lilly is in court now for Zyprexa over at Furious Seasons.
Stephany, at soulful sepulcher