My son gained 90 pounds on atypicals in 15 months while in foster care. It took a year to slowly wean him from what his pediatrician and psychiatrist agreed after discharge was over-medication. It took 4 years for the weight to drop off. Some young people with similar response have collapsed in a coma due to high blood sugar and died. The psychiatrist in his RTC scoffed when I asked about FDA warnings. He did not have significant behavior problems before he went on the drugs or after he was finally weaned completely from them. He hated the “drugged feeling”–which simply added to his frustration and contributed to difficult behavior.

I think there can be a place for off label use–but that does not mean MA programs should have free rein. My state’s policy that exempts psych drugs from prior authorization also exempts cancer and HIV drugs. In other words, the formulary does not restrict which of these drugs can be prescribed without prior authorization. It does NOT exempt drugs to treat many other serious illnesses, such as heart disease or serious auto-immune disorders. I don’t see the justification–any patient whose mental condition is severe enough that death or serious injury may result without the latest brand-name drug (instead of an older, cheaper drug) needs to be closely monitored even if the drug is administered, even more so (since starting a new drug can precipitate more serious psych problems). I am in favor of requiring review and prior authorization before administering expensive, new-generation drugs for off label uses on children.

See this blog…

http://blog.myspace.com/index.cfm?fuseaction=blog.ListAll&friendID=400510998

look at the videos and click on the links.

http://profile.myspace.com/index.cfm?fuseaction=user.viewprofile&friendid=400510998

NJ… stop drugging our kids, teens, moms, dads….society….all for big Pharm $$$$.

As for pediatric abuse: if a drug is not FDA-approved for pediatric use, then doesn’t that mean that there is no “label” listing approved Indications that a doctor can then prescribe “off-label”?

The FDA says for many of these that “this drug is not approved for use in pediatric patients” (see http://www.psychdrugdangers.com/NotApprovedForPediatricUse.html for a complete list). Why? Because it has not been demonstrated that these drugs are effective and/or safe in pediatric patients. How is any off-label use (if “off-label” is even the correct term) justified?

Every one of these not FDA-approved psychiatric drugs have laundry lists of reported adverse reactions including suicidal and homicidal ideation, murders, suicides and deaths.

Why are my (and your) tax dollars being spent to pay for a completely unproven (as far as the FDA is concerned) “treatment”?

This isn’t “somebody elses” money that paid (and is paying) for these. Medicaid is fully State and matching Federal tax funded, so you either paid the full portion of the estimated $7 Billion in pediatric Rxs for unapproved drugs if the patient resided in your State, or you paid half with your Federal taxes if the patient resided in any other State.

Then why are controlled clinical studies the ONLY thing that the FDA looks at when a drug comes up for approval?
Why does the FDA dismiss their own Medwatch reports as “anecdotal”, when they are patients firsthand reporting of their experiences on a particular drug due to them not being “controlled reports”?
If a doctor is prescribing off label, without the patients knowledge, then he is in fact conducting his own trial without the rigors that the clinical trial system requires. This practice opens a pandoras box of misinterpretation of information based on one practitioners use.
We have drug approvals for a reason.

Lisa - I hope you’re OK.

Would you please e-mail me. I would like to seek your advice on an oncolgy issue.

The estimates I’ve seen suggest that off-label use is in the neighborhood of 20%-30%. However, much of that may be technically off-label, but quite accepted. In other words, there are large quantities of peer-reviewed data to support a product’s use in a condition, but, no pharma company has bothered getting an approval. This is not uncommon for for instance in older, generic cancer drugs. The more interesting figure would be the percentage of scripts for drugs when little data is available to support the off-label use. I suspect that this is far, far smaller, probably in the low single digits.

Atlex

With regards to your second point, a blanket answer is probably not appropriate.

Also guessing it includes things like doxycycline for rosacea, “cortisone” injections for inflamed joints, etc. Would what is already known about such medications (a great deal) be enough to inform patients, even in the absence of approved indication?

“While controlled trials are very valuable they are not the only source of information on what are effective treatments”

No Placebo Controlled Studies; No FDA Approval.
Negative Placebo Controlled Studies; No FDA Approval.

Since when have Parents allowed Society to dictate or determine what is an effective treatment for their child.