The past few months have seen renewed vigor from FDA's DDMAC (Division of Drug Marketing, Advertising, and Communications) in scrutinizing manufacturers' claims of safety and efficacy. In particular, DDMAC has cracked down on makers and marketers of ADHD medications for their alleged false and misleading claims.

Shire Development (Wayne, PA) has received a warning letter from FDA for what the agency says are overstatements of the efficacy and understatements of the risk of Adderall XR, the firm's popular ADHD medication. The claim's were voiced in a testimonial by none other than Ty Pennington, host of ABC's "Extreme Makeover: Home Edition," on its own web site and on a popular Internet video site.

Why do men have all the fun when it comes to mid-life crises? With male mid-life crisis one pictures Harleys and trophy wives.  Think female mid-life crisis and you get  divorce, eldercare...

News came this week of a study (for a brief summary, click here) suggesting that, by mid-life, women are the sadder sex. The study's results were published in the improbably titled Journal of Happiness Studies.  Fortunately for some, there are pharmaceuticals to help with all this.  As for me, I'm taking the kids and grandma for a spin on the Harley.

--AMS

Take two valium, get some anger-management counseling, and stop working for PhRMA....

I haven't been keeping up with the news too well lately.  But I was surprised to learn from PharmaMarketing blog and PharmaGossip that T.V. talk show host Montel Williams recently confronted a high school intern working for a Savannah, Georgia newspaper who had asked him a challenging question (something along the lines of "Why are prescription drug costs so high?") during a press conference. 

He was in town to promote a lower-cost prescription program.  Click here for more from FOX News.  When he found the reporter at his hotel (she was there covering another event), he probably suspected that she was stalking him and reportedly told her "I can look you up, find out where you live and blow you up." Way to go. What a fine example and what a way to talk to a young person.

John Mack, PharmaGossip and others have suggested that PhRMA fire Montel.

Mr. Williams, a spokesperson for PhRMA, suffers from MS.  Perhaps his loyalty to companies that are working on a cure for this terrible condition overcame his reason.  I wish him well in his treatments.

 But it now appears that he could have used a few other prescriptions, too. 

I don't want to think of PhRMA's public relations people as the gang that couldn't shoot straight, given the combined brain power and funding, but does PhRMA really need any more P.R. liabilities?  We've definitely seen some over the years---- remember that lame spy novel? 

Perhaps Montel will voluntarily step down, admit to having an anger-management problem (and thus open up a whole new spokesperson opportunity, once a treatment for rage is approved for DTC advertising) and issue a public, televised apology?

AMS

Oh my.  Just after filing the last item, just noticed this tidbit of news from upstate New York. A school nurse reportedly passed a bottle of Ritalin to a teacher, to distribute to her kindergarten class, thinking it was fluoride tablets.  ( I knew that schools were able to recommend Ritalin to parents, but the prospect of school nurses being able to make this kind of mistake is beyond belief...shouldn't any student taking this medication receive the dosage at home, from a parent or caregiver, rather than at school?).  More evidence that Japan's on the right track in limiting access... 

-AMS

In a world where schools are often the first link in the marketing chain for pharmaceuticals treating ADD/ADHD, Japan has set an interesting precedent by stringently controlling access to the central nervous system stimulant.

The drug will be approved only for treatment of  narcolepsy and subject to controls similar to those for narcotic pain relievers. Novartis Pharma K.K., which makes and distributes the drug, will develop a new distribution system by next year, and hospitals and pharmacies that prescribe the drug will have to be pre-registered.  Janssen Pharmaceutical in Japan has proposed a similar management system for the ADHD drug, Concerta. More from Japan's Yomiuru Shinbun.

Perhaps the rest of the world could consider similar controls. ADD and ADHD may be bona fide conditions, but the terms also serve as overly broad umbrellas covering a huge range of potential underlying problems and conditions.  All of which means that all too many children are receiving treatment for "conditions" that they don't really have and taking medications that wreak havoc with their nervous systems.

-AMS

Lawyers are better known for creating depression (especially after submitting their bills)than suffering from it. Do you know a pharma lawyer or two who could use some special support?  (I'm imagining a certain team at an unnamed PFarma company handling a major international case that might want to visit the site at some point this summer). You might direct them to Lawyerswithdepression.com.  For more information, click here.  

All kidding aside, three cheers for Daniel Lukasik, Esq. who established this site, whose mission is explained here.

Hat tip to Nima Taradji's legal blog (which I discovered while trying to find more information on "Olagunju vs. Novartis" case...a fruitles search so far. A legal expert who contacted me says the case may be pending, which would explain why information is not available).

-AMS

ABC News aired an unusual spot last night, about a new virtual reality tool developed by Janssen Pharma in New Jersey, designed to educate physicians and law enforcement personnel on how it feels to be schizophrenic.  It puts the viewer directly in a kitchen where the news report is directed personally against them, the newspaper headline is against them, voices call the viewer "stupid," the recently delivered pizza is poison (and even smells poison)The goal is to better inform and improve response. 

For more on this,  click here.  To watch a video (including a short demo clip) click here.

But the ending is a bit sinister.  "Miss your dose of medication?" a helpful woman asks.  Of course, drugs do help those afflicted with this horrible disorder, but the film does have a Big Brother feel to it.  What do you think?

-AMS

Daniel Carlat has launched a "Doctors for Dollars" award,  to recognize companies whose CME programs overstep the boundaries between legitimate CME and marketing.  The first winner: Shire Pharma (a leader in ADD/ADHD drug development), its marketing and medical partners.  For more, read on.

This week marked the 20th anniversary of Prozac.  Columnist Anna Moore shared insights and 20 observations on the drug, its history its legacy and uncertain future in "Eternal Sunshine," this recent op-ed  published in the U.K.'s Observer.  The drug, and other treatments for psychological conditions, are being given to patients who have absolutely no say in their treatments.

Maybe we can understand its being given to some pets.  Maybe. Over 10 years ago, before there was an FDA-approved form of the drug for dogs, Michael Moore (of SiCKO fame) aired a "Pets on Prozac" segment in his series, TV Nation.  The five-minute clip follows one Long Island pooch's road to recovery from OCD, touching on a parrot's experience as well.  To view, click here.  Treatment for each veterinarian patient is estimated to cost $100 per month for each pet, begging the question: just who is (or should be) the patient here?

But, as Anna Moore writes, Prozac and drugs like it are being prescribed to young children and even toddlers.  Between 1995 and 1999, use of antidepressants to treat children aged 7 - 12 increased by 151%, and treatment of those under 6 grew by 580%.  In 2004, children ages 5 and under were the fastest growing non-adult patient group.

Antidepressants, she writes, have been most often used in this age segment to treat "selective mutism" (a "condition" in which children do not speak up in preschool class). 

There's no way that this could be caused by an overbearing parent or teacher, or an aggressive classmate.  Or simply getting used to the structure of school after the freedom of all-day play. Nope. Must be a neutrotransmitter imbalance.  

Selective mutism has  joined other disorders that we never knew existed, such as social anxiety disorder (once known as shyness) or  oppositional defiant disorder, in which children do not listen to or comply with elders' requests. It used to be called "backtalking."  Some might argue that this isn't the result of inconsistent parenting, but rather an organic condition.

But, ODD is often linked to ADD and ADHD, thus all roads lead straight to the medicine cabinet. And all too often, schools, although well-meaning, appear to become the first stop in the path to unnecessary medication.

It's tempting to imagine how great figures in history would have turned out in a system such as the one that we see at many schools in the "no child left behind" U.S. today. Attached, a  riff on Mrs. Mozart's encounter with the school principal before her son's first IEP meeting. mrs-mozarts-iep.doc