Florida To Review Antipsychotic Guidelines For Kids
24 CommentsBy Ed Silverman // June 25th, 2008 // 8:12 am
A long-awaited meeting will be held today in Florida to discuss changing state guidelines on paying for antipsychotic drugs for children. At stake is the future treatment of more than 18,000 Florida children who receive atypical antipsychotics for conditions ranging from ADHD to bipolar disorder and schizophrenia.
The number of children in the Florida Medicaid program prescribed the powerful drugs has nearly doubled from 9,364 kids in 2000 to 18,137 in 2006, according to published reports. Among those children, the most common primary diagnosis has been ADHD, an ailment not approved for treatment with antipsychotics by the FDA, which is a key reason the meeting is being held.
However, the state Agency for Health Care Administration has been maneuvering around the topic even before today’s event. Without any apparent public notice, the agency in February began requiring prior authorization before antipsychotics can be prescribed for any child younger than 5, according to a spokesman, although that would still include treatment for ADHD.
The agency is also proposing a rule change to permit Medicaid reimbursement under one of two circumstances: if an antipsychotic has an FDA-approved use or is listed in an official compendium or - and this is the new twist - if prior authorization is granted. Both moves would continue to make it possible for very young children to receive antipsychotics. Only Johnson & Johnson’s Risperdal is approved for children as young as 5, and only for treating irritability associated with autism.
By contrast, a state-funded study in 2005, by the Medicaid Drug Therapy Management Program for Behavioral Health at the University of South Florida, recommended antipsychotics should not be used primarily to target ADHD or be given to children younger than age 6 except under the most extraordinary circumstances.
Meanwhile, one panel member continues to generate controversy. Rajiv Tandon, chief of psychiatry for the state Department of Children and Families and a former University of Michigan professor who was once a consultant and speaker for drugmakers that sell antipsychotics. Tandon tells us he ended his pharma consulting when he joined the state agency in 2004, which a DCF spokeswoman verified.
A recent disclosure form indicates he has been a member of the national scientific advisory board for the National Association of the Mentally Ill between 2005 and 2007. NAMI is partly funded by drugmakers that market antipsychotics (see the annual report). However, it should be noted that his NAMI affiliation is listed as an uncompensated position.
When asked why Tandon was chosen for today’s panel meeting, a spokesman for the AHCF wrote us that “a large proportion of Medicaid recipients receiving the medication that will be reviewed are Foster Care Children that fall under his purview as chief psychiatrist for DCF. We feel that it is appropriate that he serve on a committee that will be reviewing the use of medications in the pediatric Medicaid population due to the impact to children under DCF care.”
The spokesman cited three other reasons for choosing its panel: the member are all health care professionals; the AHCF had the opportunity to work with the panel members in the past and is confident in their expertise; and the panel members were all available and willing to serve. Here are the disclosure forms filed by the panel members.
Lisa Van S
A Fox in charge of the Hen House,.. how comforting. Has Dr. Tandon pulled a Biederman? Id like to know if he has any financial interests that he has failed to disclose.
Sam
According to the Center for Medicare & Medicaid Services http://www.cms.hhs.gov/MedicaidDrugRebateProgram/SDUD/List.asp
In 2006 Florida Medicaid paid the following for Atypical Antipsychotics:
aripiprazole (Abilify) $26,901,998.01
clozapine $1,311,989,76
olanzapine (Zyprexa) $17,271,486.89
quetiapine (Seroquel) $38,042,173.44
risperidone (Risperdal) $36,415,307.93
ziprasidone (Geodon) $8,683,077.23
—————
$128,626,798.22
This is for all ages as the CMS does not include patient ages. A similar report on Medicaid spending in Michigan in 2005 which was only for pediatric Rxs shows a 12.74% pediatric portion of the total Medicaid payments, which gives a ballpark figure for Florida Medicaid payments for pediatric Rxs for 2006 of $13 Million.
Medicaid is funded by taxpayer dollars: 1/2 comes from State taxes and the other half comes from Federal taxes, so even if you don’t live in Florida, your Federal taxes helped pay the above amount.
Also note that while this review concerns the atypical antipsychotics, there are a number of other psychiatric drugs that are not FDA-approved for pediatric use or are only approved for specific indications, such as the SSRIs (Prozac is only FDA-approved for MDD and OCD; Paxil is not FDA-approved for pediatric use; Zoloft is only FDA-approved for OCD) or SNRIs (Effexor is not FDA-approved for pediatric use). The total Medicaid reimbursements for Florida for 2006 for not FDA-approved or limited approval was $254,020,456.84.
You can see the National Summaries for these drugs at http://www.psychdrugdangers.com/US/MedicaidPayments.html which covers the CMS data for 2004 through the 3rd quarter of 2007. The huge drop from 2005 to 2006 ($14 billion in 2005 to a mere $4 billion in 2006) is when Medicare Part D kicked in (CMS does not have payout statistics for Medicare).
Ed Silverman
Hi Lisa Van S,
In response to your question, I’ve added a link at the very bottom of the post that shows the disclosure forms filed by the panel members.
Hope that helps,
ed
Lisa Van S
Ed,
“Dr. Tandon has authored more than 250 scientific publications, edited two books, and given over 600 National and International Scientific Presentations.”
1.) Has any of those articles been ghost written.
2.) What books were edited and where did the financing/payments come from.
3.)I have traveled Nationally and Internationally,.. I can assure you it isnt cheap,.. so who payed for his travel and speaking engagements?, his employer the University?.. I dont think so!!
Disclosure is incomplete, yes?
Ed Silverman
Hi Lisa,
I can’t say whether the disclosure was complete or incomplete, I only offered what I had, which was what he submitted prior to today’s meeting.
You asked some good questions, although it seems the state has decided to draw a line in the sand - before and after his state employment. Should the timeframe matter? I suppose that will depend on different viewpoints. The state says no. Others may say yes. That’s why I made this info available - to let everyone sort it out.
However, if his travel to, say, a NAMI speaking engagement was paid for by the organization or, theoretically, a drugmaker, that should have been noted. His affiliation is described as uncompensated, which is supposed to be mean just that - he travels on his own dime.
I’m afraid I can’t answer your question right now about any ghostwriting, which is a more complicated undertaking to address at the moment.
Regards
ed
Lisa Van S
A Psychiatrist traveling on his “own” dime!.. I dont think so. Traveling over 600 times would take a huge chunk out of ones own pocket.
The American Taxpayer deserves full disclosure!!
Ed Silverman
Hi Lisa,
What I don’t know is when those trips occurred - before or after he began working for the state of Florida, since the state has decided that his consulting work prior to his employment with its agency is not an issue.
ed
Lisa Van S
Since Dr. Rajiv Tandon is affiliated w/NJ Health Services his consulting work prior, is a HUGE ISSUE, since he was a clinical investigator for Abilify, the most prescribed antipsychotic to Children in New Jersey’s Foster Care Program.
Lisa Van S
I’d also like to know if he visited key policy makers here in NJ and if he did who payed for his travel expenses? Great question,dont you think
Susan
We need to tread very carefully in how we handle off-label uses, especially in a very selective fashion, on an expensive drug.
Speaking personally, my bright, funny daughter has ADHD (with behavioral issues, but no comorbid diagnosis), and we have gone through three years of intensive behavioral work as well as endless medication changes to try to find the right mix.
This fall (after much discussion) we tried adding extremely low dose Abilify to her other ADHD prescription, and the change was dramatic. She is now having much greater success both in school and in her social interactions — she is thrilled, her teachers are thrilled, her father and I are thrilled. We track and watch for side effects very carefully, but this drug has been transformational for her, off-label or not.
Every time I see the $500 list price on the label when I pick up her monthly prescription, I murmur thanks to my employer’s generous Rx coverage, and cringe at the thought that I could ever be stuck picking up the cost for a drug that does so much for my child.
Three years ago I might have been one of those “informed” observers making statements about the overuse of drugs for ADHD. Now I’ve lived it, and I know that the story is more complicated, and that our children’s success and happiness depend on us getting this right.
AA
Susan,
As one who has a family history of ADHD and who is probably borderline myself, I am not one of those folks who thinks it is a made up diagnosis.
However, I think you are making a big mistake putting your daughter on Abilify. Yeah, she is getting benefits now but over the long term, this drug destroys learning capability along with having some nasty side effects including withdrawal symptoms. As one who has LD, I find it very cruel that psych meds made my LD and borderline ADHD alot worse. Do you really want to do that to your daughter?
I am not saying this to condemn you by the way. I definitely understand the despair in trying to find anything that can help. But I really feel your daughter’s success and happiness is being jeapordized long term even though it may not seem like that now.
I would strongly urge you if you haven’t done so already to look at non med alternative like fish oil capsules. The Nordic Brand with high EPA worked great. Unfortunately, they caused insomnia which is a whole other issue.
I have also seen studies that show that fish oil capsules with just EPA and no DHA work great.
You also might want to go to http://www.vitasearch.com and plug in ADHD. Yes, in the name of disclosure, it is sponsored by a vitamin company. But the links are to mainstream journals.
Good luck.
AA
Margaret
In memory of little Rebecca Riley, I find these numbers disgusting, though I also do not condemn - only warn - Susan. I suspect atypical antipsychotic use went up dramatically in children (the psychiatrist has to have something to hand out, right?)when SSRIs were given a black box warning for those up to age 24. Thank God for that, but where is the black box warning for this class of lethal drugs being given to children? Perhaps it’s the lack of suicides.
Sam
Margaret,
The atypicals have been reported to the FDA’s MedWatch system as the Primary Suspect Drug for an impressive number of Suicidal Ideations, Attempted and Completed Suicides, Deaths (not from Suicide), Homicial Ideations and Homicides in addition to a laundry list of adverse reactions that, cut-and-paste, fill 25 pages of a Word document. Go to http://www.psychdrugdangers.com/?drugtable=atypical and then click on the Combined Summary link. Why the FDA has not ordered Black Box Warnings for the atypical antipsychotics like the SSRIs is a mystery to me.
Sam
Perry Mason
Your honor,
If I may I’d like to approach the bench and offer the below as Exhibit A into evidence:
June 1, 2004
http://tinyurl.com/4js8yx
FACULTY DISCLOSURE STATEMENT:
Dr. Tandon is on the Speakers Bureau for Astra Zeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, and Pfizer
If there is no objection your honor, I’d like to make a motion that Rajiv Tandon be found quilty of conflict of interest. Conflict: Speaker’s Bureau of drug companies while employed by the State of Florida in the capacity of influcencing drug policies.
Lisa Van S
Hey Ed,.. I find your selective reporting on Dr. Tandon and this issue Quite Disturbing. Our children deserve better than that from you!!!
Lisa Van S
Hey Ed,.. No response? Or just being a coward? I challenge you to do your job!!!!!!!!!!!!
Ed Silverman
Hi Lisa,
No selective reporting. To reiterate, I’ve noted both in this post and previous posts that Tandon has acted as a paid consultant to industry. The info provided by ‘Perry Mason’ had been reported by newspapers in Florida earlier this year and was included in my earlier posts.
In Florida, state officials have decided his previous work for pharma - which occurred prior to his role as a state employee since 2005 - is not relevant to his participation on the panel. I included all this info in this latest post, and some folks may agree with the state’s view and others may not. But I’ve put it out there for those who want to mull it over.
As to his efforts in other states, I don’t know yet if he was a paid consultant or not. I just haven’t gotten there yet. My job, as you know, involves scanning the universe all day, every day - even on most weekends - and actual reporting takes more time than hunting and gathering and linking to something else. So please be patient.
Regards
ed
Perry Mason
Your honor,
No newspaper has written on the very extensive evidence available on Rajiv Tandon. A slight mention was made one single time. And here is that mention: “he was a paid consultant and on the speaker’s bureau for several drug companies that make atypicals.” April 13, 2008, St. Petersburg Times
He started working in Florida in 2004 - not 2005.
His work for pharma did occur after his employment with the State of Florida.
The previous documentation certainly is valid and this makes it even more clear:
December 2004
http://tinyurl.com/62guqc
Rajiv Tandon, MD, Chief of Psychiatry, Florida Department of Children and Families, Tallahassee, Florida
Dr Tandon reports serving as a consultant to AstraZeneca LP, Bristol-Myers Squibb Company, Eli Lilly and Company, Janssen Pharmaceutica, and Pfizer Inc.
Ed Silverman
Hi Perry,
I think you misunderstand me. I am merely trying to point out that, right or wrong, the Florida AHCF has chosen to decide that Tandon’s consulting work for the various drugmakers is now irrelevant to his employment with the state.
You are correct in that he began work for the state’s AHCF in the spring of 2004. My apologies.
I do have several examples - including the one you offered - in which he is listed as an author on papers that were published in the following 12 months or so. However, the disclosures made in those papers may reflect the fact that the papers were submitted around the time he still worked for the University of Michigan and as a pharma consultant, based on the wording of the journals’ disclosure forms (which I have not seen).
For the moment, the state AHCF spokeswoman maintains that Tandon ended his industry consulting after his employment began, and claims to have been aware of the specific relationships cited in the various journal studies that list his relationships to those drugmakers.
That said, I am in the process of following up other leads that may shed more light on this situation.
Regards
ed
Perry Mason
Your Honor,
The documented drug ties clearly conflict with the Florida flack’s assertion that this was all pre-Florida. The documents clearly show drug ties years after he was hired by the State of Florida.
It’s all over the net. Here’s yet another solid reference:
November 22, 2006
http://tinyurl.com/6caggw
Rajiv Tandon, M.D., of the University of Florida in Tallahassee gave a presentation. Both Dr Tandon and Dr. Feldman are members of the speakers bureau for Janssen, the sponsor of the symposium, and have financial relationships with Pfizer, AstraZeneca, and Bristol-Meyers Squibb as well.
Ed Silverman
Hi Perry,
As I indicated earlier, I’m aware of potential examples and I am following the trail. You seem to want to argue instead.
ed
Perry Mason
Your honor,
That’s what we’re trained to do in this profession - argue.
And present evidence.
And blow smoke when necessary.
No smoke here though - all fire:
2007
AstraZeneca Pharmaceuticals LP4; Bristol-Myers Squibb Company4; Eli Lilly and Company4;Janssen Pharmaceutica Products, LP 4; National Institute of Mental Health 4; Otsuka America Pharmaceutical, Inc4 ; Pfizer Inc.4
(1 = consultant or advisory board; 4 = speakers’ bureau)
Perry Mason
Your honor,
That’s what we’re trained to do in this profession - argue.
And present evidence.
And blow smoke when necessary.
No smoke here though - all fire:
2007
http://www.psychsearch.net/apa2007.pdf
AstraZeneca Pharmaceuticals LP4; Bristol-Myers Squibb Company4; Eli Lilly and Company4;Janssen Pharmaceutica Products, LP 4; National Institute of Mental Health 4; Otsuka America Pharmaceutical, Inc4 ; Pfizer Inc.4
(1 = consultant or advisory board; 4 = speakers’ bureau)
Lisa Van S
Ed,
Thanks for your response I appreciate it. If Tandon has some shady ties he should be exposed.