This one is courtesy of The Insider, at PharmaGossip:
. . . .Monday, January 18 live from 7:00-8:00 p.m. EST on the Philadelphia CNN-News affiliate WFMZ-TV and streaming online at WFMZ.com, The American Law Journal presents "Ask Your Doctor If 'x' is Right for You — Does Drug Advertising Help or Hurt the Consumer?" Philadelphia-based lawyers and a prominent pain physician address the legal, medical and social implications of direct to consumer drug advertising. Former New Jersey prosecutor Christopher Naughton, a legal commentator and 20-year legal broadcasting veteran, hosts the program.
On the panel representing consumers and pharmaceutical whistleblowers in nationwide, complex pharmaceutical litigation and recent landmark pharmaceutical settlements is Stephen Sheller, Esq. of the law firm of Sheller, P.C.. Raymond Williams, Esq. of DLA Piper brings his expertise defending top-tier pharmaceutical companies in high-profile cases to the conversation. Joining Sheller and Williams is physician Frank J.E. Falco, M.D., CEO of the Mid-Atlantic Spine & Pain Physicians and Vice President of the American Society of Interventional Pain Physicians. The program will address both informational and product drug advertising with an emphasis on the rapid growth of marketing and prescribing antidepressant and antipsychotic drugs. . . .
I'll post a streaming link, once one is made available.
4 comments:
There is a great discussion underway over at PharmaLot -- of the news that antipsychotic medication prescriptions in young children have doubled in the last decade. Clearly, DTC is playing an awful role here.
Particularly cogent are Salmon's comments in this discussion, thus:
. . . .I’d like to expand on Dr. Helm’s comments on the prevalence of significant psychopathology in childhood requiring the use of antipsychotics. I think it might also put in perspective the arguments of those who point out that there is for some a real need.
There are some children who have such blatent psychopathology that using antipsychotics is really a last ditch effort. However these are few and far between. For example it’s likely that most of us (including psychiatrists) have never been exposed to young profoundly mentally retarded and/or autistic children with IQ’s in the 30s who constantly hurt themselves for example by slamming their heads against the floor. These children are typically institutionalised and the alternative (or additive) is physical restraint. Even so we really don’t have good data on if the drugs really work.
Howevere in all honesty the debate of use of antipsychotics in children is not in these children. It’s in children who are much less severely effected.
The most severely ill institutionalized really add up to no more than a handful per state yet private health insurance and medicaid figures put the numbers of children being medicated at 1% and 4% respectively. For Medicaid this is greater than the % of adults with schizophrenia and bipolar 1 disorder who might benefit. So it’s clear that there’s a gross amount of overprescribing.
These numbers include children down to 5 years old and since you expect the cases to be rarer and rarer as you go younger and since the drug companies claim that not even all adolescents who should be treated are (i.e. ~ 0.1% - 0.2% of the population). Then clearly the only way to obtain these numbers (1% - 4%) is to have a huge percentage of young children younger than 12 years of age on these meds. (This is confirmed when you look at the data by age which shows about half the pediatric usage is in the under 12 age group.)
Information presented at recent FDA advisory committee meeting indicate that schizophrenia is so uncommon in children less than 15 years that it’s almost unheard of, and is about 0.1% from 15 - 18 yo. As for bipolar illness 0.3% develop initial symptoms between 13 and 18 years yet the severity isn’t sufficient to make a diagnosis in the majority for at least 8 years on average, i.e. when patients actually have a manic attach (which even then may not be severe enough to justify antipsychotics). . . .
[To be continued, below. . .]
PART II:
. . . .Over the past several years there has been a push to identify children who become ‘agitated’ on methyphenidate (for ADHD) as possibly having bipolar disorder. This has resulted in class warnings in labeling for ADHD drugs. However an FDA advisory committee held in 2005 which looked at this used a definition of agitation not as psychotic agitation (which might truly be a predictor) but any irritability (which might only mean overdosage). All told in post marketing reports there was only around 70 cases of any ‘agitation’. FDA analysis revealed that the vast majority were plain irritability and occurred in very young children who were started on extremely high dosages, most others were in children who had been stabilized but whose dosages were then increased (also an indication of overdosage). There was only 1 good case of psychotic agitation with a low subtherapeutic initial dose and this was in an 18 year old and so this 1 case of inducement of possible psychotic agitation (indicating a possible propensity toward mania or schizophrenia) was not even in a pediatric patient.
Followup analysis by Andy Mosholder of the FDA (the reviewer who revealed suicidality with antidepressants)revealed and incidence of irritability in around 1% of young patients (6 - 12 yo) with ADHD. If we take the incidence of ADHD at 4% this results in being able to induce a possible indicator of mania in 0.04% of children (i.e. 1 in 2500). Even so inducing a possible indicator does not mean that the psychopathology rises to the level indicating the need for antipsychotics (i.e. acute mania with psychotic features).
I am not saying that the use of antipsychotics in young children is never needed. However the numbers indicate the appropriate usage for pediatric bipolar might be on the order of 1 in 25,000 whereas the actual usage of antipsychotics is at least greater than 1 in 100 and up to 1 in 25 in the Medicaid population, i.e. possibly 1000 fold higher than it should be.
-- Salmon
Posted January 17th, 2010 @ 12:14 pm
I appreciate your highlighting of my comments and the posting of the Dr. Laughren's (the current FDA Psych division director) on concerns regarding asenapine during development.
I don't believe you've addressed it but about 10 days ago (Jan 8 - 10th) there was a thread on Cafepharma discussing rumors that Merck was shopping for a buyer for asenapine (Saphis).
I found this interesting, for if it's true it means that Merck believes it's more advantageous to sell asenapine (Saphis) to another company rather than keep it in house.
Per Fred SP purchased Organon for $9 billion for their late stage compounds. Of the 5 late stage compounds, asenapine (Saphis) was supposed to account for 50% - 75% of the expected sales from these compounds. (Depending on if you took older projected sales of $2 Billion or $1 Billion per year).
Approval was then delayed, but in early 2009 FDA (via an approvable letter and initiation of labeling negotiations) signaled that approval would be coming. A few weeks later the sale to Merck was announced ($41 Billion). Based upon what I've seen it seems that this NME was the feather in the cap of this deal.
Saphis was then approved in Aug 2009 with a market launch ceremony headed up by Fred in early October 2009. Approximately 1 month later the deal with Merck closed.
It's now 3 months since launch and the comments on Cafepharma indicate that sales may top at 3-5% of antipsychotics. Even so that means sales of up to $1 Billion per year in the US alone (which is higher than earlier projected total sales).
Even if this is a $500 Million per year drug it seems to me after shelling out so much and not having a pipeline that it doesn't make sense to sell it for projected poor sales.
So if the rumors of a sale are true does this mean that there is something else going on? For example a safety issue that Merck doesn't want to have any responsibility for.
Salmon
Thanks Salmon -- I do always appreciate your input -- well-informed, and timely!
I did see that CafePharma posting -- but I've been waiting to see if any financial news outlet runs a similar rumor piece, before commenting on it, here.
That out of the way, I do think Merck will have liability, no matter what -- it has operated the Saphris franchise for almost a full quarter now. Whatever Schering-Plough knew, Merck may now fairly be charged with knowing.
So -- at least from my vantage point -- if the rights to Saphris are sold-off later this year, it will be just one more chunk of Fred Hassan's "bust-up" by bumbling -- by accident. More proof that this was no merger-of-equals, at all.
Though truthfully, I think Fred's actions were no accident -- at all.
Namaste
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