Which brings me nicely to a study recently published regarding a clinical trial involving a widely prescribed antidepressant. Citalopram, known better by its brand names of Celexa in the US and Cipramil in the UK.
Citalopram was tested in kids between 1999 and 2002 and was known as CIT-MD-18 pediatric depression trial. The results and subsequent publication of those results were, as we've come to expect, ghostwritten by PR company Weber Shandwick, more specifically it was ghostwritten by Natasha Mitchner at Weber Shandwick Communications, under instruction from Jeffrey Lawrence (Product Manager Forest Marketing)
For those who don't know, Forest Labs are the American pharmaceutical company that market Celexa. Forest Labs are a subsidiary of Forest Pharmaceuticals.
“A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents,” was published in the American Journal of Psychiatry in June 2004. However, its lead author wasn't neither Mitchner or Lawrence.
Some 10 years after publication a lawsuit against Forest was, in part, settled. The lawsuit, Celexa and Lexapro Marketing and Sales Practices Litigation, had during its intensive investigation, found the confidential documents relating to CIT-MD-18, 750 of which, have now been made public on the on the Drug Industry Document Archive (DIDA) website. In all, over 63,000 documents were handed over to plaintiff lawyers who were suing Forest Labs for the safety and efficacy of Celexa and Lexapro (US trade names for citalopram and escitalopram respectively) in marketing the drugs “off-label” for pediatric use.
The 750 public documents have been desconstructed by Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry and the results are startling, to say the least.
"The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance" shows, amongst other things, that;
CIT-MD-18...
- Contained efficacy and safety data inconsistent with the protocol criteria.
- Procedural deviations went unreported.
- Negative secondary outcomes were not reported.
- Adverse events were misleadingly analysed.
- Manuscript drafts were prepared by company employees and outside ghostwriters with academic researchers solicited as ‘authors’.
- Authors failed to mention that the five citalopram-treated subjects discontinuing treatment did so due to one case of hypomania, two of agitation, and one of akathisia, none of these conditions were found in the placebo group.
The deconstruction of the 750 documents also showed the authors that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. In other words, children taking citalopram found it as effective as taking a sugar-coated pill.
This is contrary to the 2004 study published in the American Journal of Psychiatry in June 2004 where it was stated that, "In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated."
Fig 1
Wagner is no stranger to controversy, she'd previously added her name to the Paxil 329 ghostwritten paper without actually looking at the raw data [which showed an increased rate of suicidal thoughts in kids taking Paxil]. It's also been learned through various litigation in the US that Wagner was paid to deliver lectures promoting the use of Paxil for depressed kids and teens to both GSK’s sales reps and doctors, this despite ever taking a look at the raw data of 329. Maybe she had faith in the ghostwriter of Paxil 329, Sally K. Laden, just as she did with the Celexa ghostwriter Natasha Mitchner ~ Who knows what makes Wagner tick?
In the complaint filed against Forest Labs it was alleged that the American pharmaceutical company arranged for Karen Wagner to give promotional presentations on the pediatric use of Celexa and to serve as the chair of a seven-city Continuing Medical Education ("CME") program on treating pediatric depression... even though the CIT-MD-18 trial was a failure.
So, to recap...
- Forest conduct clinical trials then write up the results of that trial via a ghostwriter.
- Once the study result are written, Forest hire well known pediatric psychiatrists to claim the the ghostwritten work is theirs.
- Despite Celexa showing no efficacy over placebo, the study (now allegedly written by Karen D. Wagner) shows that it "reduced depressive symptoms to a significantly greater extent than placebo."
- Forest Labs are denied a licence to sell Celexa for child depression but, none the less, send out reps to promote it's safety to prescribing physicians, who were often "dined and dashed" in efforts to get them to prescribe Celexa, the drug that was shown not to work in kids, to kids.
Oh, I forgot to mention, the kids targeted by Forest, Wagner et al were age 7 to 17.
Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry conclude their findings with...
"It is important to make these articles transparent to correct the scientific record. It is furthermore imperative to inform the medical community of mischaracterized data that could lead to potential harm to children and adolescents who are vulnerable to the effects of medication on the growing brain and may increase suicidal thinking and behaviour."
I couldn't agree more.
Jureidini, Amsterdam, and McHenry ~ take a bow. I salute you all.
Drs. Amsterdam and Jureidini were engaged by Baum, Hedlund, Aristei & Goldman as experts in the Celexa and Lexapro Marketing and Sales Practices Litigation.
Dr. McHenry was also engaged as a research consultant in the case. Dr. McHenry is a research consultant for Baum, Hedlund, Aristei & Goldman.
"The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance" appears in the International Journal of Risk & Safety in Medicine, vol. 28, no. 1, pp. 33-43, 2016
Fiddy Rant.
So, here we see yet another pharmaceutical company hiring the ghost writing services of a PR firm. Yet another pharmaceutical company who make claims that a drug is safe and effective when it isn't. Once again we see prominent psychiatrists adding their names to published papers when their input to these published papers is minimal to say the least. Furthermore, and yet again, we see a pharmaceutical company promote the use of a non-efficacious drug by wining and dining health care professionals.
Citalopram is from a group of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIS). It has been well documented that Citalopram can induce thoughts of suicide and homicide in many numbers of people that take it. Why then, did Forest Labs spin the data on the CIT-MD-18 pediatric depression trial? Why did Karen Wagner et al claim to have written the study when court documents show that it was written by someone else?
Moreover, what is it with pharmaceutical companies and top paediatric psychiatrists and their apparent lack of care for the safety of 7-to 17 year-olds?
Criminal charges need to be brought against those who played a part in the manipulation of this study. That goes for the top executives at Forest Labs, the reps who promoted its use in kids and the top psychiatrists who put their names to support the data (without actually looking at the data). Charges too should be brought against any doctor who received a bribe from Forest Lab reps, be that a free dinner of tickets to the baseball game.
Off-label prescribing of antidepressants to kids is wrong. I know there are some that disagree with me but look at the facts now. Study 329 (Paxil didn't work in kids) - CIT-MD-18 (Celexa didn't work in kids) ~ So, why prescribe something that doesn't work?
The side effects of Celexa are pretty horrific for adults let alone children ~ don't even get me started on they harm the can cause to fetuses!
The evidence in these two recent cases now show that neither Paxil or Celexa is beneficial to children yet in 2016 both drugs are still prescribed to children. The heavy illegal promotion undertaken by GlaxoSmithKline and Forest Labs reps still works to this day.
Shit doesn't just stink, it sticks.
Over to you, DOJ.
Bob Fiddaman.
Related
The jewel in the crown ~ Mikey Nardo
No comments: