One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”
Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded atCourtroomView Network.)
In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk (click to enlarge):
But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines (pictured) had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:
When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:
The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”
Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J … [and] no competent person would have let [the 'dear doctor letter'] go out”:
J&J faces up to $36 million in fines as a result.
And make sure you read Mr. Edwards Related Reports.
Related:
- J&J Drug Is a Wash for Schizophrenia but Worked Wonders on Taxpayers
- J&J May Be Liable for Antipsychotic Kickback Scheme Despite “Legal” Contract
- Dumbest PowerPoint Ever? J&J’s P&L Slideshow of Alleged Kickback Scheme
This kills me...The betrayal and outrage is at times overwhelming. When this drug was started my son he was 8---and it was for prescribed "off label" for his aggression--in lieu of the psycho/social and cognitive behavioral intensive in-home mental health services that were recommended by multiple doctors to treat his complex PTSD.
ReplyDeleteMy son had complex PTSD due to being the victim of violent crime in foster care.
Was Rispredal even approved for use in children at all in 1996?
I also discovered that the use of antipsychotics was shown in multiple studies to be ineffective to treat aggressive behavior in children---years prior to them being given to MY son "off-label" FOR AGGRESSION. "Off-label use is supposed to be for drugs shown to be effective---but have not been ot shown in research YET, so not approved for that use or group; IT IS NOT TO PRESCRIBE DRUGS FOR USES WHICH HAVE BEEN SHOWN TO BE INEFFECTIVE IN MULTIPLE CLINICAL TRIALS!!!!!
I now know it was the effects of this drug, among others, which made my son steadily worse and NEVER better---I am so angry---effects of the drugs were attributed to the worsening of my son's condition when they were in fact worsening his condition! The "side-effects" were even believed by some of those who "worked with" him to be choices he was making...He just did not want to get better, do well, etc. He was labeled "oppositional defiant" by the idiots who held him to a standard of accountability they themselves as his "role models;" teachers, doctors and therapists did not require of themselves! Who in the hell wouldn't become oppositional and defiant with this kind of "treatment"?!
With 2 posts, just 2, these Doktors are left with only 1 Courtroom excuse.
ReplyDeletehttp://psychroaches.blogspot.com/search/label/Akathisia
They're too stupid to be Doctors. If they admitted that they Do know what they're doing, any jury in the land would throw the book at them in a 12 to nothing heartbeat.
These people make 6 figures. They work with these drugs 40 hours a week, for Decades. It's their Job & their Responsibility to know what these drugs are.
But they're 'Off The Hook' because the manufacturer wrote them a false and misleading Dear Healthcare Provider Letter.
It's intentional. It's wink and a nod, because a private Citizen has a Snowball's chance in Hell of suing a Drug Company, so the Drug Company takes the heat by pretending to deceive their pseudo-Doctors who peddle their drugs at street level.
But then what can you expect from an industry which reveres an extra-marital affair peddling, horoscope casting Gasbag who claimed that Hitler was a Demi-Deity? (since their Freud Fraud has Already been pretty much yanked out from under them)
"Was Risperdal even approved for use in children at all in 1996?"
ReplyDeletehttp://freepdfhosting.com/420b178a4d.pdf (pg 7)
On Dec 29, 1993, the FDA approved Risperdal oral tablets for the management of the manifestations of psychotic disorder in adults.
On June 10, 1996, the FDA approved Risperdal Oral Solution for the management of the manifestations of psychotic disorder in adults.
In 2000, the FDA required Defendants to revise the Risperdal label to clarify that its FDA approval was for use in schizophrenic adults only. Thus, in early 2002, the description of the approved use for Risperdal was changed from "management of the manifestations of psychotic disorders" to "treatment of schizophrenia".
On April 2, 2003, the FDA approved Risperdal M-Tab (a melt-away form of Risperdal) for the treatment of schizophrenia in adults.
On October 29, 2003, the FDA approved Risperdal Consta (a long-acting injectable form of Risperdal) for the treatment for the treatment of schizophrenia in adults.
On December 4, 2003, the FDA approved Risperdal oral tablets, Risperdal Oral solution and Risperdal M-Tab for the short-term treatment of acute manic or mixed episodes associated with Bipolar I disorder in adults.
From the product launch in 1994 until late 2006, Risperdal had no FDA approved indication for any use in the child and adolescent population. In October 2006, Risperdal received a very narrow indication for use in a limited population of children and adolescents (age 5-17) for irritability associated with a diagnosis of autism. Additional extremely narrow indications for Risperdal were approved by the FDA in August 2007, for Schizophrenia in adolexcents (age 13-17) and for manic or mixed episodes of Bipolar I in children and adolescents (age 10-17).
So, in answer to your question, no, at least not by the FDA until 10 years later in 2006.