Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, January 31, 2014

Karen Wagner on Treating Kids With Antidepressants




Dr Karen Wagner, "no financial relationships with pharmaceutical companies"



You'd have to be from the planet Zog if you didn't know who Karen Wagner was.

Her name is synonymous with antidepressant pediatric studies. She 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] - The result of that piece of Pharmafia fraud told millions of prescribing physicians that Paxil was safe to use in children and adolescents...when in actual fact it wasn't.

Wagner has been relentless to disprove those who believe antidepressant use in kids is wrong. She sees no problem with it...despite overwhelming evidence that shows just how dangerous antidepressant use in kids can be.

An article published in Clinical Psychiatry News a couple of days ago shows Wagner, once again, promoting the use of SSRi medication in children and adolescents.

Wagner was present at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry where she claimed that "...60% of youngsters will respond favorably to their first antidepressant medication – generally a selective serotonin reuptake inhibitor (SSRI)"

Wagner also went on to claim that Switching to a different antidepressant will help about 50% of those who don’t respond. But adding psychotherapy will grab about 10% more – bringing the total response rate up to around 70%". She was referring to a 2008 study, TORDIA (Treatment of Resistant Depression in Adolescents)

So, Wagner hits the stage at these types of events, she's a key opinion leader, in other words, those employed in the same field as her look up to her, respect her, hang on to her every word. She is the Geldof of the pop world, pushing her message at every given opportunity. Quite why she sticks her middle finger up at evidence that shows kids kill themselves whilst on these drugs kind of alarms me.

So, is Wagner on a mission to help depressed children and teens, does she genuinely care about this population or are there more sinister undertones?

It would help if she and the article published in Clinical Psychiatry News was actually more transparent about her relationship and financial ties to the pharmaceutical industry [Pharmafia].

Upon reading the article I had to do a double take at the end... "Dr. Wagner has no financial relationships with pharmaceutical companies."

Um, excuse me?

Was this a line Wagner told the writer of the article, Michele Sullivan, or has Sullivan just not done her homework?

The content of the article doesn't interest me. Anything that comes out of the mouth of Karen Wagner should be carefully scrutinised given her links to the Paxil 329 study...and other studies for that matter.

What interests me is the startling revelation that Wagner has "no financial relationships with pharmaceutical companies."

Let's just dispel this shoddy piece of journalism.

An article from Alicia Mundy in 2009 [Wall Street Journal] shows that Wagner didn't report some $150,000 in funds such as speakers fees received from GlaxoSmithKline, she also failed to report a trip to Paris.

In fact the then Iowa Republican, Senator Charles Grassley, claimed that the amount Wagner didn't report may have been as high as $230,000.

Wagner, who at the time was working out of the University of Texas, had the backing of her peers who told Grassley they were never aware of any discrepancies regarding Dr. Wagner’s reporting of income from GSK.

Wait a minute... Let's just go back to the recent article in the Clinical Psychiatry News. "Dr. Wagner has no financial relationships with pharmaceutical companies."

Maybe someone should inform Michele Sullivan that she has dropped a clanger in her article.

Sullivan should have also noted that Wagner, according to documents disclosed by GSK under court order, was paid to deliver lectures promoting the use of Paxil for depressed kids and teens to both GSK’s sales reps and doctors.

At a training session for the sales reps, Wagner told the sales force that depression in adolescents was a lethal disorder that, if untreated, could lead to suicide and linger into adulthood. Wagner told the sales reps that the study in question demonstrated that Paxil was both safe and effective treatment for adolescent depression, and that they could expect the positive results for the first of the Paxil studies to be published in early 2000. [Complaint, United States v. GlaxoSmithKline, et al. (“GSK Complaint”), para 52, and Ex. 3 thereto]

Wagner also appeared at no less than 5 “Paxil forum” meetings, which were resort holidays sponsored by GSK for high-prescribing psychiatrists. In these meetings, Wagner falsely claimed that adolescent patients who received Paxil in GSK’s study “showed significantly greater improvement.”

She was also persuasive: according to internal memos, to psychiatrists attending the meetings who reported feeling more comfortable prescribing Paxil to young patients. Paxil revenues went up at least $900,000 from these doctors in 2000 alone. [GSK Complaint, para. 72-76]

Wagner has also been named in a complaint against Forest Labs. In a nutshell the complaint alleges that Forest promoted its antidepressants for pediatric use without FDA approval, and paid kickbacks to doctors to encourage prescriptions. The complaint also alleges that  Forest Labs 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.

Are we expected to believe that Wagner received no payment for this and she just attended the promotional presentations out of the goodness of her heart?

As, I said earlier, the content of Sullivan's article in the Clinical Psychiatry News is irrelevant. It should, however, be scrutinised given what we know about Wagner's links to the Pharmafia dollar. If the author of the article cannot even get one simple fact correct, a very important fact, then the content, in my opinion, is highly questionable.

I'll leave it to Michele Sullivan to rectify.

Forest Pharmaceuticals and Forest Labs are on the verge of getting a severe spanking after a lawsuit filed by two mothers from Missouri has alleged that Forest Pharmaceuticals and Forest Labs “misrepresented and concealed” information concerning the effectiveness of two company drugs for the treatment of depression in pediatric patients. It will be interesting to see if Wagner is brought to task over her dealings with Forest in this particular case. The suit was filed on behalf of the two Missouri mothers by Baum, Hedlund, Aristei & Goldman, PC and Pendley, Baudin & Coffin LLP.



Bob Fiddaman




No comments:


Please contact me if you would like a guest post considered for publication on my blog.