1 Boring Old Man

Those of you who have been at this a while must giggle at people like me who are new to the scene as we discover things that you’ve known for a long time. I’ve been at this for a while now. I know that because I start looking something up, and find a link to something I personally already wrote, but hadn’t connected my new line of investigation. That happened yesterday. I was looking at the things Martin Keller signed onto after Study 329 [which was brought into question as soon as it was published in 2001] and I ran into the article below [again]. Here’s how I reproduced the abstract back in October [the apogee…]:

At the time, I was focused on the fact that this article was accepted in May 2006, just a few months before Drs. Carrol and Rubin challenged Dr. Nemeroff’s article in the journal he edited [Neuropsychopharmacology] and Dr. Nemeroff ended up stepping down as editor because of undeclared conflicts of interest. Last month, I was thinking about Nemeroff’s hubris in publishing such a PHARMA-friendly article and the irony that all the authors in bold were later shown to have used ghost-writer Sally Laden and STI to write articles [paid by GSK][roaches…]. Yesterday [a walk on the wrong side side of the street?…], I was looking at the same article focusing on Martin Keller continuing to be a PHARMA sign-on lackey even after his poor show with Study 329. Now, I’m looking at the same article from yet another angle.

This article iteslf is actually a complaint against the FDA and the media. After years of haggling, the FDA finally had a hearing about the complaint that Paxil and the other SSRI’s could cause suicidality in some adolescents, and subsequently required warnings to be appended to these drugs for children and adolescents. Nemeroff et al are implying that the suicidality thing might have been overdone, and as a result, prescription rates had fallen dramatically in the younger age group. Here’s the kicker – their argument was that kids are being deprived of effective treatment because of the FDA and media. Unbelievable! But you already knew that.

So why are Dr. Nemeroff, Dr. Charney, Dr. Keller, and Dr. Schatzberg – all Department Chairmen of prestigious Departments of Psychiatry – writing this article? None of them are even Child and Adolescent Psychiatrists! I expect we would all suspect that they were PHARMA prostitutes, and that was why they were writing [or signing on to] this article. But who was getting paying them to do it? That lead me to get curious about those people in the author list I’d never heard of a month ago, but I was still too naive to look them up [so I put them in a background color] – Amir Kalali MD, … Susan E. Lenderts, Elisa F. Cascade, Hugo Stephenson MD.

As the global pioneer in pharmaceutical services, Quintiles helps deliver new drugs and cures for the world’s most challenging diseases. We are the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of more than 20,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.

^{We obtained retail pharmacy prescription data from Verispan, Yardley, Pa, a joint venture between Quintiles Transnational and McKesson, San Francisco, Calif. The Verispan data capture more than 1.4 billion patient-centric prescriptions per year, nearly half of all prescription activity in the United States. This data set includes prescriptions from a variety of retail channels [eg, national retail chains and mass merchandisers] from a near census of US pharmacies. The Verispan retail pharmacy database also captures information from all payer types, including cash…}

Amir Kalali MD: Vice President, Medical and Scientific Services, CNS Global Therapeutic Team Leader
^{Amir Kalali, MD, is Vice President, Medical and Scientific Services, and CNS Global Therapeutic Team Leader for Quintiles. He is an expert in CNS clinical trial methodology, and is globally responsible for the medical and scientific aspects of development programs in psychiatry and neurology. Dr. Kalali is also Professor of Psychiatry at the University of California, San Diego. As the Founding Chairman and current Executive Secretary of the Executive Committee of the International Society for CNS Drug Development, and as a member of the Scientific Committee of the International Society for CNS Clinical Trials and Methodology, Dr. Kalali actively facilitates scientific collaboration between academia, government, and pharmaceutical industry scientists. Dr. Kalali is the Editor of the journal Psychiatry and has published numerous peer-reviewed papers.
The Journal Psychiatry is now called Innovations in Clinical Neuroscience. It’s a monthly on-line peer reviewed Journal published by Quintiles for psychiatrists. All of the "academic" authors above are on the Editorial Board.}

Hugo Stephenson MD: President of MediGuard

Elisa F. Cascade: Vice President of MediGuard
<sup>MediGuard is a free medication monitoring service designed for specifically for patients – allowing them to take a more active role in their treatment through:
1. MediGuard Safety Checks: Screening for drug-drug and drug-disease interactions.
2. Sending you email alerts and updates as important safety information arises for your medications.
3. Sharing feedback from other members on side effects and other important information.
4. Providing you with a printable list of your medications.
While MediGuard is an Internet "service" with 2.5 million subscribers. It is used by Quinitiles to track medication use for their marketing research – crossreferenced from patient records. Listen to the audio presentation by clicking on Elisa Cascade’s link.</sup>

Susan E. Lenderts: Manager of Strategic Analytics
^{[I have no idea what that means but they list her as a "pharma manager" and a "rising star"]}

By early 2006, the collusion between the pharmaceutical industry and parts of academic psychiatry was rampant, out of control, often mediated through the clinical research organizations like Quintiles. Using their extensive marketing research networks, Quintiles found that the FDA Warnings of suicidality in adolescents on SSRIs was having a major impact on physician prescribing habits and that there was a dramatic fall in kids being put on these drugs. <Some Pharmaceutical Company or Companies> paid Quintiles to mount a campaign against the FDA/Media to improve SSRI sales. Using their marketing research data, Quintiles wrote an article claiming that this fall in prescriptions meant that children and adolescents were being deprived of necessary and effective treatment. They got four Psychiatry Department Chairmen who were already on board [Nemeroff, Charney, Keller, and Schatzberg] to sign on as guest authors and got it published in the Archives of General Psychiatry. In this same time frame, Drs. Nemeroff and Charney et al published a ghost written positive review of a VNS stimulator that both had a financial interest in in a journal Dr. Nemeroff edited [Neuropsychopharmacology] without revealing those interests. Also in this time frame, Drs. Nemeroff and Keller et al published a study fallaciously claiming that Risperdal augmentation of SSRIs was helpful in Treatment Resistant Depression [also in Neuropsychopharmacology].