Posted on Tuesday 22 November 2011

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…]:

Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States
by Charles B. Nemeroff, Amir Kalali, Martin B. Keller, Dennis S. Charney, Susan E. Lenderts, Elisa F. Cascade, Hugo Stephenson, and Alan F. Schatzberg
Archives of General Psychiatry. 2007 64(4):466-472.

Conclusions: The effect on antidepressant prescribing volume observed in our analysis of the Verispan data parallels earlier findings reported by Medco Health Solutions, Inc, and NDC Health that the FDA actions have had a significant effect on the prescribing of antidepressants to children and adolescents. Together, these findings underline the importance of presenting a fair balance within the media due to the significant reach of this channel among prescribing physicians.
I usually leave off the Author’s Financial Disclosures, but in this case, they seemed pertinent:
Dr Nemeroff has received grants from or performed research for the American Foundation for Suicide Prevention, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories, Inc, Janssen Pharmaceutica, NARSAD: The Mental Health Research Association, the National Institute of Mental Health, Pfizer Pharmaceuticals, and Wyeth-Ayerst Laboratories; has been a consultant to Abbott Laboratories, Acadia Pharmaceuticals, Bristol-Myers Squibb, Corcept Therapeutics, Cypress Bioscience, Cyberonics, Eli Lilly and Co, Entrepreneur’s Fund, Forest Laboratories, Inc, GlaxoSmithKline, i3 DLN, Janssen Pharmaceutica, Lundbeck, Otsuka America Pharmaceutical, Inc, Pfizer Pharmaceuticals, Quintiles Transnational, UCB Pharma, and Wyeth-Ayerst Laboratories; has been on the speakers bureau for Abbott Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, and Pfizer Pharmaceuticals; is a stockholder in Acadia Pharmaceuticals, Corcept Therapeutics, Cypress Bioscience, and NovaDel Pharma Inc; is on the board of directors of the American Foundation for Suicide Prevention, the American Psychiatric Institute for Research and Education, the George West Mental Health Foundation, NovaDel Pharma Inc, and the National Foundation for Mental Health; holds patents on a method and devices for transdermal delivery of lithium [US 6,375,990 B1] and on a method to estimate serotonin and norepinephrine transporter occupancy after drug treatment using patient or animal serum [provisional filing April 2001]; and holds equity in Reevax, BMC-JR LLC, and CeNeRx.
Dr Kalali is on the advisory board or speakers bureau of AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutica, Pfizer Inc, and Shire.
Dr Keller has been a consultant to or has received honoraria from Collegium, Cypress Bioscience, Cyberonics, Eli Lilly and Co, Forest Laboratories, Inc, Janssen Pharmaceutica, Organon, Otsuka America Pharmaceutical, Inc, Pfizer Inc, Pharmastar, Sepracor, Vela Pharmaceuticals Inc, and Wyeth Pharmaceuticals; has received grants from or performed research for Eli Lilly and Co, Forest Laboratories, Inc, Pfizer Inc, and Wyeth Pharmaceuticals; and has been on the advisory board of Abbott Laboratories, Bristol-Myers Squibb, Cyberonics, Cypress Bioscience, Eli Lilly and Co, Forest Laboratories, Inc, GlaxoSmithKline, Janssen Pharmaceutica, Novartis, Organon, Pfizer Inc, Sepracor, and Wyeth Pharmaceuticals.
Dr Charney has consulting agreements with Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Cyberonics, Gene Logic Inc, the Institute of Medicine, Neurogen Corp, the Neuroscience Education Institute, Novartis Pharmaceuticals Corp, OREXIGEN Therapeutics, Inc, Organon International, Otsuka America Pharmaceutical, Inc, Quintiles Transnational, and Sepracore Inc; and has a confidentiality agreement with Forest Laboratories, Inc, and Novartis Pharmaceuticals Corp.
Dr Schatzberg is a consultant to Eli Lilly and Co, Wyeth Pharmaceuticals, Corcept Therapeutics, Bristol-Myers Squibb, Novartis, Abbott Laboratories, Forest Laboratories Inc, Quintiles Transnational, and Lundbeck; is a cofounder of Corcept Therapeutics and has equity in Forest Laboratories, Pfizer Inc, and Merck and Co; and has received research funding from GlaxoSmithKline and Wyeth Pharmaceuticals.

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.

Who are Amir Kalali MD, Susan E. Lenderts, Elisa F. Cascade, and Hugo Stephenson MD?  They all work for Quintiles Transnational, the largest Clinical Research Organization in the world. That’s who:
    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.
So we know "who was getting paying them to do it?" Three of the four Department Chairmen were on Quintiles payroll already. This was a Quintiles article/project that was complaining that the FDA and Media were interfering with drug sales. Here’s some data from the article:
Where would four psychiatry department chairmen get that kind of data?
    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…
The department chairmen wouldn’t get it anywhere. That’s the stuff of marketing research, and if you look into our foursome from Quintiles – that’s what they do [among other things]:
    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
      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.
    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"]

So, I have to start this post all over. Here’s what I think I should’ve said:
    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].
We are eternally grateful for Drs. Carroll and Rubin, Senator Grassley and Paul Thacker, and many others for raising our awareness to this kind of manipulation of the psychiatric literature and getting it curbed. I expect it continues at some level, but not like 2006. I hope I was right to call 2006 an apogee, the highest point on a curve that’s now falling…
    Bernard Carroll
    November 22, 2011 | 4:16 AM

    One might say the apogee for the compromised KOLs was the nadir for the rest of us. Have we escaped the gravitational pull of Pharma and Pharma’s money? Not really. The journals that were corrupted by your cited examples have never publicly dissociated themselves from these compromised publications. The professional societies that installed Nemeroff, Charney, and Schatzberg as presidents have never disowned them, much less expelled them. The drug companies that enjoy corporate member status in these professional societies continue to be tolerated, despite the findings that many are guilty of felony criminal conduct, and most are guilty of plea bargained misdemeanor conduct for which billions of dollars in fines have been levied.

    We still have a long way to go to put 2006 behind us.

    November 22, 2011 | 9:10 AM

    This stuff goes back decades. Anyone who “told” what was going on was black balled.

    November 22, 2011 | 9:49 AM

    I agree with Dr. Carroll; another aspect of this is how difficult it is going to be to change the mindset of the public wrt the medications. I think most of “the public” still believes psychotropic drugs are universally helpful, the normal course of treatment, have minimal side effects, aren’t addictive, and have proven efficacy. It is maddening.

    November 22, 2011 | 10:35 AM

    I find it very interesting that Quintiles was behind the 2007 rant about the FDA’s black box warnings about antidepressants, since it is also the CRO that is putting together the deal that will allow drug companies to mine the medical records databases of 13 New York hospitals to recruit patients for their clinical trials. As I blogged about recently at http://alison-bass.com/blog, this partnership raises troubling privacy and ethical concerns.

    November 22, 2011 | 4:58 PM

    Oops…forgot to mention, Mickey, we don’t giggle at you! We’re just grateful you’re here now to dig WAY below the surface!

    November 25, 2011 | 8:30 PM

    Some professional societies suffer schisms when members decide not to renew memberships in protest. Why isn’t this happening to the American Psychiatric Association?

    And how did Alan Schatzberg get elected president there anyway? What is the election process?

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