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Increasing Government Oversight Of IRBs Could Help Prevent Seeding Trials

July 21st, 2011 by Glenn Laffel, M.D., Ph.D. in News, Opinion
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I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.

Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.

Now, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.

The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.

The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.

The trial worked, from Parke-Davis’ point of view. Read more »

*This blog post was originally published at Pizaazz*

The Business Of Anticoagulation

December 28th, 2010 by RyanDuBosar in Opinion, Research
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This is a guest post by Dr. Juliet Mavromatis:

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The emergence of a new generation of anticoagulants, including the direct thrombin inhibitor, dabigatran and the factor Xa inhibitor, rivaroxaban, has the potential to significantly change the business of thinning blood in the United States. For years warfarin has been the main therapeutic option for patients with health conditions such as atrial fibrillation, venous thrombosis, artificial heart valves and pulmonary embolus, which are associated with excess clotting risk that may cause adverse outcomes, including stroke and death. However, warfarin therapy is fraught with risk and liability. The drug interacts with food and many drugs and requires careful monitoring of the prothrombin time (PT) and international normalized ratio (INR).

Recently, when I applied for credentialing as solo practioner, I was asked by my medical malpractice insurer to detail my protocol for monitoring patients on anticoagulation therapy with warfarin. When I worked in group practice at the Emory Clinic in Atlanta I referred my patients to Emory’s Anticoagulation Management Service (AMS), which I found to be a wonderful resource. In fact, “disease management” clinics for anticoagulation are common amongst group practices because of the significant liability issues. Protocol based therapy and dedicated management teams improve outcomes for patients on anticoagulation with warfarin. Read more »

*This blog post was originally published at ACP Hospitalist*