Healthy Skepticism Library item: 19480

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Whistleblower Lawsuits And Off-Label Marketing
Pharmalot 2011 Apr 6
http://www.pharmalot.com/2011/04/whistleblower-lawsuits-and-off-label-marketing/

Full text:

For the past few years, a steady flow of whistleblower lawsuits have been settled over off-label marketing practices by a laundry list of drugmakers. But what do the activities described in those lawsuits say exactly about the specific sorts off-label marketing practices? A new analysis suggests these are rather difficult to control, despite various measures taken over the past decade.
In the study, which appears in PLoS Medicine, the researchers examined 41 lawsuits filed by 55 whistleblowers in fraud cases brought against 18 drugmakers that were settled or unsealed between January 2004 and October 2010. At the time of the alleged fraud, 71 percent of the whistleblowers worked as sales reps, 20 percent were accounting managers and 9 percent were unaffiliated doctors.
And what did they discover? The off-label schemes described in the lawsuit had three non–mutually exclusive goals. One was expanding to unapproved diseases – 35 of 41 lawsuits, or 85 percent. For example, Neurontin was approved as adjunctive treatment for certain types of epilepsy, but also allegedly promoted to treat bipolar disorder or depression. Another goal was expanding usage to unapproved disease subtypes – 22 of 41 lawsuits, or 54 percent. Take Natrecor, which was approved for acutely decompensated heart failure, but allegedly promoted to prevent chronic stable heart failure. Both groups of patients had heart failure, but the researchers note these are different manifestations. The third goal was expanded to unapproved doses – 14 or 41 lawsuits, or 34 percent.
Drugmakers allegedly used four non–mutually exclusive types of marketing practices: prescriber-related, which occured in all the lawsuits; business-related in 37 of the 41 lawsuits; payer-related discussions with prescribers about ways to ensure insurance reimbursement for off-label prescriptions in 56 percent of the lawsuits, and consumer-related, which usually involved reviewing confidential patient charts to identify people who could be off-label users – 44 percent of the lawsuits.
As for prescriber-related practices, these included what the researchers called “self-serving” presentations of medical literature that was either false or unbalanced study data supporting an unapproved use; this occured in 76 percent of the lawsuits. There were also free samples cited in 20 percent of the lawsuits, direct financial incentives to docs cited in 85 percent of the lawsuits, and Continuing Medical Education seminars that were organized with speakers known to promote off-label uses mentioned in 54 percent of the lawsuits.
Thirty-seven, or 90 percent of the lawsuits detailed particular internal practices intended to bolster off-label marketing. All of the practices described were reported to be companywide, rather than the work of an individual manager or group of managers, according to the study. In 73 percent of the cases, an off-label marketing strategy was implemented through intramural meetings and seminars in which marketing practices were discussed. And 46 percent of the time, brochures and other materials were used to disseminate info. Finally, in 51 percent of the case, employees other than sales reps, such as internal physicians and scientists, were involved.
Meanwhile, 68 percent of the lawsuits described internal practices by drugmakers to conceal off-label marketing activities, and 64 percent described warnings from legal teams to avoid off-label marketing. A third of the lawsuits included reports of direct orders to conceal, such as “cleaning” internal reports and memoranda of all mentions of off-label marketing, according to the study.
Forty-one percent of the reports of internal strategies described incentives or other aspects of employees’ compensation plans that were directly tied to effectively implementing an off-label prescription strategy. In one case involving a drug approved by the FDA for a rare indication, a whistleblower reported the drugmaker imposed sales quotas on reps that could only be met through expanding use beyond the limited approved indication, the researchers write.
And 72 percent of the cases reported discussions with prescribers to educate them about how to manage the billing system to ensure off-label prescriptions were reimbursed, including advice on ways to bypass insurer restrictions on prescriptions. For example, one whistleblower reported being taught to overcome a requirement that patients receive a trial of a rival’s drug first by instructing doctors to issue two different prescriptions simultaneously – one for the competitor’s drug the patient could ignore, the other for the company’s drug. The other strategy commonly reported was to encourage providers to falsify billing codes.
“These findings suggest that no regulatory strategy will be complete and effective unless physicians themselves fully understand the range of off-label marketing practices and their consequences for public health and act as a bulwark against continued efforts to engage in off-label promotion,” the researchers conclude. “Aside from sales representatives and other company insiders, who play important roles as whistleblowers, physicians are alone in having a full view of many of the most insidious forms of illegal marketing outlined in the complaints we reviewed. As physicians’ understanding of these practices and the consequences of inappropriate off-label promotion for public health evolves, so may their enthusiasm for shutting them down.”