InterMune: A Failed Trial Behind the Sales Pitch

In the InterMune Actimmune settlement, the company agreed to pay more than $36.9 million following allegations that its promotion led to uncovered prescriptions. InterMune sold Actimmune, a drug whose clinical-trial results became part of the company’s deferred prosecution agreement in the criminal case. If you worked on the trial analysis, medical review or promotion, you may recognize the distance between what a study showed and what a company wanted physicians to hear.

The Department of Justice announced the resolution on October 26, 2006. Taxpayers funding Medicaid were among those paying for prescriptions the government alleged should not have been covered. The case puts the scientific message described in the deferred prosecution agreement alongside the bills that followed it.

What Is Considered Off-Label Promotion?

Off-label promotion means marketing a drug for a use outside its approved labeling. In the Actimmune matter, the deferred prosecution agreement described representations about a clinical trial, and the civil settlement addressed uncovered prescriptions. The settlement resolved allegations that InterMune knowingly caused false claims for Actimmune that were not eligible for reimbursement because they were for unnecessary or off-label uses. The drug’s approved uses were chronic granulomatous disease, a disorder of the immune system, and severe, malignant osteopetrosis.

For a medical affairs or sales employee, the issue is the evidence behind the promoted use. The trial analysis and the message approved for physicians can tell different stories. An insider who saw both can explain where the message went beyond the results.

The Clinical-Trial Press Release

The Actimmune trial met neither its primary nor its secondary endpoints, according to InterMune’s deferred prosecution agreement. Those were the results the trial was meant to measure. The agreement also addressed how InterMune represented the trial in a company press release. The scientific results and the public message belong side by side.

That is the comparison at the center of clinical-trial data false claims. An employee who worked on the analysis may know what the results supported. Someone who reviewed the promotional language may know how the company presented those results outside the business. We look at those accounts together.

The wording matters because a physician sees the claim the company chose to publish. Someone inside the business may also have seen the analysis behind it, the review comments and the changes to the message. Our experts work through that difference with the insider.

A Study Can Become a Claim It Never Tested

The whistleblower’s complaint against Shire gives a concrete parallel. It alleged that the company promoted Adderall XR as superior to competing drugs at normalizing children with ADHD, using a study that did not measure that result. The complaint described the mismatch directly:

A study that did not compare the drugs became, according to the complaint, a reason to claim one was better. The scientific limitation was exactly what the sales claim needed the reader to overlook. The complaint also alleged that the comparison between drugs came from an analysis performed after the study. Its point was specific: Shire was claiming superiority from a study that had not been designed to compare the drugs.

Shire’s September 2014 civil settlement resolved allegations about drug marketing and efficacy claims affecting prescriptions and program reimbursement. The parallel with InterMune’s deferred prosecution agreement is the gap between the underlying evidence and the claim used to promote the drug.

How the Alleged Promotion Reached Government Claims

InterMune’s settlement addressed allegations about uncovered Actimmune prescriptions. For a manufacturer-side insider, the prescription and payment records may sit outside the company whose message they know firsthand.

The usual physical path through the drug business runs from manufacturer to wholesaler to dispenser. Payment follows its own arrangements. For this kind of case, we connect the company’s promotion to the use behind the bill.

For an allegation about uncovered prescriptions such as InterMune’s, the use being billed matters. Medicaid’s medically accepted indications include uses supported by recognized drug references beyond the FDA-approved labeling.

A 2018 Managed Care article on indication-specific drug pricing describes an information gap that matters here. It reports that a drug’s indication may be recorded in the patient’s electronic medical record without being captured when the pharmacy dispenses it.

The dispensing data and the clinical record can answer different questions. One records the drug supplied. The other may explain the condition being treated. In an allegation about uncovered prescriptions, the reason for prescribing is part of the story the product name alone leaves out.

How the InterMune Settlement Was Split

InterMune’s civil payments allocated $30.2 million to the federal government, for losses to the federal share of Medicaid, Medicare, the Veterans Administration, the Department of Defense and the Federal Employees Health Benefits Program, and nearly $6.7 million to state Medicaid programs under separate agreements with the states. InterMune also agreed to a five-year corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

What an Insider’s Records Could Add

An insider can explain how the study result became the company’s message. Someone in clinical development may understand the analysis behind the claim. A medical reviewer may know what wording was questioned or changed. A sales employee may know which version reached physicians and how the company expected it to influence prescribing.

Our work with pharmaceutical whistleblowers starts with the part they understand firsthand. We connect that account to the scientific material, the company’s communications and the government-payment question.

The strongest detail may be a change in wording that looked small inside the company. Describing a study as comparative, choosing which result to emphasize, or leaving a limitation out of a sales message can change what a physician takes from it. The Shire complaint makes that problem tangible. InterMune’s resolution shows why the resulting prescription claims also deserve attention.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know Where the Message Changed

If you know how a trial result became a claim the science could not support, speak to our whistleblower experts about what changed between the analysis and the sales message. We build the case with you and bring in pharmaceutical fraud whistleblower lawyers who understand clinical evidence, promotion and government reimbursement. We stay beside you as your knowledge of the campaign becomes the foundation of the case.