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$95 Million Says Cardiovascular Drugs Were Marketed Improperly

  • November 7, 2012
  • RPh on the Go

$95 Million Says Cardiovascular Drugs Were Marketed Improperly

The U.S. Justice Department had a lot to say about the way Boehringer Ingelheim Pharmaceuticals Inc. was promoting four of their prescription medications. A $95 million settlement resolves the allegations at Boehringer Ingelheim’s promotion of Aggrenox, Combivent, and Micardis, as well as dosage issues with Atrovent.

The improper promotion allegations are as follows:

Aggrenox has been approved by the Food and Drug Administration (FDA) for stroke prevention, but the pharma company was also promoting it for myocardial infarction and peripheral vascular disease. Combivent has been approved for treating bronchospasm in chronic obstructive pulmonary disease (COPD) patients who are already on a bronchodilator, but the company was promoting its use in patients who are not on a bronchodilator. Micardis has been approved to treat high blood pressure, but it was being promoted for treatment of early diabetic kidney disease.

“Off-label marketing” is a problem because drugs are only deemed safe and effective for their use as approved by the FDA, and since other uses are not deemed medically acceptable, they are not eligible for reimbursement by federal health care programs like Medicare and Medicaid. The allegations concerning Atrovent, a COPD treatment drug, claim that the company promoted its use at dosages that were higher than what federal health care programs would cover.

Additionally, the settlement resolves a sticky issue involving kickbacks paid by Boehringer Ingelheim to health care professionals to encourage them to prescribe these four drugs. These came in the form of payments for participation in speaker programs, speakers’ training programs, consultant programs, and advisory boards.

Why does this all matter? It matters because physicians and other health care professionals should not prescribe medications based on personal financial incentives. While many health care professionals will argue that they can remain objective regardless of any perks the pharmaceutical reps may dangle in front of them, it’s hard to see how one could not be swayed in favor of a drug that they’ve been paid to speak or consult about. The familiarity needed to speak on a subject comes with a predilection to think of it first. If a doctor has been asked to speak about off-label use of a high blood pressure drug for early diabetic kidney disease, what do you think he will prescribe when one of his patients presents with early diabetic kidney disease?

This becomes an important issue when patients are enrolled in a federal health care program. If their physician prescribes a drug that isn’t covered by their health care plan, that presents a financial burden that could result in noncompliance with their physician’s orders. Medicaid beneficiaries especially are at a disadvantage in this matter, as enrollment in the program is based on financial hardship, and many Medicare beneficiaries are on a fixed income, as well. These patients cannot afford extra out-of-pocket costs associated with prescription drugs.

Have you ever had to tell someone at your pharmacy that their medication wouldn’t be covered by their health care plan because its use was off-label? What sort of advice did you offer them?

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