Pfizer’s $68 billion acquisition of Wyeth last year has turned into a full-employment act for the drugmaker’s outside law firms.
Yesterday the company was slapped with a whistleblower lawsuit alleging Wyeth detailers promoted the off-label use of the immunosuppressant drug Rapamune for kidney transplant patients even though the Food and Drug Administration has explicitly warned about serious side effects and increased mortality associated with switching them from safer drugs. According to Jim Edwards’ report on Bnet, the complaint alleges African-Americans were specifically targeted by salesmen since they are considered “high-risk” patients due to their higher organ rejection rates.
Edwards writes:
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The suit claims that there is limited data on Rapamune use in black patients, who need a different dosing regimen than whites. Nonetheless, Wyeth targeted another hospital that primarily serves the black community for Rapamune “conversion.” Conversion is the practice of switching a patient from their existing transplant drugs to Rapamune. The FDA has only ever approved Rapamune for first-line use in kidney patients, and since 2004 the drug has carried a black box warning against conversion. Even Wyeth’s own internal studies did not show improved outcomes on Rapamune converted patients.
You can download a copy of the suit on the Bnet website. Pfizer did not respond to Bnet’s request for comment. Pharmalot also carried a story on the suit.
Wyeth has been sued by thousands of women for its off-label promotion of Prempro, the combination of estrogen and progestin used to curb symptoms of menopause. Rapamune (sirolimus) generates far less sales for Pfizer/Wyeth — an estimated $210 million last year — and even that is in jeopardy. The company recently sued generic firms Ranbaxy and Watson for violating its patents on the drug, the oldest of which expired earlier this month, according to the FDA’s Orange Book.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
