Boston Globe Examines AIDS Advocates’ Lobbying Efforts Against AIDS-Related Wasting Drug Maker Serono

The Boston Globe on Monday examined how "soured relations" between HIV/AIDS advocates and Swiss biotechnology company Serono over pricing practices of its AIDS-related wasting drug Serostim "threaten to haunt" the company as it seeks FDA approval for a new use for the drug (Kerber, Boston Globe, 11/14). Serono in October agreed to pay $704 million to settle a Department of Justice investigation into the company's sales and pricing practices of Serostim. The company will pay $136.9 million in criminal fines and $567 million to settle civil liabilities, which include $305 million to federal agencies that paid for unnecessary prescriptions for the drug and almost $262 million to state Medicare programs. In 2001, the U.S. attorney's office in Boston subpoenaed from Serono nearly 10 years' worth of documents pertaining to Serostim as part of an ongoing grand jury investigation into the company's practices. U.S. Attorney General Roberto Gonzales said Serono profited by $90 million during the period of illegal activity, which took place between 1996 and 2004, according to DOJ (Kaiser Daily HIV/AIDS Report, 10/18). Some HIV/AIDS advocates have said the "bad blood" with Serono will not affect their position on new uses for Serostim, the Globe reports. However, "it's clear this vocal and influential constituency, which often weighs in with regulators on AIDS drugs, now doesn't trust Serono and will be skeptical of any new promises or clinical claims from the company," according to the Globe. Kevin Frost, vice president for clinical research at amfAR in New York, said that the settlement Serono reached with prosecutors will not change the strain resulting from the "issues that have hung over Serono in its dealings with the community" (Boston Globe, 11/14).