By Christopher Cappiello

Serono Pleads Guilty to AIDS Drug Marketing Scam

The Swiss biotechnology company Serono agreed to play more than $700 million to settle criminal and civil charges that it illegally promoted the AIDS drug Serostim from 1996 to 2004, the Justice Department announced on Oct. 18. "Serono generated millions of dollars in profit by flouting our health-care laws, rules and ethics, in a comprehensive effort to create a market for its expensive drug Serostim," Michael Sullivan, the U.S. attorney for Massachusetts, told Reuters.

Serono Labs, the company's Massachusetts-based American marketing division, received a patent in 1996 to market Serostim, a human growth hormone used to reverse the effects of AIDS wasting, or rapid, significant weight loss. At that same time, however, cocktails of protease inhibitors were being developed to control many of the side-effects of AIDS, including wasting, rendering Serostim unnecessary in most cases. "When the demand for Serostim began to wane, Serono put a plan for fraudulent marketing into high gear," U.S. Attorney General Alberto Gonzales told the Wall Street Journal. This plan included creating dubious testing devices to diagnose wasting and sponsoring luxurious overseas conferences to convince doctors to continue to prescribe the highly expensive drug.

According to federal charges, Serono Labs worked with RJL Sciences, Inc. to develop machines used to measure body cell mass, claiming that this was a reliable way to identify patients in need of Serostim. The Food and Drug Administration never approved the software for these devices, however, and the computerized diagnoses led to Serostim being prescribed to some patients who had exhibited no weight loss and, in some cases, had actually gained weight. Sullivan told The New York Times the procedure was "almost voodoo-like," resulting in unnecessary prescriptions of Serostim in 85 percent of the cases, with each 12-week treatment costing approximately $21,000. In April 2005, Rudolph J. Liedtke, RJL's president and principal owner, pleaded guilty to conspiracy charges and awaits sentencing, according to the Boston Globe.

Serono also pleaded guilty to providing all-expense-paid trips to Cannes, France, for a group of AIDS doctors in 1999. In what Gonzales told the Globe was "The Cannes Kickback campaign," Serono flew these doctors to a "conference" in Cannes in exchange for agreements to write up to 30 more prescriptions for the $7,000-a-month drug. Sullivan, the U.S. attorney from Massachusetts, refused to tell The New York Times if any of the doctors were targeted by the federal investigation.

The plea agreement calls for Serono to pay $136.9 million in a criminal fine. In addition, the company will pay $305 million to federal agencies, and more than $260 million to state agencies, reimbursing them for Medicaid payments made for falsely prescribed Serostim from 1996-2004. The Justice Department reports that the $704 million total as the largest in a Medicaid fraud case, and the third largest health-care fraud recovery in U.S. history. The agreement also calls for Serono Labs to be excluded from all federal health-care programs for five years.

According to the Wall Street Journal, five former Serono sales reps face charges of offering kickbacks to doctors for prescribing Serostim. The federal investigation began four years ago, when a Serono employee from Massachusetts accused the company of filing false claims. That charge was repeated later when four additional employees, from Connecticut and Maryland, brought similar charges. Those five employees stand to share an expected $75 million award under the federal whistleblower law intended to encourage workers to come forward and report corporate wrongdoing.

The Los Angeles-based AIDS Healthcare Foundation also stands to benefit from the whistleblower law following a 2004 suit filed against Serono. In 2002 AHF convinced Medi-Cal, the California state Medicaid program, to make its reimbursement requirements stricter for Serostim prescriptions. This "resulted in the savings of tens of millions of dollars" for the state, according to an AHF press release. "We are extremely pleased by the news that Serono is being held accountable for what has been shown to be an almost completely unnecessary drug," said Michael Weinstein, president of AHF. "On behalf of those AIDS patients and providers like Medi-Cal who were taken advantage of by Serono's fraudulent marketing practices, we are also pleased that AHF's efforts helped contribute to this result."


Australia Quietly Asks and Tells

In a landmark decision, the Australian Defense Force (ADF) quietly issued an Oct. 21 memo that will allow gay and lesbian service members in committed relationships the same benefits extended to married heterosexual soldiers, pilots and sailors, according to Australia's Sunday Times. The changes are expected to take effect Dec. 1.

"It's not something that will really excite too many people," Australian Defense Association spokesman Neil James told the Times. "It's not going to shock anyone. The ADF has allowed same-sex relationships for about 15 years now."

While it is true that the Australian military has allowed openly gay recruits to serve, the Defense Gay & Lesbian Information Service (DEFGLIS) has been lobbying for years for equal benefits.

The new change will mean that same-sex couples will enjoy all the same benefits of housing, education assistance, and compensation for moving and travel expenses. It is not clear, however, if pension benefits are included.

"The new group will include ADF members who are involved in interdependent relationships with a same-sex partner," the ADF memo states, according to the Times. "Defense places great emphasis on ensuring its people work in an environment that is fair and inclusive, recognizing that this enhances operational capability and effectiveness." Ironically, issues like "operational capability and effectiveness" are exactly the grounds used by the U.S. military to justify it's discriminatory "Don't Ask, Don't Tell" policy.

In the same article, DEFGLIS estimates that 2-3 percent of Australia's military personnel will be affected by the new policy. The Labor government's Defense Spokesman Robert McClelland told the Times he hoped the changes would boost recruitment efforts. "We need to ensure our forces receive comparable remuneration and allowances with the private sector to ensure we recruit the best people," McClelland said.


Two Arrested in London Homophobic Murder

Two men were arrested in London Oct. 21 and charged with the brutal Oct. 14 murder of 24-year-old Jody Dobrowski, in what authorities believe was an anti-gay attack, according to the BBC. The young bar manager was beaten so badly that family members could not identify him. His face was so disfigured and his teeth were so severely shattered that he had to be identified using fingerprints from his home.

The two suspects, Thomas Pickford, 25, and Scott Walker, 33, gave no fixed addresses to the court during their Oct. 25 arraignment, and are believed to be homeless, the BBC reports. The men were remanded in custody and will return to court Jan. 31.

The murder took place in Clapham Common, a park and popular gay cruising area. Witnesses told police they heard anti-gay epithets being shouted and found Dobrowski's unconscious body. He died later that night in the hospital. It is not known if the victim as gay, but "certainly those who carried out the attack thought he was gay," Detective Chief Inspector Nick Scola told the BBC. Authorities are investigating whether there is any connection between Dobrowski's murder and other recent attacks and robberies in the park. The two suspects are also under investigation for an attempted sexual assault against a woman in the park the same night, according to the BBC.


Gay Unions Get Blessed in Sweden

In a long expected vote on Oct. 27, the Assembly of the Church of Sweden voted overwhelmingly to approve a new official church ceremony blessing same-sex partnerships, according to The Local, an English-language Swedish news outlet. The 160-81 vote was not surprising, but capped a long process of developing a liturgy designed specifically for same-sex unions. Clergy have blessed same-sex unions, but without a formal, church-sanctioned ceremony.

"We officially accept same-sex relations within the church," said Bo Larsson, head of the office of Archbishop K. G. Hammar, the leader of the Church of Sweden, to the Ecumenical News International in 2004. "And many of us are not only glad and proud of it, but we want to talk about it. Jesus and the Gospel stand for everybody's right to equality and freedom from oppression."

Since 1995 the Swedish government has offered virtually all the benefits of marriage to same-sex partnerships. While same-sex relationships are widely referred to as "marriages" among Swedes, the official government designation remains "partnership." In 2002 gay Swedes were given the right to adopt children. A 2004 Agence France-Presse survey reported that 61 percent of Swedes favored gay marriage, and only 30 percent were against it.

While most Swedes are baptized, married, and buried in the Swedish Church, the Scandinavian denomination that dates back to the 16th-century Reformation led by Martin Luther reports some of the lowest regular attendance rates in the world.

 
© 2005 IN Los Angeles Magazine. All Rights Reserved