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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.
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