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Behind the Paxil Scandals
I n June 2004 New York State Attorney General Eliot Spitzer brought suit against Glaxo, alleging that it had engaged in repeated and persistent fraud with respect to Paxil (a $3.1 billion grossing drug in 2003). Spitzer had evidence that the giant pharmaceutical corporation Glaxo had suppressed the results of studies on children and adolescents that showed Paxil to be ineffective and to increase the risk of suicidal thinking and behavior. When he first announced the suit, Spitzer stated, “By concealing critically important scientific studies on Paxil, GlaxoSmithKline impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety.” Spitzer had an internal Glaxo memo from 1998 stating that the company intended to “manage the dissemination of the data in order to minimize any potential negative commercial impact.”
In a quick settlement with Spitzer in August 2004, Glaxo agreed to pay a $2.5 million fine and disclose all clinical trial study data. Though Spitzer had smoking-gun evidence that Glaxo had concealed scientific studies that jeopardized the health and safety of children, Glaxo executives faced no criminal charges.
While Eliot Spitzer, a rising star in the Democratic Party, achieved a tough-on-corporations headline, Glaxo was quietly pleased with the outcome. Wall Street investors saw the $2.5 million fine and the rest of the deal as a slap on the wrist, a gentle one at that. Immediately after the settlement was announced, Glaxo shares rose a half point in morning trading.
At the same time Glaxo was managing the impact of Eliot Spitzer on Wall Street, it also had a problem with Ricky Williams and Main Street. In July 2004, Miami Dolphins star running back Ricky Williams stunned Glaxo when, in announcing his early retirement from football, he declared that he had found marijuana to be 10 times more helpful than Paxil.” Williams, along with former Pittsburgh Steeler quarterback Terry Brad- shaw, had been a Glaxo celebrity spokesperson, sponsored by Glaxo to tour the U.S. for the purpose of erasing the stigma of psychiatric treatment.
The Eliot Spitzer and Ricky Williams stories received a great deal of coverage from the mainstream media, which, in contrast, gave scant attention to another story: does Paxil become safe after we’ve turned 18?
In July 2003 the European Agency for the Evaluation of Medicinal Products, which licenses drugs for use in the European Union, recommended that Paxil should be prescribed with extra caution to those between 18 and 29. The EU regulatory agency stated that Paxil could result in an increased risk of “suicide-related behavior in young adults” and required doctors to warn all patients under 30 of the suicide risk posed by Paxil (known as Seroxat in Europe).
A Wyoming jury in 2001 had ordered Glaxo to pay $6.4 million to relatives of Donald Schell, aged 60, who had been taking Paxil for just 48 hours when he shot and killed his wife, his daughter, his granddaughter, and himself. Glaxo lost the case because its internal documents showed it was aware that a small number of people could become agitated or violent from Paxil. Glaxo was seen as liable because, despite this knowledge, its Paxil packaging did not include a warning about suicide.
The sad story goes beyond Paxil and Glaxo to other antidepressants, other giant pharmaceutical corporations, the FDA, and psychiatry.
In December 2003 the British Medicines and Healthcare Products Regulatory Agency (the British FDA equivalent) told physicians that depressed patients under 18 should not be prescribed Zoloft, Lexapro, Celexa, Luvox, Effexor, Serzone, Remeron, and Paxil. The MHPRA concluded the lack of these antidepressants’ safety—including the risk of suicidal behavior and hostility—far outweighed any evidence of effectiveness. What was the FDA’s response?
An epidemiologist at the FDA, Dr. Andrew Mosholder, its leading expert on the safety and effectiveness of antidepressants, agreed with the British, but senior officials at the FDA gagged him. Mosholder concluded there is a statistically significant risk of serious suicidal behavior among children taking these antidepressants. Children given the drugs were 1.89 times more likely to become suicidal than those given placebos. However, FDA bosses did not allow Mosholder to testify at the FDA advisory meeting about antidepressants and suicidal behavior in children held in February 2004. Finally, in September 2004—because of an onslaught of public pressure—the FDA convened another advisory panel. This panel recommended warning labels on these antidepressants but did not, unlike the British, ban drugs for children that science is now describing as dangerous and ineffective.
In October 2004 the FDA carried out the advisory panel’s recommendations by ordering that all antidepressants’ packaging display a black-box warning (the most serious warning) of increased risk of suicidal thoughts and behaviors in children. However, by the end of 2004, black-box warnings were not yet on antidepressants. Robert Temple, director of FDA’s Office of Medical Policy, stated in late December, “I’m sympathetic to the idea that you don’t want to let a lot of time go by. But [when] we ask the companies to modify labeling that they own…the right to disagree [over the wording] is reasonable.”
The FDA, especially in the area of antidepressants, has long been seen by much of the scientific community as compromised by drug company influence and it is decreasingly recognized as a serious regulatory agency. In a 1991 FDA “blue ribbon” panel investigating the association between Prozac-type antidepressants and violence, five of the nine FDA panel doctors had ties to pharmaceutical corporations. The panel voted not to require these antidepressants to display a violence warning label. T his was aided by Paul Leber, d irector of the FDA ’ s Division of Neuropharma- cological Drug Products, who in the late 1990s left the FDA to direct a consulting firm that specializes in advising pharmaceutical companies that are attempting to gain FDA approval for new psychiatric drugs. The revolving door of employment between the FDA and Big Pharma resembles other governmental-industrial arrangements where regulatory favors routinely result in future industry income. In 2001 The Lancet , Great Britain’s respected medical journal, described the FDA as a “servant of industry.”
Before approving a drug, the FDA does no research on that drug. Instead, the FDA evaluates studies handed to them by the pharmaceutical company that created the drug. Despite repeated evidence of untrustworthiness and outright fraud, the FDA continues to trust Big Pharma data.
Psychiatrists and other prescribing physicians, who should know the deficiencies of the FDA drug approval process, are these days taking cover, saying that these antidepressants were FDA approved. However, psychiatry’s textbooks have for over a decade told them that antidepressants have not proven to be better than a placebo for children and adolescents. Psychiatrists know that unhappy kids with no history of self-harm have become suicidal after taking antidepressants. No mental health professional should be shocked at parent Tom Woodward’s testimony at the September 2004 FDA hearing: “Julie never harmed herself in her 17 years—the only variable was 7 days of Zoloft. We are certain that Zoloft killed our daughter…. Julie began experiencing akathisia [an intense agitation] almost immediately after taking the first pill.”
U.S. psychiatry is awash with Big Pharma money. Psychiatric journals are replete with drug company advertising, and the American Psychiatric Association’s annual convention has so many lavish drug company booths that it appears more like a drug-selling bazaar than a scientific conference.
The U.S. has more people incarcerated in prisons and jails than any other industrialized nation as a result of drug laws severely punishing those who are selling drugs to others who, for the most part, are well aware of the dangers. At the same time, pharmaceutical corporations receive tiny fines for fraudulently selling dangerous drugs to unaware parents of troubled children. Big Pharma executives, far from doing jail time, are not even sweating out criminal charges.
Bruce E. Levine, a psychologist, is author of Commonsense Rebellion: Taking Back Your Life from Drugs, Shrinks, Corporations, and a World Gone Crazy (Continuum, 2003).
Z Magazine Archive
AnnouncementsLABOR - May 1 is May Day. Workers of the world will celebrate the 124th anniversary of International Worker’s Day. Born out of a call for an 8-hour workday in the United States, this day is an opportunity for all workers to show their solidarity with one another, as well as to renew the call for labor rights.
FARM CONFERENCE - The Farm Conference on Community and Sustainability will be held May 24-26 in Summertown, TN, in partnership with the Fellowship of Intentional Communities. Tour green homes, see sustainable food production, learn about solar installations, alternative education, midwifery, and more.
Contact: Douglas@thefarmcommunity.com; http://www.thefarmcommunity.com/.
PALESTINE - The Conference of the Palestinian Shatat in North American will be held June 3-5 in Vancouver. The conference will examine the future of the Palestinian liberation movement.
Contact: email@example.com; http://www.palestinianconference.org/.
LABOR - The Pacific Northwest Labor History Association’s 45th annual conference will be held May 3-5, in Portland, OR. This year’s theme is Labor Under Attack: Learning from the Past and Preparing for the Future. A call for presentations, workshops and papers is currently underway.
Contact: PNLHA, 27920 68th Ave. East, Graham, WA 98338; 206-406-2604; PNLHA1@aol.com; http://www3.telus.net.
MARIJUANA - On the first Saturday of May marijuana legalization activists will hold informational and educational events, rallies and marches in over 300 cities around the world.
ECONOMICS - The Union For Radical Political Economics will hold its 39th annual conference May 9-11 in New York City.
RECLAIM THE DREAM - The 2013 Poor People’s Campaign & March from Baltimore to Washington D.C. will be May 11. Communities, schools and unions interested in participating are encouraged to contact the Baltimore People’s Assembly.
Contact: 410-500-2168; 410-218-4835; BaltimorePeoplesAssembly@gmail.com; Southern Christian Leadership Conference of Baltimore and the Baltimore Peoples Power Assembly, 2011 N. Charles St., Baltimore, MD 21218.
MOTHER’S DAY - The 17th Annual Mother’s Day Walk For Peace will be May 12th, in Dorchester, MA. The walk began in 1996 for families who had lost children to violence. The day has become a way for thousands of people to financially support the work of the Louis Brown Peace Institute.
Contact: http://www.ldbpeaceinstitute.org/; http://mothersdaywalk4peace.org/.
NATO 5 - An International Week of Solidarity with the NATO 5 has been called for May 16-21. Supports call on supporters to raise awareness of the NATO 5 and support funds for the defendants on the one-year anniversary of their preemptive arrests.
Contact: firstname.lastname@example.org; https://nato5support.wordpress.com.
MOUNTAINTOP - The 2013 Mountain Justice Summer Activist Training Camp will be held May 19-27 in Damascus, VA. It will be a week of workshops, field trips to view Mountain Top Removal coal mines, direct actions, and service project.
FEMINIST SCI-FI - The feminist science fiction convention WisCon 37 is scheduled for May 24-27 in Madison, WI.
Contact: WisCon, ? SF3, PO Box 1624, Madison, WI 53701; email@example.com; http://www.wiscon.info/.
ANARCHY FEST - A month-long Festival of Anarchy is scheduled for May in Montreal. The festival includes The Montreal Anarchist Bookfair (May 19-20).
Contact: http://www.anarchistbookfair.ca/; http://www.radicalmontreal.com/.
LABOR - The International Labor Rights Forum will present: Down the Supply Chain, Driving Corporate Accountability, on May 22 in Washington, DC. The Labor Rights Awards Ceremony and Reception will honor pioneers in supply chain worker organizing, working solidarity and international labor rights policy.
MULTICULTURE - The 26th annual National Conference on Race & Ethnicity in American Higher Education (NCORE) will take place May 28-June 1, in New Orleans.
Contact: SWCHRS, 3200 Marshall Avenue, Suite 290, Norman, OK 73072; 405-325-3694; firstname.lastname@example.org; www.ncore.ou.edu.
MEDIA - The 2013 Alliance for Community Media Annual Conference will be held May 29-31, in San Francisco, CA. Participants will include educators, community leaders, media professionals, journalists, nonprofit leaders, policymakers and students.
RADIO - The 38th Annual Community Radio Conference is schedule for May 29-June 1, in San Francisco, CA, with discussions and workshops.
Contact: 1101 Pennsylvania Ave. NW, Suite 600, Washington, DC 20004; 202-756-2268; email@example.com; http://www.nfcb.org/.
BRADLEY MANNING - On June 1, a rally will be held at Fort Meade in support of Bradley Manning.
BIKES - Bikes Not Bombs is holding its 24th annual Bike-A-Thon and Green Roots Festival in Boston, MA on June 3, with several bike rides scheduled, music, exhibitors and more.
Contact: Bikes Not Bombs, 284 Amory St., Jamaica Plain, MA 02130; 617-522-0222; firstname.lastname@example.org; www.bikesnotbombs.org.
LEFT FORUM - The 2013 Left Forum will be held June 7-9, at Pace University in New York City.
Contact: 365 Fifth Avenue, CUNY Graduated Center, ? Sociology Dept., New York, NY 10016; http://www.leftforum.org/.
VEGAN FEST - Mad City Vegan Fest will be held in Madison, WI, June 8. The annual event features food, speakers, and exhibitors.
Contact: 122 State Street, Suite 405 B, Madison, WI 53701; email@example.com; http://veganfest.org/.
ADC CONFERENCE - The American-Arab Anti-Discrimination Committee (ADC) holds its annual conference June 13-16, in Washington, DC, with panel discussions and workshops on civil rights, media and other topics.
Contact: 1990 M Street, Suite 610, Washington, DC, 20036; 202-244-2990; firstname.lastname@example.org http://convention.adc.org/.
CUBA/SOCIALISM - A Cuban-North American Dialog on Socialist Renewal and Global Capitalist Crisis will be held in Havana, Cuba, June 16-30. There will be a 5 day Seminar at University of Havana, plus visits to a cooperative, urban garden, community development project, social research centers, and educational & medical institutions.
Contact: email@example.com; http://www.globaljusticecenter.org/.
NETROOTS - The 8th Annual Netroots Nation conference will take place June 20-23 in San Jose, CA. The event features panels, trainings, networking, screenings, and keynotes.
Contact: 164 Robles Way, #276, Vallejo, CA 94591; firstname.lastname@example.org; http://www.netrootsnation.org/.
MEDIA - The 15th annual Allied Media Conference will be held June 20-23, in Detroit.
Contact: 4126 Third Street, Detroit, MI 48201; http://alliedmedia.org/.
GRASSROOTS - The United We Stand Festival will be hosted by Free & Equal, June 22 in Little Rock, Arkansas. The festival aims to reform the electoral process throughout the U.S.
SOCIALISM - The Socialism 2013 Conference is scheduled for June 27-30 in Chicago, featuring talks and panel discussions.
Contact: email@example.com; http://www.socialismconference.org.
LITERACY - The National Association for Media Literacy Education (NAMLE) will hold its conference July 12-13 in Los Angeles under the heading, Intersections: Teaching and Learning Across Media.
Contact: 10 Laurel Hill Drive, Cherry Hill, NJ 08003; http://namle.net/conference/.
IWW - The North American Work People’s College will take place July 12-16 at Mesaba Co-op Park in northern Minnesota. The event will bring together Wobblies from branches across the continent to learn new skills and build One Big Union.
PEACESTOCK - On July 13th, the 11th Annual Peacestock: A Gathering for Peace, will take place at Windbeam Farm in Hager City, WI. The event is a mixture of music, speakers and community for peace. Sponsored by Veterans for Peace.
Contact: Bill Habedank, 1913 Grandview Ave., Red Wing, MN 55066; 651-388-7733; firstname.lastname@example.org; http://www.peacestockvfp.org.
CHILDREN’S DEFENSE - July 15-19, join clergy, seminarians, Christian educators, young adult leaders and other faith-based advocates for children at CDF Haley Farm in Clinton, Tennessee, for five days of spiritual renewal, networking, movement building workshops, and continuing education about the urgent needs of children at the 19th annual Proctor Institute for Child Advocacy Ministry.
Contact: email@example.com; http://www.childrensdefense.org.
ACTIVIST CAMP - Youth Empowered Action (YEA) Camp will have sessions in July and August in Ben Lomond, CA; Portland, OR; Charlton, MA. YEA Camp is designed for activists 12-17 years old who want to make a difference in the world.
Contact: firstname.lastname@example.org; http://yeacamp.org/.
LA RAZA - The annual National Council of La Raza (NCLR) Conference is scheduled for July 18-19 in New Orleans, with workshops, presentations and panel discussions.
Contact: NCLR Headquarters Office, Raul Yzaguirre Building, 1126 16th Street, NW, Washington, DC 20036; 202-785-1670; www.nclr.org.
LABOR - The Eastern Conference For Workplace Democracy: Growing Our Cooperatives, Growing Our Communities, will be held at Drexel University in Philadelphia, PA, July 26-28.
Contact: email@example.com; http://east.usworker.coop/.
WOMEN/LYNNE STEWART- Radical Women is asking for support letters and cards to be sent to Lynne Stewart. Stewart is a civil rights attorney and political prisoner who is currently in jail. She has breast cancer and authorities have denied her request for transfer from her Texas prison to the New York City hospital where she received medical attention during a prior bout of breast cancer. Send messages and cards to: Lynne Stewart 53504-054, Federal Medical Center Carswell, P.O. Box 27137, Fort Worth, TX 76127.
Contact: 747 Polk Street, San Francisco, CA 94109; 415-864-1278; RadicalWomenUS@gmail.com; http://lynnestewart.org/; http://www.radicalwomen.org/.
HAITI/WOMEN - Haiti’s government is considering a legal reform measure that would prohibit and punish all sexual assault, including marital rape. MADRE and the International Campaign to Stop Rape & Gender Violence in Conflict are launching a petition to raise international support for this push to address violence against women in Haiti.
Contact: 121 West 27th Street, #301, New York, NY 10001; 212-627-0444; firstname.lastname@example.org; http://www.madre.org.
SYRIA/MIDDLE EAST - The Middle East Children’s Alliance (MECA) is currently seeking funds to assist more than 200,000 refugees fleeing violence in Syria.
FOLK FESTIVAL - The Falcon Ridge Folk Festival will be held August 2-4, in the Berkshires, NY.
Contact: http://www.falconridgefolk.com/; email@example.com.
WAR RESISTERS - The War Resisters League will hold its 90th anniversary conference, Revolutionary Nonviolence: Building Bridges Across Generations and Communities, August 1-4, at Georgetown University. The event will focus on the U.S.’ long history of antimilitarism.
Contact: 339 Lafayette Street, New York, NY 10012; 212-228-0450; firstname.lastname@example.org; http://www.warresisters.org.
POPULAR ECONOMICS - The Center for Popular Economics is holding its 2013 Summer Institute August 4-9 at Hampshire College in Amherst, MA. No background in economics is needed for this intensive training. This year’s theme is, The Care Economy: Building a Just Economy with a Heart.
Contact: Center for Popular Economics, PO Box 785 Amherst, MA 01004; 413-545-0743; email@example.com; www.populareconomics.org.
VETERANS - Veterans for Peace is holding the 28th annual convention August 6-11 in Madison, WI. This year’s theme is, Power To The Peaceful.
DEMOCRACY - The Democracy Convention will take place August 7-11 in Madison, WI. The convention brings together nine conferences including topics such as media, education, defense, race, environment and others.
MEN - The 38th National Conference on Men & Masculinity: Forging Justice: Creating Safe, Equal and Accountable Communities, presented in partnership with HAVEN, will be held in Detroit, MI, August 8-10.
Contact: firstname.lastname@example.org; http://www.nomas.org/.
OCCUPY - An Occupy National Gathering will be held in Kalamazoo, MI, August 21-25.
Contact: email@example.com; http://occupynationalgathering.net/.
COMMUNITIES - The Communities Conference is a networking and learning opportunity for co-operative or communal lifestyles, with workshops, events and entertainment; scheduled for August 30-September 2 at the Twin Oaks Community in Louisa, Virginia.
LABOR DAY - The 29th annual Bread and Roses Festival, a celebration of the ethnic diversity and labor history of Lawrence, MA, will be held September 2, in honor of the 1912 Bread and Roses Strike. There will be music, dance, poetry, drama, ethnic food, historical demonstrations, walking & trolley tours.
Contact: PO Box 1137, Lawrence, MA 01842; 978-794-1655; http://www.breadandrosesheritage.org/.
OCCUPY WALL STREET - September 17 is the two-year anniversary of the Occupy Wall Street movement. Events are planned in New York City and worldwide.
TEACHERS - The 13th Annual Conference, “Teaching for Social Justice: The Politics of Pedagogy,” will be held October 12 in San Francisco, CA. The free event features workshops, resources, and free childcare.
Contact: 415-676-7844; firstname.lastname@example.org; http://www.t4sj.org/.
HAITI - International Action, which brings clean water and chlorinators to Haiti, seeks office space capable of housing up to six people and their office equipment.
Contact: Zach Bremer, Zbrehmer@haitiwater.org; 202-488-0735; http://www.haitiwater.org/.
MEDIA - The Union for Democratic Communications and Project Censored are sponsoring a joint conference on media democracy, media activism and social justice to be held November 1-3 at the University of San Francisco. Proposals for presentations, workshops and panels from activists and critical scholars are invited.