by
Evelyn Pringle
FDA Protects SSRI Makers
With Misleading Suicide Warning
On May 2, 2007, the FDA announced its most misleading warnings to date about
selective serotonin reuptake inhibitor antidepressants when it said the drug
makers would revise the current black box warning of an increased risk of
suicidality in children and adolescents to include adults, but only young
adults ages 18 to 24. Apparently at the ripe old age of 25 the increased
risk no longer exists.
An FDA advisory committee held a public hearing on December 13, 2006 to
review drug company data that show SSRIs to be associated with suicidality
in adults. The commonly prescribed SSRIs in the US include Prozac, by Eli
Lilly, Paxil by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro by
Forest Labs, along with various generic versions of the drugs.
Many of the world's leading experts on psychiatric drugs traveled to
Washington to appear at the hearing, some of whom have spent years
investigating the adverse events associated with SSRIs, to testify about the
need to extend the back box warnings about suicidality to all age groups.
Needless to say, advocates and experts alike are outraged over the limited
warning, which is widely viewed as another gift to the drug makers by the
FDA. "Keeping up with its support of the Psychiatric community and
pharmaceutical industry the FDA has again taken the low road," says Kelly
Patricia O'Meara, author of "PSYCHED OUT: How Psychiatry Sells Mental
Illness and Pushes Pills That Kill."
"Not only is it continuing to minimize the adverse reactions of the
antidepressants on the entire population," she notes, "it has now become a
cheerleader for the psychiatric community." "When will the well-being of the
American People," Ms O'Meara asks, "get the protection it needs and deserves
from the nation's leading drug watchdog and when will this nation's
lawmakers stand up and be counted on this issue?"
Attorney Karen Barth Menzies is one of the nation's most relentless
advocates in the legal field when it comes to pushing the FDA to add
warnings about adverse events to the labels of SSRIs. In fact, she has
traveled to Washington to speak on behalf of SSRI victims numerous times.
"As I stated in my testimony before the FDA in December 2006," Ms Menzies
notes, "it is not the FDA's job to promote the virtues of particular drugs
nor is it FDA's job to suggest what treatment people should receive for a
particular medical problem."
"Even the FDA's Dr. Robert Temple said as much during the December hearing,"
she points out.
"Yet that is what the FDA has done with its announcement of the expanded
warnings on antidepressants," she says.
"Aside from the very serious risks of these drugs," she explains, "there is
an overarching issue related to their over-prescription and drug
manufacturers preying on vulnerable people by telling them they have a
disease that must be treated with their medication."
A partner in the Baum Hedlund law firm, Ms Menzies considers the FDA's
expanded warning a hollow victory. "While it appears that the FDA has
finally taken the issue more seriously," she notes, "it is 20 years and
thousands of lives too late."
In addition, in the agency's press release and accompanying Q & A document,
Ms. Menzies warns, "The FDA has made some seriously misleading statements
that will lead patients and physicians into a false sense of security."
Ms Menzies says she believes "without question" that drug makers are putting
pressure on the FDA. "Despite the controversy over the failures of the FDA
in the past several years," she points out, "it appears that the FDA simply
cannot muster the guts to act without industry influence."
Critics say the nation's regulatory agencies under the Bush administration
have evolved into a protection network for drug makers, in large part,
because the industry has created a revolving door where top officials move
directly from their government employment into high-paying positions with
drug companies.
The latest evidence of this charge appeared in the media on May 4, 2007,
with a press release by Prozac-maker Eli Lilly, announcing that Alex Azar II
will be joining Lilly as senior vice president, who until February 3, 2007,
was the Deputy Secretary of Health and Human Services and served as the
"chief operating officer of the largest civilian department in the federal
government."
"Azar supervised all
operations of the HHS, including the regulation of food and drugs," the
press release said, and agencies under his direction included, among others,
the FDA.
Azar follows in his former partner, Daniel Troy's footsteps in defending the
drug industry. While Troy left his position as chief counsel at the FDA to
work for a law firm representing drug companies, Azar (also a lawyer) went
straight to the drug industry itself.
At Lilly, Azar will be responsible for "public relations, governmental
affairs, public policy planning and development, external and internal
communications, corporate branding and community relations."
FDA Protects SSRI Makers With Misleading Suicide Warning - 1
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