Protects SSRI Makers With Misleading Suicide Warning
By Evelyn Pringle
21 May, 2007
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.”
According to the Indianapolis Star, Azar “takes over the Lilly
post as seven states are suing the company, alleging that it promoted
off-label uses for Zyprexa, its top-selling drug approved for schizophrenia
and bipolar disorder.
“Like other pharmaceutical companies,” the Star points out,
“Lilly also faces an array of public- policy challenges, including
criticism that it is too cozy with doctors and regulators.”
There is one positive to be noted, at least Troy and Azar are no longer
pretending to be protectors of the public health.
Experts say the suicidality risk applies to all SSRI users. "The
simple truth is that antidepressants cause suicide in all age groups,"
according to psychiatrist, Dr Peter Breggin, a court-certified expert
on SSRIs, and author of "The Anti-Depressant Fact Book."
"Dragged kicking and screaming into admitting that children and
now young adults are at risk for antidepressant-induced suicidality,"
he says, "the FDA continues to evade reality."
"If the relatively insensitive drug-company rigged short clinical
trials pick up suicidality in any age group," Dr Breggin says,
"it's almost a certainty that they are causing actual suicides
in all ages."
Many other experts agree that safety decisions should not be based on
drug maker studies. "The fundamental problem continues to be that
the FDA is basing their decisions on studies that are designed and paid
for by the very companies that make these drugs," said Dr Timothy
Scott, author of, “America Fooled: The Truth about Antidepressants,
Antipsychotics and How We've Been Deceived.”
"It is a case," he says, "of the fox guarding the chicken
"The research designs used by these studies," he notes, "are
incredibly unfair and yet the FDA is allowing this system to continue."
"Dishonest research designs," Dr Scott says, "do not
give an honest assessment of the physical or the psychological dangers
of long-term antidepressant use."
"Independent research investigations," he states, "repeatedly
find adverse events are much, much higher than the rates reported in
the studies submitted to the FDA by the drug manufacturers."
For over a decade and a half, Attorney Menzies points out, SSRI makers
have enjoyed enormous financial benefits from their manipulations of
the clinical trial data and the FDA continues to ignore all evidence
aside from data provided by the drug companies. "The FDA is ignoring,"
she says, "independent analyses conducted by scientists in the
field, as well as historical and foreign regulatory actions dating back
over 20 years."
Ms Menzies states that clinical trial data from before SSRIs were even
approved, signaled the suicidality risk. Documents obtained in litigation
show that as early as 1984, Eli Lilly was aware of an increased risk
of suicidality with Prozac.
Attorney Menzies calls the FDA's statement that “scientific data
does not show an increased risk in adults older than 24, and that adults
ages 65 and older taking antidepressants have a decreased risk of suicidality,”
“Rather than accurately informing the public that suicidality
can occur in some people at any age,” she notes, “this new
warning gives the false perception that certain age groups are entirely
safe while others are not. I know for a fact from my review of internal
drug company documents that that is not true,” she says.
Critics also find this statement disturbing in light of other independent
studies, including a study reported in the May 1, 2006, London Free
Press, conducted at the Toronto's Institute for Clinical Evaluative
Sciences, that identified suicides among older Ontarians, 66 and up,
and found that for patients who were prescribed antidepressants in the
6 months before their deaths, the risk of suicide in the first month
for those taking SSRIs was nearly 5 times higher than for seniors taking
older antidepressants called tricyclics such as Elavil.
Other experts also object to the piecemeal addition of SSRI warnings.
"When the FDA ordered a black box warning for only those 18 and
under, it defied common sense that as soon as one turned 19, one was
safe," says Dr Bruce Levine, PhD, Clinical Psychologist, author
of "STAR*D Wars: The Corruption of the National Institute of Mental
Health and the Failure of Antidepressants."
"And now that the warning will extend until 24," Dr Levine
adds, "it defies common sense that one becomes safe on one's 25th
"While some people report antidepressants have benefited them,"
he notes, "legitimate science shows that these antidepressants
are no more helpful for depression than a placebo or no treatment at
According to a study analyzing clinical trials submitted to the FDA
for drug approval, the efficacy data submitted to the FDA for the six
most widely prescribed antidepressants approved between 1987 and 1999,
“the pharmacological effects of antidepressants are clinically
negligible.” The Emperor’s New Drugs: An Analysis of Antidepressant
Medication Data Submitted to the U.S. Food and Drug Administration by
Irving Kirsch, Thomas J. Moore, Alan Scorboria and Sarah S. Nicholls.
According to Kirsch, “[a]lthough antidepressant medication is
widely regarded as efficacious, a recent meta-analysis of published
clinical trials indicates that 75 percent of the response to antidepressants
is duplicated by placebo.” Kirsch & Sapirstein, G. (1998).
Listening to Prozac but hearing placebo: A meta analysis of antidepressant
Two recent studies conducted in the UK report that exercise in a green
environment may be the best remedy for depression. In response to the
high cost of drugs, the rise in prescriptions and the fact that 93 percent
of GPs reported that “they have prescribed antidepressants against
their better judgment owing to a lack of alternatives,” the studies
found that “participating in green exercise activities provides
substantial benefits for health and wellbeing.”
The “green activities” included gardening, walking, running
and bicycling, particularly in a “green” environment.
Another of the world's leading experts on psychiatric drugs, Dr David
Healy, author of, "The Creation of Pharmacology (Harvard 2002),"
also a frequent visitor traveling from the UK to Washington to testify
at FDA hearings, says, "The clinical trial data pointing to a risk
was compelling 17 years ago."
"In between 1990 and now," he notes, "the FDA and drug
companies have argued that their assessment of risk benefit ratios has
not warranted issuing warnings."
"But if we look at the supposed benefits," he explains, "in
milder depressions - the vast majority of people who get antidepressants
- the FDA analysis in December 2006 showed that only 1 in 10 people
who are given antidepressants in clinical trials respond to the drug."
"Four out of 10 respond to being seen and given sensible advice,"
"Putting this 1 in 10 response rate against a 1 in 100 rate of
suicidal acts might not seem a bad bet," Dr Healy says, "but
suicidal acts are not the only risk of treatment - patients can become
severely anxious, homicidal, are at increased risk of broken bones,
strokes and bleeds into the gut and other organs, weight gain and its
He also notes that one in two patients on antidepressants experience
sexual dysfunction and that it now seems that in a proportion of these
people, the problem may be permanent.
"In the case of children," he says, "there are additional
risks like failure to grow."
Another serious adverse event with SSRIs is a discontinuation syndrome.
Psychiatrist Dr Grace Jackson, author of, "Rethinking Psychiatric
Drugs: A Guide for Informed Consent," warns that some patients
may not be able to return to living without the drugs, not because they
develop a “craving," but because the withdrawal effects they
experience during drug cessation are intolerable and are misinterpreted
by doctors as “proof” of depressive relapse, for which “lifelong
therapy” is mandated.
Over the past several years, many new adverse events related to SSRI
use have emerged, including life-threatening birth defects in infants
born to mother's taking SSRIs during pregnancy. But because SSRI makers
have hidden negative studies for years, experts say patients and doctors
were not informed of all the known risks associated with SSRIs.
“Informed consent cannot be obtained for antidepressants---or
for any pharmaceutical---unless all of the drugs’ risks are known
to the prescribers," according to psychiatrist, Dr Stefan Kruszewski,
Faculty, Eastern University, Department of Addictions.
"They cannot be known," he says, "if all of the data
is not made available to review or made public - as was the case with
According to Dr Healy, a bigger issue stems from company efforts to
make billions of dollars out of these drugs by having them given to
people who have little to gain from treatment and a lot to lose."
Dr Healy says most patients with milder depression would get well if
seen by a sympathetic physician or therapist and describes three side
effects that have resulted from the SSRI controversy:
(1) Physicians have lost confidence in their own ability to help patients
(2) A great deal of the problem stems from the fact that close to all
of the literature physicians now read is ghostwritten and the articles
overemphasize the benefits of treatment and hide the risks.
(3) Antidepressants might be useful drugs, if primarily used for those
with severe disorders, but at the moment the drugs probably pose a greater
risk than the illness to the lives, careers and relationships of those
to whom they are being given.
Clinical pharmacologist, Andrew Herxheimer, also says doctors should
be advised not to prescribe drugs, especially SSRIs, to patients with
only mild or moderate depression, and if prescribing is deemed necessary,
to use the lowest dose that is effective for the individual.
According to Dr Levine, the SSRI makers are not as unhappy as some might
think with the warnings and negative publicity. "Patents have run
out or are soon to run on all their big sellers," he explains,
"and they are preparing their next generation of worthless, dangerous
but patented drugs to replace the SSRIs."
Ms Menzies reports that there is a big push to switch people over from
taking antidepressants to antipsychotics under the guise that people
aren’t depressed after all, they actually have bipolar disorder.
“It is a very cleverly orchestrated marketing scheme and it’s
a continuation of the manipulation of a vulnerable population,”
Vince Boehm, another persistent advocate for warnings on SSRIs agrees,
"This is all about marketing, and not about safety."
"This latest ploy" regarding the expanded antidepressant warnings,
Boehm explains, "is a delaying action on the part of the manufacturers
with FDA complicity."
"The FDA just commissioned a series of three year studies to evaluate
the adult suicide problem," he notes, "and by the time these
studies are done and released, the bulk of the medications listed in
this announcement will be either off or going off patent."
(Written as part of the Paxil Litigation Monthly Round-Up, Sponsored
by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department)
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist
focused on exposing corruption in government and corporate America)
it! And spread the word!
Here is a unique chance to help this article to be read by thousands
of people more. You just Digg it, and it will appear in the home page
of Digg.com and thousands more will read it. Digg is nothing but an
vote, the article with most votes will go to the top of the page. So,
as you read just give a digg and help thousands more to read this article.
here to comment
on this article