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.”

“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 house.”

“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,” “extremely misleading.”

“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 birthday.”

“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 all.”

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 medication.

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,” he notes.

“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 attendant risks.”

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 Paxil.”

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 without drugs.

(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 anti-depressants to anti-psychotics 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,” she says.

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.”

For more information see:
A Paxil Lawyer Source
Anti-depressant Adverse Reactions
Paxil Birth Defects

(Written as part of the Paxil Litigation Monthly Round-Up, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)

Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America. She can be reached at: evelyn-pringle@sbcglobal.net. Read other articles by Evelyn, or visit Evelyn's website.

5 comments on this article so far ...

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  1. Daniel Haszard said on May 22nd, 2007 at 5:55am #

    Lilly Zyprexa Lawsuit 8 State Countdown

    Zyprexa targeted by AG’s for Criminal Fraud

    Utah Latest state to sue Eli Lilly in developing “Viva Zyprexa” Scandal.

    Side effects to Zyprexa can include high blood sugar levels, acute weight gain and pancreatitis, according to the lawsuit.

    “Utah has paid millions of dollars for inappropriate and medically unnecessary doses of Zyprexa. As a result, Lilly has been illegally enriched at the expense of the State,” the lawsuit said.

    The state is seeking civil damages and penalties, including $5,000-$10,000 for each prescription that was “not medically necessary.”

    Lilly also faces lawsuits filed by attorneys general of Alaska, Louisiana, Mississippi, New Mexico and West Virginia alleging that it marketed Zyprexa for unapproved uses or hid the risks of weight gain and diabetes.

    Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.

    Not fair!

    Daniel Haszard http://www.zyprexa-victims.com

    (Don’t shoot the messengers)

  2. Carole Lieberman, M.D., M.P.H. said on May 22nd, 2007 at 8:57am #

    As a psychiatrist and NIMH award recipient in public health, I have long studied the problem of deteriorating psychiatric health care in America. The problem is not the antidepressants themselves, but rather who and how they are administered. Too many non-psychiatrists hand out prescriptions for antidepressants and other psychiatric medications like candy, without the years of psychiatry specialization behind them. And too many psychiatrists give out prescriptions, while only seeing patients for brief monthly visits – instead of treating them with intensive psychotherapy along with the medications. It is not a new phenomenon that antidepressants can activate a depressed patient’s suicidal thoughts. However, when the patient is being seen in psychotherapy, these can be dealt with appropriately before the patient is in danger.

  3. Chris Davis, MSII said on June 1st, 2007 at 3:27pm #

    To Dr. Lieberman:

    As a Medical Student and as a patient that is on an SSRI. I blame psychiatry, not primary care patients or doctors for this mess. Honestly, how can you expect patients to pay hunderds of dollars per hour to see a psychiatrist? Why should they when someone else can perscribe for less than a third of the price? If we really want medical patients to recieve the proper care we must take cost into consideration. States should follow the current plan in the state of New Mexico that gives psychologist (Ph.D, not M.D. or D.O.) the right to perscribe SSRI’s. This would give patients the specialist care that they need while keeping costs down.

  4. Maddox Stockton said on June 14th, 2007 at 2:32am #

    This one makes sence “One’s first step in wisdom is to kuesstion everything – and one’s last is to come to terms with everything.”

  5. anna said on January 23rd, 2009 at 5:33am #

    If psychiatrists were concerned about the truth or a medical aspect of their prescriptions, they would not become psychiatrists. What I observed is this:
    1. 99 % of the time psychiatrists are attracted to this type of practice to find the context for their own mental problems. Their problems are REAL compared to their patients! Most of the discoveries are made when they are observed or experienced in the “Self” and it is nothing new; except in psychiatry, the focus is on projecting the psychiatrist’s self control or lock of self control
    (that’s why so often they have sexual relationships with their patients or commit different kinds of crimes) on their patients! What APA’s diagnostic system represents is THE PSYCHOLOGICAL PICTURE OF THEIR OWN MEMBERS!
    Studying this system will tell you who they are! If you look at psychiatrists from this prospective you will realize that we are taken over by the MAD MAN ARMY- 38,000 plus PSYCHIATRISTS.
    2. What they are really interested in is the control of others not the CURE.
    Brain manipulating substances are produced to THEIR order.
    The real margin of possible application of such a chemical is so narrow that it would have to be passed to smallest pharmaceutical companies with a very tiny profit to them.
    What is expending the application is addictive nature of this medication and madness as a effect
    of its use use. Therefore the current application is mainly to produce illness not to CURE.
    From a business prospective PSYCHIATRISTS are a DRUG DEALERS working for a Drug Cartel
    and should fell legally to the same category as street drug dealers. Until this happens people will be getting mad and will be dying as a result of State sponsored Psychiatry.
    When you realize this you will understand that Psychiatrist know what we know, but their agenda is not from our world. We want peace and calmness they want the thrill of their own mania.
    Psychiatrists who can see the truth will not survive within the group. They have to become dissidents because their real characters will be assassinated right away. Psychiatry uses political authoritarian methods of neutralizing their opponents and they are a real POLITICAL MOVEMENT, NOT DOCTORS, and they don’t want to have anything to do with medicine. They could read the same books as we do if they wanted to. They are after us ( sane people) because of their desire to control and have power, not compassion and mercy, like a doctors should… not to mentioned “Premium non nocere?: Above all, do not harm. ” Psychiatrists’ collaboration with the pharmaceutical companies is also misinterpreted. Being a business person I know the limitation of the sales script. Psychiatry WANTS to use pharmaceutical companies to create a public illusion so they can depend on other institutions for their own judgment. They really don’t depend on the FDA or Pharmaceutical labels any more then the CHURCH does. Why does the CHURCH today recommend psychiatrists for spiritual problems? The same reason: hierarchy of control. Somehow psychiatry got before the CHURCH. So it is not about medicine, it is about control. My question will be: who hired them and who pays them to abuse us with OUR tax payer’s money???