FDA Protects SSRI Makers With Misleading Warning
FDA Protects SSRI Makers With Misleading Suicide Warning
By Evelyn Pringle
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.”
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 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,” 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."
By Evelyn Pringle
(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