October 12, 2011
The Huffington Post
By: Dr. Peter Breggin
My October 3, 2011 blog on The Huffington Post described a recent precedent-setting criminal case in which a Winnipeg, Manitoba judge confirmed my written opinion and courtroom testimony that Prozac adverse drug effects drove a 16-year-old boy to stab a friend to death. I have now made the judge’s opinion available online and also as a part of my more extensive report on the case on my website.
In the case of “C.J.P,” Judge Robert Heinrichs concluded, “Dr. Breggin’s explanation of the effect Prozac was having on C.J.P.’s behavior both before that day and in committing an impulsive, inexplicable violent act that day corresponds with the evidence” (p. 18). My written report in the case stated, “At the time of the assault, [C.J.P] was suffering from a Prozac-Induced Mood Disorder (292.84) with manic features (especially extreme irritability) caused by Prozac. I want to emphasize that, within a reasonable degree of medical certainty, he would not have become violent without the exposure to Prozac, and he will not become violent again.”
Judge Heinrichs also found, “There is clear medical and collateral evidence that the Prozac affected his behavior and judgment, thereby reducing his moral culpability” (p. 20). In my report I observed that C.J.P.’s adverse reactions to Prozac exactly paralleled the description of adverse drug reactions contained in the FDA-approved label for Prozac, including the “emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down” (p. 8). C.J.P. had deteriorated emotionally over a three month period on Prozac, including an increase in dosage 17 days prior to the assault.
The case of C.J.P. and its violent outcome can be compared to a similar case that I describe in “Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime.” A very gentle teenage girl whom I called Emily Ashton developed a sudden urge to thrust a knife into her mother’s back during her second week of taking Prozac. Like C. J. P., she was 16 years old; but unlike him, she showed no outward signs of a worsening mental condition and displayed no anger at all until the sudden compulsive urge to stab her mother began to overtake her. At the time, there were no angry conflicts in the family. Fortunately, Emily told her mother about the bizarre and violent compulsion. As in C.J.P.’s case, Emily’s mother knew that violence was wholly out of character for her daughter and she suspected the Prozac.
Again as in C.J.P.’s case, Emily’s mother took her back to her prescribing family doctor who then referred her to a psychiatrist. There the comparison ends. Unlike C.J.P.’s tragic case, the consultant psychiatrist recognized the problem as Prozac-induced and immediately stopped the anti-depressant, after which the compulsion gradually subsided. Emily went on to live a normal, productive adult life and to raise a family. Nonetheless, she continued to feel guilty about her violent impulse that overcame her at the age of 16. She felt relieved many years later when we talked and I was able to reassure her that the impulse had been chemically-driven by the drug.
All of the newer anti-depressants carry the same warnings as Prozac concerning “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression and suicidal ideation.” These drugs include Celexa, Lexapro, Luvox, Prozac or Serafem, Paxil, Cymbalta, Effexor, Wellbutrin or Zyban, and Pristiq.
Many tragic acts of suicide and violence could be averted by reducing or stopping the use of anti-depressant drugs, by greater professional and public awareness of the dangers associated with these drugs, by withdrawal from the drugs at the earliest sign of mental and behavioral deterioration, and by greater reliance on individual and family psychotherapy.
The effectiveness of anti-depressants has been increasingly called into question. At the same, the risk of withdrawing from them has become more obvious, and cutting back or stopping them requires experienced clinical supervision and a slow, cautious taper. Many psychotherapists successfully treat depressed patients without resort to these drugs.
Click here for the full report from The Huffington Post
August 16th, 2011
By: Ethan A. Huff
It is truly astounding to witness the utter corruption that takes place — and practically in plain sight — within the pharmaceutical drug industry. The US Food and Drug Administration (FDA) has announced that drug firm Cetero Research, for many years knowingly forged thousands of clinical trial documents for drug companies in order for them to gain drug approval. The FDA’s response to this, though is that this massive corruption is basically no big deal.
It is no secret, of course, that the FDA routinely works in illicit tandem with drug companies to get dangerous drugs on the market in exchange for cash. One example of this includes the Lexapro scandal in which the FDA approved this dangerous antidepressant drug for children at the same time as federal and state governments were suing Forest Laboratories, maker of the drug, for pushing it on children.
The FDA’s own scientists have even publicly indicted the agency for censoring truthful scientific data, intimidating and unfairly targeting supplement companies, and using the drug approval system to extort cash from drug companies in exchange for its rubber stamp of approval.
The entire racket between the FDA and Big Pharma is mind-bogglingly extensive, and it is even seen in the FDA’s recent announcement “against” Cetero. While it initially appears that the FDA is upset at Cetero for lying via its clinical trial documents, the agency’s solution is to tell the drug companies to go back and redo them themselves.
FDA not interested in truly regulating drug industry, tells it to go regulate itself
In the FDA’s recent announcement concerning Cetero, the agency declared that both an internal company investigation and a third-party audit revealed “significant instances of misconduct and violations” in conducting clinical trials. Between April 2005 and June 2009, there were at least 1,900 instances of fraud and falsified studies, and each one of these instances was falsely used to prove that a drug was safe before it went on the market.
“The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame,” said the FDA, noting that drug companies may have to go back and perform new safety studies.
But the real kicker is that the FDA also stated that this is not really that big of a deal. Millions of people’s lives are on the line as potentially fatal drugs were approved with false data — but according to the FDA, nobody should be concerned. In fact, the FDA has known for years that Cetero has been falsifying data, and the agency has done absolutely nothing about it.
FDA does not even know which companies used Cetero’s corrupt services
One would assume that the nation’s food and drug regulatory agency would at least have saved records of which drug companies used Cetero for their early clinical trials. Such information is standard on any drug application, right? Apparently not. The FDA actually has no idea which drug companies used Cetero’s services, and it is now asking drug companies to search their records and determine whether or not they contracted with Cetero.
Even a cursory analysis of this whole approach shows how utterly foolish it actually is. Does the FDA really think the drug companies that used Cetero, are going to willingly participate in this? Of course not. It would mean the companies would have to go back and redo their clinical trials if they fess up.
These are important questions that should be asked:
- Why does the FDA itself not have records of the research companies used for the drugs that it approves?
- Why is the FDA apparently unconcerned about the safety of these drugs, considering they were approved using falsified data?
- Why is the FDA not attempting to hold Cetero accountable for its actions, other than to make an announcement about them?
Despite the nonchalant way in which the mainstream media is reporting on this issue, what Cetero has done is nothing short of high-profile crime. By falsifying drug trial data, Cetero has willingly put millions of people’s lives at risk. The only right thing to do is immediately shut down the company and order a full investigation. All parties involved must be held accountable, including those at the FDA that may have been complicit as well.
However, in the real world, the FDA’s solution is to tell the fox to go back and guard the hen house a little bit better, while simultaneously reassuring the world that the fox itself is safe and would never hurt anybody. In fact, the agency is actually alleging that all approved drugs — even those that were approved with falsified Cetero data — are perfectly safe and “unlikely to be affected” by this massive criminal cover up.
So there you have it. While it is absolutely insane to make such a claim, the FDA has done just that, and it expects the world to take it seriously. The FDA’s logic is essentially no different than, say, an amusement park claiming that all of its roller coasters are safe, even after it was determined by multiple investigations that the manufacturer of the coasters had lied about the quality of the materials used, and that the pieces may not actually hold together.
The question remains, would you ride those roller coasters, or have the nerve to tell other people to ride those roller coasters? The FDA did.
Click here for the full report from Natural News
July 11, 2011
New York Times
By Laurie Tarkan
A new study found an elevated risk of autism in children whose mothers took a popular type of antidepressant during the year before delivery. But the authors reassured women taking these drugs — so-called S.S.R.I.’s like Prozac, Zoloft, Celexa and Lexapro — that the risk was still quite low: 2.1 percent in children whose mothers used them in the year before delivery, and 2.3 percent in the first trimester of pregnancy.
Dr. Joseph Coyle, the editor in chief of the psychiatry journal, called the two studies “game changers.”
Clara Lajonchere, an author of the twin study and vice president of clinical programs for the research and advocacy organization Autism Speaks, said that “much more emphasis is going to be put on looking at prenatal and perinatal factors with respect to autism susceptibility.”
She added, “We need to not just study the environmental factors, but the relation between the genes and the environment.”
“For pregnant women or those thinking about having a family,” she said, “prenatal care is critical, and if a pregnant woman is taking any kinds of medication, she should work closely with a physician.”
Click here for the full report from the New York Times.
June 10, 2010
By S.L. Baker
(NaturalNews) Of the 35 million Americans who are age 65 or older, the National Institutes of Health (NIH) claims about 7 million of them suffer from clinical depression — and millions are on the prescription antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs) such as Prozac, Paxil, Lexapro and Zoloft. Hyped by Big Pharma as the way to solve depression problems in all age groups, these medications come with a litany of serious side effects, including some that are particularly dangerous for elders.
For example, a University of Minnesota study found SSRIs increase the rate of bone loss in older men and women. And now there’s even more reason for seniors to be wary of taking SSRIs. New research just published in Ophthalmology, the journal of the American Academy of Ophthalmology, concludes taking these antidepressants substantially raises the risk of sight-threatening cataracts.
A cataract is a clouding of the lens in the eye that affects vision. In fact, as cataracts progress, they can cause enough deterioration of eyesight that surgery is needed to remove them. Although cataracts are common in older people, there are many factors that can increase a person’s risk of actually developing the eye problem, including exposure to cigarette smoke, air pollution, and heavy alcohol consumption. And now you can add taking SSRIs to that list.
Click here for the full report.
April 5, 2010
Wall Street Journal
By Shirley S. Wang and Melanie Trottman
The Federal Aviation Administration will let some pilots who take four popular antidepressants return to the skies, saying Friday that it is easing its long-standing ban on psychiatric medications.
The old policy stemmed in part from concerns over possible side effects of psychiatric drugs, including sedation. But newer medications have fewer side effects, and pilots’ associations have pressured the agency to reconsider the ban.
FAA Administrator Randy Babbitt said some pilots with depression likely weren’t being treated or were doing so in secret out of fear of losing their jobs. “We need to change the culture and remove the stigma associated with depression,” said Mr. Babbitt.
Starting Monday, the agency will consider granting waivers that will allow pilots to fly while taking Prozac, Zoloft, Celexa or Lexapro, as well as their generic equivalents.
Medical experts and mental-health organizations supported the move, noting that untreated depression itself has an impact on job performance. They cautioned that the FAA needed to monitor the changes and keep pilots’ confidentiality in mind.
Another risk: If some pilots who come forward aren’t granted waivers, the agency may inadvertently discourage others from doing so, said Ken Duckworth, a psychiatrist and medical director of the National Alliance on Mental Illness, an advocacy organization.
The Air Line Pilots Association, the world’s largest pilot union, backed the move. “This policy change should improve aviation safety and pilot health,” it said in a statement.
The FAA says it can’t estimate how many pilots might come forward but believes pilots’ depression rate doesn’t differ much from that of the general population, about 10%.
Antidepressants are the fourth biggest-selling class of drugs in the U.S., netting nearly $10 billion in sales in 2009. For the four antidepressants, nearly 75 million prescriptions were dispensed in the U.S. last year, according to IMS Health, which tracks prescription-drug sales.
The new policy doesn’t mean pilots who want to begin taking one of the medications can get in the cockpit right away. Before being granted a waiver by a physician certified by the FAA, a pilot must be considered “satisfactorily treated” for 12 months; in the meantime, he or she will be grounded.
For pilots who have been secretly taking antidepressants, the FAA is offering a grace period. The agency said it wouldn’t take action against such pilots if they come forward within six months. However, pilots with a recent case of depression or who want to begin a new medication regimen will be subject to the one-year waiting period, according to FAA spokeswoman Alison Duquette. “We’re really looking for stability,” she said.
Pilots must be examined by an aviation medical examiner every six months to one year to be recertified. They are required disclose what medications they are taking; lying on the form is considered a federal offense. The FAA says it doesn’t track the number of pilots who have been grounded because they are taking psychiatric medications.
Psychiatrists said it usually takes three to six weeks for an antidepressant to begin taking effect, and doctors should have a good sense of how people are responding within three months. It takes an additional six months or so to get a sense of whether the depression will recur while on the medication.
The four medications that are allowed by the new policies are part of the so-called SSRI family. They work by preventing a brain chemical called serotonin from being reabsorbed by neurons. Their most common side effects are nausea and sexual dysfunction, said psychiatrists.
The FAA said it would consider allowing other psychiatric medicines in the future.
Psychiatrists say that it is far better to encourage pilots to get help than allow them to fly with untreated mental illness. “Untreated depression affects cognition probably more than any possible detrimental effect of any of these antidepressants,” said P. Murali Doraiswamy, a professor of biological psychiatry at Duke University Medical Center.
Click here for the full report.
January 27th, 2010
WebMD Health News
By Salynn Boyles
Early research suggests a link between antidepressant use and breastfeeding difficulties in new moms.
The risk of delayed lactation after giving birth was twice as great among women in the study taking selective serotonin reuptake inhibitor (SSRI) antidepressants as among new mothers who did not take the drugs.
Just eight, or about 2%, of the 431 study participants were taking the antidepressants, however, so the findings are far from conclusive.
But the study is the first to explore the impact of antidepressant use on lactation in humans.
“Delayed lactation is very common in the United States, but we don’t really understand the reasons for it,” researcher Nelson D. Horseman, PhD, of the University of Cincinnati College of Medicine tells WebMD. “This may end up being one of the few concrete explanations for at least some of the delayed lactation we see.
“Earlier research in Nelson’s lab found that the hormone serotonin plays a role in breast function, including the ability to secrete milk when needed.
The finding led the researchers to wonder if drugs that affect serotonin levels, such as SSRI antidepressants, would also affect the ability of the breasts to secrete milk when needed.
SSRIs are the most widely prescribed antidepressants. They include the drugs Zoloft, Celexa, Prozac, Paxil, and Lexapro.
In an effort to answer the question, Nelson and colleagues followed 431 first-time mothers from childbirth through the first days of motherhood.
For the purposes of the study, the researchers considered breastfeeding delayed when a woman did not have copious milk production within three days, or 72 hours, of giving birth.
All the women in the study were eventually able to breastfeed, whether they were taking antidepressants or not.
But the average time to lactation for the eight women taking SSRIs was almost 86 hours after childbirth, which was almost a day later than the average time it took women who did not take the antidepressants to establish a milk supply.
Lactation specialist Laurie Nommsen-Rivers, PhD, tells WebMD that this extra day can be the difference between success or failure for women anxious to provide their babies nutrition.
A co-author of the study, Nommsen-Rivers is also an epidemiologist with Cincinnati Children’s Hospital Medical Center. “That delay can be the point where many women throwing in the towel and decide they can’t breastfeed,” she says. “It is important to point out that all the women in our study eventually lactated. SSRI use doesn’t prevent women from breastfeeding, but it might take SSRI users a little longer.
“Nommsen-Rivers says that while all new moms should have access to breastfeeding support, such support may be especially important for new moms who take antidepressants.
The study appears in the February issue of the Journal of Clinical Endocrinology and Metabolism.
“These women need to know that delay doesn’t mean it isn’t going to happen,” she says.
Texas Tech University Medical School health psychologist and lactation consultant Kathleen Kendall-Tackett, PhD, points to numerous studies that have explored the impact of SSRIs on babies born to women who use them.
“To my knowledge this lactation delay has not been documented before,” she tells WebMD. “I would guess that if this is happening, it is rare.”
She points out that pregnant women are at the highest risk for depression in their last trimester and in the early weeks after giving birth.
While she feels too many women may be taking antidepressants when other treatments might work for them, Kendall-Tackett also warns that moms-to-be and new moms should never stop taking SSRIs or any other prescribed antidepressant without their doctor’s approval.
“Generally speaking, if a woman is on an antidepressant during the last trimester of pregnancy she probably needs to stay on it, and she should never go off it on her own,” she says.
Click here for the full report
August 11, 2009
By Julie Steenhuysen
People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an analysis by U.S. Food and Drug Administration researchers released on Tuesday showed.
The report by the FDA scientists confirms earlier studies and supports the agency’s age-related warnings on the drugs’ labeling.
U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.
In February 2005, the FDA added a so-called black box warning — the agency’s strongest warning — on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.
Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment for depression, the leading cause of suicide. In fact, recent studies have suggested the warnings triggered an 8 percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years.
A LASTING DECLINE
A study published in June in the journal Archives of General Psychiatry said the FDA’s decision to impose black box warnings for children and young adults had a spillover effect on depression care in older adults, resulting in a lasting decline in depression diagnosis and treatment.
Those researchers urged the FDA to revise its policy.
The FDA analysis by Dr. Marc Stone, Dr. Thomas Laughren and colleagues involved a review of data from eight drug makers on 372 clinical trials involving nearly 100,000 adults.
Overall, they found the risk of suicide was “strongly age-dependent,” with higher risks in people under 25, no difference among those 25 to 64, and lower risks in people 65 and older.
The researchers said the findings, published on the British Medical Journal website, support the agency’s warnings on antidepressant drug labeling for people under 25, and they also support the notion that antidepressant drugs can have two distinct effects.
In some patients, they can promote suicidal thoughts or behavior — but this risk appears to diminish with age. In others, the drugs provide relief from depression, reducing the risk of suicide. They said more research is needed to understand these differences.
John Geddes from the University of Oxford and colleagues said in a commentary the findings were not new and noted that the trials studied by the FDA excluded sicker patients. The study did, however, make clear differences in risks among specific antidepressants, they said.
They noted specific differences in commonly used drugs called selective serotonin reuptake inhibitors, or SSRIs.
For example, the odds of suicidal behavior by people taking Pfizer Inc’s Zoloft, or sertraline, were around half of those who took placebo. By comparison, Forest Laboratories Inc’s Celexa, or citalopram, and Lexapro, or escitalopram, “seem to increase the risk of suicidal events,” Geddes and colleagues wrote.
“Increased risk is probably restricted to younger people and varies greatly between individual medicines.”
Click here for the full report from Reuters