INTRODUCTION
In 1990, the Citizens Commission on Human Rights (CCHR) asked American psychiatrists and the Food and Drug Administration (FDA) to issue warnings about the latest psychiatric drug causing violence and suicide: the antidepressant Prozac. CCHR filed complaints and provided evidence. In response, on September 20, 1991, the FDA ordered an advisory committee to hold a hearing to investigate the safety and effectiveness of antidepressant drugs. A panel of nine psychiatrists, many with financial ties to pharmaceutical companies, heard chilling testimony from medical experts as well as the victims of these drugs—and did nothing.
It wasn’t until 13 years later, on October 15, 2004, that the FDA finally ordered pharmaceutical companies to add a “black box” warning to antidepressants, saying the drugs could cause suicidal thoughts and actions in children and teenagers. It took nine months for the FDA to issue another advisory, warning doctors to watch for suicidal behavior in adults taking antidepressants.
The FDA advisories vindicated CCHR’s allegations and patient and family testimony in 1991. However millions of men, women and children were needlessly subjected to dangerous drugs for more than a decade. Now, with controversy growing over the previously undisclosed dangers of psychiatric drugs, international warnings are being issued at escalating rates, citing side effects of drug dependence, addiction, mania, hostility, aggression, psychosis, suicide and violence.
Following is a brief summary of the warnings issued since October 15, 2004:
September 20, 1991: The FDA ordered an advisory committee to hold a hearing to investigate the safety and effectiveness of antidepressant drugs. The panel’s chairman, Dr. Daniel Casey, stated: “I do not find from the evidence today, that there is credible evidence to support a conclusion that antidepressant drugs cause the emergence and/or the intensification of suicidality and/or other violent behaviors.”1
13 years later:
October 15, 2004: The FDA ordered pharmaceutical companies to add a “black box” warning to antidepressants, saying the drugs could cause suicidal thoughts and actions in children and teenagers. The agency also directed the manufacturers to print and distribute medication guides with every antidepressant prescription and to inform patients of the risks.2
December 17, 2004: The FDA required that a new warning be added to the packaging of the “ADHD” stimulant, Strattera, showing that the drug should be discontinued in patients who develop jaundice or liver damage. The FDA noted, “The labeling warns that severe liver damage may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients.”3
April 11, 2005: The FDA asked manufacturers of the atypical [new] antipsychotic drugs to add a warning to their labeling that the drugs could increase the risk of death in elderly patients suffering dementia.4
April 25, 2005: The European Medicines Agency scientific committee issued a statement concluding that suicide-related behavior and hostility were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebos.5
June 28, 2005: A document on the FDA website announced the identification of possible safety concerns with methylphenidate drug products. Specifically noted were psychiatric adverse events linked to Concerta, Ritalin and other drugs used to treat children diagnosed ADHD (Attention Deficit Hyperactivity Disorder) such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior. The FDA announced its intention to make labeling changes and examine other stimulant drug products approved for treatment of ADHD.6
June 30, 2005: The FDA issued a Public Health Advisory entitled "Suicidality in Adults Being Treated with Antidepressant Medications." The advisory states that several recent scientific publications suggest the possibility of an increased risk of suicidal behavior in adults taking antidepressants and while a review of all available data is being undertaken by the FDA, it is recommended that physicians should monitor adults who take antidepressants for suicidal tendencies.7
July 7, 2005: The National Center on Addiction and Substance Abuse issued a report that 15 million Americans were getting high on prescription drugs, painkillers and psychiatric drugs such Xanax, Ritalin and Adderall, abusing these drugs more than cocaine, heroin and methamphetamines combined. Some 2 .3 million teens were abusing the drugs per the report. Further, the study found that teens who abuse controlled prescription drugs were 12 times likelier to use heroin, 14 times likelier to use ecstasy and 21 times likelier to use cocaine, compared to teens who do not abuse prescription drugs.8
July 16, 2005: The British Medical Journal published a study by Joanna Moncrieff, senior lecturer in psychiatry at University College London, who found that antidepressants are no more effective than a placebo and do not reduce depression. The study found that trials of antidepressants with negative results are less likely to be published than those with positive results and that within published trials, negative outcomes may not be presented. Moncrieff found "no good evidence that these drugs work."9
August 2005: Columbia University came out with a study on the abuse of prescription drugs by teens; titled "National Survey of American Attitudes on Substance Abuse X: Teens and Parents," which found that the number of Americans who abuse controlled prescription drugs has nearly doubled between 1992 and 2003, with the number of 12-17 year olds having jumped 212%. Further, the study shows that the percentage of teens who have known someone who has abused prescription drugs jumped 86% from 2004 to 2005.10
August 19, 2005: The Commission of the European Communities, representing 25 countries, issued its decision to endorse and issue the strongest warning yet against child antidepressant use as recommended by Europe's Committee for Medicinal Products for Human Use (CHMP). This followed a review of clinical trials that showed the drugs cause suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility and/or related behavior.11
August 22, 2005: A study by Norwegian researchers disclosed that Paxil (known in Norway as Paroxetine) increases suicide risk in adults. The study of more than 1,500 patients found that 7 patients taking Paxil attempted suicide compared to one suicide attempt by those on placebo. The study also says that the recommendation to not prescribe Paxil to children and adolescents should be extended to include usage by adults.12
September 13, 2005: The Drug Effectiveness Review Project of Oregon State University published a major study questioning the effectiveness of ADHD drugs. The researchers reviewed 2287 studies, virtually every study ever done on ADHD, and released a 731 page report which found that there is little evidence that the drugs used to treat ADHD actually work or are safe in the long term or that they help school performance.13
September 22, 2005: Dr. Jeffrey Lieberman of Columbia University released a federally funded study in the New England Journal of Medicine that found that 74% of the patients in the study discontinued antipsychotic medication before the end of their treatment due to inefficacy, intolerable side effects or other reasons.14
September 23, 2005: Lester Crawford resigned as the Commissioner of the FDA . Amongst many speculations of the reason for this resignation, The New York Times reported "Critics, including many in Congress, said the agency had tried to stifle one of its own scientists who had evidence that the use of antidepressants could cause children and teenagers to become more suicidal."15
September 28, 2005: The British National Health Service Institute for Health and Clinical Excellence released a study that details the best practice advice on the care of children and young people with depression and gives Clinical Guidelines on "Depression in Children and Young People." The Guideline specifies regular exercise, sleep and a balanced diet as the first levels of therapy and further states that antidepressants should not be used for the initial treatment of children and young people with mild depression.16
September 29, 2005: The FDA ordered that "black box" warnings be placed on a commonly prescribed ADHD drug, after clinical trials linked the drug to suicidal thoughts and behavior. The FDA indicated that the new warning stems from an ongoing review of all ADHD drugs and their possible association with suicide.17
September 30, 2005: In a landmark report, the United Nations Committee on the Rights of the Child, the world’s premier children’s rights body, issued a strong warning against falsely labeling youth with the psychiatric diagnosis of “Attention Deficit Hyperactivity Disorder (ADHD)” and administering powerful ADHD-drugs. In its Concluding Observations on reports by Australia, Finland and Denmark regarding their compliance to the U.N. Convention on the Rights of the Child, the Committee expressed concern that “[ADHD] and Attention Deficit Disorder (ADD) are being misdiagnosed and therefore psycho-stimulant drugs are being over-prescribed, despite growing evidence of the harmful effects of these drugs.”18
October 17, 2005: The FDA ordered Eli Lilly & Co. to add a warning to its latest depression drug, Cymbalta, that it can cause liver damage.19
October 19, 2005: A University of Southern California study reinforced the earlier FDA warnings that antipsychotic drugs increase the risk of death in the elderly.20
November 2005: The FDA's Safety Information and Adverse Event Reporting Program reported "homicidal ideation:" as an adverse event of Effexor ER (extended release).21
February 10, 2006: An advisory committee to the FDA urged the agency to issue its most serious warning, the “black box,” on drugs prescribed to treat the so-called psychiatric disorder ADHD. The recommendation followed evidence that these drugs are linked to numerous deaths and cardiovascular problems such as heart attacks and strokes.22
March 22-23, 2006: Two FDA advisory panels held hearings into the risk of stimulants and another new “ADHD” drug called Sparlon. Between January 2000 and June 30, 2005, the FDA had received almost 1,000 reports of kids experiencing psychosis or mania while taking the drugs. The first panel recommended stronger warnings against stimulants, emphasizing these on special handouts called “Med Guides” that doctors must give to patients with each prescription. The second committee recommended not to approve Sparlon, which the manufacturer, Cephalon, estimated would lose them $100 million in drug sales. 23
March 28, 2006: The Australian Therapeutic Goods Administration announced its review of reports of 400 adverse reactions to stimulants in children taking them. CCHR had filed a Freedom of Information Act request with the TGA to obtain the reports and released this to the media that ran the story internationally.24
May 1, 2006: An American Journal of Psychiatry study revealed that elderly people prescribed antidepressants such as Prozac, Paxil, and Zoloft are almost five times more likely to commit suicide during the first month on the drugs than those given other classes of antidepressants.25
May 2, 2006: FDA adverse drug reaction reports linked 45 child deaths to new antipsychotic drugs. There were also more than 1,300 reports of other potentially life-threatening adverse reactions such as convulsions and low white blood cell count.26
May 12, 2006: GlaxoSmithKline, the manufacturer of Paxil, sent a letter to doctors warning that its antidepressant increases the risk of suicide in adults. It was the first warning of its kind by a manufacturer.27
July 19, 2006: The FDA said antidepressant packaging should carry warnings that they may cause a fatal lung condition in newborns whose mothers took SSRI antidepressants during pregnancy. Migraine sufferers also need to be warned that combining migraine drugs with SSRIs could result in a life-threatening condition called serotonin syndrome.28
August 2006: In August, the Archives of General Psychiatry published a study by Mark Olfson, MD, MPH; Steven C. Marcus, PhD; David Shaffer, MD, on “Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults.” The study determined that children taking antidepressants were 1.52 times more likely to attempt suicide and 15 times ore likely to succeed in the attempt than those not taking the drugs.29
September 2006: A study came out in the Public Library of Science Medicine journal. The study was done by psychiatrist David Healy and his team of researchers. The study found that the psychiatric drug Paxil raises the risk of severe violence in a small percentage of people. The researchers looked at clinical trial data from the manufacturer of the drug, GlaxoSmithKline, and found a higher rate of hostile behavior (0.38 percent to 0.66 percent) in patients taking Paxil than in patients taking other antidepressants.30
October 18, 2006: The Australian Therapeutic Goods Administration (equivalent to the FDA) ordered manufacturers of “ADHD” drugs, Ritalin, Strattera and dexamphetamine to add stronger warnings to their information packaging, because of complaints that Ritalin caused headache, nausea, anorexia, somnolence and depression; Strattera caused aggression, and dexamphetamine caused agitation, tachycardia (rapid heartbeat), hypertonia (abnormally tight muscles), hyperkinesia (muscle spasm) and insomnia.31
November 2006: The journal Epidemiology, published a study entitled “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital [defects from birth] Malformations.” Researchers from Aarhus University in Denmark found that pregnant women who take the newer type of antidepressants, such as Prozac, are more likely to have babies with birth defects than mothers who don’t take these drugs. 32
November 6, 2006: The UK Medicines and Healthcare Products Regulatory Agency, announced that it was updating the product information for methylphenidate (Ritalin to “advise about serious cardiovascular adverse effects” and to recommend that methylphenidate not be used in children or adolescents with known serious structural cardiac abnormalities.33
November 27, 2006: The FDA has issued a public health advisory which warns that people receiving treatment with methadone have died and suffered life threatening side effects because of overdoses, including slow or shallow breathing and dangerous changes in heart beat that may not be felt by the patient.34
November 30, 2006: The obstetric (Obstetrics is the branch of medicine which deals with pregnancy and child birth) practice committee of the American College of Obstetricians and Gynecologists (Gynecologists are doctors that specialize in the female reproductive system and disorders that can occur with it) issued a statement that pregnant women and those who plan to become pregnant should avoid taking the antidepressant Paxil if possible because of the risk of birth defects.35
December 13, 2006: The FDA held a hearing into the relationship between antidepressants and suicide in those 18-25 years of age (“young adults”). The FDA Psychopharmacological Committee heard testimony from about 75 people who slammed the FDA for having the information 15 years ago about suicide/violence risks and failed to act. Several abuse cases that testified accused the FDA of murder, with one stating that the FDA has known for 15 years that these drugs cause suicide. This ran on national TV. The Committee voted to extend the black box warning to ages 18 to 25.36
February 21, 2007: The FDA directed ADHD drug manufacturers to distribute “patient-friendly” guides to consumers warning about serious psychiatric and cardiovascular problems, including stroke, heart attack, sudden death and psychotic reactions caused by ADHD drugs.
March 14, 2007: The FDA announced that all sleeping pills (also known as “sedative-hypnotic products”), including Ambien and Lunesta, can cause the dangerous side effect of “sleep-driving,” which is driving while not fully awake and having no memory of doing so, and may also cause life-threatening allergic reactions. The FDA told manufacturers to write letters to doctors to notify them of the new warnings, and all prescription sleeping pills will now come with special brochures called "Medication Guides" that spell out the risks for patients in easy-to-understand language.
April 2007: The Australian Therapeutic Goods Administration issued an Adverse Reactions Bulletin stating that atypical antipsychotics may cause neuroleptic malignant syndrome (NMS). They had received 85 reports of NMS for Clozapine, 49 reports for Olanzapine (Zyprexa), 45 reports for Risperidone and there were another 46 reports for other anitpsychotics.37
April 25, 2007: In the UK, the National Institute for Health and Clinical Excellence (NICE) issued a warning to doctors about prescribing the antidepressant venlafaxine (Effexor), recommending its use only after two other antidepressants had been used and failed. Doctors were warned to be aware of the higher risk of fatal overdoses, cardiotoxicity, and potentially intolerable side effects in patients taking the serotonin and noradreline reuptake inhibitor. For new patients, Effexor should be considered only once two other antidepressants have been tried. In all cases, GPs must ensure hypertension is controlled before prescribing Effexor, and patients on the drug must receive regular blood pressure checks and monitoring for cardiac dysfunction. The drug is contraindicated in patients with a high risk of serious cardiac arrhythmias and recent myocardial infarction. The MHRA warned that fatality rates in single overdose cases range from 10% (according to the drug's manufacturer) to 27% (reported to the UK ADROIT database). Fatal doses have been as low as 2 grams, involving seizure, coma, or cardiac effects. The percentage of overdoses involving more than one drug range from 57-67%. The MHRA also could not rule out drug-induced suicidality, particularly for 18-29 year-olds. Effexor may be associated with a higher rate of some side effects, such as nausea, dizziness, headache and withdrawal reactions.38
May 2, 2007: The FDA announced that it was extending the black box warnings on antidepressants about them causing suicide, to those 18-24 years of age (“young adults”). While the black box warnings in 2004 determined a suicide risk for those under 18 taking the drugs, the FDA Psychopharmacological Committee heard testimony in December 2006 from about 75 people who said the warning was insufficient—that people aren’t suddenly no longer at risk of suicide when they turn 19. The Committee indicated that evidence existed to extend the black box warning from age 18 to 24.
June 2007: The Australian Therapeutic Goods Administration issued an Adverse Reactions Bulletin stating that a range of cardiac disorders are associated with the use of the antipsychotic, Clozapine. A boxed warning alerting prescribers has been placed on the product information. Prescribers have been warned that potentially fatal myocarditis (inflammation of the heart muscle) may develop after commencement of Clozapine.
June 14, 2007: Health Canada further advised consumers not to use Optimum Health Care SleePlus TCM or BYL SleePlus, because the products contain clonazepam, habit-forming within a few months of use. Clonazepam is like Valium and is a benzodiazepine.39 The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.
July 9, 2007: “Cures killing hundreds” was the headline in The Daily Telegraph in Australia, which reporting that the Therapeutic Goods Administration (Australia’s equivalent of the FDA) has revealed that hundreds of Australians have died and thousands more suffered gruesome side effects after taking anti-psychotic drugs. An Australian law firm is taking on drug giant Eli Lilly in a class action for a group of Australians who suffered side effects after taking the anti-psychotic drug Zyprexa. The article cites CCHR ally lawyer Simon Harrison, stating, “We are now in the double figures with clients from Zyprexa and we are seeing a number of alleged problems… The problems vary from inadequate policing of the medication to the alleged side effects of the medication not being conveyed.”40
July 18, 2007: Health Canada is advising consumers not to use the sleep supplement product Optimum Health Care Sleep Easy, because the product contains the undeclared drug clonazepam, a tranquilizer. Health Care Sleep Easy has a different name but has the same formulation as Optimum Health Care SleePlus TCM and BYL SleePlus, which were the subject of a Health Canada public advisory issued on June 14, 2007. All of these products are promoted as sleeping aids and are not authorized for sale in Canada.41 The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.
August 2007: The Therapeutic Goods Administration issued an Adverse Reactions Bulletin about newer antipsychotic agents can cause extrapyramidal side effects, EPS (involuntary movements and muscle rigidity). There had been 3,775 reports for Clozapine and 1,203 reports for Olanzapine (Zyprexa). About one third of patients experiencing EPS had not recovered.
September 2007: The FDA warned healthcare professional that, “Due to a number of case reports of sudden death, TdP [Torsades de Pointes] and QT prolongation [Tdp and QT prolongation are type of heart abnormalities] in patients treated with haloperidol (especially when the drug is given intravenously or at doses higher than recommended), the sponsor has updated the labeling for haloperidol.” In addition ECG [Electrocardiogram – a graphical recording of the cardiac cycle produced by a special machine] monitoring is recommended if haloperidol is given intravenously, even though Haloperidol is not approved for intravenous administration.
October 2, 2007: The FDA sent Eli Lilly a letter about their CYMBALTA professional mailers. Stating the mailers are “false or misleading in that it overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use.”
October 5, 2007: According to New York Times and PR Newswire, Eli Lilly announced it is adding new warnings for weight gain and increased blood sugar to the Zyprexa and Symbyax U.S. labels. “For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.” Based on Lilly’s internal documents that had been released, there are implications that Lilly was aware of these risks of weight gain and high blood in the late 1990’s but down played the risks until now.42
October 19, 2007: “Antidepressant Ritalin to be delisted because of abuse” Daily Yomiuri Online. In Japan the Health, Labor and Welfare Ministry panel (similar to the U.S.’ FDA) decided to remove Ritalin from their list of approved medicines to treat depression. The panel made this decision because of the large amount of abuse that has been going on with Ritalin and wants to prevent any further increase of this.
November 7, 2007: The Japan Health Ministry ordered pharmaceutical firms to include warnings about the increased suicide risk associated with taking antidepressant drugs in patients aged 24 or younger. According to the Health, Labor and Welfare Ministry, recent clinical tests overseas found that patients aged 24 and younger on antidepressants were at greater risk of contemplating or attempting suicide than those not taking the drugs.
January 2008: The UK’s Medicines and Healthcare Products Regulatory Agency issued an update to the product labeling and all antidepressants patient information leaflets to include information on the increased risk of suicide for children to young adults.
January 31, 2008: The FDA put out a warning to healthcare professionals about the risk of suicidal thoughts and behavior with Antiepileptic drugs. “The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks.”
February 5, 2008: A direction was issued by the UK Government's Medicines and Healthcare Products Regulatory Agency, that antidepressant manufacturers will be soon receiving letters asking them to update the warnings on suicidal thoughts and behavior, to keep in line with European agreements.
February 21, 2008: “Zolpidem (‘Stilnox’) - updated information - February 2008.” The Australian Therapeutic Goods Administration imposed a boxed warning in the product information documents for medicines containing zolpidem. This follows continuing Australian reporting of bizarre and sometimes dangerous sleep related behaviors such as sleep walking and sleep driving in some users of zolpidem. A boxed warning is a succinct warning statement printed at the start of the approved product information, designed to alert prescribers to an important safety issue with a medicine. The warning is highlighted by a bold black surround or "box". The wording of the boxed warning for zolpidem is “Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to four weeks maximum under close medical supervision.”
March 17, 2008: Heath Canada sent out a letter to health care professionals, subject “New Safety Information for the anti-epileptic drug TEGRETOL.” They advised health professionals that there is some new safety information added to Tegretol. They warned that serious and sometimes fatal dermatologic reactions, including Toxic Epidermal Necrolysis [disintegration of dead skin] (TEN) and Stevens-Johnson Syndrome (SJS), have been reported with TEGRETOL, an antiepileptic drug.
March 20, 2008: “Health Canada Endorsed Important Safety Information on TEGRETOL (carbamazepine).” Health Canada warned that serious and sometimes fatal dermatologic reactions, including Toxic Epidermal Necrolysis [disintegration of dead skin] (TEN) and Stevens-Johnson Syndrome (SJS), have been reported with TEGRETOL, an antiepileptic drug.
April 2008: The Australian Therapeutics and Goods Administration issued in their Adverse Drug Reactions Bulletin (Vol. 27, No. 2) a report on the antiepileptic drug Topiramate. Topiramate previously was rarely linked to causing angle-closure glaucoma [a painful eye disorder caused by fluid blockage in the eye]. This bulletin went over a published review of reports of ocular [relating to eyes or eyesight] reactions to topiramate. Ocular reactions became onset one to 49 days after starting topiramate, with 85% of cases occurring in the first two weeks of treatment. Permanent vision loss was described in seven reports. Topiramate was also associated with a number of other ocular adverse effects, including acute myopia [shortness of eyesight], suprachoroidal effusions [body fluid oozing out of a specific area of the eye], periorbital oedema [swelling around the eye], and scleritis [inflammation of the external covering of the eyeball].
May 2008: Medsafe (New Zeleand) posted a prescriber update called “Clozapine and Achy Breaky Hearts.” This report warns that Clozapine can cause myocarditis [inflammation of the heart muscle], which may be fatal. It has also been associated with cardiomyopathy [disease of the heart muscle]. While risk factors are unknown, pre-treatment cardiovascular screening is recommended.
May 2008: Medsafe (New Zeleand) posted a prescriber update called “Impulsive Behaviours with Dopamine Agonists.” This report warns that Impulse control disorders such as pathological gambling and hypersexuality can occur in patients taking dopamine agonists for Parkinson's disease. Due to the unusual nature of these behaviours, often an association is not made with the medicine. High doses and dose increases of dopamine agonists can trigger the development of impulsive behaviours.
May 2008: Medsafe (New Zeleand) posted their June 2008 “Watching Briefs”. In this report they included a brief warning entitled “Use of clozapine in older people requires extra care”. This warning states, “Clozapine is only licensed for treatment-resistant schizophrenia. Its use for other indications requires informed consent. Use of clozapine in older patients carries a higher risk of adverse reactions such as postural hypotension, falls, sedation, and constipation, compared to use in younger patients. Therefore, increased clinical monitoring of the elderly is necessary to ensure their safety.”
June 2008: The FDA issued a warning to healthcare professionals that conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. Of course noting that antipsychotics are not indicated for the treatment of dementia-related psychosis. In addition, the FDA is requiring the manufacturers of these drugs to add a boxed warning about this risk to the prescribing information.
In Summary
Over 80 warnings have been issued internationally on the previously undisclosed dangers of psychiatric drugs since October 2004. This comes on the heels of public awareness campaigns by watchdog organizations, independent medical doctors, patients and their families repeatedly requesting independent evaluations of clinical drug trials and accountability for the harm and loss of lives. While drug regulatory agencies such as the FDA should be accountable for failing to act sooner, it must be noted that psychiatrists have been their advisors, and have a vested interest in maintaining a multi-billion dollar psychiatric drug industry.
Psychiatric drug sales have soared in recent years based solely on psychiatry’s criteria for a myriad of “mental disorders,” which are simply a checklist of behaviors, emotions and attitudes. Promoting these disorders as medical conditions requiring drug treatment is misleading to the public, governments and patients.
There are no blood tests, X-rays, brain scans or any scientific/medical means by which psychiatry’s diagnoses can be verified. Subsequently millions of men women and children have been wrongly diagnosed as mentally ill, and prescribed dangerous and potentially lethal psychiatric drugs.
The FDA should not be approving such drugs for mental “disorders” that cannot be medically/scientifically proven to exist.
Recommendations
1) The FDA must act in the public’s interest by swiftly acting on adverse reaction reports and taking immediate action to issue warnings.
2) All treatment options should include checking for underlying medical conditions that could cause a patient’s mental or emotional duress.
3) Health insurance coverage for mental health problems should only be provided on the provision that full, searching physical examinations are first undertaken to determine that no underlying untreated physical condition is causing the person’s mental or emotional problems. Such examinations would be covered under existing health insurance coverage.
4) Doctors should follow the British National Health Service's Institute for Health and Clinical Excellence (NICE) medical advisory, which recommends first line treatment for mental or emotional problems involve non-harmful medical solutions, including regular sleep, exercise and nutrition.
5) The Diagnostic and Statistical Manual of Mental Disorders (DSM), psychiatry’s billing manual for mental disorders, is the key to false escalating mental illness statistics and psychiatric drug prescriptions and usage worldwide. Untold harm and colossal waste of mental health funds occur because of it. It is imperative that the DSM diagnostic system be abandoned before real mental health reform can occur.
6) Doctors and insurance companies should report all instances of patients who have been prescribed psychiatric drugs and experienced adverse effects to the FDA or their national drug regulatory agency.
References:
1 Transcript of Proceedings, FDA Psychopharmacological Drugs Advisory Committee, 20 Sept. 91, p. 290.
2 “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications”, FDA Public Health Advisory, 15 Oct. 04.
3 “New Warning for Strattera,” FDA Talk Paper, 17 Dec. 04.
4 “FDA Issues Public Health Advisory for Antipsychotic Drugs Used for Treatment of Behavioral Disorders in Elderly Patients,” FDA Talk Paper, 11 Apr. 05.
5 “European Medicines Agency finalises review of antidepressants in children and adolescents,” European Medicines Agency Press Release, 25 Apr. 05.
6 “Statement on Concerta and Methylphenidate,” Statement posted on the FDA website, 28 June 05.
7 “Suicidality in Adults Being Treated with Antidepressant Medications,” FDA Public Health Advisory, 30 June 05.
8 “Accompanying Statement by Joseph A. Califano, Jr., Chairman and President,” Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S., National Center on Addiction and Substance Abuse at Columbia University, July 05, pp. i-iii.
9 Joanna Moncrieff and Irving Kirsch, “Efficacy of Antidepressants in Adults,” British Medical Journal, Vol. 331, 16 July 05, pp. 155-157.
10 “Accompanying Statement by Joseph A. Califano, Jr., Chairman and President,” National Survey of American Attitudes on Substance Abuse X: Teens and Parents, National Center on Addiction and Substance Abuse at Columbia University, Aug. 05, pp. i-ii.
11 “Annex II,” Commission Decision of 19-VIII-2005, Commission of the European Communities, 19 Aug. 05.
12 Ivar Aursnes, et al., “Suicide Attempts in Clinical Trials with Paroxetine Randomised Against Placebo,” BMC Medicine, Vol. 3, pp. 14-18.
13 Marian S. MacDonagh, PharmaD, and Kim Peterson, MS, “Drug Class Review on Pharmacologic Treatment for ADHD: Final Report,” Oregon Health and Science University, Sept. 05, pp. 13-20.
14 Jeffrey A. Lieberman, MD, et al., “Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia,” New England Journal of Medicine, Vol. 353, No. 12, 22 Sept. 05, pp. 1209-1232.
15 Lauren Neergaard, “FDA Commissioner Lester Crawford Resigns,” Associated Press, 23 Sept. 05; Robert Pear and Andrew Pollack, “Leader of the F.D.A. Steps Down After a Short, Turbulent Tenure,” New York Times, 24 Sept. 05.
16 "Depression in Children and Young People," National Institute for Health and Clinical Excellence, Sept. 05, pp. 16, 18 and 28.
17 “Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine),” FDA Public Health Advisory, 29 Sept. 05.
18 “Concluding Observations (Australia),” UN Committee on the Rights of the Child, 40th Session, 30 Sept. 05; “Concluding Observations (Denmark),” UN Committee on the Rights of the Child, 40th Session, 30 Sept. 05; “Concluding Observations (Finland),” UN Committee on the Rights of the Child, 40th Session, 30 Sept. 05.
19 “2005 Safety Alerts for Drugs, Biologics, Medical Devises, and Dietary Supplements,” FDA MedWatch, 17 Oct. 05.
20 Lori Oliwenstein, “Study Notes Risks of Antipsychotic Drugs,” University of Southern California Public Relations, 21 Oct. 05.
21 FDA's Safety Information and Adverse Event Reporting Program, Effexor ER, Nov. 2005.
22 Ricardo Alonso-Zaldivar, “Warning Urged for ADHD Drugs,” Los Angeles Times, 10 Feb. 06.
23 Ricardo Alonso-Zaldivar, “New Warning Advocated for ADHD Drugs,” Los Angeles Times, 23 Mar. 06.
24 Clara Pirani, “Dark Side of a Wonder Drug,” The Australian, 28 Mar. 06.
25 David N. Juurlink, M.D., Ph.D., et al., “The Risk of Suicide With Selective Serotonin Reuptake Inhibitors in the Elderly,” American Journal of Psychiatry, Vol. 163, No. 5, May 2006, pp. 813-821.
26 Marilyn Elias, “Adult antipsychotics can worsen troubles; Critics: Look at other causes before medicating children,” USA Today, 2 May 2006.
27 Letter to Healthcare Professionals on Important Prescribing Information from GlaxoSmithKline, May 2006.
28 “Treatment Challenges of Depression in Pregnancy,” FDA Public Health Advisory, 19 July 2006.
29 Mark Olfson, M.D., MPH, Steven C. Marcus, Ph.D., David Shaffer, M.D., “Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults,” Archives of General Psychiatry, Vol. 63, Aug. 2006, pp. 865-872.
30 David Healy, Andrew Herxheimer, David B. Menkes, “Antidepressants and Violence: Problems at the Interface of Medicine and Law,” PloS Medicine, Vol. 3, Iss. 9, Sept. 2006.
31 Franklin, Matthew, “ADHD drug risk for kids,” The Australian, 18 Oct. 2006.
32 Wogelius, Gislum, Mette, et. al., “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations,” Epidemiology, Vol. 17, No. 6, Nov. 2006.
33 “Yesterday in Parliament,” Guardian Unlimited, 7 Nov. 2006.
34 “Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in Breathing and Heart Beat,” FDA Public Health Advisory, 27 Nov. 2006.
35 American College of Obstetricians and Gynecologists, “ACOG Committee Opinion – Committee on Obstetric Practice – Treatment with Selective Serotonin Reuptake Inhibitors During Pregnancy,” Dec. 2006.
36 Graham, Judith, “The furor over antidepressants -- Noting a higher risk among young adults, FDA panel urges suicide label warning,” Chicago Tribune, 14 Dec. 2006.
37 Australian Adverse Drug Reactions Bulletin, Volume 26, Number 2, Apr. 2007, http://www.tga.gov.au/adr/aadrb/aadr0704.htm
38 “GPs warned about antidepressant,” OnMedica.net, 25 Apr. 2007
39 “Sleep Supplements Found to Contain Habit-forming Drug,” Health Canada Advisory, 14 June 2007.
40 Clare Masters, "Cures Killing Hundreds," Daily Telegraph, 9 July 2007
41 “Sleep Supplements Found to Contain Habit-forming Drug,” Health Canada Advisory, 18 July 2007.
42 Alex Berenson. “Lilly Adds Label Warnings for Mental Illness Drug.” Nytimes.com. 5 Oct 2007; “Lilly Announces Updates to the Zyprexa and Symbyax U.S. Labels.” Prenewswire.com. 5 Oct 2007.
