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Rapid Responses: Rapid Responses published:
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The belief that fluoxetine is effective for depressed children persists but is unjustified
- Peter R Mansfield, Jon N Jureidini, Peter Parry (31 December 2004)
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Studie Warnings WERE out in 1988 in US
- Delores Boone (1 January 2005)
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Your coverage is sensationalist
- Simon Sobo, M.D. (1 January 2005)
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The Word "Missing" is Misleading
- Jerrold S. Parker (1 January 2005)
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A life almost lost to prozac
- Peggy Beck (2 January 2005)
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Yeah, I know
- Melody A. Booth (2 January 2005)
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Urgent need for investigation
- Anita M. Knight, Phillip J Hilts, Jeffrey Kluger, Dr. Scott Masten (2 January 2005)
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Missing the point
- Kathy C. Guis (2 January 2005)
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Re: Your coverage is sensationalist
- Sara L. Bostock (3 January 2005)
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Prozac-We Should Have Known
- Ann Blake-Tracy, PhD (3 January 2005)
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Many patients on Prozac do not tell their physician what is happening to them because they do not recognize it as aberrant behavior.
- Rosie C. Meysenburg (3 January 2005)
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Prozac: A Controversial Issue
- Maja L Scotland (5 January 2005)
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Re: Your coverage is sensationalist
- Thomas Zaleski (5 January 2005)
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Prozac Kills
- Anonymous **** (5 January 2005)
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Lack of Science Finally Surfacing
- Hans E. Eisenman (5 January 2005)
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Re: Many patients on Prozac do not tell their physician what is happening to them because they do not recognize it as aberrant behavior.
- susanne mccabe (6 January 2005)
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Estimates of "Harm"
- Graham J Aldred (6 January 2005)
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BMJ loses credibility by using tabloid journalism
- Leslie E Evans (6 January 2005)
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From a long time user
- Josee Laverdiere (6 January 2005)
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Finally The Truth May Come Out
- Gina M Dempski (6 January 2005)
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SSRIs, suicide and violent behavior: is there a need for a better definition of depression?
- Chantal HENRY, Jacques Demotes-Mainard (11 January 2005)
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Peter R Mansfield, Director Healthy Skepticism Inc, 34 Methodist St, Willunga SA 5172, Australia, Jon N Jureidini, Peter Parry
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We congratulate Jeanne Lenzer on her ongoing investigation of antidepressants. The belief that fluoxetine has been shown to be effective for depressed children is false but dissemination continues, including in a recent editorial in the New Engl J Med.<1> We wrote the following letter for that journal but they declined it: David Brent claimed that three clinical trials have shown that fluoxetine is effective for depressed children.<1> However, two of those trials were negative on primary endpoints.<2> The third was positive on a categorical clinical improvement endpoint but negative on a more informative continuous scale endpoint.<3> Overall results for fluoxetine match our meta-analysis finding of a mean benefit from new antidepressants equivalent to 3-4 points (95% CI 1-8) on the Children's Depression Rating Scale (range 17-113) compared to a mean improvement from baseline of 15-25 points in placebo groups.<2> The clinical impression of worthwhile benefit is an illusion probably arising from non- drug effects of consultations, regression to the mean, improvement that would have occurred without treatment, and unjustified faith in drugs. The evidence of harm from antidepressants is more compelling than the evidence of benefit.<2> More children benefit than are harmed but the magnitude of harm is greater.<2> The risks of untreated depression do not justify doing more harm than good. By contrast, cognitive behavior therapy is better than doing nothing<4> and family therapy deserves research.<5> 1. Brent DA. Antidepressants and pediatric depression--the risk of doing nothing. N Engl J Med. 2004;351(16):1598-601. 2. Jureidini JN, Doecke CJ, Mansfield PR, Haby MM, Menkes DB, Tonkin AL. Efficacy and safety of antidepressants for children and adolescents. Brit Med J 2004;328:879-83 3. Jureidini JN, Tonkin AL, Parry P, Menkes DB, Mansfield PR, Doecke CJ. Concerns about the TADS study. bmj.com, September 25, 2004 http://bmj.bmjjournals.com/cgi/eletters/329/7468/748#75635 (accessed October 28, 2004) (Accepted for publication.) 4. Compton SN, March JS, Brent D, Albano AM 5th, Weersing R, Curry J. Cognitive-behavioral psychotherapy for anxiety and depressive disorders in children and adolescents: an evidence-based medicine review. J Am Acad Child Adolesc Psychiatry. 2004 Aug;43(8):930-59. 5. Sander FM. Re: No more secrets. bmj.com, September 28, 2004 http://bmj.bmjjournals.com/cgi/eletters/329/7461/307#75292 (Accessed October 28, 2004) Competing interests: None declared |
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Delores Boone, Retired R.N. Retired, 98272
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I worked as a psychiatric nurse in 1988 when a Rhuematologist inquired about the side effects listed in this article. So, I do know for a fact that these concerns were announced in journals and shortly there after in public. Then came the claims from patient families about "Prozac causing" mood change problems. Any mental health care professional knows all antidepressants MAY potentially cause suicide. It is the lethargy of suicidal ideation that prevents suicide normally and when the depression begins to lift the patient has the energy to follow through if therapy does not include working through problems. One cannot rely on a pop a pill resolve for cliinical depression and expect all to be well. The negative mood changes however are another question to be answered. As an additional note I started taking Prozac myself in the nineties and have not found it harmful to me, nor did it seem to create a problem with patients during my nursing career that I am aware of. Competing interests: None declared |
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Simon Sobo, M.D., psychiatrist 06776
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I found your coverage of the risk from SSRIs extremely unbalanced. In particular, quoting Peter Breggin's absurd statistics is over the top. The BBC used a claim by Dr. Healy claim that 2 out of 20 normal people developed suicidal ideation and that is complete rubbish. I have prescribed these drugs for years and while I have seen patients get more agitated and suicidal after beginning them it is extremely rare!!! What should make my observations trustworthy on this score is that I have been warning for years that these meds are being given out like candy and this practice must be reevaluated. In fact Dr. Breggin has asked me to write for him (which I refused because of his way out of balance views) and I have asked Dr. Healy to write for a book I am putting together which he refused because of time commitments) I have been concerned that doctors have been far too casual about the use of SSRI but I am not in favor of the way these drugs are being slammed right now. Why must reporters make stories so black and white rather than examine an issue with shades of grey? Finding extremists on one side and then the other and calling the story "balanced" does not further the public's information, it creates confusion. This is inexcusable in an area where patients may be desperate and meds can make the difference between life and death. What is your news department trying to accomplish? I have attached a link to an article by me which is #1 on a google search for "psychiatric diagnosis" out of 1.9 million entries. It is # 1 as well on a number of other key searches, meaning a lot of people have found it helpful. I hope you will take the time to read it. It is extremey critical of the way meds are being prescribed and the misinformation being spread by drug companies and, unfortunately, my profession. It even raises the possibility (in 1999) that SSRIs could play a role in a murderer's action by lessening his sense of consequence, but that is a far cry from the context being discussed now. Here is the link through google http://www.google.com/search?hl=en&q=psychiatric+diagnosis&btnG=Google+Search You will also find in that article a link to another article by me that is very critical of the influence of drug companies and the way they are now making a push with "adult ADHD" to get a lot of people hooked on stimulants. The article is very hard on the "expert" myth, professors at very prestigious universities whose main income comes from drug companies. So it isn't as if I am rooting for the drug companies and against critical stories. I just think SSRIs, with qualifications, are extremely effective and save far more lives than they endanger. It isn't even close!!!!! Since this issue does not look like it is going to go away, I am hoping your reporters will take the time to educate themselves on this subject. It is too important to be treated in a hysterical manner Simon Sobo MD Competing interests: None declared |
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Jerrold S. Parker, Attorney 111 Great Neck Road, Great Neck, New York USA 11021
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I would like to thank the British Medical Journal and Jeanne Lenzer for the important article "FDA to review 'missing" drug company documents" which will hopefully finally open the door to all of the data and information that was ever in the possession or knowledge of Ely Lilly & Co. regarding suicidality and violent behavior caused or activated by fluoxetine (Prozac®). As one of the trial lawyers who started the worlds 1st lawsuit against Eli Lilly & Co. claiming that fluoxetine caused suicidal ideations resulting many times in completed or attempted suicide, self mutilation and violent behavior, recent events are starting to vindicate the important work of the trial lawyers dating back to 1990 and that of Harvard professor and researcher Dr. Martin Teicher, who in 1990, published a study in the American Journal of Psychiatry suggesting such a connection. As one of the of the trial lawyers who filed the Wesbecker lawsuit referred to by Jeanne Lenzer in her article and who at the time was very involved in the Prozac litigation and as a member of the Plaintiff's Steering Committee for the Multi District Litigation in Federal Court concerning Prozac, I can say that the use of the word "missing" in the article is very misleading and unfortunate. The word "missing" has given rise to the belief by the world’s media that the reports and memos belonging to Lilly and which were anonymously supplied to Jeanne Lenzer and the British Medical Journal linking Prozac® to suicidal behavior, activation of negative thoughts and violence were “lost” or “misplaced”. The fact is that Lilly never turned over those reports and memos to the plaintiff's in that litigation. And apparently and with consistency, Lilly never turned them over to the FDA. As reported in the article by Jeanne Lenzer, Dr. Richard Kapit, the FDA reviewer who in 1987, originally approved fluoxetine said that he had never been given the Lilly data. "If we have good evidence that we were misled and that data was withheld, then I would change my mind [about the safety of fluoxetine]," he said in a statement. "These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it. … I do agree now that these stimulatory side effects, especially in regard to suicidal ideation and homicidal ideation, are worse than I thought at the time that I reviewed the drug." Of course Lilly is quick to take advantage of the misperception and jump on the poor use of words, releasing a statement to the New York Times "To our knowledge, there has never been any allegation of missing documents" from lawsuits involving Lilly. Lilly was correct. The trial lawyers never said that documents were "missing" - these documents were not missing - they were never disclosed to us or the FDA! Unfortunately, this type of conduct is nothing new to the pharmaceutical industry. Just look at the recent events of many of the pharmaceuticals we have been reading about. But this type of conduct - hiding negative data from the public and regulators – has been standard operating procedure for pharmaceutical companies worldwide for many decades and continues to date and is only one of the many ways the pharmaceutical companies use to mislead and misinform the regulators, physicians, patients and lawyers as to what the studies truly demonstrated. It is only because of the diligence of the trial lawyers, medical researchers and the brave individuals within the regulatory bodies that the unlawful conduct of the pharmaceutical companies is being brought to light and very ironically, saving lives as a result. Competing interests: I am one of the attorneys who prepared and filed the original complaint in the Joseph Wesbecker case and for a period of time was involved in the litigation of that case as well as hundreds of other cases with claims that Prozac caused suicidality and violent behavior. |
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Peggy Beck, pieceworker Faithworks- 04240
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A very good friend of mine was put on Prozac about 1998.He was thinking of suicide every day he was on it. I came home one evening to find him sitting in a puddle of blood. Because he took a razer blade and sliced his arm. He was in the hospital for a few day's, And then put him in a psyche ward for a month. They took him off Prozac,and he did alittle better. now he is on a medication that has made a big differnce. He does still have those suicide feelings once in awhile,but not often and he doesn't act upon them. Prozac had a very bad affect on him. And I would perfer never to see that happen to anyone again. Competing interests: None declared |
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Melody A. Booth, on social security no address, 78223
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So Prozac can cause side effects. So can aspirin or any other drug. I have a life now that I have been on Prozac. I knew the controversy when it was prescribed. It was 3 months before I told my parents I was taking the drug. I have told them many times: The people placed on Prozac are ALREADY suicidal. I don't know all the chemical reactions on different people. All I know is that on Prozac I can laugh again and enjoy life. I had no life before. Thank You. Competing interests: None declared |
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Anita M. Knight, retired retired, home zipcode 33714, Phillip J Hilts, Jeffrey Kluger, Dr. Scott Masten
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Dear Editor, I have several references to the problems with fluorinated antidepressants that point to the possibly criminal treatment of children. There are 4, and the essence of each: 1. New York Times article: "Ethics Officials to Investigate Drug Experiments on Children", April 15, 1998. Fluorinated diet drug, Fenfluramine was given intravenously to measure for a chemical believed linked to agression, violent or criminal behavior. 2. Time magazine, November 30, 1998, several articles on the Columbine school massacre, all were ADHD (Attention Deficit Hyperactive Disorder) and prescribed fluorinated antidepressants, Prozac (page 94), Paxil, and Luvox. 3. Toxicological Profile for Fluorides, Hydrogen Fluoride and Fluorine (F) 1993, U.S. Department of Health & Human Services, page 125. "Neurotoxicity - Because fluoride interacts with calcium ions needed for effective neurotransmission, fluoride can affect the nervous system." 4. Federal Register/Vol.65,No. 233/Monday,December 4, 2000/Notices, page 75728. U.S. Environmental Protection Agency (EPA) nominated for neurotoxicity studies, Aluminum-fluoride. The Merck Index, 1997, under 'fluorine' defines the halogen gas as the most reactive of all the elements and will combine with all but argon, helium and neon. But check under those 3 and it says fluorine will combine with them as well. Four of the 6 drugs that have recently been taken off market are fluorinated. Anita M. Knight Competing interests: None declared |
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Kathy C. Guis, student Cornell University 14850
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While I agree that the recent backlash against the overuse of antidepressants has taken on an hysterical aspect, it seems that many of the responses to this article missed the most important point the author raised: Lilly hid important information. It is silly to deny that Prozac can be effective in many cases and in other cases tragically harmful. What merits investigation is Lilly's conduct, as it points to a need for more widespread investigation of the policies of drug approval and the conduct of pharmaceutical giants. Competing interests: None declared |
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Sara L. Bostock, Advocate 94027
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Dear Dr. Sobo, If anyone is over reacting I believe it's you. For far too long these drugs have been harming innocent people unaware of the risks that have been hidden and discredited by the drug companies. Even if millions are benefiting as you claim and frankly the objective proof for this benefit is far from compelling, is that worth the hundreds, probably thousands, of people whose lives have been lost unnecessarily from suicide and murder as we drug awarenenss advocates fervently believe? Please acknowledge the emotional devastation that is left behind by losing a loved one in this unexpected and violent manner. If even one person has died or been harmed by these drugs in the way mounting evidence suggests, it is time to sound the alarm and take urgent action to stop further murder and mayhem. From my point of view nothing that could have saved my daughter's life is too "sensationalistic". Yours sincerely, Sara Bostock Competing interests: My 25 year old daughter took her life after 18 days on antidepressant medication with no history of suicidality. |
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Ann Blake-Tracy, PhD, Executive Director, International Coalition For Drug Awareness www.drugawareness.org , Salt Lake City, UT 84088 atracyphd1@aol.com
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After testifying as an expert witness in criminal cases involving SSRI antidepressants for 13 years, I am very grateful for your article. The fact remains that over the past five decades mainstream medical research on serotonin has supported the fact that when serotonin reuptake is inhibited the end result will be mania/psychosis, severe loss of memory, horrifying nightmares, tension and anxiety that appear from nowhere, cravings for alcohol and other drugs, impulsive behavior with no concern for punishment, including impulsive murder or suicide, violent crime, road rage, argumentative behavior, etc. For 15 years I have warned that all of these reactions should be expected with the SSRI antidepressants because their mode of action is inhibition of the reuptake of serotonin. This new information from the BMJ on what Lilly knew about Prozac and when they knew it only backs up all of this existing research. This is research that was available for anyone to read over the past five decades. So, I want to know - why did no one in a position of authority read that research BEFORE these drugs were approved? I have never doubted that the manufacturer of each SSRI antidepressant knew their drugs would produce these results. They could not have missed it. And it was only a matter of time before it surfaced. My only remaining question has been, "How many would die before this information surfaced?" Clearly this is an international tragedy and I am convinced that as we count the dead and damaged stemming from the use of these antidepressants all will be in shock. Ann Blake Tracy, Ph.D., Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio tape on safe withdrawal: "Help! I Can't Get Off My Antidepressant!" Competing interests: None declared |
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Rosie C. Meysenburg, retired teacher retired: Zipcode 75218
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As Assistant National Director of the Prozac Survivor's Support Group, I receive many calls from people who have had an adverse reaction to Prozac. However, some of the most heartbreaking stories have been from family members who cannot fathom the depth of the change in their loved one's personality since the loved one started on Prozac. These people on Prozac developed erratic behavior, family break-ups, personal unacceptable behavior, risk taking, etc. Yet these Prozac patients did not tell their physicians what was happening to them. They and their physicians [if the physicians even knew about this behavior and usually they did not] failed to recognize that these behaviors were the result of the Prozac. You have done a great service to report the "activation" syndrome that is so common on these drugs. However, this is only one part of the problem. Most of the problems the Prozac Survivor's Group receives are centered on "personality changes" involving unusual and sometimes dangerous behaviors. Sincerely, Rosie Meysenburg U.S.A. Competing interests: None declared |
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Maja L Scotland, S/User (SAP Trainer) Nestlé 5201
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I would like to first of all mention that I am a bi-polar II sufferer who was only diagnosed correctly in 1998 when I turned 40. This led me into a lot research into what this specific "illness" "imbalance" is and what types of medication is curently on the market to help people like us. I have suffered from mood swings from my early teens and I have always felt that I was often "mad" and why couldn't I cope with life like "normal" people. Since the age of 22 I have been put through the mill, sleep therapy, ECT, librium, rohypnol, and many others (etamine, I think was one which almost made me catatonic!). I have changed pyschiatrists until I finally met my current psychiatrist who diagnosed me with a mood disorder. I remember asking her if I was a manic depressive (ignoramus?) and she would always reply "something like that", although she did not tell the whole story. Eventually during her CBT with me, we found a medication that would not make me feel as though I was living in a cloud, but let me feel NORMAL. We tried many and eventually found the right combination, and in South Africa this medication needs to declared a chronic condition with the medical aid, so she submitted a report which stated my diagnosis. Well, that is how I discovered the name to me disorder, so know thine enemy - that's where my investigations started. Since then I have taken a very deep interest in psychiatry and I have found, my to my horror, that anti-depressants are being handed out willy nilly, but by non-specialists like the family doctor. In my opinion this is a very specialised field and can have dire consequences on any patient, and family of the patient. With medication must come counselling, acceptance and knowledge. Since being on Lilly Fluoxetine (a generic of Prozac), I have not had one suicide attempt, nor have I had violent outbursts which occured quite frequently during my hypomanic episodes. What I am trying to state is that in my personal experience yes, Prozac (fluoxetine), does help, but it MUST be administered by a specialist not a general practitioner. A specialist should then monitor side affects, as my psychiatrist did until I was well balanced again. If I look back at my life, I have had more suicide attempts THAN I CAN COUNT but none since correct medication has been administered, and maybe, my life could have been a lot, lot HAPPIER than it has been... life only started for me at 40, so what is right, and what is wrong? Competing interests: None declared |
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Thomas Zaleski, Financial Financial Firm 53092
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A member of my family was nearly suicidal this past weekend and has been on Prozac for several years. In this case the prescription was stopped for six weeks (too "busy" to refill the prescription), then started again for a week, then stopped again when on a family vacation for the weekend (forgot it at home). The second day into being off of it again, resulted in a trip to the emergency room for safety due to thoughts of suicide. Cleary the on again, off again nature has more to do with this, medicinally, than anything else, but to what extent does the effects of Prozac have? That's what I am attempting to uncover now. How appropriate that this issue was again brought to the public eye at this time? Further, my son is ADHD is on low doses of Adderall. I have been fighting with his mom (my ex-wife) to maintain a regimen of therapy and behavior modification, with the Adderall as an aid only. My hope is to eventually ween him off the Adderall as he learns how to deal with his issues. This is not to say, however, that I feel that he shouldn't take the medicine. I just don't feel that it is the be all and end all of his treatment. I took it upon myself to research all available alternatives. This research included, but was not limited to, interviewing several doctors that are reputable in this field in order to form a qualified opinion to the best of my ability. The bottom line message that one must take from the Prozac, and similar, stories, and from Dr. Sobo's reply and articles is one of reasonability, the forest from the trees, as it were. Too often we, as humans, get caught up in extremes. I have found, dealing with the public daily, that there are generally THREE sides to every story...not two. "My" side, "your" side and what is actually the case. The pharmaceutical industry is not "evil", nor is it the answer to all our ailments. Too often we see profits outweighing sound medical decisions while the original intent is to cure. The fact is that we are all responsible for what I would call "due diligence". Question why a drug or treatment is being prescribed. What can one expect? What are the potential side effects? Is this the right treatment for me? Get a second, third, fourth, etc., opinion if you are not satisfied. We hear these words time and again but rarely heed them. It is far too easy to sit back and wait for something to go wrong, blame someone else, and say we didn't know. This is similar to suing McDonalds for burning yourself on a hot cup of coffee. Doctors should be looked up to for their knowledge as well as their ability to help and heal. However, they are also human and can make mistakes. We carry a responsibilty to learn all we can to augment treatment. Of course, all the so-called "due diligence" in the world is worthless if the information one seeks is being deliberately withheld. Therein lies the true story here. Competing interests: None declared |
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Anonymous ****
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Editor - Jeanne Lenzer reported that documents reporting an activation rate of 38% with fluoxetine (prozac) was suppressed by Lilly and has only come to light from an anonymous source last month.1 I am outraged! Had I been aware of this data, I would never have taken fluoxetine myself or prescribed this drug so frequently to my patients as a GP. On 6 September I was offered fluoxetine by my own GP to deal with an episode of depression secondary to multiple life stressors. I was of the belief, as many GPs are, that it is an FDA- approved, safe and effective first-line SSRI and that the benefit is a shorter depressive episode instead of enduring depression for 6-9 months without medication. On 23 September I found myself taking one painkiller after another. I was at a loss to understand my actions. I sought help from my partner to keep an eye on me and cancelled all my clinical sessions. I could not understand why I was both obsessing about suicide and acting upon these thoughts 2.5 weeks after commencing fluoxetine. I had no prior history of suicidal thoughts, depression or mental illness. I decided to keep a diary. I found myself attempting an almost fatal overdose on the 6th of October. I stopped momentarily after taking 13 tablets of coproxamol thinking I might actually die. What am I doing? My partner rushed me to Casualty. I felt as though I was literally under the control of a mind-altering drug, like LSD; although I have never taken illicit drugs. I had constant visual obtrusive thoughts and imagery of seeing myself commit suicide. Even after discharge, the imagery persisted, changing to a scene of me jumping out of a window. I could not stop shaking; I was agitated and manic and thought I need mood-stabilising drugs! I have been fortunate that between the rapid access psychiatric team and me, we reasoned that it must be the effects of prozac, and this was stopped. It took 2 weeks to clear from my system during which time I experienced my last suicide attempt on 19 October; I found myself walking backwards on an underground train platform onto the white line prepared to jump in the path of a train! Fortunately my partner never left my side and I did not die. I am fine now and have no further episodes of agitation, mania or thoughts of suicide. Now with the passage of time alone and no magic pills, the stressors in my life have resolved and my mood has lifted. I decided to enquire among colleagues about fluoxetine and was saddened to hear that the elderly Catholic aunt of my best friend from medical school was not so fortunate. She jumped out of a 23-storey window in NYC 3 weeks after taking prozac last year. Her aunt had sought help from her priest the day prior, as she was also aware that something was wrong. Prozac is no longer a first-line drug for my patients! Prozac kills and the medical community needs to be informed! Competing interests: None declared |
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Hans E. Eisenman, Snr VP New Product Development NTC, Palm Harbor, FL 34683
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As a father of two (and another on the way), I would like to first thank you for making this information public. For too long we have remained in the dark while the world's children have become targets of greedy pharmaceutical companies like Lilly. We have, what, 8+ million _children_ on Schedule II (prone to cause addiction) drugs like Ritalin and 35 million people have taken Prozac. And now we see that the 1988 documents Lilly withheld showed 3.7% on the drug actually attempted suicide, more than 12 times that of any other anti-depressant. They didn't just consider suicide--they DID it (and hopefully failed). That means that Lilly has the distinction of potentially causing 129,500 suicides if the 35 million above continue to take the drug. But hey, how can you argue with outrageous profits, right? How long are we doing to stand by and wait for more bad news--student's opening fire at school, or another Wesbecker whipping out an AK-47 and taking lives? And what are the responses from Lilly and their psychiatrist flunkies when that happens? We just need to get them some "help" and here's a prescription for more psychotropic, mind-altering drugs--maybe a whole cocktail this time. Anyone see a pattern here? And now here in the US, we have the TeenScreen program drilling their way deep into our school systems to get access to our kids' personal information so they can identify who is "suicidal". Using a subjective, unscientific "survey" they ask questions that, on a bad day, any kid could flunk and therefore be labeled. What, might one ask, is the next step for our poor adolescent targets? Ask Lilly. They funded the Tennessee TeenScreen program and probably are behind the others for all we uninformed parents know. Thanks to the efforts people behind BMJ and other concerned netizens, we need not be in the dark any longer. http://www.psychsearch.net/teenscreen.html My family and I thank all of you again for what you are doing to expose this unscientific madness in the name of profits. Hans Eisenman Competing interests: None declared |
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susanne mccabe, retired cf24 3pf
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Equally many people do report harmful side effects, not just of Prozac but many other drugs too. Too often they have then been positioned as neurotic, 'anti-medication', uneducated or misinformed, They have been manipulated against their better judgement into carrying on with them and even now many are not properly informed, including of potential adverse effects. In the UK it is not uncommon for psychiatrists and other health workers to evade responding to questions about medication honestly, (rather than being misinformed about them themselves, re previous anonymous rapid response from a GP), by fobbing off questions with statements such as, 'they are not addictive, they cannot possibly harm you, they will make you feel better, think of yoursef as having diabetes, you will probably need to take medication for the rest of your life'. The issue of informed consent comes way down the list compared with 'getting them on medication'. We are not even talking about people labelled as potentially dangerous, it is across the board. It is often very powerful and potentially harmful medication with huge implications for quality of life. When side effects become so serious they cannot be ignored there is no guarantee the episode will be reported accurately if at all on the Yellow Card Scheme for fear of disclosing mistakes or careless treatment. It is not easy to register with another doctor so cover ups of adverse effects are an unknown quantity. In the field of mental health but other areas as well feedback about adverse effects has been so underreported/unreported that members organisations such as MIND set up their own Yellow Card Scheme. This needs to be formally extended so that people are either given evidence that an accurate report of their experience has been made or they have the means to report the adverse or unusual effects themselves. Competing interests: None declared |
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Graham J Aldred, System Design (Rtd.) Disley, Cheshire SK12 2DE,,
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Dear Editor, May I thank you for the publication of Jeanne Lenzer's article which contributes greatly to issues of drug regulation and the priority assigned to drug safety by industry. It is stated that Lilly said that " .....[Prozac] has been prescribed for more than 50 million people worldwide ...." Epidemiological studies and clinical trials show that those treated with SSRIs demonstrate more suicidal behaviour than those who are not treated, and now Lilly's own hitherto undisclosed 1988 trial data confirms that Lilly may have known this 15 years ago but failed to tell the MCA in the application for approval of Prozac. As reported by M/s Lenzer, Lilly found that suicidal symptoms were doubled in prozac patients versus untreated patients and amazingly Lilly "had excluded 76 of 97 cases of reported suicidality". i.e. 78% of adverse results !. Lilly's figure of 50 million patients worldwide is interesting and is supported by other independent estimates. 50 million patients can be expressed as 500 x 100,000 patients. Very many clinical and epidemiological studies show that the rate for excess suicides under SSRI treatment could lie somewhere in the rate range of 20 to 180 suicides/100K patients (these are in excess of any background suicides that may occur in those who are not treated). So this would suggest, worldwide, a potential range of (500x20) = 10,000 to (500x180) = 90,000 excess suicides since 1988. Whatever the excess suicide rate, it is definitely not zero, if it is only 1 excess suicide per 100K patients then 500 people have died, if it is 5 then 2500 people have died, if it is 10 then 5000 people have died, etc etc. And there are more than 8 other SSRIs used in similar volumes throughout the world. I agree with Simon Sebo, SSRIs should not be "handed out like candy " for normal life problems by GPs who do not have specific knowledge of the drug and the patient so as to be able to evaluate daily all the effects that signal inappropriate therapy for this patient and onset of agitation and covert suicidality. Many doctors and patients believe that these drugs are effective, many other doctors and patients know that these drugs produce dangerous symptoms that compound and exaggerate the original mood condition. Lilly's results from 1988, if true, will only confirm yet again that these drugs should never have been so extensively used in primary care and their use should have been restricted to certain serious depression indications which may carry significant risks of suicide if not treated. Lilly's assertion of more than 50M prozac users worldwide has, perhaps quite unintentionally, confirmed an estimate of the possible extent and scale of this avoidable manmade international tragedy that Lilly will find difficult to deny. 10,000 to 90,000 (or more) potential suicides must now challenge those who would justify and equate lethal harm for some patients with uncertain benefit for others and claim that they were "striking the right balance !" Graham Aldred Competing interests: None declared |
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Leslie E Evans, clinical pharmacist LasVegas 89119
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Bypassing peer review and not adequately reviewing or researching information is not acceptable... unless one wants to boost readership using proven British tabloid tactics. Perhaps a bit more discretion next time...? Competing interests: None declared |
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Josee Laverdiere, Administrative Assistant Place Ville Marie
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I'm from Montreal Canada and read the article concerning the contreversy of Prozac in a French newspaper. I have to admit that I was really concern since I've been using Prozac (the generic Novo-Fluoxetine)for the last 10 years. I use to suffer of severe depression, anxiety attacks, panick attacks and more. Doctors prescribed me Xanax with therapy. Xanax really didn't do me good. I was willing to do more stuff but the medication sucked out all of my energy. I went to my familly doctor and told him about the Xanax. He then prescribed the Prozac and told me that if that drug suited me, I was a really lucky person and that life will be better for me. He explained that I suffer from chemical imbalance in my brain (a gland that secretes that chemical isn't working good) so I have to take the Prozac to maintain a balance. Good news, I started with 40 mg a day and things were great. Went down to 30 mg and things are still great. I am a good candidate for Prozac and when I read that article, it really made me think that if these sad things really happened with users of the medication, I blame their doctors for not keeping a close look at them. My doctor clearly told me that not all people are good candidate and followed me on a bi-monthly basis. After ten years, he still follows me but every three months. Prozac was a life saver for me so please, don't point at the medication but at the person that prescribed it wrong. I can't take Tylenol because it hurts my stomach but some other people can, so same thing for Prozac and all medications. Thank you Competing interests: None declared |
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Gina M Dempski, House Wife 92065
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It is a sad day when the almighty dollar means more than human life. Eli Lilly knew what Prozac was doing to people, nevertheless they saw its income potential and ran with it. I really hope that the justice system will finally admit that Prozac can cause people to commit violent acts. Many people who are taking this medication commit crimes or acts of violence and if they had not been on this deadly medication the thought would have never crossed their minds. Maybe now the justice system will swallow their pride and give leniency to those poor people sitting in jail because they trusted Prozac to help them. Competing interests: None declared |
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Chantal HENRY, MD-PhD, Hospital psychiatrist CH Charles Perrens, 33076 Bordeaux, FRANCE, Jacques Demotes-Mainard
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To what extent do SSRIs increase the risk of suicide or violent behaviour? A recent meta-analysis on both published and unpublished data (Whittington et al., 2004) indicates that some SSRIs lack a favourable 'risk–benefit' profile for treating childhood and adolescent depression. This study underscored the need for improved transparency in clinical studies, and led to a statement by the International Committee of Medical Journal Editors (ICMJE) requiring open registration of such studies (Abbasi, 2004). In addition, the BMJ recently reported (Lenzer, 2005) that documents could cast doubt on conclusions that fluoxetine treatment was not associated with violence observed. This controversy raises other critical issues of SSRI use that merit our consideration. First, it questions the external validity of clinical trials in which ‘depressed’ patients at high suicide risk are excluded, and therefore potentially different from those treated by SSRIs in primary care settings. Second, SSRI treatment can trigger mood changes in undiagnosed bipolar patients (Henry and Demotes-Mainard, 2003) resulting in agitation and disinhibition, and such effects may lead to suicide and violence. Finally, although all these subjects can be viewed as suffering from depression, far less is known concerning the nature of their depression. The defining criteria for DSM-IV (APA, 1994) major depression remain in fact very similar to those employed during 19th century, where pharmacotherapy was absent and descriptions of depression phenomenology were typically restricted to profoundly depressed patients. Currently, a large number of patients are diagnosed as depressed because they complain about sadness, however it is not clear if they should be considered as depressed. They may certainly have severe depressed mood that merits attention, but do they necessarily exhibit the same illness needing the same medication? An increasing amount of data now shows that some types of depression recover under antidepressants, whereas some other forms are worsened under the same treatment (Henry et al., 2003; Benazzi et al., 2004). These studies demonstrate that patients may fulfil all DSM-IV criteria for major depressive episode, but they show highly divergent clinical patterns: responders to antidepressants appear to correspond to the former ‘endogeneous depression’ description (characterised by psychomotor retardation, affective anaesthesia, and inhibition) whereas patients worsened by antidepressants have a mixture of depressive symptoms and agitation (restlessness, racing thoughts, emotional lability and hyper -reactivity). As we now have access to efficient drug treatment, it is important to reconsider diagnostic categories in the light of patient response to treatment (as is the case for other medical fields). Perhaps differential response to antidepressants could lead practitioners to better define depression, and its subtypes. Chantal Henry and Jacques Demotes-Mainard
Whittington CJ., Kendall T., Fonagy P., et al. SSRIs in childhood depression: systematic review of published versus unpublished data. The Lancet, vol 363: 1341-1345 Abbasi K. Compulsory registration of clinical trials. BMJ, 2004, vol 329, 637-638 Lenzer J. FDA to review ‘missing’ drug company documents. BMJ 2005, 330:7 Henry C., Demotes-Mainard J. Avoiding drug-induced switching in patients with bipolar depression. Drug Safety 2003, 26:337-351. American Psychiatric Association. Diagnostic and statistical Manual of Mental Disorders (DSM-IV), 1994. Henry C., Van den Bulke, Demazeau N., Demotes-Mainard J. Why are some depressions worsened by antidepressant? Bipolar Disorders 2003: 5(1): 24. Benazzi F., Koukopoulos A., Akiskal HS. Toward a validation of a new definition of agitated depression as a bipolar mixed state (mixed depression). Eur Psychiatry. 2004, 19(2): 85-90. Competing interests: None declared |
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