September 19, 2007Worse Than Vioxx: Zyprexa, Risperdal, Clozaril, And Paxil Killed Thousands Of AmericansLast week, there was much media coverage of a large jump in adverse events reports and deaths due to the use--and, perhaps, misuse--or prescription drugs. Most of the coverage cited the general trend, noted how many thousands of deaths occurred among users of opiate painkillers, and moved along. I wrote about the study here, but at the time had not obtained the entire paper. I have rectified that situation. What the media failed to report is that Zyprexa, Risperdal, and Clozaril, three atypical antipsychotics, and Paxil, an SSRI anti-depressant, were tied to the deaths of 6,225 Americans from 1998 to 2005. These numbers are shocking and far outpace estimates I've run into previously. That this data was not reported by the media is inexcusable, given the millions of Americans--and others around the world--who take these four drugs. The numbers come from a study in the Archives of Internal Medicine and are based upon reports in the FDA's adverse events database. There are limits to the numbers from this study. I'll get to those in a bit. The study may be accessed here. Since news broke around Zyprexa last year and accusations that its maker, Eli Lilly, had downplayed and covered up known injuries caused by the drug, the media has not provided an accounting of how many people died as a result of taking the drug. For my part, I downplayed the numbers I ran across in press accounts and in the Zyprexa documents. I didn't want to cast false aspersions. But, now, I can say this: Eli Lilly, your drug killed 1,005 Americans. And, Janssen/J&J: your drug killed 1,093 Americans. GSK and makers of generic Paxil: you guys make a drug that killed 850 Americans. As for Novartis, makers of Clozaril, and whomever makes its generic form: you asshats killed 3,277 Americans. The doctors who prescribed these drugs are just as responsible, ethically if not legally. And I have a question for you guys: How's it feel? Excepting Paxil, each of these drugs killed more people than Vioxx, which claimed 932 lives, according to the study. Vioxx was pulled from the market in 2004, following intense publicity around its association with heart attacks. Some estimates of deaths related to Vioxx go as high as 55,000 deaths, but I don't know how solid those numbers are. Zyprexa, Risperdal, Clozaril, and Paxil are all still on the market in the US. Zyprexa and Risperdal account for about $8 billion in sales each year. Why are these drugs still available? Partly because the FDA allows them to remain on-sale, partly because researchers continue to go to bat for these drugs, and partly because the media has failed to adequately police these issues (the New York Times gets a pass from this criticism). Back in 2004, America's media spilled ink all over the street about Vioxx. Good, decent, hard-working Americans taking that drug for arthritis and other pains were having heart attacks and dying out of the blue. That wasn't right--any editor could understand that--and the media responded appropriately. So why is it that the New York Times was virtually alone in reporting on Lilly's attempts to downplay problems with Zyprexa and accusations that it marketed the drug off-label? The documents were in the hands of NPR, the Wall Street Journal, and the Washington Post--and yet these media giants remained largely silent. Wimps. I know some far-flung reporters are trying to now play catch up. Good for them. Just a note for you guys: Zyprexa and Risperdal aren't just so-called "crazy people" drugs, or for schizophrenia and chronic mania, if you prefer. They were actively pushed by their makers for use in lighter forms of bipolar disorder, depression, and dementia--hardly the crazy folks the media seems to have been willing to blow off as unimportant somehow, at least in comparison with the solid citizens being wounded by Vioxx. And, these drugs were actively pushed for long-term use, not just a day or two here and there. Most outrageously, Risperdal, a drug associated with over 1,000 deaths, is used in children--and the FDA approved its use. In the case of child bipolar disorder, Risperdal is being used in children when psychiatrists cannot even agree upon whether the diagnosis exists and if using atypicals is an appropriate response. Something is deeply wrong with this picture and its time for this rotten situation to be cleared up. That means it's time for the FDA, Congress and the media to do their jobs. And it's time for the doctors who prescribe these drugs to wake up and recognize that you are endangering your patients. What I find puzzling is that I've been told by numerous practitioners that no one prescribes Clozaril anymore due to known problems with the drug. But the Archives report also contains data on non-fatal adverse events and breaks them out by year between 1998 and 2005. There were more adverse events reports for Clozaril in 2005 than there were in 1998. I've been told that Paxil scripts are way down too, but in 2005 there were over twice as many adverse events reports for the anti-depressant as in 1998. Some of this can be explained by the argument that the adverse events reporting system is still fairly new, that reporting is voluntary, that other factors may explain the events (for example, multiple drugs in the same patient) and that the boost in events reports in the last few years can be explained by lawyers pushing clients to file reports with the FDA. Maybe. Keep in mind that if lawyers were really pushing their clients to file adverse events reports willy-nilly, then there would be approximately 30,000 or more adverse events reports in the FDA system for Zyprexa alone--one for each plaintiff in lawsuits already settled by Lilly. According to the study, there are only 4,110 adverse events reports on file for Zyprexa. By comparison, 8,698 adverse events reports were filed for Vioxx. Why aren't there 30,000 or so events reports for Zyprexa, for example? Likely because plaintiffs who settled claims against Lilly signed a confidentiality agreement and are reportedly muzzled from speaking to the press about their experiences and probably also believe that they cannot make reports to the FDA. That's some breathtaking legal advocacy by Lilly's outside attorneys and some bizarre work on the bench by US District Court Judge Jack Weinstein. As for adverse events as a whole, several psych meds had more than 500 adverse events reports between 1998 and 2005. In order and using brand names: Paxil--8,945 Some of the Depakote, Tegretol and Lamictal events could be as a result of their use in epilepsy. Cymbalta's reports would be based on less than two years of patient experience since the drug was approved in 2004. I'm not trying to ignore the rest of the world, but I simply don't have access to many numbers concerning these drugs in other countries, except for the 399 deaths recently reported among Australians who were given atypical antipsychotics. In closing, I want to cycle back to a post I did over a year ago. In it, I groused that a thought leader in the medical community had told me that Zyprexa's use was, on the whole, therapeutic for patients. I wonder if he's even read the Archives study. Posted by Philip Dawdy at September 19, 2007 12:28 AMComments
The medspeak for their screwups is "adverse health events" and I am willing to bet that this suffers from massive under reporting. Posted by: Mad Crone at September 19, 2007 03:45 AM"As for Novartis, makers of Clozaril, and whomever makes its generic form: you asshats killed 3,277 Americans. The doctors who prescribed these drugs are just as responsible, ethically if not legally."-Dawdy Excuse me while I sob, and send the link to my article I wrote after reading this entry. Thank you Philip, for writing this, everyone please pay attention. Not only has my daughter been prescribed Clozaril, it appears to help her mind, and that of 60% of a local residential care facility accord to the onsite psychiatrist who has 60% of his patients using it. A Mother's Love:the advocacy journey, and Clozaril-Soulful Sepulcher Posted by: Stephany at September 19, 2007 05:36 AMYour article is interesting and it is important to raise awareness to the precautions that need to be taken with these drugs. thanks maggie. as far as the antipsychs go, the main causes of death appear to be diabetes, pancreatitis and cardiac problems, not suicides as is more common with the anti-depressants. i'm not sure what patient education would do about pancreatitis Posted by: Philip Dawdy at September 19, 2007 09:07 AMPoint well taken in general--many of these drugs are directly dangerous. But to deal narrowly with the antidepressants for a minute, which have not been shown to cause any physiological disturbance even sort of similar to the antipsychotics: these drugs are usually prescribed to depressed people, and depressed people are at risk of suicide whether or not they are medicated. I can't find any reporting of what the adverse events actually were (heart attack? stroke? suicide?), which would go a long way towards clearing the issue up. But let's say that most or all of the adverse events relating to the SSRIs were suicides. Then there is a correlation between the drugs and suicide. And correlation is not causation. Posted by: techne at September 19, 2007 09:08 AMWhy is it okay to kill psych patients but Vioxx gets pulled to protect people in physical pain? Who's protecting us? Posted by: Gianna at September 19, 2007 09:35 AMThis is not pleasant reading. However, I've determined not to get embroiled in a debate about side effects until somebody explains what the benefit of these psychotropic drugs is - "efficacy" being the first criteria, in assessment. If you think that this is a diversion, you should take a look at the way the MHRA, in the UK, squirmed, when I started quizzing it on this point: http://itsquiteanexperience.blogspot.com/ Read back through July and August, principally. Rather than stand and argue its position, it stonewalled me. It seems pretty plain that these drugs don't work: that's the upshot, and the regulatory licensing process appears to be designed not to pick this up. Matt Posted by: Matthew Holford at September 19, 2007 11:27 AMWhen I go to the doctor I expect my doctor to make the determine what is wrong with me. If the doctor is to write me a prescription I expect the doctor to know exactly what will happen while on the medication. This is the doctors job. This is what makes them the doctor. If I make a suggestion as to what I might feel is the better medication, because maybe I heard it has fewer side effects, I am told flat out "I'm the doctor. I know what is best for you". (In another words, "don't question me") Yes, I suppose if I had money and or insurance I could pick another doctor. One willing to educate me instead of ridiculing me. But hey, in the real world thats just not possible. So, I leave my decission making to the educated doctor, who has made it prefectly clear, he knows whats best! I leave the office educated and assured that my doctor knows best and I needn't have any concerns. There really is no reason for me to question it any further. Maybe someone can explain to me just where am I suppose to get educated about drug safety? We just learned my doctor really isn't interested in me knowing anything except how smart he is. The websites listed on the TV ads the drug company's display? Heck, their websites would surely educate me to all the deaths and other serious side effects associated with their drugs. Maybe you think I should be able to pull up the actual research done on each drug I am prescribed. Yep, could probably learn alot from those with my high school degree! But then again, since it is only a couple doctors with their names on all the research, I might get confortable in their writting styles and actually learn alot. The fact is, I pay my doctor to know what he is prescribing me . I expect the doctor to stay current on what he/she is prescribing. I expect the doctor to file and adverse effect report. I expect my doctor to encourage me and advise me to write a report. I expect my doctor to question the research. I expect my doctor to question the authors of the study, who paid for the study, the results of the study. I expect to be helped, not harmed when taking a medication and it is the doctors responsiblity to assure me that does not happen. Oh, and to tell me someone else's life was saved on the same medication that killed, caused diabetes, caused serious MI symptoms, heart disease in a love one will not resolve the abuses of the drug companies and doctors and make the drugs safer. The drug companies, researchers, prescribing doctors and the FDA all have a responsibilty in assuring my safety. Don't blame me for a lack of education, especially when there is no place to be educated. Thanks to these blogs the general public is getting assess to information that has been kept hidden. Posted by: Jane at September 19, 2007 11:53 AMMy post pretains to the posted comment from Maggie Posted by: Jane at September 19, 2007 11:56 AMJane how about this: my daughter when she was 17, researched Zyprexa diabetes on her own, took the paperwork to her psych and he told her to "take a walk" to lose weight. She FIRED him. [She had been on that drug since she was 11, and it's only because of MY research that I knew to watch for pancreatitus re: Depakote, and Polycystic Ovary Syndrome[black box warning].She didn't get pancreatitus, but DOES have Polycystic Ovary syndrome, a permanent DAMAGE that leaves a 19 yr old most likely unable to have kids and has increased cancer risk. Educating patients is something doctors do not do. I was also told "I'm the doctor". "If your mother wanted to be a psychiatrist then she should go to school to become one." "In my 30 years experience, and I'm the doctor." ---the list goes on and on and guess what? I was right ALL of the time, per topic that had been raised. One doctor did tell me due to my SSRI information and suicidal ideation[per Zoloft in 2001 when my daughter was 13]that he was going to "re-think how I medicate patients now due to your mother's research."[he told that to my daughter.] I WISH I didn't have to learn so much about chemistry, medications, and see adverse affects in someone I love and try and convince a doctor it was the med. Posted by: Stephany at September 19, 2007 03:44 PMYou're right, Zyprexa and Risperdal aren't just I was actually quite surprised with the numbers of reported adverse events from psych meds. It's nice to see that some doctors are reporting. Maybe part of the problem when to it comes to reporting adverse effects with psych meds is that so many patients these days are on more than one at a time. It's probably not that easy to isolate the culprit. I was on Effexor, Wellbutrin, Lamictal, and a couple of others thrown in to the mix. Then, they take you off one and put you on another, increase this one, decrease that one. So, who knows what caused what. I realize that taking any drug involves risk. I would, however, like to be the one to choose what risks I am willing to accept. That should always be the patient's decision. I'm not willing to risk diabetes, weight gain, and tardive dyskinesia to address problems with insomnia. If that made me a bad psych patient, sorry. Posted by: Lisa at September 19, 2007 04:25 PMI've been treating patients who are under the watchful eyes of good psychiatrists who watch them carefully when they are on these types of medications. To me this isn't about the drugs, which usually save lives not take them, it's about the management of the patient and poor history-taking. Posted by: therapydoc at September 19, 2007 09:11 PMMaggie, therapydoc said: "...To me this isn't about the drugs, which usually save lives not take them, it's about the management of the patient and poor history-taking." This is about the drugs, therapydoc, and it is also about the way that both the manufacturers and the drugs are controlled. Can you honestly tell me that these things (SSRIs, for example) work? How do you know that they work, and how do you know that they work outside the acknowledged benefit of the placebo effect? I don't believe that you can tell me that, any more than the MHRA could. This whole business looks like a scam, where those in charge are incapable of presenting the very information that should have been established as a primary consideration. And this is done on the basis that the information is proprietary, commercial data? Purr-lease. Matt Posted by: Matthew Holford at September 20, 2007 03:33 AM"To me this isn't about the drugs, which usually save lives not take them, it's about the management of the patient and poor history-taking." I have always understood this website to be pro-patient and pro-information. In light of that, I am appalled by your statement. FYI, doc, "history-taking" is what slots people into DSM-dictated boxes. Secondly, I'm a person, not a "patient" and I don't need to be "managed." Thanks for your contribution, "therapydoc." Eli Lilly has a website you might want to check out. Posted by: Francesca Allan at September 20, 2007 07:33 AMWord. And a cyber-bouquet for Franseca. Posted by: flawedplan at September 21, 2007 03:42 AMI agree with a lot of what you had to say on this topic. The media should really step it up and bring more light to such issues on reported adverse events. This, in turn, would increase public awareness. However, I could not help but wonder if more media coverage on these drug related deaths would ultimately lead patients to experience feelings of betrayal and mistrust toward their health care providers. In other words, patients being handed prescriptions will no longer trust the doctors issuing them. This might even cause them to avoid seeking treatment for their illness or deny drug therapy altogether. It hurt me most to hear that “Risperdal, a drug associated with over 1,000 deaths, is used in children--and the FDA approved its use”. How can drugs such as this one, which is used to treat schizophrenia, continue to be prescribed? It might be true that this drug has helped many. But, the FDA has to ask itself the pressing question: do the benefits outweigh the serious risks. I believe that risks such as death and disability outweigh the benefits. More research needs to be conducted on these drugs, in order to properly label all the side effects and to determine whether it is best to simply take the drugs off the market as was the case with Vioxx. Posted by: IC at September 24, 2007 10:07 PMI think this article is great and really informative, but what is this about "crazy-people" drugs? What about the so called "crazy people" diagnosed with so called serious mental illnesses that these drugs are killing? I guess they dont matter? It dosnt matter if they r prescribed for "crazy people" or "lighter" things like bi polar they r still harming people and all these people are humans and dont deserve to be forced or coerced onto these drugs whether they are so called "crazy people" or "normal" people. Posted by: Susan at October 6, 2007 08:17 PMYou have to address the risk vs benefit in psychiatric drugs. The drugs should NEVER be prescribed unless absolutely neccessary. Perhaps, there should be stricter rules for prescribing. Clozaril is already controlled. A patient had to have been treatment-resistant to at least 3 other antipsychotics. Blood tests are given often and the pharmacist must get the results before dispensing. Schizophrenia is a very serious illness. It can be fatal or make the patient wish it were fatal. Fatalities are caused by suicide or poor decision making that puts the patient in dangerous situations. The suffering from this illness is horrible. Untreated, people with schizophrenia often end up homeless or in institutions. Even with treatment, many people are never able to do what the rest of us take for granted, like marriage, children, or a job. If you'd ever watched a loved one struggling with severe mental illness, perhaps you'd understand why family members, psychiatrists, and the patient if capable, make the decision to take clozaril, the antipsychotic of last resort. When that doesn't work, the only recommendation left is electoshock therapy, which will make you long for the days that dangerous medication was effective. Posted by: Mary at October 12, 2007 09:55 PMMary, good point--the one about psych meds not being RX unless necessary. I'm perplexed by psychiatrists who use these meds so casually, and in the case of my daughter--I think a few who saw her are now questioning their reason for medicating her. Considering she was dx "Impulse Control Disorder" a year ago and sent out of a hospital on CLozaril--every 2 weeks a blood draw, not all pharmacies carry it, and yes the test is mandatory--by law--because it is THAT dangerous. In my opinion, ALL antipsychotics are THAT dangerous, each one carries deadly side effects, and Clozaril is actually so far not the last resort antipsyhotic given to my daughter. It appeared to help "bring her back" as a 18 yr old w/second grade reading level--but once off of it, she crashed. Now back on it, she is at zero reading level, ability to function has become questionable, and now they say it's Schizophrenia. After 8 years, starting with OCD in 1999. One doc off record has told me he agrees the meds could have caused brain damage. A doc off record asked me about ECT. She won't have it. Unless she can read, write and understand her own consent for treatment form--no one has permission to do that to her. What's left? this is where doctors give up. They send them to long term care in institutions. Oh, I've seen suffering, far too much, and the pain I feel is equal, with an added dimension of being told I will never see her again, the girl I once knew. The doc said it so casually too. I think that has to be worse than telling someone they are dying. Because she isnt dying. But she is only 19 and what now. Mary, I'm curious, what specifically does someone have to do to be given this drug? Do people request it ever? If someone who is labeled schizophrenic is not going to be able to marry, work, or have children, and is so disliked by his family that he is not allowed in their home and is thus on the streets, what benefit can clozaril be to them? I've worked for a diagnosed paranoid schizophrenic (can't say who, it's destroy his life) who is a divorced father with custody of his children and is off all psych meds living in an apartment, paying rent and working on an advanced college degree. Posted by: Sally at October 14, 2007 08:06 AMAmong the things that concern me about Mary's last post on this thread is this: She's flat out saying schizophrenics are not like you and I, they're not fully human, therefore, it's okay to give them drugs that will make them very very uncomfortable, unhappy and physically sick. Here's where she says it: "Untreated, people with schizophrenia often end up homeless or in institutions. Even with treatment, many people are never able to do what the rest of us take for granted, like marriage, children, or a job." Underneath all of the AOT is NAMI/TAC's pretty clear rage over deinstitutionalization. How far are we from a NAMI mandatory sterilization legislative initiative? A prohibition against people labeled schizophrenic and bipolar marrying? Think about it, their current policy is based on the idea that some people are mentally ill and thus are not fully human, are in fact so sick that if allowed to act on their own ideas, are dangerous. Scary stuff. In the 70's if a stay at home mother was unhappy and frustrated with her children, she went to therapy and changed to become happy. Today, she takes the child to get drugged and blames all of her feelings on the child. There's some much potential for good and healing in the mental health field. It's ashamed its being drowned out by the bad. Posted by: Sally at October 16, 2007 08:43 AMEli-Lilly have only agreed to settle diabetes and weight gain claims out of the goodness of their heart. The crimes are about off-label deaths of men, women and children. Lawyers are offering settlements for small amount of money. Today I noticed the judge plans to clean his docket of settled claims. Lawyers received a lump sum then offer settlements. To me this means my cry for justice will happen only if I go with my state sueing. I live in mississippi, no more waiting for my lawyer to communicate with Eli-Lilly for me. I know now my lawyer cheated and was not working for me. My lawyer is from Viriginia. Posted by: madandhurt at January 3, 2008 05:59 PMEli-Lilly was forced to admit to diabetes and weight gain. Eli-Lilly is also guilty of off-label marketing that they have not accepted blame. I live in Jackson Mississippi where this drug company target their zyprexa for dementia. My husband had Blue Cross and Blue Shield plus medicare he was only 45 years old when he died in 2005. Now my lawyer is trying to force my dementia case into settlement with diabetes, offering 15 Thousand after lawyer fees (which I refused). I want to go to trial but the law and our courts are not ready because of mass tort problems Eli-Lilly caused. That is what happens when you spread your poison around, but they are back to business as usual. Posted by: madandhurt at January 21, 2008 04:42 PMDoes anyone know exactly what CLOZARIL does to the body that causes weight gain? More importantly, does anyone know how to reverse it after it's done the damage and you're no longer taking it? I'm so sick of being fat because of this stupid crap! Risperdal is a dangerous drug that needs to be pulled off the market. Although it causes diabetes, it's mainly damages the heart. My son, Chris, was prescribed Risperdal in 1998. Two months later he began having heart issues. I carried him to a cardiologist who assured me that he would be ok. Then one night in 1999 I had to rush him to the ER because his heart was racing and beating hard. Chris is non-verbal and has autism. He could not relay to me what was going on, but I could tell that his heart was beating fast and hard from watching his chest. After taking an x-ray in the ER and having an EKG, I was told he had a hole in his heart. I carried him to another cardiolgist who confirmed that he has a leaking valve, which could someday lead to Pulmonary Hypertension. I can imagine that other non-verbal people have suffered the same injury that my son has and there are people out there who are aware of this, yet no one is saying anything. Risperal is a dangerous drug that needs to be pulled off the market as well as a lot of other psych medications. In Canada, this drug is being exposed for what it does to people. Only in America is Risperdal being held as a safe remedy for autism and bipolar disorder. Posted by: Patricia Wattley at May 7, 2008 11:28 AMPost a comment
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