September 19, 2007

Worse Than Vioxx: Zyprexa, Risperdal, Clozaril, And Paxil Killed Thousands Of Americans

Last 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:


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 AM Digg it Google Netscape reddit

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 AM

Your article is interesting and it is important to raise awareness to the precautions that need to be taken with these drugs.
However; the side effect related to Vioxx was heart failure and was unkown in initial trials. When discovered that this was an unpreventable and unpredictable side effect with no warning signs-the medication was pulled.
While the main side effect you are referring to with the psychotropic meds is an increased risk of suicide. There are MANY precautions and guidelines for these meds in regard to the increase in suicidal ideations. Patient education is key here.
While the possibility of an increase in suicidal thought related to these drugs is extremely important; the responsability lies also with the physicians, the patient and the families to observe closely for any increase in increased symptomatology.
I am not defending the pharmacuetical industry. However; you cannot bash these companies without realizing that there is accountability on all sides. These drugs have also SAVED millions of lives. A point you seem to have forgotten.

Posted by: Maggie at September 19, 2007 09:02 AM

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 AM

Point 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 AM

Why 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 AM

This 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:

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.


Posted by: Matthew Holford at September 19, 2007 11:27 AM

When 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 AM

My post pretains to the posted comment from Maggie

Posted by: Jane at September 19, 2007 11:56 AM

Jane 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 PM

You're right, Zyprexa and Risperdal aren't just
so-called "crazy people" drugs. I was prescribed Risperdal and Seroquel (at different times) for SSRI and SNRI induced insomnia. I was being treated for recurrent major depression, not psychosis. Antipsychotics for insomnia, it's all the rage these days.

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 PM

I'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 PM

Actually it took Merck 4 years to pull Vioxx and they buried the first study that warned of problems.

Posted by: Mad Crone at September 20, 2007 03:19 AM

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.


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 AM

Word. And a cyber-bouquet for Franseca.

Posted by: flawedplan at September 21, 2007 03:42 AM

I 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 PM
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