Antidepressant Backlash: Choose Your Weapon
74 CommentsBy Ed Silverman // November 14th, 2007 // 8:02 am
That’s the theme of a video clip posted this week on YouTube by a group that opposes anitdepressants and uses school shootings to underscore its message. As you may recall, antidepressants regularly emerge as a subplot when gunmen are found - or are believed - to have taken one of these meds. The latest episode occurred last week in Finland, where nine people were shot and killed, although antidepressant use hasn’t yet been confirmed.
The group that posted this and two other videos is the Citizens Commission on Human Rights, which was established by the Church of Scientology and is a lightning rod for controversy. But we post the clip here because the video is a sophisticated attempt to further a debate that appears unlikely to diminish any time soon.
Lisa Van S
Ed,
You can visit http://www.sssristories.com
Here you will find Media/press accounts of school shootings,violent and suicidal acts of children,Homicidal/suicidal adults.You name it…SSRI stories has it……..
Nathan
Lisa,
You should consider the other side of the story:
A research study in 2003 reported that SSRI’s lower the rate of suicide, particular in the elderly.
http://www.webmd.com/news/20030508/antidepressants-suicide
A research study reported in 2006 reports that SSRI’s lower rates of suicide in children:
http://www.lifescript.com/channels/well_being/News_Bites/antidepressants_lower_suicide_rate_in_young_kids.asp
Here’s a quote:
“In those counties where antidepressant use among children was lowest, suicide rates among young people were almost double compared to counties with the highest child antidepressant use.”
Here’s an article from the american association of psychiatry that comes to the same conclusion:
http://ajp.psychiatryonline.org/cgi/content/abstract/163/11/1898
If you look up “antidepressant and suicide” on Google, you’ll find a huge number of articles, press releases, and news reports that link antidepressant use to LOWER suicide rates. Even the black-box warning on the use of SSRI’s in children is very contriversial. The statistics that the FDA needed to make a good decision just aren’t avaliable. See this link for details: http://www.stats.org/stories/2004/antidepressants_suicide_oct05_04.htm
If you want to convince people that SSRI’s are such an evil thing, you’ll need to point to some clinical studies — not to “ssristories.com”. Your website is a collection of user-submitted stories and any media reported story in which the “bad guy” happens to be taking an SSRI. This is a long, long, long way from being a clinical study.
Lisa Van S
CORRECTION http://www.ssristories.com
Ken Thomas,RN
Bravo !!
James
Correlation does not equal causation.
Or, to put it another way, I’m shocked, shocked to learn that someone who kills classmates, and themselves, would be anti-depressants. Maybe because someone who kills classmates and themselves are depressed?
Nah. Couldn’t be. The drugs did it, of course.
Lisa, Ken, Scientologists and others of your ilk kill your credibility when you immediately blame the drugs, no matter what other factors may be involved.
Laurie
“Correlation does not equal causation.”
Ah, the pharma mantra. The reality is that school shootings were few and far between prior to the ssri mass marketing. No, the connection cannot be definitively proven, but that doesn’t mean that the connection is not valid. If you look back into the history of these shooters, prior to ssri’s, there was no violent history. That, in my opinion, points in the direction of the drug. I have talked to many who luckily didn’t act on the impulses, but they can tell you that they could have killed at the drop of a hat. Once off the drug those impulses are gone. People can draw their own conclusions.
Donna
Jame’s,
Your right, there could’nt be a link , anyone on antidepressant’s who kill’s classmate’s and then themselve’s, could’nt possibly have anything to do with the drug… it’s just one “HUGE coincidence…….Hello!!
Lisa Van S
“Correlation does not equal causation”
HMMM,Then one could say the “Drugs Dont Work”.
“your ilk”, have no idea what you mean by that.
James
Laurie,
Not a pharma mantra–a well known and appropriate counter to those who constantly dig up “evidence” to back up their agenda.
As for a correlation between school shootings and anti-depressants:
Seung-Hui Cho, shooter at Virginia Tech. He had been treated for anxiety and depression via therapy prior to entering VT, but there is no evidence that he took an SSRI before or during his residency at Tech.
Andrew Golden and Mitchell Johnson, shooters at Jonesboro, AR, 1998. Both students were known bullies. No evidence indicates either took anti-depressants at any time.
Michael Carneal, shooter at Heath High School, KY, 1998. Carneal pled guilty but mentally ill, due to paranoia and a schizophrenia-like personality disorder. No mention of SSRIs or other anti-depressants.
Eric Harris and Dylan Klebold, Columbine. There is no evidence that Klebold was on any anti-depressant. Harris was, indeed, reported to have Levox in his system upon his death. However, based upon his writings and activities, he was less likely depressed, and more likely suffering from clinical narcissism, a personality disorder that is much more difficult to treat, and certainly cannot be treated effectively with SSRIs.
So, the four best known school shootings of the last decade, and only one of 6 shooters had a history of taking SSRIs (and he was most likely in need of stronger medication than that, and should have possibly been monitored more closely).
I’m sure I could do more research, and find more cases where some shooters were taking SSRIs, and where some were not. Yes, you and other can draw whatever conclusions you like. But the facts do not support yours.
Reality
Laurie,
“Correlation does not imply causation” is indeed a mantra, but it’s one you learn on your first day of Statistics 101, not once you go work for pharma.
Lisa,
You’re absolutely correct that one could say the drugs don’t work. That is exactly why statisticians perform power calculations to ensure that the likelihood of a false positive is very small, typically set at 5%.
Thus, any time you see a statistically significant result, there is at most a 5% chance a positive result is actually a false-positive, and the lower the p-value for the result, the greater confidence one can have that the findings are not the result of chance alone.
Lisa Van S
James,
Cho was diagnosed w/selective mutism and prescribed Paxil.And no “PROOF” that he ever stopped taking it!!!
Cho’s Toxicology Report has not been made Public.
Cho’s Mental Health Records are missing, and some were destroyed..HOW CONVENIENT!!!
Eric Harris was first prescribed Zoloft in Feb 1998. Zoloft was discontinued due to Homicidal/Suicidal thoughts. He was then Prescribed Luvox, and over the following year his Luvox was increased 3 more times, reaching 200mg,the last dose increase was approx 2 Weeks before the Columbine Tragedy. Eric had no “History of Violence”
And… No one knows what was in Klebolds system, you know why….they never tested for prescription drugs…only illicit drugs and alcohol.
Just because its not reported that the others were on antidepressants,does not mean they were not..
James
And Lisa, just because it is not reported that Ed Silverman was a member of Tom Petty and the Heartbreakers doesn’t mean he is not.
What kind of flimsy argument is that?
Lisa Van S
Reality,
We can debate this issue forever,”Causal Role” or “No Efficacy”. But the end result are “Dead Kids” and lives of Family and Friends,.. are changed forever.
My Daughter lost a dear Friend due to the Tragedy at Virginia Tech…He had planned to take a job in the Pharmaceutical Industry as a Sales Rep. How ironic!
Lisa Van S
James,
It could be as “Flimsy as Yours”
Nathan
Lisa, you state “But the end result are “Dead Kids†and lives of Family and Friends,.. are changed forever.”
The same can be said of the thousands of suicides that take place in the US every year. Thanks to SSRIs and other antidepresents, many hundreds of families in the US every year don’t have to go through the agony of suicide. Don’t forget those families. They are just as important as the ones you mention.
Lisa Van S
Nathan,
Informed Consent,..Parents must have all information available. Efficay is an issue….
Morgan
Nathan sounds like he is towing the pharmaceutical/psychiatric lobby line. Anyone who doesn’t even believe that an investigation is merited when the majority of recent school shooters were under the influence of violence and suicide inducing antidepressants has got to be either someone with a vested interest or someone who doesn’t bother to read FDA warnings.
We already know that the FDA warns that antidepressants increase suicidality in children, teens and young adults. The FDA has also warned that the antidepressant Effexor causes “homicidal ideation,†and issued a public health advisory in March 2004 stating, “Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement, mild mania] and mania [psychosis characterized by exalted feelings, delusions of grandeur and overproduction of ideas], have been reported in adult and pediatric patients being treated with antidepressants…â€
Nathan cites a Webmd article which he says “reported that SSRI’s lower the rate of suicide,†when in fact, the very article he cites states, “…the study does not show a cause and effect relationship between antidepressant use and suicide risk.â€
As far as the 2006 research he cited from the American Psychiatric Association, the New York Times published an article where experts explained how the study data did not support the conclusion that antidepressants lower suicide rates: “… the data in the study, which was published in The American Journal of Psychiatry and received widespread publicity, do not support that explanation, outside experts say.â€
The NYT also states, “In an interview, Robert D. Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago and the lead author of the journal article, acknowledged that the data from the United States that he and his colleagues analyzed did not support a causal link between prescription rates and suicide in 2004.â€
As far as studies on antidepressants and suicide/violence, Nathan needs to learn how to search on google, as these are easily available:
Dr. David Healy, director of Cardiff University’s North Wales department of psychological medicine, published a study in September last year in the Public Library of Science Medicine journal which found that Paxil increases the risk of violence in children and adults. Dr. Healy also found that one in 500 users of antidepressant drugs will complete suicide because of the drug.
In August 2004, the FDA announced that the Columbia University review of the pediatric clinical trials of Zoloft, Celexa, Effexor, Wellbutrin, Paxil and Prozac, found that young people who took the antidepressants were more likely than those taking a placebo to experience suicidal thoughts or actions.
Psychiatric Times published an article entitled “APA: SSRIs More Likely in Suicides than in Other Young Deaths,†about a study of SSRIs appearing in the bloodstream of “unnatural†deaths recorded by the Virginia Medical Examiner’s Office between 1987 through 2003. The study found that antidepressants were discovered in the blood stream of suicide victims significantly more often than in accident or murder victims.
sheila matthews
It’s simple it is not a debate, it is evidence. A person is labeled with depression and receives mental health treatment and is placed on antidepressants and kills themselves or others, the treatment failed. Another person is diagnosed with a different psychiatric label, not depression, but let’s take adhd, takes the mental health treatment and is placed on antidepressants and kills themselves or others. What do these two have in common, the both took the recommended treatment “antidepressants” and they are both dead. It’s all about evidence and facts. Let’s take the blood of all suicide victims and create a database and count up how many had antidepressants in their bloodstream and how many did not. The answers are obtainable, but some would prefer a debate to divert the collection of evidence. Suicide is murder of one’s self, by law it use to be investigated the same as a murder, evidence was collected. Along the way, the rules got bent, it’s time we bend them back.
Nathan
Morgan,
Thanks for a well thought out responce. I’m not advocating that we don’t investigate. I’m not saying that the drugs don’t cause bad effects. I’ll state the same thing that I’ve stated in previous conversation on this website: Drugs are approved based on the cold, hard data of a clinical trial. Drugs should be investigated and pulled from the market based on the same standard. We shouldn’t pull a drug from the market based on a bunch of stories collected at “ssristories.com”. Do the trial. Get the evidence. Show me the research.
Nathan
Morgan,
Incedently, you guessed correctly. I do work at a pharmaceutical company. It’s not a big conspiracy. We’re a bunch of scientists and buisnesspeople who work hard and try to make a living by getting safe and effective drugs to the market. It’s a hard buisness and lately it’s a thankless buisness. No one out there is praising pharmaceutical researchers for prolonging lives, keeping people out of hospitals, and keeping diseases at bay. Instead the average American thinks that employees of pharmaceutical companies are part of a big moneymaking conspiracy pedeling dangerous chemicals for outrageous prices.
Bob
I knew Crackpot, I mean Lisa, would have about 10 posts in here.
Glad to see you don’t disappoint.
Laurie
What scientific evidence would it take to prove a causal role? I’m being serious. We have drugs that are deemed effective based on what the patient reports. Why wouldn’t that same standard of evaluating efficacy apply to evaluating adverse reactions?
It goes back to the same rhetoric that we’ve heard for years now. Positive effect is directly related to the drugs efficacy…negative reactions are dismissed as anecdotal. Why is there such a different standard of evaluation when the data collection source is the same? Just because no one is collecting the negative data, doesn’t mean that it doesn’t exist.
Janet
Nathan,
Part of the problem is that you can have hundreds or thousands of good, honest employees at a pharmaceutical company, but at the end of the day, if senior management/marketing/sales reps minimize risks or otherwise act unethically, then it reflects negatively on all employees as well as impacts patient safety. A relatively few people can have a tremendous impact, and can negate the best intentions of many.
Donna
Bob,
i’m disappointed i thought crackpot was my pet name…
Donna
Nathan,
we know that these med’s benefit some taker’s, but harm alot, that’s the only point trying to stress…
sheila matthews
Nathan, Good for you coming out of the closet like that on your job with the pharmaceutical companies. There are some life saving drugs out there, but antidepressants, and SSRIs are just not them. Most Americans understand that the pharmaceutical companies are very powerful. Mixing good in with bad doesn’t dilute the bad. Honest, ethical behavior changes bad to good. I don’t see that happening here. I see the pharmaceutical companies still peddling the bad stuff and lying and cheating. But I also see the pharmaceutical companies saving lives for sure. But it doesn’t make it right to hide, lie, or cheat. So until, they come clean, start acting ethical on all fronts, they deserve the backlash they are receiving for not informing the public of the suicides their drugs are inducing. As a family member I wished that my sister and brother-in-law had the information on the suicidal side effects prior to treatment, he just might be alive today, but no he was told nothing of the suicidal side effects, why because just maybe they would have just say NO,- I don’t want to take that chance, what else do you have Doctor? He wasn’t given that chance. Great Public Announcement and Great Job CCHR!
Lisa Van S
Nathan,
Decrease in Youth Suicide due to Black Box
http://www.examiner.com/a-998062~state_officials_say_children_s_health_improving.html
Coroner- Many who die are taking Antidepressants
http://www.courierpress.com/news/2007/sep/28/lifesavers-walk-targets-suicides/
And Look Here,No Efficacy….
SSRIS Lower response rate for African Americans,..Latinos
http://www.sciencedaily.com/releases/2007/11/071113100326.htm
Lisa Van S
Nathan,
I have posted links, But unfortunately, Ed at Pharmalot has not released them from moderation. Wyeth, in Aug. 2003 instructed Healthcare providers, “NOT” to prescribe Effexor to children due to Suicide/Hostility, As we all know, Hostility in the context of a clinical trial “means” Homicide.GSK also sent out a Healthcare provider letter telling physicians not to prescribe Paxil to those under 18. You know why…Increased risk of Suicide/Hostility…..And “No Efficacy. Hmmm,…Imagine that.
James
Lisa, do you even read the stories you post? Your own links give further evidence of the outlandish and inaccurate nature of your claims.
From the Courier Press article:
Locally, the coroner’s office is finding many who die by suicide are taking antidepressant medication but are not undergoing counseling. Groves said a combination of medication and therapy is most effective.
The article in no way states that SSRIs cause suicide. Rather, people who are depressed commit suicide (big shock there). But taking drugs is not the only solution.
From the Examiner article:
The health secretary said a decrease in prescribing antidepressant drugs for children, which have been associated with suicide, may be contributing to the decline.
A health official, based upon their personal evaluations, says that something *may* be *contributing* to the decline.
Not exactly academic, peer-reviewed research, is it?
From the Science Daily article:
“African Americans who suffer from depression had a much lower success rate with medication than whites, and Latinos did somewhat more poorly in response to medication,” Dr. Lesser said. “We found that these two groups tended to be more disadvantaged socioeconomically, had more medical problems, less education and higher unemployment rates. As a result, they may need more treatment, including talk therapy, to overcome their depression.”
In other words, they are depressed because there are things in their life depressing them. Reduced efficacy is a result of them not getting a combination of drugs and therapy, NOT because the SSRIs are not effective.
Thanks for helping to prove my point, Lisa. Keep at it.
Lisa Van S
James,
Spin,..Spin,..Spin,.. Nice Try.
Lisa Van S
James,
If antidepressants are so efficacious you “wouldn’t” need therapy, right.
Reality
Laurie,
I’d say the biggest hurdle to studying safety issues prospectively–for any drug–is that you need a huge sample size to counterbalance the relatively low rate of events in order to have enough events to adequately power the study. Just to give you an idea, the studies specifically designed to compare gastrointestinal event rates with coxibs vs. NSAIDs, which have event rates of approximately 0.5% to 1.5%, enrolled 8000-13,000 patients, whereas the Phase III efficacy studies probably enrolled 1000 patients at most. Looking at the statin and COX-2 studies that evaluate cardiovascular and mortality outcomes, and you’re looking at anywhere from 10,000 to 30,000 patients and may take 5 years to complete.
For a similar study in suicides with SSRIs, which occur at about a much lower rate of 0.15% (from what I can tell), and 0.1% with placebo, you’re looking at a huge, enormously expensive, and lengthy trial.
And, for better or worse, there’s little incentive for a company to undertake such a trial when it’s probably a no-win situation. They have very little to gain and everything to lose unless forced to undertake conduct them in order to keep their drug on the market.
Nathan
Lisa,
If cholesterol lowering drugs are truely effective, I can eat 3 meals at day at McDonalds and skip out on the gym, right? Woopee!
Drugs are part of a physicians toolkit. We aren’t claiming that an SSRI “cures” depression. It is one (of many) tools to help TREAT depression.
James, thanks for saving me some typing. I agree completely. Those three articles were a rather funny way of trying to make a point… Lisa, if you are so passionate about SSRI’s being dangerous, surely you have better evidence than this to support your beliefs?
Lisa Van S
Nathan,
If GSK and Wyeth send out approximately 450,000 Dear Dr. Letters saying, do not prescribe our drug to anyone under 18 due to increased risk of Suicide/Hostility,and then state there is no Efficacy. Would you ignore the letters and prescribe the drug anyway? And do you believe that a Dr. doesnt have to tell the Parent.
Industry Warning Letters trump any Study you can muster up.
Nathan
Lisa,
In the below NBCnews link you’ll find that the FDA panel that voted on the “black box” warning for antidepressants largely to simply set a higher bar for prescriptions to children. They did not say that the antidepressants were ineffective. The NBC news article below points out that “the 2 percent to 3 percent increased risk of suicidal thoughts that alarmed the panel was overshadowed by the 15 percent risk of suicides by children with untreated depression.”
http://www.msnbc.msn.com/id/5989348/
If you want a truly reputable article that supports your beliefs, try this one:
http://content.nejm.org/cgi/content/full/351/16/1595
It’s an article by one of the FDA advisory board members. However, note that the FDA advisory panel explicitly recommends “that the products not be contraindicated in this country because the Committees thought access to these therapies was important for those who could benefit “
Lisa Van S
Nathan,
I attended both FDA and Congressional Hearings regarding Antidepressants in Children.
Wyeth’s, Dr. Camardo, testified under oath, before the Energy and Commerce-Subcommittee on Oversight and Investigations, that Effexor increases Suicide/Hostility and lacks Efficacy, Are you trying to imply that maybe Wyeth’s Represenative lied under Oath. Hmmm
GSK’s Represenative admitted that Paxil has no Efficacy and increses suicide in children under 18. Did he lie under oath also.
May I suggest you read the FDA and Congressional testimony !!!
Lisa Van S
Nathan & James,
Here are quite a few GSK Paxil Docs,..should keep you both busy for awhile..
http://www.healthyskepticism.org/documents/paxilstudy329.php
Bob
We could run a study on watching someone (Lisa Van Crackpot) spiral into a delusional mess.
Laurie
“And, for better or worse, there’s little incentive for a company to undertake such a trial when it’s probably a no-win situation. They have very little to gain and everything to lose unless forced to undertake conduct them in order to keep their drug on the market.”
This is the controversy in a nutshell. There is no incentive to do a full comprehensive clinical trial on suicidality and homicidality. But lack on a clinical trial does not mean that the adverse effect doesn’t exist. The initial small increase seen in suicidality in the widely reported clinical trial was a VERY short term trial(12 weeks, if I’m not mistaken). The signal was there, even in that limited, short term use.
Now take patients that are on these drugs for 10-12 years. I know for a fact that suicidality and homicidality are widely reported by long term users, from first hand reports by ssri users. Most have that symptom denied by their prescribing physician and once doubted they rarely return to that physician.Most resort to GP’s who are willing to continue to prescribe without questions, and weaning ensues. So these are reports that are never documented. They ARE documented in the ADR reporting system, which is also ignored.
I’m sure we will never see a long term effect clinical trial, and with that knowledge the causality will never be proven. So you can now see why the “causality has never been proven” truly means nothing in light of the firsthand experience of ssri users.
Sadly, that low rate of occurance(which is for short term users only) when applied to the overall number of ssri users becomes alot of people being effected directly, and add in those indirectly effected and it’s a catastrophe.
I appreciate your reply, and I do believe you do understand the frustration on my part.
On a daily basis I have people asking me “Why didn’t my doctor tell me this could happen?”. And there begins the anger.
sheila matthews
In all due respect, Nathan you are incorrect about why the black box warning was issued. I was at that hearing before the FDA advisory panel so were hundreds of victims families from drug induced suicide via antidepressants and SSRIs. Again, let’s not pin one against each other, let’s look at the evidence at the blood at time of death. If the person was taking antidepressants and killed themselves, the treatment is a failure. One cannot spin that data. The personal attacks on Lisa are below your intelligence. I know few mothers who would dedicate their time to warn other moms and dads of the deadly side effects of antidepressants. Are you to say that no children or adults have died as a result of these drugs? You cannot dismiss the pictures of these children that the parents held up in front of the panel. Even the drug companies asked one ablechild.org member, did that parent fill out a medwatch report on behalf of their child. If we start to work together to give proper informed consent and the right to refuse psychiatric drug treatment, people can either decide to use the drugs or not. Right now just look at the laws we have on the books of forced psychiatric treatment of foster care children, and those mandated by courts to psychiatric drug treatment to stand trial. I would be happy to provide the public act numbers. Have a honest debate, don’t trash talk. Wiping away a human life should not be such an easy task. Again, let’s look at the evidence.
Lisa Van S
Nathan & James,
Here you can pull down the Effexor and Paxil– Dear Healthcare provider Letters. Id like to know your reasoning,as to why tou believe Dr.s shouldnt tell Parents. We also have some Pfizer Docs thrown in for good measure.
Let me know what you:
http://www.paxilprogress.org/forums/showthread.php?420527#post420527
Lisa Van S
Bob,
You are a Perfect example of the Industry’s Mentality, And as a Christian, I have to believe that some in the Idustry cringe everytime you open mouth…..
Lisa Van S
CORRECTION:
http://www.paxilprogress.org/forums/showthread.php?p=420527#post420527
Hopefully the third time is the charm
Reality
Laurie,
Let me just say that it is not my intent or desire to discuss the association — I’ll leave that to other people — but to continue to address the trial conundrum.
You’re right that the incentive is part is a problem, some of which is an ethical/moral issue, some of which is a feasibility and practical issue. As you can imagine, a trial of this size is a beast to coordinate, and might take several years before you enroll a single patient. Not to mention additional staff needed, etc. AND, I would guess that given the seriousness of the issue and the skepticisim not just of pharma, but of psych pharma in particular, they would need to have the result independently verified by a 3rd party statistical firm which is another huge expense and time drain. You could easily be looking at $100 million trial.
Add to that, a lot of these meds are generic at this point, making the incentive that much less.
Mind you, I’m not saying they’re justified or not, or that it’s not worth pursuing, just that the logistics are not mere speed bumps–they’re mountains.
Also in addition to what I said about the no-win situation, part of that also is that for some critics, nothing will ever satisfy them, no matter who designs and conducts the study or verifies the results, if they come out in favor of the drugs, they still won’t believe them.
Sometimes with things like these, companies will say to the regulatory authorities or national agencies (e.g., NIH, NHLBI, et al), “hey, if you want this answer so bad Iand want it to be independent), do it yourself. Here’s the drugs and placebos for free–have a ball.”
At least as a consolation, several folks have made due with the next best thing — pooled studies, case-control studies, and meta-analyses, which have been a mixed bag at best, leaving people on both sides somewhat dissatisfied.
Lisa Van S
Reality,
Arent placebo controlled studies used to determine whether or not a drug receives FDA approval,and if all the studies you have mentioned above are ok in assesing safety and efficacy, than why havent antidepressants(Prozac excluded) been FDA approved for the use in children w/MDD?
See GSK Healthcare Provider:
http://www.healthyskepticism.org/documents/documents/2004dearhcp.pdf
Dont’t Parents deserve the truth? Do we not deserve to know that antidepressants lack safety and Efficacy? Children are, our most precious gifts from God.Dont you think its time to stop playing Russian Roulette with our Children’s lives?
Libby, Brent, Gibbons, are well aware these letters exist and yet they leave this vital information out of their studies. The Question Remains, Why?
Laurie
With the obvious roadblocks to a large, independent clinical trial, do we just ignore the potential risks that are out there? This is all I want to see. Full disclosure of risks as we know it to be today. The black box warning and the lack of clinical trial should be known to any parent who is deciding on giving their child one of these drugs.
With no definitive trial do we just ignore the risks that are documented in story after story?
No, we make parents aware of the potential risk so, at the minimum, they know what to look for in their child taking one of these drugs.
We don’t spin the potential risk as “Causality hasn’t been proven”. The risk should be presented and acknowledged by the user or users parent in an open discussion with their doctor. Proving causality without that huge, expensive, independent trial is impossible, so the focus should be on education regarding the potential downsides. One of the big things we read here on pharmalot is “every drug has risks”…so why are the ssri’s the group that have been chosen as that one group that the risks shouldn’t be relayed to the patient? Are those who are depressed/anxious singled out to be left in the dark?
That is my concern.
jason
Nathan, James, Bob, Reality,
Don’t know how you do it. Gave this up for a couple of weeks, checked back to see if anything changed. I gave up pounding my head against a wall, feel much better. The air is cleaner, the birds sound better. The truth is there will always be naysayer in anything. We just have to go on and do our jobs becuase people actually count on us. If pharma/medicine were as worthless as the posters here contend I would have been out of a job years ago. But it seems like I see more people, not less. Don’t let the vocal minority get to you — I am glad I broke the cycle and got away and I prescribe that you do the same and let those have this site to themselves. Many other sites out there without an antimedicine slant.
Just BTW to those wanting parents to have full consent — If you have a child you take in for medical treatment of a psych problem — If you aren’t watching for suspicious behavior including potential suicide you should be charged with child endangerment/neglect. In many cases I would blame environment/parenting over potential drugs — but then again it is a little easier to blame a big anon company then take a good look in the mirror. Until we hold parents just as culpable as medications we will not have resolution of this problem. Have suicides gone away after the warnings? Let’s take a good look at parenting and environment - if you don’t think there is at least a good reason to look/study it then you aren’t being objective.
James
Laurie,
You make some excellent points. I couldn’t agree with you more on the importance of disclosure on safety and efficacy.
One of the many problems in dealing with anti-depressants, however, is that depression is far more complicated than many diseases out there. With cancer, you do chemo/radiation/surgery, and either the tumor goes away or it doesn’t.
In many cases, depression is tough to diagnose and tough to determine if it is “cured”. It can be treated in some w/ therapy alone, in some w/ drugs alone, in some w/ a combination. Some people feel “better” simply with exercise. Some people get “better” simply when their life situations change. Very complex.
So determining efficacy simply based upon anecdotal events is flawed–there are so many factors that can contribute to an action that a depressed person takes. No reasonable person would say that drugs are a magic bullet that “cures” everyone.
Likewise, no reasonable person should be using as proof of safety and efficacy “well, some kid shot someone, so not only did the drug not cure the kid, the drug CAUSED him to do it!”
Ultimately, I agree with you–parents should be presented with the facts, both in terms of safety and efficacy of drugs, and be told of the importance of therapy, and of making changes in the home if needed, and of making changes in the child’s activities, if needed.
Lisa Van S
Jason and Everyone else,
OK,..Please expalin to me, why a Physician, who has received an Industry Healthcare Provider Letter, stating their drug increases suicide and lacks efficacy, and in Wyeth’s case(who I Applaud) say dont prescibe our drug to children,yet a Dr. does it anyway. Why?
And when an antidepressant causes a child to harm others, shouldnt a Physician then be held responsible because they failed warn.!!!
And Jason,…When a Dr. makes a Misdiagnosis, is that the Parent’s fault.!!
Have any more sermons from the Pulpit!!!!
Nathan
Jason, thanks for the advice. Although I like Ed Silverman’s coverage of the industry, I have noticed a rather “anti-medicine” slant to the articles and especially amoung the readers (commenters). I was hoping to bring a small dose of reality back to the conversation — but, alas, I have better things to do with my time. Maybe I could actually be in the lab trying to make some new drugs rather than convincing people about things that they’ve already made up thier mind about.
Back to work and enough of this nonsense!
Chris
In the past, certain of those Dear Healthcare providers letters were not intended to change behavior, they were intended to shift liability away from the pharm companies and respond to some people who had a safety concern (some internal, some external). I would bet that if you listened to the sales reps and the majority of other communications coming from the company afterwards, that these risks or messages were subsequently downplayed.
Janet
Nathan, James, Bob, Reality, Jason, Todd and others -
I really enjoy your posts and the discussion (even if I do not agree at times), and would hope that the minority who seem to want to constantly pick a fight will not stop you from participating. I think there is some validity to what both/all sides are saying.
Lisa Van S
Chris,
I agree with you 100% “Communications”–Id like to refer to them as “Apologists”. An Industry Rep. told one of my State Senators that I had bashed them during a May Hearing on Parental Informed Consent.(I used their documents).I defend myself by sharing, Bob’s, Industry Perception of NJ Moms. “Bob’s comments”, have raised a few eyebrows.
Chris
It made me nervous just now to see Lisa agreeing with a post by Chris ;-) Just to be clear, that poster is a different Chris. I’m the one who is typically more supportive of pharma (or at least a more balanced debate on its merits/demerits). And I type with a British accent.
Lisa Van S
Chris,
I like the sound of a British Accent.
Laurie
I totally agree that depression is complicated and the mechanism behind it is at best unknown. But with that lack of etiology of the “disease” do we blindly attribute changes in behavior that occur only after the introduction of a new drug to that “disease”, or to the drug?
Someone who has had a history of depression for years, who starts an ssri and becomes homicidal….it doesn’t make any sense to blame the “disease” that has been long standing. With any drug reaction you look at the “last drug in” when you have a change in a patient symptoms, except in the case of ssri’s. That change is denied and attributed to the patients “disease”. That’s not right and that is how people who have these types of reactions end up moving through the gamut of psychotropic drugs, when in reality it was probably the initial drug that caused the problem. What is gained by this denial?
There is validity on both “sides”. Some do great on ssri’s and have made the decision to take them and that’s their decision. I would be naive to think that these drugs are going anywhere.
What I am seeking is full disclosure of the good and the bad, and acknowledgment that there is a potential downside for some who take these drugs.
Lisa Van S
In case anyone has trouble accessing Wyeth’s Effexor Letter from Paxil Progress.
http://www.effexorxr.com/pdf/wyeth_hcp.pdf
Reality
Laurie,
One of thing I’ve found odd that we’ve known about the suicide issue since at least the early ’90s. At that time, the theory was not that the SSRIs caused suicidality per se, but that with SSRI treatment, the negative symptoms (e.g., motivation, malaise, interest, etc.) were relieved earlier, and patients ended up having the energy and wherewithal to act on any suicidal ideation. And docs were to keep a close watch on their patients when initiating therapy because of this.
Perhaps the theory has changed since then, but it certainly made sense and I think still makes sense.
Ed Silverman
Dear Nathan and Jason,
Gents, just to be clear, I work hard not to infuse my posts with any particular slant. For instance, I take meds and so does my family. In fact, I have friends and family in the biz. I post what I do to engender discussion and debate, and because some topics are controversial.
At the end of the day, I consider myself to be a journalist, and advocate for more insight and information. I would offer that, if one looks at the spectrum of posts and topics covered of late, you may find that the material is all over the map.
Ironically, I’m accused by others of being pro-industry. This has happened twice in the past week.
I do my best, and only offer my own opinion, or comments, when I feel qualified to do so, or have a particular insight. That said, if I make mistakes, I will correct them. And if I miss something, I want to know. I hope you’ll continue to drop by.
Regards,
ed at Pharmalot
Ken Thomas, RN
At this point, I just laugh at anyone trying to defend SSRIs an non-dangerous or effective. This fraud has been debunked thoroughly for anyone who understands the research data. I refer anyone to read “America Fooled” by Dr. Timothy Scott, Professor of Psychology http://www.americafooled.com The Biological Psychiatry Fraud and it’s financial funnel source Pharma will be brought eventually to a more ethical level. I know of many attorneys readying to ponce.
Atlex
Ed,
Like Nathan, I believe that your blog does have a minor anti-industry bias. However, I consider this “nature of the beast.” Unfortunately, the negative is far more newsworthy than the positive. Ten thousand reps doing their job in an ethical manner is not news; but 1 caught delivering off-label information is. Moreover, as a journalist your job is to be skeptical; that naturally leads you to question the motives behind industry activities, even when the motives are in the right.
I think that those of us whose interests lie with the industry get more frustrated that the responses inevitably devolve into rants against the industry rather than informed dialog. That’s not your fault, but I think our view of your blog gets clouded by the constant industry bashing carried on by some of your regular responders.
Atlex
Janet
Are you perhaps (mis?)interpreting criticisms of certain practices as criticisms of the industry as a whole?
Ed Silverman
Hi Atlex,
Thanks for the note. You’re right. I try to be skeptical. I was trained that way and, to be honest, it’s in my nature, although not about every single thing.
And I really don’t have a bias. I live in an area - suburban NJ - that would suffer economically if a couple of big drugmakers went down the tubes. My housing value would drop and taxes could rise. Friends may be out of work, causing my son’s playmates to move. A couple of well-like relatives could get caught up in all that, too.
Meanwhile, I’d still have to take my two meds each day (when I’m in compliance) for a couple of chronic conditions, and that’s besides the other scrips I fill for the kids at the pharmacy. Speaking of which, one of my grandfathers was a pharmacist who always spoke highly of his sales rep friend at Merck, Sharp & Dohme (the old days).
So I really can see both sides - so to speak - of the safety debate, or any other debate involving pharma. And as debates go, I think some of the ‘rants’ others complain about generally occur in response to posts about certain topics. The recent give-and-take over the notion of prizes instead of patents drew a very different kind of dialogue, although at times, it was just as vociferous.
But this is an open site and people are free to stop by and comment, or not comment, as they see fit. I would like to think that some comments, however one views them, wouldn’t detract from the purpose and usefulness of the site. And if my posts - right or wrong, pithy or full of typos - were simply full of gee-whiz cheerleading that never questioned anything or pointed out issues or inconsistences, I venture it wouldn’t be viewed as terribly useful.
The idea here is to provide info and encourage discussion. This has been, for several years, a controversial industry undergoing tremendous change and challenge. I may miss the mark sometimes, but my general approach is to track the various strands that tell the story. There is no effort to take sides, such as they are. I know I can’t please everyone all the time - hence, the strange experience of being called pro-pharma and anti-industry more than once in the same week by various people - but my hope is to create enough space for competing views to get hashed out.
I don’t know if this matters to anyone, but it’s the Pharmalot philosophy, for what it’s worth.
Best
ed at Pharmalot
Lisa Van S
Atlex,
I’d like to add to what to what Ed has said. My Mother has cardiovascular and thyroid disease and takes medication. A recent stroke left her with a seizure disorder and takes antiseizure medication. The med has made her at times, different, but in her case the benefits outweigh the risks.(If Reality recalls I have asked questions). My mother needs her Meds to survive.Late this summer, my mother, inspite of having a stroke earlier in the year, danced at her Granddaughter’s Wedding.
My sister, whose son is a Marine, who recently returned from Iraq took anti anxiety and sleep medication to get her through the long days of worrying about her son.She was aware of the risks, this allowed vigilant monitoring to occur.
I personally have taken at times powerful antibiotics to treat my Lyme Disease. Ketek was a drug I had declined to take, why, because of a whistleblower who did the right thing by exposing the truth.Liver failure was a risk I wasnt willing to take.
With all that said,….We are adults who need medication. Powerful psychotrpic drugs are being prescribed to Infants and Toddlers at an alarming rates, why? Off-label Prescribing,..Greed. These drugs are not safe in the pediatric population.
Reality
I would say that it’s not so much that Pharmalot or Ed is antipharma so much as the majority of stories focus on negative aspects of pharma. And those that do describe positive aspects of pharma tend to be followed by a big “BUT”. But it’s Ed’s blog and his prerogative.
That said, in personal communications with Ed, I believe he really doesn’t have a bias, just some unrealistic expectations of pharma. ;-)
Ed Silverman
Hi Reality,
Some posts do, some don’t have that ‘comma, but….’ synrdome. Last week at this time, I was immersed in Vioxx coverage and there was nothing particularly negative about the posts, and there were four of them - the straight news about the deal; the payout terms; the piece saying a big winner is Merck’s Ken Frazier, and a Q&A with a law professor pointing out the details, including ethical issues for plaintiffs’ lawyers.
There are other examples, believe it or not; I’ve been doing this nearly a year now. But I can’t take the time now to delve into the archives - I’m still working and there’s more to do. My week isn’t over.
As for being unrealistic, well, I hope not too unrealistic. I’ve written before that I think improvement is a worthy goal. Maybe the bar is set too high, at times. But that’s not out of some bias or negative slant. We’ll never live in a perfect pharma world, I know, but I don’t think it’s a bad thing to push for change.
I hope this helps.
All best,
ed at Pharmalot
Laurie
“Perhaps the theory has changed since then, but it certainly made sense and I think still makes sense.”
It only makes sense if the suicidality only occurs with those prescribed these drugs for depression. That is not the case. Suicides have happened across the diagnosis spectrum. Anxiety, migraines, school phobia, IBS, abdominal pain etc…… have all had suicidal reactions.
AND if that theory is true…then why are patients handed a prescription and not warned of that potential reaction? It all comes down to the passage of information from practitioner to patient, regardless of your beliefs related to the cause.
Want me to tackle the diabetes/insulin argument? :)
Look, I have given more drugs that probably everyone on this site. Most drugs are saving lives, no one can or would deny that. But just because some drugs save lives, doesn’t mean that there aren’t going to be some problems with some. Identifying and warning about those reactions is part of ethical medicine.
AA
1.http://www.commondreams.org/headlines03/1208-02.htm
“Glaxo Chief: Our Drugs Do Not Work on Most Patients”
AA
http://tinyurl.com/2f48cg
The Treatment for Adolescents With Depression Study (TADS)
Intention-to-treat analyses on the Children’s Depression Rating Scale–Revised identified a significant time x treatment interaction (P
AA
Hi,
The 2nd email went through before I was finished. Here is the relevant information:
“Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%).”
Lisa Van S
Reality,
Laurie makes an excellent point.
Lisa Van S
Omaha Mall Shooter was on Zoloft and Ritalin since the tender age of 5. His first Psychiatric Hospitalization,..age 6. Maybe, Individuals should refrain from making statements like, the earlier the treatment, the better the outcome.
Atlex
Lisa,
As usual, you only mention part of the story. One news report quoted tjhe shooter’s mother as saying that he was on Zoloft a dozen years ago. Other news reports said that the shooter left treatment some time ago. Thus, maybe the treatment he was receiving before he stopped was actually preventing him from some horrific act. I wonder, maybe he was taken off treatment becuase his doctor was concerned about the black box warning. (Please note that may last sentence is meant to be sardonic. I actually don’t believe that anyone took him off treatment, butthat he left on his own and fell through the cracks of “the system.”)
Atlex
Lisa Van S
Good Morning, Atlex
This young man was hospitalized in 2005-06, and a friend, stated live on CNN that he had been on an antidepressant for the last two months. With that said, I agree with you, the system failed. Do I place some blame on his parents,..absolutely.. What kind of Mother would give her child up to the system.
And, as I said last night, the special interest groups should refrain from saying the earlier the treatment, the better the outcome. And they have to stop giving abusive parents a free ride, by stating that Parents arent to blame for their child’s psychological problems.
Merry Christmas, Happy Holidays to you, and your family.