January 17, 2008

Pharma Companies Hid Anti-Depressant Data

An important study is out today in the New England Journal of Medicine pretty much confirming what many of us have been saying the 'Net for ages, which is that a whole slew of pharma companies hid data about negative results from anti-depressants from the public and doctors going all the way back to 1987. (Update: the full paper is now available on my site here.)

Press coverage of this study here and here, and CL Psych has a lengthy roundup of the news here. Companies could hide data because the FDA does not require that all clinical trials data that a company obtains on a drug be published or made publicly available. Some companies like Eli Lilly do now publish their data on a company website, but they only began the practice in 2004.

By mostly only publishing positive studies of anti-depressants (a few negative studies were published) companies were able to make inflated claims about the effects sizes of their drugs--i.e., how much a drug outperformed placebo. That's nice for them and their shareholders I'm sure, but it made it impossible for doctors and patients to evaluate just how good these drugs were or weren't. Perhaps just as important is that such non-publishing practices worked to coverup data on side effects from the drugs.

From the WSJ:

"A total of 74 studies involving a dozen antidepressants and 12,564 patients were registered with the FDA from 1987 through 2004. The FDA considered 38 of the studies to be positive. All but one of those studies was published, the researchers said.

"The other 36 were found to have negative or questionable results by the FDA. Most of those studies -- 22 out of 36 -- weren't published, the researchers found. Of the 14 that were published, the researchers said at least 11 of those studies mischaracterized the results and presented a negative study as positive."

What drugs were involved, you ask? Prozac, Paxil, Zoloft, Effexor, Cymbalta, Serzone, Remeron, Lexapro, Celexa, and Wellbutrin. In other words, pretty much every anti-depressant approved by the FDA since 1987.

By not publishing negative findings or by misrepresenting them, Zoloft's effects size was overstated by 64 percent and Paxil's was overstated by 40 percent, according to the study.

On a personal level, this practice by Big Pharma and the FDA's complicity in the same really infuriates me. Back in 1993, I was taking Prozac and went to my doctor complaining of agitation. He said there was no data to support such a problem with the drug, so the problem must be mine alone. He upped my dose from 40 mgs. a day to 60 mgs. a day at which point I began acting oddly and had repeated suicidal ideations. I asked my doctor again what was up. He said he'd checked in with Lilly (meaning the sales rep, of course) and was told that there were no similar problems reported with the drug, so it was basically my fault. He upped my dose of Prozac to 80 mgs. and I went utterly manic and lost my job as a result. I know that I am far from the only person who experienced a similar dynamic on Prozac and got similar answers from their docs. Some people ended up dead as a result.

Is it too late for me to go back and sue Lilly's pants off? Probably. Is it too late to hold them accountable? Never.

Posted by Philip Dawdy at January 17, 2008 10:47 AM
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Comments

Glad you're feeling better. The personal experience you describe with your doctor and Prozac is chilling and of course has occurred countless times to others and probably still is happening every single day. Anyone who escapes with their life with this sort of mishandling is damn lucky in my view as you seem to appreciate.

Posted by: Sara at January 17, 2008 11:23 AM

And why is it that the doctors don't get it? Even if, for argument's sake, a side effect was yours and yours alone, so what?! It's still impacting you! I had a doctor tell me, "oh, that happens to me all the time," when i said on a particular dosage of lexapro i several times was totally unable to type anything other than jibberish no matter how many times i tried. We might be more "responsive" to their "help" if they would just bloody listen.

Posted by: anne at January 17, 2008 12:45 PM

I'd look into (or have your lawyer look into) the statute of limitations for a case like that before you dismiss it.

Posted by: NAP at January 17, 2008 03:55 PM

Your experience on Prozac is so tragic - yet so common. Over 3 million people have been hospitalized [in the last 15 years] due to SSRI mania and this was reported in a study out of Yale University Hospital. This Yale University study is posted on the Index to www.ssristories.com

Your Website is so informative and so well done that I appreciate you telling of your sad story about Prozac because I know many people will read it and be forewarned. It might help some other person who is having problems with Prozac/SSRIs or even help someone who is considering taking one of these drugs.

Yes, we were lied to by the pharmaceutical companies. I hope this is one of many "turning points" in the relationship between the medical community and the pharmaceutical industry.

Posted by: Rosie at January 17, 2008 08:52 PM

Hey Philip,

Amusingly, the MHRA, in the UK, has a means at its disposal of flushing out unreported trials. All trials have to be licensed, and they have to be notified to the regulator, when they finish. There is no requirement to provide data to the regulator of any trial.

Now, given this, the regulator has a record of every trial, which it has licensed, for any given drug (as of at least 2004, when the Medicines for Human Use (Clinical Trials) Regulations came into force). When an application for a marketing authorization (licence) is made, it would be simplicity itself to scan down the list of supporting "positive" trials that have been provided, and compare it to the list of trials that have been conducted. But it doesn't, it told me.

Apathy, incompetence, or corruption? You decide.

Matt

Posted by: Matthew Holford at January 18, 2008 03:15 AM

I had the same thing happen to me with another SSRI and a psychiatrist who thought he was one of the deity's gifts. I am convinced at some level, that psychiatrists know that they damage their patients when these "you can't have such a reaction" events occur, but have long quit giving a damn.

It's a conspiracy of mediocrities and dunces.

Posted by: s at January 18, 2008 08:49 AM

Oh yes the good ol' "THIS drug could NEVER cause THAT symptoms/side effect... it must be YOUR illness. Yes, let's up the dose." response. ... and then you end up in the looney bin and trying to off yourself, with a new and worse off diagnosis.
Yup, I've always apreciated that doctors DON'T LISTEN to thier patients and somehow, for some reason that is beyond my comprehension, approach treating a human being as if they are treating completely alike machines...
Why don't doctors of all people GET that each person has an individual chemistry, metabolism and makeup and that ANY person can have ANY reaction to a medication or treatment. That even if it's not doccumented in thier PDRs and the info that is hand picked and given to them by the pharma reps, That it can STILL happen anyways.
No wonder doctors and the medications and treatments they prescribe are the THIRD LEADING CAUSE OF DEATH IN THIS COUNTRY. How can they be anything else when they are so ARROGANT as to completely disregard what the patient has to say about how they think they are reacting to any medication or treatment?
I think I just went on a tangent about this very same thing the other day over at MoodGarden in response to a general "I hate doctors" post.

IMO if there was any ONE THING that could drasticaly change the outcomes of treatment for patients, it would be doctors learning to LISTEN to us when we say "I think I have gotten worse since starting this medication, maybe there is something else we should try and I should get off this stuff". Instead of shutting us down with thier BS "I am the all knowing genius of the universe and for all I know this reaction never has happened befor and therefor can never happen, so you need to shut up your ignorant self and take more of this drug, and do a good job at stroking my ego in the process....or face my WRATH."
And believe me a doctors wrath can be quite damaging. I was once told there is "no hope for me" (when i was already quite depressed) and that I was "obsessing about my medications" because I refused one medication which I read the PI sheet for, found out it had SSRI/SNRI action as well as antipsychotic action (Geodon), and told the doc that I was still unwilling to take anything that was similar to any of the newer antidepressants due to my having gone insane each and every time I tried them.
I recieved some BS answer about how if we started at the higher dose that the antipsychotic action would cancel out the antidepressant action... to which I replied, "Well then what is the point of using this exact drug anyways, aren't there about 10 other antipsychotics that don't carry that sort of risk for me to try?". And that's when I got the "you're being obsessive" and "well I guess there is no hope for you then" response.

Yes my doctor would rather I leave the office in suicidal despiar thinking there is no hope for me, than to admit that maybe I should have some say in my own treatment, and that yes I had caught him trying to play a dirty little trick on me and trying to get me to essentially try another antidepressant (the AD action is why Geodon makes more people go manic than other APs) even though I had told him countless times befor that Antidepressants don't work for me, they make me go insane and I will NEVER take another one in my life. I guess I hurt his ego when I said "no" and I actually had a medicaly sound reason for doing so... oh and I wasn't being a good patient and going along with the "well if we start at the higher doses this wont be a problem" sneaky line of BS just so my idiot doc could test out his theory that antidepressants really are actually safe for me and that I am just a lair, cause of course I have to be a liar because my experience wasn't one that the literature was admitting is a very common one. ... yes I sure deserved to be told there was no hope left for me, and basicaly faced the silent treatment for the rest of my 50min visit because I had hurt mr.big-dick's ego and so didn't deserve to have him go over the many other treatment options there were for me at the time.
Oh and to top it all off, at the very end of my session, the last five mins or so, the doc starts asking me "well are there any safety issues for you right now?"... basicaly trying to get me to say that I was suicidal etc. and it was a very thinly vieled threat to try and get me committed to the hospital (which i did not need). My reply was "well it doesn't matter because I'll be done and gone from your office befor you have a chance to call the looney bin".

Needless to say I haven't gone back to see this guy and I've found a new doctor who will give me the meds I want, and amazingly they are helping, unlike what Dr.Dick-Head would have liked me to believe THERE IS HOPE FOR ME.

Posted by: katielou82 at January 18, 2008 01:21 PM

Dear Philip,


“He upped my dose from 40 mgs. a day to 60 mgs. a day at which point I began acting oddly and had repeated suicidal ideations…He upped my dose of Prozac to 80 mgs. and I went utterly manic and lost my job as a result.” --- Philip Dawdy


I’m just curious where’s you’re good sense at when your body/mind was telling you something wasn’t right and that you didn’t stop or withdraw but then further allowed the doctor to increase your dosage a second time? Why weren’t you advocating for yourself and making your voice heard with your doctor as you do on this forum?

I read “katielou82” post and bravo to her for recognizing the side-effects and her body/mind response without necessarily lambasting the drugs and also acknowledging that she still utilizes drugs and in her case is aiding her wellness and there is hope.

Boo to her former psychiatrist for not listening carefully to his patient and trying to aspire beyond his medical degree for status as a deity. Boo also to her former physician for ever stating to any patient suffering from a serious mood disorder there is "no hope…”

And “katielou82” in my opinion there is certainly hope for you and others through continuing education, hope and persistence.

It took us some 36 years of numerous treatments and physicians to achieve a relative degree of wellness for my spouse. We only had hope and persistence and my research to not give up and the good fortune to associate with caring physicians who listened to us and helped open doors.

I think it’s wonderful that all these folks advocate for each other on these forums but “katielou82” in my opinion sends an even stronger message to advocate for one’s own wellness in collaboration with a caring physician and to make sure the physician is attentive. If not and in my opinion move on and find a physician that will work hand in hand with a patient.

Warmly,
Herb
VNSdepression.com

Posted by: herb at January 19, 2008 09:31 AM

I am not usually this blunt..
But persoanlly , after being lied to about Paxil for the 4 years i was prescribed it( I am now off it 6 years).. I hope every Psychiatrist who was aware of the SSRI dangers but prescribed them reagrdless rots in a cesspool of crap for eternity.. They deserve no better fate, what they have done is unforgivable..

Posted by: truthman30 at January 30, 2008 09:46 AM

I can't believe how cavalier psychiatrists can be about prescribing new meds and then denying that your symptoms or withdrawal nightmare could be drug-related.

I started on Lexapro and although I did feel better, I gained 30# in a year. I tapered myself off of Lexapro, at what I thought was a slow rate, but ended up with a weird dizzy feeling that stopped only when I lay down.

I switched doctors and the new one believed me when I related my symptoms. He switched me to Prozac which, because of its longer half life, is supposed to be easier to discontinue. I ended up staying on 10 mg of Prozac as it balances out the Wellbutrin I've been on for 8 years. Wellbutrin has been great for me although it is not for everyone. My big concern is staying on it forever. I would love not to have my well-being dependent on a drug. But I've been told that because of my history, it would be too dangerous not to be on meds.

Thank you for your website, which I've just discovered. It's hard being alone in all this.

Posted by: Jayme at February 10, 2008 06:35 PM
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