Yes, it appears the makers of Paxil may have been a bit disingenuous in their publication of the risks of suicide associated with their medication back in the early 1990s. The U.S. Senate has made available an in-depth report (4 MB PDF) written by Joseph Glenmullen, a Harvard psychiatry professor, who examined the drug company’s data on Paxil. There apparently were some serious discrepancies in the original researchers’ data analysis.
One of those discrepancies was a pretty big one — that Paxil resulted in a suicide rate 8 times greater than a sugar pill. That’s a huge, major difference.
The researchers were clever in their cover-up. They included 2 people who apparently committed suicide before the study even began and attributed their suicides to the placebo control group. Nobody, of course, would’ve ever discovered this creative data interpretation if it weren’t for a lawsuit filed against GlaxoSmithKline (the makers of Paxil) in California.
There isn’t much dispute about whether the original researchers’ data analysis was proper in any form, manner or universe — it wasn’t. It was a crass manipulation of the data in order to gain market approval for the drug (which was later accepted by the FDA as a part of the drug’s safety and efficacy new drug application).
The report also noted that suicides during these kinds of research trials should be fairly rare anyways, because the researchers specifically stack the cards:
During the wash-out period [a period of 1 to 2 weeks before the study begins where subjects are removed from all existing medications], all patients are given daily placebo pills. Hence, another name for this pre-study period is the “placebo wash-out phase.” Patients whose depressions quickly improve during this time are labeled “placebo responders” and excluded from the actual study. Administering a placebo during the wash-out phase is also a technique used by pharmaceutical companies to wee out patients who would respond quickly to a placebo in the official study. This weakens the performance of the placebo by removing quick placebo responders, thereby making the performance of the antidepressants look better.
Pharmaceutical companies use this technique because the placebo effect accounts for such a high percentage of an antidepressant’s effect. According to the FDA, the placebo effect accounts for about 80% of the effect of antidepressants. […] If the pharmaceutical companies did not use the placebo wash-out procedure, the difference between placebo and antidepressants would be even smaller. Thus, the placebo wash-out phase accomplishes two tasks: washing out patients’ old drugs and weeding out placebo responders.
In other words, some pharmaceutical companies go to great lengths to “stack the deck” to ensure that when the study begins, they get the best results possible.
Keep in mind, too, that anyone who is seriously suicidal or depressed is actually excluded from participating in these kinds of studies. This only reinforces the importance of these findings — these are people who were not actively or seriously suicidal before taking Paxil.
Many psychiatrists and doctors consider Paxil a good “go-to” antidepressant for folks with depression and a little anxiety. It tends to be more calming than some other SSRI antidepressants, and therefore was very widely prescribed in the 1990s and even now. Undoubtedly such prescriptions have helped millions of Americans over the past two decades in grappling with their depression.
But it likely has also caused more harm than doctors or patients were aware of, because of these kinds of data manipulations that understated the risk of suicide.
I sincerely hope pharmaceutical companies are learning from these mistakes — all research data will eventually become public knowledge. So ensure you don’t cut any corners to get your drug approval, or else the chickens will come home to roost one day.
13 comments
The drug companies will never learn from their mistakes as long as their profits increase. It’s horrible, but unfortunately it’s probably a problem that will only get worse.
Although I am not a fan of medication individuals unless it is a necessity to do so, I am also aware of the risks that psychotropic medications can do to people. Because medications of all kinds run a risk of side effects that are unintended as a result of medicating people, and also the risk of suicides as a possible risk, I beleive that the FDA should heavily regulate the different medications to insure the public of the risks even though there are riskson the label. In response to you blog, I personally feel that there should be more governmental actions in regards to the cover up regarding Paxil and other meds. In the past, there have been research trials led by the leading pharmacitical companies for other psychotropic medications and its effects to teens and children which have proven that some drugs do cause suicidal risks among the youth, however are deemed safe for adults. I think that these drug companies do try to make a profit at the expense of the people.
In treating mental illness, I do believe in encompassing holistic medicine which can be benificial to the patients which is good. For example,if yoga can calm someone with ADHD, we should incoperate it in therapy.
Another one.
I recall at least three regular posters on a single forum on “the other board” posting about Paxil and suicidal thoughts, one to the point of planning how, where and when TWICE. Both times she was hospitalized. She called someone (thank you, posters, who stayed on the board and on the phone with her all evening and night) after she wrote that she was terrified because she was feeling compelled to hurt her children. I don’t know where she found the strength and ability to reason in the chaos of her mind, but she loved her kids so much. Her doctor kept her on Paxil and upped the dose.
When they were taken off the drug, despite having it withdrawn slowly, they went through the fires of hell to get off it.
One time in my entire life I wanted to report a serious response to a drug (suicidal thoughts that progressed to the red zone before I called my doctor and told him I had stopped the med on my own). I located the FDA’s Internet feedback system. The FDA wanted to know enough about me over the Internet, me personally, including name, address and phone, that the first time I capitulated and never hit “send.”
They give people a little check box at the end, after they’ve filled out page after page after page, if they don’t want to have information (personal, too) sent to the drug company. Not a choice if they DO want their information sent on, but if they don’t. Otherwise it’s automatically sent to the drug company.
Geeez, I didn’t even want the FDA to know that much about me. I found the little box because I read everything, including the small print. Why would they even do that to begin with, give the drug companies an opportunity to craft responses and manipulate information before the FDA even asks questions?
A month later, after similar stories about others kept coming, my conscience won and I submitted the information.
I thought, if it’s this intimidating for a patient to report anecdotal information, I can finally understand why so few doctors will report an “adverse event” (love that term).
But doctors talk to each other and post on private boards. They know what others are seeing in their patients. They warn their colleagues about side effects, the ones they not reporting to the FDA. And still doctors keep ordering. Where does their responsibility for irresponsibility come in?
This whole mess is sickening.
When I first tried to wean off Paxil (under the care of a well-renowned psychiatrist) I had the first and only suicidal thoughts I’ve ever had. Whenever I would drive, I couldn’t stop thinking about running my car into other moving vehicles, and then I’d get home and cry hysterically because something was so wrong with me and I didn’t know what. It was the scariest thing I’ve ever gone through, and it would have helped knowing that weaning of Paxil is a daunting and physically painful task, as a rule, not an “uncommon side effect.”
For anyone who wants to wean off this drug (and i stress the word “wean” because going cold turkey is harder than coming off heroin, or so says my doctor) I strongly suggest talking to your doctor about taking the liquid form of the drug, and weaning off in small increments. I think my schedule was 1mL at a time over the course of 3 or 4 months.
I’m finally off it (and on Prozac, which is the next task) and better off for doing so.
It sickens me when I think of the now thousands and thousands of people whose lives have been destroyed since these drugs came out. No responsibility, no accountability and no help for the casualties. The only way most of us have stayed alive is because of the internet and the incredible support forums here. Sadly, there are many who never got that far and now they’re dead. How many dead bodies and ruined lives does it take over how many years? What is an acceptable amount of “collateral damage” for the few that benefit and get off the drugs without a problem — from what I hear that’s 30% — before something is done?
That’s not all they are covering up. I would like to tell everyone about my experience with taking Paxil. I am doing this so that you may make an informed decision should you decide to take this drug. I was not given that option because certain side effects, though known, have not been disclosed to the FDA, physicians, or consumers.
I was prescribed Paxil by my doctor during an especially stressful time in my life. I had no history of mental illness nor was I diagnosed with an anxiety disorder. I took this medicine, actually a very low dose, from 2001 – 2005. When I decided to stop taking it, I cut my dose back gradually and weaned myself off of it entirely.
I began having gastric distress. This began as I was cutting back on the Paxil and continued long after I quit taking it. I had diarrhea every day for 2-1/2 years. Just about everything I ate went right through me. This lasted all day long, every day. From my research, I have since learned that most of the serotonin in your body is located in your intestines, so it makes sense that if you take something that adjusts that serotonin level, then your intestines would be affected.
I will try to tell you how this has changed my life. It affects everything that I do, from what kind of job I have, where I go, vacations, where and what I can eat. I have had many tests run by specialists and there is no other cause for the diarrhea. I can also tell you that there have been some very embarrassing moments because of this.
About 2 months ago, as an experiment, I started taking the Paxil again. And guess what? The diarrhea stopped almost immediately. I found a blog called Paxil Progress, which is a blog for people who are trying to wean off of Paxil and it seems that my story is not unique at all. This drug causes bowel incontinence, bloating, horrible gas and pain along with the chronic diarrhea.
I wish I had known what this drug would do to me before I started taking it. Please do your homework. The doctors will not tell you about the side effects and withdrawal symptoms, nor will GlaxoSmithKline, the makers of Paxil. Can you guess why they don’t tell you? $$$$$$$$$$$$$$
I took Paxil for years and thank god I was never suicidal. I do suffer from chronic pain from osteoarthritis, referred pain, emotionally-related myofascial pain and atypical sciatica, on a daily basis and before my doctor put me on Lyrica which reduces my pain considerably, I used to think to myself and told my partner and sister that sometimes I want to go to sleep and not wake up. I’m taking another anti-depressant, Cipralex, which is help for depression, anxiety and OCD. It’s a great medication and I’ve been on multiple anti-depressants since the early ’80’s.
I’m aware that a lot goes on behind the scenes of the marketing of a drug before it’s shopped to doctors. The drug companies and their ad agencies do a fine job by themselves, advertising in the print media and on t.v.
I stopped Paxil simply because it wasn’t helping me with depression nor reactive (health) depression. Sometimes, when one is desperate, you’re willing to try almost anything, however, each medication I discuss taking with my doctor, I research online.
Help how do I go off Paxil I have tried weaning and it is awful help me please. I am on it for Panic Attacks but I want to go off it and Can’t I have tried 5 times I am down to 10 ML and when I quit I freak out my Head spins I think it must be withdrawl symptoms like from Heroin. I don’t know Help is there some place I can check my self into to be supervised to go off it.
My father placed a shotgun in his mouth 4days ago.I buried him today. He had never been suicidal but started taking paxil a week earlier because the doctor thought he looked alittle depressed. It has changed my life forever
One of my staff, a beautiful intelligent nurse and mother of two teenagers shot herself in the head. This was about two weeks ago and I am a physician who believes that he has the training and experience to pick up on suicidal tendencies. She exhibited none of that but only a withdrawing and contracted type of personality which was not her-She was always bubbly and happy but had been experiencing some marital problems. It was only after the funeral to be learned that she was on Paxil from another physician. How can a physician, even with the blackbox warning, pick up on one of his many patients suicidal ideations when I and the other staff, working closely with her every day, did not see this coming? She put a gun to her head was already dressed for work that morning. Two teenagers lives are permanently marred by this drug…a lifetime of holding guilt that they were somehow a cause.