The antidepressant paroxetine (Paxil) offers at best only a modest advantage over a placebo for the treatment of anxiety as well as depression, according to a new meta-analysis that looked at both published and unpublished clinical trial data.
The study, which appears in the journal PLOS ONE, found that the published data from paroxetine’s manufacturer, GlaxoSmithKline (GSK), overestimates the drug’s effectiveness. For when the company’s unpublished data was included in the meta-analysis, paroxetine provided benefits of only two to three points on common rating scales for depression and anxiety.
That is an underwhelming difference.
“About 80 percent of the effect can be accounted for by the placebo effect,” said lead author Michael Sugarman, a doctoral candidate at Wayne State University, in a phone conversation Thursday with MinnPost. “It’s hard to argue that that’s clinically significant.”
In fact, as Sugarman and his co-authors, who include the noted Harvard University placebo researcher Irving Kirsch, explain in their study, some research has suggested that changes of less than three points on those rating scales should be described as “no improvement.”
This is not the first time a meta-analysis has found that paroxetine offers little benefit over placebo for the treatment for depression. It is the first time, however, such a finding has been found for anxiety.
‘One is about the same as another’
The meta-analysis’ results have implications for other commonly used selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine (Prozac) and sertraline (Zoloft).
“Previous analyses have shown that one SSRI is just about the same as another one,” said Sugarman. “There isn’t a lot of difference among the drugs.”
That similarity includes side effects. One study found, for example, that more than 70 percent of people who take SSRIs report symptoms of sexual dysfunction, compared to 10 percent of people receiving a placebo. Other common SSRI side effects include drowsiness and weight gain. Less common are an increased risk of suicidal thoughts and a potentially life-threatening buildup of the hormone serotonin in the body (a condition known as serotonin syndrome).
“It’s hard to justify these risks given the minimal differences that we see in benefits,” said Sugarman.
“It’s also not medically necessary to take these drugs,” he added. “There are other options available.”
The leading option is psychotherapy with a trained professional. Studies have shown that although psychotherapy and drug interventions perform equally well over the short term — less than 12 weeks — psychotherapy is clearly superior to drug therapy over longer periods of time.
“Part of the reason we see that is because [psychotherapy] involves skills training to help prevent future occurrences or continuation of the mental illness,” said Sugarman.
Another concern about drug therapy for depression and anxiety, he added, is that once people start taking the drugs, they generally stay on them for a long period of time, usually years.
“That long-term therapy may not be necessary in a majority of cases,” he said.
Need for open data
The finding from this meta-analysis also underscores the need for researchers to have unfettered access to unpublished drug data. As supporters of the ongoing open data campaign have noted, it’s “absurd” to let pharmaceutical companies decide what clinical trial data the public — and even regulators — get to see.
Sugarman and his colleagues were able to include unpublished GSK data about Paxil in their meta-analysis because of a past lawsuit against the company. In 2004, GSK was sued for not disclosing negative data that linked Paxil to suicidal thoughts in children. As part of that settlement, GSK agreed to post all the results of its clinical trials online, including those that it had never published. That data led researchers to discover that the company’s type 2 diabetes drug, Avandia, significantly increased the risk of heart attacks and heart failure. In 2012, GSK pled guilty to misdemeanor charges for not disclosing negative data about Avandia — and for marketing Paxil and another anti-depressant, Wellbutrin, for unapproved uses.
PLOS ONE is an open-access journal, so you can read the study in full at the journal’s website.
PLOS One
is a journal of questionable repute among many.
Risky
Using some studies to invalidate a drug completely is as bad as using some to inflate the value of the drug. Drug companies have bias, no doubt.
I think it’s important to remember that antidepressants were discovered incidentally when treating another illness. A random finding that wasn’t part of the study.
Next, the effectiveness ratings of antidepressants are better than statins and many other drugs. Again, I’m not excusing any of them, but targeting psychiatric drugs is just a further attack on mental health issues as being different than medical issues. This leads to more stigma and ultimately less care.
Prozac was great in that it got people talking about depression and anxiety with their doctors. Every time you claim that the medicine is no better than placebo, you are calling into question the treatment response someone had on those medicines. You are basically saying, “it’s all in your head.”
I understand the point of this study was to attack the drug companies, and often I’m first in line to do so, but be careful for unintended consequences and be sure to include ALL information so you don’t fall into the same patters the drug companies do.
In addition
Sorry for not including this in my first reply.
I think it’s irresponsible to claim the drugs have no place when there are “other options.”
Therapy is expensive and out of the reach of many people that suffer from depression. Lacking motivation to get out of bed, having a very busy work schedule, or lacking insurance are just three very common roadblocks.
That drug response in the first 12 weeks may be what it takes to get the person into therapy in the first place.
I’ve read good PLOS papers. Either the one cited here is incredibly biased, or the quotes that were used here were chosen for an agenda.
Current recommendations for treating moderate to severe depression include combination of pharmaceuticals and therapy. Mild depression is likely therapy only.
Pharma will have another Darling Drug soon anyway
As we learned recently in the news, depression is not something to scoff at. Or to treat ineffectively.
Its easier & probably cheaper to give pills than find enough therapists.
A never-ending cycle of new drugs with remarkably stupid names get pushed, rotated in & out of advertising favor all the time.
If we look at the classes of drugs sold by TV commercial – which barely describes what they are even for – rather their color, I think it bears out the idea this is an advertising paradise.
If there is no recognizable improvement with these some of these drugs then why are they hawked & sold? That is blatantly irresponsible.
Do you have enough purple in your life?
I wonder….
what percentage of people on these drugs are for conditions that meet the clinical criteria for depression and how many are on them as a treatment for what appears to be boredom?
Antidepressants should be banned….
First of all there is NOTHING of questionable repute when it comes to PLOS. It is well respected. Most likely the only ones questioning their repute after this study are those connected to the $11 Billion (Plus) income coming in from antidepressants. 🙂
No one should find the results of this study surprising at all because it is only supporting old news. I believe it was back in 2008 the news broke that studies kept hidden by the antidepressant manufacturers for 20 years, even kept hidden from the FDA, demonstrated there was no more benefit from antidepressants than placebo. Google it.
So no benefit, yet if you read the side effects it is clear to see that the risk to benefit ratio of these drugs is “down the toilet”!
The drugs carry warnings of both suicidal and homicidal ideation (that is constant compulsive thoughts of killing oneself or others along with the same constant compulsive thoughts of various ways to kill).
Antidepressants are also found in 86% of the diagnosed cases of REM Sleep Disorder where patients act out nightmares in a sleep state and which is also known to include both murder and suicide.
All this negative potential when a placebo would offer as much in the way of benefit?! Seriously?
And suicidal and homicidal compulsions are only the tip of the antidepressant iceberg! You also have the 7 times greater chance of breast cancer with Paxil which is now being touted for menopause under the new name Brisdelle and specifically for women with a greater risk of breast cancer!
Then there is the three to four times greater rate of Autism for the children born to moms who take antidepressants, not to mention all the babies born with holes in their hearts or transposed arteries – both requiring open heart surgeries at birth and a lifetime of medical issues after..
And to top that off the hypothesis behind the drugs is backwards. Serotonin was never low in depression! What was low in depression, anxiety, suicide, psychosis, mania, impulsive murder or suicide, cravings for alcohol, etc was serotonin metabolism – the exact thing antidepressants are designed to inhibit! Which means the drugs should cause all of the above reactions. (See my 2004 testimony before the FDA Advisory Committee for additional data on that issue.) Just read a package insert for warnings of most all of the above as possible “side effects.”
Add to all that the fact that antidepressants produce horrible and very dangerous withdrawal for many unless they know enough to go down EXTREMELY slowly taking months or years (depending on how long they have been on the drugs) to wean off only a granule or two at a time in order to do so safely and successfully, Most patients and their doctors attempt to wean much too rapidly producing rebound depression from the withdrawal thus causing the patient to end up back on the drugs again. This is the reason people stay on antidepressants for so long – THEY DO NOT KNOW HOW TO GET OFF SAFELY!!!
Clearly there is no benefit that justifies any of the risks!
Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness