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Paxil vs. Placebo: 2014 Meta-Analysis with Unpublished Data Questions Drug’s Efficacy

A new meta-analysis recently showed that the antidepressant Paxil (Paroxetine) is only slightly more effective than a placebo for both depression and anxiety disorders. Prior to this finding, it was assumed that all SSRI antidepressants were significantly more effective than a placebo, hence getting approval to treat depression. In the article I wrote entitled “Do Antidepressants Work?” I discuss the fact that these drugs go through rigorous testing by the FDA and must show efficacy to get approved.

But based on newer research, it seems as though the reported efficacy is somewhat tainted – at least in the case of Paxil. A study by PLOS One was able to determine that GSK (Glaxo Smith Kline), the company that developed Paxil overestimated its efficacy and specifically omitted data that suggested it didn’t work very well.

PLOS One (2014) Study: Paxil vs. Placebo Findings

This new study may take some people by surprise because this drug has been on the market for years. In order to get approval, it must demonstrate safety and efficacy. Although it has been found to be effective and relatively safe, it is considered one of the most problematic SSRIs. Paxil is the only SSRI that is linked to birth defects and is associated with significant weight gain and sexual dysfunction.

Slight advantage: The study showed only a slight over a placebo, compared to a significant one. It was previously thought that Paxil provided a significant benefit in comparison to a placebo. Based on unpublished data, it was found that it only provides mood improvement by 2 to 3 points on Hamilton rating scales for depression and anxiety.

Unpublished data: This study took a look at unpublished data from GSK – the company responsible for Paxil. In clinical trials, specific data was kept unpublished in order to build a strong case for the FDA approval of Paxil. Most companies omit data that they don’t want published in order to get a particular drug approved, ultimately so that they can make money. With big pharmaceutical companies, honesty, integrity, and ethics goes out the window – their goal is to follow the rules (even if it means omitting data) in order to get drugs approved. In the case of Paxil, the unpublished reports suggested that it didn’t work very well.

Placebo effect: Lead author of the study Michael Sugarman believes that up to “80 percent” of the effect from Paxil is placebo. He specifically was quoted saying “It’s hard to argue that that’s clinically significant.” This research suggests that most people getting any significant benefit from the antidepressant Paxil are likely experiencing a placebo effect.

No benefit: Some would argue that only experiencing improvement by 2 to 3 points on a Hamilton rating scale for depression or anxiety is so minimal that it’s arguably “no improvement.” Notable placebo researcher Irving Kirsch believes that these slight improvements are so minimal that they shouldn’t be considered significant. This research confirms previous meta-analyses that have found Paxil to offer little advantage when compared to a placebo for the treatment of depression. What’s interesting is that this is the first research that suggests Paxil also offers little benefit for treating anxiety.

  • Source: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0106337

How did researchers obtain unpublished data for Paxil?

The only reason that Sugarman et al. were able to gather data from GSK in regards to Paxil was due to a lawsuit filed in 2004. Back in 2004, a lawsuit was filed for not providing data that Paxil increased suicidal thoughts in children. (This goes along with the finding that antidepressants can increase depression and suicidality).

Anyways, an agreement in the lawsuit settlement was that GSK needed to give open access to all of its clinical trials online – including those that were unpublished. This opened up a Pandora’s box and other drugs such as Avandia (a Type 2 diabetes drug) was found to increase risk of heart attacks. This lead GSK to plead builty to misdemeanor for lack of disclosure regarding Avandia and for marketing Paxil, and Wellbutrin (another antidepressant) for unapproved conditions.

Are some antidepressants better than others?

The general knowledge among psychiatrists is that all antidepressants have a relatively equal chance of working. Different individuals will respond to different antidepressants and what works for one individual may not work for another. The consensus among professionals seems to be that there is no drug that can be regarded as the universal, “best antidepressant.”

Although some meta-analysis suggest that certain drugs may work slightly better for treating depression than others, the differences in efficacy are regarded as insignificant. Therefore all antidepressants have an equal chance of working. With this study coming into play, it could now be suggested that other antidepressants may be significantly more effective than Paxil.

What this study suggests: Paxil vs. Placebo (2014)

Several implications that can be derived from this particular study.

  1. Certain drugs shouldn’t have gotten FDA approval: This study suggests that certain medications maybe shouldn’t have been approved. Not only does it suggest that Paxil may have never obtained FDA approval, but other medications (even non-psychotropic drugs) maybe shouldn’t be on the market. The efficacy of many of these drugs is often overstated and the long-term health concerns are often excluded.
  2. Corruption: This study also suggests a slight degree of corruption by pharmaceutical companies. It’s easy to point the finger at GSK for their efforts to cover up unpublished data, but it would be silly to think that they are the only company operating with corrupt agendas. Most pharmaceutical companies do a good job of covering up their tracks and making their drugs look as good as possible. Only years later we find out that certain drugs are linked to problems and we see commercials for lawyers hoping to sue the pharmaceutical company.
  3. May be a problem with other drugs: The fact that Paxil wasn’t found to be marginally more significant than a placebo may be a problem with other drugs. Many other SSRIs or antidepressants may have been demonstrated as highly effective in studies, but unpublished data may suggest less efficacy.
  4. Published data skews perception: The published data on certain drugs often leads us to believe that the drug is highly effective when compared to a placebo. Although the published data may be highly accurate, the unreleased, unpublished data may make us think twice about certain medications.
  5. Unpublished data is often important: Companies are getting away with the omission of data from the general public and researchers. There are campaigns in place to help promote more public data – especially in regards to pharmaceutical drug studies. Without having open data, pharmaceutical companies are essentially skewing the odds of getting a (potentially poor) drug approved by the FDA. Much of this unpublished data provides much-needed insight in regards to the safety and efficacy of a drug; it is usually left unpublished to hide something.

Should Paxil be discontinued or withdrawn from the market?

Personally I don’t believe Paxil should be discontinued from the market, even after experiencing first-hand what it’s like to be on the drug and have it stop working (i.e. Paxil poop out), followed by the full array of Paxil withdrawal symptoms. My experience coming off of this drug was nothing short of hellacious (read: Quitting Paxil Cold Turkey). It was among the most difficult experiences I’ve ever been through in my life. I experienced symptoms for over 6 months after stopping this drug – my life was a struggle.

Even though my negative experience coming off the drug significantly outweighed the positive experience I had on the drug, I believe that without it, I wouldn’t have ever been able to function in social situations. At the time, I had a severe case of social anxiety and comorbid depression – Paxil worked wonders for about 8 months. That being said, I could easily string together an argument as to why it should be discontinued – this study adding further fuel to that argument.

Case for Paxil being discontinued

Below are a few thoughts in regards to making a case for pulling Paxil from the market.

  • Awful side effects: The side effects from this drug are considered among the worst of any SSRI. Most people tend to experience significant weight gain as they increase their dosage along with sexual dysfunction.
  • Birth defects: This is considered the only SSRI medication linked to birth defects. If you are taking it and you get pregnant, you will need to stop it in order to minimize your risk. Unfortunately stopping it can lead to significant withdrawals during pregnancy and create an emotionally unstable mother.
  • Debilitating withdrawal: Paxil has one of the worst documented withdrawals of any antidepressant. There are websites and forums just dedicated to helping people get through the withdrawal process and people who believe that withdrawing from this medication is as severe as even the most illicit drugs.
  • Increase in suicidal thoughts: The fact that this drug can increase suicidal thinking and/or depression in some people is a cause for concern. Drugs that are aimed to treat depression shouldn’t increase it.

Case for Paxil staying on the market

Below are a few thoughts in regards to making a case for Paxil staying on the market.

  • Considered safe: Other than causing birth defects, this drug is largely considered safe in terms of side effects. Although the side effects may be unwanted (such as weight gain), they are not life-threatening. Compared to other classes of medications, Paxil is pretty safe.
  • It works for some: Another case for keeping this drug on the market is that works well for certain individuals. Although this meta-analysis may suggest that they are experiencing the placebo effect, not everyone is. Some people try it and take it for an extended period of time with success as a result of the drug’s effects.
  • May be the only drug that works for some people: For other individuals, Paxil is the only drug that works. I can attest to this one because for me it was the only antidepressant that provided me with powerful relief from my anxiety and depressive symptoms. If certain people have tried a number of antidepressants and find that only Paxil is effective are we going to cut them off from this treatment? Probably not a good idea.
  • Lack of psychiatric treatments: A major problem is that we currently lack effective psychiatric treatment for many mental illnesses. Even though depression and anxiety are treatable with medication, for many the medications don’t work, or only one provides relief. In some cases, the only medication that may work is Paxil. By suggesting that it doesn’t work or removing it from the market, we would have one less option for treating those who are severely debilitated by their particular depression or anxiety disorder.

Paxil, Unpublished Data, and FDA Approval

Authors of this study believe that with all of the antidepressant side effects such as weight gain, sexual dysfunction, drowsiness, etc. – the drug better at least provide enough antidepressant effect to justify them. If you’re on a drug and feeling tons of unwanted side effects and aren’t really getting a clinically significant benefit from the drug, it negates the purpose of taking it.

Researchers in this study also suggest that it’s not always necessary to take antidepressant medications for mental illness like depression. There are other natural antidepressants and anxiety available. With such minimal benefit being discovered for a drug like Paxil, we can only wonder if other psychotropic and even general non-psychotropic drugs are less efficacious and more problematic than reported.

With the need for more effective psychotropic drugs on the market, companies are doing everything in their power to get more treatments approved by the FDA. In turn however, they are leaving out vital unpublished data that may change our minds about even trying a “new” treatment. Researchers and the FDA alike now must face the challenge of unveiling all data (even unpublished), while simultaneously fast-tracking treatments for those who are suffering and demanding more options. This is a difficult balancing act to perform, but one that clearly needs to be improved.

What do you think about the drug Paxil and pharmaceutical companies like GSK?  Do you think that all data should be published or do you think that drug companies should be allowed to keep private data hidden from the FDA and consumers?  Feel free to share your opinions in the comments section below.

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