Tianeptine, Politics and the Pharmaceutical Industry
Tianeptine is unique drug with a broad range of possibilities and applications. Not only is it a viable anti-depressant, it’s also used for the treatment and management of a huge range of ailments. In fact if you haven’t already, go and read our other article on future uses of tianeptine [insert link] to find out exactly how tianeptine has been proven useful in the treatment of asthma, anxiety, erectile dysfunction and irritable bowel syndrome. Interestingly, however, tianeptine is NOT available in the USA and remains a ‘niche’ drug even in countries where it is available. So why does a drug with so much scientifically proven potential remain widely unused and underutilised? This article addresses the complex truth behind the politics of tianeptine.
The basic story of Tianeptine in the USA
Without getting bogged down in a historical narrative, here’s a brief summary of tianeptine in the USA. First off, Servier, the maker of tianeptine, wanted to market the drug for disorders other than depression and anxiety. It wasn’t until the late 1980’s that the company chose to sell it as an anti-depressant and by that time their patent had expired, meaning that other companies could essentially copy the drug.
Now, getting a drug into the US market is tough, particularly because the Federal Drug Administration requires assortments of extremely expensive tests and procedures before they will give approval. Unfortunately, because of the expired patent, Servier calculated that the money it would cost to introduce tianeptine in the US would never be recouped.
In essence, why would any company pay huge sums of money when as soon as they get approval any other company in the world can start selling the product on the same ticket? The answer of course is that they won’t, meaning that tianeptine remains unapproved and officially unavailable in the US.
The FDA and US Economic Protectionism
You might be thinking, ‘hold on, if tianeptine is so useful and has such a successful track record, why can’t the FDA make special considerations?’ Good question! The answer is simple, US Economic Protectionism.
At the end of the day Servier is a European company not an American one. The profits of tianeptine sales would largely be redirected back to Europe and this would be of no benefit to the US economy. If tianeptine is ever to be approved by the FDA, it will likely only happen AFTER an American made drug that works in the same ways as tianeptine was approved and released into the US marketplace.
This may sound slightly conspiratorial, so how about an extremely relevant example? The most well -known anti-depressant in the world, Prozac, is commonly referred to as the world’s first SSRI. Interestingly, however, numerous SSRI’s had been produced in Europe years beforehand but had been shut out from the American market. Once Prozac, the all-American anti-depressant, had been approved and marketed, then the European drugs were given approval.
Larger Problems with the Pharmaceutical Industry
Market Protectionism, expensive FDA approval and expired US Patents do offer some explanation of why tianeptine isn’t available by prescription in the United States. What these reasons don’t explain is why tianeptine is also unavailable in Canada, the United Kingdom and Australia. Perhaps, then, there are some other factors at play.
Tianeptine is in many ways just the tip of the iceberg when it comes to the complex workings of the pharmaceutical industry. Now, it’s easy when talking about pharmaceuticals to get bogged down in the ‘big pharma conspiracy,’ yet to do so is often intellectually lazy. As such, any following claims made about the pharmaceutical industry will be directly linked to studies, research and articles for you to pursue and personally verify should you wish to do so.
One of the biggest issues of pharmaceutical industry is that of ‘publication bias.’ This refers to the unethical influence of pharmaceutical companies on the studies and trials that they sponsor. Basically the companies exploit a loophole in the legal system. Companies carrying out their own clinical trials must register them in a database. However, the companies are NOT required to disclose the results of all of their trials. Pharmaceutical companies therefore can register trials but choose not to disclose any negative results or findings. In essence the companies can, and do, choose to only publish the results of studies that positively back up the claims made by the company.[i]
To put this into practice, it’s completely possible that a pharmaceutical company could sponsor a hundred different trials into the effects of its drug. Ninety-nine of those trials could show that the drug is worthless, yet the company could still legally claim that the drug worked based on the results they publish from the single positive trial!
Other duplicitous publication habits[ii]
Don’t go believing that the problem of publication bias ends with cherry picking positive studies and hiding negative ones. Companies have yet more options available to them:
- They can publish the same positive study numerous times to make it look like lots of different ones.
- They can ‘bury’ negative data in masses of text but leave it out of published graphs, images and summaries.
- They can completely ignore people who drop out of the trials. (i.e. due to side effects or negative reactions to the drug)
- They can simply not ask any questions or monitor any side effects, therefore removing the obligation to publish them.
- They can choose not to include people known to respond well to placebo. This is especially useful in manipulating placebo controlled studies.
Placebo versus SSRI
The manipulation of placebo controlled studies has been highlighted by the work of Irving Kirsch, Associate Director of the Program in Placebo Studies at Harvard Medical School. He headed up a project analysing every single FDA registered study for the six most common SSRI’s. What he and his team found was that although SSRI’s did give statistically significant changes to depression scores, these changes were small enough to make LITTLE OR NO CLINICALLY SIGNIFICANT DIFFERENCES in the treatment of depression when compared to placebo administration.
The project summarises its findings by saying that “there is little reason to prescribe new-generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective.” Kirsch talks at length about his findings in The Emperors new drugs.[iii]
Moreover, Kirsch’s team aren’t the only group to conduct this kind of research. In 2002, Arif Khan spearheaded a team that requested all the FDA data on SSRIs and came to similar results as Kirsch. Additionally the Journal of the American Medical Association published a meta-analysis in 2010 looking at published data on SSRIs. They concluded, like Kirsch, that all but the most severely depressed fail to get much benefit from SSRIs beyond the placebo effect.
Mistrust and Meta-analyses
Now, if regulators and practitioners are aware of biased studies, surely they can rely on meta-analyses instead? Think again…
An upcoming issue of the Journal of Clinical Epidemiology contains a review of 185 meta-analyses, and concludes that “a massive number of meta-analyses of antidepressant clinical trials have financial conflicts of interest and are unduly influenced by pharmaceutical companies”
The review, conducted by Ebrahim[iv] and his colleagues, discovered that 79% of all antidepressant meta-analyses published over the past seven years were linked to or created by the pharmaceutical industry. (For example by funding, sponsorship or authors/researchers who were industry employees and/or had conflicts of interest)
The review also revealed that fifty-four meta-analyses (29%) had authors who were employees of the assessed drug manufacturer, and that meta-analyses including an author employed by the manufacturer of the assessed drug were 22-fold less likely to have negative statements about the drug than other meta-analyses.
Worryingly then, the very studies that are designed to review and analyse research for mistakes and bias have become just as biased as the research that they’re designed to review.
Pharma funding and lobby groups
At this point you might be wondering exactly how scientific studies can become biased on such a significant and widespread level. The answer, unfortunately, is that large channels of money and favour are in action between researchers, businesses and politicians.
Thanks to the work of the Centre for Responsive Politics[v] it is possible for anyone, including you, to search for the exact amounts of money transferred between clients, lobby groups and politicians across America. (The site is called opensecrets.org should you wish to verify any figure in this article.) The results of such searches can be somewhat terrifying.
Take for example the total amounts of money spent on lobbying in America’s biggest industries. The totals below are from 1998-2015[vi]
|Electronics Mfg & Equip||$1,853,271,085|
|Oil & Gas||$1,750,255,336|
|Misc Manufacturing & Distributing||$1,442,304,755|
|Securities & Investment||$1,287,877,075|
|Civil Servants/Public Officials||$1,235,147,415|
You’ll notice that the pharmaceutical industry is the single biggest spender on lobbying in the United States, spending $3.2 billion over seventeen years in order to sway legal and political decisions in its favour.
The oil and energy industries often get a lot of bad press for this type of behaviour, yet the reality is that both of these industries spend less than half the money that the pharmaceutical industry does.
Medicare, Chuck Grassley and Buying Support
Here is a prime example of how decisions can be swayed through the purchase of political support.
You might remember that back in 2007 a bill to let Medicare negotiate drug prices with manufacturers was controversially blocked. This meant the government lost the opportunity to potentially save billions of dollars. The biggest voice opposing the bill was Senator Chuck Grassley, a republican candidate from Iowa. However, if you head back to opensecrets.org and look at Mr. Grassley’s sources of political fundraising you’ll find that across the last decade the medical industry has been one of his biggest sources of funding.[vii]
Apologies to Senator Grassley is he feels he’s being singled out here, because the reality is that he’s one of hundreds if not thousands of US politicians to have done this. Again, head over to opensecrets.org and do the research yourself. See how deep the rabbit hole goes.
Returning to the discussion of Tianeptine – An Unfortunate Reality
Whether we like it or not the drug industry is a mammoth, and the anti-depressant industry alone is worth an estimated $150 billion. Drug’s like tianeptine represent a viable, inexpensive alternative to SSRI’s and because of this they cannot (at least in the eyes of drug industry shareholders) be allowed to enter common usage. Through a combination of legal action, lobbying, scientific falsehood and clever marketing, tianeptine has been forced to remain on the side-lines specifically because it threatens the pockets of a very loud and powerful minority.
What this means for you, and for medicine as a whole, is that although tianeptine may be a better alternative for the treatment of various ailments, it won’t be prescribed by your local doctor any time soon. Indeed for many sufferers of depression, anxiety or even chronic asthma for that matter, SSRI’s will remain the go-to prescription despite the alarming number of side effects.
In the future then, if medicine is to take steps forward and start pursuing drugs based on efficacy rather than economics, serious changes are needed to the processes through which studies are conducted and reviewed. Lastly, if you happen to look into tianeptine or any other non-mainstream drugs, this article has hopefully demonstrated to you the value of double checking the credentials and funding of the information you find.
[iii] Irving Kirsh, The Emperor’s New Drugs: Exploding the Antidepressant Myth (2009 Bodley Head)
[iv] Ebrahim, S., Bance, S., Athale, A., Malachowski, C., & Ioannidis, J. P. (2015). Meta-analyses with industry involvement are massively published and report no caveats for antidepressants. Journal of Clinical Epidemiology. http://www.jclinepi.com/article/S0895-4356(15)00429-1/abstract