Why Aren’t More Drugs Approved for Bipolar Disorder?

Why Aren’t More Drugs Approved for Bipolar Disorder?

November 12, 2017 Bipolar blog FDA treatment issues

Thoughts on My Time with the Food and Drug Administration (FDA)

Have you ever considered why more drugs aren’t approved in the treatment of bipolar disorder? I have. I, specifically, wonder why there aren’t more drugs for bipolar depression, considering that the depressed state outweighs the presence of mania/hypomania 3:1 in many cases. Here’s what I think about why there aren’t drugs getting approved for bipolar disorder.

I’m in an Uber being whisked away from the Food and Drug Administration campus in White Oak. I just had the privilege to speak in a listening session with the FDA. At the listening session, I told my story about not having any treatment options, being denied access to healthcare and then attempting suicide. I and others in the room were stressing the importance of new treatment options for bipolar disorder and bipolar depression suicidality in particular.

Why Does the FDA Think More Drugs Aren’t Approved for Bipolar Disorder?

And this got us into the question as to why there aren’t more bipolar drugs getting approved. The “Head Honcho” (HH) (the guy that would finally sign new drugs into being) had a few thoughts on the matter. His basic point was this: the FDA is not the roadblock. The FDA has never not approved a treatment for bipolar disorder. The FDA approves trials for bipolar disorder medication as they come up. The problem is that drugs aren’t being taken to the FDA for approval.

In other words, companies aren’t putting money into research and development of bipolar drugs.

Okay. Fine. So what makes a bipolar drug a bad bet when there are 5.7 million people in the US with bipolar disorder? What makes a bipolar drug so undesirable when we’re so chronically ill? What makes a bipolar drug a bad idea when there are such insufficiencies in existing treatment?

On this point, HH made no comment, but I will. The reason there aren’t more drugs approved for bipolar disorder is simple: money. People with severe mental illness don’t have it.

The Effect of Money on Bipolar Drug Approval

While bipolar disorder is a disease that can affect anyone, the fact is that if you have been seriously affected by it, it has probably hurt your ability to make a living. Not for everyone, of course, but for so very many. For so very many of us, we never get better enough to have a full-time career. Many of us are on social assistance. Bipolar disorder does that to people.

And this is unlike many other illnesses. Take cancer, for example. Anyone, rich or poor, can get cancer. And cancer can royally mess your life up – for a time. Because the fact is, you either beat the cancer and go on to live a full and productive life or, possibly, you die. But you aren’t chronically sick for the rest of your life and forced to go on disability. That doesn’t typically happen. So whatever money you had before the illness hit, you can spend on treatment. And you’re much more likely to have access to good healthcare if a disease strikes you impermanently, in the middle of your life. And, of course, people put a high price on their own lives and on the lives of people with cancer in general so money is deemed worthy of spending.

There aren't enough drugs being approved by the FDA for bipolar disorder, but why is it that bipolar disorder drugs aren't getting approved?Bipolar is not like this. Twenty percent of people develop bipolar symptoms in adolescence. This means that many of us will never make it into the workforce as a fully-functioning employee. Some of us will, of course, but many of us won’t. And even of those who do enter the workforce in a standard fashion often get chronically ill and have to secede from the workforce.

And all of this amount to a population with less money than everyone else. We’re less likely to have good insurance (in the United States, where drug companies can charge the most) and we’re less likely to have the money to pay for expensive treatments. We have been disabled by the illness and that has impacted our ability to pay.

And the drug companies know it. They know we are a poor population and they know our average income is low. They know we are on government assistance. We just aren’t the rich population they can make a drug for and charge whatever they want. It’s just a fact that not enough people would be able to pay the prices that drug companies would want to charge (some people can’t afford to pay the prices now).

This is because drug companies are always looking for insane amounts of profit and aren’t prepared to do something that would be good for people alone. That is not their job. They have a fiduciary responsibility to their stakeholders to maximize profit. So what if people with serious mental illness get stepped on in the process?

Bipolar Drugs Are Hard to Develop, Clearly

Additionally, targeting bipolar disorder with a drug is hard. Over the last approximately 70 years, there haven’t been any drugs designed for bipolar disorder, just other medications repurposed to treat bipolar disorder. This is why we are treated with anticonvulsants and antipsychotics – there isn’t a class of “bipolar” medication (save lithium, of course).

On this point, I feel for the researchers. I know how complicated the brain is. I know how complicated my brain is. I wouldn’t want to have to be responsible for targeting it with some magic med.

Okay, fine, so it’s hard.

But all diseases are hard until enough research dollars are put into them. There are all kinds of things we can eradicate today that we couldn’t when I was born. That’s research dollars at work.

And on top of the fact that drug companies feel that we aren’t worthy of their money, other sources of research grants seem to agree. We are the red-headed stepchild of the serious illness family.

And even though the people in the room today at the FDA likely don’t think of people with bipolar disorder as homeless leeches, many people do. When I do talks, some people are visibly stunned when I say I have bipolar disorder because I don’t “look” like I have bipolar disorder. I’m too well put together. I’m too “normal” looking.

Approval of New Bipolar Disorder Treatments Would Give Us Money

There aren't enough drugs being approved by the FDA for bipolar disorder, but why is it that bipolar disorder drugs aren't getting approved?This is the discrimination we face. It is true, of course, that many homeless people have bipolar disorder, I don’t deny that, but if they had effective treatment would they still be homeless? I don’t know the answer to that question, but I suspect not.

If we had effective treatment, so much of the bipolar population could get off of government assistance and earn their own livings. This would save the government money, increase the tax base and put more money into the economy in general.

But that’s the long view. And who the heck takes the long view? Certainly not drug companies. And governments aren’t exactly known for doing this either.

What to Do to Get More Bipolar Disorder Treatment Approved

So what do we do? What does a little-ol’-bipolar living in the middle of the nowhere do? I’m not entirely sure. I think speaking out is a good start. I think showing that we are living, breathing people and not caricatures is a good start. I think standing up for ourselves and advocating loudly and with purpose is a good start.

I know how hard this is. I know how hard it is to be really sick and have to advocate for yourself. I know how unfair it is to place that burden on a sick person. I know.

But if not us, then who? We crossed the drug companies and governments off the list so if they’re not going to do the work of their own volition we need to force them into doing the work through our voices.

I was reminded of this today at the FDA. I was reminded that there are people in the system who very much want effective treatments for bipolar disorder but whose hands are tied. Because, of course, if the drug development isn’t done then it’s irrelevant as to whether it would get approved by the FDA or not.

So what I’m encouraging you to do is to use your voice. Your voice is a powerful tool. Back initiatives for bipolar disorder with your voice. Don’t let there be a vacuum around the topic of bipolar disorder. Stand up and be heard. Be loud so, eventually, others must listen. We are a huge patient population and together, we can do great things. Drug companies may think we’re powerless and penniless, but this isn’t true. We’re strong and we can do this.

Some organizations you might want to look into that support those with serious mental illness (often by encouraging legislation change) and educate about serious mental illness include:

I’m sure there are many more great organizations as well. Please feel free to mention them in the comments.

Image one by Flickr user Images Money.

Image two by tOrange.biz.


About Natasha Tracy

Natasha Tracy is an award-winning writer, speaker and consultant from the Pacific Northwest. She has been living with bipolar disorder for 18 years and has written more than 1000 articles on the subject.

Natasha’s New Book

Find more of Natasha’s work in her new book: Lost Marbles: Insights into My Life with Depression & Bipolar. Media inquiries can be emailed here.

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