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.
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
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:
- The National Council for Behavioral Health (Yes, I hate the name.)
- Some National Alliance for the Mentally Ill (NAMI) affiliates (Some really don’t focus on serious mental illness, though.)
- MentalIllnessPolicy.org (What you really need to know about the effects of serious mental illness.)
- Brain and Behavioral Research Foundation
- Treatment Advocacy Center
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.
When I read the story about how lithium became a drug for bipolar, it seems like dumb luck that they found out it would have such a big effect. And even now researchers don’t really understand why it works. Otherwise it would be easy for them to churn out drugs based on variation targeting specific receptors or whatever. Antipsychotics and antidepressants are a massive moneymaker for big pharma so I don’t buy your argument that the higher ups are saying mentally ill people don’t have enough money. I think where they don’t care is the side effects like obesity and diabetes that make existing drugs less attractive options. If it’s making them tons of money as is, and people don’t express that something better is needed then why bother investing the millions in r&d in coming up with something new. I’m glad you were able to speak up with the FDA and hope you can let the rest of us know how to make our voices heard.
Here in South Africa we have the same problem with medicine. Only certain things are approved and then it is so expensive that our medical funds ate exhausted round about June/July.
I am 47 and quite stable with the medicine I use. I even started my own business, and heaven alone knows that so far it’s going good. I was diagnosed late in my life trying to commit suicide. More or less 11 years I was diagnosed.
With this I am a cutter as well, why? When the blood flow it’s if the self didsapointmen flows with it. I hate doing it, and I was ‘clean’ for almost 2 years. As we know we tend to recognize our triggers and just when I think I am okay, trigger strikes again.
When I hit my ‘high’ I can move mountains so it feels, but when the low comes, I have to get up and continue even if I don’t feel like it.
With 2 gitls 13 & 11 years, it’s getting more of a challenge, but as I said before…..I don’t know how I get through each day. There are blank spots sometimes that I can not recall, that worries me.
I also tend to keep to myself and overthink every little detail of what I do.
Sometimes I feel like socialise with people for short times and then it happens that I just want to be left alone.
Do you also feel like this sometimes?
There are other mood stabilizers besides lithium that are specifically meant for bipolar and illnesses like it. They have a better side effect profile than many antipsychotics and work well. Some can be taken alongside lithium and don’t cause the same issues with toxicity.
The issue is not money. It is finding successful drugs that do not cause more risk to people. They make no money off of keeping us all insane.
Drugs are used to treat multiple issues because they work on multiple body systems at a time or on specific neurotransmitters that may affect different illnesses. benzodiazepines have always been effective for seizure treatment and can also be used for withdrawal from alcohol for instance. These are not changes in medication but how these medications are utilized by practitioners who have studied the body and the medications and understand how they work. Unless you have gone to medical school or nursing school, it is going to be pretty difficult to understand every single medication and every single process.
Because bipolar disorder affects multiple neurotransmitters and multiple body systems, it is harder to target pharmaceutically. Imbalances are inconsistent and vary between patients. It may be that at some point we need a medication that works in a manner closer to insulin, and the bipolar patient checks their levels daily and doses themselves based on specific balances. Even a system like that would be INCREDIBLY complex to produce. If you are looking for a magic pill though, I don’t think it is going to pop up.
Why don’t you ever mention the fact that they are labelling people as “bipolar” due to the effects of their own drugs? Ritalin and SSRIs prescribed to people cause manic episodes in a subset of the people they are prescribed to. They are conveniently rebranded as “bipolar episodes”, and the people are branded as people having “bipolar disorder”.
Imagine you have tuberculosis. You go to an infectious diseases doctor who prescribes Isoniazid which makes you psychotic, and the doctor tells your whole family that you have “schizophrenia” and the drug just “unmasked” an underlying “schizophrenic disorder”. That’s how ludicrous this is. They are iatrogenically creating bipolar diagnoses in people. Granted not all people are like that. But several of them are.
Nobody has “bipolar disorder” except in the same sense that they have “fever disorder” and “headache disorder”. By stating this, I don’t mean the thoughts, feelings and life experiences associated with that term are not real. They are. After all, even fevers and headaches are real. I am not even stating that you should or should not take drugs. That’s your choice.
However, the truth about a person is descriptive. Obfuscating that truth away using DSM labels is disgusting.
I didn’t actually read your blog topic but I have some theories as to why more pharma meds are not created, generated, specifically for Bipolar. One of those theories is: There is really no clear cut Bipolar any longer.
In the 90’s and early 2000’s.. Bipolar was tossed onto nearly everyone who came in with a relative symptom reported or two (in that there is no distinct medical diagnostic test still to determine Bipolar so, it’s based primarily upon report of symptoms and behaviors). There was no longer a clear Bipolar.
Back in the day; there was only 1 Bipolar.. which is now typically referred to as Bipolar I. There was no Bipolar 2, Cyclothymia, Dysthymia, etc. Bipolar shares so many common traits with other mental illnesses and/or disorders. Is it Major Depressive, Schizophrenic, a Personality Disorder (aka Borderline), etc.?
Second theory: So many pharma meds are cross labeled. Anti-Psychotics are for psychosis and/or Schizophrenia for the most part. Yet, they are now re-marketed as Anti-Depressants or Sleep Inducers. Mood Stabilizers are Anti-Epileptics. Benzos are also Anti-Epileptics.
Topomax was created for Migraines, which then rolled into Epilepsy and now.. in many cases.. it’s for Bipolar AND to help offset weight gain brought on by Anti-Psychotics (in some women I personally know, their pdocs prescribe Topomax for weight gain due to APs).
Three: there isn’t a market share to win. Pharma has to have monies and that comes often due to greater market share. To get greater market share, a prescriber must prescribe and a patient must buy. There isn’t that much gain in marketing specific Bipolar meds when there are a plethora of meds out there currently being cross-used and off-labeled prescribed.
The meds for Bipolar and other mental illnesses are for symptoms, not the disease and/or disorder. With mutliple anti-depressants, anti-psychotics and mood stabilizers… the symptoms reported have 2-3 meds used for each already.
Just my 2 cent thoughts only.
Great article! Well written! I agree with you!!!
Happy Holidays,
Cookie
i hope it’s okay to disagree here — if you read my other comments here, natasha, you’ll find that i’m generally on your side.
imho, the explosion in bipolar diagnoses since the 1990s represents more a “labeling” change than an actual increase in bipolar disorder itself. (i see the proliferation of the bipolar label as analogous to the autism epidemic, eg, increased popularity of the term, not an actual increase in incidence.) if i’m correct, use of antipsychotics and anticonvulsants is not so much repurposing but continuation. if you’re taking meds typically associated with some other mental illness, chances are the label “bipolar” is what has been repurposed.
also, i’m not sure your profit-motive argument holds up. big pharma *loves* lifelong meds — it’s the one and done meds such as antibiotics which get neglected. in the usa, the deepest of deep-pocket payers are medicaid and medicare, neither of whom shy away from effective treatments for chronic illnesses such as heart disease, diabetes and mental illness. of course, high income patients always will always have better access to new meds, but with boh ssri’s and post-haldol antipsychotics available as generics, the poor are in relatively good shape.
i admit to bias — i’ve been taking lithium for almost forty years. it’s so cheap i could afford it without insurance if i had to. still, lately i’ve had unrelated (?) health problems which require switching to something new. all of a sudden my mental health is a mess. i keep reminding myself that it’s unlikely that the whole world has become an evil depressing hell overnight… that the change here is me. with the clarity that desperation brings, i realize i’m willing to take schizophrenia drugs, epilepsy drugs, *any* damn drug that’s going to bring the world back. in other words, i’m willing to give up my classic bipolar snobbery in a heartbeat if it will save my life.
It would be interesting to see how much money other countries with socialized medicine put toward R & D for bipolar medications. There wouldn’t be Big Pharma in those countries, or at least their influence would be mitigated I would hope.
True, but at the same time, it’s not like drugs don’t cross borders. I imagine f there were some great bipolar drugs elsewhere, and there was at least some money to be made, they’d be licensed and then marketed by pharmaceutical companies in other countries.
I’m not sure what the stats are on how much of all global Rx R&D happens in the USA.
It’s not like governments who provide drug coverage to some/all its citizens (which I imagine includes every G20 country) are looking to spend more unless they have to doing so (i.e. big public push), which would leave market demand in the same sorry state…
Good analysis. Not a lucrative enough market… sounds about right, unfortunately. The only drug I can think that they tried to push for bipolar recently was the (repurposed antipsychotic) lurasidone. Which does suggest at least there’s some will on the marketing side (for drugs under patent protection) to target bipolar. But the drug development side is way more expensive, with less guarantee of payout. While I’m sure the difficulty is a factor, I’d bet you’re right that not thinking its worth the investment financially is the main factor.
The comment about looking too normal is striking. There are a lot of people with relatively milder forms of the illness who do well in very high-functioning occupations, but I also imagine they’re well enough served by existing meds. Which I guess raises the question of whether there’s any data looking at what percentage of people with (presumably more severe) bipolar aren’t at least adequately served by existing treatments? But I don’t imagine anyone is going to be stepping up to fund those studies either.
As a side note, there have been some newer anti-epileptic drugs that came onto the market in the last decade or so; any idea if there have been studies seeing if they help with bipolar?
Glad you got the opportunity to share your experiences with the FDA, and in turn their perspective with us. Thanks.
I am thankful for Lamotrogin and Lamictal. That is the formula for a stable me. However, as you found out Big Pharma, not FDA, is the bottle neck here. We, like many, are pawns in their numbers game. I would rather see money to push cures forward than develop more drugs, that require more drugs.
Another good organization is the Depression and Bipolar Support Alliance (DBSA) I used to be the president of the local affiliate. It’s sad to hear that some NAMIs don’t focus on SMI. Our local affiliate (Kokomo, IN) certainly does!
I too believe that we should speak up, and I do whenever I have a chance.
Thank you thank you thank you I just told my nurse practitioner psychiatrist who I trust explicitly who finally talked me into taking an antipsychotic which they’ve always told me to and I always tell them you take it and tell me how you like it I told her that here I’m spending the time of my life and they finally figure out a decent medication
Money. Right. All the more reason for single payer health care? I wonder if that would change the situation for bipolar drugs being presented for approval. As for riding in Uber, we need to support responsible taxi companies, and vote with our dollars. This multi-billion dollar company is breaking laws in the cities they come into illegally. They are putting local taxi companies out of business. One company in my city has already folded, and the other cab companies’ business is way down. Uber is considered so undesirable in London that they are no longer allowed there. From The Guardian newspaper: ” Uber stripped of London licence due to lack of corporate responsibility. US ride-hailing company to appeal against ruling but new chief executive admits it is the ‘cost of a bad reputation’” When they were required to have the same regulations as the legitimate taxi companies in some cities, they left those cities. Lots of women won’t ride this type of service due being told our whole lives not to take rides from people we do not know.