What happens when the drug pipeline for common mental health concerns — such as depression, anxiety and bipolar disorder — starts to dry up?
“Most psychiatric drugs in use today originated in serendipitous discoveries made many decades ago,” according to a recent article on Science News by Laura Sanders. And it’s true — we can trace back today’s most popular psychiatric drugs to discoveries made over 30 — and in some cases, 40! — years ago.
Because of the heady cost of drug development — costing hundreds of millions of dollars to bring a new drug to market — most pharmaceutical companies have been playing it safe these past few decades. They’ve been working on developing “me too” drugs — subtle molecular changes to existing compounds.
Which means the pipeline is darned near empty of truly new drugs likely to come out in the next 5 to 10 years for the most common types of mental illness.
This provides the drug company with two things. The first is a new medicine they can patent and sell at a significant markup over the old, generic drug it’s based off of. The second is the illusion of progress, of releasing something that is “new and better” than the old thing — but which additional research almost always demonstrates is simply as good — not better — than the old thing (and usually with a different — not better — side effect profile).
So the “new” SSRIs of the 1990s did away with tricyclics’ side effects, but brought on a whole host of their own, new side effects (chief among these, sexual dysfunction… as though nobody cared much about the quality of their sex lives).
The one thing these “me too” drugs don’t provide is any additional, substantial relief to patients.
So it should come as no surprise that most pharmaceutical companies’ psychiatric drug pipelines are… how shall we say?… empty.
Not a single drug designed to treat a psychiatric illness in a novel way has reached patients in more than 30 years, argues psychiatrist Christian Fibiger of the University of British Columbia in Kelowna, who described the problem in a 2012 Schizophrenia Bulletin editorial. “For me, the data are in,” says Fibiger, who has developed drugs at several major pharmaceutical companies.
“We’ve got to change. This isn’t working.”
The biggest problem, from mine and other researchers’ perspective, is the simple lack of understanding of the organ we’re trying to impact with these drugs — the brain.
Perhaps the largest impediment to the development of new psychiatric drugs is the brain itself. A complex web of interconnected systems constantly altered by the environment, the brain is difficult to study.
Even though it’s nestled right in our heads, the brain is hard to reach. A blood pressure cuff can be slapped on for an instant and objective measure of what’s happening with the heart. A needle biopsy can physically pull out suspected breast cancer cells for further tests. But when it comes to the brain, there is no easy way to identify and measure the thing that isn’t working.
As neuroscientist Steven Hyman of the Broad Institute of MIT and Harvard says in the article, “You can’t just open up the hood, take out a chunk and see what’s happening.”
Thomas Insel, director of the National Institute of Mental Health, believes there is hope by pursuing a new path in research — understanding the very basics of the brain’s functioning. Combined with Obama’s announcement of the Brain Activity Map project to be undertaken by the U.S. later this year, there is hope that we can greatly increase our understanding of the body’s most vital organ.
The situation is grim, but not hopeless, says Insel. At a time when major pharmaceutical companies are abandoning psychiatric drug development, Insel says he is doubling down, investing federal grant money in places where investors fear to tread.
“There are a whole series of pretty amazing developments that I think are worth investing in,” he says.
That’s the good news… But it’s going to take years — and more likely, decades — before we will see the benefit of such research efforts.
But it Hasn’t Stopped Drug Sales…
But that hasn’t stopped the sales of all of these me-too psychiatric drugs:
Which only goes to show you that pharmaceutical company marketing works better than perhaps some would give it credit for.
Read the full Science News article (lengthy, but gives many examples and further details about this issue): No New Meds
5 comments
Why are you blaming pharmaceutical companies? Do you actually think that they wouldn’t love to develop and market truly new and more effective products? Why wouldn’t they?
The reason it costs so much to develop a new drug and bring it to market is over-regulation.
If you vote to have an ever-growing, ever more regulatory state, then you vote to stifle new drug development. You are getting what you voted for. Elections have consequences.
I’m not sure I’d agree with the suggestion that prescription medicines in the U.S. are over-regulated. As we’ve seen in the less-regulated supplement market, if you don’t have in-place these kinds of regulations, you get marketing companies making all sorts of unsubstantiated claims about the amazing benefits of their products (we’ve also seen it in other markets, too, like “brain games,” demonstrating that profits will always trump data).
The core problem, as I noted in the article, is without understanding the brain itself, drug makers are researching fairly blindly. The big discoveries in psychiatric drugs occurred largely by chance decades ago. A more systematic effort to understand how the brain works is needed — and what the federal government has undertaken and committed to funding over the next decade.
Which means the pipeline for truly new psychiatric drugs is quite dry until then…
What are some of the gems involving psychotropics alone in the past 20 plus years?
Xanax was released not only as without risks for physical dependency, a benzodiazepine based product mind you, but also initially sold to treat depression as well as anxiety. We all know how that played out!
What was the title of Peter Kramer’s book, “listening to Prozac”? Yeah, we now know what we heard, through the other Prozac wannabes like Paxil and Lexapro, and it was not a fun show. SSRIs did not, do not, and will not change personalities. Kramer, in my opinion, deserves us an apology for that fraud of an interpretation!
Zyprexa was going to be the second coming of Clozaril, honestly said to me in 1996! Oh yeah, it was clearly a sibling, with ALL the poisons, yet, Lilly had not interest in any acceptance of the responsibilities until not only the FDA made it clear they had accountability, but, the drop in sales made a very clear exclamation point!!!
Risperdal was only a step away from treating the common cold, but, again, Johnson and Johnson did not understand that meds don’t treat everything. How many other states are waiting their turn at the Courtroom table?
Ambien? Can’t remember what I was going to say with all this food in my hands while walking on the street. I hope most readers figure out that bad pun!
Paxil? Hope no one was pregnant on this drug. Oh, and hope no one is considering using it in children, men, and basically anyone who has the capacity to open their mouth and swallow a tablet.
And finally, just as a class, second generation antipsychotics, including the above Zyprexa and Risperdal with Seroquel, Abilify, Geodon, and while I do not write much for Fanapt, Saphris, and Latuda, sure these newcomers aren’t angels in the wings. When companies tell you their drugs can go outside initial indications faster than you can say, “what was that?”, well, if that is not a reason to hit the brakes and back up, I don’t know what is!!!
Been practicing 20 years now, and I think the psychotropic assembly line has basically reinforced the adage, the more things change the more they stay the same. Yes, I would rather write for Zoloft than Elavil, Seroquel than Thorazine, and Depakote than Lithium, but, I would not exclude the latter choices all the time, nor would I exclusively write for the formers either.
As my banner at my blog says:
If you want to get better, take a pill, but if you want to get it right, face the truth.
Doubt anyone involved in the pharmaceutical industry even understands that comment, much less would want to hear it!!!
What about Ketamine and safe Ketamine-like drugs such as Glyx-13
I’d like to know which drugs came out in the 90s and are still being used today to create these mass murderers. ALL of them have been a little off and we didn’t have a problem until doctors started abusing the psych drugs and giving them to patients like candy on Easter morning.