Why don’t we have better psychiatric drugs? After a few years in the pharmaceutical industry, I think I finally understand why.
Four years ago, I left full-time academic employment to take full-time research employment at a pharmaceutical company. I wrote a commentary about it for Medscape soon thereafter titled “How Academia Left Me.” Now it’s time for the completion of the cycle.
At that time, I wrote that many colleagues kept asking me, “Why did you leave academia?” In fact, I hadn’t, I replied. I kept doing everything I had always done: teaching, writing academic scientific articles, and even doing patient consultations at the academic hospital (much less frequently, of course). I just wasn’t being paid for it anymore. Most people don’t realize that the majority of academic work isn’t reimbursed. You’re only paid for patient care primarily, and for research if you obtain grants. So I was still “in” academia; I just wasn’t being compensated.
And, as I explained at the time, I hadn’t left academia; rather, academia left me. In other words, my values and goals hadn’t changed. I just realized I couldn’t achieve them anymore purely in academia.
So, I left.
Then for the past 4 years, on top of my continued unpaid academic work, I was employed full-time at the early research branch at Novartis Institutes for BioMedical Research (NIBR) in Cambridge, Massachusetts.
I left NIBR a few months ago. This time, when people ask me why I left, the question is apt. I did actually leave the pharmaceutical industry; it didn’t leave me. My values and goals had changed, and I realized I couldn’t meet them in the current setup of the pharmaceutical and biotechnology industries. Let me explain why.
But before I do so, a reader might wonder what I’m doing now. Technically, I’m “back” in academia, although I’m still doing basically the same thing I did for the past 4 years: teaching, writing scientific articles, some clinical consultation. I’m just being paid very part-time. It may be that being “in” or “out” depends on whether you get a monthly check. But I’m not back in full-time academia in any case. Maybe this is just a professional purgatory, except that purgatory implies a temporary resting place before you go somewhere else. Traditionally, the destinations were heaven or hell. Maybe those are still the options.
Going From a Room Full of Experts to Being the Lone Authority
I’m tempted to say I left the pharmaceutical industry for the same reasons I went there: to try to implement new and non-mainstream ideas in developing novel drugs in psychiatry. I couldn’t get enough traction with those ideas in academia, which is dominated by an institutional conservatism when it comes to what’s possible. By comparison, the pharmaceutical industry promised to be more intellectually flexible, willing to try new ideas, pragmatic, answering to real-world impacts rather than traditional beliefs.
I found that this difference was true to an extent. My experience was that many pharmaceutical industry colleagues were much more open-minded and willing to move along new ideas than my academic psychiatry colleagues. Partly, this was a function of the structure of the industry.
People like me are hired as “subject matter experts,” meaning I was expected to be the expert in psychiatry. If I held a view, it was assumed that I was right and that no one else expertise in the room likely had more on that topic than I did in order to disagree. In contrast, in academia, everyone thinks he or she is an expert, and it is common for one professor to disagree with another. I felt liberated by this respect for my expertise.
As Drugs Advance, Your Influence Diminishes
After a year or two, as a drug project would advance along the various research milestones, I began to be restricted again. Once a study showed a benefit and another, larger one had to be planned — for instance, moving from a small phase 2 study to a large phase 3 study — my role diminished.
We would have to organize an expert advisory board, the type of which I had participated in dozens of times over two decades in academia myself. I found myself faced again with my old academic colleagues, spouting the old, dead conservative ideas in psychiatry. And my innovations — in this case, for new clinical indications not in the Diagnostic and Statistical Manual of Mental Disorders (DSM) — were rejected.
To my surprise, my pharmaceutical industry physician colleagues in decision-making roles deferred to the academic experts rather than to me, their in-house expert. They had to do so. They could not advance a drug to later stages of development for innovative clinical indications without the support of the academic expert leadership, because this group’s support would be needed for multiple purposes: to achieve US Food and Drug Administration (FDA) approval (which depends on academic advisory input), and later to spread the new ideas once in the marketplace.
So, academia had followed me deep into the heart of the pharmaceutical industry. Even there, the tendrils of academic conservatism snuffed out innovation.
Commercial Interests Trump All
Another impediment to moving psychiatric drugs in a new direction has to do with the influence of the commercial part of the pharmaceutical company. Large pharmaceutical companies have at least three or four major branches.
First, there’s the early drug discovery group, the lab PhD folks working with animals and molecules in test tubes. They’re generally left alone to do their own thing. Next, there’s the early clinical research group, the physicians who conduct the first human studies after the lab folks show the drug is safe in animals and has possible human benefits; that was my role. Then, there’s the late clinical research group, the physicians who do the huge studies targeted to FDA requirements for approval. Finally, there’s the commercial group, the people who organize the introduction of the drug to the marketplace of insurance companies and government payers after FDA approval. Notice that the first three groups were all PhDs or MDs. The fourth group almost always consists of MBAs, not physicians or scientists.
Yet, in terms of influence, the tail definitely wags the dog. The commercial group may be the last in the sequence, but it is the first in influence. Even in early clinical research, they would give input as to whether a certain indication was more or less likely to be acceptable to them. Their judgments were purely economic: How likely would it be that eventually we could convince doctors and patients to take a drug for a specific purpose? If it was likely to be difficult, they’d be opposed.
The Status Quo That’s Stifling Innovation
The problem is that any truly new idea, any real innovation, will be difficult to convince doctors and patients to accept. The world always sides with the status quo, because people want and need security and reliability. People don’t like change, all the lip-service to innovation, creativity and progress notwithstanding.
All the players are the same. I’ve already described how academia is decrepit, tied into an inherent love of past beliefs. The FDA doesn’t change its policies easily either; it’s committed to the current consensus. Insurance companies are making fine profits as things are, and government payers barely can afford what they have to pay as it is; they don’t want new risks. And the pharmaceutical companies aren’t going to take risks when no one else is going to do so. They’re not opposed to new ideas per se; They just have to make a profit too, so they need to go along with everyone else.
The system is set up to limit, not promote, innovation. No wonder we don’t have any truly revolutionary or transformative drugs in psychiatry.
That’s the sad reality. And once I recognized it, I had to leave.
Small Biotech Companies Aren’t Immune to These Problems
Some readers might say that this analysis applies only to large pharmaceutical companies. What about the small biotechnology companies, which are “agile” and not risk-averse, which build a whole company around one idea or one drug and are willing to pursue it?
Well, when it comes to innovation, I found out that the biotech companies are even worse than the large pharmaceutical companies. You don’t solve the problem I described by getting rid of the commercial branch, or just having such a small company that everybody is involved in all aspects. In fact, if your whole company rises or falls if a single idea or drug is proven true or untrue, you are much more motivated to twist the facts and spin the data to make it seem true.
Real innovation means being willing to fail and lose money. Small biotech companies go bankrupt if they fail. They’re not willing. So they spin and they sell ideas that often are false, and the world goes even further in the wrong direction.
Let’s Take Aim at These Core Falsehoods
I won’t explain all the ways in which the academic psychiatric profession and the pharmaceutical industry are failing patients in producing better psychiatric drugs. That’s not the main purpose of this commentary. That requires delineation in scientific articles, which is something I plan to do.
In the meantime, let me just provide a list of the false ideas of the status quo, of what needs to be changed, and what I saw that cannot be changed in the current system anytime soon. Here are the false gods of our age, in no special order:
Using false DSM diagnoses that do not correspond to biological/pharmacologic realities
Focusing on drugs for clinical symptoms (like aspirin for fever) rather than for the underlying disease processes (like statins for cholesterol lowering)
False maintenance clinical trial designs that always “show” efficacy (ie, randomized discontinuation trials)
Excessive focus on safety at the expense of efficacy, especially in early animal research (our most effective psychiatric drugs, like lithium and divalproex and tricyclic antidepressants, would never reach the market today)
Until these falsehoods are corrected, we won’t have better psychiatric drugs.
Almost 4 years ago, I wrote here on Medscape about entering the “Dark Side” in the pharmaceutical industry. Now I can say I learned a lot while there, perhaps the most important lesson being that the Dark Side is all around us, wherever we are.
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