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Dead Space in the Pharma Pipeline

This article is a few months old but just now showed up in my LinkedIn updates.  It’s another indication of disintegration in the pharmaceutical industry as it heads towards the “patent cliff”:

Scientists warn on “dead space” as pharma giants shuns neuropsych:

European experts are sounding an alarm about the recent pullout of GlaxoSmithKline and AstraZeneca from the brain disorder arena.  David Nutt, a professor Imperial College London, and Oxford’s Guy Goodwin are calling for a rapid response to what they term a collapse in R&D spending in the field.

“What we have forgotten, and must not forget, is if we stop this research we will have a dead space of 20 to 30 years before we can re-tool again,” Nutt tells The Guardian. “Despite the public health imperative, not only has EU research funding remained very low, but–even worse–big pharma is increasingly coming to see research into better neuropsychiatric drug targets as economically non-viable.”

That effectively sums up the position of GSK’s Andrew Witty, who has explained that the huge risk associated with developing new drugs for neuroscientists is just too high to justify the investment necessary. The Guardian notes that the average time it takes to develop a new drug for a brain disorder is 13 years-considerably higher than the average program and significantly more expensive.

The article goes on to say that the authors have proposed that pharmas be encouraged to give this area of research to academic labs and that government make an effort to protect small labs and companies who agree to do this research.

The reason why neuropsychiatric medications are so “economically non-viable” is because the body protects the brain from foreign, potentially toxic substances with a physiological feature known as the “blood-brain barrier”.  Basically, there is an extra “layer” of protection around the central nervous system that drugs have to cross in order to reach their targets.  That means, the compounds that might be the most effective have to first be bioavailable to the body and then have to have  certain additional physical properties to cross the blood-brain barrier.  Developing these kinds of drugs is very time consuming and has a high failure rate.  Messing with the brain is not for the faint of heart.  There are specificity issues to deal with as well.  I once worked on a project where the drug was initially developed to target a serotonin receptor in the brain in order to reduce appetite.  It turned out that it also caused severe priapism in primates.  We must be very, very careful or someone’s going to lose a penis.

For those of you who might be hoping for a treatment for Alzheimers, schizophrenia, bipolar disorder, epilepsy or stroke, the authors of this article are saying that the research in these areas are so expensive for big pharma that they are mothballing the projects.  Starting them up again, and finding chemists who understand what it takes to make compounds that cross the blood-brain barrier is going to set back research by 20-30 years.  Then, if a company or academic lab does decide to take this on, they’re going to need governmental protections, to keep them from going under while they work out the kinks.  Presumably, this would include some kind of insurance against the inevitable class-action lawsuits as well as some kind of patent protection.

The patent reform act that was signed recently will probably not be a friend to small labs.  The change from “first to invent” to “first to file” puts a lot of burdens on small labs that may not have a fully staffed patent department to work through a patent application.  That leaves them vulnerable to large pharmas who will make them an offer they can’t refuse.  If I were reforming the patent problem, I would have split off biomedical patents from other patents and then, counterintuitively, extended the patents for new drug entities.  Before you get your knickers in a twist, hear me out.  One of the reasons that drugs are so expensive is because they spend a lot of time in development and clinical trials and those trials eat up the time left on the patent.  These days, the FDA requires more safety data and clinical trials before a drug is approved.  (I *know* there will be some readers who will insist that drugs are fast tracked but they are not paying attention.  Fast tracked drugs are mostly oncology drugs where there is a bargain between patients who are terminally ill who may be willing to forgo the additional safety requirements.  Fast track for all other drugs is very rare)  The longer the drug sits at the FDA, the greater the potential high cost to consumers and marketing executives, seeing an opportunity to increase share holder value, may pad that price even more, using the FDA holdup as an excuse.

Pharma is also not well served by the frenzy of the financial markets to produce higher profits every 3 months.  When push comes to shove, the human body will do what it damn well pleases.  You can’t force Mother Nature to perform on a quarterly basis.  See Derek Lowe’s post on GSK’s mystifying new scheme for creating a pharma division with a racecar fuel manufacturing facility.  We have no idea what GSK is thinking but we are aware of some computer chip manufacturers complete cluelessness when it comes to drug research.  You can’t research a drug the same way you research a chip.   And MBAs who do not understand their business will do dumb things when they are under pressure to produce profits.  Biomedical research is unlike any other form of high tech research.  You can’t pair the two and expect that the cells that the biologists are working with will suddenly get a clue and get with the program.  And this is why the patent problem is also different for the pharma industry because shortened research cost recuperation times leads to a lot of very stupid short-term thinking.

If I were to reform patents, I’d stop the patent clock while the drug was going through the clinical and approval process and resume it after approval.  Then make a deal with the pharma industry to ease up on pricing in exchange for longer exclusivity.  This accomplishes two goals: it takes the pressure off of pharma to price the hell out of the drug and it steers them back towards long term planning.  If they know the patent cliff isn’t looming a few years down the line, the pace of mergers and restructuring might slow down and research would have some breathing room to get back to business.  It’s a theory.  There’s always a way for the financial class to game the system so thinking this through carefully and plugging the loopholes would be very important.  But that’s what I expect from my congressmen- careful, meticulous examination of the problem with reasonable solutions.  Changing the first to invent to first to apply rule did not do that and may have inadvertently exposed entrepreneurial labs to additional risk and expense.  Well, inadvertently to Congress; opportunistically to the big pharma vulture capitalists.  Hey, it’s a business.

Anyway, it’s something to think about.  It’s not just CNS drugs.  Antibiotics are also losing their shine with the big pharma giants.  Too many lawsuits.  Oh, well.