What’s the Role of Experts? A Review of The Death of Expertise and Some Thoughts for Biopharma

This piece originally appeared in The Timmerman Report. 

 

The Death of Expertise by Tom Nichols, 2017, Oxford University Press.

If you’re reading this, chances are you’re an expert or well on your way to becoming one. The Timmerman Report is tailored by content and intent to be valuable to those with the knowledge, experience and interest to make biopharma news worth reading. Experts, in other words.

This isn’t a trivial point: for the vast majority of people—that is, those non-expert in biopharma—news in sites like this one or STAT or Endpoints is as useful as scuba equipment to an octopus. And that’s fine; that’s how our knowledge-based society works. Individuals become experts in specific fields, they take the time and effort to master a specific area and they build up the intellectual framework to enable advances, discoveries and explanations. Specialization underlies the technological, societal and scientific wonders we take for granted today. There are just too many fields of study for any one person to master, the Maesters of a Song of Ice and Fire aside. Divide and conquer isn’t just for Roman governance philosophy; it also makes for progress.

The natural corollary is that we are all affected by what experts outside our field say and do. Lacking a working and academic knowledge of biopharma does not immunize a person from the impact of the kinds of issues, news, and discoveries discussed and reported here. Drug pricing, innovation, access and healthcare quality and affordability have huge impacts on everyone in the US.

And boy, do many of them have opinions about that! Opinions that they hold tighter and higher than the words of experts. Opinions that influence the ways in which they speak, act, think and yes, sometimes, vote.

This growing issue is at the heart of Tom Nichols’ book, The Death of Expertise. Nichols, a professor in National Security Affairs at the Naval War College and adjunct at the Harvard Extension School, is a former Senate aide and an expert in Soviet studies. I first became familiar with his work when, after last year’s US Presidential Election, I started consciously expanding the circle of thinkers I listened to. Like Daniel MacArthur and many others of a more liberal bent, I’ve tried to find and listen to people on the center and right.

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Why Every Biopharma Lab Should Have a 3D Printer (and a Laser Cutter Too)

This article first appeared in the Timmerman Report.

If there’s something most drug development people can agree upon today it’s that the industry needs more valuable new products. Too many drugs seem incremental, and me-too drugs, while providing nuance, flexibility and value within a given drug class, are not by definition innovative, unless your definition of innovative is “like that, but in red.” And that’s why I’d like to propose something that would be simple, cheap and yet also have the potential to unlock creativity on a broad scale.

The biopharma industry should dive into the maker movement and buy up a bunch of 3D printers. Laser cutters too.

For those unfamiliar, a consumer-grade 3D printer is simply a device that, using one of several methods, extrudes plastic in a controlled way to build a three dimensional object. The plastic is cheap (it’s the same stuff LEGOs are made of) and the resulting items can be impressively complex. Look here to get an idea of the kinds of things people make.

Neat, huh?

When I first started learning about 3D printers, the first consumer models were just coming out. They have gone from novelty to ubiquitous in just a few years. They’re at hobby stores and even those strange stores you only ever see in airports. You know, the ones that sell stylized toys for businesspeople who’ve realized at the last minute they forgot to buy the loved ones a gift. But don’t underestimate 3D printers as cheap commodity tools. There may be an advantage in getting them into your lab.

But I’m getting ahead of myself. Why would you want one?

Let’s break up reasons into the practical, the aspirational and the big picture.

On the practical level—have you noticed just how many things in the lab are flimsy pieces of plastic? Test tube holders and racks. Spacers. Gel combs. Which leads to another question: Have you noticed how  a gel comb from Fisher Scientific can cost $77? With a 3D printer and some basic CAD software (there are many cheap and free programs) you could create a comb of whatever dimensions you’d like for a few dollars of plastic and a few hours printing time. Also, there are several online libraries (here’s one. Here’s another) where you can just search for patterns, without having to design items yourself. Like any kind of code, once a pattern is written, it’s there forever to be used and modified, creating exponential levels of creativity and a long tail market for ideas.

And that’s the second reason: aspiration. Using a 3D printer gives people an opportunity to tinker, to design, to grow. It’s been shown for a while that employee engagement is a key factor in increasing the probability of business success. For some workers (I freely admit, not all), the chance to design one’s own tools in the lab could lead to greater engagement in problems and experiments, and the opportunity to think of different ways to approach experiments. Tapping into that creativity, especially among technicians who do the majority of lab work, could be powerful. While the US leads the world in the leeway and freedom it allows technicians, I’ve known many people who work at that level whose talents weren’t fully utilized because there weren’t enough outlets for their thinking.

Last, I don’t know if you’ve noticed but there have been some big picture issues lately with sustainability in the industry. While we’ve got more tools, more smart people, and more money in the industry than ever before, the rate of new drug approvals isn’t keeping pace. And with the new Tweeter-in-chief, it’s unlikely price increases will be able to keep the industry afloat, despite what some commentators say. That means companies need to start thinking outside of the box to come up with more new products. Several striking papers have come out over the past few years about using 3D printing to create various kinds of medical devices such as prosthetics, and even tissues. The 3D printing community has largely been driven by architects and engineers and designers. Biopharma and biomedical researchers ought to be able to figure out the business opportunities.

And I haven’t even gotten to laser cutters, which provide a whole additional way to create new designs and constructs (full disclosure: I know several people at GlowForge, a laser-cutter startup in Seattle) by etching and cutting a wide variety of materials at the micron scale. The potential for combining 3D printers and laser cutters to create innovative microfluidic devices, for example, seems huge.

So here’s my advice: most 3D printers are probably below your purchasing authority. Get one, sneak it in, hide it in your office or maybe on a low shelf near the old copies of Nature that your boss will never throw out, and tell anyone who asks that it’s a broken microwave. And then, when no one’s looking…create!

 

It’s time for biopharma to embrace public health

This piece first appeared in the Timmerman Report.

Some years ago when I was working for a large biopharma, I heard a story. It seems a senior scientific executive had visited and given a seminar in which he described the company’s portfolio of drugs for type 2 diabetes. The company was projecting great uptake and profits. A member of our site raised his hand and said, “But if people just ate less and exercised a little more, they could prevent type 2 diabetes and the market would disappear.”

The answer: “Yeah, but they won’t.”

Harsh! But that executive was right. The Institute for Health Metrics and Evaluation (IHME) recently published a paper in JAMA describing how much different health conditions contribute to private and public health spending in the US. Number one? Diabetes. Following that were heart disease and chronic pain. These are chronic lifestyle diseases with big environmental and behavioral components, and the data make me wonder if there’s an opportunity here for the industry to zig and do some things that, in the long run, may make drug development more sustainable.

I think it’s time for biopharma to get involved in public health. Continue reading

How Brexit changed the way I look at biopharma’s reputation problem

This piece originally appeared in the Timmerman Report.

You may have heard something recently about Britain, the European Union (EU), some vote or other, chaos, turmoil, blah, blah, blah…You might also have heard how the presumptive Republican nominee for President of the United States has gotten to that position by identifying a strong thread of anti-establishment, populist sentiment in the US. And you may have heard that biotech and pharma is suffering from a reputation problem.

One of these things is not like the other, right?

I’m not so sure.

That biopharma has a reputation problem isn’t in doubt. The question, though, is how the industry got here. I want to know this because, thinking like many drug developers, I believe that by knowing the cause of a condition a fix can more easily be found.

There have been numerous candidate reasons, and I’m open to the idea that the cause is multifaceted just like it is for many chronic diseases. In the past year alone we’ve had the Martin Shkreli circus, admonishments about drug pricing from political candidates, analyses of how yearly increases in pricing often outstrip inflation, Pfizer pursuing quizzical acquisitions to avoid paying taxes, and companies suing the FDA to prevent generic competition. Biopharma’s problems go further back, as well, and examples of less than exemplary behavior abound. Hey, I was working at Merck when Vioxx was happening.

But Brexit points to something else. While it makes sense to look for behaviors by biopharma for causes for the reputation problem, business doesn’t happen in a vacuum. Political and social trends over the past few years suggest a rejection of elite opinion and earned expertise that is touching many parts of society and culture. Derek Lowe at In the Pipeline had a recent fascinating post on this phenomenon in the context of Right to Try laws (and also delving into Trump and Brexit). As he points out, Right to Try laws sit in that thorny spot where technological knowledge of drug development and Libertarian impulses collide. I can come up with a half dozen reasons why I think Right to Try laws are in general a bad idea, and none of them will sway someone who wants access to an experimental therapy for their dying child. You can see this playing out in the debate about whether eteplirsen should be approved for Duchenne Muscular Dystrophy.

Where did this suspicious, and sometimes hostile, reaction to elites and expert opinion come from? MSNBC anchor Chris Hayes, among others, has posited that over the past several years many people have suffered the effects of broken promises and crippled expectations. If the social contract between elites and the rest of the population is that if the elites (whether they are Democrats or Republicans) are given power, everyone will benefit, then breaking that contract leads to disillusionment and, eventually, rejection. A similar analysis from another part of the political spectrum was made by Charles Murray (H/T to @ScottGottliebMD). One can also point to growing partisanship as, if not causal, at least maintaining and contributing to the diminishment of expert and elite opinion. Unfortunately, there is no precision discrediting. When one calls to question the statements of scientists on specific topics such as global warming or vaccinations, one tars with a broad brush and the whole scientific edifice takes a hit. It’s like those kids with the paint rollers in Splatoon.

From this perspective, the poor reputation of biopharma stems at least in part from larger societal trends in how people perceive expertise. Healthcare is highly complicated and technical, and it’s not a stretch to say it’s associated with the expert and the elite. Taking this perspective has some good and some bad implications for biopharma. On the good side, one can say it’s not (all) the fault of the biopharma companies’ specific actions that the industry’s reputation has suffered. But on the bad side, this makes it that much harder to fix the problem. Better general overall behaviors by companies are a prerequisite for improving biopharma’s rep, but not the final cure.

However, if biopharma is serious about its reputation, and buys into this theory, it could use this perspective in a few ways.

First, it can look at the one industry that is highly expert driven and still has a good reputation: high technology, as represented by companies like Apple and Amazon, among others. I would conjecture that these companies, by taking a very consumer-focused approach and a real dedication to innovation, simply show people repeatedly, several times a day, that they are trustworthy and worth the money. Now, this is hard to do in biopharma where product development cycles are pretty much the diametric opposite of the fail fast, hard and often ethos found in Silicon Valley companies. But the industry can do a better job of explaining its innovative and impactful products, and being honest about when new products have neither—and pricing them accordingly.

The second thing is biopharma could start taking a longer, more societally focused view in how it uses its considerable lobbying muscle. To take one example, many in the US (and Europe) feel betrayed by the obvious effects of globalization on unemployment in some job sectors. Those in favor of globalization routinely argue that everyone benefits from cheaper prices on manufactured goods and also that hundreds of millions of people in the developing world are seeing a substantial increase in their living standards. This is measurably true. It’s also an argument that doesn’t resonate at all with someone who trained and worked as a machinist for fifteen years and lost her job due to outsourcing. There’s an asymmetry in perceived benefit versus experienced insult and loss

Biopharma could push for greater investments in job retraining, in both the public and private sectors, as well as for extensions to programs such as unemployment benefits to allow people the time to get retrained. You might say that this is outside the scope of what biopharma is responsible for, but that’s a self-imposed limit. One of the arguments for why elites and experts have lost their status is that so many organizations seem to be concerned solely with narrowly defined self-interest and shareholder value; not with the workers, customers and society within which they operate.

It’s a problem, figuring out the best way to rehabilitate biopharma’s rep, but it’s a necessary one to solve for the industry’s long term health. The Trump and Sanders campaigns have demonstrated that there are large reservoirs of resentment out there that shouldn’t be ignored. And it’s not hopeless either. Large scale societal change in attitudes can be done. Canada, unlike much of the developed world, has created a culture welcoming of immigrants, and this was accomplished via a long standing, coordinated effort by the Canadian government and others to make openness a core Canadian trait. They persisted and took the long view. If biopharma can spend decades and billions of dollars in dogged pursuit of specific targets (I’m looking at you, amyloid beta), then perhaps it can do the same to try and change the environment in which we all live and work.

 

How Distributed R&D Could Spark Entrepreneurship in Biopharma

This piece originally appeared in the Timmerman Report.

Remember the patent cliff and the general lack of new and innovative medicines in the industry pipeline? That was the big story of the past decade in biopharma. It caused a lot of searching for the next best way to organize R&D to improve productivity. One doesn’t hear that quite as often today. There are more innovative drugs both recently approved and moving forward through the pipelines of several biopharma.

The conversation these days has shifted toward drug pricing, and how the public is going to pay for some of these new, exciting drugs (the answer, in some cases, is maybe it can’t).

I don’t think the industry out of the woods yet. One of the main reasons drug prices have become such an issue is because even though there are new, innovative drugs, there aren’t enough of them. At the same time many of the drugs being approved are incrementally better but nevertheless being priced at a premium. And good reporting has made the public more aware of how many of our existing drugs are rising in price on a yearly basis. Especially in a time of little inflation, prices of most goods have not been going up at nearly the rate of pharmaceuticals.

Biopharma sits in a tough place. Analyses suggest the cost of developing a new drug has generally been doubling every nine years, which may be a by-product of some combination of the complexity of biology, our inability to predict which drugs will work, and the “better than the Beatles” problem. The question then is how to overcome these issues and increase the efficiency of developing new, innovative drugs. Without some kind of change, the industry is looking at a very difficult future in which price hikes run headlong into the wall of payers who finally say enough. Then what? Continue reading