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.

Maybe this seems counterproductive. As that executive pointed out, large numbers of people with chronic illnesses equate to a steady market of consumers for drugs to keep insulin levels in check, or that help people lose weight, or that keep their blood pressure low and their cholesterol levels at recommended levels. Why get involved in public health efforts aimed at preventing or reducing the severity of chronic conditions like type 2 diabetes or hypertension? After all, the biopharma companies aren’t in the business of regulating behavior and environment; they make drugs to treat conditions once they arise.

Yeah, but times have changed. Here’s why better public health can, counterintuitively, benefit the biopharma industry. If fewer people got type 2 diabetes, that would mean fewer sales for insulin and sitagliptins and GLP1 analogues, yes. But it would also mean fewer doctor visits, fewer hospitalizations and treatments for complications, fewer expenditures overall. Those spending categories far outstrip prescription drug costs. While I disagree with our President-elect on damn near everything, his zero-sum view of the world does have some application to things like healthcare budgets. As a country, there are limited dollars being chased by far too many services, providers and drugs. If one wanted to free up dollars to pay for new, innovative, expensive drugs, one way would be to make people healthier. Another, better way would be single-payer healthcare, but that’s clearly a non-starter for this time and culture.

Further, on a practical level many of these chronic diseases present huge challenges under current business models. when I look at those indications I see diseases in which we’re nearing the plateau in terms of improvements. Much more incremental change than quantum leap. The recent struggles faced by the makers of modern insulins and other anti-diabetic drugs are examples of how years of diligent R&D and drug engineering are adding up to one big yawn on the part of payers, doctors, and regulators. As patents expire, there’s less incentive on the part of patients and providers to use any of the expensive new drugs with incremental improvements—especially when they’re priced as if they’re the best thing since someone figured out you could take all the extra parts of a pig and turn them into Spam (I’m from Hawaii, this metaphor might not mean as much to you).

I’ve written before about the 80:20 rule and how it seems to apply to drug development. Another recent take on that idea is here. For many chronic, lifestyle diseases, we’ve passed the place where big leaps in efficacy can be done with relatively—relatively—little effort. The move over the past few decades to biologics and orphan indications seem like a pretty clear, if tacit, admission that this is true. Many of the orphan diseases affecting fewer people, or disease subtypes if you’ve got a precision medicine inclination, still present opportunities for big leaps with new drugs.

However, to make that model work long term, these drugs have to be priced at a high level on a per-patient basis. For a while it seemed that payers wouldn’t balk at paying these high prices given the size of orphan populations, but the Exondys 51 rollout suggests that may be ending. I’m curious to see how Biogen’s Spinraza, with a price of $750K for the first year for spinal muscular atrophy, will fare.

The other way for orphan and precision medicine drugs to provide a sustainable path is by having a much higher success rate than drugs for broader indications. While this recent report from BIO suggests rare disease drugs have up to a three times higher success rate when compared to chronic, high prevalence disease drugs (25.3% versus 8.7%), it’s unclear if that’s enough to compensate for the much smaller market without charging high yearly costs. To put it another way, unless three average orphan populations add up to the number of adults with hypertension, a company is still looking at high per patient prices to make a profit.

What would biopharma support for public health look like? Well, one practical approach would be to support initiatives like the soda taxes recently approved by Albany, San Francisco and Oakland, California, and by Boulder, Colorado. These taxes aren’t guaranteed to work, but early suggestions from Mexico and Berkeley are hopeful. Sugary beverages are one of the big sources of empty calories in the US diet and reducing soda consumption could help reduce overall incidence of diabetes and obesity.

Another approach would be working with and funding people and organizations who have made contributions to reducing obesity and increasing exercise. Michelle Obama comes to mind. I understand she may have some free time soon. And we’re soon going to need more non-governmental organizations getting involved in things like public health because early signs are the role of the federal government in that sphere may be shrinking over the next few years.

A more radical idea would be to fund work on other kinds of behavioral interventions that might help reduce obesity. While studies suggest mobile health tools like fitbits or weight loss apps aren’t going to be a cure-all, it’s early days and those kinds of tools may be part of a tailored approach to health—finding the right tools for each person rather than one size fits all. Kind of like…precision medicine?

A public health approach would have other benefits. One would be in clinical trials. Another anecdote from another friend in the industry is how once, when we were meeting for beers, he was half an hour late. When he arrived, we asked him what had happened and he said they ran into a dosing problem for a trial and he had to consult. It turns out a prospective patient weighed more than they had planned for in their enrollment criteria and their dosage tables had to be extended. By a lot. Here’s a problem with that: the pharmacokinetics and pharmacodynamics of drug engagement and clearance vary with degree of obesity (one review in antimicrobials here). If the overall population could be made healthier, these kinds of expensive exceptions would be less frequent.

And there’s always the point of reputation. Every biopharma company has as its goal the improvement of human health but that has been obscured lately. Biopharma needs a reputation overhaul. That doesn’t just have to be through not doing bad stuff. Actively doing good stuff helps too.

This is a long-term approach to improving industry health, no doubt. But with all those repatriation dollars looking likely to come back to the US, and the cost multiplier on potential acquisitions rising, maybe pushing public health, counterintuitively, could create a sustainable path for biopharma.

 

 

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