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 Valeant, Anthem, and chirping crickets suggest Saunders’ social contract is doomed

This piece originally appeared in the Timmerman Report.

When Allergan CEO Brent Saunders announced his manifesto on drug pricing at Allergan just after Labor Day, he was met with acclaim and approval (some examples here and here). He called for a return to the social contract between biopharma companies and patients. In his view, patients understood in the past that developing drugs was risky and cost a lot of time and money, and therefore patented drugs would be expensive. Drug companies, holding up their end of the social contract, felt an obligation above simple profit-making—that drugs are supposed to keep patients healthy or to get them back to that state. That meant pricing had to take into account the public good, not just profit maximizing, and be reasonable. Moving forward, Saunders announced that, among other things, Allergan would commit to value-based pricing and to limit price increases to no more than single-digit percentage hikes per year.

These are worthy and admirable goals. But I look at other recent events and can’t help feeling his effort is doomed. Continue reading

One way to improve clinical trial reporting: a Yelp-style rating system

This piece originally appeared in the Timmerman Report.

STAT recently published an in-depth report about the many research centers that don’t bother to publicly disclose the results of their clinical trials, even though they are required to do so. This follows on a New England Journal of Medicine article back in March that had a similar analysis of the lack of reporting and publication of clinical trial data to clinicaltrials.gov.

Most observers of biomedical research would agree that getting clinical trial data out about what happened in a trial is pretty important, whether the trial succeeded or failed. After all, biomedical translational research is most meaningful when done on human subjects and negative information can be quite informative and useful. Animal models are nice, but translation of results from animals to humans is a spotty proposition at best. We need to know what’s working, and what’s not, to know how to best allocate our research resources and how to treat patients.

The lack of reporting is an embarrassment for research. It’s also understandable, because so far the FDA hasn’t used its authority to punish anyone for delayed reporting. Nobody appears to have lost any research funding because they failed to post trial results in a timely manner. Universities told STAT their researchers were “too busy,” given other constraints on their time, to report their results. So what really seems to be going on is that reporting is prioritized below most other activities in clinical research.

It was interesting and eye-opening that industry fared better than academia in both the STAT story and the NEJM article with respect to how many studies have been reported. Having seen the industry process first-hand, I’d speculate that (at least for positive trials) there’s a much stronger incentive to get data out in public. Successful trial results can create buzz among clinicians and patients, revving up trial enrollment which can then help get a new drug on the market faster, and convince people to use it when it’s available. It may be that in academia the effort of getting trial results in the required format for clinicaltrials.gov is perceived as too much work, relative to the rewards. Academics are naturally going to spend more energy on directly rewarded activities like writing grant proposals and writing peer-reviewed scientific publications that help them win even more grants, promotions, and other accolades. Well okay. If this is the case, then figuring out new incentives may be key.

So what would work? Anyone who participates in a clinical trial is providing time, may be subject to risks and often is asked to provide samples that are biobanked to support future exploratory and translational research. It’s like when people donate to food banks. I’m pretty sure they mean that food to be eaten and not to sit on a shelf. These participants in clinical trials deserve to have their volunteerism rewarded.

This got me thinking about how to empower patients to get more of what they want. Patient-centered research is a buzzword these days, and for good reason. Patients have at times been an afterthought in the biomedical research enterprise. I thought of services like Yelp and Uber and Angie’s List and other peer-to-peer systems that allow users to get information, provide feedback and give ratings to specific providers. And I wondered: could this be a way to apply pressure to clinical trial researchers to improve their reporting? Continue reading

No, CRISPR-Cas won’t save the day for ag biotech

You want to know how to drive a scientist crazy? Insist that you believe something that’s not supported by current scientific evidence. Tell her vaccines cause autism, or creationism is just as valid a theory as evolution, or that climate change isn’t really happening, I mean, after all, a monster blizzard hit Washington DC this January! Global warming, pssh…

There’s an old episode of Friends that did a good job of showing how this kind of conversation goes. Phoebe professes not to believe in evolution and Ross, a paleontologist, keeps trying to convince her that evolution is real using scientific evidence and logic. He grows increasingly frustrated and insistent as she continues to deny the basis of his life’s work, finally losing it when she goads him into admitting (like a good scientist) that even theories like evolution are not immune from questioning and testing.

We train scientists to carefully generate, weigh and use evidence. To no one’s surprise, this leads many scientists to generalize and think that in all matters having to do with the physical world we all should and of course will follow the evidence. Yes, sometimes that leads to unpopular ideas, and sometimes the ideas change as the weight of evidence changes. This training can make scientists kind of boring at cocktail parties. Still, the overall scientific process keeps moving forward and it’s because of this reliance on evidence.

But many people (including, at times, even some scientists) don’t always think the same way about things in the physical world. And that’s why I’m pessimistic that CRISPR-Cas technology will peacefully resolve the Genetically Modified Organism (GMO) debate. Continue reading