Modernizing Medicare's rules

Credit: Bloomua / Shutterstock

Credit: Bloomua / Shutterstock

Technology promises to transform healthcare. It’s redefining how we interact with, and act on, our health data, and reshaping how care is delivered and coordinated. But uptake so far has been limited, particularly among the elderly and others who could benefit most from a better, smarter healthcare system.

To understand why, I argue in a new piece in TechCrunch that we need to look at federal reimbursement policies and their far-reaching, albeit often overlooked, influence on tech innovation.

Full article link here

FDA warnings: the ripple effect

Many have now added the Internet to their personal health toolbox, helping themselves and their loved ones better understand what might be ailing them.
— Pew Trust

Nearly 60% of all Americans sought health information online in 2013 (Pew Internet Project), and roughly 50% of these 'online diagnosers' subsequently consulted a clinician.

This isn't surprising.

Now, vast amounts of medical / scientific information find their way onto sites indexed by search engines (i.e., Google) and eventually filtered by sites like Wikipedia, WebMD, and others.

The real question is the filter. How accurate is the information that appears on these sites?

Take FDA's drug safety warnings, for example. It is not until new drugs and devices are used in the real world that we begin to be able to detect rare safety events. When these unanticipated side effects do emerge, it is an important job of the regulator to let patients taking the medicine and their doctors know; and we would hope that this info is available online and readily accessible.

So, along with co-authors Drs. Bourgeois and Seeger, we designed a simple study to investigate the effect (or digital imprint, if you will) of these safety warnings on Google search and Wikipedia page traffic as well as Wikipedia content. As you might have guessed, there was a surge in search traffic and page views immediately following FDA warnings.

Overall, 41% of Wikipedia pages pertaining to the drugs with new safety warnings were updated within 2 weeks after the warning was issued with information provided in the FDA announcements. Yet, 23% of Wikipedia pages were updated more than 2 weeks after the FDA warning was issued (average, 42 days), and 36% of pages remained unchanged more than 1 year later (as of January 2014).

There were other differences in how quickly the Wikipedia pages were updated. Pages for drugs treating 'common' diseases (affecting more than 1 million people in the US) were more likely to be updated quickly (58% were updated within 2 weeks) than were those for drugs designed to treat less-prevalent conditions (20% were updated within 2 weeks, P=0.03 for log-rank χ²). 

These disparities are troubling, because this information is important. Knowledge of a drug's side effects are necessary for patients to make informed decisions that weight the risks and benefits of a particular treatment.

We offer a few recommendations in our NEJM article. There are likely many, many more ways that we can improve the quality of the health information online. 

Ultimately, I suspect we canand shoulddo (much) better.

Antibiotic innovation, part I

Our article in Science on antibiotic R&D will go online later today. It’s a product of some time spent thinking about biopharmaceutical innovation and the ways that the public sector can help entrepreneurs develop the next generation of therapeutics.

There’s been a bit of press on the need for new antibiotics (Maryn McKenna has a brilliant Medium post on the topic). Antibiotics are a fundamental part of modern medicine. But, partly due to their own success, resistance to commonly prescribed antibiotics (fluoroquinolones, beta-lactams, etc.) has rapidly proliferated. The CDC estimates that ~23,000 people die annually from infections caused by antibiotic-resistant bacteria.

Yet, there’s also been a noticeable decline in new antibiotics approved by the FDA in the past decade, and even fewer new antibiotics with novel mechanisms of action.

Are antibiotics harder to get through clinical trials? Who’s developing the next generation of antibiotics and other antimicrobial drugs?

To sketch a fuller picture of the past and present of antibiotic R&D, we merged compound-by-compound data from Pharmaprojects and EvaluatePharma from 1990 to 2012. We found that nearly 60% of antibiotics are being developed by small- and medium-sized companies.

For each compound, we had information on when it entered clinical trials, and if it had failed a trial or had been discontinued for other reasons (financial, safety concerns, etc.). We fit our data to accelerated failure time models to quantify whether and to what extent antibiotics were more or less likely to survive in clinical trials than other drugs.

What does all of this mean?

We offer a few ideas in our paper. The data suggest that policymakers should focus on raising the level of antibiotic drugs entering clinical trials (since they appear to survive well once they’re in trials) and supporting small companies developing innovative new antibiotics.

There are other proposals – such as prizes – which sadly we didn’t have enough wordcount to delve into. But there are many more ways that we – consumers, government, payers, industry, clinicians, investors – can ensure that future generations have access to these lifesaving medicines. In the meantime, we should lay the groundwork for more candidates to come through the pipeline.