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No. 158: Drug Research Oversight

Private equity firms now control the watchdogs tasked with protecting patients in drug trials, and they're selling services to the same pharmaceutical companies they're supposed to oversee.

No. 158: Drug Research Oversight
Photo by Christina Victoria Craft / Unsplash

The idea of a watchdog or third party implies a sort of trust that comes from being an independent observer. That is increasingly not the case for drug trials, however, as commercial ethics boards with ties to private equity are largely replacing university-based oversight.

It makes sense if you're the company – there's an efficiency, and therefore profitability, to be gained if you control all aspects of the development pipeline – but there's a benefit to slow, deliberate independence when it comes to safety. That applies not just to pharmaceutical research but to other safety-critical industries as well.

On the job front this week, I'm sharing an excellent people function role with an organization that focuses on a better justice system and its impact on our communities. I'm also revisiting my love for recommerce with links to two major players in the space – ideal for finding bargains at popular retailers by giving products a second life.

~ Greg

What we're reading

Private equity firms now control the watchdogs tasked with protecting patients in drug trials, and they're selling services to the same pharmaceutical companies they're supposed to oversee. (NYT)

  • Commercial ethics boards have replaced university-based nonprofit panels as the primary gatekeepers for human trials. Two companies control most of this market, both of which are backed by private equity with deep pharmaceutical industry ties.
    • For example, Novo Nordisk's corporate parent invested in WCG Clinical in 2019. Since that investment, Novo's use of WCG for trial reviews jumped from 17 approvals over seven years to 46 approvals thereafter.
    • That sort of horizontal integration makes sense financially, but it raises questions about independence when your owner is also your client.
  • Compounding the concern is that these firms like WCG have expanded beyond their oversight roles into helping companies design and execute drug trials as well.
    • Imagine if building inspectors also offered construction consulting to developers then reviewed those same buildings for code compliance. The conflicts seem obvious from the outside, yet there's minimal regulatory scrutiny of this arrangement.
  • WCG now makes more revenue helping companies design and execute trials than it does reviewing them for safety. Private equity changes the incentives.
    • Former staffers describe intense pressure to process reviews faster, including daily quotas for consent form approvals and bonuses tied to volume.
    • The emphasis on speed doesn't leave much room for pausing to ask harder questions about participant protection. If anything, you want the ethics board to be more deliberate about participation than the patients, some of whom are on drug trials simply because they're out of options and are more willing to take a risk on something new.
  • What worries me is the opacity of the oversight process. There's no way to evaluate the quality of individual reviews, no prohibition on performance metrics that prioritize throughput, and no mechanism to determine if corporate relationships compromise decisions.
    • You've heard me say before – quoting Switch – that what looks like a people problem is often a situation problem. We discuss incentives and how they drive behaviors, and if you want to make a difference in social impact, you need to ask why people are behaving the way they are.
    • In this case, we know some of the incentives at play but the system is opaque. Until there's sufficient transparency, it's near impossible to ensure patient health is prioritized over the profit objectives of private equity.

Job of the week

This week, I'm highlighting an opportunity at the Center for Justice Innovation, a longstanding nonprofit that focuses on safety and racial justice by partnering with their communities and the court system to improve outcomes. We've discussed the need to drive to root cause when we're implementing social impact solutions, and the Center is a great example of what it means to work on the foundational issues driving people into the justice system.

You'll find a series of job opportunities on their website, but I'll highlight one at the center of their people function: Director, Employee Experience and Organizational Development. This is the kind of role perfect for someone who loves building culture and understands how different aspects of the employee experience – recognition, benefits, wellness, and recruiting – intersect to create the kind of place people love to work. If that sounds like your next passion project, be sure to check this one out.

Community roundup

  • It's no secret that what gets reported in the media has an impact on public opinion, and fossil fuels tend to get the most attention when it comes to greenhouse gas emissions. Food and agriculture also contribute one-third of greenhouse gas emissions, however, and Sentient Media recently studied how that relationship gets communicated in major media outlets. (The Guardian)
    • In short, not very much: only 4% of the articles they reviewed mentioned animal agriculture and meat production as a source of carbon emissions.
    • At one point, there was a major push for plant-based foods with climate impact as one of the key selling points. I can't imagine a lot of revenue growth in that industry if you aren't top of mind in the media.
  • I mentioned a while back that some major banks had stepped out of the Net-Zero Banking Alliance in response to political and market pressures. The Alliance was set to discuss a framework initiative rather than a membership-based organization, but at that meeting, they dissolved the group altogether. (Reuters)
    • The underlying guidance and resources to help banks decarbonize will remain, but I doubt we'll see cooperation like this in the near future.
  • In another example of an industry falling behind on their climate commitments, utilities are doing worse now than they were five years ago when the Sierra Club started tracking their efforts. (Grist)
    • Two drivers of the backwards trend are the increased electricity demand to power data centers, particularly for artificial intelligence, and a resurgence of fossil-fuel-friendly policies at the national level.
  • A company has a futuristic idea – some might say far-fetched – to protect the San Rafael, California Canal area from rising sea levels by using robots to raise the land. (Inside Climate News)
    • The company, Terranova, would drill into the ground and inject it with wood, water, and thickening agents to effectively inflate the land from below. Sequestering the carbon in the wood would help generate carbon credits to offset the cost of the project.
    • That cost is substantial, as you can imagine: $92 million up front plus $1.5 million in maintenance every year thereafter.
  • Lastly, Jane Goodall, famed primatologist and conservationist, has passed away at 91. (NYT)

Civic corner

  • I noted above that utilities are falling behind in part due to the demands of data centers. In New Jersey, the legislature has sent a bill to the governor's desk that would require data center operators to disclose their water and electricity usage on a quarterly basis. (Inside Climate News)
    • The New Jersey Business & Industry Association is lobbying the governor's office to veto the bill, saying it's redundant. They note that the current usage meets existing environmental and utility regulations.
    • I kind of buy that argument – the law is complicated enough as is without two laws trying to do the same type of thing. But rather than veto this bill and walk away, I'd like to see the legislature amend the existing regulations to include this provision.
  • Democrats have reintroduced a bill aiming to expand the Child Care Access Means Parents in School program, which provides child care grants to low-income students to help them shoulder the costs while pursuing higher education. (The 19th)
    • The existing program is already in the crosshairs: the Department of Education has not opened the application process for this year and has notified more than a dozen colleges that they will not be receiving grant funding.
  • The government shutdown has made it difficult for the National Parks to remain open and increased the risk of vandalism due to the lack of support staff. Some local governments and nonprofit organizations are stepping up in the meantime to keep the parks open. (National Parks Traveler)
    • The Utah Office of Tourism and Film has committed to keeping the five Utahn National Parks open in partnership with public and private partners, something it did during the shutdowns in 2013 and 2018.
    • Likewise, The Friends of Vicksburg is paying $2,000 per day to keep the Vicksburg National Military Park in Mississippi open throughout the shutdown. They specifically cited relic hunters as a concern, which makes sense given park is a former Civil War battlefield.
    • I have been looking at Recreation.gov and the NPS apps on my phone, and both have disclaimers about the lack of services and support, including the inability to make reservations and site closures.
  • Also adding pressure to the shutdown, the Department of Energy announced that it was terminating $7.56 billion of clean energy funding, specifically in states that voted for Harris in 2024. (Axios)

Hot job opportunities

Resource of the week

One trend that I love to see is the rise of recommerce sites: websites from major brands like Levi's, Patagonia, and REI that sell used versions of their products to give them a second life.

I've purchased a number of items this way, and every time I do so it feels like I got a great deal. For example, I managed two pairs of Allbirds shoes for under $100, one that was used and one that was a factory second – that's when it's a perfectly serviceable product with some sort of minor quality defect. I also picked up a used quarter zip pullover and fleece jacket from The North Face a while back, and again, I saved a buck and felt like I was doing something tangible to reduce waste.

Lest you wonder whether you're making a compromise by going the recommerce route, that hasn't been my experience – I literally got complimented by a stranger at Costco about my new (used) pullover.

Two major players in this circular approach to e-commerce are Trove and Archive – they power a lot of these storefronts with their software. If you visit their websites, they share links to their partners' storefronts – one page for Trove, and one page for Archive. Both sources are great places to dip your toe into recommerce if you've never tried it.

Test your knowledge

You know Earth Day, right? Well, a new group recently created a nationwide event focused on solar energy that was designed to channel the impact of the original Earth Day, and I asked you to guess what it was.

It's called Sun Day, not to be confused with Sunday, which is in fact when it took place – Sunday, September 21st. There's a good chance there was an event taking place near you, and I wouldn't be surprised if you participated: more than 450 Sun Day events were planned.

Up near where I live in the Pacific Northwest, much has been made of a series of dam removals and their impact on the local wildlife and surrounding communities. Any chance you're familiar with the associated river?

What river’s dams were recently removed, prompting indigenous kayakers to complete a journey from its headwaters to the Pacific Ocean for the first time in a century?

Email me your guess, and I'll send one lucky winner a couple of One Work stickers!

If you read this far, I have some news: this month will be my last writing the One Work newsletter. I've enjoyed the opportunity to share this corner of the internet with you, and even some in person time, too. Unfortunately, my circumstances have changed such that I need more flexibility than a weekly newsletter provides, and I didn't feel like I could consistently deliver the kind of quality you deserve in your inbox.

That said, I've been thinking about how to turn what I've written into a resource you can use even after the newsletters stop flowing. If you have any feedback on what you'd find most useful, feel free to reply to this email – I'd love to support your social impact endeavors if I can!