COMMENTARY

Are All Relationships With Industry Inherently Bad?

Michelle L. O'Donoghue, MD, MPH

Disclosures

May 25, 2016

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Hi. This is Dr Michelle O'Donoghue, reporting for Medscape. Today I thought I'd wade into some potentially dangerous waters and tackle the topic of relationships with industry. It's interesting that I'm almost nervous to broach the topic for discussion because many people have become very passionate [about it], and this has contributed to somewhat of a growing backlash against many of those who have reported relationships with industry.

The key question that I wanted to discuss with you is whether all relationships with industry are inherently a bad thing.

Understandably, there are concerns that relationships with industry may introduce the possibility of bias and may cloud our judgment. Undoubtedly, there have been instances where that is true. However, several favorable steps have been taken over the past several years to ensure greater transparency in terms of physician payments. Greater restrictions have been put in place for interactions between pharmaceutical companies and clinicians, including many restrictions on gifts. I think most of these changes are absolutely appropriate and probably long overdue.

But some of the murkier waters exist for those of us who work on clinical trials.

In our current regulatory environment, the cost of clinical trials has been exponentially increasing over the past few decades. As you are all aware, in order to be adequately powered for clinical outcomes, many cardiovascular trials are now requiring enrollment of more than 10,000 or 20,000 patients. The US Food and Drug Administration (FDA) has required greater levels of granularity on the data collected, including complete follow-up on all patients and greater depth in terms of safety assessments.

Many of these requirements are spot-on. They make intuitive sense. At the same time, they've contributed to the growing cost of clinical trials.

I mention this because it has become nearly prohibitive for government agencies such as the National Institutes of Health (NIH) to sponsor most cardiovascular trials. It has put us [researchers] in the position that we need to rely on pharmaceutical companies and industry in order to continue to advance cardiovascular research at the pace that it's been advancing.

Although there's been a call to simplify clinical trials—and hopefully we will be moving in that direction—that has not yet made it to prime time. For this reason, those of us who work on clinical trials typically receive grant funding from multiple different sponsors. Consulting agreements are often put in place so that clinical trialists can offer insights on unanswered questions and possible trial designs. Most academic research groups, however, now require that the sponsor provide an independent copy of the database at the end of the trial so that our own analyses can be conducted [and published] completely independently of the sponsor.

However, despite all of this, without a doubt it is human nature that most investigators would prefer to have a favorable outcome for their study than a neutral or negative outcome. This exists regardless of whether a trial is sponsored by the NIH, another type of government agency, or by Big Pharma. So, I think we need to move away from the concept that investigators who are conducting pharmaceutical-sponsored research have been tainted by industry.

For instance, when Rob Califf was under review to become the commissioner of the FDA, many questioned his suitability as a candidate due to his relationships with industry. However, wouldn't we want somebody at the FDA who has lived and breathed clinical trials over the past few decades and who understands intimately the challenges that exist in the current regulatory environment?

Similarly, it does not seem optimal to remove the most experienced clinical trialists as voting members of the guideline committees.

I appreciate that there are a lot of differing viewpoints on this subject and I welcome your thoughts on this. I'm sure [we can] create a healthy discussion because there will be differing viewpoints. I look forward to continuing the conversation with you. Reporting for Medscape, this is Dr Michelle O'Donoghue.

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