Public Commenting Has Been Hijacked by Biopharma

Vinay Prasad, MD, MPH


November 21, 2019

Often when a new drug or medical process is being considered for a government program, a "public comment" period is opened to get input on the potential impact. But is this input really from the public, or has this process been hijacked by the pharmaceutical industry for its own gain?

Last week in JAMA Internal Medicine, researchers at Oregon Health and Science University, including myself, published data suggesting that the public comment process has indeed been hijacked. We looked at public comments submitted to two state Medicaid agencies, Oregon and Washington, which have transparent public processes. These verbal and written "public comments" are meant to influence decisions on what services should be covered by Medicaid and for whom.

Obviously, the companies making these often costly, invasive products would prefer that they be used early, frequently, and broadly. But citizens may have different views. They may, for example, want the limited reserve of Medicaid dollars, a safety net for the most vulnerable, to be used to cover high-value, life-and-death services for as many people as possible. Rather than having these funds cover the newest drugs and devices, citizens may want them to go toward treatments that yield the greatest good.

In our analysis, led by medical student Rosa Ahn, we found that nearly all public comments were enthusiastic or advocated to expand coverage (98%). Despite inconsistent standards for disclosure, we found that 47% of "public" commenters had financial ties to the companies whose products were being discussed. These commenters were eager to cite references to justify their views, offering more than 600 in total, but these were largely poor and unreliable forms of evidence. In fact, just 31% were randomized trials.

It appears that these efforts bore fruit. When decisions changed after public comment, coverage only ever expanded.

Our paper is the latest in a growing body of work suggesting that public commenting has been hijacked. Previously we found that 30% of public speakers at US Food and Drug Administration oncology drug advisory meetings had financial ties to drug makers and 92% called for the approval of products under consideration. In a separate study, Matthew McCoy and colleagues found that 25% of public commenters at the Anesthetic and Analgesic Drug Products Advisory Committee had financial ties to a drug manufacturer. In the McCoy study, when conflicts were present, speakers were six times more likely to support drug approval.

It is not hard to see what is going on. Highly technical, bureaucratic meetings to decide whether to approve or pay for drugs and medical devices don't exactly excite the average person. The people who come to these meetings and give their feedback have to be extremely motivated and educated on the topic. While we all know a patient here or there who is passionate and devoted to one disease, ailment, or therapy, the more common scenario is that the people with the greatest desire to influence these decisions are the folks who profit from the use of these products. If there is an open mic to decide whether to pay for an implantable device, the only person I can guarantee who will show up is someone from that company.

And yet, this runs counter to the very purpose of public commenting. Medicaid agencies engage in this process because they truly want to hear the values and preferences of the people they serve. Moreover, prior to public commenting, pharmaceutical companies and device manufacturers have already had the chance to make their case. For instance, they are allocated time to present at FDA drug advisory committee meetings. Yet, it appears that this is not enough for them; many companies now seek to exert influence in the public comment portion of policy deliberations as well.

If you ask me, that's the definition of hijacking an opportunity meant for others.

Here is one proposed solution. If these agencies truly want the input of the public—and I genuinely believe that they do—they have to go out and get it. Instead of setting out a microphone or taking feedback by email, which is prone to manipulation, you have to find people where they are. Convene a focus group of randomly selected citizens in the same way that juries are solicited. Present it as a civic duty and pay a modest stipend. Explain the issue and decision at hand: What would it mean to pay for this new drug or device? What would we not be able to pay for as a result? Who benefits? And who might be harmed? In looking at this decision, what values should guide us?

We don't select juries by asking the defendant to enlist his 12 closest friends. Likewise, we can't call something "public comment" when it is one-sided and conflicted.

The public commenting process has been hijacked by biopharma and I'm afraid it can't be saved. We need a new way to hear from the people when tax dollars are being used to pay for our government's medical decisions. We need to know the values and preferences of all citizens, not just those selected by pharma.

Vinay Prasad, MD, MPH, is a hematologist/oncologist and associate professor of medicine at Oregon Health and Science University. He studies cancer drugs, health policy, and evidence-based medicine. He is the coauthor of the book Ending Medical Reversal and author of the forthcoming book Malignant: How Bad Policy and Bad Evidence Harm People with Cancer. Follow him on Twitter: @VPrasadMDMPH

Follow Medscape on Facebook, Twitter, Instagram, and YouTube


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as: