A recent commentary from Nature Medicine explained how recent “concerns about conflicts of interest have driven a wedge between academia and the pharmaceutical and devices industries.”
The article, written by three researchers from the University of California, San Francisco, noted that, “Although elevated concern for bias is justified, particularly when academics may affect drug sales, partnerships between industry and academia are essential to achieve the full promise of health improvement from the public investment in biomedical research.”
Instead of creating further separation between academia and industry, the authors asserted that, “new models for such partnerships should be encouraged” and policies should be created to ensure that these relationships continue to develop.
“Conflicts of Interest”
Over the past several years, a few rare cases of “conflicts of interest” have occurred involving undisclosed financial ties between faculty at academic medical centers and industry, some with multimillion-dollar payouts to prominent experts. These cases “have led to pillorying of the academics and, by association, their home institutions, putting a chill on ties between academia and industry.”
The chill has come from strict policies and rules prohibiting physician-industry relationships. The problem with such changes is that “not all such ties are nefarious, and much value may be lost if collaboration is discouraged.”
There is no doubt that conflicts of interest have important consequences, particularly when bias could affect the approval or use of therapeutics. For example, when a “lecturer recommends a treatment from a manufacturer with which he or she has undisclosed ties, a breach of trust has occurred. Similarly, conflicts may subvert the objectivity of guideline development. Accordingly, the authors noted “the need for greater transparency and control of potential conflicts.”
While increasing transparency is certainly appropriate to ensure that academic-industry relationships are viewed favorably, academic institutions have responded to revelations of conflicts of interest by setting policies that are more explicit. These policies include requiring full public disclosure of all financial ties, limiting campus access of pharmaceutical company employees and setting strict limits on the types of ties and amounts of compensation. However, in the heat of apprehension and sometimes embarrassment, “such policies may have unintended negative consequences, driving a wedge between academia and industry.”
For example, the need to declare travel reimbursement as a conflict of interest for attendance at an industry-sponsored professional meeting (the current policy at our institution) “seems an excessive regulation that stigmatizes useful and mutually beneficial relationships.” However, there is no place for promotional junkets, gifts and expensive entertainment, and personal compensation should never be the primary motivation for academics to work with industry.
Alternatively, the authors noted that, “relationships with industry that are not financial in nature but valuable to the academic investigator’s career—for example, deals involving access to industry-owned technology, use of databases or leadership of clinical trials—may not require disclosures in the current academic environment but probably should, as these are potentially significant sources of bias.”
Consequently, policies at academic medical centers have created an “atmosphere of inquisition that has forced distance, causing many faculty to avoid contacts with industry in fear of being called out as corrupt.” And the press has continued to fuel this concern by publishing sensationalist articles discussing many prominent experts “for reasons other than glorious discoveries.”
Physician-Industry Relationships
Critics of industry cannot deny the importance of academic-industry collaboration in improving health. “Academic researchers judge their relationships with industry to be very meaningful, and nonfinancial relationships may be as important as financial ones.”
Physician-industry relationships include many examples of discoveries made and patented by universities, now licensed by pharmaceutical and device companies, and. several of these are blockbuster drugs with major health benefits and financial returns to academia. The discovery and development of imatinib— a highly effective and widely used cancer drug—is a compelling example.
A scientist from industry, Nicholas Lydon, partnered with an academic investigator, Brian Druker, to identify novel compounds to inhibit a tyrosine kinase inhibitor implicated in chronic myelogenous leukemia (CML). The identification and early clinical testing of imatinib was recognized by their selection, along with Charles Sawyers, as Lasker-DeBakey Clinical Medical Research Award recipients in 2009. Imatinib is now recommended as first-line therapy for many patients with CML and has been credited with substantial improvements in quality of life.
Although “Academic medical centers are a natural engine for biomedical discovery … academics also tend to be inefficient and distractible, and may not be focused on a mission of improving health.” Moreover, “academia is not charged or organized to bring therapies to the public … and faculty members often lack the knowledge and interest to identify discoveries that could form the basis for new therapies and to shepherd an agent forward through development.” In addition, access is limited to funding and infrastructure to support the practical steps of translation.
The role that academia and industry have in improving health through biomedical sciences is critical, considering the rate of new drug approvals continues to decrease. Even with a profound increase in the funding of medical research over the last 20 years, the rate of new drug approvals has not increased. “Given that translation is generally dependent on passing the baton to industry, discouraging free discourse between academia and industry is likely to result in an even slower rate of new drug discovery.”
While some have suggested eliminating intellectual property concerns from academic discoveries to improve translational research, the authors asserted two reasons why this notion is problematic.
“First, given the low yield of candidate drugs in development, the inability to control intellectual property would become a major disincentive for companies to invest the money required to take a potential drug through clinical testing to market, recently estimated to average $171 million; when failures are considered, the cost of development is estimated at $1.2 billion for a drug that ultimately is approved by the US Food and Drug Administration.”
“Second, without free transfer of knowledge, skill sets and reagents between academia and industry, the energy of activation to move some discoveries into further development may be too great.”
Conclusion
The biomedical industry and academic investigators share the same goal of improving health and patient outcomes. For example, preclinical research, early-phase clinical trials, and incentives to produce reliable evidence and report it accurately are important to both industry and academics. However, several incidents in the past have impaired public trust in academic medical centers, which is troublesome because trust is a chief predictor of successful university-industry partnerships.
To restore the trust in academic-industry relationships and collaboration, academic medical centers have begun to fully disclose and carefully manage research collaborations. These relationships should be disclosed “not as scarlet letters but as medals of pride.” Those capitalizing most on academic-industry collaborations are more likely to improve public health through new discoveries, a major accomplishment and the truest measure of success.
Consequently, “new partnerships will need to reduce barriers, improve trust, preserve scientific freedom and deliver adequate returns for both parties: a tall order that will require careful planning and management.”
Ultimately, the public benefits of discoveries made in academia are realized only when they have been translated into use through industry. Unlike academia, “industry is designed to effectively and efficiently produce and distribute therapies. Thus, academia and industry each have an essential role in improving health through biomedical discoveries.” Accordingly, we should be searching for ways to promote strategic research interactions between academia and industry, not setting policies that prevent them.