During a recent interview, Dr. Guy Chisolm, Director of the Innovation Management and Conflict of Interest program at the Cleveland Clinic, discussed the importance of maintaining and preserving academic-industry collaboration. He clearly emphasized that this partnership benefits patients, and went on to discuss a number of ways academic-industry relationships have provided innovation and better outcomes to the public.
To begin with, Dr. Chisolm explained to Dr. Steve Freeman why AMCs interact with pharmaceutical and device companies in the first place. Dr. Chisolm explained that AMCs only generate basic, translational, and clinical science. Out of those endeavors come discoveries, and from those discoveries come the potential for intellectual property, which if it comes to fruition can benefit patients.
AMCs however, are not manufacturers of science, and in order to bring discoveries into the hands of patients for their benefit, Dr. Chisolm asserted that there has to be a partnership with industry. He also recognized that this kind of interaction between academia and industry is extremely beneficial to patients.
A second reason why AMCs collaborate with industry is through consulting. Since faculty and staff at AMCs consume themselves with research, consulting gives companies a chance to understand what is needed in the medical world, where there are gaps in treatment and care, and what diseases or conditions should be focused on. This gives companies an idea of where there are markets and opportunities for devices and drugs, and it falls on the academics to consult them on what avenues for research are preferred. Dr. Chisolm explained that this interaction is also very beneficial to patients.
Another way industry and academia interact that is beneficial to patients is through clinical trials. Dr. Chisolm explained that academic-industry collaboration is crucial for performing clinical trials. This partnership is essential because every innovation and drug truly advances between AMCs and industry.
The discussion then shifted from all of the benefits from academic-industry collaboration to the potential problems. Dr. Chisolm explained that if you have faculty or the AMC itself, which are benefitting from ties with industry, there needs to be caution about the decision making process. He asserted that in cases where ties exist, faculty and AMCs must ensure that making decisions is still in line with the best interests of patients, and that all data is absolutely valid and verifiable so there is no undue influence.
Despite this potential for conflicts of interest (COI), Dr. Chisolm expressed that given the many benefits from industry-academia interactions, no one in academia or industry wants to end these beneficial partnerships, and neither does the public. Instead of trying to eliminate or hinder these relationships, he suggested that a better model is more transparency about these partnerships. This will help mitigate the influence of the financial aspect of the relationships so that it does not influence data.
Part of adopting this transparent model is to end the framing bias of calling such relationships “conflicts.” He explained how calling academic-industry partnerships a “conflict of interest” is like convicting someone of something. Such a negative connotation he recognized is not necessary. Instead, he noted the correct terminology should be “innovation management” because such relationships between AMCs and industry are productive, collaborative relations. Dr. Chisolm also recognized how institutions are beginning to use the term “outside interests,” instead of using COI.
Another function of this model, which the Cleveland Clinic has adopted, is that it does not try to hide or mask the financial relationships. It merely brings out equally the values and the potential risks of academic-industry collaboration.
In explaining the potential risks associated with academic-industry collaboration, Dr. Chisolm noted that COIs could occur when choosing what kind of drug or device to use, running a clinical trial, recruiting subjects, and the motivations behind conducting a trial (i.e. financial). However, as a recent story highlighted, the potential for COIs are not just associated with industry funding, they happen in purely academic areas as well.
Dr. Chisolm explained that in academia, you do not want to interpret data in a biased fashion because of industry involvement. Yet he recognized that it would be very difficult for an investigator in an AMC to misinterpret data because there are multiple centers collecting data. Since multiple people are handling the data, and only one has the relationship with the company, Dr. Chislom recognized that it would be a rare phenomenon with so many interactions that data could be perverted by just one of those interactions.
As a result, he acknowledged how infractions are rare. It is only because of newspaper articles that highlight these rare incidents that make them seem more prevalent. The reality is the news media are only looking for outliers because they are inherently interesting and newsworthy, which helps them sell stories. However, as Dr. Chisolm correctly pointed out, those rare infractions are not representative of what goes on, and if the public hears about a rare COI, they should recognize that.
While they may show what has happened in the past, institutions, individuals, industry and agencies have adjusted their behaviors, policies, and regulations. Dr. Chisolm noted how the people he knows in science are highly ethical. This means that when looking at these outliers in the press, people must read them with skepticism and look for corroboration of their sources.
The interview then discussed the ways AMCs can ensure that their interactions with industry are appropriate. Dr. Chisolm asserted the need for AMCs to be transparent and expose these relationships to the public so that they can answer questions from patients and the public about such partnerships. Using the Cleveland Clinic as an example of transparency, he noted how they were the first AMC to tell the public about what companies had ties to physician by using broad categories such as consulting, speaking, and education.
He recommended that AMCs should similarly develop websites and brochures for patients and the public that include the risks and benefits associated with collaborating with industry. He also noted that AMCs should be gathering information of faculty ties to industry to be looked at data by a COI committee. This committee would determine if there could be an apparent or real COI, and if so, manage it.
To measure the impact of Cleveland Clinic’s transparency, they conducted a survey last year of 1,400 patients. The survey asked questions about what patients wanted to know about doctor ties to companies. The participants were self-selected.
The results of the survey showed that the majority of patients saw the Cleveland Clinic in a positive light for willing to be transparent about ties to companies, and many felt they were handling COIs because they were being transparent about it. With respect to payments, there was a consensus among participants that payment from industry between $5,000 and $10,000 was positive because it showed that industry relied on these doctors for information the doctor knew. When payments were over $100,000, participants were more skeptical and wanted to know why so much money.
Participants also found that when physicians were making money from several different companies, they believed that doctor was on the cutting edge of innovation. When there was no money for a doctor, participants wondered if the doctor knew what was going on in his field. Overall, participants thought the ties to industry were beneficial.
The last part of the interview discussed the negative effects COI has placed on AMCs and individuals. Dr. Chisolm noted that AMCs are facing a regulatory burden that forces them to pay additional costs for resources, personnel, and infrastructure. This makes AMCs less productive in other areas like research. He touched on the recent NIH rules, and noted how NIH is aware of the beneficial ties of academia and industry, and hopes they move towards rules like innovation management.
What this means is that AMCs must be proactive about educating the public of the real risks and benefits of industry-academic ties so that we can better identify and manage the good ones, which benefit the public and patient populations. This is crucial because collaboration is so important for new products and educating doctors about new breakthroughs.
In the end, he recommended that private organizations, not the government, achieve guidelines for transparency that will help rebuild the public trust and assure them that the ways AMCs collaborate with industry will benefit them. Taking this step is important since the public, AMCs and industry does not want to end these beneficial partnerships.