In CV research, academic-industry collaborations can fuel new advances

Eugene Braunwald

MUNICH — The history of cardiovascular discoveries is rooted in the collaboration of researchers from academia and industry, who share common goals to improve health but also must avoid conflicts that can call objectivity into question, according to a speaker at the European Society of Cardiology Congress.

The groundbreaking discoveries of the steps behind the biosynthesis of cholesterol, the identified receptors for LDL and the eventual statin therapies that followed were all the result of collaborations between academic and industry researchers, who often shared information to advance a goal, Eugene Braunwald, MD, founding chairman of the TIMI Study Group, professor of medicine at Harvard Medical School and a member of the Cardiology Today Editorial Board, said during a keynote presentation. That joint research, Braunwald said, demonstrated academic/industrial relations at their best.

“The basic research was extraordinary, but despite their five combined Nobel prizes, the scientists and their universities and their research institutes were not equipped to develop an efficacious state of the drug,” Braunwald said. “To accomplish this, industry, with its massive intellectual and physical resources, was essential.”

In additional to the discoveries that led to statin therapy, there are hundreds of other examples in which academia and industry have had joint supporting roles, Braunwald said, including in the development of PSCK9 monoclonal antibodies and sacubitril/valsartan for the treatment of HF. Interventional cardiology, too, has seen developments thanks to these collaborations, including inserted defibrillators, transcatheter aortic valve replacement and drug-eluting stents, in which engineers and industry have played important roles to create life-prolonging discoveries, he said.

“I believe that investigators working in academia and in industry share common, overriding goals to improve health,” Braunwald said. “Both groups also want the results of their work to contribute meaningfully to these goals.”

Maintaining objectivity

There are different incentives behind the two sides of research, Braunwald said.

Investigators working within academia have a responsibility for teaching students and mentoring the next generation of scientists, he said, whereas in industry, investigators are expected to develop clinical advances to enhance the financial return to the investors in the companies which employ them. Investigators often receive performance-driven bonuses, often in the form of company stocks, which can provide additional incentive to reach their goals, he said.

“There have been concerns that these financial considerations might introduce some bias to the interpretation of their research; however, we have to remember, before a product can be registered and marketed, the design of the studies are carefully assessed by the regulatory agencies who are often working with independent academic reviewers,” Braunwald said.

Ideally, Braunwald said, the research of academic investigators is the disinterested search for the truth; however, like their counterparts in industry, academic investigators also have a lot riding on the outcomes of their research.

“These outcomes influence their future research or their academic rank, and in many instances, their salaries,” Braunwald said, “Therefore, both academic and industry investigators are motivated to achieve positive outcomes in their research.”

Academic researchers have not been immune when it comes to concerns regarding financial matters or bias, Braunwald said. There is a wide spectrum of relationships between academic investigators and industry, ranging from industry grants to a researcher’s institution, impacting the person’s salary, to an academic investigator performing consultant services. Problems can arise when academics receive a significant fraction of their income directly from industry, Braunwald said. Examples include academics serving as spokespersons for specific products or delivering a series of sponsor-developed lectures.

“These activities may be quite rewarding financially, but they often result in the investigators objectivity being questioned,” Braunwald said. “Fortunately, there are now strict rules for the complete disclosure of industry relations in all journal articles and public presentations. These disclosures are an example of the adage that sunlight is the best disinfectant.”

Future of research

The last 6 decades have produced groundbreaking discoveries in cardiovascular medicine, Braunwald said, and the recent advances in genetics, chemistry, bioengineering and the management of big data mean more exciting advances in clinical cardiovascular research are on the horizon.

“One thing is clear: Collaboration between academia and industry will become even more important when applying these emerging technologies,” Braunwald said. “While we take pride in the accomplishments of cardiovascular research over the last 65 years, I firmly believe the best is yet to come.” – by Regina Schaffer

Reference:

Braunwald E. Inaugural session. Presented at: European Society of Cardiology Congress; Aug. 25-29, 2018; Munich.

Disclosure: Braunwald reports he receives grant/research support from Merck.