HRS: Industry-physician relations needed, but with caveats
DENVER—While oversight committees and others have concerns about medical and industry financial relationship, Susan J. Thompson, JD, of Boston Scientific, said these relationships have the potential to lead to better patient outcomes, during a presentation Wednesday here at the 31st annual Heart Rhythm Society scientific sessions.
“I think it’s important to step back and ask, Why are we [the industry] paying for anything at all?'” said Thompson during a health policy town hall meeting regarding the financial relationships with the industry.
According to Thompson, collaborations between physicians and medical device and pharmaceutical company’s may actually lead to improved patient care, increased physician training and greater industry innovation.
“At a fundamental level, it’s really about improving patient care and improving the quality of care,” said Thompson.
Additionally, she said that these collaborations can provide companies with corporate citizenship”and often corporations support the space in which they operate.
“So, if everything is all baseball and apple pie, why are we having this conversation?” asked Thompson. “There’s a right way to do things and there is a wrong way to do things, sometimes you do things the right way, but you give the impression that you are doing them the wrong way,” she explained.
Thompson explained that often there are a large number of red flags that are often raised during the linked agendas which comprise device companies, physicians and continued medical education (CME) programs.
“The industry is providing something of value to healthcare professionals and with the independent device we are selling you, there is always the risk that we are doing so for the wrong reasons and we are trying to buy a business,” she said.
Thompson said that one of the major missteps that the industry can make is the utilization of grant support, donations or anything that is directed by sales and marketing.
“The theory is that there’s an inherent conflict of interest when someone on your sales force is paid commission to sell devices and is involved in the decision making around something of value,” she said.
Recently, said Thompson, slight missteps in disclosing the proper information to policymakers has raised eyebrows and has led to the tightening of ACC and other guidelines.
Thompson said that an education initiative funded by the industry that is “light in content” and may not be as educational or scientific in nature is something that can cause problems.
Thompson also offered advice to shy away from off-label concerns, what she said is the industry's greatest risk.
She defines this issue as tricky due to the fact that physicians can use and implant devices in an off-label manner. Although they may not be reimbursed for its use, the FDA forbids device corporations from promoting off-label uses for devices and drugs.
“The threshold question for the FDA is, 'Is this truly an independent program and therefore not regulated speech or is this really just a promotional program disguised as a CME program?'”
To moderate the aforementioned risks, Thompson said that a company should set up a grant committee where all decisions are made on an ad-hoc basis. “You want the full picture and you want the right folks making that decision.”
One decision maker, even if this person is an executive leader, may not be enough, she said. A grant committee comprising members of medical, clinical, regulatory and legal affairs can help to properly evaluate the programs.
More importantly, though, is establishing grant decision making criteria. “Having no criteria is bad, but establishing criteria and not following it is arguably worse,” she said.
Additionally, to avoid the subpoenas that so many device companies have been hit with she urged those in the industry to follow processes and document and disclose information well.
Steve Nissen, MD, of the Cleveland Clinic, asked why the medical industry thinks its okay to have CME programs paid for by the industry when most other professions pay out of pocket for continued education.
Panelists said that if the industry didn't pay for fellows, etc., there would most likely be "huge implications," including significant increases in dues.
“I think it’s important to step back and ask, Why are we [the industry] paying for anything at all?'” said Thompson during a health policy town hall meeting regarding the financial relationships with the industry.
According to Thompson, collaborations between physicians and medical device and pharmaceutical company’s may actually lead to improved patient care, increased physician training and greater industry innovation.
“At a fundamental level, it’s really about improving patient care and improving the quality of care,” said Thompson.
Additionally, she said that these collaborations can provide companies with corporate citizenship”and often corporations support the space in which they operate.
“So, if everything is all baseball and apple pie, why are we having this conversation?” asked Thompson. “There’s a right way to do things and there is a wrong way to do things, sometimes you do things the right way, but you give the impression that you are doing them the wrong way,” she explained.
Thompson explained that often there are a large number of red flags that are often raised during the linked agendas which comprise device companies, physicians and continued medical education (CME) programs.
“The industry is providing something of value to healthcare professionals and with the independent device we are selling you, there is always the risk that we are doing so for the wrong reasons and we are trying to buy a business,” she said.
Thompson said that one of the major missteps that the industry can make is the utilization of grant support, donations or anything that is directed by sales and marketing.
“The theory is that there’s an inherent conflict of interest when someone on your sales force is paid commission to sell devices and is involved in the decision making around something of value,” she said.
Recently, said Thompson, slight missteps in disclosing the proper information to policymakers has raised eyebrows and has led to the tightening of ACC and other guidelines.
Thompson said that an education initiative funded by the industry that is “light in content” and may not be as educational or scientific in nature is something that can cause problems.
Thompson also offered advice to shy away from off-label concerns, what she said is the industry's greatest risk.
She defines this issue as tricky due to the fact that physicians can use and implant devices in an off-label manner. Although they may not be reimbursed for its use, the FDA forbids device corporations from promoting off-label uses for devices and drugs.
“The threshold question for the FDA is, 'Is this truly an independent program and therefore not regulated speech or is this really just a promotional program disguised as a CME program?'”
To moderate the aforementioned risks, Thompson said that a company should set up a grant committee where all decisions are made on an ad-hoc basis. “You want the full picture and you want the right folks making that decision.”
One decision maker, even if this person is an executive leader, may not be enough, she said. A grant committee comprising members of medical, clinical, regulatory and legal affairs can help to properly evaluate the programs.
More importantly, though, is establishing grant decision making criteria. “Having no criteria is bad, but establishing criteria and not following it is arguably worse,” she said.
Additionally, to avoid the subpoenas that so many device companies have been hit with she urged those in the industry to follow processes and document and disclose information well.
Steve Nissen, MD, of the Cleveland Clinic, asked why the medical industry thinks its okay to have CME programs paid for by the industry when most other professions pay out of pocket for continued education.
Panelists said that if the industry didn't pay for fellows, etc., there would most likely be "huge implications," including significant increases in dues.