The time is now: What the opioid crisis revealed about ‘Big Pharma’

In early September 2021, the Sackler family, who made billions from OxyContin, won immunity from the opioid lawsuits that have been sweeping across the nation. But what has the opioid crisis taught us about how big pharmaceutical companies like Purdue do business?

In order to better understand, let us take a closer look at the history of scientific communication and the need for science-based roles in the pharmaceutical industry. In 1967, the company Upjohn Pharmaceuticals (now: Pfizer) recognized the need for scientifically trained staff to build rapport with Key Opinion Leaders (KOLs) in fields of different therapeutic areas and research ¹. Prior to field-based teams with scientific backgrounds, the pharmaceutical sales representative would interact and communicate with physicians and other stakeholders. With the increasing complexity of science, there was a greater need for scientific and clinically-educated teams to translate intricate data. This need gave rise to the medical science liaison (MSL) role, therefore shifting the role away from a traditional pharmaceutical sales rep as the key relationship manager with external experts.

By 2015, there was an increase in the number of medical science liaisons (MSLs) with estimates that there are now approximately over 300,000 MSLs ².  In 2016, the Accreditation Council for Medical Affairs (ACMA) launched the first accredited MSL Board Certification known as the Board Certified Medical Affairs Specialist (BCMAS) program.  The premise was simple: to provide a uniform set of standard competencies for MSLs and medical affairs professionals as well as to  assess these competencies to ensure that these standards are met. 

For ACMA Founder Dr. William Soliman, success is getting to see the pharmaceutical Industry improve. Soliman, a former pharmaceutical industry executive, has made it his mission to revolutionize the industry through the important work that is being done by the ACMA.

Making sure we don’t repeat history again with another opioid crisis

Between 2013 and 2017, there were several large settlements between the U.S. Department of Justice and pharmaceutical industry manufacturers. The majority of the corporate integrity agreements (CIAs) that were set in place were due to off-label promotion and violations of the False Claims Act as well as kickbacks to physicians. These were mostly executed by the sales and marketing arms of pharmaceutical companies. 

In the early 2000s, the U.S.-based Pharmaceutical Research and Manufacturers Association (PhRMA) updated its code of ethics, providing guidance on how pharmaceutical industry employees should engage with healthcare providers (HCPs). Unfortunately, there was no standard in place for pharmaceutical industry representatives to assess their competencies and certify or credential them independently. The numerous incidents that have made headlines highlighting the sometimes nefarious intentions of pharmaceutical sales representatives to obtain more sales are a lesson we should remember forever. 

The increase in the number of MSLs in the last decade presents an opportunity to prevent history  from repeating itself. MSLs play an important role in offering objective education to HCPs. They are not an extension of sales reps in the pharmaceutical industry, but rather an arm within the medical affairs function. MSLs and medical affairs professionals routinely engage HCPs and are purveyors of important information to HCPs. Certifying MSLs is an opportunity for Big Pharma to get it right this time.

But what constitutes a valid Medical Affairs and MSL Board Certification?

A recent article which provided a comprehensive review of current MSL board certifications revealed that the primary MSL board certification with accreditation, training content and global reach was the Board Certified Medical Affairs Specialist (BCMAS™) program.  The ACMA was invited to brief the U.S. Congress on the matter-an indication that the government is watching this issue closely. 

The implications for the pharmaceutical industry are important, and senior level executives who work within pharmaceutical industry compliance or medical affairs should sit up and take notice. There is a new era being ushered in which demands that MSL professionals who engage the HCP community meet independently accredited standards and undergo training to ensure they are benchmarked against global standards of excellence.  

FDA, COVID-19 and Big Pharma

The unfolding saga around the opioid crisis reveals that there were opportunities to improve protocols, procedures, and training in big pharma for those individuals who were engaging HCPs. Coupled with the recent concern around the Food and Drug Administration’s role with Biogen and COVID-19 booster approvals, helping to improve public perception of the pharmaceutical industry has never been more important.

Tomorrow’s new MSL, the GenZ MSL, approaches the industry with higher expectations from companies to do what’s ethical before focusing on profit. They are more technology-inclined and are able to access information more readily. GenZ MSLs will look for that type of support from pharmaceutical companies.

COVID-19, the opioid crisis and the recent allegations about the relationship between the FDA and Big Pharma have ushered in a new era in the pharmaceutical industry with a greater scrutiny on the role that medical science liaisons play in engaging healthcare providers. This makes board certification for MSLs and medical affairs professionals a ‘need to have’ versus a ‘nice to have.’

References

1.     Albert, E., & Sass, C. The Medical Science Liaison: An A to Z Guide. eBookIt. 2011.

2.     Moss RJ, Black J. Health Care Professionals’ Expectations of the Medical Science Liaison: A Blinded Survey. Therapeutic Innovation & Regulatory Science. 2013;47(2):203-208. doi:10.1177/2168479012470649

Pure Technology compensated Ascend Agency for this article.

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