Speaker Programs: A Threat to Public Trust in Medicine

Public trust in the American healthcare system is unacceptably low. A 2011 International Social Survey Programme survey found that among a group of 29 industrialized countries, the U.S. ranked 24th in the public’s trust for physicians (ISSP Research Group). This low ranking is part of an unfortunate trend of Americans’ declining trust in their nation’s healthcare system. In 1966, 73% of U.S. residents trusted their medical leaders; this dropped to 34% by 2012 (Blendon et al.).

Healthcare professionals and academics predicted before the COVID-19 pandemic that this drop in trust would be a problem for addressing future public health crises and pandemics (Khullar; Gille et al.). In the current COVID-19 pandemic, Americans have observed the harsh reality of what happens when the public loses trust in the healthcare system and medical science: as of January 28, 2022, only 63.7% of Americans are fully vaccinated despite the healthcare community’s recommendations (“CDC Covid Data Tracker”). The issue stretches beyond COVID-19: medical mistrust on an individual level is associated with many knock-on effects, including delayed care-seeking and failure to refill a prescription, which can lead to worse patient outcomes (LaVeist et al.).

Some academics argue that public trust in the healthcare system can be built up by increasing transparency in the patient-physician relationship, particularly regarding potential physician conflicts of interest, like pharmaceutical company-sponsored speaker programs that reward physicians who prescribe the company's medications (Montgomery et al.). These speaker programs were used by companies like Purdue Pharma to provide a financial incentive to physicians to prescribe more opioids, exacerbating the opioid epidemic at the cost of patient outcomes (Tokar). Thus, one way to address the worrying trend in public trust is to eliminate speaker programs.

The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) defines speaker programs as “company-sponsored events at which a physician or other health care professional (collectively, ‘HCP’) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company” (“Special Fraud Alert: Speaker Programs”). Pharmaceutical companies argue that these programs actually help doctors and the patients they treat (“Code on Interactions with Health Care Professionals”) by providing information to the medical community.

Despite these claimed benefits of speaker programs, on November 16, 2020, the OIG released a report highlighting “the fraud and abuse risks associated with the offer, payment, solicitation and receipt of remuneration relating to speaker programs” (“Special Fraud Alert”). The OIG’s special fraud alert specifically discusses the points of concern with speaker programs. The most striking, however, is that pharmaceutical companies hire “high-prescribing HCPs” to serve as speakers and condition their compensation on whether or not they hit sales targets. These valuable rewards given to high-prescribing HCPs through speaker programs suggest that rather than being a way to educate medical professionals and help the patient as pharmaceutical companies argue, speaker programs are instead designed to induce HCPs to prescribe the company’s medication, regardless of patient outcomes.

Accusations of fraud have resulted in legal and ethical disputes surrounding speaker programs. The primary tool used by the OIG and the Department of Justice (DOJ) is the Anti-Kickback Statute (AKS), which is part of a cohort of laws meant to fight Medicare fraud. The AKS, in particular, makes it illegal to provide any remunerations, financial or non-financial, to physicians to “induce or reward” patient referrals or generate business for the company. A recent example of the AKS in practice concerns the U.S opioid epidemic: the Justice Department used the AKS against companies like Purdue Pharma and Insys that used speaker programs as bribes to increase opioid prescriptions (Tokar).

However, regardless of their legality, all speaker programs are ethically nebulous. HCPs should focus on their patients’ best interests. Speaker programs directly attack this by bringing in a perverse incentive for HCPs to prescribe a pharmaceutical company’s medication. Adding this secondary interest can come at the cost of patient outcomes, like with the doctors that prescribed opioids (Tokar). This secondary interest can affect patient trust: if a patient believes that their doctor has an interest beyond treating them when they prescribe a certain medication or perform a particular treatment, the patient would be less likely to trust the doctor.

The Pharmaceutical Research and Manufacturers of America (PhRMA) - an organization representing research-based pharmaceutical and biotechnology companies - issued the first PhRMA Code on Interactions with HCPs in 2002 to provide guidance on the ethicality of interactions between pharmaceutical companies and HCPs (Silver et al.; “Statement on Revisions…”). The PhRMA code is voluntary, meaning that it in and of itself has no regulatory power. Companies can choose to be part of it or not part of it; if a company that chooses to follow the PhRMA code decides it would be in their best interests to break it, there is no cost.

Following the OIG’s in late 2020 special fraud alert, PhRMA modified the PhRMA in 2021. The revised code includes prohibits pharmaceutical companies from using non-educational venues for speaker programs, providing alcohol, and, notably, basing speaker reimbursement on how much of the company’s medications the speaker has prescribed in the past (“Code…”). These and other revisions are meant to address the specific criticisms that the OIG brought up in the Special Fraud Alert.

While these changes do play an important role in making speaker programs more ethical, these changes to the PhRMA Code point to an issue with self-regulation. True changes in policy or practice rarely come about from a company's own moral convictions but rather from criticism from the American public or government. In the case of the revised PhRMA Code, it was the OIG’s special fraud alert that pushed PhRMA to modify the code, not PhRMA’s own understanding of the unethicality of providing rewards to high-prescribing HCPs. However, the OIG cannot be expected to continuously investigate speaker programs, which are already suspect, every time they want to induce a change to the PhRMA code. The investigations into speaker programs would be time-consuming and costly; the resources could be used to better serve the American people in some other way. So, the federal government needs to pass legislation to solve the speaker program problem and hopefully improve patient trust by remedying or completely removing physicians’ secondary, financial interest.

Policymakers have many potential options to address speaker programs. The easiest solution to pass would be to legally require pharmaceutical companies to follow the PhRMA code. States like California have already passed such legislation, demonstrating the feasibility of implementing similar legislation in other states or even at a national level (Buchman). This option would undoubtedly be helpful: it makes the PhRMA code legally binding, so companies could not simply break the code without any repercussions. However, the PhRMA code would still be made by PhRMA, a group of pharmaceutical companies. There is no expectation that PhRMA would choose to increase regulations on speaker programs without some severe inducement, especially if they know that any more stringent regulations would subsequently become law. Moreover, making the PhRMA code into law would not address the enforcement issue raised earlier: the OIG and other regulatory agencies still have to spend the money and time.

A more thorough alternative would be to prohibit speaker programs altogether. Without speaker programs, there would be no need to worry about a PhRMA code and the inherent difficulties in using self-regulation because there would be nothing to regulate. A simple way to prohibit speaker programs while also maintaining the educational aspect of speaker programs is to limit all communications between pharmaceutical companies and HCPs to packets of peer-reviewed research papers. These papers would inform the HCP about the efficacy of a given company’s treatment compared to the current standard.

An argument against a proposal like this one would be that doctors do not have the time to read these papers and therefore require someone to interpret the data for them in a quick and easy format. However, the amount of time required to read papers would almost certainly be less than the amount of time spent at speaker events. The information from these peer-reviewed papers would also be significantly less biased than the advertisements at speaker programs. Moreover, doctors spend years in undergrad, medical school, and residency learning about scientific and health-related issues and how these issues relate to treating their future patients. So, contrary to what pharmaceutical companies argue, doctors do not need well-paid speakers to interpret pharmaceutical information and advertise a company’s medication to them.

Speaker programs and the pharmaceutical companies that fund them are a pernicious trust to public trust in the healthcare system. A doctor’s main responsibility is to treat the patient and ensure the best possible patient outcome. However, speaker programs introduce a secondary interest: maintaining a constant flow of kickbacks and rewards from pharmaceutical companies by prescribing high amounts of their medications and treatments. As was the case with the opioid epidemic, this secondary interest comes at the cost of the best patient outcome. Once the patient becomes aware that their doctor’s main interest is not in treating them, but rather in getting kickbacks through speaker programs, trust in the doctor and the healthcare system drop. Prohibiting speaker programs is the only solution that would ensure that this is no longer an issue and can work to repair falling trust in the healthcare system.