Pharma Connections in Patient Advocacy Leadership Raises Conflict of Interest Concerns
(Thursday, August 24, 2023)
Patient advocacy organizations (PAOs) have a vital role in raising awareness about diseases and representing patient interests with the industry and FDA. In the last few years, PAOs played a critical role in raising patients’ opinions about controversial new drugs with the FDA, in turn leading to the approval of those drugs by the FDA. Hence, the relationship between some PAOs and the pharmaceutical industry raises concerns about potential conflicts of interest that could impact the true objectives of these organizations.
PAOs are often the link between patients and medical product makers. However, when people who've worked for pharmaceutical or medical device companies are part of PAOs' leadership or boards, questions arise about where their priorities lie. A recent research based on publicly available information on about 50 highest earning PAOs in the US in 2022 found that 74% had board members, senior executives, or paid staff with prior or current affiliations with the pharmaceutical and medical device sectors. Some top PAOs had leaders who were also on the boards of pharmaceutical companies. This double role, serving patients and companies, can create a conflict of interest. For instance, leaders from groups focused on cancer and Parkinson's disease were also linked to companies like Genentech and Pfizer. It would be a fair question if these PAOs are genuinely advocating for patients or if they're swayed by industry interests.
Why does this matter so much? These organizations talk about what treatments are best, what medicines work, and what policies should be in place. If they're connected to pharmaceutical companies, their recommendations might not always be unbiased – they might lean towards what benefits the companies. In recent years, PAOs have become increasingly aggressive in supporting individual treatments, and companies developing those treatments have used these connections to influence the FDA. A report published a few years ago showed how Sarepta hired consultants and personnel with the sole mandate of getting PAO support for its products. It was quite successful. The same strategy was repeated by Amylyx, Biogen, and several other companies following pretty much the same model as Sarepta.
While there is nothing illegal about this practice, it does raise serious concerns about the transparency of these relations. Would patients support these efforts if they knew of the financial relationship between their advocacy group leadership and the industry? Would FDA consider these PAO efforts the same way, if it knew about this conflict of interest?
The answer depends on who you ask. On one hand, the connection between the leadership at the PAOs to the pharmaceutical world provides them a better insight into the products in development, the ability to influence the conduct of clinical trials, and better present the patients’ perspective to the FDA. On the other hand, patients need transparency about these relationships, independent assessment of benefits to the patients of the support activities done by the PAO, and the ability to influence the decisions of the developers about the drug the patients supported, post-approval, particularly around pricing, through their PAOs. When PAOs talk about treatments or policies, we want to believe that they're genuinely looking out for the patients.
PAOs play a crucial role in advocating for patients and disease awareness. However, there is a pressing need for transparency and accountability within PAOs, particularly in terms of leadership affiliations. Organizations that aim to advocate for patients and influence health policy must take decisive steps to mitigate potential conflicts of interest. As the saying goes, "Sunlight is the best disinfectant." The first reaction to such findings is cynical feelings and mistrust as it indicates improper conduct. But these connections are also important for the PAOs to do their job. By openly disclosing financial relationships and leadership ties with the pharmaceutical industry, PAOs can bolster public trust in their independence and credibility.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC