Understanding the degree of awareness among medical professionals regarding the ethics of pharmaceutical marketing activities in context of revised medical council of India code of ethics

Background: Pharmaceutical marketing activities are regarded as ethically challenging by most medical professionals. This study was planned to understand the extent of the interaction of pharmaceutical companies with healthcare providers & to determine the level of awareness about the ‘Medical Council of India (MCI) Code of Ethics’.Methods: A questionnaire based survey was conducted among 100 consultants and residents. The questionnaire mainly dealt with ethical issues about accepting free gifts, medicines and other sponsorships from pharmaceutical representatives, interactions and expectations from representatives of pharmaceutical companies by doctors and ascertaining among them the level of awareness about the MCI’s code of ethics.Results: 59.4% residents and 58.8% consultants do not consider small gifts (stationery/books/drug samples) as ethically problematic. 88% residents and 85% consultants felt that offers should be limited. 72% of consultants were aware of the revised MCI code of ethics as compared to 28% of residents.Conclusions: Most physicians do maintain a code of ethics with regards to accepting gifts and they felt that inexpensive gifts do not influence clinical judgment. Consultants were of the view that amended MCI code of ethics would not affect their clinical practice significantly

Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial

Background: Cancer patients show increased morbidity with COVID-19 and need effective immunization strategies. Many healthcare regulatory agencies recommend administering ‘booster’ doses of COVID-19 vaccines beyond the standard two-dose series, for this group of patients. Therefore, studying the efficacy of these additional vaccine doses against SARS-CoV-2 and variants of concern is of utmost importance in this immunocompromised patient population Methods: We conducted a prospective single arm clinical trial enrolling patients with cancer that had received two doses of mRNA or one dose of AD26.CoV2.S vaccine and administered a third dose of mRNA vaccine. We further enrolled patients that had no or low responses to three mRNA COVID vaccines and assessed the efficacy of a fourth dose of mRNA vaccine. Efficacy was assessed by changes in anti-spike antibody, T-cell activity, and neutralization activity, which were again assessed at baseline and 4 weeks. Results: We demonstrate that a third dose of COVID-19 vaccine leads to seroconversion in 57% of patients that were seronegative after primary vaccination series. The immune response is durable as assessed by anti-SARS-CoV-2 (anti-S) antibody titers, T-cell activity, and neutralization activity against wild-type (WT) SARS-CoV2 and BA1.1.529 at 6 months of follow-up. A subset of severely immunocompromised hematologic malignancy patients that were unable to mount an adequate immune response (titer <1000 AU/mL) after the third dose and were treated with a fourth dose in a prospective clinical trial which led to adequate immune boost in 67% of patients. Low baseline IgM levels and CD19 counts were associated with inadequate seroconversion. Booster doses induced limited neutralization activity against the Omicron variant. Conclusions: These results indicate that third dose of COVID vaccine induces durable immunity in cancer patients and an additional dose can further stimulate immunity in a subset of patients with inadequate response. Funding: Leukemia Lymphoma Society, National Cancer Institute. Clinical trial number: NCT05016622