A new study by researchers in Cleveland Clinic's Taussig Cancer Institute and Lerner Research Institute describes a novel class of targeted cancer drugs that may prove effective in treating certain common types of leukemia. The results first appeared online in Blood Cancer Discovery.
A report launched by pharmaceutical company Takeda UK reveals that, despite heightened public and media attention on the industry’s efforts to develop vaccines and treatments, the COVID-19 pandemic has had little positive impact on perceptions of pharmaceutical companies.
The Pharma: Repurposed report explores the importance of ‘purpose’ to the pharmaceutical industry and provides recommendations on how the sector can convey a stronger purpose to build trust and ultimately improve the lives of patients.
For the report, Takeda UK commissioned Ipsos MORI to conduct online interviews among adults ages 16-75 from the United Kingdom. A total of 1104 interviews were conducted in October 2020 and key findings include: Only 17% of respondents said their impression of pharmaceutical companies had improved, based on how the industry had reacted to the coronavirus pandemic over the previous six months. Over half (54%) said their impression had stayed the same and 16% said their impression had got worse.
The pandemic has had a positive impact on UK adults’ perceptions of healthcare professionals, with 44% of respondents saying their impression had improved. In contrast, UK adults’ impression of politicians has got markedly worse, with 51% of respondents saying their opinion of government ministers had worsened over the last six months.
When respondents were asked to express their opinion on a range of organisations and roles within the sector, just 38% had a total favourable opinion of pharmaceutical companies.
As per the survey, Over a third of respondents (36%) had neither a favourable nor unfavourable view of the pharmaceutical sector, suggesting that the industry has more work to do to engage the public with its role and activities. The survey revealed a high total favourable result for healthcare professionals (74%), and for healthcare charities (58%). Scientists within the pharmaceutical industry (53%) were also well regarded.
Total unfavourable views of Government ministers stood at 55% and other politicians at 54%. Less than half (48%) of respondents trust the pharmaceutical industry to act in the best interest of society. In contrast, 82% of respondents trust healthcare professionals to act in society’s best interests and over 70% trust healthcare charities to do so.
Jon Neal, MD UK and Ireland at Takeda, said: “The pharmaceutical industry has faced several reputational challenges over the years. However, perhaps now more than ever, the development of new treatments relies on cross-sector collaborations and public trust and willingness to engage with the sector. Therefore, we need to address perceptions of the industry to improve the future of healthcare and ultimately save lives.
“We hope this report will lead to further discussion about how the industry can convey a stronger purpose to build trust with both patients and other healthcare organisations. Employees in pharma companies such as Takeda are completely committed to improving the lives of patients and yet this research shows our commitment to patients and our purpose is not widely understood or accepted. We need to do more and I hope this report will lead to further discussion and opportunities to work with others from across the industry to increase understanding of our role in society and how we operate.”
Ben Page, Chief Executive of Ipsos MORI, commented: “Our research with Takeda suggests that the public have a higher opinion of roles or organisations that articulate a strong purpose around their role in and value to society. The pharmaceutical industry has historically struggled to clearly articulate what it does and what it stands for. If the sector wants to better connect with the public, it needs to start talking much more openly about its activities and values.
US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively).
With no approved therapies for HFpEF to address the prevention of HF hospitalizations and urgent visits, a significant unmet medical need exists for a treatment to reduce the burden associated with this debilitating condition. The FDA is expected to make a decision on the supplemental New Drug Application (sNDA) in the first quarter of 2021.
“Managing HFpEF has historically been a clinical and scientific challenge due to the heterogeneity of the condition,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair. “Today’s vote represents much needed progress in this area of unmet need and is a positive step toward bringing a potential therapy to millions of patients suffering from this type of heart failure.”
The Committee’s positive decision is based on the totality of evidence from efficacy and safety analyses, including findings presented from a pre-specified subgroup analysis of PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with HFpEF and additional evidence from PARAMOUNT (a Phase II trial in HFpEF), as well as PARADIGM-HF (a Phase III trial in HFrEF). Data from PARAGON-HF demonstrated a favorable safety profile for Entresto in patients with HFpEF, which is in line with the vast clinical and post-marketing experience in HFrEF, and showed clinical benefit of Entresto in HFpEF patients.
“Our commitment to reimagine medicine through our extensive clinical trials program on heart failure has been unwavering, and we are encouraged by the Committee’s response today,” said David Soergel, MD, Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “We appreciate the valuable insights shared by the patient and advocacy community about this devastating disease, and we look forward to FDA’s decision on the potential approval of this new indication.”
HFpEF affects more than 3 million Americans, and is increasing in prevalence as the population ages. It is a complex disease for which it is difficult to develop treatments due to its heterogeneous pathophysiology and the varied impact of symptoms among patients, despite decades of research. HFpEF can change the structure of the heart and occurs when the muscle tissue of the heart thickens and stiffens so that it cannot expand to fill with enough blood to meet the body’s needs. HFpEF is associated with high rates of recurring heart failure hospitalizations, emergency room visits and urgent doctor’s office appointments. Each hospitalization event is associated with worsening long-term prognosis, and approximately one in four patients are re-admitted for heart failure within one year of discharge.
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