A new BMJ investigation raises questions behind the motives used for post-marketing studies of new diabetes therapies. To ensure “a proper balance” between commercial and clinical functions, the BMJ demands better regulations for these types of studies.
A former drug industry employee admitted that many of these studies “had more marketing than science behind them,” which confirms the experts’ view that these studies increase “catastrophic health expenditure” in low-income countries.
The primary reason for post-marketing studies is to demonstrate the safety and efficacy of a new drug. However, concerns exist that many of these studies, first and foremost, appear to serve for marketing purposes, i.e. to promote new and more expensive therapies and to persuade physicians to prescribe these drugs.
Concerned about the role and legitimacy of post-marketing studies for new insulin products, Edwin Gale, Emeritus Professor of Diabetic Medicine at the University of Bristol was concerned about the function and legitimacy of post-marketing studies for new insulins and decided to examine the products from three main insulin manufacturers, namely Eli Lilly, Novo Nordisk and Sanofi-Aventis.
According to their findings, new analogue insulins are almost four times more expensive than conventional human insulin. According to evidence, the majority of type 2 diabetes patients only gain little benefit from taking these drugs.
Professor Gale discovered that since 2005, worldwide, almost 400,000 people have been recruited to participate in post-marketing studies of insulin analogues, and that one company alone recruited almost 360,000 individuals. Most of these studies promoted using the more expensive insulins, but they were of limited scientific value and were conducted in low or middle-income countries. The majority of study participants tended to continue using the new insulins once their respective studies had finished.
Gales writes that it is questionable whether a company that invests in such large-scale activities would do so mainly to test their product’s benefits without putting the intention of commercial vested interests first. He says that even though physicians may participate in good faith, “the patient or healthcare system pays for a more expensive agent instead of one that is cheaper and equally effective, and the public is offered misleading claims of comparative merit based on studies of limited scientific value.”
John Yudkin, Emeritus Professor of Medicine at the University College London argues in a linked comment that post-marketing studies “may be driving households into catastrophic health expenditure.”
He refers to Novo Nordisk’s PREDICTIVE study of Levemir, an insulin analogue, in which doctors received payments in 26 countries to start a total of 47,565 diabetic people on Levemir.
According to professor Yudkin’s calculations, the yearly cost of Levemir for 3,435 patients who enrolled in this study in India, where patients have to pay for their medication themselves, would be 8-times higher compared with the cost of generic human insulin.
He continues writing that although Novo Nordisk has reasons to be proud of some of their social responsibility initiatives over the decade, “but it now needs to reclaim the moral high ground.”
A former drug industry employee admits in a third article that some post-marketing studies “had more marketing than science behind them” and that company’s were “playing” with the data “to ensure that the benefits of the drug were emphasized and the disadvantages were minimized where possible.”
The employee, who wishes to remain anonymous, reveals other dubious practices, such as using key opinion leaders to make the results more credible and to influence decision makers as well as patients.
The study concludes, writing:
“Allowing companies to focus more time and efforts on drug development, or increasing transparency by encouraging industry authors to disclose the fact that the research has commercial objectives (as long as these are balanced with scientific value) would definitely help to develop better drugs for patients.”
Written By Petra Rattue