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Big pharma has historically made some substantial missteps regarding the full reporting of clinical trial results, but a new initiative by GlaxoSmithKline is a move in the right direction.
A new initiative for ensuring the reproducibility of biomedical research is commendable, but the involvement of a for-profit company may not be the right path forward.
This summer, researchers launched a strategy to accelerate finding a cure for HIV. The effort aims to revolutionize treatment of the infection, but the inherent risks require that regulators ensure a measured approach.
Biomedical research faces budgetary cuts in the United States and abroad. But although solutions to manage the restricted funds can be found, initiating change may be the greater hurdle.
Novartis's recent legal action against the UK National Health Service to prevent the off-label use of Avastin for macular degeneration challenges the current regulatory structures ensuring accountability for the safety and quality of drugs.
Recent advances in asthma research have altered views of how the disease is triggered and sustained. What remains to be seen is whether this knowledge can be integrated into the clinic to alter the natural course of disease.
Translational research that takes place in academic settings is increasingly being funded by private-public partnerships. As these partnerships become more prevalent, scientists need to strike a balance between the benefits from this welcome funding source and the protection of their academic freedom.
Despite intense efforts to rid the world of poliovirus, it continues to persevere. Given the serious limitations of the existing vaccines, the feasibility of eradication must be reassessed.
Budget cuts and administrative changes that have eliminated the Ministry of Science in Spain illustrate the need to safeguard science funding and policies in European countries immersed in the economic crisis.
Emergency contraceptive pills have long been a hot button issue in US politics due to their mischaracterization as inducing abortion and promoting promiscuity, leading to delayed approvals and restricted access. A recent decision on the Plan B One-Step pill suggests that, once again, science has taken a back seat to politics.
Retracting a paper is perhaps the most unpleasant task a journal has to face, particularly if the retraction involves scientific misconduct. With the number of retractions on the rise, an improved mechanism to deal with misconduct is necessary.
Treating costly conditions such as Alzheimer's disease may soon collapse healthcare systems around the world, yet companies hesitate to invest in the long, large clinical trials required to discover disease-modifying therapies. New incentives are necessary to turn this tide.
The starting point for many drug discovery programs is a published report on a new drug target. Assessing the reliability of such papers requires a nuanced view of the process of scientific discovery and publication.
Global health programs have made great strides in the last ten years, mobilizing billions of dollars to provide life-saving drugs and immunizations to people in resource-poor settings. But these myriad initiatives need to get in step to improve integration of healthcare delivery.
Conditional approval aims to speed the delivery of drugs to patients in need. But when full approval is denied, complications arise for patients, companies and regulatory agencies alike.
An association between a retrovirus and chronic fatigue syndrome has courted controversy since it was first announced. In light of new data discounting this link, medical decisions made on its basis—some of which were encouraged by the patient advocate community—might have been premature.
Off-label prescribing of drugs can add to a clinician's toolbox, but it may also pose risks to patients. Careful monitoring and clinical validation should increase the safety and guarantee the efficacy of using existing drugs for new indications.
The production setbacks for Genzyme's rare-disease drug Fabrazyme are tragic for the people who need the medicine. But a petition to break the company's patent exclusivity could do far more harm than good.
The US Food and Drug Administration (FDA) wants to create a way to fast-track approval of new medical devices, but they must first address the problems of the existing accelerated process for bringing devices to market that are substantially equivalent to ones already in commercial distribution.
