by Donald Singer

The question of whether there is a need for the pharma industry to consult clinicians and pharmacologists is not at issue. What is critical is that everyone is open about this involvement, says Professor Donald Singer, Secretary of the European Association for Clinical Pharmacology and Therapeutics

donaldsingerAs an active clinician with interests in drug discovery, the mechanisms underlying vascular disease and the use of non-invasive biomarkers to inform prevention and monitor the effectiveness of drugs, Professor Singer has a deep professional awareness of the need for pharmaceutical companies to access the expertise of clinicians and pharmacologists when shaping and advancing drug discovery and development programmes.

“This is an essential component in structuring and informing research by pharma companies,” Professor Singer said. “Without these insights the industry cannot fully understand the medical needs of patients.”

In addition, companies need access to the insights of clinical pharmacologists in building on new understanding of disease biology, in order to assess where the therapeutic opportunities might lie, and to inform preclinical development.

And once a new drug is approved clinicians require information on how they should be used and prescribed. “There’s a problematic vacuum from governments in terms of supporting this type of training for clinicians,” Professor Singer noted.

Instilling confidence in medicines – and governance at large

Professor Singer is also involved in promoting better public understanding of treatments and the risks and benefits of new medicines. In this context he believes there is a need to make it clear to the public and the media that the exchange of expertise, “is not only sensible, it is essential” in the development of new drugs.

While the medical profession is used to declaring conflicts of interest, the move to publish details of payments and say why they were made, marks a step upwards in terms of transparency. Professor Singer suggests this will help to increase confidence in decision-making. “Overall, I see a need to know who is being paid, and on precisely what evidence decisions are based,” he said.

Conflicts of interest in personalised medicines

One emerging area of pharmaceuticals that exemplifies this need to know exactly what evidence is being weighed in decision-making is personalised medicine, a field in which Professor Singer is closely involved.

Developments in the science of genomics and proteomics are making it possible to detect and understand the factors underlying differences in individual responses to medicines, presenting the opportunity to improve treatments, predict who will be more likely to respond, and reduce the occurrence of adverse drug reactions.

Realising this potential depends on the discovery and validation of biomarkers that can be used to identify subsets of likely responders when staging clinical trials, and to form the basis for companion diagnostics once a drug is approved.

Professor Singer notes that many hundreds of such potential (often competing) diagnostics are being queued while awaiting consideration by regulatory organisations such as the FDA. “There is a clear risk for conflicts of interest in terms of what and how to prioritise.”

In conclusion, while he believes transfers of value from pharma companies to pharmacologists and clinicians should be disclosed, Singer says it is important this information is not used to “create a market” for this expertise.

 

Professor Singer is Secretary of the European Association for Clinical Pharmacology & Therapeutics and a member of the Council of the British Pharmacological Society. He is an active clinician and is interested in drug discovery, vascular mechanisms and non-invasive biomarkers important for prevention and treatment of cardiovascular disease, and improving safety and effectiveness in use of medicines. Professor Singer is also interested in promoting better public understanding of new treatments, and the benefits and risks of medicines.