Sir Michael Rawlins: Regulation and Reputation

Oct 01, 2011
By Pharmaceutical Executive

Sir Michael Rawlins
The last 50 years have witnessed extraordinary growth in the world's pharmacotherapeutic armamentarium. Nowhere is this more evident than in the state of medical science depicted in the first edition of the Laurence and Moulton text, "Clinical Pharmacology" (1960). For managing cardiovascular disease in 1960 there were no effective ways to reduce blood lipids; antihypertensive therapy relied on bretylium, reserpine, hydrallazine, and pempidine; and thiazides were the only oral diuretics. There were no oral contraceptives, beta blockers, H2 receptor antagonists, proton pump inhibitors, benzodiazepines, angiotensin converting enzyme inhibitors, and little in the way of drug treatments for malignant diseases.

The effective treatments we now possess owe almost everything to the pharmaceutical industry. Although my colleagues in academia have been responsible for identifying many drugable targets, it is the pharmaceutical and biopharmaceutical industries that have converted these ideas into effective therapeutic agents.

Nevertheless, despite the substantial increase in expenditure in R&D over the past two decades, the industry has disappointed. The numbers of new active substances reaching the market has not increased proportionately and drug hunting has unquestionably become more difficult. It has also become more expensive, and the costs of clinical development are unsustainable. Many senior executives in the industry accept that this "business model" needs to change—but so, too, does the current regulatory model.

We need new innovative products that not only serve an "unmet need," but that make a real difference to quality and length of life. It is not enough to show that a novel product acts on some novel target. Unless it makes a real difference to patients, and comes at a price the healthcare system can afford, it does not represent an innovation.

Added to these difficulties is the fact that the industry has forfeited the respect of many physicians, patients, and the public. This is in part due to the ways that companies promote—directly and indirectly—their products, as well as the persistent failure to place results of clinical studies in the public domain. I detect some improvement in the industry's performance, in both of these areas, but the drive for change has largely come from external critics rather than any obvious internal recognition of the problems.