According to three new studies in the latest issue of the American Journal of Hypertension, almost half of the 50 million Americans with hypertension haven't been prescribed the drug that would work best for them.
"Our current prescribing methods are very primitive. We haven't increased the success rate [in treating hypertension] in 35 years," says Michael Alderman, a blood-pressure expert at the Albert Einstein College of Medicine in New York City, and a co-author of one of the new studies.
One study shows some drugs work better in certain ethnic groups than in others. The two other studies recognize the importance of testing patients' levels of renin, a hormone produced by the kidneys, as a guide in prescribing blood-pressure medicine. Researchers in each of the studies emphasized that larger-scale trials would be necessary before the findings could become part of official treatment guidelines.
Welcome to what “personalized medicine” really means. Not “bespoke” or tailored medicines, but rather a focus on the “four rights” – the right medicine in the right dose for the right patient at the right time.
One of the studies, co-authored by Ajay Gupta of Imperial College London, looked at drug responses among 5,425 patients in various countries and across different ethnic groups. For example, in the U.K., south Asians are often given ace inhibitors as a first-line treatment, though the effectiveness of such prescriptions isn't based on any hard evidence. Dr. Gupta's study, for the first time, confirms that south Asians respond especially well to such drugs.
U.K. medical-treatment guidelines say that first-line drug therapies should be guided by a patient's age and race. (Guidelines in the U.S. don't include such suggestions – but since we’re looking at the NHS to learn about comparative effectiveness, maybe we should broaden our field of study, especially considering that our new CMS chief is such a fan of the UK model.)
And, while we're on the subject of the NHS, a brief digression. Did you see today's news that NICE has rejected Avastin for use in patients with colerectal cancer that has spread? It's the second time that the agency has issued such guidance. At the same time, NICE Chairman Sir Michael Rawlins has suggested that the best way to counteract the dearth of real science behind HTA is for drug companies to just lower their prices. Sir Michael is a bright guy and needs to do better than such a simplistic answer to the problem of 21st century HTA's lack of scientific integrity.
The two other studies focused on the hormone renin. Medical experts say few doctors today measure a patient's renin level, despite a study in the 1970s that suggested it might be used as a biomarker for prescribing the drugs. One of the new studies, involving 363 patients, confirmed the 1970s finding, showing that measuring the renin level can be an effective method for selecting a blood-pressure medication.
"These are not fundamentally novel biological discoveries," says Morris Brown, professor of clinical pharmacology at the University of Cambridge, U.K., who wasn't involved in the studies. But they constitute "a wake-up call that we should be using renin measurements as a systematic form of help" for prescribing hypertension drugs.
And it should also serve as a wake-up call to those who aren't paying close enough attention to the future of diagnostics development and approval.