Pharma Would Also Benefit
If there is a test to predict adverse reactions or resistance to a drug or to target the patient selection for a clinical trial, the risk of clinical failure goes down tremendously. It would seem that development of a drug based on genetic information may also shorten the time of development, which today stands at about 12 years. More importantly, it should require fewer dollars from R&D to the clinic and on to the market.
The number of serious adverse drug events reported to the FDA more than doubled between 1998 and 2005 as did deaths associated with adverse drug events. In recent years, we have seen several drugs pulled from the market, including Vioxx, Bextra, and Tysabri. These facts highlight the importance of the public health problem and illustrate the need for improved systems to manage the risks associated with drugs.
A handful of theranostic products on the market have already led to successful treatment decisions for patients with cancer and HIV. Yet, the number of such commercialized products today is still unacceptably low. Some of these tests are DAKO’s Herceptin Hercep genotyping test; BRCA1/BRCA2 test for breast and ovarian cancer risk; Roche’s AmpliChip that predicts a patient’s response to therapies; Monogram’s Trofile for HIV tropism; and Bayer’s Trugene HIV tests.
In development are DNA Print Genomics’ Statinome, designed to measure a patient’s likelihood of developing myalgia as an adverse response to the commonly prescribed statins Lipitor and Zocor, and DermTech’s noninvasive skin test for melanoma. With Roche Diagnostics and Abbott Diagnostics dominating the in vitro diagnostic industry, and Becton Dickinson gaining significant diagnostic technologies through the acquisition of GeneOhm, it is hoped that we will see new products in the future.
Theranostics and personalized medicine have the potential to transform the medical industry and the overall approach to healthcare. Clearly, widespread adoption of theranostics will eliminate unnecessary treatment of patients for whom the treatment is ineffective or even dangerous, with an end result being major drug cost savings for the patients and the entire healthcare industry.
Yet, a paradigm shift from the blockbuster drug model to a theranostics and personalized medicine model will require investors and pharmaceutical companies to accelerate their investment in this sector. Despite the advancements made in genomics and proteomics in the last decade, the diagnostics industry has only seen a growth rate of about 4% per year.
Private insurers rarely reimburse for genetic tests, thus, new policies and government-funded medical care issues also need to be addressed.
For the first time in the history of the U.S., the largest proportion of the population is older than 65. The theranostics industry, which is currently experiencing a lack of significant investment or acceptance, provides benefits that are evident. Clearly, widespread adoption of theranostics will eliminate unnecessary, ineffective, and dangerous treatment of patients, which will mea n significant cost savings for the patients and the entire healthcare industry.