Dr. Andrew Cutler and Meridien Research have been at the forefront of pharmaceutical research. They have witnessed first-hand the benefits their patients receive from the latest innovations in drug therapies. Having a more complete picture of the pharmaceutical industry is important in learning how physicians and patients can contribute to the health and well-being of future generations.
The Cost of Research
It’s a very long and expensive journey for a drug to be approved by the FDA. On average, pharmaceutical companies spend $2.6 billion to develop and test a new drug through all of the phases of FDA approval, which usually takes 10 years or more. “No other country in the world requires some of the scientific standards that the United States’ FDA does,” said Andrew Cutler, a Meridien Research Principal Investigator as well as Chief Medical Officer (CMO). “For example, we are the only country in the world that requires a new medicine to work better than a placebo. Also, we are now required to demonstrate safety for much longer periods before approval than before, and in many cases for a longer term than in other countries. The requirements keep growing over time, which has added considerably to the investment of money and time required to get a new medicine on the market.”
To add to the equation, costs continue to rise after approval, due to post-approval safety and monitoring requirements and evolving marketing and distribution procedures. Once the drug is available, it has to be incorporated into a doctor’s therapeutic repertoire. This is no easy feat when considering the amount of health care systems and private practices around the country and throughout the world.
Unfortunately, the pharmaceutical industry has been vilified in the media as a whole. The news may be eye-catching, but fails to tell a complete story. Last year, Forbes published a story highlighting a report in the journal Health Affairs that described how the high price of many specialty drugs can be justifiedbecause of the ever increasing costs of bringing a new drug to market. Pharmaceutical companies have an enormous challenge in meeting the public demand for drug therapies that save lives and meet their financial goals.
Changes in health care delivery and payment have affected the health care innovation landscape. Revenue streams feel more pressure from government regulation and health care management companies. The government has prioritized their funding toward disease prevention, more so than treatment. However, the rates for adults with chronic diseases are increasing. In 2012, half of the adults in the US had one or more chronic health conditions. The pharmaceutical industry has adapted to these changes from all sides of their business and continues to provide therapeutic treatments that improve or save lives.
Genetic research has also opened doors into new therapies that had otherwise been closed. Medicine and drug therapies will become personalized and targeted. Because of these innovations, the future roll of pharmaceutical research will take on a more individual approach to treatment and cure of diseases.
Benefits of Research
Canada recently studied the benefits of pharmaceutical interventions and found that the benefits to public health and well-being outweighed the costs for new or improved medications. For many seeking relief for physical and mental health disorders, the benefits are found in improved function and interpersonal relationships with family and friends.
It’s true that the expense of some new drugs are well into the hundreds per pill and tens of thousands per injection or infusion. Yet, many of those drugs treat what were typically regarded as fatal diseases, and are now described as treatable. Also some treatments are now available for rare or “orphan” diseases, for which there is a smaller market for a drug company to recoup their investment in developing a medicine. The FDA has provided incentives for the development of treatments for such orphan conditions in the form of accelerated approval and decreased costs.
Other innovations in pharmaceutical research are not nearly as expensive and provide patients with a better quality of life and greater productivity at work that may not have been possible in the past.
The value and long-term benefits of a drug are not found on a balance sheet. Instead, the benefits to patients are found in the research and physician clinics throughout the world.