Medical Innovation and Safety: A Delicate Balance

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As we approach the November 2012 elections, there is an increasing amount of noise from politicians, pundits and talking heads on both sides of the aisle about major health care issues.  Controversial and polarizing topics such as reforming Medicare and Medicaid, the Supreme Court’s review of Obama’s health care law, and the general fairness and legality of the individual mandate have come to the forefront of the national conversation many times in the presidential campaign.

And while these issues will certainly continue to be discussed and debated as we approach Election Day, it is important to understand the key challenges in the health care industry that lie beneath the noise.

The health industry is faced with the task of finding a balance between the desire to invest in the research and development of new medicines quickly and aggressively, and the need to ensure that safety is part of each step of every medical innovation and advancement.  Unfortunately, there is no simple method, model or standard to bring new medicines to patients both safely and effectively.

The demand for investment in research and development of new medicines is greater than ever, as drug shortages have become a growing and critical problem in America.  In 2011, there were a record-high 267 new prescription drug shortages.  This is 56 more than in 2010 and more than four times greater than the number of medication shortages in 2004, when just 58 drug shortages were reported.

The worsening drug shortage problem impacts patient care, especially in hospitals, as chemotherapy, surgery and care for patients with pain and infections are disrupted as a result of a lack of critical medicines.  The shortages have also delayed clinical trials and have led to extraordinary price extortion, causing many hospitals to have to pay extremely large markups for limited drugs.

The pharmaceutical industry has worked hard to proactively address this problem by working closely with FDA and supply chain partners to address disruptions, and by making continual investments in technology and manufacturing processes to improve quality control.  However, many current shortages will not be resolved soon, due to key manufacturers that have had to shut down production because of contamination or other quality problems, or because certain medicines only have one other manufacturer, which lacks the capability to fill the gap.

Thus, while the pharmaceutical industry is taking great measures to address current drug shortages, they are also investing heavily in research and development, which helps lead to both medical advances and job growth.

Indeed, America’s biopharmaceutical research companies are working to help foster an environment conducive to the development of new treatments.  More than 3,000 medicines were in development in 2011, and dozens of new drugs were approved by the FDA.  2011 marked one of the highest numbers of drug approvals in the past decade, and many of these new drugs reflect significant advances, including two new treatments for hepatitis C, a drug for lung cancer, and the first drug for lupus in 50 years. Seven medicines provide major progress in cancer treatments and almost half were judged by the FDA to be significant therapeutic advances for ailments such as kidney transplant rejection and heart attack.

This progress has been made in light of the daunting task that investing in such research and development has become.  It is lengthy, expensive and risky.   It takes 10 to 15 years for the initial discovery of the medicine to availability to patients, costs more than $1 billion for the development of a new medicine, and just two in ten approved medicines produce revenues that exceed the average research and development costs.  In short, it is an enormous investment and commitment.

Yet despite these challenges, America’s biopharmaceutical research companies maintain committed first and foremost to patient safety.  Throughout the entire process – from the initial stages, to the clinical trials, to after a medicine comes to market and even after the investors have long moved on to other things, these companies do not waver when it comes to safety.   By striving for modern regulatory systems that evolve with science and development, safety is insured as innovation, the development of new medical technologies and the use of science to treat patients in novel ways continues to evolve.

As health care issues evolve and become more complex going forward, so does the need to balance research and development, safety, and investment in medical innovations.

Douglas E. Schoen is a Democratic pollster, strategist, and commentator.   Schoen, who served as a pollster for President Bill Clinton, is author of several books including the forthcoming “Hopelessly Divided: The New Crisis in American Politics and What It Means for 2012 and Beyond” (Rowman and Littlefield)