Statistics tell us that a medical revolution has taken place over the last 50 years. People are living longer. Illnesses that were once practically a death sentence for a patient -- such as heart disease, diabetes and HIV/AIDS -- are today often controllable and treatable as chronic conditions. Even the war on cancer is showing signs of promise as cancer death rates have fallen in two of the last three years as a result of better health, detection and treatments. And the prospect for even better treatments and cures for many diseases is hopeful because of our ever-increasing knowledge of human genetics, biology and biotechnology.

The fact is, there’s been so much quantifiable medical progress in our lifetime that it may be easy to forget that new cures and treatments are not inevitable. All great medical innovations and medicines, of course, start with a great idea about how a disease can be treated or even cured, but we should never lose sight of the fact that most promising ideas never make it out of the laboratory. In any given year, for example, medical researchers explore thousands of possible new approaches to fighting a disease as a first step in the quest for a potential new medicine. But only about 5 of 10,000 compounds looked at as a potential new medicine ever make it all the way through testing, clinical trials and U.S. Food and Drug Administration (FDA) approval for patient use.

To put this in perspective, in 2007 the FDA approved 26 new medicines for patient use. To get a new treatment to pharmacy shelves typically requires anywhere from 10 to 15 years of research and development, involving thousands of researchers, patients and government regulators. The average research and development cost can reach as much as $1.3 billion dollars.

In other words, the ongoing search for new medicines requires a profound dedication to both the hope of helping patients and the extraordinary hard work of the the researchers involved in drug development and approval process. Both the individuals and companies that take this challenge on do so with few illusions. I’ve been privileged to speak with many pharmaceutical research scientists who have spent their entire professional careers researching and developing new medicines. They frequently tell me that there were times when they would ask themselves whether it is worth the time, money and effort – especially if they spent years working on an idea that went nowhere. Many also say that their work more likely than not led to small incremental advances in the treatment of a disease as opposed to working on some medical-science or technology changing discovery.

But the thing that impresses me most about these scientists is that most never stop trying.

The reason they don’t stop is that each one of the more than 500,000 dedicated men and women who today work for one of America’s pharmaceutical research and biopharmaceutical companies understands that the risk of failure is nothing compared to the suffering of patients and families waiting for a new medicine or better treatment. They live with the uncertainty and setbacks because the successes when they occur – even the incremental ones -- can dramatically and positively change patients’ lives. A new medicine that helps reduce chronic pain; a new drug that allows a formerly disabled patient to hold a job and be productive; a better treatment that helps a cancer survivor live to see their children reach adulthood: These are the goals that keep scientists in the laboratory and that keep America’s pharmaceutical research companies investing in new research and development.

These are also the reasons that America’s pharmaceutical research companies exist. Each has a long, distinguished history of pioneering great medicines that have not just advanced our understanding of disease and how to treat it, but have also helped patients to live longer, healthier lives.

Last year, PhRMA member companies invested an estimated $44.5 billion in new medical research and development – a significant part of the nearly $59 billion cumulatively invested by all pharmaceutical research companies. This investment in new research and development is critical because it fuels the process of turning great ideas and innovative technologies into usable, safe and effective medicines.

In my role as president & CEO of PhRMA, I have often encountered pharmaceutical industry critics skeptical of the role that pharmaceutical research and biopharmaceutical companies play in developing new medicines. “Isn’t that what the National Institutes of Health (NIH) do?” They ask, “Aren’t you just taking research that the taxpayer paid for and turning it into a product?”

The answer is a definitive “no.” The private-sector investment in new pharmaceutical and biotech medical research far exceeds the public investment in NIH. In fact, the 2007 funding for all of NIH activities – including research as well as administrative and other costs – totaled $28.6 billion dollars.

Of course the work NIH does is extremely important. It conducts critical basic research that helps to lay the scientific foundation for many great ideas that are shaping our understanding of disease and how it can be fought. But the hard, expensive and time-consuming work of taking that basic research and transforming it into medicines that doctors can use to treat or cure is work for the most part done by America’s pharmaceutical research companies.

And, the fact that so much of this innovative research and development is done here in the United States and that the resulting medicines and treatments are often first approved for patient use here is an important added benefit to American patients.

We’ve been fortunate in this country because the medical progress we’ve experienced over the last 50 years allows many to hope that even better cures and treatments are in the research and development pipeline. That hope is not misplaced. One or more of the 2,000-plus new medicines created by one of America’s pharmaceutical research companies and now in late-stage development or in the final approval process may hold the promise of dramatically improving the care and treatment of any number of diseases. Then again, not every one of these 2,000 potential medicines will make it through to final FDA approval. For some incredible researchers, this will literally mean heading back to the drawing board to start again. But when you dedicate your career to finding new ways to fight cancer, prevent Alzheimer’s disease or help someone with rheumatoid arthritis to live a better; pain-free life, those are risks you are willingly take.

We have long been able to look forward and dream of a time when the most intractable of diseases can be prevented, treated or even cured. We believe this future is possible because our experience over the past 50 years tells us that no challenge is too great.

To fulfill the promise, we must all be cognizant of the incentives needed to inspire groundbreaking medical research and development. Particularly and most importantly, we need to foster an economic environment that promotes innovative medical research and development. Pharmaceutical research and biotechnology companies need to be confident that their significant investment of time, effort and money will be rewarded should they discover a new and better medicine.





PhRMA President & CEO

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