Published in the Home News Tribune (NJ) June 2, 2009

The swine flu outbreak was a vivid reminder of how far we've come in dealing with the threat of viral pandemics. Health authorities around the globe responded in record time, limiting the spread of the virus and the loss of life, at least so far.

Most of the patients who died had other health complications that were exacerbated when they contracted swine flu. For most everyone else, the availability of antiviral drugs like Tamiflu and Relenza have proven immensely effective in treating the illness, calming fears about the spread of the virus. Further, researchers are working hard to develop a vaccine that they hope to have available by this fall.

It seems a paradox then that the pharmaceutical industry, which we rely on to develop these medicines, is generally scorned by politicians and even by many citizens. This attitude isn't just disingenuous … it's dangerous.

The flu epidemic of 1918 killed at least 30 million people worldwide. Some put the number as high as 100 million. There were no treatments to halt its spread, and many of the actions by government actually exacerbated the epidemic.

America has made great progress over the last century in preventing outbreaks of deadly diseases with a combination of public health measures to prevent and contain outbreaks and continued innovation, including development of new medicines and vaccines.

Many say we have all the medicines we need and that further research to develop new drugs is too costly. But tell that to a cancer or Alzheimer's patient or someone suffering from a rare disorder. They know we must continue pharmaceutical research to advance our understanding of these diseases to develop treatments and even cures.

Although many of the barriers to curing these illnesses are scientific, many of the greatest challenges in the 21st century will be economic and political.

The government cannot develop and deliver the drugs we need. In fact, government research makes a significant contribution to the creation of only one in 10 new drugs. Continued progress in medical innovation requires continued investment in new research by private industry.

Government's role should be to provide a stable climate for investors so research can continue. But that's not the political climate in Washington today.

Case in point is a bill introduced in the House of Representatives by Rep. Henry Waxman, D-Calif., called the Promoting Innovation and Access to Life-Saving Medicine Act. Waxman claims his bill would expand access to high-tech medicines derived using biotechnology and lower their prices. In reality, though, the bill would have the effect of dramatically reducing investment into these treatments.

These drugs, typically called ""biologics,'' are grown in living organisms such as plant and animal cells. Biologics have shown unprecedented promise in treating an array of diseases, including cancer, Alzheimer's and arthritis.

But these drugs are enormously expensive to develop. On average, it takes more than $1 billion to bring one to market. And then it takes 17 years to break even on the investment, according to a recent paper from Joseph Golec of the University of Connecticut and John Vernon of the University of North Carolina.

Despite this, Waxman's legislation gives biotechnology companies just five years of market exclusivity before requiring them to hand over their proprietary research data to competitors. Competitors could then use that data to produce and sell copycat versions, called ""biosimilars.''

This short, five-year exclusivity provision would virtually guarantee that investors would pull their capital out of research on new biologics because they'd have almost no chance of recovering their investment. This would mean much less research into future medicines.

The idea behind the Waxman legislation is hardly new. Indeed, the belief that drug companies are heartless corporations that profit off the sick helps explain America's current vaccine shortage.

Even though 26 different companies manufactured vaccines in 1967, just five make vaccines today. The reason? Price controls and excessive regulation of their products. In fact, according to the health policy journal Health Affairs, ""the high cost of compliance with regulations contributed to the U.S. flu vaccine shortage of 2004.''

We want to make sure that the researchers are hard at work to prepare defenses against life threatening diseases and future viral pandemics. We must be careful not to sacrifice these longer-term needs with short-sighted legislation that dries up the investment in new medicines.

Grace-Marie Turner is president of the Galen Institute of Alexandria, Va., a nonprofit research organization focusing on patient-centered solutions to health reform.

Published in the Home News Tribune (NJ) June 2, 2009

The swine flu outbreak was a vivid reminder of how far we've come in dealing with the threat of viral pandemics. Health authorities around the globe responded in record time, limiting the spread of the virus and the loss of life, at least so far.

Most of the patients who died had other health complications that were exacerbated when they contracted swine flu. For most everyone else, the availability of antiviral drugs like Tamiflu and Relenza have proven immensely effective in treating the illness, calming fears about the spread of the virus. Further, researchers are working hard to develop a vaccine that they hope to have available by this fall.

It seems a paradox then that the pharmaceutical industry, which we rely on to develop these medicines, is generally scorned by politicians and even by many citizens. This attitude isn't just disingenuous … it's dangerous.

The flu epidemic of 1918 killed at least 30 million people worldwide. Some put the number as high as 100 million. There were no treatments to halt its spread, and many of the actions by government actually exacerbated the epidemic.

America has made great progress over the last century in preventing outbreaks of deadly diseases with a combination of public health measures to prevent and contain outbreaks and continued innovation, including development of new medicines and vaccines.

Many say we have all the medicines we need and that further research to develop new drugs is too costly. But tell that to a cancer or Alzheimer's patient or someone suffering from a rare disorder. They know we must continue pharmaceutical research to advance our understanding of these diseases to develop treatments and even cures.

Although many of the barriers to curing these illnesses are scientific, many of the greatest challenges in the 21st century will be economic and political.

The government cannot develop and deliver the drugs we need. In fact, government research makes a significant contribution to the creation of only one in 10 new drugs. Continued progress in medical innovation requires continued investment in new research by private industry.

Government's role should be to provide a stable climate for investors so research can continue. But that's not the political climate in Washington today.

Case in point is a bill introduced in the House of Representatives by Rep. Henry Waxman, D-Calif., called the Promoting Innovation and Access to Life-Saving Medicine Act. Waxman claims his bill would expand access to high-tech medicines derived using biotechnology and lower their prices. In reality, though, the bill would have the effect of dramatically reducing investment into these treatments.

These drugs, typically called ""biologics,'' are grown in living organisms such as plant and animal cells. Biologics have shown unprecedented promise in treating an array of diseases, including cancer, Alzheimer's and arthritis.

But these drugs are enormously expensive to develop. On average, it takes more than $1 billion to bring one to market. And then it takes 17 years to break even on the investment, according to a recent paper from Joseph Golec of the University of Connecticut and John Vernon of the University of North Carolina.

Despite this, Waxman's legislation gives biotechnology companies just five years of market exclusivity before requiring them to hand over their proprietary research data to competitors. Competitors could then use that data to produce and sell copycat versions, called ""biosimilars.''

This short, five-year exclusivity provision would virtually guarantee that investors would pull their capital out of research on new biologics because they'd have almost no chance of recovering their investment. This would mean much less research into future medicines.

The idea behind the Waxman legislation is hardly new. Indeed, the belief that drug companies are heartless corporations that profit off the sick helps explain America's current vaccine shortage.

Even though 26 different companies manufactured vaccines in 1967, just five make vaccines today. The reason? Price controls and excessive regulation of their products. In fact, according to the health policy journal Health Affairs, ""the high cost of compliance with regulations contributed to the U.S. flu vaccine shortage of 2004.''

We want to make sure that the researchers are hard at work to prepare defenses against life threatening diseases and future viral pandemics. We must be careful not to sacrifice these longer-term needs with short-sighted legislation that dries up the investment in new medicines.

Grace-Marie Turner is president of the Galen Institute of Alexandria, Va., a nonprofit research organization focusing on patient-centered solutions to health reform.