By Richard C. Duke
More than 100 Colorado residents die from skin cancer each year. According to the Centers for Disease Control, our state has one of the nation’s highest death rates from melanoma.
Fortunately, there are new treatments in the works. Biomedical researchers now have two separate therapeutic vaccines in development — a viral injection that stimulates the body’s immune system and another that trains the body’s own defenses to identify and kill cancer cells.
These new weapons in the battle against skin cancer represent just a couple of the many powerful drugs now in development. But medical innovation doesn’t happen by accident. For Coloradans and all Americans, it’s crucial that legislators craft a favorable regulatory environment that enables and supports new drug research.
According to a new report, the nation’s biotech industry has 907 medicines and vaccines in development, targeting more than 100 different diseases.
Many of these medications are being developed right here in Colorado. Since 1999, 3,551 clinical trials have been conducted in Colorado and hundreds are still underway and recruiting patients. Of the 3,551 clinical trials, 1,705 have focused on the nation’s most debilitating chronic diseases like asthma, cancer, diabetes, heart disease, mental illness, Alzheimer’s and stroke.
There is hope for patients starting at home in Colorado, but the process is not quick or cheap. The average drug requires over a decade of research and costs $1.2 billion to bring to market.
With the right policy environment, the future of medicine is bright. In just a few years, we may have new therapies to treat lupus, which afflicts 20,000 Coloradans; a third-generation medicine to treat lymphoma, a blood cancer that kills 20,000 Americans every year; an antibody that assists with regenerating injured spinal cords, which harm 11,000 Americans annually; and a treatment that could block rheumatoid arthritis, which now affects 21,580 Coloradans, mostly women.
These medicines are made possible by innovative biotechnologies. “Interferons” stop unwanted cells from reproducing. Other drugs can block cells from producing toxic proteins. And there’s the microscopic miracle of nanotechnology, which many new treatments now use to deliver drugs more effectively and with fewer side-effects. Biotechnology is also paving the way for “personalized medicine” — targeted treatments based on an individual’s unique genetic makeup.
Meanwhile, thanks to the Medicare Part D prescription drug program, 50 million Americans — including more than 600,000 eligible Coloradans — have robust access to breakthrough medicines. Part D’s market-based structure has kept program costs down. This year, the program’s average monthly premiums are half the amount originally forecast. Premiums have held steady for three years running.
Unfortunately, some in Washington have proposed changing the way Medicare covers drugs for low-income seniors. They want drug makers to pay a rebate to the government on prescriptions sold to these enrollees, effectively imposing price controls on Part D biopharmaceuticals. The result would be fewer resources available to invest in the research and development of new life-saving medications.
At the same time, the White House has proposed reducing the period of time granted to biotech companies after they’ve introduced a new drug during which competitor firms are prevented from selling copies of that medicine. Sadly, this would undermine the critical intellectual property protections that have helped encourage investment and research in new treatments since this period of protection is crucial in providing drug firms an incentive to make the massive investments needed to develop new medicines. Scaling back this protection would chill research into new medications. Potential investors would be left to worry about recouping their investment before competitors can enter the market and siphon away sales.
Promising research conducted right here in Colorado is helping to create new treatments to fight cancer, asthma, lupus and other devastating diseases. For this research to continue to flourish as rapidly as possible and to the fullest degree, Congress needs to stand firm to defend Medicare Part D and intellectual property protection for medical innovations.
Richard C. Duke, Ph.D., is the founder and chief scientific officer of CID4, Colorado Institute for Drug, Device and Diagnostic Development, www.cid4.com.
Opinions communicated in Solutions represent the view of individual authors, and may not reflect the position of the University of Colorado Denver or the University of Colorado system.