The Times (Munster, IN), June 10, 2009
Wenatchee World (WA), June 11, 2009
Imagine you have a young daughter with psoriasis. The disease affects her immune system, creating inflamed patches on her skin and causing constant joint pain. In addition to the physical irritations, she is self-conscious about her outbreaks — and thus finds it difficult to socialize and make friends.
The moisturizing lotions recommended by the doctor have helped, but occasionally, she still has severe outbreaks. You’re desperate for a more effective treatment. So when the doctor’s office calls to ask if you’d be interested in putting her on a promising new treatment, you quickly sign up.
To your astonishment, within just a few weeks of getting on the new drug regime, your daughter’s symptoms clear up. The rashes are significantly less frequent and less severe. The joint pain has eased. Her improved appearance had led to increased confidence, and she’s much happier and more sociable at school.
Such a profound life change could soon be a reality for children suffering from psoriasis. A study published earlier this month found that a cutting-edge biologic drug called etanercept clears symptoms and significantly improves quality of life for moderate to severe psoriasis patients between ages 4 and 17.
This is an incredible development. Widespread use of etanercept in the treatment of juvenile psoriasis could vastly improve the well-being and health of the 20,000 children diagnosed with the disease annually.
What’s also important to remember, though, is the other side of the human equation. It took thousands of man-hours from chemists, biomedical engineers, physicians and research scientists — plus hundreds of millions of dollars from investors — to develop etanercept in the first place.
Indeed, etanercept is a biologic, meaning it was manufactured using living tissue. That’s a particularly expensive process. It costs roughly $1.5 billion to research, develop and bring a typical biologic therapy to market, according to health care economists at Tufts and Duke.
Etanercept was originally developed back in the early 1990s by scientists at the University of Texas. They took on this huge upfront cost because if the drug did in fact make it to market, they’d have the exclusive right to sell it. And through those sales, they might be able to make back their investment and perhaps even turn a profit.
Sure enough, once etanercept proved effective in treating autoimmune disorders, researchers patented the drug. Eventually, they sold the rights to the biotech company Immunex, which was later acquired by Amgen.
Had researchers not had the exclusive rights to their final product, they would have had effectively zero chance of making back their investment in sales — and likely wouldn’t have developed etanercept at all. This holds true for virtually all medical research. Government regulations greatly influence the rate of innovation, the law structures and the incentives that drive companies to take on the risk of developing new treatments.
In the case of biologics, an important legal protection being considered by Congress is known as “data exclusivity.” For a pre-specified period of time, companies would be allowed to keep the research data on a new biologic private. After data exclusivity expires, competitor firms would gain access to that research and could use it to create “biosimilars,” which are essentially copies of biologic drugs.
If data exclusivity is too short, biosimilars will hit the market before the firms that create original biologics have a chance to make back their investment. Biologic research companies would see the possibility of digging themselves out of the red decrease dramatically, and they’d likely respond by ceasing to fund research into new therapies.
If that happens, we won’t just lose out on breakthrough psoriasis treatments. Biologics have proven effective at combating a wide range of major maladies, including Alzheimer’s, multiple sclerosis, cancer, and arthritis. The next generation of drugs would be threatened if data exclusivity is cut short.
Fortunately, Congress is considering legislation that would establish 12 years of data exclusivity for biologics. Academic research suggests that this is just about enough time for biologic firms to break even. The bill that provides this 12-year period was introduced in Congress by Reps. Anna Eshoo, D-Calif.; Jay Inslee, D-Wash.; and Joe Barton, R-Texas.
If this bill passes, biologic firms will continue to develop breakthrough treatments for psoriasis and countless other ailments.
Sally C. Pipes is President and CEO of the Pacific Research Institute. The opinion expressed in this column is the writer’s and not necessarily that of The Times.