Innovation in medicine and medical technology has led to tremendous achievements in American’s quality of life and health care. Over the past century, the life expectancy went from just over forty-seven years to nearly seventy-eight in 2006. “Diseases that had once been a death sentence were eradicated or cured. Conditions that had once been disabling were now manageable.”
As Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) recently pointed out, “Many of these gains were made possible by the great leaps in biomedical science, from the discovery of insulin to the identification of effective therapies for HIV.” What she forgot to mention is that the pharmaceutical and medical device industry have overwhelmingly been responsible for this progress and improvements.
Consequently, in a recent article in the Journal of Health Affairs, Secretary Sebelius noted that America now has the chance to improve healthcare and medicine with even “bigger opportunities.” She pointed to “new treatments, such as cell-based therapies, which introduce new cells into body tissues to treat diseases such as diabetes, show great promise.” In addition, Secretary Sebelius championed “unlocking the human genome” as a way to “facilitate personalized treatments for diseases such as cancer, based on each person’s unique DNA.”
However, she recognized that gains from these breakthroughs “are not guaranteed.” Instead, she acknowledged that new “treatments and cures for cancer, Alzheimer’s disease, and HIV/AIDS will be made only if there is a robust pipeline that carries promising ideas forward from the microscope to the medicine chest.”
The only way to accomplish this robust pipeline according to the Secretary, “is with a new level of coordination among all of the partners in the research process.”
From Research To Final Product
Part of the problem why America is facing a challenge with discovering new drugs is that the “road from the research lab to an approved and marketable drug is a long one, and today there are many detours and obstacles along the way.” As Secretary Sebelius acknowledges, “despite billions of dollars invested every year in research and development, just twenty-one new drugs made it to market in 2008.”
She noted however that the Obama administration supports innovation and the potential of biomedical research, evidenced by the American Recovery and Reinvestment Act of 2009, which invested an additional $10.4 billion over two years in the National Institutes of Health (NIH), with the vast majority of those funds going directly to scientific research.
Despite this investment, Secretary Sebelius acknowledged that “more is needed than writing bigger checks” to enhance the drug pipeline. She asserted that “resources must be invested so they will have the largest impact possible and will deliver greater numbers of cutting-edge drugs, therapies, and medical devices more quickly to the patients who need them the most.”
Stronger Public-Private Partnerships
To accomplish this kind of impact, Secretary Sebelius noted that the government has begun to “broaden its role from funding discovery to building innovative networks of all of the stakeholders in the development process.” Members of the networks include “foundations, such as the Bill & Melinda Gates Foundation, which are deploying funds to generate treatments and cures for diseases that disproportionately affect people in the world’s poorest countries; and patient advocacy groups, which can help collect patient blood, tissue, and other samples for basic research and connect their members with clinical trials.”
One such network is the Biomarkers Consortium, a public-private partnership that includes scientists from the National Cancer Institute, the Food and Drug Administration (FDA), major pharmaceutical companies, and nearly twenty major cancer research centers across the country. The consortium is now working on a clinical trial to improve the odds of survival for women with high-risk, fast-growing breast cancers.
Another example of partnership is the NIH Therapeutics for Rare and Neglected Diseases program, which links small companies or academic labs doing basic research on diseases such as sickle-cell disease and hookworm, with government researchers who can use high throughput screening and medicinal chemistry to move these discoveries closer to clinical trials.
The Cures Acceleration Network, which was enacted in the Affordable Care Act of 2010, is another example of private-public partnership. It gives the NIH director the flexibility to fund a variety of innovative projects from the public, private, nonprofit, and academic sectors, with the goal of advancing research in areas where success is not a given but the payoff could be very high.
The Secretary also discussed how HHS will be forging stronger partnerships inside government, such as the NIH and FDA working together on translational efforts and developing standards for safety and effectiveness. However, the Secretary did not mention industry’s role in this partnership. It is crucial that industry has a seat at the table in discussing solutions and ideas for increasing the pipeline as well.
She also discussed a recommendation that NIH create a new center devoted to translational science that would generate new approaches for building bridges to link basic discovery research with the development of new therapeutics and clinical care. NIH is currently gathering input from the public and a broad range of stakeholders, and if all goes as planned, the new center will be established by October 1, 2011.
Conclusion
As Secretary Sebelius acknowledged, “some of the roadblocks that have held back the development of new medicines can be eliminated” by projects and partnerships with industry. Specifically, she recognized that “Public-private partnerships are needed to build new paradigms for drug development, not just when it’s time to manufacture and market a product, but from the beginning of the development process.”
Moving forward, policymakers must continue to include industry in regulatory discussions so that America can continue to develop a new generation of cures and treatments that could dramatically improve the lives of Americans and people around the world. By having “a broader conversation among stakeholders in government, academe, industry, and nonprofits about how everyone can do better,” America can fill its pipeline once again and create new jobs, revenue and medicine that will improve our health care system.