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Moving Beyond the Stem Cell Stalemate

September 28, 2011
By Michael J. Werner, Alliance for Regenerative Medicine

For the past several years, attendees at the World Stem Cell Summit have focused their energies primarily on legislative and legal efforts to protect human embryonic stem cell research. When folks gather at this year's meeting, they will once again confront the reality that research opponents will continue to try to block these efforts.

[caption id="attachment_4384" align="alignright" width="115" caption="Michael J. Werner is a partner at the law firm of Holland & Knight, LLP and Executive Director of the Alliance for Regenerative Medicine."]Michael Werner[/caption]

James Sherley has filed an appeal to the US Court of Appeals, DC Circuit seeking to overturn that court's ruling this summer that threw out his lawsuit against the National Institutes of Health (NIH) and the implementation of its policy to fund embryonic stem cell research.

In addition, earlier this month research opponents introduced legislation in Congress, The Patients First Act (H.R. 2951). This bill would require the Secretary of Health and Human Services to "conduct and support" research seen as most likely to lead to benefits to patients, as long as it does not involve "the creation of a human embryo for research purposes; the destruction of or discarding of, or risk of injury to, a living human embryo."

Research opponents' prospects of blocking NIH funding are slim. Nonetheless, these actions demonstrate that research supporters must remain vigilant in their defense of the research.

Of course, efforts to somehow statutorily codify President Obama's Executive Order are also unlikely to succeed. The result is a stalemate that will last at least until the 2012 Presidential election. This, even though Congress, the courts, and the last three US Presidents have all said embryonic stem cell research should be allowed to proceed under strict ethical and regulatory guidelines.

But what's different about this year's Summit is that attendees will also be discussing ways to promote the entire field of regenerative medicine. Regenerative medicine excites patients and researchers because it holds the promise of transforming the way medicines are discovered and produced and the way health care is delivered. It represents a new paradigm in health care that will meet unmet medical needs by focusing on the underlying causes of disease.

The National Institutes of Health define regenerative medicine as the process of creating functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. It also empowers scientists to use all types of stem cells to grow cells, tissues and organs to repair damaged or destroyed cells and tissue the body cannot heal by itself.

Regenerative medicine products currently on the market have successfully treated conditions such as cartilage damage and diabetic foot ulcers. These are just the tip of the iceberg as there are currently about 250 therapies currently in clinical development that aim to treat heart disease, stroke, diabetes, spinal cord injury, and a host of other diseases.

The demographic trends in our country make these products even more necessary. A recent study from the American Heart Association found that not only is heart disease the leading cause of death in the U.S., but it is also responsible for 17 percent of national healthcare expenditures. When future estimates of disease incidence are included, the direct costs of all heart disease are projected to increase from $273 billion in 2010 to $818 billion in 2030. For heart failure and stroke – both central in regenerative medicine research programs – real medical costs are expected to increase by 200 percent and 238 percent, respectively, over the next twenty years.

The Alliance for Regenerative Medicine -- a multi-stakeholder group comprised of life sciences companies, patient advocacy groups, nonprofit organizations, research institutions and investors -- has advocated for a national strategy on regenerative medicine. This strategy would include developing a clear and predictable regulatory pathway at FDA so safe and effective regenerative medicine products reach patients as soon as possible. It also includes a reimbursement framework to reward innovation, and funding policies across the federal government to discover answers to key scientific questions.

The Regenerative Medicine Promotion Act of 2011 (HR 1862) contains provisions designed to develop and implement this strategy. This bi-partisan bill calls for a US GAO report on current federal activities as well as creation of a Regenerative Medicine Coordinating Council comprised of key federal agencies, private sector product developers, academic researchers and patients to set national goals and priorities. The Act also establishes grant programs to support translational research and regulatory science research designed to facilitate product development.

Kick-starting the field of regenerative medicine will be at the forefront of the Summit's agenda and top of mind among participants. It will be an exciting discussion.