USA2 SPOTLIGHT

A March 24, 2015 Portland Press Herald article highlighted a U.S. Senate hearing on Alzheimer’s and Senator Susan Collin’s (R-ME) commitment to fighting Alzheimer’s. According to Sen. Collins, “Alzheimer’s is a devastating disease that exacts a tremendous personal and economic toll on the individual, the family and our society…In addition to the human suffering it causes, Alzheimer’s costs the United States more than $226 billion a year, including $153 billion in costs to Medicare and Medicaid.” Sen. Collins is a member of WomenAgainstAlzheimer’s Honorary Congressional Committee. 

MUST READS

A March 24, 2015 CBS News article reported on Harvard University's A4 study and the importance of clinical trial participation. According to the article, “Helene DeCoste of Boston is a patient in a ground breaking clinical trial, testing whether a drug called Solanezumab can slow down or even prevent Alzheimer's disease. No drug has even come close before, but researchers have never tested patients quite like Helene in quite this way before…"I'm going to do everything I can do to help myself put it off as long as I can," DeCoste told me. Dr. Sperling and DeCoste did not know each other before, but they have the same personal reasons for fighting Alzheimer's. Dr. Sperling lost her grandfather to Alzheimer's; DeCoste has watched her sister who has the disease, and her mother, who died because of it, both suffer anguishing declines.”

A March 24, 2015 The Fiscal Times opinion piece by Michael Hodin underscored the global threat that Alzheimer’s poses. According to Hodin, “Yet Alzheimer’s demands attention not because of its horrible impact on one person but because of the vast numbers it will affect if we don’t find a cure. In this century Alzheimer’s will affect billions of people around the globe when you multiply the tens of millions by the impact on whole families and communities. The $604 billion spent on it today, or roughly one percent of global GDP, will in time be dwarfed. We’re living 30 years longer on average than people did in the last century – so the age when Alzheimer’s would have affected just a tiny number of people is long gone. We fail to get this at our peril.” Michael Hodin is the executive director of the Global Coalition on Aging.

A March 25, 2015 Los Angeles Times article reported that Silicon Valley venture capitalist Mark Stevens and his wife Mary are “donating $50 million to a USC brain research institute in hopes of treating such disorders as Alzheimer’s disease, autism and traumatic brain injuries.” According to the article, “Stevens said he has “a front row seat” to the toll of such neurological diseases as Alzheimer’s, from which his father suffers. “If you look at the spectrum of neurological disorders, I would argue that it touches more families than cancer and heart disease. It touches youth and it touches old age,” said Stevens, who also noted that friends’ children have autism.”

POLICY AND REGULATORY ROUNDUP

A March 24, 2015 The Lebanon Democrat opinion piece by Senator Lamar Alexander (R-TN) highlighted his commitment to reforming the process of getting innovative medical devices and treatments from labs to patients. According to Sen. Alexander, “This year, the Senate health committee, which I chair, began work to modernize that development process to help make Americans healthier. This week, we held the first hearing on our bipartisan initiative to look at how we get drugs, devices and treatments from the discovery process through the regulatory process into our medicine cabinets and doctors’ offices, and to discuss ways Congress can help improve this process…In the words of Dr. Andrew Eschenbach, the former Commissioner of the FDA and Director of the National Cancer Institute: “We stand on the cusp of a revolution in health care. Advances in molecular medicine will allow us to develop powerful new treatments that can cure or even prevent diseases like Alzheimer’s and cancer. Tomorrow’s high-tech cures can also slash health-care costs and eliminate ineffective treatments.” Our goal is simple but ambitious: to work in a bipartisan way to make sure policies support medical innovation and patient access to important medicines and medical technologies. If we do it right, our work here will help improve the lives of every single American.”

A March 24, 2015 Forbes opinion piece by biotech entrepreneurs Robert Nelsen and Hans Bishop underscored the need to protect emerging biotech companies from harmful provisions of the Innovation Act (H.R. 3309). According to the authors, “Why should we care if changes in arcane patent law help rich companies get richer? For one thing, your life could depend on it. If adopted, this insult to the basic property rights of inventors will cause toxic side effects for true innovators in biotechnology. Weakening patent laws will decimate long-term investment in cures for diseases such as Alzheimer’s, Parkinson’s, and Huntington’s, as well as funding for new therapies to treat autism and breast, colon, lymphoma and prostate cancers. If you have relatives awaiting cures or work for a foundation or university that funds medical research, you should be apoplectic….Backers should embrace carving out universities and emerging growth companies defined by Title I of the Jumpstart Our Business Startups (JOBS) Act. True patent trolls who buy their patents and cause real damage are not operating companies would still be covered under the provisions of the Innovation Act. Small innovators are truly operating companies, not trolls, so let us give these American innovators the benefit of the doubt. There is precedent for this kind of exception. The Patent Act itself creates a safe harbor to protect drugs under clinical development from infringement litigation. Why not extend that protection to all start-ups and inventors, giving them a chance to be successful? This simple fix solves the troll problem and protects startups until they are big.” Robert Nelsen, Co-founder and Managing Director, ARCH Venture Partners, has helped to create over 30 biotech companies during the past three decades. Hans Bishop is the CEO of Juno Therapeutics, Inc., a clinical-stage company developing novel cellular immunotherapies to treat cancer.

A March 20, 2015 Regulatory Affairs Professionals Society post highlighted new legislation introduced by the House that “would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe.” According to the article, “The bill, the Speeding Access to Already Approved Pharmaceutical Act, is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014. As with the original, the bill targets something known in the pharmaceutical industry as "drug lag"—the difference between when one product is approved and marketed in one country and when it is finally approved and marketed in subsequent countries.”

MINORITY IMPACT