Gina Kelly Rice, Vice President, Marketing and Communications, Society for Women's Health Research (SWHR). SWHR, a national non-profit organization based in Washington D.C., is the thought leader in research on biological differences in disease, and is dedicated to transforming women’s health through science, advocacy and education.

We don’t have to look back very far at all, since prior to 1990, women were routinely not included, if not outright prohibited, in medical research studies, and no one thought about possible differences between men and women, other than reproductive issues.

Part of the reason was to protect women during their reproductive years, but the other reason was that scientists believed women and men to be biologically the same.Clinical trials for drugs and devices included mostly men, and it was assumed that the results could be applied to both men and women.

Why Gender Does Matter?

When it comes to health, there are many crucial differences between men and women. Yet many women do not know that they react differently to some medications, are more vulnerable to some diseases, and may have different symptoms. Just a few examples from Women’s Health A-Z:

• Heart Disease kills over 50,000 more women than men each year.
• Depression – Women are two-to-three times more likely than men to suffer from depression.
• Osteoporosis – Women comprise 80 percent of the population suffering from osteoporosis.
• Smoking – Smoking-related diseases kill more than 140,000 American women annually.
• Autoimmune Disease – Three out of four people suffering from autoimmune diseases, such as multiple sclerosis, rheumatoid arthritis, and lupus, are women.
• Alcohol – About 1.6 million alcoholics in the US are women, who are the fastest growing segment of the alcohol abusing population.
• Pain – Many chronic pain conditions are more common in women, such as rheumatoid arthritis, fibromyalgia, migraine, and osteoarthritis (after age 45).
• Stroke – Each year, approximately 40,000 more women than men suffer from a stroke.

SWHR’s What a Difference an X Makes – The State of Women’s Health Research” Conference, July 18 -19, 2013 is designed to raise awareness about the importance of sex differences in various diseases and conditions that affect both men and women or women disproportionately. This conference will address the state-of-the-science in various scientific fields, while highlighting future research and knowledge gaps in knowledge.

Get engaged in National Women's Health Week, by visiting swhr.org to learn about how sex differences affect your health.

Today's guest blog was written by Kim Cantor, Senior Director, Public Policy and Government Relations of the Lupus Foundation of America, Inc.

What is lupus? This is a question that I get asked often working for the Lupus Foundation of America. Lupus is a mysterious and devastating disease that ravages different parts of the body and has no known cause and no known cure.

The disease is more pervasive and more severe than people think, and has an impact that the public doesn’t realize. A recent survey revealed nearly three-fourths of Americans ages 18 to 34 – those at the highest risk for lupus – have never heard of lupus or know little or nothing about lupus beyond its name.

Building awareness of lupus is essential to improving the diagnosis and treatment of this cruel disease that disproportionately affects minorities and women in the prime of their lives. I have heard many heartfelt stories of people struggling for years to find a diagnosis, managing and overcoming serious and life-threatening health consequences, or lost loved ones to lupus.

Efforts for are underway for Lupus Awareness Month, but it’s not too late to join the fight against lupus and take action to help expand lupus research efforts.

We are empowering individuals, organizations, and companies to educate people in their communities about lupus and the need to expand lupus medical research. During May, the Lupus Foundation of America will provide free tools and resources online at lupus.org/awareness.

Here are a few ways you can join the fight to end lupus during Lupus Awareness Month:

• Sign the petition. We are urging the public to help us solve the cruel mystery by signing a petition that asks Congress to fund more lupus research efforts. The petition is available online at lupus.org/petition
• Put on Purple Day-May 17th. Purple is the color used for lupus awareness. The Foundation asks everyone to wear purple, work with community leaders to illuminate local fountains and buildings in purple that day.
• Share Lupus Information with Friends, Family and Colleagues – Post fliers throughout the office and the community. Share daily facts about lupus or place a banner within newsletters, on websites, and on social media sites.

For more information about Lupus Awareness Month and other ways to join the fight, visit the Lupus Foundation of America’s website.

• 1983: The Orphan Drug Act passed, encouraging the development of new medicines and treatments for rare diseases. Since then, the number of approved medicines for rare diseases has risen dramatically.
• 1984: The Drug Price Competition and Patent Term Restoration Act of 1984, colloquially known as the Hatch-Waxman Act, preserved financial incentives for the research and development of innovative medicines, while making room for the modern U.S. generics market to emerge. Since Hatch-Waxman there has been a 25-30% reduction in the prices of medicine and over $193 billion in cost savings.
• 1992: The Prescription Drug User Fee Act was enacted to help expedite the drug approval process. Since PDUFA came into effect, patients in the U.S. have had speedier access to over 1,500 new medicines.
• 2003: Medicare Part D was created to expand access to prescription medicines for seniors. Since Part D came into effect, over 31.5 million seniors have enrolled in the program—that’s more than the populations of Belgium, Portugal, and Sweden combined!
• 2011: The Leahy-Smith America Invents Act (AIA) provided the most comprehensive update to the patent system since 1836. Since AIA came into effect, the patent backlog has decreased from over 700,000 to about 640,500. As time goes on, the legislation is projected to decrease the backlog to just 330,000 and cut the process time by over one year.

Looking to the past can provide insights into the path to the future. Medical innovation has brought us a long way. When policies support an innovative ecosystem, it helps ensure that we can continue to bring patients access to the medicines of today and tomorrow. For more information about the impact of legislation on innovation, check out our interactive innovation infographic!

Today’s guest blog was written by Helen H. Miller, LCSW, ACSW, Chief Executive Officer of CancerCare. Ms. Miller has an extensive background directing cancer research prevention and wellness programs for major cancer centers.

Founded in 1944, CancerCare is one of the country’s largest cancer support organizations reaching more than 1,000,000 people affected by cancer each year. Our professional support services help people cope with the emotional, practical and financial challenges of cancer.

In my three decades practicing clinical and executive management in social service settings, I’ve witnessed many breakthroughs in treatment leading to better prognoses for people with cancer. Still, oncology social workers report that clients feel their health care team has not adequately addressed their emotional and practical concerns.

The landmark IOM report, “Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs,” found attention to psychosocial needs to be the exception rather than the rule. Seven years after the report was published, despite overwhelming evidence that support services help relieve emotional stress and lead to better patient outcomes, too many providers undervalue psychosocial care.

Apart from medical challenges, patients and their loved ones must cope with myriad concerns impacting treatment compliance, including: feelings of depression and anxiety, financial uncertainty, a lack of information about diagnosis and treatment and difficulty balancing work/school/family responsibilities.

Many patients and caregivers would benefit from counseling with a professional oncology social worker. CancerCare client Ekata, a young woman diagnosed with chronic lymphocytic leukemia, was skeptical when her health care team and brother recommended seeking individual counseling services to help her cope with her diagnosis. One of Ekata’s main concerns centered on shielding her family from her anxiety.

Through meeting with her social worker for counseling, Ekata learned to focus on herself rather than feel occupied with what people around her are feeling. “When I come to CancerCare,” Ekata says, “that is my safe place to talk about anything. My social worker has been an amazing validation for me.”

Along with receiving individual counseling, many patients and caregivers benefit from participating in a support group. Organizations such as CancerCare offer free support groups for patients and caregivers. We also refer patients and loved ones to resources in their community that provide additional emotional and practical support.

Many patients and caregivers report feeling particularly stressed regarding financial and insurance concerns. The website of the Cancer Financial Assistance Coalition provides a searchable database of regional and national organizations providing financial help for treatment-related expenses such as lodging, transportation, child care and over-the-counter medications.

People coping with cancer often share with our oncology social workers that they feel rushed at their appointments and/or do not want to “bother” their health care team with non-medical concerns. While factors such as personnel shortages, an increased number of cases, and established clinical practice procedures may certainly impact the amount of time spent with each patient, they should not do so at the expense of adequate doctor/patient communication.

Tomorrow, the Government of Peru will host stakeholders from around the world during the 17^thround of negotiations on the Trans-Pacific Partnership (TPP). The TPP provides an opportunity to strengthen U.S. trade relationships in one of the most robust, dynamic regions in the world. The White House has cited the TPP’s potential to create a truly 21^st century trade agreement. But what does that really mean? When we talk about a 21^st century trade agreement and gold-standard intellectual property protections, it may sound like science fiction, but it has very real implications for the United States and partner countries.

What is a 21^st century trade agreement?

The world looks very different today than a generation ago. As stakeholders approach negotiations, the agreements must represent the unique challenges, values, and priorities of the 21^st century. The U.S. has demonstrated a commitment to creating jobs, and promoting innovation and competitiveness. In order to meet the 21^st century challenges to innovation and economic growth, the TPP must recognize and preserve the critical role of intellectual property standards.

How can we provide gold-standard IP protections?

The TPP needs to provide a gold-standard for intellectual property protections to meet the new and emerging challenges of the 21^st century. As negotiators discuss the best course of action, the U.S. Trade Representative must push for international standards that match U.S. law. These high standards would ensure that American companies can compete with their foreign competitors on a level playing field.

A successful TPP agreement would match international standards to U.S. intellectual property laws:

Patents: Under the Hatch-Waxman Act, the U.S. patent linkage system protects marketing rights for new medicines as they move through the regulatory approval process.

Data Exclusivity: The size and complexity of biologic compounds make them inherently difficult for IP protection. Since they cannot be patented with a molecular formula, data exclusivity or data protection is critical for biologics. For this reason, U.S. law provides 12-years of data exclusivity for biologics. To spur research and development in the Asia-Pacific region, the TPP must meet this robust standard.

Applying these standards internationally would help foster innovation, support economic growth, and ensure that the U.S. can remain economically competitive in the global marketplace.

The TPP announcement in November 2011 represented a commitment from nine countries—Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore, Vietnam, and the United States. Since then, three additional countries, Canada, Mexico, and Japan, have sought membership in this consortium of countries committed to enhancing trade, spurring investment, promoting innovation, and fostering economic growth. As more countries recognize the value of the TPP and seek membership in the agreement, the increasing scope creates a pressing need for high-quality standards that will realize the agreement’s full potential. Through strong IP and market access rules, TPP member countries can set forth a template for 21st century trade that promotes innovation and produces economic growth for all participants.

• This Baltimore Sun article explains “Operation Bitter Pill,” an international initiative resulting in the seizure of 686 websites in more than 100 countries, and the confiscation of 3.7 million doses of counterfeit medications worth $10.5 million.
• The Star Ledger reported on last year’s bust of what officials called the largest-ever counterfeit smuggling ring. 29 people were arrested and charged for the $325 million enterprise that smuggled everything from counterfeit Uggs to drugs.
• The United States Department of Immigration and Customs Enforcement shared a statement detailing the successes of “Project Cyber Monday 3,” which seized 132 domains around the world that were engaging in the sale of counterfeit goods. Rob Wainwright, the director of Europol released a statement that, “IPR theft is not a harmless and victimless crime. It can cause serious health and safety risks and it undermines our economy.”

Lilly has vocally advocated for coordinated action to combat fake medicines. Earlier this year, we partnered with Interpol and other stakeholders to strengthen the network of active participants in this fight. The Global Intellectual Property Center’s celebration of preserving intellectual property rights highlights the important health, safety and economic concerns associated with counterfeiting. This holds particularly true in the health industry, where counterfeit drugs pose serious and potentially fatal health consequences for patients exposed to inauthentic medications. Congratulations to all those recognized!

Innovation, in its traditional form, is hard to find in the Johannesburg, South Africa township of Zandspruit, where we launched the Lilly NCD Partnership last year with our partner, Project HOPE . Most homes are made from irregular cuts of corrugated metal. Roofs are held down by stones. Sewage seeps through streets that are criss-crossed with illegally connected electrical wires.

It’s in this environment – and in others like it in Brazil, India, and Mexico – that the Lilly NCD Partnership hopes to find an innovative and cost-effective model for improving the health of patients through better diagnosis, treatment and long-term management of chronic diseases, especially diabetes. Ultimately, we hope these evidence-based models can be replicated and scaled up by governments around the world.

But as I walk past the lines of people waiting to see one of the two nurse practitioners in a clinic that serves 70,000 people, I can’t help but think that this going to take some of the best innovation we’ve got.

Patients who speak any number of 11 languages, often lack basic nutrition and health education. Volunteers and clinic staff go door-to-door checking blood glucose levels of reluctant residents. When they face so many other life challenges, those who are diagnosed often find it difficult to visit the clinic for medications and long-term disease management.

And yet, I have every confidence we will succeed. Because here where the challenges seem insurmountable, innovation may simply be the ability to deliver quality healthcare and relentless follow-up and education.

Just like the discovery and development of new medicines, it’s the passion, knowledge, and tenacity of the people behind the innovation who will make it happen. Judging from the staff and volunteers I have met, I am confident innovation is coming to Zandspruit. It has to.

Today’s blog is written by Sarah Butler, MS, RN, CDE, NCSN, Director of Diabetes and Nursing Education; Angela Shubert, Assistant Director of Government Affairs; and Nichole Bobo, MSN, RN, Director of Nursing Education, at the National Association of School Nurses (NASN). NASN advances the specialty practice of school nursing to improve the health and academic success of all students.

Today, May 8, is National School Nurse Day, a time when we celebrate and honor the more than 74,000 school nurses who make a difference in the lives of children every day. School nurses care for students and communities, serving a critical role in improving public health and promoting students’ academic success for more than 110 years. Research shows that healthier students are better learners. Indeed, school nurses contribute to their communities by helping students stay healthy, in school, and ready to learn, and keeping parents and families at work.

School nurses use their specialized knowledge and assessment skills to manage children’s increasingly complex medical conditions to prevent complications when at school, including type 1 diabetes (T1D). School nurses are responsible for coordinating and overseeing the medical management and safety of students with T1D.

Together, the school nurse, appropriate school officials and family develop an individualized healthcare plan (IHP) and other educational plans, including 504 plan and IEP, as needed. The IHP includes emergency care plans that help direct the actions of teachers and school staff. While school nurses focus on meeting the immediate needs of children and adolescents with T1D, they also support the student transition toward self-management. Key to successful diabetes management in school, school nurses empower students to stay healthy, active, safe and successful.

Managing diabetes at school is most effective when there is a partnership among students, parents, school nurse, healthcare providers, teachers, counselors, coaches, transportation providers, food service employees and administrators. The National Association of School Nurses (NASN) develops and offers school nurses educational opportunities and resources to support them in their key role as care coordinator.

H.A.N.D.S.^SM(Helping Administer to the Needs of the Student with Diabetes in School) is a live program that more than 8,500 school nurses have participated in nationally since 2008. The educational training provides updated clinical information, resources and tools. NASN’s publication, Managing Diabetes at School: Tools for the School Nurse, and e-learning modules build on H.A.N.D.S.^SM These resources support the school nurse in developing the IHP and facilitate the safe and effective care of students with diabetes in school.

A top priority of this nation should be ensuring that children have a healthy and successful future, equipping them to become productive citizens in society. School nurses are transforming communities by making this vision a reality every day.

• Yesterday, the Council for Affordable Health Coverage launched Prescriptions for a Healthy America: A Partnership for Advancing Medication Adherence to advance solutions that help reduce health care costs and improve patient health across the nation.
• A survey conducted by Greenberg Quinlan Rosner Research and Public Opinion Strategies to coincide with the launch of the partnership highlighted national attitudes towards medication adherence.
• An article in Forbes discusses how increasing medication adherence can help to lower health care costs, and the new technologies that make adherence easier for patients.
• ZocDoc COO and Founder, Oliver Kharraz M.D., explains the role that doctor-patient relationships play in promoting medication adherence.

Tackling adherence barriers represents one route to lowering health costs and improving sustainability in the health care system. While the variance and breadth of these barriers provides a challenge, Executive Director of the Health IT Now Coalition, Joel White points to Medicare Part D as one successful program to increase patient access to medicines. Policies, like Part D, that help minimize factors that contribute to non-adherence can play an important role in improving patient health, reducing the strain on the health care system, and ultimately, bolster the sustainability of the system as a whole. 

In the Senate, Chairman Harkin, Ranking Member Alexander, and Senators Bennet and Burr submitted draft legislation to the Committee on Health, Education, and Pensions. In reference to the need for national track-and-trace standards, Senator Bennet remarked, “Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves. In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death.” This bipartisan move represents a promising step toward the kinds of standards necessary to ensure patients receive safe and effective medicines. However, the Senate isn’t the only side of Congress recognizing this critical need.

Last week, the House Energy and Commerce Subcommittee on Health held a hearing on the pharmaceutical supply chain and the creation of federal track-and-trace standards. In her presentation to the Subcommittee, Director of the Center for Drug Evaluation and Research, Janet Woodcock, M.D. highlighted the need to strengthen the current medical safety net to avoid counterfeit drugs entering the supply. In particular, Woodcock noted that the proposed programs could enable the Food and Drug Administration (FDA) to more efficiently recall medications once they learn of breaks in the supply chain. During the meeting, E&C Committee Chairman Upton joined by Subcommittee Chairman Pitts and Rep. Latta, praised the draft legislation.

The Pharmaceutical Distribution Security Alliance (PDSA), a coalition of over 25 stakeholders from throughout the supply chain noted that the Senate’s draft legislation marks an important bipartisan effort to enact a single, national, and uniform drug supply chain. We join PDSA in applauding the progress and commitment from members of Congress on this critical issue. During the hearing, Representative Latta called the legislation a practical approach to improve the supply chain through a collaborative and transparent process between the FDA and private business. As conversations about the standards for track and trace legislation continue in both the House and Senate, Lilly looks forward to working with stakeholders and lawmakers to develop standards that safeguard the pharmaceutical supply chain and protect the health of patients.

• Dementia now costs the U.S. alone up to $215 billion a year in medical care and other costs.
• According to the Alzheimer's Association, more than 5 million Americans are affected by Alzheimer's. That includes 1 of every 8 Americans 65 and older.
• By 2050, 16 million Americans likely will have Alzheimer's, and costs in the U.S. could surpass $1 trillion.

The fact that Alzheimer's is an emerging health crisis is no big surprise.But it's worth noting that funding for medical innovation must be ramped up to find adequate treatments. As John wrote in Forbes:

"The fact is, breakthrough treatments for Alzheimer's disease are likely to come from labs at companies like ours. A study released earlier this year found that there are currently 125 potential treatments for AD in human testing in the global pharmaceutical pipeline. So the most important role that the federal government can play is to create and sustain the conditions where that breakthrough research can thrive and bear fruit."

The Forbes blog nicely outlines the rationale for the medical innovation ecosystem.

Today’s guest blog comes from Ido Hadari, CEO of Treato. As an innovative brand intelligence service for pharmaceutical marketers and agencies, Treato Pharma provides real-time insights into patients’ opinions and attitudes, enabling them to understand competitive positioning, determine priorities, and enhance patient engagement. This post originally appeared on Treato’s Blog.

Earlier this month, I spent two days in San Diego attending the 55th annual PhRMA meeting. Listening to the industry’s leaders, innovators and researchers, these are some of the key challenges that pharma innovation will need to overcome over the coming years, affecting patients, physicians and industry as one:

1. Startup funding drying up – Venture capital has almost disappeared from early stage startups. They are focusing on later clinical stages, typically waiting for phase 2. This poses a major risk for innovation in the industry; to think that there will never be another Genentech rising from within the industry. The reason for this is risk aversion. True biotech is a long process that takes a long time to deliver ROI for the LP, often an investment horizon of 10-15 years. As a result, access to VC capital in early stage is drying up and consequently, so is the innovation pipeline.
2. Budgets getting squeezed – Another major issue is the decreasing budget for R&D. The NIH budget has been and is being cut and this impacts grants and research. This is a national strategic problem impacting the US’s ability to compete globally. The industry is cautiously optimistic; to quote Winston Churchill: Americans always do the right thing after they have exhausted all the other alternatives.
3. FDA casting a shadow – Regulation is proving to be an obstacle in the eyes of many in the industry. In the attempt to balance safety and innovation, the sense among PhRMA participants is that the bar is switched to caution, leaving very little room for innovation in the way pharma develops products, tests them and takes them to market.
4. Business models need to evolve – How pharma companies get paid is becoming a riddle. The traditional models are becoming less and less applicable. A recent Forbes estimate has calculated that the cost to get a new drug to market may be as high as $8B. On the flip side of these rising costs, gone are the days of multi-billion dollar blockbuster drugs. With recent proposed policy change banning “pay for delay” and other restrictions, the industry will need to define how pharma can justify these investments in a manner that would encourage innovation and pipeline expansion.
5. Liability – There’s an overall sense throughout the pharmaceutical industry of exposure to legal action for “doing the right thing”, from clinical trial efforts through marketing activities. Big pharma is often a target for individuals and organizations who scrutinize every step they make. While the benefits of these watchdogs is obvious, it also lowers pharma companies’ appetite for actions that could drive innovation and patient benefits.

Interestingly enough, aside from the usual ways to address these concerns which were typically in the hands of the industry, thought leaders have started recognizing that the solution may actually lie with those who will suffer the most and have been silent listeners so far: the patients. The argument is that patients need to support not only research. They need to become a part of these discussions: Instead of being informed of new policy – participate in setting it, instead of waiting outside the budgetary discussions halls – sit through the discussions and take a proactive role in them, instead of taking a backseat on topics such as regulation, commercial models and federal budget allocation – move over to the driver’s seat alongside traditional stakeholders. The patient role here is critical. They are the only ones the can resolve some of these issues.

Now, the program is going global.

Lilly and Disney Publishing Worldwide announced today that the program is being expanded to 18 more countries, with books being translated and made available for children at various stages of diabetes.

"Lilly Diabetes' objective is to bring safety, health, comfort, and a bit of magic to children worldwide," said Andrew Hodge, vice president, International, Lilly Diabetes. "We saw the positive impact our collaboration with Disney Publishing Worldwide had on families living with type 1 diabetes in the U.S. over the last two years, and we are excited to expand our reach globally."

Why is this partnership a big deal? Because nearly 500,000 young people are living with type 1 diabetes, with an estimated 78,000 new cases diagnosed each year. A diagnosis can be devastating and confusing for the entire family, but education -- along with proper diet, exercise, and medicine -- can help produce a healthy lifestyle.

Lilly's deep experience in diabetes, combined with the storytelling abilities of Disney, can inspire children when they need it most.

• A blog from the Pharmaceutical Researchers and Manufacturers of America (PhRMA) explains how strong intellectual property protections will help spur innovation and reach the full potential of the Trans-Pacific Partnership (TPP).
• The Information Technology and Innovation Foundation’s Innovation Files blog discusses the recent Senate Finance Committee’s Hearing on TPP, and the need to address intellectual property protection in the trade agreement.
• In an interview with the 2013 BIO International Convention Buzz Center, Former USPTO David Kappos discusses how regional differences in interpretation of IP law affect the marketplace for innovation.

When LillyPad talks about the future of innovation, we are talking about the future of medicine. The world health care system still maintains a substantial amount of unmet need and potential for better treatments. Meeting the health challenges of tomorrow requires strong intellectual property protections at every leg of the innovation journey to ensure that patient get access to new, vital medicines.

I had the opportunity to go to India through this program and it forever changed the way I look at the world, my job, even my family.

Through Connecting Hearts Abroad, we are not only helping people in need, we are growing as people and helping Lilly become a more globally aware and stronger company. It gets us out of the labs and out from behind our computers so that we can better understand and meet the diverse needs of patients and communities around the world.

This year, we’re also piloting a new skills-based aspect to the program where our specialized volunteers will support our diabetes work with Project HOPE in South Africa through The Lilly NCD Partnership. Stay tuned for more blogs from South Africa to hear how our team of doctors, pharmacists, diabetes educators, and communicators are applying their expertise to truly make a difference.

You can learn more about the program through the press release we issued today. You can also view this brief video of Bart Peterson, Lilly senior vice president of corporate affairs and communications, and Steve Rosenthal, executive director of our primary partner organization, Cross-Cultural Solutions, who talk about the partnership and the benefits for all involved. And below is a more in-depth video that gives you a sense of the type of work our volunteers do.

Connecting Hearts Abroad, indeed.