Archive for the ‘Health Policy’ Category

Ricki McCarroll
Ricki
McCarroll

FDA beats out European Counterpart in Oncology Drug Approval

Thursday, June 16th, 2011

The FDA is proving to be a top contender in the international space in its efforts to fight the battle on the Big C, yes we’re talking cancer.

Source: Friends of Cancer Research Study

A new study released online today by Friends of Cancer Research in Health Affairs reports that the U.S. Food and Drug Administration (FDA) has a faster approval rate for oncology drugs than their European counterpart agency, the European Medicines Agency (EMA).

The study was held over a seven year period beginning 2003 through 2010. Authors Samantha A. Roberts, Jeff D. Allen, and Ellen V. Sigal investigated 35 drugs going through approval process in both markets and compiled their results in an eight-page report complete with graphics and pull quotes.

FDA v. EMA Stats

  • 35 drugs were investigated
  • FDA approved 32 oncology drugs while the EMA approved only 26
  • In addition, FDA’s approval for said drugs was over 31 percent more time efficient that the EMA

Statistically speaking, the approval ratio is less than one.

Finding the data

Authors of the study utilized public data bases on the FDA and EMA websites to conduct their research. Drugs used in the study are direct oncology treatments, drugs related to “supportive care” such as pain relievers and anti-nausea medications were omitted in their findings.

Check it Out

The Friends of Cancer Research study is currently available online and will be available in the July issue of Health Affairs.

What’s the spark under the FDA?

Posted in Cancer, Health Policy, Research
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Frannie Marmorstein
Frannie
Marmorstein

Lupus Advocates Take On the Hill

Tuesday, March 29th, 2011

Last week I had the opportunity to participate in the Lupus Research Institute’s Tell Congress Event on Captiol Hill. Lupus is an autoimmune disorder with an unknown cause that affects the skin, joints, kidneys and other organs and involves the immune system attacking healthy cells and tissue because it cannot tell the difference between normal and unhealthy substances.

I spent the afternoon lobbying on the Hill with a dozen Lupus advocates, meeting with senators and listening as advocates voiced their concerns about Lupus awareness and increasing funding for lupus research. Advocates strived to make an impact by sharing with their senators their personal connections with the disease. Patients shared their difficulties living with chronic fatigue and joint pain, family members honored those they had lost to Lupus and caregivers, including children, discussed the hardship of caring for a parent with Lupus. Everyone had a story to share.

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Posted in Health Care Reform, Health Policy, Public Health, Research, Women's Health
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jseng
John
Seng

Terrible Tuesday?

Monday, November 1st, 2010

Will tomorrow’s mid-term elections spell doom for House Democrats and open the door to potential repeal of the Patient Protection and Affordable Care Act?

In the past two days, I decided to quiz a couple of experts who also happen to be friends: Marsha Simon and Tim Donner.

Marsha Simon, PhD, Health Policy Expert President, MJ Simon & Company

Marsha Simon, PhD, Health Policy Expert President, MJ Simon & Company

Marsha is a former Ted Kennedy staffer and prominent health lobbyist whose firm MJ Simon & Company partners with Spectrum. She is an expert in legislative strategy, nonprofit management, and public policy research, with over 20 years of experience, including nearly a decade working for the United States Senate.

Tim Donner is a film-maker, baseball radio show host, and President of One Generation Away, an independent, nonpartisan education, research and public policy organization.

John: What’s your prediction for Tuesday’s elections?

Marsha: Republicans will take the House, Democrats will hang on in the Senate, but with smaller voting margins. The Democrats will run for cover and avoid major legislative initiatives for at least the next two years.

Tim: Republicans will take the House. This wave is extraordinary, given that we’re going to see two waves in a row. It’s never happened before in U.S. politics, with the second wave reversing the first. There’s a decent chance the Senate could topple, too. Generally, in a wave election, both Houses go.

John: If people are angry with the new health care reform legislation, why?

Tim Donner, President, One Generation Away

Tim Donner, President, One Generation Away

Marsha: The anger is more with a sense of misplaced priorities than with the specific provisions of the health reform bill. I think voters are angry about the state of the economy and do not see the relevance of health reform to their immediate problems. Health reform is based on employer-based, private insurance – especially the early market reforms such as coverage on parents’ policies for young adults – and those without a job have none.

Tim: People are extremely unhappy with the new health care legislation, most of which they cannot understand. And it’s an impediment to increasing unemployment. Companies have cash, but they remain on the sidelines, because they don’t know the cost. (more…)

Posted in Congress, Health Care Industry, Health Policy, Public Affairs, Public Health
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Megan Ricther
Megan
Richter

8 Goals, in 7 Categories, Over 5 Years: The District unleashes a plan to thwart obesity

Friday, May 14th, 2010

On May 6th, Mayor Adrian M. Fenty and Department of Health’s Director, Dr. Pierre Vigilance, unveiled the first-ever Obesity Report and Obesity Action Plan for the District of Columbia. The report lays the landscape of obesity in the District and details the multifaceted issues surrounding the epidemic that affects 35 percent of children and 55 percent of adults. Among health behavior change researchers, the prevention and treatment of obesity requires an ecological model that analyzes the influences on an individual, social and cultural and environmental level. Mirroring such theory, Obesity in the District of Columbia assessed a plethora of health behaviors in all eight of the city’s wards, detailing obesity rates, income, diet and nutrition. Moreover, the report analyzed gender, race, crime, access to and types of food options, and demographic information. Providing the statistics on youth, data was pulled from the Youth Behavior Risk Survey (YBRS) and Advisory Neighborhood Council (ANC). Key insights from the report pertaining to food include:

Obesity in the District of Columbia

Obesity in the District of Columbia

• Wards two and three had the most grocery stores, organic food and farmers markets, and also had the lowest rates of obesity
• Ward eight had the fewest healthy food options and had the highest rate of obesity
• For high school youth, rates of physical activity as well as fruit and vegetable consumption decreased over a five year period from 2003-2007
• The environment of unhealthy food thwarts good nutrition standards in schools (more…)

Posted in Health Policy, Public Health
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Spectrum

Will BPA Bump Food Safety to Back Burner?

Friday, May 7th, 2010

With another food contamination outbreak in the headlines – this time E. coli-tainted romaine lettuce traced to an Ohio food company that has sickened at least 19 people- the question of how and when food safety legislation will move forward is more timely than ever. While the House passed its version of The Food Safety Enhancement Act last July, the Senate has been much slower to act. food-nutrition
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Posted in Congress, Food Policy and Nutrition, Health Policy, Public Health
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Spectrum

Technology Tuesday: Empowering the Research Enterprise in a Post-Reform World

Tuesday, April 6th, 2010

With the passage of health care reform, the research community is ready to shift the national health policy conversation to a new dialogue on enhancing biomedical research and scientific innovation. In the past few weeks, discussion on topics such as the need to improve the translation of research discoveries into better health outcomes and the research ROI  for improving the nation’s overall health have gained traction alongside continued analysis of the final health reform provisions.

At the recent Research!America National Forum, experts from across the government, industry, academia and patient advocacy sectors discussed priorities to speed translational research, improve health outcomes and ultimately, as panelist Dr. Robert Tijian, president of the Howard Hughes Medical Institute put it, identify new pathways to “move beyond therapeutics and treatment to prevention.”  Yet transformation of this level requires a deep commitment to enhancing cross stakeholder collaborations and sustained communication, a challenge with so many players involved in the research process.innovation-technology
(more…)

Posted in Congress, Health Care Reform, Health Policy, Innovation, Research, Technology
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