Blog Home

Archive for the 'Science and Health' Category




To Advance Medical Innovation, Put International Best Practices In A National Context


March 4th, 2015

Editor’s note: This post is part of a series of several posts related to the 4th European Forum on Health Policy and Management: Innovation & Implementation, held in Berlin, Germany on January 29 and 30, 2015. For updates on the Forum’s results please check the Center for Healthcare Management’s website or follow on Twitter @HCMatColumbia.

Innovation is a driving force of any nation’s economy, shaping the delivery of new services and the development of new products. Nowhere is this more true than in the US health care system which represents nearly a fifth of GDP. Medical innovation has catalyzed improvements in the tools and therapies used to deliver health care, the practices of managing its delivery, and even the financing of its delivery.

These innovations evolve primarily through research supported by universities and government institutions including the National Institutes of Health (NIH). Research supported by the NIH allows for development of treatments that target a large number of diseases and conditions. However, identifying new therapies is only a fraction of the work needed to ensure that the right patients receive that treatment at the right time, the right dose, and for the right reasons.

Read the rest of this entry »

How Menu Labeling Could Spark Change Beyond The Menu Board


February 24th, 2015

If there’s one thing we’ve learned about catalyzing changes that prevent illness in the first place, it’s that passage of a single policy can be like lighting a match — illuminating the way towards strategies with greater impact and igniting the energy of leaders. The success of a menu labeling might be the match needed to inspire further policy change to shift the trend of increased diet-related chronic disease in the United States.

In November, the Food and Drug Administration released the final rule guiding calorie labeling of menu items at chain food service establishments with 20 or more outlets nationally. The rule will apply to fast-food and sit-down restaurants, supermarkets, convenience stores and movie theaters, and will take effect on December 1, 2015.

Once implemented, calorie counts will be posted for all items (including alcoholic drinks) on menus and menu-boards, and on display tags for salad bars, bakery items, and soda dispensers. A companion rule requiring calorie labeling for vending machines will take effect one year later.

Read the rest of this entry »

In Regulating E-Cigarettes, No Easy Fix For The FDA


February 20th, 2015

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

It is a victory that was made possible, in large measure, by a constellation of state and federal regulatory interventions: laws regulating the marketing and sale of cigarettes, barring sales to youth, banning indoor smoking, and taxing cigarette sales have all played a role in reducing rates of smoking.

Read the rest of this entry »

Request For Abstracts: Health Affairs Food And Health Theme Issue


February 4th, 2015

Health Affairs is planning a theme issue on food and health in November 2015. The issue will present work that explores the relationship between the food we consume and our wellbeing on the individual, societal, and global levels. Articles will address causes and consequences of dietary excess and insufficiency, analyze policies and programs aimed at influencing these, and explore the roles of public policy, industry, and stakeholder groups in the context of dietary behavior.

We invite all interested authors to submit abstracts for consideration for this issue.

The issue will consider the implications of global food production and distribution for the health of consumers and food workers, environmental quality, and food prices, among other things. It will also examine actions taken from the community level upward to address increasingly universal concerns about food-related illness. Several papers will provide broad overviews of key issues, but we are particularly interested in empirical analyses of specific policies, programs, and practices aimed at influencing dietary behavior and clarifying our thinking about food’s role in health.

Read the rest of this entry »

The Puzzle Of Antibiotic Innovation


February 3rd, 2015

Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

Dame Sally Davies, the Chief Medical Officer of England, warns that we are approaching an antibiotic apocalypse. A former chief economist at Goldman Sachs estimates that unless dramatic action is taken now, antimicrobial resistance could kill 50 million people a year and cause $100 trillion in cumulative economic damages.

In the US, dire warnings have issued from the Centers for Disease Control and Prevention (CDC), the President’s Council of Advisors on Science and Technology, and the President himself through an Executive Order on Combating Antibiotic-Resistant Bacteria in September 2014 (summary here). The President’s new budget asks for $1.2 billion to be spent on antibiotic resistance.

But last week, the science press breathlessly celebrated the discovery of a new antibiotic, teixobactin, cultured from soil samples collected in a grassy field in Maine (the study was published in Nature). Crisis over?

Read the rest of this entry »

Health Affairs Event Reminder: Biomedical Innovation


February 3rd, 2015

Biomedical innovation lengthens and enriches our lives through breakthroughs in medications and care, but it is has also been the leading source of health care cost growth over the past few decades. The February 2015 thematic issue of Health Affairs examines the topic from many perspectives.

You are invited to join us on Thursday, February 5, at a forum featuring authors from the new issue at the W Hotel in Washington, DC. Panels will cover pharmaceuticals; biotechnology; medical devices; and accelerating, diffusing, and financing innovation.

WHEN: 
Thursday, February 5, 2015
9:00 a.m. – 12:30 p.m.

WHERE: 
W Hotel Washington
515 15th Street NW
Washington, DC, Great Room, Lower Level

REGISTER NOW!

Follow live Tweets from the briefing @Health_Affairs, and join in the conversation with #HA_BiomedInnovation.

See the full agenda. Among the confirmed speakers are:

Read the rest of this entry »

Health Affairs’ February Issue: Biomedical Innovation


February 2nd, 2015

The February issue of Health Affairs includes a number of studies examining issues pertaining to biomedical innovation. Some of the subjects covered: how declining economic returns for new drugs may affect future investments, the changing landscape of Medicare coverage determinations for medical interventions, the slowly emerging US biosimilar market, and more.

With declining economic returns, can manufacturers afford to continue investing?

Ernst Berndt of Massachusetts Institute of Technology’s Alfred P. Sloan School of Management and coauthors compared present values of average lifetime pharmaceutical revenues to present values of average drug research and development, and lifetime operating costs. Upon examining new prescription drugs launched over four distinct time periods between 1991 and 2009, the authors found that net economic returns reached a peak in the late 1990s and early 2000s.

Read the rest of this entry »

Health Affairs Briefing: Biomedical Innovation


January 20th, 2015

Biomedical innovation lengthens and enriches our lives through breakthroughs in medications and care, but it is has also been the leading source of health care cost growth over the past few decades. The upcoming February 2015 thematic issue of Health Affairs examines the topic from many perspectives.

You are invited to join us on Thursday, February 5, at a forum featuring authors from the new issue at the W Hotel in Washington, DC.  Panels will cover pharmaceuticals; biotechnology; medical devices; and accelerating, diffusing, and financing innovation.

WHEN: 
Thursday, February 5, 2015
9:00 a.m. – 12:30 p.m.

WHERE: 
W Hotel Washington
515 15th Street NW
Washington, DC, Great Room, Lower Level

Register Now!

Follow live Tweets from the briefing @Health_Affairsand join in the conversation with #HA_BiomedInnovation.

Read the rest of this entry »

CMS Proposes Coverage For Lung Cancer Screening With Low Dose CT


December 9th, 2014

On November 11, the Centers for Medicare and Medicaid Services (CMS) released its Proposed Decision Memo for Screening Lung Cancer with Low Dose Computed Tomography (LDCT), which is expected to be finalized in mid-December. Despite a negative assessment by its own advisory committee, CMS has proposed coverage with evidence development (CED) for an annual “lung cancer screening counseling and shared-decision-making visit” and, for appropriate beneficiaries, additional screening with LDCT.

Under CED, Medicare provides conditional coverage for a new treatment or technology while additional data is collected to confirm its effectiveness and make a final determination. Through this proposed decision, CMS has followed the lead of numerous other expert and advisory groups, which have concluded that the overall benefits of such screening for at-risk individuals outweigh concerns regarding gaps in evidence, generalizability and potential harms.

Read the rest of this entry »

Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process


November 17th, 2014

The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the generic arena over three decades ago.

However, widespread criticism of BPCIA provisions to facilitate interactions between biosimilar applicants and reference biologic sponsors regarding application submission and patent status was swift and unrelenting. Attorneys practicing in the realm of Hatch-Waxman litigation for generic drugs balked at the drastic differences between the familiar public process grounded in required patent disclosures, FDA Orange Book listings, and generic applicant certifications and the private, iterative process set forth in the BPCIA. Legal scholars, industry representatives, and practitioners alike projected that a courtroom battle regarding real-world operation of the provisions was imminent.

Read the rest of this entry »

The United States’ Misguided Self-Interest On Ebola


October 31st, 2014

The Ebola epidemic in West Africa is spiraling out of control. The international community allowed a manageable outbreak to mushroom into a health and humanitarian crisis. The World Health Organization (WHO) has been enfeebled and largely sidelined. Belatedly, the United States sent military troops into Liberia and spearheaded a United Nations Security Council resolution. Yet since isolated Ebola cases have appeared on our shores, the US has begun to look inward, at risk of falling into a trap that I will call “misguided self-interest.”

While the West African epidemic rages, the US delayed significant action until long after the unprecedented nature of the Ebola epidemic became clear, and even now the response is incommensurate with the massive need. Now we are transferring our gaze from the real crisis and headed on an insular journey.

I grant the premise that a country’s first responsibility is to protect its inhabitants. But calls for a travel ban from the region and newly announced state quarantine policies that would ensnare travelers from affected countries appear selfish. To put it in perspective, the US has experienced only a few domestically diagnosed cases, with an exceedingly low risk of an outbreak.

Read the rest of this entry »

Integrity In Retail Health Care: Rethinking The Sale Of Tobacco Products


September 3rd, 2014

Retail health care is a relatively new development in American health care.  It is true that much of the dispensing of medications has historically occurred through retail pharmacies, which sold a variety of other goods and services, but somehow that was not seen as the provision of health care.   Health care institutions, including doctors’ offices, hospitals and clinics, were the places that people went to be diagnosed and treated.  And those institutions did little other than health care; they did not, and still do not today, offer any products other than provision of care, including testing and treatment.  As such, these institutions demonstrated high integrity, defined as a state of being whole, and synonymous with cohesion and unity of purpose.

Now retail pharmacies, mass merchandisers and grocery stores are adding “health care” as another consumer good to be purchased on a mass scale.  Retail health care is in some cases, extending what the pharmacist does in the retail pharmacy: providing more advice about a variety of health care issues, giving vaccines, and working more closely with doctors’ offices.  In other cases, it is the opening of small clinic practices, often staffed by nurse practitioners, caring for minor ailments.  These kinds of clinics make great sense from the point of view of convenience and cost and have proven to be very popular, particularly given the shortage of convenient primary care that exists in many communities.

There are signs that the scope of retail health is deepening.  Pharmacies are planning to do more laboratory testing, in part to support a broader array of health advice from pharmacists, and in part to allow a wider set of complaints to be addressed in the retail pharmacies.  Walgreens has developed accountable care organizations with hospital partners.  At CVS Health, we have been very public about our effort to align with integrated delivery systems to help them manage population health by emphasizing joint efforts to improve medication adherence, support the management of complex patients, and create direct electronic medical record connectivity between our 900 retail clinics and the doctors’ offices.  Just last month, Walmart announced that their new clinics would be primary care offices, capable of caring for a range of chronic disease.

Read the rest of this entry »

Recent Health Policy Brief: E-Cigarettes And Federal Regulation


July 11th, 2014

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) describes federal policy makers’ recent efforts to propose rules for e-cigarette regulation. E-cigarettes, virtually non-existent ten years ago, have skyrocketed in popularity, including among people who claim to use e-cigarettes as a tool to help them quit smoking altogether.

The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products such as cigarettes, tobacco in cigarettes, roll-your-own, and smokeless tobacco. But it left unregulated other tobacco products such as cigars, pipe and hookah tobacco, nicotine gels, and e-cigarettes.

Read the rest of this entry »

Interview: IOM President Harvey Fineberg Reflects On Lessons Learned


July 10th, 2014

On June 16, 2014, I spoke with Dr. Harvey V. Fineberg, as he wrapped up his second six-year term as president of the Institute of Medicine (IOM). We discussed how requests for work come to the IOM, the attributes of IOM reports that make them effective, and how the IOM maintains a strong voice in a crowded field.

Dr. Fineberg shared lessons learned from his analysis of events surrounding the Swine Flu immunization effort of 1976, and how, today, those lessons help him guide the IOM’s thinking about program assessment. We also discussed Dr. Fineberg’s work to bring together the various arms of the National Academies of Sciences to improve health.

You can listen to the full podcast at Health Affairs. These are a few of my favorite quotations taken from our discussion:

Read the rest of this entry »

Health Affairs Entry Point: The Science Behind Alzheimer’s Disease


April 30th, 2014

The Department of Health and Human Services (HHS) recently released the 2014 update on its National Plan to Address Alzheimer’s Disease, including strategies for identifying and expanding research in the prevention of Alzheimer’s. In the April issue of Health Affairs, senior editor Jonathan Bor reports on the science behind the disease and the implications for future funded research.

In “The Search For Effective Alzheimer’s Therapies: A Work in Progress,” Bor illustrates that in the thirty years since research began on the disease, no one has discovered a cure or effective ways to chronically manage the condition. Regardless, HHS intends to find a suitable treatment by 2025, as outlined in its National Plan, reports Bor.

Even though research suggests a protein is to blame for altering the brain’s make-up and therefore contributing to the onset of Alzheimer’s, there’s disagreement on which protein bears the responsibility. Furthermore, the results of clinical trials aimed at combating the negative effect of protein plaque buildup, have been surprisingly disappointing, says Bor.

Read the rest of this entry »

What’s Past Is Prologue: Making The Case For PET Beta-Amyloid Imaging Coverage


April 9th, 2014

Editor’s note: This post is published in conjunction with the April issue of Health Affairs, which features a series of articles on Alzheimer’s disease.

In September of 2013, CMS issued its final decision memo that concluded positron emission tomography- amyloid beta (PET Aβ) imaging is “not reasonable or necessary”, finding “insufficient evidence” that use of this diagnostic tool would improve health outcomes for patients with dementia or neurodegenerative disease. As such, PET Aβ imaging to help diagnose Alzheimer’s disease (AD) is not a covered service for Medicare beneficiaries except for those enrolled in CMS-approved clinical trials.

CMS’ final decision underscores the emerging new paradigm for coverage decision-making, requiring innovators not only to demonstrate to FDA’s satisfaction that their products are effective, but also to prove to CMS and other payors that their use will improve clinical outcomes. This paradigm will increase confidence in the value and health benefit of new technologies, although it will make the path to coverage more difficult and uncertain for diagnostic developers.

Read the rest of this entry »

The Privacy Conundrum And Genomic Research: Re-Identification And Other Concerns


September 11th, 2013

No matter what the arena — finance, health care, or national security — questions surrounding the provision of personal data are always the same: how much benefit vs. how much risk? Who handles these data, and can those individuals be trusted? How do organizations guard against data misuse? What are the legal safeguards to protect privacy, and are they sufficient in an era when more data are shared more widely?

Nowhere is the privacy discussion more personal than in genomics, the very hardwiring of our existence. Genomic data are unique to individuals (or identical twins) and, except for occasional mutations, do not change over a lifetime, thereby rendering disclosures permanent. Genomic data also have special properties regarding privacy, especially as comprehensive whole genome sequencing becomes the major technique.

The benefits of amassing genomic data in sufficient case numbers for validity and making this knowledge available to an appropriately wide body of expert investigators are extensive. Research derived from genomic databases offers potentially large health payoffs. Genomics can help scientists predict who will develop a disease (e.g., Huntington’s Disease) and tailor treatments. It also holds the potential to bring about a paradigm shift in how we think about and classify disease; i.e., allowing us to move from the pathology-based approach begun in the late 19th century — which focuses on the progression of disease in a specific organto a biochemical-and genomics-based approach. This new approach is already being applied to a number of diseases, including certain cancers.

Read the rest of this entry »

Collaborative Filtering: An Interim Approach To Identifying Clinical Doppelgängers


June 17th, 2013

“The real challenge of human biology, beyond the task of finding out how genes orchestrate the construction and maintenance of the miraculous mechanism of our bodies, will lie ahead as we seek to explain how our minds have come to organize thoughts sufficiently well to investigate our own existence.”

The initial enthusiasm following the mapping of the human genome has given way to a more circumspect outlook. With the exception of a small number of promising interventions, advances in genomic science have yet to yield a critical mass of therapeutic breakthroughs – thus forestalling the birth of the era of precision medicine (PM).

While a comprehensive genomic understanding of disease and concomitant molecular-based patient taxonomy would doubtless hasten the arrival of PM, a significantly less costly alternative offers a promising interim approach. A methodology known as collaborative filtering (CF) which has already achieved widespread use in advertising and marketing, has the potential to offer powerful insights not only to advertisers and others desiring to influence purchasing behavior but also to physicians, allied health care professional, patients, and their families by offering personalized advice and recommendations regarding health and disease.

CF relies directly on aggregated subject/user behavior to reveal complex and unexpected patterns that would otherwise be difficult to capture using known data attributes. Recommendations generated from analyses of these patterns have demonstrated significantly greater reliability than those using more traditional demographic categories. The core idea behind applying CF to clinical decision-making is to make decisions about a patient based on historical data derived from multiple “similar” patients presenting multiple “similar” cases. As Victor Streecher explains, “collaborative filtering in the health area could match the coping strategies, medical decisions, and preferences of similar others with specific needs and interests of the user.”

Read the rest of this entry »

Rapid Learning For Precision Medicine: A Big Data To Knowledge (BD2K) Initiative


February 21st, 2013

Proposal

The National Research Council’s Precision Medicine report found that it is imperative to create a new scientific base for biomedical research, clinical care, and public health that accurately reflects the genetic variations in diseases and in individual responses to therapies.

This proposal calls for using the nation’s rapidly expanding capabilities for computerized biomedical research to accomplish this goal as quickly as possible. Research databases and analyses for most diseases would be completed over the next three years (by the end of 2015).

Background

The US-led Human Genome Project was finished ten years ago (2003). In the past several years, key elements for moving forward on a Precision Medicine-type initiative have been coming together.

Read the rest of this entry »

A Cure For Patent Pathology? The Supreme Court Reviews The Patentability Of Human Genes


December 7th, 2012

“Are human genes patentable?” On November 30, 2012, the U.S. Supreme Court agreed to answer this single question in Association for Molecular Pathology v. Myriad Genetics. Of course, the petitioners, including health care providers, professional associations, and patients, worded the question to favor the answer they want: “No, human genes are not patentable.” For Myriad Genetics, the patent owner who would like its patent rights upheld, the question is better phrased as whether one can patent “isolated molecules of deoxyribonucleic acid that were identified and defined by human inventors.”

The practical stakes in the Court’s decision, which should come in the first half of 2013, are enormous. The U.S. Patent and Trademark Office (USPTO) has issued tens of thousands of patents on genetic sequences over the past few decades, and the U.S. Court of Appeals for the Federal Circuit, the appellate court entrusted with hearing virtually all U.S. patent appeals, has never declared such sequences to be non-patentable subject matter. For more than a century, patents have issued on isolated versions of naturally occurring substances other than DNA.

Many believe that gene patents are crucial to the modern biotechnology industry. On the other hand, many researchers and clinicians feel that gene patents, particularly human gene patents, are commonly unnecessary to spur innovation and in fact interfere significantly with scientific and technological progress, whether by slowing or diverting research, impeding the provision of diagnostic tests, or generally increasing costs for clinical and scientific work.

The patents at issue in Myriad make such concerns particularly poignant. These patents relate to BRCA1 and BRCA2, genes associated with a predisposition to breast cancer. The obvious public interest in ready access to cancer diagnosis helps account for the fact that petitioners’ lead lawyers are not the normal high-priced advocates for a private company accused of patent infringement. Instead, those lawyers work for the American Civil Liberties Union Foundation, an organization more commonly associated with battles for civil rights than rights in technological innovations.

Read the rest of this entry »

Click here to email us a new post.