The Exton, Pennsylvania-based medical device company focused on regenerative medicine will develop and review whether the use of a bioadhesive device can create stronger repairs than the current practice of suturing the tendon to enhance repair efficacy and improve patient outcomes.

Doug Evans, Kensey Nash’s chief operating officer said: “This grant will allow us to explore new applications for our recently acquired adhesive technology in combination with our other extracellular matrix, collagen and polymer-based biomaterials to develop new solutions for existing medical problems.”

Kensey Nash’s business model relies on strategic partners to distribute and sell the products it develops and manufactures.

In January, Kensey Nash acquired Wisconsin-based medical adhesives business Nerites Corp. for about $20 million. By 2015, the U.S. medical adhesive and sealant markets are projected to be more than $1 billion.

Real Time Tomography, a Villanova, Pennsylvania-based company, received $150,000 from “the Bens” after getting $200,000 from the Garber Venture Capital Fund, an MBA student-centric VC fund at the Penn State University’s Smeal College of Business, in May.

One of the challenges the company seeks to overcome is the relatively poor quality of 3D tomographic images with digital breast tomosynthesis when they are reconstructed from 2D projection images, said Susan Ng, the CEO of the company.

“At the time of my research, reconstruction of a single patient dataset was taking several hours and image quality was very poor. In addition to the technical challenge of image reconstruction was the recognition that the large number of images generated would present a challenge to conventional workflow. It was with these challenges in mind that we developed DRR as both a technical solution to fast image reconstruction and a clinical workflow solution.”

Ng said she researched several emerging technologies in medical imaging, but digital breast tomosynthesis was a technology that most interested her because of its application to breast cancer detection and its potential to mitigate the problems with mammography without increased radiation dose.

She added: “The importance of this study is to show the clinical benefit and to reduce radiation exposure to women. We feel this will definitely show the benefits of Dynamic Reconstruction and Rendering Technology,” Ng said.

The DRR technology can view the breast in various planes and at different angles.

Early detection of breast cancer is a critical factor in survival. With breast density also an issue, the higher resolution images generated by the DRR technology could make a difference.

The company’s products include the Adara 2D image processing and enhancement software for digital mammography and the Briona 3D image reconstruction software for Digital Breast Tomosynthesis.

A reader study will involve radiologists reading scans produced with the DRR technology.

The company is currently looking to establish a strategic partnership with a manufacturer.

Ng, who co-founded Real Time Tomography with Peter Ringer, enjoys the entrepreneurial process, and started the company five years ago after working for Siemens Medical Solutions with  a Small Business in Research (SBIR) grant from the National Institutes of Health.

“We were fortunate to have been awarded two SBIR grants from the NIH. Ringer and I had worked together in two previous medical imaging companies, including a startup that was acquired by Siemens.”

Ng worked at Siemens for several years until it moved the division overseas, prompting her to launch RTT. The staff engineer is also a former colleague from the same startup. The research engineer has a PhD in medical imaging and the business development director was a sales executive with several years’ experience in women’s imaging.

The company’s target customer is a medical equipment manufacturer.

Viamet Pharmaceuticals will work with the National Institutes of Health  to develop one of the company’s compounds into a treatment for the fungal infection cryptococcal meningitis.

An antifungal compound from Morrisville, North Carolina-based Viamet has been selected for inclusion in the NIH’s Therapeutics for Rare and Neglected Diseases Program, a government-funded program designed to speed developments of new therapies for rare and neglected diseases. Viamet’s compound was one of only four selected for funding. Financial terms were not disclosed.

Cryptococcal meningitis is a fungal infection that affects the membranes covering the brain and spinal cord. It afflicts more than 1 million people in the developing world annually and kills  about 500,000, according to research reports.

Viamet President and CEO Dr. Robert Schotzinger said in a statement that animal tests show that the Viamet compound selected for the NIH program has shown better efficacy against cryptococcal meningitis compared to standard therapies.

“With the significant financial support of the TRND program, we will be able to rapidly move this promising therapy forward in development,” Schotzinger said.

Viamet has developed a proprietary technology that helps develop drugs that shut down the actions of enzymes that need the presence of a metal to start chemical reactions. The company’s proprietary “metalophile technology” has been used to develop compounds that address unmet medical needs in oncology and infectious disease. Viamet last year signed a licensing deal with Novartis (NYSE:NVS) that could bring Viamet up to $200 million if  the company’s technology can develop certain enzymes for the Swiss pharma giant.

Viamet was co-founded by Holden Thorp, who is now chancellor at the University of North Carolina at Chapel Hill. The company has raised more than $24 million in venture capital from investors that include Intersouth Partners, Hatteras Venture Partners, Novartis Option Fund, Lilly Ventures, Lurie Investment Fund, Astellas Venture Management and Headlands Ventures.

It is the largest ever NIH grant that was awarded exclusively to the university and won’t be shared with other institutions, said a University of Minnesota spokesman.

Through the award, the U of M joins a national consortium of institutions dedicated to joint efforts between universities and the community to quickly and efficiently transfer discoveries in labs to clinical trials that may then be translated into new treatments for patients. Currently, 58 other institutions are part of this national consortium.

The U of M beat institutions that had already received a CTSA grant before and had applied for refunding, which underscores how big this win was, said Dr. Aaron Friedman, vice president of health sciences at the university and the dean of its medical school.

The money will be devoted to researching five broad disease categories: diabetes, cancer, cardiology, neurological disorders and infectious diseases, Friedman said.

He added that being a part of the CTSA consortium will allow U researchers to share information and collaborate to tackle large healthcare questions. Because the grant is an infrastructure grant, it will help the U to quickly sponsor clinical trials.

A crucial element of the program is community engagement and Friedman said the U of M has to demonstrate how the money has been used to involve the larger community outside the U hospitals, clinics, as well as businesses. An annual report will need to be provided to the NIH that shows progress on clinical trials, community engagement and other aspects of the program, he said.

Depending on how successful they are, the NIH may choose to provide additional funding once this money is close to running out. But there are no guarantees. Friedman said that this time around, at least two other institutions that had applied to get the grant anew were rejected, while the U as a first-time applicant won the award.

Not surprisingly, various university officials were cheering this award.

“Successfully competing for the CTSA is a major victory for the University of Minnesota,” said President Robert H. Bruininks, in a statement. “This is just the latest example of the ways in which the extraordinary knowledge and productivity of our talented faculty and staff garner new resources, discover new knowledge, and develop real solutions to health concerns in Minnesota, across the nation, and around the world.”

Appearing in the March 31 issue of PLoS Genetics, the research suggests that an injury to chromosomes alters the expression of a family of genes known as Toll-like receptors (TLRs) [1]. TLRs are proteins that play a role in the immune system by defending the body from infection. Following damage, the TLRs interact with the tumor suppressor gene p53 to regulate the amount of inflammation. The NIEHS investigators also establish that the integration of p53 and inflammation only occurs in primates.

Healthy volunteers with informed consent donated their blood cells for the study. The scientists separated white blood cells from the samples and exposed the cells to anti-cancer agents to activate p53. They then examined the expression of TLR genes. The team detected large variations among individuals, but found that p53 generally led to the activation of several TLR genes in patients’ cells. They also found that TLR activation could be prevented by adding the p53 inhibitor pifithrin.

“We would not have found this connection if we only worked with rat or mice cells,” said Michael Resnick, Ph.D., principal investigator in the Laboratory of Molecular Genetics (LMG) and corresponding author on the paper. “We needed to have human samples, so our collaboration with the CRU was crucial for these experiments.”

Stavros Garantziotis, M.D., a principal investigator in the Laboratory of Respiratory Biology (LRB) and the medical director for the CRU, is a co-author on the article. He said that the publication had two main findings: humans evolved an inflammatory response when subjected to DNA damage, and the variation in TLR activity among humans suggests that some people are more prone to inflammation following DNA damage, for example, after receiving cancer therapy.

“Physicians don’t have this information now, but understanding who would likely benefit from anti-inflammatory treatment after chemotherapy would greatly increase a doctor’s ability to help his or her patient in the future,” Garantziotis continued.

As a physician and co-author of the publication, LRB principal investigator Michael Fessler, M.D., went a step further in his explanation of how stimulating the human immune system could treat infection, and autoimmune and environmental diseases.

“The immune system very likely plays a role, not only in all inflammatory diseases that afflict humans, but also in cancer,” Fessler concluded. “Because of the new connection discussed in our paper, we may have a new means to manipulate the responses that affect those diseases.”

Now, the researchers are taking advantage of another NIEHS translational program, the Environmental Polymorphisms Registry (EPR), an ongoing study to collect DNA samples from nearly 20,000 North Carolinians. The EPR study will allow scientists to look for genes linked to disease. The study is a collaborative effort between NIEHS and the General Clinical Research Center at the University of North Carolina at Chapel Hill.

Daniel Menendez, Ph.D., and Maria Shatz, Ph.D., are two LMG scientists who share first authorship on the paper. Menendez added that the EPR work will permit researchers to further examine the association between p53 and inflammation. “In related studies, we are looking at individuals who have genetic alterations in the way they might respond to p53 activation,” he said. “We will try to determine if their cells behave differently, and if these subjects have changes in their inflammatory response, or an increased risk for certain inflammatory diseases.”

Source: NIH News

References

1. Menendez et al. The Toll-Like Receptor Gene Family Is Integrated into Human DNA Damage and p53 Networks. PLoS Genet. 2011 Mar;7(3):e1001360. Epub 2011 Mar 31
   View abstract

Dr. Reuben Harris

The National Institutes of Health has awarded a University of Minnesota researcher and others a five-year, $10 million grant to study a human protein that may hold the key to treat HIV and other viral diseases

Dr. Reuben Harris, professor in the University of Minnesota’s College of Biological Sciences and a project leader, and other recipients will study a human protein — the so-called APOBEC3G. The goal of the study is to produce atomic-resolution images of the protein in order to better grasp how it interacts with other proteins in human cells and with HIV to prevent the virus from attaching to and entering cells.

“You have to understand the nuts and bolts of the system before you can make alterations to interfere with the process,” said Harris, an associate professor of biochemistry, molecular biology and biophysics, in a statement. “I’m very optimistic that this research will enable us to use this novel protein against HIV and other diseases.”

The U’s statement noted that focusing on a human protein represents a radically different approach from conventional efforts in treating viral diseases, which mainly focus on the virus than on the host.

Aside from Harris, Matsuo Hiroshi, associate professor in the College of Biological Sciences, and Joachim Mueller, associate professor in the College of Science and Engineering’s Department of Physics, will also play key roles. Roughly $5 million of the grant is expected to remain at the U.

Quintiles, which has run countless clinical trials for cancer drug candidates, is taking a turn as a financial supporter for a study with a $2.6 million contribution directed toward a breakthrough breast cancer trial.

I-SPY 2, is a clinical trial sponsored by The Biomarkers Consortium, a public-private partnership that includes the U.S. Food and Drug Administration, the National Institutes of Health and several major pharmaceutical companies. The trial is designed for women with newly diagnosed, locally advanced breast cancer to test whether investigational drugs can improve upon standard treatment and increase the odds of survival.

Development costs for breast cancer therapies can exceed $1 billion and take up to 15 years to bring an approved product to market. I-SPY 2 is designed to be a faster and less expensive clinical trial. I-SPY 2 trials started last year and are projected to cost $26 million over five years. Durham, North Carolina-based Quintiles is making its contribution over the next four years of the trials.

The trial, which involves 800 patients, employs a design that uses outcome information from each patient as she goes through the study to help in the treatment plan for the next patient. Conventional clinical trials don’t reveal the results to investigators until a trial’s conclusion. The trial is also using biomarkers from individual patient’s tumors to screen multiple therapies simultaneously, allowing investigators to quickly measure effectiveness. Testing multiple drugs makes it more likely to produce more than one successful treatment that can advance to late-stage clinical trials.

Funding for I-SPY 2 is coming from a variety of sources and includes contributions from grocery retailer Safeway and Johnson & Johnson (NYSE:JNJ). The Foundation for the National Institutes of Health has been working to secure additional funds from companies working in the pharmaceutical industry. Quintiles’ grant is being made through the QuantumLeap Healthcare Collaborative, a nonprofit foundation and a co-manager of the trial.

This video from the Foundation for the National Institutes of Health explains the I-SPY 2 trial:

More than one-third of adults in the United States and nearly 17 percent of the nation’s children are now obese, which increases a person’s chance of developing many health problems, including type 2 diabetes, heart disease, high blood pressure, fatty liver disease, and some cancers. Although American obesity rates leveled off in 2007, in 2008, obesity-related medical costs were an estimated $147 billion. Government, nonprofit and community groups, businesses, health care professionals, schools, families, and individuals are taking action to address this public health problem — and research can provide the foundation for these efforts.

NIH funds research to reduce the prevalence of obesity and its health consequences, an investment of $824 million in fiscal year 2010, plus awards totaling $147 million made in the same year through the Recovery Act. This NIH strategic plan, developed by the NIH Obesity Research Task Force, recognizes that eating less and exercising more is easier said than done. Highlighting the crucial role of research in efforts to reduce obesity, the plan emphasizes moving science from laboratory to clinical trials to practical solutions, and is designed to help target efforts and resources in areas most likely to help [1].

NIH Director Francis S. Collins, M.D., Ph.D. said:

Obesity has many causes and contributing factors. This plan is a bold blueprint that will encourage the research community to examine the epidemic of obesity from diverse perspectives. Through the scientific opportunities outlined in the strategic plan, researchers can work together toward the goals of preventing and treating obesity, to help people lead healthier and more fulfilling lives.

The task force is co-chaired by Griffin P. Rodgers, M.D., director of the National Institute of Diabetes and Digestive and Kidney Diseases; Susan B. Shurin, M.D., acting director of the National Heart, Lung, and Blood Institute; and Alan E. Guttmacher, M.D., director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. These three institutes, along with the National Cancer Institute, led in the plan’s development.

The research recommendations include:

• Discover key processes that regulate body weight and influence behavior
• Understand the factors that contribute to obesity and its consequences
• Design and test new approaches for achieving and maintaining a healthy weight
• Evaluate promising strategies to prevent and treat obesity in real-world settings and diverse populations
• Use technology to advance obesity research and improve healthcare delivery

To increase the reach of research and improve public health, the plan also highlights education and outreach to move proven strategies into community programs and medical practice.

Since the release of the first strategic plan in 2004, research produced many advances, including:

• Lifestyle interventions for weight loss reduce risk for heart disease and type 2 diabetes. NIH-funded studies are testing ways to bring these proven strategies to more people.
• When a woman with obesity or diabetes becomes pregnant, her child’s risk of developing obesity may increase, suggesting a critical period to intervene. Researchers can study approaches to help women achieve a healthy weight before and during pregnancy.
• Many genes and other aspects of our biology, from body fat to the gastrointestinal system and brain, influence whether we’re likely to become obese. Researchers are delving deeper into these pathways and how they’re affected by our environment.

Tips and tools

While research continues, NIH resources can help people achieve or maintain a healthy weight now. You can find tips and tools from the following resources:

The Weight-control Information Network provides up-to-date, science-based information on weight control, obesity, physical activity and related nutritional issues.

Aim for a Healthy Weight from the National Heart, Lung and Blood Institute offers the Aim for a Healthy Weight booklet includes portion and serving size information, sample reduced calorie menus, tips on dining out, a sample walking program, a weekly food and activity diary and more.

We Can! (Ways to Enhance Children’s Activity & Nutrition) from the National Heart, Lung and Blood Institute is a national movement designed to give parents, caregivers, and entire communities a way to help children 8 to 13 years old stay at a healthy weight.

The Let’s Move campaign, led by the White House, is dedicated to solving the problem of obesity within a generation, so that children born today will grow up healthier and able to pursue their dreams. It combines comprehensive strategies with common sense, putting children on the path to a healthy future during their earliest months and years, and giving parents helpful information and fostering environments that support healthy choices.

Learn more about obesity research at NIH, see a video about the plan from Collins, and view or request a free copy of the summary or complete Strategic Plan for NIH Obesity Research at www.obesityresearch.nih.gov.

Source: NIH News

References

1. Strategic Plan for NIH Obesity Research. NIH Obesity Research. Accessed 2010 Mar 31.

NIDDK Director Griffin P. Rodgers, M.D. said:

By setting priorities and identifying the most compelling research opportunities, the strategic plan will guide NIH, other federal agencies and the investigative community in efforts to improve diabetes treatments and identify ways to keep more people healthy.

The plan, Advances and Emerging Opportunities in Diabetes Research: A Strategic Planning Report of the Diabetes Mellitus Interagency Coordinating Committee, focuses on 10 areas of diabetes research with the most promise [1]. The goal is to accelerate discovery on several fronts, including:

• the relationship between obesity and type 2 diabetes, and how both conditions may be affected by genetics and environment
• the autoimmune mechanisms at work in type 1 diabetes
• the biology of beta cells, which release insulin in the pancreas
• development of artificial pancreas technologies to improve management of blood sugar levels
• prevention of complications of diabetes that affect the heart, eyes, kidneys, nervous system and other organs
• reduction of the impact of diabetes on groups disproportionately affected by the disease, including the elderly and racial and ethnic minorities

Under the plan, NIH will continue to emphasize clinical research in humans, which already has led to highly effective methods for managing diabetes and preventing complications, Rodgers said.

The NIH strategy for fighting diabetes addresses type 1 and type 2 diabetes. Type 1 diabetes, which affects about 5 percent of individuals with diagnosed diabetes, is an autoimmune disease that most often develops during childhood. Type 2 diabetes accounts for 90 to 95 percent of diagnosed diabetes cases in the United States, and is strongly associated with overweight and obesity. In addition, the plan addresses gestational diabetes, a condition that some women develop during pregnancy, but which usually goes away after their child is born. Women who develop gestational diabetes during pregnancy are at increased risk for developing type 2 diabetes, and the child of that pregnancy may also be at increased risk for obesity and type 2 diabetes.

Today, about 1 in 10 adults in the United States has diabetes, according to the Centers for Disease Control and Prevention. About 1.9 million Americans aged 20 years or older were newly diagnosed with diabetes in 2010. In addition, an estimated 79 million American adults have pre-diabetes, a condition in which blood sugar levels are higher than normal but not high enough to be diagnosed as diabetes. By 2050, as many as 1 in 3 adults could be diagnosed with diabetes if current trends continue, according to the CDC. The projection assumes that recent increases in new cases of diabetes will continue and people with diabetes will also live longer, which adds to the total number of people with the disease.

Diabetes eventually damages nearly every organ system in the body. People with diabetes are at increased risk for blindness, kidney failure, and lower limb amputation. Overall, the risk for death among people with diabetes is about twice that of people of similar age without diabetes. In addition, it is a very expensive disease to manage. Total costs of diabetes, including medical care, disability, and premature death, reached an estimated $174 billion in 2007 in the United States.

The plan was developed by the Diabetes Mellitus Interagency Coordinating Committee (DMICC), a congressionally authorized workgroup chaired by the NIDDK. Established in 1974, the DMICC facilitates cooperation, communication, and collaboration on diabetes research across the federal government. Key elements of the report were identified by multiple public and private stakeholders, including representatives of DMICC member agencies, health advocacy groups and external scientists who are leaders in the diabetes research field. To ensure broad input, a draft of the strategic plan was also posted for public comment prior to publication. The strategic plan is available electronically at http://diabetesplan.niddk.nih.gov/. Printed copies can be requested from the National Diabetes Information Clearinghouse beginning April 1, 2011, at 1-800-860-8747 and by email at ndic@info.niddk.nih.gov. Single copies are free.

The NIDDK, a component of the National Institutes of Health (NIH), conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see www.niddk.nih.gov.

Source: NIH News

References

1. Diabetes Research Strategic Plan. NIDDK. Accessed 2010 Mar 20.

Johns Hopkins University led all institutions in funding from the National Institutes of Health last year with $686 million. Meanwhile, California receives more NIH dollars than any other state, according to a third-party analysis that combined NIH and American Recovery and Reinvestment Act dollars from last year.

The NIH is the largest funder of biomedical research in the world.

A ranking of the Top 100 institutions getting NIH grants, followed by a ranking of all 50 states, is below. Johns Hopkins’ is a runaway leader in getting NIH grants, followed next by the University of Pennsylvania ($577 million), University of Washington ($571 million), University of Michigan ($565 million) and University of California San Francisco ($538 million).

Look at the list and consider the debate over NIH budget cuts and increases currently going on in Congress. President Obama has proposed upping by $1 billion the agency’s $31.3 billion budget in fiscal 2012, saying that biomedical research is “essential” to the health of individuals and the economy. House Republicans have taken the opposite tack, proposing $1 billion in NIH budget cuts to rein in federal spending in a move that they, too, say will help the economy (nevermind if that latter view isn’t supported by basic economics).

The data below combines information regarding direct NIH grants in 2010 with research dollars awarded as part of 2009′s federal stimulus package. The figures are often adjusted during the course of the following year, so the final 2010 amounts could change slightly.

Here is a list of funding by state.

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The home of medical research institutions, including the University of Minnesota and Mayo Clinic, came in 15th in the country for  funding in 2010, bringing in $535.4 million. Minnesota is 21st in population size among the states, according to U.S. Census figures.

The NIH funding coming into the state included $461.3 in direct grants from the agency and $74.1 million in American Recovery and Reinvestment Act medical research dollars. The NIH is the largest funder of biomedical research in the world.

The University of Minnesota was the top receiver of NIH funding in the state. It came in 20th among research  institutions across the country, receiving $303.8 million in funding. The Rochester, Minnesota-based Mayo Clinic, which also has facilities in Arizona and Florida, came in 33rd, with $205.5 million in funding.

Look at the list and consider the debate over NIH budget cuts and increases currently going on in Congress. President Obama has proposed upping by $1 billion the agency’s $31.3 billion budget in fiscal 2012, saying that biomedical research is “essential” to the health of individuals and the economy. House Republicans have taken the opposite tack, proposing $1 billion in NIH budget cuts to rein in federal spending in a move that they, too, say will help the economy (never mind if that latter view isn’t supported by basic economics).

The data below combines information regarding direct NIH grants in 2010 with research dollars awarded as part of 2009′s federal stimulus package. The figures are often adjusted during the course of the following year, so the final 2010 amounts could change slightly.

The Minnesota Daily, the University of Minnesota’s student newspaper, recently reported that NIH grants support 80 percent of the research budget at the university’s medical school.

“NIH grant funding is absolutely critical to the University’s ongoing medical research that leads directly to the cures and therapies of tomorrow,” Dr. Mark Paller, the medical school’s executive vice dean, said in a statement.

“NIH funding in the past has helped our university develop treatments that are commonplace in medicine today,” Paller said.

Dr. Aaron Friedman, vice president for health sciences and dean of the medical school, said in a recent news release that for “every dollar in funding a university takes in, we generate $2 in economic development by purchasing supplies, hiring new staff and — in some cases — constructing new facilities or laboratories.”

More than $141 million of NIH funding to the University of Minnesota went to its medical school in 2010. NIH grants to the university included an annual $3.8 million support grant to the Masonic Cancer Center at the school. A collaboration between University of Minnesota and Medical University of South Carolina researchers received $3.2 million to study stroke risks associated with blood pressure medication.

Mayo Clinic pointed out in a statement that NIH money helps fund the jobs of more than 3,200 Mayo Clinic researchers and allied health professionals, supporting research into cancer, cardiology, diabetes, aging and more.

Mayo continued in the statement: “It is clear that NIH-supported research studies lead to better patient outcomes, improved delivery of treatment options and shorter hospital stays, ultimately improving the efficiencies of patient care.”

Click here to see a ranking of the Top 100 institutions getting NIH grants, followed by a ranking of all 50 states.

Photo courtesy of Andrew Magill on Flickr.

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Ohio pulled in $778 million last year, up slightly from $769 million in 2009. The figures include funding awarded directly by the NIH, plus dollars specified in 2009′s federal American Recovery and Reinvestment Act, better known as the “stimulus.” (Credit and thanks go to BioOhio, the state’s biomedical trade group, for wading through and aggregating the data.)

The figures are often adjusted during the course of the following year, so the final 2010 amount could grow slightly, BioOhio said.

NIH funding is important because it can be the first step in paying for research that leads to innovative new products that build companies, create jobs and generate wealth. Such research is often too risky and early stage for private companies to engage in, so the government frequently funds nascent research projects until the research shows enough promise for private industry to take over.

“NIH funding in Ohio supports critical research projects that will ultimately translate into new cures, treatments and medical products that improve and save lives in America, and around the world,” said John Lewis, BioOhio’s chief operating officer.

NIH dollars have funded research and development efforts at a number of promising Ohio biomedical companies, including stem cell developer Arteriocyte, imaging firm Imalux and drug developer Great Lakes Pharmaceuticals.

Ohio’s take far exceeded the national average of $497 million per state. Considering that Ohio ranks seventh among states in population, it seems appropriate that the state would be among the nation’s leaders in research funding.

Five individual recipients in the state — Case Western Reserve University, Ohio State University, University of Cincinnati, Cincinnati Children’s Hospital Medical Center and Cleveland Clinic — ranked among the top 100 across the nation.

At No. 39, Case topped all other Ohio institutions with $185 million in NIH funding last year. Ohio State nipped at Case’s heels at No. 40, with $180 million. As for the rest, University of Cincinnati finished at No. 62 with $123 million, Cincinnati Children’s placed at No. 69 with $107 million and Cleveland Clinic was No. 74 with $90 million.

Just five other states placed more institutions in the top 100 than Ohio’s five: Massachusetts (13), California (11), New York (10), Texas (7) and Pennsylvania (6).

In overall 2010 dollars, California finished first with $3.9 billion, far outpacing closest follower Massachusetts, which drew $2.8 billion in NIH funding last year.

But just as NIH dollars that flow to Ohio help grow the state’s biomedical industry, a reduction in those dollars could hurt the industry’s progress. House Republicans propose cutting $1 billion from the NIH’s annual $31 billion budget.

“Regardless of how a reduction of NIH funds coming into Ohio might happen, it would slow the momentum of our state’s bioscience R&D engine,” Lewis said. “It would not, however immediately impact Ohio biomedical commerce.”

Antiviral therapeutics company Chimerix has received a federal contract that could reach $81 million in value if the company successfully develops a medical countermeasure to a smallpox bioterrorism agent.

The contract awarded by the Biomedical Advanced Research and Development Authority, or BARDA, gives Durham, North Carolina-based Chimerix $24.8 million during the contract’s first year. The announcement comes on the heels of a Feb. 14 announcement that the company has completed a $45 million series F round of fundraising.

Chimerix is studying an antiviral drug candidate that for now is called CMX001. While the compound is in mid-stage clinical trials as a broad-spectrum antiviral, CMX001 also has shown potential against double-stranded DNA (dsDNA) viruses that cause morbidity and mortality in humans, including smallpox. The BARDA grant builds on $37 million in grant funding that Chimerix previously received from the National Institutes of Allergy and Infectious Diseases, a part of the National Institutes of Health. That funding was also directed toward development of CMX001 as a smallpox treatment.

Chimerix said that the BARDA contract will support expanded clinical studies of  CMX001, including a recently started study of the compound for the treatment of 12 life-threatening or serious conditions caused by dsDNA viruses.

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But the party is over. The budget cuts proposed by a leading House Republican this week included cancellation of the $1 billion that the Obama administration wanted to add to the $31 billion NIH budget.

It was part of a broad assault on science funding that was announced by appropriations chairman Hal Rogers, R-Ky., who also called for large cuts at the National Science Foundation, the White House Office of Science, the National Oceanic and Atmospheric Administration and the National Aeronautics and Space Administration.

The purpose, according to Rogers, is “to rein in spending to help our economy grow and our businesses create jobs.”

If creating jobs is his goal, Rogers might want to take a look at a new study that appeared in the New England Journal of Medicine, which found that publicly-funded research is a far more important contributor to the creation of new drugs and vaccines than previously thought. The classical view of innovation is that government funds basic science, while industry comes up with the new and innovative products based on that science.

But innovation never was solely the province of private actors pursuing their self interest. And it turns out that now it is even less so. Nearly one out of every five important medical advances approved by the Food and Drug Administration between 1990 and 2007 was invented in a federally-funded lab, according to the study, which previous estimates had put at closer to one in 15.

Moreover, those inventions, which included 40 new drugs for cancer, are currently generating in excess of $100 billion a year in sales for drug and biotechnology firms. That’s about one-sixth the total revenue for the entire global pharmaceutical industry.

“These federal grants are not for product development, they’re for advancing basic science,” said study author Ashley J. Stevens, a senior researcher at Boston University’s School of Management. “But they happen to have both significant public health benefits as well as economic development benefits.” The transmission belt that allows transfer of government-funded inventions from grant recipients to the private sector was built in 1980 with passage of the Bayh-Dole Act, named after its two Senate sponsors, Democrat Birch Bayh of Indiana and Republican Bob Dole of Kansas. The law became a core element of the U.S. innovation system, and a major source of the U.S.’s competitive advantage in global commerce.

It allows scientists and their institutions to patent government-funded inventions and license them to the private sector. Prior to Bayh-Dole, those breakthroughs were put in the public domain, which eliminated the incentive for commercialization since no firm would invest in developing the product when another company could simply copy the invention.

In the wake of that law, the role of the public sector in spurring biomedical innovation surged, the study found. Over the past 40 years, 153 new FDA-approved drugs, vaccines or new indications for existing drugs were discovered through research carried out at public institutions with federal funding. More than half were used to treat or prevent cancer and infectious diseases, which isn’t surprising since the National Cancer Institute ($5 billion) and the National Institute for Allergy and Infectious Diseases ($4.7 billion) are the two largest institutes at NIH.

Last month, NIH announced plans to take its efforts to spur biomedical innovation to a higher level by creating a new institute specifically aimed at generating new products for industry. NIH director Francis Collins stripped $700 million from existing NIH science budgets to get the project up and running, and asked Secretary of Health and Human Services Kathryn Sebelius to seek an additional $1 billion from Congress for the program.

That’s wishful thinking now. The once-powerful lobbying groups that push for increased NIH funding – ranging from patient advocacy groups to university medical centers to drug and biotech firms – fear the cancellation of the president’s proposed increase is just the first wave of what will shortly become a major assault on federally-funded biomedical science. “We seem to be treating defense like an entitlement while carving deeper and deeper into discretionary budgets,” said Mary Woolley, president of Research America.

“Congress should definitely cut NIH spending,” said Michael Cannon, a health care analyst at the libertarian Cato Institute, which backs large cuts in federal spending. “Cutting NIH spending probably would result in less innovation, but it is less clear that the benefits of those forgone innovations exceed the costs.”

The chairman of Research America is former Republican Rep. John Porter of Illinois, who spent his years on Capitol Hill as the chief champion of increased NIH funding. Unfortunately for Porter and Research America, moderate Republicans like himself have gone the way of the dodo bird.

“This will undercut U.S. competitiveness in biomedical research in a very big way,” Woolley said. “Other countries have learned from the U.S. that putting resources behind biomedical research will lead not only to better health outcomes but economic growth.” That isn’t a message with much appeal to the new House majority.

Molecular pathways that are implicated in single-gene disorders may hold important clues for the diagnosis and treatment of common disease, according to the strategic plan, Charting a Course for Genomic Medicine from Base Pairs to Bedside, in the Feb. 10 issue of the journal Nature [1]. The new strategic plan comes on the 10th anniversary of the first analysis of the human genome sequence. Eric Green, M.D., Ph.D., NHGRI director, said:

Researchers around the world are working towards a future when healthcare providers will use information about our individual genomes to better diagnose and treat disease. While significant challenges remain to our understanding of how the genome operates in health and disease, there are enough examples to say with confidence that genomics research will lead to important advances in medicine.

The new vision, produced in consultation with the research community over the past two and a half years, is framed in terms of five research domains. They span activities from basic research into how the human genome is organized and functions to clinical applications that will use knowledge of the genome and genomic technologies to improve medical care and health maintenance. The research domains are:

1. Understanding the structure of genomes
2. Understanding the biology of genomes
3. Understanding the biology of disease
4. Advancing the science of medicine
5. Improving the effectiveness of healthcare

The plan envisions continuing to expand the understanding of the biology of the genome, including creating more diverse and complete catalogs of genomic and other “-omic” information, along with new tools and technologies to develop and interrogate those catalogs. Investigators in all fields of biomedical research use these resources to identify the functional contributors within the genome that determine normal, healthy biology, as well as those that, when altered, lead to common as well as rare diseases.

The new sequencing technologies, which have been widely adopted in the past three years, are a major driver of the developments in genomics research. Co-author Mark Guyer, Ph.D., director of the NHGRI Division of Extramural Research, said:

It took all the sequencing capacity in the world about 13 years to produce the first human genome sequence. In 2003, around the time we completed the Human Genome Project, technology had improved to the point where 100 machines could sequence a human-sized genome in about three months. In 2011, one machine can produce a human-sized sequence in about five days.

DNA sequencing technologies, however, are just one of the tools needed to answer the research questions that will advance human health. Technological improvements in many other areas will be critical to successfully integrate genomic knowledge into clinical care. The plan calls for fast, low-cost and highly accurate tools that will allow researchers to read and interpret much longer sections of the human genome and clinicians to use sequence information at the point of care.

The plan also calls for new technologies to measure the interaction between the environment, behavior and genes and for routine clinical applications of genomic tools such as newborn genetic screening and other types of diagnostic screening. It also calls for electronic medical records systems that integrate family histories and genomic data to generate personalized diagnoses, treatments, and prevention plans.

Development of new analytical methods, software tools and a robust computational infrastructure will be essential. Researchers need these tools for accessing, analyzing, integrating and storing the mountains of complex genomic data that will be gathered from thousands of individuals, according to the report.

With this ever-expanding body of knowledge, scientists will likely identify the genetic basis of most single-gene disorders in the next decade, the plan asserts. Furthermore, molecular pathways that are implicated in single-gene disorders may hold important clues for the diagnosis and treatment of common disease, the plan says.

The plan anticipates the increasingly important role of multi-disciplinary and international teams for collaboratively producing and analyzing comprehensive sets of data about a condition. Rapid data release for immediate research applications, which has been essential to genomic research, will continue to be fundamental for the field’s success, according to the plan.

Beyond technology, educational efforts will be critical to making genomic medicine practical for both clinicians and the public, according to the plan. Healthcare providers must be trained to interpret genomic information and to use it in counseling patients. Health consumers will need to familiarize themselves with genomic medicine so they can understand their personal risks, participate in clinical decisions, make the best use of new therapeutics and, if they so choose, modify their behaviors in response to genome-based health information. Legislators and policymakers must craft policies that continue to promote the confidentiality of participation in genomics research. Other policies will be needed to protect individual privacy and access to health coverage, and to encourage investment in genomic health technologies through intellectual property incentives.

Genomic medicine will only reach its full potential when its benefits become accessible to all, including at-risk and low-income individuals around the world. Towards this end, the plan notes the need for greater reliance on non-geneticist healthcare providers and a consideration of the larger societal implications of increasing genomic knowledge.

Dr. Green said:

Our base-pairs-to-bedside plan maps the next steps in the herculean endeavor not only to discover medical secrets hidden within the human genomes, but to bring those discoveries to the practitioner and patient. All of us in this field share a sense of urgency about using genomics for clinical applications. The challenges are enormous, but we believe that, working together, the goal of improving human health is within reach.

Dr. Green observed that genomic approaches already inform some medical treatments. Breast cancer and colorectal cancer patients are now tested for Her2 and KRAS gene mutations, respectively, in order to guide drug choices. Likewise, genetically guided prescriptions of the anti-retroviral abacavir (Ziagen) are now the standard of care for patients with HIV, and the uses of tamoxifen, clopidogrel (Plavix) and possibly warfarin will soon benefit from genetic guidance. These successes demonstrate that genomic science is already having an impact on medical care, and portend much wider application as genomics increasingly becomes an integral part of health research and development, Dr. Green said.

NHGRI is one of the 27 institutes and centers at the National Institutes of Health, an agency of the Department of Health and Human Services. Additional information about NHGRI can be found at its website, www.genome.gov.

The $3.6 million multidisciplinary grant will bring together medical doctors and physicists from the university. The grant will be applied to a study that began last fall and will take four years to complete. The researchers will develop computer models of a child’s airway. These models will allow doctors to determine which medical or surgical approaches are appropriate for children with specific upper respiratory conditions.

The UNC study will specifically focus on infants and children up to 10 years old with Pierre Robin sequence, a congenital condition characterized by a smaller than normal lower jaw, a tongue that falls back in the throat and difficulty breathing. The computer models can be applied to other airway problems as well.

Four additional sites were awarded similar grants and all of them will collaborate to share their findings.

A video from UNC describes the computer models of pediatric airways:

Overall, the company, based in Minneapolis, is seeking $5 million to develop a device that treats patients suffering from urinary  incontinence. Founder and president Dr. Gerald Timm did not immediately return a call seeking comment.

The disposable device, called ActiCuf Compression Pouch, helps males manage urine flow by applying pressure on the urethra. ActiCuf, which is worn on the penis, also captures any leaked urine.

GT Urological estimates that 13 million Americans suffer from urinary incontinence, a large market that has attracted considerable interest from Minnesota’s medical device community.

Players include large manufacturers like Medtronic, American Medical Systems, and Coloplast to startups like Uromedica and Uroplasty, which recently won Medicare reimbursement for its neuromodulation therapy.

In February, GT Urological said it raised $1 million from investors, with commitments for $3 million should the startup hit certain milestones this year and in 2011.

Since its founding in 2003, the company has raised  about $11 million, including $9 million in private capital and $2.2 million in Small Business Innovative Research grants from the National Institutes of Health.

The program will use “behavioral interventions” to reduce obesity and high blood pressure by increasing physical activity, along with healthy eating, sleeping and stress management, according to a statement from Case. The funding comes from the National Institutes of Health (NIH).

Case’s research project is one of  four programs selected to participate in the NIH’s national Childhood Obesity Prevention and Treatment Research (COPTR) initiative. The Cleveland, Ohio, university, three other universities, and the Battelle Health and Life Sciences Global Business will share the initiative’s $72.5 million to evaluate community-based programs for their influence on childhood obesity.

The project will involve 450 overweight and obese children from Cleveland schools. Each child will be assigned to one of three interventional groups: The first group focuses on building skills and increasing “intrinsic” motivation; the second emphasizes redesigning the family environment and daily routines; and the third takes a more traditional approach, centering primarily on providing educational materials.

Workers from University Hospitals‘ Rainbow Babies & Children’s Hospital will provide clinical expertise for the project.

Cleveland’s childhood overweight and obesity rate is approximately 40 percent, according to Case.

One of the pancreas’ jobs is to regulate insulin levels in the bloodstream, but if the organ doesn’t function correctly, diabetes can result. A future solution to the disease that 171 million people suffer from worldwide may be to develop an artificial pancreas, according to the World Health Organization

A Nov. 10 public workshop called “Innovations in Technology for the Treatment of Diabetes: Clinical Development of the Artificial Pancreas” will feature diabetes specialists who will discuss strategies for future clinical studies that could facilitate the testing and eventual delivery of an artificial pancreas.

Such a device would be comprised of a “closed-loop system that would dispense insulin based on real-time changes in blood sugar levels,” according to the FDA, and would “provide a better quality of life and glucose control for those who require daily insulin administration.”

The workshop’s agenda includes researchers from the Juvenile Diabetes Research Foundation‘s Artificial Pancreas Project, including Boston University’s Edward Damiano.

The FDA-hosted meeting will be videotaped and webcast for those who are unable to attend.

Dr. Stanley Hazen

Cleveland Clinic researchers have won $11.7 million from the National Institutes of Health (NIH) to find out why “good” cholesterol sometimes goes bad, and then to harness their discoveries as new diagnostic tests or therapies for heart disease.

Dr. Stanley Hazen, section head of Preventive Cardiology at Cleveland Clinic’s Miller Heart & Vascular Institute and a staff member in the Department of Cell Biology of its Lerner Research Institute, is the principal investigator on the grant.

Hazen, discoverer of a heart inflammation biomarker, will lead three projects under the latest grant to develop a comprehensive understanding of high-density lipoprotein (HDL) cholesterol and its relationship to atherosclerotic heart disease. He already has landed at least $25 million in grants for heart disease research this year.

Hazen also is a driving force behind a recently struck research deal with Esperion Therapeutics Inc. in Plymouth, Minnesota, to develop good cholesterol therapies to fight cardiovascular disease.

“HDL is typically a protective particle that carries ‘good’ cholesterol,” Hazen said in a Clinic release. “It is considered ‘good’ because it normally helps prevent development of plaque; however, it can become dysfunctional within the vessel wall and lose its beneficial functions. This is why a high HDL cholesterol level is not always protective.”

Plaque that builds up in artery walls can cause heart attacks or strokes.

“Our goal is to discover the biologic mechanisms that render HDL dysfunctional, and to harness this information for both improved diagnostic tests, and new therapeutic interventions,” Hazen said.

Hazen will lead Project 1 under the latest grant to figure out how and where HDL becomes “dysfunctional” in atherosclerosis. The project also will develop and validate a test for dysfunctional HDL “as a new and powerful diagnostic tool for heart disease risk,” the Clinic said in its release.

Jonathan Smith, a staff member in the Lerner Research Institute’s Cell Biology Department, will lead Project 2, which will try to understand how HDL is made  and test engineered forms of HDL as therapies for atherosclerosis.

Finally, Dr. Ed Fisher will lead Project 3, which will seek to understand the molecular mechanisms that cause plaque to regress. Fisher is director of  New York University Medical Center’s Vascular Biology and Disease Program.

Hazen’s heart inflammation biomarker — myeloperoxidase — has been commercialized as a test called CardioMPO done by Cleveland Clinic spinoff company Cleveland HeartLab. Hazen is Cleveland HeartLab’s chief scientific officer.

The program is aimed at improving data for scientists and regulatory reviewers on medical device safety and at improving the “evaluation and availability of new medical products to the community,” according to a press release.

The FDA will put about $950,000 toward the grants, according to the release. It’s part of a joint effort announced early this year designed to speed innovative medical technologies to market. When the cooperative effort was announced, the agencies said their total kitty was about $6.75 million over three years.

Regulatory science is the “development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality,” according to the February announcement of the program.

Here are the details on the recipients of the four grants:

• Dr. Donald Ingber of Harvard University Medical School in Boston — “Heart-Lung Micromachine for Safety and Efficacy Testing”
• Dr. William Barsan, Donald Berry and Roger Lewis of the University of Michigan in Ann Arbor — “Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design”
• Daniel Cerven and George DeGeorge of MB Research Laboratories Inc. in Spinnerstown, Pennsylvania — “Replacement Ocular Battery (ROBatt)”
• Dennis Hourcade of Washington University in St. Louis — “Characterization/Bioinformatics-modeling of Nanoparticle: Complement Interactions”

“These four projects were chosen among many applications because they were the most meritorious proposals for addressing high-priority areas in cutting-edge biomedical research and regulatory science. This partnership marks the beginning of our work with FDA to use new scientific and technological tools to aid/enhance the review of new drugs and devices. It is one facet of our shared commitment to speed the delivery of new medical products to patients,” NIH director Dr. Francis Collins said in prepared remarks.

“These projects show the potential breadth of opportunity that comes from advancing regulatory science. The results are likely to have broad application to researchers across scientific disciplines and will result in better-informed regulatory decision-making and faster drug development and approval processes,” added FDA commissioner Dr. Margaret Hamburg.

The National Institutes of Health (NIH) is launching two major research efforts — worth $72.5 million — to find ways to end the childhood obesity epidemic in the United States.

Battelle’s Health and Life Sciences Global Business has won a $23 million contract to study community programs for their roles in increasing or decreasing the risk of childhood obesity.

The Columbus, Ohio, charitable trust is using the grant from the National Heart, Lung and Blood Institute — and its own experience in large program evaluation and community health studies — to subcontract with the likes of University of California, Berkeley, to find new ways to evaluate community-based programs for their influence on childhood obesity.

Obesity rates have increased four-fold among children in the past 40 years, the NIH says. Today, 17 percent of U.S. children and adolescents are obese.
Since the 1970s when Battelle started down the research path of understanding the childhood obesity trend, the rate of obese children and adolescents has roughly tripled.

“The need to identify the most promising approaches that communities can use to reduce the obesity epidemic is urgent,” said Howard Fishbein, Battelle’s principal investigator for the study, in a press release. “This study represents an opportunity for conducting a comprehensive and systematic evaluation of the strategies that communities across the country have initiated to prevent childhood obesity.”

The project goal is to build a platform so study partners, including the National Institutes of Health, Robert Wood Johnson Foundation and Centers for Disease Control and Prevention,  can evaluate individual programs. The end-goal is to find was to prevent childhood obesity.

The rest of the NIH research effort — $49.5 million — will launch the Childhood Obesity Prevention and Treatment Research program, which aims to be different from other childhood obesity studies. Two obesity prevention and two obesity treatment randomized clinical trials will be conducted over seven years, the NIH said in a release.

Investigators will collaborate with local, state and national organizations to test long-term interventions through several levels of influence — community youth organizations, schools, primary care providers, home and families — rather than focus solely on individual behavior, as past studies have done.

The prevention and treatment research program will be conducted at four universities and coordinated by the University of North Carolina, Chapel Hill (principal investigator: June Stevens):

• Vanderbilt University School of Medicine, Nashville, Tennessee (principal investigator: Dr. Shari L. Barkin)
• Case Western Reserve University, Cleveland, Ohio (principal investigator: Dr. Leona Cuttler)
• Stanford University, Palo Alto, California (principal investigator: Dr. Thomas N. Robinson)
• University of Minnesota, Twin Cities (principal investigator: Simone French)

Dr. Richard Weinshilboum is one of 21 researchers across the country to receive a collective $161.3 million over the next five years to study pharmacogenomics.

The scientists will use genome sequencing techniques to identify genetic variants that predict how patients suffering from breast cancer and depression respond to drugs. Based on that information, researchers could adjust doses to maximize therapy and reduce side effects.

“Our ability to use this kind of science to apply drug response has turned out to already be penetrating clinical practice in rather dramatic ways,” Dr. Weinshilboum said in a statement. “We want to be sure that patients who come to Mayo can benefit from the application of this science, which is moving at warp speed.”

Mayo also received a $3.1 million grant for its Pharmacogenomic Ontology Network Resource and a $2.3 million award for next generation DNA sequencing.

“Thanks to breakthroughs in genome sequencing technologies and our growing understanding of genetic variation among individuals, there has never been a better time to propel the field of pharmacogenomics,’’ NIH Director Dr. Francis S. Collins said in a statement. “Through these studies, we are moving closer to the goal of using genetic information to help prescribe the safest, most effective medicine for each patient.”

Mayo is also one of six medical research centers in the United States tapped by the NIH  to study the long-term reactions of human immune systems to diseases and vaccines.

NIH hopes the five-year, $100 million effort, funded by the federal stimulus law, will help researchers design better vaccines to treat diseases like influenza, pneumococcus and the West Nile virus.

The five-year grant comes from the National Institute of General Medical Sciences. The study will be led by Wolfgang Sadee, who chairs Ohio State’s pharmacogenomics program, according to a statement from the OSU Medical Center.

On Tuesday, the National Institutes of Health said it had committed to invest $161.3 million over five years to expand the Pharmacogenomics Research Network, a nationwide collaboration of scientists focused on understanding how genes affect a person’s response to medicines.

“We want to improve our ability to give the right drug to the right patient at the right time at the right dosage,” Sadee said.

Sadee estimated that 30-to-70 percent of people who take medications don’t respond favorably or experience adverse reactions. Much of that may be due to genetic differences in people that cause their bodies to respond to medication in different ways. Sadee’s research will focus on identifying the genetic differences so researchers can predict which drugs will be most suitable for certain patients.

“Our project uses a novel approach to finding these critical genetic differences and testing them immediately in clinical trials that are under way here at Ohio State and across the world,” he said.

In addition to Sadee’s research, the grant funds Ohio State as a member of the nationwide Pharmacogenomics Research Network, which connects 14 research centers across the U.S. that are working towards improving drug response rates and decreasing adverse medication events, according to the statement.

The four-year study will compare the long-term effects of ethosuximide (Zarontin) to valproic acid (Depakote) and lamotrigine (Lamictal), according to a statement from the hospital.

Seizures of childhood absence epilepsy are usually staring spells during which the child is not aware or responsive. Each spell lasts about 10 seconds, and the seizures may happen up to 100 times a day, often when a child is exercising.

The new study will involve 31 medical centers across the country and follow 441 patients who participated in an earlier phase of the study. The results of the earlier phase of the study concluded that ethosuximide — the oldest and least expensive of the three medications — also provided the best short-term results for controlling absence seizures with the least negative effects on attention.

“The first study showed that newer isn’t necessarily better,” said Dr. Tracy Glauser, director of the Comprehensive Epilepsy Center at Cincinnati Children’s. “Now, we’re asking whether ethosuximide remains the best drug for long-term therapy.”

Glauser is the study’s lead researcher.

Though the concept of comparative effectiveness research – which, as the name implies, entails studying different drugs or procedures for the same condition to determine which works best — seems benign, it has generated a bit of controversy as it’s drawn more attention in recent years.

Some critics contend that it could be used to limit the use of drugs or treatments that are best for certain groups of patients, and it’s also been a popular target for the “Don’t-let-some-government-bureaucrat-stand-between-you-and-your-doctor” crowd.

Last year’s federal stimulus package allocated $1.1 billion for comparative effectiveness research to three federal agencies.