A new study claims to have found the neural differences between men and women. But the story’s not that simple.
The latest neuroscience study of sex differences to hit the popular press has inspired some familiar headlines. The Independent, for example, proclaims that:
The hardwired difference between male and female brains could explain why men are “better at map reading” (And why women are “better at remembering a conversation”).
The study in question, published in PNAS, used a technology called diffusion tensor imaging to model the structural connectivity of the brains of nearly a thousand young people, ranging in age from eight to 22.
It reports greater connectivity within the hemispheres in males, but greater connnectivity between the hemispheres in females. These findings, the authors conclude in their scientific paper,
suggest that male brains are structured to facilitate connectivity between perception and coordinated action, whereas female brains are designed to facilitate communication between analytical and intuitive processing modes.
One important possibility the authors don’t consider is that their results have more to do with brain size than brain sex. Male brains are, on average, larger than females and a large brain is not simply a smaller brain scaled up.
Larger brains create different sorts of engineering problems and so – to minimise energy demands, wiring costs, and communication times – there may physical reasons for different arrangements in differently sized brains. The results may reflect the different wiring solutions of larger versus smaller brains, rather than sex differences per se.
But also, popular references to women’s brains being designed for social skills and remembering conversations, or male brains for map reading, are utterly misleading.
In an larger earlier study (from which the participants of the PNAS study were a subset), the same research team compellingly demonstrated that the sex differences in the psychological skills they measured – executive control, memory, reasoning, spatial processing, sensorimotor skills, and social cognition – are almost all trivially small.
To give a sense of the huge overlap in behaviour between males and females, of the twenty-six possible comparisons, eleven sex differences were either non-existent, or so small that if you were to select a boy and girl at random and compare their scores on a task, the “right” sex would be superior less than 53% of the time.
Even the much-vaunted female advantage in social cognition, and male advantage in spatial processing, was so modest that a randomly chosen boy would outscore a randomly chosen girl on social cognition – and the girl would outscore the boy on spatial processing – over 40% of the time.
As for map-reading and remembering conversations, these weren’t measured at all.
Yet the authors describe these differences as “pronounced” and as reflecting “behavioural complementarity” – scientific jargon-speak for “men are from Mars, women are from Venus”. Rather than drawing on their impressively rich data-set to empirically test questions about how brain connectivity characteristics relate to behaviour, the authors instead offer untested stereotype-based speculation. Even though, with such considerable overlap in male/female distributions, biological sex is a dismal guide to psychological ability.
Also missing from the study is any mention of experience-dependent brain plasticity. Why?
As prominent feminist neuroscientists have noted, the social phenomenon of gender means that a person’s biological sex has a significant impact on the experiences (including social, material, physical, and mental) she or he encounters which will, in turn, leave neurological traces.
Yet the researchers do not pay any attention to the gendered experiences (such as hobbies, subjects studied at school or higher education, or participation in sporting activities) of the young males and females in their sample.
This absence has two consequences. First, the researchers miss an opportunity to investigate whether gendered experiences might influence brain development and enhance the acquisition of important skills valuable to all. The second consequence is that, by failing to look at gendered social influences, the authors guarantee that no data will be produced that challenge the notion of “hardwired” male/female neural signatures.
These characteristics of the PNAS study are very common in neuroscientific investigations of male/female sex differences, and represent two important ways in which scientific research can be subtly “neurosexist”, reinforcing and legitimating gender stereotypes in ways that are not scientifically justified. And, when researchers are “blinded” by sex, they can overlook potentially informative research strategies.
Returning to the popular representations, we can now see a striking disconnect with the actual data. The research provides strong evidence for behavioural similarities between the sexes. It provides no evidence that those modest behavioural sex differences are associated with brain connectivity differences. And, it offers no information about the developmental origins of either behavioural or brain differences.
Yet, the popular press presents it as evidence that “hardwired” sex differences explain why men are from Mars and women are from Venus. While this is tediously predictable, what is more surprising is for a study author to push along such misinterpretations, claiming to have found evidence for “hardwired” sex differences, and suggesting that this might explain behavioural sex differences not actually measured in the study, such as in “intuition” skills “linked with being good mothers”.
In the latest issue of Trends in Cognitive Sciences, co-authors Rebecca Jordan-Young, Anelis Kaiser and Gina Rippon and I argued that scientists investigating sex differences have a responsibility to realise “how social assumptions influence their research and, indeed, public understanding of it.” We then called on scientists working in this area to:
recognise that there are important and exciting opportunities to change these social assumptions through rigorous, reflective scientific inquiry and debate.
The continuing importance of this message is only reinforced by this latest case study in how easily scientific “neurosexism” can, with a little stereotype-inspired imagination, contribute toinaccurate and harmful lay misunderstanding of what neuroscience tells us about the sexes.
Cordelia Fine receives funding from an ARC Future Fellowship.
The new USB standard, called Type C, will not connect to existing USB ports, but that’s a small price to pay.
A helpful guide to urine appearance
The sperm can be used to reseed the reef in the future.
Well, that’s one way to go about it. Over the past few weeks, Australian scientists have collected billions of sperm from spawning coral in the Great Barrier Reef, Australian news station ABC News reports. The sperm are to be cryogenically frozen, in case scientists want to rebuild parts of the reef in the future.
Since 1985, the Great Barrier Reef has lost more than half of its coral, one study found last year. The losses stem primarily from tropical cyclones, coral bleaching and predation by a certain species of starfish. Storms and coral bleaching will worsen with climate change.
If Australian scientists decide one day to thaw their collected sperm, they would use it to seed the ocean, where hopefully it will combine with fresh eggs released by existing coral. The frozen sperm could add genetic diversity back into coral populations that have fallen too low to be diverse. The reseeding could help the reef better weather further change, Taronga Zoo researcher Rebecca Spindler told ABC News. Spindler will be in charge of the Great Barrier Reef sperm bank, which will be the largest cryogenically frozen population in the world.
Several zoos in the U.S. maintain conservation-minded sperm banks, including the National Zoo (many species), the Cincinnati Zoo & Botanical Garden (rhinos) and the Memphis Zoo (amphibians). Researchers in Hawaii pioneered the techniques needed to freeze coral sperm and embryos, and there’s a bank at the University of Hawaii. One of the technique’s creators, marine biologist Mary Hagedorn, will help with the Australian effort.
Target e*CTR® (eClinical Trial Record), the eSource Solution for Clinical Trials, When Fully Integrated with EDC Systems, Eliminates Paper Source Records and Provides Significant Cost Savings
Target e*CTR® (eClinical Trial Record), the eSource solution for clinical trials:
1. enables clinical research sites to enter subject level data directly into EDC system at the time of the office visit, thus dramatically reducing the need for paper source records, and source document verification and review.
2. coupled with direct data-entry (DDE) and real-time, risk-based monitoring, can save pharmaceutical companies a minimum of $10,000 per site per year. For larger pharmaceutical companies, this one factor alone can translate to cost savings of $50,000,000 to $80,000,000 per year.
3. provides sites with a contemporaneous, independent, investigator copy (CIIC) of the trial data – no other EDC system provides this capability today.
4. has been implemented in 16 clinical trials under 10 INDs (drugs) and 1 IDE (devices).
Additional Advantages Include the Following:
1. Knowledge about issues in real time enables rapid fire corrective actions.
2. Improved quality of data with associated cost savings.
a. Lessons learned across sites achieve better overall quality at lower cost.
b. Reduces the number of protocol violations.
c. Reduces the number of queries.
3. Increased productivity savings accrued to the clinical study sites.
a. Once the subject leaves the clinic, the only activity is responding to queries.4. Improved site/sponsor relationships allows for a more focused level of cooperation.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchelor Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.
THANKSGIVING CALORIES, Plus Fat Alert Quiz (scroll down)
Do You Know the Calories in Thanksgiving Food?
Thanksgiving Weekend Fat Alert Quiz
Q:Weight loss occurs in the belly before anywhere else. ___________
Check One: A) True or B) False
Whether you’re an apple shape with excess belly fat or a pear with wide hips and thighs, when you lose weight, you’ll most likely lose proportionately more from the abdominal region than elsewhere. Belly fat is more metabolically active and easier to lose than subcutaneous fat under the skin, especially if you have plenty of it.
Q:Belly (abdominal) fat is also known as _______________ fat.
Check One: A) Brown; B) Visceral; C) Baby; D) Saturated or E) All of the above?
Belly is fat is also called visceral fat, which is found deep in the belly and around internal organs. There is no disputing the fact that visceral fat is the most dangerous for our health. Visceral fat is easy to lose and can be lost without any changes to your diet.
Q:Crunches (sit-ups) will flatten your belly. _____________
Check One: A) True or B) False
Hundreds of crunches each day won’t flatten your belly if you need to lose weight. If your abdominal muscles aren’t covered with excess fat, strengthening them can help you look tighter and thinner, but spot exercises won’t banish belly fat.
Q:Men have too much belly fat if their waists are more than 40 inches around. _______
Check One: A) True or B) False
Men with waists that measure more than 40 inches have too much belly fat and may be at risk for heart disease and other conditions. Men in this situation should lose weight.
Q:Eating a diet rich in ______________ helps to reduce fat.
Check One: A) Whole grains or B) Dairy?
Eating a diet rich in whole grains (which also tend to be higher in fiber) helps improve insulin sensitivity. This, in turn, helps the body more efficiently use blood glucose, lowers blood glucose levels, and reduces fat deposition.
Q:Which food is considered a whole grain? ____________
Check One: A) Popcorn; B) Broccoli; C) Peas; D) All of the above
A whole grain is a grain that still has its outer covering, which is nutritionally rich in vitamins, minerals, and fiber. Examples of whole grains include popcorn, whole grain corn, whole oats/oatmeal, brown rice, whole rye, whole grain barley, wild rice, buckwheat, triticale, bulgur (cracked wheat), millet, quinoa, sorghum, and 100% whole wheat flour. Please note that many commercially available microwave popcorns have additional ingredients which can add calories to these products.
Q:Belly fat acts like an organ in the body. _________________
Check One: A) True or B) False
Belly fat doesn’t just lay idle at your beltline. Researchers describe it as an active “organ” in your body — one that churns out hormones and inflammatory substances. Abdominal fat is thought to break down easily into fatty acids, which flow directly into the liver and into muscle. Fats and clots get into the bloodstream, and that sets the stage for diabetes, heart disease, and more.
Q:Can skinny people have hidden belly fat? __________
Check One: A) Yes or 2) No
Even skinny people can have unhealthy hidden belly fat. Research shows that fat may be folded deep inside the belly around the stomach organs, visible only by CT or MRI imaging. This fat puts skinny people at the same health risks as someone with more obvious big girth, researchers say.
Q:What is the golden path to belly fat loss? __________
Check One: A) Liposuction; B) Bariatric surgery; C) Walking; D) Tummy tuck
Exercise such as walking is the golden path to help lose belly fat. Cutting calories is part of it, but physical activity is really the answer. Liposuction can’t get rid of enough fat to eliminate the health risks. Bariatric (gastric bypass) surgery, though more effective, is not ideal.
Q:Who collects more belly fat? ______________
Check One: A) Men; B) Women; C) Both
Men tend to collect more belly fat than women, and it starts early in life. In adolescence and post-adolescence, men start collecting abdominal fat. It’s one of the reasons men have more coronary disease than women.
Government Healthcare in the 1700s 1800s 1900s and 2000s
Campus of the NIH in Bethesda, Maryland
Editor’s Note: Research for this article was done by the Editor in Chief of On Target, Joyce Hays, CEO of Target Health. The following article describes the involvement of the United States government in healthcare and medical research. Americans should be more aware of the extensive, completely bi-partisan, involvement of our federal government in these achievements. Up until about the 1980s and 90s our political parties operated, for the most part, in a cooperative way, when it came to healthcare and medical research. Time to get back to the basics.
Going forward, we will continue to inform you, from time to time, with historical summaries, of the deep commitment by our nation, to healthcare and medical research. There is every reason for American citizens to feel proud of our government’s accomplishments in these endeavors.
The city of New Orleans, Louisiana, deserves special mention for contributing two important hospitals in the early 1700s. The first was the Royal Hospital, which had humble beginnings when it was built in 1722 as a small military infirmary, but grew to importance when the Ursuline Sisters took over the management of it in 1727 and made it a major hospital for the public, with a new and larger building built in 1734. The other major New Orleans hospital was the Charity Hospital, which was staffed by many of the same people but was established in 1736 as a supplement to the Royal Hospital so that the poorer classes (who usually could not afford treatment at the Royal Hospital) had somewhere to go.
In most of the American colonies, medicine was rudimentary for the first few generations, as few upper-class British physicians emigrated to the colonies. The first medical society was organized in Boston in 1735. In the 18th century, 117 Americans from wealthy families had graduated in medicine in Edinburgh, Scotland, but most physicians learned as apprentices in the colonies. In Philadelphia in 1765, the Medical College of Philadelphia was founded, and became affiliated with the university in 1791. In New York, the medical department of King’s College was established in 1767, and in 1770, awarded the first American M.D. degree.
Smallpox inoculation was introduced 1716-1766, well before it was accepted in Europe. The first medical schools were established in Philadelphia in 1765 and New York in 1768. The first textbook appeared in 1775, though physicians had easy access to British textbooks. The first pharmacopoeia appeared in 1778. The number of physicians was small, and the national resources were stretched thin by the medical needs of the Revolutionary Army, where supplies and facilities were often inadequate.
State and city funded pest houses aimed at newly arrived infected sailors were established in port cities, notably Boston (1710), Philadelphia (1740) Charleston (1752) and New York (1757). The first general hospital was established in Philadelphia in 1752.
NIH’s (National Institutes of Health) roots extend back to a Marine Hospital Service in the late 1790s that provided medical relief to sick and disabled men in the U.S. Navy. By 1870, a network of marine hospitals had developed and was placed under the charge of a medical officer within the Bureau of the Treasury Department. In the late 1870s, Congress allocated funds to investigate the causes of epidemics like cholera and yellow fever, and it created the National Board of Health, making medical research an official government initiative.
In the American Civil War (1861-65), as was typical of the 19th century, more soldiers died of disease than in battle, and even larger numbers were temporarily incapacitated by wounds, disease and accidents. Conditions were poor in the Confederacy, where doctors and medical supplies were in short supply. The war had a dramatic long-term impact on American medicine, from surgical techniques to hospitals to nursing and to research facilities. The hygiene of the training and field camps was poor, especially at the beginning of the war when men who had seldom been far from home were brought together for training with thousands of strangers. First came epidemics of the childhood diseases of chicken pox, mumps, whooping cough, and, especially, measles. Operations in the South meant a dangerous and new disease environment, bringing diarrhea, dysentery, typhoid fever, and malaria. There were no antibiotics, so the surgeons prescribed coffee, whiskey, and quinine. Harsh weather, bad water, inadequate shelter in winter quarters, poor policing of camps, and dirty camp hospitals took their toll. This was a common scenario in wars from time immemorial, and conditions faced by the Confederate army were even worse. The Union responded by building army hospitals in every state. What was different in the Union was the emergence of skilled, well-funded medical organizers who took proactive action, especially in the much enlarged United States Army Medical Department, and the United States Sanitary Commission, a new private agency. Numerous other new agencies also targeted the medical and morale needs of soldiers, including the United States Christian Commission as well as smaller private agencies such as the Women’s Central Association of Relief for Sick and Wounded in the Army (WCAR) founded in 1861 by Henry Whitney Bellows, and Dorothea Dix. Systematic funding appeals raised public consciousness, as well as millions of dollars. Many thousands of volunteers worked in the hospitals and rest homes, most famously poet Walt Whitman. Frederick Law Olmstead, a famous landscape architect (designed Central Park in NYC), was the highly efficient executive director of the Sanitary Commission.
States could use their own tax money to support their troops as Ohio did. Following the unexpected carnage at the battle of Shiloh in April 1862, the Ohio state government sent 3 steamboats to the scene as floating hospitals with doctors, nurses and medical supplies. The state fleet expanded to eleven hospital ships. The state also set up 12 local offices in main transportation nodes to help Ohio soldiers moving back and forth. The U.S. Army learned many lessons and in 1886, it established the Hospital Corps. The Sanitary Commission collected enormous amounts of statistical data, and opened up the problems of storing information for fast access and mechanically searching for data patterns. The pioneer was John Shaw Billings (1838-1913). A senior surgeon in the war, Billings built the Library of the Surgeon General’s Office (now the National Library of Medicine, the centerpiece of modern medical information systems. Billings figured out how to mechanically analyze medical and demographic data by turning it into numbers and punching onto cardboard cards as developed by his assistant Herman Hollerith, the origin of the computer punch card system that dominated statistical data manipulation until the 1970s.
After 1870 the Nightingale model of professional training of nurses was widely copied. Linda Richards (1841-1930) studied in London and became the professionally trained American nurse. She established nursing training programs in the United States and Japan, and created the first system for keeping individual medical records for hospitalized patients. In 1887, an NIH laboratory for the study of bacteria, the Hygienic Laboratory, was established at the Marine Hospital in New York. In the early 1900s, Congress began appropriating funds for the Marine Hospital Service. In 1902, the: U.S. Public Health Service was created. In1922, this organization changed its name to Public Health Services and established a Special Cancer Investigations laboratory at Harvard Medical School. This marked the beginning of a partnership with universities.
In June 1906, Republican President Theodore Roosevelt signed into law the government agency, Food and Drug Act, also known as the Wiley Act after its chief advocate Dr. Harvey Washington Wiley who riveted the country’s and eventually congress’s attention with public hygiene demonstrations. This act was the basis for the modern USFDA, being originally given the name of the Food, Drug, and Insecticide organization. The name eventually was shortened to the Food and Drug Administration (FDA) a few years later.
In 1930, the Hygienic Laboratory was re-designated as the National Institutes of Health by the Ransdell Act and was given $750,000 to construct two NIH buildings. Over the next few decades, Congress would increase its funding tremendously to the NIH, and various institutes and centers within the NIH were created for specific research programs.
Republican President Warren G. Harding proposed a Department of Education and Welfare as early as 1923.
Under President Franklin D. Roosevelt, and Supreme Allied Commander in Europe, Dwight D. Eisenhower, and due to the tremendous WW2 war effort, in the first 5 months of 1943, 400 million units of penicillin were produced in the US. In the next 7 months, 20.5 billion units were produced, an increase of over 500 times. In 1945, 650 billion units of penicillin were distributed each month in the US and also in 1945, the first vaccine for influenza was produced.
Under Harry S. Truman, The Communicable Diseases Center was founded July 1, 1946 as the successor to the World War II Malaria Control in War Areas program of the Office of National Defense Malaria Control Activities. Preceding its founding, organizations with global influence in malaria control were the Malaria Commission of the League of Nations and the Rockefeller Foundation. The Rockefeller Foundation greatly supported malaria control, sought to have the governments take over some of its efforts, and collaborated with the agency.
CDC headquarters in Druid Hills, Georgia, as seen from Emory University
CDC’s Roybal campus in Atlanta, GA
The new agency was a branch of the U.S. Public Health Service and Atlanta was chosen as the location because malaria was endemic in the Southern United States.
Under President Lyndon B. Johnson, in 1965, Medicare and Medicaid were introduced to the U.S. healthcare system for, respectively, senior citizens and the poor. In 1967, the Division of Regional Medical Programs was created to administer government grants for research for heart disease, cancer, and strokes. That same year, the NIH director lobbied the White House for increased federal funding in order to increase research and the speed with which health benefits could be brought to the people. An advisory committee was formed to oversee further development of the NIH and its research programs.
By 1971, cancer research was in full force and President Nixon signed the National Cancer Act, initiating a National Cancer Program, President’s Cancer Panel, National Cancer Advisory Board, and 15 new research, training, and demonstration centers. In 1979, the Department of Health, Education, and Welfare was renamed the Department of Health and Human Services (HHS), when its education functions were transferred to the newly created United States Department of Education under the Department of Education Organization Act. HHS was left in charge of the Social Security Administration, agencies constituting the Public Health Service, and Family Support Administration.
By the 1990s, the focus of the NIH committee had shifted to DNA research, and the Human Genome Project was launched. In 2009, President Obama reinstated federally funded stem-cell research, revoking the ban imposed in 2001. From logistical restructuring, to funding increases, to research prioritization, to government expansion and political influence, the history of the National Institutes of Health is extensive and full of change. The NIH has grown to encompass nearly 1% of the federal government’s operating budget. The NIH now controls more than 50% of all funding for health research, and 85% of all funding for health studies in universities. In 1995, the Social Security Administration was removed from the Department of Health and Human Services, and established as an independent agency of the executive branch of the United States Government. In 2000, scientists with the International Human Genome Project release a rough draft of the human genome to the public. For the first time the world can read the complete set of human genetic information and begin to discover what our roughly 23,000 genes do.
In 2007, scientists discover how to use human skin cells to create embryonic stem cells.
In 2010, The Patient Protection and Affordable Care Act (PPACA), commonly called Obamacare or the Affordable Care Act (ACA), is signed into law by President Barack Obama, creating America’s first government health insurance program.
In May 2011, the state of Vermont became the first state to pass legislation establishing a Single-Payer health care system. The legislation, known as Act 48, establishes health care in the state as a human right and lays the responsibility on the state to provide a health care system which best meets the needs of the citizens of Vermont. The state is currently in the studying phase of how best to implement this system.
In 2012, The U.S. Supreme Court upheld the constitutionality of most of the ACA in the case National Federation of Independent Business v. Sebelius.
In 2013, for the first time in US history, American citizens were able to sign up for healthcare under the ACA federal law.
Sources: Medical Advances Timeline | Infoplease.com; Stanford.edu, The New York Times, Wikipedia, Scott Harrah inAcademics, U.S. Medical History, UMHS News;http://www.medpagetoday.
Effect of Thalidomide on Clinical Remission in Children and Adolescents With Refractory Crohn Disease
Pediatric-onset Crohn disease is more aggressive than adult-onset disease, has high rates of resistance to existing drugs, and can lead to permanent impairments. Few trials have evaluated new drugs for refractory Crohn disease in children. As a result, a study published in the Journal of the American Medical Association (2013;310:2164-2173) was performed to determine whether thalidomide is effective in inducing remission in refractory pediatric Crohn disease.
The investigation was a multicenter, double-blind, placebo-controlled, randomized clinical trial of 56 children with active Crohn disease despite immunosuppressive treatment. The study was conducted in 6 pediatric tertiary care centers in Italy.
For the study, thalidomide (1.5 to 2.5 mg/kg per day), or placebo was administered once daily for 8 weeks. Twenty-eight children were randomized to thalidomide and 26 to placebo. In an open-label extension, nonresponders to placebo received thalidomide for an additional 8 weeks. All responders continued to receive thalidomide for an additional minimum 52 weeks. The primary outcomes were clinical remission at week 8, measured by Pediatric Crohn Disease Activity Index (PCDAI) score and reduction in PCDAI by >25% or >75% at weeks 4 and 8. Primary outcomes during the open-label follow-up were clinical remission and 75% response.
Results showed that clinical remission was achieved by significantly more children treated with thalidomide (46.4% vs. 11.5%; P=0.01. In terms of the criterion of 75% response, responses were not different at 4 weeks, but greater improvement was observed at 8 weeks in the thalidomide group 75% response (46.4% vs. 11.5%; P=0.01; and 25% response (64.2% vs. 30.8%; P=0.01). Of the non-responders to placebo who began receiving thalidomide, 52.4% subsequently reached remission at week 8 (P=0.01). Overall, 63% of children treated with thalidomide achieved clinical remission, and 65.3% achieved 75% response. Mean duration of clinical remission in the thalidomide group was 181.1 weeks vs. 6.3 weeks in the placebo group (P <0.001). Peripheral neuropathy the most frequent severe adverse event.
According to the authors, in children and adolescents with refractory Crohn disease, thalidomide compared with placebo resulted in improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in an open-label follow-up, and that the findings require replication to definitively determine clinical utility of this treatment.
Gene Hastens Kidney Disease Progression in African-Americans
An estimated 20 million or more American adults have chronic kidney disease (CKD), and over 400,000 people in the United States and 2 million worldwide depend on dialysis to treat kidney failure. Although exceedingly rare in white people, the APOL1 gene variant is found in 13-15% of African-Americans. Some have speculated that it evolved to protect against one of the two forms of African sleeping sickness, a lethal parasitic disease transmitted by the tsetse fly.
Investigators from the Chronic Renal Insufficiency Cohort (CRIC) study and the African American Study of Kidney Disease and Hypertension (AASK) published joint results in the New England Journal of Medicine (12 November 2013). The authors noted that a gene variant common in African-Americans predicts that people with that gene who also have chronic kidney disease (CKD) are twice as likely to progress to kidney failure as African-Americans without the high-risk gene and white people with CKD. People with the high-risk gene also tend to lose kidney function at twice the rate of those without the gene.
The impact of the gene variant — known as APOL1 — on risk for and rate of CKD progression was consistent in both studies, regardless of whether patients maintained good blood pressure control or had diabetes. High blood pressure and diabetes are major risk factors for CKD and its progression to kidney failure.
The discovery builds on landmark 2008 research by NIH kidney specialist Dr. Jeffrey Kopp and others, led by Dr. Martin Pollak at The Laboratory of Inherited Kidney Disease at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, which found the APOL1 gene variant to be a risk factor for kidney disease that wasn’t associated with diabetes.
AASK is the largest and longest completed study of CKD in African-Americans. Beginning as a randomized clinical trial in 1995, the investigation was completed in 2007 as a cohort study. The CRIC study is one of the largest and longest ongoing studies of CKD epidemiology in the United States. CRIC recently embarked on an expansion to add more than 1,500 patients over the next five years, increasing the study’s total size to approximately 5,500.
TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area.
NIH to Retire Research Chimps
Will there be a time that we will not have to test new drugs on animals or at least fine-tune the rules and evaluate the benefit to risk for each proposed study based on previous knowledge.
The following is from Francis S. Collins, M.D., Ph.D., Director, National Institutes of Health.
With an immense sense of gratitude, I applaud today’s action by President Barack Obama that will enable the National Institutes of Health (NIH) to retire most of our research chimpanzees. Americans have benefitted greatly from chimpanzees’ service to biomedical research, but new scientific methods and technologies have rendered their use in research largely unnecessary [our emphasis). Consequently, it is now time to move most of the NIH-owned chimpanzees to the federal sanctuary system. Profound thanks are due to the bipartisan effort in both the House and Senate that made it possible for this legislation to be passed and sent to the White House. By signing into law Senate Bill 252 (S. 252), the President has provided us with the means to fund the care of all NIH-owned and supported chimpanzees — including those that are retired — over the next five years.
Specifically, S. 252 contains amendments approved by both the Senate and House that removes the spending cap set forth in The Chimpanzee Health Improvement, Maintenance, and Protection (CHIMP) Act. With the funding roadblock removed, NIH can move forward with our previously stated plans to transfer all but 50 of its 347 research chimpanzees into the federal sanctuary system, which currently consists only of Chimp Haven in Keithville, LA. The remaining animals will be maintained, but not bred, for possible future research that is consistent with the principles set forth by the Institute of Medicine’s 2011 report on the use of chimpanzees in biomedical research. Another 208 chimpanzees owned by NIH are already retired and are housed at Chimp Haven or scheduled to move there when new construction is completed early next year.