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The latest in medical research, news and commentaries, from New Haven and around the world.

Friday, July 29, 2011

DeLauro weighs in on medical device testing

U.S. Rep. Rosa L. DeLauro, D-3, this afternoon issued a letter she wrote to the commissioner of the Food and Drug Administration, Dr. Margaret Hamburg, castigating the agency for not heeding a report calling for better testing of medical devices (see previous entry). Here's the text of DeLauro's letter.

July 29, 2011

Margaret Hamburg, M.D.


U.S. Food and Drug Administration

U.S. Department of Health and Human Services

10903 New Hampshire Ave

Silver Spring, MD 20993-0002

Dear Commissioner Hamburg:

I write to underscore my continued concern about the Food and Drug Administration’s (FDA) medical device approval and post-market surveillance and the agency’s response to a new review of that process.

The number of Americans that are affected by the safety and effectiveness of medical devices, specifically those that are life-sustaining or intended to be permanent implants, continues to increase. More than three-quarters of a million Americans have a hip or knee replaced each year. And more than half of the top five elective inpatient procedures reimbursed by Medicare in FY2006 included the insertion or repair of a medical device – a list that included both a hip or knee replacement and the repair of a previous hip or knee replacement.

Earlier today, the Institute of Medicine (IOM) released its findings on the 510(k) clearance process. The FDA requested this IOM review in 2009, and yet – on the very day the requested report has been released— FDA officials appear to have already reached a conclusion about the value and implementation of the report and its recommendations.

I am astonished that the agency tasked with protecting the public health may have already determined that the IOM recommendations cannot be implemented. The committee’s recommendations warrant meaningful consideration by the agency and advocates for both consumers and industry. They are clearly intended to better protect the public health by ensuring that the medical devices available are safe, effective, and appropriately monitored after approval.

A series of Government Accountability Office (GAO) studies and findings over the years clearly illustrate that the 510(k) process does not optimally protect the public health and needs to be reformed. Just this year, the FDA announced a series of changes and proposed changes to the 510(k) process based on identified shortfalls of the current inadequate process. Yet, as the IOM review clearly reinforces, there are fundamental concerns with the framework of the process that must be addressed if we are to truly protect the public health by ensuring the safety and efficacy of medical devices. A comprehensive review of medical devices, including both pre-market and post-market surveillance, is needed.

The questions and recommendations posed to the agency by the IOM are critical if Congress is to use the opportunity to review the Medical Device User Fee and Modernization Act as an opportunity to make the updates that are desperately needed to ensure the safety and effectiveness of medical devices.

Again, I strongly urge you to consider the IOM findings and recommendations as the agency continues to evaluate the approval and post-market surveillance of medical devices.

Thank you for your attention to this critical public health issue. I look forward to our continued work to protect the health of Americans.



Member of Congress

Report calls for overhaul in testing medical devices

When your surgeon uses a new tool to perform an operation, or when you get an artificial hip to replace your old, arthritic one, you’d like to know that device was safe, wouldn’t you?

Unfortunately, because of a loophole in the law, the Food and Drug Administration doesn’t test 90 percent of new devices in 2009, according to a story by Christine Mai-Duc of the Chicago Tribune. A report by the Institute of Medicine, an arm of the National Academy of Sciences, said the system needs to be overhauled.

According to Mai-Duc, “more than 90,000 artificial hips were recalled last summer after studies showed that about one in eight recipients needed to have them replaced. The hips, manufactured by a subsidiary of Johnson & Johnson, were found to release small metallic particles into patients’ bloodstreams over time.”

The problem is that the law that gave the FDA authority to test new medical devices, passed in 1976, grandfathered in many devices that already existed and allowed an expedited process for devices that are similar to those old devices.

Independent organizations such as the ECRI Institute outside Philadelphia test devices for safety and effectiveness, but they have no authority to stop an unsafe device from going to market; they can just warn the FDA.

Read the full story and read a summary of the report here.

Medical Devices and the Public's Health

Wednesday, July 27, 2011

Court allows federal funds for embryonic stem cell research

Federal funding of embryonic stem cell research can go forward under a judge's ruling today. A lawsuit had said the Obama administration's approval of this research violated a law barring federal funding on stem cells that come from embryos.

“This court, following the D.C. Circuit’s reasoning and conclusions, must find that defendants reasonably interpreted the Dickey-Wicker Amendment to permit funding for human embryonic stem cell research because such research is not ‘research in which a human embryo or embryos are destroyed,’” U.S. District Judge Royce Lamberth wrote in his opinion.

Read the full story.

Monday, July 25, 2011

Yale study to test new drug to treat depression; it's already used for Lou Gehrig's disease

A medication used to treat Lou Gehrig’s disease shows promise as a completely new type of anti-depressant. To find out if riluzole, marketed as Rilutek, is as effective as preliminary studies show, Dr. Gerard Sanacora and the Yale Depression Research Clinic are seeking patients for a controlled study.

Read my full story.

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Friday, July 22, 2011

Yale's OB/GYN chairman named Ohio State medical school dean

Dr. Charles Lockwood, chairman of the Yale School of Medicine’s Department of Obstetrics, Gynecology and Reproductive Sciences will leave to become dean of Ohio State University’s College of Medicine, starting Sept. 1.

Lockwood’s research has focused on preventing recurrent pregnancy loss, premature births and maternal thrombophilia, a disorder that increases the risk of blood clots. He has been credited with helping to develop a test for the presence of fetal fibronectin, the first biochemical predictor of prematurity. He has served as president of the Society for Gynecologic Investigation and has written more than 200 scholarly articles and edited four textbooks. Read more here.

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Thursday, July 21, 2011

State awards $9.8 million for stem cell research; Yale, UConn big winners

Adapted from a press release from Gov. Dannel P. Malloy's office:

Twenty stem cell researchers were awarded a total of $9.8 million by the state Stem Cell Research Advisory Committee at its Tuesday grant review meeting in Farmington, Gov. Dannel P. Malloy announced today.

The grants included $500,000 to expand the Human Embryonic Stem Cell Core Facilities at the Yale Stem Cell Center. Eight Yale investigators also received funds.

Seventy-nine applications were accepted for consideration in January. The Connecticut Stem Cell Research Peer Review Committee reviewed these applications in accordance with National Institutes of Health guidelines and provided its recommendations to the advisory committee with respect to the scientific merits of each application.

“These awards signal Connecticut’s commitment to stem cell research and the life sciences sector,” Malloy said in a statement. “Connecticut continues to conduct some of the finest stem cell research in the country, and these awardees further demonstrate Connecticut’s promise as a leader in bioscience.”

This year’s awardees submitted a wide range of research projects ranging from basic stem cell research to a new disease directed category of grants which are closer to clinical application,” said Dr. Jewel Mullen, chairwoman of the advisory committee and commissioner of the state Department of Public Health. “I applaud the committee members for their commitment to this important effort.”

The following awards were made:

  • Identification of novel targets abnormally expressed in Prader-Willi Syndrome

University of Connecticut Health Center, Farmington, Kristin Martins-Taylor, Principal Investigator, $200,000

  • Regulation of mRNA stability and translation in pluripotent and differentiated hES cells

University of Connecticut Health Center, Farmington, Alissa Resch, Principal Investigator, $200,000

  • Single Cell Molecular Signatures for Hematopoietic Differentiation of Human Embryonic Stem Cells

Yale University, New Haven, Rong Fan, Principal Investigator, $195,251

  • Role of Kalirin, a risk factor for schizophrenia, in human stem cells

University of Connecticut Health Center, Farmington, Xin-Ming Ma, Principal Investigator, $200,000

  • The Role of Endocardial Cells in Human Down Syndrome-Related Heart Defects

Yale University, New Haven, Peter Amos, Principal Investigator, $200,000

  • Role of the histone variant H2A.X in the establishment of the epigenetic landscape of human embryonic stem cells

Yale University, New Haven, Pascal Drane, Principal Investigator, $200,000

  • MicroRNA mediated derivation of hemapoietic stem cells from human embryonic stem cells

Yale University, New Haven, Shangqin Guo, Principal Investigator, $200,000

  • Investigation of gene expression adaptations to alcohol in iPS cell derived neural cultures from alcohol dependent control subjects

University of Connecticut Health Center, Farmington, Jonathan Covault, Principal Investigator, $196,836

  • Identification and purification of smooth muscle cells from differentiating human embryonic stem cells for vascular tissue engineering

Yale University, New Haven, Sumati Sundaram, Principal Investigator, $200,000

  • Cytoplasmic dsRNA response in human embryonic stem cells

University of Connecticut Health Center, Farmington, Gordon Carmichael, Principal Investigator, $750,000

  • Devising a multidisciplinary approach for the treatment of articular cartilage damage using human ESC-derived chondrocytes

University of Connecticut Health Center, Farmington, Hicham Drissi, Principal Investigator, $650,000

  • Phosphorylation Dynamics of Pluripotent Stem Cells

University of Connecticut Health Center, Farmington, David Han, Principal Investigator, $570,000

  • Pulsatile tissue-engineered grafts for surgical correction of single ventricle cardiac anomalies

Yale University, New Haven, Yibing Qyang, Principal Investigator, $375,000

  • Mechanisms of RNA Surveillance in Human Embryonic Stem Cells

Yale University, New Haven, Sandra Wolin, Principal Investigator, $750,000

  • Differentiation of human iPSC and ES into functional neurons

Yale University, New Haven, Flora Vaccarino, Principal Investigator, $744,446

  • Elucidating the development and disease of cortical motor neuron using human pluripotent stem cells

UConn Health Center, Farmington, Xue Jun Li, Principal Investigator, $337,470

  • Angiogenesis of Embryonic Stem Cell Derived Hippocampus Transplants

Wesleyan University, Middletown, Laural Grabel, Principal Investigator, $750,000

  • Development of a Potential Therapy for Osteoarthritic Cartilage Damage using hESC-derived Chondrogenic Cells

Chondrogenics, Inc., Farmington, Caroline Dealy, Principal Investigator, $1,290,499

  • Continued Operation and Expansion of the Human Embryonic Stem Cell Core Facilities at the Yale Stem Cell Center

Yale University, New Haven, Haifan Lin, Principal Investigator, $500,000

  • Stem Cell Approaches for Defining Patient-specific Predisposition to Idiosyncratic Drug-induced Liver Injury

University of Connecticut, Storrs, Urs Boelsterli, Principal Investigator, $1,290,499

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Yale-New Haven emergency department warns against dangerous heat this weekend

A press release from Yale-New Haven Hospital:

Doctors at Yale-New Haven Hospital emergency department are cautioning Connecticut residents against dangerously high temperatures that are forecast over the next three days. With temperatures forecast for the mid to high 90s through early next week, coupled with high levels of humidity, the heat index could easily make normally routine outdoor activities extremely stressful, especially for those most susceptible to extreme temperatures.

"We are cautioning residents of Connecticut to be very mindful of how quickly your body can shut down in the event of heat exhaustion," said Gail D'Onofrio, YNHH chief, emergency medicine. "The eldery and small children are the most vulnerable to warm weather problems. The prolonged high heat and humidity this weekend could translate to more and more people coming to the emergency departments."

"Its important for people to try and schedule their outdoor, high-stress activities before 10 a.m., or after 3 p.m. in order to reduce the likelihood of problems," said Dr. D'Onofrio. "If you must work outside during these hours, take frequent breaks in a cool, shaded place, drink generous amounts of sports-related drinks that replace essential vitamins, nutrients and electrolytes, refrain from alcoholic beverages, and wear cool, light, loose-fitting clothing. Most heat-related problems are avoidable and occur when people don't use common sense.

During 1979-1999, the most recent years for which national data are available, 8,015 deaths in the United States were heat-related. An average of 182 deaths per year were associated with excessive heat resulting from weather conditions.

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Wednesday, July 20, 2011

Calorie counts listed on menus mostly accurate, JAMA says

If you’re watching your weight, it’s a good idea to patronize restaurants that list calorie counts on their menus, but the accuracy of those listings varies, according to a study published in today’s issue of the Journal of the American Medical Association.

The study, led by Lorien E. Urban of Tufts University, Boston, looked at the menus at 40 fast-food and sit-down restaurants in Massachusetts, Indiana and Arkansas and found that the calorie listings on menus were accurate for the most part, according to the JAMA study.

However, foods that were listed as lower in calories tended to be higher than stated, while those with high calorie listings tended to be overstated. One reason, especially in sit-down restaurants, may be poor portion control, the authors said.


“The prevalence of obesity in the United States increased from 14 percent of the population in 1976 to 34 percent in 2008,” according to the article, “Accuracy of Stated Energy Contents of Restaurant Foods.”

“Reducing energy intake by self-monitoring or selecting foods with lower energy contents is widely recommended for the prevention and treatment of obesity. However, the feasibility of reducing energy intake using these approaches depends in part on the availability of accurate information on the energy contents of different foods.”

According to the article, “From 2005 through 2006, 49 percent of U.S. residents ate out at least three meals per week and 12 percent ate out more than seven meals per week, making foods consumed away from home a major contributor to dietary energy.”

Of 269 food items tested, “108 (40 percent) had measured energy contents at least 10 kcal (calories)/portion higher than the stated energy contents and 141 (52 percent) had measured energy contents at least 10 kcal/portion lower than the stated energy contents,” according to a press release.

“Nineteen percent of foods contained greater than 100 kcal/portion more than the stated energy contents. The researchers found significantly greater variability in the discrepancy between the stated and measured energy contents in all foods from sit-down restaurants compared with all foods from quick-serve restaurants.”

For some food items, such as salads, fast-food restaurants scored better on accuracy than sit-down restaurants, according to the researchers. One item came in at 1,000 calories more than the menu stated.

So pay attention to the calorie listings on your restaurant menu, but be cautious, especially about those diet items.

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ICYMI: Blumenthal sponsors bill to improve Lyme disease reporting

U.S. Sen. Richard Blumenthal, D-Conn., this week announced he is sponsoring a bill that would improve reporting and diagnosis of Lyme disease. Read the story here and watch the videos here:

(By the way, ICYMI stands for "In case you missed it"!)

Monday, July 18, 2011

'I can't hear you!' Secondhand smoke linked to hearing loss

It may not just be loud rock music that is hurting teens’ hearing. According to a report in the July issue of Archives of Otolaryngology–Head and Neck Surgery, released today, exposure to secondhand smoke has been linked to increased risk of hearing loss in adolescents.

Dr. Anil K. Lalwani and others from New York University’s Langone Medical Center studied 1,533 youths from 12 to 19 years old, who participated in the National Health and Nutrition Examination Survey from 2005 to 2006, according to a press release.

They found that those exposed to secondhand smoke had a greater risk of low- and high-frequency hearing loss than those who were not exposed, although more than 80 percent of them did not know it, according to the release.

Secondhand smoke has already been connected to low birth weights, respiratory infections and inner-ear infections. “Secondhand smoke may also have the potential to have an impact on auditory development, leading to sensorineural hearing loss (SNHL),” the authors said in the release.

Hearing loss, in turn, can result in problems with child development. “Adolescents who are exposed to (secondhand smoke) may need to be more closely monitored for hearing loss,” the researchers said in the statement. “In addition, they should be educated about risk factors for hearing loss, such as recreational or occupational noise exposure and SHS.”

For some, sweating is more than a clammy inconvenience; it's a real problem

This week is supposed to be hot and humid. And August is coming. So sweating—or actually avoiding sweating—is on many of our minds.

But while all of us get damp when we’re out in the hot summer sun, some people have a real medical problem with excessive sweating. More than 9 million Americans, in fact, suffer from this condition, called hyperhidrosis.

Lisa Collier Cool, on her blog Healthline (an Examining Room-recommended blog), talks about how to treat this problem, which actually can be more than embarrassing and uncomfortable. She points out that excessive perspiration can lead to fungal and bacterial infections, warts and skin rashes!

Check out Lisa’s article. You’ll be surprised at some of the ways doctors treat hyperhidrosis, including zapping underarms with microwaves! I don’t think I’ll be complaining about the rivulet of sweat running down my side the next time I’m sitting in the sun!

Wednesday, July 13, 2011

Invasive diagnostic procedure for children with cystic fibrosis does not improve outcomes

Compared to a standard diagnostic procedure, infants with cystic fibrosis who received treatment based on a diagnostic procedure involving obtaining and culturing fluid samples from the lungs did not have a lower prevalence of lung-damaging infection or structural lung injury at 5 years of age, according to a study in the July 13 issue of the Journal of the American Medical Association. Read the full release.

Tuesday, July 12, 2011

My journey in the health care system: An intro

I recently had to have minor surgery. I went to the Shoreline Medical Center in Guilford, convenient to where I live in Branford.

Unfortunately, when I woke up from anesthesia, there was a complication, so the doctor sent me to the emergency department.

The ambulance was called, and two wonderful EMTs lifted me onto a gurney, put me in the ambulance and drove me … downstairs.

Even though I was going to another part of the same building, I had to go by ambulance.

Rob Hutchison, a spokesman for Yale-New Haven Hospital (Shoreline Medical Center is a satellite), said it’s a problem of staffing.

“We don’t have the personnel” in Guilford to transport patients to the ED, he said, so private ambulance services are hired. “We have transport teams and co-teams in New Haven that are dedicated to transporting patients from one area of the hospital to another. We just don’t have those teams out at Shoreline.”

It’s like if you were walking by a hospital and had a heart attack. They wouldn’t come out of the hospital with a gurney and wheel you in. An ambulance would be called.

It’s all part of the complex American health care system in a specialized, litigious society.

(By the way, after a second ambulance trip to the Yale-New Haven ED, with “lights and sirens,” I was pronounced OK and sent home.)

Here’s another story from the American health care system:

At Yale Medical School, in New Haven and at the West Campus, scientists like Dr. Joseph “Yossi” Schlessinger are examining the genes that control our cells and sometimes make them go out of control. This is the world’s best hope for defeating the scourge of cancer. Companies are investing money in this work, hoping to bring the new treatments to market.

This highly technical, cutting-edge work could some day result in a prescription that will shrink a tumor.

This blog will focus on medicine and health care, from cutting-edge research to the daily challenges of caregiving. Through our reporting, information from New Haven’s two research hospitals and news from around the world, this will be the place to keep up with the ever-changing, complex, fascinating world of medical care.

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