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Evidence lacking about breast implant safety

By Guest PostFebruary 14, 2016Healthamy earley, breast implant safety, esther avendano, ethan balk, evidence lacking, fda, gowri raman

A review of more than 30 studies seeking answers about silicone gel breast implant safety finds that the studies don’t provide definitive evidence. The new paper may help inspire improved analyses of existing data as well as a new registry to provide better data.

PROVIDENCE, R.I. [Brown University] — Uncertainty about safety has swirled around silicone gel breast implants for years. They were suspended from the market in 1992 and then allowed again in 2006. Throughout, despite many studies, definitive evidence about whether they are linked to health problems ranging from cancer to connective tissue disorders to depression has remained elusive. (more…)

New Robotic Instruments to Provide Real-Time Data on Gulf of Maine Red Tide

By Guest PostJune 2, 2013Environmentalexandrium bloom season, alexandrium fundyense, amnesic shellfish poisoning, asp, chris scholin, coast of portsmouth, coastal waters, current status, dennis mcgillicuddy, diatom, don anderson, environmental sample processors, epa, espchris, espdon, esps, fda, greg doucette, gulf of maine, habs, harmful algal blooms, kohl kanwit, MIT, molecular biology labs, neracoos, new england, new robotic instruments, nh, noaa, paralytic shellfish poisoning, pseudo nitzschia, psp, real time data, red tide, sea grant program, single celled algae, toxins, WHO

Deployment could lead transformation of toxic HAB monitoring

A new robotic sensor deployed by Woods Hole Oceanographic Institution (WHOI) in Gulf of Maine coastal waters may transform the way red tides or harmful algal blooms (HABs) are monitored and managed in New England. The instrument was launched at the end of last month, and a second such system will be deployed later this spring.

The results will add critical data to weekly real-time forecasts of New England red tide this year distributed to more than 150 coastal resource and fisheries managers in six states as well as federal agencies such as NOAA, the FDA and the EPA. Researchers also plan to add data from the sensor to regular updates provided on the “Current Status” page of the Northeast PSP website. (more…)

Research Enables Fishermen to Harvest Lucrative Shellfish on Georges Bank

By Guest PostMay 13, 2013Environment, Sciencealexandrium cells, alexandrium fundyense, bloom dynamics, cape cod, chrissy petitpas, cysts, darcie couture, dave townsend, dave wallace, deana erdner, delaware, dennis mcgillicuddy, dna evidence, don anderson, ecohab, fda, georges bank, gomtox project, gulf of maine, harmful algal blooms, marine biotoxins, massachusetts, microscope, mindy richlen, nccos, new england shellfisheries, new jersey, noaa, nova scotia, ocean quahogs, offshore population, paralytic shellfish poisoning, phytoplankton, psp, red tides, rhode island, robert magnien, sea watcher, sea water samples, smast, stacey degrasse, surf clams, toxicity, toxicity in shellfish, united states, university of maine, university of massachusetts, university of texas, whoi

Combined research efforts by scientists involved in the Gulf of Maine Toxicity (GOMTOX) project, funded by NOAA’s Ecology and Oceanography of Harmful Algal Blooms (ECOHAB) program, and administered by the National Centers for Coastal Ocean Science (NCCOS), have led to enhanced understanding of toxic algal blooms on Georges Bank. This new information, coupled with an at-sea and dockside testing protocol developed through collaboration between GOMTOX and U.S. Food and Drug Administration (FDA) investigators, has allowed fishermen to harvest ocean quahogs and surf clams in these offshore waters for the first time in more than two decades.

The shellfish industry estimates the Georges Bank fishery can produce up to 1 million bushels of surf clams and ocean quahogs a year, valued $10 – 15 million annually. “There is a billion dollars’ worth of shellfish product on Georges Bank that is property of the United States but that can’t be harvested because of the threat of toxicity, and 99.9% of the time, it is good wholesome product,” says Dave Wallace of North Atlantic Clam Association and a GOMTOX participant. “In an unusual and unique partnership, we worked with GOMTOX scientists, the FDA, and the states of Massachusetts, Rhode Island, New Jersey and Delaware and now that huge resource can go into commerce, which helps the entire country.” (more…)

Common Food Preservative May Slow, Even Stop Tumor Growth

By Guest PostOctober 30, 2012Healthanti tumor, antibacterial agent, antimicrobial, bacteria, bad cell, calcium, cancer fighting, cancer medicine, cancerous tumor, cell carcinoma, cell death, cell head, cell membrane, chac1, fda, food preservative, good cell, human consumption, key regulator, michigan, neck cancer, nisin, nisin treatment, oral cancer, potential, properties, protein, squamous, therapy, tumor, university, yvonne kapila

ANN ARBOR — Nisin, a common food preservative, may slow or stop squamous cell head and neck cancers, a University of Michigan study found.

What makes this particularly good news is that the Food and Drug Administration and the World Health Organization approved nisin as safe for human consumption decades ago, says Yvonne Kapila, the study’s principal investigator and professor at the University of Michigan School of Dentistry. (more…)

Doctors Wary of Studies Funded by Pharmaceutical Industry, Study Shows

By Guest PostOctober 8, 2012General, Healthaaron kesselheim, arizona, biomedical research, christopher robertson, clinical trial, doctor, fda, federal budget, good drug, good science, high quality, method, methodological rigor, nih, pharmaceutical company, physician, quality, research, trust, university

Physicians are about half as willing to prescribe drugs tested in pharmaceutical-industry funded trials than those in NIH-funded studies, a new study finds.

Physicians are less likely to trust the results of clinical trials when they know those trials were funded by pharmaceutical companies, regardless of the quality of the research, a recent study in the New England Journal of Medicine shows.

The study, led by Dr. Aaron Kesselheim of the Harvard Medical School in Boston and co-authored by University of Arizona associate professor of law Christopher Robertson, evaluated physicians’ confidence in the results of drug trials conducted with a high, medium or low level of methodological rigor. It then looked at how their confidence in those same results changed when a trial’s funding source was revealed as either the National Institutes of Health or a company in the pharmaceutical industry, versus when no funding source was disclosed. (more…)

Groundbreaking Research Paves Way for HIV Prevention Drug Approval

By Guest PostJuly 15, 2012Healthafrica, antiretroviral drugs, connie celum, fda, hiv, hiv infection, hiv prevention, hiv treatment, hiv vaccine, hiv-positive, jared baeten, Kenya, kenya puppets, nelly mugo, partners prep, placebo, prevention drug, tenofovir, thika, truvada, uganda

For the first time, the U.S. Food and Drug Administration is considering approving a drug that helps prevent someone from acquiring HIV. It’s called Truvada, and has been approved for use since 2004 to treat infected people.

Now it has been shown to protect healthy people who are exposed to HIV. The UW’s International Clinical Research Center, within the Department of Global Health, played a key role in examining the drug’s effectiveness for HIV prevention.

Researchers Connie Celum and Jared Baeten led a study, published this week in the New England Journal of Medicine, of pre-exposure prophylaxis among heterosexual couples in Kenya and Uganda. One partner had HIV (and was not yet eligible for HIV treatment) and the other partner did not have HIV. Uninfected partners were given either Truvada or Tenofovir (both antiretroviral drugs) or a placebo. (more…)

Rebuilding a Heart, Saving a Life

By Guest PostApril 19, 2012Healthamerican patient, angela irizarry, birthday, blood vessel, blue babies, bone marrow, bridgeport, cardiac surgeon, christopher breuer, circulatory system, claudia irizarry, congenital heart defect, connecticut, fda, function, gary kopf, hypoplastic, infection, inflammatory response, left heart syndrome, mark saltzman, natural cell, operation, organ, oxygenated blood, polymer, synthetic grafts, synthetic nature, tissue engineered, toshi shinoka, united states, yale doctor, young girl

A young girl in Bridgeport, Connecticut, born with one of the most serious, life-threatening congenital heart defects known, is on her way to living a normal life thanks to Yale doctors who developed and performed the first operation of its kind in the United States.

Angela Irizarry was the first American patient to receive a tissue-engineered blood vessel made of her own natural cells. (more…)

Optimizing Eyesight: R&D Collaboration Focuses on New System for Measuring and Improving Human Vision

By Guest PostJuly 14, 2011Scienceatlanta based company, chief technology officer, computer controlled lens fabrication technology, david roberts, digitalvision, disruptive technology, eye chart, fda, food and drug administration, georgia research alliance, georgia tech research institute, gra, gtri, humphrey system, humphrey vision analyzer, jose garcia, keith thompson, leanne west, lee herron, ophthalmologists, optical system, optometrists, phoropter, vision, visionoptimizer

With research and development assistance from the Georgia Tech Research Institute (GTRI) and seed funding from the Georgia Research Alliance (GRA), an Atlanta-based company is developing what it hopes will be the next-generation instrument for optimizing eyesight for the hundreds of millions of people who wear glasses or contacts – or who are candidates for corrective surgery.

To be used by optometrists and ophthalmologists, the instrument – known as the VisionOptimizer – is intended to provide more accurate vision measurements, along with a more patient-friendly and engaging vision test. The company believes its system will facilitate the custom-manufacturing of spectacles and contact lenses that provide better eyesight and improved wearing comfort compared to conventional prescriptions. (more…)

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