March 15th, 2011 by Elaine Schattner, M.D. in Opinion, Research
Tags: Autoimmune Disease, B-Cell Activity, B-Lymphocyte Stimulator, Belimumab, Benlysta, BlyS, Clinical Trials, Dr. Elaine Schattner, FDA, Food and Drug Administration, Human Genome Sciences, Immunology, Lupus, Medical Lessons, Monoclonal Antibody, Rheumatology, Steroids
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Lupus, an autoimmune disease, [recently] turned up on the front page of the Wall Street Journal (WSJ). It cropped up, also, on the first page of the New York Times business section, and elsewhere. Scientific American published a nice online review just now. The reason is that the FDA has approved a new monoclonal antibody for treatment of this condition.
The drug belimumab (Benlysta), targets a molecule called BlyS (B-lymphocyte Stimulator). The newspapers uniformly emphasize that this drug marks some sort of triumph for Human Genome Sciences, a biotech company that first reported on BlyS in the journal Science way back in 1999. BlyS triggers B cells to produce antibodies that in patients with lupus tend to bind and destroy their own cells’ needed machinery, causing various joint, lung, liver, kidney, brain, blood vessel and other sometimes life-threatening problems. So if and when Benlysta works, it probably does so by blocking aberrant autoimmune B-cell activity.
The newspapers don’t give a lot of details on the drug’s effectiveness, except that it appears to help roughly one in 11 patients, and the main benefit may be that some lupus patients on Benlysta can reduce their use of steroids, which have long-term and toxic effects on many organs. The most recent major medical publication on a trial on the drug came out in the Lancet two weeks ago.
Some reported caveats are that the drug has not been adequately tested or approved for patients with severe kidney or neurological manifestations of the disease, and that its activity, marginal as it is, appears to be less in patients of African heritage based on trials completed thus far. Additional trials are in the works.
The drug is expensive, to the updated tune of $35,000 per year. According to the WSJ: “Estimates of how many Americans are affected range from 161,000 to 1.5 million.” (How’s that for a wide ballpark figure? Likely a function of how hard it is to define and establish diagnosis for this disease, which anticipates how hard it will be to measure this drug’s effects — see below.) The same WSJ piece says analysts expect the drug to become a blockbuster, with annual sales eventually topping $1 billion. Read more »
*This blog post was originally published at Medical Lessons*
March 15th, 2011 by Berci in Better Health Network, Research
Tags: Academia, Dr. Bertalan Mesko, International Centre for Guidance Studies, Research and Social Media, Research Information Network, Science Roll, Scientific Research, Social Media Tools
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I’ve recently come across a great guide about using social media in science. I cover this issue in my university course, Internet in Medicine, and I’ll definitely update my materials with these suggestions. From the Research Information Network:
This guide has been produced by the [University of Derby] International Centre for Guidance Studies (iCeGS), and aims to provide the information needed to make an informed decision about using social media and select from the vast range of tools that are available.
One of the most important things that researchers do is to find, use and disseminate information, and social media offers a range of tools which can facilitate this. The guide discusses the use of social media for research and academic purposes and will not be examining the many other uses that social media is put to across society.
*This blog post was originally published at ScienceRoll*
March 14th, 2011 by GarySchwitzer in News, Research
Tags: ABC News, Association Vs. Causation, Cause-And-Effect, CBS News, Coffee Consumption, Correct Medical Language, Duke University Medical Center, Evidence-Based Health Reporting, Gary Schwitzer, HealthDay, HealthNewsReview.org, Inaccurate Health Reporting, Journalism Credibility, Media Inaccuracy, Misinterpreted Observational Studies, Responsible Health Reporting, Risks vs. Benefits, Science and Medicine Reporting, Stroke Risk, USA Today
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Here we go again. Headlines across America blaring lines like, “Coffee may reduce stroke risk.”
It was a big study, but an observational study. Not a trial. Not an experiment. And, as we say so many times on this website that you could almost join along with the chorus, observational studies have inherent limitations that should always be mentioned in stories. They can’t prove cause and effect. They can show a strong statistical association, but they can’t prove cause and effect. So you can’t prove benefit or risk reduction. And stories should say that.
USA Today, for example, did not explain that in its story. Nor did it include any of the limitations that were included in, for example, a HealthDay story, which stated:
“The problem with this type of study is that there are too many factors unaccounted for and association does not prove causality, said Dr. Larry B. Goldstein, director of the Duke Stroke Center at Duke University Medical Center.
“Subjects were asked about their past coffee consumption in a questionnaire and then followed over time. There is no way to know if they changed their behavior,” Goldstein said.
And, he noted, there was no control for medication use or other potential but unmeasured factors.
“The study is restricted to a Scandinavian population, and it is not clear, even if there is a relationship, that it would be present in more diverse populations. I think that it can be concluded, at least in this population, that there was not an increased risk of stroke among coffee drinkers,” he said.”
When you don’t explain the limitations of observational studies — and/or when you imply that cause and effect has been established — you lose credibility with some readers. And you should. Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
March 14th, 2011 by RyanDuBosar in Better Health Network, Research
Tags: ACP Internist, American College Of Physicians, Cancer Screening, Cancer Survivors, Cancer Survivorship, CDC, Centers For Disease Control and Prevention, Dr. Arica White, Epidemiology, Living Persons Diagnosed With Cancer, Mortality And Morbidity, National Cancer Institute, National Institutes of Health, NCI, NIH, Oncology, Ryan DuBosar, U.S. Preventive Services Task Force, USPSTF
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The number of cancer survivors in the United States increased to 11.7 million in 2007, according to a report released by the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Women survive more often, and survive longer, according to the report.
There were 3 million cancer survivors in 1971 and 9.8 million in 2001. Researchers attributed longer survival to a growing aging population, early detection, improved diagnostic methods, more effective treatment and improved clinical follow-up after treatment.
The study, “Cancer Survivors in the United States, 2007,” is published today in the CDC’s Morbidity and Mortality Weekly Report.
To determine the number of survivors, the authors analyzed the number of new cases and follow-up data from NCI’s Surveillance, Epidemiology and End Results Program between 1971 and 2007. Population data from the 2006 and 2007 Census were also included. The researchers estimated the number of persons ever diagnosed with cancer (other than non-melanoma skin cancer) who were alive on Jan. 1, 2007. Read more »
*This blog post was originally published at ACP Internist*
March 13th, 2011 by Medgadget in Better Health Network, Research
Tags: Anesthesia & Analgesia, Anesthesia Medications, Anesthesiology, BIS, Bispectral Index Monitor, Closed-Loop Coadministration, General Anesthesia, General Surgery, Medgadget, Medical Technology, Pharmacology, Propofol, Remifentanil
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A team of French anesthesiologists has developed an automatic delivery system of propofol and remifentanil, which they recently tested in a multi-center trial involving 196 surgical patients. The researchers reported in Anesthesia & Analgesia that the system, which uses a Bispectral Index (BIS) monitor as a guide, performed better than manual administration:
We have developed a proportional-integral-derivative controller allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor, during induction and maintenance of general anesthesia. The controller was compared with manual target-controlled infusion.
The controller allows the automated delivery of propofol and remifentanil and maintains BIS values in predetermined boundaries during general anesthesia better than manual administration.
Abstract in Anesthesia & Analgesia: Closed-Loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index: A Randomized Multicenter Study
*This blog post was originally published at Medgadget*
