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February 8, 2015- By Steven E. Greer, MD
Robert Califf, MD is a cardiologist at Duke University who led the “Translational Medicine Institute”. Read more »
February 16, 2011
Produced and interviewed by Steven Greer, MD
In Part 1 of our interview with Margaret Hamburg, MD, Read more »
FDA, Policy | apples49 | 
February 6, 2015 12:53 pm | 
Comments (1)
Update January 13, 2015- Yet another study was published highlighting the risks of daily aspirin. Read more »
Cardiac surgery, Cardiology, FDA, Internal medicine, JAMA, Late Breaking Data, Neurology, Neurosurgery, Policy | apples49 | February 5, 2015 12:44 am | Comments (0)
February 2, 2015- By Steven E. Greer, MD
People have asked me my opinion of the Republican field for 2016 and I have told them that Dr. Rand Paul seems pretty electable now, but my experience tells me that he will let rip a great gaffe soon exposing his Read more »
FDA, Infectious Disease, Op-Ed, Pediatrics, Policy, Preventive Medicine | apples49 | February 2, 2015 10:02 pm | Comments (1)
January 18, 2015- By Steven E. Greer, MD
On July 20th, 2011, the FDA convened an advisory committee to help it determine whether to approve the first ever TAVR device called the Sapien, made by Edwards Lifesciences. I was a public speaker raising the Read more »
Cardiac surgery, Cardiology/interventional, CMS Medicare Medicaid, Columbia University, FDA, JAMA, Medical Devices, Neurology, Op-Ed, Policy, Univ Pennsylvania | apples49 | January 25, 2015 6:58 pm | Comments (0)
(best viewed in full-screen)
Update: June 11, 2012
The FDA briefing documents for the June 13 advisory committee to review the PARTNER-A label expansion indicate that the trial was biased by the fact that 7% of the patients randomized to open heart surgery never received surgery. Read more »
Cardiac surgery, Cardiology/interventional, FDA, Medical Devices, New York Presbyterian, Policy | apples49 | January 18, 2015 5:00 pm | Comments (0)
July 2, 2014- Interviewed by Steven E. Greer, MD
The New England Journal of Medicine recently published the early clinical data on the “bionic pancreas” being developed by engineers at Boston University and medical doctors at Massachusetts General hospital. We interviewed Ed Damiano, PhD, the lead biomedical engineer, and Steven Russell, MD PhD, the lead endocrinologist. In Part 1, they review the clinical data.
The research was funded by the NIH and not a medical device or drug company. The researchers selected the components based on merit. They chose the Dexcom G4 Platinum continuous glucose sensor and a Tandem Diabetes t:slim pump, and used software that ran on a standard Apple iPhone 4S.
In Part 2, the team discusses the details of the pivotal study, that could be concluded by 2016, allowing for an FDA approval by 2017. Industry partners yet to be determined would be involved. However, the final marketed product will not require any particular smartphone to be used by the patient.
Boston University, Diabetes, Endocrinology, FDA, Harvard affiliates, Internal medicine, Medical Devices, NEJM, NIH, Nutrition, Pediatrics, Preventive Medicine, Wound Care | apples49 | January 16, 2015 10:36 pm | Comments (0)
November 3, 2014- Interviewed by Steven E. Greer, MD
Inhaled insulin will make a comeback when Read more »
Diabetes, FDA, Medical Devices, Pediatrics, Univ Miami | apples49 | January 15, 2015 2:07 pm | Comments (0)
February 7, 2014- By Steven E. Greer, MD
The Patient Centered Outcome Research Institute (PCORI) was created by the PPACA “ObamaCare” law in 2010. Well-funded with approximately $3 Billion over ten years, the mission was, among other things, supposed to be to conduct comparative effectiveness research (CER) that would determine whether costly therapies are any better than cheaper alternatives.
The rise of CER has been one of the most feared developments by the drug and device industries. To avoid powerful lobbying efforts that could have resulted in de-funding and the death of PCORI before it got started, the institute steered away from even hinting at conducting CER. Now, almost four years later, PCORI is finally funding CER research. However, critics, such as former White House Director of Office of Management and Budget, Peter Orzag, say that the money spent by PCORI on CER is still not enough.
Meanwhile, a leading doctor in charge of PCORI research strategies, Harlan Krumholz, MD, Read more »
AHRQ, Biostatistics, CMS Medicare Medicaid, FDA, HHS, Op-Ed, Policy, Yale | apples49 | January 14, 2015 8:47 am | Comments (1)
October 31, 2014- Interviewed by Steven E. Greer, MD
Type 1 diabetes patients using continuous glucose monitors have been creating their own software, or hacking, to allow their CGM to send the data to a more manageable smartphone. This allows parents and other parties to monitor the health of loved ones, as well as makes the data more easily available to see on Read more »
Diabetes, Endocrinology, FDA, Internal medicine, Medical Devices, Pediatrics, Univ Miami | apples49 | December 23, 2014 11:42 am | Comments (7)
