Category: Harvard affiliates

How did a small academic lab succeed where big medical device companies failed?

July 5, 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 3, we asked them how their small lab funded only by the NIH succeeded at developing the bionic pancreas when large companies, such as Roche, Medtronic, Abbott, and JNJ all failed.

 

The bionic pancreas data

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.

 

Has the ACA law begun to reduce the uninsured, and at what cost?

July 27, 2014- Interviewed by Steven E. Greer, MD

Ben Sommers, MD PhD, from the Harvard School of Public Health has a new article in the NEJM that attempts to quantify the total number of uninsured people in the country, and map it out temporally to show whether the newly implemented Obamacare law is working as intended.

Preventing HIV infection

July 28, 2014- Interviewed by Steven E. Greer, MD

Rajesh Tim Gandhi, MD of the Massachusetts General Hospital discusses the NEJM review paper he co-wrote with his sister, Monica Gandhi, MD, discussing the current state of therapy for HIV-infected patients. He then addresses the ways to prevent HIV infection either after or before exposure.

Single-pill combo regimens for HIV

July 28, 2014- Interviewed by Steven E. Greer, MD

Rajesh Tim Gandhi, MD of the Massachusetts General Hospital discusses the NEJM review paper he co-wrote with his sister, Monica Gandhi, MD, discussing the current state of therapy for HIV-infected patients. He then addresses limitations of the existing drugs and how future medications can improve.

100 HIV researchers killed as Russian missile takes down jetliner MH17

19jet4-superJumboJuly 19, 2014- By Steven E. Greer, MD

I emailed earlier today a leading HIV researcher, Monica Gandhi MD, MPH from Read more »

Atul Gawande’s surgical checklist fails in real world study

March 15, 2014- By Steven E. Greer, MD

In 2009, Atul Gawande, MD, MPH and his large international team published in the New England Journal of Medicine (NEJM) an observational study that showed a significant reduction of death and “complications” after non-cardiac surgery. The World Health Organization (WHO) created the checklist used in the NEJM paper. After this non-randomized, non-controlled, observational study was published, entire nations adopted the surgical checklist system.

Now, in 2014, a population study drawing from Ontario surgical patient data, published in the NEJM, showed no significant benefit from the widespread adoption of the same WHO surgical safety checklist that Dr. Gawande popularized. This study was also observational, but it was stronger than the 2009 Gawande study in that it included the entire population within a region.

What went wrong? Read more »

NEJM letter casts doubt on original Gawande checklist paper

June 11, 2014- By Steven E. Greer, MD

When the recent Canadian studied published in the NEJM failed to show any benefit from the WHO surgical checklist championed by Atul Gawande, The Healthcare Channel pointed out that the original Gawande paper was possibly the problem. It was designed poorly, and collected data from non-U.S. countries with little oversight.

Now, in the current online NEJM, letters to the editor are coming in. One writer echoes our concerns about the original Gawande paper. Read more »

FDA official, William Maisel, pleads guilty to crime, keeps job

April 24, 2013 By Steven E. Greer, MD

In July of 2012, the New York Times reported on an FDA scandal of the agency spying on internal whistleblowers, by hacking into their work and personal emails. The FDA employees who were the victims filed lawsuits, and The Healthcare Channel interviewed the plaintiff’s lawyer, Stephen Kohn.

One month later, a senior FDA official who was named as a defendant in the lawsuit above, William Maisel, MD, PhD (a former Harvard cardiologist), was a arrested in a Maryland suburb on five counts relating to soliciting a prostitute. The story was not reported well in the national press and the fate of Dr. Maisel at the FDA had been unknown. Read more »

The Medicaid Roundtable

Part 1: Medicaid primer

Part 2: State spending on Medicaid

Part 3: Impact of Medicaid expansion to hospitals, states, and mortality

Part 4: Efforts by individual states to reform Medicaid away from fee-for-service

Part 5: Will other states adopt bundled payment plans for Medicaid and stop fee-for-service?

Part 6: What does the ACA ObamaCare law mean for Medicaid?

Part 7: Will individual state reforms of Medicaid lead to a more global reform of American healthcare?

Part 8: Impact the healthcare companies

Part 9: The outcome of the election and Medicaid/ACA law

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