Category: NIH

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.

 

Man who oversaw one of the biggest academic research frauds in medical history is poised to become the next FDA Commissioner

Robert CaliffFebruary 8, 2015- By Steven E. Greer, MD

Robert Califf, MD is a cardiologist at Duke University who led the “Translational Medicine Institute”. Read more »

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.

 

Quarantining Ebola caregivers arriving from Africa is the right thing to do

Update November 6, 2014- Despite more than 80% of responders in various polls feeling that the Obama administration’s handling of Ebola was wrong, on Face the Nation, President Obama said this (see video).
Read more »

Vincent Young, MD PhD: The NIH Human Microbiome Project

Produced and interviewed by Steven E. Greer, MD

Infectious disease specialist Dr. Vincent Young from the University of Michigan discusses the NIH project to catalog the bacterium that normally live within the human body and assist in normal physiology.

Jay Skyler discusses the recent bionic pancreas data

June 22, 2014- By Steven E. Greer, MD

This week, the mainstream press reported on the “bionic pancreas” data published in the NEJM by a group from Boston University and Harvard. Last September, The Healthcare Channel interview Jay Skyler, MD, PhD, an NIH researcher and Type-1 diabetes expert, about this very same program. At the 5:00 mark of the video, Dr. Skyler discusses the bionic pancreas.

Gordon Guyatt, MD: Update on the problem of clinical trials being stopped early to inflate efficacy of drugs

Gordon Guyatt, MD, epidemiologist, internist, and biostatistician at McMaster University updates us on the progress being made against the problem of clinical trials being stopped early to inflate efficacy of drugs. Since our first coverage of the topic two years ago, the FDA, the Cochrane group, and other agencies have implemented changes in policy.  Dr. Guyatt discusses the Crestor JUPITER trial as an example of a trial that was stopped early and inflated efficacy.

 

Updates on new therapies for Type 1 diabetes

Interviewed by Steven E. Greer, MD

Jay Skyler, MD, PhD, Deputy Director of the Diabetes Research Institute at The University of Miami, and Chairman of the NIH’s TrialNet, discusses the latest clinical research on Type 1 diabetes. He discusses in-depth the ongoing efforts to create the “artificial pancreas” closed loop system.

 

 

Disclosure: Jay Skyler, MD, has disclosed the following relevant financial relationships:
Served as an advisor/consultant for: Sanofi-Aventis; Gilead Sciences, Inc., Merck & Co., Inc.; Takeda Pharmaceuticals North America, Inc.; Cebix, Incorporated; Lilly USA, LLC, Dr. Skyler is an unpaid member of the scientific advisory board of MannKind

Received grants for clinical research from: Halozyme Therapeutics; Intuity Medical, Inc.; Mesoblast Limited; Osiris Therapeutics, Inc.

Owns stocks, stock options, or bonds from: Dexcom, Inc.; Amylin Pharmaceuticals, Inc.; Moerae Matrix; Opko Health Inc.; Patton Medical Devices, LP

 

Will IBM’s Watson replace doctors, then be hijacked by industry bias?

mag-article-largeFebruary 21, 2013 By Steven E. Greer, MD

The Atlantic article on IBM’s Watson is triggering rebuttals on medical blogs asserting that human doctors cannot be replaced. I hate to break it to internists, but Watson and other computer algorithms will indeed make most functions of the internist obsolete. A nurse with a Watson-type resource can deliver the same care (if not better) as what your internist provides now.

The real question is whether the industry biased “guidelines” for “gold standard” care will become integrated into Watson’s list of recommended therapies and medical diagnostic tests to be ordered. If they are, then Watson will be a menace to society.

Fortunately, we still have wise doctors who know how to ignore the harmful garbage in the medical society guidelines and industry-paid journals, or know how to be prudently cautious “late adopters” of new drugs. The insight that the best doctors have, which cannot be duplicated by computers, is based on the ability of one human brain to decipher the human nature of other brains. They realize, for example, that clinical trials are woefully underpowered to detect real-life adverse events, and are too often based on overseas clinical data of dubious reliability. These wise doctors know that money trumps science and influences journal editors and medical societies, which literally would not exist without drug and device industry funding.

The impressive “medical society guidelines” that seem so official and irrefutable, drafted by doctors who or are often highly paid by the drug and device industries, have caused over history tremendous harm to the population. To list just a few examples:

  • Millions of people currently take muscle fatiguing, dementia causing, cholesterol-lowering statin drugs, but they actually do not need them (because they have not had a heart attack and there is no data to support “primary prevention” use)
  • Millions of people are taking daily aspirin and, as a result, thousands of them are suffering strokes and GI bleeds caused by the thin blood. Once again, the data do not support that the patients have received a beneficial reduced risk of a heart attack from the aspirin (in patients who have not had a hear attack, or “primary prevention”)
  • Millions of people are on antidepressants despite the fact that the drugs cause harm, in the form of suicide, and have very questionable efficacy at reducing suicide.
  • Millions of patients receive cardiology related procedures, such as coronary stents, and have suffered unnecessary radiation and vascular complications, while not benefiting from the procedures.
  • Millions of patients have received knee arthroscopy, despite the procedures being of no use.
  • Millions of people receive cancer-causing CT scans who do not need them.
  • Millions of people were placed on the low-fat diet, despite the fact that it was ineffective and harmful.
  • ….and so on, and so on

It is quite likely that Watson-type medical algorithm programs will be hijacked by the healthcare industry junk science and guidelines, and therefore be “junk in, junk out”. The best way to prevent this is to eliminate fee-for-service financial incentives.

 

60 Minutes exposes Duke medical center for failing to expose cancer researcher’s fruadulent work

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