Category Archives: FDA

Hormone replacement therapy is safe and effective after all

November 14, 2017- Interviewed by Steven E. Greer, MD We interviewed JoAnn Manson, MD, DrPH about her JAMA paper that followed the cohorts in

Posted in - JAMA, Cardiology, Diabetes and endocrinology, FDA, Geriatrics, Harvard, Obstetrics and Gynecology, Oncology, Orthopedic surgery, Primary care medicine | Leave a comment

Interview with the CEO of Neovasc, Alexei Marko

Posted in - Medical Devices, Cardiology, FDA | Leave a comment

How the FDA regulates compounding pharmacies

April 5, 2015- Interviewed by Steven E. Greer, MD Few people knew what a compounding pharmacy was until a meningitis outbreak traced to the

Posted in - Policy, FDA | 1 Comment

The FDA pathway for biosimilar drug approvals

March 26, 2015- Interviewed by Steven E. Greer,

Posted in - Biotech, - Generics, FDA | Leave a comment

Is Vitamin-D deficiency overdiagnosed?

November 8, 2016- Interviewed by Steven E. Greer, MD We interviewed JoAnn E. Manson, MD, DrPH, Chief, Division of Preventive Medicine,  Brigham

Posted in - NEJM, - Policy, CDC, Diabetes and endocrinology, FDA, Harvard, Primary care medicine | Leave a comment

An emerging safety problem for TAVR patients

March 16, 2017- produced and interviewed by Steven E. Greer, MD We interviewed William O’Neill, MD, one of the first to implant a Transcatheter Aortic Valve Replacement (TAVR) valve. The products have been approved by the FDA for several years, … Continue reading

Posted in - Medical Devices, Cardiac surgery, Cardiology, FDA | Leave a comment

Early stoppage of clinical trials

April 16, 2009– Dr. Guyatt explained in a previous post why early stoppage of clinical trials results

Posted in Cardiac surgery, FDA, McMaster University | Leave a comment

The 23andMe home genetics test kit controversy

December 19, 2013- Interviewed by Steven E. Greer,  MD

Posted in Columbia, FDA, Genetics, NIH, Oncology, Psychology Psychiatry | Leave a comment

CDER Director Janet Woodcock on new drug safety strategies

November 16, 2010- by Steven E. Greer, MD We interviewed Dr. Janet Woodcock, long-time Director of CDER, the FDA center responsible

Posted in - Pharma, FDA | Leave a comment

The super shady methods of pricing generic drugs in America: case study- Sildenafil

May 15, 2016- by Steven E. Greer, MD The last I read, Teva and Mylan were not supposed to launch their approved generic of Viagra (sildenafil)

Posted in - Generics, - Opinion, - Pharma, CMS, Congress, FDA | Leave a comment

President-elect Trump adopts plan by The Healthcare Channel to bring back drug manufacturing jobs

Update January 11, 2017- By Steven E Greer, MD Last November, I sent my idea, below, directly to the Commissioner of the FDA, Robert Califf. I also sent it

Posted in - Opinion, - Pharma, - Policy, CMS, Congress, FDA | Leave a comment

CBS News Promotes More Pro-Coffee Junk Science

July 11, 2017- by Steven E. Greer, MD How does one become a successful TV medical doctor pundit? First, you have to leave your medical ethics

Posted in - Opinion, Cardiology, CDC, Congress, Cornell, FDA, Primary care medicine, Psychology Psychiatry | Leave a comment

The Lotus TAVR valve recall

March 16, 2017- produced and interviewed by Steven E. Greer, MD We interviewed William O’Neill, MD, one of the first to implant a Transcatheter Aortic Valve Replacement

Posted in - Medical Devices, Cardiac surgery, Cardiology, FDA | Leave a comment

The Biggest Healthcare Stories of 2016

December 26, 2016- by Steven E. Greer, MD for The Healthcare Channel Policy changes dominated the 2016 year in healthcare news. There were few important new drug

Posted in - Biotech, - Generics, - Medical Devices, - Opinion, - Pharma, - Policy, - The Weekly Summary, CMS, FDA | Leave a comment

Google wants your DNA now (Not just with 23andMe)

Opinion December 17, 2013- By Steven E. Greer, MD The Wall Street Journal published an article explaining how the pharmaceutical industry data mines

Posted in - Opinion, - Policy, FDA, Genetics | Leave a comment

Robert De Niro gives credibility to vaccine truthers

Update March 27, 2016- Less than 24-hours after our story, this film has been pulled from the lineup. It was our story that got the heads of

Posted in - Pharma, - Reviews, books, devices, CDC, FDA, NIH, Pediatrics, Primary care medicine | Leave a comment

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

Update February 7, 2016- Key senators, including Bernie Sanders, are now threatening to filibuster

Posted in - Opinion, - Policy, Cardiology, FDA, NIH | Leave a comment

Are the new PCSK9 cholesterol lowering drugs worth the high cost?

December 16, 2015- Interviewed by Steven E. Greer, MD

Posted in - Biotech, - NEJM, - Opinion, - Pharma, - Policy, Cardiology, CMS, FDA | Leave a comment

Martin Shkreli, CEO of Turing Pharmaceuticals, could be the Bernie Madoff of the drug industry

September 22, 2015- by Steven E. Greer, MD Making national news today was Martin Shkreli, the baby-faced, greasy-haired, disheveled-looking

Posted in - Biotech, - Pharma, Congress, FDA | Leave a comment

Stephen Colbert mocks the new “female viagra” flibanserin

September 20, 2015- Well, the real CBS news did an atrocious job covering this story, so the fake newsman

Posted in - Opinion, FDA, Obstetrics and Gynecology, Psychology Psychiatry, Urology | Leave a comment