Biosimilars: Much Ado About Nothing, Part 2

By Brittany | March 30, 2012 | Category: Pharmacotherapy
Biosimilars: Much Ado About Nothing, Part 2
By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC
Middletown, NJ

Let’s not forget the reason for the FDA’s existence. The agency was formed to assure the purity of food and drug products (1906). They went on to regulate drug safety (1937) and then drug efficacy (1962). The efficacy regulations were in response to what was truly a safety issue—the use of thalidomide in pregnant women. The FDA is the institutionalized embodiment of the Hippocratic Oath to “first do no harm.” They are cautious because that is their job. Safety does come first. You can always replace a drug that’s not working, but you cannot replace a patient who has died. Suggesting biosimilars could be approved without clinical data is not a very cautious position to take and leads one to wonder about the possible motivation of the FDA in taking that position.

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Biosimilars: Much Ado About Nothing, Part 1

By Brittany | March 23, 2012 | Category: Pharmacotherapy
Biosimilars: Much Ado About Nothing, Part 1
By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC
Middletown, NJ

The eagerly awaited draft guidance on biosimilars* was finally issued by the FDA on February 9, 2012. It was drafted in the spirit of enlightened health care reform, with a view towards fiscal responsibility and. . . to annoy the nemesis of all that is good in health care, “Greedy Big Pharma.”

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Are Your Vitamin Supplements Curing You or Killing You?

Are Your Vitamin Supplements Curing You or Killing You?
By Patricia J. Sulak, MD
Dudley P. Baker Endowed Professor, Research and Education in Obstetrics and Gynecology, and Medical Director, Division of Research Department, Obstetrics and Gynecology, Texas A&M College of Medicine, Scott & White Clinic/Memorial Hospital, Temple, TX

Are any readers of this blog NOT on a vitamin, mineral, or other type of supplement such as glucosamine/chondroitin or omega fatty acids? Among the elderly, use of supplements has increased dramatically over the past two decades. An estimated $20 billion is spent annually on these products. While originally thought to be helpful and not harmful, high doses of certain dietary supplements have been shown to have no benefit and sometimes increase health risks.

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Patients Need Physicians, Not Technocrats: Part 2

By Brittany | March 09, 2012 | Category: Practice management in ObGyn
Patients Need Physicians, Not Technocrats: Part 2
By Mary Jane Minkin, MD
Clinical Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine; and Obstetrics, Gynecology and Menopause Physician, PC, New Haven, CT.

I have never minded spending any amount of time when a patient needed me or to do anything that bettered patient care. I am sure that none of you have ever minded being awakened at night by a patient who was ill and needed attention: hey, we’re ObGyns. I would not object to spending any amount of time on the conversion to an electronic medical records (EMR) system if I thought it would really benefit patient care. But I am convinced that it does not.

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Patients Need Physicians, Not Technocrats: Part 1

By Brittany | March 01, 2012 | Category: Practice management in ObGyn
Patients Need Physicians, Not Technocrats: Part 1
By Mary Jane Minkin, MD
Clinical Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine; and Obstetrics, Gynecology and Menopause Physician, PC, New Haven, CT.

I knew that I would have problems with our new electronic medical record (EMR) system on the first day of training. The initial training was conducted by a programmatic, not medically trained “yuppette” from the IT Department, who extolled to a 60-year-old Mac user the wonders of the EMR system: you should right click here, single click there (oops, don’t double click!), and then enter some esoteric bit of medical history.

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