Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, 16 March 2022

Crohn’s Disease: A Curable Disease Held Hostage?| Chapter 20 | Issues and Developments in Medicine and Medical Research Vol.11

The present focus of Crohn's disease treatment has been sclerosed for a long time. In 40% of cases, biologics cause brief remissions. They have yet to achieve long-term remissions. The FDA's insistence on clinical validation through comparative, placebo-controlled, double-blinded trials has created a barrier to the acceptance of alternative medicines as standard of care. By doing so, the FDA has effectively handed over control of the Crohn's disease therapeutic debate to those who can profit from such research.

Author(s) Details:

Gilles R. G. Monif.
Infectious Diseases, Incorporated, 17121 Lakewood Drive, Bellevue NE, 68123-3954, USA.

Please see the link here: https://stm.bookpi.org/IDMMR-V11/article/view/6092

Friday, 14 May 2021

E-Cigarette Tipping Points Revisited, with Historical Perspective: A Mini Review | Chapter 11 | Challenges in Disease and Health Research Vol. 7

 In August of 2017, I wrote about the topic of e-cigarette tipping points for the first time. 1st In this article, I return to this topic [2] to see what, if anything, has changed since then. E-cigarettes claimed to have reached two big tipping points when the 2017 paper was published. The first was because of their widespread use, with an estimated 10% of the adult population in the United States using or having used e-cigarette products [3]. The second had to do with public perceptions of protection and benefit to public health [4]. I noted at the time that the American Food and Drug Administration (FDA) was projecting a harshly negative view of e-cigarette safety, only grudgingly recognizing that there could be personal and public health benefits. Since then, the FDA and the broader American tobacco control culture have become so hostile to e-cigarettes that each product is now facing forced withdrawal from the market unless the manufacturer can apply a "viable" Pre-Market Tobacco Application as soon as possible (PMTA). Because of the expense of the studies needed to prepare the application, as previously mentioned [1], such an application is physically impossible for 99 percent or more of e-cigarette manufacturers. This essay will discuss how and why the majority of the e-cigarette industry in the United States is on its way out, and what, if anything, can be done about it.

Author (s) Details

Joel L. Nitzkin
R Street Institute, Washington DC, c/o JLN, MD Associates, LLC, New Orleans, Louisiana, USA.

View Book :- https://stm.bookpi.org/CDHR-V7/article/view/925

Thursday, 13 May 2021

E-Cigarette Tipping Points Revisited, with Historical Perspective: A Mini Review | Chapter 11 | Challenges in Disease and Health Research Vol. 7

 In August of 2017, I wrote about the topic of e-cigarette tipping points for the first time. 1st In this article, I return to this topic [2] to see what, if anything, has changed since then. E-cigarettes claimed to have reached two big tipping points when the 2017 paper was published. The first was because of their widespread use, with an estimated 10% of the adult population in the United States using or having used e-cigarette products [3]. The second had to do with public perceptions of protection and benefit to public health [4]. I noted at the time that the American Food and Drug Administration (FDA) was projecting a harshly negative view of e-cigarette safety, only grudgingly recognizing that there could be personal and public health benefits. Since then, the FDA and the broader American tobacco control culture have become so hostile to e-cigarettes that each product is now facing forced withdrawal from the market unless the manufacturer can apply a "viable" Pre-Market Tobacco Application as soon as possible (PMTA). Because of the expense of the studies needed to prepare the application, as previously mentioned [1], such an application is physically impossible for 99 percent or more of e-cigarette manufacturers. This essay will discuss how and why the majority of the e-cigarette industry in the United States is on its way out, and what, if anything, can be done about it.

Author (s) Details

Joel L. Nitzkin
R Street Institute, Washington DC, c/o JLN, MD Associates, LLC, New Orleans, Louisiana, USA.

View Book :- https://stm.bookpi.org/CDHR-V7/article/view/925