Blood Test Abnormalities Rare During Isotretinoin Treatment for Cystic Acne

MedicalResearch.com Interview with:

John Barbieri, MD, MBA Hospital & Health Care University of Pennsylvania 

Dr. Barbieri

John Barbieri, MD, MBA
Hospital & Health Care
University of Pennsylvania 

MedicalResearch.com: What is the background for this study? Would you briefly describe the type of acne treated with Isotretinoin?

Response: Isotretinoin is often used to treat moderate to severe acne or acne that has been unresponsive to other treatments. It is also used for patients with scarring acne. While highly effective for acne, due to concerns about medication related side-effects, patients are often monitoring with frequent blood tests, sometimes up to once per month.

However, there have been several studies over the past two decades questioning the value of these frequent blood tests for patients on isotretinoin for acne. The purpose of this study was to examine whether blood test monitoring has been decreasing over time in response to these studies. We also evaluated the frequency of blood test abnormalities for patients being treated with isotretinoin.

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Some Physicians Who Advise FDA Later Form Financial Relationships with Pharmaceutical Companies

MedicalResearch.com Interview with:

Stephanie L. Kuschel, B.A Indiana University School of Medicine Indianapolis, IN, 46202

Dr. Kuschel

Stephanie L. Kuschel, MD
Indiana University School of Medicine
Indianapolis, IN, 46202

Robert Dellavalle, MD, PhD, MSPH
Professor of Dermatology and Public Health
University of Colorado School of Medicine
Colorado School of Public Health
Chief, Dermatology Service
US Department of Veterans Affairs
Eastern Colorado Health Care System
Denver, CO 80220 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Physicians can serve as external experts and voting members of FDA advisory committee panels, which help determine if a drug is acceptable for the US market. Considering that financial conflicts of interest (FCOI) have been shown to influence voting member habits, the FDA has regulations in place to minimize these FCOI. However, the FDA can grant waivers for some financially conflicted individuals if they meet certain requirements (like offering key insights that may out-weigh the risk of a possible FCOI). Additionally the FDA does not make stipulations regarding post-advisory role financial relationships. In fact, many former FDA committee advisors later engage in financial relationships with pharmaceutical companies. Some worry these post-hoc financial relationships could pose an ethical dilemma whereby future FDA advisory members are incentivized to alter their voting habits in expectation of future rewards. Others argue the situation may be more complex than expected.

For example, the author of one study, found that while there was evidence for a pro-industry voting bias among committee members with exclusive financial relationships to the sponsoring manufacturer (of the drug under review), this was not the case for members with nonexclusive financial ties to both the sponsor and its competitors 1. Furthermore, the author found that advisors with many corporate ties were (on average) actually more likely than their peers without any financial ties to vote against the sponsor. The author argued that these advisors were more likely to be experienced researchers, and their voting habits may reflect their experience evaluating medical research.

While this author and others have offered valuable insights into financial relationships of advisors during their advisory role, unfortunately little information is available regarding post-advisory role financial relationships and whether these relationship have any influence on the integrity of the voting process. The purpose of our study was to review Open Payment data on industry payments to former physician FDA dermatologic drug committee members.  Continue reading

Are Overweight or Obese Adolescents More or Less Prone to Acne?

MedicalResearch.com Interview with:
Igor Snast, MD

Department of Dermatology
Rabin Medical Center–Beilinson Hospita
Israel. 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Acne is the most common skin disorder among adolescents. Obesity has been suggested to promote acne, however various studies evaluating the relationship between obesity and acne have yielded contradictory outcomes.

Our population-based study demonstrates that overweight, obese and severely obese youths have decreased odds of having acne (20%, 35% and 50% respectively) compared to normal-weight subjects. Continue reading