Continued from page 1
Dr. Bremner’s findings call for further investigation of
drug isotretinoin. However, insufficient funding may impede such a study. The American Academy of Dermatology wants clinical trials to prove that isotretinoin causes depression or “psychiatric events” before it encourages stronger warnings and tighter regulations of
acne drug. Yet,
FDA does not have
funding to cover
testing.
While delving into
affects of Accutane Dr. Bremner has come to agree with David J. Graham, MD, MPH-
Associate Director for Science and Medicine in FDA’s Office of Drug Safety. Graham warns that Accutane should be taken off
market.
Dr. David Graham paints a daunting image of how
FDA determines a drug’s safely. He relates that using
Center for Drug Evaluation and Research’s (CDER) standard for drug safety to a pistol holding 100 chambers. The gun symbolizes a drug while
bullets represent a serious safety problem with
drug. “Using CDER’s standard, only when you have 95 bullets or more in
gun will you agree that
gun is loaded and a safety problem exists,” explains Dr. Graham. He adds that if only 90 bullets were in
chamber, CDER would conclude that
gun is not loaded and
drug is therefore safe.
The FDA is strengthening its risk minimization action plan (RiskMAP) for Accutane and generic version of isotretinoin in hopes of reducing
possibility of birth defects associated with fetal exposure to
acne drug. Women will now have to present negative pregnancy tests before filling their isotretinoin prescription each month. Some dermatologists have practiced this pregnancy monitoring without prodding from
FDA. This new measure makes no mention of depression or suicide that may result from isotretinoin usage.
Dr. Bremner adds that patients taking isotretinoin have to be asked about depression, they don’t just openly talk about it. Discussing symptoms of depression is an added measure that doctors prescribing isotretinoin can make to ensure
well-being of their patients.
It’s great to live in a country that inspires enterprise, invention and independence. All these things come with a price. The buyer gets to decide how much they’re willing to pay. The FDA exists to protect
consumer. Whether you feel
FDA’s efforts are insufficient or overbearing, you have medical options. Geoffrey Redmond MD, author of The Good News about Women’s Hormones, suggests using hormone therapy and/or using Retin-A if Accutane seems too risky.

Health author and Noixia campaigner Naweko San-Joyz lovingly writes from her home in San Diego. Her works include “Acne Messages: Crack the code of your zits and say goodbye to acne” (ISBN: 0974912204) and the upcoming work “Skinny Fat Chicks, Why we’re still not getting this dieting thing” (ISBN: 0974912212) for release in June of 2005. For useful acne self-help articles visit http://www.Noixia.com.