Give Me Accutane or Give Me Death: The Politics of Prescriptions

Any teenager will tell you that acne can drive you crazy, but is it dismal enough to drive you to kill yourself? Since its market debut in 1982, enraged parents and lawyers have implicated Accutane in the hospitalizations and suicide deaths of over 200 teenagers in the US.

Accutane (isotretinoin) is one of Hoffman-LaRoche's most popular and controversial pharmaceuticals. Doctors prescribe Accutane for patients with severe nodular acne that does not respond to systemic treatments with antibiotics.

Michigan Democrat Representative Bart Stupak lost his son, BJ, to suicide in May of 2000 while the teenager was using Accutane. Since then, Congressman Stupak has led a crusade for further research to establish Accutane's risks of birth defects and psychiatric disorders like depression and suicide.

While the safety of isotretinoin is hotly contested, there are previous Accutane users such as 21 year-old Krista Savino who view the drug as a Godsend. The antithesis of Congressman Stupak, Savino vows to do whatever she can to keep Accutane on the market. Savino sometimes experiences acne so severe that she deems her condition the "social equivalent of suicide". Accutane gives her clear skin and the confidence to leave her home without feeling overly self-conscious.

Hoffman-LaRoche, following FDA guidelines, lists depression as a possible Accutane side effect. Notwithstanding, the link between isotretinoin and the development of depression and/or suicide remains marred.

Like Senator Stupak, Dublin accountant Liam Grant, blames Roaccutane for the suicide death of his 20 year-old son, also named Liam. Grant alleges that his son exhibited signs of severe depression after taking Roaccutane in the months prior to his death.

According the British newspaper, The Sunday Times, Grant has spent almost £500,000 on independent research to try to prove that Roaccutane causes depression. Grant hired Douglas Bremner, MD of the Emory University School of Medicine to conduct the investigation. Grant hopes to use this research to force Roche Pharmaceuticals to admit liability for Liam's death.

Dr. Bremner's results, which were published in the American Journal of Psychiatry, have made strides in identifying Accutane's influence on the brain. Dr. Bremner explains that to invoke depression, isotretinoin must affect the brain.

Dr. Bremner's Roaccutane study involved 28 healthy men and women between the ages of 18 and 50. During the investigation, brain function of the subjects was measured using positron emission tomography (PET) before and after four months of treatment with isotretinoin. Isotretinoin treatment was associated with decreased brain metabolism in the orbitofrontal cortex- the area of the brain known to mediate symptoms of depression. Yet, there were no differences in severity of depressive symptoms between the isotretinoin and antibiotic treatment groups before or after treatment. The study concluded that isotretinoin treatment is associated with changes in brain function.

Dr. Bremner's findings call for further investigation of the 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 the acne drug. Yet, the FDA does not have the funding to cover the testing.

While delving into the affects of Accutane Dr. Bremner has come to agree with David J. Graham, MD, MPH- the Associate Director for Science and Medicine in FDA's Office of Drug Safety. Graham warns that Accutane should be taken off the market.

Dr. David Graham paints a daunting image of how the FDA determines a drug's safely. He relates that using the Center for Drug Evaluation and Research's (CDER) standard for drug safety to a pistol holding 100 chambers. The gun symbolizes a drug while the bullets represent a serious safety problem with the drug. "Using CDER's standard, only when you have 95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists," explains Dr. Graham. He adds that if only 90 bullets were in the chamber, CDER would conclude that the gun is not loaded and the 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 the possibility of birth defects associated with fetal exposure to the 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 the 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 the 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 the consumer. Whether you feel the 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 for you.

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

---

Google News Updated : Thu, 24 Jul 2008 06:51:44 GMT Powerful quake injures 92 in Japan - CNN Boston Globe Powerful quake injures 92 in Japan CNN - 2 hours ago (CNN) -- A strong earthquake injured 92 people and destroyed 31 buildings in northern Japan on Thursday, authorities said. People at an auto dealership in Karumai, Japan, clean up glass shards after a strong earthquake Thursday. Japan's North Hit by Magnitude-6.8 Quake; 95 Injured (Update3) Bloomberg Powerful earthquake hits Japan, dozens injured The Associated Press Jerusalem Post - Reuters - AFP all 766 news articles Publ.Date : Thu, 24 Jul 2008 04:51:37 GMT "X-Files" movie both satisfies and disappoints - Seattle Times "X-Files" movie both satisfies and disappoints Seattle Times - 50 minutes ago Mulder and Scully are together again in "X-Files: I Want to Believe." The story may be silly, but the agents' romance is compelling as ever. The X-Files: I Want to Believe AU Review IGN Scully have I loved Salon Daytona Beach News-Journal - The State - The Star-Ledger - NJ.com - Youngstown Vindicator all 557 news articles Publ.Date : Thu, 24 Jul 2008 06:01:06 GMT Bashir Visits Darfur, Pledges Sudan Will Protect Relief Workers - Bloomberg Voice of America Bashir Visits Darfur, Pledges Sudan Will Protect Relief Workers Bloomberg - 4 hours ago By Paul Tighe July 24 (Bloomberg) -- Sudan's President Umar al-Bashir, indicted by the International Criminal Court for alleged war crimes in the Darfur conflict, visited the region yesterday and pledged to provide security for international relief ... Bashir returns to Darfur New York Times How Sudan Was Brought to Court TIME The Press Association - The Epoch Times - Voice of America - Times Online all 1,663 news articles Publ.Date : Thu, 24 Jul 2008 02:39:29 GMT Dynamo top United at soggy RFK - MLS - Major League Soccer The Money Times Dynamo top United at soggy RFK MLS - Major League Soccer - 1 hour ago By Charles Boehm / MLSnet.com Staff WASHINGTON -- After two aborted tries on previous dates, DCUnited and the Houston Dynamo finally completed the first of their two league meetings on Wednesday night -- and some of Thursday morning, ... Mullan, Ching power Dynamo over DC United 2-0 Houston Chronicle Dynamo outlasts United despite lengthy delay Seattle Post Intelligencer The Canadian Press - FC Dallas - Washington Post - United Press International all 144 news articles Publ.Date : Thu, 24 Jul 2008 05:07:00 GMT Pittsburgh Cancer Center Warns of Cell Phone Risks - ABC News China Daily Pittsburgh Cancer Center Warns of Cell Phone Risks ABC News - 6 hours ago By JENNIFER C. YATES and SETH BORENSTEIN AP Writers AP The head of a prominent cancer research institute issued an unprecedented warning to his faculty and staff Wednesday: Limit cell phone use because of the possible risk of cancer. Red alert! The cellphone warning has been issued Los Angeles Times Pittsburgh cancer center warns of cell phone risks The Associated Press DetNews.com - USA Today - Julie's Health Club - Chicago Tribune Blog all 436 news articles Publ.Date : Thu, 24 Jul 2008 00:01:03 GMT Oklahoma determined to have a strong finish - Fort Worth Star Telegram NCAAfootball.net Oklahoma determined to have a strong finish Fort Worth Star Telegram - 1 hour ago By MIKE JONES "Our whole mentality now is WTLG [win the last game]," Harris said Wednesday. "Come out and finish. It’s national championship or bust. Sooner, the better Topeka Capital Journal Players put success on Stoops Daily Camera SportingNews.com - Chicago Tribune - ESPN - Norman Transcript all 38 news articles Publ.Date : Thu, 24 Jul 2008 05:03:29 GMT Obama lavished with airtime -- and criticism - Los Angeles Times ABC News Obama lavished with airtime -- and criticism Los Angeles Times - 1 hour ago As the media moves to correct itself for glowing coverage of the Democrat, it's entering a period of shallow analysis. By ON THE MEDIA, JAMES RAINEY It seems like just about everybody has spent the last week beating up on the media for showering too ... Veterans group hits McCain on troop pullout The Associated Press 'Generation Gap' Widens in the 2008 Electorate Wall Street Journal Boston Globe - New York Times - CQPolitics.com - Right Pundits all 2,612 news articles Publ.Date : Thu, 24 Jul 2008 05:43:11 GMT Work From Home Add RSS Feeds To My Web Pages

PARLOT::Ebooks, Scripts, Websites, and more...

Adsense websites

Hypothermia - The Cold Facts

If you ever go to cold countries, you should undoubtedly... Read More

Three Antioxidants (ginko biloba, grade seed extract, and selenium) for Alzheimers Treatment

Checklist of Treatments for Alzheimer's DiseasePart 3 of 83. Three... Read More

Family Notification in Seven Quick and Easy Steps

The Seven Steps to Successful Notification is an easy-to-use system... Read More

What Not to Tell Your Doctor?

For many years since medicine has been established as an... Read More

Stop Taking Blood Pressure Medications with Your Doctors Approval

I have been swallowing three varieties of blood pressure pills... Read More

Ulcers Are No Laughing Matter

Peptic ulcers, which are in the stomach and the duodenum... Read More

Bextra and Vioxx -- Alternative Medications Have Warnings, Too

At the urging of the Food and Drug Administration, the... Read More

Mend Your Arthritis Pain Relief

=====KNOW YOUR ARTHRITIS=====Arthritis is referred to as the nation?s number... Read More

?Doc, my mouth is so dry all the time. What could be the problem??

Sjogren's syndrome is an autoimmune disorder ? a disorder in... Read More

Sinusitis: Sinus Infection Deals a Corporate KO

Sinusitis and Sinus Infection Starts with a Little SniffleYes, I... Read More

Christopher Reeve To Have Promoted Basement Lab

Chrisopher Reeve has died. But his vision of a "Cure"... Read More

Traditional Treatments for Back Pain... Which Ones Work and Which Ones Don?t?

When Dorothy followed the yellow brick road, she was told... Read More

Medical Testing: Health By The Numbers Doesnt Work

Perhaps one of the most insidious dangers in modern technology... Read More

Stem Cell Research

How To Buy Your Way Out Of An Early Death... Read More

Heart Disease: The Dangers Of Coronary Heart Attack And How To Avoid It

What is a coronary heart attack?Are you at the risk... Read More

When Your John Doe Is Homeless

The patient, known only as John Doe, was difficult to... Read More

Understanding Tumescent Liposuction

Tumescent liposuction is done using a local aesthetic. A large... Read More

Rheumatoid Arthritis : the time bomb

The beginning is very much hard to spot as we... Read More

Onychomycosis - One Of The Many Nail Fungus Out There

Many natural changes in fingers and toenails come with age.... Read More

CRP And Your Heart

Monitoring your CRP level is vitally important because it is... Read More

Cetyl Myristoleate Seperating Fact From Fiction

I am a strong believer in Cetyl Myristoleate for the... Read More

Check Out The Wonders Of Tea Tree Oil

Tea tree oil is the essential oil comes from the... Read More

The Last Line of Defense Against Medication Errors: What You Need to Know to Keep your Family Safe

This is a true story.Yesterday, I picked up a new... Read More

Low Blood Pressure ? Why is Your Blood Pressure Low?

Why is your blood pressure low?As a doctor with an... Read More

Naturopathic Medicine

Naturopathic Medicine is an holistic approach that relies on natural... Read More