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
Food for Thought
Depression is a disorder marked by sadness, low energy, impaired concentration, and feelings of dejection. Some people believe that depression is normal. Hectic daily activities and the conflict between family and career cause constant stress. Yet depression and anxiety as a response to stress are not normal. They can be signs of illness, which may worsen and result in physical symptoms or an inability to function.
10 Benefits of an Electronic Medical Record
Electronic Medical Record
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Lunesta Memory Problems
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What Not to Tell Your Doctor?
For many years since medicine has been established as an ethical profession and gained widespread credence people have believed that they could and should tell their doctor everything even remotely pertinent to their health and that it was held in the strictest confidence. Furthermore, how can the physician make accurate judgments when important or significant information is missing? This system worked very well until relatively recently but there now exists a breach of this confidence that people should know about and this breach has developed from the advent of third party investigations into people's backgrounds. Your medical records are no longer confidential because you are forced to reveal them. Let us look at some scenarios.
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?Doc, my mouth is so dry all the time. What could be the problem??
Sjogren's syndrome is an autoimmune disorder ? a disorder in which your body attacks its own tissues because it thinks they are foreign. It prevents your body's exocrine (moisture-producing) gland from producing enough moisture for different areas of your body. This leads to chronic and lifetime dryness. Sjogren's syndrome affects many areas of your body. In addition to the mouth and eyes, other affected areas include the skin, vagina, respiratory tract (lungs), and gastrointestinal tract (stomach and intestines).
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The Equine Cushings Cure
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Naturopathic Medicine is an holistic approach that relies on natural remedies. Sunlight, air, and water are thought of as natural healers; this, along with nutritional supplements and massage therapies are all part of naturopathic medicine.
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Check Out The Wonders Of Tea Tree Oil
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A Closer Look at Neck Pain Relief
Neck pain afflicts many people at some point in their life - two-thirds of American adults report having experienced at least one incidence of neck pain in their lives. You can strain your neck during exercise, at work, or even something as simple as turning over in your sleep. It's an ailment so common that it has even earned it's own colloquialism. But while your boss, neighbor, or even children can all be a real "pain in the neck" sometimes, so can the pain in your neck!
Viga Lies Cause Potential Fatalities
Viga and Viga for Women is a dietary supplement sold OTC and via the internet that marketed itself not as a prescription drug but as a dietary supplement pill. It was a dietary supplement version of Viagra, which is a drug for erectile dysfunction. Viga was supposed to be natural thus eliminating the dangerous or unpleasant side effects of the prescription drug Viagra. Viagra cannot be purchased over the counter because it is a prescription drug containing the ingredient sildenafil. However, sildenafil was illegally added to Viga. The manufacturers however (a step further into illegality), failed to include sildenafil on the product ingredient label. It is not legal for dietary supplements to contain prescription ingredients because they are not as firmly regulated and can create greater potential for serious injuries or risks in people who take the pill.
Bextra Recall: Lawyer Says Help Is On The Way
By now, you have probably heard of the prescription drug Bextra. You may not know, however, why that a recall is in order. The reason is quite simple. The FDA has asked Pfizer to withdraw Bextra from the market because of increased risks of heart attack and stroke.
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Looking for the best doctor to suite your medical needs can be a problem, especially if you don't have time and you need to research the doctor's credentials. Whether you're in urgent need of help, or just need a second opinion, I will show you how to access all the information you need ? through the Internet's Virtual Top Doctor Consultant.
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