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  1. #1
    Join Date
    Feb 2005

    System Said to Fail to Steer Women From Acne Drug

    System Said to Fail to Steer Women From Acne Drug

    GAITHERSBURG, Md., Feb. 10 — The government-approved system for preventing pregnant women from taking Accutane, the acne drug linked to miscarriages and severe birth defects, is a "disaster," the nation's leading dermatology association told a federal advisory panel on Friday.

    "Pharmacies, prescribers and patients are confused and frustrated," said Dr. Diane M. Thiboutot of the American Academy of Dermatology, who held a stack of what she said were samples of 200 complaints from dermatologists. She asked the panel to delay the system's mandatory starting date of March 1 by at least two months.

    But advocates of regulating Accutane said complaints about the new system were exaggerated.

    Dr. Sandra Kweder, deputy director of the Food and Drug Administration's office of new drugs, said after the meeting that the agency would decide on that request within a week.

    The federal government has undertaken more than 40 efforts over the last 23 years to prevent women from becoming pregnant while taking Accutane. Nothing has worked.

    Accutane is approved to treat severe, disfiguring acne, a problem that is estimated to afflict only about 6,000 patients, nearly all of them male. For such patients, Accutane is a near-miraculous cure.

    But physicians, who are allowed by law to prescribe drugs as they see fit, write more than 170,000 Accutane prescriptions each month. Half go to women, hundreds of whom become pregnant each year, according to federal estimates.

    Fearing that the F.D.A. would take the drug off the market if the mounting toll of miscarriages, abortions and deformed babies was not drastically reduced, the drug's four manufacturers agreed last year to construct a system that required doctors, pharmacists, wholesalers and patients to participate in a tightly controlled distribution system mostly operated on the Internet.

    The system, called iPledge, requires female patients to take pregnancy tests and birth control. But doctors say that is inconvenient, cumbersome and sometimes impossible to manage.

    Dr. Kathleen Carney-Godley, a dermatologist from East Greenwich, R.I., said that she tried to enter her patients into the system from home one Sunday but could not because she did not have her patients' Social Security numbers.

    Her partner tried to enter a patient into the system, failed, called for help, was put on hold and had time enough to excise a cancerous skin lesion in another patient before being able to talk to an operator, Dr. Carney-Godley said.

    Other doctors complained of nonsensical instructions from the system — like requiring pregnancy tests for male patients — and long waits on the phone.

    "I'm concerned that the regulation has gone so overboard that an important drug will not be available because dermatologists won't bother to prescribe it," Dr. Carney-Godley said.

    Dr. Kweder said the F.D.A. was well aware of the problems. A representative from Covance, the company that operates iPledge, told the committee that Covance is responding to complaints and fixing problems as it is made aware of them. Those repairs, she said, sometimes take weeks to carry out and more weeks to become apparent to others.

    Arthur A. Levin, a panel member who is director of the Center for Medical Consumers in New York City, said the system's problems "have to be addressed very quickly."

    "I think it would be tragic if this kind of program got a bad reputation," Mr. Levin said.

    But Dr. Peter A. Gross, the panel's chairman and chairman of the department of internal medicine at Hackensack University Medical Center in New Jersey, dismissed the complaints.

    "You get no sympathy from me," Dr. Gross said. "If it takes a little more time, tough."

    Advocates for greater regulation of Accutane agreed.

    "There is this never-ending whimpering coming from many dermatologists that someone is cramping their style and making it more difficult to prescribe something," said Dr. Sidney Wolfe, director of health research at one such group, Public Citizen. "The reason there are all these failed efforts to limit pregnancies is that dermatologists are prescribing Accutane to way too many people."

    In interviews, dermatologists said Accutane could transform the lives of patients with even mild forms of acne by restoring their self-esteem.

    Representative Bart Stupak, a Democrat from Michigan who has long advocated that Accutane be withdrawn from the market, said complaints about the new system were exaggerated. Mr. Stupak sent a letter to the committee insisting that there be no delays in putting the new control system in place.

    "But I expect that the F.D.A. will once again cop out and not do the right thing" and agree to a delay, Mr. Stupak said in an interview.

  2. #2
    Join Date
    Jun 2014

    Re: System Said to Fail to Steer Women From Acne Drug

    Acne, one of the commonest skin problem that ails the human kind irrespective of the age,caste,colour gender etc. Acne is a tremendously embarrassing and burdensome problem. Acne can be defined, as red eruptions on the skin some time filled with a white substance, is itchy and also painful. It is a problem on which we do not have our control.

    There are different ways to treat acne .one can o for medication from a skin specialist or one can also try home or natural remedies. Natural remedies are less time consuming, less costly, and have no side effects. It only requires a little more patience because the routine has to be followed diligently to get rid of the problem once and for all. A natural remedy for acne is just as effective as medication.

    Here are a few natural remedies to cure your acne.
    To start with, your daily consumption of water should be minimum of eight to ten lasses. This helps us to detoxicate our system and kill harmful bacteria that cause acne. Too much of oily food also leads to acne, so fried and spicy food should be strictly avoided. Including chromium in your diet also helps to cure acne. There should be a combination of right nutritional balance and proper skin care.

    A mixture of nutmeg powder with unboiled milk when applied on the affected area regularly also helps to cure acne. Cinnamon powder mixes with honey is equally effective in curing acne. Boiled neem leaves when applied on acne acts as a disinfectant. The infected area should be washed with anti acne soap at least three to four times a day.

    Makeup should be strictly avoided when one is suffering from acne. Makeup makes the acne conditions worse. Acne should never be squeezed as it may spread and become worse. Squeezing your acne may also lead to permanent mark on your skin, which leaves your skin, looking ugly. Avoid your hair to fall on the acne-affected area. Hair should be kept tied to avoid contact with acne. Pillow covers should be washed on daily basis to avoid the germ to spread. Regular cleansing of your skin should be done to keep it free from germs.

    Apart from all these a healthy lifestyle should be followed, with proper balance of food, exercise and sleep. Remember if you take proper care of yourself no ailments can trouble you leave apart a small thing as acne!

    Please REGISTER AT SCAM.COM and join our community !

  3. #3
    Join Date
    Apr 2014
    Orlando, FL

    Re: System Said to Fail to Steer Women From Acne Drug

    Accutane SEVERELY dehyrates the body. The only one that would take that medication would be a teen mom. Don't take anything while pregnant no matter what anyone says.
    When in doubt, Meditate!

  4. #4

    Re: System Said to Fail to Steer Women From Acne Drug

    I don't consider Accutane a scam. Sorry, but unless you've actually HAD acne that was resistant to conventional treatments, you have no idea what it's like to suffer from the condition into adulthood. My side effects from Accutane were nil compared to countless antibiotics, topicals I've been prescribed or have purchased over the counter.
    Personally, I'd rather take the risks associated with the drug rather than spend the thousands of dollars required to try this new treatment and that new treatment. I wish I had been prescribed the drug PRIOR to all the antibiotics I've been prescribed for the condition-- now most antibiotics do nothing to me when I'm ill with an infection of any sort.
    If someone is experiencing bad side effects, naturally they should stop the treatment ASAP, but normally patients are warned about them prior to prescribing. Most drugs out there are contraindicated in pregnancy (being female and having had a child, I can attest to that). The two times I was on Accutane, I was also on an IUD. Perhaps that should be prescribed to females when physicians are anxious about their adherence to birth control measures.
    Keep in mind that although it seems like purely an issue related to vanity-- it *is* a skin infection... and often times mistaken for drug abuse (meth face) when one is an adult and still has it.

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