It's the only treatment she's found that works, and the one dermatologists say is most effective against severe acne. But Accutane has come under increasing scrutiny in the past year because of concerns about the pill's possible side effects, including birth defects when women get pregnant while taking it, and because of a personal crusade by Rep. Bart Stupak (D-Mich.), who blames the drug for his son's depression and suicide.

The U.S. Food and Drug Administration is considering recommendations by an advisory committee to add Accutane to a list of medications that can be obtained only by registered physicians and patients, as well as require stronger warnings to patients.

``I feel like it will keep people from asking for it,'' said Bell, who believes the drug is safe. ``They will immediately equate it with government, and people will see hassle.''

While there is some disagreement about whether patients will be reluctant to seek treatment, physicians' groups, including the American Medical Association, the American Academy of Dermatology and the American Society for Dermatologic Surgery, believe that limiting Accutane will severely restrict access to it, making it difficult to obtain, especially for patients in rural areas where registered doctors might be hard to find.

``While I share the FDA's concerns regarding the serious side effects of this powerful medication, it is crucial that we be allowed to offer all treatment options to our patients,'' said Dr. Harold Brody, Bell's doctor and the president of the ASDS. ``This action would be an immense disservice to patients everywhere, particularly those with severe, disfiguring acne.''

Acne afflicts some 17 million Americans. Though milder forms can be controlled by over-the-counter products, topical medications and/or oral antibiotics, the doctors' groups endorse Accutane as the only medication proven to effectively control resistant nodular cystic acne, the most serious form of the skin disease.

The FDA approved Accutane in 1982 for treatment of severe acne that has not responded to other treatments and believes it is safe for most patients. So far, the most serious warning that the government and the drug's maker, Roche Laboratories, have issued is that it should not be taken by women during pregnancy because it can cause severe birth defects.

The proposed tougher restrictions on who can take Accutane and which doctors can prescribe it are an attempt to counter problems in pregnant women, said Dr. Jonca Bull of the FDA's Center for Drug Evaluation and Research.

``It's not a matter of restricting access as it is to ensure the safe use of the drug,'' she said. ``The agency well appreciates the effectiveness of the drug, but additional measures to manage risk and fully inform families need to be instituted.''

Bull said a significant number of birth defects have occurred, because patients were pregnant when they began Accutane treatment or became pregnant while taking it.

``These events are entirely preventable, and a systems approach is necessary to better ensure safe use,'' Bull said.

She said patients also should be informed about a possible connection between the drug and mood swings. While there is no scientific proof that Accutane causes depression or suicide, Bull said there is reasonable suspicion of an association.

Melissa Ziriakus, director of public affairs for manufacturer Roche, said that data provided to the company by patients and doctors does not indicate that the drug affects moods. And clinical trials of Accutane showed no such relationship. A report that Roche submitted to the FDA indicates that some Accutane users - teen-agers with severe acne - might already be prone to depression before taking the drug.

^^^ *FUCKING DUH!* ^^^

But to address the FDA's concerns, Ziriakus said, Roche is developing a new medical guide for patients taking Accutane and is seeking FDA approval for a revised informed-consent form that patients will sign, certifying that they understand the risks. And Roche plans soon to begin research studies to further investigate any link between Accutane and mood.

Brody attributes the FDA's concern to pressure from Stupak, who believes that Accutane led to his son's death last spring. Bart Stupak Jr., known as ``BJ,'' shot himself in the head in the early hours of May 14, the morning after his senior prom. Stupak has said that BJ had never shown suicidal tendencies before taking Accutane.

Stupak's congressional Web site, www.house.gov/stupak, has a section on Accutane that describes his position and the FDA's cautions to doctors about the drug.

``Personally, I think it should be banned,'' Stupak said in a telephone interview. ``As a congressman, I've never called for a ban. We've called for a full disclosure of the risks involved.

``Patients have a right to know that this is a very powerful and dangerous drug, and knowing all that, if they still wish to take it, then they can,'' the congressman said. ``But we know doctors are not adequately explaining it to the patients, pharmacists are not adequately discussing this with the person who picks up the prescription, and yet if you go to the `Physicians' Desk Reference,' all those warnings are there.''

Stupak's office has received inquiries from several metro Atlanta families who also blame Accutane for their children's suicides.

``My son would be alive today if it had not been for this drug,'' said Peter Dufresne of Marietta of Matthew Dufresne, who died in February 1999 at age 16. Dufresne said the only warning the family received about Accutane was that it might cause mood changes.

When Dufresne saw Stupak discussing Accutane on television late last year, he said, ``I shut my eyes. That was our story exactly, except the method was different.''

While both Brody's group, the ASDS, and the AAD advocate more education about Accutane, they maintain that it is not only the most effective treatment available, but that it's safe.

Dr. Stephen Webster, a dermatologist at Gundersen-Lutheran Medical Center in LaCross, Wis., and a professor of dermatology at the University of Minnesota, calls Accutane an ``extremely valuable'' drug in treating acne that does not respond to other therapy. He is one of several dermatologists who recently submitted testimony to the FDA in support of Accutane.

But Webster said, ``As with all medications, it does have potential side effects that need to be gone over with prospective patients, particularly women of childbearing age.''

He said that women should be given a blood test before taking Accutane to make sure they're not pregnant and subsequent pregnancy tests throughout their treatment. And he said that sexually active women taking Accutane should use two methods of birth control and should discuss this with any sexual partner.

``It's an ethical agreement that we are entering into when I prescribe the medication,'' Webster said. ``The good thing is, most doctors also are selective. If they feel it is not a reliable patient, then the drug is usually not given.''

To guard against any other adverse effects, Webster said he always asks patients to call immediately if they begin to experience depression or mood swings.

``I've seen one patient in the years I've been using (Accutane) who felt he was depressed while using it,'' he said. ``But some of my most grateful patients have been those who found it hard to get jobs or to have a relationship because of severe acne. So Accutane made a great difference in their lives.''

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