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WSJ: Illegal Internet Sales and Accutane .
Restrictions Curb Use of Powerful Acne Drug --- Patients Who Want Isotretinoin, Despite Risk of Birth Defects, Struggle With Onerous New Rules Jennifer Corbett Dooren September 12, 2006 The Wall Street Journal D1 THE GOVERNMENT'S most-aggressive effort yet to curb drug side effects is having an impact on a popular and highly effective acne drug -- with some doctors and pharmacists saying they have stopped dispensing it and some patients turning to illegal Internet sales. In March, the Food and Drug Administration launched a program known as iPledge, which aims to keep pregnant women from taking Accutane or its generic, isotretinoin. The drug is linked to a very high incidence of birth defects, including misshapen heads, missing ears and heart defects. But patients clamor for it despite the frightening risks, because it is the only effective treatment for the most disfiguring form of acne. There had been a number of previous efforts to educate patients and require women to sign statements that they understand the dangers, but still up to about 200 women a year were becoming pregnant while using the drug, according to FDA estimates. So, under pressure from the FDA, the four manufacturers of isotretinoin got together and designed the current program. Isotretinoin is sold as Accutane, from Roche Holding AG, and in three generic versions: Amnesteem from Mylan Laboratories Inc., Claravis from Barr Pharmaceuticals Inc. and Sotret from Ranbaxy Laboratories Ltd. Now, to obtain the drug, patients must register online for the iPledge program with the FDA, see their dermatologist monthly to get a fresh prescription, answer monthly online questionnaires and fill their prescription within a seven-day window after it is written. Women must also visit a certified lab for a blood pregnancy test each month and be on two forms of birth control. The testing and office visits are usually covered by insurance. But if the steps aren't completed properly, the patient will be denied that month's prescription at the pharmacy. Copyright © Toxic Discovery 1994 - 2006 7 There were many initial glitches with the iPledge system that kept doctors and patients on the phone for hours, and prevented many patients from getting the drug at first. These have largely been worked out, the FDA says. But doctors and patients remain frustrated with the program, saying that people are frequently denied access to the drug for even minor missteps, resulting in interruption of treatment. Men, too, must participate in parts of the program, to monitor other potential serious side effects such as liver damage and suicidal thoughts. Some patients like Tiffany Smith, a college student from Havre de Grace, Md., say that even though they complied with the requirements, they still couldn't get isotretinoin. Both Ms. Smith and her dermatologist, David Jaffe, say she was listed as "inactive" in the iPledge computer for two months before she got her first prescription in July. Ms. Smith also says she had to call three pharmacies before finding one that participated in iPledge. "It's been horrible trying to get the prescription," says Ms. Smith, who must now drive home from school in Pennsylvania for the next few months to complete her treatment. "It's just a continuous nightmare," says Lawrence Parish, a Philadelphia dermatologist who practices with his daughter, Jennifer Parish. He says all five of the patients he has had on the drug have had trouble registering or getting their prescriptions each month. Dr. Parish says he recently had a 40- year-old male patient denied his monthly supply because he went to the pharmacy eight days after the prescription was written, rather than the required seven. Sandra Kweder, the FDA's office of new drugs deputy director, concedes that isotretinoin is "a pain in the neck to get," but says the restrictions need to be tough to be meaningful. "This is a pretty toxic drug," she says. "It's not Tylenol." Indeed, some doctors say that while focusing on preventing pregnancies is important, patients on the drug -- including men -- need to be monitored for other serious side effects like liver damage, possible links to suicidal thoughts in adolescents, brain pressure, vision problems, bone and muscle damage, along with blood lipid and cholesterol problems. Prescriptions and sales of isotretinoin and Accutane are down dramatically. The number of Accutane prescriptions fell by 46% and prescriptions for the leading generic brand dropped by 16% during the first half of 2006, compared with the same time in 2005, according to IMS Health, which tracks prescription sales. Roughly one million prescriptions for isotretinoin were written annually before this, with about a combined $300 million in sales. "The intention is good," says David Pariser, who runs a five-clinic dermatology practice in the Norfolk, Va., area. "But it's really become a barrier to care." Although he still has several patients on the drug, Dr. Pariser says he will now use isotretinoin as only a last resort for the most severe cases. He says some smaller practices in the area have stopped prescribing it altogether. It is too soon to say if iPledge has lowered the pregnancy rate. So far, no pregnancies have been reported, according to the FDA. But the program may turn into something of a referendum on the agency's ability to manage the risk and benefits of powerful drugs. Paul Seligman, the FDA's new director for drugsafety policy and communication, says the agency has started a planned review Copyright © Toxic Discovery 1994 - 2006 8 of all of its restricted-distribution programs to see "what is working and what is not." The FDA has been under increasing pressure since Merck & Co.'s Vioxx was taken off the market two years ago to do more to protect consumers from being hurt by prescription drugs. A recent drug-safety bill introduced last month by Sen. Michael Enzi (R., Wyo.) and Sen. Edward Kennedy (D., Mass.) would require drug makers to submit post-marketing risk-management plans as part of the drugapproval process. The bill is unlikely to pass this year, but legislators need to approve a funding bill for the FDA next year, which could provide a vehicle for drug-safety provisions. Isotretinoin is one of roughly two dozen drugs subject to some type of restricted-access plan intended to curb misuse or unnecessary side effects. Most of the FDA's risk-management programs are reserved for drugs that are administered in hospitals or doctors' offices, such as the multiple sclerosis drug Tysabri, or certain cancer drugs. But some -- like Accutane, or the antipsychotic clozapine, which can lead to a condition that harms the immune system -- are filled at pharmacies. Because these drugs are self-administered, regulators are especially concerned about ensuring proper use. FDA officials say that Accutane faces more hurdles for patients and doctors than any of the other restricted drugs. While a treatment interruption is inconvenient, many dermatologists say it doesn't derail acne treatment because isotretinoin appears to work cumulatively even with breaks in treatment. The drug is approved to treat severe nodular acne that can lead to disfiguring scars and doesn't respond well to other existing treatments, such as Retin-A or antibiotics. However, many dermatologists also use isotretinoin to treat milder cases of acne that have failed to respond to treatment. Most cases of all types clear up permanently with a one-time four- or five-month treatment course with isotretinoin. Ms. Smith, the college student in Pennsylvania, says she is aware of the dangers of isotretinoin. But after living since her early teens with severe acne that she struggled to hide, and spending "thousands and thousands of dollars" on treatments, this is the first thing that is starting to work. "I can look in the mirror and I'm totally satisfied," she says. "There are a lot of risks but it's worth it." A few dermatologists try to give patients additional medicine so there is no break in the treatment, says Dr. Parish. The iPledge program is designed to dispense only a 30-day supply of medicine at one time. But Dr. Parish explains that because it is dosed by weight, a prescription can be written based on a heavier weight, giving patients additional medicine. Sandra Read, a Washington, D.C., dermatologist, says she sees a few patients who have turned to the Internet to buy isotretinoin illegally. But when she tells them she won't treat them under those terms and urges them to go through iPledge, "they don't come back," she says. FDA officials don't want patients to turn to the Internet and say they will discuss with the four drug manufacturers during the next six months ways to make some changes to iPledge -- including more flexibility in the monthly scheduling of office visits. They may also ease the seven-day rule for picking Copyright © Toxic Discovery 1994 - 2006 9 up a prescription, or allow pharmacists and doctors to override denials in some cases. The agency is also working on a consumer-education Web site designed to pop up whenever someone might type in "buy isotretinoin" into a search engine to help them think twice about buying over the Internet by warning them about the risks associated with the drug. Toeing the Line for an Acne Drug Some features of the iPledge program that restricts access to isotretinoin (brand name Accutane), which carries a high risk of birth defects if taken while pregnant. Patients typically take a four-or five-month course of the acne medication. -- All patients, physicians, pharmacists and drug distributors involved with isotretinoin must register with iPledge, via a password-protected Web site ( www.ipledgeprogram.com ). -- Women of child-bearing age must take an initial pregnancy test and then be on two forms of birth control for 30 days. They then must obtain a second, blood test for pregnancy within five days of their periods to receive their prescription. -- Each month, women must visit their dermatologists, visit a lab for another pregnancy test, and use the online iPledge system to answer questions about pregnancy prevention and attest to using two forms of birth control. Doctors also must enter the patient's birth-control information each month. -- Answers from doctors and patients about the birth control being used must match, or the system will deny the monthly prescription at the pharmacy. If women don't log on to iPledge every month, they also would be denied a prescription at the pharmacy. -- Men also must visit their doctors each month to receive a new 30-day prescription. A doctor cannot call or fax in a prescription without first seeing the patient. -- Patients have seven days -- including weekends and holidays -- after a prescription is written to get it filled, otherwise they will be denied that month's prescription. Women must obtain a negative pregnancy test during that same time frame. -- If a pregnancy test were to be positive, a woman wouldn't be able to receive isotretinoin. As of March 31, the most recent time frame for which figures are available, there were no reports of pregnancies. Source: The Food and Drug Administration ~~~~~~~~~~~ www.BreastImplantAwareness.org/Polevoy.htm |
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WSJ: Illegal Internet Sales and Accutane .
Hi Twittering one One ... here is the quote:
THE GOVERNMENT'S most-aggressive effort yet to curb drug side effects is having an impact on a popular and highly effective acne drug -- with some doctors and pharmacists saying they have stopped dispensing it and some patients turning to illegal Internet sales. Sandra Read, a Washington, D.C., dermatologist, says she sees a few patients who have turned to the Internet to buy isotretinoin illegally. |
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WSJ: Illegal Internet Sales and Accutane .
One click away from Polevoy's Pimple Site to buy accutane (top link on
left side) goes to commissioned sales site Here's what it says: Best Prices on Accutane Online Save $$$ Great Discounts on Isotretinoin (Accutane) Get Access to Over 400 Medications Online. Fast International shipping for Brand Name or Generic Meds BEST PRICE FOR GENERIC ACCUTANE PLUS Our Pharmacy Is Called The Generic Superstore,All FDA App,No Rx,Stop Paying High Prices For Brand And Buy Generics,ACCUTANE,AMBIEN,PROVIGIL,ANTIBIOTICS,ORDE R NOW(... Accutane. Only US $ 2.00 per pill. Sale! Buy Accutane - The Best Quality Pills. Accutane Online Pharmacy. Only $ 2.00 per pill. Fastest World Wide Shipping!!! |
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WSJ: Illegal Internet Sales and Accutane .
Ilena Rose wrote:
One click away from Polevoy's Pimple Site to buy accutane (top link on left side) goes to commissioned sales site Here's what it says: Best Prices on Accutane Online Save $$$ Great Discounts on Isotretinoin (Accutane) Get Access to Over 400 Medications Online. Fast International shipping for Brand Name or Generic Meds BEST PRICE FOR GENERIC ACCUTANE PLUS Our Pharmacy Is Called The Generic Superstore,All FDA App,No Rx,Stop Paying High Prices For Brand And Buy Generics,ACCUTANE,AMBIEN,PROVIGIL,ANTIBIOTICS,ORDE R NOW(... Accutane. Only US $ 2.00 per pill. Sale! Buy Accutane - The Best Quality Pills. Accutane Online Pharmacy. Only $ 2.00 per pill. Fastest World Wide Shipping!!! I have looked at the site. There is no such link. Please either provide the URL or stop your lying. Jeff |
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WSJ: Illegal Internet Sales and Accutane .
Ilena I know that you don't know how to tell the truth to anyone that
e-mails you or who posts here. Why don't you provide all of us with the URL from which you base this accusation? As Jack Nicholson once ranted in a "A Few Good Men": "You can't handle the truth!" So dearie, fess up and tell us that you lied again. |
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WSJ: Illegal Internet Sales and Accutane .
Twittering one asked:
Do they send the Accutane based on their "onsite prescriber," or they sell the medication based on communication with the patient's personal physician? Hi Twittering one ... I don't know the answer ... it looks like the #1 site on Polevoy's page is a threshhold to buy any pharmaceuticals ... I've never bought anything from online drug website ... here is all i know from the ads linked to Polevoy site. Best from Ilena www.BreastImplantAwareness.org/Polevoy.htm http://www.BreastImplantAwareness.or...WatchWatch.htm One click away from Polevoy's Pimple Site to buy accutane (top link on left side) goes to commissioned sales site Here's what it says: Best Prices on Accutane Online Save $$$ Great Discounts on Isotretinoin (Accutane) Get Access to Over 400 Medications Online. Fast International shipping for Brand Name or Generic Meds BEST PRICE FOR GENERIC ACCUTANE PLUS Our Pharmacy Is Called The Generic Superstore,All FDA App,No Rx,Stop Paying High Prices For Brand And Buy Generics,ACCUTANE,AMBIEN,PROVIGIL,ANTIBIOTICS,ORDE R NOW(... Accutane. Only US $ 2.00 per pill. Sale! Buy Accutane - The Best Quality Pills. Accutane Online Pharmacy. Only $ 2.00 per pill. Fastest World Wide Shipping!!! |
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WSJ: Illegal Internet Sales and Accutane .
lena,
You are still about as stupid as they come. No make that there is nobody stupider than you when it comes to answering a simple question. Do you know what the definition of a URL is? If you do, the post the URL to the site that you call "YOUR commissioned webpage" IF you can't do this basic thing then stop posting lies about my web site. http://www.acnedocs.com |
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