CBC's Marketplace Accutane show - Acne and Skin Care Clinic
CBC's Marketplace Accutane show - Acne and Skin Care Clinic
CBC's Marketplace Accutane show - Acne and Skin Care Clinic
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<strong>Marketplace</strong> - <strong>Accutane</strong>homeshop · help · contact · searchAir Date: February 6, 2001Producer: Christian Côté | Researcher: Colman Jones<strong>Marketplace</strong><strong>Marketplace</strong> FilesHealth &Safety »Your Food »Your Home »Travel &Recreation »The Environment »Your Car »Services »Scams »Your Money »<strong>Accutane</strong> is a wildly successful acne drug. It's number onewith Canadians, who spent close to $40 million on it last year.Doctors call the drug a miracle. But there can be dangerousside effects.Women taking <strong>Accutane</strong> are warned not to get pregnant whileon the drug. It can cause birth defects. There is anotherdangerous connection, about which little has been said inCanada: mood swings, depression, even reports of suicide.Watch this storyin Real Videoin QuickTime[Download Players]Warnings &RecallsMicroscopePast ShowsLettersForumNewsletterSubscriptionSearchStreet CentsConsumerNewsCBC.caLast fall, American lawmakers listened to people forThere have been acouple of importantchanges in HealthCanada's position on<strong>Accutane</strong> since this storyfirst aired on<strong>Marketplace</strong>.Patients must now sign aconsent form in Canadabefore they receive<strong>Accutane</strong>.Health Canada hasupdated its Web siteinformation on the drug.whom <strong>Accutane</strong> was not amiracle drug: a teenagerrelated her tale of depression<strong>and</strong> suicidal thoughts; parentsbroke down as they describedhow their children took theirown lives.● Join our <strong>Accutane</strong> discussionboard"My downfall started themoment I took the first pill,"teenager Am<strong>and</strong>a Callais ofLouisiana told theCongressional hearing. "I foundmyself feeling sad <strong>and</strong> I oftencried for no reason. I hatedmyself more <strong>and</strong> more eachday <strong>and</strong> I began to cut my h<strong>and</strong>s with razor blades."<strong>Accutane</strong>Page OnePage Two<strong>Accutane</strong> FactsCMA response to<strong>Marketplace</strong> survey ofdoctorsUS <strong>and</strong> CanadianWarningsLinksDo you have a comment aboutthis - or any other - story on the<strong>Marketplace</strong> site? E-mail us.Callais' family is one of several in the United States now suinghttp://cbc.ca/consumers/market/files/health/accutane/ (1 of 3) [29/08/01 15:39:15]
<strong>Marketplace</strong> - <strong>Accutane</strong>Hoffman LaRoche, the makers of <strong>Accutane</strong>. There has beenlegal action in Canada as well. In 1995, an Edmonton medicalstudent sued Hoffman LaRoche for more than $10 million.The suit claimed <strong>Accutane</strong> is a "…dangerously defectiveproduct"…that allegedly caused the student to fly into sudden<strong>and</strong> dramatic rages…[<strong>and</strong> to have] psychotic-like depression,<strong>and</strong> thoughts of suicide. As a result, the medical studentclaimed she had to quit school, <strong>and</strong> be committed to apsychiatric hospital. Hoffmann LaRoche denied any of thiscould be linked to <strong>Accutane</strong>. The company insisted the drug is"…a safe <strong>and</strong> efficacious product when used as directed."The medical student recovered <strong>and</strong> returned to school.The lawsuit was settled out of court last June. The terms of thesettlement forbid anyone involved from speaking publicly. Butothers are speaking out.Nancy Daines of Richmond, Ont.,believes <strong>Accutane</strong> is linked to herdaughter's depression which ledto overdose of pills. Erin Dainesrecovered.<strong>Accutane</strong>-depression link?Erin Daines of Richmond, Ontario, was an angry, frustratedteenager in 1998. Life hadn't been easy for her family sinceher father's death ten years earlier. At 16, Erin was alsodealing with the problems of adolescence <strong>and</strong> severe acne."It was frustrating cause it wouldn't go away," Erin told<strong>Marketplace</strong>. "I'd use a lot of makeup <strong>and</strong> it just wouldn't, youcould still see it, like it…wasn't good enough. So I had to findsome way to get rid of it."Media coverage of possible linkbetween <strong>Accutane</strong> <strong>and</strong>depression caught the attentionof Daines.Erin began taking <strong>Accutane</strong> <strong>and</strong> it was working well. However,five weeks into the therapy, something went wrong. She saidshe had a sore leg — so she took 15 Tylenol pills. Erin wasrushed to hospital <strong>and</strong> treated for an overdose.Months later, Erin's mother Nancy Daines came across a storyabout <strong>Accutane</strong> in the Ottawa Citizen. She came away fromthat story wondering whether there was a link between<strong>Accutane</strong> <strong>and</strong> Erin's overdose.Manufacturer says no link between <strong>Accutane</strong> <strong>and</strong>psychiatric problemsHoffmann LaRoche says there is no causal relationshipbetween <strong>Accutane</strong> <strong>and</strong> depression or suicide. Experts pointout that no one factor causes suicide <strong>and</strong> that a highpercentage of <strong>Accutane</strong> users — teens <strong>and</strong> young adults —are already more likely to get depressed. But some doctorssay there's plenty of evidence to support a link between<strong>Accutane</strong> <strong>and</strong> depression <strong>and</strong> suicide.Hoffman LaRoche maintains that<strong>Accutane</strong> is a safe, effectivetreatment for problem acne,when used as directed.http://cbc.ca/consumers/market/files/health/accutane/ (2 of 3) [29/08/01 15:39:15]
<strong>Marketplace</strong> - <strong>Accutane</strong>Some say evidence of the link dates back to Arctic explorersof the 19th century. Diaries tell of how some sailors sufferedpolar madness. Experts today say it was from eating polarbear liver, which is full of vitamin A. In large doses Vitamin Acan cause brain toxicity seizures <strong>and</strong> behavioural changes.<strong>Accutane</strong> is a derivative of vitamin A.More recently there have been dozens of cases of peopleusing vitamin A derivatives — including <strong>Accutane</strong> — whoreported suffering psychiatric side effects.There is also compelling evidence from Hoffman LaRoche'sown trials of <strong>Accutane</strong>. As many as 26 people out of a total of600 tested reported psychiatric side effects."I've had three or four patientswho I have no doubt in my ownmind that they developedpsychiatric manifestations."Ottawa dermatologist Dr ElginDuke, who also stresses that<strong>Accutane</strong> is a wonder drug.Dr. Elgin Duke calls <strong>Accutane</strong> a wonder drug. He's adermatologist who has been treating patients from his Ottawaoffice for the past thirty years. While he's convinced of thedrug's effectiveness, he's also very cautious, because of whathe has seen."I've had three or four patients who I have no doubt in my ownmind that they developed psychiatric manifestations," Duketold <strong>Marketplace</strong>. "It's a pretty rare phenomenon, but still avery real phenomenon <strong>and</strong> it has to be watched."Health Canada has been monitoring <strong>Accutane</strong>. From 1983 —when the drug arrived on the Canadian market — until 1997,Health Canada received 8 reports of depression <strong>and</strong> otherpsychiatric reactions associated with the use of <strong>Accutane</strong>.In the last three years, those numbers have more th<strong>and</strong>oubled. Since 1998 there have been twenty reports ofpsychiatric side effects including delirium; suicidal tendencies;<strong>and</strong> one suicide. Many researchers believe the numbers maybe significantly higher because adverse drug reactions areunder-reported.More >>Page One | Page Two | <strong>Accutane</strong> Warnings |<strong>Accutane</strong> Facts | Links |Copyright © CBC All Rights Reserved.http://cbc.ca/consumers/market/files/health/accutane/ (3 of 3) [29/08/01 15:39:15]
<strong>Marketplace</strong> - <strong>Accutane</strong>homeshop · help · contact · searchAir Date: February 6, 2001Producer: Christian Côté | Researcher: Colman Jones<strong>Marketplace</strong><strong>Marketplace</strong> FilesHealth &Safety »Your Food »Your Home »Travel &Recreation »The Environment »Your Car »Services »Scams »Your Money »Warnings &RecallsMicroscopePast ShowsLettersForumNewsletterSubscriptionSearchStreet CentsConsumerNews
<strong>Marketplace</strong> - <strong>Accutane</strong>Health Canada information out of dateSo what does Health Canada tell consumers about <strong>Accutane</strong>?Its website includes information that is more than eleven yearsold. There is no warning about the reports of depression orsuicide.Dr. Brian Gillespie, Health Canada's senior medical advisor,says there are plans to update the information on the website.The department, he says, is also in the process of determiningwhether Hoffman LaRoche will have to strengthen thewarnings on <strong>Accutane</strong> sold in Canada."We're examining that issue, <strong>and</strong> as to whether or not in theCanadian context it would enhance adherence to the warnings<strong>and</strong> precautions that are in the <strong>Accutane</strong> prescribinginformation," Gillespie told <strong>Marketplace</strong>. "At the present timewe have not made any decision, it is still under review.""At the present time we have notmade any decision, it is stillunder review." Dr. BrianGillespie, Health Canada's seniormedical advisor on whetherCanada will strengthen <strong>Accutane</strong>warnings.Ottawa dermatologist Dr. Elgin Duke says it's ultimately up todoctors who prescribe <strong>Accutane</strong> to make their patients awareof the risks."As far as the depression is concerned, I discuss it with thepatient, but I now ask a member of the family to be presentwhen we discuss it," Duke explained. "I want a father, brother,mother, somebody to be aware that a personality change <strong>and</strong>depression may occur. It's an extremely rare risk <strong>and</strong> it's not areason to not take the drug, but if they notice any change thenwe would stop the drug <strong>and</strong> look for something alternative."Duke believes dermatologists in Canada are warning theirpatients. But he's not so sure about the increasing number offamily doctors who are prescribing <strong>Accutane</strong>."I think that people should knowabout it. Like that's why I'm doingthis, because I don't want peopleto make the same mistake I did."Erin Daines, who overdosed onTylenol while on <strong>Accutane</strong>treatment.<strong>Marketplace</strong> conducted a small survey of Toronto area doctorswho prescribe <strong>Accutane</strong> to find out what kinds of warningsthey are giving their patients.Of ten doctors, only one said he warned patients about the linkto depression <strong>and</strong> suicide. Some said they weren't aware ofsuch a link <strong>and</strong> others did not think it was that serious. (ForCanadian Medical Association response to the <strong>Marketplace</strong>survey of doctors, click here.)Nancy Daines says doctors should know better. She wantsHealth Canada <strong>and</strong> Hoffmann LaRoche to offer the samewarnings to Canadians now being given Americans."Some kids could die," Daines told <strong>Marketplace</strong>. "Depression Ihttp://cbc.ca/consumers/market/files/health/accutane/index2.html (2 of 3) [29/08/01 15:39:54]
<strong>Marketplace</strong> - <strong>Accutane</strong>think…runs high with teens on a normal basis, so if they dohappen to be taking this medication, they should definitely bevery cautious about it."Her daughter Erin agrees."I think that people should know about it," Erin said. "Likethat's why I'm doing this, because I don't want people to makethe same mistake I did."Page One | Page Two | <strong>Accutane</strong> Warnings |<strong>Accutane</strong> Facts | Links |Copyright © CBC All Rights Reserved.http://cbc.ca/consumers/market/files/health/accutane/index2.html (3 of 3) [29/08/01 15:39:54]
<strong>Marketplace</strong> - <strong>Accutane</strong>homeshop · help · contact · searchAir Date: February 6, 2001Producer: Christian Côté | Researcher: Colman Jones<strong>Marketplace</strong><strong>Marketplace</strong> FilesHealth &Safety »Your Food »Your Home »Travel &Recreation »The Environment »Your Car »Services »Scams »Your Money »Warnings &RecallsMicroscopePast ShowsLettersForumNewsletterSubscriptionSearchStreet CentsConsumerNewsCBC.ca<strong>Accutane</strong> Warnings<strong>Accutane</strong> is described as a powerful, yet safe, drug for thetreatment of severe acne, when used as directed.However, there are several well-documented side effects —<strong>and</strong> others that are suspected.●Join our <strong>Accutane</strong> discussion boardRecently, in the United States, <strong>Accutane</strong> warnings werestrengthened to reflect concerns that the drug may be linked todepression <strong>and</strong> thoughts of suicide in some people.Warnings for Canadian consumers of the drug have notchanged. Health Canada's website contains information on<strong>Accutane</strong> that dates back to 1989.Below are excerpts from two <strong>Accutane</strong> warning publicationsgiven to patients when they pick up their prescription. The firstone is for Americans, the second for Canadians.Possible serious side effects of taking <strong>Accutane</strong>include birth defects <strong>and</strong> mental disorders2. Mental problems <strong>and</strong> suicide. Somepatients, while taking <strong>Accutane</strong> or soon afterstopping <strong>Accutane</strong>, have become depressed ordeveloped other serious mental problems. Signsof these problems include feelings of sadness,irritability, unusual tiredness, troubleconcentrating, <strong>and</strong> loss of appetite. Somepatients taking <strong>Accutane</strong> have had thoughtsabout hurting themselves or putting an end totheir own lives. There were reports that some ofthese people did not appear depressed. No oneknows if <strong>Accutane</strong> caused these behaviours or ifWatch this storyin Real Videoin QuickTime[Download Players]<strong>Accutane</strong>Page OnePage Two<strong>Accutane</strong> FactsCMA response to<strong>Marketplace</strong> survey ofdoctorsUS <strong>and</strong> CanadianWarningsLinksDo you have a comment aboutthis - or any other - story on the<strong>Marketplace</strong> site? E-mail us.http://cbc.ca/consumers/market/files/health/accutane/warnings.html (1 of 2) [29/08/01 15:40:14]
<strong>Marketplace</strong> - <strong>Accutane</strong>they would have happened even if the persondid not take <strong>Accutane</strong>.The above excerpt is from the <strong>Accutane</strong> Medication guide,published by the US Food <strong>and</strong> Drug Administration, January23, 2001. It is in addition to the patient insert that comes withthe medication.SPECIAL SYMPTOMS YOU SHOULDTELL YOUR DOCTOR ABOUT:If you feel or become depressed, havethoughts of suicide, are unable to sleep<strong>and</strong> have mood swings while taking'<strong>Accutane</strong>', tell your doctor as soon aspossible. These feelings, although they donot happen very often, may occur whenyou are taking '<strong>Accutane</strong>' or after you havestopped taking '<strong>Accutane</strong>'. It has not beenestablished whether or not these symptomsmight be related to '<strong>Accutane</strong>'. However, itis important to tell your doctor as soon aspossible, if you have such feelings.<strong>Accutane</strong> pamphlet available inCanada makes passingreference to depression <strong>and</strong>/ormood swings.The above excerpt is from the product insert (Information forthe Patient) provided by Hoffman LaRoche with everyprescription of <strong>Accutane</strong> in Canada. The insert was issued inApril of 2000.Page One | Page Two | <strong>Accutane</strong> Warnings |<strong>Accutane</strong> Facts | LinksCopyright © CBC All Rights Reserved.http://cbc.ca/consumers/market/files/health/accutane/warnings.html (2 of 2) [29/08/01 15:40:14]
<strong>Marketplace</strong> - <strong>Accutane</strong>homeshop · help · contact · searchAir Date: February 6, 2001Producer: Christian Côté | Researcher: Colman Jones<strong>Marketplace</strong><strong>Marketplace</strong> FilesHealth &Safety »Your Food »Your Home »Travel &Recreation »The Environment »Your Car »Services »Scams »Your Money »Warnings &RecallsMicroscopePast ShowsLettersForumNewsletterSubscriptionSearchStreet CentsConsumerNewsCBC.ca<strong>Accutane</strong> Facts<strong>Accutane</strong> has been available through prescription as atreatment for severe acne since 1983. It is currently availablein about 80 countries.It is expensive. The drug costs from $500 to $600 for ast<strong>and</strong>ard first treatment of about 16 weeks. Most drug planscover the drug — they will usually place some limits oncoverage.Canadian spent approximately $38.5 million on <strong>Accutane</strong>prescriptions last year. Pharmacists filled 291,000 <strong>Accutane</strong>prescriptions in 2000.In 1995, 71.8 per cent of all <strong>Accutane</strong> prescriptions wereissued by dermatologists. General practitioners issued 25.1per cent of <strong>Accutane</strong> prescriptions. By last year, prescriptionsissued by dermatologists accounted for 60 per cent of thetotal. General practitioners issued 35 per cent of all <strong>Accutane</strong>prescriptions. (Source: IMS Health, CompuScript 2000)This slight shift in who is prescribing <strong>Accutane</strong> raises someconcerns in light of <strong>Marketplace</strong>'s mini-study of Toronto-areadoctors. Only one of ten general practitioners we spoke withsaid they warned patients of the possible risk of depression<strong>and</strong> suicidal thoughts. (For Canadian Medical Associationresponse to the <strong>Marketplace</strong> survey of doctors, click here.)Other known side effects of <strong>Accutane</strong>:Watch this storyin Real Videoin QuickTime[Download Players]<strong>Accutane</strong>Page OnePage Two<strong>Accutane</strong> FactsCMA response to<strong>Marketplace</strong> survey ofdoctorsUS <strong>and</strong> CanadianWarningsLinks●●●●●●dryness of the skin, lips, mouth <strong>and</strong> lining of the nosefacial or body rash, flaking of the skin, itching, peelingof the palms <strong>and</strong> solesincreased sensitivity to the suninflammation of the lips, mild nose bleedbleeding <strong>and</strong> inflammation of the gumsaches <strong>and</strong> pains in the jointsDo you have a comment aboutthis - or any other - story on the<strong>Marketplace</strong> site? E-mail us.http://cbc.ca/consumers/market/files/health/accutane/facts.html (1 of 2) [29/08/01 15:40:24]
<strong>Marketplace</strong> - <strong>Accutane</strong>●●increased fatiguedecreased night visionPeople on <strong>Accutane</strong> are also warned to avoid excessiveexposure to the sun <strong>and</strong> not to use vitamin preparations orhealth food supplements that contain vitamin A.Patients are also advised to avoid waxing for 5-6 months aftertaking <strong>Accutane</strong> — because of the risk of scarring.Page One | Page Two | <strong>Accutane</strong> Warnings |<strong>Accutane</strong> Facts | Links |Copyright © CBC All Rights Reserved.http://cbc.ca/consumers/market/files/health/accutane/facts.html (2 of 2) [29/08/01 15:40:24]
<strong>Marketplace</strong> - <strong>Accutane</strong>homeshop · help · contact · searchAir Date: February 6, 2001Producer: Christian Côté | Researcher: Colman Jones<strong>Marketplace</strong><strong>Marketplace</strong> FilesHealth &Safety »Your Food »Your Home »Travel &Recreation »The Environment »Your Car »Services »Scams »Your Money »Warnings &RecallsMicroscopePast ShowsLettersForumNewsletterSubscriptionSearchStreet CentsConsumerNewsCBC.caLinksCBC Online does not endorse the content of external sites.Links will open in a new window.● Hoffman LaRoche Canada● <strong>Accutane</strong> Information from the company● Letter from Roche Laboratories, Inc. to health careproviders <strong>and</strong> pharmacists● <strong>Acne</strong> information from Health Canada - including<strong>Accutane</strong>● Revised <strong>Accutane</strong> Label (U.S.), January 17, 2001[Roche Laboratories, Inc.] (WARNINGS,PRECAUTIONS, <strong>and</strong> ADVERSE EVENTS sectionsextensively revised) (PDF Format)● New <strong>Accutane</strong> Medication Guide (U.S.), January 22,2001 [Roche Laboratories, Inc.] (PDF Format)● Revised Informed Consent Form (U.S.), January 22,2001 [Roche Laboratories, Inc.] (PDF Format)● Images of birth defects caused by <strong>Accutane</strong> (JamesMadison University)● Articles about 1996 <strong>Accutane</strong> lawsuit from theColumbus Dispatch● "New Safety Information about <strong>Accutane</strong>" Updatedinformation from MedWatch Program, U.S. Food <strong>and</strong>Drug Administration dated 26 February 1998● U.S. Congressman Bart Stupak's <strong>Accutane</strong> site● FDA's Dermatologic <strong>and</strong> Ophthalmic Drugs AdvisoryCommittee meeting on isotretinoin (<strong>Accutane</strong>),September 18, 2000 (background info on pregnancy,psychiatric events risk management issues)● Comments of Larry D. Sasich, Pharm.D., M.P.H,FASHPPublic Citizen's Health Research Group before theFDA● Testimony from Government Reform Committee,"<strong>Accutane</strong> - Is this <strong>Acne</strong> Drug Treatment Linked toDepression <strong>and</strong> Suicide?" Washington, D.C.,December 5, 2000Watch this storyin Real Videoin QuickTime[Download Players]<strong>Accutane</strong>Page OnePage Two<strong>Accutane</strong> FactsCMA response to<strong>Marketplace</strong> survey ofdoctorsUS <strong>and</strong> CanadianWarningsLinksDo you have a comment aboutthis - or any other - story on the<strong>Marketplace</strong> site? E-mail us.http://cbc.ca/consumers/market/files/health/accutane/links.html (1 of 2) [29/08/01 15:40:32]
<strong>Marketplace</strong> - <strong>Accutane</strong>●●●●●<strong>Accutane</strong>/Ro<strong>Accutane</strong> Action Group"<strong>Accutane</strong> avengers", discussion group on adverseside effects linked to <strong>Accutane</strong>/Ro<strong>Accutane</strong><strong>Accutane</strong> Discussion BoardAbsolute <strong>Acne</strong> Forum<strong>Acne</strong> <strong>and</strong> <strong>Accutane</strong> - Dr. StollPage One | Page Two | <strong>Accutane</strong> Warnings |<strong>Accutane</strong> Facts | Links |Copyright © CBC All Rights Reserved.http://cbc.ca/consumers/market/files/health/accutane/links.html (2 of 2) [29/08/01 15:40:32]
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