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Posted by: Bill Vanderlinde ® 06/17/2003, 22:20:05 Author Profile |
There was an interesting report on Dateline NBC tonight about Irena Medavoy's lawsuit against her doctor and Allergan for her alleged adverse reaction to BOTOX. A summary is located here:
http://www.msnbc.com/news/927823.asp Bill Vanderlinde
Modified by Bill Vanderlinde at Tue, Jun 17, 2003, 22:21:02 |
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Posted by: Renee ® 06/17/2003, 23:29:44 Author Profile |
I'm glad this case is getting some media coverage. If you remember, I first brought this up awhile ago that this item was written about in Vanity Fair magazine. I didn't get too much response from my original post, but I think that this is an important lawsuit that may affect the SD community. In my next SD support group meeting we are going to talk about this very case. It will be interesting to see what happens with it...
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Posted by: Lynne Martinez ® Moderator-LM 06/18/2003, 17:52:39 Author Profile |
Bill, Thanks for the alert. I watched it. Your statement about "interesting report" may be an understatement for people on this BB. I hope every medical Botox patient watched "Dateline" last night or reads the transcript, and understands the issues/terminology. I was stunned. This lawsuit against Allergan could affect people with SD and other dystonias. It's being perpetrated/promoted by someone who started using Botox for wrinkles. The Hollywood scenario. As Renee says, she was the first person on the BB to alert us to this lawsuit, per the article in *Vanity Fair.* The word, "vanity," is most appropriate. I answered Renee's BB-post on April 27th. She was onto something then - still is. As a new Support Group Leader, to discuss this at her meeting, is inspiring. Excellent job, Renee. For anyone who did not watch the Dateline segment, I'll summarize, but encourage everyone on this BB (who takes Botox) to read the URL Bill put out and engage in discussion on this. It could affect your life. Summary is: gorgeous blond wife of a powerful Hollywood producer (famous name) was getting Botox for wrinkles for years, but also had headaches. So she said. She may have only been under the same stress we all deal with. So, she asked her doc to inject her for migraines. So her doc - Klein, esteemed in the medical community, but located in Hollywood - *dermatogist (Botox-injector) to the stars*- suggested he could also inject her neck for migraines, as Botox has been used succesfully for years for migraines. She had a strong reaction, thus is suing Dr. Arnold Klein, as well as Allergan, the producer of Botox. If she would have read this BB, she would have been fully informed that Botox *does* have side-effects. We discuss it on this BB daily. There are major issues involved in this case, which affect ALL patients who need medical Botox. The plaintiff says that 86 units of Botox in her neck (for migraines) was too much. As a patient-advocate, I'm with people everyday who get regular injections of 200-400 units (for Cervical Dystonia) on a 3-month basis. For Cervical Dystonia patients, Botox and Myobloc are on now "on label." SD patients get less, but that is because of the small-size of our laryngeal muscles. The plaintiff also states she would have NEVER had Botox for her migraines, if she knew it was *off-label.* Actually, she talks about having injections for many years (into her face, to erase wrinkles) when Botox was *off-label* for that purpose. Botox-Cosmetic was only approved by the FDA last year, for wrinkles. Off-label before that. We discussed that issue with the docs at the Arizona SD Symposium in March, 2002. They weren't happy that the FDA had finally approved Botox for cosmetic purposes, thus, putting it "ON label." Many people in Hollywood had Botox injections for years, when it was "off-label." The plaintiff did also. She signed a release. So "off-label" to erase wrinkles is OK, but she now complains and files a huge lawsuit since Botox for migraines is off label? In the interest of education on this Bulletin Board, I hope everyone understands what the term "OFF LABEL" means and that Botox for SD patients is still "off-label." My layperson's definition of "off-label" is (several medical symposiums worth) that it has not been approved for a specific use by the FDA. Means they couldn't do a study to approve it for *on-label* due to not enough study-subjects. I asked why several years ago. They couldn't find enough SD study subjects. We all know that Botox for SD-patients works (very well in some cases - sporadic in others) but the official definition of "off-label" still trails SD patients. When someone, such as this plaintiff (who is filthy rich) says she signed papers but didn't understand what "off-label" meant, I'm amazed. SD patients needing Botox should pay attention to this case. Elizabeth Taylor has come out to defend the doc (someone who's been injecting her with Botox Cosmetic for years). Ignorance is not a defense. Botox for SD'ers is "off-label" and it's never been a secret. The good thing about this lawsuit is that issues may come out. The bad thing is that it could severely affect medical patients receiving Botox. It's important to pay attention to this lawsuit, because these people have money and could make an impact. It's also important to know what terminology means. Botox for SD'ers is still off-label. Always has been. "Off-label" means not approved by the the FDA for that particular purpose. Does not mean bad. --Lynne (AD-SD; Northern California)
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Posted by: Linda S. Adamson ® 06/18/2003, 18:03:57 Author Profile |
I'm so discouraged that, once again, the opportunity to get SD on the public's radar screen was missed. The piece could have included more than a cursory mention of the variety of conditions for which Botox is the only currently successful treatment, on or off label. And our disorder was not in the mix that was mentioned.
Ah, well. It's a real service to all of us to be sure we know about this issue. Information is our friend, always. Thanks, Bill. Linda Adamson Annapois, MD -- AB |
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Posted by: Amelia ® 06/18/2003, 18:36:17 Author Profile |
I seen this broadcast and was disappointed as well that our condition wasn't mentioned. I was wondering if our botox use is on or off label? I assume it is on label since my insurance is covering it, but wasn't sure. Amelia, MN |
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Posted by: Lynne Martinez ® 06/18/2003, 19:20:54 Author Profile |
Hi Amelia, Read my post above. Botox use for SD'ers is OFF-LABEL. Always has been. The person filing the lawsuit is just talking about Botox (not medical conditions). Botox and the conditions it treats are not necessarily connected. She was talking about her own problems: wrinkles and headaches. "Off-label" does not mean bad (less than a viable drug or workable treatment) or not covered by insurance companies. "Off-label" means that the FDA has not given its seal of approval to a particular drug for a very specific purpose. It means there has been no official study of Botox for SD patients. We all know it works for many SD patients, even though it is off-label. The reason why Botox and Myobloc have been approved by the FDA for Cervical Dystonia (torticollis) patients is because they make an excellent study group. There are *many more of them*, than us. Also, in both cases, torticollis patients (CD) are injected with huge doses of the toxin. 100 to 400 units per treatment. They are easier to study than we are. Thus, the FDA has approved Botox and Myobloc for CD, but not for SD. Botox has been used successfully for Spasmodic Dysphonia patients for 14 years. However, you bring up a valid issue. When I was seeking treatment around 10 years ago, I had surgery (rather than Botox) because Botox was going to cost me alot of money and surgery was free. I had already lost my life savings of 25 years and was penniless, so could not pay for Botox. This may be an issue for SD Botox patients to pursue. Would it be cheaper, if it was "on-label?" Good question. The issue is, however, that the FDA is not going to launch a study in this day-and-age, to see if Botox works for SD patients. It's already acknowledged that it works for SD patients. But, it's still "off-label." Hope this information helps. Write me off the BB for additional info. --Lynne
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Posted by: arlene porter ® 06/18/2003, 21:16:48 Author Profile |
Lynne I appreciate your post on botox. I didn't realize it was "off label" or any of that stuff. Are there studies out there that we can participate in and if so how do we find out about them? Arlene
Keep your fingers crossed that I have a good "off label" shot Friday. |
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Posted by: Lynne Martinez ® Moderator-LM 06/18/2003, 22:42:13 Author Profile |
Hi Arlene, Yes, Botox for SD cases has always been off-label, but does it matter? Botox has helped alot of SD patients resume their lives, being able to talk again. There are many studies. We've been discussing them on the BB. You could do a search or write me offline. Bill knows also. If you want to be in one, you're in a good spot, being in the East (near the NIH) and also being on Botox, rather than having irreversible surgery. Actually, I didn't post on Botox. I responded to what Bill V. posted. Fascinating report on "Dateline" last night. Glad I saw that thing Bill mentioned. Isn't it weird for people in Hollywood who make mega-millions every year to say they don't understand the term "off-label?" so they will sue for malpractice and more millions, to raise our insurance rates? "Oh...I never would have had shots if I'd known it was off-label." Botox has been working for many people with SD for many years. Lots of research done. And, also, if anyone reads THIS bulletin board, they understand that there is no panacea. No perfect world. No perfect treatment. We all just do our best, looking for treatments and trying to support others. On this BB, we've documented flu symptoms, dysphasia (swallowing problems), droopy eyelids, breathiness, and many other things, with SD patients on Botox and not - including not being able to talk at all and losing long-term careers, etc. I'm not impressed with a Hollywood case, when it was "by choice." Most of us SD'ers don't have many options left, when we take Botox or other treatments in order to talk or live. The only reason the Irena Medavoy case interests me is if it impacts medical Botox patients, and if we can learn something from it. Best wishes on your upcoming "off-label" shot. Hope it goes well. --Lynne PS: Good to see you on chat yesterday.
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Posted by: fosterkappy ® 06/19/2003, 16:07:59 Author Profile |
I posted something on the BB about my pneumonia three days post botox. I was hospitalized for four days with a large intubated left lung in Feb of this year. It was on the left which is the same side as the injection I recieved for ABSD. I always thought it was related and was very scared to be so sick after the injection. I called my otolary.before I was hospitalized with the complaints of high fever and pain radiating from the neck down to below the ribcage. I was told it was just a coincidence. I did not believe that. I am newly diag. and that was my first "succesful injection", unfortunately I did not get the voice back. Once again, I just wanted to put this out there. I think it may be unsafe, at least it was for me... |
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Posted by: John Comer ® 06/19/2003, 16:41:43 Author Profile |
I read the trail of messages on this posting. Interesting case ! Who do you imagine will pay the cost of the litigation and the settlement? You guessed it. Us. John Comer ABSD |
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Posted by: Bill Vanderlinde ® 06/20/2003, 10:30:35 Author Profile |
I'm sorry that Mrs. Medavoy had such a difficult time after receiving BOTOX for her migraine headaches. But she did a really foolish thing, she had two different doctors treat her migraines without having them coordinate treatment. Here is a quote from the article: START QUOTE:
Maybe she just had a bad reaction to BOTOX, but it is quite possible that the BOTOX treatment for the migraines interacted in some unpredictable way with the migraine medication she received from her neurologist. Safety tip: ALWAYS tell your doctor what treatment you are receiving from other doctors, especially if you have two doctors treating the same disorder. Two different treatments may not give you twice the benefit, they could make you much worse. Bill Vanderlinde
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Posted by: Renee ® 06/20/2003, 21:59:09 Author Profile |
Good point, Bill... Renee ADSD/ Austin, TEXAS |
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