Well, it's official, BOTOX in the mainstream


Posted by Ken C. , Apr 15,2002,14:40   Archive

http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01147.html


FDA APPROVES BOTOX TO TREAT FROWN LINES

FDA today announced the approval of Botulinum Toxin Type A (Botox Cosmetic) to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines), a medical condition that is not serious. The product's manufacturer, Allergan, Inc., Irvine, California, is now allowed to market Botulinum Toxin Type A for this new indication.

Botulinum Toxin Type A is a protein produced by the bacterium Clostridium botulinum. When used in medical settings as an injectable form of sterile, purified botulinum toxin, small doses of the toxin are injected into the affected muscles and block the release of the chemical acetylcholine that would otherwise signal the muscle to contract. The toxin thus paralyzes or weakens the injected muscle.

Botox was first approved in December 1989, to treat two eye muscle disorders (blepharospasm and strabismus) and in December 2000 to treat cervical dystonia, a neurological movement disorder causing severe neck and shoulder contractions.

In placebo-controlled, multicenter, randomized clinical trials involving a total of 405 patients with moderate to severe glabellar lines who were injected with Botox Cosmetic, data from both the investigators' and the patients' ratings of the improvement of the frown lines were evaluated. After 30 days, the great majority of investigators and patients rated frown lines as improved or nonexistent. Very few patients in the placebo group saw similar improvement.

In these studies, the severity of the glabellar lines was reduced somewhat for up to 120 days for those patients who received Botox Cosmetic. Most of the patients in the study were female, and the majority was under 50 years old. It is recommended that Botox Cosmetic be injected no more frequently than once every three months, and the lowest effective dose should be used.

The most common adverse events following injection were headache, respiratory infection, flu syndrome, blepharoptosis (droopy eyelids) and nausea. Less frequent adverse reactions (less than 3% of patients) included pain in the face, redness at the injection site and muscle weakness. These reactions were generally temporary, but could last several months.

Because Botox Cosmetic is a prescription drug, it must be used carefully under medical supervision.

Related link: http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01147.html




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Re: Well, I'm steaming!

Re : Well, it's official, BOTOX in the mainstream --- Ken C.
Posted by Sally - in - Idaho , Apr 15,2002,16:45 Top of Thread Archive
We've spent much time discussing the possible benefits to our cause (BEB) when Botox becomes FDA approved for cosmetic use, and it appears that day has arrived. It's nice to know that frown lines are a "medical condition that is not serious." And also kind of the article's author to mention the use of Botox for strabismus and blepharospasm.

I stopped in to give my mother her mail and see how she was this morning and was greeted by, "Oh, I saw a show on TV about that Botox you take and how it is used to remove wrinkles." "Yes, Mother, but it's not approved by FDA for that condition yet (I had not read BB) and is being used as a vanity tool by people who can pay for it; they even have Botox wrinkle-removing parties." "Then what you are doing is purely cosmetic. I didn't realize that wrinkles around your eyes bothered you that much. How come your insurance pays for it?" She did not want to listen to any explanation of the differences in usage, so I gave up and came home in a steaming huff.

Now my own mother is convinced that I'm just indulging my vanity and when her friends begin talking about all the people who get their wrinkles removed via Botox, she will be able to say, "My daughter has those shots around her eyes."!!!!!!!!

Will we ever succeed in getting our message across?

Sally in North Idaho where it has sun-shined, hailed, snowed, rained and blasted cold wind today. Can't make up its mind.




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Re: Well, I'm steaming!/Sally

Re : Re: Well, I'm steaming! --- Sally - in - Idaho
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 16,2002,06:23 Top of Thread Archive
Sally, sometimes people make up their minds before we even have a chance to speak and "hear" what they WANT to hear. Interesting tho that those who get it for wrinkles could have the same possible side effects as some of us experience.



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Re: Well, I'm steaming!/Sally

Re : Re: Well, I'm steaming!/Sally --- Kathy in Atlanta
Posted by Ruth D. Barth , Apr 16,2002,07:26 Top of Thread Archive
The papers are all full of articles on botox here in Connecticut. The only reference I saw to bephlarospasm was that this drug was once used for a "rare neurological condition." My own sister who lives in another part of the country and who was never particularly interested in my medical problems (perhaps she forgot) told me of this new wonder drug that was going to keep her from having a face lift in a few years! How nice for Allergan stockholders!



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Re: Well, I'm steaming!/Sally

Re : Re: Well, I'm steaming!/Sally --- Kathy in Atlanta
Posted by Sally - in - Idaho , Apr 16,2002,20:23 Top of Thread Archive
Kathy, I found that interesting too (side effects) and am printing out the link from Ken to take to my neurologist tomorrow. When I told him that I had severe flu symptoms for two or three days once, and slight symptoms a couple of other times, he didn't think it was related to Botox, said he had never heard of such reaction. So I want to show him that I wasn't imagining. One time it really hit me hard within an hour or so after the injections and I had been perfectly well until the shots. We just have to keep reading (when we're able), talking and sharing information and educating our doctors.

Sally in North Idaho who had to explain blepharospasm to the endocrinologist today when trying to tell him why I can't go out for long walks.




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Re: Well, I'm steaming!/Sally

Re : Re: Well, I'm steaming!/Sally --- Sally - in - Idaho
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 17,2002,12:44 Top of Thread Archive
I have definitely had flu-like symptoms on more than a few occasions from my injections. You can tell him that.



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Re: Well, I'm steaming!/Sally

Re : Re: Well, I'm steaming!/Sally --- Kathy in Atlanta
Posted by Sally - in - Idaho , Apr 17,2002,18:49 Top of Thread Archive
I showed him the printout that Ken posted this morning when I was in for my injections and told him that several of my BB friends have had flu-like symptoms. He said he still doubts the connection as flu is prevalent all year long. He said he'd be more likely to believe it in someone (such as June) who reports always having those symptoms afterward. I asked why they were listed in that article and his answer was that they have to list anything that anyone reports.

Sally in North Idaho who doesn't have the flu ... yet.




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Re: Well, I'm steaming!/Sally

Re : Re: Well, I'm steaming!/Sally --- Sally - in - Idaho
Posted by June in Toronto (June Floyd,June in Toronto), Apr 17,2002,20:53 Top of Thread Archive
I'll just `pop over there', Sally and tell him all about my flu symptoms after botox - also about my sinus', bruising, blurred/double vision, pain side effects as well - what do you think, would he listen???

June in Toronto




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Re: He would listen

Re : Re: Well, I'm steaming!/Sally --- June in Toronto
Posted by Sally - in - Idaho , Apr 18,2002,10:48 Top of Thread Archive
June, he said he would be interested in hearing from someone who had those symptoms consistently, not just a couple of times as I did.

Sally in North Idaho who really must get on her way to the city.




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Re: flu symptoms after BOTOX

Re : Re: Well, I'm steaming!/Sally --- Sally - in - Idaho
Posted by Shirley-Arkansas-USA , Apr 17,2002,21:59 Top of Thread Archive
Sally, you can add me to your list of people that has developed flu-like symptoms several times within a few hours of getting BOTOX. Achiness, feverish and a little shaky. Just feeling "under attack" like I am coming down with something. Usually goes away within 24 hours. I remember this happened the first time that I got BOTOX. I woke up that night feeling sick and very trembly. I rarely notice it anymore. It seemed like the first time was the worst and then those symptoms decreased with severity each time that I got the BOTOX.

Shirley in Arkansas




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Re: flu symptoms after BOTOX

Re : Re: flu symptoms after BOTOX --- Shirley-Arkansas-USA
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 18,2002,16:00 Top of Thread Archive
I've actually thrown up.



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Re: flu symptoms after BOTOX

Re : Re: flu symptoms after BOTOX --- Kathy in Atlanta
Posted by Shirley-Arkansas-USA , Apr 18,2002,16:08 Top of Thread Archive
Now, look who's being graphic. ;-)
You win the emesis basin door prize!

Shirley




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Re: flu symptoms after BOTOX

Re : Re: flu symptoms after BOTOX --- Shirley-Arkansas-USA
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 18,2002,16:11 Top of Thread Archive
Well I'm sorry, but it's true. If we had a contemporary thesaurus of slang words for what i said, you'll find i was being most understated in my choice of words.



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Re: flu symptoms after BOTOX

Re : Re: flu symptoms after BOTOX --- Kathy in Atlanta
Posted by Lile , Apr 20,2002,02:27 Top of Thread Archive
Hi, I`m still around.I had to say that the first time i had BOTOX,I was sick as a dog(sorry ).I thought I had gotten food poison (cause I had gone to Papacitos to eat (a great Mex.food restaurant).2nd.and 3rd.time too.Nausea,vomit(even through my nose),chills,the worse I had ever been like flu.I had figured out what it was the 2nd. time.So the 4th. time I told my doctor.He found it unusual, but gave me Trimethobenzamide 200 suppositories. I read the cautions ,they didn`t sound too good . The side effects were worse .They said if you experience loss of balance,uncontrolled movements of arms and legs,shuffling walk,or rash contact your Dr. as soon as possible.I got rid of them quick. I took chamomile and (spanish name)istafiate, (silver sage bush,in English) tea.It worked .Now before I go for my shots I fix a big pot of the tea nd start drinking it ,as soon as I get home .For 2 days I keep it up .I`ve had shots about 6 times after that . I just follow my routine. Never got that awful flu symtom again.We have to be so careful with what the doctors give us(they haven`t got a clue).The pharmacy even put on directions unwrap and insert 1 supp. by mouth every 6 to 12 hours ( I called them cause I was so mad at their mistake). Live and Learn ,Lile -Tex.



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Re: flu symptoms after BOTOX/Lile

Re : Re: flu symptoms after BOTOX --- Lile
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 20,2002,12:42 Top of Thread Archive
I'm glad the chamomile tea helped. I've taken it at bedtime occasionally to help me sleep.



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Re: flu symptoms after BOTOX

Re : Re: flu symptoms after BOTOX --- Lile
Posted by Sally - in - Idaho , Apr 20,2002,14:24 Top of Thread Archive
Funny/not funny: "insert 1 supp. by mouth ...."

I also was given a shot to stop the vomiting a couple of years ago when I had severe gastritis. A while later, I read on the BB that Compazine (which I had) could have dystonia as a side effect! Now I will never allow it again. They also prescribed suppositories, which I dutifully purchased at the pharmacy but never used. The vomiting had stopped and I just drank tea and ate toast and applesauce for a couple of days.

Sally in North Idaho, where medical errors are made, too!




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Re: flu symptoms after BOTOX

Re : Re: flu symptoms after BOTOX --- Sally - in - Idaho
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 21,2002,12:51 Top of Thread Archive
wha is gastritus? a stomach virus? or flu? Was this since you've had your injections or before?



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Re: Well, I'm steaming!/Sally

Re : Re: Well, I'm steaming!/Sally --- Kathy in Atlanta
Posted by Ann Doyle , Apr 17,2002,10:06 Top of Thread Archive
Sally, your mom doesn't want to know you have a (condition,, symptom, illness , disease((someone else used a better word but I can't think of it}}. Ann Doyle I an breaking out in my allergy as we speak. Ann



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Re: Well, I'm steaming!/Sally/Ann

Re : Re: Well, I'm steaming!/Sally --- Ann Doyle
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 17,2002,12:46 Top of Thread Archive
Disorder. neurological disorder.



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Re: Well, I'm steaming!/Sally/Ann

Re : Re: Well, I'm steaming!/Sally/Ann --- Kathy in Atlanta
Posted by June in Toronto (June Floyd,June in Toronto), Apr 17,2002,13:08 Top of Thread Archive
Disease is the term I use - its gets more attention and, let's face it, Dystonias don't get that!

June in Toronto (beb/meige) who was advised by a neurologist to use the word disease for Dystonias.

--modified by June in Toronto at Wed, Apr 17, 2002, 20:54:15




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Re: Well, I'm steaming!/Sally/Ann/June

Re : Re: Well, I'm steaming!/Sally/Ann --- June in Toronto
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 18,2002,16:20 Top of Thread Archive
June, I've been chastised quite firmly for using disease as a description of beb, both by the BEBRF and people who immediately move away from as I try to describe it. I mean rapidly they move away, as that connotes a contagious factor.



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Re: Well, I'm steaming!/Sally/Ann/June

Re : Re: Well, I'm steaming!/Sally/Ann/June --- Kathy in Atlanta
Posted by June in Toronto (June Floyd,June in Toronto), Apr 18,2002,17:12 Top of Thread Archive
I'm still gonna use it!

June who has beb/meige disease!




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Re: Well, I'm steaming!/Sally/Ann/June

Re : Re: Well, I'm steaming!/Sally/Ann/June --- Kathy in Atlanta
Posted by Alan Phair , Apr 18,2002,20:21 Top of Thread Archive
Kathy, several years ago, there were a few people on the Bulletin Board that got upset when people referred to BEB/Meige as a disease. If you notice in my postings, I rarely if ever call it a disease and usually just refer to it as a disorder. I only do this because it wasn't worth arguing with them. Their logic was that if we called it a disease, we were sort of giving in to it which of course was absurd. Anyway, when I talk to others outside of the BB, I refer to it as a disease which it is. I think that it puts it in it's proper perspective as something that is not just a minor thing such as a cold. Just thought that I would give you a little background history. I didn't know that people still got upset over such trivial things...Alan



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Re: Well, I'm steaming!/Sally/Ann/June/Alan

Re : Re: Well, I'm steaming!/Sally/Ann/June --- Alan Phair
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 20,2002,12:45 Top of Thread Archive
Thanks for the bit of history. I'm not upset.



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Re: Well, I'm steaming!/Sally/Kathy/June/Alan

Re : Re: Well, I'm steaming!/Sally/Ann/June/Alan --- Kathy in Atlanta
Posted by Ann Doyle , Apr 21,2002,10:07 Top of Thread Archive
I was just trying to be light hearted. I don't care what anyone calls it as long as you don't call it an inconvenience. Ann D.



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Re: Well, I'm steaming!/Sally/Kathy/June/Alan

Re : Re: Well, I'm steaming!/Sally/Kathy/June/Alan --- Ann Doyle
Posted by Pippa , Apr 22,2002,09:08 Top of Thread Archive
I laughed at this, Ann! I have, in true British understatement and misplaced humour, called it an "inconvenience", or "nuisance", sometimes to people who are getting upset for me when my eyes spasm, in order to calm THEM down...and to prevent myself using more extreme unladylike language! I think they know however that I really feel it is the understatement of the year!
Pippa, after a wonderful weekend being visited by my brother and wife for the first time for years, wonderful weather, barbeques and enough wine to make me very happy indeed! Yes, Scotland does have good Springtimes. (Pity about it's "summers".)



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Re: Well, I'm steaming!/Sally/Ann/June

Re : Re: Well, I'm steaming!/Sally/Ann/June --- Kathy in Atlanta
Posted by Sally - in - Idaho , Apr 19,2002,23:41 Top of Thread Archive
I've settled on "neurological disorder which causes my eyes to clamp shut and spasm, similar to having a Charlie horse." Disease does tend to drive some people away, but this annoying problem is worthy of some sort of strong term!

Sally in North Idaho whose eyes have felt hot and burning all day.




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Re: Well, I'm steaming!/for Sally

Re : Re: Well, I'm steaming!/Sally/Ann/June --- Sally - in - Idaho
Posted by Ann Doyle , Apr 21,2002,06:08 Top of Thread Archive
I'm with you Sally. I looked up the definitions of condition, disease, symptem and disorder and disorder does fit the best. With my short term memory loss, I'll forget next time. Very frustating. It took me months to remember that I have Benign Essential Blepharospasm with Meige Syndrome. I had practice though because 2 years ago I had to learn that my husband has antiphosforescent syndrome. No doctor has heard of that one either but if we end up in the ER with him, I tell them it's serious that he get a breathing machine immediately (true) and we are put at the top of the list
Off the track: I was talking about shots and someone corrected me to call them injections--sounds less painful maybe? I looked that one up and it seemed either would be appropriat. Asked a Dr. and he said it's like the difference between a broken arm and a fractured are---lay speak, DR. speak. Ann Doyle



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Re: Injections vs. Shots

Re : Re: Well, I'm steaming!/for Sally --- Ann Doyle
Posted by Sally - in - Idaho , Apr 21,2002,18:22 Top of Thread Archive
Injections vs. shots ... I always think of it as "injections" sounds more upper crust! "Shots" is more on the peasant level! How about that?

Sally in North Idaho who falls somewhere in between, so I get half and half: injections on one side, shots on the other. Take your pick, they all feel the same!

--modified by Sally - in - Idaho at Sun, Apr 21, 2002, 18:23:28




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Re: Injections vs. Shots/sally

Re : Re: Injections vs. Shots --- Sally - in - Idaho
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 23,2002,10:40 Top of Thread Archive
Sally, You ARE Hilarious!! I have to end my computer time right here this morning before my eyes get bad. I am still laughing!!

--modified by Kathy in Atlanta at Tue, Apr 23, 2002, 10:40:47




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Re: Could this be good for us?

Re : Well, it's official, BOTOX in the mainstream --- Ken C.
Posted by Kelly Saffell , Apr 16,2002,15:35 Top of Thread Archive
I spoke at length with the Allergan rep at my support group meeting about this topic. She personally feels like we do in that BOTOX is sooo much bigger than wrinkles. However, since BOTOX did not require any additional testing in order to be approved cosmetically, all of the money made from the cosmetic market can be used for R&D for US! I would challenge you to make your voices heard. I have been interviewed for a magazine, been on the news, and was just interviewed today by a local newspaper for a health segment to appear later this week. Be persistent and help spread the word. There are alot of people out there willing to listen and who are very interested in what we have to say-we just have to find them.



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Re: Grass roots movement

Re : Well, it's official, BOTOX in the mainstream --- Ken C.
Posted by denise mckew , Apr 19,2002,08:31 Top of Thread Archive
Hi,

I can see both sides of the picture, the "supply and demand", which may help us. And the "hey what about us who truely need Botox" side, which which the cosmetic use belittles. So I went ahead and sent the following e-mail to the Portland ME, NBC affliate. It seems that none of the big-time shows, Oprah, The Veiw etc. are interested, so I though maybe the local stations may take an interest.
Here's what I wrote:

Good morning,

Botox has been in the news a lot lately as it was just approved for cosmetic use. There is however, a more serious condition called dystonia for which Botox is used. I would like to see Channel 6 do a story on this condition. It is very upsetting to us who have to have Botox injections for health reasons, to see people getting together for Botox parties to make themselves a little younger.

I personally have the dystonia called blepharospasm w/apraxia. Blepharospasm, which is a rare neurological motion disorder causes excessive blinking and twitching of the eyes, facial spasms, and in severe cases can cause the eyes to close completely for extended amounts of time.

Please visit: www.blepharospasm.org and www.dystonia-foundation.org for more information on the seriousness of these conditions.

Thank you for your time. I hope to hear from you soon.

Denise McKew
Lewiston ME

Lets hope I get a response.

Take care -
Denise




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Re: Grass roots movement

Re : Re: Grass roots movement --- denise mckew
Posted by Sally - in - Idaho , Apr 19,2002,23:43 Top of Thread Archive
Good going, Denise. I keep intending to send a letter to our daily newspaper, but just continue to put it off. Another big article today about Botox. Rather a negative viewpoint of all the vanity shots.



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Re: Grass roots movement/Denise and Sally

Re : Re: Grass roots movement --- Sally - in - Idaho
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), Apr 20,2002,12:48 Top of Thread Archive
Good work Denise. Sally. I'm sort of noticing a negative tone also to some of the stories covering the botox for wrinkles.



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Re: Grass roots movement/Denise and Sally

Re : Re: Grass roots movement/Denise and Sally --- Kathy in Atlanta
Posted by Sally - in - Idaho , Apr 20,2002,14:20 Top of Thread Archive
I am seriously considering responding to the editorial that was in the "Spokesman Review" two days ago since it was quite negative toward cosmetic Botox, but still didn't bring out the medical use. This just might be an appropriate time and catch the interest of one of the editors.

Sally in North idaho who just came back from the twice-monthly visit of the county bookmobile to our village. Now all I want to do is curl up and read!! The year and a half or more that I couldn't read was such torture that I have treated myself with permission to spend as much time as possible reading now, in the event that the ability is once again taken from me. So ... dust bunnies, go forth and multiply; I don't care!




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Re: READING AND DUST BUNNIES

Re : Re: Grass roots movement/Denise and Sally --- Sally - in - Idaho
Posted by June in Toronto (June Floyd,June in Toronto), Apr 20,2002,19:13 Top of Thread Archive
Let the dust bunnies fall where they may, Sally. Read a good book for me and tell me all about it sometime.

June in Toronto who would love to be able to read a good book again.




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