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Poisonous protein or medical miracle - Botox uncovered

What is Botox?
Botulinum toxin is a neurotoxin protein produced by the bacterium Clostridium botulinum. It is one of the most poisonous naturally occurring substances in the world, and it is the most toxic protein. Though it is highly toxic, it is used in minute doses both to treat painful muscle spasms, and as a cosmetic treatment in some parts of the world. It is sold commercially under the brand names Botox and Dysport for this purpose. The terms Botox and Dysport are trade names and are not used generically to describe the neurotoxins produced by the clostridia species. Small and diluted amounts of the protein can be injected directly into the muscles affected, thus causing a controlled weakening of the muscles. [Wikipedia]

Botulinum toxin is marketed under a few brand names for cosmetic purposes. One of the most popular trade name for the substance is Botox. In the late 1980s, the FDA approved the usage of Botox after studies had proven that it could stop illnesses like strabismus (lazy eye) and blepharospasm (uncontrolled blinking). Botox has been used by cosmetic doctors and surgeons for years to treat facial creases and wrinkles. In April 2002, the FDA approved Botox as a treatment for glabellar lines, which are moderate-to-severe frown lines that develop between the eyebrows. Botox has also be used to treat other areas of the face, however, this use has NOT been approved by the FDA as safe.

Understanding wrinkles
There are what we call static or dynamic lines/wrinkles on our face.
Dynamic wrinkles are present only when you animate your face, whereas static wrinkles are present all the time.
Dynamic wrinkles, if they're in the forehead or crow's feet area, can be treated very well with Botox. However, Botox would not be a good treatment for a static wrinkle or for a nasal labial fold wrinkle (the line to the sides of the nose and mouth). Rather use a filler such as Restylane on these lines.

How is the cosmetic procedure done?
Botox injection takes only a few minutes to administer. The cosmetic procedure is done without using anesthesia. The substance is injected into the affected muscles by using a fine needle to avoid discomfort and pain. Generally, it takes three to seven days for Botox treatment to take full effect. It is also advisable to avoid drinking alcohol one week before undergoing the cosmetic surgery. The intake of aspirin and anti-inflammatory medicines should be stopped two weeks before undergoing Botox treatment. Remember: The safest form of Botox is administered by a board registered cosmetic surgeon.

How does the treatment work?
Once injected, Botox blocks the transmission of signals from the nerves to the muscles. As a result, the injected muscle can no longer contract, thus causing the wrinkles on the face to soften and relax.
This cosmetic procedure is usually used to treat frown lines, crow's feet, and forehead lines. It must be noted that wrinkles caused by gravity and sun damage cannot be treated by Botox.

How long does botox last?
The effects of Botox treatment last between four and six months. Wrinkles and lines will eventually re-appear as muscle action returns. But this time, the lines and wrinkles are less serious considering that the muscles are being trained by the substance to relax.

What are the complications of Botox treatment?
The most common side-effect of Botox treatment is temporary and partial bruising. Headaches can also occur in rare instances. Meanwhile, some patients may develop eye drooping, which resolves usually in three weeks. This complication results from the migration of the Botox. For this reason, rubbing the treated area within 12 hours after the procedure is discouraged. Patients are advised to lie down for three to four hours after taking Botox treatment.

Who are the candidates qualified for Botox?
Botox treatment is obviously a tempting procedure for people who want to enhance their facial appearance. But not everyone is qualified to undergo the cosmetic procedure. If you are planning to have such treatment, it is advisable for you to consult first with your doctor and discuss whether you are qualified for Botox or not. It is also important for your doctor to know your medical history in order to avoid complications during and after the procedure. Pregnant women, women who are breastfeeding their babies and people who suffer from neurological disease are not allowed to undergo Botox treatment.

What are the side effects?
Important Safety Information
Serious heart problems and serious allergic reactions have been reported rarely in BOTOX® Cosmetic treatment. If you think you're having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately.

The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising may be associated with the injection. Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects. BOTOX® Cosmetic is administered by physicians and is available only by prescription.
Please See Full BOTOX® Cosmetic Product Information (PDF) - The 'small print' side effects, you know, the ones they don't really want you to know about. (The document will open in a blank new window - please wait for the document to download - it shouldn't take long)

THE OTHER SIDE OF BOTOX
A few articles and press reports regarding the dark side of botox. As with everything in life, Botox also has it's risks.

Botox may cause new wrinkles
People who have botox injections may develop new wrinkles as a result of the treatment, it has been claimed. A leading expert has suggested people unconsciously recreate facial expressions in the area where the facial muscles have been paralysed. This can sometimes cause other nearby muscles to compensate, which in turn can create new wrinkles. http://news.bbc.co.uk/2/hi/health/2772263.stm

Eye droop after years of botox
Hi, I'd been having botox to my forehead for two years without complication, then in Dec 04 i had a droop in my right eyelid lasting 5 months. In June this year I asked my consultant whether I should risk botox again and she said yes it was very unlikely to reoccur so I went ahead and had only 15 units. Now 6 months later I have lowered eyebrows and a 4mm droop to the right eye and 2mm droop to the left eye. Today I paid to see a neurologist who said it is unlikely that the problem will resolve as in his opinion I have withered the muscle fibre in eyelids and forehead with repeated use of botox. He said this is commonly known to happen after using for a couple of years. Yet the consultant who injected me has been having it herself for 8 years with no ill effect. He suggested a brow lift and eyelid surgery but the consultant swears it should wear off in 8 to 12 months. Please has anyone heard of botox lasting this long or of anyone suffering similar ill effects. I cannot believe that a procedure heralded as safe and temporary could cause permanent damage. I look awful, have lost all confidence, please can anyone offer any information?
http://www.makemeheal.com/forum/viewThread.jsp?forum=7&thread=53784

Paralysed by a quest for perfection
By Chris Ayres (The Times)
Black market botox has cost the health of a doctor and his patients

HE WAS a brilliant and handsome doctor from New Jersey who had won a coveted fellowship and once been an Episcopalian altar boy and high-school football star. But Bach McComb, 47, is now paralysed and suffering from pneumonia after becoming the unlikely victim of one of the worst cosmetic surgery disasters in recent memory. The Florida doctor injected himself, along with his girlfriend and two patients, with a huge quantity of cheap, imitation Botox, the anti-wrinkle treatment, which turned out to be raw botulinum toxin, the same lethal bacterium used in biological weapons.

The other victims of the black-market Botox disaster include Eric Kaplan, 52, a chiropractor and Mr Kaplan’s wife, Bonnie, 53, also in a critical condition. Dr McComb’s girlfriend and assistant, Alma “AJ” Hall, 34.
All of them had simply wanted to get rid of a few facial wrinkles. Instead, it is thought that the victims suffered dry mouths, slurred speech, double vision, diarrhoea and vomiting before the onset of progressive muscle paralysis. Friends and family say that they are unable to do anything but wiggle a few fingers and toes. For two of the victims — Dr McComb and Mr Kaplan — the horror was made worse by their medical knowledge. As the symptoms of weapons-grade botulism became obvious, they must have known their fates.

Allergan, the only company that makes approved Botox treatment in the US, said in a statement that its product had nothing to do with the horrific botulism infections at the clinic in Broward, near Miami, in Florida. A vial of Botox contains about 100 units of botulinum toxin, which paralyses facial muscles for up to eight months, temporarily getting rid of wrinkles. Mr Kaplan and his wife both received up to six shots from a vial which may have contained as many as ten million units of raw botulinum toxin.
http://www.timesonline.co.uk/article/0,,11069-1407629,00.html

If you're considering Botox® injections, there are important precautions to take:
1. Know the qualifications of the doctor who would be administering the treatment.
2. Ask the doctor how many patients he or she has successfully treated with Botox®.
3. Ask if it's possible for you to speak with any of them so you can know, from the patient's perspective, what to expect.
4. Don't hesitate to see the vial of Botox®. Allergan is the only company approved to sell botulinum toxin for human use. If what you see isn't from Allergan, do NOT continue with the procedure. [see picture at top of page]

Dark Side of Beauty: BOTOX Testing Kills Animals
Whether for therapeutic or cosmetic application, each batch of Botox must be tested before Allergan releases it to doctors and dermatologists; to determine the right potency of Botox - the key ingredient of which is botulinum toxin, the most poisonous substance known to mankind - Allergan uses the highly questionable test known as LD50 whose sole purpose is to find the dose that kills 50% of the animals used in the test.

You read that right: The end point of the LD50 test is death to 50% of the animals used. The test's full name is Lethal Dose 50 Percent.

Botox, or Botulinum Toxin Type A, comes from the waste of the bacteria Clostridium botulinum, the same toxic byproduct that causes botulism food poisoning. Botox works by blocking nerve signals between the brain and muscles, effectively paralyzing the muscles that cause wrinkles and certain medical disorders. Because Botox is produced from bacteria, it is created with varying levels of potency-some batches of the drug, in other words, are stronger than others. To determine the proper strength for each vial of Botox, Allergan must test each and every batch of botox.

The LD50 Test: A Failing Grade
Little information is available publicly about the types of potency testing, if any, that the FDA requires Allergan to conduct on Botox. Repeated Freedom of Information Act requests by The HSUS (Humane Society of the United States) to the FDA yielded little pertinent information. However, given that the LD50 test is the international standard for assessing potency of botulinum toxin products, there is little doubt that the FDA holds Allergan to this standard.

Whether or not the FDA mandates the test, we do know that Allergan uses LD50 to test Botox batches. This test involves giving mice a single injection of the product into their abdominal cavity and seeing if the animal dies within 3-4 days. The mice are first assigned to one of various groups; each group will receive a different strength of the product in order to estimate the strength that kills half of the targeted group. That strength (the LD50 value) is then considered a single "unit" of Botox; from there, Allergan packages a given number of units into a vial for human use.

Approximately 100 mice have conventionally been used per test, and there are indications that each batch of botulinum toxin product is tested more than once. Allergan has claimed to The HSUS that the company has significantly reduced this number.

Of all the tests done on animals, the conventional or classical LD50 is one of the most brutal. In Botox testing, animals endure differing levels of muscular paralysis and suffer from impaired vision and dry mouth. Animals who die do so from suffocation, after their diaphragms become paralyzed, and they can no longer breathe. Those who don't die immediately may languish with varying degrees of paralysis before being euthanized at the end of the three - to four - day test.

[Information comes courtesy of the Humane Society of the United States (http://www.hsus.org/ace/21435 ) who believe this type of testing must end. The HSUS is urging consumers who use Botox purely for cosmetic purposes to avoid the product until Allergan stop testing it on animals. There are additional calls for individuals to write to Allergan to convince the company that animals should not die in the name of beauty and to contact the US Food and Drug Administration to demand that the agency funds, researches and approves alternatives to LD50 testing.]

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