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Allergan, the maker of Botox and Latisse sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses. Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

The impetus for the lawsuit is an FDA requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment. According to an Allergan spokesperson, "Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment." In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

Allergan estimates that 20% of Botox usage is off-label for unapproved indications. Because of this, the company believes that it is important to “proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique to ensure that physicians are equipped to treat patients as safely and successfully as possible. And, “without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution." 

It sounds to me like the lawsuit is more about increasing the annual sales of Botox for a growing number of unapproved indications rather than ensuring patient safety. These types of lawsuits have becoming increasingly popular because of previous legal precedent that extends an individual’s right to freedom of speech to corporations and other entities. However, more importantly, if Allergan is successful, it could signal the end of the regulations and ban on off label promotion of prescription drugs and devices. Is eliminating a few wrinkles from aging baby boomers (like me) worth all the trouble?

Until next time...

Good Luck and Good Job Hunting (hmm...maybe if I look younger I might be able to find a job?)

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One day after the US Food and Drug Administration (FDA) approved Dysport, a new product that will compete with Botox, the agency ordered that labels for all botulinal toxin-based drugs must carry a black box safety warning. For those of you who may not know, that is the most stringent kind of safety warning label—viewed by many in the industry as “the kiss of death”— that the agency can order to appear on the products that it regulates. 

Black boxes (literally a black box with bold-face risk information) are typically reserved for medications that are know to have serious or life-threatening side effects or risks. For example, many antidepressants—most recently serotonin re uptake inhibitors (SRIs)—carry black box warnings of increased danger of suicidal thoughts and actions. 

Over the last 20 years FDA approved Botox to treat crossed eyes, eyelid spasm, severe underarm sweating and cervical dystonia (a painful and severe neck condition that can cause an abnormal head position) Cosmetic Botox was approved to treat skin folds and wrinkles in 2002. Allergan, the company that manufactures Botox, reported $1.3 billion in worldwide sales of the drug in 2008. 

Botox and Dysport are injectible products made from the highly paralytic toxins produced by the bacterium Clostridium botulinum. Botulinal toxins interfere with muscle contractions and patients with botulism food poisoning exhibit what is known as “flaccid paralysis.” Afflicted individuals cannot breather and will die without early intervention. FDA order the black box safety warning labels because there were numerous reports of serious health problems, complications and deaths caused by the drug spreading from the site of injection to other parts of the body. 

Most of the problems with Botox resulted from the overuse of Botox for unapproved treatments like limb spasticity in children with cerebral palsy (although misuse of the product for cosmetic purposes may have also contributed to the problems). The agency will now require that all botulism-based products carry a black box warning explaining that the medication has the potential to spread from the site of injection to other body sites—with the potential to cause serious problems like difficulties swallowing or breathing. Also, it will require manufacturers of botulinal products [Allergan (Botox) and Ipsen/Medicis Pharmaceuticals (Dysport)] to send physicians letters warning of the risks and to craft medical guides given to patients at the time of injection. 

The new warning labels will likely do little to discourage the rampant use of Botox and Dysport for cosmetic indications. After all, beauty will always come before safety! 

Until next time... 

Good Luck and Good Job Hunting (looking younger may help)

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Allergan, the drug maker that brought us Botox is at it again! The company has a new FDA-approved drug called Latisse that can be used to grow longer, lusher eyelashes. It will be available by prescription at the end of this month.

Latisse contains the same prostaglandin analog that is found in Allergan’s Lumigan, an eye drop treatment for glaucoma. A side effect of the analog is to make the eyelashes of many patients who use the eye drops longer and fuller. Other side effects can include red, itchy eyes and changes in eyelid pigmentation.

Allergan conducted a 16 week clinical trial with about 280 volunteers to assess the safety and efficacy of Latisse. In the study, half of the participants used Latisse daily for 16 weeks. Study results showed that the eyelashes of patients treated with Latisse typically grew 25 percent longer, 106 percent thicker and 18 percent darker. While 3.6 percent of patients experienced eye itching and red eyes, none exhibited a change of eye color. These results were reviewed by the Food and Drug Administration, which approved the drug in late December, 2008.

While some medical experts are concerned about these Latisse’s side effects, the financial upside for the drug is considered by some analysts to be substantial. At present, the annual size of the worldwide mascara market is about $5 billion. Allergan expects sales of Latisse to eventually rival those of Botox —Allergan’s other FDA-approved drug used for therapeutic and cosmetic purposes. Sales for cosmetic use of Botox were $600 million in 2007.

Longer, lusher lashes will come at a price for the people who chose to get a prescription for Latisse. Unlike mascara which is relatively inexpensive (so I am told), a monthly dose of Latisse will cost $120. However, according to my wife, longer, lusher lashes are the equivalent of the Holy Grail for most women. When I mentioned the Latisse’s monthly cost, she said quickly replied “I don’t care. I would still do it”—this from a woman who rarely wears any make up. Although my wife doesn’t constitute a valid statistical sample size, her responses suggests that Latisse just might be the biggest thing to hit cosmetic medicine market since well—uh— Botox!

Until next time…..

Good Luck and Good Job Hunting (try Allergan, they are hiring!)

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Allergan Inc., the maker of Botox, will close a plant in Ireland, eliminating 300 jobs, and transfer production to a factory in Costa Rica.

Ireland has lost about 10 percent of its manufacturing jobs over the last six years, as labor costs climb. As many of you may know, many US pharmaceutical and biotechnology companies set up production facilities in Ireland over the past 10 years or so because of its well trained workforce and lower labor costs.  However, because the Irish economy has grown so quickly and its middle has prospered, labor costs have been rising and manufacturers are now looking elsewhere to control costs. Unfortunately, this is likely to be harbinger of things to come for markets that were once sources of cheap, skilled labor.

Until next time….

Good Luck and Good Job Hunting Lasses and Laddies!!!!!!!!

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