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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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There is a growing worldwide shortage of nurses and other typically female-dominated medical professionals. The acute shortage of nurses in Europe has induced at least one Czechoslovakian clinic to develop a novel—albeit somewhat controversial— approach to retain and recruit hospital personnel. According to an article in today’s New York Times (which was also reported on NPR several weeks ago) “When Petra Kalivodova, a 31-year-old Czechoslovakian nurse, was considering whether to renew her contract at a private health clinic special perks helped clinch the deal: free German lessons, five weeks of vacation, and a range of plastic-surgery options, including complimentary silicone-enhanced breasts.” She opted for cosmetic breast surgery (which normally cost about $3,500) and also had liposuction on her thighs and stomach citing that she her appearance is important to her and her patients.  Perhaps, more importantly, she could never have afforded to have the procedures done on her current salary which is lower than most bus drivers. Of the 50 nurses working at the clinic, 10 opted for plastic surgery, while several more were considering it. And, at least one male employee is seriously considering liposuction.

While offering plastic surgery as an inducement to recruit and retain hospital employees is somewhat controversial, it highlights the need to improve the salaries and benefits of nursing and other medical care professionals. In many places in Europe, nurses and other hospital employees make considerably less than bus, truck drivers and other non-technical workers. The same is true in the US which has also been experiencing ongoing nursing shortages. But, hospitals and clinics here have yet to offer plastic surgery options to recruit or retain medical and support staff personnel. Unlike Europe, where cosmetic surgery is booming, plastic surgery procedures have dropped about 9 per cent this year as compared with years past.

Like it or not, cosmetic surgery is an option in today’s world and, accordingly, people ought to have the right to choose whether or not it is right for them. However, it is important to remember that cosmetic surgery is invasive and potentially serious medical complications including infection, disfiguration and death can occur. The fact that 20 per cent of the Czech nurses chose cosmetic surgery over more vacation time or free German lessons may be indicative of the growing pressure placed on both women and men to look young, vibrant and remain sexy. Further, there are marketing and employment studies which suggest that younger more attractive people get hired more easily and advance their careers more rapidly than average, older-looking ones.

When Petra Kalivodova, the 31-year-old Czechoslovakian nurse who opted for breast augmentation and liposuction was asked about her choice she said “People of my mother’s generation look down on me for getting the surgery—“I see it in their eyes. But I don’t care. I did this because I wanted to and I didn’t ask anyone’s permission, including my boyfriend.” I think her comments reflect a changing and growing attitude among women 35 and under who believe that personal choice, feminine beauty and pursuing professional careers are no longer mutually exclusive.

Until next time.

Good Luck and Good Job Hunting!!!!

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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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I spent the entire morning reading various articles, blog posts and comments about what is wrong with the US Food and Drug Administration (FDA). Not surprisingly, phrases like “drug lag”, the large size and costs of clinical trials, political and corporate influence, reduced numbers of NME approvals etc appeared ad nauseum. These are the same old, tired complaints with the agency that have been bandied about for the past 10 years or so. 

In my opinion, the bottom line is this: the agency is egregiously under staffed and under funded despite the fact that companies pay steep user fees for regulatory reviews. I can understand why corporate America is dissatisfied with the service that it receives from FDA. It is natural to expect good customer service after paying large sums of money to a service provider.  However, it is important to note, that the words “customer service” don’t appear any where in the Food, Drug and Cosmetic Act of 1938 (although it can possibly be implied fromPDUFA in 1992 and FDAMA in 1997).  Nevertheless, what is mentioned in the FD&C is SAFE and EFFICACIOUS pharmaceuticals, biologics and medical devices. Put simply, safe and efficacious products, not customer service, is REAL the mission of FDA.  With this in mind, the agency is legally required to do everything in its power to provide Americans with carefully scrutinized and safe medical devices, pharmaceutical and biotechnology products.

If we Americans want FDA to accomplish its REAL mission, then the agency must be sufficiently funded, adequately staffed and have strong, non-partisan leadership. Unless this occurs, FDA will continue to struggle and remain dysfunctional well into the 21^st century.

Until next time…

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