Newsinferno.com posted a story that spotlights a trend in which the Australians continue to scrutinze the medical and comsetic uses of botulinum toxin Type A:

On Tuesday, The Cosmetic Physicians Society of Australasia (CPSA) told its physicians to avoid using Botox and similar products on pregnant women.  “Botulinum toxin should not be prescribed to pregnant women and we advise our members to strictly follow these guidelines,” said the CPSA’s Dr Gabrielle Caswell said in a statement. “. . . there are some circumstances, such as during pregnancy, breastfeeding, glaucoma and neuromuscular disease where it is not an appropriate medication.”

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According to a review that was recently published in the Truth in Aging blog, the new Botox competitor, Reloxin, is poised to take down the established botulinum toxin Type A champ, Botox. This is an easy claim to make, seeing as how every aesthetic-industry pundit this side of the Atlantic has been, for years, sighing that Botox really needs a competitor. However, Truth in Aging at least makes the case without resorting to too much hype or hyberbole.

Though it is superficially identical to Botox, Reloxin is different in that it is suspended in lactose, whereas Botox is suspended in sodium chloride. Also, Botox is provided in 100-unit vials, as opposed to Reloxin’s 500-unit vials, making the preparation less expensive for doctors- a bonus likely to be passed on to consumers. Doctors typically pay over $500 per vial of Botox, enough to treat only five different facial areas, or 1-2 patients. With the entry of Reloxin in the arena of injectable treatments for wrinkles, a marketing battle and pricing war are expected to ensue.

Officially termed “botulinum toxin type A” (since it is made from the same bacteria that causes botulism food poisoning), Reloxin was originally submitted to the FDA for approval in March of 2007, with the expectation that it would be reviewed within 10 months and ready for commercialization in North America shortly thereafter. Though the FDA confirmed that the facilities of Reloxin’s manufacturer, Ipsen, are in compliance with current Good Manufacturing Practices, the drug remains in limbo for the U.S. market. It is currently approved for aesthetic use in 23 countries (Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, El Saldavor, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Russia, Slovak Republic, South Korea, Ukraine, Uruguay, Venezuela, and Vietnam).

With the FDA’s seal of approval, Reloxin will prove that it is comparable to the cosmetic gold standard that Botox has become over the past seven years.

Well, the reviewer cannot avoid the hype, after all.

Besides longevity and price, Reloxin has shown to differ from Botox in effect, spreading farther from the injection site. In areas such as the forehead, this characteristic might be considered favorable, since it would reduce the quantity of injections required and subsequently minimize the potential for bruising. However, in areas where more precision is desired, Reloxin may not be the best solution. Ultimately, each drug might one day be used either in concert or as distinct treatments for targeted facial zones.

Read it all.

Howard Brody's excellent medblog, Hooked: Ethics, Medicine, and Pharma, recently focused on the status of the FDA's new proposed rule on off-label marketing, now that the Bush administration's people are in their last days in DC: Getting in Its Last Licks: The Bush FDA and Off Label Marketing:

A little less than a year ago, Brody said that the FDA's proposal would allow companies to start marketing drugs off label if they distribute to physicians only peer-reviewed medical journal articles describing the proposed off label use; and accompany any such article with a clear statement that the use described is not FDA approved.

I said then it was a rotten idea. Apparently the FDA agreed as they are now rushing to slip the rule into force during the last days of the outgoing Bush Administration.

Presumably the only way to get this measure through was to speed it up before the Obama people rolled into town with their generally less-compliant attitude toward the large dug companies. The measure primarily addresses giving docs reprints of medical journal articles that describe off-label uses of a medication. (See my previous post on why I thought the rule was generally misguided.)

The FDA claims that these rules tighten up the process because they discourage ghostwriting. How do they discourage it? Well, the rules recommend that companies disclose any financial relationships between them and an article's authors. Yeah, I am sure that will be a water-tight safeguard.

Read it all here. Also, check out the detailed response by Dan Abshear, which casts a historical perspective on the relationship between the FDA and pharmas:

The presumed intimacy between these two organizations, the pharmaceutical industry and the FDA, does in fact seem to continue to worsen. For example, and recently, the FDA considered supporting overtly this massive and necessary client of theirs, the pharmaceutical industry, to allow their promoters to discuss their products that may or may not have been approved by the FDA for particular disease states. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative of the marketer of a particular medication, which remarkably mirrors the premise and objective of this industry already. So this strategy, void of any protection of the public health and potential dangers associated with this practice, illustrates once again the present state of the FDA and its need for reform.

Read the whole thing at the bottom of this page.