I have significant contractor in both hands and have chosen to go with the Xiaflex treatment. I just finished with my second injection and underwent a manipulation a couple of weeks ago. Because of the confluence and number of my cords involved, there is significant breakage that must occur.

Other than the pain associated with the cord breakage, I am pleased with the results (4 more injections to go). How about others? Care to share your experiences?

Edited 06/10/10 17:48

I understand Xiaflex was approved by FDA back in Feb of this year (http://www.fda.gov/NewsEvents/Newsroom/P...s/ucm199736.htm). I tracked the drug through the FDA process, and when released, my MD worked with my insurance company to cover the cost for treatment in both hands.

I've had two treatments so far, and its helping. The pain associated with the cord breakage was the worst part.

deggleston:

---

I understand Xiaflex was approved by FDA back in Feb of this year (http://www.fda.gov/NewsEvents/Newsroom/P...s/ucm199736.htm). I tracked the drug through the FDA process, and when released, my MD worked with my insurance company to cover the cost for treatment in both hands.

I've had two treatments so far, and its helping. The pain associated with the cord breakage was the worst part.

Edited 06/12/10 06:34

Another Round of FDA Warning Letters Issued
By Lisa LaMotta Jun 17, 2010 2:45 pm
The government oversight agency issues four more warning letters related to misleading drug marketing.
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Pharmaceutical companies never learn their lessons. It doesn’t seem to matter how many times the FDA cites a company or its competitors for marketing unapproved drugs, misleading marketing, or failing to report adverse events; the companies just keep committing the offenses.

The latest round of warning letters were published on the FDA website on Thursday for issues related mostly to misleading marketing practices. Four companies -- Auxilium Pharmaceuticals (AUXL), Eisai, Sepracor, and Cumberland Pharmaceuticals (CPIX) -- were the current offenders.

The FDA’s Division of drug Marketing, Advertising, and Communication cited Auxilium for a brochure that it put out on its drug Xiaflex, which was approved in February for the treatment of a disease that impairs hand function called Dupuytren’s contraction. The letter, dated June 10, said the brochure “broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts.”

Cumberland committed similar offenses for its drug Acetadote, which is used for the treatment of acetaminophen overdose. The company is guilty of omitting and minimizing the risks associated with the drug as well.

The company has been considered by some as the worst IPO of the last year. The stock has fallen dramatically, dropping to a price just below $7 from its offering price of $17 last August. The company’s CEO A.J. Kazimi told the Nashville Business Journal that “introducing a product to the hospital market takes time.”

Sepracor was accused of similar transgressions for its sleep-aid Lunesta, while Eisai violated marketing guidelines for its brain-tumor treatment Gliadel in promotional materials on its website.

It’s easy to see why pharmaceutical companies might want to exaggerate the positives and downplay the negatives of their products in advertising. Their bottom line depends heavily on how doctors view the product and if they'll prescribe one particular drug over another. More than 60 warning letters have been issued so far in 2010, with the majority of them relating to advertising.

The FDA tends to post these letters to its site in bunches in an effort to draw more attention to the violations. As evidenced by the number of letters already issued this year, these letters aren't uncommon. Companies receive them for all sorts of violations beyond misleading marketing. Pfizer (PFE) recently made headlines when it received a letter from the FDA for its failure to report adverse side effects for some of its drugs. While all of the safety concerns affiliated with the adverse events have been addressed, the pharmaceutical company is required by law to inform the FDA when these sorts of complaints come in.

The FDA has been cracking down on violations like these more frequently over the last couple of years. The stringent enforcement comes as the agency tries to make itself more transparent to consumers. The new administration at the FDA under the oversight of Commissioner Margaret Hamburg has been trying to improve the agency’s disclosure and formed the Transparency Task Force to propose changes to the current system. If the guidelines are put into place, the public will have more access to other violations that companies have committed.

Moondanc brings up a good point – How comfortable are you with your treatment choice? I chose Xiaflex based on my own research and treatment options. Every treatment has a certain amount of risk and doing nothing was not an option for me.