Here is an interesting development: Astellas Pharma has filed a lawsuit againstPrescrire, a medical journal that is published by a non-profit organization, for publishing articles the drugmaker maintains has tarnished the reputation of its Protopic ointment used to treat eczema.
An article run last year questioned the preventive use of the ointment and maintained the risk-benefit balance was negative. An Astellas spokeswoman writes us to say that the drugmaker believes the article is "misleading." The magazine counters that "freedom of expression and exercise of freedom of criticism are at stake," according to Le Figaro), which also reported the drugmaker believes the criticism is part of a smear campaign. Prescrire has run several articles, actually, about the ointment, which is also known as tacrolimus (see the list).
"Protopic has undergone one of the most extensive clinical testing programmes in dermatology," the Astellas spokeswoman adds. "To date, more than 24,000 patients have been treated...Across all studies and post-marketing surveillance, Protopic is well tolerated with an acceptable safety profile..." She notes the European Medicines Agency approved the ointment for preventing eczema flare-ups.
Of course, the lawsuit was filed in France, and laws differ among countries. Nonetheless, the move raises the prospect of similar actions that could be pursued in certain venues against a publisher that runs critical articles of a medicine. The notion of a smear campaign is disturbing, of course. On the other hand, there is also the matter of free speech. Medical journals make plenty of mistakes (can you say 'ghostwriting' or 'Andrew Wakefield and autism?'), but these publications are designed to further scientific discourse, which is an important service provided by reputable journals. Astellas may want to consider fighting speech with more speech.
4 Comments
This is great. But for this lawsuit no one would have known about Prescrire or the toxicity and uselessness of this drug. Astellas Pharma also sued the fda. (http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/08/astellas-sues-fda-after-the-agency-substantially-denies-prograf-citizen-petition-and-approves-generi.html)
I hate all those lawsuits by plaintiff lawyers; this society is way too litiginous. These corporate suits that try to shut up independent scientists however are a different matter. They help spread the word about how dangerous drugs like Fujimycin (trade name in case someone does a google search on this posting)really are. this is my opinion only of course
Here in the US, the First Amendment is often invoked by pharmaceutical companies to assert their rights to promote products, including DTC advertising. A First Amendment absolutist like myself supports this position.
However, turnabout is fair play. Unless an article's assertions are demonstrably inaccurate, it would be difficult to support such litigation in this country.
Salient... I agree.
The simple truth about tacrolimus is that because it has an unsaturated carbon in it's molecular make up, it binds to anything in the body after it is absorbed in the blood stream. This includes peripheral lympho nodes.
Thus, the cancer black box warning.
Tacrolimus is the topical formulation of Prograf. Prograf, as you are already probably aware, is used in organ transplant patients to help suppress their immune system so their own system will not reject the foreign organ.
The company claims that the topical formulation blood serum levels are too low to have immuno suppressive effect. It has been documented that thousands and thousands of patients have been studied with success.
There is one fundemental problem with their argument. There are a whole host of factors that can come into play regarding absorption; Age of the patient (Younger patients, especially infants absorb things at a much greater rate than adults), Severity of disease ( severe atopic dermatitis often has excoriation which will allow for more absorption), Area of application ( the face is 7x more absorbant than other parts of the body), Finally, absorption rates vary depending on the individual (some systems just allow more to pass into the blood stream than others).
I don't believe this lawsuit will go anywhere. It is just another attempt of Big Pharma trying to suppress any negatives about their drug.
If I were a doctor treating atopic dermatitis, I would follow the U.S. label and use as a last resort when other first line therepies have not been successful. Even then, I would use with extreme caution, especially with children.
pharmaceutical companies should NOT be considered citizens and should NOT be able to claim the privileges in the Bill of Rights. they are in no sense of the word "people"