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The PIP prosthesis lawsuit

17 May

It is not the first time in France that a lawsuit is intended on the basis of the bad quality of a health product.

The photograph shows grade IV capsular contrac...

The photograph shows grade IV capsular contracture in the right breast of a 29-year-old woman seven years after subglandular placement of 560cc silicone gel-filled breast implants. (Photo credit: Wikipedia)

Mastectomie

Mastectomie (Photo credit: Wikipedia)

Figure of the anatomical position of a subglan...

Figure of the anatomical position of a subglandular breast implant. (Photo credit: Wikipedia)

Chest X-ray showing bilateral breast implants.

Chest X-ray showing bilateral breast implants. (Photo credit: Wikipedia)

We all remember the case of the Human Immunodeficiency Virus contaminated blood in the transfusion centers case. Now the lights of the actuality are focused on the Poly Implant Prosthèse, a brand of breast implants made in France. At the difference with the transfusion scandal where the French health services where solely implicated, in the PIP case, there are some intermediaries. Indeed those devices were guarantied by a Community European (CE) label and controlled, on behalf of the governments agencies by a private audit society, in that case a German certifying company called TÜV Rheinland Holding. Recently Dominique Maraninchi the director since February 2011 of the former Agence Française de Sécurité Sanitaire des Produits de Santé (French Agency for the Safety of Health Products AFSSAPS), now called since May 1st 2012 the Agence Nationale de Sécurité du Médicament et des Produits de Santé ( National Agency for the Safety of Medicines and Health Products ANSM), which, in parentheses, is not much easier to pronounce and far of the simplicity of the name of its American counterpart the FDA, said that (quoted): “Our oversight system isn’t adequate. It allowed a fraud of this size to take place for years. The system is based on certifying companies that check only what is presented to them”, end of quotation. It is interesting to notice that the Professor Maraninchi being a specialist in oncology has been at the head of the Regional Centre of Cancer of Marseille during 16 years and that the PIP prosthesis were for a large part implanted in the aftermath of breast cancer treatments. Thus we can think that the Professor Maraninchi has at heart that the cancer patients will be heard and exactly compensated be they victim of a PIP defective breast implant. It is also an other Doctor from Marseille, the plastic surgeon Christian Marinetti, who whistle blowed years ago against the particular fragility of the PIP implants.
So the less that we can say is that the responsibilities where diluted between the European Community label (CE), countries governmental agencies and the private certifying company. As the lawyers use to proceed pragmatically and knowing that PIP has just run into bankruptcy, guess whom they will attack first.

More content:

http://www.businessweek.com/articles/2012-03-29/europe-weighs-tougher-breast-implant-scrutiny

http://www.tuv.com/en/geschaeftsbericht/auf_einen_blick/unternehmensprofil/unternehmensprofil.jsp

http://www.ansm.sante.fr/

http://www.ansm.sante.fr/var/ansm_site/storage/original/application/0262abf0685c8e136443cd73f0986a12.pdf

French wine will not be replaced

12 Jan

A scientist tried to replace wine with a pill, fortunately he fabricated data!

wines we tasted

Image by nyaa_birdies_perch via Flickr

The protective action of red wine against cardiovascular events is well known (at least at low doses!). But a damned scientist tried to put the protective factor that is contained into wine in a single pill. Such trying by his research to replace a glass of wine by swallowing a pill containing resveratrol, a red wine molecule! Luckily, thank god, he fabricated and falsified the data of his research!
French way of live is for a while still a healthy way of life, not challenged by pills as fake studies attempted to demonstrate. This welcomed falsification of data was brought to my attention by the chronicle of higher education, Pharmalott and retraction watch. A three years long University of Connecticut enquiry revealed the misconduct.
Read more here:

http://chronicle.com/blogs/percolator/uconn-investigation-finds-that-health-researcher-fabricated-data/28291

http://www.pharmalot.com/2012/01/heart-researcher-falsified-red-wine-research/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29

http://retractionwatch.wordpress.com/2012/01/11/uconn-resveratrol-researcher-dipak-das-fingered-in-sweeping-misconduct-case/#more-5849

http://retractionwatch.wordpress.com/2012/01/12/resveratrol-fraud-case-update-dipak-das-loses-editors-chair-laywer-issues-statement-refuting-all-charges/

Bogus evidence

5 Jan

Full access to raw data becomes more and more necessary.

Photo of linear accelerator

Image via Wikipedia

The number of scientists which manipulate data increases tremendously, one solution could be the obligation to make raw data accessible on the internet. A second solution is to make mandatory the publication of all the randomized controlled trials that have been registered even if they conclude to less benefit or more harm for the studied innovative procedure. A third solution is to be very circumspect if the authors have already patented their own research topics. For example prostate cancer screening and lung cancer screening are two field of highly interesting the biomedical industry and associated with large amount of potential revenue.

The latest example is a Prostate cancer screening marker research which appeared to be entirely fake. Moreover the scientist involved had already sold the discovery to a bio engineering start-up. All that stuff ended up before a court, you can see a report of the lawsuit here. The lung cancer screening has become also a competition for X-ray industrials and searchers as you can see here.
When are at stake the academic glory, the economic greed and some time no more than just finding a job for a post doc searcher the pressure to publish always surpasses the sense of honour and the Hippocratic oath?
The BMJ journal has just been recently whistle-blowing the problem in a in-depth review of the question. Bogus evidences are not only dangerous for patients but also lead to unjustified health care spending deepening the nation debt crisis.
More information on the topic is findable below:

http://www.naturalnews.com/034577_quack_science_clinical_trials_BMJ.html

http://retractionwatch.wordpress.com/2012/01/04/hopkins-scientists-retract-prostate-cancer-screening-study-at-center-of-2009-lawsuits/

http://retractionwatch.wordpress.com/2012/01/04/cancer-issues-expression-of-concern-about-two-henschke-i-elcap-lung-cancer-screening-papers/#more-5783

Keep libel laws out of science

11 Nov

Keep Libel Laws out of Science

When a lawyer of San Francisco threatens a scientific journal for having published an article which alter the economic interests of his client there is a problem. But when the scientific journal retracts the article saying there is a conflict of interest there is really an expression of concern.
The full article of retraction watch his readable here.

An other article have been retracted for politic reasons here.

Science appears more and more in danger of being attacked by lawyers or politics. That’s why a charitable trust named Sense About Science is struggling for independence of science.

Lawsuit against a sales rep

23 Sep

For the first time a lawsuit charges not only the drug-maker but also a sales rep for not having accurately describe the adverse effects of a drug when visiting the provider. That’s America!

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