Tag Archives: cancer

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

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

SEXUAL HABITS

9 Dec

Cancer vs hpv vs time

Image via Wikipedia

SEXUAL HABITS (FOR MEN)

I have just discovered, surfing at random on the Web, this incredible 94 pages questionnaire.

The subjects were interrogated about A. GENERAL INFORMATION, B. HEALTH QUESTIONS, C. SMOKING HABITS, D. ALCOHOL DRINKING HABITS, E. SEXUAL HABITS (FOR WOMEN) and E. SEXUAL HABITS (FOR MEN)

 

All the subjects were included in a cohort aiming to follow carcinomas of the head and neck.

The questionnaire was approved by the board of the Johns Hopkins Hospital and all the subjects gave their informed written consent. Control subjects (cancer free) fulfilled the same questionnaire. Two controls were matched for each case of cancer. In the interest of science searchers inquired deeply in the privacy of the participants. But the topic of the study fully legitimated this indiscretion: Human Papilloma Virus (HPV) is a highly sexual transmissible infection often associated with uterine cervical cancer but also, as in the study here reported, with oropharyngeal cancer. If the recent trends continue the HPV positive oropharyngeal cancers could surpass the HPV positive cervix cancers scientists said.

Maura L. Gillison, from the Ohio State University,Columbus, OH, participated to the two studies. You can listen to her in her post cast (link below to an mp3 file). According to her the question is: given that gender equity will be completed before long, should men benefit from HPV vaccination and/screening like women do?

Maura L. Gillison’s postcast (mp3 file)

Reference of the article focused on incidence trend of HPV positive oropharyngeal cancer:

Chaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, et al. Human Papillomavirus and Rising Oropharyngeal Cancer Incidence in the United States. Journal of Clinical Oncology. 2011 Nov;29(32):4294-4301. Available from: http://dx.doi.org/10.1200/JCO.2011.36.4596.

The entire full text of the case control study and  the 94 pages questionnaire are readable here: nejmoa065497 and here: nejm_dsouza_1944sa1

cancer mortality

6 Nov

According to the INVS, mortality from cancer has diminished since 1990. I notice that this was the case especially for the two localizations that have benefited from screening: prostate cancer for men with the generalized use of PSA in individual screening and breast cancer for women with the generalization of organized screening with mammogram. These cancer mortality statistics published by the well-known French epidemiologist Catherine Hill are very encouraging with regard of public health.  They must contribute to the recent debate on whether screening for prostate and breast cancer is justified. In my opinion people who are not in favor of such screening should look closely to the figures that Catherine Hill reports.

You can get access to the full text report on mortality from cancer here:

Catherine Hill Report

Reference:
Hill C, Doyon F, Mousannif A. Évolution de la mortalité par cancer en France de 1950 à 2006. Saint-Maurice (Fra) : Institut de veille sanitaire, mai 2009, 272 p. available on: http://www.invs.sante.fr

Metastatic breast cancer

4 Oct

Beside advanced diagnoses and over diagnoses stands also the metastatic breast cancer.It’s the ultimate stake for screening: to avoid the occurrence of this endless chronic condition. The video depicts testimonies from women suffering from this particular condition that is very different from the early stage disease targeted by the organised screening programs.

October 13 is the national metastatic breath cancer awareness day.

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