NobelDirect On Hold?
Posted in Dental Implant News Nobel Biocare
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Subscribe to this PostAny thoughts on Nobel´s recently announced decision to put promotional material for NobelDirect on hold for 60 days?
Last week, Nobel stated that it sent a letter to the Swedish Medical Product Agency (SMPA) proposing steps towards a constructive dialogue and informed the SMPA, that it decided to put promotional material for NobelDirect voluntarily for 60 days on hold.Nobel Biocare re-emphasized its need to have access to all studies and data of the Gothenburg Group provided to others. Otherwise a meaningful analysis and constructive discussion of their allegations would be impossible. This access has not been given yet.
Furthermore, Nobel stated that it, "fundamentally believes in the intrinsic quality of its product. In this sense it submitted 3 studies for peer review to professional journals, one of them a prospective multi-center study. In the same sense, NobelBiocare wants to reconfirm its offer to have a periodic, open and constructive dialogue with SMPA on the progress of the on-going prospective study."
How do you feel this NobelDirect Saga will eventually play out? Please leave your comments below. For another extensive blog on NobelDirect, please click here.
Concerning the posts about NobelDirect, and the defamatory comments constantly being made by Dr Niznick, readers should check out the following book written by R. Barker Bausell, a biostatistician at the University of Maryland, and Director of Research for UM’s Center of Complementary and Alternative Medicine. His book, “Snake Oil Science” addresses the many “medical professionals’, such as yourself, who try and make useless studies seem important and relevant. Bausell’s book could give one the idea that the two most dangerous words in medicine are “studies show.” Check out this accurate excerpt from that book, which illustrates the tactic of using worthless studies such as Niznick’s “Brazilian Studies” which appear on his website concerning the safety of his unproven knock off implants: “Researchers, even those without a direct financial stake in the outcome of a trial, often have a psychological investment in what they’re testing. Their papers get published because the editors of journals in fields like homeopathy start from the premise that the whole thing isn’t a preposterous hoax, as Bausell and most mainstream doctors believe.”
Read the book, understand that people like Niznick, who trumpet the validity of his studies, but debunk the published, peer reviewed, multi-center studies that Nobel and other implant companies conduct, is attempting to deceive through statistics. While Niznick criticizes the massive 40 year history that Nobel has concerning its implants, he fails to address the flaws, lack of credibility and omission of ANY PEER REVIEWED PUBLISHED STUDIES cited by the “Nobel Direct Study” by Tomas Albrektsson and Lars Sennerby. Niznick, or anyone for that matter, fails to address the methods, sample sizes, or lack of multi-center double blind methodology in the Albrektsson, et al, “studies”. All the “data” on the NobelDirect study, is truly only anecdotic information which has no validity or place in modern medical treatment. Niznick will go on about how strong his Titanium is, how much stronger his implant is, how much better designed his threads are. The reality is there is NO, ABSOLUTELY NO, published, valid statistical data to back up these claims. The same holds true for the Albrecktsson study which Niznick loves to cite. By his own admission, Niznick’s business is booming. Booming for an implanted medical device that is surgically placed in a patient’s bone, but has not one published safety study. But the large implant companies are the people who are deceiving the doctors? That is the ultimate hypocrisy.