Anonymous
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Anonymous
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This "biologist" is an angry former employee.
This "biologist" is an angry former employee.
I am a biologist, not a dental health professional, but, after looking at the FDA label for Arestin, it sure looks more like a money-making scam than a useful product. In the clinical studies the average pre-treatment pocket depth was about 5.8 mm. With standard scraping and root planing (SRP) alone, the pocket depth was reduced an average of about 1.2 mm to a final depth of about 4.6 mm. With SRP plus the expensive Arestin antibiotic treatment, the pocket depth was reduced an average of about 1.4 mm to a final depth of about 4.4 mm.
That 0.2 mm difference in pocket depth reduction seems to have narrowly reached statistical significance, so the FDA approved it. But even if it is assumed that the 0.2 mm difference is real, there seems to be no study or claim made that the difference between 4.4 mm and 4.6 mm final pocket depth has any clinical relevance to justify the costs (including time spent at multiple visits) and the potential side-effects of the drug.
What am I missing here?
You are missing nothing. It is the lack of ethics all around the board. I am a registered dental hygienist with over 10 years experience. I cannot stand by this product for the exact reason you are citing. You are correct in your analysis. Here is the icing on the cake though- we are taught that a difference of only 1 mm can be atributed to "inter-operator" reliability. Therefore 2 people or the same person measuring on 2 separate occasions can be within 1 mm difference and their probing depths are considered equal. Isn't that interesting?!
Issues with practices pushing arestin also include the fact that people don't bother reading/ studying or bother to try to understand statistics. Doctors and sometimes hygienists are too preoccupied with the production goals. When your staff benefits financially from the sale of a product via bonuses or incentives- that is when you get the "pushy" practices.
I have used arestin but I am very clear about the result. I will use it in an area in which the bleeding cannot be controlled- but I promise nothing in regards to pocket improvement. I have not seen much clinical improvement with arestin. With most cases, a patient can be well controlled with scaling and root planing and thorough--not aggressive homecare.
To be fair to some hygienists though- depending on the state that you practice- sometimes you are stuck doing what the dentist wants- (placing arestin)- even if you don't agree-Especially if you NEED your job. Dentists are ultimately responsible for the diagnosis and treatment recommendations.
I am a hygienist and a former employee. I have and continue to see the benefits of Arestin everyday. I was frustrated by the expense of Arestin as well. Unfortunately, it is not cheap to manufacture but it does work! The 'biologist' who broke down the clinical studies failed to realize that millimeters is a very small measurement and therefore a .3mm change might not seem significant to him. Also, it seems he doesn't understand that even a seemingly insignificant decrease in bacteria may be all the body needs to stop the path of destruction.
To the patient who was diagnosed today, please understand that Arestin is NOT a scam. It is an FDA approved low dose antibiotic that can help control the bacteria that is causing your gum infection. Not treating or finding a Dr who doesn't use it or doesn't diagnose periodontal infection is the real fraud! Although, scientifically much different Arestin at the same time as non-surgical periodontal therapy works on you and your son's gum infection like that bubble gum flavored antibiotic you got him for every ear infection as a kid! It is the lowest dosage, most effective, time tested, least side effect antibiotic to treat this type of gum infection! If you have questions on the science then by all means, don't do it, but if your issue is solely cost, consider that the cost to replace a SINGLE tooth lost because of a periodontal infection is generally about $4,000!
OraPharma has really worked hard to get the cost of Arestin down for a patient. It is available by prescription and could be covered by your medical plan for a $75 copay! Chances are that your dentist or hygienist pays $16-$20 per site and turns around to charge you $50 or $60! Rest assured that OraPharma communicates a $35-$40 fee to cover cost and time of the hygienst or Dr. Your practitioner is going to charge whatever they want! Your best bet is to determine how many sites you need and ask them if they can order it through your prescription plan. If its covered by Your plan, It will take 1-2 weeks to process and arrive in the office, but it could save you hundreds of dollars! That being said, if Arestin was a scam, the FDA wouldn't approve it, pharmacies wouldn't carry it, and medical plans wouldn't recognize it.
You're kidding right? The FDA could then approve orange juice to cure cancer since the dangers don't outweigh the benefits. The manufacturer has to prove efficacy. Almost every drug out there has side effects. Nothing would get approved if that is all the FDA does. Read up on your facts dude.
Hi all. If this product (Arestin) was not a scam, why does it NOT have ADA approval? Also, if you do the math, the active ingredient costs more than $1,000,000 per ounce! No wonder with this profit margin it is so heavily promoted by the manufacturer. You can buy 100mg capsules of minocycline for less than $1 each retail. Who wouldn't like to make over a million $$ with an investment of less than $300! Think about how much advertisement and incentives the supplier could afford at this markup!
The phase 4 clinical study had similar results to the data I summarized above, and it was authored by employees of the company that sells it and others who were paid to do the study for them. Excuse my skepticism over this snake oil.
Who cares about Atridox? Lasers are the future.If all the negative posts are from some disgruntled Atridox rep, consider for a moment the frustration of having been on the market essentially the same amount of time as Arestin, and suffering the worst head-to-head beating in dental history. The facts are tough to swallow for those guys and Arestin's choke hold is a strong one still. Some good advice for the Atridox crew to follow: "Don't throw rocks at a man carrying a machine gun." - Rowdy Roddy Piper