Dead Jaw - This Newly Documented Untreatable Necrosis is Caused by Commonly Prescribed Class of Drugs
by Sandra Cassidy
Biphosphonate Osteo Necrosis or 'BON' litigation has been certified as a new litigation group by the American Association of Justice at the Miami convention. The litigation group, headed by interim chair Michael Monheit of Jenkintown Pennsylvania will cover all biphosphonates including Fosamax. This group of drugs is used to treat osteoporosis/osteopenia and to strengthen the bones of bone cancer patients.
Bisphosphonates are touted to increase bone density but are also potent inhibitors of bone remodeling and bone turnover.
The precise mechanism is unknown. Some studies call it ‘a complex interplay of bone metabolism, local trauma, increased demand for bone repair, infection and hypovascularity.’ But at least one study reports 'from our observations it does appear that bisphosphonates may be at least partially responsible.' The mechanism involves the unique bacterial environment present in the jaw which combines to make presentation nearly exclusively in the jawbone. Patient’s condition is first noticed by their dentist following dental treatment.
An older version called Phossy Jaw found in 19th century workers who use phosphorus (match makers and munitions manufacturers) has striking similarities but may imply more of a bacterial element then here, but otherwise it has similarities enough for one studies author to recommend it be called bis-phossy jaw and states he “hope(s) his article will show that phossy jaw offers itself as a model to base current therapies…” Current Therapy Bisphosphonate osteochemonecrosis (Bis-Phossy Jaw): Is This Phossy jaw of the 21st century? John W. Hellstein, DDS, MS and Ciindy L. Marek, BS Pharm;
In Phossy jaw patients present with purulent foul smelling worm-eaten or pumice-like pieces of necrotized bone separated from surrounding tissue (sequestered). There are reports of entire mandibles being sequestered.
The biphosphonate drugs implicated are very commonly prescribed and are those primarily given in intraveneous forms (pamidronate or zoledronic acid). They are used to stop bone loss in cancer patients they are widely used because they also have tumoricidal properties. There is a 4% risk of BON for pamidronate use at 36 months with a mean time of onset of 6 years and a 10% risk of BON for zoledronic acid use with a mean time of onset of 18 months.
They are also commonly used in their oral form (alendronate) in osteoporosis patients although there have been few reported cases (7 of 63 cases associated with chronic oral bisphosphonate use.)
Biphosphonate’s half life is very long and it lodges in the bone and stays there.
No treatments have proven successful -- including local surgical debridement, bone curettage, local irrigation with antibiotics and hyperbaric oxygen. Only prevention is available. Protocol now includes completing all dental work before a course of biphosphonate drugs as the clinical course is always preceded by a dental visit. The notion is that the bone turnover prevention mechanism somehow works in tandem with the bacteria in the jaw to create the environment for necrosis.
One studies author states “ I cannot help but think that we may be only witnessing the tip of the iceburg in a possible bis- phossy jaw epidemic”. Id.
Guilty Pleas: Purdue Pharma, President , General Counsel and Chief Medical Officer Plead Guilty
Makers of Oxycotin, a highly additictive pain killer, plead guilty U.S. District Court, Virginia, for illegally misbranding the drug OxyContin from 1996 through 2001. Purdue admitted that it intended to mislead and defraud the public and agreed to pay over $600 million in criminal and civil fines. The three executives paid $34.5 million.
Purdue admitted that it illegally marketed and promoted OxyContin by falsely claiming that the drug was less addictive, less subject to abuse and diversion and less likely to cause withdrawal symptoms than other pain medications – all in an effort to maximize its profits.
Of the total $634.5 million in fines: (i) $276.1 million will be forfeited to the U.S., a portion of which will be shared with state and federal law enforcement agencies for the investigation; (ii) $130 million will be paid for compensation and settlement of private OxyContin civil liabilities; and (iii) $159.9 million will go to the U.S. and State Medicaid Programs as reimbursement for payments made by the federal agencies and Medicaid for settlement of false claims.
The plea agreement also settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.
According to U.S. Attorney John Brownlee, “With its OxyContin, Purdue unleashed a highly abusive, addictive and potentially dangerous drug on an unsuspecting and unknowing public. For these mis-representations and crimes, Purdue and its executives have been brought to justice.”
Ken Jost of the Justice Department’s Office of Consumer Litigation said that this case should put pharmaceutical companies on notice that they won’t be able to get away with breaking the law to make a profit. “The things that they plot in their boardrooms, the things that they do behind closed doors will not stay behind closed doors,” Jost said. We have the people, we have the resources. We’ll take the time and we’ll take the effort to find out what they did and how they did it.
OxyContin, a time-release painkiller, can be highly addictive. Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected. According to the U.S. Attorney’s Office, "the results of Purdue’s crimes were staggering [as] the number of oxycodone-related deaths increased 400% between 1996 and 2001. In some communities, there were sharp increases, up to 75% from prior years, in crimes that were directly attributable to the abuse of OxyContin."
New Verdicts: SSRI, Paxil and other selective serotonin reuptake inhibiters cause suicidal and homicidal tendencies
Tobin vs. GlaxoSmithKline (2001 WY) 164 F. Supp. 2d 1278 resulted in a 6.4 million dollars awarded to the survivors of a Paxil induced murder/suicide. Attorney Andrew Vickery represented the family in Tobin and now represents family's around the country in SSRI cases. The research shows that the new Prozac family of antidepressants known as SSRI's, which includes Paxil, are designed to increase levels of serotonin and they do so by inhibiting serotonin reuptake or, in other words, by decreasing one's ability to metabolize serotonin. Although the public and even treating physicians have been led to believe that increasing serotonin is needed to cure depression, suicidal tendencies and anxiety, etc., years of research shows the exact opposite. For those who can not metabolize serotonin rising levels cause poisoning which is related to aggression, horrifying nightmares and violence. A decreased ability to metabolize serotonin is found in many illnesses including schizophrenia, mania and mood disorders and among many who are incarcerated for violent crime. The Tobin case presented compelling proof that up to 10% of the population lacks the ability to metabolize serotonin and when this population is exposed to SSRI's the combined effect produces a toxicity known as Serotonin Syndrome. The toxicity is reached quickly and can induce mental changes within 24 hours leading to rapid impulsive and aggressive reactions. Cases around the country involve sudden and completely out of character violence, including suicides, homicides and most, if not all deaths, are by extremely violent means.
Sources
http://www.rhuematology.org
J Oral Maxillofac Surg 63:682-689, 2005; Current Therapy;
Bisphosphonate Osteochemonecrosis (Bis-Phossy jaw): Is This Phossy Jaw of the 21st Century? John W. Hellstein, DDS; Cindy L. Marek, BS Pharm
In Re: Aredia and Zometa Produsts Liability Litigation (MDL No. 1760); No. 3:06-MD-1760
J Oral Maxillofac Surg 62:527-534, 2004; Clinical Articles; Osteonecrosis of the jaw Associated With the Use of Bisphosphonates: A Review of 63 Cases; Salvatore L. Ruggiero, MD et. al.
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