Flap's Blog – FullosseousFlap's Dental Blog

The Flap is about the illegal transfer of ownership of a dental practice, owned by a North Carolina dentist, Gary Cameron to Heartland Dental Care in violation of North Carolina law.

Here is the consent order.

Bone drugs from Warner Chilcott Plc, Roche Holding AG, Merck & Co. and Novartis AG need labeling changes to reduce the risk of fractures, a U.S. panel said.

The companies should add clarifications on the length of time that osteoporosis patients may take the medicines, outside advisers to the Food and Drug Administration said today in a 17- 6 vote in Adelphi, Maryland. The FDA isn’t required to follow its panels’ recommendations.

The agency has evaluated the safety of the drugs, known as bisphosphonates, for almost four years and cited possible links to unusual thigh fractures and jawbone deterioration in 2010. The agency said in July it also was examining conflicting studies on whether bisphosphonate pills such as Warner Chilcott’s Actonel, Merck’s Fosamax and Roche’s Boniva raise esophageal cancer risks.

A revised label should “be very clear that efficacy may fall off after a period of time, perhaps five years,” panelist Lewis Nelson, director of the medical toxicology fellowship program at New York University, said after the vote. “Serious concerns have been raised about risk, and those need to be continually evaluated as well.”

There needs to be additional research, period.

Mere warning labels are not going to answer the questions from every day patients – how long do I take the medicine and what protocol do I use? Or, what is the chance my femur will fracture or will I develop osteonecrosis of the jaw (ONJ) if I have a tooth removed.

The next trial date for a Fosamax lawsuit involving jaw necrosis is scheduled to begin early next month.

The Fosamax trial will involve a complaint brought by Linda Secrest, of Florida, who alleges that Merck failed to adequately warn that side effects of Fosamax, the popular osteoporosis drug, can lead to severe jaw bone decay. Trial is scheduled to begin on September 7, in the U.S. District Court for the Southern District of New York.

Fosamax is an osteoporosis drug that belongs to a family of similar medications known as bisphosphonates. Long-term use of oral bisphosphonates has been linked to an increased risk of serious and debilitating jaw problems, known as osteonecrosis of the jaw. The condition causes the jaw bone to decay and rot, often resulting in the need for surgery to remove portions of the jaw.

Merck currently faces more than 1,100 Fosamax jaw lawsuits, most of which have been consolidated and centralized for pretrial proceedings in the U.S. District Court for the Southern District of New York as part of an MDL or multidistrict litigation.

There have already been several trials for Fosamax jaw necrosis lawsuits that have been held in the federal MDL over the last two years. While Merck has successfully defended its medication in three cases, one lawsuit resulted in an $8 million jury award for Fosamax jaw damage last year, finding that Merck failed to adequately research the potential side effects of warn about the risk of jaw necrosis from Fosamax.

A few more cases and Merck will probably propose some industry-wide settlement agreement.

Next up will be the lawsuits over bone fractures from Fosamax.

A former Costa Mesa dentist who served more than a quarter of a century in prison for murder after three of his patients died in his dental chair from improper use of anesthesia in the 1980s was paroled from Folsom Prison Tuesday.

Tony Protopappas, who made national headlines in the early 1980s when he was convicted of three counts of second-degree murder, was picked up by his brother at the gates of Folsom Prison shortly after 9 a.m. Tuesday, said Santa Ana attorney Rich Pfeiffer, Protopappas’s appellate lawyer.

“He was very, very thankful,” Pfeiffer said. “He was crying tears of joy.”

Protopappas was ordered released on parole in June by the Fourth District Court of Appeal in June in a ruling that overturned a decision by former Gov. Arnold Schwarzenegger in 2010. Schwarzenegger reversed a decision by a state parole board granting Protopappas’ release because he no longer presents a risk of danger to others.

Pfeiffer then appealed Schwarzenegger’s reversal, insisting that there is no evidence that Protopappas is an unreasonable risk to society, Pfeiffer said Protopappas should have been released from prison last week under the appellate decision, adding that he has filed a writ seeking to hold prosecutors in the state attorney general’s office in contempt of court for not allowing the former dentist to be released on time.

Protopappas is now 65 years old and will NEVER practice dentistry again. But, three patients are dead and will have no life, because of his grossly negligent conduct.

Granted he never intended to kill his victims, but he did, and for that he deserves to spend the rest of his life in prison.

Abstract

OBJECTIVES:

The objectives of this study were to define the incidence, pain, and healing in cancer patients treated with intravenous bisphosphonates.

STUDY DESIGN:

The study included long-term follow-up of 99 bisphosphonate-using patients (group A) and conservative treatment of 67 patients with bisphosphonate-related osteonecrosis of the jaw (BRONJ, group B) using 3 antibiotic schemes and oral hygiene.

RESULTS:

The frequency of zoledronic acid single-agent use was 85.9% and 69.8% in group A and B, respectively. Median follow-up was 13 months (group A) and 16 months (group B). Two patients in group A developed BRONJ (2%). Of those with BRONJ in group B who completed follow-up, healing occurred in 14.9% (7/47) and pain subsided in 80.9% (38/47). Healing was significant in patients who received pamidronate followed by zoledronic acid (P = .023) and with BRONJ stages 0 and stage I (P = .003).

CONCLUSIONS:

This case series suggests that oral hygiene and conservative antibiotic therapy play a role in healing and pain alleviation in BRONJ. Oral hygiene and follow-up may decrease incidence of BRONJ.

This sounds a reasonable course, knowing that this complication will be found to occur with increasing frequency. Let us hope a conservative protocol can be developed for these unfortunate patients.