A federal advisory panel recommended approval on Wednesday of a rheumatoid arthritis pill that could offer patients an alternative to the injectable medicines already on the market, but several members expressed concern about safety and urged the Food and Drug Administration to require rigorous follow-up studies.
The arthritis advisory committee voted 8 to 2 that the drug, known as tofacitinib, offered enough benefits to overcome potential safety risks, including higher rates of lymphoma and other cancers and serious infections. The agency, which is scheduled to decide on approval by August, usually — but not always — follows the advice of advisory committees.
Pfizer, which is developing tofacitinib, has hailed the drug as one of its most promising prospects as the company works to regain sales after its blockbuster cholesterol drug, Lipitor, lost its patent protection last year.
If the drug is approved, it could prove to be a potent competitor to Humira, a drug made by Abbott that brought in nearly $2 billion in sales during the first quarter of this year.
During Pfizer’s presentation to the panel, company officials said the drug’s safety risks were comparable to those of rheumatoid arthritis drugs already on the market. But an F.D.A. reviewer said his analysis showed that cancer rates in the study seemed to increase in higher doses of the drug and over time. It was these safety concerns that led two of the committee members to vote against approval. “It was unexpected and is of major concern,” said the reviewer, Dr. Nikolay P. Nikolov. Pfizer is asking the agency to approve the drug in both a 5-milligram and 10-milligram dose. Read More
Dentists may soon be getting a potent new weapons with which to wage the global fight against cavities. The University of Maryland has developed a novel new nanocomposite material that can be used not only as filling for cavities, but that will also kill any remaining bacteria in the tooth and regenerate the actual structure lost to decay.
The nanocomposite is made up of silver nanoparticles and calcium phosphate nanoparticles, both of which are piped into the tooth as filler for a cavity. The silver nanoparticles along with a few other ingredients in the material kill off whatever bacteria is still lingering inside the tooth, paving the way for the calcium phosphate to regenerate tooth minerals. Over time, the tooth strengthens again.
But as IEEE Spectrum notes, the silver nanoparticles could prove to be problematic, and this is probably why this treatment is offered as a cavity filling rather than a toothpaste or mouthwash. Silver nanoparticles aren’t totally understood, and there have been some concerns voiced about the potential risks and perils associated with ingesting the stuff. The nanocomposite is currently undergoing both human and animal testing right now, hopefully with an eye toward clarifying and alleviating any health concerns. If the composite can pass muster, dentists everywhere can get down to the business of rolling back the clock on cavities. Read More
If you’re planning a trip to the dentist, it might not be the wisest decision to make your appointment with the person with whom you just broke up.
A Polish woman is facing three years in prison after she removed all of her ex-boyfriend’s teeth during dental surgery just days after their breakup.
“I tried to be professional and detach myself from my emotions,” Anna Mackowiak, 34, told the Austrian Times. “But when I saw him lying there I just thought, ‘What a bastard’ and decided to take all his teeth out.”
Marek Olszewski, 45, reportedly showed up at Mackowiak’s dental office complaining of toothache just days after he broke up with her. She then allegedly gave him a “heavy dose” of anesthetic, locked the door and began removing all of his teeth one at a time.
“I knew something was wrong because when I woke up I couldn’t feel any teeth and my jaw was strapped up with bandages,” Olszewski said.
“She told me my mouth was numb and I wouldn’t be able to feel anything for a while and that the bandage was there to protect the gums, but that I would need to see a specialist,” he said.
“I didn’t have any reason to doubt her, I mean I thought she was a professional.” Read More