Business briefs: Alexion, AMA, Eli Lilly
Just as Japan backs off its push for HPV vaccination, a CDC report indicates that infection rates have plummeted almost 50% among US teenage girls over the last ten years. The New York Times notes that only 33% of girls have gotten all three doses of the vaccine in the US. Japan has had a comprehensive vaccine program in effect, but announced this week it was no longer actively promoting HPV vaccination until it can sort through reports of side effects that have been sent to its health ministry. The sexually transmitted disease is linked to cervical cancer, certain cancers of the head and neck and genital warts, among other conditions. The Centers for Disease Control estimates that HPV vaccination could cut cancer cases by 21,000.
Rare disease drug maker Alexion has a new HQ in the works in New Haven, Conn, and expects to move in 2015. CEO Leonard Bell said in a statement that the move “is a homecoming for our company,” which was founded in the Ivy League town 20 years ago. The new site will be home to 400 employees who will be moved from other sites. FierceBiotech noted Tuesday that the company also stands to gain $51 million from Connecticut if it manages to add between 200 and 300 jobs.
The American Medical Association voted to classify obesity as a disease, overriding the group's council, reported MedPage Today, which previously noted the council discussion triggered a 45 minute debate among members on Sunday. Supporters argued that obesity is a hormonal and metabolic condition, while opponents said obesity has no clear definition, and worried disease status would harm prevention efforts. The Obesity Society issued a supportive press release, saying the AMA's decision. The society launched a “Treat Obesity Seriously” campaign in May. Former FDA Associate Commissioner and president of the Center for Medicine in the Public Interest Peter Pitts tells MM&M the issue now is reimbursement, but the classification of a condition as a disease or otherwise does not have an impact on the FDA's approval process. "Drugs don't necessarily treat diseases. They meet endpoints," he explains, meaning if a drug sets out to ameliorate a condition, like sleeplessness, and it does,that is the basis of approval, not if sleeplessness is a disease.
The FDA is investigating two patient deaths associated with Zyprexa injections. The patients died three or and four days after receiving injections of Eli Lilly's long-acting schizophrenia drug. The patients had high olanzapine blood levels, which can cause heart attacks and comas. FDA said in a statement that it is not clear if the medication is linked to the deaths.