FDA panel recommends restricting anemia drug to chemo patients
WASHINGTON A Food and Drug Administration panel has recommended that such anemia drugs as Aranesp and Epogen manufactured by Amgen and Procrit by Johnson & Johnson should be restricted to chemotherapy patients and limited to those with uncurable forms of cancer.
The cancer experts overwhelmingly voted to keep the drugs on the market for chemotherapy patients, but said use should be limited to those with uncurable forms of cancer. The experts also voted 9-5 to withdraw the drug’s use in patients with breast or head-and-neck cancers, such as those affecting the sinuses, throat and lymph nodes. Another positive for the companies was when the panel asked whether it recommended the drugs for anemia caused by cancer treatment, the FDA committee voted 13-1 in favor.
In a statement after the meeting, Amgen said it “takes very seriously the safety signals seen in recent trials where [the drugs] were used outside of the labeled indication. The role of the [panel] is to advise the FDA. We are committed to working with the FDA to consider the input from the committee and to implement future label changes.”
Aranesp sales totaled $3.6 billion in 2007, with more than $2 billion related to cancer. J&J said at least half of Procrit’s $1.7 billion in U.S. sales last year was related to cancer treatment.
NACDS Foundation, eHealth Initiative to host health technology conference
ALEXANDRIA, Va. Scrambling to keep its members abreast of rapid changes in health information technology and electronic communications, the National Association of Chain Drug Stores Foundation will co-host a two-day conference in June on the advances transforming health care.
The NACDS Foundation is collaborating with eHealth Initiative, a Washington-based nonprofit organization specializing in quality and health information technology, to sponsor the event. Titled “HIT, EMR, PHR- Transforming Patient Care,” the conference is set for June 11 to 12 at the Sheraton Crystal City in Arlington, Va.
Among the topics the meeting will address are the use of technology in electronic prescribing, medication therapy management, patient education programs, comprehensive medication review and other initiatives to manage data and improve patient health.
“Advances in health information technology, new electronic prescribing regulations and increased adoption of electronic medical records are changing the landscape of pharmacy provided patient services,” said foundation president Phil Schneider. “As other sectors of the healthcare system adopt health information technology practices, the opportunity is tremendous for community pharmacy to play an integral role in new ways to provide patient care.”
Janet Marchibroda, chief executive officer of eHealth Initiative, said the event would focus on “highlighting significant progress made—across a variety of sectors of health care, including pharmacies—in using health information technology to transform patient care.” The conference, she continued, “will offer practical guidance and best practices for using health IT to improve the quality, safety and effectiveness of health care in the United States.”
Medical Marts clinics lose funding, are forced to close
LAS VEGAS Medical Marts, an operator of physician-staffed clinics located in select Meijer, Sears/Kmart and ShopKo stores, has closed its doors.
Ken Richmond, who had served as vice president and chief medical officer of Medical Marts, told Drug Store News that the venture capitalists backing the operation changed their mind for reasons that are unclear and decided to move in another direction.
When it closed, the company had operated 13 clinics in Utah, Illinois and Virginia. The physician-staffed clinics were within retailers ShopKo, Meijer and Sears/Kmart. It staffed about 75 employees, of which more than 20 were physicians.
Medical Mart, which opened its first clinic in Salt Lake City in November 2006, had planned to open up to 100 more clinics in 2008.
Dismayed over the company’s decision to close, Richmond said he believes the concept “is a winner” that addresses many of the problems in mainstream healthcare, especially access to healthcare.
“This is the first way in which physicians were truly community based,” said Richmond. “Rather than physicians saying to the public you come to us, we came to the public and made ourselves available at their convenience.”