FDA launches Sentinel Initiative health system
WASHINGTON The Food and Drug Administration has unveiled its new health system, the Sentinel Initiative, according to published reports. This system will allow the agency to use information on Medicare claims to immediately assess the risks of drugs already on the market.
With Sentinel, the agency could ask Medicare officials to count the number of patients on a certain medication who later saw their doctors or checked themselves into a hospital with an ailment. Then, it could compare the overall number of that same ailment among Medicare beneficiaries.
The use of Medicare records may solve many of these problems because the agency could get a clear idea of what percentage of a drug’s recipients suffer a certain effect. But there are several problems with this new system.
Most importantly, Medicare collects data only when a doctor, hospital or other medical provider is seeking payment. These are called “claims data,” and they are far less accurate than actual patient health records.
For instance, when a hospital bills Medicare for treating a patient with a heart attack, it is not always the case that the patient actually suffered a heart attack any time recently. So using Medicare data to assess health outcomes is problematic.
Another issue is that sometimes patients suffer problems after receiving drugs because they are sick, not because the drug is to blame. Finally, Medicare beneficiaries use an average of 28 prescriptions in a year, compared with an average among all Americans of 13 prescriptions. Sorting out which medicine caused any single problem can be difficult in the elderly.
To assess the accuracy of the Sentinel system, the FDA will initially conduct studies of drug side-effects that are already well known, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. The agency is in discussions with private insurers to add their records to the system.
Health officials also said they could use the Sentinel system to identify drugs that are not working, a result that could save the government money and relieve patient suffering.
Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said his organization supported the FDA initiative “because it allows regulators and health care professionals to move from reliance on voluntary reporting of side effects to proactive monitoring of medicines.”
Pfizer invests in FivePrime for diabetes, cancer treatments
SAN FRANCISCO Pfizer has taken an equity investment in FivePrime Therapeutics as part of a new research and licensing deal to find antibody targets and therapeutic protein products to treat diabetes and cancer, according to published reports.
FivePrime, a preclinical stage company expected to file an investigational new drug application for its lead oncology compound within the next six weeks, will receive an upfront payment and the equity investment from Pfizer. It also will get three years of committed research funding.
The deal is one of the first by Pfizer’s new Biotherapeutics and Bioinnovation Center. The center is trying to boost the company’s pipeline by acquiring companies with promising drug developments.
Pfizer will have exclusive worldwide rights to develop and commercialize certain products and targets that are discovered, while FivePrime will receive future milestone and royalty payments.
The deal helps FivePrime take several of its potential cancer products into clinical trials while expanding its discovery work, said president and chief executive officer Gail Maderis.
The companies did not disclose figures for those aspects of the deal.
H-E-B, Kraft partner to offer health screenings
NEW YORK H-E-B, the Texas grocery chain, will offer health screenings at all its pharmacies on the second Saturday of every month until October.
The “Second Saturday Health and Wellness Screenings” program is sponsored by Kraft and offers free glucose and blood pressure screenings, as well as discounts on lipid panel, A1C and cholesterol screenings. Customers will receive free samples of healthy products as well.
Each screening has a theme: children for June, the military for July, the beginning of the school year for August, fitness for September and wellness for October.