PHARMACY

Diabetes drug may aid cancer therapies, study finds

BY Allison Cerra

NEW YORK Researchers at McGill University and the University of Pennsylvania have discovered that a widely used anti-diabetic drug can boost the immune system and increase the potency of vaccines and cancer treatments. Their findings were published June 3 in the journal Nature.

The discovery was made by Russell Jones, an assistant professor at McGill’s Goodman Cancer Centre and the Department of Physiology, faculty of medicine; Yongwon Choi, PhD, professor of pathology and laboratory medicine, and postdoctoral fellow Erika Pearce, PhD, of the University of Pennsylvania.

The researchers discovered that the widely prescribed diabetes treatment metformin increases the efficiency of the immune system’s T-cells, which in turn makes cancer and virus-fighting vaccines more effective. In diabetics, metformin works by stimulating AMP-activated protein kinase or AMPK, a master circuit for energy metabolism in the body.

T-cells remember pathogens they have encountered from previous infections or vaccinations, enabling them to fight subsequent infections much faster. Now, the researchers said, they can use diabetic therapies to manipulate T-cell response and enhance the immune system’s response to infections and cancer alike.

“Many genes involved in diabetes regulation also play a role in cancer progression,” Jones explained. “There is also a significant body of data suggesting that diabetics are more prone to certain cancers. However, our study is the first to suggest that by targeting the same metabolic pathways that play a role in diabetes, you can alter how well your immune system functions.”

The recent findings suggest a new link between the metabolic pathways deregulated in cancer and diabetes and their role in immune cell function. The results suggest that common diabetic therapies which alter cellular metabolism may enhance T-cell memory, providing a boost to the immune system. This could lead to novel strategies for vaccine and anti-cancer therapies.

“Our findings were unanticipated, but are potentially extremely important and could revolutionize current strategies for both therapeutic and protective vaccines,” Choi said.

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NCPA appealing AWP pricing settlement

BY Jim Frederick

ALEXANDRIA, Va. Stoking a long-simmering dispute over drug payments by health plan sponsors to pharmacies, the nation’s largest independent pharmacy group is appealing a lower court’s settlement of a lawsuit that would reduce the published average wholesale price figures used in pharmacy reimbursement contracts.

If the settlement is not overturned, said the National Community Pharmacists Association, the resulting cutbacks in pharmacy payment rates on many drugs could be devastating to community pharmacies. In response, NCPA said Wednesday it has filed an appeal with the First U.S. Circuit Court of Appeals.

The appeal seeks to freeze AWP-based payment rates to pharmacies at their current levels until the federal court has reviewed the mid-March settlement.

The original case revolved around the prices that union pension funds, teachers’ unions and other health plan sponsors were paying pharmacies to dispense drugs to their members. Historically, reimbursement rates have been based on the drug’s AWP. But the plan payers acting as plaintiffs in the original case charged in U.S. District Court that drug-price publishers had allowed those rates to rise to unrealistic levels, leading them to pay a 25% premium over AWP for some 8,000 drugs dispensed to their plan members.

Originally named in the health plans’ suit was First DataBank, which was accused of conspiring with McKesson Corp. to set AWP rates artificially high. But in May 2007, Medi-Span, a division of Wolters Kluwer Health, was named as a defendant in a similar class action involving the publication of AWPs.

“The groups alleged that the two publishers and the wholesalers illegally conspired to inflate the markup between Wholesale Acquisition Cost and AWP from 1.20 to 1.25. This resulted in higher costs to patients and third party payers,” NCPA noted in a statement.

Three years ago, the independent pharmacy group joined the National Association of Chain Drug Stores and the Food Marketing Institute in opposing a proposed settlement that would have rolled back the increase on those 8,000 drugs. That intervention, noted NCPA, “resulted in a $291 per day saving for every community pharmacy when U.S. District Court Judge Patti B. Saris rejected that settlement, savings that continue.”

In January 2008, the judge agreed with NCPA that the rollbacks on the 8,000 brand name drugs would be devastating to community pharmacy. Earlier this year, she pared the list to about 1,400 drugs to be reimbursed at lower rates, and extended the effective date from three months to six months after the settlement, as NCPA requested. “However,” the pharmacy group noted today, “even the reduced list will cause major reductions in Medicaid payments and a 4% cut in AWP-based reimbursements for pharmacies unable to renegotiate their PBM contracts by Sept. 26.”

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Mylan COO says Congress must ‘look further into use, abuse of authorized generics’

BY Alaric DeArment

PITTSBURGH An executive from generic drug maker Mylan said in testimony before Congress Wednesday that “authorized generics” launched by brand drug makers during a generic company’s customary six months of market exclusivity undermine competition.

Testifying before the House Judiciary Subcommittee on Courts and Competition Policy, Mylan COO Heather Bresch also said authorized generics – branded drugs that brand companies release under their generic names, often through third-party companies – delay access to generic medications for patients, taxpayers, government agencies and businesses.

“When it comes to settlements, Congress need look no further than the use and abuse of authorized generics by brand manufacturers,” Bresch said in the hearing, which the subcommittee convened to debate so-called “pay-to-delay” agreements between brand and generic drug companies. “The increase in the number of patient litigation settlements in recent years is directly related to the increased use of authorized generics during the 180-day market exclusivity period.”

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