0 New Diabetes Drug Gets FDA Panel Backing

Last Friday, the day after the FDAs Endocrinologic & Metabolic Drugs Advisory Committee endorsed the inhaled insulin Exubera^TM, it gave its nod to another new diabetes drug, Pargluva^TM.

Unlike Exubera^TM, Pargluva^TM (also known as muraglitazar) is not an insulin, nor is it inhaled. It is a new oral medication developed by Bristol-Myers Squibb and Merck for the treatment of type 2 diabetes.

Pargluva^TM falls into the new class of diabetes drugs called glitizars. It is designed not only to lower blood glucose but to improve triglyceride and HDL (good cholesterol) levels as well.

The drug received endorsement in spite of:

1. Questions of conflict-of-interest among panel members. (See New York Times story below.)
   
   
2. Possible health risks. The non-profit group Public Citizen (see story below) is arguing against FDA approval of Pargluva based on risks, notably heart problems, uncovered during clinical trials.

Again, as with Exubera^TM, endorsement by an FDA panel does not assure final FDA approval. But this action brings the drug that much closer to marketability.

________
Bristol-Myers Squibb/Merck press release:
Bristol-Myers Squibb And Merck Joint Statement On FDA Advisory Committee Vote On Pargluva™ (Muraglitazar), An Investigational Oral Treatment For Type 2 Diabetes

New York Times story, Sept. 10:
Panel Backs Drug Amid Conflict Concerns

Public Citizens press release:
Testimony Before FDA Advisory Committee on New Diabetes Drug Muraglitazar (Pargluva): Risks Outweigh the Benefits

0 The Centers for Medicare Medicaid Services CMS Gets Nudged to Do Something About Shared Decision Making SDM

Medicare tackles the shared decision
making requirement in the ACA

In a recent New England Journal of Medicine article, Emily Lee and Ezekiel Emanuel point out that its high time for the Centers for Medicare and Medicaid Services (CMS) to wake up and do something about Section 3506 of the Affordable Care Act.

Thats the section of the law that deals with "shared decision making" (SDM):

"The Secretary shall establish a program to provide for the phased-in development, implementation, and evaluation of shared decision making using patient decision aids to meet the objective of improving the understanding of patients of their medical treatment options...."

In particular, they argue that CMS should expedite the creation of an independent entity that would certify and implement patient decision aids and begin piloting SDM among Medicare beneficiaries who are contemplating having one of the 20 most frequently performed procedures (a list can be found on page 3).

And they dont stop there. 

They recommend that Medicares coverage for the "top 20" should be made contingent on the documented delivery of SDM to the beneficiary

"To give such a requirement teeth, full Medicare reimbursement could be made contingent on having documentation in the patients file of the proper use of a decision aid for these 20 procedures. Providers who did not document the shared-decision-making process could face a 10% reduction in Medicare payment for claims related to the procedure in year 1, with reductions gradually increasing to 20% over 10 years. This payment scheme is similar to that currently tied to hospital-readmissions metrics."

In contrast to the NEJM readership, the thousands of regular visitors to the Disease Management Care Blog arent surprised. Theyve known all along that "shared decision making was an important if unknown part of the Affordable Care Act.  To them its not news that SDM is an evidence based approach that combines patient engagement with physician participation to optimize the utilization of potentially harmful therapies.

Pity that CMS leadership isnt regularly reading the DMCB.  Whether a NEJM article by one of D.C. health care mandarins spurs CMS to action remains to be seen.

Stay tuned!