Category: Pharmaceutical Industry

FDA Panel Finds Opana-ER Not Worth The Risk!

Opana ER is the brand name of the specific extended release preparation of oxymorphone HCL marketed by Endo Pharmaceuticals, Inc.  This was the drug of choice that underlay the explosion of opioid addiction and of HIV/AIDS and hepatitis infections in intravenous users in nearby Scott County, Indiana.  Opana is back in the news, but not in a good way for Endo.  The FDA assembled an expert review panel last week to opine on whether the benefits of Opana ER outweighed its risk to its users.  The short summary of its findings and recommendations is that the benefits do not outweigh the risks, and that the drug’s continued marketing should be controlled in a variety of possible ways including removal from the market, or restrictions on who can prescribe it and under what conditions.

To summarize the findings of the article below, Opana ER is not a big player in the prescription opioid market in any event.  Its active ingredient, oxymorphone,  is manufactured or distributed in the US by at least 19 different companies but fills less than 1% of opioid prescriptions.  (I must admit up front that have no idea who actually makes what pills or where the active ingredient in the various preparations comes from.) A detailed list of individual versions of oxymorphone by NDC from the labelers below is available here. (or here as Excel file.) It occurs to me as I see such long lists of labeler names, that with so many ways for a drug to enter the community, opportunities for diversion from supervised distribution become correspondingly more numerous. Given all the apparent distributors, is it even possible for an Endo or a Mallinckrodt to know where the drugs they might manufacture end up? Mallinckrodt in particular has been accused of not keeping very good track at all, at least in Florida. Continue reading “FDA Panel Finds Opana-ER Not Worth The Risk!”

Potpourri of Health Policy Issues in June.

My cup runneth over with potential issues to explore.

June has been a busy month both locally and nationally insofar as things I like to write about. The shame-on-me is that I have not carved out enough time to do so!  In part I am still picking up the pieces after my early spring travels. Exploring how to unpack and deal with the new Medicare prescription drug data base also took a lot of time.  The truth is that I am a slow writer handicapped by a default and probably over-wordy professorial style.  I haven’t even been able to update the Institute’s Facebook and Twitter pages!  What follows is a list of things that occured during the month that I wanted to write about and hope to do so in more detail later.  These are not necessarily in chronological order or of importance.

The Supremes Rock & Rule!
We were presented with two back-to-back major decisions by the U.S. Supreme Court. The first, King v. Burwell, allows federal subsidies of health insurance premiums for low income individuals and their families to continue even if their insurance was purchased in states that chose to allow the federal government to operate their health insurance exchanges.  The lawsuit brought by Obama/Obamacare-haters to limit premium support to insured individuals in states like Kentucky that chose to operate their own exchanges would have essentially gutted the Affordable Care Act (ACA) and tossed millions back into the uninsured category. For the time being, Obamacare stands intact for at least the next year and a half, despite promises by opponents to throw up additional challenges. All our legislators should be working together to deal with a major remaining deficiency of the ACA.  The Act has been very successful in decreasing the number of uninsured people, but it makes little headway against the exploding costs of unnecessary, marginally effective, or for that matter even necessary medical care.  Continuing to forbid the federal government to negotiate over the prices of drugs is a case in point. Subsidies were deemed necessary for a reason! Continue reading “Potpourri of Health Policy Issues in June.”

Narcotized Elderly America: Diseased, Stoned, or Dealing?

pills-15The Federal Government has been releasing an avalanche of health care utilization data over the past very few years while the rest of use are still trying to figure out how to use the information.  While there exists the potential to use the data to evaluate healthcare quality and safety, to ferret out best medical practices, to more efficiently use increasingly limited healthcare dollars, or to otherwise guide good public policy; the most apparent utility so far is to identify medical fraud. It is easier to justify looking for fraud than to confront entrenched interests dug in deep in this profitable segment of the economy.

Medicare prescription drug cost and utilization data.
One month ago, the Centers for Medicare and Medicaid Services (CMS) published another data-dump. It was the first compilation of all drugs and selected supplies prescribed by physicians and other healthcare professionals to the majority of Medicare patients in 2013.  Included beneficiaries number 35.7 million and include those enrolled in freestanding Medicare Part-D drug plans, or those covered by drug plans that are part of Medicare Part-C (managed care) Advantage plans. These make up about 68% of all Medicare beneficiaries. Medicare fee-for-service patients are not included.  Recall also that a proportion of all Medicare beneficiaries are enrolled because they are disabled, not because they are over 65 years old.   Each provider has a line item for every discrete drug prescribed more than ten times by them (to protect patient privacy) including the number of unique beneficiaries receiving the drug, the number of times times prescribed or renewed, the number of days worth of of drug prescribed, and the total amount paid for the drug by the patient, Medicare, and any third party payers.  In the full data file there are 23,650,520 line items for more than 1 million individual providers prescribing 3449 different drugs or supplies. Continue reading “Narcotized Elderly America: Diseased, Stoned, or Dealing?”

Initial Release of CMS Open Payments Program Deeply Deficient.

As a teacher I give a grade of D- with a C+ for effort.

Yesterday I began to dig into the first public report by the Center for Medicare and Medicaid Services of their Open Payments program, also known as the Sunshine Act. Under this part of the Accountable Care Act (ACA), some (but not all) payments and transfers of value to physicians and teaching hospitals by pharmaceutical companies, medical device manufacturers, and group purchasing organizations must be reported. There is little doubt that such payments powerfully influence the practice of medicine for better, but mostly for worse. Initial reporting in the media finds individual physicians and organizations scrambling to justify or to correct the often very startling amounts received.

I still believe the program is a great idea. The public has no idea of the extent to which industry has captured the health policy market, including the professional activities of physicians and other practitioners. Much will be learned by focusing on the outliers on both ends of the curve are already emerging from the mass of data. Indeed, I hope to be able to contribute myself. Nonetheless, in fairness to all involved, it must be recognized that this was a deeply flawed implementation. Continue reading “Initial Release of CMS Open Payments Program Deeply Deficient.”