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Is The Adderall Shortage A Harbinger Of Future Drug Supply Problems?

December 8th, 2011 by SteveSimmonsMD in Expert Interviews, Opinion, Video

Tags: ADD, Adderall, Adderall XR, ADHD, DEA, Drug Supply Problems, Economic Impact, FDA, Shire, Shortages

Today, most- if not all- Doctor’s offices are strained by the shortage of some prescription medication or vaccine.  A month ago, President Obama signed his executive order, directing the FDA to take steps to reduce drug shortages as the White House stated that drug shortages have nearly tripled over the past five years reaching the stunning number of 178 in 2010.  These shortages make regular news:  Cancer patients without the chemotherapy needed to keep them alive, antibiotics unavailable to treat life-threatening infections, or intravenous nutrition to support the critically ill fighting to live while medical teams and families search for elusive remedies.

As this new reality plays out in hospitals and homes the media is provided a steady stream of drama for our morning paper or evening news.  Meanwhile, time and focus is repeatedly stolen from physicians, patients, and parents in a myriad of ways.  Currently, my medical practice- in primary care Internal Medicine- has been negatively affected by the shortage of Adderall, a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD).  What this medical condition may lack in dramatic news-worthiness it more than makes up for in sheer numbers with an estimated 4.5 million Americans living with this condition today.

I had my first inkling several months ago of the affect the Adderall shortage would have on my practice after one of my patients called frustrated  that their pharmacy did not have their Adderall at the prescribed dosage.  By calling several pharmacies I was able to find their medication at a smaller dose. Advising my patient to “double-up” I wrote another prescription and had to direct my patient to return to my office to pick up the rewritten  prescription- a time-consuming process that doctors and patients can ill afford to repeat on a regular basis.

Unfortunately, this scenario -initially thought an exception- has now become the rule monopolizing my own time while draining the daily resources of my staff, nurse, and medical partner.  Most ironically though, Read more »

Optimal Salt Intake May Be Double The Currently Recommended Amount

December 7th, 2011 by DrRich in Health Policy, News, Opinion, Research

Tags: Cardiac Events, Healthcare Policy, Optimal Levels, Salt Intake, Sodium Restriction

This past summer, DrRich wrote a post on the utter arrogance of the public health experts who are urging the FDA – and international bodies of busybodies – to mandate a policy of strict sodium restriction across the globe.

DrRich attempted to show how such a broad-based salt restriction at this juncture is ill-advised for three reasons. First, the conclusion that a population-wide salt restriction would actually do any good is not based on any actual prospective studies, but on a contrived extrapolation of observational data. Second, there is some evidence that a salt restriction would be harmful to at least a substantial minority of people, even if the overall effect on the population turns out to be positive. And third, there is good reason to believe that the degree of sodium restriction which is being recommended by the public health experts is below the level which is dictated by human physiology.

Perhaps salt restriction for the entire population will turn out to be a good idea. But perhaps not. So in his previous post, DrRich was advocating a prospective, randomized controlled trial to test this proposition before just going ahead and inflicting it upon hundreds of millions of Americans.

And now, as it happens, in recent weeks new studies have been published which question the safety of salt restriction for the whole population. In fact, five studies have been published just this year suggesting that salt restriction might be unsafe.

The latest, published this week in the Journal of the American Medical Association,  suggests that when you compare cardiovascular events (such as heart attack and stroke) to sodium intake, the incidence of those events follows a “J” curve. That is, cardiovascular events are lowest at an “optimal” level of sodium intake. But if sodium intake goes above that optimal level – or if it goes below it – the incidence of cardiovascular events increases. Read more »

*This blog post was originally published at The Covert Rationing Blog*

How To Make Meaningful Use Of Social Media

December 7th, 2011 by Bryan Vartabedian, M.D. in Opinion

Tags: Content, How To, Physician, Social Media, Twitter, Video

I know this woman – a physician.  She spends a lot of time on Twitter.  She has a Tumblr presence but it’s sparse and not very memorable.  All day long she polishes her Twitter presence.  She’s everyone’s friend.  And to her credit she’s a wonderful curator.  We caught up recently and she wanted to know how she could bring herself to the next level.  Despite her time and investment in the latest real-time social tools she felt that her ideas didn’t get the traction that they deserved.

Here’s what I suggested:  Twitter works for interaction and dissemination.  But ultimately you have to create the stuff that defines you.  Retrievable text, video and audio is where your ideas will live.

It’s about content, not Klout.  You can share and engage, but it’s what you make that lasts.

*This blog post was originally published at 33 Charts*

FDA Regulation May Squelch Development Of Some Medical Apps

December 7th, 2011 by admin in Health Policy, Opinion

Tags: FDA, Innovation, Medical Aps, Oversight, Regulation

We’ve been considering FDA oversight of medical apps for a while, over at Medgadget.com. Now, the public comment period has concluded on the FDA’s draft of how this oversight might look. The story:

The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:

* Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.

* Applications that allow the user to view patient-specific lab results.

* Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.

Great, right? The apps that do heavy lifting of patient information and connect to real medical devices get regulated, but the fun and educational apps I am working on remain free and open. Still, Harvey Castro, my favorite EM-doc-and-app-developer, was worried:

“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”

“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”

For their part, the FDA said it’s nothing to worry about: Read more »

*This blog post was originally published at Blogborygmi*

Why No One Knows What Generic Lipitor Costs

December 6th, 2011 by DrWes in Opinion

Tags: Cardiology, Cholesterol, Cost Drivers, Generic Costs, Lipitor, Medicine, Middle Men, Pharmacy, Prescription

Several days ago, the world’s leading cholesterol-lowering “statin” drug, Lipitor, went generic. Doctors are bearing the brunt of the conversion with little information about what the new drug will cost for their patients.