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Latest Posts

Is The FDA Too Lenient When Reviewing Medical Devices?

I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with potholes and trapdoors and the analysis by the FDA is rigorous.

But for years we’ve been hearing that it is much less rigorous when it comes to medical devices. Artificial hip joints and stents to open blocked arteries fall into this category. And recently, the less stringent review process has been highlighted in the news. Metal-on-metal hip joints are being removed from patients who had them implanted. They thought Read more »

*This blog post was originally published at Andrew's Blog*

Managing The Drug Shortage: Many Hospitals Are Buying “Gray Market” Drugs

Severe shortages for life-saving medications have driven a “gray market” in the wholesale drug supply industry, a watchdog group reports.

And the mark-up on gray market drugs is a budget-buster, reports the Institute for Safe Medication Practices, a Philadelphia-based nonprofit organization devoted entirely to medication error prevention and safe medication use. Purchasing agents and pharmacists at 549 hospitals responded to a survey on gray market activities associated with drug shortages.

The report includes chilling anecdotes from the respondents about pressure from physicians and administrators to ensure drugs are available, and drastic price gouging from the gray market suppliers. Price mark-ups of 10 times or more than the contract price were reported by about a third of respondents from critical access hospitals and community hospitals, and more than half of university hospitals. Examples include a box of calcium gluconate that cost $750 instead of the contract price of $50 (1,400% mark-up), and a supply of propofol that cost $25,000 instead of $1,500 (1,567% mark-up). Oh, and there’s exorbitant shipping and handling fees, too. Read more »

*This blog post was originally published at ACP Hospitalist*

Physician Suggests Ways To Fix Medicare Part D

Twenty seven million individuals were enrolled in Medicare Part D as of December 2009. The government spent $51 billion to subsidize Medicare Part D in 2009. The $51 billion spent is in addition to seniors’ premiums and co-pays. The government subsidy was $1,889 per individual subscriber.

Who is making the money?

“A provision in the Medicare Modernization Act (MMA), known as the “noninterference” provision, expressly prohibits the Medicare program (the government) from directly negotiating lower prescription drug prices with pharmaceutical manufacturers.”

This was a gift to the healthcare insurance industry by the government as a result of intense lobbying efforts.

Over 300 private plans (Medicare Plan D sponsors) enter into negotiations with pharmaceutical manufacturers separately to deliver Medicare Part D benefits.

Medicare Part D eligible seniors are forced to deal with Read more »

*This blog post was originally published at Repairing the Healthcare System*

The Perspective Of The Clinical Trial That You Need To Know

There are big companies like Quintiles that run clinical trials around the world. There are local clinics that specialize in clinical trials and make a lot of money at it. There are, of course, pharmaceutical companies and device manufacturers who depend upon the results to gain marketing approval for new products. People in all those groups know a lot about trials.

But the perspective that counts is the view from you and me – patients. Most of us do not enroll in clinical trials. We don’t want to get too up close and personal with anything “experimental.” And often our doctors never tell us about available trials anyway since it can be a lot of paperwork for them. Given that most people don’t enroll in trials and new science is delayed because of it and also because most people in trials are not journalists, I thought I’d put hunt and peck to the computer keyboard and speak out about trials. I am especially motivated because I have participated twice. The first one, a leukemia trial in 2000, I believe, saved my life. And I enrolled in a second one, studying a new drug for clots in the legs (deep vein thrombosis or DVT) just a week and a half ago.

I enrolled in the DVT trial because 1) the first one worked for me and 2) I crow all the time about how patients should always consider being in a trial as a treatment option. I had to put up or shut up. So I signed on the dotted line.

This particular trial, Read more »

*This blog post was originally published at Andrew's Blog*

Will We Ever See Accountability And Transparency In Our Healthcare System?

President Obama, where is your promise about transparency and accountability in Obamacare?

A major problem in the healthcare system is the lack of transparency and accountability. It has been unchecked for a very long time.

Both primary and secondary stakeholders act in their self-interest. These stakeholders have had ample opportunity to be non-transparent and non-accountable. All the stakeholders have abused the healthcare system.

I hit a nerve with my last blog “Patients And Physicians Must Control Costs”. Multiple readers responded with the usual comments:

Patients are not smart enough to handle their own healthcare dollars.”

“Your basic idea makes sense, but in reality I doubt that a patient knows enough to make intelligent medical/financial decisions, because there are too many unknowns and variables.”

“Physicians over use the fee for service system in order to make more money.”

“If a physician tells a patient that there is only a 1/10,000 chance that an MRI will yield something useful, if the patient doesn’t have to pay for it, the patient wants the MRI.

Patients (consumers) must be taught and motivated to manage their own healthcare dollars. Patients’ choice Read more »

*This blog post was originally published at Repairing the Healthcare System*

Latest Interviews

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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