"Science" Takes ACLS Backwards

Food and Drug Administration (FDA) regulations have become the new pathway to riches for the pharmaceutical industry.

First, there was generic colchicine, used for years and years to treat gout for  pennies a pill.  The only problem was, there wasn't an FDA trial proving colchicine's efficacy in the treatment of gout.  Takeda Pharmaceutical, seeing the opening, performed a trial and rebranded the formerly generic colchicine to Colcrys®, "the only authorized generic indicated to prevent and treat gout attacks."  And how much does Colcrys® cost?  Just $203 for thirty tablets at Costco.

But that's not all.

Today I learned that generic vasopressin (which can be stored at room temperature in stable form on crash carts), must be switched to the FDA-approved brand called Vasostrict® that requires dilution and refrigeration.  It seems the generic form of vasopressin will no longer be available to be kept on crash carts since it's not "FDA-approved" for the indication of "increasing blood pressure in adults with vasodilatory shock (post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines." Vasostrict®, on the other hand, is "now the first and only vasopressin injection, USP, product with an NDA approved by the FDA." The catch is, it must diluted before use and discarded after 18 hrs (or after 24 hrs if refrigerated). This little regulatory quirk is a big deal for America's hospitals looking to save costs.

But hey, why should we worry about costs in health care?  After all, you can never be too safe.

-Wes

Medicine's Love-Me Wall

“We can never be gods, after all--but we can become something less than human with frightening ease.”

― N.K. Jemisin, The Hundred Thousand Kingdoms

I know it's click bait, but the top 100 most influential people in health care, according the Modern Healthcare, is worth a look. It contains the following individuals in its "Top Ten:"

• Kathleen Sebelius (#1) who resigned as the head of Health and Human Services after the botched Healthcare.gov rollout
• Oregon Governor John Kitzhaber (#2) who jettisoned the state's $248 million dollar attempt to arrange its own health care exchange website
• President Barack Obama(#3) - of course
• Mr. Stephen Hemsley of UnitedHealthcare (#4) who made a cool, $4.57 million in compensation last year and exercised $9.48 million in stock in 2013
• Marilyn Taviner (#5), CMS who gets a little love each year from her prior employer, the Hospital Association of America on top of her salary as CMS Director
• Mark Bertolini (#6), CEO of Aetna, who made $2.66M in compensation and exercised $4.52M in stock in 2013
• Richard Bracken (#7), CEO of HCA, who earned $38.6 million for his role as CEO in 2013 before retiring and pocketed a cool $46.3M in 2012
• newcomer Joseph Swedish (#8), CEO of WellPoint, who earned only $7.48M in 2013
• George Halvorson (#9), of Kaiser Permanente, who doesn't report compensation (a bit of "Sunshine law" needed, perhaps?) but other sources pegged his compensation at $6.7 million back in 2009
• Sister Carol Keehan (#10), of Catholic Health Association who likely made well in excess of $1M in 2011

And the list goes on...

Yet we wonder why our health care costs are so high.

Really?

-Wes

The Iron Triangle and Evidence-based Medicine

From the Journal of Evaluation in Clinical Practice:

It is naïve to think that we can prevent vested interests from introducing bias. Politicians cannot tally their votes and in sport we rely on umpires, not player, to call the penalties. What are we thinking relying on industry provide evidence about health interventions that they have developed, believe in and stand to profit from? We need to recognize this inherent bias and take action against it.

It is beyond the scope of this paper to discuss practical solutions in great detail, however, we make the following suggestions:

1. The sensible campaign to formalize and enforce measure sensuring the registration and reporting of all clinical trials (see http:// www.alltrials.net/) should be supported – otherwise trials that do not give the answer industry wants will remain unpublished.
2. More investment in independent research is required. As we have described, it is a false economy to indirectly finance industry-funded research through the high costs of patented pharmaceuticals.
3. Independent bodies, informed democratically, need to set research priorities.
4. Individuals and institutions conducting independent studies should be rewarded by the methodological quality of their studies and not by whether they manage to get a positive result (a ‘negative’ study is as valuable as a ‘positive’ one from a scientific point of view).
5. Risk of bias assessment instruments susch as the Cochrane risk of bias tool should be amended to include funding source as an independent item.
6. Evidence-ranking schemes need to be modified to take the evidence about industry bias into account. There are already mechanisms within EBM evidence-ranking schemes to up- or downgrade evidence based on risk of bias. For example, the Grading of Recommendation Assessment, Development and Evaluation (GRADE) system allows for upgrading observational evidence demonstrating large effects, and downgrading randomized trials for failing to adequately conceal allocation (and various other factors). However, currently such schemes are agnostic to the origins of evidence and do not expressly recognize the high risk of bias when the producers of evidence have an invested interest in the results. It would be easy to introduce an evidence quality item based on whether a trial was conducted or funded by a body with a conflict of interest. If so, the evidence could be downgraded. Given the failure of current evidence-ranking schemes to detect and rule out industry-funding bias, this is a necessary step if EBM critical appraisal is to remain credible.

Read the whole thing.

-Wes

h/t: Ivan Oransky on Twitter

What's Wrong With This Picture?

A US medical conference opening plenary session:

Heart Rhythm Society Meeting 2014 (Click to enlarge) From https://twitter.com/HugoOC/status/464204486576058368

A European medical conference opening plenary session:

NICE Annual Conference 2014 (Click to enlarge) From https://twitter.com/LockOn_Tweets/status/466514188521598976

Just sayin' -

-Wes

The Health Care Industrial Complex and the Iron Triangle

Walking to the 2014 Heart Rhythm Society (HRS) Scientific Sessions this morning, I couldn't help but marvel how beautiful San Francisco seemed today. The weather was perfect, the streets bustling, the quaint shops and eateries doing brisk business in a very hip metropolitan city with a distinctive West Coast vibe. As I walked up to the Moscone Conference Center, I was struck by the size and scope of the facility and its cool, corporate look.

"Welcome," I thought, "to the Health Care Industrial Complex."  This meeting was, after all, designed for me and the other Heart Rhythm Specialists from all over the world.

HRS Infinity Circle Supporters

After picking up my badge I shuttled off to my first session and picked up the fresh flier published on the previous day's events.  The publication was remarkably professional, processed with all the proper public relation jargon and complementary hyperbole.  The Heart Rhythm Society app that I downloaded on my iPhone, too,  looked eerily similar to the polished one at the ACC meeting earlier this year, just the sponsor page that blinked "Biotronik" instead of  "Amgen" as it had earlier this year.  Finally, as I turned by attention back to the flier, there on page two was a picture of Hugh Calkins, MD the current President of HRS and James Youngblood, the Society's "professional" CEO, honoring the "HRS Infinity Circle Supporters" from Medtronic.  Infinity Circle Gold members from Biosense Webster, Boerhinger Ingelheim, Boston Scientific and Janssen and Silver member St. Jude Medical also were honored in the picture's caption.

Of course they were.

Twenty-six years ago I entered the North American Society and Pacing and Electrophysiology (NASPE) as a young fellow in cardiac electrophysiology competing for the Young Investigator Competition.  I was nervous as hell as I practice and re-practiced by presentation.  I was competing against some of the best and brightest and was thrilled at the opportunity, the heady notoriety, and the opportunity to rub noses with the reviewers (international senior mentors) first hand.  Back then I did not have the perspective I have now with the interplay of forces that have come to define US health care.  I had no concept of the powerful influence that the vast sums of money, lobbies, special interests, regulators, and oversight agencies have in medicine.

Since that time, NASPE has changed its name to the Heart Rhythm Society to reflect a more global mission.  Over the years I have seen the bureaucratic and political influence change the landscape of medicine as I never imagined as I struggle to cope with what it means to practice medicine today.  I suppose when one considers that for many communities in America, health care is their economy, I shouldn't be surprised that the business and politics of medicine are now more important than ever.

Years ago near the start of the Vietnam War, President Dwight D. Eisenhower coined the phrase "military industrial complex" in his farewell speech to America.  He was describing the policy and monetary relationships that exist between legislators, our national armed forces, and the military industrial base that supports them.  These relationships include political contributions, political approval for military spending, lobbying to support bureaucracies and oversight of the industry.  The concept began with the concept of coordination between the government and the private sector to provide weaponry to government-run forces.

Now we have the private sector providing funding for our instruments of health care.  We see companies that supply medical devices, drugs, insurance, electronic medical records and companies that support lobbying efforts and data mining and richly-paid oversight entities.  Today, however, the budget is much, much larger for medicine than the military.  Our "health care industrial complex" has grown into the monster it is today with a supporting flotilla of corporate, special interest, regulators and oversight entities, with doctors and patient's swept up by its wake.

Some have called this the "Iron Triangle."  And just like it's original reference for the military, we should recognize that it pertains to health care, too.  While this may be distasteful to many (including myself), I have also come to recognize that like the military, we need health care.  Unfortunately for all of us, this monstrous bureaucratically-wasteful system is what we've created.   For me, I find it helpful to understand this interplay, because it helps me focus on my role as a doctor today.

The Iron Triangle

I can only hope that our younger medical students, residents, fellows, and younger doctors get taught this perspective.  Much too often I see them looking more like lambs being led to slaughter.  Hopefully, a little insight will help them cope with the seemingly endless bureaucratic and oversight "ideas" that keep surfacing as we struggle to care for our patients.  Hopefully this perspective will keep them engaged in pushing back when the onerous becomes intolerable.  Hopefully they'll come to understand what they're up against before they throw up their hands in disgust.

Perhaps bringing these concepts to consciousness will allow us to become coordinated advocates for our patients who are being affected by these very same forces.  Maybe then, we can continue to hold true to what we love about medicine, and beat back the Iron Triangle that is making it so difficult to do so.

-Wes