A glimpse of Senate sausage-making: Hatch & supplements

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The following is a guest post by Dr. Bradley Flansbaum, who blogs on The Hospitalist Leader, is a Hospitalist at Lenox Hill Hospital in New York City and is active in health policy at local and national levels.


Given the cost restraints our health system must undergo, it is incumbent on our elected officials to oversee government spending prudently, regardless of political stripe.  Most officials align with that goal, although they may differ on the means to achieve it.  They may attempt to score political points and finger point at the other side in front of the microphone, but behind closed doors, I believe they realize we have a catastrophe in waiting.

A common refrain I hear is, “care decisions are best left to physicians,” with the assumption being, doctors have all the answers and given the choice between treatment x and y, they will choose correctly.

That is false, as the unknowable often exceeds the knowable, and quantifying the troves of studies available to arrive at the optimal decision is beyond the capacity of most physicians.  We need assistance, and left unchecked, a disorganized system without an instruction manual, as our current one is, is worse than the alternative.  The words inefficient and harmful come to mind.

Some pols rail against comparative effectiveness research.  I am not certain it’s posturing or a genuine state of certitude derived from careful scrutiny.  Either way, as the adults in the room—the ones making the hard decisions and as the stewards of our limited resources—we rely on them as sound gatekeepers.  This is as relevant to clinical care as it is to education and defense.

For example, a foundational determination process, sound and system wide, must apply to the costly procedure or medical device just as it does to the simple pill.  Consistency and a “harm versus benefit” approach should support our coverage and care decisions.

As an illustration, envision a patient having an adverse reaction to a common medication such as a statin.  In response, would you expect the responsible physician to prescribe an alternative therapy, such as coenzyme Q10?  Probably not the first thing that comes to mind and the evidence is instructive:

We conclude that there is insufficient evidence to prove the etiologic role of CoQ10 deficiency in statin-associated myopathy and that large, well-designed clinical trials are required to address this issue. The routine use of CoQ10 cannot be recommended in statin-treated patients. Nevertheless, there are no known risks to this supplement and there is some anecdotal and preliminary trial evidence of its effectiveness. Consequently, CoQ10 can be tested in patients requiring statin treatment, who develop statin myalgia, and who cannot be satisfactorily treated with other agents. Some patients may respond, if only via a placebo effect.

Of course, with a paucity of data—whether it’s CoQ10 and statin therapy, or biologic treatments in autoimmune illness, the search for evidence is the right pursuit.  A decision maker would certainly desire some process, some channel to facilitate this evaluation, and they would advocate for a mechanism to achieve this objective. In addition, CER “divergence” and its utility in practice are great, as exemplified here and here.

In addition, without the evidence, prudence would carry the day, and tax dollars—precious as they are—would not deliver treatments of uncertain value:

The Family Retirement and Health Investment Act of 2011(HR 2010, S 1098) would allow US citizens to use their Flexible Spending Arrangement and Health Saving Account (HSA) dollars on dietary supplements and meal replacement products.

On the other hand, perhaps our judgment is betraying us.  Here is the rejoinder.

Click on this link and forward the video to the 74:30 mark on the scrollbar beneath the video.


You’ll hear Senator Orrin Hatch of Utah.  The New York Times wrote about Hatch:

“…(he) has spent his career in Washington helping the $25-billion-a-year (dietary supplement) industry thrive.

He was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable.”

In this video, you can hear Hatch interrupt Chet Burrell, President and Chief Executive Officer, CareFirst BlueCross BlueShield, Washington, DC.  Hatch asks, then asserts:

“Are doctors being educated at all on people using dietary supplements? For instance, it’s my understanding that if you’re on Crestor, that it would be very wise to take CoQ10 – a dietary supplement to make up for some of the deficits that occur from taking Crestor.  And this is an area that is really not very well defined.”

Not well defined, indeed.  This is troublesome.  In a public hearing on physician payment reform; given all that is wrong with healthcare; with all the misallocation of resources; with the need to promote evidence-based practice; and with all the bickering on rationing care and resource conservation, is this the best congress can do?

I don’t know if CoQ10 is effective or not, but knowing what we know, is the national stage, in the corridors of the capital, the right place and time for product promotion (of indeterminate value).  More importantly, again, is this the best our leadership can put forth, and is this how we instruct the public?  It dampens my confidence that some of those discussions behind closed doors are any more than detours without a meaningful destination.

More here.


Publisher’s Note:  While we’re on the topic of supplements, we should note the Chicago Tribune report, “Dietary supplements:  Manufacturing troubles widespread, FDA inspections show.”

And just today, the Tribune reported on other Senators “calling supplement-makers to account.”

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