Tuesday, July 17, 2012

A glimpse of the Senate make sausage: Hatch & supplements

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

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Given the cost constraints that must be submitted to our healthcare system, it is for our elected officials to oversee expenses with prudence, regardless of Government policy.  Most employees align with this goal, although they may differ with the means to achieve it.  They can try to score political points and finger point on the other side in front of the microphone, but behind closed doors, I think they realize that we have a disaster in waiting.

A common refrain I hear is, "clinical decisions are better for physicians," with the assumption of being, the doctors have all the answers and given the choice between treatment x and y, they will choose correctly.

This is false, as the unseen, often goes beyond the knowable, and quantify the findings of studies available to reach the best decision is beyond the capacity of most doctors.  We need help, and left unchecked, a disorganized system, without an instruction manual, as our current is, it is worse than the alternative.  Inefficient and harmful words come to mind.

Some rail placement against comparative effectiveness research.  I am not sure that it is a posture or a genuine State of certainty derived from a thorough analysis.  Anyway, as the adults in the room — the difficult decisions and how administrators of our limited resources — we can rely on them as the guardians of sound.  This is as relevant to clinical care, such as education and defense.

For example, a fundamental determination process, the sound and the whole, the system must apply the expensive procedure or medical device as well as it does for the simple pill.  Consistency and an approach to "harm versus benefit" should support our care and coverage decisions.

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

We can conclude that there is sufficient evidence to prove the etiologic role of CoQ10 in myopathy deficiency associated with Statin and that large and well-designed clinical trials are needed to resolve this problem. The routine use of CoQ10 may not be recommended in patients treated with Statin. However, there are no known risks to this supplement and there is some experimental evidence anecdotal and preliminary effectiveness. Consequently, CoQ10 can be tested in patients requiring Statin Treatment, who develop Statin myalgia, and that cannot be satisfactorily treated with other agents. Some patients may respond, if only through a placebo effect.

Of course, with a scarcity of data — whether CoQ10 and statin therapy or biological treatments in autoimmune disease, the search for evidence is the exercise of the right.  A decision maker would will certainly some process, some channel to facilitate the assessment, and would advocate a mechanism to achieve this objective. In addition, the CER "divergence" and its usefulness in practice are large, as exemplified here and here.

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

The family health and retirement Investment Act of 2011 (h.r. 2010, 1098 S) would allow citizens to use their flexible spending arrangement dollars and health savings account (HSA) food supplements and meal replacement products.

On the other hand, maybe our judgment is betraying us.  Here's the Rejoinder.

Click this link and send the video to the 74: 30 mark in the scroll bar below the video.

http://www.Finance.Senate.gov/hearings/Watch/?ID=d77c8f52-5056-A032-52EF-33d9c61fd865

You'll hear Sen. Orrin Hatch of Utah.  The New York Times wrote about Hatch:

“…(he) has spent his career in Washington help the industry US $ 25 billion per year (dietary supplement) thrive.

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

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

"Doctors Are being educated in all people using dietary supplements? For example, it is my understanding that if you are on Crestor, it would be very wise to take CoQ10-a dietary supplement to compensate for some of the deficits that occur from taking Crestor.  And this is an area that is not really well defined.

Is not well defined, in fact.  This is problematic.  At a public hearing on medical payment reform; given everything that's wrong with health; with all the misallocation of resources; with the need to promote evidence-based practice; and with all disputes in rationing of care and resources conservation, this is the best Congress can do?

Do not know if CoQ10 is effective or not, but knowing what we know, is the national phase, in the corridors of the capital, the right place and time for product promotion (indeterminate value).  More important, again, this is the best of our leadership can put forth, and that's how we can educate the public?  Dampens my confidence that some of these discussions behind closed doors are more than diversions without significant destination.

More here.

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Editor's Note: while we're on the subject of the supplements, we should note the report of the Chicago Tribune, "dietary supplements: widespread problems, FDA inspections show."

And just today, the Tribune reported the other senators "calling the supplement manufacturers account."


View the original article here

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