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Comparative Effectiveness Research—Will the Risks as Well as the Benefits Be Considered?

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According to the FDA News, a bill to establish a comparative effectiveness research institute is scheduled for introduction in the Senate. The Comparative Effectiveness Research Act of 2008, sponsored by Sens. Kent Conrad (D-ND) and Max Baucus (D-MT), would evaluate the effectiveness of different drugs and medical devices that exist for the same treatment. The Medicare Payment Advisory Commission (MedPAC), an independent agency that advises Congress on issues affecting Medicare, has held a public meeting on the issue. MedPAC supports a comparative effectiveness program and has recommended that Congress establish an independent entity to sponsor prospective, head-to-head clinical trials of competing products as well as clinical reviews.

AAHF is working to see that natural products are considered along with non-natural and therefore patentable products offered by the drug industry.

In addition, good medicine demands that each patient be informed of all treatment options and the risk-to-benefit of each treatment approach. The risks of widely used treatments can be higher than most people realize. Recently 3,200 Florida veterans were advised to be tested for HIV and hepatitis following the announcement that improperly cleaned colonoscopy equipment had exposed them to possible infection; 6,400 veterans in Tennessee were notified last month they may have been exposed to body fluids and possible infections during colonoscopies from 2003 to 2008, and 1,100 vets in Georgia were notified in a separate incident.

The British Medical Journal has revealed that high-volume scope settings can have a higher mortality rate. This may be linked to the inability to completely clean equipment between patient procedures.

Every medical procedure and treatment has its benefits and its risks. The risks must be carefully weighed by the patient after counsel by the physician to decide whether the diagnostic or treatment course is right for them. There is no one right way.
Let’s hope that in the new era of comparing competing products head-to-head, we don’t forget biochemical individuality and risk-to-benefit analysis in deciding what is right for the individual patient. Health freedom is critical for the well-being of every healthcare consumer.

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