Friday, September 19, 2008

Health Care Reform: Time for American Medical Leadership to Start Thinking Ouside the Box. Part One

A recent Perspective article in the New England Journal of Medicine raises concern that because the federal Food and Drug Administration (FDA) has approved certain drugs, citizens could not sue drug companies in state courts because of the preemption clause in the U.S. constitution which states that federal laws trump state laws. The article, Why Doctors Should Worry About Preemption, was written by three physicians on the Journal staff . Given their positions, they are among the top leaders in the medical community and exert considerable influence.

FDA approval is based on a four phase process with all information supplied by the drug company at a cost to the company of over eight hundred million dollars. There is much debate as to how to improve this process. Aside from this debate, the authors of this article support the concept that after FDA approval, state tort litigation augments drug safety and enhances consumer confidence in the safety of medications and devices.

I disagree and here's why:

1) Legal action does not address the fundamental problem of our drug/device approval process. Presently clinical research to define the efficacy and safety of these commodities are funded, designed and controlled by these companies. The cost of bringing a new drug/device to market is enormous with failure risking the viability of the company. As has been repeatedly shown in the recent past this research is tainted by inappropriate design, withholding of results, and conflicts of interest.

2) Patients have confidence in drugs and devices when prescribed by their physicians even though the safety and efficacy may be proven otherwise somewhere down the road. It takes many years before tort cases reach any helpful conclusion and, by that time, many patients may have been harmed.

3) Allowing drug/devise direct marketing to the public has distorted the public's view of the safety and efficacy of these products, while considerably increasing their cost.

A possible solution to this litany of problems is to have all drug and device clinical research funded by the companies, but through the National Institutes of Health (NIH). This would ensure rigorous design, honest and timely reporting of results. We might then have more high quality information disseminated to the medical community. People with conflicts of interest at the NIH would be excluded from this activity.

Funding by the companies would also be mandated to include follow-up of all products to spot any problems that occur once the drug is available to the mass market. If problems do occur or efficacy is not proven, the FDA could immediately withdraw the product from the market.

Using this system, knowledge from rigorous scientific processes would drive the system, rather than a drawn-out legal process that also has the potential for emotional misadventure, as occurred with the silicon breast implant litigation. I also propose the discontinuance of direct advertising to the public that creates excess demand for newer more expensive products that may have no benefit over older off-patent material.

It is my hope that the leadership of the prestigious New England Journal of Medicine will expand the scope of their view to consider fundamental change to the oversight of this industry rather than a slow, extremely expensive and some times grossly inappropriate legal system. We must use knowledge and science to better treat our patients, not the courtroom.

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