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FDA Set To Cut Off 17,000 Women Annually From Lifesaving Drug

by: warner todd huston | published: 12 08, 2010

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Obama's Food and Drug Administration (FDA) is due to take up the case of Avastin, a cancer drug that successfully treats some 17,000 women annually. With a coming December 17 decision, the FDA seems poised to take this drug away from these patients quite despite the fact that their doctors find the drug effective.

The most dangerous period of time in Washington D.C. is that time we call the lame duck session (I call it the zombie congress; dead men walking). It is that time when those elected officials that are about to be ingloriously shipped off home for the last time due to losing election results make a mad scramble to grab for as much as they can get.

In the case of regulatory agencies like the FDA the lame duck session is not treated in exactly the same manner, but it is sure that when congress is about to have its majority party change over with the president's party on the losing side of the switch, regulatory agencies often try to push through favored policies before the new congress is seated and before that new congress is in a position to put any pressure on those agencies to prevent them from pushing the president's agenda.

We are currently seeing this lame duck scramble happening in Obama's regulatory agencies. The FCC was pushing its ruinous Net Neutrality ideas, the National Labor Relations Board (NLRB) has been changing labor rules to favor unions, and the FDA is about to eliminate Avastin putting at risk the lives and cancer treatment regimens of thousands of women suffering from metastatic breast cancer.

Recently five members of congress sent a letter to FDA Commissioner Margaret Hamburg presenting their "serious concerns" over the hasty decision to take Avastin away from these breast cancer sufferers. The letter was signed by Representatives Kay Granger (R, TX); Rodney Alexander (R, LA); Jo Bonner (R, AL); Tom Latham (R, IA); and Dennis Rehberg (R, MT). (Download letter HERE)

These congressmen feel that if the FDA takes Avastin off the market for treating cancer it will be engaging in yet another "large-scale intrusion into Americans' lives and their personal health care decisions that have previously been left up to a patient and their health care provider."

It's hard to beat that logic, for sure.

The quintet of representatives related that Avastin has proven to be a viable treatment that helps over 17,000 patients manage their disease and "live more productive lives." Further the congressmen feel that the decision to eliminate Avastin is merely based on cost cutting and rationing instead of on any real medical basis. (My bold)

In addition to these facts, patients from all over the country have been sharing their stories in response to the very real threat o being denied further access to this treatment. Many patients have had miraculous results form Avastin and have been living disease-free for years. While there are certain risks associated with taking Avastin, most patients would agree that the biggest risk is the one associated with dying from their disease. We fail to see why this Administration would want to remove a viable treatment option that has the support of thousands of doctors and patients around the country. Limiting access to this treatment is unthinkable and we are struggling to see any justification other than cost.

The United States health care system is unrivaled anywhere else on the globe. Unlike other countries, where agencies like the National Institute for Clinical Excellence (NICE) [NICE is the British health care regulatory system - WTH] frequently deny patients access to treatments deemed not to be cost-effective, our system has provided patients with unparalleled access to innovative, cutting edge medical technologies that have improved the lives of millions of individuals. Perhaps most important, the decision about what course of treatment is best kept between the patient and their health care provider, not a group of bureaucrats whose mission is to contain costs. Nowhere has this been more prevalent than in the area of cancer, where the United States leads the world in survival rates because of a historical commitment to early diagnosis, introduction of innovative treatments, and strong government programs that provide coverage and access to these services. We are concerned that this decision is the beginning of eroding this successful system in a manner that will harm patients in order to save money i a health care system fraught with other inefficiencies that can be addressed without limiting patient choice.

The congressmen are worried that this move will be at the van of a wave of Obamacare-like decisions by government agencies that will threaten the "fundamental pillars of access, physician choice, and innovation that have led us to prominence" in our current health care system. The five wrap up their letter saying, "we express our strong concern that the current Administration is overreaching into the personal health care options of Americans."

It seems that the Avastin decision is the first major example of Obamacare rationing and cost-cutting measures all based on bean counting instead of medicine.

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