drugs

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

-By Warner Todd Huston

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.

During Breast Cancer Month Obama's FDA Ponders Delisting Cancer Drug

-By Warner Todd Huston

So you have Avastin, a drug used to treat breast cancer that has a record of extending the lives of sufferers for at least five and a half months, and it's October, the month declared Breast Cancer Awareness Month. If you are the Obama Federal Drug Administration, what do you do? Apparently you look to delist the drug.

This October the FDA is trying to decide to delist Avastin because in keeping with its new Obamacare rationing impulses it has decided Avastin costs too much.

In September the FDA announced that it was going to delay its final decision perhaps until December on whether or not to take Avastin off the market for breast cancer patients. There was no clear indication of just when the decision would be made, but conveniently the decision certainly will be delayed until after the coming elections. As a result President Obama won't have to worry about taking a drug away from breast cancer patients in the midst of an election cycle.

The calculation of skipping past the elections is hard to ignore.

Senator David Vitter (R, LA) has pointed out the "rationing" aspect of the whole Avastin debate. In a letter to the FDA Senator Vitter said, “Taking Avastin off-label for breast cancer treatment is essentially government rationing."

Avastin has many fans. One young man even made a video in support of Avastin saying that the drug has helped improve the life of his mother who has been diagnosed as stage 4 metastatic breast cancer.

Christi Turnage has also started a FaceBook page and launched a petition to stay the FDA's rationing hand.

Opponents of the drug say that its track record is not successful enough to justify the costs of the drug and the FDA has citied costs as being one of the reasons that Avastin is about to be delisted.

But in this month of breast cancer awareness month the specter of delisting looms for those that feel the drug works for them. The biggest question here is one of propriety. Is it a good idea that we give government the power to take away drugs that are successful for some people just because its costs too much? Should we give government the power to decide how much is too much to save lives?

This Is Your Brain On Obama

The Onion would be hard pressed to mock Obama’s message of “Hope” better than MoveOn has done, albeit unintentionally. Their newest ad starts by implying that Hope is some form of a sexually transmitted disease, presumably meaning that American’s have been making efforts to avoid “contracting” hopeyness. The end of the ad is even more amusing even somewhat ironic when looked upon through skeptical eyes.

The reference being made to the famous “this is your brain on drugs” commercial sums up the Obama campaign quite nicely. Illegal narcotics thrive in this country because Americans use them as an escape from reality. They become an addiction because of the perception of living a happier life while intoxicated by the drugs affect. As anyone who has experienced withdrawal symptoms will tell you however, when the affect of the drug wears off, you are certainly worse off then when you took it. Your pockets are empty, your depression has worsened, you may even be unemployed, all because a salesman convinced you his product would change your life. While that change did occur, it was a change for the worse you have experienced. This is your brain on Obama, Any Questions?

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