Drug A is approved by the Food and Drug Administration to treat a disease.

Drug B is not.

Drug A is proven effective to treat a serious disease.

Drug B is not.

Drug A is proven safe.

When Drug B is taken scientists report a higher rate of “serious systematic events” when it is taken.

If you are a government bureaucrat which drug do you recommend a patient take?

If you are an Obama ideologue driven by a desire to limit the cost of health care, you choose Drug B.

This is not a theoretical example but is the new reality of “comparative effectiveness,” a cornerstone of the president’s health care initative where cost trumps everything. The cheaper the cost, the more the government will push a drug despite safety consquences.

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In the days before ObamaCare, there was a clear delineation between the American medical industry and the government.  The industry would invest – often with the assistance of government policy initiatives — in finding cures and the government would ensure the new drugs were safe.  It was a simple equation that worked and helped make American medicine the envy of the world.

Since the election of President Obama and the enactment of his government takeover of our health care system, the emphasis is no longer on finding cures but limiting cost.  In fact, limiting cost is taking precedent over protecting the safety of patients.

The foundation of this effort was laid in the president’s ill-fated stimulus plan.  A provision in the bill set aside over $1 billion for “comparative effectiveness” research – certainly a “shovel ready project” if we every saw one – but that is a debate for a different day.  Betsy McCaughey of the Hudson Institute warned that the provisions “treats health care the way European governments do: as a cost problem instead of a growth industry.” Rep. Charles Boustany Jr., (R-LA) a heart surgeon, warned that it would lead to “denying seniors and the disabled lifesaving care.”  Sen. Jon Kyl (R-AZ) unsuccessfully proposed amendments to bar the federal government from using the research to eliminate treatments for the elderly or deny care based on age.  How right they were.

The National Institute of Health will release their first high profile multi-million study next week to determine whether the drug Avastin (the same drug the Food and Drug Administration is trying to deny to breast cancer patients) can be injected into the eye to combat wet age related macular degeneration instead of the FDA approved drug Lucentis.  Avastin was never approved for this purpose but the cost of Avastin is cheaper than the cost of Lucentis.

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Senator Jon Kyl and a group of Senators – including Sens. Mitch McConnell (Ky.), John Barrasso (R-Wyo.), Tom Coburn (R-Okla.), Mike Crapo (R-Idaho), and Pat Roberts (R-Kan.) have introduced critical legislation that seeks to protect the doctor and patient relationship from the oncoming onslaught of ObamaCare.

Known as the PATIENTS Act, the bill works to protect the individualized relationship between doctors and patients ensuring that new government rules and mandates that put a premium on cost never interfere with the practice of quality medicine.

To better understand how that will happen if ObamaCare is not defunded or repealed, it is critical to understand the nature of “comparative effectiveness research.” In order to save money for the cost of socialist health care regimes, bureaucrats often play the “comparative effectiveness research” card to mandate that doctors provide inferior care and treatment that often does not work.

These studies, for which there is nearly a billion dollars worth of funding in the ObamaCare bill, become the basis of bureaucratic mandates that substitute the government’s judgment for that of a doctor. For instance, if a government study says that drug X is as effective as drug Y (which is cheaper), the government will often begin to deny coverage for drug X forcing the doctor to use drug Y. In some instances, patients only respond to drug X. Doctors and patients should never be forced to take drugs that don’t work. Doctor’s need to be able to make these decisions without interference from a bureaucrat. That is what the Kyl bill seeks.

This is not a theoretical argument any longer.

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It’s hard not to imagine that some bureaucrats that the National Institute’s of Health were not thinking of Robert Burns’ “best laid plans of mice and men” when they heard the results of a recent “comparative effectiveness” study of the drugs Lucentis and Avastin.

“Comparative effectiveness” studies are the shoehorn for government interference between the doctor/patient relationship. These studies allow bureaucrats to dictate health care decisions that should be made by doctors by determining that certain drugs or treatments are comparable and the cheaper drug becomes the one the government covers for treatment. The ObamaCare takeover of our health care system appropriated nearly $1 billion for these studies.

The National Institute for Health (NIH) initiated a study into the “comparative effectiveness” of the drugs Lucentis and Avastin – both made by the same manufacture. The basis of the study was to determine whether Avastin could be used as a substitute for Lucentis when treated macular degeneration. Avastin was never approved by the FDA for macular degeneration while Lucentis was tried, tested and approved for such purpose.

The initial test results showed the danger of such a strategy.

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Senator Jon Kyl (R-AZ) has introduced critical legislation that aims to stem the coming tide of rationing of America’s health care services. The PATIENT’s Act will ensure doctors and patients have the final say about medical treatment and new ObamaCare created “comparative effectiveness research” will not put a government created barrier to better treatment.

On the surface, there is nothing inherently wrong with “comparative effectiveness research.” Advocates believe it will save the taxpayers money by studying whether alternative and cheaper treatments are just as effective as currently prescribed methods of treatment. ObamaCare appropriated nearly $1 billion for such studies.

The problem, however, is when government takes that research and mandates a “one-size-fits-all” health care regimen that does not fit every patient . And with government mandated to reduce the cost of health care, these studies will assuredly become the intellectual justification of rationing. Here’s why.

Doctors have a unique relationship with their patients. They know how they respond to treatments. Government bureaucrats do not know, and frankly do not care, how an individual responds. They care about the big picture – the bottom line. If they can show cost savings by swapping a drug, they will do it. That appears to be happening with the drugs Lucentis and Avastin.

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As breast cancer patients anxiously await a June Food and Drug Administration (FDA) hearing to determine whether they will continue to have access to the life-saving drug Avastin, members of Congress are standing up for patients. Most notably Sen. David Vitter in the Senate and Rep. Kay Granger in the House, and now Rep. Alan Nunnelee, have recognized the dangerous precedent of the Avastin case. Including costs in the evaluation process will limit access of drugs to patients, interfere with the doctor/patient relationship and start American down the road to rationing.

Avastin is an (expensive) anti-cancer drug that has been proven to extend the life of patients. Some unfortunately do not see great gains – perhaps only a few months – while others live for years, crediting the drug for their survival. The FDA is attempting to “de-label” the drug, meaning the drug would be available if you could afford to pay for the drug out of your own pocket. Insurance and Medicare would no longer assist patients in paying for the drug.

At a House Appropriations Subcommittee hearing, Granger raised her concerns about the pending Avastin decision directly to the Secretary of Health and Human Services, Kathleen Sebelius. Granger pointed out that patients and doctors in her district have alerted her to the decision and believe having the Avastin option is a critical tool in fighting breast cancer. Granger pressed Sebelius to assure seniors that Medicare would continue to allow doctors the choice of prescribing Avastin and cover its costs. Sebelius could not or would not. Should the FDA move forward, cancer patients will be on their own – the first victims of the effort to “bend the health care cost curve.”

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