I spent over 15 years practicing as a trauma and emergency medical specialist. During those years, I learned that many patients -- especially those facing death, imminent limb loss, or another devastating outcome -- are willing to try potentially risky, but cutting-edge interventions, as long as there's a reasonable chance of improving their outcomes.
Indeed, if you're suffering from a life-threatening illness or injury and traditional treatments aren't working, there's nothing to be lost by trying a riskier treatment -- and everything to gain.
Yet, a recent ruling from the Food and Drug Administration eliminates that option for thousands of late-stage breast cancer patients. And, even worse, that decision appears to be part of a broader push to put the government and its regulators between patients and their doctors, and to weigh cost over outcomes.
In December, the FDA rescinded approval for Avastin in the treatment of advanced breast cancer. Initially approved for the disease in 2008, the drug has been shown, when coupled with chemotherapy, to delay tumor growth by a median of 11 months -- almost five months more than chemotherapy alone.
But upon re-evaluating Avastin, FDA officials decided that the drug's potential side effects outweighed its benefits for breast cancer patients and voted to withdraw its approval for that disease.
That decision is now being appealed, but assuming FDA approval for Avastin is withdrawn, public and private insurers will likely scale back their coverage of the drug for breast cancer, leaving these patients to either pick up the drug's $90,000 per-year price tag on their own, or forgo it. Most simply cannot afford it.
People in truly life-or-death situations will take on extra risk for the chance of months or years of additional life. Many advanced breast cancer patients are in exactly such a situation. Conventional treatments haven't worked, and the disease continues to progress. Without action, they can, and will, die quickly.
Avastin won't save all of them; for some, however, it could provide a significant extension of life. Yes, the drug might have some adverse side effects, but shouldn’t the ultimate determinant of that risk be the individual who stands both to benefit or to suffer from that choice? Neither I, as a physician, nor the government, have the right to make that choice for someone else.
The Avastin ruling seems to be driven largely by cost concerns, and public insurance programs no doubt, stand to reap huge savings if they stop paying for the drug for breast cancer.
Unfortunately, the Avastin decision isn't an isolated incident. The Obama administration is pushing rationing, insidious as it may be, on multiple fronts.
Last year, the Agency for Healthcare Research and Quality changed mammography guidelines to tell women they shouldn't get their first exam until age 50. This modified guideline wasn't based on a new study evaluating the effectiveness of mammograms; it was based on an actuarial evaluation indicating that exams for women under 50 didn't have sufficiently high cost-benefit ratios.
In May, the National Institute of Health (NIH) released the results of a comparison study between Avastin and the biological drug, Lucentis, for the treatment of age-related, "wet" macular generation (AMD).
This time, however, the government looks to be coming down in favor of Avastin -- but for the same purpose of blind cost-cutting.
Lucentis is officially approved by the FDA to treat wet AMD, which can cause blindness, while Avastin is not. However, when broken up into small bits and injected into the eye, Avastin has been shown to stop the progress of the disease, and doctors have taken to prescribing it off-label for this purpose.
These two drugs drew the government's attention because of their price difference: A Lucentis regimen for AMD costs about $2,000 per year. A similar course of Avastin clocks in at just $50.
The NIH found that Avastin is "as effective" as Lucentis -- even though 5 percent of patients on Avastin encountered more "serious adverse events" than those on Lucentis. Many fear that the government will use the NIH comparison to influence its public insurance policies. Specifically, officials could impose a "fail first" in Medicare for wet AMD treatment, forcing patients to try Avastin first.
There is a serious danger in such a policy. While these two drugs might be comparable for most wet AMD patients, there is a select group for whom Lucentis works better. Human bodies are amazingly complex and can react to drugs in vastly different ways, for reasons we don't yet understand. If that select group is forced to use less effective Avastin first, their eyesight could be permanently compromised.
In all these cases, the message from the government is clear: we're putting cost savings before human lives and outcomes.
Lowering healthcare costs will require identifying and eliminating wasteful spending and fraud in the system, improving the overall health of Americans, and allowing the free market to create natural cost pressures. But giving breast cancer patients a serious shot at additional years of life isn't a waste. Neither is screening women in their 40s for the disease. Or giving people facing permanent blindness the best options for saving their eyesight.
Our government needs to get out of the doctor's office.
