If you would understand why reform of our medical system is so difficult consider the case of the angiogenesis inhibitor Avastin. The drug had been used in combination with other therapies to treat metastatic breast cancer. “The FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for bevacizumab (Avastin) because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.”
“The FDA based its decision on the results of four clinical trials that showed Avastin, when used in combination with chemotherapy, did not improve overall survival among women with metastatic (spreading) breast cancer. The risks — including high blood pressure; bleeding; holes in the nose, stomach, and intestines; heart attack; and heart failure — were also significant in these studies, according to the FDA.” (This quotation from WebMD)
This action has unleashed an emotional response from usually conservative commentators who have a personal stake in this treatment. If the drug, which is very expensive, is not FDA approved for breast cancer medical insurance will not pay for it. Timothy Riley, who opposes the recently enacted health care legislation, has written a piece that that is an exemplar of the overwrought thinking that makes medical care so expensive. He writes that Avastin is a ‘miracle’. If it were a miracle drug four clinical trials would not have shown it to lack effect on women with metastatic breast cancer.
Patient testimonials about its effectiveness are not evidence no matter how poignant they may be. In fact it is axiomatic that if you need a clinical trial to tell whether a drug works or not the drug in question either doesn’t work or works only at the margin. You don’t need a clinical trial to know that insulin lowers blood sugar, that morphine relieves pain, or that penicillin cures syphilis.
Mr Riley goes on to say that, “Life doesn’t have a price.” Does he really mean this? Even Harry Reid wouldn’t spend $10 trillion to save a single life. I can certainly understand why patients and their families desperate for hope when confronted by a terrible illness will grasp at any purchase. This is the reason that disinterested observers are asked to make decisions about potentially life saving treatments.
Riley goes on to fault the FDA advisory panel for having only two breast cancer oncologists (out of 13) as members. Breast cancer oncologists are expert at treating the disease but are not typically expert at interpreting clinical trials. This expertise belongs to clinical epidemiologists.
Timothy Kalley, in a cri de couer (his wife has been on Avastin for two years) in the National Review Online blames the government for taking this action. While his suffering deserves respect and compassion it cannot be used as justification for spending someone else’s money on an ineffective treatment. Remember that all patients receiving Avastin are receiving multiple therapies. If they are doing well neither they nor their doctors can tell which of these treatments is/are responsible for the positive outcomes. That’s why it’s necessary to do clinical trials and why testimonials are useless.
So how do we cut medical costs? Liberals want to spend more out of generalized compassion while conservatives are OK with cutting costs until they are personally affected. The government is either doing too much or too little depending on your political bias. But all seem to agree that villainy is at the heart of our medical problems. The government and insurance companies are the offenders. There seems to be no exit. If we are going to spend huge amounts of other people’s money on medical treatment there has to be some standard of efficacy that guides our actions.
The FDA’s mandate is to determine the efficacy and safety of medical treatments. According to the best available data Avastin for breast cancer is neither efficacious nor safe. Denying patients access to useless treatment is not the same as rationing effective medical care. Failing to make this distinction makes our ponderously overburdened medical “system” even more difficult to reform.