by James L. Martin

More than 17,000 women with late-stage breast cancer rely on a drug called Avastin to extend and save their lives.  But the drug may be taken away as a treatment option for most doctors and patients if the Food and Drug Administration (FDA) has its way.  Such a decision would bankrupt families, create a two-tier health care system in the United States, and literally kill women and seniors who are denied access to the drug.  The stakes could not be higher.

Avastin is the first FDA-approved therapy designed to stop the process by which blood vessels feed cancer tumors.  It has become a valuable treatment option for doctors and patients.  Peter Pitts, a former FDA commissioner, has pointed out that  “a clinical trial that took place from December 2001 to May 2004 found that Avastin boosted the amount of time that breast cancer patients lived without the disease spreading or worsening.  The drug, in combination with chemotherapy, delayed tumor growth for about 11 months, which was more than five months longer than chemo alone.  Follow-up studies indicated a less robust response, yet still found an average delay in tumor growth of between one and three months.”  Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston, said, “There is almost certainly a group of women who get a big benefit.”

But now the FDA, by proposing to “de-label” Avastin, is pulling the rug out from under cancer patients.  De-labeling the drug is the bureaucratic process that essentially keeps the drug on the market but requires patients to pay for the drug out of their own pockets.  Once a drug is de-labeled, Medicare and private insurance companies will no longer cover the drug for treatment.

This is a critical distinction.  The FDA apparently believes the drug is plenty safe for those patients who can afford to pay the $90,000 a year out of pocket and thus continue to receive its benefits.  It’s just those who rely on insurance or Medicare that are out of luck.  Families would be faced with the horrifying choice of ending treatment or going bankrupt.  If the FDA is successful in de-labeling the drug, it will create a two-tier health care system—one for the rich and one for everyone else.  So it is evident that the FDA’s actions are based on one simple factor—cost.

That’s because we live in the era of ObamaCare, in which the government has been told it must “bend the cost curve” of health care downward.  The government has one tool in its arsenal to accomplish that goal—rationing of care and treatments for the sick and elderly—and the FDA has taken up the crusade.

The danger of that precedent cannot be understated.  Avastin will be the first, but certainly not the only, drug that will be de-labeled.  If the decision stands, more and more patients will be denied access to critical drugs and treatments as a way to save money.  And of course, seniors, who by the simple fact of being older require more medical services, will take the biggest hit.  It already happens in Great Britain, and now it is happening here.

Patient groups, seniors groups, doctors, and breast cancer patients are protesting the decision but are running up against a bureaucratic wall.  Patients Christi Turnage and Patricia Howard are typical of the “super responders”—who have lived for years because of Avastin—and are aghast at the prospect of losing insurance coverage for the drug.  Turnage has started an online petition to the FDA that has more than 10,000 signatures.  Howard reports that infusions of Avastin every three weeks over the past two years have shrunk tumors in the lining of her lung and eliminated fluid that hampered her breathing.  Now she enjoys shopping and golf, and describes her life as “beyond fabulous.”

Life won’t be fabulous for Howard and millions more Americans if the FDA’s precedent-setting actions are allowed to stand.  Congress must ensure that the drug is not taken away from patients and their doctors.  We cannot allow government to deny patients the treatment options they desperately need.  We cannot turn America’s health care system into a version of the British health care system, in which treatments are routinely rationed because of their costs.

If Congress does not act soon, which member will be willing to step forward and explain why it didn’t to Christie Turnage, Patricia Howard, and thousands others like them?

As published in Human Events