Rationing hope: FDA’s cancer drug ban preview of the future

Grace-Marie Turner's picture

Great Britain’s national health agency late last year reaffirmed its decision to deny the breakthrough drug Avastin to patients with advanced breast cancer. Just days later, the U.S. Food and Drug Administration (FDA) followed suit, denying treatment — and hope — to the 17,500 American breast cancer patients prescribed Avastin each year.

This is a sign of things to come. Under the new health overhaul law, far too many medical decisions will be made by bureaucrats — not doctors and patients.

The British agency was at least open about its decision, saying that “the benefits offered [don’t] justify the cost the NHS is being asked to pay.” The FDA, which only has statutory authority to make decisions based on safety and effectiveness — not cost — said that the drug didn’t provide “a sufficient benefit in slowing disease progression.”

The thousands of women with terminal breast cancer who have lived on months or even years of borrowed time thanks to Avastin would beg to differ.

To government bean counters, Avastin’s $88,000 yearly per-person cost is a very compelling reason to find its benefits insufficient to justify coverage. The ability to see your child graduate from high school or walk down the aisle is the sort of sufficiency that only matters to dying cancer patients, their families, and the doctors who treat them.

And, hope? It has no place in the sterile analysis of rationed healthcare.

Who defines what benefits are “sufficient”? Will it be patients and doctors — as has been the American tradition? Or will it be bureaucrats?

In Britain, the government-heavy model has produced far lower survival rates for breast cancer. Lancet Oncology, the prestigious medical journal, reports that 84 percent of U.S. women live at least five years after breast cancer diagnosis. Only 69 percent of British women survive as long.

Does Avastin have awful side effects? Yes. But, patients and doctors should be the ones to evaluate whether those side effects are a risk worth taking.

Once the FDA finalizes its withdrawal of Avastin for advanced breast cancer, doctors will still be able to prescribe the medicine for “off-label” use.

But off-label prescriptions are rarely covered by Medicare or Medicaid, and private insurers typically take their cues from their public counterparts. Terminal breast cancer patients would have to pay the full cost of the life-saving drug themselves, putting Avastin out-of-reach for all but the wealthiest Americans.

Ironically, the FDA’s decision — as well as the billions in new taxes on pharmaceuticals and the 159-plus new micromanaging bureaucracies in the new health overhaul law — will likely drive up the cost of producing breakthrough medicines.

The average biologic already costs $1.3 billion to develop, test, and bring to market. Genentech says it spent $2.25 billion to develop Avastin. It uses a novel cancer-fighting technology that slows the growth of cancer by cutting off the blood supply to tumors. The FDA approved the drug six years ago for the treatment of colon cancer, and the agency has since approved it to treat other cancers, including for lung and brain.

Avastin is a cautionary tale of what’s to come in our medical future. In years to come, it would practically be financial malpractice for a pharmaceutical CEO to take risks with his shareholders’ money if the government could effectively block access to its new products. American medical research — which has led the world in new discoveries — will shrivel.

An estimated 150,000 American women are living with metastatic breast cancer. These patients — heroes who deal with crippling pain, fatigue, hair-loss, depression, and worse — hope to find a medicine that simply keeps cancer at bay until that next holiday, that next anniversary, or the next medical miracle comes around.

For many women, that treatment is Avastin and the successors that surely will come. As Christi Turnage of Mississippi has said, “this drug is literally keeping me alive.” Julie Heppe of Missouri, who has been taking Avastin for two years, says bluntly, “with every drug, there are severe risks that we are willing to take in exchange for life. I am living with cancer, due to this drug.”

The more government controls health spending, the more control it has to make these top-down decisions. The better solution is a diffused and competitive marketplace where people have other options for coverage, where health plans continue to conduct private comparative effectiveness studies, and where the government is not the central player.

[Grace-Marie Turner is president of the Galen Institute, a non-profit research organization focusing on patient-centered solutions to health reform.]