Highly centralized national health care systems such as the United Kingdom's National Institute for Clinical Excellence and now the U.S. Affordable Care Act, known as Obama care, enforce cost judgments about what types of care are appropriate for the greatest number of people. The British version recently issued statements indicating that it will no longer support licensing applications for eight cancer drugs because of their rare usage by a small number of patients, despite a cancer survival rate half that of the United States.
Following closely in Great Britian's footsteps, the U.S. Food and Drug Administration under Obama care, “at the discretion” of Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, is looking to strip a crucial piece of cancer artillery of its own in early 2011, and the victims will be women — specifically, women with advanced breast cancer.
According to a Dec. 17 Washington Post article, “Federal regulators took the unusual step Thursday of moving to revoke approval of a drug that women with advanced breast cancer turn to in a last-ditch effort to save their lives.” The debate over the cancer drug Avastin, prescribed to about 17,500 women with breast cancer each year, has become mired in the politically volatile struggle over medical spending and effectiveness that flared during the deliberations over health-care reform. The FDA's revocation of Avastin raises serious questions about how the government balances patient protections and controls costs without restricting access to state-of-the-art, and often costly, treatments.
Many have been howling for years for government to keep their hands and laws off their bodies, particularly their private parts. “My body, my life” shout the placards; “Keep your f---ing laws off my body!” screams another. A particular favorite is, “Keep your rosaries off my ovaries,” a sentiment seen scrawled at a political rally attended by a number of presumably Catholic pro-life politicians.
But now our government, which at airports sticks its hands down little Billy's Underoos looking for an explosives belt, seeks to control everyone's bodies through cost-cutting measures implemented by the passing of Obama care, with women suffering late-stage or terminal breast cancer in the first volley.
Avastin, which costs between $4,000 and $8,000 per month, was fast-tracked through the FDA approval process in July 2009 when complaints about the time it takes to get new life-or-death treatments approved reached a zenith. The drug works extremely well for a large number of women whom other treatments have failed.
Avastin is no benign, off-the-shelf concoction — it's a cancer-clobbering juggernaut, part of a new generation of treatments that seek out and destroy only the diseased cells. Avastin has proven effective (when combined with Interferon Alpha) against not only metastatic breast cancer but also other metastatic carcinomas, colorectal and some lung cancers. It is used rarely, and only in very particular circumstances — which makes it outrageously expensive, raising the eyebrows of the FDA.
“It's hard to talk about Avastin without talking about costs,” said Eric Winer, director of the breast oncology center at Boston's Dana-Farber Cancer Institute. “Avastin has become … the poster child of high-priced anti-cancer drugs.”
It's unknown to the general public why cancer drugs such as Avastin, Erbitux ($17,000 per month) and Zevalin ($24,000 per month) are so expensive, because their pricing practices are confidential and protected by Congress — strange bedfellows indeed, especially in light of the FDA's proposal.
The food and drug regulator is prohibited by law from considering costs in its decisions to implement or cut the approval of life-saving drugs. If the agency rescinds approval of Avastin, however, health insurers — who would be forced to classify the drug as experimental — would stop paying for its use. Government providers like Medicare, which pay only for cancer drugs and none other, and Tri-Care would certainly stop covering it, making its prescription an “out-of-pocket” expense, setting the precedent of making the best care available only for the rich who can afford it.
It's unlikely the FDA would even be reviewing Avastin if it weren't for the cost issue. The FDA rarely reconsiders approvals unless deadly contra-indications present themselves. But with overly bureaucratic Obama care regulations and procedures taking hold, cost consideration is now an integral part of the agency's approval process in defiance of its original mission, which is supposed to only rank product safety and effectiveness. High-dollar Cadillac drugs are becoming the first casualties and more will follow, despite President Obama's promises to the contrary.
If the FDA indeed rescinds the coverage of Avastin based on cost, it will be the first step in a politicization of the agency that may render future decisions suspect, and start the slippery slope of health-care rationing that opponents of the Obama mandate warned us about. Regard very cautiously the FDA's mumbled explanations regarding “efficacy,” which will serve only as feeble distractions from the real issue at hand.
Everyone — especially women who resent government entities that attempt to dictate their personal care — should be appalled that government-run American health care will boil down to the same cost vs. care issues so despised of the private insurers and so rampant in the British system. It's a shame those women who need the care most stand to be the first victims of health care rationing.
All the pink ribbons in the world can't take the place of an effective private treatment stripped away by cost-obsessed government bean counters working at “the discretion of the secretary.”
Dale Brumfield is a writer and payroll services broker who lives in Doswell.
Opinions expressed are those of the writer and not necessarily those of Style Weekly.